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  <FMTR>
    <TITLEPG>
      <CODE>CODE OF FEDERAL REGULATIONS32</CODE>
      <SUBJECT>National Defense<PRTPAGE P="1"/>
      </SUBJECT>
      <PARTS>PARTS 191 TO 399</PARTS>
      <REVISED>Revised as of July 1, 1999</REVISED>
      <CONTAINS/>
    </TITLEPG>
  </FMTR>
  <P>CONTAINING</P>
  <P>A CODIFICATION OF DOCUMENTS</P>
  <P>OF GENERAL APPLICABILITY</P>
  <P>AND FUTURE EFFECT</P>
  <DATE>AS OF JULY 1, 1999</DATE>
  <ANCIL>With Ancillaries</ANCIL>
  <PUB>
    <P>Published by</P>
    <P>the Office of the Federal Register</P>
    <P>National Archives and Records</P>
    <P>Administration</P>
  </PUB>
  <SPECED/>
  <P>as a Special Edition of</P>
  <P>the Federal Register</P>
  <BTITLE>
    <PRTPAGE P="?ii"/>
    <GPO>U.S. GOVERNMENT PRINTING OFFICE</GPO>
    <CITY>WASHINGTON : 1999</CITY>
    <FORSALE>
      <P>For sale by U.S. Government Printing Office</P>
      <P>Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328</P>
    </FORSALE>
  </BTITLE>
  <TOC>
    <PRTPAGE P="iii"/>
    <HD SOURCE="HED">Table of Contents</HD>
    <PGHD>Page</PGHD>
    <EXPL>
      <SUBJECT>Explanation</SUBJECT>
      <PG>v</PG>
    </EXPL>
    <TITLENO>
      <HD SOURCE="HED">Title 32:</HD>
      <SUBTI>
        <HD SOURCE="HED">Subtitle A—Department of Defense (Continued):</HD>
      </SUBTI>
      <CHAPTI>
        <SUBJECT>Chapter I—Office of the Secretary of Defense (Continued)</SUBJECT>
        <PG>5</PG>
      </CHAPTI>
    </TITLENO>
    <FAIDS>
      <HD SOURCE="HED">Finding Aids:</HD>
      <SUBJECT>Table of CFR Titles and Chapters</SUBJECT>
      <PG>1097</PG>
      <SUBJECT>Alphabetical List of Agencies Appearing in the CFR</SUBJECT>
      <PG>1115</PG>
      <SUBJECT>List of CFR Sections Affected</SUBJECT>
      <PG>1125</PG>
    </FAIDS>
  </TOC>
  <CITE>
    <PRTPAGE P="iv"/>
    <P>Cite this Code:<E T="01">CFR</E>
    </P>

    <CITEP>To cite the regulations in this volume use title, part and section number. Thus, <E T="01"> 32 CFR 191.1</E> refers to title 32, part 191, section 1.</CITEP>
  </CITE>
  <EXPLA>
    <PRTPAGE P="v"/>
    <HD SOURCE="HED">Explanation</HD>
    <P>The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.</P>
    <P>Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:</P>
    <IPAR>
      <P SOURCE="P1">Title 1 through Title 16 </P>
      <STUB>as of January 1</STUB>
      <P SOURCE="P1">Title 17 through Title 27 </P>
      <STUB>as of April 1</STUB>
      <P SOURCE="P1">Title 28 through Title 41 </P>
      <STUB>as of July 1</STUB>
      <P SOURCE="P1">Title 42 through Title 50 </P>
      <STUB>as of October 1</STUB>
    </IPAR>
    <P>The appropriate revision date is printed on the cover of each volume.</P>
    <SIDEHED>
      <HD SOURCE="HED">LEGAL STATUS</HD>
      <P>The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510).</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">HOW TO USE THE CODE OF FEDERAL REGULATIONS</HD>
      <P>The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule.</P>
      <P>To determine whether a Code volume has been amended since its revision date (in this case, July 1, 1999), consult the “List of CFR Sections Affected (LSA),” which is issued monthly, and the “Cumulative List of Parts Affected,” which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">EFFECTIVE AND EXPIRATION DATES</HD>
      <P>Each volume of the Code contains amendments published in the Federal Register since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut-off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">OMB CONTROL NUMBERS</HD>

      <P>The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agencies to display an OMB control number with their information collection request. <PRTPAGE P="vi"/>Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">OBSOLETE PROVISIONS</HD>
      <P>Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before January 1, 1986, consult either the List of CFR Sections Affected, 1949-1963, 1964-1972, or 1973-1985, published in seven separate volumes. For the period beginning January 1, 1986, a “List of CFR Sections Affected” is published at the end of each CFR volume.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">CFR INDEXES AND TABULAR GUIDES</HD>

      <P>A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR <E T="04">Index and Finding Aids.</E> This volume contains the Parallel Table of Statutory Authorities and Agency Rules (Table I). A list of CFR titles, chapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.</P>
      <P>An index to the text of “Title 3—The President” is carried within that volume.</P>
      <P>The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the “Contents” entries in the daily Federal Register.</P>
      <P>A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">REPUBLICATION OF MATERIAL</HD>
      <P>There are no restrictions on the republication of material appearing in the Code of Federal Regulations.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">INQUIRIES</HD>
      <P>For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency's name appears at the top of odd-numbered pages.</P>
      <P>For inquiries concerning CFR reference assistance, call 202-523-5227 or write to the Director, Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408 or e-mail info@fedreg.nara.gov.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">SALES</HD>
      <P>The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. For GPO Customer Service call 202-512-1803.</P>
    </SIDEHED>
    <SIDEHED>
      <HD SOURCE="HED">ELECTRONIC SERVICES</HD>
      <P>The full text of the Code of Federal Regulations, The United States Government Manual, the Federal Register, Public Laws, Weekly Compilation of Presidential Documents and the Privacy Act Compilation are available in electronic format at www.access.gpo.gov/nara (“GPO Access”). For more information, contact Electronic Information Dissemination Services, U.S. Government Printing Office. Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, gpoaccess@gpo.gov.</P>

      <P>The Office of the Federal Register also offers a free service on the National Archives and Records Administration's (NARA) World Wide Web site for public <PRTPAGE P="vii"/>law numbers, Federal Register finding aids, and related information.  Connect to NARA's web site at www.nara.gov/fedreg. The NARA site also contains links to GPO Access.</P>
    </SIDEHED>
    <SIG>
      <NAME>Raymond A. Mosley,</NAME>
      <POSITION>Director,</POSITION>
      <OFFICE>Office of the Federal Register.</OFFICE>
    </SIG>
    <DATE>July 1, 1999.</DATE>
  </EXPLA>
  <THISTITL>
    <PRTPAGE P="ix"/>
    <HD SOURCE="HED">THIS TITLE</HD>
    <P>Title 32—<E T="04">National Defense</E> is composed of six volumes. The parts in these volumes are arranged in the following order: parts 1-190, parts 191-399, parts 400-629, parts 630-699, parts 700-799, and part 800 to end. The contents of these volumes represent all current regulations codified under this title of the CFR as of July 1, 1999.</P>
    <P>The current regulations issued by the Department of Defense appear in the volumes containing parts 1-190 and parts 191-399; those issued by the Department of the Army appear in the volumes containing parts 400-629 and parts 630-699; those issued by the Department of the Navy appear in the volume containing parts 700-799, and those issued by the Department of the Air Force, Defense Logistics Agency, Selective Service System, Central Intelligence Agency, Information Security Oversight Office, National Security Council, Office of Science and Technology Policy, Office for Micronesian Status Negotiations, Office of the Vice President of the United States, and Presidential Commission on the Assignment of Women in the Armed Forces appear in the volume containing part 800 to end.</P>
    <P>For this volume, Shelley C. Featherson was Chief Editor. The Code of Federal Regulations is published under the direction of Frances D. McDonald, assisted by Alomha S. Morris.</P>
    <GPH DEEP="544" SPAN="1">
      <PRTPAGE P="x"/>
      <GID>CFRORDR.FRM</GID>
    </GPH>
  </THISTITL>
  <TITLE>
    <CFRTITLE>
      <LRH>32 CFR Ch. I (7-1-99 Edition)</LRH>
      <RRH>Office of the Secretary of Defense</RRH>
      <TITLEHD>
        <PRTPAGE P="1"/>
        <HD SOURCE="HED">Title 32—National Defense</HD>
        <P>(This volume contains parts 191 to 399) </P>
      </TITLEHD>
      <CFRTOC>
        <PTHD>Part</PTHD>
        <SUBTI>
          <HD SOURCE="HED">SUBTITLE A—Department of Defense (Continued):</HD>
        </SUBTI>
        <CHAPTI>
          <SUBJECT>
            <E T="04">Chapter I</E>—Office of the Secretary of Defense (Continued)</SUBJECT>
          <PG>191</PG>
        </CHAPTI>
      </CFRTOC>
      <LRH>32 CFR Ch. I (7-1-99 Edition)</LRH>
      <RRH>Office of the Secretary of Defense</RRH>
    </CFRTITLE>
    <SUBTITLE>
      <PRTPAGE P="3"/>
      <HD SOURCE="HED">Subtitle A—Department of </HD>
      <HD SOURCE="HED">Defense (Continued)</HD>
      <TOC/>
    </SUBTITLE>
    <LRH>32 CFR Ch. I (7-1-99 Edition)</LRH>
    <RRH>Office of the Secretary of Defense</RRH>
    <CHAPTER>
      <TOC>
        <TOCHD>
          <PRTPAGE P="5"/>
          <HD SOURCE="HED">CHAPTER I—OFFICE OF THE SECRETARY OF DEFENSE </HD>
          <HD SOURCE="HED">(CONTINUED) </HD>
        </TOCHD>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER M—MISCELLANEOUS</HD>
        </SUBCHAP>
        <PTHD>Part</PTHD>
        <PGHD>Page</PGHD>
        <CHAPTI>
          <PT>191</PT>
          <SUBJECT>The DOD Civilian Equal Employment Opportunity (EEO) Program</SUBJECT>
          <PG>11</PG>
          <PT>192</PT>
          <SUBJECT>Equal opportunity in off-base housing</SUBJECT>
          <PG>18</PG>
          <PT>193</PT>
          <SUBJECT>Highways for national defense</SUBJECT>
          <PG>26</PG>
          <PT>194</PT>
          <SUBJECT>International co-production projects and agreements between the United States and other countries or international organizations</SUBJECT>
          <PG>28</PG>
          <PT>195</PT>
          <SUBJECT>Nondiscrimination in Federally assisted programs of the Department of Defense—Effectuation of Title VI of the Civil Rights Act of 1964</SUBJECT>
          <PG>30</PG>
          <PT>196</PT>
          <RESERVED>[Reserved]</RESERVED>
          <PT>199</PT>
          <SUBJECT>Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)</SUBJECT>
          <PG>41</PG>
          <PT>203</PT>
          <SUBJECT>Technical Assistance for Public Participation (TAPP) in defense environmental restoration activities</SUBJECT>
          <PG>315</PG>
          <PT>204</PT>
          <SUBJECT>User charges</SUBJECT>
          <PG>325</PG>
          <PT>205</PT>
          <SUBJECT>End use certificates (EUCs)</SUBJECT>
          <PG>332</PG>
          <PT>206</PT>
          <SUBJECT>National Security Education Program (NSEP) grants to institutions of higher education</SUBJECT>
          <PG>334</PG>
          <PT>207-209</PT>
          <RESERVED>[Reserved]</RESERVED>
          <PT>210</PT>
          <SUBJECT>Enforcement of State traffic laws on DoD installations</SUBJECT>
          <PG>340</PG>
          <PT>211</PT>
          <SUBJECT>DoD Foreign Tax Relief Program</SUBJECT>
          <PG>341</PG>
          <PT>212</PT>
          <SUBJECT>Private organizations on DoD installations</SUBJECT>
          <PG>344</PG>
          <PT>215</PT>
          <SUBJECT>Employment of military resources in the event of civil disturbances</SUBJECT>
          <PG>347</PG>
          <PT>216</PT>
          <SUBJECT>Military Recruiting and Reserve Officer Training Corps Program access to institutions of higher education</SUBJECT>
          <PG>354<PRTPAGE P="6"/>
          </PG>
          <PT>218</PT>
          <SUBJECT>Guidance for the determination and reporting of nuclear radiation dose for DoD participants in the atmospheric nuclear test program (1945-1962)</SUBJECT>
          <PG>359</PG>
          <PT>219</PT>
          <SUBJECT>Protection of human subjects</SUBJECT>
          <PG>364</PG>
          <PT>220</PT>
          <SUBJECT>Collection from third party payers of reasonable costs of healthcare services</SUBJECT>
          <PG>375</PG>
          <PT>221</PT>
          <SUBJECT>Department of Defense participation in the National Practitioner Data Bank (NPDB)</SUBJECT>
          <PG>385</PG>
          <PT>223</PT>
          <SUBJECT>Department of Defense Unclassified Controlled Nuclear Information (DoD UCNI)</SUBJECT>
          <PG>387</PG>
          <PT>224</PT>
          <SUBJECT>DoD Committee Management Program</SUBJECT>
          <PG>394</PG>
          <PT>226</PT>
          <SUBJECT>Shelter for the homeless</SUBJECT>
          <PG>396</PG>
          <PT>228</PT>
          <SUBJECT>Security Protective Force</SUBJECT>
          <PG>398</PG>
          <PT>229</PT>
          <SUBJECT>Protection of archaeological resources: uniform regulations</SUBJECT>
          <PG>400</PG>
          <PT>230</PT>
          <SUBJECT>Procedures governing banking offices on DoD installations</SUBJECT>
          <PG>414</PG>
          <PT>231</PT>
          <SUBJECT>Financial institutions on DoD installations</SUBJECT>
          <PG>425</PG>
          <PT>231a</PT>
          <SUBJECT>Procedures governing credit unions on DoD installations</SUBJECT>
          <PG>431</PG>
          <PT>234</PT>
          <SUBJECT>Conduct on the Pentagon Reservation</SUBJECT>
          <PG>440</PG>
          <PT>235</PT>
          <SUBJECT>Sale or rental of sexually explicit material on DoD property</SUBJECT>
          <PG>445</PG>
          <PT>237a</PT>
          <SUBJECT>Public affairs liaison with industry</SUBJECT>
          <PG>447</PG>
          <PT>238</PT>
          <SUBJECT>Armed Forces community relations</SUBJECT>
          <PG>449</PG>
          <PT>239</PT>
          <SUBJECT>Homeowners Assistance Program—application processing</SUBJECT>
          <PG>473</PG>
          <PT>240</PT>
          <SUBJECT>Criteria and procedures for providing assistance to local educational agencies</SUBJECT>
          <PG>481</PG>
          <PT>242</PT>
          <SUBJECT>Admission policies and procedures for the School of Medicine, Uniformed Services University of the Health Sciences</SUBJECT>
          <PG>484</PG>
          <PT>242a</PT>
          <SUBJECT>Public meeting procedures of the Board of Regents, Uniformed Services University of the Health Sciences</SUBJECT>
          <PG>489</PG>
          <PT>242b</PT>
          <SUBJECT>General procedures and delegations of the Board of Regents of the Uniformed Services University of the Health Sciences</SUBJECT>
          <PG>494</PG>
          <PT>243</PT>
          <SUBJECT>Intergovernmental coordination of DoD Federal development programs and activities</SUBJECT>
          <PG>498</PG>
          <PT>245</PT>
          <SUBJECT>Plan for the security control of air traffic and air navigation aids (short title: SCATANA)</SUBJECT>
          <PG>500</PG>
          <PT>246</PT>
          <SUBJECT>Stars and Stripes (S&amp;S) newspaper and business operations</SUBJECT>
          <PG>511</PG>
          <PT>247</PT>
          <SUBJECT>Department of Defense newspapers, magazines and Civilian Enterprise publications</SUBJECT>
          <PG>524</PG>
          <PT>248</PT>
          <SUBJECT>Department of Defense periodicals</SUBJECT>
          <PG>543<PRTPAGE P="7"/>
          </PG>
          <PT>249</PT>
          <SUBJECT>Presentation of DoD-related scientific and technical papers at meetings</SUBJECT>
          <PG>545</PG>
          <PT>250</PT>
          <SUBJECT>Withholding of unclassified technical data from public disclosure</SUBJECT>
          <PG>550</PG>
          <PT>252</PT>
          <SUBJECT>Department of Defense offshore military activities program</SUBJECT>
          <PG>558</PG>
          <PT>253</PT>
          <SUBJECT>Assignment of American National Red Cross and United Service Organizations, Inc., employees to duty with the Military Services</SUBJECT>
          <PG>560</PG>
          <PT>254</PT>
          <SUBJECT>Teacher and Teacher's Aide Placement Assistance Program</SUBJECT>
          <PG>561</PG>
          <PT>256</PT>
          <SUBJECT>Air installations compatible use zones</SUBJECT>
          <PG>566</PG>
          <PT>257</PT>
          <SUBJECT>Acceptance of service of process</SUBJECT>
          <PG>574</PG>
          <PT>258</PT>
          <SUBJECT>Cooperation with allies in research and development of defense equipment</SUBJECT>
          <PG>575</PG>
          <PT>259</PT>
          <SUBJECT>Uniform relocation assistance and real property acquisition for Federal and federally-assisted programs</SUBJECT>
          <PG>577</PG>
          <PT>260</PT>
          <SUBJECT>Vending facility program for the blind on Federal property</SUBJECT>
          <PG>577</PG>
          <PT>261</PT>
          <SUBJECT>Armed Services military club and package stores</SUBJECT>
          <PG>583</PG>
          <PT>263</PT>
          <SUBJECT>Traffic and vehicle control on certain Defense Mapping Agency sites</SUBJECT>
          <PG>585</PG>
          <PT>264</PT>
          <SUBJECT>International interchange of patent rights and technical information</SUBJECT>
          <PG>586</PG>
          <PT>266</PT>
          <SUBJECT>Audits of State and local governments, institutions of higher education, and other nonprofit institutions</SUBJECT>
          <PG>589</PG>
          <PT>268</PT>
          <SUBJECT>Collecting and reporting of foreign indebtedness within the Department of Defense</SUBJECT>
          <PG>592</PG>
          <PT>269</PT>
          <SUBJECT>Civil monetary penalty inflation adjustment</SUBJECT>
          <PG>595</PG>
          <PT>270</PT>
          <SUBJECT>Compensation of certain former operatives incarcerated by the Democratic Republic of Vietnam</SUBJECT>
          <PG>596</PG>
          <PT>271</PT>
          <SUBJECT>Obtaining information from financial institutions</SUBJECT>
          <PG>609</PG>
          <PT>272</PT>
          <SUBJECT>Administration and support of basic research by the DoD</SUBJECT>
          <PG>611</PG>
          <PT>274</PT>
          <SUBJECT>Regulations governing competitive bidding on U.S. Government guaranteed military export loan agreements</SUBJECT>
          <PG>612</PG>
          <PT>275</PT>
          <SUBJECT>Obtaining information from financial institutions: Rights to Financial Privacy Act of 1978</SUBJECT>
          <PG>614</PG>
          <PT>277</PT>
          <SUBJECT>Implementation of the Program Fraud Civil Remedies Act</SUBJECT>
          <PG>622</PG>
        </CHAPTI>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER N—FREEDOM OF INFORMATION ACT PROGRAM</HD>
        </SUBCHAP>
        <CHAPTI>
          <PT>285</PT>
          <SUBJECT>DOD Freedom of Information Act (FOIA) Program</SUBJECT>
          <PG>637<PRTPAGE P="8"/>
          </PG>
          <PT>286</PT>
          <SUBJECT>DoD Freedom of Information Act Program Regulation</SUBJECT>
          <PG>638</PG>
          <PT>286h</PT>
          <SUBJECT>Release of Acquisition-Related Information</SUBJECT>
          <PG>692</PG>
          <PT>287</PT>
          <SUBJECT>Defense Information Systems Agency (DISA) Freedom of Information Act Program</SUBJECT>
          <PG>695</PG>
          <PT>290</PT>
          <SUBJECT>Defense Contract Audit Agency (DCAA) Freedom of Information Act Program</SUBJECT>
          <PG>697</PG>
          <PT>291</PT>
          <SUBJECT>Defense Nuclear Agency (DNA) Freedom of Information Act Program</SUBJECT>
          <PG>711</PG>
          <PT>292</PT>
          <SUBJECT>Defense Intelligence Agency (DIA) Freedom of Information Act</SUBJECT>
          <PG>726</PG>
          <PT>293</PT>
          <SUBJECT>Defense Mapping Agency (DMA) Freedom of Information Act Program</SUBJECT>
          <PG>731</PG>
          <PT>295</PT>
          <SUBJECT>Office of the Inspector General, Freedom of Information Act Program</SUBJECT>
          <PG>737</PG>
          <PT>296</PT>
          <SUBJECT>National Reconnaissance Office Freedom of Information Act Program regulation</SUBJECT>
          <PG>757</PG>
          <PT>298</PT>
          <SUBJECT>Defense Investigative Service (DIS) Freedom of Information Act Program</SUBJECT>
          <PG>759</PG>
          <PT>299</PT>
          <SUBJECT>National Security Agency (NSA) Freedom of Information Act Program</SUBJECT>
          <PG>761</PG>
        </CHAPTI>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER O—PRIVACY PROGRAM</HD>
        </SUBCHAP>
        <CHAPTI>
          <PT>310</PT>
          <SUBJECT>DoD Privacy Program</SUBJECT>
          <PG>763</PG>
          <PT>311</PT>
          <SUBJECT>OSD Privacy Program</SUBJECT>
          <PG>815</PG>
          <PT>312</PT>
          <SUBJECT>Office of the Inspector General (OIG) Privacy Program</SUBJECT>
          <PG>822</PG>
          <PT>313</PT>
          <SUBJECT>The Chairman of the Joint Chiefs of Staff and the Joint Staff Privacy Program</SUBJECT>
          <PG>828</PG>
          <PT>314</PT>
          <SUBJECT>Defense Advanced Research Projects Agency, Privacy Act of 1974</SUBJECT>
          <PG>828</PG>
          <PT>315</PT>
          <SUBJECT>Uniformed Services University of Health Sciences, Privacy Act of 1974</SUBJECT>
          <PG>829</PG>
          <PT>316</PT>
          <SUBJECT>Defense Information Systems Agency Privacy Program</SUBJECT>
          <PG>829</PG>
          <PT>317</PT>
          <SUBJECT>Defense Contract Audit Agency Privacy Act Program</SUBJECT>
          <PG>833</PG>
          <PT>318</PT>
          <SUBJECT>Defense Threat Reduction Agency (DTRA)</SUBJECT>
          <PG>880</PG>
          <PT>319</PT>
          <SUBJECT>Defense Intelligence Agency Privacy Program</SUBJECT>
          <PG>885</PG>
          <PT>320</PT>
          <SUBJECT>National Imagery and Mapping Agency (NIMA) Privacy Program</SUBJECT>
          <PG>889</PG>
          <PT>321</PT>
          <SUBJECT>Defense Investigative Service, Privacy Act of 1974</SUBJECT>
          <PG>895</PG>
          <PT>322</PT>
          <SUBJECT>Privacy Act systems of records—disclosures and amendment procedures—specific exemptions, National Security Agency</SUBJECT>
          <PG>907</PG>
          <PT>323</PT>
          <SUBJECT>Defense Logistics Agency Privacy Program</SUBJECT>
          <PG>915<PRTPAGE P="9"/>
          </PG>
          <PT>324</PT>
          <SUBJECT>DFAS Privacy Act Program</SUBJECT>
          <PG>940</PG>
        </CHAPTI>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER P—OBTAINING DOD INFORMATION</HD>
        </SUBCHAP>
        <CHAPTI>
          <PT>336</PT>
          <SUBJECT>Publications of proposed and adopted regulations affecting the public</SUBJECT>
          <PG>949</PG>
          <PT>337</PT>
          <SUBJECT>Availability of DoD directives, DoD instructions, DoD publications, and changes</SUBJECT>
          <PG>952</PG>
          <PT>338</PT>
          <SUBJECT>Availability to the public of Defense Nuclear Agency (DNA) instructions and changes thereto</SUBJECT>
          <PG>952</PG>
        </CHAPTI>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER Q[RESERVED]</HD>
        </SUBCHAP>
        <SUBCHAP>
          <HD SOURCE="HED">SUBCHAPTER R—ORGANIZATIONAL CHARTERS</HD>
        </SUBCHAP>
        <CHAPTI>
          <PT>342</PT>
          <SUBJECT>Department of Defense Civilian Personnel Management Service</SUBJECT>
          <PG>954</PG>
          <PT>343</PT>
          <SUBJECT>Under Secretary of Defense for Personnel and Readiness (USD(P&amp;R))</SUBJECT>
          <PG>956</PG>
          <PT>344</PT>
          <SUBJECT>Assistant Secretary of Defense for Reserve Affairs (ASD(RA))</SUBJECT>
          <PG>959</PG>
          <PT>345</PT>
          <SUBJECT>Department of Defense section 6 schools</SUBJECT>
          <PG>961</PG>
          <PT>346</PT>
          <SUBJECT>Department of Defense education activity</SUBJECT>
          <PG>964</PG>
          <PT>347</PT>
          <SUBJECT>Department of Defense Dependents Schools (DoDDS)</SUBJECT>
          <PG>966</PG>
          <PT>348</PT>
          <SUBJECT>Defense Medical Programs Activity (DMPA)</SUBJECT>
          <PG>970</PG>
          <PT>350</PT>
          <SUBJECT>Assistant Secretary of Defense for Command, Control, Communications, and Intelligence (ASD(C31))</SUBJECT>
          <PG>972</PG>
          <PT>352a</PT>
          <SUBJECT>Defense Finance and Accounting Service (DFAS)</SUBJECT>
          <PG>975</PG>
          <PT>353</PT>
          <SUBJECT>Assistant Secretary of Defense (Legislative Affairs)</SUBJECT>
          <PG>978</PG>
          <PT>362</PT>
          <SUBJECT>Defense Information Systems Agency (DISA)</SUBJECT>
          <PG>979</PG>
          <PT>363</PT>
          <SUBJECT>Defense Security Assistance Agency</SUBJECT>
          <PG>987</PG>
          <PT>364</PT>
          <SUBJECT>Washington Headquarters Services</SUBJECT>
          <PG>989</PG>
          <PT>365</PT>
          <SUBJECT>Office of Economic Adjustment</SUBJECT>
          <PG>993</PG>
          <PT>366</PT>
          <SUBJECT>Assistant Secretary of Defense (Program Analysis and Evaluation)</SUBJECT>
          <PG>995</PG>
          <PT>367</PT>
          <SUBJECT>Assistant Secretary of Defense for Health Affairs</SUBJECT>
          <PG>997</PG>
          <PT>367a</PT>
          <SUBJECT>Uniformed Services University of the Health Sciences (USUHS)</SUBJECT>
          <PG>999</PG>
          <PT>368</PT>
          <SUBJECT>Functions of the Department of Defense and its major components</SUBJECT>
          <PG>1003</PG>
          <PT>369</PT>
          <SUBJECT>Principal Deputy Under Secretary of Defense for Acquisition and Technology (PDUSD(A&amp;T))</SUBJECT>
          <PG>1016</PG>
          <PT>370</PT>
          <SUBJECT>DoD Health Council</SUBJECT>
          <PG>1016</PG>
          <PT>371</PT>
          <SUBJECT>Defense Prisoner of War/Missing in Action Office (DPMO)</SUBJECT>
          <PG>1019</PG>
          <PT>373</PT>
          <SUBJECT>Inspector General of the Department of Defense</SUBJECT>
          <PG>1020<PRTPAGE P="10"/>
          </PG>
          <PT>376</PT>
          <SUBJECT>Department of Defense Support Activities (DSAs)</SUBJECT>
          <PG>1025</PG>
          <PT>377</PT>
          <SUBJECT>Defense Investigative Service (DIS)</SUBJECT>
          <PG>1028</PG>
          <PT>378</PT>
          <SUBJECT>Assistant to the Secretary of Defense for Intelligence Oversight (ATSD(IO))</SUBJECT>
          <PG>1032</PG>
          <PT>380</PT>
          <SUBJECT>Director of Operational Test and Evaluation</SUBJECT>
          <PG>1034</PG>
          <PT>381</PT>
          <SUBJECT>Defense Nuclear Agency</SUBJECT>
          <PG>1037</PG>
          <PT>382</PT>
          <SUBJECT>Under Secretary of Defense (Acquisition)</SUBJECT>
          <PG>1042</PG>
          <PT>383a</PT>
          <SUBJECT>Defense Commissary Agency (DeCA)</SUBJECT>
          <PG>1049</PG>
          <PT>384</PT>
          <SUBJECT>Under Secretary of Defense for Acquisition and Technology</SUBJECT>
          <PG>1053</PG>
          <PT>385</PT>
          <SUBJECT>Defense Intelligence Agency</SUBJECT>
          <PG>1058</PG>
          <PT>386</PT>
          <SUBJECT>Central Imagery Office</SUBJECT>
          <PG>1063</PG>
          <PT>387</PT>
          <SUBJECT>Defense Contract Audit Agency</SUBJECT>
          <PG>1066</PG>
          <PT>388</PT>
          <SUBJECT>Ballistic Missile Defense Organization (BMDO)</SUBJECT>
          <PG>1069</PG>
          <PT>390</PT>
          <SUBJECT>Armed Forces Radiobiology Research Institute</SUBJECT>
          <PG>1074</PG>
          <PT>391</PT>
          <SUBJECT>Director of Administration and Management</SUBJECT>
          <PG>1077</PG>
          <PT>392</PT>
          <SUBJECT>Director of Small and Disadvantaged Business Utilization</SUBJECT>
          <PG>1078</PG>
          <PT>394</PT>
          <SUBJECT>General Counsel of the Department of Defense</SUBJECT>
          <PG>1080</PG>
          <PT>395</PT>
          <SUBJECT>Defense Legal Services Agency</SUBJECT>
          <PG>1081</PG>
          <PT>396</PT>
          <SUBJECT>DoD coordinator for drug enforcement policy and support</SUBJECT>
          <PG>1083</PG>
          <PT>398</PT>
          <SUBJECT>Defense Logistics Agency (DLA)</SUBJECT>
          <PG>1084</PG>
          <PT>399</PT>
          <SUBJECT>Defense Mapping Agency (DMA)</SUBJECT>
          <PG>1089</PG>
        </CHAPTI>
      </TOC>
      <LRH>32 CFR Ch. I (7-1-99 Edition)</LRH>
      <RRH>Office of the Secretary of Defense</RRH>
      <SUBCHAP TYPE="N">
        <PRTPAGE P="11"/>
        <HD SOURCE="HED">SUBCHAPTER M—MISCELLANEOUS</HD>
        <PART>
          <EAR>Pt. 191</EAR>
          <HD SOURCE="HED">PART 191—THE DOD CIVILIAN EQUAL EMPLOYMENT OPPORTUNITY (EEO) PROGRAM</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>191.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <SECTNO>191.2</SECTNO>
            <SUBJECT>Applicability and scope.</SUBJECT>
            <SECTNO>191.3</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <SECTNO>191.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <SECTNO>191.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <SECTNO>191.6</SECTNO>
            <SUBJECT>Procedures.</SUBJECT>
            <SECTNO>191.7</SECTNO>
            <SUBJECT>Civilian EEO program staff.</SUBJECT>
            <SECTNO>191.8</SECTNO>
            <SUBJECT>Defense equal opportunity council and EEO boards.</SUBJECT>
            <SECTNO>191.9</SECTNO>
            <SUBJECT>Information requirements.</SUBJECT>
            <SECTNO>191.10</SECTNO>
            <SUBJECT>Effective date.</SUBJECT>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 301, 10 U.S.C. 113.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>53 FR 30990, Aug. 17, 1988, unless otherwise noted.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 191.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <P>This part:</P>
            <P>(a) Implements the DoD Humans Goals Charter; 29 U.S.C. 791, 792, 793, and 795; guidance from the Equal Employment Opportunity Commission (EEOC); guidance from the Office of Personnel Management (OPM); Executive Order 11830; General Services Administration Order ADM 5420.71A; Executive Orders 11141; 11246 Part II, 11375, and 12086; Office of Management and Budget (OMB) Circular No. A-11; 42 U.S.C. 2000E-16; Executive Order 11478; 38 U.S.C. 2014; 29 U.S.C. 631(b) and 633a; 5 U.S.C. chapters 43 and 72; Secretary of Defense Policy on Sexual Harassment, July 17, 1981; Assistant Secretary of Defense (Manpower, Reserve Affairs and Logistics) Multiple Addressee Memorandum, August 16, 1981; and 29 U.S.C. 206(d) by establishing the Civilian Equal Employment Opportunity (EEO) Program, to include affirmative action programs, consistent with guidance from the Equal Employment Opportunity Commission (EEOC), Office of Personnel Management (OPM), and the DoD Human Goals Charter.</P>
            <P>(b) Consolidates in a single document provisions of Secretary of Defense Multiple Addressee Memorandum, June 23, 1981; DoD Directive 1100.11, DoD Directive 1450.1, DoD Directive 5120.46, and DoD Directive 1100.15, therefore cancelling each document.</P>
            <P>(c) Authorizes, as an integral part of the Civilian EEO Program, the establishment of Special Emphasis Programs (SEPs) entitled the Federal Women's Program (FWP), the Hispanic Employment Program (HEP), and the Program for People with Disabilities (PPD), the Asian/Pacific Islander Employment Program (AEP), the American Indian/Alaskan Native Employment Program (AIEP), and the Black Employment Program (BEP).</P>
            <P>(d) Establishes the Defense Equal Opportunity Council (DEOC), the Civilian EEO Review Board, the SEP Boards.</P>
            <P>(e) Authorizes the issuance of DoD Instructions and Manuals to implement this part and guidance from standard-setting agencies such as EEOC and OPM, consistent with DoD 5025.1-M.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 56 FR 10170, Mar. 11, 1991; 57 FR 35755, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.2</SECTNO>
            <SUBJECT>Applicability and scope.</SUBJECT>
            <P>This part:</P>
            <P>(a) Applies to the Office of the Secretary of Defense (OSD) and activities supported administratively by OSD, the Military Departments, the Organization of the Joint Chiefs of Staff (as an element of the OSD for the purposes of this program), the Unified and Specified Commands, the Defense Agencies, the Army and Air Force Exchange Service, the National Guard Bureau, the Uniformed Services University of the Health Sciences, the Office of Civilian Health and Medical Programs of the Uniformed Services, and the DoD Dependents Schools (hereafter referred to collectively as “DoD Components”).</P>
            <P>(b) Applies worldwide to all civilian employees and applicants for civilian employment within the Department of Defense in appropriated and non-appropriated fund positions.</P>
            <P>(c) Does not apply to military personnel, for whom equal opportunity is covered by DoD Directive 1350.2 <SU>1</SU>
              <FTREF/>.</P>
            <FTNT>
              <P>
                <SU>1</SU> Copies may be obtained from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161.</P>
            </FTNT>
            <PRTPAGE P="12"/>
            <P>(d) Covers Federal employment issues under section 504 of the Rehabilitation Act of 1973, as amended, even though DoD Directive 1020.1 <SU>2</SU>
              <FTREF/> implements section 504 with respect to programs conducted and assisted by the Department of Defense. The standards established under section 501 of the Rehabilitation Act of 1973, as amended, (29 U.S.C. 791, 792, 793, and 795), are to be applied under section 504 of the Act with respect to civilian employees and applicants for civilian employment in Federal Agencies.</P>
            <FTNT>
              <P>
                <SU>2</SU> See footnote 1 to § 191.2(c).</P>
            </FTNT>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 56 FR 10170, Mar. 11, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.3</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <P>
              <E T="03">Affirmative action.</E> A tool to achieve equal employment opportunity. A program of self-analysis, problem identification, data collection, policy statements, reporting systems, and elimination of discriminatory policies and practices, past and present.</P>
            <P>
              <E T="03">Age.</E> A prohibited basis discrimination. For purposes of this Directive, persons protected under age discrimination provisions are those 40 years of age or older, except when a maximum age requirement has been established by statute or the OPM. Aliens employed outside the limits of the United States are not covered by this definition.</P>
            <P>
              <E T="03">Discrimination.</E> Illegal treatment of a person or group based on race, color, national origin, religion, sex, age, or disability.</P>
            <P>
              <E T="03">Equal Employment Opportunity (EEO).</E> The right of all persons to work and advance on the basis of merit, ability, and potential, free from social, personal, or institutional barriers of prejudice and discrimination.</P>
            <P>
              <E T="03">Minorities.</E> All persons classified as black (not of Hispanic origin), Hispanic, Asian or Pacific Islander, and American Indian or Alaskan Native.</P>
            <P>
              <E T="03">National origin.</E> A prohibited basis for discrimination. An individual's place of origin or his or her ancestor's place of origin or the possession of physical, cultural, or linguistic characteristics of a national origin group.</P>
            <P>
              <E T="03">People with disabilities.</E> People who have physical or mental impairments that substantially limits one or more major life activities, has a record of such impairment, or is regarded as having such an impairment. For purposes of this part, such term does not include any individual who is an alcoholic or drug abuser and whose current use of alcohol or drugs prevents such individual from performing the duties of the job in question, or whose employment, by reason of such current alcohol or drug abuse, would constitute a direct threat to property or to the safety of others. As used in this paragraph:</P>
            <P>(a) <E T="03">Physical or mental impairment.</E> Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more of the following body systems: neurological; musculoskeletal and special sense organs; respiratory, including speech organs; cardiovascular; reproductive; digestive; genitourinary; hemic and lymphatic; skin; and endocrine; or any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities.</P>
            <P>(b) <E T="03">Major life activities.</E> Functions such as caring for one's self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working.</P>
            <P>(c) <E T="03">Has a record of such impairment.</E> Has a history of, or has been misclassified as having, a mental or physical impairment that substantially limits one or more major life activities.</P>
            <P>(d) <E T="03">Is regarded as having an impairment.</E> Has:</P>
            <P>(1) A physical or mental impairment that does not substantially limit major life activities but is treated by an employer as constituting such a limitation;</P>
            <P>(2) A physical or mental impairment that substantially limits major life activities only as a result of the attitude of others toward such impairment; or</P>
            <P>(3) None of the impairments defined above but is treated by an employer as having an impairment.</P>
            <P>
              <E T="03">Race.</E> A prohibited basis for discrimination. For purposes of this part, all persons are classified as black (not of Hispanic origin), Hispanic, Asian or Pacific Islander, American Indian or Alaskan Native, and White, as follows:<PRTPAGE P="13"/>
            </P>
            <P>(a) <E T="03">Black (not of Hispanic origin).</E> A person having origins in any of the black racial groups of Africa.</P>
            <P>(b) <E T="03">Hispanic origin.</E> A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin regardless of race.</P>
            <P>(c) <E T="03">Asian or Pacific Islander.</E> A person having origin in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent, or the Pacific Islands. This area includes, for example, China, India, Japan, Korea, the Philippine Islands, and Samoa.</P>
            <P>(d) <E T="03">American Indian or Alaskan Native.</E> A person having origins in any of the original peoples of North America, and who maintains cultural identification through tribal affiliation or community recognition.</P>
            <P>(e) <E T="03">White.</E> A person having origins in any of the original peoples of Europe, North Africa, or the Middle East.</P>
            <P>
              <E T="03">Religion.</E> Traditional systems of religious belief and moral or ethical beliefs as to what is right and wrong that are sincerely held with the strength of traditional religious views. The phrase “religious practice” as used in this part includes both religious observances and practices. DoD Components are expected to accommodate an employee's religious practices unless doing so causes undue hardship on the conduct of the Component's business.</P>
            <P>
              <E T="03">Sexual Harassment.</E> A form of sex discrimination that involves unwelcomed sexual advances, requests for sexual favors, and other verbal or physical conduct of a sexual nature when:</P>
            <P>(a) Submission to or rejection of such conduct is made either explicitly or implicitly a term or condition of a person's job, pay, or career; or</P>
            <P>(b) Submission to or rejection of such conduct by a person is used as a basis for career or employment decisions affecting that person, or</P>
            <P>(c) Such conduct interferes with an individual's performance or creates an intimidating, hostile, or offensive environment.</P>
            <FP>Any person in a supervisory or command position who uses or condones implicit or explicit sexual behavior to control, influence, or affect the career, pay, or job of a military member of civilian employee is engaging in sexual harassment. Similarly, any military member of civilian employee who makes deliberate or repeated unwelcomed verbal comments, gestures, or physical contact of a sexual nature is also engaging in sexual harassment.</FP>
            <P>
              <E T="03">Special Emphasis Program (SEPs).</E> Programs established as integral parts of the overall EEO program to enhance the employment, training, and advancement of a particular minority group, women, or people with disabilities.</P>
            <P>
              <E T="03">Standard-setting agencies.</E> Non-DoD Federal Agencies authorized to establish Federal Government-wide EEO policy or program requirements. The term includes the EEOC; OPM: DoL, Office of Federal Contract Compliance Programs (OFCCP); and OMB.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 54 FR 15752, Apr. 19, 1989; 57 FR 35755, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <P>It is DoD Policy to:</P>
            <P>(a) Recognize equal opportunity programs, including affirmative action programs, as essential elements of readiness that are vital to the accomplishment of the DoD national security mission. Equal employment opportunity is the objective of affirmative action programs.</P>
            <P>(b) Develop and implement affirmative action programs to achieve the objective of a civilian work force in which the representation of minorities, women, and people with disabilities at all grade levels, in every occupational series, and in every major organization element is commensurate with the representation specified in EEOC and OPM guidance. Such programs, which shall be designed to identify, recruit, and select qualified personnel, shall be coordinated with the cognizant legal offices.</P>
            <P>(c) Ensure that Civilian EEO Program activities for minorities, women, and people with disabilities are integrated fully into the civilian personnel management system.</P>

            <P>(d) Assess progress in DoD Component programs in accordance with the affirmative action goals of the Department of Defense.<PRTPAGE P="14"/>
            </P>
            <P>(e) Prohibit discrimination based on race, color, religion, sex, national origin, mental or physical disability, or age.</P>
            <P>(f) Eliminate barriers and practices that impede equal employment opportunity for all employees and applicants for employment, including sexual harassment in the work force and at work sites and architectural, transportation, and other barriers affecting people with disabilities.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 54 FR 15752, Apr. 19, 1989; 57 FR 35756, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <P>(a) The <E T="03">Assistant Secretary of Defense (Force Management and Personnel</E> (ASD(FM&amp;P)), or designee, shall:</P>
            <P>(1) Represent the Secretary of Defense in all matters related to the DoD Civilian EEO Program, consistent with DoD Directive 5124.2 <SU>3</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>3</SU> See footnote 1 to § 191.2(c).</P>
            </FTNT>
            <P>(2) Establish and chair the DEOC.</P>
            <P>(3) Establish a Civilian EEO Review Board.</P>
            <P>(4) Develop policy and provide program oversight for the Civilian EEO Program.</P>
            <P>(5) Ensure full implementation of this part, monitor progress of affirmative action program elements, and advise the Secretary of Defense on matters relating to the Civilian EEO Program.</P>
            <P>(6) Ensure that realistic goals that provide for significant continuing increases in the percentages of minorities, women, and people with disabilities in entry, middle, and higher grade positions in all organizations and occupations are set and accomplished until the overall DoD objective is met and sustained.</P>
            <P>(7) Prepare a new DoD Human Goals Charter each time a new Secretary of Defense is appointed.</P>
            <P>(8) Ensure fair, impartial, and timely investigation and resolution of complaints of discrimination in employment, including complaints of sexual harassment.</P>
            <P>(9) Establish DoD SEPs for the FWP, HEP, HIP, AEP, AIEP, and BEP.</P>
            <P>(10) Establish DoD Special Emphasis Program Boards to assist with implementation of SEPs under this part.</P>
            <P>(11) Establish DoD Civilian EEO Award Programs to provide for the annual issuance of Secretary of Defense Certificates of Merit to DoD Components and individuals for outstanding achievement in the major areas covered by this part, and to review all awards and management training programs within the Department of Defense to ensure that minorities, women, and people with disabilities receive full and fair consideration consistent with their qualifications and the applicable program criteria.</P>
            <P>(12) Issue implementing instructions and other documents, as required, to achieve the goals of the DoD Civilian EEO Program and to provide policy direction and overall guidance to the DoD Components.</P>
            <P>(13) Represent the Department of Defense on programmatic EEO matters with EEOC, OPM, the Department of Justice, other Federal Agencies, and Congress.</P>
            <P>(14) Represent the Department of Defense on the Interagency Committee on Handicapped Employees under E.O. 11830, as amended, and the Council on Accessible Technology under General Services Administration Order ADM 5420.71A.</P>
            <P>(15) Represent the Department of Defense at meetings and conferences of non-Federal organizations concerned with EEO programs, and coordinate DoD support of such organizations’ activities with the Assistant Secretary of Defense (Public Affairs) and with DoD General Counsel in accordance with DoD Directive 5410.18 <SU>4</SU>
              <FTREF/>, DoD Instruction 5410.19 <SU>5</SU>
              <FTREF/>, DoD Directive 5500.2 <SU>6</SU>
              <FTREF/>, and DoD Directive 5500.7 <SU>7</SU>
              <FTREF/>.</P>
            <FTNT>
              <P>
                <SU>4</SU> See footnote 1 to § 191.2(c). </P>
            </FTNT>
            <FTNT>
              <P>
                <SU>5</SU> See footnote 1 to § 191.2(c). </P>
            </FTNT>
            <FTNT>
              <P>
                <SU>6</SU> See footnote 1 to § 191.2(c). </P>
            </FTNT>
            <FTNT>
              <P>
                <SU>7</SU> See footnote 1 to § 191.2(c). </P>
            </FTNT>

            <P>(16) Serve as the DoD liaison with the Office of Federal Contract Compliance Programs (OFCCP), Department of Labor (DoL), for the purpose of providing contract information, forwarding complaints of discrimination filed against DoD contractors, and implementing administrative sanctions imposed against DoD contractors for <PRTPAGE P="15"/>violations of E.O. 11141; E.O. 11246; as amended by E.O. 11375, E.O. 12088; and DoL implementing regulations.</P>
            <P>(17) Ensure that the DoD FAR Supplement contains appropriate contract provisions for EEO for Government contractors and subcontractors under Executive Orders 11141, 11246 Part II, 11375, and 12086; Section 402 of the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended; Section 503 of the Rehabilitation Act of 1973, as amended; and DoL implementing regulations.</P>
            <P>(b) The <E T="03">Heads of DoD Components,</E> or their designees, shall:</P>
            <P>(1) Ensure that all EEO policies are disseminated widely and that they are understood and implemented at all levels within their Components.</P>
            <P>(2) Ensure that their Components comply with EEOC and OPM guidance and this part and that minorities, women, and people with disabilities receive full and fair consideration for civilian employment in all grade levels, occupations, and major organizations, with special emphasis on mid-level and higher grades and executive-level jobs, including the Senior Executive Service (SES) and SES candidate pools.</P>
            <P>(3) Treat equal opportunity and affirmative action programs as essential elements of readiness that are vital to accomplishment of the national security mission.</P>
            <P>(4) Designate a Director of Civilian Equal Opportunity and allocate sufficient staff and other resources to ensure a viable EEO program under this Directive. This includes assignment of staff to be responsible for EEO and affirmative action programs generally and SEP Managers for the SEPs established under this part at the Component level.</P>
            <P>(5) Establish DoD SEPs, for the FWP, HEP, PPD, AEP, AIEP, and BEP at Headquarters level and at all field activities levels unless exemptions are granted to field activities. Authority to grant exceptions to field activities of DoD Components is delegated to the Component Heads who, in turn, may redelegate this authority.</P>
            <P>(6) Require that EEO be included in critical elements in the performance appraisals of all supervisors, managers, and other Component personnel, military and civilian, with EEO responsibilities.</P>
            <P>(7) Ensure fair, impartial, and timely investigation and resolution of complaints of discrimination in employment, including complaints of sexual harassment.</P>
            <P>(8) Set realistic Component goals and motivate subordinate managers and supervisors to set and meet their own goals until overall DoD and Component goals are met and sustained.</P>
            <P>(9) Evaluate employment policies, practices, and patterns within their respective Components and identify and correct and institutional barriers that restrict opportunities for recruitment, employment, advancement, awards, or training for minorities, women, and people with disabilities and ensure that EEO officers and civilian personnel officers provide leadership in eliminating these barriers.</P>
            <P>(10) Ensure that installations and activities establish focused external recruitment programs to produce employment applications from minorities, women, and people with disabilities who are qualified to compete effectively with internal DoD candidates for employment at all levels and in all occupations.</P>
            <P>(11) Establish a continuing EEO educational program (including training in the prevention of sexual harassment) for civilian and military personnel who supervise civilian employees.</P>
            <P>(12) Establish EEO Awards Programs to recognize individuals and organizational units for outstanding achievement in one or all of the major EEO areas covered by this part.</P>
            <P>(13) Review all award and management training programs to ensure that minorities, women, and people with disabilities are considered, consistent with their qualifications and program criteria.</P>

            <P>(14) At military installations having a civilian work force and military units, ensure that the Civilian EEO Program is managed by and conducted for civilian personnel only and that the Military Equal Opportunity Program is managed by and conducted for military personnel only. Any exceptions to this <PRTPAGE P="16"/>policy must be authorized by the Component head.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 56 FR 10170, Mar. 11, 1991; 57 FR 35756, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.6</SECTNO>
            <SUBJECT>Procedures.</SUBJECT>
            <P>(a) Officials designated in this Directive shall allocate resources necessary to develop methods and procedures to ensure that all elements of this part are fully implemented and are in compliance with the spirit and intent of the DoD Human Goals Charter, laws, executive orders, regulatory requirements, and other Directive and Instructions governing the Civilian EEO Program within the Department of Defense.</P>
            <P>(b) Heads of DoD Components, in accordance with EEOC and OPM guidance and subject to oversight by and supplemental guidance from the ASD(FM&amp;P), or designee shall:</P>
            <P>(1) Develop procedures for and implement an affirmative action program for minorities and women, consistent with section 717 of the Civil Rights Act of 1964, as amended; E.O. 11478; guidance from EEOC; and guidance from OPM.</P>
            <P>(2) Develop procedures for and implement an affirmative action program for people with disabilities consistent with section 501 of Rehabilitation Act of 1973, as amended, and guidance from EEOC.</P>

            <P>(3) Develop procedures for and implement an affirmative action program for disabled veterans, consistent with DoD Directive 1341.6.<E T="51">8</E>
              <FTREF/> This program shall be consistent with the program established in paragraph (b)(2) of this section and coordinated with the Component's PPD manager.</P>
            <FTNT>
              <P>
                <SU>8</SU> See footnote 1 to § 191.2(c).</P>
            </FTNT>
            <P>(4) Develop procedures for and implement systems for investigation and resolution of complaints of employment discrimination under section 717 of the Civil Rights Act of 1964, as amended; sections 501, 503, and 504 of the Rehabilitation Act of 1973, as amended and DoD Directive 1020.1; section 402 of the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended; the Age Discrimination in Employment Act of 1967, as amended; guidance from EEOC; and applicable case law.</P>
            <P>(5) Develop procedures for and implement a Federal Equal Opportunity Recruitment Program for minorities and women and a comparable special recruitment program for people with disabilities in accordance with the Civil Service Reform Act of 1978; EEOC instruction concerning affirmative action programs for people with disabilities; guidance from OPM; external recruitment programs to obtain employment applications from minorities, women, and people with disabilities who are competitive with internal DoD candidates for employment at all levels.</P>
            <P>(6) Develop procedures for and implement all SEPs established under this part at the Component level. These SEPs shall be integral parts of the Civilian EEO Program and shall be conducted in accordance with the provisions of this part and applicable EEOC and OPM guidance.</P>
            <P>(7) Develop procedures for and implement a program to eliminate sexual harassment in Component work places, consistent with DoD Policy on Sexual Harassment memorandums, and to ensure compliance with the Equal Pay Act.</P>
            <P>(8) Develop procedures for and implement a program of employment preference for spouses of military personnel, in accordance with DoD Instruction 1404.12.<SU>9</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>9</SU> See footnote 1 to § 191.2(c). </P>
            </FTNT>
            <P>(9) Develop procedures for and implement a selective placement program for people with disabilities in accordance with guidance from OPM. This program shall be consistent with the program established in paragraph (b)(2) of this section, and coordinated with the Component's PPD manager.</P>

            <P>(10) Develop procedures for and implement staffing initiatives, training and development programs, and upward mobility programs designed to increase the representation of qualified minorities, women, and people with disabilities on certificates of eligibility and accompanying lists of individuals eligible for special appointments that are provided to selecting officials at all levels within the Component. These <PRTPAGE P="17"/>programs should include SES candidate programs and shall be targeted in career field in which there is underrepresentation and a likelihood of vacancies (e.g., science and engineering positions).</P>
            <P>(11) Develop procedures for and implement a program to evaluate all supervisors and managers with EEO responsibilities on their contributions to and support of the Component's EEO program. Specifically, Component SES and General Manager personnel, when appropriate, shall have their EEO responsibilities defined as a critical element in their performance appraisals in accordance with the Civil Service Reform Act of 1978.</P>
            <P>(12) Develop procedures for an implement a program to participate in and conduct ceremonies, where appropriate, at all levels of the Component to observe nationally proclaimed or other specially-designated community activities that particularly affect minorities, women, and people with disabilities and that support the Civilian EEO Program. Military and civilian personnel should both participate whenever possible. Example of special observances include Dr. Martin Luther King Jr.'s Birthday, Black History Month, National Women's History Week, Women's Equality Day, Hispanic Heritage Week, National Disability Employment Awareness Month, and the Decade of Disabled Persons.</P>
            <P>(13) Develop procedures for and implement a program to revise documents and change practices and policies that discriminate against civilian personnel on the basis or race, color, sex, religion, national origin, mental or physical disability, or age.</P>
            <P>(14) Develop procedures for and implement and affirmative action program for the continued Federal employment of minorities, women, and people with disabilities who have lost their jobs in DoD Components because of contracting decisions made under OMB Circular No. A-76. (Under OMB Circular Federal employees have, in general, the right of first refusal of employment under these contracts.)</P>
            <P>(15) Develop precedures for and implement a program for computer support of employees with disabilities consistent with DoD participation in activities of the Council on Accessible Technology in accordance with General Services Administration Order ADM 5420.71A.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 54 FR 15752, Apr. 19, 1989; 57 FR 35756, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.7</SECTNO>
            <SUBJECT>Civilian EEO program staff.</SUBJECT>
            <P>(a) EEO Managers, including SEP Managers and other staff who are responsible for EEO and affirmative action programs, shall function at a level that is sufficiently responsible with the assigned organization to enable them to communicate effectively the goals and objectives of the program and to enable them to obtain the understanding, support, and commitment of managers and other officials at all levels within the organization.</P>
            <P>(b) It shall be the responsibility of EEO Managers, SEP Managers, and other program staff to develop, coordinate, implement, and recommend to managers, other officials, and covered groups the policy, guidance, information, and activities necessary to attain the goals of the SEPs and the overall DoD Civilian EEO Program.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.8</SECTNO>
            <SUBJECT>Defense equal opportunity council and EEO boards.</SUBJECT>
            <P>(a) The DEOC shall be chaired by the ASD (FM&amp;P) and shall coordinate policy for and review civilian and military equal opportunity programs, monitor progress of program elements, and advise the secretary of Defense on pertinent matters. One of the mandates of the DEOC shall be to pursue an aggressive course of action to increase the numbers of minorities, women, and people with disabilities in management and executive positions at grades 13 and above, including the SES and, at the request of the Secretary of Defense, Schedule C, and other noncareer executive positions in the SES and on the Executive Schedule. Members of the DEOC shall include the assistant Secretary of Defense (Reserve Affairs), Director of Administration and Management, and the Assistant Secretaries with responsibility for personnel policy and reserve affairs in the Military Departments.</P>

            <P>(b) The Civilian EEO Review Board shall be chaired by the ASD(FM&amp;P), or <PRTPAGE P="18"/>designee. The Board shall support the DEOC and shall be made up of designated EEO and personnel representatives from the DoD Components and such other individuals as may be necessary to carry out the work of the DEOC and implement this part. The Board shall work with career management officials, other key management officials, and union representatives in developing policies, programs, and objectives.</P>
            <P>(c) The DoD SEP Boards shall be chaired by the DoD SEP Managers. These Boards shall be comprised of designated SEP Managers from the DoD Components and such other individuals as may be necessary to advise and assist in EEO activities and policy development in the Department of Defense. The Boards shall work with career management officials, other key management officials, and union representatives in developing policies, programs, and objectives.</P>
            <P>(d) The DEOC, Civilian EEO Review Board, and each SEP Board established at the DoD level shall have a Charter that describes its organization, management, functions, and operating procedures, consistent with DoD Directive 5105.18.<SU>1</SU>
              <SU>0</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>1</SU>
                <SU>0</SU> See footnote 1 to § 191.2(c).</P>
            </FTNT>
            <P>(e) Civilian EEO Review Boards and SEP Boards may be established at Component, command, and installation levels as well as the DoD level to assist in program activities.</P>
            <P>(f) Members of covered groups should be represented on Civilian EEO Review Boards, SEP Boards, and subcommittees at all levels; and consideration should be given to participation by military personnel and by Federal employees who are union representatives.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 54 FR 15752, Apr. 19, 1989; 57 FR 35756, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.9</SECTNO>
            <SUBJECT>Information requirements.</SUBJECT>
            <P>(a) The ASD(FM&amp;P) shall:</P>
            <P>(1) Submit an annual report to the Secretary of Defense on the status of the DoD EEO program. This report shall be developed from existing documents, such as affirmative action plan accomplishment reports, civil rights budget reports, semiannual discrimination complaint reports, and Federal Equal Opportunity Recruitment Program reports, plus statistical data obtained from the Defense Manpower Data Center and reports of visits to DoD installations.</P>
            <P>(2) Submit consolidated DoD annual reports on discrimination complaints to the EEOC in accordance with EEOC guidance. This reporting requirement is assigned Interagency Report Control Number 0288-EEO-NA.</P>
            <P>(b) Heads of DoD Components shall:</P>
            <P>(1) Submit annual reports on discrimination complaints to the ASD(FM&amp;P), or designee, in accordance with guidance from the EEOC. This reporting requirement is assigned Interagency Report Control Number 0288-EEO-NA.</P>
            <P>(2) Submit copies of affirmative action program plan, affirmative action program plan updates, and affirmative action plan accomplishment reports for minorities, women, and people with disabilities to the ASD(FM&amp;P), or designee, in addition to copies of annual reports for the Federal Equal Opportunity Recruitment Program.</P>
            <P>(3) Ensure that designated officials submit information for an annual report on computer support of employees with disabilities and for reports on individual computer accommodations for employees with disabilites. These reporting requirements are assigned RCS DD-FM&amp;P (A) 1731 and RCS DD-FM&amp;P (AR) 1732.</P>
            <CITA>[53 FR 30990, Aug. 17, 1988, as amended at 54 FR 15752, Apr. 19, 1989; 57 FR 35756, Aug. 11, 1992]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 191.10</SECTNO>
            <SUBJECT>Effective date.</SUBJECT>
            <P>This part is effective May 21, 1987.</P>
          </SECTION>
        </PART>
        <PART>
          <EAR>Pt. 192</EAR>
          <HD SOURCE="HED">PART 192—EQUAL OPPORTUNITY IN OFF-BASE HOUSING</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>192.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <SECTNO>192.2</SECTNO>
            <SUBJECT>Applicability.</SUBJECT>
            <SECTNO>192.3</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <SECTNO>192.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <SECTNO>192.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <SECTNO>192.6</SECTNO>
            <SUBJECT>Procedures.</SUBJECT>
            <APP>
              <E T="05">Appendix A to Part 192—Checklist for Commanders</E>
            </APP>
            <APP>
              <E T="05">Appendix B to Part 192—Procedures and Reports</E>
            </APP>
          </CONTENTS>
          <AUTH>
            <PRTPAGE P="19"/>
            <HD SOURCE="HED">Authority:</HD>
            <P>42 U.S.C. 3601 et seq.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>55 FR 6248, Feb. 22, 1990, unless otherwise noted. Redesignated at 56 FR 32964, July 18, 1991.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 192.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <P>This part:</P>
            <P>(a) Revises 32 CFR part 192.</P>
            <P>(b) Revises the references, policies, and procedures covering off-base housing and fair housing enforcement.</P>
            <P>(c) Outlines discrimination complaint inquiries or investigative procedures and hearing requirements.</P>
            <P>(d) Deletes the requirement for each Military Department to submit a semi-annual housing discrimination report to the Assistant Secretary of Defense (Force Management and Personnel) (ASD(FM&amp;P)).</P>
            <P>(e) Requires each Military Service to report to the ASD(FM&amp;P) any housing discrimination cases and their results in their Annual Military Equal Opportunity Assessment Report to the ASD(FM&amp;P).</P>
            <P>(f) Requires each Military Department to maintain all completed or resolved housing discrimination cases.</P>
            <P>(g) Emphasizes liaison with other Government (local, State, or Federal) agencies.</P>
            <CITA>[55 FR 6248, Feb. 22, 1990. Redesignated and amended at 56 FR 32964, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 192.2</SECTNO>
            <SUBJECT>Applicability.</SUBJECT>
            <P>This part applies to the Office of the Secretary of Defense (OSD), the Military Departments, the Joint Chiefs of Staff (JCS), the Joint Staff, the Unified and Specified Commands, the Inspector General of the Department of Defense (IG, DoD), the Uniformed Services University of the Health Sciences (USUHS), the Defense Agencies, and DoD Field Activities (hereafter referred to collectively as “DoD Components”). The term “Military Services,” as used herein, refers to the Army, Navy, Air Force, and Marine Corps. DoD civilian employees (as defined in § 192.3) will be offered the same services that members of the Armed Forces receive.</P>
            <CITA>[55 FR 6248, Feb. 22, 1990. Redesignated and amended at 56 FR 32964, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 192.3</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <P>
              <E T="03">Agent.</E> Real estate agency, manager, landlord, or owner of a housing facility doing business with DoD personnel or a housing referral service (HRS).</P>
            <P>
              <E T="03">Area Outside the United States.</E> Foreign countries where DoD personnel reside.</P>
            <P>
              <E T="03">Commander.</E> The military or civilian head of any installation, organization, or agency of the Department of Defense who is assigned responsibility for the off-base housing program.</P>
            <P>
              <E T="03">Commuting Area.</E> That area which is within a 1 hour commute by a privately-owned vehicle during rush hour and no farther than 30 miles from the installation, or within other limits to satisfy mission requirements.</P>
            <P>
              <E T="03">Complainant.</E> A member of the Armed Forces (or authorized dependent designated by the member) or a civilian employee of the Department of Defense (or authorized dependent designated by the civilian employee) who submits a complaint of discrimination under this part.</P>
            <P>
              <E T="03">Discrimination.</E> An act, policy, or procedure that arbitrarily denies equal treatment in housing because of race, color, religion, sex, national origin, age, handicap, or familial status to an individual or group of individuals.</P>
            <P>
              <E T="03">DoD Personnel.</E> (1) Members of the Armed Forces (and their dependents) authorized to live off-base.</P>
            <P>(2) DoD civilian employees (and their dependents) who are transferred from one place of residence to another because of job requirements or recruited for job opportunities away from their current place of residence in the United States, and all DoD U.S. citizen appropriated fund and nonappropriated fund civilian employees and their dependents outside the United States.</P>
            <P>
              <E T="03">Familial Status.</E> One or more individuals (who have not attained the age of 18 years) being domiciled with a parent or another person having legal custody of such an individual or individuals; or the designee of such parent or other person having such custody, with the written permission of such parent or other person.</P>
            <P>
              <E T="03">Listed Facility.</E> A suitable housing facility (not on restrictive sanction) listed with the HRS as available for occupancy by DoD personnel.<PRTPAGE P="20"/>
            </P>
            <P>
              <E T="03">Minorities.</E> All persons classified as black (not of Hispanic origin), Hispanic, Asian or Pacific Islander, or American Indian or Alaskan native.</P>
            <P>
              <E T="03">Relief for the Complainant.</E> Action taken by a commander for the benefit of a complainant.</P>
            <P>
              <E T="03">Restrictive Sanctions.</E> Actions taken by a commander to prevent military personnel from moving to, or entering into a rental, lease, or purchase arrangement with, a housing facility, when its agent has been found to have discriminated against DoD personnel. Restrictive sanctions are effective against the agent and the facility.</P>
            <P>
              <E T="03">Survey.</E> The procedure by which the HRS identifies housing resources to ascertain the availability of housing facilities for occupancy by DoD personnel.</P>
            <P>
              <E T="03">Verifiers.</E> Volunteers used by the commander during the course of a housing discrimination investigation to determine if, in fact, housing discrimination is being practiced by an agent, as alleged. Verifiers are not required to be prospective tenants.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 192.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <P>It is DoD policy that under DoD Directive 1350.2 <SU>1</SU>
              <FTREF/> the Department of Defense is fully committed to the goal of obtaining equal treatment for all DoD personnel. Specific guidance on off-base housing and fair housing enforcement is as follows:</P>
            <FTNT>
              <P>
                <SU>1</SU> Copies of all DoD issuances listed in this part may be obtained, at cost, from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. </P>
            </FTNT>
            <P>(a) <E T="03">National Housing Policy.</E> Federal law prohibits discrimination in housing in the United States against any person because of race, color, religion, sex, age, national origin, handicap, or familial status.</P>
            <P>(1) Title VIII of P.L. 90-284 contains the following:</P>
            <P>(i) The fair housing provisions.</P>
            <P>(ii) Outlines the responsibilities of the Secretary of Housing and Urban Development (HUD) with regard to Public Law 90-284.</P>
            <P>(iii) Requires all Executive Departments and Agencies to administer housing and urban development programs and activities under their jurisdiction in a manner that shall reflect “affirmatively” the furthering of title VIII.</P>
            <P>(2) Title IX of Public Law 90-284 makes it a crime to intimidate willfully or interfere with any person by force or threat because of that person's activities in support of fair housing.</P>
            <P>(3) Title 42 U.S.C. 1982 prohibits discrimination in housing in the United States. This statute protects DoD personnel.</P>
            <P>(4) Public Law 100-430 amends title VIII of Public Law 90-284 by revising the procedures for the enforcement of fair housing requirements and adding protected classes of individuals.</P>
            <P>(5) Title VIII of Public Law 90-284, as amended by Public Law 100-430, does not limit the applicability of any reasonable local, State, or Federal restrictions regarding the maximum number of occupants permitted to occupy a dwelling. Additionally, provisions of such title VIII regarding familial status do not apply with respect to housing intended for, and solely occupied by, persons 62 years of age or older or intended and operated for occupancy, but at least one person 55 years of age or older. For guidance regarding housing occupied by those 55 years of age or older, use the statutory provision at section 805 b(2)(c), 102 Stat. 1623, of Public Law 100-430.</P>
            <P>(b) <E T="03">DoD Fair Housing Policy.</E> The Department of Defense intends that Federal fair housing law shall be supported and that DoD personnel shall have equal opportunity for available housing regardless of race, color, religion, sex, age, national origin, handicap, or familial status.</P>
            <P>(1) That policy includes the objective of eliminating discrimination against DoD personnel in off-base housing. That objective is not achieved simply by finding a place to live in a particular part of town or in a particular facility for a specific person.</P>

            <P>(2) The intent is achieved when a person meeting the ordinary standards of character and financial responsibility is able to obtain off-base housing equally as any other person anywhere in the area surrounding a military installation, without suffering discrimination based on race, color, religion, <PRTPAGE P="21"/>sex, age, national origin, handicap or familial status.</P>
            <P>(i) The accomplishment of this objective shall not be hampered by requiring the submission of a formal complaint of discrimination. A suspected discriminatory act, with or without the filing of a formal complaint, is a valid basis for investigation and, if discrimination is substantiated, imposition of restrictive sanctions.</P>
            <P>(ii) On substantiation that an agent practiced discrimination, restrictive sanctions shall be imposed for a minimum of 180 days.</P>
            <P>(iii) The fact that Public Law 90-284, 42 U.S.C. 1982, and Public Law 100-430 may or may not provide a remedy in a given case of discrimination affecting DoD personnel does not relieve a commander of the responsibility to ensure equal treatment and equal opportunity for such personnel or to impose restrictive sanctions against the agent and/or facility, when appropriate.</P>
            <P>(iv) Military installations shall develop information programs to apprise Service members of the DoD policy and program for equal opportunity in off-base housing. Commanders should use local community resources, such as civil rights organizations, religious and service groups, and local information media, in support of their programs.</P>
            <CITA>[55 FR 6248, Feb. 22, 1990. Redesignated and amended at 56 FR 32964, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 192.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <P>The <E T="03">Secretaries of the Military Departments</E> shall:</P>
            <P>(a) Ensure nondiscrimination in referring DoD personnel to off-base housing facilities.</P>
            <P>(b) Continue efforts (as described in DoD 4165.63-M <SU>2</SU>
              <FTREF/> to identify and solicit nondiscriminatory assurances for housing facilities within the commuting area, which are considered to be suitable for occupancy by Service members.</P>
            <FTNT>
              <P>
                <SU>2</SU> See footnote 1 to § 192.4.</P>
            </FTNT>
            <P>(c) Ensure that an office and staff required by DoD 4165.63-M are available in conjunction with the cognizant staff judge advocate or other legal authority to advise Service members on the following:</P>
            <P>(1) The procedures in this part.</P>
            <P>(2) The application of Public Law 90-284, 42 U.S.C. 1982, and Public Law 100-430 in specific situations.</P>
            <P>(3) The rights of individuals to pursue remedies through civilian channels, without recourse and in addition to the procedures prescribed in this part, including the right to:</P>
            <P>(i) Make a complaint directly to the Department of HUD and/or to the Department of Justice (DoJ) in the United States.</P>
            <P>(ii) Bring a private civil action in any court of competent jurisdiction.</P>
            <P>(d) Periodically review off-base housing procedures and policies to ensure effectiveness and compliance with this part. (Appendix A to this part is a checklist to help commanders with this review.)</P>
            <P>(e) Cooperate with other Government Agencies investigating housing discrimination complaints filed by Service members.</P>
            <P>(f) Ensure that each Military Service reports any housing discrimination cases and their results in the Annual Military Equal Opportunity Assessment Report required by DoD Instruction 1350.3.</P>
            <CITA>[55 FR 6248, Feb. 22, 1990. Redesignated and amended at 56 FR 32964, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 192.6</SECTNO>
            <SUBJECT>Procedures.</SUBJECT>
            <P>(a) Appendix B to this part contains the detailed procedures for assisting Service members, investigating housing complaints, and reporting requirements for housing discrimination complaints.</P>
            <P>(b) The complaint and investigative report required in section B., appendix B to this part is exempt from formal approval and licensing under DoD 7750.5-M.<SU>3</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>3</SU> See footnote 1 to § 192.4.</P>
            </FTNT>
            <CITA>[55 FR 6248, Feb. 22, 1990. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <APPENDIX>
            <EAR>Pt. 192, App. A</EAR>
            <HD SOURCE="HED">Appendix A to Part 192—Checklist for Commanders</HD>
            <P>A. Are all assigned personnel informed of the Equal Opportunity in Off-Base Housing Program requirements before obtaining housing off base?</P>

            <P>B. Is there an effective information program ensuring equal opportunity in off-base housing information program?<PRTPAGE P="22"/>
            </P>
            <P>C. Are community resources being used to support the equal opportunity in off-base housing information program?</P>
            <P>D. Are housing discrimination complaints being processed within the required time?</P>
            <P>E. Are complainants being informed in writing of the results of housing discrimination inquiry and/or investigating actions?</P>
            <P>F. Are housing surveys being conducted periodically to obtain new listings?</P>
            <P>G. Are restrictive sanctions being imposed immediately for a minimum of 180 days on agents found to be practicing discrimination?</P>
            <P>H. Are the services of command representatives provided to assist applicants in their search for housing?</P>
            <P>I. Are HHS personnel and equal opportunity personnel aware of and sensitive to housing problems encountered by DoD personnel?</P>
            <P>J. Are equal opportunity in off-base housing reports being submitted accurately and on time?</P>
          </APPENDIX>
          <APPENDIX>
            <EAR>Pt. 192, App. B</EAR>
            <HD SOURCE="HED">Appendix B to Part 192—Procedures and Reports</HD>
            <HD SOURCE="HD2">A. Off-Base Housing Procedures</HD>
            <P>DoD personnel seeking off-base housing shall be processed as follows:</P>
            <P>1. Seen by an HRS when available (optional for DoD civilian personnel).</P>

            <P>2. Provided assistance in seeking temporary and permanent off-base housing, as follows:
            </P>
            <P>a. Counseling on the equal opportunity in off-base housing program with particular emphasis placed on reporting any indication of discrimination against DoD personnel in their search for housing.</P>
            <P>b. Counseling and personal assistance shall include the following services:</P>
            <P>(1) Offering to check by telephone the availability of selected listings. A record shall be made and retained for future reference of the date, time, and nature of any conversation confirming the availability of a facility. The race, color, religion, sex, national origin, handicap, or familial status of the applicant shall not be divulged. Caution must be exercised to ensure that a pattern of “confirmation only for minorities” does not develop.</P>
            <P>(2) Offering the services of a command representative (such as a unit sponsor or other designated person, when available) to accompany and assist the applicant in the search for housing.</P>
            <P>(3) Explaining various discriminatory methods that may be employed by agents. For instance, an agent may arbitrarily refuse to accept or consider the applicant as a tenant, falsely indicate the unit sought has been rented to another applicant, or refuse to make the unit available under the same terms and conditions as are ordinarily applied to applicants for the facilities. In such instances the following shall apply:</P>
            <P>(a) The agent shall be queried on the reasons why the unit is not available. After all reasonable steps have been taken to ascertain whether any valid nondiscriminatory reason can be shown for the agent's rejection of the applicant, and if there appears to be no such reason, a reasonable effort shall be made to persuade the agent to make the unit available to the applicant.</P>
            <P>(b) The incident shall be reported immediately by the command representative and the applicant to the HRS for appropriate command action.</P>
            <HD SOURCE="HD2">B. Complaint Procedures—United States</HD>
            <P>Commanders shall ensure that all DoD personnel are informed of the scope and provisions of the DoD Equal Opportunity in Off-Base Housing Program and advised to report immediately to the HRS (when available) any form of discrimination encountered when seeking housing within a Civilian Community. Incidents should be reported to base agencies or command representatives when an HRS is not available (i.e., equal opportunity officer, unit commander, supervisor). A verbal or written statement of discriminatory policy by an agent is considered to be an act or incident of discrimination, and the investigative procedures outlined in this appendix shall be followed.</P>
            <P>1. <E T="03">Inquiry into Complaint.</E> Complaints of off-base housing discrimination must receive prompt attention. An inquiry into the complaint shall begin within 3 working days after receipt of the complaint. The inquiry may be informal, but must be detailed sufficiently to determine if discrimination occurred. Upon receipt of a discrimination complaint, the HRS (if there is no HRS, a command designated representative) shall take the following action:</P>
            <P>a. Immediately notify the commander.</P>
            <P>b. Promptly interview the complainant to determine the details and circumstances of the alleged discriminatory act.</P>
            <P>c. Immediately telephone or visit the facility and/or agent concerned, if the complaint is received shortly after the time of the alleged act and it concerns the change in availability of a vacancy (i.e., “just rented,” etc.). Attempt to determine if a vacancy exists without making reference to the complaint received. Request the commander to authorize the use of verifiers, as necessary. (See this appendix, subsection B.2.)</P>

            <P>d. Advise the complainant of the provisions and procedures in this Instruction and of the right to pursue further actions through HUD, DoJ, and local or State agencies. Coordinate efforts with the Office of Judge Advocate or other cognizant legal counsel to determine <PRTPAGE P="23"/>to what extent legal assistance can be provided to the complainant. Assist the complainant in completing seven signed, dated, and notarized copies of HUD Form 903, “Housing Discrimination Complaint.” The fact that a complainant might report an act of alleged discriminatory treatment, but declines completing a HUD Form 903, does not relieve the command of responsibility for making further inquiry and taking such subsequent actions, as may be appropriate.</P>
            <P>e. Document the complainant's action for future reference and inform the commander of the results of the HRS preliminary inquiry and actions taken. The commander shall take action to assist the complainant in obtaining suitable housing. If, due to previous discriminatory practices in the community, suitable housing cannot be obtained by the complainant in a reasonable amount of time, the complainant and the commander may use this fact to justify a request for priority in obtaining military housing or for humanitarian reassignment. Reassignment action is a last resort and must be justified fully through command personnel channels.</P>
            <P>2. <E T="03">Use of Verifiers.</E> Verifiers are authorized to determine if a vacancy exists and whether or not rental or such practices are discriminatory. Verifiers shall not be used only for determining sincerity or normal practices of an agent about whom the HRS has not received a housing discrimination complaint.</P>
            <P>a. When selecting and using verifiers, the following applies:</P>
            <P>(1) Verification of the vacancy shall be made expediently after alleged act of discrimination.</P>
            <P>(2) Verifiers may be volunteers. (The equal opportunity office is a possible source for identifying individuals to be used as verifiers.)</P>
            <P>(3) The purpose of verification is to isolate the attribute of race, color, religion, sex, national origin, age, handicap, or familial status that is the suspected basis for the alleged discrimination against the complainant. Except for those attributes that are considered to be the source of the discrimination complaint, the verifier should possess attributes that are similar to the complainant. If two verifiers are used, one may possess similar attributes to the complainant. Ideally, two verifiers should be used.</P>
            <P>b. Instructions provided to the verifiers by HRS personnel should include the following:</P>
            <P>(1) Explanation of the equal opportunity in off-base housing and off-base housing referral programs.</P>
            <P>(2) Verifiers are to obtain information only on agent and/or facility operating policies, practices, and procedures for subsequent determination of complaint validity.</P>
            <P>(3) Verifiers are not to make a verbal or written contract for the housing unit, pay any money, or say they want the housing unit.</P>
            <P>(4) Verifiers shall be knowledgeable concerning family composition, pets, and housing requirements of the complainant; they shall ask for identical housing requirements.</P>
            <P>(5) The following information shall be obtained by the verifier, if possible:</P>
            <P>(a) <E T="03">Concerning the Facility.</E> What is available? Does it meet the requirements of the complainant? Amount of rent or cost of facility? Deposit required? Is an application required? What is the time between filing an application and permission to move in? Are there minority families and/or singles in the facility? Make a note of the presence or absence of a vacancy sign, and any other information deemed appropriate.</P>
            <P>(b) <E T="03">Concerning the Prospective Tenants/Purchasers.</E> If possible, ascertain criteria and qualifications that must be met (credit rating, salary, marital status, deposit, written application, etc.) and obtain a complete description of all procedures for becoming a tenant/purchaser including all steps from initial inquiry to moving in. Does the agent's subjective impression of the applicant appear to play any part in the decision to rent the unit?</P>
            <P>(6) The verifier's statement shall be completed immediately after the verification visit, if possible. It shall be accurate, objective, and factual. Include the following in the statement:</P>
            <P>(a) Date, time of visit, persons contacted, positions of persons contacted. Include any other pertinent information obtained during visit; i.e., length of time employed at facility, in addition to the information in this appendix, subparagraph B.2.b.(5), above.</P>
            <P>(b) When reconstructing a conversation, write in the first person and try to use direct quotes. Do not use pronouns such as “he,” “she,” or “they.” Clearly identify who said what to whom.</P>
            <P>(c) Sign and date statement. Give full name, address, telephone number (duty or home), race, color, religion, sex, national origin, age, handicap or familial status, as relevant to the complaint.</P>
            <P>3. <E T="03">Complaint Process</E>. If the basic facts of the HRS preliminary inquiry appear to substantiate the complaint, the commander shall ensure that the following actions begin within 3 working days of receipt of the inquiry report:</P>
            <P>a. <E T="03">Informal Hearing</E>. Give written notice to the agent explaining the nature of the complaint and the agent's right to request an informal hearing with the commander. The notification shall state specifically the nature of the discrimination complaint and the right of the agent to appear personally at the hearing, to be represented by an attorney, to present evidence, and to call witnesses. The notification also shall state that the agent has 5 days after receipt of the written notice to request a hearing. If no request <PRTPAGE P="24"/>is received within 5 days, the lack of response shall be considered as a waiver of the right to such hearing. The written notification either shall be delivered to the agent personally by a representative of the commander, or shall be sent to the agent by certified mail with return receipt requested.</P>
            <P>(1) <E T="03">Composition of an Informal Hearing</E>. The informal hearing shall be conducted by the commander or designee at a convenient location. The agent, agent's attorney, the complainant, the complainant's attorney, the equal opportunity officer, the HRS, the Staff Judge Advocate or other cognizant legal counsel, or other designated persons may attend.</P>
            <P>(2) <E T="03">Record of Hearing</E>. A summary of the hearing shall be made a part of the complaint file.</P>
            <P>b. <E T="03">Legal Review</E>. A legal review shall be accomplished following the inquiry and informal hearing (if applicable) and before the commander's final decision that the inquiry supports or fails to support the complaint. The summary and other pertinent documents shall be reviewed for content and completeness. A statement that such a review was conducted and signed by the Staff Judge Advocate or other cognizant legal counsel performing the review shall be made a part of the case file. That statement shall include:</P>
            <P>(1) Any necessary explanatory remarks, including comments on the facts and evidence presented.</P>
            <P>(2) Information known about pending complaints brought by other parties on the same facility and/or agent.</P>
            <P>(3) Comments on the civil rights laws relevant to the particular case.</P>
            <P>4. <E T="03">Commander's Decision</E>. The responsibility for imposition of restrictive sanctions rests with the commander and cannot be delegated. The commander's decision shall be based on a full and impartial review of all facts and the policies and requirements as stated in this part. The commander's options include the following:</P>
            <P>a. If the commander determines that more information is required, or for any reason further inquiry is deemed necessary, an officer shall be appointed from sources other than the HRS to conduct a formal inquiry or investigation, as the situation warrants. The officer, if not an attorney, shall be afforded the advice and assistance of a Staff Judge Advocate or other cognizant legal counsel.</P>
            <P>b. If, in the commander's judgment, the inquiry or investigation fails to support the complaint the case shall be considered closed and the commander shall:</P>
            <P>(1) Inform the complainant in writing of all actions taken and advise the complainant of rights to pursue further actions to include the following:</P>
            <P>(a) The right to submit a complaint to the HUD and the DoJ.</P>
            <P>(b) The right to bring a private civil action in a State or Federal court of competent jurisdiction.</P>
            <P>(c) The availability of legal assistance from their local Staff Judge Advocate or other cognizant legal counsel in pursuing civil redress.</P>
            <P>(2) Summarize in the report file the practices giving rise to the complaint, the actions and results of the inquiry or investigation, and if discriminatory practices were found, written assurances from the agent on future facility and/or agent practices. The following statement, completed by the complainant, shall be included, as part of the case file: “I am (am not) satisfied with the efforts taken by the commander on my behalf to achieve satisfactory resolution of my off-base housing discrimination complaint.” If the complainant indicates a lack of satisfaction, the reasons must be included in the case file.</P>
            <P>(3) Inform the agent of the results of the inquiry by command correspondence if an informal hearing was held. Such correspondence should reiterate DoD policy and requirements for equal opportunity in off-base housing.</P>
            <P>(4) Forward unsubstantiated complaint reports and HUD Form 903 to the HUD and the DoJ if requested by the complainant.</P>
            <P>(5) Retain a copy of the report file for 2 years for future reference.</P>
            <P>c. If the inquiry or investigation supports the complainant's charge of discrimination and the discriminatory act is determined by the commander to conflict with DoD policy, the commander shall:</P>
            <P>(1) Impose restrictive sanctions against the agent and/or facility for a minimum of 180 days. Sanctions shall remain in effect until the requirements in this appendix, subparagraphs B.6.a.(1) or B.6.a.(2), below, are met. Restrictive sanctions shall be imposed when a suspected discriminatory act, despite the absence of a formal complaint, is investigated and found valid. The fact that a validated discrimination complaint and/or incident has been or is scheduled to be forwarded to another Agency (the HUD, the DoJ, etc.) is not cause for withholding sanction action pending the outcome of that Agency's further review or investigation. When imposing a restrictive sanction, the commander shall:</P>
            <P>(a) Remove the facility listing(s) from HRO files.</P>
            <P>(b) Impose restrictive sanctions against all facilities owned or operated by the agent concerned.</P>
            <P>(c) Place the facility on the restrictive sanction list maintained by the HRS. The restrictive sanction list shall be prepared on official letterhead stationery, signed by the commander, and include the authority for and conditions of the restrictive sanctions.</P>

            <P>(d) Inform the agent concerned by command correspondence that:<PRTPAGE P="25"/>
            </P>
            <P>(1) Restrictive sanctions have been imposed.</P>
            <P>(2) The reasons, nature, and minimum duration of the restrictions.</P>

            <P>(3) The action required for the removal of sanctions at the conclusion of the minimum period.
            </P>
            <FP>The notification of restrictive sanctions shall be sent by certified mail, return receipt requested or delivered to the agent personally by a command representative.</FP>
            <P>(e) Provide all DoD personnel reporting to the HRS with a copy of the restrictive sanction list, and advise members of the Armed Forces that they may not rent, lease, purchase, or reside in any of the listed facilities. Obtain a signed acknowledgment of receipt of the restrictive sanction list from the HRS using a DD Form 1746, “Application for Assignment to Housing.”</P>
            <P>(f) Advise other military installations of the restrictive sanction action taken when the sanctioned facility is located within the commuting area of their military installations.</P>
            <P>(2) Inform the complainant in writing of all actions taken and advise the complainant that his or her case will receive continuing action to include, if the complainant requests, forwarding the case file to the HUD and/or the DoJ for action.</P>
            <P>(3) Before forwarding the report to the respective Military Department, prepare a memorandum outlining the following:</P>
            <P>(a) The base efforts made to obtain housing relief for the complainant.</P>
            <P>(b) The impact of restrictive sanctions on the off-base housing program and DoD personnel and their dependents.</P>
            <P>(c) Any other considerations deemed relevant.</P>
            <P>(4) Include a statement completed by the complainant for the case file. (See this appendix, subparagraph B.4.b.(3), above.)</P>
            <P>(5) If the act of discrimination falls within existing regulations, forward a copy of the complaint and investigation report directly to the HUD within 180 days after the occurrence of the alleged discriminating act, using HUD Form 903. The original report shall be sent to the appropriate HUD Regional Office or the U.S. Department of Housing and Urban Development Office of Fair Housing and Equal Opportunity, 451 7th Street SW., Washington, DC 20410. A copy of the complaint and investigation report shall be forwarded to the Civil Rights Division, Department of Justice, Washington, DC 20530.</P>
            <P>(6) When more than one complaint alleging discrimination in the same facility or by the same agent has been received, consolidate the complaints for the inquiry, legal review, and commander's memorandum.</P>
            <P>d. When a commander receives a complaint alleging further discrimination in a facility or by an agent after a completed case file has been closed, the commander shall forward the summary of the facts on the subsequent complaint, outlined in this enclosure, subparagraph B.4.c.(6), above. Include brief comments indicating the extent to which the new complaint affects the previous action.</P>
            <P>5. <E T="03">Followup Actions.</E> After forwarding the report and all required attachments to the HUD and the DoJ, the commander shall take the following actions:</P>
            <P>a. Cooperate with the HUD, the DoJ, and the local and State agency representatives during their investigation and processing of the case, should those entities seek assistance.</P>
            <P>b. Periodically determine the status of the case by maintaining liaison with the HUD office concerned. Contact shall be maintained until such time as the case is resolved by the HUD.</P>
            <P>c. Ensure that the complainant is kept informed directly by the HUD and/or the DoJ.</P>
            <P>d. Ensure that DoD personnel comply with the restrictive sanctions imposed on the facility and/or the agent. Housing personnel will comply with the following:</P>
            <P>(1) Military personnel moving into or changing their place of residence in the commuting area of a military installation or activity may not enter into a rental, purchase, or lease arrangement with an agent or a facility that is under restrictive sanction.</P>
            <P>(2) Implement procedures for ensuring that DoD personnel seeking housing are made aware of, and are counselled on, current restrictive sanctions.</P>
            <P>(3) Sanctions are not applicable to the DoD personnel who may be residing in a facility when the sanction is imposed or to the extension or renewal of a rental or lease agreement originally entered into before the imposition of the sanction. Relocation of a military tenant within a restricted facility is prohibited without the written approval of the commander.</P>
            <P>(4) If it is determined that a member of the Armed Forces has intentionally taken residency in a restricted facility contrary to instructions received by Housing Referal personnel, the commander shall take appropriate disciplinary action against that number.</P>
            <P>(5) Periodically publish a current listing of restricted facilities in the base bulletin (or other appropriate means of internal distribution). Minimally, such publication shall occur when there has been an addition or deletion to the list.</P>
            <P>6. <E T="03">Removal of Restrictive Sanction</E>
            </P>

            <P>a. A facility and/or agent may be removed from restrictive sanction only if one of the following actions is taken:<PRTPAGE P="26"/>
            </P>
            <P>(1) The restrictive sanction may be removed before completion of the 180 day restrictive period if an approved waiver request is obtained from the senior installation commander concerned, or designee. Consideration shall be given to lifting an imposed sanction only in exceptional circumstances and in conjunction with a written assurance of nondiscrimination from the agent concerned.</P>
            <P>(2) After completion of 180 days on restrictive sanction, if the agent provides written assurance of future nondiscrimination to the HRS.</P>
            <P>b. The commander shall inform the HRS, the equal opportunity office, and the agent in writing of the removal from restrictive sanction.</P>
            <P>7. <E T="03">“Privacy Act” and “Freedom of Information Act” Inquiries.</E> Requests for information from reports of housing discrimination shall be processed in accordance with 32 CFR parts 285 and 286a.</P>
            <HD SOURCE="HD2">C. Compliant Procedures—Outside the United States</HD>
            <P>Commanders of installations or activities outside the United States shall ensure that all DoD personnel, on reporting to the HRS, are clearly informed of the scope and provisions of the DoD Equal Opportunity in Off-Base Housing Program and advised to report immediately to the HRS any form of discrimination encountered as a tenant, prospective tenant, or purchaser. Incidents reported to base agencies or representatives other than the HRS (i.e., equal opportunity officer, unit commander, supervisor) shall be brought to the immediate attention of the HRS for appropriate action. On receiving a complaint of discrimination, the commander and HRS shall:</P>
            <P>1. Consult with the Staff Judge Advocate or other cognizant legal counsel to determine if the laws of the country concerned (or any subdivision thereof) prohibit any of the actions outlined in this appendix, section B., above.</P>
            <P>2. Take actions outlined in this appendix, section B, above, except that a HUD Form 903 shall not be completed because reports of cases arising outside the United States are not forwarded to the HUD or the DoJ. Complainants should understand that the fair housing provisions of the P.L. 90-284, “Civil Rights Act,” Title 42, United States, 1982, and Public Law 100-430, “Fair Housing Amendments Act of 1988,” September 13, 1988, are not applicable in areas outside the United States.</P>
            <P>3. Determine, with legal advice, whether redress for the discriminatory act should be sought from authorities in the host country. Redress shall be based on the laws of the country (or subdivision thereof) concerned.</P>
            <HD SOURCE="HD2">D. Reporting Requirements</HD>
            <P>1. A copy of each complaint and investigative report that substantiates a housing discrimination shall be submitted to the appropriate Military Department (manpower and reserve affairs and/or the equal opportunity office) not later than 45 days from the date the case is completed. Under normal circumstances, the commander of the installation concerned shall complete the required investigation and processing complaints within 45 days from the date that a housing complaint is filed by a complainant.</P>
            <P>2. A copy of complaint and investigative reports that do not substantiate allegations of housing discrimination shall be kept on file at the installation level for a 24-month period beginning from the date the case was completed.</P>
          </APPENDIX>
        </PART>
        <PART>
          <EAR>Pt. 193</EAR>
          <HD SOURCE="HED">PART 193—HIGHWAYS FOR NATIONAL DEFENSE</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>193.1</SECTNO>
            <SUBJECT>Purpose and scope.</SUBJECT>
            <SECTNO>193.2</SECTNO>
            <SUBJECT>Applicability.</SUBJECT>
            <SECTNO>193.3</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <SECTNO>193.4</SECTNO>
            <SUBJECT>Authorities and responsibilities. </SUBJECT>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 301.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>33 FR 13016, Sept. 14, 1968, unless otherwise noted.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 193.1</SECTNO>
            <SUBJECT>Purpose and scope.</SUBJECT>
            <P>This part sets forth policy, responsibilities, and authority in matters pertaining to Department of Defense highway needs and, when appropriate, to the highway needs of other Federal agencies, during peacetime and emergencies in the United States and its territories and possessions.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 193.2</SECTNO>
            <SUBJECT>Applicability.</SUBJECT>
            <P>The provisions of this part apply to all components of the Deparment of Defense.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 193.3</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <P>In order to insure that the national defense is served by adequate, safe and efficient highway transportation, it shall be the policy of the DoD to (a) integrate the highway needs of the national defense into the civil highway programs of the various State and Federal agencies, and (b) cooperate with those agencies in matters pertaining to the use of public highways and in planning their development and construction.</P>
          </SECTION>
          <SECTION>
            <PRTPAGE P="27"/>
            <SECTNO>§ 193.4</SECTNO>
            <SUBJECT>Authorities and responsibilities.</SUBJECT>
            <P>(a) The Secretary of the Army, as the Single Manager for Military Traffic, Land Transportation, and Common-User Ocean Terminals (see DoD Directive 5160.53, Single Manager Assignment for Military Traffic, Land Transportation, and Common-User Ocean Terminals, March 24, 1967 (32 FR 5295)), is hereby designated as the Executive Agent for the Department of Defense (hereinafter referred to as the Executive Agent), in matters pertaining to public highways to serve the national defense in meeting both peacetime and mobilization highway transportation needs in the United States, its territories and possessions; and highway needs of other Federal agencies, when appropriate. The Executive Agent, or his designee, under the policy guidance of the Assistant Secretary of Defense (Installations and Logistics), will:</P>
            <P>(1) Coordinate the defense transportation interest in public highways, including the implementation of subsection (h), section 210 of Title 23 U.S. Code, and integrate foreseen DoD highway needs and operational requirements into the highway programs of the United States, its territories and possessions.</P>
            <P>(2) Review and analyze DoD access road needs, and, when appropriate, those of other Federal agencies from the standpoint of approved transportation engineering practices, statutory provisions, and policies and procedures of the Bureau of Public Roads, Department of Transportation.</P>
            <P>(3) Represent the DoD in matters pertaining to highways to serve the national defense in liaison with the Bureau of Public Roads, the American Association of State Highway Officials, and other appropriate Government and non-Government agencies.</P>
            <P>(4) Certify on behalf of the Secretary of Defense to the appropriate Government agency, the public highway needs of the DoD and, when appropriate, the needs of other Federal agencies, as being important to the national defense. (See section 210, Title 23, U.S. Code.)</P>
            <P>(5) Advise and assist the Assistant Secretary of Defense (Comptroller) in matters pertaining to the (i) preparation and justification of budget requirements for defense access road needs, and (ii) transfer of funds appropriated for this purpose to the Bureau of Public Roads.</P>
            <P>(6) Develop and maintain an efficient relationship between the design of military vehicles and State and Federal standards for the design of public highways to ensure the effective and efficient utilization of such highways by military vehicles.</P>
            <P>(7) Provide highway traffic engineering services to DoD components, when requested.</P>
            <P>(8) Insure effective cooperation between the Department of Defense and state highway authorities in matters pertaining to special defense utilization of public highways.</P>
            <P>(b) The other DoD Components will:</P>
            <P>(1) Maintain official liaison with the Executive Agent in matters pertaining to the provision of public highways to serve the national defense and the access road needs of new or expanded DoD installations and activities.</P>
            <P>(2) Furnish the Executive Agent with information and data on current and potential access-road and highway-system needs on request.</P>
            <P>(c) The Secretaries of the Military Departments, or their designees, are authorized to act for the Secretary of Defense under the provisions of subsection (h) of section 210, Title 23, U.S. Code, in determining, in connection with the funding of contracts for the construction of classified military installations and facilities for ballistic missiles, that construction estimates and the bids of contractors did not include allowances for repairing road damages.</P>
            <P>(d) The Secretaries of the Military Departments and the Directors of DoD Agencies will program, budget, and finance for the responsibilities assigned by this part and their access road requirements (see Pub. L. 90-180, Military Construction Appropriation Act, fiscal year 1968, and successor statutes) in accordance with applicable program and financial guidelines and procedures.</P>
          </SECTION>
        </PART>
        <PART>
          <PRTPAGE P="28"/>
          <EAR>Pt. 194</EAR>
          <HD SOURCE="HED">PART 194—INTERNATIONAL CO-PRODUCTION PROJECTS AND AGREEMENTS BETWEEN THE UNITED STATES AND OTHER COUNTRIES OR INTERNATIONAL ORGANIZATIONS</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>194.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <SECTNO>194.2</SECTNO>
            <SUBJECT>Applicability and scope.</SUBJECT>
            <SECTNO>194.3</SECTNO>
            <SUBJECT>Concept.</SUBJECT>
            <SECTNO>194.4</SECTNO>
            <SUBJECT>Objectives and policies.</SUBJECT>
            <SECTNO>194.5</SECTNO>
            <SUBJECT>Responsibilities and procedures.</SUBJECT>
            <SECTNO>194.6</SECTNO>
            <SUBJECT>Security.</SUBJECT>
            <SECTNO>194.7</SECTNO>
            <SUBJECT>Reports required.</SUBJECT>
            <SECTNO>194.8</SECTNO>
            <SUBJECT>Effective date and implementation. </SUBJECT>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 301.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>33 FR 13016, Sept. 14, 1968, unless otherwise noted.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 194.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>

            <P>This part supplements the international logistics policies established in DoD Directive 5100.27, Delineation of International Logistic Responsibilities, December 29, 1964;<E T="21"> 1</E>

              <FTREF/> DoD Directive 5132.3 (28 FR 7611); DoD Instruction 2000.8, Cooperative Logistic Support Arrangements, February 14, 1964;<E T="21"> 1</E> part 258 of this subchapter; DoD Instruction 2015.4, Mutual Weapons Development Data Exchange Program and Defense Development Exchange Program, November 5, 1963;<E T="21"> 1</E>
              <E T="03">DoD</E> Directive 2100.3, “U.S. Policy Relative to Commitments to Foreign Governments Under Foreign Assistance Programs, July 11, 1963.<E T="21"> 1</E> Its purpose is to prescribe general policies and principles governing international co-production projects negotiated under agreements between the U.S. Government and eligible foreign governments, international organizations, foreign producers, or other approved agencies. Policy guidance pertaining to the general areas of the Military Assistance Program (MAP), Foreign Military Sales (FMS), and international Cooperative Logistics Support Arrangements (CLSA) is not affected by this part.</P>
            <FTNT>
              <P>
                <E T="21">1</E> Copies available from Naval Supply Depot, 5801 Tabor Avenue, Philadelphia, Pa. 19120, Attention: Code 300. </P>
            </FTNT>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.2</SECTNO>
            <SUBJECT>Applicability and scope.</SUBJECT>
            <P>The provisions of this part are applicable to those offices responsible for negotiation, implementation, monitorship and financial and management control of the co-production projects within OSD, DSA, and the Departments of the Army, Navy, and Air Force.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.3</SECTNO>
            <SUBJECT>Concept.</SUBJECT>
            <P>(a) The term <E T="03">co-production</E> as used herein encompasses any program wherein the U.S. Government, under the aegis of an international diplomatic level or Ministry of Defense-to-Department of Defense agreement, either directly through the FMS program, or indirectly through specific licensing arrangements by designated commercial firms, enables an eligible foreign government, international organization or designated commercial producer to acquire the “know-how” to manufacture or assemble, repair, maintain and operate, in whole or in part, a specific weapon, communication or support system, or an individual military item. The “know-how” furnished may include research, development production data and/or manufacturing machinery or tools, raw or finished materiel, components or major subassemblies, managerial skills, procurement assistance or quality-control procedures. Third country sales limitations and licensing agreements are also included as required.</P>
            <P>(b) Co-production may be limited to the assembly of a few end-items with a small input of local country parts, or it may extend to a major manufacturing effort requiring the build-up of capital industries.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.4</SECTNO>
            <SUBJECT>Objectives and policies.</SUBJECT>
            <P>(a) The major objectives to be attained through co-production projects are to:</P>
            <P>(1) Enable eligible countries to improve military readiness through expansion of their technical and military support capability.</P>
            <P>(2) Promote United States-Allied standardization of military materiel and equipment, which, in turn, would generate the establishment of uniform logistics support, procedures and expanded multinational operational capabilities.</P>

            <P>(b) Co-production programs directly benefit the United States through:<PRTPAGE P="29"/>
            </P>
            <P>(1) Creating in-country compatability with the U.S. standardized equipment, thereby creating Allied capability of supporting deployment of U.S. forces.</P>
            <P>(2) Promoting the standardization of materiel or equipment to integrate and strengthen international military operations in times of emergency or hostilities.</P>
            <P>(3) Encouraging multinational acceptance of strategic and tactical concepts and doctrine through the utilization of common military materiel.</P>
            <P>(4) Encouraging the creation of complementary forces in Allied countries.</P>
            <P>(5) Establishing or broadening the base for common and interchangeable logistics among free or Allied nations.</P>
            <P>(6) Serving to improve procurement, production, contract administration and mutual support capability of friendly Allied nations.</P>
            <P>(c) Co-production is considered to be an important component of the U.S. military foreign sales program and, as such, represents an essential element of U.S. foreign policy. Accordingly, it is DoD policy that initiation of co-production project agreements will be encouraged and supported by all elements of DoD under the following circumstances. When they:</P>
            <P>(1) Advance the objectives outlined in paragraphs (a) and (b) of this section.</P>
            <P>(2) Supplement and reinforce the U.S. FMS program.</P>
            <P>(3) Are in the best interest of the United States.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.5</SECTNO>
            <SUBJECT>Responsibilities and procedures.</SUBJECT>
            <P>(a) Co-production projects may be initiated by ASD(ISA) or, subject to prior ASD(ISA) approval, by the Military Departments; the Military Assistance Advisory Groups; and by authorized representatives of foreign governments and international organizations.</P>
            <P>(1) The cognizant DoD component will ensure appropriate coordination with ASD(ISA) and furnish technical and negotiating assistance as required.</P>
            <P>(2) After the agreement is signed, the appropriate DoD component will perform necessary managerial and reporting functions.</P>
            <P>(b) In conformance with responsibilities assigned in DoD Directive 5100.27.</P>
            <P>(1) The Assistant Secretary of Defense (International Security Affairs) will:</P>
            <P>(i) Develop and coordinate DoD positions for the negotiation of co-production agreements with foreign governments and international organizations; and</P>
            <P>(ii) Either conduct negotiations for specific agreements, or delegate this responsibility to an appropriate DoD component.</P>
            <P>(2) The Assistant Secretary of Defense (Installations and Logistics) will:</P>
            <P>(i) Assure during coordination of formal agreements, that the materiel to be committed under the co-production project will not adversely affect the U.S. defense supply or production base, or further limit critical materiel; that consideration had been given to the future logistical support of the equipment to be produced; and</P>
            <P>(ii) Monitor and act as OSD coordinator for implementation of co-production projects under formal agreements, in coordination with other elements of the Office of the Secretary of Defense, as required.</P>
            <P>(3) The Office of the General Counsel of the Department of Defense will assure necessary legal clearance, as required, prior to formalization of co-production project agreements.</P>
            <P>(4) The Assistant Secretary of Defense (Comptroller) will assist the ASD(ISA) and the ASD(I&amp;L) during coordination, as required, of formal coproduction agreements by providing necessary DoD representation and financial guidance with respect to pricing policies for U.S. military services and equipment, cost sharing, and reporting requirements under co-production agreements as they relate to international balance of payments.</P>
            <P>(5) Other OSD organizational elements will assist ASD(I&amp;L), as required, in assuring that the terms and conditions of co-production project agreements are met.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.6</SECTNO>
            <SUBJECT>Security.</SUBJECT>

            <P>(a) Classified information and materials will be treated as exchanges between those governments involved and will be safeguarded by each government in accordance with existing agreements.<PRTPAGE P="30"/>
            </P>
            <P>(b) In addition to adherence to existing security agreements, a security annex or clause will be developed as a part of the co-production agreement which will cover all security factors involved.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.7</SECTNO>
            <SUBJECT>Reports required.</SUBJECT>
            <P>(a) A short narrative type report will be submitted to ASD(I&amp;L) by the cognizant DoD component on a quarterly basis covering all formalized co-production projects and agreements including pending agreements with a high potential of being finalized within the next three (3) quarters. The report will briefly state project, project officer, background highlights, current production and status including anticipated and approximate monetary return to the United States, current problem areas (if any) and future major events or milestones. This reporting requirement has been assigned Report Control Symbol DD-I&amp;L (Q)834.</P>
            <P>(b) This report will be submitted in triplicate to OASD(I&amp;L) by the close of the last working day of the month following the close of the quarter. The first report under this part will cover the quarter ending March 31, 1968, and be due April 30, 1968. In addition, copies will be forwarded to the appropriate Unified Commands and MAAG's of the countries involved. Further distribution may be prescribed by the Military Department concerned.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 194.8</SECTNO>
            <SUBJECT>Effective date and implementation.</SUBJECT>
            <P>This part is effective immediately and encompasses all co-production agreements in effect or pending on the date of this part, and such agreements consummated subsequently.</P>
          </SECTION>
        </PART>
        <PART>
          <EAR>Pt. 195</EAR>
          <HD SOURCE="HED">PART 195—NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OF THE DEPARTMENT OF DEFENSE—EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>195.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <SECTNO>195.2</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <SECTNO>195.3</SECTNO>
            <SUBJECT>Application.</SUBJECT>
            <SECTNO>195.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <SECTNO>195.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <SECTNO>195.6</SECTNO>
            <SUBJECT>Assurances required.</SUBJECT>
            <SECTNO>195.7</SECTNO>
            <SUBJECT>Compliance information.</SUBJECT>
            <SECTNO>195.8</SECTNO>
            <SUBJECT>Conduct of investigations.</SUBJECT>
            <SECTNO>195.9</SECTNO>
            <SUBJECT>Procedure for effecting compliance.</SUBJECT>
            <SECTNO>195.10</SECTNO>
            <SUBJECT>Hearings.</SUBJECT>
            <SECTNO>195.11</SECTNO>
            <SUBJECT>Decisions and notices.</SUBJECT>
            <SECTNO>195.12</SECTNO>
            <SUBJECT>Judicial review.</SUBJECT>
            <SECTNO>195.13</SECTNO>
            <SUBJECT>Effect on other issuances.</SUBJECT>
            <SECTNO>195.14</SECTNO>
            <SUBJECT>Implementation.</SUBJECT>
            <APP>
              <E T="05">Appendix A to Part 195—Programs to Which This Part Applies</E>
            </APP>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>Sec. 602, 78 Stat. 252; 42 U.S.C. 2000d-1; and the laws referred to in appendix A.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>29 FR 19291, Dec. 31, 1964, unless otherwise noted. Redesignated at 56 FR 32965, July 18, 1991.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 195.1</SECTNO>
            <SUBJECT>Purpose.</SUBJECT>
            <P>The purpose of this part is to effectuate the provisions of Title VI of the Civil Rights Act of 1964 (referred to in this part as the “Act”) to the end that no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program or activity receiving Federal financial assistance from any component of the Department of Defense.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.2</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <P>(a) <E T="03">Component</E> means the Office of the Secretary of Defense, a military department or a Defense agency.</P>
            <P>(b) <E T="03">Responsible Department official</E> means the Secretary of Defense or other official of the Department of Defense or component thereof who by law or by delegation has the principal responsibility within the Department or component for the administration of the law extending such assistance.</P>
            <P>(c) The term <E T="03">United States</E> means the States of the United States, the District of Columbia, Puerto Rico, the Virgin Islands, American Samoa, Guam, Wake Island, the Canal Zone, and the territories and possessions of the United States, and the term “State” means any one of the foregoing.</P>
            <P>(d) The term <E T="03">Federal financial assistance</E> includes:</P>
            <P>(1) Grants and loans of Federal funds,</P>
            <P>(2) The grant or donation of Federal property and interests in property,</P>
            <P>(3) The detail of Federal personnel,<PRTPAGE P="31"/>
            </P>
            <P>(4) The sale and lease of, and the permission to use (on other than a casual or transient basis), Federal property or any interest in such property without consideration or at a nominal consideration, or at a consideration which is reduced for the purpose of assisting the recipient, or in recognition of the public interest to be served by such sale or lease to the recipient, and</P>
            <P>(5) Any Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance.</P>
            <P>(e) The term <E T="03">program</E> includes any program, project, or activity for the provision of services, financial aid, or other benefits to individuals, or for the provision of facilities for furnishing services, financial aid or other benefits to individuals. The services, financial aid, or other benefits provided under a program receiving Federal financial assistance shall be deemed to include any services, financial aid, or other benefits provided with the aid of Federal financial assistance or with the aid of any non-Federal funds, property, or other resources required to be expended or made available for the program to meet matching requirements or other conditions which must be met in order to receive the Federal financial assistance, and to include any services, financial aid, or other benefits provided in or through a facility provided with the aid of Federal financial assistance or such non-Federal resources.</P>
            <P>(f) The term <E T="03">facility</E> includes all or any portion of structures, equipment, or other real or personal property or interests therein, and the provision of facilities includes the construction, expansion, renovation, remodeling, alteration or acquisition of facilities.</P>
            <P>(g) The term <E T="03">recipient</E> means any State, political subdivision of any State, or instrumentality of any State or political subdivision, any public or private agency, institution, or organization, or other entity, or any individual, in any State, to whom Federal financial assistance is extended, directly or through another recipient, for any program, including any successor, assign, or transferee thereof, but such term does not include any ultimate beneficiary under any such program.</P>
            <P>(h) The term <E T="03">primary recipient</E> means any recipient which is authorized or required to extend Federal financial assistance to another recipient for the purpose of carrying out a program.</P>
            <P>(i) The term <E T="03">applicant</E> means one who submits an application, request, or plan required to be approved by a responsible Department official, or by a primary recipient, as a condition to eligibility for Federal financial assistance, and the term “application” means such an application, request or plan.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.3</SECTNO>
            <SUBJECT>Application.</SUBJECT>

            <P>This part applies to any program for which Federal financial assistance is authorized under a law administered by any component of the Department of Defense, including the federally assisted programs and activities listed in appendix A of this part. This directive applies to money paid, property transferred, or other Federal financial assistance extended under any such program after January 7, 1965 pursuant to an application approved prior to such date. This directive does not apply to: (a) Any Federal financial assistance by way of insurance guaranty contracts, (b) money paid, property transferred, or other assistance extended under any such program before January 7, 1965, (c) any assistance to any individual who is the ultimate beneficiary under any such program, or (d) any employment practice, under any such program, of any employer, employment agency, or labor organization, except as noted in § 195.4(b)(5) of this part. The fact that a program or activity is not listed in appendix A shall not mean, if title VI of the Act is otherwise applicable, that such program is not covered. Other programs under statutes now in force or hereinafter enacted may be added to this list by notice published in the <E T="04">Federal Register</E>.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17959, July 5, 1973. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.4</SECTNO>
            <SUBJECT>Policy.</SUBJECT>
            <P>(a) <E T="03">General.</E> No person in the United States shall, on the ground of race, color, or national origin be excluded from participation in, be denied the benefits of, or be otherwise subjected <PRTPAGE P="32"/>to discrimination under any program to which this (part) applies.</P>
            <P>(b) <E T="03">Specific discriminatory actions prohibited.</E> (1) A recipient under any program to which this part applies may not, directly or through contractual or other arrangements, on the ground of race, color, or national origin:</P>
            <P>(i) Deny an individual any service, financial aid, or other benefit provided under the program;</P>
            <P>(ii) Provide any service, financial aid, or other benefit to an individual which is different, or is provided in a different manner, from that provided to others under the program;</P>
            <P>(iii) In determining the site or location of facilities, a recipient may not make selections with the purpose of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any program to which this part applies, on the ground of race, color, or national origin; or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this part.</P>
            <P>(iv) Subject an individual to segregation or separate treatment in any matter related to his receipt of any service, financial aid, or other benefit under the program;</P>
            <P>(v) Restrict an individual in any way in the enjoyment of any advantage or privilege enjoyed by others receiving any service, financial aid, or other benefit under the program;</P>
            <P>(vi) Treat an individual differently from others in determining whether he satisfies any admission, enrollment, quota, eligibility, membership or other requirement or condition which individuals must meet in order to be provided any service, financial aid, or other benefit provided under the program;</P>
            <P>(vii) Deny an individual an opportunity to participate in the program through the provision of services or otherwise or afford him an opportunity to do so which is different from that afforded others under the program;</P>
            <P>(viii) Deny a person the opportunity to participate as a member of a planning or advisory body which is an integral part of the program.</P>
            <P>(2) A recipient, in determining the types of services, financial aid, or other benefits, or facilities which will be provided under any such program, or the class of individuals to whom, or the situations in which, such services, financial aid, other benefits, or facilities will be provided under any such program, or the class of individuals to be afforded an opportunity to participate in any such program, may not, directly or through contractual or other arrangements, utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program as respect individuals of a particular race, color, or national origin.</P>
            <P>(3) As used in this section the services, financial aid, or other benefits provided under a program receiving Federal financial assistance shall be deemed to include any service, financial aid, or other benefit provided in or through a facility provided with the aid of Federal financial assistance.</P>
            <P>(4)(i) In administering a program regarding which the recipient has previously discriminated against persons on the ground of race, color, or national origin, the recipient must take affirmative action to overcome the effects of prior discrimination.</P>
            <P>(ii) Even in the absence of such prior discrimination, a recipient in administering a program may take affirmative action to overcome the effects of conditions which resulted in limiting participation by persons of a particular race, color, or national origin.</P>

            <P>(5) Where a primary objective of the Federal financial assistance is not to provide employment, but nevertheless discrimination on the grounds of race, color or national origin in the employment practices of the recipient or other persons subject to this Directive tends, on the grounds of race, color, or national origin of the intended beneficiaries, to exclude intended beneficiaries from participation in, to deny them benefits of, or to subject them to discrimination under any program to which this Directive applies, the recipient or other persons subject to this Directive are prohibited from (directly or <PRTPAGE P="33"/>through contractual or other arrangements) subjecting an individual to discrimination on the grounds of race, color, or national origin in its employment practices under such program (including recruitment or recruitment advertising; employment, layoff or termination; upgrading, demotion or transfer; rates of pay and/or other forms of compensation; and use of facilities), to the extent necessary to assure equality of opportunity to, and nondiscriminatory treatment of the beneficiaries. Any action taken by a component pursuant to this provision with respect to a state or local agency subject to Standards for a Merit System of Personnel Administration, 45 CFR part 70, shall be consistent with those standards and shall be coordinated with the U.S. Civil Service Commission.</P>
            <P>(6) The enumeration of specific forms of prohibited discrimination in this section does not limit the generality of the prohibition in paragraph (a) of this section.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17959, July 5, 1973]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.5</SECTNO>
            <SUBJECT>Responsibilities.</SUBJECT>
            <P>(a) The Assistant Secretary of Defense (Manpower) shall be responsible for insuring that the policies of this part are effectuated throughout the Department of Defense. He may review from time to time as he deems necessary the implementation of these policies by the components of the Department of Defense.</P>
            <P>(b) The Secretary of each Military Department is responsible for implementing this part with respect to programs and activities receiving financial assistance from his Military Department; and the Assistant Secretary of Defense (Manpower) is responsible for similarly implementing this part with respect to all other components of the Department of Defense. Each may designate official(s) to fulfill this responsibility in accordance with § 195.2(b).</P>
            <P>(c) The Assistant Secretary of Defense (Manpower) or, after consultation with the Assistant Secretary of Defense (Manpower), the Secretary of each Military Department or other responsible Department official designated by the Assistant Secretary of Defense (Manpower) may assign to officials of other departments or agencies of the Government, with the consent of such departments or agencies, responsibilities in connection with the effectuation of the purposes of Title VI of the Act and this part (other than responsibility for final decision as provided in § 195.11), including the achievement of effective coordination and maximum uniformity within the Department and within the Executive Branch of the Government in the application of Title VI and this part to similar programs and in similar situations.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.6</SECTNO>
            <SUBJECT>Assurances required.</SUBJECT>
            <P>(a) <E T="03">General.</E> (1)(i) Every application for Federal financial assistance to carry out a program to which this part applies, except a program to which paragraph (b) of this section applies, and every application for Federal financial assistance to provide a facility shall, as a condition to its approval and the extension of any Federal financial assistance pursuant to the application, contain or be accompanied by an assurance that the program will be conducted or the facility operated in compliance with all requirements imposed by or pursuant to this part.</P>

            <P>(ii) In the case where the Federal financial assistance is to provide or is in the form of personal property, or real property or interest therein or structures thereon, the assurance shall obligate the recipient, or, in the case of a subsequent transfer, the transferee, for the period during which the property or structures are used for a purpose for which the Federal financial assistance is extended or for another purpose involving the provision of similar services and benefits, or for as long as the recipient retains ownership or possession of the property, whichever is longer. In all other cases the assurance shall obligate the recipient for the period during which Federal financial assistance is extended pursuant to the application. In any case in which Federal financial assistance is extended without an application having been made, such extension shall be subject to the same assurances as if an application had been made. The responsible <PRTPAGE P="34"/>Department official shall specify the form of the foregoing assurances for each program, and the extent to which like assurances will be required of subguarantees, contractors and subcontractors, transferees, successors in interest, and other participants in the program. Any such assurance shall include provisions which give the United States a right to seek its judicial enforcement.</P>
            <P>(2) In the case of real property, structures or improvements thereon, or interest therein, which was acquired through a program of Federal financial assistance, or in the case where Federal financial assistance is provided in the form of a transfer of real property or interest therein from the Federal Government, the instrument effecting or recording the transfer, shall contain a covenant running with the land assuring nondiscrimination for the period during which the real property is used for a purpose for which the Federal financial assistance is extended or for another purpose involving the provision of similar services or benefits, or for as long as the recipient retains ownership or possession of the property, whichever is longer. Where no transfer of property is involved, but property is improved under a program of Federal financial assistance, the recipient shall agree to include such a covenant in any subsequent transfer of such property. Where the property is obtained from the Federal Government, such covenant may also include a condition coupled with a right to be reserved by the Department to revert title to the property in the event of a breach of the covenant where, in the discretion of the responsible Department official, such a condition and right of reverter is appropriate to the program under which the real property is obtained and to the nature of the grant and the grantee. In the event a transferee of real property proposes to mortgage or otherwise encumber the real property as security for financing construction of new, or improvement of existing facilities on such property for the purposes for which the property was transferred, the responsible Department official may agree, upon request of the transferee and if necessary to accomplish such financing, and upon such conditions as he deems appropriate, to forbear the exercise of such right to revert title for so long as the lien of such mortgage or other encumbrance remains effective. In programs receiving Federal financial assistance in the form, or for the acquisition of real property or an interest in real property, to the extent that rights to space on, over, or under any such property are included as part of the program receiving such assistance, the nondiscrimination requirements of this part shall extend to any facility located wholly or in part in such space.</P>
            <P>(3) The assurance required in the case of a transfer of surplus personal property shall be inserted in a written agreement by and between the Department of Defense component concerned and the recipient.</P>
            <P>(b) <E T="03">Continuing State programs.</E> Every application by a State agency to carry out a program involving continuing Federal financial assistance to which this part applies shall as a condition to its approval and the extension of any Federal financial assistance pursuant to the application (1) contain or be accompanied by a statement that the program is (or, in the case of a new program, will be) conducted in compliance with all requirements imposed by or pursuant to this part, and (2) provide or be accompanied by provision for such methods of administration for the program as are found by the responsible Department official to give reasonable assurance that the applicant and all recipients of Federal financial assistance under such program will comply with all requirements imposed by or pursuant to this part. In cases of continuing State programs in which applications are not made, the extension of Federal financial assistance shall be subject to the same conditions under this subsection as if applications had been made.</P>
            <P>(c) <E T="03">Assurances from institutions.</E> (1) In the case of Federal financial assistance to an institution of higher education, the assurance required by this section shall extend to admission practices and to all other practices relating to the treatment of students.<PRTPAGE P="35"/>
            </P>
            <P>(2) The assurance required with respect to an institution of higher education, or any other institution, insofar as the assurance relates to the institution's practices with respect to admission or other treatment of individuals as students of the institution or to the opportunity to participate in the provision of services or other benefits to such individuals, shall be applicable to the entire institution unless the applicant establishes, to the satisfaction of the responsible Department official, that the institution's practices in designated parts or programs of the institution will in no way affect its practices in the program of the institution for which Federal financial assistance is sought, or the beneficiaries of or participants in such program. If in any such case the assistance sought is for the construction of a facility or part of a facility, the assurance shall in any event extend to the entire facility and to facilities operated in connection therewith.</P>
            <P>(d) <E T="03">Elementary and secondary schools.</E> The requirement of paragraph (a), (b), or (c) of this section, with respect to any elementary or secondary school or school system shall be deemed to be satisfied if such school or school system (1) is subject to a final order of a court of the United States for the desegregation of such school or school system, and provides an assurance that it will comply with such order, including any future modification of such order, or (2) submits a plan for the desegregation of such school or school system which the responsible official of the Department of Health, Education, and Welfare determines is adequate to accomplish the purposes of the Act and this part, and provides reasonable assurance that it will carry out such plan; in any case of continuing Federal financial assistance the said Department officer may reserve the right to redetermine, after such period as may be specified by him, the adequacy of the plan to accomplish the purpose of the Act or this part within the earliest practicable time. In any case in which a final order of a court of the United States for the desegregation of such school or school system is entered after submission of such a plan, such plan shall be revised to conform to such final order, including any future modification of said order.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17960, July 5, 1973]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.7</SECTNO>
            <SUBJECT>Compliance information.</SUBJECT>
            <P>(a) <E T="03">Cooperation and assistance.</E> Each responsible Department official shall to the fullest extent practicable seek the cooperation of recipients in obtaining compliance with this part and shall provide assistance and guidance to recipients to help them comply voluntarily with this part.</P>
            <P>(b) <E T="03">Compliance reports.</E> Each recipient shall keep such records and submit to the responsible Department official timely, complete and accurate compliance reports at such times, and in such form and containing such information, as the responsible Department official may determine to be necessary to enable him to ascertain whether the recipient has complied or is complying with this part. In general, recipients should have available for the Department racial and ethnic data showing the extent to which members of minority groups are beneficiaries of federally assisted programs. In the case of any program under which a primary recipient extends Federal financial assistance to any other recipient, such other recipient shall also submit such compliance reports to the primary recipient as may be necessary to enable the primary recipient to carry out its obligations imposed pursuant to this part.</P>
            <P>(c) <E T="03">Access to sources of information.</E> Each recipient shall permit access by the responsible Department official during normal business hours to such of its books, records, accounts, and other sources of information, and its facilities as may be pertinent to ascertain compliance with this part. Where any information required of a recipient is in the exclusive possession of any other institution or person and this institution or person shall fail or refuse to furnish this information, the recipient shall so certify in its report and shall set forth what efforts it has made to obtain the information.</P>
            <P>(d) <E T="03">Information to beneficiaries and participants.</E> Each recipient shall make available to participants, beneficiaries, and other interested persons such information regarding the provisions of <PRTPAGE P="36"/>this part and its applicability to the program under which the recipient receives Federal financial assistance, and make such information available to them in such manner, as the responsible Department official finds necessary to apprise such persons of the protections against discrimination assured them by the Act and this part.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17960, July 5, 1973]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.8</SECTNO>
            <SUBJECT>Conduct of investigations.</SUBJECT>
            <P>(a) <E T="03">Periodic compliance reviews.</E> The responsible Department official or his designee(s) shall from time to time review the practices of recipients to determine whether they are complying with this part.</P>
            <P>(b) <E T="03">Complaints.</E> Any person who believes himself or any specific class of individuals to be subjected to discrimination prohibited by this part may by himself or by a representative file with the responsible Department official a written complaint. A complaint must be filed not later than 180 days from the date of the alleged discrimination, unless the time for filing is extended by the responsible Department official.</P>
            <P>(c) <E T="03">Investigations.</E> The responsible Department official will make a prompt investigation whenever a compliance review, report, complaint, or any other information indicates a possible failure to comply with this part. The investigation should include, where appropriate, a review of the pertinent practices and policies of the recipient, the circumstances under which the possible noncompliance with this part occurred, and other factors relevant to a determination of whether the recipient has failed to comply with this part.</P>
            <P>(d) <E T="03">Resolution of matters.</E> (1) If an investigation pursuant to paragraph (c) of this section indicates a failure to comply with this part, the responsible Department official will so inform the recipient and the matter will be resolved by informal means whenever possible. If it has been determined that the matter cannot be resolved by informal means, action will be taken as provided in § 195.9.</P>
            <P>(2) If an investigation does not warrant action pursuant to paragraph (d)(1) of this section, the responsible Department official will so inform the recipient and the complainant, if any, in writing.</P>
            <P>(e) <E T="03">Intimidatory or retaliatory acts prohibited.</E> No recipient or other person shall intimidate, threaten, coerce, or discriminate against any individual for the purpose of interfering with any right or privilege secured by section 601 of the Act or this part, or because he has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under this part. The identity of complainants shall not be disclosed except when necessary to carry out the purposes of this part including the conduct of any investigation, hearing, or judicial proceeding arising thereunder.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17960, July 5, 1974. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.9</SECTNO>
            <SUBJECT>Procedure for effecting compliance.</SUBJECT>
            <P>(a) <E T="03">General.</E> If there appears to be a failure or threatened failure to comply with this part, and if the noncompliance or threatened noncompliance cannot be corrected by informal means, compliance with this part may be effected by the suspension or termination of or refusal to grant or to continue Federal financial assistance or by any other means authorized by law as determined by the responsible Department official. Such other means may include, but are not limited to (1) a reference to the Department of Justice with a recommendation that appropriate proceedings be brought to enforce any rights of the United States under any law of the United States (including other titles of the Act), or any assurance or other contractual undertaking, and (2) any applicable proceedings under State or local law.</P>
            <P>(b) <E T="03">Noncompliance with § 195.6.</E> If an applicant fails or refuses to furnish an assurance required under § 195.6 or otherwise fails or refuses to comply with a requirement imposed by or pursuant to that section Federal financial assistance may be refused in accordance with the procedures of paragraph (c) of this section. The component of the Department of Defense concerned shall not be required to provide assistance in such a <PRTPAGE P="37"/>case during the pendency of the administrative proceedings under such paragraph except that the component shall continue assistance during the pendency of such proceedings where such assistance is due and payable pursuant to an application therefor approved prior to the effective date of this part.</P>
            <P>(c) <E T="03">Termination of or refusal to grant or to continue Federal financial assistance.</E> Except as provided in paragraph (b) of this section no order suspending, terminating or refusing to grant or continue Federal financial assistance shall become effective until (1) the responsible Department official has advised the applicant or recipient of his failure to comply and has determined that compliance cannot be secured by voluntary means, (2) there has been an express finding, after opportunity for a hearing (as provided in § 195.10), of a failure by the applicant or recipient to comply with a requirement imposed by or pursuant to this part, (3) the action has been approved by the Secretary of Defense pursuant to § 195.11, and (4) the expiration of 30 days after the Secretary of Defense has filed with the committee of the House and the committee of the Senate having legislative jurisdiction over the program involved, a full written report of the circumstances and the grounds for such action. Any action to suspend or terminate or to refuse to grant or to continue Federal financial assistance shall be limited to the particular political entity, or part thereof, or other applicant or recipient as to whom such a finding has been made and shall be limited in its effect to the particular program, or part thereof, in which such noncompliance has been so found.</P>
            <P>(d) <E T="03">Other means authorized by law.</E> No action to affect compliance by any other means authorized by law shall be taken until (1) the responsible Department official has determined that compliance cannot be secured by voluntary means, (2) the action has been approved by the Assistant Secretary of Defense (Manpower), (3) the recipient or other person has been notified of its failure to comply and of the action to be taken to effect compliance, and (4) the expiration of at least 10 days from the mailing of such notice to the recipient or other person. During this period of at least 10 days additional efforts shall be made to persuade the recipient or other person to comply with this part and to take such corrective action as may be appropriate.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.10</SECTNO>
            <SUBJECT>Hearings.</SUBJECT>
            <P>(a) <E T="03">Opportunity for hearing.</E> Whenever an opportunity for a hearing is required by § 195.9, reasonable notice shall be given by registered or certified mail, return receipt requested, to the affected applicant or recipient. This notice shall advise the applicant or recipient of the action proposed to be taken, the specific provision under which the proposed action against it is to be taken, and the matters of fact or law asserted as the basis for this action, and either (1) fix a date not less than 20 days after the date of such notice within which the applicant or recipient may request of the responsible Department official that the matter be scheduled for hearing or (2) advise the applicant or recipient that the matter in question has been set down for hearing at a stated place and time. The time and place so fixed shall be reasonable and shall be subject to change for cause. The complainant, if any, shall be advised of the time and place of hearing. An applicant or recipient may waive a hearing and submit written information and argument. The failure of an applicant or recipient to request a hearing under this paragraph or to appear at a hearing for which a date has been set shall be deemed to be a waiver of the right to a hearing under section 602 of the Act and § 195.11(c) and consent to the making of a decision on the basis of such information as is available.</P>
            <P>(b) <E T="03">Time and place of hearing.</E> Hearings shall be held at the offices of the responsible component of the Department of Defense in Washington, D.C., at a time fixed by the responsible Department official unless he determines that the convenience of the applicant or recipient or of the component requires that another place be selected. Hearings shall be held before the responsible Department official or, at his discretion, before a hearing examiner designated by him.<PRTPAGE P="38"/>
            </P>
            <P>(c) <E T="03">Hearing examiner.</E> The examiner shall be a field grade officer or civilian employee above the grade of GS-12 (or the equivalent) who shall be a person admitted to practice law before a Federal court or the highest court of a State.</P>
            <P>(d) <E T="03">Right to counsel.</E> In all proceedings under this section, the applicant or recipient and the responsible component of the Department shall have the right to be represented by counsel.</P>
            <P>(e) <E T="03">Procedures.</E> (1) The recipient shall receive an open hearing at which he or his counsel may examine any witnesses present. Both the responsible Department official and the applicant or recipient shall be entitled to introduce all relevant evidence on the issues as stated in the notice for hearing or as determined by the officer conducting the hearing at the outset of or during the hearing.</P>
            <P>(2) Technical rules of evidence shall not apply to hearings conducted pursuant to this part, but rules or principles designed to assure production of the most credible evidence available and to subject testimony to test by cross-examination shall be applied where reasonably necessary by the officer conducting the hearing. The hearing officer may exclude irrelevant, immaterial, or unduly repetitious evidence. All documents and other evidence offered or taken for record shall be open to examination by the parties and opportunity shall be given to refute facts and arguments advanced on either side of the issues. A transcript shall be made of the oral evidence except to the extent the substance thereof is stipulated for the record. All decisions shall be based upon the hearing record and written findings shall be made.</P>
            <P>(f) <E T="03">Consolidated or joint hearings.</E> In cases in which the same or related facts are asserted to constitute noncompliance with this part with respect to two or more programs to which this part applies, or noncompliance with this part and the regulations of one or more other Federal departments or agencies issued under Title VI of the Act, the Assistant Secretary of Defense (Manpower), the Secretary of a Military Department, or other responsible Department official designated by the Assistant Secretary of Defense (Manpower) after consultation with the Assistant Secretary of Defense (Manpower) may, by agreement with such other departments or agencies where applicable, provide for the conduct of consolidated or joint hearings, and for the application to such hearings of appropriate procedures not inconsistent with this part. Final decisions in such cases, insofar as this part is concerned, shall be made in accordance with § 195.11.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 30 FR 133, Jan. 7, 1965. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.11</SECTNO>
            <SUBJECT>Decisions and notices.</SUBJECT>
            <P>(a) <E T="03">Decision by person other than the responsible department official.</E> If the hearing is held by a hearing examiner such hearing examiner shall either make an initial decision, if so authorized, or certify the entire record including his recommended findings and proposed decision to the responsible Department official for a final decision, and a copy of such initial decision or certification shall be mailed to the applicant or recipient. Where the initial decision is made by the hearing examiner the applicant or recipient may within 30 days of the mailing of such notice of initial decision file with the responsible Department official his exceptions to the initial decision, with his reasons therefor. In the absence of exceptions, the responsible Department official may on his own motion within 45 days after the initial decision serve on the applicant or recipient a notice that he will review the decision. Upon the filing of such exceptions or of such notice of review the responsible Department official shall review the initial decision and issue his own decision thereon including the reasons therefor. In the absence of either exceptions or a notice of review the initial decision shall constitute the final decision of the responsible Department official.</P>
            <P>(b) <E T="03">Decisions on record or review by the responsible department official.</E> Whenever a record is certified to the responsible Department official for decision or he reviews the decision of a hearing examiner pursuant to paragraph (a) of this section or whenever the responsible Department official conducts the hearing, the applicant or recipient shall be <PRTPAGE P="39"/>given reasonable opportunity to file with him briefs or other written statements of its contentions, and a copy of the final decision of the responsible Department official shall be given in writing to the applicant or recipient and to the complainant, if any.</P>
            <P>(c) <E T="03">Decisions on record where a hearing is waived.</E> Whenever a hearing is waived pursuant to § 195.10(a), a decision shall be made by the responsible Department official on the record and a copy of such decision shall be given in writing to the applicant or recipient, and to the complainant, if any.</P>
            <P>(d) <E T="03">Rulings required.</E> Each decision of a hearing officer or responsible Department official shall set forth his ruling on each finding, conclusion, or exception presented, and shall identify the requirement or requirements imposed by or pursuant to this part with which it is found that the applicant or recipient has failed to comply.</P>
            <P>(e) <E T="03">Approval by the Secretary of Defense.</E> Any final decision of a responsible Department official which provides for the suspension or termination of, or the refusal to grant or continue Federal financial assistance, or the imposition of any other sanction available under this part or the Act, shall promptly be transmitted to the Secretary of Defense, who may approve such decision, may vacate it, or remit or mitigate any sanction imposed.</P>
            <P>(f) <E T="03">Contents of orders.</E> The final decision may provide for suspension or termination of, or refusal to grant or continue Federal financial assistance, in whole or in part, under the program involved, and may contain such terms, conditions, and other provisions as are consistent with and will effectuate the purposes of the Act and this part, including provisions designed to assure that no Federal financial assistance will thereafter be extended under such program to the applicant or recipient determined by such decision to be in default in its performance of an assurance given by it pursuant to this part, or to have otherwise failed to comply with this part, unless and until it corrects its noncompliance and satisfies the responsible Department official that it will fully comply with this part.</P>
            <P>(g) <E T="03">Post-termination proceedings.</E> (1) An applicant or recipient adversely affected by an order issued under paragraph (f) of this section shall be restored to full eligibility to receive Federal financial assistance if it satisfies the terms and conditions of that order for such eligibility or if it brings itself into compliance with this part and provides reasonable assurance that it will fully comply with this part.</P>
            <P>(2) Any applicant or recipient adversely affected by an order entered pursuant to paragraph (f) of this section may at any time request the responsible Department official to restore fully its eligibility to receive Federal financial assistance. Any such request shall be supported by information showing that the applicant or recipient has met the requirements of paragraph (g)(1) of this section. If the responsible Department official determines that those requirements have been satisfied, he shall restore such eligibility.</P>
            <P>(3) If the responsible Department official denies any such request, the applicant or recipient may submit a request for a hearing in writing, specifying why it believes such official to have been in error. It shall thereupon be given an expeditious hearing, with a decision on the record, in accordance with rules of procedure issued by the responsible Department official. The applicant or recipient will be restored to such eligibility if it proves at such a hearing that it satisfied the requirements of paragraph (g)(1) of this section. While proceedings under this subsection are pending, the sanctions imposed by the order issued under paragraph (f) of this section shall remain in effect.</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 38 FR 17960, July 5, 1973. Redesignated and amended at 56 FR 32965, July 18, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.12</SECTNO>
            <SUBJECT>Judicial review.</SUBJECT>
            <P>Action taken pursuant to section 602 of the Act is subject to judicial review as provided in section 603 of the Act.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.13</SECTNO>
            <SUBJECT>Effect on other issuances.</SUBJECT>

            <P>All issuances heretofore issued by any officer of the Department of Defense or its components which impose requirements designed to prohibit any discrimination against individuals on the ground of race, color, or national <PRTPAGE P="40"/>origin under any program to which this part applies, and which authorize the suspension or termination of or refusal to grant or to continue Federal financial assistance to any applicant for or recipient of such assistance under such program for failure to comply with such requirements, are hereby superseded to the extent that such discrimination is prohibited by this part, except that nothing in this part shall be deemed to relieve any person of any obligation assumed or imposed under any such superseded regulation, order, instruction, or like direction prior to the effective date of this part. Nothing in this part, however, shall be deemed to supersede any of the following (including future amendments thereof):</P>
            <P>(a) Executive Orders 10925 and 11114 and issuances thereunder,</P>
            <P>(b) The “Standards for a Merit System of Personnel Administration,” issued jointly by the Secretaries of Defense, of Health, Education, and Welfare, and of Labor, 28 FR 734, or</P>
            <P>(c) Executive Order 11063 and issuances thereunder, or any other issuances, insofar as such Order or issuances prohibit discrimination on the ground of race, color, or national origin in any program or situation to which this part is inapplicable, or prohibit discrimination on any other ground.</P>
          </SECTION>
          <SECTION>
            <SECTNO>§ 195.14</SECTNO>
            <SUBJECT>Implementation.</SUBJECT>
            <P>The Secretary of each Military Department shall submit regulations implementing this part to the Assistant Secretary of Defense (Manpower).</P>
          </SECTION>
          <APPENDIX>
            <EAR>Pt. 195, App. A</EAR>
            <HD SOURCE="HED">Appendix A to Part 195—Programs to Which This Part Applies</HD>
            <P>1. The Army and Air National Guard (Title 32, United States Code).</P>
            <P>2. Various programs involving loan or other disposition of surplus property (various general and specialized statutory provisions including: 40 United States Code 483, 484, 512; 49 United States Code 1101-1119; 10 United States Code 2541, 2542, 2543, 2572, 2662, 7308, 7541, 7542, 7545, 7546, 7547).</P>
            <P>3. National Program for Promotion of Rifle Practice (10 United States Code 4307 and annual Department of Defense Appropriation Act).</P>
            <P>4. National Defense Cadet Corps Program (10 United States Code 3540(b), 4651).</P>
            <P>5. Office of Civil Defense assistance to programs of adult education in civil defense subjects (50 United States Code App. 2281 (e), (f)).</P>
            <P>6. Office of Civil Defense radiological instruments grants (50 United States Code App. 2281(h)).</P>
            <P>7. Office of Civil Defense program (with Public Health Service) for development of instructional materials on medical self-help (50 United States Code App. 2281 (e), (f)).</P>
            <P>8. Office of Civil Defense university extension programs for civil defense instructor training (50 United States Code App. 2281 (e)).</P>
            <P>9. Office of Civil Defense programs for survival supplies and equipment, survival training, emergency operating center construction, and personnel and administrative expenses (50 United States Code App. 2281(i), 2285).</P>
            <P>10. Office of Civil Defense Shelter Provisioning Program (50 United States Code App. 2281(h)).</P>
            <P>11. Office of Civil Defense assistance to students attending Office of Civil Defense schools (50 United States Code App. 2281(e)).</P>
            <P>12. Office of Civil Defense loans of equipment or materials from OCD stockpiles for civil defense, including local disaster purposes (50 United States Code App. 2281).</P>
            <P>13. Navy Science Cruiser Program (SecNav Instruction 5720.19A).</P>
            <P>14. Civil Air Patrol (10 United States Code 9441).</P>
            <P>15. Research grants made under the authority of Pub. L. 85-934 (42 United States Code 1892).</P>
            <P>16. Contracts with nonprofit institutions of higher education or with nonprofit organizations whose primary purpose is the conduct of scientific research, wherein title to equipment purchased with funds under such contracts may be vested in such institutions or organizations under the authority of Pub. L. 85-934 (42 United States Code 1891).</P>
            <P>17. Army Corps of Engineers participation in cooperative investigations and studies concerning erosion of shores of coastal and lake waters (33 United States Code 426).</P>
            <P>18. Army Corps of Engineers assistance in the construction of works for the restoration and protection of shores and beaches (33 United States Code 426e-h).</P>
            <P>19. Public park and recreational facilities at water resource development projects under the administrative jurisdiction of the Department of the Army (16 United States Code 460d and Federal Water Project Recreation Act, Pub. L. 89-72, 79 Stat. 218, July 9, 1965).</P>

            <P>20. Payment to States of proceeds of lands acquired by the United States for flood control, navigation, and allied purposes (33 United States Code 701-c-3).<PRTPAGE P="41"/>
            </P>
            <P>21. Grants of easements without consideration, or at a nominal or reduced consideration, on lands under the control of the Department of the Army at water resource development projects (33 United States Code 558c and 702d-1; 10 United States Code 2668 and 2669); 43 United States Code 961; 40 United States Code 319).</P>
            <P>22. Army Corps of Engineers assistance in the construction of small boat harbor proj-ects (33 United States Code 540 and 577, and 47 Stat. 42, Feb. 10, 1932).</P>
            <P>23. Emergency bank protection works constructed by the Army Corps of Engineers for protection of highways, bridge approaches, and public works (33 United States Code 701r).</P>
            <P>24. Assistance to States and local interests in the development of water supplies for municipal and industrial purposes in connection with Army Corps of Engineers reservoir projects (Water Supply Act of 1958, 43 United States Code 390b).</P>
            <P>25. Army Corps of Engineers contracts for remedial works under authority of section 111 of Act of July 3, 1958 (33 United States Code 633).</P>
            <CITA>[29 FR 19291, Dec. 31, 1964, as amended at 31 FR 6831, May 7, 1966]</CITA>
          </APPENDIX>
        </PART>
        <PART>
          <RESERVED>PART 196 [RESERVED]</RESERVED>
        </PART>
        <PART>
          <EAR>Pt. 199</EAR>
          <HD SOURCE="HED">PART 199—CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS)</HD>
          <CONTENTS>
            <SECHD>Sec.</SECHD>
            <SECTNO>199.1</SECTNO>
            <SUBJECT>General provisions.</SUBJECT>
            <SECTNO>199.2</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <SECTNO>199.3</SECTNO>
            <SUBJECT>Eligibility.</SUBJECT>
            <SECTNO>199.4</SECTNO>
            <SUBJECT>Basic program benefits.</SUBJECT>
            <SECTNO>199.5</SECTNO>
            <SUBJECT>Program for Persons with Disabilities (PFPWD).</SUBJECT>
            <SECTNO>199.6</SECTNO>
            <SUBJECT>Authorized providers.</SUBJECT>
            <SECTNO>199.7</SECTNO>
            <SUBJECT>Claims submission, review, and payment.</SUBJECT>
            <SECTNO>199.8</SECTNO>
            <SUBJECT>Double coverage.</SUBJECT>
            <SECTNO>199.9</SECTNO>
            <SUBJECT>Administrative remedies for fraud, abuse, and conflict of interest.</SUBJECT>
            <SECTNO>199.10</SECTNO>
            <SUBJECT>Appeal and hearing procedures.</SUBJECT>
            <SECTNO>199.11</SECTNO>
            <SUBJECT>Overpayments recovery.</SUBJECT>
            <SECTNO>199.12</SECTNO>
            <SUBJECT>Third party recoveries.</SUBJECT>
            <SECTNO>199.13</SECTNO>
            <SUBJECT>Active duty dependents dental plan.</SUBJECT>
            <SECTNO>199.14</SECTNO>
            <SUBJECT>Provider reimbursement methods.</SUBJECT>
            <SECTNO>199.15</SECTNO>
            <SUBJECT>Quality and utilization review peer review organization program.</SUBJECT>
            <SECTNO>199.16</SECTNO>
            <SUBJECT>Supplemental Health Care Program for active duty members.</SUBJECT>
            <SECTNO>199.17</SECTNO>
            <SUBJECT>TRICARE program.</SUBJECT>
            <SECTNO>199.18</SECTNO>
            <SUBJECT>Uniform HMO Benefit.</SUBJECT>
            <SECTNO>199.20</SECTNO>
            <SUBJECT>Continued Health Care Benefit Program (CHCBP).</SUBJECT>
            <SECTNO>199.21</SECTNO>
            <SUBJECT>TRICARE Selected Reserve Dental Program (TSRDP).</SUBJECT>
            <SECTNO>199.22</SECTNO>
            <SUBJECT>TRICARE Retiree Dental Program (TRDP).</SUBJECT>
            <APP>
              <E T="05">Appendix A to Part 199—Acronyms</E>
            </APP>
          </CONTENTS>
          <AUTH>
            <HD SOURCE="HED">Authority:</HD>
            <P>5 U.S.C. 301; 10 U.S.C. chapter 55.</P>
          </AUTH>
          <SOURCE>
            <HD SOURCE="HED">Source:</HD>
            <P>51 FR 24008, July 1, 1986, unless otherwise noted.</P>
          </SOURCE>
          <SECTION>
            <SECTNO>§ 199.1</SECTNO>
            <SUBJECT>General provisions.</SUBJECT>
            <P>(a) <E T="03">Purpose.</E> This part prescribes guidelines and policies for the administration of the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) for the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard, the Commissioned Corps of the U.S. Public Health Service (USPHS) and the Commissioned Corps of the National Oceanic and Atmospheric Administration (NOAA).</P>
            <P>(b) <E T="03">Applicability—</E>(1) <E T="03">Geographic.</E> This part is applicable geographically within the 50 States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, and the United States possessions and territories, and in all foreign countries, unless specific exemptions are granted in writing by the Director, OCHAMPUS, or a designee.</P>
            <P>(2) <E T="03">Agency.</E> The provisions of this part apply throughout the Department of Defense (DoD), the Coast Guard, the Commissioned Corps of the USPHS, and the Commissioned Corps of the NOAA.</P>
            <P>(c) <E T="03">Authority and responsibility—</E>(1) <E T="03">Legislative authority—</E>(i) <E T="03">Joint regulations.</E> 10 U.S.C. chapter 55 authorizes the Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Transportation jointly to prescribe regulations for the administration of CHAMPUS.</P>
            <P>(ii) <E T="03">Administration.</E> 10 U.S.C. chapter 55 also authorizes the Secretary of Defense to administer CHAMPUS for the Army, Navy, Air Force, and Marine Corps under DoD jurisdiction, the Secretary of Transportation to administer CHAMPUS for the Coast Guard, when the Coast Guard is not operating as a service in the Navy, and the Secretary of Health and Human Services to administer CHAMPUS for the Commissioned Corps of the NOAA and the USPHS.<PRTPAGE P="42"/>
            </P>
            <P>(2) <E T="03">Organizational delegations and assignments—</E>(i) <E T="03">Assistant Secretary of Defense (Health Affairs) (ASD(HA)).</E> The Secretary of Defense, by 32 CFR part 367, delegated authority to the ASD(HA) to provide policy guidance, management control and coordination as required for CHAMPUS, and to develop, issue, and maintain regulations with the coordination of the Military Departments and consistent with DoD 5025.1-M.<SU>1</SU>
              <FTREF/> Additional implementing authority is contained in DoD Directive 5105.46.<SU>2</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>1</SU> Copies may be obtained, if needed, from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161.</P>
            </FTNT>
            <FTNT>
              <P>
                <SU>2</SU> Copies may be obtained; if needed from the Naval Publications and Forms Center, 5801 Tabor Avenue, Code 301, Philadelphia, PA 19120.</P>
            </FTNT>
            <P>(ii) <E T="03">Department of Health and Human Services.</E> The Secretary of Health and Human Services has delegated authority to the Assistant Secretary for Health, DHHS, to consult with the Secretary of Defense or a designee and to approve and issue joint regulations implementing 10 U.S.C. chapter 55. This delegation was effective April 19, 1976 (41 FR 18698, May 6, 1976).</P>
            <P>(iii) <E T="03">Department of Transportation.</E> The Secretary of Transportation has delegated authority to the Commandant, United States Coast Guard, to consult with the Secretary of Defense or a designee and to approve an issue joint regulations implementing 10 U.S.C., chapter 55.</P>
            <P>(iv) <E T="03">Office of CHAMPUS (OCHAMPUS).</E> By DoD Directive 5105.46, OCHAMPUS was established as an OSD field activity under the policy guidance and direction of the ASD(HA). The Director, OCHAMPUS, is directed to execute the following responsibilities and functions:</P>
            <P>(A) Supervise and administer the programs and missions to:</P>
            <P>(<E T="03">1</E> ) Provide technical direction and guidance on organizational, administrative, and operational matters.</P>
            <P>(<E T="03">2</E> ) Conduct studies and research activities in the health care area to assist in formulating policy required to guide OCHAMPUS in carrying out its programs.</P>
            <P>(<E T="03">3</E> ) Enter into agreements through the Department of Defense with respect to the Military Departments or other U.S. Government entities, as required, for the effective performance of CHAMPUS.</P>
            <P>(<E T="03">4</E> ) Supervise and administer OCHAMPUS financial management activities to include:</P>
            <P>(<E T="03">i</E> ) Formulating budget estimates and justifications to be submitted to the Deputy Assistant Secretary of Defense (Administration) (DASD(A)) for inclusion in the overall budget for the Office of the Secretary of Defense.</P>
            <P>(<E T="03">ii</E> ) Ensuring the establishment and maintenance of necessary accounting records and submission of required financial reports to the DASD(A).</P>
            <P>(<E T="03">iii</E> ) Ensuring the effective execution of approved budgets.</P>
            <P>(<E T="03">5</E> ) Contract for claims processing services, studies and research, supplies, equipment, an other services necessary to carry out the CHAMPUS programs.</P>
            <P>(<E T="03">6</E> ) Monitor claims adjudication and processing contracts to ensure that CHAMPUS fiscal intermediaries are fulfilling their obligations.</P>
            <P>(<E T="03">7</E> ) Convey appropriate CHAMPUS information to providers of care, practitioners, professional societies, health industry organizations, fiscal agents, hospital contractors, and others who have need of such information.</P>
            <P>(<E T="03">8</E> ) Collect, maintain, and analyze program cost and utilization data appropriate for preparation of budgets, fiscal planning, and as otherwise needed to carry out CHAMPUS programs and missions.</P>
            <P>(<E T="03">9</E> ) Arrange for the facilities logistical and administrative support to be provided by the Military Departments.</P>
            <P>(<E T="03">10</E> ) Execute such other functions as appropriate to administer the programs and missions assigned.</P>
            <P>(B) Direct and control of the office, activities, and functions of OCHAMPUS Europe (OCHAMPUSEUR).</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The Director, OCHAMPUS, may also establish similar offices for OCHAMPUS Southern Hemisphere (OCHAMPUSSO) and OCHAMPUS Pacific (OCHAMPUSPAC).</P>
            </NOTE>

            <P>(C) Develop for issuance, subject to approval by the ASD(HA), such policies <PRTPAGE P="43"/>or regulations as required to administer and manage CHAMPUS effectively.</P>
            <P>(v) <E T="03">Evidence of eligibility.</E> The Department of Defense, through the Defense Enrollment Eligibility Reporting System (DEERS), is responsible for establishing and maintaining a listing of persons eligible to receive benefits under CHAMPUS. Identification cards or devices bearing information necessary for preliminary evidence of eligibility, subject to verification through the DEERS, shall be issued to eligible persons by the appropriate Uniformed Services (DoD 1341.1-M, “Defense Enrollment Eligibility Reporting System (DEERS) Program Manual”).</P>
            <P>(d) <E T="03">Medical benefits program.</E> The CHAMPUS is a program of medical benefits provided by the U.S. Government under public law to specified categories of individuals who are qualified for these benefits by virtue of their relationship to one of the seven Uniformed Services. Although similar in structure in many of its aspects, CHAMPUS is not an insurance program in that it does not involve a contract guaranteeing the indemnification of an insured party against a specified loss in return for a premium paid. Further, CHAMPUS is not subject to those state regulatory bodies or agencies that control the insurance business generally.</P>
            <P>(e) <E T="03">Program funds.</E> The funds used by CHAMPUS are appropriated funds furnished by the Congress through the annual appropriation acts for the Department of Defense and the DHHS. These funds are further disbursed by agents of the government under contracts negotiated by the Director, OCHAMPUS, or a designee, under the provisions of the Federal Aquisition Regulation (FAR). These agents (referred to in this part as CHAMPUS fiscal intermediaries) receive claims against CHAMPUS and adjudicate the claims under this part and in accordance with administrative procedures and instructions prescribed in their contracts. The funds expended for CHAMPUS benefits are federal funds provided CHAMPUS fiscal intermediaries solely to pay CHAMPUS claims, and are not a part of or obtained from the CHAMPUS fiscal intermediary's funds related to other programs or insurance coverage. CHAMPUS fiscal intermediaries are reimbursed for the adjudication and payment of CHAMPUS claims at a rate (generally fixed-price) prescribed in their contracts.</P>
            <P>(f) <E T="03">Claims adjudication and processing.</E> The Director, OCHAMPUS, is responsible for making such arrangements as are necessary to adjudicate and process CHAMPUS claims worldwide.</P>
            <P>(1) <E T="03">The United States</E>—(i) <E T="03">Contracting out.</E> The primary method of processing CHAMPUS claims in the United States is through competitively procured, fixed-price contracts. The Director, OCHAMPUS, or a designee, is responsible for negotiating, under the provisions of the FAR, contracts for the purpose of adjudicating and processing CHAMPUS claims (and related supporting activities).</P>
            <P>(ii) <E T="03">In-house.</E> The Director, OCHAMPUS, or a designee, is authorized to adjudicate and process certain CHAMPUS claims in-house at OCHAMPUS, when it is determined to be in the best interests of CHAMPUS subject to applicable considerations set forth in OMB Circular A-76. Such in-house claims processing may involve special or unique claims, or all claims for a specific geographic area.</P>
            <P>(2) <E T="03">Outside the United States</E>—(i) <E T="03">Special subsidiary office or contracting out.</E> For adjudicating and processing CHAMPUS claims for services or supplies provided outside the United States, the Director, OCHAMPUS, or a designee, has the option of either setting up a special subsidiary claims paying operation (such as OCHAMPUSEUR) or contracting out as described in paragraph (f)(1)(i) of this section. Such claims paying operations are reviewed periodically to determine whether current arrangements continue to be appropriate and the most effective.</P>
            <P>(ii) <E T="03">Support agreements.</E> In those situations outside the United States that demand special arrangements, the Director, OCHAMPUS, may enter into support agreements through the Department of Defense with any of the Military Departments or other government agency to process CHAMPUS claims in specific geographic locations. Such agreements may be negotiated for such period of time as the Director, <PRTPAGE P="44"/>OCHAMPUS, or designee, may determine to be necessary to meet identified special demands.</P>
            <P>(g) <E T="03">Recommendations for change to part.</E> The Director, OCHAMPUS, or a designee, shall establish procedures for receiving and processing recommendations for changes to this part from interested parties.</P>
            <P>(h) <E T="03">CHAMPUS, claims forms.</E> The Director, OCHAMPUS, or a designee, is responsible for the development and updating of all CHAMPUS claim forms and any other forms necessary in the administration of CHAMPUS.</P>
            <P>(i) <E T="03">The CHAMPUS handbook.</E> The Director, OCHAMPUS, or a designee, shall develop the CHAMPUS, Handbook. The CHAMPUS Handbook is a general program guide for the use of CHAMPUS beneficiaries and providers and shall be updated, as required.</P>
            <P>(j) <E T="03">Program integrity.</E> The Director, OCHAMPUS, or a designee, shall oversee all CHAMPUS personnel, fiscal intermediaries, providers, and beneficiaries to ensure compliance with this part. The Director, OCHAMPUS, or a designee, shall accomplish this by means of proper delegation of authority, separation of responsibilities, establishment of reports, performance evaluations, internal and external management and fiscal audits, personal or delegated reviews of CHAMPUS responsibilities, taking affidavits, exchange of information among state and Federal governmental agencies, insurers, providers and associations of providers, and such other means as may be appropriate. Compliance with law and this part shall include compliance with specific contracts and agreements, regardless of form, and general instructions, such as CHAMPUS policies, instructions, procedures, and criteria relating to CHAMPUS operation.</P>
            <P>(k) <E T="03">Role of CHAMPUS Health Benefits Advisor (HBA).</E> The CHAMPUS HBA is appointed (generally by the commander of a Uniformed Services medical treatment facility) to serve as an advisor to patients and staff in matters involving CHAMPUS. The CHAMPUS HBA may assist beneficiaries or sponsors in applying for CHAMPUS benefits, in the preparation of claims, and in their relations with OCHAMPUS and CHAMPUS fiscal intermediaries. However, the CHAMPUS HBA is not responsible for CHAMPUS policies and procedures and has no authority to make benefit determinations or obligate Government funds. Advice given to beneficiaries as to determination of benefits or level of payment is not binding on OCHAMPUS or CHAMPUS fiscal intermediaries.</P>
            <P>(l) <E T="03">Cooperation and exchange of information with other Federal programs.</E> The Director, OCHAMPUS, or a designee, shall disclose to appropriate officers or employees of the DHHS:</P>
            <P>(1) <E T="03">Investigation for fraud.</E> The name and address of any physician or other individual actively being investigated for possible fraud in connection with CHAMPUS, and the nature of such suspected fraud. An active investigation exists when there is significant evidence supporting an initial complaint but there is need for further investigation.</P>
            <P>(2) <E T="03">Unnecessary services.</E> The name and address of any provider of medical services, organization, or other person found, after consultation with an appropriate professional association or appropriate peer review body, to have provided unnecessary services. Such information will be released only for the purpose of conducting an investigation or prosecution, or for the administration of titles XVIII and XIX of the Social Security Act, provided that the information will be released only to the agency's enforcement branch and that the agency will preserve the confidentiality of the information received and will not disclose such information for other than program purposes.</P>
            <P>(m) <E T="03">Disclosure of information to the public.</E> Records and information acquired in the administration of CHAMPUS are records of the Department of Defense and may be disclosed in accordance with DoD Directive 5400.7<SU>3</SU>
              <FTREF/>, DoD 5400.7-R<SU>4</SU>
              <FTREF/>, and DoD 5400.11-R<SU>5</SU>
              <FTREF/> (codified in 32 CFR parts 286 and 286a), constituting the applicable DoD Directives and DoD Regulations implementing the Freedom of Information and the Privacy Acts.</P>
            <FTNT>
              <P>
                <SU>3</SU> See footnote 2 to § 199.1(c)(2)(i)</P>
            </FTNT>
            <FTNT>
              <P>
                <SU>4</SU> See footnote 1 to § 199.1(c)(2)(i)</P>
            </FTNT>
            <FTNT>
              <P>
                <SU>5</SU> See footnote 1 to § 199.1(c)(2)(i)</P>
            </FTNT>
            <PRTPAGE P="45"/>
            <P>(n) <E T="03">Discretionary authority</E>. When it is determined to be in the best interest of CHAMPUS, the Director, OCHAMPUS, or a designee, is granted discretionary authority to waive any requirements of this part, except that any requirement specifically set forth in 10 U.S.C. chapter 55, or otherwise imposed by law, may not be waived. It is the intent that such discretionay authority be used only under very unusual and limited circumstances and not to deny any individual any right, benefit, or privilege provided to him or her by statute or this part. Any such exception granted by the Director, OCHAMPUS, or a designee, shall apply only to the individual circumstance or case involved and will in no way be construed to be precedent-setting.</P>
            <P>(o) <E T="03">Demonstration projects</E>. (1) <E T="03">Authority.</E> The Director, OCHAMPUS may waive or alter any requirements of this regulation in connection with the conduct of a demonstration project required or authorized by law except for any requirement that may not be waived or altered pursuant to 10 U.S.C. chapter 55, or other applicable law.</P>
            <P>(2) <E T="03">Procedures.</E> At least 30 days prior to taking effect, OCHAMPUS shall publish a notice describing the demonstration project, the requirements of this regulation being waived or altered under paragraph (o)(1) of this section and the duration of the waiver or alteration. Consistent with the purpose and nature of demonstration projects, these notices are not covered by public comment practices under DoD Directive 5400.9 (32 CFR part 296) or DoD Instruction 6010.8.</P>
            <P>(3) <E T="03">Definition.</E> For purposes of this section, a “demonstration project” is a project of limited duration designed to test a different method for the finance, delivery or administration of health care activities for the uniformed services. Demonstration projects may be required or authorized by 10 U.S.C. 1092, any other statutory provision requiring or authorizing a demonstration project or any other provision of law that authorizes the activity involved in the demonstration project.”.</P>
            <P>(p) <E T="03">Military-Civilian Health Services Partnership Program.</E> The Secretary of Defense, or designee, may enter into an agreement (external or internal) providing for the sharing of resources between facilities of the uniformed services and facilities of a civilian health care provider or providers if the Secretary determines that such an agreement would result in the delivery of health care in a more effective, efficient or economical manner. This partnership allows CHAMPUS beneficiaries to receive inpatient and outpatient services through CHAMPUS from civilian personnel providing health care services in military treatment facilities and from uniformed service professional providers in civilian facilities. The policies and procedures by which partnership agreements may be executed are set forth in Department of Defense Instruction (DoDI) 6010.12, “Military-Civilian Health Services Partnership Program.” The Director, OCHAMPUS, or a designee, shall issue policies, instructions, procedures, guidelines, standards, or criteria as may be necessary to provide support for implementation of DoDI 6010.12, to promulgate and manage benefit and financial policy issues, and to develop a program evaluation process to ensure the Partnership Program accomplishes the purpose for which it was developed.</P>
            <P>(1) <E T="03">Partnership agreements.</E> Military treatment facility commanders, based upon the authority provided by their representative Surgeons General of the military departments, are responsible for entering into individual partnership agreements only when they have determined specifically that use of the Partnership Program is more economical overall to the Government than referring the need for health care services to the civilian community under the normal operation of the CHAMPUS Program. All such agreements are subject to the review and approval of the Director, OCHAMPUS, or designee, and the appropriate Surgeon General.</P>
            <P>(i) <E T="03">External Partnership Agreements.</E> The external partnership agreement is an agreement between a military treatment facility Commander and a CHAMPUS-authorized institutional provider, enabling Uniformed Services health care personnel to provide otherwise covered medical care to CHAMPUS beneficiaries in a civilian facility. Authorized costs associated <PRTPAGE P="46"/>with the use of the facility will be financed through CHAMPUS under normal cost-sharing and reimbursement procedures currently applicable under the basic CHAMPUS. Savings will be realized under this type of agreement by using available military health care personnel to avoid the civilian professional provider charges which would otherwise be billed to CHAMPUS.</P>
            <P>(ii) <E T="03">Internal Partnership Agreements.</E> The internal partnership agreement is an agreement between a military treatment facility commander and a CHAMPUS-authorized civilian health care provider which enables the use of civilian health care personnel or other resources to provide medical care to CHAMPUS beneficiaries on the premises of a military treatment facility. These internal agreements may be established when a military treatment facility is unable to provide sufficient health care services for CHAMPUS beneficiaries due to shortages of personnel and other required resources. In addition to allowing the military treatment facility to achieve maximum use of available facility space, the internal agreement will result in savings to the Government by using civilian medical specialists to provide inpatient care in Government-owned facilities, thereby avoiding the civilian facility charges which would have otherwise been billed to CHAMPUS.</P>
            <P>(2) <E T="03">Beneficiary Cost-Sharing.</E> Beneficiary cost-sharing under the Partnership Program is outlined in § 199.4(f)(5) of this part.</P>
            <P>(3) <E T="03">Reimbusement.</E> Reimbursement under the Partnership Program is outlined in § 199.14(f) of this part.</P>
            <P>(4) <E T="03">Beneficiary Eligibility and Authorized Providers.</E> Existing requirements of this Regulation remain in effect as concerns beneficiary eligibility and authorized providers.</P>
            <P>(5) <E T="03">Range of Benefits.</E> Health care services provided CHAMPUS beneficiaries under the terms of the Partnership Program must be consistent with the CHAMPUS range of benefits outlined in this Regulation. The services rendered must be otherwise covered. Charges allowed for professional services provided under the Partnership Program may include costs of support personnel, equipment, and supplies when specifically outlined in the partnership agreement, However, all CHAMPUS coverage and provider requirements must be met.</P>
            <P>(q) <E T="03">Equality of benefits</E>. All claims submitted for benefits under CHAMPUS shall be adjudicated in a consistent, fair, and equitable manner, without regard to the rank of the sponsor.</P>
            <P>(r) <E T="03">TRICARE program.</E> Many rules and procedures established in sections of this part are subject to revision in areas where the TRICARE program is implemented. The TRICARE program is the means by which managed care activities designed to improve the delivery and financing of health care services in the Military Health Services System(MHSS) are carried out. Rules and procedures for the TRICARE program are set forth in § 199.17.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 52 FR 38754, Oct. 19, 1987; 53 FR 27961, July 26, 1988; 55 FR 43338, Oct. 29, 1990; 60 FR 52094, Oct. 5, 1995]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.2</SECTNO>
            <SUBJECT>Definitions.</SUBJECT>
            <P>(a) <E T="03">General</E>. In an effort to be as specific as possible as to the word and intent of CHAMPUS, the following definitions have been developed. While many of the definitions are general and some assign meaning to relatively common terms within the health insurance environment, others are applicable only to CHAMPUS; however, they all appear in this part solely for the purpose of the Program. Except when otherwise specified, the definitions in this section apply generally throughout this part.</P>
            <P>(b) <E T="03">Specific definitions.</E>
            </P>
            <P>
              <E T="03">Abortion.</E> Abortion means the intentional termination of a pregnancy by artificial means done for a purpose other than that of producing a live birth. A spontaneous, missed or threatened abortion or termination of an ectopic (tubal) pregnancy are not included within the term “abortion” as used herein.</P>
            <P>
              <E T="03">Absent treatment</E>. Services performed by Christian Science practitioners for a person when the person is physically present.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>Technically, “Absent Treatment” is an obsolete term. The current Christian Science terminology is “treatment through <PRTPAGE P="47"/>prayer and spiritual means,” which is employed by an authorized Christian Science practitioner either with the beneficiary being present or absent. However, to be considered for coverage under CHAMPUS, the beneficiary must be present physically when a Christian Science service is rendered, regardless of the terminology used.</P>
            </NOTE>
            <P>
              <E T="03">Abuse.</E> For the purposes of this part, abuse is defined as any practice that is inconsistent with accepted sound fiscal, business, or professional practice which results in a CHAMPUS claim, unnecessary cost, or CHAMPUS payment for services or supplies that are: (1) Not within the concepts of medically necessary and appropriate care, as defined in this part, or (2) that fail to meet professionally recognized standards for health care providers. The term “abuse” includes deception or misrepresentation by a provider, or any person or entity acting on behalf of a provider in relation to a CHAMPUS claim.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Unless a specific action is deemed gross and flagrant, a pattern of inappropriate practice will normally be required to find that abuse has occurred. Also, any practice or action that constitutes fraud, as defined by this part, would also be abuse.</P>
            </NOTE>
            <P>
              <E T="03">Accidental injury</E>. Physical bodily injury resulting from an external force, blow or fall, or the ingestion of a foreign body or harmful substance, requiring immediate medical treatment. Accidental injury also includes animal and insect bites and sunstrokes. For the purpose of CHAMPUS, the breaking of a tooth or teeth does not constitute a physical bodily injury.</P>
            <P>
              <E T="03">Active duty</E>. Full-time duty in the Uniformed Services of the United States. It includes duty on the active list, full-time training duty, annual training duty, and attendance while in the active Military Service, at a school designated as a Service school by law or by the Secretary of the Military Department concerned.</P>
            <P>
              <E T="03">Active duty member</E>. A person on active duty in a Uniformed Service under a call or order that does not specify a period of 30 days or less.</P>
            <P>
              <E T="03">Acupuncture</E>. The practice of inserting needles into various body parts to pierce specific peripheral nerves for the production of counter-irritation to relieve the discomfort of pain, induce surgical anesthesia, or for other treatment purposes.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Acupuncture is not covered by CHAMPUS.</P>
            </NOTE>
            <P>
              <E T="03">Adequate Medical Documentation, Medical Treatment Records.</E> Adequate medical documentation contains sufficient information to justify the diagnosis, the treatment plan, and the services and supplies furnished. Under CHAMPUS, it is required that adequate and sufficient clinical records be kept by the health care provider(s) to substantiate that specific care was actually and appropriately furnished, was medically necessary and appropriate (as defined by this part), and to identify the individual(s) who provided the care. All procedures billed must be documented in the records. In determining whether medical records are adequate, the records will be reviewed under the generally acceptable standards such as the applicable Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards, the Peer Review Organization (PRO) standards (and the provider's state or local licensing requirements) and other requirements specified by this part. In general, the documentation requirements for a professional provider are not less in the outpatient setting than the inpatient setting.</P>
            <P>
              <E T="03">Adequate Medical Documentation, Mental Health Records.</E> Adequate medical documentation provides the means for measuring the type, frequency, and duration of active treatment mechanisms employed and progress under the treatment plan. Under CHAMPUS, it is required that adequate and sufficient clinical records be kept by the provider to substantiate that specific care was actually and appropriately furnished, was medically or psychologically necessary (as defined by this part), and to identify the individual(s) who provided the care. Each service provided or billed must be documented in the records. In determining whether medical records are adequate, the records will be reviewed under the generally acceptable standards (e.g., the applicable JCAHO standards and the provider's state or local licensing requirements) and other requirements specified by this part. It must be noted that the psychiatric and psychological evaluations, physician orders, the treatment plan, integrated progress notes <PRTPAGE P="48"/>(and physician progress notes if separate from the integrated progress notes), and the discharge summary are the more critical elements of the mental health record. However, nursing and staff notes, no matter how complete, are not a substitute for the documentation of services by the individual professional provider who furnished treatment to the beneficiary. In general, the documentation requirements of a professional provider are not less in the outpatient setting than the inpatient setting. Furthermore, even though a hospital that provides psychiatric care may be accredited under the JCAHO manual for hospitals rather than the consolidated standards manual, the critical elements of the mental health record listed above are required for CHAMPUS claims.</P>
            <P>
              <E T="03">Adjunctive dental care</E>. Dental care which is medically necessary in the treatment of an otherwise covered medical (not dental) condition, is an integral part of the treatment of such medical condition and is essential to the control of the primary medical condition; or, is required in preparation for or as the result of dental trauma which may be or is caused by medically necessary treatment of an injury or disease (iatrogenic).</P>
            <P>
              <E T="03">Admission.</E> The formal acceptance by a CHAMPUS authorized institutional provider of a CHAMPUS beneficiary for the purpose of diagnosis and treatment of illness, injury, pregnancy, or mental disorder.</P>
            <P>
              <E T="03">Adopted Child</E>. A child taken into one's own family by legal process and treated as one's own child. In case of adoption, CHAMPUS eligibility begins as of 12:01 a.m. of the day of the final adoption decree.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>There is no CHAMPUS benefit entitlement during any interim waiting period.</P>
            </NOTE>
            <P>
              <E T="03">All-Inclusive Per Diem Rate.</E> The OCHAMPUS determined rate that encompasses the daily charge for inpatient care and, unless specifically excepted, all other treatment determined necessary and rendered as part of the treatment plan established for a patient, and accepted by OCHAMPUS.</P>
            <P>
              <E T="03">Allowable charge.</E> The CHAMPUS-determined level of payment to physicians, other individual professional providers and other providers, based on one of the approved reimbursement methods set forth in § 199.14 of this part. Allowable charge also may be referred to as the CHAMPUS-determined reasonable charge.</P>
            <P>
              <E T="03">Allowable cost.</E> The CHAMPUS-determined level of payment to hospitals or other insitutions, based on one of the approved reimbursement methods set fourth in § 199.14 of this part. Allowable cost may also be referred to as the CHAMPUS-determined reasonable cost.</P>
            <P>
              <E T="03">Ambulance.</E> A specially designed vehicle for transporting the sick or injured that contains a stretcher, linens, first aid supplies, oxygen equipment, and such lifesaving equipment required by state and local law, and that is staffed by personnel trained to provide first aid treatment.</P>
            <P>
              <E T="03">Amount in dispute.</E> The amount of money, determined under this part, that CHAMPUS would pay for medical services and supplies involved in an adverse determination being appealed if the appeal were resolved in favor of the appealing party. See § 199.10 for additional information concerning the determination of “amount in dispute” under this part.</P>
            <P>
              <E T="03">Anesthesia services.</E> The administration of an anesthetic agent by injection or inhalation, the purpose and effect of which is to produce surgical anesthesia characterized by muscular relaxation, loss of sensation, or loss of consciousness when administered by or under the direction of a physician or dentist in connection with otherwise covered surgery or obstetrical care, or shock therapy. Anesthesia services do not include hypnosis or acupuncture.</P>
            <P>
              <E T="03">Appealable issue.</E> Disputed questions of fact which, if resolved in favor of the appealing party, would result in the authorization of CHAMPUS benefits, or approval as an authorized provider in accordance with this part. An appealable issue does not exist if no facts are in dispute, if no CHAMPUS benefits would be payable, or if there is no authorized provider, regardless of the resolution of any disputed facts. See § 199.10 for additional information concerning the determination of “appealable issue” under this part.</P>
            <P>
              <E T="03">Appealing party.</E> Any party to the initial determination who files an appeal <PRTPAGE P="49"/>of an adverse determination or requests a hearing under the provisions of this part.</P>
            <P>
              <E T="03">Appropriate medical care.</E> (i) Services performed in connection with the diagnosis or treatment of disease or injury, pregnancy, mental disorder, or well-baby care which are in keeping with the generally accepted norms for medical practice in the United States;</P>
            <P>(ii) The authorized individual professional provider rendering the medical care is qualified to perform such medical services by reason of his or her training and education and is licensed or certified by the state where the service is rendered or appropriate national organization or otherwise meets CHAMPUS standards; and</P>
            <P>(iii) The services are furnished economically. For purposes of this part, “economically” means that the services are furnished in the least expensive level of care or medical environment adequate to provide the required medical care regardless of whether or not that level of care is covered by CHAMPUS.</P>
            <P>
              <E T="03">Approved teaching programs.</E> For purposes of CHAMPUS, an approved teaching program is a program of graduate medical education which has been duly approved in its respective specialty or subspecialty by the Accreditation Council for Graduate Medical Education of the American Medical Association, by the Committee on Hospitals of the Bureau of Professional Education of the American Osteopathic Association, by the Council on Dental Education of the American Dental Association, or by the Council on Podiatry Education of the American Podiatry Association.</P>
            <P>
              <E T="03">Assistant Secretary of Defense (Health Affairs).</E> An authority of the Assistant Secretary of Defense (Health Affairs) includes any person designated by the Assistant Secretary to exercise the authority involved.</P>
            <P>
              <E T="03">Attending physician.</E> The physician who has the primary responsibility for the medical diagnosis and treatment of the patient. A consultant or an assistant surgeon, for example, would not be an attending physician. Under very extraordinary circumstances, because of the presence of complex, serious, and multiple, but unrelated, medical conditions, a patient may have more than one attending physician concurrently rendering medical treatment during a single period of time. An attending physician also may be a teaching physician.</P>
            <P>
              <E T="03">Authorized provider.</E> A hospital or institutional provider, physician, or other individual professional provider, or other provider of services or supplies specifically authorized to provide benefits under CHAMPUS in § 199.6 of this part.</P>
            <P>
              <E T="03">Backup hospital.</E> A hospital which is otherwise eligible as a CHAMPUS institutional provider and which is fully capable of providing emergency care to a patient who develops complications beyond the scope of services of a given category of CHAMPUS-authorized freestanding institutional provider and which is accessible from the site of the CHAMPUS-authorized freestanding institutional provider within an average transport time acceptable for the types of medical emergencies usually associated with the type of care provided by the freestanding facility.</P>
            <P>
              <E T="03">Balance billing.</E> A provider seeking any payment, other than any payment relating to applicable deductible and cost sharing amounts, from a beneficiary for CHAMPUS covered services for any amount in excess of the applicable CHAMPUS allowable cost or charge.</P>
            <P>
              <E T="03">Basic program.</E> The primary medical benefits authorized under chapter 55 of title 10 U.S. Code, and set forth in § 199.4 of this part.</P>
            <P>
              <E T="03">Beneficiary.</E> An individual who has been determined to be eligible for CHAMPUS benefits, as set forth in § 199.3 of this part.</P>
            <P>
              <E T="03">Beneficiary liability.</E> The legal obligation of a beneficiary, his or her estate, or responsible family member to pay for the costs of medical care or treatment received. Specifically, for the purposes of services and supplies covered by CHAMPUS, beneficiary liability includes any annual deductible amount, cost-sharing amounts, or, when a provider does not submit a claim on a participating basis on behalf of the beneficiary, amounts above the CHAMPUS-determined allowable cost or charge. Beneficiary liability also includes any expenses for medical <PRTPAGE P="50"/>or related services and supplies not covered by CHAMPUS.</P>
            <P>
              <E T="03">Birthing center.</E> A health care provider which meets the applicable requirements established by § 199.6(b) of this part.</P>
            <P>
              <E T="03">Birthing room.</E> A room and environment designed and equipped to provide care, to accommodate support persons, and within which a woman with a low-risk, normal, full-term pregnancy can labor, deliver and recover with her infant.</P>
            <P>
              <E T="03">Brace.</E> An orthopedic appliance or apparatus (an orthosis) used to support, align, or hold parts of the body in correct position. For the purposes of CHAMPUS, it does not include orthodontic or other dental appliances.</P>
            <P>
              <E T="03">Capped Rate.</E> The maximum per diem or all-inclusive rate that CHAMPUS will allow for care.</P>
            <P>
              <E T="03">Case management.</E> Case management is a collaborative process which assesses, plans, implements, coordinates, monitors, and evaluates the options and services required to meet an individual's health needs, using communication and available resources to promote quality, cost effective outcomes.</P>
            <P>
              <E T="03">Case managers.</E> A licensed registered nurse, licensed clinical social worker, licensed psychologist or licensed physician who has a minimum of two (2) years case management experience.</P>
            <P>
              <E T="03">Certified nurse-midwife.</E> An individual who meets the applicable requirements established by § 199.6(c) of this part.</P>
            <P>
              <E T="03">Certified psychiatric nurse specialist.</E> A licensed, registered nurse who meets the criteria in § 199.6(c)(3)(iii)(G).</P>
            <P>
              <E T="03">CHAMPUS DRG-Based Payment System.</E> A reimbursement system for hospitals which assigns prospectively-determined payment levels to each DRG based on the average cost of treating all CHAMPUS patients in a given DRG.</P>
            <P>
              <E T="03">CHAMPUS fiscal intermediary.</E> An organization with which the Director, OCHAMPUS, has entered into a contract for the adjudication and processing of CHAMPUS claims and the performance of related support activities.</P>
            <P>
              <E T="03">CHAMPUS Health Benefits Advisors (HBAs).</E> Those individuals located at Uniformed Services medical facilities (on occasion at other locations) and assigned the responsibility for providing CHAMPUS information, information concerning availability of care from the Uniformed Services direct medical care system, and generally assisting beneficiaries (or sponsors). The term also includes “Health Benefits Counselor” and “CHAMPUS Advisor.”</P>
            <P>
              <E T="03">Chemotherapy.</E> The administration of approved antineoplastic drugs for the treatment of malignancies (cancer) via perfusion, infusion, or parenteral methods of administration.</P>
            <P>
              <E T="03">Child.</E> An unmarried legitimate child, adopted child, stepchild, or illegitimate child, who otherwise meets the requirements (including age requirements) set forth in § 199.3(b)(2)(iv) of this part.</P>
            <P>
              <E T="03">Chiropractor.</E> A practitioner of chiropractic (also called chiropraxis); essentially a system of therapeutics based upon the claim that disease is caused by abnormal function of the nerve system. It attempts to restore normal function of the nerve system by manipulation and treatment of the structures of the human body, especially those of the spinal column.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Services of chiropractors are not covered by CHAMPUS.</P>
            </NOTE>
            <P>
              <E T="03">Christian science nurse.</E> An individual who has been accredited as a Christian Science Nurse by the Department of Care of the First Church of Christ, Scientist, Boston, Massachusetts, and listed (or eligible to be listed) in the Christian Science Journal at the time the service is provided. The duties of Christian Science nurses are spiritual and are nonmedical and nontechnical nursing care performed under the direction of an accredited Christian Science practitioner. There exist two levels of Christian Science nurse accreditation:</P>
            <P>(i) <E T="03">Graduate Christian Science nurse.</E> This accreditation is granted by the Department of Care of the First Church of Christ, Scientist, Boston, Massachusetts, after completion of a 3-year course of instruction and study.</P>
            <P>(ii) <E T="03">Practical Christian Science nurse.</E> This accreditation is granted by the Department of Care of the First Church of Christ, Scientist, Boston, Massachusetts, after completion of a 1-year course of instruction and study.</P>
            <P>
              <E T="03">Christian Science practitioner.</E> An individual who has been accredited as a Christian Science Practitioner for the <PRTPAGE P="51"/>First Church, Scientist, Boston, Massachusetts, and listed (or eligible to be listed) in the Christian Science Journal at the time the service is provided. An individual who attains this accreditation has demonstrated results of his or her healing through faith and prayer rather than by medical treatment. Instruction is executed by an accredited Christian Science teacher and is continuous.</P>
            <P>
              <E T="03">Christian Science sanatorium.</E> A sanatorium either operated by the First Church of Christ, Scientist, or listed and certified by the First Church of Christ, Scientist, Boston, Massachusetts.</P>
            <P>
              <E T="03">Chronic medical condition.</E> A medical condition that is not curable, but which is under control through active medical treatment. Such chronic conditions may have periodic acute episodes and may require intermittent inpatient hospital care. However, a chronic medical condition can be controlled sufficiently to permit generally continuation of some activities of persons who are not ill (such as work and school).</P>
            <P>
              <E T="03">Chronic renal disease (CRD).</E> The end stage of renal disease which requires a continuing course of dialysis or a kidney transplantation to ameliorate uremic symptoms and maintain life.</P>
            <P>
              <E T="03">Clinical psychologist.</E> A psychologist, certified or licensed at the independent practice level in his or her state, who meets the criteria in § 199.6(c)(3)(iii)(A).</P>
            <P>
              <E T="03">Clinical social worker.</E> An individual who is licensed or certified as a clinical social worker and meets the criteria listed in § 199.6.</P>
            <P>
              <E T="03">Clinically Meaningful Endpoints.</E> As used the definition of <E T="03">reliable evidence</E> in this paragraph (b) and § 199.4(g)(15), the term clinically meaningful endpoints means objectively measurable outcomes of clinical interventions or other medical procedures, expressed in terms of survival, severity of illness or condition, extent of adverse side effects, diagnostic capability, or other effect on bodily functions directly associated with such results.</P>
            <P>
              <E T="03">Collateral visits.</E> Sessions with the patient's family or significant others for purposes of information gathering or implementing treatment goals.</P>
            <P>
              <E T="03">Combined daily charge.</E> A billing procedure by an inpatient facility that uses an inclusive flat rate covering all professional and ancillary charges without any itemization.</P>
            <P>
              <E T="03">Complications of pregnancy.</E> One of the following, when commencing or exacerbating during the term of the pregnancy:</P>
            <P>(i) Caesarean delivery; hysterotomy.</P>
            <P>(ii) Pregnancy terminating before expiration of 26 weeks, except a voluntary abortion.</P>
            <P>(iii) False labor or threatened miscarriage.</P>
            <P>(iv) Nephritis or pyelitis of pregnancy.</P>
            <P>(v) Hyperemesis gravidarum.</P>
            <P>(vi) Toxemia.</P>
            <P>(vii) Aggravation of a heart condition or diabetes.</P>
            <P>(viii) Premature rupture of membrane.</P>
            <P>(ix) Ectopic pregnancy.</P>
            <P>(x) Hemorrhage.</P>
            <P>(xi) Other conditions as may be determined by the Director, OCHAMPUS, or a designee.</P>
            <P>
              <E T="03">Confinement.</E> That period of time from the day of admission to a hospital or other institutional provider, to the day of discharge, transfer, or separation from the facility, or death. Successive admissions also may qualify as one confinement provided not more than 60 days have elapsed between the successive admissions, except that successive admissions related to a single maternity episode shall be considered one confinement, regardless of the number of days between admissions.</P>
            <P>
              <E T="03">Conflict of Interest.</E> Includes any situation where an active duty member (including a reserve member while on active duty) or civilian employee of the United States Government, through an official federal position, has the apparent or actual opportunity to exert, directly or indirectly, any influence on the referral of CHAMPUS beneficiaries to himself or herself or others with some potential for personal gain or appearance of impropriety. For purposes of this part, individuals under contract to a Uniformed Service may be involved in a conflict of interest situation through the contract position.<PRTPAGE P="52"/>
            </P>
            <P>
              <E T="03">Congenital anomaly.</E> A condition existing at or from birth that is a significant deviation from the common form or norm and is other than a common racial or ethnic feature. For purposes of CHAMPUS, congenital anomalies do not include anomalies relating to teeth (including malocclusion or missing tooth buds) or structures supporting the teeth, or to any form of hermaphroditism or sex gender confusion. Examples of congenital anomalies are harelip, birthmarks, webbed fingers or toes, or such other conditions that the Director, OCHAMPUS, or a designee, may determine to be congenital anomalies.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Also refer to §199.4(e)(7) of this part.</P>
            </NOTE>
            <P>
              <E T="03">Consultation.</E> A deliberation with a specialist physician or dentist requested by the attending physician primarily responsible for the medical care of the patient, with respect to the diagnosis or treatment in any particular case. A consulting physician or dentist may perform a limited examination of a given system or one requiring a complete diagnostic history and examination. To qualify as a consultation, a written report to the attending physician of the findings of the consultant is required.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Staff consultations required by rules and regulations of the medical staff of a hospital or other institutional provider do not qualify as consultation.</P>
            </NOTE>
            <P>
              <E T="03">Consulting physician or dentist.</E> A physician or dentist, other than the attending physician, who performs a consultation.</P>
            <P>
              <E T="03">Conviction.</E> For purposes of this part, “conviction” or “convicted” means that (1) a judgment of conviction has been entered, or (2) there has been a finding of guilt by the trier of fact, or (3) a plea of guilty or a plea of <E T="03">nolo contendere</E> has been accepted by a court of competent jurisdiction, regardless of whether an appeal is pending.</P>
            <P>
              <E T="03">Coordination of benefits.</E> The coordination, on a primary or secondary payer basis, of the payment of benefits between two or more health care coverages to avoid duplication of benefit payments.</P>
            <P>
              <E T="03">Corporate services provider.</E> A health care provider that meets the applicable requirements established by § 199.6(f).</P>
            <P>
              <E T="03">Cosmetic, reconstructive, or plastic surgery.</E> Surgery that can be expected primarily to improve the physical appearance of a beneficiary, or that is performed primarily for psychological purposes, or that restores form, but does not correct or improve materially a bodily function.</P>
            <P>
              <E T="03">Cost-share.</E> The amount of money for which the beneficiary (or sponsor) is responsible in connection with otherwise covered inpatient and outpatient services (other than the annual fiscal year deductible or disallowed amounts) as set forth in §§199.4(f) and 199.5(b) of this part. Cost-sharing may also be referred to as “co-payment.”</P>
            <P>
              <E T="03">Custodial care.</E> Care rendered to a patient:</P>
            <P>(i) who is disabled mentally or physically and such disability is expected to continue and be prolonged, and</P>
            <P>(ii) who requires a protected, monitored, or controlled environment whether in an institution or in the home, and</P>
            <P>(iii) who requires assistance to support the essentials of daily living, and</P>
            <P>(iv) who is not under active and specific medical, surgical, or psychiatric treatment that will reduce the disability to the extent necessary to enable the patient to function outside the protected, monitored, or controlled environment.</P>
            <P>A custodial care determination is not precluded by the fact that a patient is under the care of a supervising or attending physician and that services are being ordered and prescribed to support and generally maintain the patient's condition, or provide for the patient's comfort, or ensure the manageability of the patient. Further, a custodial care determination is not precluded because the ordered and prescribed services and supplies are being provided by an R.N., L.P.N., or L.V.N.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The determination of custodial care in no way implies that the care being rendered is not required by the patient; it only means that it is the kind of care that is not covered under CHAMPUS. A program of physical and mental rehabilitation which is designed to reduce a disability is not custodial care as long as the objective of the program is a reduced level of care.</P>
            </NOTE>
            <P>
              <E T="03">Days.</E> Calendar days.</P>
            <P>
              <E T="03">Deceased service member.</E> A person who, at the time of his or her death, was an active duty member of a Uniformed Service under a call or order <PRTPAGE P="53"/>that did not specify a period of 30 days or less; or a retiree of a Uniformed Service.</P>
            <P>
              <E T="03">Deductible.</E> Payment by a beneficiary of the first $50 of the CHAMPUS-determined allowable costs or charges for otherwise covered outpatient services or supplies provided in any one fiscal year; or for a family, the aggregate payment by two or more beneficiaries who submit claims of the first $100.</P>
            <P>
              <E T="03">Deductible certificate.</E> A statement issued to the beneficiary (or sponsor) by a CHAMPUS fiscal intermediary certifying to deductible amounts satisfied by a CHAMPUS beneficiary for any applicable fiscal year.</P>
            <P>
              <E T="03">Defense Enrollment Eligibility Reporting System (DEERS).</E> The automated system that is composed of two phases:</P>
            <P>(i) Enrolling all active duty and retired service members, their dependents, and the dependents of deceased service members, and</P>
            <P>(ii) Verifying their eligibility for health care benefits in the direct care facilities and through CHAMPUS.</P>
            <P>
              <E T="03">Dental care.</E> Services relating to the teeth and their supporting structures.</P>
            <P>
              <E T="03">Dentist.</E> Doctor of Dental Medicine (D.M.D.) or Doctor of Dental Surgery (D.D.S.) who is licensed to practice dentistry by an appropriate authority.</P>
            <P>
              <E T="03">Dependent.</E> A person who bears any of the following relationships to an active duty member (under a call or order that does not specify a period of 30 days or less), retiree, or deceased active duty member or retiree, of a Uniformed Service, that is, lawful spouse, former spouse (in certain circumstances), unremarried widow or widower, or child; or a spouse and child of an active duty member of the armed forces of foreign North Atlantic Treaty Organization (NATO) nations (refer to § 199.3(b) of this part).</P>
            <P>
              <E T="03">Deserter or desertion status.</E> A service member is a deserter, or in a desertion status, when the Uniformed Service concerned has made an administrative determination to that effect, or the member's period of unauthorized absence has resulted in a court-martial conviction of desertion. Administrative declarations of desertion normally are made when a member has been an unauthorized absentee for over 30 days, but particular circumstances may result in an earlier declaration. Entitlement to CHAMPUS benefits ceases as of 12:01 a.m. on the day following the day the desertion status is declared. Benefits are not to be authorized for treatment received during a period of unauthorized absence that results in a court-martial conviction for desertion. Dependent eligibility for benefits is reestablished when a deserter is returned to military control and continues, even though the member may be in confinement, until any discharge is executed. When a deserter status is later found to have been determined erroneously, the status of deserter is considered never to have existed, and the member's dependents will have been eligible continuously for benefits under CHAMPUS.</P>
            <P>
              <E T="03">Diagnosis-Related Groups (DRGs).</E> Diagnosis-related groups (DRGs) are a method of dividing hospital patients into clinically coherent groups based on the consumption of resources. Patients are assigned to the groups based on their principal diagnosis (the reason for admission, determined after study), secondary diagnoses, procedures performed, and the patient's age, sex, and discharge status.</P>
            <P>
              <E T="03">Diagnostic admission.</E> An admission to a hospital or other authorized institutional provider, or an extension of a stay in such a facility, primarily for the purpose of performing diagnostic tests, examinations, and procedures.</P>
            <P>
              <E T="03">Director, OCHAMPUS.</E> An authority of the Director, OCHAMPUS includes any person designated by the Director, OCHAMPUS to exercise the authority involved.</P>
            <P>
              <E T="03">Doctor of Dental Medicine (D.M.D.).</E> A person who has received a degree in dentistry, that is, that department of the healing arts which is concerned with the teeth, oral cavity, and associated structures.</P>
            <P>
              <E T="03">Doctor of Medicine (M.D.).</E> A person who has graduated from a college of allopathic medicine and who is entitled legally to use the designation M.D.</P>
            <P>
              <E T="03">Doctor of Osteopathy (D.O.).</E> A practitioner of osteopathy, that is, a system of therapy based on the theory that the body is capable of making its own remedies against disease and other toxic <PRTPAGE P="54"/>conditions when it is in normal structural relationship and has favorable environmental conditions and adequate nutrition. It utilizes generally accepted physical, medicinal, and surgical methods of diagnosis and therapy, while placing chief emphasis on the importance of normal body mechanics and manipulative methods of detecting and correcting faulty structure.</P>
            <P>
              <E T="03">Domiciliary care.</E> Inpatient institutional care provided the beneficiary not because it is medically necessary, but because the care in the home setting is not available, is unsuitable, or members of the patient's family are unwilling to provide the care. Institutionalization because of abandonment constitutes domiciliary care.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The terms “domiciliary” and “custodial care” represent separate concepts and are not interchangeable. Domiciliary care is not covered under either the CHAMPUS Basic Program or the Program for Persons with Disabilities (PFPWD).</P>
            </NOTE>
            <P>
              <E T="03">Donor.</E> An individual who supplies living tissue or material to be used in another body, such as a person who furnishes a kidney for renal transplant.</P>
            <P>
              <E T="03">Double coverage.</E> When a CHAMPUS beneficiary also is enrolled in another insurance, medical service, or health plan that duplicates all or part of a beneficiary's CHAMPUS benefits.</P>
            <P>
              <E T="03">Double coverage plan.</E> The specific insurance, medical service, or health plan under which a CHAMPUS beneficiary has entitlement to medical beneifts that duplicate CHAMPUS benefits in whole or in part. Double coverage plans do not include:</P>
            <P>(i) Medicaid.</P>
            <P>(ii) Coverage specifically designed to supplement CHAMPUS benefits.</P>
            <P>(iii) Entitlement to receive care from the Uniformed Services medical facilities; or</P>
            <P>(iv) Entitlement to receive care from Veterans Administration medical care facilities.</P>
            <P>
              <E T="03">Dual Compensation.</E> Federal Law (5 U.S.C. 5536) prohibits active duty members or civilian employees of the United States Government from receiving additional compensation from the government above their normal pay and allowances. This prohibition applies to CHAMPUS cost-sharing of medical care provided by active duty members or civilian government employees to CHAMPUS beneficiaries.</P>
            <P>
              <E T="03">Durable equipment.</E> A device or apparatus which does not qualify as Durable Medical Equipment (as defined in this section), and which is essential to the efficient arrest or reduction of functional loss resulting from a qualifying condition as provided by § 199.5.</P>
            <P>
              <E T="03">Durable medical equipment.</E> Equipment for which the allowable charge is over $100 and which:</P>
            <P>(1) Is medically necessary for the treatment of a covered illness or injury;</P>
            <P>(2) Improves the function of a malformed, diseased, or injured body part, or retards further deterioration of a patient's physical condition;</P>
            <P>(3) Is primarily and customarily designed and intended to serve a medical purpose rather than primarily for transportation, comfort, or convenience;</P>
            <P>(4) Can withstand repeated use;</P>
            <P>(5) Provides the medically appropriate level of performance and quality for the medical condition present (that is, nonluxury and nondeluxe);</P>
            <P>(6) Is other than spectacles, eyeglasses, contact lenses, or other optical devices; hearing aids; or other communication devices; and</P>
            <P>(7) Is other than exercise equipment, spas, whirlpools, hot tubs, swimming pools or other such items.</P>
            <P>
              <E T="03">Economic interest.</E> (1) Any right, title, or share in the income, remuneration, payment, or profit of a CHAMPUS-authorized provider, or of an individual or entity eligible to be a CHAMPUS-authorized provider, resulting, directly or indirectly, from a referral relationship; or any direct or indirect ownership, right, title, or share, including a mortgage, deed of trust, note, or other obligation secured (in whole or in part) by one entity for another entity in a referral or accreditation relationship, which is equal to or exceeds 5 percent of the total property and assets of the other entity.</P>

            <P>(2) A referral relationship exists when a CHAMPUS beneficiary is sent, directed, assigned or influenced to use a specific CHAMPUS-authorized provider, or a specific individual or entity eligible to be a CHAMPUS-authorized provider.<PRTPAGE P="55"/>
            </P>
            <P>(3) An accreditation relationship exists when a CHAMPUS-authorized accreditation organization evaluates for accreditation an entity that is an applicant for, or recipient of CHAMPUS-authorized provider status.</P>
            <P>
              <E T="03">Emergency inpatient admission.</E> An unscheduled, unexpected, medically necessary admission to a hospital or other authorized institutional provider for treatment of a medical condition meeting the definition of medical emergency and which is determined to require immediate inpatient treatment by the attending physician.</P>
            <P>
              <E T="03">Entity.</E> For purposes of § 199.9(f)(1), “entity” includes a corporation, trust, partnership, sole proprietorship or other kind of business enterprise that is or may be eligible to receive reimbursement either directly or indirectly from CHAMPUS.</P>
            <P>
              <E T="03">Essentials of daily living.</E> Care that consists of providing food (including special diets), clothing, and shelter; personal hygiene services; observation and general monitoring; bowel training or management; safety precautions; general preventive procedures (such as turning to prevent bedsores); passive exercise; companionship; recreation; transportation; and such other elements of personal care that reasonably can be performed by an untrained adult with minimal instruction or supervision.</P>
            <P>
              <E T="03">External Partnership Agreement.</E> The External Partnership Agreement is an agreement between a military treatment facility commander and a CHAMPUS authorized institutional provider, enabling Uniformed Services health care personnel to provide otherwise covered medical care to CHAMPUS beneficiaries in a civilian facility under the Military-Civilian Health Services Partnership Program. Authorized costs associated with the use of the facility will be financed through CHAMPUS under normal cost-sharing and reimbursement procedures currently applicable under the basic CHAMPUS.</P>
            <P>
              <E T="03">External Resource Sharing Agreement.</E> A type External Partnership Agreement, established in the context of the TRICARE program by agreement of a military medical treatment facility commander and an authorized TRICARE contractor. External Resource Sharing Agreements may incorporate TRICARE features in lieu of standard CHAMPUS features that would apply to standard External Partnership Agreements.</P>
            <P>
              <E T="03">Extramedical individual providers of care.</E> Individuals who do counseling or nonmedical therapy and whose training and therapeutic concepts are outside the medical field, as specified in § 199.6 of this part.</P>
            <P>
              <E T="03">Extraordinary condition.</E> A complex clinical condition, which resulted, or is expected to result, in extraordinary TRICARE/CHAMPUS costs or utilization, based on thresholds established by the Director, OCHAMPUS, or designee.</P>
            <P>
              <E T="03">Former spouse.</E> A former husband or wife of a Uniformed Service member or former mmeber who meets the criteria as set forth in § 199.3(b)(2)(ii) of this part.</P>
            <P>
              <E T="03">Fraud.</E> For purposes of this part, fraud is defined as (1) a deception or misrepresentation by a provider, beneficiary, sponsor, or any person acting on behalf of a provider, sponsor, or beneficiary with the knowledge (or who had reason to know or should have known) that the deception or misrepresentation could result in some unauthorized CHAMPUS benefit to self or some other person, or some unauthorized CHAMPUS payment, or (2) a claim that is false or fictitious, or includes or is supported by any written statement which asserts a material fact which is false or fictitious, or includes or is supported by any written statement that (a) omits a material fact and (b) is false or fictitious as a result of such omission and (c) is a statement in which the person making, presenting, or submitting such statement has a duty to include such material fact. It is presumed that, if a deception or misrepresentation is established <E T="03">and</E> a CHAMPUS claim is filed, the person responsible for the claim had the requisite knowledge. This presumption is rebuttable only by substantial evidence. It is further presumed that the provider of the services is responsible for the actions of all individuals who file a claim on behalf of the provider <PRTPAGE P="56"/>(for example, billing clerks); this presumption may only be rebutted by clear and convincing evidence.</P>
            <P>
              <E T="03">Freestanding.</E> Not “institution-affiliated” or “institution-based.”</P>
            <P>
              <E T="03">Full-time course of higher education.</E> A complete, progressive series of studies to develop attributes such as knowledge, skill, mind, and character, by formal schooling at a college or university, and which meets the criteria set out in § 199.3 of this part. To qualify as full-time, the student must be carrying a course load of a minimum of 12 credit hours or equivalent each semester.</P>
            <P>
              <E T="03">General staff nursing service.</E> All nursing care (other than that provided by private duty nurses) including, but not limited to, general duty nursing, emergency room nursing, recovery room nursing, intensive nursing care, and group nursing arrangements performed by nursing personnel on the payroll of the hospital or other authorized institution.</P>
            <P>
              <E T="03">Good faith payments.</E> Those payments made to civilian sources of medical care who provided medical care to persons purporting to be eligible beneficiaries but who are determined later to be ineligible for CHAMPUS benefits. (The ineligible person usually possesses an erroneous or illegal identification card.) To be considered for good faith payments, the civilian source of care must have exercised reasonable precautions in identifying a person claiming to be an eligible beneficiary.</P>
            <P>
              <E T="03">Habilitation.</E> The provision of functional capacity, absent from birth due to congenital anomaly or developmental disorder, which facilitates performance of an activity in the manner, or within the range considered normal, for a human being.</P>
            <P>
              <E T="03">Handicap.</E> For the purposes of this part, the term “handicap” is synonymous with the term “disability.”</P>
            <P>
              <E T="03">High-risk pregnancy.</E> A pregnancy is high-risk when the presence of a currently active or previously treated medical, anatomical, physiological illness or condition may create or increase the likelihood of a detrimental effect on the mother, fetus, or newborn and presents a reasonable possibility of the development of complications during labor or delivery.</P>
            <P>
              <E T="03">Hospice care.</E> Hospice care is a program which provides an integrated set of services and supplies designed to care for the terminally ill. This type of care emphasizes palliative care and supportive services, such as pain control and home care, rather than cure-oriented services provided in institutions that are otherwise the primary focus under CHAMPUS. The benefit provides coverage for a humane and sensible approach to care during the last days of life for some terminally ill patients.</P>
            <P>
              <E T="03">Hospital, acute care (general and special).</E> An institution that meets the criteria as set forth in § 199.6(b)(4)(i) of this part.</P>
            <P>
              <E T="03">Hospital, long-term (tuberculosis, chronic care, or rehabilitation).</E> An institution that meets the criteria as set forth in § 199.6(b)(4)(iii) of this part.</P>
            <P>
              <E T="03">Hospital, phychiatric.</E> An institution that meets the criteria as set forth in § 199.6(b)(4)(ii) of this part.</P>
            <P>
              <E T="03">Illegitimate child.</E> A child not recognized as a lawful offspring; that is, a child born of parents not married to each other.</P>
            <P>
              <E T="03">Immediate family.</E> The spouse, natural parent, child and sibling, a dopted child and adoptive parent, stepparent, stepchild, grandparent, grandchild, stepbrother and stepsister, father-in-law, mother-in-law of the beneficiary, or provider, as appropriate. For purposes of this definition only, to determine who may render services to a beneficiary, the step-relationship continues to exist even if the marriage upon which the relationship is based terminates through divorce or death of one of the parents.</P>
            <P>
              <E T="03">Independent laboratory.</E> A freestanding laboratory approved for participation under Medicare and certified by the Health Care Financing Administration.</P>
            <P>
              <E T="03">Infirmaries.</E> Facilities operated by student health departments of colleges and universities to provide inpatient or outpatient care to enrolled students. When specifically approved by the Director, OCHAMPUS, or a designee, a boarding school infirmary also is included.<PRTPAGE P="57"/>
            </P>
            <P>
              <E T="03">Initial determination.</E> A formal written decision on a CHAMPUS claim, a request for benefit authorization, a request by a provider for approval as an authorized CHAMPUS provider, or a decision disqualifying or excluding a provider as an authorized provider under CHAMPUS. Rejection of a claim or a request for benefit or provider authorization for failure to comply with administrative requirements, including failure to submit reasonably requested information, is not an initial determination. Responses to general or specific inquiries regarding CHAMPUS benefits are not initial determinations.</P>
            <P>
              <E T="03">In-out surgery.</E> Surgery performed in the outpatient department of a hospital or other institutional provider, in a physician's office or the office of another individual professional provider, in a clinic, or in a “freestanding” ambulatory surgical center which does not involve a formal inpatient admission for a period of 24 hours or more.</P>
            <P>
              <E T="03">Inpatient.</E> A patient who has been admitted to a hospital or other authorized institution for bed occupancy for purposes of receiving necessary medical care, with the reasonable expectation that the patient will remain in the institution at least 24 hours, and with the registration and assignment of an inpatient number or designation. Institutional care in connection with in and out (ambulatory) surgery is not included within the meaning of inpatient whether or not an inpatient number or designation is made by the hospital or other institution. If the patient has been received at the hospital, but death occurs before the actual admission occurs, an inpatient admission exists as if the patient had lived and had been formally admitted.</P>
            <P>
              <E T="03">Institution-affiliated.</E> Related to a CHAMPUS-authorized institutional provider through a shared governing body but operating under a separate and distinct license or accreditation.</P>
            <P>
              <E T="03">Institution-based.</E> Related to a CHAMPUS-authorized institutional provider through a shared governing body and operating under a common license and shared accreditation.</P>
            <P>
              <E T="03">Institutional provider.</E> A health care provider which meets the applicable requirements established by § 199.6(b) of this part.</P>
            <P>
              <E T="03">Intensive care unit (ICU).</E> A special segregated unit of a hospital in which patients are concentrated by reason of serious illness, usually without regard to diagnosis. Special lifesaving techniques and equipment regularly and immediately are available within the unit, and patients are under continuous observation by a nursing staff specially trained and selected for the care of this type patient. The unit is maintained on a continuing rather than an intermittent or temporary basis. It is not a postoperative recovery room nor a postanesthesia room. In some large or highly specialized hospitals, the ICUs may be further refined for special purposes, such as for respiratory conditions, cardiac surgery, coronary care, burn care, or neurosurgery. For the purposes of CHAMPUS, these specialized units would be considered ICUs if they otherwise conformed to the definition of an ICU.</P>
            <P>
              <E T="03">Intern.</E> A graduate of a medical or dental school serving in a hospital in preparation to being licensed to practice medicine or dentistry.</P>
            <P>
              <E T="03">Internal Partnership Agreement</E>. The Internal Partnership Agreement is an agreement between a military treatment facility commander and a CHAMPUS-authorized civilian health care provider which enables the use of civilian health care personnel or other resources to provide medical care to CHAMPUS beneficiaries on the premises of a military treatment facility under the Military-Civilian Health Services Partnership Program. These internal agreements may be established when a military treatment facility is unable to provide sufficient health care services for CHAMPUS beneficiaries due to shortages of personnel and other required resources.</P>
            <P>
              <E T="03">Internal Resource Sharing Agreement.</E> A type of Internal Partnership Agreement, established in the context of the TRICARE program by agreement of a military medical treatment facility commander and authorized TRICARE contractor. Internal Resource Sharing Agreements may incorporate TRICARE features in lieu of standard CHAMPUS features that would apply to standard Internal Partnership Agreements.<PRTPAGE P="58"/>
            </P>
            <P>
              <E T="03">Item, Service, or Supply.</E> Includes (1) any item, device, medical supply, or service claimed to have been provided to a beneficiary (patient) and listed in an itemized claim for CHAMPUS payment or a request for payment, or (2) in the case of a claim based on costs, any entry or omission in a cost report, books of account, or other documents supporting the claim.</P>
            <P>
              <E T="03">Laboratory and pathological services.</E> Laboratory and pathological examinations (including machine diagnostic tests that produce hard-copy results) when necessary to, and rendered in connection with medical, obstetrical, or surgical diagnosis or treatment of an illness or injury, or in connection with well-baby care.</P>
            <P>
              <E T="03">Legitimized child.</E> A formerly illegitimate child who is considered legitimate by reason of qualifying actions recognized in law.</P>
            <P>
              <E T="03">Licensed practical nurse (L.P.N.).</E> A person who is prepared specially in the scientific basis of nursing; who is a graduate of a school of practical nursing; whose qualifications have been examined by a state board of nursing; and who has been authorized legally to practice as an L.P.N. under the supervision of a physician.</P>
            <P>
              <E T="03">Licensed vocational nurse (L.V.N.)</E> A person who specifically is prepared in the scientific basis or nursing; who is a graduate of a school of vocational nursing; whose qualifications have been examined by a state board of nursing; and who has been authorized legally to practice as a L.V.N. under the supervision of a physician.</P>
            <P>
              <E T="03">Long-term hospital care.</E> Any inpatient hospital stay that exceeds 30 days.</P>
            <P>
              <E T="03">Low-risk pregnancy.</E> A pregnancy is low-risk when the basis for the ongoing clinical expectation of a normal uncomplicated birth, as defined by reasonable and generally accepted criteria of maternal and fetal health, is documented throughout a generally accepted course of prenatal care.</P>
            <P>
              <E T="03">Major life activity.</E> Breathing, cognition, hearing, seeing, and age appropriate ability essential to bathing, dressing, eating, grooming, speaking, stair use, toilet use, transferring, and walking.</P>
            <P>
              <E T="03">Marriage and family therapist, certified.</E> An extramedical individual provider who meets the requirements outlined in § 199.6.</P>
            <P>
              <E T="03">Maternity care.</E> Care and treatment related to conception, delivery, and abortion, including prenatal and postnatal care (generally through the 6th post-delivery week), and also including treatment of the complications of pregnancy.</P>
            <P>
              <E T="03">Medicaid.</E> Those medical benefits authorized under Title XIX of the Social Security Act provided to welfare recipients and the medically indigent through programs administered by the various states.</P>
            <P>
              <E T="03">Medical.</E> The generally used term which pertains to the diagnosis and treatment of illness, injury, pregnancy, and mental disorders by trained and licensed or certified health professionals. For purposes of CHAMPUS, the term “medical” should be understood to include “medical, psychological, surgical, and obstetrical,” unless it is specifically stated that a more restrictive meaning is intended.</P>
            <P>
              <E T="03">Medical emergency.</E> The sudden and unexpected onset of a medical condition or the acute exacerbation of a chronic condition that is threatening to life, limb, or sight, and requires immediate medical treatment or which manifests painful symptomatology requiring immediate palliative efforts to alleviate suffering. Medical emergencies include heart attacks, cardiovascular accidents, poisoning, convulsions, kidney stones, and such other acute medical conditions as may be determined to be medical emergencies by the Director, OCHAMPUS, or a designee. In the case of a pregnancy, a medical emergency must involve a sudden and unexpected medical complication that puts the mother, the baby, or both, at risk. Pain would not, however, qualify a maternity case as an emergency, nor would incipient birth after the 34th week of gestation, unless an otherwise qualifying medical condition is present. Examples of medical emergencies related to pregnancy or delivery are hemorrhage, ruptured membrane with prolapsed cord, placenta previa, abruptio placenta, presence of shock or unconsciousness, suspected heart attack or stroke, or trauma (such as injuries received in an automobile accident).<PRTPAGE P="59"/>
            </P>
            <P>
              <E T="03">Medical supplies and dressings (consumables).</E> Necessary medical or surgical supplies (exclusive of durable medical equipment) that do not withstand prolonged, repeated use and that are needed for the proper medical management of a condition for which benefits are otherwise authorized under CHAMPUS, on either an inpatient or outpatient basis. Examples include disposable syringes for a diabetic, colostomy sets, irrigation sets, and ace bandages.</P>
            <P>
              <E T="03">Medically or psychologically necessary.</E> The frequency, extent, and types of medical services or supplies which represent appropriate medical care and that are generally accepted by qualified professionals to be reasonable and adequate for the diagnosis and treatment of illness, injury, pregnancy, and mental disorders or that are reasonable and adequate for well-baby care.</P>
            <P>
              <E T="03">Medicare.</E> These medical benefits authorized under Title XVIII of the Social Security Act provided to persons 65 or older, certain disabled persons, or persons with chronic renal disease, through a national program administered by the DHHS, Health Care Financing Administration, Medicare Bureau.</P>
            <P>
              <E T="03">Mental disorder.</E> For purposes of the payment of CHAMPUS benefits, a mental disorder is a nervous or mental condition that involves a clinically significant behavioral or psychological syndrome or pattern that is associated with a painful symptom, such as distress, <E T="03">and</E> that impairs a patient's ability to function in one or more major life activities. Additionally, the mental disorder must be one of those conditions listed in the DSM-III.</P>
            <P>
              <E T="03">Mental health counselor.</E> An extramedical individual provider who meets the requirements outlined in § 199.6.</P>
            <P>
              <E T="03">Mental health therapeutic absence.</E> A therapeutically planned absence from the inpatient setting. The patient is not discharged from the facility and may be away for periods of several hours to several days. The purpose of the therapeutic absence is to give the patient an opportunity to test his or her ability to function outside the inpatient setting before the actual discharge.</P>
            <P>
              <E T="03">Missing in action (MIA).</E> A battle casualty whose whereabouts and status are unknown, provided the absence appears to be involuntary and the service member is not known to be in a status of unauthorized absence.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Claims for eligible CHAMPUS beneficiaries whose sponsor is classified as MIA are processed as dependents of an active duty service member.</P>
            </NOTE>
            <P>
              <E T="03">Morbid obesity.</E> The body weight is 100 pounds over ideal weight for height and bone structure, according to the most current Metropolitan Life Table, and such weight is in association with severe medical conditions known to have higher mortality rates in association with morbid obesity; or, the body weight is 200 percent or more of the ideal weight for height and bone structure according to the most current Metropolitan Life Table. The associated medical conditions are diabetes mellitus, hypertension, cholecystitis, narcolepsy, pickwickian syndrome (and other severe respiratory diseases), hypothalmic disorders, and severe arthritis of the weight-bearing joints.</P>
            <P>
              <E T="03">Most-favored rate.</E> The lowest usual charge to any individual or third-party payer in effect on the date of the admission of a CHAMPUS beneficiary.</P>
            <P>
              <E T="03">Natural childbirth.</E> Childbirth without the use of chemical induction or augmentation of labor or surgical procedures other than episiotomy or perineal repair.</P>
            <P>
              <E T="03">Naturopath.</E> A person who practices naturopathy, that is, a drugless system of therapy making use of physical forces such as air, light, water, heat, and massage.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Services of a naturopath are not covered by CHAMPUS.</P>
            </NOTE>
            <P>
              <E T="03">NAVCARE clinics.</E> Contractor owned, staffed, and operated primary clinics exclusively serving uniformed services beneficiaries pursuant to contracts awarded by a Military Department.</P>
            <P>
              <E T="03">Nonavailability statement.</E> A certification by a commander (or a designee) of a Uniformed Services medical treatment facility, recorded on DEERS, generally for the reason that the needed medical care being requested by a non-TRICARE Prime enrolled beneficiary cannot be provided at the facility concerned because the necessary resources are not available in the time frame needed.<PRTPAGE P="60"/>
            </P>
            <P>
              <E T="03">Nonparticipating provider.</E> A hospital or other authorized institutional provider, a physician or other authorized individual professional provider, or other authorized provider that furnished medical services or supplies to a CHAMPUS beneficiary, but who did not agree on the CHAMPUS claim form to participate or to accept the CHAMPUS-determined allowable cost or charge as the total charge for the services. A nonparticipating provider looks to the beneficiary or sponsor for payment of his or her charge, not CHAMPUS. In such cases, CHAMPUS pays the beneficiary or sponsor, not the provider.</P>
            <P>
              <E T="03">North Atlantic Treaty Organization (NATO) member.</E> A military member of an armed force of a foreign NATO nation who is on active duty and who, in connection with official duties, is stationed in or passing through the United States. The foreign NATO nations are Belgium, Canada, Denmark, France, Federal Republic of Germany, Greece, Iceland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Turkey, and the United Kingdom.</P>
            <P>
              <E T="03">Not-for-profit entity.</E> An organization or institution owned and operated by one or more nonprofit corporations or associations formed pursuant to applicable state laws, no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual.</P>
            <P>
              <E T="03">Occupational therapist.</E> A person who is trained specially in the skills and techniques of occupational therapy (that is, the use of purposeful activity with individuals who are limited by physical injury of illness, psychosocial dysfunction, developmental or learning disabilities, poverty and cultural differences, or the aging process in order to maximize independence, prevent disability, and maintain health) and who is licensed to administer occupational therapy treatments prescribed by a physician.</P>
            <P>
              <E T="03">Official formularies.</E> A book of official standards for certain pharmaceuticals and preparations that are not included in the <E T="03">U.S. Pharmacopeia.</E>
            </P>
            <P>
              <E T="03">Optometrist (Doctor of Optometry).</E> A person trained and licensed to examine and test the eyes and to treat visual defects by prescribing and adapting corrective lenses and other optical aids, and by establishing programs of exercises.</P>
            <P>
              <E T="03">Oral surgeon (D.D.S. or D.M.D.).</E> A person who has received a degree in dentistry and who limits his or her practice to oral surgery, that is, that branch of the healing arts that deals with the diagnosis and the surgical correction and adjunctive treatment of diseases, injuries, and defects of the mouth, the jaws, and associated structures.</P>
            <P>
              <E T="03">Orthopedic shoes.</E> Shoes prescribed by an orthopedic surgeon to effect changes in foot or feet position and alignment and which are not an integral part of a brace.</P>
            <P>
              <E T="03">Other allied health professionals.</E> Individual professional providers other than physicians, dentists, or extramedical individual providers, as specified in § 199.6 of this part.</P>
            <P>
              <E T="03">Other special institutional providers.</E> Certain specialized medical treatment facilities, either inpatient or outpatient, other than those specifically defined, that provide courses of treatment prescribed by a doctor of medicine or osteopathy; when the patient is under the supervision of a doctor of medicine or osteopathy during the entire course of the inpatient admission or the outpatient treatment; when the type and level of care and services rendered by the institution are otherwise authorized in this Regulation; when the facility meets all licensing or other certification requirements that are extant in the jurisdiction in which the facility is located geographically; which is accredited by the Joint Commission on Accreditation if an appropriate accreditation program for the given type of facility is available; and which is not a nursing home, intermediate facility, halfway house, home for the aged, or other institution of similar purpose.</P>
            <P>
              <E T="03">Outpatient.</E> A patient who has not been admitted to a hospital or other authorized institution as an inpatient.</P>
            <P>
              <E T="03">Ownership or control interest.</E> For purposes of § 199.9(f)(1), a “person with an ownership or control interest” is anyone who</P>

            <P>(1) Has directly or indirectly a 5 percent or more ownership interest in the entity; or<PRTPAGE P="61"/>
            </P>
            <P>(2) Is the owner of a whole or part interest in any mortgage, deed of trust, note, or other obligation secured (in whole or in part) by the entity or any of the property or assets thereof, which whole or part interest is equal to or exceeds 5 percent of the total property and assets of the entity; or</P>
            <P>(3) Is an officer or director of the entity if the entity is organized as a corporation; or</P>
            <P>(4) Is a partner in the entity if the entity is organized as a partnership.</P>
            <P>
              <E T="03">Partial hospitalization.</E> A treatment setting capable of providing an interdisciplinary program of medical therapeutic services at least 3 hours per day, 5 days per week, which may embrace day, evening, night and weekend treatment programs which employ an integrated, comprehensive and complementary schedule of recognized treatment approaches. Partial hospitalization is a time-limited, ambulatory, active treatment program that offers therapeutically intensive, coordinated, and structured clinical services within a stable therapeutic environment. Partial hospitalization is an appropriate setting for crisis stabilization, treatment of partially stabilized mental health disorders, and a transition from an inpatient program when medically necessary. Such programs must enter into a participation agreement with CHAMPUS, and be accredited and in substantial compliance with the standards of the Mental Health Manual of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (formerly known as the Consolidated Standards).</P>
            <P>
              <E T="03">Participating provider.</E> A CHAMPUS-authorized provider that is required, or has agreed by entering into a CHAMPUS participation agreement or by act of indicating “accept assignment” on the claim form, to accept the CHAMPUS-allowable amount as the maximum total charge for a service or item rendered to a CHAMPUS beneficiary, whether the amount is paid for fully by CHAMPUS or requires cost-sharing by the CHAMPUS beneficiary.</P>
            <P>
              <E T="03">Party to a hearing.</E> An appealing party or parties and CHAMPUS.</P>
            <P>
              <E T="03">Party to the initial determination.</E> Includes CHAMPUS and also refers to a CHAMPUS beneficiary and a participating provider of services whose interests have been adjudicated by the initial determination. In addition, a provider who has been denied approval as an authorized CHAMPUS provider is a party to that initial determination, as is a provider who is disqualified or excluded as an authorized provider under CHAMPUS, unless the provider is excluded based on a determination of abuse or fraudulent practices or procedures under another federal or federally funded program. See § 199.10 for additional information concerning parties not entitled to administrative review under the CHAMPUS appeals and hearing procedures.</P>
            <P>
              <E T="03">Pastoral counselor.</E> An extramedical individual provider who meets the requirements outlined in § 199.6.</P>
            <P>
              <E T="03">Pharmacist.</E> A person who is trained specially in the scientific basis of pharmacology and who is licensed to prepare and sell or dispense drugs and compounds and to make up prescriptions ordered by a physician.</P>
            <P>
              <E T="03">Physical medicine services or physiatry services.</E> The treatment of disease or injury by physical means such as massage, hydrotherapy, or heat.</P>
            <P>
              <E T="03">Physical therapist.</E> A person who is trained specially in the skills and techniques of physical therapy (that is, the treatment of disease by physical agents and methods such as heat, massage, manipulation, therapeutic exercise, hydrotherapy, and various forms of energy such as electrotherapy and ultrasound), who has been authorized legally (that is, registered) to administer treatments prescribed by a physician and who is entitled legally to use the designation “Registered Physical Therapist.” A physical therapist also may be called a physiotherapist.</P>
            <P>
              <E T="03">Physician.</E> A person with a degree of Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) who is licensed to practice medicine by an appropriate authority.</P>
            <P>
              <E T="03">Physician in training.</E> Interns, residents, and fellows participating in approved postgraduate training programs and physicians who are not in approved programs but who are authorized to <PRTPAGE P="62"/>practice only in a hospital or other institutional provider setting, e.g., individuals with temporary or restricted licenses, or unlicensed graduates of foreign medical schools.</P>
            <P>
              <E T="03">Podiatrist (Doctor of Podiatry or Surgical Chiropody).</E> A person who has received a degree in podiatry (formerly called chiropody), that is, that specialized field of the healing arts that deals with the study and care of the foot, including its anatomy, pathology, and medical and surgical treatment.</P>
            <P>
              <E T="03">Preauthorization.</E> A decision issued in writing by the Director, OCHAMPUS, or a designee, that CHAMPUS benefits are payable for certain services that a beneficiary has not yet received.</P>
            <P>
              <E T="03">Prescription drugs and medicines.</E> Drugs and medicines which at the time of use were approved for commercial marketing by the U.S. Food and Drug Administration, and which, by law of the United States, require a physician's or dentist's prescription, except that it includes insulin for known diabetics whether or not a prescription is required. Drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered under CHAMPUS as if FDA approved.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The fact that the U.S. Food and Drug Administration has approved a drug for testing on humans would not qualify it within this definition.</P>
            </NOTE>
            <P>
              <E T="03">Preventive care.</E> Diagnostic and other medical procedures not related directly to a specific illness, injury, or definitive set of symptoms, or obstetrical care, but rather performed as periodic health screening, health assessment, or health maintenance.</P>
            <P>
              <E T="03">Primary caregiver.</E> An individual who renders to a beneficiary services to support the essentials of daily living (as defined in § 199.2) and specific services essential to the safe management of the beneficiary's condition.</P>
            <P>
              <E T="03">Primary payer.</E> The plan or program whose medical benefits are payable first in a double coverage situation.</P>
            <P>
              <E T="03">PRIMUS clinics.</E> Contractor owned, staffed, and operated primary care clinics exclusively serving uniformed services beneficiaries pursuant to contracts awarded by a Military Department.</P>
            <P>
              <E T="03">Private duty (special) nursing services.</E> Skilled nursing services rendered to an individual patient requiring intensive medical care. Such private duty (special) nursing must be by an actively practicing registered nurse (R.N.) or licensed practical or vocational nurse (L.P.N. or L.V.N.) only when the medical condition of the patient requires intensive skilled nursing services (rather than primarily providing the essentials of daily living) and when such skilled nursing care is ordered by the attending physician.</P>
            <P>
              <E T="03">Private room.</E> A room with one bed that is designated as a private room by the hospital or other authorized institutional provider.</P>
            <P>
              <E T="03">Program for Persons with Disabilities PFPWD).</E> The CHAMPUS benefits described in § 199.5.</P>
            <P>
              <E T="03">Progress notes.</E> Progress notes are an essential component of the medical record wherein health care personnel provide written evidence of ordered and supervised diagnostic tests, treatments, medical procedures, therapeutic behavior and outcomes. In the case of mental health care, progress notes must include: the date of the therapy session; length of the therapy session; a notation of the patient's signs and symptoms; the issues, pathology and specific behaviors addressed in the therapy session; a statement summarizing the therapeutic interventions attempted during the therapy session; descriptions of the response to treatment, the outcome of the treatment, and the response to significant others; and a statement summarizing the patient's degree of progress toward the treatment goals. Progress notes do not need to repeat all that was said during a therapy session but must document a patient contact and be sufficiently detailed to allow for both peer review and audits to substantiate the quality and quantity of care rendered.</P>
            <P>
              <E T="03">Prosthetic device (prosthesis).</E> An artificial substitute for a missing body part.</P>
            <P>
              <E T="03">Provider.</E> A hospital or other institutional provider, a physician, or other individual professional provider, or other provider of services or supplies as specified in § 199.6 of this part.</P>
            <P>
              <E T="03">Provider exclusion and suspension.</E> The terms “exclusion” and “suspension”, when referring to a provider under CHAMPUS, both mean the denial of status as an authorized provider, resulting in items, services, or supplies <PRTPAGE P="63"/>furnished by the provider not being reimbursed, directly or indirectly, under CHAMPUS. The terms may be used interchangeably to refer to a provider who has been denied status as an authorized CHAMPUS provider based on (1) a criminal conviction or civil judgment involving fraud, (2) an administrative finding of fraud or abuse under CHAMPUS, (3) an administrative finding that the provider has been excluded or suspended by another agency of the Federal Government, a state, or a local licensing authority, (4) an administrative finding that the provider has knowingly participated in a conflict of interest situation, or (5) an administrative finding that it is in the best interests of the CHAMPUS or CHAMPUS beneficiaries to exclude or suspend the provider.</P>
            <P>
              <E T="03">Provider termination.</E> When a provider's status as an authorized CHAMPUS provider is ended, other than through exclusion or suspension, based on a finding that the provider does not meet the qualifications, as set forth in § 199.6 of this part, to be an authorized CHAMPUS provider.</P>
            <P>
              <E T="03">Psychiatric emergency.</E> A psychiatric inpatient admission is an emergency when, based on a psychiatric evaluation performed by a physician (or other qualified mental health care professional with hospital admission authority), the patient is at immediate risk of serious harm to self or others as a result of a mental disorder and requires immediate continuous skilled observation at the acute level of care.</P>
            <P>
              <E T="03">Public facility.</E> A public authority or entity legally constituted within a State (as defined in this section) to administer, control or perform a service function for public health, education or human services programs in a city, county, or township, special district, or other political subdivision, or such combination of political subdivisions or special districts or counties as are recognized as an administrative agency for a State's public health, education or human services programs, or any other public institution or agency having administrative control and direction of a publicly funded health, education or human services program.</P>
            <P>
              <E T="03">Public facility adequacy.</E> An available public facility shall be considered adequate when the Director, OCHAMPUS, or designee, determines that the quality, quantity, and frequency of an available service or item otherwise allowable as a CHAMPUS benefit is sufficient to meet the beneficiary's specific disability related need in a timely manner.</P>
            <P>
              <E T="03">Public facility availability.</E> A public facility shall be considered available when the public facility usually and customarily provides the requested service or item to individuals with the same or similar disability related need as the otherwise equally qualified CHAMPUS beneficiary.</P>
            <P>
              <E T="03">Qualified accreditation organization.</E> A not-for-profit corporation or a foundation that:</P>
            <P>(1) Develops process standards and outcome standards for health care delivery programs, or knowledge standards and skill standards for health care professional certification testing, using experts both from within and outside of the health care program area or individual specialty to which the standards are to be applied;</P>
            <P>(2) Creates measurable criteria that demonstrate compliance with each standard;</P>
            <P>(3) Publishes the organization's standards, criteria and evaluation processes so that they are available to the general public;</P>
            <P>(4) Performs on-site evaluations of health care delivery programs, or provides testing of individuals, to measure the extent of compliance with each standard;</P>
            <P>(5) Provides on-site evaluation or individual testing on a national or international basis;</P>
            <P>(6) Provides to evaluated programs and tested individuals time-limited written certification of compliance with the organization's standards;</P>
            <P>(7) Excludes certification of any program operated by an organization which has an economic interest, as defined in this section, in the accreditation organization or in which the accreditation organization  has an economic interest;</P>

            <P>(8) Publishes promptly the certification outcomes of each program evaluation or individual test so that it is available to the general public; and<PRTPAGE P="64"/>
            </P>
            <P>(9) Has been found by the Director, OCHAMPUS, or designee, to apply standards, criteria, and certification processes which reinforce CHAMPUS provider authorization requirements and promote efficient delivery of CHAMPUS benefits.</P>
            <P>
              <E T="03">Radiation therapy services.</E> The treatment of diseases by x-ray, radium, or radioactive isotopes when ordered by the attending physician.</P>
            <P>
              <E T="03">Rare Diseases.</E> CHAMPUS defines a rare disease as one which affects fewer than one in 200,000 Americans.</P>
            <P>
              <E T="03">Referral.</E> The act or an instance of referring a CHAMPUS beneficiary to another authorized provider to obtain necessary medical treatment. Under CHAMPUS, only a physician may make referrals.</P>
            <P>
              <E T="03">Registered nurse.</E> A person who is prepared specially in the scientific basis of nursing, who is a graduate of a school of nursing, and who is registered for practice after examination by a state board of nurse examiners or similar regulatory authority, who holds a current, valid license, and who is entitled legally to use the designation R.N.</P>
            <P>
              <E T="03">Rehabilitation.</E> The reduction of an acquired loss of ability to perform an activity in the manner, or within the range considered normal, for a human being.</P>
            <P>
              <E T="03">Reliable evidence.</E> (1) As used in § 199.4(g)(15), the term reliable evidence means only:</P>
            <P>(i) Well controlled studies of clinically meaningful endpoints, published in refereed medical literature.</P>
            <P>(ii) Published formal technology assessments.</P>
            <P>(iii) The published reports of national professional medical associations.</P>
            <P>(iv) Published national medical policy organization positions; and</P>
            <P>(v) The published reports of national expert opinion organizations.</P>
            <P>(2) The hierarchy of reliable evidence of proven medical effectiveness, established by (1) through (5) of this paragraph, is the order of the relative weight to be given to any particular source. With respect to clinical studies, only those reports and articles containing scientifically valid data and published in the refereed medical and scientific literature shall be considered as meeting the requirements of reliable evidence. Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions. Also not included in the meaning of reliable evidence is the fact that a provider or a number of providers have elected to adopt a drug, device, or medical treatment or procedure as their personal treatment or procedure of choice or standard of practice.</P>
            <P>
              <E T="03">Representative.</E> Any person who has been appointed by a party to the initial determination as counsel or advisor and who is otherwise eligible to serve as the counsel or advisor of the party to the initial determination, particularly in connection with a hearing.</P>
            <P>
              <E T="03">Resident (medical).</E> A graduate physician or dentist who has an M.D. or D.O. degree, or D.D.S. or D.M.D. degree, respectively, is licensed to practice, and who choose to remain on the house staff of a hospital to get further training that will qualify him or her for a medical or dental specialty.</P>
            <P>
              <E T="03">Residential treatment center (RTC).</E> A facility (or distinct part of a facility) which meets the criteria in § 199.6(b)(4)(v).</P>
            <P>
              <E T="03">Respite care.</E> Respite care is short-term care for a patient in order to provide rest and change for those who have been caring for the patient at home, usually the patient's family.</P>
            <P>
              <E T="03">Retiree.</E> A member or former member of a Uniformed Service who is entitled to retired, retainer, or equivalent pay based on duty in a Uniformed Service.</P>
            <P>
              <E T="03">Routine eye examinations.</E> The services rendered in order to determine the refractive state of the eyes.</P>
            <P>
              <E T="03">Sanction.</E> For purpose of § 199.9, “sanction” means a provider exclusion, suspension, or termination.</P>
            <P>
              <E T="03">Secondary payer.</E> The plan or program whose medical benefits are payable in double coverage situations only after the primary payer has adjudicated the claim.</P>
            <P>
              <E T="03">Semiprivate room.</E> A room containing at least two beds. If a room is designated publicly as a semiprivate accommodation by the hospital or other authorized institutional provider and contains multiple beds, it qualifies as a <PRTPAGE P="65"/>semiprivate room for the purposes of CHAMPUS.</P>
            <P>
              <E T="03">Serious physical disability.</E> Any physiological disorder or condition or anatomical loss affecting one or more body systems which has lasted, or with reasonable certainty is expected to last, for a minimum period of 12 contiguous months, and which precludes the person with the disorder, condition or anatomical loss from unaided performance of at least one Major Life Activity as defined in this section.</P>
            <P>
              <E T="03">Skilled nursing facility.</E> An institution (or a distinct part of an institution) that meets the criteria as set forth in § 199.6(b)(4)(iv) of this part.</P>
            <P>
              <E T="03">Skilled nursing service.</E> A service that can only be furnished by an R.N., or L.P.N. or L.V.N., and is required to be performed under the supervision of a physician to ensure the safety of the patient and achieve the medically desired result. Examples of skilled nursing services are intravenous for intramuscular injections, levin tube or gastrostomy feedings, or tracheotomy aspiration and insertion. Skilled nursing services are other than those services that provide primarily support for the essentials of daily living or that could be performed by an untrained adult with minimum instruction or supervision.</P>
            <P>
              <E T="03">Specialized Treatment Service Facility.</E> A military or civilian medical treatment facility specifically designated pursuant to § 199.4(a)(10) to be a referral facility for certain highly specialized care. For this purpose, a civilian medical treatment facility may be another federal facility (such as a Department of Veterans Affairs hospital).</P>
            <P>
              <E T="03">Spectacles, eyeglasses, and lenses.</E> Lenses, including contact lenses, that help to correct faulty vision.</P>
            <P>
              <E T="03">Sponsor.</E> An active duty member, retiree, or deceased active duty member or retiree, of a Uniformed Service upon whose status his or her dependents’ eligibility for CHAMPUS is based.</P>
            <P>
              <E T="03">Spouse.</E> A lawful wife or husband regardless of whether or not dependent upon the active duty member or retiree.</P>
            <P>
              <E T="03">State.</E> For purposes of this part, any of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, and each territory and possession of the United States.</P>
            <P>
              <E T="03">State victims of crime compensation programs.</E> Benefits available to victims of crime under the Violent Crime Control and Law Enforcement Act.</P>
            <P>
              <E T="03">Student status.</E> A dependent of a member or former member of a Uniformed Service who has not passed his or her 23rd birthday, and is enrolled in a full-time course of study in an institution of higher learning.</P>
            <P>
              <E T="03">Supplemental insurance plan.</E> A health insurance policy or other health benefit plan offered by a private entity to a CHAMPUS beneficiary, that primarily is designed, advertised, marketed, or otherwise held out as providing payment for expenses incurred for services and items that are not reimbursed under CHAMPUS due to program limitations, or beneficiary liabilities imposed by law. CHAMPUS recognizes two types of supplemental plans, general indemnity plans, and those offered through a direct service health maintenance organization (HMO).</P>
            <P>(1) An indemnity supplemental insurance plan must meet all of the following criteria:</P>
            <P>(i) It provides insurance coverage, regulated by state insurance agencies, which is available only to beneficiaries of CHAMPUS.</P>
            <P>(ii) It is premium based and all premiums relate only to the CHAMPUS supplemental coverage.</P>
            <P>(iii) Its benefits for all covered CHAMPUS beneficiaries are predominantly limited to non-covered services, to the deductible and cost-shared portions of the pre-determined allowable charges, and/or to amounts exceeding the allowable charges for covered services.</P>
            <P>(iv) It provides insurance reimbursement by making payment directly to the CHAMPUS beneficiary or to the participating provider.</P>
            <P>(v) It does not operate in a manner which results in lower deductibles or cost-shares than those imposed by law, or that waives the legally imposed deductibles or cost-shares.</P>

            <P>(2) A supplemental insurance plan offered by a Health Maintenance Organization (HMO) must meet all of the following criteria:<PRTPAGE P="66"/>
            </P>
            <P>(i) The HMO must be authorized and must operate under relevant provisions of state law.</P>
            <P>(ii) The HMO supplemental plan must be premium based and all premiums must relate only to CHAMPUS supplemental coverage.</P>
            <P>(iii) The HMO's benefits, above those which are directly reimbursed by CHAMPUS, must be limited predominantly to services not covered by CHAMPUS and CHAMPUS deductible and cost-share amounts.</P>
            <P>(iv) The HMO must provide services directly to CHAMPUS beneficiaries through its affiliated providers who, in turn, are reimbursed by CHAMPUS.</P>
            <P>(v) The HMO's premium structure must be designed so that no overall reduction in the amount of the beneficiary deductibles or cost-shares will result.</P>
            <P>
              <E T="03">Suppliers of portable X-ray services.</E> A supplier that meets the conditions of coverage of the Medicare program, set forth in the Medicare regulations (42 CFR 405.1411 through 405.1416 (as amended)) or the Medicaid program in the state in which the covered service is provided.</P>
            <P>
              <E T="03">Surgery.</E> Medically appropriate operative procedures, including related preoperative and postoperative care; reduction of fractures and dislocations; injections and needling procedures of the joints; laser surgery of the eye; and those certain procedures listed in § 199.4(c)(2)(i) of this part.</P>
            <P>
              <E T="03">Surgical assistant.</E> A physician (or dentist or podiatrist) who assists the operating surgeon in the performance of a covered surgical service when such assistance is certified as necessary by the attending surgeon, when the type of surgical procedure being performed is of such complexity and seriousness as to require a surgical assistant, and when interns, residents, or other house staff are not available to provide the surgical assistance services in the specialty area required.</P>
            <P>
              <E T="03">Suspension of claims processing.</E> The temporary suspension of processing (to protect the government's interests) of claims for care furnished by a specific provider (whether the claims are submitted by the provider or beneficiary) or claims submitted by or on behalf of a specific CHAMPUS beneficiary pending action by the Director, OCHAMPUS, or a designee, in a case of suspected fraud or abuse. The action may include the administrative remedies provided for in § 199.9 or any other Department of Defense issuance (e.g. DoD issuances implementing the Program Fraud Civil Remedies Act), case development or investigation by OCHAMPUS, or referral to the Department of Defense-Inspector General or the Department of Justice for action within their cognizant jurisdictions.</P>
            <P>
              <E T="03">Teaching physician.</E> A teaching physician is any physician whose duties include providing medical training to physicians in training within a hospital or other institutional provider setting.</P>
            <P>
              <E T="03">Timely filing.</E> The filing of CHAMPUS claims within the prescribed time limits as set forth in § 199.7 of this part.</P>
            <P>
              <E T="03">Treatment plan.</E> A detailed description of the medical care being rendered or expected to be rendered a CHAMPUS beneficiary seeking approval for inpatient benefits for which preauthorization is required as set forth in § 199.4(b) of this part. A treatment plan must include, at a minimum, a diagnosis (either ICD-9-CM or DSM-III); detailed reports of prior treatment, medical history, family history, social history, and physical examination; diagnostic test results; consultant's reports (if any); proposed treatment by type (such as surgical, medical, and psychiatric); a description of who is or will be providing treatment (by discipline or specialty); anticipated frequency, medications, and specific goals of treatment; type of inpatient facility required and why (including length of time the related inpatient stay will be required); and prognosis. If the treatment plan involves the transfer of a CHAMPUS patient from a hospital or another inpatient facility, medical records related to that inpatient stay also are required as a part of the treatment plan documentation.</P>
            <P>
              <E T="03">TRICARE extra plan.</E> The health care option, provided as part of the TRICARE program under § 199.17, under which beneficiaries may choose to receive care in facilities of the uniformed <PRTPAGE P="67"/>services, or from special civilian network providers (with reduced cost sharing), or from any other CHAMPUS-authorized provider (with standard cost sharing).</P>
            <P>
              <E T="03">TRICARE prime plan.</E> The health care option, provided as part of the TRICARE program under § 199.17, under which beneficiaries enroll to receive all health care from facilities of the uniformed services and civilian network providers (with civilian care subject to substantially reduced cost sharing.</P>
            <P>
              <E T="03">TRICARE program.</E> The program establish under § 199.17.</P>
            <P>
              <E T="03">TRICARE standard plan.</E> The health care option, provided as part of the TRICARE program under § 199.17, under which beneficiaries are eligible for care in facilities of the uniformed services and CHAMPUS under standard rules and procedures.</P>
            <P>
              <E T="03">Uniform HMO benefit.</E> The health care benefit established by § 199.18.</P>
            <P>
              <E T="03">Uniformed Services.</E> The Army, Navy, Air Force, Marine Corps, Coast Guard, Commissioned Corps of the USPHS, and the Commissioned Corps of the NOAA.</P>
            <P>
              <E T="03">Unlabeled or Off-Label Drugs.</E> Food and Drug Administration (FDA) approved drugs that are used for indications or treatments not included in the approved labeling. The drug must be medically necessary for the treatment of the condition for which it is administered, according to accepted standards of medical practice.</P>
            <P>
              <E T="03">Veteran.</E> A person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Unless the veteran is eligible for “retired pay,” “retirement pay,” or “retainer pay,” which refers to payments of a continuing nature and are payable at fixed intervals from the government for military service neither the veteran nor his or her dependents are eligible for benefits under CHAMPUS.</P>
            </NOTE>
            <P>
              <E T="03">Waiver of benefit limits.</E> Extension of current benefit limitations under the Case Management Program, of medical care, services, and/or equipment, not otherwise a benefit under the TRICARE/CHAMPUS program.   </P>
            <P>
              <E T="03">Well-child care.</E> A specific program of periodic health screening, developmental assessment, and routine immunization for dependents under six years of age.</P>
            <P>
              <E T="03">Widow or widower.</E> A person who was a spouse at the time of death of the active duty member or retiree and who has not remarried.</P>
            <P>
              <E T="03">Worker's compensation benefits.</E> Medical benefits available under any worker's compensation law (including the Federal Employees Compensation Act), occupational disease law, employers liability law, or any other legislation of similar purpose, or under the maritime doctrine of maintenance, wages, and cure.</P>
            <P>
              <E T="03">X-ray services.</E> An x-ray examination from which an x-ray film or other image is produced, ordered by the attending physician when necessary and rendered in connection with a medical or surgical diagnosis or treatment of an illness or injury, or in connection with maternity or well-baby care.</P>
            <CITA>[51 FR 24008, July 1, 1986]</CITA>
            <EDNOTE>
              <HD SOURCE="HED">Editorial Note:</HD>
              <P>For <E T="04">Federal Register</E> citations affecting § 199.2, see the List of CFR Sections Affected in the Finding Aids section of this volume.</P>
            </EDNOTE>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.3</SECTNO>
            <SUBJECT>Eligibility.</SUBJECT>
            <P>(a) <E T="03">General.</E> This section sets forth those persons who, by the provisions of 10 U.S.C., chapter 55, and the NATO Status of Forces Agreement, are eligible for CHAMPUS benefits. For additional statements concerning the special requirements of the Program for Persons with Disabilities (PFPWD), refer to § 199.5. A determination that a person is eligible does not entitle such a person automatically to CHAMPUS payments. Other sections of this part set forth additional requirements that must be met before any CHAMPUS benefits may be extended. Additionally, the use of CHAMPUS may be denied if a Uniformed Services medical facility capable of providing the needed care is available.</P>
            <P>(b) <E T="03">Persons eligible—</E>(1) <E T="03">Retiree.</E> A member or former member of a Uniformed Service who is entitled to retired, retainer, or equivalent pay based on duty in a Uniformed Service.</P>
            <P>(2) <E T="03">Dependent.</E> A person who bears one of the following relationships to an active duty member (under a call or order that does not specify a period of 30 days or less), to a retiree, to a NATO <PRTPAGE P="68"/>member who is stationed in or passing through the United States on official business, or to a deceased person who, at the time of death, was an active duty member or a retiree.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>According to section 767 of the Department of Defense Appropriation Act, 1981, (Pub. L. 96-527), from December 15, 1980, through September 30, 1981, spouses and children of NATO members are eligible only for <E T="03">outpatient</E> CHAMPUS benefits while officially accompanying the NATO member who is stationed in or passing through the United States on official business. Availability of benefits after September 30, 1981, will depend on the language of future appropriation acts.</P>
            </NOTE>
            <P>(i) <E T="03">Spouse.</E> A lawful husband or wife, regardless of whether or not dependent upon the active duty member or retiree.</P>
            <P>(ii) <E T="03">Former spouse.</E> There are two groups of former spouses; (<E T="03">i.e.,</E> spouses who were married to a military member or former member but whose marriage has been terminated by a final decree of divorce, dissolution, or annulment). To be eligible for CHAMPUS benefits a former spouse must meet the criteria of paragraphs (b)(2)(ii)(A) through (b)(2)(ii)(E) of this section and must qualify under either the group defined in paragraph (b)(2)(ii)(F)(<E T="03">1</E>) or (b)(2)(ii)(F)(<E T="03">2</E>) of this section.</P>
            <P>(A) Must be unremarried;</P>
            <P>(B) Must not be covered by an employer-sponsored health plan;</P>
            <P>(C) Must have been married to a member or former member who performed at least 20 years of service which can be credited in determining the member's or former member's eligibility for retired or retainer pay;</P>
            <P>(D) Must not be eligible for part A of title XVIII of the Social Security Act (Medicare);</P>
            <P>(E) Must not be the dependent of a NATO member;</P>

            <P>(F) Must meet the requirements of either paragraph (b)(2)(ii)(F)(<E T="03">1</E>), or (b)(2)(ii)(F)(<E T="03">2</E>) of this section.</P>
            <P>(<E T="03">1</E>) The former spouse must have been married to the same member or former member for at least 20 years, at least 20 of which were creditable in determining the member's or former member's eligibility for retired or retainer pay. Eligibility continues indefinitely unless affected by any of the conditions in paragraphs (b)(2)(ii)(A) through (b)(2)(ii)(E) of this section.</P>
            <P>(<E T="03">i</E>) If the date of the final decree of divorce, dissolution, or annulment is before February 1, 1983, the former spouse is eligible for CHAMPUS coverage of health care received on or before January 1, 1985.</P>
            <P>(<E T="03">ii</E>) If the date of the final decree of divorce, dissolution of marriage, or annulment was on or after February 1, 1983, the former spouse is eligible for CHAMPUS coverage of health care which is received on or after the date of the divorce, dissolution, or annulment.</P>
            <P>(<E T="03">2</E>) The former spouse must have been married to the same military member or former member for at least 20 years, and at least 15, but less than 20 of those married years were creditable in determining the member's or former member's eligibility for retired or retainer pay.</P>
            <P>(<E T="03">i</E>) If the date of the final decree of divorce, dissolution of marriage, or annulment, is before April 1, 1985, the former spouse is eligible only for health care received on or before January 1, 1985, or the date of the divorce, dissolution, or annulment, whichever is later.</P>
            <P>(<E T="03">ii</E>) If the date of the decree was on or after April 1, 1985, but before September 29, 1988, the former spouse is eligible only for care received from the date of the divorce, dissolution, or annulment until December 31, 1988, or for two years from the date of the divorce, dissolution, or annulment, whichever is later.</P>
            <P>(<E T="03">iii</E>) If the date of the final decree of divorce, dissolution, or annulment is on or after September 29, 1988, the former spouse is eligible only for care received within the 365 days (366 days in the case of a leap year) immediately following the date of the divorce, dissolution, or annulment.</P>
            <P>(<E T="03">iv</E>) Former spouses listed under paragraphs (b)(2)(ii)(F)(<E T="03">2</E>)(<E T="03">ii</E>) or (b)(2)(ii)(F)(<E T="03">2</E>)(<E T="03">iii</E>) of this section, who purchase a DoD designated health insurance policy upon termination of their eligibility, or within 90 days of termination of their eligibility, under paragraphs (b)(2)(ii)(F)(<E T="03">2</E>)(<E T="03">ii</E>) or (b)(2)(ii)(F)(<E T="03">2</E>)(<E T="03">iii</E>) of this section, are eligible for an additional year of coverage at military treatment facilities and under CHAMPUS for preexisting <PRTPAGE P="69"/>conditions. Preexisting conditions are those for which coverage is denied by the conversion health plan, solely because the conditions existed in the twelve month period prior to the purchase of the conversion insurance policy.</P>
            <P>(iii) <E T="03">Widow or widower.</E> A person who was a spouse at the time of death of the active duty member or retiree and who has not remarried.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>For purposes of this part, an unremarried widow or widower is not an eligible dependent of a NATO member.</P>
            </NOTE>
            <P>(iv) <E T="03">Child.</E> To be eligible, the child must be unmarried and a member of one of the classes set forth in paragraph (b)(2)(iv) (A) or (B) of this section, and who also meets the requirements of paragraph (b)(2)(iv)(C) of this section.</P>
            <P>(A) Child of active duty member.</P>
            <P>(<E T="03">1</E> ) A legitimate child.</P>
            <P>(<E T="03">2</E>) An adopted child whose adoption has been legally completed. For eligibility under this provision, adoption must take place on or before the child's twenty-first birthday.</P>
            <P>(<E T="03">3</E> ) A legitimate stepchild.</P>
            <P>(<E T="03">4</E> ) An illegitimate child of a male member whose paternity has been determined judicially, or an illegitimate child of record of a female member who has been directed judicially to support the child.</P>
            <P>(<E T="03">5</E> ) An illegitimate child of a male active duty member whose paternity has not been determined judicially, or an illegitimate child of record of a female active duty member who:</P>
            <P>(<E T="03">i</E> ) Resides with or in a home provided by the member; and</P>
            <P>(<E T="03">ii</E> ) Is and continues to be dependent upon the member for over 50 percent of his or her support.</P>
            <P>(<E T="03">6</E> ) An illegitimate child of the spouse of an active duty member (that is, the active duty member's stepchild) who:</P>
            <P>(<E T="03">i</E> ) Resides with or in a home provided by the active duty member or the parent who is the spouse of the member; and</P>
            <P>(<E T="03">ii</E> ) Is and continues to be dependent upon the member for over 50 percent of his or her support.</P>
            <P>(B) Child of retiree, or deceased member or retiree.</P>
            <P>(<E T="03">1</E> ) A legitimate child.</P>
            <P>(<E T="03">2</E> ) An adopted child whose adoption has been legally completed. For eligibility under this provision, adoption must take place on or before the child's twenty-first birthday.</P>
            <P>(<E T="03">3</E> ) A legitimate stepchild.</P>
            <P>(<E T="03">4</E> ) An illegitimate child of a male retiree whose paternity has been determined judicially, or an illegitimate child of record of a female retiree who has been directed judicially to support the child.</P>
            <P>(<E T="03">5</E> ) An illegitimate child of a male retiree, or deceased male member or retiree whose paternity has not been determined judicially or an illegitimate child of record of a female retiree, or deceased female member or retiree who—</P>
            <P>(<E T="03">i</E> ) Resides with or in a home provided by the retiree, or which was being provided by the deceased member or retiree at the time of death; and</P>
            <P>(<E T="03">ii</E> ) Is and continues to be dependent upon the retiree for over 50 percent of his or her support, or who was so dependent on the deceased member or retiree at the time of death.</P>
            <P>(<E T="03">6</E> ) An illegitimate child of the spouse of a retiree or deceased member or retiree (that is, the retiree's stepchild or stepchild of a deceased member or retiree at the time of death) who—</P>
            <P>(<E T="03">i</E> ) Resides with or in a home provided by the retiree or the parent who is the spouse of the retiree or was the spouse of the deceased member or retiree at the time of death; and</P>
            <P>(<E T="03">ii</E> ) Is and continues to be dependent upon the retiree for 50 percent of his or her support, or who was so dependent on the deceased member or retiree at the time of death.</P>
            <P>(C) Additional requirements for a child who is a member of one of the classes in paragraphs (b)(2)(iv) (A) and (B) of this section. The child must not be married. Additionally, he or she must be in one of the following three age groups:</P>
            <P>(<E T="03">1</E> ) Not passed his or her 21st birthday.</P>
            <P>(<E T="03">2</E> ) Passed his or her 21st birthday but incapable of self-support because of a mental or physical incapacity that existed before his or her 21st birthday and dependent on the member or retiree for over 50 percent of his or her <PRTPAGE P="70"/>support, or dependent upon the member or retiree for over 50 percent of his or her support on the date of the member's or retiree's death. Such incapacity must be continuous. If the incapacity significantly improves or ceases at any time after age 21, even if such incapacity recurs subsequently, CHAMPUS eligibility cannot be reinstated on the basis of the incapacity. If the child was not handicapped mentally or physically at his or her 21st birthday, but becomes so incapacitated after that time, no CHAMPUS eligibility exists on the basis of the incapacity.</P>
            <P>(<E T="03">3</E> ) Passed his or her 21st birthday but not his or her 23rd birthday, dependent upon the member or retiree for over 50 percent of his or her support, or dependent upon the member or retiree for over 50 percent of his or her support on the date of the member's or retiree's death, and pursuing a full-time course of education in an institution of higher learning approved by the Secretary of Defense or the Department of Education (as appropriate) or by a state agency under 38 U.S.C. chapters 34 and 35.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>Courses of education offered by institutions listed in the “Education Directory, Part 3, Higher Education” or “Accredited Higher Institutions” issued periodically by the Department of Education meet the criteria approved by the Secretary of Defense or the Department of Education (refer to paragraph (b)(2)(iv)(C)(<E T="03">3</E>) of this section. For determination of approval of courses offered by a foreign institution, by an institution not listed in either of the above directories, or by an institution not approved by a state agency pursuant to chapters 34 and 35 of 38 U.S.C., a statement may be obtained from the Department of Education, Washington, DC 20202.</P>
            </NOTE>
            <P>(c) <E T="03">Beginning dates of eligibility</E>—(1) <E T="03">General.</E> The beginning date of eligibility is dependent upon the class to which the person belongs and the date the person became a member of the class. Those who join after the class became eligible attain individual eligibility on the date they join.</P>
            <P>(2) <E T="03">Beginning dates of class eligibility</E>—(i) <E T="03">Spouse, legitimate child, adopted child, or (legitimate) stepchild of an active duty member</E>.</P>
            <P>(A) For the medical benefits authorized by the Dependents’ Medical Care Act of 1956, December 7, 1956.</P>
            <P>(B) For outpatient medical benefits under the Basic Program, October 1, 1966.</P>
            <P>(C) For inpatient medical benefits under the Basic Program, January 1, 1967.</P>
            <P>(D) For benefits under the PFPWD, January 1, 1967.</P>
            <P>(ii) <E T="03">Retiree.</E> For medical benefits under the Basic Program, January 1, 1967.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Retirees and their dependents are not eligible for benefits of the PFPWD.</P>
            </NOTE>
            <P>(iii) Spouse, legitimate child, adopted child, or (legitimate) stepchild of a retiree or of a deceased member or retiree; widow or widower of deceased member or retiree. For medical benefits under the Basic Program, January 1, 1967.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>These classes do not have eligibility for benefits of the PFPWD.</P>
            </NOTE>
            <P>(iv) Illegitimate child of a male active duty member or retiree (or deceased member or retiree) whose paternity has been determined judicially or an illegitimate child of record of a female active duty member or retiree (or deceased member or retiree) who has been directed judicially to support the child. For all benefits for which otherwise eligible, August 31, 1972.</P>
            <P>(v) Illegitimate child of male active duty member or retiree (or deceased male member or retiree) whose paternity has not been determined judicially, or an illegitimate child of record of a female active duty member or retiree (or deceased female member or retiree) who resides with or in a home provided by the active duty member or retiree (or which was being provided by the deceased member or retiree at the time of death) and who is dependent on the member for over 50 percent of his or her support (or was so dependent on the deceased member or retiree at the time of death). For all benefits for which otherwise eligible, January 1, 1969.</P>

            <P>(vi) Illegitimate child of the spouse of an active duty member or retiree (that is, the member or retiree's stepchild or stepchild of a deceased member or retiree at the time of death) who resides with or in a home provided by the active duty member or retiree, or the parent who is the spouse of the active duty member or retiree (or was the <PRTPAGE P="71"/>spouse of the deceased member or retiree at the time of death), and who is dependent upon the active duty member or retiree for over 50 percent of his or her support (or was so dependent on the deceased member or retiree at the time of death). For medical benefits under the Basic Program, January 1, 1969. For benefits under the PFPWD, dependents of an active duty member only, January 1, 1969.</P>
            <NOTE>
              <HD SOURCE="HED">Note.</HD>
              <P>Retirees or their dependents do not have eligibility for benefits of the PFPWD.</P>
            </NOTE>
            <P>(d) <E T="03">Dual coverage.</E> When an active duty member is also the dependent of another active duty member, a retiree, or a deceased active duty member or retiree, dual coverage, that is, entitlement to direct care from the Uniformed Services medical care system and CHAMPUS is the result. Since the active duty status is primary, and it is the intent that all medical care be provided an active duty member through the Uniformed Services medical care system, CHAMPUS eligibility of dual coverage is therefore terminated as of 12:01 a.m. on the day following the day dual coverage begins. (However, any dependent children in a marriage of two active duty persons or an active duty member and a retiree, are CHAMPUS eligible in the same manner as dependent children of a marriage involving only one CHAMPUS sponsor.) Should a spouse or dependent who has dual coverage leave active duty status, that person's CHAMPUS eligibility is reinstated as of 12:01 a.m. of the day active duty ends, if he or she otherwise is eligible as a dependent of a CHAMPUS sponsor.</P>
            <P>(e) <E T="03">Changes in and termination of eligibility.</E> (1) <E T="03">Changes in status of active duty member.</E> When an active duty member's period of active duty ends (for any reason other than retirement or death), his or her dependents lose their eligibility as of 12:01 a.m. of the day following the day the active duty ends. Entitlement to CHAMPUS benefits also ceases as of 12:01 a.m. of the day following the day a member is placed in desertion status. The member's dependent regains eligibility when the member is returned to military control. A member serving a sentence of confinement in conjunction with a sentence of a punitive discharge is still considered on active duty until such time as the discharge is executed.</P>
            <P>(2) <E T="03">Changes in status of retiree.</E> Should a retiree cease to be entitled to retired, retainer, or equivalent pay for any reason, that person and his or her dependents lose their eligibility as of 12:01 a.m. of the day following the day the retiree ceases to be entitled to such pay unless such persons are otherwise eligible. A retiree who waives his or her retired, retainer, or equivalent pay is still considered a retiree for the purposes of CHAMPUS eligibility.</P>
            <P>(3) <E T="03">Changes in status of dependent—</E>(i) <E T="03">Divorce.</E> Except as provided in paragraph (b)(2)(ii) of this section, a spouse separated from an active duty member or retiree by a final divorce decree loses all eligibility based on his or her former marital relationship as of 12:01 a.m. of the day following the day the divorce becomes final. The eligibility of the member's or retiree's own children (including adopted and eligible illegitimate children) is unaffected by the divorce. An unadopted stepchild, however, loses eligibility with the termination of the marriage, also as of 12:01 a.m. the day following the day the divorce becomes final.</P>
            <P>(ii) <E T="03">Annulment.</E> Except as provided in paragraph (b)(2)(ii) of this section, a spouse whose marriage to an active duty member or retiree is dissolved by annulment loses eligibility as of 12:01 a.m. of the day following the date the court grants the annulment order. The fact that the annulment legally declares the entire marriage void from its inception does not affect the termination date of CHAMPUS eligibility. When there are children, the eligibility of the member's or retiree's own children (including adopted and eligible illegitimate children) is unaffected by the annulment. An unadopted stepchild, however, loses eligibility with the annulment of the marriage, also as of 12:01 a.m. of the day following the day the court grants the annulment order.</P>
            <P>(iii) <E T="03">Adoption.</E> A child of an active duty member or retiree who is adopted by a person, other than a person whose dependents are eligible for CHAMPUS benefits while the active duty member or retiree is living, thereby severing the legal relationship between the <PRTPAGE P="72"/>child and the sponsor, loses eligibility as of 12:01 a.m. of the day following the day the adoption becomes final. However, an adoption occurring after the death of an active duty member or retiree would not result in loss of the child's eligibility, since there would be no termination of the legal relationship between the child and the deceased sponsor.</P>
            <P>(iv) <E T="03">Marriage of child.</E> A child of an active duty member or retiree, who marries a person whose dependents are not eligible for CHAMPUS, loses eligibility as of 12:01 a.m. of the day following the day of the marriage. However, should the marriage be terminated by death, divorce, or annulment before the child is 21 years old, the child again becomes a CHAMPUS eligible dependent as of 12:01 a.m. of the day following the day of the occurrence that terminates the marriage and continues up to age 21 if the child does not marry before that time. If the marriage terminates after the child's 21st birthday, there is no reinstatement of CHAMPUS eligibility.</P>
            <P>(v) <E T="03">Marriage of widow or widower.</E> The remarriage of a widow or widower of an active duty member or retiree to a person whose dependents are not eligible for CHAMPUS terminates his or her CHAMPUS eligibility as of 12:01 a.m. of the day following the day of marriage. Even if such remarriage should terminate for any reason, CHAMPUS benefits cannot be reinstated. However, the child of the widow or widower who was the stepchild of the deceased active duty member or retiree at the time of death continues to have the same CHAMPUS eligibility as other classes of dependent children.</P>
            <P>(vi) Attainment of entitlement to hospital insurance benefits (Part A) under Medicare. Retirees, and all other CHAMPUS eligible persons except dependents of active duty members lose their eligibility for CHAMPUS if they become eligible for hospital insurance benefits (Part A) of Medicare. This is true even though the persons attaining such status live outside the United States where Medicare benefits are not available.</P>
            <P>(A) Loss of CHAMPUS eligibility: Age. All CHAMPUS beneficiaries, except dependents of active duty members, and beneficiaries not eligible for Part A of Medicare, lose CHAMPUS eligibility at midnight on the last day of the month preceding the month of attainment of age 65. (For Medicare purposes, an individual attains age 65 the day before his or her 65th birthday.) If the person is not eligible for Part A of Medicare, he or she must file a Social Security Administration “Notice of Disallowance” certifying to that fact with the Uniformed Service responsible for the issuance of his or her identification card so a new card showing CHAMPUS eligibility can be issued.</P>

            <P>(B) Loss of CHAMPUS eligibility: End stage renal disease and disability—(<E T="03">1</E> ) <E T="03">End stage renal disease.</E> Medicare coverage begins with the third month after the month a course of maintenance dialysis begins, or with the first month of dialysis if the individual participates in a self-dialysis training program during the 3-month waiting period, or with the month in which a patient enters the hospital to prepare to receive a transplant (providing the transplant is performed within the following 2 months). If a transplant is delayed more than 2 months after the preparatory hospitalization, Medicare coverage will begin with the second month prior to the month of transplant. All beneficiaries, except dependents of active duty members, lose their CHAMPUS eligibility when Medicare coverage becomes available to a person because of chronic renal disease.</P>
            <P>(<E T="03">2</E> ) <E T="03">Disability.</E> Each case relating to Medicare eligibility resulting from being disabled requires individual investigation. All beneficiaries except dependents of active duty members lose their CHAMPUS eligibility when Medicare coverage becomes available to a disabled person.</P>
            <P>(C) Reinstatement of CHAMPUS eligibility—(<E T="03">1</E> ) Age limitation. Beneficiaries who lose their CHAMPUS eligibility because they reached the age limitation and were eligible for Part A, cannot be reinstated under CHAMPUS.</P>
            <P>(<E T="03">2</E> ) End stage renal disease. Medicare coverage ceases for end stage renal disease patients with the 36th month after the month in which a successful kidney transplant takes place or with the 12th month after the month in which the course of maintenance dialysis ends. At <PRTPAGE P="73"/>this point CHAMPUS eligibility resumes if the person is otherwise still eligible. He or she is required to take action to be reinstated as a CHAMPUS beneficiary and to obtain a new identification card.</P>
            <P>(<E T="03">3</E> ) Disability. Some disabilities are permanent, other temporary. Each case must be reviewed individually. When disability ends and Medicare eligibility ceases, CHAMPUS eligibility resumes if the person is otherwise still eligible. Agan, he or she is required to take action to obtain a new CHAMPUS identification card.</P>
            <P>(D) Other Medicare entitlement. Entitlement only to supplementary medical insurance (Part B) of Medicare, but not Part A, or to Part A through the Premium-HI provision (provided for under the 1972 Amendments to the Social Security Act), does not affect CHAMPUS eligibility for any class of beneficiary. The only impact relates to double coverage (refer to § 199.8 of this part).</P>

            <P>(vii) Disabling illness or injury of child age 21 or 22 who has eligibility based on his or her student status. A child 21 or 22 years old who is pursuing a full-time course of higher education and who, either during the school year or between semester, suffers a disabling illness or injury with resultant inability to resume attendance at the institution remains eligible for CHAMPUS medical benefits for 6 months after the disability is removed or until the student passes his or her 23rd birthday, whichever occurs first. However, if recovery occurs before the 23rd birthday and there is resumption of a full-time course of higher education, CHAMPUS benefits can be continued until the 23rd birthday. The normal vacation periods during an established school year do not change the eligibility status of a dependent child 21 or 22 years old in full-time student status. Unless an incapacitating condition existed before, and at the time of, a dependent child's 21st birthday, a dependent child 21 or 22 years old in student status does not have eligibility related to mental or physical incapacity as described in paragraph (b)(2)(iv)(C)(<E T="03">2</E> ) of this section.</P>
            <P>(f) <E T="03">Determination of eligibility status—</E>(1) <E T="03">Eligibility determinations responsibility of Uniformed Services.</E> Determination of a person's eligibility as a CHAMPUS beneficiary is the responsibility of the Uniformed Service in which the active duty member, retiree, deceased member, or deceased retiree is, or was, a member, or in the case of dependents of a NATO military member, the Service that sponsors the NATO member. For the purpose of program integrity, the appropriate Uniformed Service shall, upon request of the Director, OCHAMPUS, review the eligibility of a specific person when there is reason to question the eligibility status. In such cases, a report on the result of the review and any action taken will be submitted to the Director, OCHAMPUS, or a designee.</P>
            <P>(2) <E T="03">Procedures for determination of eligibility.</E> Procedures for the determination of eligibility and issuance of identification cards evidencing eligibility are prescribed by the following regulatory documents:</P>
            <P>(i) <E T="03">Department of Defense.</E> DoD Instruction 1000.13.<SU>6</SU>
              <FTREF/>
            </P>
            <FTNT>
              <P>
                <SU>6</SU> See footnote 2 to § 199.1(c)(2)(i).</P>
            </FTNT>
            <P>(ii) <E T="03">Army.</E>  AR 640-3, “Identification Cards, Tags, and Badges.”</P>
            <P>(iii) <E T="03">Navy.</E> (A) NAVPERS 15560, articles 4620150 (active duty members) and 4620250 (retired members).</P>
            <P>(B) NAVMILPERSCOMINST 1750.1 series, Uniformed Services Identification and Privilege Card (DD Form 1173); regulations governing.</P>
            <P>(iv) <E T="03">Marine Corps.</E> (A) MCO in P1900 series, Separation and Retirement Manual (DD Form 2MC-RETIRED).</P>
            <P>(B) MCO in P1750 series, Uniformed Services Identification and Privilege Card (DD Form 1173).</P>
            <P>(v) <E T="03">Air Force.</E> AFR 30-20, “Issue and Control of Identification Cards.”</P>
            <P>(vi) <E T="03">U.S. Public Health Service.</E> CC29.2, Personnel Instruction 1 and 2.</P>
            <P>(vii) <E T="03">Coast Guard.</E> Personnel Manual (CG 207, Chapter 13, Section E, and Chapter 18, Section C).</P>
            <P>(viii) <E T="03">NOAA.</E> No published regulations. Identification cards are issued by Headquarters, NOAA, or the applications are verified by Headquarters, NOAA, and presented to any Uniformed Service facility for issuance of a card.</P>
            <P>(g) <E T="03">Evidence of eligibility required.</E> Eligibility for CHAMPUS benefits will be <PRTPAGE P="74"/>verified through the DEERS (DoD 1341.1-M <SU>7</SU>
              <FTREF/>).</P>
            <FTNT>
              <P>
                <SU>7</SU> See footnote 1 to § 199.1(c)(2)(i).</P>
            </FTNT>
            <P>(1) <E T="03">Acceptable evidence of eligibility—</E>(i) <E T="03">DEERS.</E> Eligibility information established and maintained in the DEERS files is acceptable evidence of eligibility.</P>
            <P>(ii) <E T="03">Identification cards or devices.</E> When the DEERS file is not accessible immediately, acceptable preliminary evidence of eligibility includes valid identification cards or devices officially prescribed and issued by the appropriate Uniformed Service. Dependents identification cards must confirm CHAMPUS eligibility.</P>
            <P>(2) <E T="03">Responsibility for obtaining evidence of eligibility.</E> It is the responsibility of the CHAMPUS beneficiary, or parent, or legal representative, when appropriate, to provide the necessary evidence required for entry into the DEERS file to establish CHAMPUS eligibility, and to ensure that all changes in status that may affect eligibility be reported immediately to the appropriate Uniformed Service for action. Ineligibility for CHAMPUS benefits may be presumed in the absence of prescribed eligibility evidence in the DEERS file or in the absence of a valid identification card or device.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 52 FR 27991, July 27, 1987; 53 FR 17191, May 16, 1988; 55 FR 27634, July 5, 1990; 62 FR 35092, June 30, 1997]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.4</SECTNO>
            <SUBJECT>Basic program benefits.</SUBJECT>
            <P>(a) <E T="03">General.</E> The CHAMPUS Basic Program is essentially a supplemental program to the Uniformed Services direct medical care system. The Basic Program is similar to private insurance programs, and is designed to provide financial assistance to CHAMPUS beneficiaries for certain prescribed medical care obtained from civilian sources.</P>
            <P>(1)(i) <E T="03">Scope of benefits.</E> Subject to all applicable definitions, conditions, limitations, or exclusions specified in this part, the CHAMPUS Basic Program will pay for medically necessary services and supplies required in the diagnosis and treatment of illness or injury, including maternity care and well-baby care. Benefits include specified medical services and supplies provided to eligible beneficiaries from authorized civilian sources such as hospitals, other authorized institutional providers, physicians, other authorized individual professional providers, and professional ambulance service, prescription drugs, authorized medical supplies, and rental or purchase of durable medical equipment.</P>
            <P>(ii) <E T="03">Impact of TRICARE program.</E> The basic program benefits set forth in this section are applicable to the basic CHAMPUS program. In areas in which the TRICARE program is implemented, certain provisions of § 199.17 will apply instead of the provisions of this section. In those areas, the provisions of § 199.17 will take precedence over any provisions of this section with which they conflict.</P>
            <P>(2) <E T="03">Persons eligible for Basic Program benefits.</E> Persons eligible to receive the Basic Program benefits are set forth in § 199.3 of this part. Any person determined to be an eligible CHAMPUS beneficiary is eligible for Basic Program benefits.</P>
            <P>(3) <E T="03">Authority to act for CHAMPUS.</E> The authority to make benefit determinations and authorize the disbursement of funds under CHAMPUS is restricted to the Director, OCHAMPUS; designated OCHAMPUS staff; Director, OCHAMPUSEUR; or CHAMPUS fiscal intermediaries. No other persons or agents (such as physicians, staff members of hospitals, or CHAMPUS health benefits advisors) have such authority.</P>
            <P>(4) <E T="03">Status of patient controlling for purposes of cost-sharing.</E> Benefits for covered services and supplies described in this section will be extended either on an inpatient or outpatient cost-sharing basis in accordance with the status of the patient at the time the covered services and supplies were provided, unless otherwise specifically designated (such as for ambulance service or maternity care). For cost-sharing provisions, refer to paragraph (f) of this section.</P>
            <P>(5) <E T="03">Right to information.</E> As a condition precedent to the provision of benefits hereunder, OCHAMPUS or its CHAMPUS fiscal intermediaries shall be entitled to receive information from a physician or hospital or other person, institution, or organization (including <PRTPAGE P="75"/>a local, state, or U.S. Government agency) providing services or supplies to the beneficiary for which claims or requests for approval for benefits are submitted. Such information and records may relate to the attendance, testing, monitoring, or examination or diagnosis of, or treatment rendered, or services and supplies furnished to a beneficiary, and shall be necessary for the accurate and efficient administration of CHAMPUS benefits. Before a determination will be made on a request for preauthorization or claim of benefits, a beneficiary or sponsor must provide particular additional information relevant to the requested determination, when necessary. The recipient of such information shall in every case hold such records confidential except when:</P>
            <P>(i) Disclosure of such information is authorized specifically by the beneficiary;</P>
            <P>(ii) Disclosure is necessary to permit authorized governmental officials to investigate and prosecute criminal actions, or</P>
            <P>(iii) Disclosure is authorized or required specifically under the terms of the Privacy Act or Freedom of Information Act (refer to § 199.1(m) of this part).</P>

            <FP>For the purposes of determining the applicability of and implementing the provisions of §§ 199.8, 199.11, and 199.12, or any provision of similar purpose of any other medical benefits coverage or entitlement, OCHAMPUS or CHAMPUS fiscal intermediaries may release, without consent or notice to any beneficiary or sponsor, to any person, organization, government agency, provider, or other entity any information with respect to any beneficiary when such release constitutes a routine use published in the <E T="04">Federal Register</E> in accordance with DoD 5400.11-R (Privacy Act (5 U.S.C. 552a)). Before a person's claim of benefits will be adjudicated, the person must furnish to CHAMPUS information that reasonably may be expected to be in his or her possession and that is necessary to make the benefit determination. Failure to provide the requested information may result in denial of the claim.</FP>
            <P>(6) <E T="03">Physical examinations.</E> The Director, OCHAMPUS, or a designee, may require a beneficiary to submit to one or more medical (including psychiatric) examinations to determine the beneficiary's entitlement to benefits for which application has been made or for otherwise authorized medically necessary services and supplies required in the diagnosis or treatment of an illness or injury (including maternity and well-baby care). When a medical examination has been requested, CHAMPUS will withhold payment of any pending claims or preauthorization requests on that particular beneficiary. If the beneficiary refuses to agree to the requested medical examination, or unless prevented by a medical reason acceptable to OCHAMPUS, the examination is not performed within 90 days of initial request, all pending claims for services and supplies will be denied. A denial of payments for services or supplies provided before (and related to) the request for a physical examination is not subject to reconsideration. The medical examination and required beneficiary travel related to performing the requested medical examination will be at the expense of CHAMPUS. The medical examination may be performed by a physician in a Uniformed Services medical facility or by an appropriate civilian physician, as determined and selected by the Director, OCHAMPUS, or a designee who is responsible for making such arrangements as are necessary, including necessary travel arrangements.</P>
            <P>(7) <E T="03">Claims filing deadline.</E> For all services provided on or after January 1, 1993, to be considered for benefits, all claims submitted for benefits must, except as provided in § 199.7, be filed with the appropriate CHAMPUS contractor no later than one year after the services are provided. Unless the requirement is waived, failure to file a claim within this deadline waives all rights to benefits for such services or supplies.</P>
            <P>(8) <E T="03">Double coverage and third party recoveries.</E> CHAMPUS claims involving double coverage or the possiblity that the United States can recover all or a part of its expenses from a third party, are specifically subject to the provisions of § 199.8 or § 199.12 of this part as appropriate.<PRTPAGE P="76"/>
            </P>
            <P>(9) <E T="03">Nonavailability statements within a 40-mile catchment area.</E> In some geographic locations, it is necessary for CHAMPUS beneficiaries not enrolled in TRICARE Prime to determine whether the required inpatient medical care can be provided through a Uniformed Services facility. If the required care cannot be provided, the hospital commander, or designee, will issue a Nonavailability Statement (DD form 1251). Except for emergencies, a Nonavailability Statement should be issued before medical care is obtained from a civilian source. Failure to secure such a statement may waive the beneficiary's rights to benefits under CHAMPUS.</P>
            <P>(i) <E T="03">Rules applicable to issuance of Nonavailability Statement (NAS) (DD Form 1251).</E>
            </P>
            <P>(A) The ASD(HA) is responsible for issuing rules and regulations regarding Nonavailability Statements.</P>
            <P>(B) For CHAMPUS beneficiaries who are not enrolled in TRICARE Prime, an NAS is required for services in connection with nonemergency inpatient hospital care if such services are available at a facility of the Uniformed Services located within a 40 mile radius of the residence of the beneficiary, except that an NAS is not required for services otherwise available at a facility of the Uniformed Services located within a 40-mile radius of the beneficiary's residence when another insurance plan or program provides the beneficiary primary coverage for the services. This requirement for an NAS does not apply to beneficiaries enrolled in TRICARE Prime, even when those beneficiaries use the point-of-service option under § 199.17(n)(3).</P>
            <P>(C) In addition to NAS requirements set forth in paragraph (a)(9) of this section, additional NAS requirements are established pursuant to paragraph (a)(10) of this section in connection with highly specialized care in national or 200-mile catchment areas of military or civilian STS facilities.</P>
            <P>(ii) <E T="03">Beneficiary responsibility.</E>  A CHAMPUS beneficiary who is not enrolled in TRICARE Prime is responsible for securing information whether or not he or she resides in a geographic area that requires obtaining a Nonavailability Statement. Information concerning current rules and regulations may be obtained from the Offices of the Army, Navy, and Air Force Surgeons General; or a representative of the TRICARE managed care support contractor's staff, or the Director, OCHAMPUS.</P>
            <P>(iii) <E T="03">Rules in effect at time civilian medical care is provided apply.</E> The applicable rules and regulations regarding Nonavailability Statements in effect at the time the civilian care is rendered apply in determining whether a Nonavailability Statement is required.</P>
            <P>(iv) Nonavailability Statement (DD Form 1251) must be filed with applicable claim. When a claim is submitted for CHAMPUS benefits that includes services for which a Nonavailability Statement was issued, a valid Nonavailability Statement authorization must be on DEERS.</P>
            <P>(v) <E T="03">Nonavailability Statement (NAS) and Claims Adjudication.</E> A NAS is valid for the adjudication of CHAMPUS claims for all related care otherwise authorized by this part which is received from a civilian source while the beneficiary resided within the Uniformed Service facility catchment area which issued the NAS.</P>
            <P>(vi) In the case of any service subject to an NAS requirement under paragraph (a)(9) of this section and also subject to a preadmission (or other pre-service) authorization requirement under § 199.4 or § 199.15, the administrative processes for the NAS and pre-service authorization may be combined.</P>
            <P>(10) <E T="03">Nonavailability Statements in national or 200-mile catchment areas for highly specialized care available in selected military or civilian Specialized Treatment Service Facilities—</E>(i) <E T="03">Specialized Treatment Service Facilities.</E> STS Facilities may be designated for certain high cost, high technology procedures. The purpose of such designations is to concentrate patient referrals for certain highly specialized procedures which are of relatively low incidence and/or relatively high per-case cost and which require patient concentration to permit resource investment and enhance the effectiveness of quality assurance efforts.</P>
            <P>(ii) <E T="03">Designation.</E> Selected military treatment facilities and civilian facilities will be designated by the Assistant <PRTPAGE P="77"/>Secretary of Defense for Health Affairs as STS Facilities for certain procedures. These designations will be based on the highly specialized capabilities of those selected facilities. For each STS designation for which NASs in national or 200-mile catchment areas will be required, there shall be a determination that total government costs associated with providing the service under the Specialized Treatment Services program will in the aggregate be less than the total government cost of that service under the normal operation of CHAMPUS. There shall also be a determination that the Specialized Treatment Services Facility meets a standard of excellence in quality comparable to that prevailing in other highly specialized medical centers in the nation or region that provide the services involved.</P>
            <P>(iii) <E T="03">Organ transplants and similar procedures.</E> For organ transplants and procedures of similar extraordinary specialization, military or civilian STS Facilities may be designated for a nationwide catchment area, covering all 50 states, the District of Columbia and Puerto Rico (or, alternatively, for any portion of such a nationwide area).</P>
            <P>(iv) <E T="03">Other highly specialized procedures.</E> For other highly specialized procedures, military or civilian STS Facilities will be designated for catchment areas of up to approximately 200 miles radius. The exact geographical area covered for each STS Facility will be identified by reference to State and local governmental jurisdictions, zip code groups or other method to describe an area within an approximate radius of 200 miles from the facility. In paragraph (a)(10) of this section, this catchment area is referred to as a “200-mile catchment area”.</P>
            <P>(v) <E T="03">NAS requirement.</E> For procedures subject to a nationwide catchment area NAS requirement under paragraph (a)(10)(iii) of this section or a 200-mile catchment area NAS requirement under paragraph (a)(10)(iv) of this section, CHAMPUS cost sharing is not allowed unless the services are obtained from a designated civilian Specialized Treatment Services program (as authorized) or an NAS has been issued. This rule is subject to the exceptions set forth in paragraph (a)(10)(vi) of this section. This NAS requirement is a general requirement of the CHAMPUS program.</P>
            <P>(vi) <E T="03">Exceptions.</E> Nationwide catchment areas NASs and 200-mile catchment area NASs are not required in any of the following circumstances:</P>
            <P>(A) An emergency.</P>
            <P>(B) When another insurance plan or program provides the beneficiary primary coverage for the services.</P>
            <P>(C) A case-by-case waiver is granted based on a medical judgment made by the commander of the STS Facility (or other person designated for this purpose) that, although the care is available at the facility, it would be medically inappropriate because of a delay in the treatment or other special reason to require that the STS Facility be used; or</P>
            <P>(D) A case-by-case waiver is granted by the commander of the STS Facility (or other person designated for this purpose) that, although the care is available at the facility, use of the facility would impose exceptional hardship on the beneficiary or the beneficiary's family.</P>
            <P>(E) The beneficiary is enrolled in TRICARE Prime.</P>
            <P>(vii) <E T="03">Waiver process.</E> A process shall be established for beneficiaries to request a case-by-case waiver under paragraphs (a)(10)(vi) (C) and (D) of this section. This process shall include:</P>
            <P>(A) An opportunity for the beneficiary (and/or the beneficiary's physician) to submit information the beneficiary believes justifies a waiver.</P>
            <P>(B) A written decision from a person designated for the purpose on the request for a waiver, including a statement of the reasons for the decision.</P>
            <P>(C) An opportunity for the beneficiary to appeal an unfavorable decision to a designated appeal authority not involved in the initial decision; and</P>
            <P>(D) A written decision on the appeal, including a statement of the reasons for the decision.</P>
            <P>(viii) <E T="03">Notice.</E> The Assistant Secretary of Defense for Health Affairs will annually publish in the <E T="04">Federal Register</E> a notice of all military and civilian STS Facilities, including a listing of the several procedures subject to nationwide catchment area NASs and the <PRTPAGE P="78"/>highly specialized procedures subject to 200-mile catchment area NASs.</P>
            <P>(ix) <E T="03">Specialized procedures.</E> Highly specialized procedures that may be established as subject to 200-mile catchment area NASs are limited to:</P>
            <P>(A) Medical and surgical diagnoses requiring inpatient hospital treatment of an unusually intensive nature, documented by a DRG-based payment system weight (pursuant to § 199.14(a)(1)) for a single DRG or an aggregated DRG weight for a category of DRGs of at least 2.0 (i.e., treatment is at least two times as intensive as the average CHAMPUS inpatient case).</P>
            <P>(B) Diagnostic or therapeutic services, including outpatient services, related to such inpatient categories of treatment.</P>
            <P>(C) Other procedures which require highly specialized equipment the cost of which exceeds $1,000,000 (e.g., lithotriptor, positron emission tomography equipment) and such equipment is underutilized in the area; and</P>
            <P>(D) Other comparable highly specialized procedures as determined by the Assistant Secretary of Defense for Health Affairs.</P>
            <P>(x) <E T="03">Quality standards</E>. Any facility designated as a military or civilian STS Facility under paragraph (a)(10) of this section shall be required to meet quality standards established by the Assistant Secretary of Defense for Health Affairs. In the development of such standards, the Assistant Secretary shall consult with relevant medical specialty societies and other appropriate parties. To the extent feasible, quality standards shall be based on nationally recognized standards.</P>
            <P>(xi) <E T="03">NAS procedures</E>. The provisions of paragraphs (a)(9)(ii) through (a)(9)(v) of this section regarding procedures applicable to NASs shall apply to expanded catchment area NASs required by paragraph (a)(10) of this section.</P>
            <P>(xii) <E T="03">Travel and lodging expenses</E>. In accordance with guidelines issued by the Assistant Secretary of Defense for Health Affairs, certain travel and lodging expenses associated with services under the Specialized Treatment Services program may be fully or partially reimbursed.</P>
            <P>(xiii) <E T="03">Preference for military facility use</E>. In any case in which services subject to an NAS requirement under paragraph (a)(10) of this section are available in both a military STS Facility and from a civilian STS Facility, the military Facility must be used unless use of the civilian Facility is specifically authorized.</P>
            <P>(11) <E T="03">Quality and Utilization Review Peer Review Organization program</E>. All benefits under the CHAMPUS program are subject to review under the CHAMPUS Quality and Utilization Review Peer Review Organization program pursuant to § 199.15. (Utilization and quality review of mental health services are also part of the Peer Review Organization program, and are addressed in paragraph (a)(12) of this section.)</P>
            <P>(12) <E T="03">Utilization review, quality assurance and reauthorization for inpatient mental health services and partial hospitalization.</E> (i) <E T="03">In general.</E> The Director, OCHAMPUS shall provide, either directly or through contract, a program of utilization and quality review for all mental health care services. Among other things, this program shall include mandatory preadmission authorization before nonemergency inpatient mental health services may be provided and mandatory approval of continuation of inpatient services within 72 hours of emergency admissions. This program shall also include requirements for other pretreatment authorization procedures, concurrent review of continuing inpatient and partial hospitalization, retrospective review, and other such procedures as determined appropriate by the Director, OCHAMPUS. The provisions of paragraph (h) of this section and § 199.15(f) shall apply to this program. The Director, OCHAMPUS, shall establish, pursuant to that § 199.15(f), procedures substantially comparable to requirements of paragraph (h) of this section and § 199.15. If the utilization and quality review program for mental health care services is provided by contract, the contractor(s) need not be the same contractor(s) as are engaged under § 199.15 in connection with the review of other services.</P>
            <P>(ii) <E T="03">Preadmission authorization.</E> (A) This section generally requires preadmission authorization for all nonemergency inpatient mental health <PRTPAGE P="79"/>services and prompt continued stay authorization after emergency admissions. It also requires preadmission authorization for all admissions to a partial hospitalization program, without exception, as the concept of an emergency admission does not pertain to a partial hospitalization level of care. This section generally requires preadmission authorization for all nonemergency inpatient mental health services and prompt continued stay authorization after emergency admissions. Institutional services for which payment would otherwise be authorized, but which were provided without compliance with preadmission authorization requirements, do not qualify for the same payment that would be provided if the preadmission requirements had been met.</P>
            <P>(B) In cases of noncompliance with preauthorization requirements, a payment reduction shall be made in accordance with § 199.15(b)(4)(iii).</P>
            <P>(C) For purposes of paragraph (a)(12)(ii)(B) of this section, a day of services without the appropriate preauthorization is any day of services provided prior to:</P>
            <P>(<E T="03">1</E>) The receipt of an authorization; or</P>
            <P>(<E T="03">2</E>) The effective date of an authorization subsequently received.</P>
            <P>(D) Services for which payment is disallowed under paragraph (a)(12)(ii)(B) of this section may not be billed to the patient (or the patient's family).</P>
            <P>(13) <E T="03">Implementing instructions.</E> The Director, OCHAMPUS shall issue policies, procedures, instructions, guidelines, standards and/or criteria to implement this section.</P>
            <P>(b) <E T="03">Institutional benefits</E>. (1) <E T="03">General.</E> Services and supplies provided by an institutional provider authorized as set forth in § 199.6 may be cost-shared only when such services or supplies: are otherwise authorized by this part; are medically necessary; are ordered, directed, prescribed, or delivered by an OCHAMPUS-authorized individual professional provider as set forth in § 199.6 or by an employee of the authorized institutional provider who is otherwise eligible to be a CHAMPUS authorized individual professional provider; are delivered in accordance with generally accepted norms for clinical practice in the United States; meet established quality standards; and comply with applicable definitions, conditions, limitations, exceptions, or exclusions as otherwise set forth in this part.</P>
            <P>(i) <E T="03">Billing practices.</E> To be considered for benefits under § 199.4(b), covered services and supplies must be provided and billed for by a hospital or other authorized institutional provider. Such billings must be fully itemized and sufficiently descriptive to permit CHAMPUS to determine whether benefits are authorized by this part. Depending on the individual circumstances, teaching physician services may be considered an institutional benefit in accordance with § 199.4(b) or a professional benefit under § 199.4(c). See paragraph (c)(3)(xiii) of this section for the CHAMPUS requirements regarding teaching physicians. In the case of continuous care, claims shall be submitted to the appropriate CHAMPUS fiscal intermediary at least every 30 days either by the beneficiary or sponsor or, on a participating basis, directly by the facility on behalf of the beneficiary (refer to § 199.7).</P>
            <P>(ii) <E T="03">Successive inpatient admissions.</E> Successive inpatient admissions shall be deemed one inpatient confinement for the purpose of computing the active duty dependent's share of the inpatient institutional charges, provided not more than 60 days have elapsed between the successive admissions, except that successive inpatient admissions related to a single maternity episode shall be considered one confinement, regardless of the number of days between admissions. For the purpose of applying benefits, successive admissions will be determined separately for maternity admissions and admissions related to an accidental injury (refer to § 199.4(f)).</P>
            <P>(iii) <E T="03">Related services and supplies.</E> Covered services and supplies must be rendered in connection with and related directly to a covered diagnosis or definitive set of symptoms requiring otherwise authorized medically necessary treatment.</P>
            <P>(iv) <E T="03">Inpatient, appropriate level required.</E> For purposes of inpatient care, the level of institutional care for which Basic Program benefits may be extended must be at the appropriate level <PRTPAGE P="80"/>required to provide the medically necessary treatment except for patients requiring skilled nursing facility care. For patients for whom skilled nursing facility care is adequate, but is not available in the general locality, benefits may be continued in the higher level care facility. General locality means an area that includes all the skilled nursing facilities within 50 miles of the higher level facility, unless the higher level facility can demonstrate that the skilled nursing facilities are inaccessible to its patients. The decision as to whether a skilled nursing facility is within the higher level facility's general locality, or the skilled nursing facility is inaccessible to the higher level facility's patients shall be a CHAMPUS contractor initial determination for the purposes of appeal under § 199.10 of this part. CHAMPUS institutional benefit payments shall be limited to the allowable cost that would have been incurred in the skilled nursing facility, as determined by the Director, OCHAMPUS, or a designee. If it is determined that the institutional care can be provided reasonably in the home setting, no CHAMPUS institutional benefits are payable.</P>
            <P>(v) <E T="03">General or special education not covered.</E> Services and supplies related to the provision of either regular or special education generally are not covered. Such exclusion applies whether a separate charge is made for education or whether it is included as a part of an overall combined daily charge of an institution. In the latter instance, that portion of the overall combined daily charge related to education must be determined, based on the allowable costs of the educational component, and deleted from the institution's charges before CHAMPUS benefits can be extended. The only exception is when appropriate education is not available from or not payable by the cognizant public entity. Each case must be referred to the Director, OCHAMPUS, or a designee, for review and a determination of the applicability of CHAMPUS benefits.</P>
            <P>(2) <E T="03">Covered hospital services and supplies—</E>(i) <E T="03">Room and board.</E> Includes special diets, laundry services, and other general housekeeping support services (inpatient only).</P>
            <P>(ii) <E T="03">General staff nursing services.</E>
            </P>
            <P>(iii) <E T="03">ICU.</E> Includes specialized units, such as for respiratory conditions, cardiac surgery, coronary care, burn care, or neurosurgery (inpatient only).</P>
            <P>(iv) <E T="03">Operating room, recovery room.</E> Operating room and recovery room, including other special treatment rooms and equipment, and hyperbaric chamber.</P>
            <P>(v) <E T="03">Drugs and medicines.</E> Includes sera, biologicals, and pharmaceutical preparations (including insulin) that are listed in the official formularies of the institution or facility at the time of use. (To be considered as an inpatient supply, drugs and medicines must be consumed during the specific period the beneficiary is a registered inpatient. Drugs and medicines prescribed for use outside the hospital, even though prescribed and obtained while still a registered inpatient, will be considered outpatient supplies and the provisions of paragraph (d) of this section will apply.)</P>
            <P>(vi) <E T="03">Durable medical equipment, medical supplies, and dressings.</E> Includes durable medical equipment, medical supplies essential to a surgical procedure (such as artificial heart valve and artificial ball and socket joint), sterile trays, casts, and orthopedic hardware. Use of durable medical equipment is restricted to an inpatient basis.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>If durable medical equipment is to be used on an outpatient basis or continued in outpatient status after use as an inpatient, benefits will be provided as set forth in paragraph (d) of this section and cost-sharing will be on an outpatient basis (refer to paragraph (a)(4) of this section).</P>
            </NOTE>
            <P>(vii) <E T="03">Diagnostic services.</E> Includes clinical laboratory examinations, x-ray examinations, pathological examinations, and machine tests that produce hard-copy results. Also includes CT scanning under certain limited conditions.</P>
            <P>(viii) <E T="03">Anesthesia.</E> Includes both the anesthetic agent and its administration.</P>
            <P>(ix) <E T="03">Blood.</E> Includes blood, plasma and its derivatives, including equipment and supplies, and its administration.</P>
            <P>(x) <E T="03">Radiation therapy.</E> Includes radioisotopes.</P>
            <P>(xi) <E T="03">Physical therapy.</E>
              <PRTPAGE P="81"/>
            </P>
            <P>(xii) <E T="03">Oxygen.</E> Includes equipment for its administration.</P>
            <P>(xiii) <E T="03">Intravenous injections.</E> Includes solution.</P>
            <P>(xiv) <E T="03">Shock therapy.</E>
            </P>
            <P>(xv) <E T="03">Chemotherapy.</E>
            </P>
            <P>(xvi) <E T="03">Renal and peritoneal dialysis.</E>
            </P>
            <P>(xvii) <E T="03">Psychological evaluation tests.</E> When required by the diagnosis.</P>
            <P>(xviii) <E T="03">Other medical services.</E> Includes such other medical services as may be authorized by the Director, OCHAMPUS, or a designee, provided they are related directly to the diagnosis or definitive set of symptoms and rendered by a member of the institution's medical or professional staff (either salaried or contractual) and billed for by the hospital.</P>
            <P>(3) <E T="03">Covered services and supplies provided by special medical treatment institutions or facilities, other than hospitals or RTCs—(</E>i) <E T="03">Room and board.</E> Includes special diets, laundry services, and other general housekeeping support services (inpatient only).</P>
            <P>(ii) <E T="03">General staff nursing services.</E>
            </P>
            <P>(iii) <E T="03">Drugs and medicines.</E> Includes sera, biologicals, and pharmaceutical preparations (including insulin) that are listed in the official formularies of the institution or facility at the time of use. (To be considered as an inpatient supply, drugs and medicines must be consumed during the specific period the beneficiary is a registered inpatient. Drugs and medicines prescribed for use outside the authorized institutional provider, even though prescribed and obtained while still a registered inpatient, will be considered outpatient supplies and the provisions of paragraph (d) of this section will apply.).</P>
            <P>(iv) <E T="03">Durable medical equipment, medical supplies, and dressings.</E> Includes durable medical equipment, sterile trays, casts, orthopedic hardware and dressings. Use of durable medical equipment is restricted to an inpatent basis.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>If the durable medical equipment is to be used on an outpatient basis or continued in outpatient status after use as an inpatient, benefits will be provided as set forth in paragraph (d) of this section, and cost-sharing will be on an outpatient basis (refer to paragraph (a)(4) of this section).</P>
            </NOTE>
            <P>(v) <E T="03">Diagnostic services.</E> Includes clinical laboratory examinations, x-ray examinations, pathological examination, and machine tests that produce hard-copy results.</P>
            <P>(vi) <E T="03">Blood.</E> Includes blood, plasma and its derivatives, including equipment and supplies, and its administration.</P>
            <P>(vii) <E T="03">Physical therapy.</E>
            </P>
            <P>(viii) <E T="03">Oxygen.</E> Includes equipment for its administration.</P>
            <P>(ix) <E T="03">Intravenous injections.</E> Includes solution.</P>
            <P>(x) <E T="03">Shock therapy.</E>
            </P>
            <P>(xi) <E T="03">Chemotherapy.</E>
            </P>
            <P>(xii) <E T="03">Psychological evaluation tests.</E> When required by the diagnosis.</P>
            <P>(xiii) <E T="03">Renal and peritoneal dialysis.</E>
            </P>
            <P>(xiv) <E T="03">Other medical services.</E> Other medical services may be authorized by the Director, OCHAMPUS, or a designee, provided they are related directly to the diagnosis or definitive set of symptoms and rendered by a member of the institution's medical or professional staff (either salaried or contractual) and billed for by the authorized institutional provider of care.</P>
            <P>(4) <E T="03">Services and supplies provided by RTCs—</E>(i) <E T="03">Room and board.</E> Includes use of residential facilities such as food service (including special diets), laundry services, supervised reasonable recreational and social activity services, and other general services as considered appropriate by the Director, OCHAMPUS, or a designee.</P>
            <P>(ii) <E T="03">Patient assessment.</E> Includes the assessment of each child or adolescent accepted by the RTC, including clinical consideration of each of his or her fundamental needs, that is, physical, psychological, chronological age, developmental level, family, educational, social, environmental, and recreational.</P>
            <P>(iii) <E T="03">Diagnostic services.</E> Includes clinical laboratory examinations, x-ray examinations, pathological examinations, and machine tests that produce hard-copy results.</P>
            <P>(iv) <E T="03">Psychological evaluation tests.</E>
            </P>
            <P>(v) <E T="03">Treatment of mental disorders.</E> Services and supplies that are medically or psychologically necessary to diagnose and treat the mental disorder for which the patient was admitted to the RTC. Covered services and requirements for qualifications of providers are as listed in paragraph (c)(3)(ix) of this section.</P>
            <P>(vi) <E T="03">Other necessary medical care.</E> Emergency medical services or other <PRTPAGE P="82"/>authorized medical care may be rendered by the RTC provided it is professionally capable of rendering such services and meets standards required by the Director, OCHAMPUS. It is intended, however, that CHAMPUS payments to an RTC should primarily cover those services and supplies directly related to the treatment of mental disorders that require residential care.</P>
            <P>(vii) <E T="03">Criteria for determining medical or psychological necessity.</E> In determining the medical or psychological necessity of services and supplies provided by RTCs, the evaluation conducted by the Director, OCHAMPUS (or designee) shall consider the appropriate level of care for the patient, the intensity of services required by the patient, and the availability of that care. In addition to the criteria set forth in this paragraph (b)(4) of this section, additional evaluation standards, consistent with such criteria, may be adopted by the Director, OCHAMPUS (or designee). RTC services and supplies shall not be considered medically or psychologically necessary unless, at a minimum, <E T="03">all</E> the following criteria are clinically determined in the evaluation to be fully met:</P>
            <P>(A) Patient has a diagnosable psychiatric disorder.</P>
            <P>(B) Patient exhibits patterns of disruptive behavior with evidence of disturbances in family functioning or social relationships and persistent psychological and/or emotional disturbances.</P>
            <P>(C) RTC services involve active clinical treatment under an individualized treatment plan that provides for:</P>
            <P>(<E T="03">1</E>) Specific level of care, and measurable goals/objectives relevant to each of the problems identified;</P>
            <P>(<E T="03">2</E>) Skilled interventions by qualified mental health professionals to assist the patient and/or family;</P>
            <P>(<E T="03">3</E>) Time frames for achieving proposed outcomes; and</P>
            <P>(<E T="03">4</E>) Evaluation of treatment progress to include timely reviews and updates as appropriate of the patient's treatment plan that reflects alterations in the treatment regimen, the measurable goals/objectives, and the level of care required for each of the patient's problems, and explanations of any failure to achieve the treatment goals/objectives.</P>
            <P>(D) Unless therapeutically contraindicated, the family and/or guardian must actively participate in the continuing care of the patient either through direct involvement at the facility or geographically distant family therapy. (In the latter case, the treatment center must document that there has been collaboration with the family and/or guardian in all reviews.)</P>
            <P>(viii) <E T="03">Preauthorization requirement.</E> (A) All admissions to RTC care are elective and must be certified as medically/psychologically necessary prior to admission. The criteria for preauthorization shall be those set forth in paragraph (b)(4)(vii) of this section. In applying those criteria in the context of preadmission authorization review, special emphasis is placed on the development of a specific diagnosis/treatment plan, consistent with those criteria and reasonably expected to be effective, for that individual patient.</P>
            <P>(B) The timetable for development of the individualized treatment plan shall be as follows:</P>
            <P>(<E T="03">1</E>) The plan must be under development at the time of the admission.</P>
            <P>(<E T="03">2</E>) A preliminary treatment plan must be established within 24 hours of the admission.</P>
            <P>(<E T="03">3</E>) A master treatment plan must be established within ten calendar days of the admission.</P>
            <P>(C) The elements of the individualized treatment plan must include:</P>
            <P>(<E T="03">1</E>) The diagnostic evaluation that establishes the necessity for the admission;</P>
            <P>(<E T="03">2</E>) An assessment regarding the inappropriateness of services at a less intensive level of care;</P>
            <P>(<E T="03">3</E>) A comprehensive, biopsychosocial assessment and diagnostic formulation;</P>
            <P>(<E T="03">4</E>) A specific individualized treatment plan that integrates measurable goals/objectives and their required level of care for each of the patient's problems that are a focus of treatment;</P>
            <P>(<E T="03">5</E>) A specific plan for involvement of family members, unless therapeutically contraindicated; and<PRTPAGE P="83"/>
            </P>
            <P>(<E T="03">6</E>) A discharge plan, including an objective of referring the patient to further services, if needed, at less intensive levels of care within the benefit limited period.</P>
            <P>(D) Preauthorization requests should be made not fewer than two business days prior to the planned admission. In general, the decision regarding preauthorization shall be made within one business day of receipt of a request for preauthorization, and shall be followed with written confirmation. Preauthorizations are valid for the period of time, appropriate to the type of care involved, stated when the preauthorization is issued. In general, preauthorizations are valid for 30 days.</P>
            <P>(ix) <E T="03">Concurrent review.</E> Concurrent review of the necessity for continued stay will be conducted no less frequently than every 30 days. The criteria for concurrent review shall be those set forth in paragraph (b)(4)(vii) of this section. In applying those criteria in the context of concurrent review, special emphasis is placed on evaluating the progress being made in the active individualized clinical treatment being provided and on developing appropriate discharge plans.</P>
            <P>(5) <E T="03">Extent of institutional benefits—</E>(i) <E T="03">Inpatient room accommodations—</E>(A) <E T="03">Semiprivate.</E> The allowable costs for room and board furnished an individual patient are payable for semiprivate accommodations in a hospital or other authorized institution, subject to appropriate cost-sharing provisions (refer to paragraph (f) of this section). A semiprivate accommodation is a room containing at least two beds. Therefore, if a room publicly is designated by the institution as a semiprivate accommodation and contains multiple beds, it qualifies as semiprivate for the purpose of CHAMPUS.</P>
            <P>(B) <E T="03">Private.</E> A room with one bed that is designated as a private room by the hospital or other authorized institutional provider. The allowable cost of a private room accommodation is covered only under the following conditions:</P>
            <P>(<E T="03">1</E>) When its use is required medically and when the attending physician certifies that a private room is necessary medically for the proper care and treatment of a patient; or</P>
            <P>(<E T="03">2</E>) When a patient's medical condition requires isolation; or</P>
            <P>(<E T="03">3</E>) When a patient (in need of immediate inpatient care but not requiring a private room) is admitted to a hospital or other authorized institution that has semiprivate accommodations, but at the time of admission, such accommodations are occupied; or</P>
            <P>(<E T="03">4</E>) When a patient is admitted to an acute care hospital (general or special) without semiprivate rooms.</P>
            <P>(C) <E T="03">Duration of private room stay.</E> The allowable cost of private accommodations is covered under the circumstances described in paragraph (b)(5)(i)(B) of this section until the patient's condition no longer requires the private room for medical reasons or medical isolation; or, in the case of the patient not requiring a private room, when a semiprivate accommodation becomes available; or, in the case of an acute care hospital (general or special) which does not have semiprivate rooms, for the duration of an otherwise covered inpatient stay.</P>
            <P>(D) <E T="03">Hospital (except an acute care hospital, general or special) or other authorized institutional provider without semiprivate accommodations.</E> When a beneficiary is admitted to a hospital (except an acute care hospital, general or special) or other institution that has no semiprivate accommodations, for any inpatient day when the patient qualifies for use of a private room (as set forth in paragraphs (b)(5)(i)(B) (<E T="03">1</E> ) and (<E T="03">2</E> ) of this section) the allowable cost of private accommodations is covered. For any inpatient day in such a hospital or other authorized institution when the patient does not require medically the private room, the allowable cost of semiprivate accommodations is covered, such allowable costs to be determined by the Director, OCHAMPUS, or a designee.</P>
            <P>(ii) <E T="03">General staff nursing services.</E> General staff nursing services cover all nursing care (other than that provided by private duty nurses) including, but not limited to, general duty nursing, emergency room nursing, recovery room nursing, intensive nursing care, and group nursing arrangements. Only nursing services provided by nursing personnel on the payroll of the hospital <PRTPAGE P="84"/>or other authorized institution are eligible under paragraph (b) of this section. If a nurse who is not on the payroll of the hospital or other authorized institution is called in specifically to care for a single patient (individual nursing) or more than one patient (group nursing), whether the patient is billed for the nursing services directly or through the hospital or other institution, such services constitute private duty (special) nursing services and are not eligible for benefits under this paragraph (the provisions of paragraph (c)(2)(xv) of this section would apply).</P>
            <P>(iii) <E T="03">ICU.</E> An ICU is a special segregated unit of a hospital in which patients are concentrated, by reason of serious illness, usually without regard to diagnosis. Special lifesaving techniques and equipment are available regularly and immediately within the unit, and patients are under continuous observation by a nursing staff specially trained and selected for the care of this type of patient. The unit is maintained on a continuing, rather than an intermittent or temporary, basis. It is not a postoperative recovery room or a postanesthesia room. In some large or highly specialized hospitals, the ICUs may be refined further for special purposes, such as for respiratory conditions, cardiac surgery, coronary care, burn care, or neurosurgery. For purposes of CHAMPUS, these specialized units would be considered ICUs if they otherwise conformed to the definition of an ICU.</P>
            <P>(iv) <E T="03">Treatment rooms.</E> Standard treatment rooms include emergency rooms, operating rooms, recovery rooms, special treatment rooms, and hyperbaric chambers and all related necessary medical staff and equipment. To be recognized for purposes of CHAMPUS, treatment rooms must be so designated and maintained by the hospital or other authorized institutions on a continuing basis. A treatment room set up on an intermittent or temporary basis would not be so recognized.</P>
            <P>(v) <E T="03">Drugs and medicines.</E> Drugs and medicines are included as a supply of a hospital or other authorized institution only under the following conditions:</P>
            <P>(A) They represent a cost to the facility rendering treatment;</P>
            <P>(B) They are furnished to a patient receiving treatment, and are related directly to that treatment; and</P>
            <P>(C) They are ordinarily furnished by the facility for the care and treatment of inpatients.</P>
            <P>(vi) <E T="03">Durable medical equipment, medical supplies, and dressings.</E> Durable medical equipment, medical supplies, and dressings are included as a supply of a hospital or other authorized institution only under the following conditions:</P>
            <P>(A) If ordinarily furnished by the facility for the care and treatment of patients; and</P>
            <P>(B) If specifically related to, and in connection with, the condition for which the patient is being treated; and</P>
            <P>(C) If ordinarily furnished to a patient for use in the hospital or other authorized institution (except in the case of a temporary or disposable item); and</P>
            <P>(D) Use of durable medical equipment is limited to those items provided while the patient is an inpatient. If such equipment is provided for use on an outpatient basis, the provisions of paragraph (d) of this section apply.</P>
            <P>(vii) <E T="03">Transitional use items.</E> Under certain circumstances, a temporary or disposable item may be provided for use beyond an inpatient stay, when such item is necessary medically to permit or facilitate the patient's departure from the hospital or other authorized institution, or which may be required until such time as the patient can obtain a continuing supply; or it would be unreasonable or impossible from a medical standpoint to discontinue the patient's use of the item at the time of termination of his or her stay as an inpatient.</P>
            <P>(viii) <E T="03">Anesthetics and oxygen.</E> Anesthetics and oxygen and their administration are considered a service or supply if furnished by the hospital or other authorized institution, or by others under arrangements made by the facility under which the billing for such services is made through the facility.</P>
            <P>(6) <E T="03">Inpatient mental health services.</E> Inpatient mental health services are those services furnished by institutional and professional providers for <PRTPAGE P="85"/>treatment of a nervous or mental disorder (as defined in § 199.2) to a patient admitted to a CHAMPUS-authorized acute care general hospital; a psychiatric hospital; or, unless otherwise exempted, a special institutional provider.</P>
            <P>(i) <E T="03">Criteria for determining medical or psychological necessity.</E> In determining the medical or psychological necessity of acute inpatient mental health services, the evaluation conducted by the Director, OCHAMPUS (or designee) shall consider the appropriate level of care for the patient, the intensity of services required by the patient, and the availability of that care. The purpose of such acute inpatient care is to stabilize a life-threatening or severely disabling condition within the context of a brief, intensive model of inpatient care in order to permit management of the patient's condition at a less intensive level of care. Such care is appropriate only if the patient requires services of an intensity and nature that are generally recognized as being effectively and safely provided only in an acute inpatient hospital setting. In addition to the criteria set forth in this paragraph (b)(6) of this section, additional evaluation standards, consistent with such criteria, may be adopted by the Director, OCHAMPUS (or designee). Acute inpatient care shall not be considered necessary unless the patient needs to be observed and assessed on a 24-hour basis by skilled nursing staff, and/or requires continued intervention by a multidisciplinary treatment team; and in addition, at least one of the following criteria is determined to be met:</P>
            <P>(A) Patient poses a serious risk of harm to self and/or others.</P>
            <P>(B) Patient is in need of high dosage, intensive medication or somatic and/or psychological treatment, with potentially serious side effects.</P>
            <P>(C) Patient has acute disturbances of mood, behavior, or thinking.</P>
            <P>(ii) <E T="03">Emergency admissions.</E> Admission to an acute inpatient hospital setting may be on an emergency or on a non-emergency basis. In order for an admission to qualify as an emergency, the following criteria, in addition to those in paragraph (b)(6)(i) of this section, must be met:</P>
            <P>(A) The patient must be at immediate risk of serious harm to self and or others based on a psychiatric evaluation performed by a physician (or other qualified mental health professional with hospital admission authority); and</P>
            <P>(B) The patient requires immediate continuous skilled observation and treatment at the acute psychiatric level of care.</P>
            <P>(iii) <E T="03">Preauthorization requirements.</E> (A) All non-emergency admissions to an acute inpatient hospital level of care must be authorized prior to the admission. The criteria for preauthorization shall be those set forth in paragraph (b)(6)(i) of this section. In applying those criteria in the context of preauthorization review, special emphasis is placed on the development of a specific individualized treatment plan, consistent with those criteria and reasonably expected to be effective, for that individual patient.</P>
            <P>(B) The timetable for development of the individualized treatment plan shall be as follows:</P>
            <P>(<E T="03">1</E>) The development of the plan must begin immediately upon admission.</P>
            <P>(<E T="03">2</E>) A preliminary treatment plan must be established within 24 hours of the admission.</P>
            <P>(<E T="03">3</E>) A master treatment plan must be established within five calendar days of the admission.</P>
            <P>(C) The elements of the individualized treatment plan must include:</P>
            <P>(<E T="03">1</E>) The diagnostic evaluation that establishes the necessity for the admission;</P>
            <P>(<E T="03">2</E>) An assessment regarding the inappropriateness of services at a less intensive level of care;</P>
            <P>(<E T="03">3</E>) A comprehensive biopsychosocial assessment and diagnostic formulation;</P>
            <P>(<E T="03">4</E>) A specific individualized treatment plan that integrates measurable goals/objectives and their required level of care for each of the patient's problems that are a focus of treatment;</P>
            <P>(<E T="03">5</E>) A specific plan for involvement of family members, unless therapeutically contraindicated; and</P>
            <P>(<E T="03">6</E>) A discharge plan, including an objective of referring the patient to further services, if needed, at less intensive levels of care within the benefit limit period.<PRTPAGE P="86"/>
            </P>
            <P>(D) The request for preauthorization must be received by the reviewer designated by the Director, OCHAMPUS prior to the planned admission. In general, the decision regarding preauthorization shall be made within one business day of receipt of a request for preauthorization, and shall be followed with written confirmation. In the case of an authorization issued after an admission resulting from approval of a request made prior to the admission, the effective date of the certification shall be the date of the receipt of the request. However, if the request on which the approved authorization is based was made after the admission (and the case was not an emergency admission), the effective date of the authorization shall be the date of approval.</P>
            <P>(E) Authorization prior to admission is not required in the case of a psychiatric emergency requiring an inpatient acute level of care, but authorization for a continuation of services must be obtained promptly. Admissions resulting from a bona fide psychiatric emergency should be reported within 24 hours of the admission or the next business day after the admission, but must be reported to the Director, OCHAMPUS or a designee, within 72 hours of the admission. In the case of an emergency admission authorization resulting from approval of a request made within 72 hours of the admission, the effective date of the authorization shall be the date of the admission. However, if it is determined that the case was not a bona fide psychiatric emergency admission (but the admission can be authorized as medically or psychologically necessary), the effective date of the authorization shall be the date of the receipt of the request.</P>
            <P>(iv) <E T="03">Concurrent review.</E> Concurrent review of the necessity for continued stay will be conducted. The criteria for concurrent review shall be those set forth in paragraph (b)(6)(i) of this section. In applying those criteria in the context of concurrent review, special emphasis is placed on evaluating the progress being made in the active clinical treatment being provided and on developing/refining appropriate discharge plans. In general, the decision regarding concurrent review shall be made within one business day of the review, and shall be followed with written confirmation.</P>
            <P>(7) <E T="03">Emergency inpatient hospital services.</E> In the case of a medical emergency, benefits can be extended for medically necessary inpatient services and supplies provided to a beneficiary by a hospital, including hospitals that do not meet CHAMPUS standards or comply with the provisions of title VI of the Civil Rights Act, or satisfy other conditions herein set forth. In a medical emergency, medically necessary inpatient services and supplies are those that are necessary to prevent the death or serious impairment of the health of the patient, and that, because of the threat to the life or health of the patient, necessitate, the use of the most accessible hospital available and equipped to furnish such services. The availability of benefits depends upon the following three separate findings and continues only as long as the emergency exists, as determined by medical review. If the case qualified as an emergency at the time of admission to an unauthorized institutional provider and the emergency subsequently is determined no longer to exist, benefits will be extended up through the date of notice to the beneficiary and provider that CHAMPUS benefits no longer are payable in that hospital.</P>
            <P>(i) <E T="03">Existence of medical emergency.</E> A determination that a medical emergency existed with regard to the patient's condition;</P>
            <P>(ii) <E T="03">Immediate admission required.</E> A determination that the condition causing the medical emergency required immediate admission to a hospital to provide the emergency care; and</P>
            <P>(iii) <E T="03">Closest hospital utilized.</E> A determination that diagnosis or treatment was received at the most accessible (closest) hospital available and equipped to furnish the medically necessary care.</P>
            <P>(8) <E T="03">RTC day limit.</E> (i) With respect to mental health services provided on or after October 1, 1991, benefits for residential treatment are generally limited to 150 days in a fiscal year or 150 days in an admission (not including days of care prior to October 1, 1991). The RTC benefit limit is separate from <PRTPAGE P="87"/>the benefit limit for acute inpatient mental health care.</P>
            <P>(ii) <E T="03">Waiver of the RTC day limit.</E> (A) There is a statutory presumption against the appropriateness of residential treatment services in excess of the 150 day limit. However, the Director, OCHAMPUS, (or designee) may in special cases, after considering the opinion of the peer review designated by the Director (involving a health professional who is not a federal employee) confirming that applicable criteria have been met, waive the RTC benefit limit in paragraph (b)(8)(i) of this section and authorize payment for care beyond that limit.</P>
            <P>(B) The criteria for waiver shall be those set forth in paragraph (b)(4)(vii) of this section. In applying those criteria to the context of waiver request reviews, special emphasis is placed on assuring that the record documents that:</P>
            <P>(<E T="03">1</E>) Active treatment has taken place for the past 150 days and substantial progress has been made according to the plan of treatment.</P>
            <P>(<E T="03">2</E>) The progress made is insufficient, due to the complexity of the illness, for the patient to be discharged to a less intensive level of care.</P>
            <P>(<E T="03">3</E>) Specific evidence is presented to explain the factors which interfered with treatment progress during the 150 days of RTC care.</P>
            <P>(<E T="03">4</E>) The waiver request includes specific timeframes and a specific plan of treatment which will lead to discharge.</P>
            <P>(C) Where family or social issues complicate transfer to a lower level of intensity, the RTC is responsible for determining and arranging the supportive and adjunctive resources required to permit appropriate transfer. If the RTC fails adequately to meet this responsibility, the existence of such family or social issues shall be an inadequate basis for a waiver of the benefit limit.</P>
            <P>(D) It is the responsibility of the patient's primary care provider to establish, through actual documentation from the medical record and other sources, that the conditions for waiver exist.</P>
            <P>(iii) RTC day limits do not apply to services provided under the Program for Persons with Disabilities (§ 199.5) or services provided as partial hospitalization care.</P>
            <P>(9) <E T="03">Acute care day limits.</E> (i) With respect to mental health care services provided on or after October 1, 1991, payment for inpatient acute hospital care is, in general, statutorily limited as follows:</P>
            <P>(A) Adults, aged 19 and over—30 days in a fiscal year or 30 days in an admission (excluding days provided prior to October 1, 1991).</P>
            <P>(B) Children and adolescents, aged 18 and under—45 days in a fiscal year or 45 days in an admission (excluding days provided prior to October 1, 1991).</P>
            <P>(ii) It is the patient's age at the time of admission that determines the number of days available.</P>
            <P>(iii) <E T="03">Waiver of the acute care day limits.</E> (A) There is a statutory presumption against the appropriateness of inpatient acute services in excess of the day limits set forth in paragraph (b)(9)(i) of this section. However, the Director, OCHAMPUS (or designee) may in special cases, after considering the opinion of the peer review designated by the Director (involving a health professional who is not a federal employee) confirming that applicable criteria have been met, waive the acute inpatient limits described in paragraph (b)(9)(i) of this section and authorize payment for care beyond those limits.</P>
            <P>(B) The criteria for waiver of the acute inpatient limit shall be those set forth in paragraph (b)(6)(i) of this section. In applying those criteria in the context of waiver request review, special emphasis is placed on determining whether additional days of acute inpatient mental health care are medically/psychologically necessary to complete necessary elements of the treatment plan prior to implementing appropriate discharge planning. A waiver may also be granted in cases in which a patient exhibits well-documented new symptoms, maladaptive behavior, or medical complications which have appeared in the inpatient setting requiring a significant revision to the treatment plan.</P>

            <P>(C) The clinician responsible for the patient's care is responsible for documenting that a waiver criterion has been met and must establish an estimated length of stay beyond the date <PRTPAGE P="88"/>of the inpatient limit. There must be evidence of a coherent and specific plan for assessment, intervention and reassessment that reasonably can be accomplished within the time frame of the additional days of coverage requested under the waiver provision.</P>
            <P>(D) For patients in care at the time the inpatient limit is reached, a waiver must be requested prior to the limit. For patients being readmitted after having received 30 or 45 days in the fiscal year, the waiver review will be conducted at the time of the preadmission authorization.</P>
            <P>(iv) Acute care day limits do not apply to services provided under the Program for Persons with Disabilities (§ 199.5) or services provided as partial hospitalization care.</P>
            <P>(10) <E T="03">Psychiatric partial hospitalization services.</E>
            </P>
            <P>(i) <E T="03">In general.</E> Partial hospitalization services are those services furnished by a CHAMPUS-authorized partial hospitalization program and authorized mental health providers for the active treatment of a mental disorder. All services must follow a medical model and vest patient care under the general direction of a licensed psychiatrist employed by the partial hospitalization center to ensure medication and physical needs of all the patients are considered. The primary or attending provider must be a CHAMPUS authorized mental health provider, operating within the scope of his/her license. These categories include physicians, clinical psychologists, certified psychiatric nurse specialists, clinical social workers, marriage and family counselors, pastoral counselors and mental health counselors. Partial hospitalization services are covered as a basic program benefit only if they are provided in accordance with paragraph (b)(10) of this section.</P>
            <P>(ii) <E T="03">Criteria for determining medical or psychological necessity of psychiatric partial hospitalization services.</E> Psychiatric partial hospitalization services will be considered necessary only if all of the following conditions are present:</P>
            <P>(A) The patient is suffering significant impairment from a mental disorder (as defined in § 199.2) which interferes with age appropriate functioning.</P>
            <P>(B) The patient is unable to maintain himself or herself in the community, with appropriate support, at a sufficient level of functioning to permit an adequate course of therapy exclusively on an outpatient basis (but is able, with appropriate support, to maintain a basic level of functioning to permit partial hospitalization services and presents no substantial imminent risk of harm to self or others).</P>
            <P>(C) The patient is in need of crisis stabilization, treatment of partially stabilized mental health disorders, or services as a transition from an inpatient program.</P>
            <P>(D) The admission into the partial hospitalization program is based on the development of an individualized diagnosis and treatment plan expected to be effective for that patient and permit treatment at a less intensive level.</P>
            <P>(iii) <E T="03">Preauthorization and concurrent review requirements.</E> All preadmission authorization and concurrent review requirements and procedures applicable to acute mental health inpatient hospital care in paragraphs (a)(12) and (b) of this section are applicable to the partial hospitalization program, except that the criteria for considering medical or psychological necessity shall be those set forth in paragraph (b)(10)(ii) of this section, and no emergency admissions will be recognized.</P>
            <P>(iv) <E T="03">Institutional benefits limited to 60 days.</E> Benefits for institutional services for partial hospitalization are limited to 60 treatment days (whether a full day or partial day program) in a fiscal year or in an admission. This limit may be extended by waiver.</P>
            <P>(v) <E T="03">Waiver of the 60-day partial hospitalization program limit.</E> The Director, OCHAMPUS (or designee) may, in special cases, waive the 60-day partial hospitalization benefit and authorize payment for care beyond the 60-day limit.</P>

            <P>(A) the criteria for waiver are set forth in paragraph (b)(10)(ii) of this section. In applying these criteria in the context of waiver request review, special emphasis is placed on determining whether additional days of partial hospitalization are medically/psychologically necessary to complete essential elements of the treatment plan prior to discharge. Consideration is also given in cases in which a patient <PRTPAGE P="89"/>exhibits well-documented new symptoms or maladaptive behaviors which have appeared in the partial hospitalization setting requiring significant revisions to the treatment plan.</P>
            <P>(B) The clinician responsible for the patient's care is responsible for documenting the need for additional days and must establish an estimated length of stay beyond the date of the 60-day limit. There must be evidence of a coherent and specific plan for assessment, intervention and reassessment that reasonably can be accomplished within the time frame of the additional days of coverage requested under the waiver provisions.</P>
            <P>(C) For patients in care at the time the partial hospitalization program limit is reached, a waiver must be requested prior to the limit. For patients being preadmitted after having received 60 days in the fiscal year, the waiver review will be conducted at the time of the preadmission authorization.</P>
            <P>(vi) <E T="03">Services and supplies.</E> The following services and supplies are included in the per diem rate approved for an authorized partial hospitalization program:</P>
            <P>(A) <E T="03">Board.</E> Includes use of the partial hospital facilities such as food service, supervised therapeutically constructed recreational and social activities, and other general services as considered appropriate by the Director, OCHAMPUS, or a designee.</P>
            <P>(B) <E T="03">Patient assessment.</E> Includes the assessment of each individual accepted by the facility, and must, at a minimum, consist of a physical examination; psychiatric examination; psychological assessment; assessment of physiological, biological and cognitive processes; developmental assessment; family history and assessment; social history and assessment; educational or vocational history and assessment; environmental assessment; and recreational/activities assessment. Assessments conducted within 30 days prior to admission to a partial program may be used if approved and deemed adequate to permit treatment planning by the partial hospital program.</P>
            <P>(C) <E T="03">Psychological testing.</E>
            </P>
            <P>(D) <E T="03">Treatment services.</E> All services, supplies, equipment and space necessary to fulfill the requirements of each patient's individualized diagnosis and treatment plan (with the exception of the five psychotherapy sessions per week which may be allowed separately for individual or family psychotherapy based upon the provisions of paragraph (b)(10)(vii) of this section). All mental health services must be provided by a CHAMPUS authorized individual professional provider of mental health services. [Exception: PHPs that employ individuals with master's or doctoral level degrees in a mental health discipline who do not meet the licensure, certification and experience requirements for a qualified mental health provider but are actively working toward licensure or certification, may provide services within the all-inclusive per diem rate but the individual must work under the clinical supervision of a fully qualified mental health provider employed by the PHP.]</P>
            <P>(vii) <E T="03">Social services required.</E> The facility must provide an active social services component which assures the patient appropriate living arrangements after treatment hours, transportation to and from the facility, arrangement of community based support services, referral of suspected child abuse to the appropriate state agencies, and effective after care arrangements, at a minimum.</P>
            <P>(viii) <E T="03">Educational services required.</E> Programs treating children and adolescents must ensure the provision of a state certified educational component which assures that patients do not fall behind in educational placement while receiving partial hospital treatment. CHAMPUS will not fund the cost of educational services separately from the per diem rate. The hours devoted to education do not count toward the therapeutic half or full day program.</P>
            <P>(ix) <E T="03">Family therapy required.</E> The facility must ensure the provision of an active family therapy treatment component which assures that each patient and family participate at least weekly in family therapy provided by the institution and rendered by a CHAMPUS authorized individual professional provider of mental health services. There is no acceptable substitute for family therapy. An exception to this requirement may be granted on a case-by-case <PRTPAGE P="90"/>basis by the Director, OCHAMPUS, or designee, only if family therapy is clinically contraindicated.</P>
            <P>(x) <E T="03">Professional mental health benefits limited.</E> Professional mental health benefits are limited to a maximum of one session (60 minutes individual, 90 minutes family) per authorized treatment day not to exceed five sessions in any calendar week. These may be billed separately from the partial hospitalization per diem rate only when rendered by an attending, CHAMPUS-authorized mental health professional who is not an employee of, or under contract with, the partial hospitalization program for purposes of providing clinical patient care.</P>
            <P>(xi) <E T="03">Non-mental health related medical services.</E> Separate billing will be allowed for otherwise covered, non-mental health related medical services.</P>
            <P>(c) <E T="03">Professional services benefit—</E>(1) <E T="03">General.</E> Benefits may be extended for those covered services described in paragraph (c) of this section that are provided in accordance with good medical practice and established standards of quality by physicians or other authorized individual professional providers, as set forth in § 199.6 of this part. Such benefits are subject to all applicable definitions, conditions, exceptions, limitations, or exclusions as maybe otherwise set forth in this or other Sections of this part. Except as otherwise specifically authorized, to be considered for benefits under paragraph (c) of this section, the described services must be rendered by a physician, or prescribed, ordered, and referred medically by a physician to other authorized individual professional providers. Further, except under specifically defined circumstances, there should be an attending physician in any episode of care. (For example, certain services of a clinical psychologist are exempt from this requirement. For these exceptions, refer to § 199.6.)</P>
            <P>(i) <E T="03">Billing practices</E>. To be considered for benefits under paragraph (c) of this section, covered professional services must be performed personally by the physician or other authorized individual professional provider, who is other than a salaried or contractual staff member of a hospital or other authorized institution, and who ordinarily and customarily bills on a fee-for-service basis for professional services rendered. Such billings must be itemized fully and be sufficiently descriptive to permit CHAMPUS to determine whether benefits are authorized by this part. See paragraph (c)(3)(xiii) of this section for the requirements regarding the special circumstances for teaching physicians. For continuing professional care, claims should be submitted to the appropriate CHAMPUS fiscal intermediary at least every 30 days either by the beneficiary or sponsor, or directly by the physician or other authorized individual professional provider on behalf of a beneficiary (refer to § 199.7).</P>
            <P>(ii) <E T="03">Services must be related.</E> Covered professional services must be rendered in connection with and directly related to a covered diagnosis or definitive set of symptoms requiring medically necessary treatment.</P>
            <P>(2) <E T="03">Covered services of physicians and other authorized profession providers.</E>
            </P>
            <P>(i) <E T="03">Surgery.</E> Surgery means operative procedures, including related preoperative and postoperative care; reduction of fractures and dislocations; injection and needling procedures of the joints; laser surgery of the eye; and the following procedures:
            </P>
            <EXTRACT>
              <FP SOURCE="FP-1">Bronchoscopy</FP>
              <FP SOURCE="FP-1">Laryngoscopy</FP>
              <FP SOURCE="FP-1">Thoracoscopy</FP>
              <FP SOURCE="FP-1">Catheterization of the heart</FP>
              <FP SOURCE="FP-1">Arteriograph thoracic lumbar</FP>
              <FP SOURCE="FP-1">Esophagoscopy</FP>
              <FP SOURCE="FP-1">Gastroscopy</FP>
              <FP SOURCE="FP-1">Proctoscopy</FP>
              <FP SOURCE="FP-1">Sigmoidoscopy</FP>
              <FP SOURCE="FP-1">Peritoneoscopy</FP>
              <FP SOURCE="FP-1">Cystoscopy</FP>
              <FP SOURCE="FP-1">Colonscopy</FP>
              <FP SOURCE="FP-1">Upper G.I. panendoscopy</FP>
              <FP SOURCE="FP-1">Encephalograph</FP>
              <FP SOURCE="FP-1">Myelography</FP>
              <FP SOURCE="FP-1">Discography</FP>
              <FP SOURCE="FP-1">Visualization of intracranial aneurysm by intracarotid injection of dye, with exposure of carotid artery, unilateral</FP>
              <FP SOURCE="FP-1">Ventriculography</FP>
              <FP SOURCE="FP-1">Insufflation of uterus and fallopian tubes for determination of tubal patency (Rubin's test of injection of radiopaque medium or for dilation)</FP>

              <FP SOURCE="FP-1">Introduction of opaque media into the cranial arterial system, preliminary to cerebral arteriography, or into vertebral and subclavian systems<PRTPAGE P="91"/>
              </FP>
              <FP SOURCE="FP-1">Intraspinal introduction of air preliminary to pneumoencephalography</FP>
              <FP SOURCE="FP-1">Intraspinal introduction of opaque media preliminary to myelography</FP>
              <FP SOURCE="FP-1">Intraventricular introduction of air preliminary to ventriculography</FP>
            </EXTRACT>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The Director, OCHAMPUS, or a designee, shall determine such additional procedures that may fall within the intent of this definition of “surgery.”</P>
            </NOTE>
            <P>(ii) <E T="03">Surgical assistance.</E>
            </P>
            <P>(iii) <E T="03">Inpatient medical services.</E>
            </P>
            <P>(iv) <E T="03">Outpatient medical services.</E>
            </P>
            <P>(v) <E T="03">Psychiatric services.</E>
            </P>
            <P>(vi) <E T="03">Consultation services.</E>
            </P>
            <P>(vii) <E T="03">Anesthesia services.</E>
            </P>
            <P>(viii) <E T="03">Radiation therapy services.</E>
            </P>
            <P>(ix) <E T="03">X-ray services.</E>
            </P>
            <P>(x) <E T="03">Laboratory and pathological services.</E>
            </P>
            <P>(xi) <E T="03">Physical medicine services or physiatry services.</E>
            </P>
            <P>(xii) <E T="03">Maternity care.</E>
            </P>
            <P>(xiii) <E T="03">Well-child care.</E>
            </P>
            <P>(xiv) <E T="03">Other medical care.</E> Other medical care includes, but is not limited to, hemodialysis, inhalation therapy, shock therapy, and chemotherapy. The Director, OCHAMPUS, or a designee, shall determine those additional medical services for which benefits may be extended under this paragraph.
            </P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>A separate professional charge for the oral administration of approved antineoplastic drugs is not covered.</P>
            </NOTE>
            <P>(xv) <E T="03">Private duty (special) nursing services.</E>
            </P>
            <P>(xvi) <E T="03">Routine eye examinations.</E> Coverage for routine eye examinations is limited to dependents of active duty members, to one examination per calendar year per person, and to services rendered on or after October 1, 1984, except as provided under paragraph (c)(3)(xi) of this section.</P>
            <P>(3) <E T="03">Extent of professional benefits</E>—</P>
            <P>(i) <E T="03">Multiple Surgery.</E> In cases of multiple surgical procedures performed during the same operative session, benefits shall be extended as follows:</P>
            <P>(A) One hundred (100) percent of the CHAMPUS-determined allowable charge for the major surgical procedure (the procedure for which the greatest amount is payable under the applicable reimbursement method); and</P>
            <P>(B) Fifty (50) percent of the CHAMPUS-determined allowable charge for each of the other surgical procedures;</P>
            <P>(C) Except that:</P>
            <P>(<E T="03">1</E>) If the multiple surgical procedures involve the fingers or toes, benefits for the first surgical procedure shall be at one hundred (100) percent of the CHAMPUS-determined allowable charge; the second procedure at fifty (50) percent; and the third and subsequent procedures at twenty-five (25) percent.</P>
            <P>(<E T="03">2</E>) If the multiple surgical procedures include an incidental procedure, no benefits shall be allowed for the incidental procedure.</P>
            <P>(<E T="03">3</E>) If the multiple surgical procedures involve specific procedures identified by the Director, OCHAMPUS, benefits shall be limited as set forth in CHAMPUS instructions.</P>
            <P>(ii) <E T="03">Different types of inpatient care, concurrent.</E> If a beneficiary receives inpatient medical care during the same admission in which he or she also receives surgical care or maternity care, the beneficiary shall be entitled to the greater of the CHAMPUS-determined allowable charge for either the inpatient medical care or surgical or maternity care received, as the case may be, but not both; except that the provisions of this paragraph (c)(3)(ii) shall not apply if such inpatient medical care is for a diagnosed condition requiring inpatient medical care not related to the condition for which surgical care or maternity care is received, and is received from a physician other than the one rendering the surgical care or maternity care.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>This provision is not meant to imply that when extra time and special effort are required due to postsurgical or postdelivery complications, the attending physician may not request special consideration for a higher than usual charge.</P>
            </NOTE>
            <P>(iii) <E T="03">Need for surgical assistance.</E> Surgical assistance is payable only when the complexity of the procedure warrants a surgical assistant (other than the surgical nurse or other such operating room personnel), subject to utilization review. In order for benefits to be extended for surgical assistance service, the primary surgeon may be required to certify in writing to the nonavailability of a qualified intern, resident, or other house physician. When a claim is received for a surgical assistant involving the following circumstances, special review is required <PRTPAGE P="92"/>to ascertain whether the surgical assistance service meets the medical necessity and other requirements of paragraph (c) of this section.</P>
            <P>(A) If the surgical assistance occurred in a hospital that has a residency program in a specialty appropriate to the surgery;</P>
            <P>(B) If the surgery was performed by a team of surgeons;</P>
            <P>(C) If there were multiple surgical assistants; or</P>
            <P>(D) If the surgical assistant was a partner of or from the same group of practicing physicians as the attending surgeon.</P>
            <P>(iv) <E T="03">Aftercare following surgery.</E> Except for those diagnostic procedures classified as surgery in paragraph (c) of this section, and injection and needling procedures involving the joints, the benefit payments made for surgery (regardless of the setting in which it is rendered) include normal aftercare, whether the aftercare is billed for by the physician or other authorized individual professional provider on a global, all-inclusive basis, or billed for separately.</P>
            <P>(v) <E T="03">Cast and sutures, removal.</E> The benefit payments made for the application of a cast or of sutures normally covers the postoperative care including the removal of the cast or sutures. When the application is made in one geographical location and the removal of the cast or sutures must be done in another geographical location, a separate benefit payment may be provided for the removal. The intent of this provision is to provide a separate benefit only when it is impracticable for the beneficiary to use the services of the provider that applied the cast originally. Benefits are not available for the services of a second provider if those services reasonably could have been rendered by the individual professional provider who applied the cast or sutures initially.</P>
            <P>(vi) <E T="03">Inpatient care, concurrent</E>. Concurrent inpatient care by more than one individual professional provider is covered if required because of the severity and complexity of the beneficiary's condition or because the beneficiary has multiple conditions that require treatment by providers of different specialities. Any claim for concurrent care must be reviewed before extending benefits in order to ascertain the condition of the beneficiary at the time the concurrent care was rendered. In the absence of such determination, benefits are payable only for inpatient care rendered by one attending physician or other authorized individual professional provider.</P>
            <P>(vii) <E T="03">Consultants who become the attending surgeon.</E> A consultation performed within 3 days of surgery by the attending physician is considered a preoperative examination. Preoperative examinations are an integral part of the surgery and a separate benefit is not payable for the consultation. If more than 3 days elapse between the consultation and surgery (performed by the same physician), benefits may be extended for the consultation, subject to review.</P>
            <P>(viii) <E T="03">Anesthesia administered by the attending physician.</E> A separate benefit is not payable for anesthesia administered by the attending physician (surgeon or obstetrician) or dentist, or by the surgical, obstetrical, or dental assistant.</P>
            <P>(ix) <E T="03">Treatment of mental disorders</E>. CHAMPUS benefits for the treatment of mental disorders are payable for beneficiaries who are outpatients or inpatients of CHAMPUS-authorized general or psychiatric hospitals, RTCs, or specialized treatment facilities, as authorized by the Director, OCHAMPUS, or a designee. All such services are subject to review for medical or psychological necessity and for quality of care. The Director, OCHAMPUS, reserves the right to require preauthorization of mental health services. Preauthorization may be conducted by the Director, OCHAMPUS, or a designee. In order to qualify for CHAMPUS mental health benefits, the patient must be diagnosed by a CHAMPUS-authorized licensed, qualified mental health professional to be suffering from a mental disorder, according to the criteria listed in the most current edition of the Diagnostic and Statistical Manual of Mental Disorders which may be purchased from the American Psychiatric Press, Inc., 1400 K Street, NW., suite 1101, Washington, DC 20005. Benefits are limited for certain mental disorders, such as <PRTPAGE P="93"/>specific developmental disorders. No benefits are payable for “Conditions Not Attributable to a Mental Disorder,” or V codes. In order for treatment of a mental disorder to be medically or psychologically necessary, the patient must, as a result of a diagnosed mental disorder, be experiencing both physical or psychological distress and an impairment in his or her ability to function in appropriate occupational, educational or social roles. It is generally the degree to which the patient's ability to function is impaired that determines the level of care (if any) required to treat the patient's condition.</P>
            <P>(A) <E T="03">Covered diagnostic and therapeutic services</E>. Subject to the requirements and limitations stated, CHAMPUS benefits are payable for the following services when rendered in the diagnosis or treatment of a covered mental disorder by a CHAMPUS-authorized, qualified mental health provider practicing within the scope of his or her license. Qualified mental health providers are: psychiatrists or other physicians; clinical psychologists, certified psychiatric nurse specialists, clinical social workers, and certified marriage and family therapists; and pastoral and mental health counselors under a physician's supervision. No payment will be made for any service listed in paragraph (c)(3)(ix)(A) of this section rendered by an individual who does not meet the criteria of § 199.6 for his or her respective profession, regardless of whether the provider is an independent professional provider or an employee of an authorized professional or institutional provider.</P>
            <P>(<E T="03">1</E> ) <E T="03">Individual psychotherapy, adult or child.</E> A covered individual psychotherapy session is no more than 60 minutes in length. An individual psychotherapy session of up to 120 minutes in length is payable for crisis intervention.</P>
            <P>(<E T="03">2</E> ) <E T="03">Group psychotherapy.</E> A covered group psychotherapy session is no more than 90 minutes in length.</P>
            <P>(<E T="03">3</E> ) <E T="03">Family or conjoint psychotherapy.</E> A covered family or conjoint psychotherapy session is no more than 90 minutes in length. A family or conjoint psychotherapy session of up to 180 minutes in length is payable for crisis intervention.</P>
            <P>(<E T="03">4</E>) <E T="03">Psychoanalysis.</E> Psychoanalysis is covered when provided by a graduate or candidate of a psychoanalytic training institution recognized by the American Psychoanalytic Association and when preauthorized by the Director, OCHAMPUS, or a designee.</P>
            <P>(<E T="03">5</E>) <E T="03">Psychological testing and assessment.</E> Psychological testing and assessment is generally limited to six hours of testing in a fiscal year when medically or psychologically necessary and in conjunction with otherwise covered psychotherapy. Testing or assessment in excess of these limits requires review for medical necessity. Benefits will not be provided for the Reitan-Indiana battery when administered to a patient under age five, for self-administered tests administered to patients under age 13, or for psychological testing and assessment as part of an assessment for academic placement.</P>
            <P>(<E T="03">6</E> ) <E T="03">Administration of psychotropic drugs.</E> When prescribed by an authorized provider qualified by licensure to prescribe drugs.</P>
            <P>(<E T="03">7</E> ) <E T="03">Electroconvulsive treatment.</E> When provided in accordance with guidelines issued by the Director, OCHAMPUS.</P>
            <P>(<E T="03">8</E> ) <E T="03">Collateral visits.</E> Covered collateral visits are those that are medically or psychologically necessary for the treatment of the patient and, as such, are considered as a psychotherapy session for purposes of paragraph (c)(3)(ix)(B) of this section.</P>
            <P>(B) <E T="03">Limitations and review requirements—(1</E> ) <E T="03">Outpatient psychotherapy.</E> Outpatient psychotherapy generally is limited to a maximum of two psychotherapy sessions per week, in any combination of individual, family, conjoint, collateral, or group sessions. Before benefits can be extended for more than two outpatient psychotherapy sessions per week, professional review of the medical or psychological necessity for and appropriateness of the more intensive therapy is required.</P>
            <P>(<E T="03">2</E>) <E T="03">Inpatient psychotherapy.</E> Coverage of inpatient psychotherapy is based on medical or psychological necessity for the services identified in the patient's treatment plan. As a general rule, up to five psychotherapy sessions per week are considered appropriate when specified in the treatment as necessary to meet certain measurable/observable <PRTPAGE P="94"/>goals and objectives. Additional sessions per week or more than one type of psychotherapy sessions performed on the same day (for example, an individual psychotherapy session and a family psychotherapy session on the same day) could be considered for coverage, depending on the medical or psychological necessity for the services. Benefits for inpatient psychotherapy will end automatically when authorization has been granted for the maximum number of inpatient mental health days in accordance with the limits as described in this section, unless additional coverage is granted by the Director, OCHAMPUS or a designee.</P>
            <P>(C) <E T="03">Covered ancillary therapies.</E> Includes art, music, dance, occupational, and other ancillary therapies, when included by the attending provider in an approved inpatient, residential treatment plan and under the clinical supervision of a licensed doctoral level mental health professional. These ancillary therapies are not separately reimbursed professional services but are included within the institutional reimbursement.</P>
            <P>(D) <E T="03">Review of claims for treatment of mental disorder.</E> The Director, OCHAMPUS, shall establish and maintain procedures for review, including professional review, of the services provided for the treatment of mental disorders.</P>
            <P>(x) <E T="03">Physical and occupational therapy.</E> Assessment and treatment services of a CHAMPUS-authorized physical or occupational therapist may be cost-shared when:</P>
            <P>(A) The services are prescribed and monitored by a physician;</P>
            <P>(B) The purpose of the prescription is to reduce the disabling effects of an illness, injury, or neuromuscular disorder; and</P>
            <P>(C) The prescribed treatment increases, stabilizes, or slows the deterioration of the beneficiary's ability to perform specified purposeful activity in the manner, or within the range considered normal, for a human being.</P>
            <P>(xi) <E T="03">Well-child care.</E> Benefits routinely are covered for well-child care from birth to under six years of age. These periodic health examinations are designed for prevention, early detection and treatment of disease and consist of screening procedures, immunizations and risk counseling.</P>
            <P>(A) The following services are covered when required as a part of the specific well-child care program and when rendered by the attending pediatrician, family physician, certified nurse practitioner, or certified physician assistant.</P>
            <P>(<E T="03">1</E>) Newborn examination, heredity and metabolic screening, and newborn circumcision.</P>
            <P>(<E T="03">2</E>) Periodic health supervision visits, in accordance with American Academy of Pediatrics (AAP) guidelines, intended to promote the optimal health for infants and children to include the following services:</P>
            <P>(<E T="03">i</E>) History and physical examination and mental health assessment.</P>
            <P>(<E T="03">ii</E>) Vision, hearing, and dental screening.</P>
            <P>(<E T="03">iii</E>) Developmental appraisal to include body measurement.</P>
            <P>(<E T="03">iv</E>) Immunizations as recommenced by the Centers for Disease Control (CDC).</P>
            <P>(<E T="03">v</E>) Pediatric risk assessment for lead exposure and blood lead level test.</P>
            <P>(<E T="03">vi</E>) Tuberculosis screening.</P>
            <P>(<E T="03">vii</E>) Blood pressure screening.</P>
            <P>(<E T="03">viii</E>) Measurement of hemoglobin and hematocrit for anemia.</P>
            <P>(<E T="03">ix</E>) Urinalysis.</P>
            <P>(<E T="03">x</E>) Health guidance and counseling, including breastfeeding and nutrition counseling.</P>
            <P>(B) Additional services or visits required because of specific findings or because the particular circumstances of the individual case are covered if medically necessary and otherwise authorized for benefits under CHAMPUS.</P>
            <P>(C) The Deputy Assistant Secretary of Defense, Health Services Financing, will determine when such services are separately reimbursable apart from the health supervision visit.</P>
            <P>(xii) <E T="03">Private duty (special) nursing.</E> Benefits are available for the skilled nursing services rendered by a private duty (special) nurse to a beneficiary requiring intensive skilled nursing care that can only be provided with the technical proficiency and scientific skills of an R.N. The specific skilled nursing services being rendered are controlling, not the condition of the patient or the professional status of <PRTPAGE P="95"/>the private duty (special) nurse rendering the services.</P>
            <P>(A) Inpatient private duty (special) nursing services are limited to those rendered to an inpatient in a hospital that does not have an ICU. In addition, under specified circumstances, private duty (special) nursing in the home setting also is covered.</P>
            <P>(B) The private duty (special) nursing care must be ordered and certified to be medically necessary by the attending physician.</P>
            <P>(C) The skilled nursing care must be rendered by a private duty (special) nurse who is neither a member of the immediate family nor is a member of the beneficiary's household.</P>
            <P>(D) Private duty (special) nursing care does not, except incidentally, include providing services that provide or support primarily the essentials of daily living or acting as a companion or sitter.</P>
            <P>(E) If the private duty (special) nursing care services being performed are primarily those that could be rendered by the average adult with minimal instruction or supervision, the services would not qualify as covered private duty (special) nursing services, regardless of whether performed by an R.N., regardless of whether or not ordered and certified to by the attending physician, and regardless of the condition of the patient.</P>
            <P>(F) In order for such services to be considered for benefits, a private duty (special) nurse is required to maintain detailed daily nursing notes, whether the case involves inpatient nursing service or nursing services rendered in the home setting.</P>
            <P>(G) Claims for continuing private duty (special) nursing care shall be submitted at least every 30 days. Each claim will be reviewed and the nursing care evaluated whether it continues to be appropriate and eligible for benefits.</P>

            <P>(H) In most situations involving private duty (special) nursing care rendered in the home setting, benefits will be available only for a portion of the care, that is, providing benefits only for that time actually required to perform medically necessary skilled nursing services. If full-time private duty (special) nursing services are engaged, usually for convenience or to provide personal services to the patient, CHAMPUS benefits are payable only for that portion of the day during which skilled nursing services are rendered, but in no event is less than 1 hour of nursing care payable in any 24-hour period during which skilled nursing services are determined to have been rendered. Such situations often are better accommodated through the use of visiting nurses. This allows the personal services that are not coverable by CHAMPUS to be obtained at lesser cost from other than an R.N. Skilled nursing services provided by visiting nurses are covered under CHAMPUS.
            </P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>When the services of an R.N. are not available, benefits may be extended for the otherwise covered services of a L.P.N. or L.V.N.</P>
            </NOTE>
            
            <P>(xiii) <E T="03">Physicians in a teaching setting</E>.</P>
            <P>(A) <E T="03">Teaching physicians.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">General.</E> The services of teaching physicians may be reimbursed on an allowable charge basis only when the teaching physician has established an attending physician relationship between the teaching physician and the patient or when the teaching physician provides distinct, identifiable, personal services (e.g., services rendered as a consultant, assistant surgeon, etc.). Attending physician services may include both direct patient care services or direct supervision of care provided by a physician in training. In order to be considered an attending physician, the teaching physician must:</P>
            <P>(<E T="03">i</E>) Review the patient's history and the record of examinations and tests in the institution, and make frequent reviews of the patient's progress; and</P>
            <P>(<E T="03">ii</E>) Personally examine the patient; and</P>
            <P>(<E T="03">iiii</E>) Confirm or revise the diagnosis and determine the course of treatment to be followed; and</P>
            <P>(<E T="03">iv</E>) Either perform the physician's services required by the patient or supervise the treatment so as to assure that appropriate services are provided by physicians in training and that the care meets a proper quality level; and</P>
            <P>(<E T="03">v</E>) Be present and ready to perform any service performed by an attending physician in a nonteaching setting when a major surgical procedure or a <PRTPAGE P="96"/>complex or dangerous medical procedure is performed; and</P>
            <P>(<E T="03">vi</E>) Be personally responsible for the patient's care, at least throughout the period of hospitalization.</P>
            <P>(<E T="03">2</E>) <E T="03">Direct supervision by an attending physician of care provided by physicians in training.</E> Payment on the basis of allowable charges may be made for the professional services rendered to a beneficiary by his/her attending physician when the attending physician provides personal and identifiable direction to physicians in training who are participating in the care of the patient. It is not necessary that the attending physician be personally present for all services, but the attending physician must be on the provider's premises and available to provide immediate personal assistance and direction if needed.</P>
            <P>(<E T="03">3</E>) <E T="03">Individual, personal services.</E> A teaching physician may be reimbursed on an allowable charge basis for any individual, identifiable service rendered to a CHAMPUS beneficiary, so long as the service is a covered service and is normally reimbursed separately, and so long as the patient records substantiate the service.</P>
            <P>(<E T="03">4</E>) <E T="03">Who may bill.</E> The services of a teaching physician must be billed by the institutional provider when the physician is employed by the provider or a related entity or under a contract which provides for payment to the physician by the provider or a related entity. Where the teaching physician has no relationship with the provider (except for standard physician privileges to admit patients) and generally treats patients on a fee-for-service basis in the private sector, the teaching physician may submit claims under his/her own provider number.</P>
            <P>(B) <E T="03">Physicians in training.</E> Physicians in training in an approved teaching program are considered to be “students” and may not be reimbursed directly by CHAMPUS for services rendered to a beneficiary when their services are provided as part of their employment (either salaried or contractual) by a hospital or other institutional provider. Services of physicians in training may be reimbursed on an allowable charge basis only if:</P>
            <P>(<E T="03">1</E>) The physician in training is fully licensed to practice medicine by the state in which the services are performed, and</P>
            <P>(<E T="03">2</E>) The services are rendered outside the scope and requirements of the approved training program to which the physician in training is assigned.</P>
            <P>(d) <E T="03">Other benefits</E>—(1) <E T="03">General.</E> Benefits may be extended for the allowable charge of those other covered services and supplies described in paragraph (d) of this section, which are provided in accordance with good medical practice and established standards of quality by those other authorized providers described in § 199.6 of this Regulation. Such benefits are subject to all applicable definitions, conditions, limitations, or exclusions as otherwise may be set forth in this or other chapters of this Regulation. To be considered for benefits under paragraph (d) of this section, the described services or supplies must be prescribed and ordered by a physician. Other authorized individual professional providers acting within their scope of licensure may also prescribe and order these services and supplies unless otherwise specified in paragraph (d) of this section. For example, durable medical equipment and cardiorespiratory monitors can only be ordered by a physician.</P>
            <P>(2) <E T="03">Billing practices.</E> To be considered for benefits under paragraph (d) of this section, covered services and supplies must be provided and billed for by an authorized provider as set forth in § 199.6 of this part. Such billing must be itemized fully and described sufficiently, even when CHAMPUS payment is determined under the CHAMPUS DRG-based payment system, so that CHAMPUS can determine whether benefits are authorized by this part. Except for claims subject to the CHAMPUS DRG-based payment system, whenever continuing charges are involved, claims should be submitted to the appropriate CHAMPUS fiscal intermediary at least every 30 days (monthly) either by the beneficiary or sponsor or directly by the provider. For claims subject to the CHAMPUS DRG-based payment system, claims may be submitted only after the beneficiary has been discharged or transferred from the hospital.<PRTPAGE P="97"/>
            </P>
            <P>(3) <E T="03">Other covered services and supplies</E>—(i) <E T="03">Blood.</E> If whole blood or plasma (or its derivatives) are provided and billed for by an authorized institution in connection with covered treatment, benefits are extended as set forth in paragraph (b) of this section. If blood is billed for directly to a beneficiary, benefits may be extended under paragraph (d) in the same manner as a medical supply.</P>
            <P>(ii) <E T="03">Durable medical equipment—</E>(A) <E T="03">Scope of benefit.</E>  Subject to the exceptions in paragraphs (B) and (C) below, only durable medical equipment (DME) which is ordered by a physician for the specific use of the beneficiary, and which complies with the definition of “Durable Medical Equipment” in § 199.2 of this part, and which is not otherwise excluded by this Regulation qualifies as a Basic Program benefit.</P>
            <P>(B) <E T="03">Cardiorespiratory monitor exception.</E> (<E T="03">1</E>) When prescribed by a physician who is otherwise eligible as a CHAMPUS individual professional provider, or who is on active duty with a United States Uniformed Service, an electronic cardiorespiratory monitor, including technical support necessary for the proper use of the monitor, may be cost-shared as durable medical equipment when supervised by the prescribing physician for in-home use by:</P>
            <P>(<E T="03">i</E>) An infant beneficiary who has had an apparent life-threatening event, as defined in guidelines issued by the Director, OCHAMPUS, or a designee, or</P>
            <P>(<E T="03">ii</E>) An infant beneficiary who is a subsequent or multiple birth biological sibling of a victim of sudden infant death syndrome (SIDS), or</P>
            <P>(<E T="03">iii</E>) An infant beneficiary whose birth weight was 1,500 grams or less, or</P>
            <P>(<E T="03">iv</E>) An infant beneficiary who is a pre-term infant with pathologic apnea, as defined in guidelines issued by the Director, OCHAMPUS, or a designee, or</P>
            <P>(<E T="03">v</E>) Any beneficiary who has a condition or suspected condition designated in guidelines issued by the Director, OCHAMPUS, or a designee, for which the in-home use of the cardiorespiratory monitor otherwise meets Basic Program requirements.</P>
            <P>(<E T="03">2</E>) The following types of services and items may be cost-shared when provided in conjunction with an otherwise authorized cardiorespiratory monitor:</P>
            <P>(<E T="03">i</E>) Trend-event recorder, including technical support necessary for the proper use of the recorder.</P>
            <P>(<E T="03">ii</E>) Analysis of recorded physiological data associated with monitor alarms.</P>
            <P>(<E T="03">iii</E>) Professional visits for services otherwise authorized by this part, and for family training on how to respond to an apparent life threatening event.</P>
            <P>(<E T="03">iv</E>) Diagnostic testing otherwise authorized by this part.</P>
            <P>(C) <E T="03">Basic mobility equipment exception.</E> A wheelchair, or a CHAMPUS-approved alternative, which is medically necessary to provide basic mobility, including reasonable additional cost for medically necessary modifications to accommodate a particular disability, may be cost-shared as durable medical equipment.</P>
            <P>(D) <E T="03">Exclusions.</E> DME which is otherwise qualified as a benefit is excluded as a benefit under the following circumstances:</P>
            <P>(<E T="03">1</E>) DME for a beneficiary who is a patient in a type of facility that ordinarily provides the same type of DME item to its patients at no additional charge in the usual course of providing its services.</P>
            <P>(<E T="03">2</E>) DME which is available to the beneficiary from a Uniformed Services Medical Treatment Facility.</P>
            <P>(<E T="03">3</E>) DME with deluxe, luxury, or immaterial features which increase the cost of the item to the government relative to a similar item without those features.</P>
            <P>(E) <E T="03">Basis for reimbursement.</E> The cost of DME may be shared by the CHAMPUS based upon the price which is most advantageous to the government taking into consideration the anticipated duration of the medically necessary need for the equipment and current price information for the type of item. The cost analysis must include comparison of the total price of the item as a monthly rental charge, a lease-purchase price, and a lump-sum purchase price and a provision for the time value of money at the rate determined by the U.S. Department of the Treasury.</P>
            <P>(iii) <E T="03">Medical supplies and dressings (consumables).</E> Medical supplies and dressings (consumables) are those that <PRTPAGE P="98"/>do not withstand prolonged, repeated use. Such items must be related directly to an appropriate and verified covered medical condition of the specific beneficiary for whom the item was purchased and obtained from a medical supply company, a pharmacy, or authorized institutional provider. Examples of covered medical supplies and dressings are disposable syringes for a known diabetic, colostomy sets, irrigation sets, and elastic bandages. An external surgical garment specifically designed for use following a mastectomy is considered a medical supply item.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Generally, the allowable charge of a medical supply item will be under $100. Any item over this amount must be reviewed to determine whether it would not qualify as a DME item. If it is, in fact, a medical supply item and does not represent an excessive charge, it can be considered for benefits under paragraph (d)(3)(iii) of this section.</P>
            </NOTE>
            <P>(iv) <E T="03">Oxygen.</E> Oxygen and equipment for its administration are covered. Benefits are limited to providing a tank unit at one location with oxygen limited to a 30-day supply at any one time. Repair and adjustment of CHAMPUS-purchased oxygen equipment also is covered.</P>
            <P>(v) <E T="03">Ambulance.</E> Civilian ambulance service is covered when medically necessary in connection with otherwise covered services and supplies and a covered medical condition. Ambulance service is also covered for transfers to a Uniformed Service Medical Treatment Facility (USMTF). For the purpose of CHAMPUS payment, ambulance service is an outpatient service (including in connection with maternity care) with the exception of otherwise covered transfers between hospitals which are cost-shared on an inpatient basis. Ambulance transfers from a hospital based emergency room to another hospital more capable of providing the required care will also be cost-shared on an inpatient basis.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The inpatient cost-sharing provisions for ambulance transfers only apply to otherwise covered transfers between hospitals, i.e., acute care, general, and special hospitals; psychiatric hospitals; and long-term hospitals.</P>
            </NOTE>
            <P>(A) Ambulance service is covered for emergency transfers from a beneficiary's place of residence, accident scene, or other location to a USMTF, and for transfer to a USMTF after treatment at, or admission to, a civilian hospital, if ordered by other than a representative of the USMTF.</P>
            <P>(B) Ambulance service cannot be used instead of taxi service and is not payable when the patient's condition would have permitted use of regular private transportation; nor is it payable when transport or transfer of a patient is primarily for the purpose of having the patient nearer to home, family, friends, or personal physician. Except as described in paragraph (d)(3)(v)(A) of this section, transport must be to closest appropriate facility by the least costly means.</P>
            <P>(C) Vehicles such as medicabs or ambicabs function primarily as public passenger conveyances transporting patients to and from their medical appointments. No actual medical care is provided to the patients in transit. These types of vehicles do not qualify for benefits for the purpose of CHAMPUS payment.</P>
            <P>(D) Ambulance services by other than land vehicles (such as a boat or airplane) may be considered only when the pickup point is inaccessible by a land vehicle, or when great distance or other obstacles are involved in transporting the patient to the nearest hospital with appropriate facilities and the patient's medical condition warrants speedy admission or is such that transfer by other means is contraindicated.</P>
            <P>(vi) <E T="03">Prescription drugs and medicines.</E> Prescription drugs and medicines that by United States law require a physician's or other authorized individual professional provider's prescription (acting within the scope of their license) and that are ordered or prescribed by a physician or other authorized individual professional provider (except that insulin is covered for a known diabetic, even though a prescription may not be required for its purchase) in connection with an otherwise covered condition or treatment, including Rh immune globulin.</P>

            <P>(A) Drugs administered by a physician or other authorized individual professional provider as an integral part of a procedure covered under paragraph (b) or (c) of this section (such as chemotherapy) are not covered under this <PRTPAGE P="99"/>subparagraph inasmuch as the benefit for the institutional services or the professional services in connection with the procedure itself also includes the drug used.</P>
            <P>(B) CHAMPUS benefits may not be extended for drugs not approved by the U.S. Food and Drug Administration for commercial marketing. Drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered under CHAMPUS as if FDA approved.</P>
            <P>(vii) <E T="03">Prosthetic devices.</E> The purchase of prosthetic devices is limited to artificial limbs and eyes, except those items that are inserted surgically into the body as an essential and integral part of an otherwise covered surgical procedure are not excluded.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>In order for CHAMPUS benefits to be extended, any surgical implant must be approved for use in humans by the U.S. Food and Drug Administration. Devices that are approved only for investigational use in humans are not payable.</P>
            </NOTE>
            <P>(viii) <E T="03">Orthopedic braces and appliances.</E> The purchase of leg braces (including attached shoes), arm braces, back braces, and neck braces is covered, orthopedic shoes, arch supports, shoe inserts, and other supportive devices for the feet, including special-ordered, custom-made built-up shoes or regular shoes subsequently built up, are not covered.</P>
            <P>(e) <E T="03">Special benefit information</E>—(1) <E T="03">General.</E> There are certain circumstances, conditions, or limitations that impact the extension of benefits and that require special emphasis and explanation. This paragraph (e) sets forth those benefits and limitations recognized to be in this category. The benefits and limitations herein described also are subject to all applicable definitions, conditions, limitations, exceptions, and exclusions as set forth in this or other sections of this part, except as otherwise may be provided specifically in this paragraph (e).</P>
            <P>(2) <E T="03">Abortion</E>. The statute under which CHAMPUS operates prohibits payment for abortions with one single exception—where the life of the mother would be endangered if the fetus were carried to term. Covered abortion services are limited to medical services and supplies only. Physician certification is required attesting that the abortion was performed because the mother's life would be endangered if the fetus were carried to term. Abortions performed for suspected or confirmed fetal abnormality (e.g., anencephalic) or for mental health reasons (e.g., threatened suicide) do not fall within the exceptions permitted within the language of the statute and are not authorized for payment under CHAMPUS.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Covered abortion services are limited to medical services or supplies only for the single circumstance outlined above and do not include abortion counseling or referral fees. Payment is not allowed for any services involving preparation for, or normal followup to, a noncovered abortion. The Director, OCHAMPUS, or a designee, shall issue guidelines describing the policy on abortion.</P>
            </NOTE>
            <P>(3) <E T="03">Family planning.</E> The scope of the CHAMPUS family planning benefit is as follows:</P>
            <P>(i) <E T="03">Birth control (such as contraception)</E>—(A) <E T="03">Benefits provided.</E> Benefits are available for services and supplies related to preventing conception, including the following:</P>
            <P>(<E T="03">1</E> ) Surgical inserting, removal, or replacement of intrauterine devices.</P>
            <P>(<E T="03">2</E> ) Measurement for, and purchase of, contraceptive diaphragms (and later remeasurement and replacement).</P>
            <P>(<E T="03">3</E> ) Prescription contraceptives.</P>
            <P>(<E T="03">4</E> ) Surgical sterilization (either male or female).</P>
            <P>(B) <E T="03">Exclusions.</E> The family planning benefit does not include the following:</P>
            <P>(<E T="03">1</E> ) Prophylactics (condoms).</P>
            <P>(<E T="03">2</E> ) Spermicidal foams, jellies, and sprays not requiring a prescription.</P>
            <P>(<E T="03">3</E>) Services and supplies related to noncoital reproductive technologies, including but not limited to artificial insemination (including any costs related to donors or semen banks), in-vitro fertilization and gamete intrafallopian transfer.</P>
            <P>(<E T="03">4</E> ) Reversal of a surgical sterilization procedure (male or female).</P>
            <P>(ii) <E T="03">Genetic testing.</E> Genetic testing essentially is preventive rather than related to active medical treatment of an illness or injury. However, under the family planning benefit, genetic testing is covered when performed in certain high risk situations. For the purpose of CHAMPUS, genetic testing includes to detect developmental abnormalities as well as purely genetic defects.<PRTPAGE P="100"/>
            </P>
            <P>(A) <E T="03">Benefits provided.</E> Benefits may be extended for genetic testing performed on a pregnant beneficiary under the following prescribed circumstances. The tests must be appropriate to the specific risk situation and must meet one of the following criteria:</P>
            <P>(<E T="03">1</E> ) The mother-to-be is 35 years old or older; or</P>
            <P>(<E T="03">2</E> ) The mother- or father-to-be has had a previous child born with a congenital abnormality; or</P>
            <P>(<E T="03">3</E> ) Either the mother- or father-to-be has a family history of congenital abnormalities; or</P>
            <P>(<E T="03">4</E> ) The mother-to-be contracted rubella during the first trimester of the pregnancy; or</P>
            <P>(<E T="03">5</E> ) Such other specific situations as may be determined by the Director, OCHAMPUS, or a designee, to fall within the intent of paragraph (e)(3)(ii) of this section.</P>
            <P>(B) <E T="03">Exclusions.</E> It is emphasized that routine or demand genetic testing is not covered. Further, genetic testing does not include the following:</P>
            <P>(<E T="03">1</E> ) Tests performed to establish paternity of a child.</P>
            <P>(<E T="03">2</E> ) Tests to determine the sex of an unborn child.</P>
            <P>(4) <E T="03">Treatment of substance use disorders.</E> Emergency and inpatient hospital care for complications of alcohol and drug abuse or dependency and detoxification are covered as for any other medical condition. Specific coverage for the treatment of substance use disorders includes detoxification, rehabilitation, and outpatient care provided in authorized substance use disorder rehabilitation facilities.</P>
            <P>(i) <E T="03">Emergency and inpatient hospital services.</E> Emergency and inpatient hospital services are covered when medically necessary for the active medical treatment of the acute phases of substance abuse withdrawal (detoxification), for stabilization, and for treatment of medical complications of substance use disorders. Emergency and inpatient hospital services are considered medically necessary only when the patient's condition is such that the personnel and facilities of a hospital are required. Stays provided for substance use disorder rehabilitation in a hospital-based rehabilitation facility are covered, subject to the provisions of paragraph (e)(4)(ii) of this section. Inpatient hospital services also are subject to the provisions regarding the limit on inpatient mental health services.</P>
            <P>(ii) <E T="03">Authorized substance use disorder treatment.</E> Only those services provided by CHAMPUS-authorized institutional providers are covered. Such a provider must be either an authorized hospital, or an organized substance use disorder treatment program in an authorized free-standing or hospital-based substance use disorder rehabilitation facility. Covered services consist of any or all of the services listed below. A qualified mental health provider (physicians, clinical psychologists, clinical social workers, psychiatric nurse specialists) (see paragraph (c)(3)(ix) of this section) shall prescribe the particular level of treatment. Each CHAMPUS beneficiary is entitled to three substance use disorder treatment benefit periods in his or her lifetime, unless this limit is waived pursuant to paragraph (e)(4)(v) of this section. (A benefit period begins with the first date of covered treatment and ends 365 days later, regardless of the total services actually used within the benefit period. Unused benefits cannot be carried over to subsequent benefit periods. Emergency and inpatient hospital services (as described in paragraph (e)(4)(i) of this section) do not constitute substance abuse treatment for purposes of establishing the beginning of a benefit period.)</P>
            <P>(A) <E T="03">Rehabilitative care.</E> Rehabilitative care in a authorized hospital or substance use disorder rehabilitative facility, whether free-standing or hospital-based, is covered on either a residential or partial care (day or night program) basis. Coverage during a single benefit period is limited to no more than inpatient stay (exclusive of stays classified in DRG 433) in hospitals subject to CHAMPUS DRG-based payment system or 21 days in a DRG-exempt facility for rehabilitation care, unless the limit is waived pursuant to paragraph (e)(4)(v) of this section. If the patient is medically in need of chemical detoxification, but does not require the personnel or facilities of a general hospital setting, detoxification services are covered in addition to the rehabilitative <PRTPAGE P="101"/>care, but in a DRG-exempt facility detoxification services are limited to 7 days unless the limit is waived pursuant to paragraph (e)(4)(v) of this section. The medical necessity for the detoxification must be documented. Any detoxification services provided by the substance use disorder rehabilitation facility must be under general medical supervision.</P>
            <P>(B) <E T="03">Outpatient care.</E> Outpatient treatment provided by an approved substance use disorder rehabilitation facility, whether free-standing or hospital-based, is covered for up to 60 visits in a benefit period, unless the limit is waived pursuant to paragraph (e)(4)(v) of this section.</P>
            <P>(C) <E T="03">Family therapy.</E> Family therapy provided by an approved substance use disorder rehabilitation facility, whether free-standing or hospital-based, is covered for up to 15 visits in a benefit period, unless the limit is waived pursuant to paragraph (e)(4)(v) of this section.</P>
            <P>(iii) <E T="03">Exclusions</E>—(A) <E T="03">Aversion therapy.</E> The programmed use of physical measures, such as electric shock, alcohol, or other drugs as negative reinforcement (aversion therapy) is not covered, even if recommended by a physician.</P>
            <P>(B) <E T="03">Domiciliary settings.</E> Domiciliary facilities, generally referred to as halfway or quarterway houses, are not authorized providers and charges for services provided by these facilities are not covered.</P>
            <P>(iv) <E T="03">Confidentialty.</E> Release of any patient identifying information, including that required to adjudicate a claim, must comply with the provisions of section 544 of the Public Health Service Act, as amended, (42 U.S.C. 290dd-3), which governs the release of medical and other information from the records of patients undergoing treatment of substance abuse. If the patient refuses to authorize the release of medical records which are, in the opinion of the Director, OCHAMPUS, or a designee, necessary to determine benefits on a claim for treatment of substance abuse the claim will be denied.</P>
            <P>(v) <E T="03">Waiver of benefit limits.</E> The specific benefit limits set forth in paragraphs (e)(4)(ii) of this section may be waived by the Director, OCHAMPUS in special cases based on a determination that all of the following criteria are met:</P>
            <P>(A) Active treatment has taken place during the period of the benefit limit and substantial progress has been made according to the plan of treatment.</P>
            <P>(B) Further progress has been delayed due to the complexity of the illness.</P>
            <P>(C) Specific evidence has been presented to explain the factors that interfered with further treatment progress during the period of the benefit limit.</P>
            <P>(D) The waiver request includes specific time frames and a specific plan of treatment which will complete the course of treatment.</P>
            <P>(5) <E T="03">Organ transplants.</E> Basic Program benefits are available for otherwise covered services or supplies in connection with an organ transplant procedure, provided such transplant procedure generally is in accordance with accepted professional medical standards and is not considered to be experimental or investigational.</P>
            <P>(i) <E T="03">Recipient costs.</E> CHAMPUS benefits are payable for recipient costs when the recipient of the transplant is a beneficiary, whether or not the donor is a beneficiary.</P>
            <P>(ii) <E T="03">Donor costs.</E> (A) Donor costs are payable when both the donor and recipient are CHAMPUS beneficiaries.</P>
            <P>(B) Donor costs are payable when the donor is a CHAMPUS beneficiary but the recipient is not.</P>
            <P>(C) Donor costs are payable when the donor is the sponsor and the recipient is a beneficiary. (In such an event, donor costs are paid as a part of the beneficiary and recipient costs.)</P>
            <P>(D) Donor costs also are payable when the donor is neither a CHAMPUS beneficiary nor a sponsor, if the recipient is a CHAMPUS beneficiary. (Again, in such an event, donor costs are paid as a part of the beneficiary and recipient costs.)</P>
            <P>(iii) <E T="03">General limitations.</E> (A) If the donor is not a beneficiary, CHAMPUS benefits for donor costs are limited to those directly related to the transplant procedure itself and do not include any medical care costs related to other treatment of the donor, including complications.<PRTPAGE P="102"/>
            </P>
            <P>(B) With respect to kidney transplants, in most cases, Medicare (not CHAMPUS) benefits will be applicable. (Refer to 199.9 (e)(3)(vi), “Eligibility.”)</P>
            <P>(C) Donor transportation costs are excluded whether or not the donor is a beneficiary.</P>
            <P>(D) When the organ transplant is performed under a study, grant, or research program, no CHAMPUS benefits are payable for either recipient or donor cost.</P>
            <P>(iv) <E T="03">Kidney acquisition.</E> With specific reference to acquisition costs for kidneys, each hospital that performs kidney transplants is required for Medicare purposes to develop for each year separate standard acquisition costs for kidneys obtained from live donors and kidneys obtained from cadavers. The standard acquisition cost for cadaver kidneys is compiled by dividing the total cost of cadaver kidneys acquired by the number of transplants using cadaver kidneys. The standard acquisition cost for kidneys from live donors is compiled similarly using the total acquisition cost of kidneys from live donors and the number of transplants using kidneys from live donors. All recipients of cadaver kidneys are charged the same standard cadaver kidney acquisition cost and all recipients of kidneys from live donors are charged the same standard live donor acquisition cost. The appropriate hospital standard kidney acquisition costs (live donor or cadaver) required for Medicare in every instance must be used as the acquisition cost for purposes of providing CHAMPUS benefits.</P>
            <P>(v) <E T="03">Liver transplants.</E> Effective July 1, 1983, CHAMPUS benefits are payable for services and supplies related to liver transplantation under the following circumstances only:</P>
            <P>(A) <E T="03">Medical indications for liver transplantation.</E> CHAMPUS shall provide benefits for services and supplies related to liver transplantation performed for beneficiaries suffering from irreversible liver injury who have exhausted alternative medical and surgical treatments, who are approaching the terminal phase of their illness, and who are considered appropriate for liver transplantation according to guidelines adopted by the Director, OCHAMPUS.</P>
            <P>(B) <E T="03">Contraindications.</E> CHAMPUS shall not provide coverage if any of the following contraindications exist:</P>
            <P>(<E T="03">1</E>) Active alcohol or other substance abuse;</P>
            <P>(<E T="03">2</E>) Malignancies metastasized to or extending beyond the margins of the liver; or</P>
            <P>(<E T="03">3</E>) Viral-induced liver disease when viremia is still present.</P>
            <P>(C) <E T="03">Specific covered services.</E> CHAMPUS shall provide coverage for the following services related to liver transplantation:</P>
            <P>(<E T="03">1</E>) Medically necessary services to evaluate a potential candidate's suitability for liver transplantation, whether or not the patient is ultimately accepted as a candidate for transplantation;</P>
            <P>(<E T="03">2</E>) Medically necessary pre- and post-transplant inpatient hospital and outpatient services;</P>
            <P>(<E T="03">3</E>) Surgical services and related pre- and post-operative services of the transplant team;</P>
            <P>(<E T="03">4</E>) Services provided by a donor organ acquisition team, including the costs of transportation to the location of the donor organ and transportation of the team and the donated organ to the location of the transportation center;</P>
            <P>(<E T="03">5</E>) Medically necessary services required to maintain the viability of the donor organ following a formal declaration of brain death and after all existing legal requirements for excision of the donor organ have been met;</P>
            <P>(<E T="03">6</E>) Blood and blood products;</P>
            <P>(<E T="03">7</E>) Services and drugs required for immunosuppression, provided the drugs are approved by the United States Food and Drug Administration;</P>
            <P>(<E T="03">8</E>) Services and supplies, including inpatient care, which are medically necessary to treat complications of the transplant procedure, including management of infection and rejection episodes; and</P>
            <P>(<E T="03">9</E>) Services and supplies which are medically necessary for the periodic evaluation and assessment of the successfully transplanted patient.</P>
            <P>(D) <E T="03">Specific noncovered services.</E> CHAMPUS benefits will not be paid for the following:</P>
            <P>(<E T="03">1</E>) Services and supplies for which the beneficiary has no legal obligation <PRTPAGE P="103"/>to pay. For example, CHAMPUS shall not reimburse expenses that are waived by the transplant center, or for which research funds are available; and</P>
            <P>(<E T="03">2</E>) Out-of-hospital living expenses and any other non-medical expenses, including transportation, of the liver transplant candidate or family members, whether pre- or post-transplant.</P>
            <P>(E) <E T="03">Implementation guidelines.</E> The Director, OCHAMPUS, shall issue such guidelines as are necessary to implement the provision of this paragraph.</P>
            <P>(vi) <E T="03">Heart transplantations.</E> CHAMPUS benefits are payable for services and supplies related to heart transplantation under the following circumstances:</P>
            <P>(A) <E T="03">Medical indications for heart transplantation.</E> CHAMPUS shall provide benefits for services and supplies related to heart transplantation performed for beneficiaries with end-stage cardiac disease who have exhausted alternative medical and surgical treatments, who have a very poor prognosis as a result of poor cardiac functional status, for whom plans for long-term adherence to a disciplined medical regimen are feasible, and who are considered appropriate for heart transplantation according to guidelines adopted by the Director, OCHAMPUS. However, benefits for heart transplantation are available only if the procedure is performed in a CHAMPUS-approved heart transplantation center or meets other certification or accreditation standards recognized by the Director, OCHAMPUS. See § 199.6(b)(4)(iii).</P>
            <P>(B) <E T="03">Specific covered services.</E> CHAMPUS shall provide coverage for the following services related to heart transplantation:</P>
            <P>(<E T="03">1</E>) Medically necessary services to evaluate a potential candidate's suitability for heart transplantation, whether or not the patient is ultimately accepted as a candidate for transplantation;</P>
            <P>(<E T="03">2</E>) Medically necessary pre- and post-transplant inpatient hospital and outpatient services;</P>
            <P>(<E T="03">3</E>) Surgical services and related pre- and post-operative services of the transplant team;</P>
            <P>(<E T="03">4</E>) Services provided by the donor acquisition team, including the costs of transportation to the location of the donor organ and transportation of the team and the donated organ to the location of the transplantation center;</P>
            <P>(<E T="03">5</E>) Medically necessary services required to maintain the viability of the donor organ following a formal declaration of brain death and after all existing legal requirements for excision of the donor organ have been met;</P>
            <P>(<E T="03">6</E>) Blood and blood products;</P>
            <P>(<E T="03">7</E>) Services and drugs required for immunosuppression, provided the drugs are approved by the United States Food and Drug Administration;</P>
            <P>(<E T="03">8</E>) Services and supplies, including inpatient care, which are medically necessary to treat complications of the transplant procedure, including management of infection and rejection episodes; and</P>
            <P>(<E T="03">9</E>) Services and supplies which are medically necessary for the periodic evaluation and assessment of the successfully transplanted patient.</P>
            <P>(C) <E T="03">Noncovered services.</E> CHAMPUS benefits will not be paid for the following:</P>
            <P>(<E T="03">1</E>) Services and supplies for which the beneficiary has no legal obligation to pay; and</P>
            <P>(2) Out-of-hospital living expenses and any other nonmedical expenses, including transportation of the heart transplant candidate or family members, whether pre- or post-transplant.</P>
            <P>(D) <E T="03">Implementation guidelines.</E> The Director, OCHAMPUS, shall issue such guidelines as are necessary to implement the provisions of this paragraph.</P>
            <P>(6) <E T="03">Eyeglasses, spectacles, contact lenses, or other optical devices.</E> Eyeglasses, spectacles, contact lenses, or other optical devices are excluded under the Basic Program except under very limited and specific circumstances.</P>
            <P>(i) <E T="03">Exception to general exclusion.</E> Benefits for glasses and lenses may be extended only in connection with the following specified eye conditions and circumstances:</P>
            <P>(A) Eyeglasses or lenses that perform the function of the human lens, lost as a result of intraocular surgery or ocular injury or congenital absence.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>Notwithstanding the general requirement for U.S. Food and Drug Administration approval of any surgical implant set forth in paragraph (d)(3)(vii) of this section, intraocular lenses are authorized under <PRTPAGE P="104"/>CHAMPUS if they are either approved for marketing by FDA or are subject to an investigational device exemption.</P>
            </NOTE>
            <P>(B) “Pinhole” glasses prescribed for use after surgery for detached retina.</P>
            <P>(C) Lenses prescribed as “treatment” instead of surgery for the following conditions:</P>
            <P>(<E T="03">1</E>) Contract lenses used for treatment of infantile glaucoma.</P>
            <P>(<E T="03">2</E>) Corneal or scleral lenses prescribed in connection with treatment of keratoconus.</P>
            <P>(<E T="03">3</E>) Scleral lenses prescribed to retain moisture when normal tearing is not present or is inadequate.</P>
            <P>(<E T="03">4</E>) Corneal or scleral lenses prescribed to reduce a corneal irregularity other than astigmatism.</P>
            <P>(ii) <E T="03">Limitations.</E> The specified benefits are limited further to one set of lenses related to one of the qualifying eye conditions set forth in paragraph (e)(6)(i) of this section. If there is a prescription change requiring a new set of lenses (but still related to the qualifying eye condition), benefits may be extended for a second set of lenses, subject to specific medical review.</P>
            <P>(7) <E T="03">Transsexualism or such other conditions as gender dysphoria.</E> All services and supplies directly or indirectly related to transsexualism or such other conditions as gender dysphoria are excluded under CHAMPUS. This exclusion includes, but is not limited to, psychotherapy, prescription drugs, and intersex surgery that may be provided in connection with transsexualism or such other conditions as gender dysphoria. There is only one very limited exception to this general exclusion, that is, notwithstanding the definition of congenital anomaly, CHAMPUS benefits may be extended for surgery and related medically necessary services performed to correct sex gender confusion (that is, ambiguous genitalia) which has been documented to be present at birth.</P>
            <P>(8) <E T="03">Cosmetic, reconstructive, or plastic surgery.</E> For the purposes of CHAMPUS, cosmetic, reconstructive, or plastic surgery is surgery that can be expected primarily to improve physical appearance or that is performed primarily for psychological purposes or that restores form, but does not correct or improve materially a bodily function.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>If a surgical procedure primarily restores function, whether or not there is also a concomitant improvement in physical appearance, the surgical procedure does not fall within the provisions set forth in this paragraph (e)(8).</P>
            </NOTE>
            <P>(i) <E T="03">Limited benefits under CHAMPUS.</E> Benefits under the Basic Program generally are not available for cosmetic, reconstructive, or plastic surgery. However, under certain limited circumstances, benefits for otherwise covered services and supplies may be provided in connection with cosmetic, reconstructive, or plastic surgery as follows:</P>
            <P>(A) Correction of a congenital anomaly; or</P>
            <P>(B) Restoration of body form following an accidental injury; or</P>
            <P>(C) Revision of disfiguring and extensive scars resulting from neoplastic surgery.</P>
            <P>(D) Reconstructive breast surgery following a medically necessary mastectomy performed for the treatment of carcinoma, severe fibrocystic disease, other nonmalignant tumors or traumatic injuries.</P>
            <P>(E) Penile implants and testicular prostheses for conditions resulting from organic origins (i.e., trauma, radical surgery, disease process, for correction of congenital anomaly, etc.). Also, penile implants for organic impotency.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Organic impotence is defined as that which can be reasonably expected to occur following certain diseases, surgical procedures, trauma, injury, or congenital malformation. Impotence does not become organic because of psychological or psychiatric reasons.</P>
            </NOTE>
            <P>(F) Generally, benefits are limited to those cosmetic, reconstructive, or plastic surgery procedures performed no later than December 31 of the year following the year in which the related accidental injury or surgical trauma occurred, except for authorized postmastectomy breast reconstruction for which there is no time limitation between mastectomy and reconstruction. Also, special consideration for exception will be given to cases involving children who may require a growth period.</P>
            <P>(ii) <E T="03">General exclusions.</E> (A) For the purposes of CHAMPUS, dental congenital anomalies such as absent tooth buds or malocclusion specifically are <PRTPAGE P="105"/>excluded. Also excluded are any procedures related to transsexualism or such other conditions as gender dysphoria, except as provided in paragraph (e)(7) of this section.</P>
            <P>(B) Cosmetic, reconstructive, or plastic surgery procedures performed primarily for psychological reasons or as a result of the aging process also are excluded.</P>
            <P>(C) Procedures performed for elective correction of minor dermatological blemishes and marks or minor anatomical anomalies also are excluded.</P>
            <P>(D) In addition, whether or not it would otherwise qualify for benefits under paragraph (e)(8)(i) of this section, the breast augmentation mammoplasty is specifically excluded.</P>
            <P>(iii) <E T="03">Noncovered surgery, all related services and supplies excluded.</E> When it is determined that a cosmetic, reconstructive, or plastic surgery procedure does not qualify for CHAMPUS benefits, all related services and supplies are excluded, including any institutional costs.</P>
            <P>(iv) <E T="03">Example of noncovered cosmetic, reconstructive, or plastic surgery procedures.</E> The following is a partial list of cosmetic, reconstructive, or plastic surgery procedures that do not qualify for benefits under CHAMPUS. This list is for example purposes only and is not to be construed as being all-inclusive.</P>
            <P>(A) Any procedure performed for personal reasons to improve the appearance of an obvious feature or part of the body that would be considered by an average observer to be normal and acceptable for the patient's age or ethnic or racial background.</P>
            <P>(B) Cosmetic, reconstructive, or plastic surgical procedures that are justified primarily on the basis of a psychological or psychiatric need.</P>
            <P>(C) Augmentation mammoplasties, except for those performed as a part of postmastectomy breast reconstruction as specifically authorized in paragraph (e)(8)(i)(D) of this section.</P>
            <P>(D) Face lifts and other procedures related to the aging process.</P>
            <P>(E) Reduction mammoplasties (unless there is medical documentation of intractable pain, not amenable to other forms of treatment, resulting from large, pendulous breasts).</P>
            <P>(F) Panniculectomy; body sculpture procedures.</P>
            <P>(G) Repair of sagging eyelids (without demonstrated and medically documented significant impairment of vision).</P>
            <P>(H) Rhinoplasties (without evidence of accidental injury occurring within the previous 6 months that resulted in significant obstruction of breathing).</P>
            <P>(I) Chemical peeling for facial wrinkles.</P>
            <P>(J) Dermabrasion of the face.</P>
            <P>(K) Elective correction of minor dermatological blemishes and marks or minor anatomical anomalies.</P>
            <P>(L) Revision of scars resulting from surgery or a disease process, except disfiguring and extensive scars resulting from neoplastic surgery.</P>
            <P>(M) Removal of tattoos.</P>
            <P>(N) Hair transplants.</P>
            <P>(O) Electrolysis.</P>
            <P>(P) Any procedures related to transsexualism or such other conditions as gender dysphoria except as provided in paragraph (e)(7) of this section.</P>
            <P>(Q) Penile implant procedure for psychological impotency, transsexualism, or such other conditions as gender dysphoria.</P>
            <P>(R) Insertion of prosthetic testicles for transsexualism, or such other conditions as gender dysphoria.</P>
            <P>(9) <E T="03">Complications (unfortunate sequelae) resulting from noncovered initial surgery or treatment.</E> Benefits are available for otherwise covered services and supplies required in the treatment of complications resulting from a noncovered incident of treatment (such as nonadjunctive dental care, transsexual surgery, and cosmetic surgery) but only if the later complication represents a separate medical condition such as a systemic infection, cardiac arrest, and acute drug reaction. Benefits may not be extended for any later care or procedures related to the complication that essentially is similar to the initial noncovered care. Examples of complications similar to the initial episode of care (and thus not covered) would be repair of facial scarring resulting from dermabrasion for acne or repair of a prolapsed vagina in a biological male who had undergone transsexual surgery.<PRTPAGE P="106"/>
            </P>
            <P>(10) <E T="03">Dental.</E> CHAMPUS does not include a dental benefit. Under very limited circumstances, benefits are available for dental services and supplies when the dental services are adjunctive to otherwise covered medical treatment.</P>
            <P>(i) <E T="03">Adjunctive dental care: Limited.</E> Adjunctive dental care is limited to those services and supplies provided under the following conditions:</P>
            <P>(A) Dental care which is medically necessary in the treatment of an otherwise covered medical (not dental) condition, is an integral part of the treatment of such medical condition and is essential to the control of the primary medical condition. The following is a list of conditions for which CHAMPUS benefits are payable under this provision:</P>
            <P>(<E T="03">1</E>) Intraoral abscesses which extend beyond the dental alveolus.</P>
            <P>(<E T="03">2</E>) Extraoral abscesses.</P>
            <P>(<E T="03">3</E>) Cellulitis and osteitis which is clearly exacerbating and directly affecting a medical condition currently under treatment.</P>
            <P>(<E T="03">4</E>) Removal of teeth and tooth fragments in order to treat and repair facial trauma resulting from an accidental injury.</P>
            <P>(<E T="03">5</E>) Myofacial Pain Dysfunction Syndrome.</P>
            <P>(<E T="03">6</E>) Total or complete ankyloglossia.</P>
            <P>(<E T="03">7</E>) Adjunctive dental and orthodontic support for cleft palate.</P>
            <P>(<E T="03">8</E>) The prosthetic replacement of either the maxilla or the mandible due to the reduction of body tissues associated with traumatic injury (e.g., impact, gun shot wound), in addition to services related to treating neoplasms or iatrogenic dental trauma.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The test of whether dental trauma is covered is whether the trauma is solely dental trauma. Dental trauma, in order to be covered, must be related to, and an integral part of medical trauma; or a result of medically necessary treatment of an injury or disease.</P>
            </NOTE>
            <P>(B) Dental care required in preparation for medical treatment of a disease or disorder or required as the result of dental trauma caused by the medically necessary treatment of an injury or disease (iatrogenic).</P>
            <P>(<E T="03">1</E>) Necessary dental care including prophylaxis and extractions when performed in preparation for or as a result of in-line radiation therapy for oral or facial cancer.</P>
            <P>(<E T="03">2</E>) Treatment of gingival hyperplasia, with or without periodontal disease, as a direct result of prolonged therapy with Dilantin (diphenylhydantoin) or related compounds.</P>
            <P>(C) Dental care is limited to the above and similar conditions specifically prescribed by the Director, OCHAMPUS, as meeting the requirements for coverage under the provisions of this section.</P>
            <P>(ii) <E T="03">General exclusions.</E> (A) Dental care which is routine, preventative, restorative, prosthodontic, periodontic or emergency does not qualify as adjunctive dental care for the purposes of CHAMPUS except when performed in preparation for or as a result of dental trauma caused by medically necessary treatment of an injury or disease.</P>
            <P>(B) The adding or modifying of bridgework and dentures.</P>
            <P>(C) Orthodontia, except when directly related to and an integral part of the medical or surgical correction of a cleft palate or when required in preparation for, or as a result of, trauma to the teeth and supporting structures caused by medically necessary treatment of an injury or disease.</P>
            <P>(iii) <E T="03">Preauthorization required.</E> In order to be covered, adjunctive dental care requires preauthorization from the Director, OCHAMPUS, or a designee, in accordance with paragraph (a)(11) of this section. When adjunctive dental care involves a medical (not dental) emergency (such as facial injuries resulting from an accident), the requirement for preauthorization is waived. Such waiver, however, is limited to the essential adjunctive dental care related to the medical condition requiring the immediate emergency treatment. A complete explanation, with supporting medical documentation, must be submitted with claims for emergency adjunctive dental care.</P>
            <P>(iv) <E T="03">Covered oral surgery.</E> Notwithstanding the above limitations on dental care, there are certain oral surgical procedures that are performed by both physicians and dentists, and that are essentially medical rather than dental care. For the purposes of CHAMPUS, <PRTPAGE P="107"/>the following procedures, whether performed by a physician or dentist, are considered to be in this category and benefits may be extended for otherwise covered services and supplies without preauthorization:</P>
            <P>(A) Excision of tumors and cysts of the jaws, cheeks, lips, tongue, and roof and floor of the mouth, when such conditions require a pathological (histological) examination.</P>
            <P>(B) Surgical procedures required to correct accidental injuries of the jaws, cheeks, lips, tongue, and roof and floor of the mouth.</P>
            <P>(C) Treatment of oral or facial cancer.</P>
            <P>(D) Treatment of fractures of facial bones.</P>
            <P>(E) External (extra-oral) incision and drainage of cellulitis.</P>
            <P>(F) Surgery of accessory sinuses, salivary glands, or ducts.</P>
            <P>(G) Reduction of dislocations and the excision of the temporomandibular joints, when surgery is a necessary part of the reduction.</P>
            <P>(H) Any oral surgical procedure that falls within the cosmetic, reconstructive, or plastic surgery definition is subject to the limitations and requirements set forth in paragraph (e)(8) of this section.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Extraction of unerupted or partially erupted, malposed or impacted teeth, with or without the attached follicular or development tissues, is not a covered oral surgery procedure except when the care is indicated in preparation for medical treatment of a disease or disorder or required as a result of dental trauma caused by the necessary medical treatment of an injury or illness. Surgical preparation of the mouth for dentures is not covered by CHAMPUS.</P>
            </NOTE>
            <P>(v) <E T="03">Inpatient hospital stay in connection with non-adjunctive, noncovered dental care.</E> Institutional benefits specified in paragraph (b) of this section may be extended for inpatient hospital stays related to noncovered, nonadjunctive dental care when such inpatient stay is medically necessary to safeguard the life of the patient from the effects of dentistry because of the existence of a specific and serious nondental organic impairment currenty under active treatment. (Hemophilia is an example of a condition that could be considered a serious nondental impairment.) Preauthorization by the Director, OCHAMPUS, or a designee, is required for such inpatient stays to be covered in the same manner as required for adjunctive dental care described in paragraph (e)(10)(iii) of this section. Regardless of whether or not the preauthorization request for the hospital admission is approved and thus qualifies for institutional benefits, the professional service related to the nonadjunctive dental care is not covered.</P>
            <P>(11) <E T="03">Drug abuse.</E> Under the Basic Program, benefits may be extended for medically necessary prescripion drugs required in the treatment of an illness or injury or in connection with maternity care (refer to paragraph (d) of this section). However, CHAMPUS benefits cannot be authorized to support of maintain an existing or potential drug abuse situation, whether or not the drugs (under other circumstances) are eligible for benefit consideration and whether or not obtained by legal means.</P>
            <P>(i) <E T="03">Limitations on who can prescribe drugs.</E> CHAMPUS benefits are not available for any drugs prescribed by a member of the beneficiary's family or by a nonfamily member residing in the same household with the beneficiary or sponsor.</P>
            <P>(ii) <E T="03">Drug maintenance programs excluded.</E> Drug maintenance programs when one addictive drug is substituted for another on a maintenance basis (such as methadone substituted for heroin) are not covered. This exclusion applies even in areas outside the United States where addictive drugs are dispensed legally by physicians on a maintenance dosage level.</P>
            <P>(iii) <E T="03">Kinds of prescription drugs that are monitored carefully by CHAMPUS for possible abuse situations—</E>(A) <E T="03">Narcotics.</E> Examples are Morphine and Demerol.</P>
            <P>(B) <E T="03">Nonnarcotic analgesics.</E> Examples are Talwin and Darvon.</P>
            <P>(C) <E T="03">Tranquilizers.</E> Examples are Valium, Librium, and Meprobamate.</P>
            <P>(D) <E T="03">Barbiturates.</E> Examples are Seconal and Nembuttal.</P>
            <P>(E) <E T="03">Nonbarbituate hypnotics.</E> Examples are Doriden and Chloral Hydrate.</P>
            <P>(F) <E T="03">Stimulants.</E> Examples are amphetamines.<PRTPAGE P="108"/>
            </P>
            <P>(iv) <E T="03">CHAMPUS fiscal intermediary responsibilities.</E> CHAMPUS fiscal intermediaries are responsible for implementing utilization control and quality assurance procedures designed to identify possible drug abuse situations. The CHAMPUS fiscal intermediary is directed to screen all drug claims for potential overutilization and irrational prescribing of drugs, and to subject any such cases to extensive review to establish the necessity for the drugs and their appropriateness on the basis of diagnosis or definitive symptoms.</P>
            <P>(A) When a possible drug abuse situation is identified, all claims for drugs for that specific beneficiary or provider will be suspended pending the results of a review.</P>
            <P>(B) If the review determines that a drug abuse situation does in fact exist, all drug claims held in suspense will be denied.</P>
            <P>(C) If the record indicates previously paid drug benefits, the prior claims for that beneficiary or provider will be reopened and the circumstances involved reviewed to determine whether or not drug abuse also existed at the time the earlier claims were adjudicated. If drug abuse is later ascertained, benefit payments made previously will be considered to have been extended in error and the amounts so paid recouped.</P>
            <P>(D) Inpatient stays primarily for the purpose of obtaining drugs and any other services and supplies related to drug abuse also are excluded.</P>
            <P>(v) <E T="03">Unethical or illegal provider practices related to drugs.</E> Any such investigation into a possible drug abuse that uncovers unethical or illegal drug dispensing practices on the part of an institution, a pharmacy, or physician will be referred to the professional or investigative agency having jurisdiction. CHAMPUS fiscal intermediaries are directed to withhold payment of all CHAMPUS claims for services and supplies rendered by a provider under active investigation for possible unethical or illegal drug dispensing activities.</P>
            <P>(vi) <E T="03">Detoxification.</E> The above monitoring and control of drug abuse situations shall in no way be construed to deny otherwise covered medical services and supplies related to drug detoxification (including newborn, addicted infants) when medical supervision is required.</P>
            <P>(12) <E T="03">Custodial care.</E> The statute under which CHAMPUS operates specifically excludes custodial care. Many beneficiaries and sponsors misunderstand what is meant by custodial care, assuming that because custodial care is not covered, it implies the custodial care is not necessary. This is not the case; it only means the care being provided is not a type of care for which CHAMPUS benefits can be extended.</P>
            <P>(i) <E T="03">Kinds of conditions that can result in custodial care.</E> There is no absolute rule that can be applied. With most conditions, there is a period of active treatment before custodial care, some much more prolonged than others. Examples of potential custodial care cases may be a spinal cord injury resulting in extensive paralysis, a severe cerebral vascular accident, multiple sclerosis in its latter stages, or presenile and senile dementia. These conditions do not result necessarily in custodial care but are indicative of the types of conditions that sometimes do. It is not the condition itself that is controlling, but whether the care being rendered falls within the definition of custodial care (refer to § 199.2 of this part for the definition of “custodial care”).</P>
            <P>(ii) <E T="03">Benefits available in connection with a custodial care case.</E> CHAMPUS benefits are not available for services related to a custodial care case, with the following specific exceptions:</P>
            <P>(A) <E T="03">Prescription drugs and medicines, medical supplies and durable medical equipment.</E> Benefits are payable for otherwise covered prescription drugs and medicines, medical supplies and durable medical equipment.</P>
            <P>(B) <E T="03">Nursing services, limited.</E> Recognizing that even though the care being received is determined primarily to be custodial, an occasional specific skilled nursing service may be required. When it is determined such skilled nursing services are needed, benefits may be extended for one hour of nursing care per day.</P>
            <P>(C) <E T="03">Physician services, limited.</E> Recognizing that even though the care being received is determined primarily to be custodial, occasional physician monitoring may be required to maintain the <PRTPAGE P="109"/>patient's condition. When it is determined that a patient is receiving custodial care, benefits may be extended for up to twelve physician visits per calendar year for the custodial condition (not to exceed one per month).</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>CHAMPUS benefits may be extended for additional physician visits related to the treatment of a condition other than the condition for which the patient is receiving custodial care (an example is a broken leg as a result of a fall).</P>
            </NOTE>
            <P>(D) <E T="03">Payment for prescription drugs, medical supplies, durable medical equipment and limited skilled nursing and physician services does not affect custodial care determination.</E> The fact that CHAMPUS extends benefits for prescription drugs, medical supplies, durable medical equipment, and limited skilled nursing and physician services in no way affects the custodial care determination if the case otherwise falls within the definition of custodial care.</P>
            <P>(iii) <E T="03">Exception to custodial care exclusion, admission to a hospital.</E> CHAMPUS benefits may be extended for otherwise covered services or supplies directly related to a medically necessary admission to an acute care general or special hospital (as defined in paragraph (b)(4)(i), section 199.6 of this part), if the care is at the appropriate level and meets other requirements of this Regulation.</P>
            <P>(iv) <E T="03">Reasonable care for which benefits were authorized or reimbursed before June 1, 1977.</E> It is recognized that care for which benefits were authorized or reimbursed before the implementation date of DoD 6010.8-R may be excluded under the custodial care limitations set forth in the Regulation. Therefore, an exception to the custodial care limitations set forth in this part exists whereby reasonable care for which benefits authorized or reimbursed under the Basic Program before June 1, 1977, shall continue to be authorized even though the care would be excluded as a benefit under the custodial care limitations of the DoD 6010.8-R. Continuation of CHAMPUS benefits in such cases is limited as follows:</P>
            <P>(A) <E T="03">Initial authorization or reimbursement before June 1, 1977.</E> The initial CHAMPUS authorization or reimbursement for the care occurred before June 1, 1977; and,</P>
            <P>(B) <E T="03">Continued care.</E> The care has been continuous since the initial CHAMPUS authorization or reimbursement; and,</P>
            <P>(C) <E T="03">Reasonable care.</E> The care is reasonable. CHAMPUS benefits shall be continued for reasonable care up to the same level of benefits and for the same period of eligibility authorized or reimbursed before June 1, 1977. Care that is excessive or otherwise unreasonable will be reduced or eliminated from the continued care authorized under this exception.</P>
            <P>(13) <E T="03">Domiciliary care.</E> The statute under which CHAMPUS operates also specifically excludes domiciliary care (refer to § 199.2 of this part for the definition of “Domiciliary Care”).</P>
            <P>(i) <E T="03">Examples of domiciliary care situations.</E> The following are examples of domiciliary care for which CHAMPUS benefits are not payable.</P>
            <P>(A) <E T="03">Home care is not available</E>. Institutionalization primarily because parents work, or extension of a hospital stay beyond what is medically necessary because the patient lives alone, are examples of domiciliary care provided because there is no other family member or other person available in the home.</P>
            <P>(B) <E T="03">Home care is not suitable</E>. Institutionalization of a child because a parent (or parents) is an alcoholic who is not responsible enough to care for the child, or because someone in the home has a contagious disease, are examples of domiciliary care being provided because the home setting is unsuitable.</P>
            <P>(C) <E T="03">Family unwilling to care for a person in the home</E>. A child who is difficult to manage may be placed in an institution, not because institutional care is medically necessary, but because the family does not want to handle him or her in the home. Such institutionalization would represent domiciliary care, that is, the family being unwilling to assume responsibility for the child.</P>
            <P>(ii) <E T="03">Benefits available in connection with a domiciliary care case</E>. Should the beneficiary receive otherwise covered medical services or supplies while also being in a domiciliary care situation, CHAMPUS benefits are payable for those medical services or supplies, or both, in the same manner as though the beneficiary resided in his or her own home. Such benefits would be cost-<PRTPAGE P="110"/>shared as though rendered to an outpatient.</P>
            <P>(iii) <E T="03">General exclusion</E>. Domiciliary care is institutionalization essentially to provide a substitute home—not because it is medically necessary for the beneficiary to be in the institution (although there may be conditions present that have contributed to the fact that domiciliary care is being rendered). CHAMPUS benefits are not payable for any costs or charges related to the provision of domiciliary care. While a substitute home or assistance may be necessary for the beneficiary, domiciliary care does not represent the kind of care for which CHAMPUS benefits can be provided.</P>
            <P>(14) <E T="03">CT scanning</E>—(i) <E T="03">Approved CT scan services</E>. Benefits may be extended for medically necessary CT scans of the head or other anatomical regions of the body when all of the following conditions are met:</P>
            <P>(A) The patient is referred for the diagnostic procedure by a physician.</P>
            <P>(B) The CT scan procedure is consistent with the preliminary diagnosis or symptoms.</P>
            <P>(C) Other noninvasive and less costly means of diagnosis have been attempted or are not appropriate.</P>
            <P>(D) The CT scan equipment is licensed or registered by the appropriate state agency responsible for licensing or registering medical equipment that emits ionizing radiation.</P>
            <P>(E) The CT scan equipment is operated under the general supervision and direction of a physician.</P>
            <P>(F) The results of the CT scan diagnostic procedure are interpreted by a physician.</P>
            <P>(ii) <E T="03">Review guidelines and criteria</E>. The Director, OCHAMPUS, or a designee, will issue specific guidelines and criteria for CHAMPUS coverage of medically necessary head and body part CT scans.</P>
            <P>(15) <E T="03">Morbid obesity</E>. The CHAMPUS morbid obesity benefit is limited to the gastric bypass, gastric stapling, or gastroplasty method.</P>
            <P>(i) <E T="03">Conditions for coverage</E>. Payment may be extended for the gastric bypass, gastric stapling, or gastroplasty method only when one of the following conditions is met:</P>
            <P>(A) The patient is 100 pounds over the ideal weight for height and bone structure and has an associated severe medical condition. These associated medical conditions are diabetes mellitus, hypertension, cholecystitis, narcolepsy, pickwickian syndrome (and other severe respiratory disease), hypothalmic disorders, and severe arthritis of the weight-bearing joints.</P>
            <P>(B) The patient is 200 percent or more of the ideal weight for height and bone structure. An associated medical condition is not required for this category.</P>
            <P>(C) The patient has had an intestinal bypass or other surgery for obesity and, because of complications, requires a second surgery (a takedown). The surgeon in many cases, will do a gastric bypass, gastric stapling, or gastroplasty to help the patient avoid regaining the weight that was lost. In this situation, payment is authorized even though the patient's condition technically may not meet the definition of morbid obesity because of the weight that was already lost following the initial surgery.</P>
            <P>(ii) <E T="03">Exclusions</E>. (A) CHAMPUS payment may not be made for nonsurgical treatment of obesity or morbid obesity, for dietary control, or weight reduction.</P>
            <P>(B) CHAMPUS payment may not be made for surgical procedures other than the gastric bypass, gastric stapling, or gastroplasty, even if morbid obesity is present.</P>
            <P>(16) <E T="03">Maternity care.</E> (i) <E T="03">Benefit.</E> The CHAMPUS Basic Program may share the cost of medically necessary services and supplies associated with maternity care which are not otherwise excluded by this part. However, failure by a beneficiary to secure a required Nonavailability Statement (NAS) (DD Form 1251) as set forth in paragraph (a)(9) of this section will waive that beneficiary's right to CHAMPUS cost-share of certain maternity care services and supplies.</P>
            <P>(ii)  <E T="03">Cost-share.</E> Subject to applicable Nonavailability Statement (NAS) requirements, maternity care cost-share shall be determined as follows:</P>

            <P>(A) Inpatient cost-share formula applies to maternity care ending in childbirth in, or on the way to, a hospital <PRTPAGE P="111"/>inpatient childbirth unit, and for maternity care ending in a non-birth outcome not otherwise excluded by this part.</P>
            <P>(B) Ambulatory surgery cost-share formula applies to maternity care ending in childbirth in, or on the way to, a birthing center to which the beneficiary is admitted and from which the beneficiary has received prenatal care, or a hospital-based outpatient birthing room.</P>
            <P>(C) Outpatient cost-share formula applies to maternity care which terminates in a planned childbirth at home.</P>
            <P>(D) Otherwise covered medical services and supplies directly related to “Complications of pregnancy,” as defined in § 199.2 of this part, will be cost-shared on the same basis as the related maternity care for a period not to exceed 42 days following termination of the pregnancy and thereafter cost-shared on the basis of the inpatient or outpatient status of the beneficiary when medically necessary services and supplies are received.</P>
            <P>(17) <E T="03">Biofeedback Therapy.</E> Biofeedback therapy is a technique by which a person is taught to exercise control over a physiologic process occurring within the body. By using modern biomedical instruments the patient learns how a specific physiologic system within his body operates and how to modify the performance of this particular system.</P>
            <P>(i) <E T="03">Benefits Provided.</E> CHAMPUS benefits are payable for services and supplies in connection with electrothermal, electromyograph and electrodermal biofeedback therapy when there is documentation that the patient has undergone an appropriate medical evaluation, that their present condition is not responding to or no longer responds to other forms of conventional treatment, and only when provided as treatment for the following conditions:</P>
            <P>(A) Adjunctive treatment for Raynaud's Syndrome.</P>
            <P>(B) Adjunctive treatment for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, or incapacitating muscle spasm or weakness.</P>
            <P>(ii) <E T="03">Limitations.</E> Payable benefits include initial intake evaluation. Treatment following the initial intake evaluation is limited to a maximum of 20 inpatient and outpatient biofeedback treatments per calendar year.</P>
            <P>(iii) <E T="03">Exclusions.</E> Benefits are excluded for biofeedback therapy for the treatment of ordinary muscle tension states or for psychosomatic conditions. Benefits are also excluded for the rental or purchase of biofeedback equipment.</P>
            <P>(iv) <E T="03">Provider Requirements.</E> A provider of biofeedback therapy must be a CHAMPUS-authorized provider. (Refer to § 199.6, “Authorized Providers). If biofeedback treatment is provided by other than a physician, the patient must be referred by a physician.</P>
            <P>(v) <E T="03">Implementation Guidelines.</E> The Director of OCHAMPUS shall issue guidelines as are necessary to implement the provision of this paragraph.</P>
            <P>(18) <E T="03">Cardiac rehabilitation.</E> Cardiac rehabilitation is the process by which individuals are restored to their optimal physical, medical, and psychological status, after a cardiac event. Cardiac rehabilitation is often divided into three phases. Phase I begins during inpatient hospitalization and is managed by the patient's personal physician. Phase II is a medically supervised outpatient program which begins following discharge. Phase III is a lifetime maintenance program emphasizing continuation of physical fitness with periodic followup. Each phase includes an exercise component, patient education, and risk factor modification. There may be considerable variation in program components, intensity, and duration.</P>
            <P>(i) <E T="03">Benefits Provided.</E> CHAMPUS benefits are available on an inpatient or outpatient basis for services and supplies provided in connection with a cardiac rehabilitation program when ordered by a physician and provided as treatment for patients who have experienced the following cardiac events within the preceding twelve (12) months:</P>
            <P>(A) Myocardial Infarction.</P>
            <P>(B) Coronary Artery Bypass Graft.</P>
            <P>(C) Coronary Angioplasty.</P>
            <P>(D) Percutaneous Transluminal Coronary Angioplasty</P>
            <P>(E) Chronic Stable Angina (see limitations below).</P>
            <P>(ii) <E T="03">Limitations.</E> Payable benefits include separate allowance for the initial <PRTPAGE P="112"/>evaluation and testing. Outpatient treatment following the initial intake evaluation and testing is limited to a maximum of thirty-six (36) sessions per cardiac event, usually provided 3 sessions per week for twelve (12) weeks. Patients diagnosed with chronic stable angina are limited to one treatment episode (36 sessions) in a calendar year.</P>
            <P>(iii) <E T="03">Exclusions.</E> Phase III cardiac rehabilitation lifetime maintenance programs performed at home or in medically unsupervised settings are not covered.</P>
            <P>(iv) <E T="03">Providers.</E> A provider of cardiac rehabilitation services must be a CHAMPUS authorized hospital. (Refer to Section 199.6, “Authorized Providers.”) All cardiac rehabilitation services must be ordered by a physician.</P>
            <P>(v) <E T="03">Payment.</E> Payment for outpatient treatment will be based on an all inclusive allowable charge per session. Inpatient treatment will be paid based upon the reimbursement system in place for the hospital where the services are rendered.</P>
            <P>(vi) <E T="03">Implementation Guidelines.</E> The Director of OCHAMPUS shall issue guidelines as are necessary to implement the provisions of this paragraph.</P>
            <P>(19) <E T="03">Hospice care.</E> Hospice care is a program which provides an integrated set of services and supplies designed to care for the terminally ill. This type of care emphasizes palliative care and supportive services, such as pain control and home care, rather than cure-oriented services provided in institutions that are otherwise the primary focus under CHAMPUS. The benefit provides coverage for a humane and sensible approach to care during the last days of life for some terminally ill patients.</P>
            <P>(i) <E T="03">Benefit coverage.</E> CHAMPUS beneficiaries who are terminally ill (that is, a life expectancy of six months or less if the disease runs its normal course) will be eligible for the following services and supplies in lieu of most other CHAMPUS benefits:</P>
            <P>(A) Physician services.</P>
            <P>(B) Nursing care provided by or under the supervision of a registered professional nurse.</P>
            <P>(C) Medical social services provided by a social worker who has at least a bachelor's degree from a school accredited or approved by the Council on Social Work Education, and who is working under the direction of a physician. Medical social services include, but are not limited to the following:</P>
            <P>(<E T="03">1</E>) Assessment of social and emotional factors related to the beneficiary's illness, need for care, response to treatment, and adjustment to care.</P>
            <P>(<E T="03">2</E>) Assessment of the relationship of the beneficiary's medical and nursing requirements to the individual's home situation, financial resources, and availability of community resources.</P>
            <P>(<E T="03">3</E>) Appropriate action to obtain available community resources to assist in resolving the beneficiary's problem.</P>
            <P>(<E T="03">4</E>) Counseling services that are required by the beneficiary.</P>
            <P>(D) Counseling services provided to the terminally ill individual and the family member or other persons caring for the individual at home. Counseling, including dietary counseling, may be provided both for the purpose of training the individual's family or other care-giver to provide care, and for the purpose of helping the individual and those caring for him or her to adjust to the individual's approaching death. Bereavement counseling, which consists of counseling services provided to the individual's family after the individual's death, is a required hospice service but it is not reimbursable.</P>

            <P>(E) Home health aide services furnished by qualified aides and homemaker services. Home health aides may provide personal care services. Aides also may perform household services to maintain a safe and sanitary environment in areas of the home used by the patient. Examples of such services are changing the bed or light cleaning and laundering essential to the comfort and cleanliness of the patient. Aide services must be provided under the general supervision of a registered nurse. Homemaker services may include assistance in personal care, maintenance of a safe and healthy environment, and services to enable the individual to carry out the plan of care. Qualifications for home health aides can be found in 42 CFR 484.36.<PRTPAGE P="113"/>
            </P>
            <P>(F) Medical appliances and supplies, including drugs and biologicals. Only drugs that are used primarily for the relief of pain and symptom control related to the individual's terminal illness are covered. Appliances may include covered durable medical equipment, as well as other self-help and personal comfort items related to the palliation or management of the patient's condition while he or she is under hospice care. Equipment is provided by the hospice for use in the beneficiary's home while he or she is under hospice care. Medical supplies include those that are part of the written plan of care. Medical appliances and supplies are included within the hospice all-inclusive rates.</P>
            <P>(G) Physical therapy, occupational therapy and speech-language pathology services provided for purposes of symptom control or to enable the individual to maintain activities of daily living and basic functional skills.</P>
            <P>(H) Short-term inpatient care provided in a Medicare participating hospice inpatient unit, or a Medicare participating hospital, skilled nursing facility (SNF) or, in the case of respite care, a Medicaid-certified nursing facility that additionally meets the special hospice standards regarding staffing and patient areas. Services provided in an inpatient setting must conform to the written plan of care. Inpatient care may be required for procedures necessary for pain control or acute or chronic symptom management. Inpatient care may also be furnished to provide respite for the individual's family or other persons caring for the individual at home. Respite care is the only type of inpatient care that may be provided in a Medicaid-certified nursing facility. The limitations on custodial care and personal comfort items applicable to other CHAMPUS services are not applicable to hospice care.</P>
            <P>(ii) <E T="03">Core services.</E> The hospice must ensure that substantially all core services are routinely provided directly by hospice employees; i.e., physician services, nursing care, medical social services, and counseling for individuals and care givers. Refer to paragraphs (e)(19)(i)(A), (e)(19)(i)(B), (e)(19)(i)(C), and (e)(19)(i)(D) of this section.</P>
            <P>(iii) <E T="03">Non-core services.</E> While non-core services (i.e., home health aide services, medical appliances and supplies, drugs and biologicals, physical therapy, occupational therapy, speech-language pathology and short-term inpatient care) may be provided under arrangements with other agencies or organizations, the hospice must maintain professional management of the patient at all times and in all settings. Refer to paragraphs (e)(19)(i)(E), (e)(19)(i)(F), (e)(19)(i)(G), and (e)(19)(i)(H) of this section.</P>
            <P>(iv) <E T="03">Availability of services.</E> The hospice must make nursing services, physician services, and drugs and biologicals routinely available on a 24-hour basis. All other covered services must be made available on a 24-hour basis to the extent necessary to meet the needs of individuals for care that is reasonable and necessary for the palliation and management of the terminal illness and related condition. These services must be provided in a manner consistent with accepted standards of practice.</P>
            <P>(v) <E T="03">Periods of care.</E> Hospice care is divided into distinct periods/episodes of care. The terminally ill beneficiary may elect to receive hospice benefits for an initial period of 90 days, a subsequent period of 90 days, a second subsequent period of 30 days, and a final period of unlimited duration.</P>
            <P>(vi) <E T="03">Conditions for coverage.</E> The CHAMPUS beneficiary must meet the following conditions/criteria in order to be eligible for the hospice benefits and services referenced in paragraph (e)(19)(i) of this section.</P>
            <P>(A) There must be written certification in the medical record that the CHAMPUS beneficiary is terminally ill with a life expectancy of six months or less if the terminal illness runs its normal course.</P>
            <P>(<E T="03">1</E>) <E T="03">Timing of certification.</E> The hospice must obtain written certification of terminal illness for each of the election periods described in paragraph (e)(19(vi)(B) of this section, even if a single election continues in effect for two, three or four periods.</P>
            <P>(<E T="03">i</E>) <E T="03">Basic requirement.</E> Except as provided in paragraph (e)(19(vi)(A)(<E T="03">1)</E>(<E T="03">ii</E>) of this section the hospice must obtain the written certification no later than <PRTPAGE P="114"/>two calendar days after the period begins.</P>
            <P>(<E T="03">ii</E>) <E T="03">Exception.</E> For the initial 90-day period, if the hospice cannot obtain the written certifications within two calendar days, it must obtain oral certifications within two calendar days, and written certifications no later than eight calendar days after the period begins.</P>
            <P>(<E T="03">2</E>) <E T="03">Sources of certification.</E> Physician certification is required for both initial and subsequent election periods.</P>
            <P>(<E T="03">i</E>) For the initial 90-day period, the hospice must obtain written certification statements (and oral certification statements if required under paragraph (e)(19(vi)(A)(<E T="03">i)(ii</E>) of this section) from:</P>
            <P>(<E T="03">A</E>) The individual's attending physician if the individual has an attending physician; and</P>
            <P>(<E T="03">B</E>) The medical director of the hospice or the physician member of the hospice interdisciplinary group.</P>
            <P>(<E T="03">ii</E>) For subsequent periods, the only requirement is certification by one of the physicians listed in paragraph (e)(19)(vi)(A)(<E T="03">2)(i</E>)(<E T="03">B</E>) of this section.</P>
            <P>(B) The terminally ill beneficiary must elect to receive hospice care for each specified period of time; i.e., the two 90-day periods, a subsequent 30-day period, and a final period of unlimited duration. If the individual is found to be mentally incompetent, his or her representative may file the election statement. Representative means an individual who has been authorized under State law to terminate medical care or to elect or revoke the election of hospice care on behalf of a terminally ill individual who is found to be mentally incompetent.</P>
            <P>(<E T="03">1</E>) The episodes of care must be used consecutively; i.e., the two 90-day periods first, then the 30-day period, followed by the final period. The periods of care may be elected separately at different times.</P>
            <P>(<E T="03">2</E>) The initial election will continue through subsequent election periods without a break in care as long as the individual remains in the care of the hospice and does not revoke the election.</P>
            <P>(<E T="03">3</E>) The effective date of the election may begin on the first day of hospice care or any subsequent day of care, but the effective date cannot be made prior to the date that the election was made.</P>
            <P>(<E T="03">4</E>) The beneficiary or representative may revoke a hospice election at any time, but in doing so, the remaining days of that particular election period are forfeited and standard CHAMPUS coverage resumes. To revoke the hospice benefit, the beneficiary or representative must file a signed statement of revocation with the hospice. The statement must provide the date that the revocation is to be effective. An individual or representative may not designate an effective date earlier than the date that the revocation is made.</P>
            <P>(<E T="03">5</E>) If an election of hospice benefits has been revoked, the individual, or his or her representative may at any time file a hospice election for any period of time still available to the individual, in accordance with § 199.4(e)(19)(vi)(B).</P>
            <P>(<E T="03">6</E>) A CHAMPUS beneficiary may change, once in each election period, the designation of the particular hospice from which he or she elects to receive hospice care. To change the designation of hospice programs the individual or representative must file, with the hospice from which care has been received and with the newly designated hospice, a statement that includes the following information:</P>
            <P>(<E T="03">i</E>) The name of the hospice from which the individual has received care and the name of the hospice from which he or she plans to receive care.</P>
            <P>(<E T="03">ii</E>) The date the change is to be effective.</P>
            <P>(<E T="03">7</E>) Each hospice will design and print its own election statement to include the following information:</P>
            <P>(<E T="03">i</E>) Identification of the particular hospice that will provide care to the individual.</P>
            <P>(<E T="03">ii</E>) The individual's or representative's acknowledgment that he or she has been given a full understanding of the palliative rather than curative nature of hospice care, as it relates to the individual's terminal illness.</P>
            <P>(<E T="03">iii</E>) The individual's or representative's acknowledgment that he or she understands that certain other CHAMPUS services are waived by the election.</P>
            <P>(<E T="03">iv</E>) The effective date of the election.<PRTPAGE P="115"/>
            </P>
            <P>(<E T="03">v</E>) The signature of the individual or representative, and the date signed.</P>
            <P>(<E T="03">8</E>) The hospice must notify the CHAMPUS contractor of the initiation, change or revocation of any election.</P>
            <P>(C) The beneficiary must waive all rights to other CHAMPUS payments for the duration of the election period for:</P>
            <P>(<E T="03">1</E>) Care provided by any hospice program other than the elected hospice unless provided under arrangements made by the elected hospice; and</P>
            <P>(<E T="03">2</E>) Other CHAMPUS basic program services/benefits related to the treatment of the terminal illness for which hospice care was elected, or to a related condition, or that are equivalent to hospice care, except for services provided by:</P>
            <P>(<E T="03">i</E>) The designated hospice;</P>
            <P>(<E T="03">ii</E>) Another hospice under arrangement made by the designated hospice; or</P>
            <P>(<E T="03">iii</E>) An attending physician who is not employed by or under contract with the hospice program.</P>
            <P>(<E T="03">3</E>) Basic CHAMPUS coverage will be reinstated upon revocation of the hospice election.</P>
            <P>(D) A written plan of care must be established by a member of the basic interdisciplinary group assessing the patient's needs. This group must have at least one physician, one registered professional nurse, one social worker, and one pastoral or other counselor.</P>
            <P>(<E T="03">1</E>) In establishing the initial plan of care the member of the basic interdisciplinary group who assesses the patient's needs must meet or call at least one other group member before writing the initial plan of care.</P>
            <P>(<E T="03">2</E>) At least one of the persons involved in developing the initial plan must be a nurse or physician.</P>
            <P>(<E T="03">3</E>) The plan must be established on the same day as the assessment if the day of assessment is to be a covered day of hospice care.</P>
            <P>(<E T="03">4</E>) The other two members of the basic interdisciplinary group—the attending physician and the medical director or physician designee—must review the initial plan of care and provide their input to the process of establishing the plan of care within two calendar days following the day of assessment. A meeting of group members is not required within this 2-day period. Input may be provided by telephone.</P>
            <P>(<E T="03">5</E>) Hospice services must be consistent with the plan of care for coverage to be extended.</P>
            <P>(<E T="03">6</E>) The plan must be reviewed and updated, at intervals specified in the plan, by the attending physician, medical director or physician designee and interdisciplinary group. These reviews must be documented in the medical records.</P>
            <P>(<E T="03">7</E>) The hospice must designate a registered nurse to coordinate the implementation of the plan of care for each patient.</P>
            <P>(<E T="03">8</E>) The plan must include an assessment of the individual's needs and identification of the services, including the management of discomfort and symptom relief. It must state in detail the scope and frequency of services needed to meet the patient's and family's needs.</P>
            <P>(E) Complete medical records and all supporting documentation must be submitted to the CHAMPUS contractor within 30 days of the date of its request. If records are not received within the designated time frame, authorization of the hospice benefit will be denied and any prior payments made will be recouped. A denial issued for this reason is not an initial determination under § 199.10, and is not appealable.</P>
            <P>(vii) <E T="03">Appeal rights under hospice benefit.</E> A beneficiary or provider is entitled to appeal rights for cases involving a denial of benefits in accordance with the provisions of this part and § 199.10.</P>
            <P>(20) <E T="03">Case management services.</E> As part of case management for beneficiaries with complex medical or psychological conditions, payment for services or supplies not otherwise covered by the basic CHAMPUS/TRICARE program may be authorized when they are provided in accordance with § 199.4(i). Waiver of benefit limits/exclusions to the basic CHAMPUS/TRICARE program may be cost shared where it is demonstrated that the absence of such services would result in the exacerbation of an existing extraordinary condition, as defined in § 199.2, to the extent that frequent or extensive services are required; and such services are <PRTPAGE P="116"/>a cost effective alternative to the Basic CHAMPUS program.</P>
            <P>(f) <E T="03">Beneficiary or sponsor liability</E>—(1) <E T="03">General.</E> As stated in the introductory paragraph to this section, the Basic Program is essentially a supplemental program to the Uniformed Services direct medical care system. To encourage use of the Uniformed Services direct medical care system wherever its facilities are available and appropriate, the Basic Program benefits are designed so that it is to the financial advantage of a CHAMPUS beneficiary or sponsor to use the direct medical care system. When medical care is received from civilian sources, a CHAMPUS beneficiary is responsible for payment of certain deductible and cost-sharing amounts in connection with otherwise covered services and supplies. By statute, this joint financial responsibility between the beneficiary or sponsor and CHAMPUS is more favorable for dependents of active duty members than for other classes of beneficiaries.</P>
            <P>(2) <E T="03">Dependents of active duty members of the Uniformed Services.</E> CHAMPUS beneficiary or sponsor liability set forth for dependents of active duty members is as follows:</P>
            <P>(i) <E T="03">Annual fiscal year deductible for outpatient services and supplies.</E>
            </P>
            <P>(A) For care rendered all eligible beneficiaries prior to April 1, 1991, or when the active duty sponsor's pay grade is E-4 or below, regardless of the date of care:</P>
            <P>(<E T="03">1</E>) <E T="03">Individual Deductible:</E> Each beneficiary is liable for the first fifty dollars ($50.00) of the CHAMPUS-determined allowable amount on claims for care provided in the same fiscal year.</P>
            <P>(<E T="03">2</E>) <E T="03">Family Deductible:</E> The total deductible amount for all members of a family with the same sponsor during one fiscal year shall not exceed one hundred dollars ($100.00).</P>
            <P>(B) For care rendered on or after April 1, 1991, for all CHAMPUS beneficiaries except dependents of active duty sponsors in pay grades E-4 or below.</P>
            <P>(<E T="03">1) Individual Deductible:</E> Each beneficiary is liable for the first one hundred and fifty dollars ($150.00) of the CHAMPUS-determined allowable amount on claims for care provided in the same fiscal year.</P>
            <P>(<E T="03">2) Family Deductible:</E> The total deductible amount for all members of a family with the same sponsor during one fiscal year shall not exceed three hundred dollars ($300.00).</P>
            <P>(C) CHAMPUS-<E T="03">approved Ambulatory Surgical Centers or Birthing Centers.</E> No deductible shall be applied to allowable amounts for services or items rendered to active duty for authorized NATO dependents.</P>
            <P>(D) <E T="03">Allowable Amount does not exceed Deductible Amount.</E> If fiscal year allowable amounts for two or more beneficiary members of a family total less than $100.00 ($300.00 if paragraph (f) (2)(i)(B)(<E T="03">2</E>) of this section applies), but more of the beneficiary members submit a claim for over $50.00 ($150.00 if paragraph (f)(2)(i)(B)(<E T="03">1</E>) of this section applies), neither the family nor the individual deductible will have been met and no CHAMPUS benefits are payable.</P>
            <P>(E) For any family the outpatient deductible amounts will be applied sequentially as the CHAMPUS claims are processed.</P>
            <P>(F) If the fiscal year outpatient deductible under either paragraphs (f)(2)(i)(A) or (f)(2)(i)(B) of this section has been met by a beneficiary or a family through the submission of a claim or claims to a CHAMPUS fiscal intermediary in another geographic location from the location where a current claim is being submitted, the beneficiary or sponsor must obtain a deductible certificate from the CHAMPUS fiscal intermediary where the applicable beneficiary or famiy fiscal year deductible was met. Such deductible certificate must be attached to the current claim being submitted for benefits. Failure to obtain a deductible certificate under such circumstances will result in a second beneficiary or family fiscal year deductible being applied. However, this second deductible may be reimbursed once appropriate documentation, as described in paragraph (f)(2)(i)(F) of this section, is supplied to the CHAMPUS fiscal intermediary applying the second deductible.</P>

            <P>(G) Notwithstanding the dates specified in paragraphs (f)(2)(i)(A) and (f)(B)(2)(i) of this section in the case of dependents of active duty members of rank E-5 or above with Persian Gulf <PRTPAGE P="117"/>Conflict service, dependents of service members who were killed in the Gulf, or who died subsequent to Gulf service, and of members who retired prior to October 1, 1991, after having served in the Gulf War, the deductible shall be the amount specified in paragraph (f)(2)(i)(A) of this section for care rendered prior to October 1, 1991, and the amount specified in paragraph (f)(2)(i)(B) of this section for care rendered on or after October 1, 1991.</P>
            <P>(ii) <E T="03">Inpatient cost-sharing.</E> Except in the case of mental health services (see paragraph (f)(2)(ii)(D) of this section), dependents of active duty members of the Uniformed Services or their sponsors are responsible for the payment of the first $25 of the allowable institutional costs incurred with each covered inpatient admission to a hospital or other authorized institutional provider (refer to § 199.6), or the amount the beneficiary or sponsor would have been charged had the inpatient care been provided in a Uniformed Service hospital, whichever is greater.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The Secretary of Defense (after consulting with the Secretary of Health and Human Services and the Secretary of Transportation) prescribes the fair charges for inpatient hospital care provided through Uniformed Services medical facilities. This determination is made each fiscal year.</P>
            </NOTE>
            <P>(A) <E T="03">Inpatient cost-sharing payable with each separate inpatient admission.</E> A separate cost-sharing amount (as described in paragraph (f)(2) of this section) is payable for each inpatient admission to a hospital or other authorized institution, regardless of the purpose of the admission (such as medical or surgical), regardless of the number of times the beneficiary is admitted, and regardless of whether or not the inpatient admissions are for the same or related conditions; except that successive inpatient admissions shall be deemed one inpatient confinement for the purpose of computing the inpatient cost-share payable, provided not more than 60 days have elapsed between the successive admissions. However, notwithstanding this provision, all admissions related to a single maternity episode shall be considered one confinement, regardless of the number of days between admissions (refer to paragraph (b) of this section).</P>
            <P>(B) <E T="03">Multiple family inpatient admissions.</E> A separate cost-sharing amount is payable for each inpatient admission, regardless of whether or not two or more beneficiary members of a family are admitted at the same time or from the same cause (such as an accident). A separate beneficiary inpatient cost-sharing amount must be applied for each separate admission on each beneficiary member of the family.</P>
            <P>(C) <E T="03">Newborn patient in his or her own right.</E> When a newborn infant remains as an inpatient in his or her own right (usually after the mother is discharged), the newborn child becomes the beneficiary and patient and the extended inpatient stay becomes a separate inpatient admission. In such a situation, a new, separate inpatient cost-sharing amount is applied. If a multiple birth is involved (such as twins or triplets) and two or more newborn infants become patients in their own right, a separate inpatient cost-sharing amount must be applied to the inpatient stay for each newborn child who has remained as an inpatient in his or her own right.</P>
            <P>(D) <E T="03">Inpatient cost-sharing for mental health services.</E> For care provided on or after October 1, 1995, the inpatient cost-sharing for mental health services is $20 per day for each day of the inpatient admission. This $20 per day cost sharing amount applies to admissions to any hospital for mental health services, any residential treatment facility, any substance abuse rehabilitation facility, and any partial hospitalization program providing mental health or substance use disorder rehabilitation services.</P>
            <P>(iii) <E T="03">Outpatient cost-sharing</E>. Dependents of active duty members of the Uniformed Services or their sponsors are responsible for payment of 20 percent of the CHAMPUS-determined allowable cost or charge beyond the annual fiscal year deductible amount (as described in paragraph (f)(2)(i) of this section) for otherwise covered services or supplies provided on an outpatient basis by authorized providers.</P>
            <P>(iv) <E T="03">Ambulatory surgery</E>. Notwithstanding the above provisions pertaining to outpatient cost-sharing, dependents of active duty members of the Uniformed Services or their sponsors <PRTPAGE P="118"/>are responsible for payment of $25 for surgical care that is authorized and received while in an outpatient status and that has been designated in guidelines issued by the Director, OCHAMPUS, or a designee.</P>
            <P>(v) <E T="03">Psychiatric partial hospitalization services.</E> Institutional and professional services provided under the psychiatric partial hospitalization program authorized by paragraph (b)(10) of this section shall be cost shared as inpatient services.</P>
            <P>(3) <E T="03">Retirees, dependents of retirees, dependents of deceased active duty members, and dependents of deceased retirees</E>. CHAMPUS beneficiary liability set forth for retirees, dependents of retirees, dependents of deceased active duty members, and dependents of deceased retirees is as follows:</P>
            <P>(i) <E T="03">Annual fiscal year deductible for outpatient services or supplies.</E> The annual fiscal year deductible for otherwise covered outpatient services or supplies provided retirees, dependents of retirees, dependents of deceased active duty members, and dependents of deceased retirees is the same as the annual fiscal year outpatient deductible applicable to dependents of active duty members of rank E-5 or above as specified in paragraph (f)(2)(i)(A) or (B) of this section.</P>
            <P>(ii) <E T="03">Inpatient cost-sharing.</E> Cost-sharing amounts for inpatient services shall be as follows:</P>
            <P>(A) <E T="03">Services subject to the CHAMPUS DRG-based payment system.</E> The cost-share shall be the lesser of: an amount calculated by multiplying a per diem amount by the total number of days in the hospital stay except the day of discharge; or 25 percent of the hospital's billed charges. The per diem amount shall be calculated so that, in the aggregate, the total cost-sharing amounts for these beneficiaries is equivalent to 25 percent of the CHAMPUS-determined allowable costs for covered services or supplies provided on an inpatient basis by authorized providers. The per diem amount shall be published annually by OCHAMPUS.</P>
            <P>(B) <E T="03">Services subject to the CHAMPUS mental health per diem payment system.</E> The cost-share is dependent upon whether the hospital is paid a hospital-specific per diem or a regional per diem under the provisions of § 199.14(a)(2). With respect to care paid for on the basis of a hospital specific per diem, the cost-share shall be 25% of the hospital-specific per diem amount. For care paid for on the basis of a regional per diem, the cost share shall be the lower of a fixed daily amount or 25% of the hospital's billed charges. The fixed daily amount shall be 25 percent of the per diem adjusted so that total beneficiary cost shares will equal 25 percent of total payments under the mental health per diem payment system. These fixed daily amount shall be updated annually and published in the <E T="04">Federal Register</E> along with the per diems published pursuant to § 199.14(a)(2)(iv)(B).</P>
            <P>(C) <E T="03">Other services.</E> For services exempt from the CHAMPUS DRG-based payment system and the CHAMPUS mental health per diem payment system and services provided by institutions other than hospitals, the cost-share shall be 25% of the CHAMPUS-determined allowable charges.</P>
            <P>(iii) <E T="03">Outpatient cost-sharing</E>. (A) <E T="03">For services other than ambulatory surgery services.</E> Retirees, dependents of retirees, dependents of deceased active duty members, and dependents of deceased retirees are responsible for payment of 25 percent of the CHAMPUS-determined allowable costs or charges beyond the annual fiscal year deductible amount (as described in paragraph (f)(2)(i) of this section for otherwise covered services or supplies provided on an outpatient basis by authorized providers.</P>
            <P>(B) <E T="03">For services subject to the ambulatory surgery payment method.</E> For services subject to the ambulatory surgery payment method set forth in § 199.14(d), the cost share shall be the lesser of: 25 percent of the payment amount provided pursuant to § 199.14(d); or 25 percent of the center's billed charges.</P>
            <P>(iv) <E T="03">Psychiatric partial hospitalization services.</E> Institutional and professional services provided under the psychiatric partial hospitalization program authorized by paragraph (b)(10) of this section shall be cost shared as inpatient services.</P>
            <P>(4) <E T="03">Former spouses</E>. CHAMPUS beneficiary liability set forth for former <PRTPAGE P="119"/>spouses eligible under the provisions of paragraph (b)(2)(ii) of § 199.3 is as follows:</P>
            <P>(i) <E T="03">Annual fiscal year deductible for outpatient services or supplies.</E> An eligible former spouse is responsible for the payment of the first $150.00 of the CHAMPUS-determined reasonable costs or charges for otherwise covered outpatient services or supplies provided in any one fiscal year. (Except for services received prior to April 1, 1991, the deductible amount is $50.00). The former spouse cannot contribute to, nor benefit from, any family deductible of the member or former member to whom the former spouse was married or of any CHAMPUS-eligible children.</P>
            <P>(ii) <E T="03">Inpatient cost-sharing.</E> Eligible former spouses are responsible for the payment of cost-sharing amounts the same as those required for retirees, dependents of retirees, dependents of deceased active duty members, and dependents of deceased retirees.</P>
            <P>(iii) <E T="03">Outpatient cost-sharing</E>. Eligible former spouses are responsible for payment of 25 percent of the CHAMPUS-determined reasonable costs or charges beyond the annual fiscal year deductible amount for otherwise covered services or supplies provided on an outpatient basis by authorized providers.</P>
            <P>(5) <E T="03">Cost-Sharing under the Military-Civilian Health Services Partnership Program</E>. Cost-sharing is dependent upon the type of partnership program entered into, whether external or internal. (See paragraph (p) of § 199.1, for general requirements of the Military-Civilian Health Services Partnership Program.)</P>
            <P>(i) <E T="03">External Partnership Agreement</E>. Authorized costs associated with the use of the civilian facility will be financed through CHAMPUS under the normal cost-sharing and reimbursement procedures applicable under CHAMPUS.</P>
            <P>(ii) <E T="03">Internal Partnership Agreement</E>. Beneficiary cost-sharing under internal agreements will be the same as charges prescribed for care in military treatment facilities.</P>
            <P>(6)-(7) [Reserved]</P>
            <P>(8) <E T="03">Cost-sharing for services provided under special discount arrangements</E>—(i) <E T="03">General rule.</E> With respect to services determined by the Director, OCHAMPUS (or designee) to be covered by § 199.14(i), the Director, OCHAMPUS (or designee) has authority to establish, as an exception to the cost-sharing amount normally required pursuant to this section, a different cost-share amount that appropriately reflects the application of the statutory cost-share to the discount arrangement.</P>
            <P>(ii) <E T="03">Specific applications.</E> The following are examples of applications of the general rule; they are not all inclusive.</P>
            <P>(A) In the case of services provided by individual health care professionals and other noninstitutional providers, the cost-share shall be the usual percentage of the CHAMPUS allowable charge determined under § 199.14(i).</P>
            <P>(B) In the case of services provided by institutional providers normally paid on the basis of a pre-set amount (such as DRG-based amount under § 199.14(a)(1) or per-diem amount under § 199.14(a)(2)), if the discount rate is lower than the pre-set rate, the cost-share amount that would apply for a beneficiary other than an active duty dependent pursuant to the normal pre-set rate would be reduced by the same percentage by which the pre-set rate was reduced in setting the discount rate.</P>
            <P>(9) <E T="03">Waiver of deductible amounts or cost-sharing not allowed—</E>(i) <E T="03">General rule.</E> Because deductible amounts and cost sharing are statutorily mandated, except when specifically authorized by law (as determined by the Director, OCHAMPUS), a provider may not waive or forgive beneficiary liability for annual deductible amounts or inpatient or outpatient cost sharing, as set forth in this section.</P>
            <P>(ii) <E T="03">Exception for bad debts.</E> This general rule is not violated in cases in which a provider has made all reasonable attempts to effect collection, without success, and determines in accordance with generally accepted fiscal management standards that the beneficiary liability in a particular case is an uncollectible bad debt.</P>
            <P>(iii) <E T="03">Remedies for noncompliance.</E> Potential remedies for noncompliance with this requirement include:</P>

            <P>(A) A claim for services regarding which the provider has waived the <PRTPAGE P="120"/>beneficiary's liability may be disallowed in full, or, alternatively, the amount payable for such a claim may be reduced by the amount of the beneficiary liability waived.</P>
            <P>(B) Repeated noncompliance with this requirement is a basis for exclusion of a provider.</P>
            <P>(10) <E T="03">Catastrophic loss protection for basic program benefits.</E> Fiscal year limits, or catastrophic caps, on the amounts beneficiaries are required to pay are established as follows:</P>
            <P>(i) <E T="03">Dependents of active duty members.</E> The maximum family liability is $1,000 for deductibles and cost-shares based on allowable charges for Basic Program services and supplies received in a fiscal year.</P>
            <P>(ii) <E T="03">All other beneficiaries.</E> For all other categories of beneficiary families (including those eligible under CHAMPVA) the fiscal year cap is $10,000.</P>
            <P>(iii) <E T="03">Payment after cap is met.</E> After a family has paid the maximum cost-share and deductible amounts (dependents of active duty members $1,000 and all others $10,000), for a fiscal year, CHAMPUS will pay allowable amounts for remaining covered services through the end of that fiscal year.</P>
            <NOTE>
              <HD SOURCE="HED">Note to paragraph <E T="01">(f)(10):</E>
              </HD>
              <P>Under the Defense Authorization Act for Fiscal Year 1993, the cap for beneficiaries other than dependents of active duty members was reduced from $10,000 to $7,500 on October 1, 1992. The cap remains at $1,000 for dependents of active duty members.</P>
            </NOTE>
            <P>(g) <E T="03">Exclusions and limitations.</E> In addition to any definitions, requirements, conditions, or limitations enumerated and described in other sections of this part, the following specifically are excluded from the Basic Program:</P>
            <P>(1) <E T="03">Not medically or psychologically necessary.</E> Services and supplies that are not medically or psychologically necessary for the diagnosis or treatment of a covered illness (including mental disorder) or injury, for the diagnosis and treatment of pregnancy or well-baby care except as provided in the following paragraph.</P>
            <P>(2) <E T="03">Unnecessary diagnostic tests.</E> X-ray, laboratory, and pathological services and machine diagnostic tests not related to a specific illness or injury or a definitive set of symptoms except for cancer screening mammography and cancer screening papanicolaou (PAP) tests provided under the terms and conditions contained in the guidelines adopted by the Director, OCHAMPUS.</P>
            <P>(3) <E T="03">Institutional level of care.</E> Services and supplies related to inpatient stays in hospitals or other authorized institutions above the appropriate level required to provide necessary medical care.</P>
            <P>(4) <E T="03">Diagnostic admission.</E> Services and supplies related to an inpatient admission primarily to perform diagnostic tests, examinations, and procedures that could have been and are performed routinely on an outpatient basis.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>If it is determined that the diagnostic x-ray, laboratory, and pathological services and machine tests performed during such admission were medically necessary and would have been covered if performed on an outpatient basis, CHAMPUS benefits may be extended for such diagnostic procedures only, but cost-sharing will be computed as if performed on an outpatient basis.</P>
            </NOTE>
            <P>(5) <E T="03">Unnecessary postpartum inpatient stay, mother or newborn.</E> Postpartum inpatient stay of a mother for purposes of staying with the newborn infant (usually primarily for the purpose of breast feeding the infant) when the infant (but not the mother) requires the extended stay; or continued inpatient stay of a newborn infant primarily for purposes of remaining with the mother when the mother (but not the newborn infant) requires extended postpartum inpatient stay.</P>
            <P>(6) <E T="03">Therapeutic absences</E>. Therapeutic absences from an inpatient facility, except when such absences are specifically included in a treatment plan approved by the Director, OCHAMPUS, or a designee. For cost-sharing provisions refer to § 199.14, paragraph (f)(3).</P>
            <P>(7) <E T="03">Custodial care.</E> Custodial care except as otherwise specifically provided in paragraphs (e)(12) (ii), (iii), and (iv) of this section.</P>
            <P>(8) <E T="03">Domiciliary care.</E> Inpatient stays primarily for domiciliary care purposes.</P>
            <P>(9) <E T="03">Rest or rest cures.</E> Inpatient stays primarily for rest or rest cures.</P>
            <P>(10) <E T="03">Amounts above allowable costs or charges.</E> Costs of services and supplies to the extent amounts billed are over the CHAMPUS determined allowable cost or charge, as provided for in § 199.14.<PRTPAGE P="121"/>
            </P>
            <P>(11) <E T="03">No legal obligation to pay, no charge would be made.</E> Services or supplies for which the beneficiary or sponsor has no legal obligation to pay; or for which no charge would be made if the beneficiary or sponsor was not eligible under CHAMPUS; or whenever CHAMPUS is a secondary payer for claims subject to the CHAMPUS DRG-based payment system, amounts, when combined with the primary payment, which would be in excess of charges (or the amount the provider is obligated to accept as payment in full, if it is less than the charges).</P>
            <P>(12) <E T="03">Furnished without charge.</E> Services or supplies furnished without charge.</P>
            <P>(13) <E T="03">Furnished by local, state, or Federal Government.</E> Services and supplies paid for, or eligible for payment, directly or indirectly by a local, state, or Federal Government, except as provided under CHAMPUS, or by government hospitals serving the general public, or medical care provided by a Uniformed Service medical care facility, or benefits provided under title XIX of the Social Security Act (Medicaid) (refer to § 199.8 of this part).</P>
            <P>(14) <E T="03">Study, grant, or research programs.</E> Services and supplies provided as a part of or under a scientific or medical study, grant, or research program.</P>
            <P>(15) <E T="03">Unproven drugs, devices, and medical treatments or procedures.</E> By law, CHAMPUS can only cost-share medically necessary supplies and services. Any drug, device or medical treatment or procedure, the safety and efficacy of which have not been established, as described in this paragraph (g)(15), is unproven and cannot be cost-shared by CHAMPUS.</P>
            <P>(i) A drug, device, or medical treatment or procedure is unproven:</P>
            <P>(A) If the drug or device cannot be lawfully marketed without the approval or clearance of the United States Food and Drug Administration (FDA) and approval or clearance for marketing has not been given at the time the drug or device is furnished to the patient.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Although the use of drugs and medicines not approved by the FDA for commercial marketing, that is for use by humans, (even though permitted for testing on humans) is excluded from coverage as unproven, drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered by CHAMPUS as if FDA approved.</P>
              <P>Certain cancer drugs, designated as Group C drugs (approved and distributed by the National Cancer Institute) and Treatment Investigational New Drugs (INDs), are not covered under CHAMPUS because they are not approved for commercial marketing by the FDA. However, medical care related to the use of Group C drugs and Treatment INDs can be cost-shared under CHAMPUS when the patient's medical condition warrants their administration and the care is provided in accordance with generally accepted standards of medical practice.</P>
              <P>CHAMPUS can also consider coverage of <E T="03">unlabeled</E> or <E T="03">off-label</E> uses of drugs that are Food and Drug Administration (FDA) approved drugs that are used for indications or treatments not included in the approved labeling. Approval for reimbursement of <E T="03">unlabeled</E> or <E T="03">off-label</E> uses requires review for medical necessity, and also requires demonstrations from medical literature, national organizations, or technology assessment bodies that the <E T="03">unlabeled</E> or <E T="03">off-label</E> use of the drug is safe, effective and in accordance with nationally accepted standards of practice in the medical community.</P>
            </NOTE>
            <P>(B) If a medical device (as defined by 21 U.S.C. 321(h)) with an Investigational Device Exemption (IDE) approved by the Food and Drug Administration is categorized by the FDA as experimental/investigational (FDA Category A).</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>CHAMPUS will consider for coverage a device with an FDA-approved IDE categorized by the FDA as non-experimental/investigational (FDA Category B) for CHAMPUS beneficiaries participating in FDA approved clinical trials. Coverage of any such Category B device is dependent on its meeting all other requirements of the laws and rules governing CHAMPUS and upon the beneficiary involved meeting the FDA-approved IDE study protocols.</P>
            </NOTE>

            <P>(C) Unless reliable evidence shows that any medical treatment or procedure has been the subject of well-controlled studies of clinically meaningful endpoints, which have determined its maximum tolerated dose, its toxicity, its safety, and its efficacy as compared with standard means of treatment or diagnosis. (See the definition of <E T="03">reliable evidence</E> in § 199.2 of this part for the procedures used in determining if a medical treatment or procedure is unproven.)</P>

            <P>(D) If the consensus among experts regarding the medical treatment or procedure is that further studies or <PRTPAGE P="122"/>clinical trials are necessary to determine its maximum tolerated doses, its toxicity, its safety, or its effectiveness as compared with the standard means of treatment or diagnosis. (See the definition of <E T="03">reliable evidence</E> in § 199.2 of this part for the procedures used in determining if a medical treatment or procedure is unproven.)</P>
            <P>(ii) CHAMPUS benefits for rare diseases are reviewed on a case-by-case basis by the Director, Office of CHAMPUS, or a designee. In reviewing the case, the Director, or a designee, may consult with any or all of the following sources to determine if the proposed therapy is considered safe and effective:</P>
            <P>(A) Trials published in refereed medical literature.</P>
            <P>(B) Formal technology assessments.</P>
            <P>(C) National medical policy organization positions.</P>
            <P>(D) National professional associations.</P>
            <P>(E) National expert opinion organizations.</P>
            <P>(iii) <E T="03">Care excluded.</E> This exclusion from benefits includes all services directly related to the unproven drug, device, or medical treatment or procedure. However, CHAMPUS may cover services or supplies when there is no logical or causal relationship between the unproven drug, device or medical treatment or procedure and the treatment at issue or where such a logical or causal relationship cannot be established with a sufficient degree of certainty. This CHAMPUS coverage is authorized in the following circumstances:</P>
            <P>(A) Treatment that is not related to the unproven drug, device or medical treatment or procedure; e.g., medically necessary in the absence of the unproven treatment.</P>
            <P>(B) Treatment which is necessary follow-up to the unproven drug, device or medical treatment or procedure but which might have been necessary in the absence of the unproven treatment.</P>
            <P>(iv) <E T="03">Examples of unproven drugs, devices or medical treatments or procedures.</E> This paragraph (g)(15)(iv) consists of a partial list of unproven drugs, devices or medical treatment or procedures. These are excluded from CHAMPUS program benefits. This list is not all inclusive. Other unproven drugs, devices or medical treatments or procedures, are similarly excluded, although they do not appear on this partial list. This partial list will be reviewed and updated periodically as new information becomes available. With respect to any procedure included on this partial list, if and when the Director, OCHAMPUS determines that based on reliable evidence (as defined in section 199.2) such procedure has proven medical effectiveness, the Director will initiate action to remove the procedure from this partial list of unproven drugs, devices or medical treatment or procedures. From the date established by the Director as the date the procedure has established proven medical effectiveness until the date the regulatory change is made to remove the procedures from the partial list of unproven drugs, devices or medical treatment or procedures the Director, OCHAMPUS will suspend treatment of the procedure as unproven drugs, devices, or medical treatments or procedures. Following is the non-inclusive, partial list of unproven drugs, devices or medical treatment or procedures, all of which are excluded from CHAMPUS benefits:</P>
            <P>(A) Radial keratotomy (refractive keratoplasty).</P>
            <P>(B) Cellular therapy.</P>
            <P>(C) Histamine therapy.</P>
            <P>(D) Stem cell assay, a laboratory procedure which allows a determination to be made of the type and dose of cancer chemotherapy drugs to be used, based on in vitro analysis of their effects on cancer cells taken from an individual.</P>
            <P>(E) Topical application of oxygen.</P>
            <P>(F) Immunotherapy for malignant disease, except when using drugs approved by the FDA for this purpose.</P>
            <P>(G) Prolotherapy, joint sclerotherapy, and ligamentous injections with sclerosing agents.</P>
            <P>(H) Transcervical block silicone plug.</P>
            <P>(I) Whole body hyperthermia in the treatment of cancer.</P>
            <P>(J) Portable nocturnal hypoglycemia detectors.</P>
            <P>(K) Testosterone pellet implants in the treatment of females.</P>
            <P>(L) Estradiol pellet implants.</P>
            <P>(M) Epikeratophakia for treatment of aphakia and myopia.</P>
            <P>(N) Bladder stimulators.<PRTPAGE P="123"/>
            </P>
            <P>(O) Ligament replacement with absorbable copolymer carbon fiber scaffold.</P>
            <P>(P) Intraoperative radiation therapy.</P>
            <P>(Q) Gastric bubble or balloon.</P>
            <P>(R) Dorsal root entry zone (DREZ) thermocoagulation or micorcoagulation neurosurgical procedure.</P>
            <P>(S) Brain electrical activity mapping (BEAM).</P>
            <P>(T) Topographic brain mapping (TBM) procedure.</P>
            <P>(U) Ambulatory blood pressure monitoring.</P>
            <P>(V) Bilateral carotoid body resection to relieve pulmonary system.</P>
            <P>(W) Intracavitary administration of cisplatin for malignant disease.</P>
            <P>(X) Cervicography.</P>
            <P>(Y) In-home uterine activity monitoring for the purpose of preventing preterm labor and/or delivery.</P>
            <P>(Z) Sperm evaluation, hamster penetration test.</P>
            <P>(AA) Transfer factor (TF).</P>
            <P>(BB) Continuous ambulatory esophageal pH monitoring (CAEpHM) is considered unproven for patients under age 12 for all indications, and for patients over age 12 for sleep apnea.</P>
            <P>(CC) Adrenal-to-brain transplantation for Parkinson's disease.</P>
            <P>(DD) Videofluoroscopy evaluation in speech pathology.</P>
            <P>(EE) Applied kinesiology.</P>
            <P>(FF) Hair analysis to identify mineral deficiencies from the chemical composition of the hair. Hair analysis testing may be reimbursed when necessary to determine lead poisoning.</P>
            <P>(GG) Iridology (links flaws in eye coloration with disease elsewhere in the body).</P>
            <P>(HH) Small intestinal bypass (jejunoileal bypass) for treatment of morbid obesity.</P>
            <P>(II) Biliopancreatic bypass.</P>
            <P>(JJ) Gastric wrapping/gastric banding.</P>
            <P>(KK) Calcium EAP/calcium orotate and selenium (also known as Nieper therapy)—Involves inpatient care and use of calcium compounds and other non-FDA approved drugs and special diets. Used for cancer, heart disease, diabetes, and multiple sclerosis.</P>
            <P>(LL) Percutaneous balloon valvuloplasty for mitral and tricuspid valve stenosis.</P>
            <P>(MM) Amniocentesis performed for ISO immunization to the ABO blood antigens.</P>
            <P>(NN) Balloon dilatation of the prostate.</P>
            <P>(OO) Helium in radiosurgery.</P>
            <P>(PP) Electrostimulation of salivary production in the treatment of xerostomia secondary to Sjogren's syndrome.</P>
            <P>(QQ) Intraoperative monitoring of sensory evoked potentials (SEP). To include visually evoked potentials, brainstem auditory evoked response, somatosensory evoked potentials during spinal and orthopedic surgery, and sensory evoked potentials monitoring of the sciatic nerve during total hip replacement. Recording SEPs in unconscious head injured patients to assess the status of the somatosensory system. The use of SEPs to define conceptional or gestational age in preterm infants.</P>
            <P>(RR) Autolymphocyte therapy (ALT) (immunotherapy used for treating metastatic kidney cancer patients).</P>
            <P>(SS) Radioimmunoguided surgery in the detection of cancer.</P>
            <P>(TT) Gait analysis (also known as a walk study or electrodynogram)</P>
            <P>(UU) Use of cerebellar stimulators/pacemakers for the treatment of neurologic disorders.</P>
            <P>(VV) Signal-averaged ECG.</P>
            <P>(WW) Peri-urethal Teflon injections to manage urinary incontinence.</P>
            <P>(XX) Extraoperative electrocorticography for stimulation and recording</P>
            <P>(YY) Quantitative computed tomography (QCT) for the detection and monitoring of osteoporosis.</P>
            <P>(ZZ) [Reserved]</P>
            <P>(AAA) Percutaneous transluminal angioplasty in the treatment of obstructive lesions of the carotoid, vertebral and cerebral arteries.</P>
            <P>(BBB) Endoscopic third ventriculostomy.</P>
            <P>(CCC) Holding therapy—Involves holding the patient in an attempt to achieve interpersonal contact, and to improve the patient's ability to concentrate on learning tasks.</P>
            <P>(DDD) In utero fetal surgery.<PRTPAGE P="124"/>
            </P>
            <P>(EEE) Light therapy for seasonal depression (also known as seasonal affective disorder (SAD)).</P>
            <P>(FFF) Dorsal column and deep brain electrical stimulation of treatment of motor function disorder.</P>
            <P>(GGG) Chelation therapy, except with products and for indications approved by the FDA.</P>
            <P>(HHH) All organ transplants <E T="03">except</E> heart, heart-lung, lung, kidney, some bone marrow, liver, liver-kidney, corneal, heart-valve, and kidney-pancreas transplants for Type I diabetics with chronic renal failure who require kidney transplants.</P>
            <P>(III) Implantable infusion pumps, <E T="03">except</E> for treatment of spasticity, chronic intractable pain, and hepatic artery perfusion chemotherapy for the treatment of primary liver cancer or metastic colorectal liver cancer.</P>
            <P>(JJJ) Services related to the candidiasis hypersensitivity syndrome, yeast syndrome, or gastrointestinal candidiasis (i.e., allergenic extracts of Candida albicans for immunotherapy and/or provocation/neutralization).</P>
            <P>(KKK) Treatment of chronic fatigue syndrome.</P>
            <P>(LLL) Extracorporeal immunoadsorption using protein A columns for conditions other than acute idopathic thrombocytopenia purpura.</P>
            <P>(MMM) Dynamic posturography (both static and computerized).</P>
            <P>(NNN) Laparoscopic myomectomy.</P>

            <P>(OOO) Growth factor, including platelet-derived growth factors, for treating non-healing wounds. This includes Procurene<E T="51">®</E>, a platelet-derived wound-healing formula.</P>
            <P>(PPP) High dose chemotherapy with stem cell rescue (HDC/SCR) for any of the following malignancies:</P>
            <P>(<E T="03">1</E>) Breast cancer, except for metastic breast cancer that has relapsed after responding to a first line treatment.</P>
            <P>(<E T="03">2</E>) Ovarian cancer.</P>
            <P>(<E T="03">3</E>) Testicular cancer.</P>
            <P>(16) <E T="03">Immediate family, household.</E> Services or supplies provided or prescribed by a member of the beneficiary's immediate family, or a person living in the beneficiary's or sponsor's household.</P>
            <P>(17) <E T="03">Double coverage.</E> Services and supplies that are (or are eligible to be) payable under another medical insurance or program, either private or governmental, such as coverage through employment or Medicare (refer to § 199.8 of this part).</P>
            <P>(18) <E T="03">Nonavailability Statement required.</E> Services and supplies provided under circumstances or in geographic locations requiring a Nonavailability Statement (DD Form 1251), when such a statement was not obtained.</P>
            <P>(19) <E T="03">Preauthorization required.</E> Services or supplies which require preauthorization if preauthorization was not obtained. Services and supplies which were not provided according to the terms of the preauthorization. The Director, OCHAMPUS, or a designee, may grant an exception to the requirement for preauthorization if the services otherwise would be payable except for the failure to obtain preauthorization.</P>
            <P>(20) <E T="03">Psychoanalysis or psychotherapy, part of education.</E> Psychoanalysis or psychotherapy provided to a beneficiary or any member of the immediate family that is credited towards earning a degree or furtherance of the education or training of a beneficiary or sponsor, regardless of diagnosis or symptoms that may be present.</P>
            <P>(21) <E T="03">Runaways.</E> Inpatient stays primarily to control or detain a runaway child, whether or not admission is to an authorized institution.</P>
            <P>(22) <E T="03">Services or supplies ordered by a court or other government agency.</E> Services or supplies, including inpatient stays, directed or agreed to by a court or other governmental agency. However, those services and supplies (including inpatient stays) that otherwise are medically or psychologically necessary for the diagnosis or treatment of a covered condition and that otherwise meet all CHAMPUS requirements for coverage are not excluded.</P>
            <P>(23) <E T="03">Work-related (occupational) disease or injury.</E> Services and supplies required as a result of occupational disease or injury for which any benefits are payable under a worker's compensation or similar law, whether or not such benefits have been applied for or paid; except if benefits provided under such laws are exhausted.</P>
            <P>(24) <E T="03">Cosmetic, reconstructive, or plastic surgery.</E> Services and supplies in connection with cosmetic, reconstructive, <PRTPAGE P="125"/>or plastic surgery except as specifically provided in paragraph (e)(8) of this section.</P>
            <P>(25) <E T="03">Surgery, psychological reasons.</E> Surgery performed primarily for psychological reasons (such as psychogenic).</P>
            <P>(26) <E T="03">Electrolysis.</E>
            </P>
            <P>(27) <E T="03">Dental care.</E> Dental care or oral surgery, except as specifically provided in paragraph (e)(10) of this section.</P>
            <P>(28) <E T="03">Obesity, weight reduction.</E> Services and supplies related to obesity or weight reduction whether surgical or nonsurgical; wiring of the jaw or any procedure of similar purpose, regardless of the circumstances under which performed; except that benefits may be provided for the gastric bypass, gastric stapling, or gastroplasty procedures in connection with morbid obesity as provided in paragraph (e)(15) of this section.</P>
            <P>(29) <E T="03">Transsexualism or such other conditions as gender dysphoria.</E> Services and supplies related to transsexualism or such other conditions as gender dysphoria (including, but not limited, to intersex surgery, psychotherapy, and prescription drugs), except as specifically provided in paragraph (e)(7) of this section.</P>
            <P>(30) <E T="03">Therapy or counseling for sexual dysfunctions or sexual inadequacies.</E> Sex therapy, sexual advice, sexual counseling, sex behavior modification, psychotherapy for mental disorders involving sexual deviations (i.e., transvestic fetishm), or other similar services, and any supplies provided in connection with therapy for sexual dysfunctions or inadequacies.</P>
            <P>(31) <E T="03">Corns, calluses, and toenails.</E> Removal of corns or calluses or trimming of toenails and other routine podiatry services, except those required as a result of a diagnosed systemic medical disease affecting the lower limbs, such as severe diabetes.</P>
            <P>(32) <E T="03">Dyslexia.</E>
            </P>
            <P>(33) <E T="03">Surgical sterilization, reversal.</E> Surgery to reverse surgical sterilization procedures.</P>
            <P>(34) <E T="03">Noncoital reproductive procedures including artifical insemination, in-vitro fertilization, gamete intrafallopian transfer and all other such reproductive technologies</E>. Services and supplies related to artificial insemination (including semen donors and semen banks), in-vitro fertilization, gamete intrafallopian transfer and all other noncoital reproductive technologies.</P>
            <P>(35) <E T="03">Nonprescription contraceptives.</E>
            </P>
            <P>(36) <E T="03">Tests to determine paternity or sex of a child.</E> Diagnostic tests to establish paternity of a child; or tests to determine sex of an unborn child.</P>
            <P>(37) <E T="03">Preventive care.</E> Preventive care, such as routine, annual, or employment-requested physical examinations; routine screening procedures; except that the following are not excluded:</P>
            <P>(i) Well-child care.</P>
            <P>(ii) Immunizations for individuals age six and older, as recommended by the CDC.</P>
            <P>(iii) Rabies shots.</P>
            <P>(iv) Tetanus shot following an accidental injury.</P>
            <P>(v) Rh immune globulin.</P>
            <P>(vi) Genetic tests as specified in paragraph (e)(3)(ii) of this section.</P>
            <P>(vii) Immunizations and physical examinations provided when required in the case of dependents of active duty military personnel who are traveling outside the United States as a result of an active duty member's assignment and such travel is being performed under orders issued by a Uniformed Service.</P>
            <P>(viii) Screening mammography for asymptomatic women 40 years of age and older, and for high risk women 35 years of age and older, when provided under the terms and conditions contained in the guidelines adopted by the Deputy Assistant Secretary of Defense, Health Services Financing.</P>
            <P>(ix) Cancer screening Papanicolaou (PAP) test for women who are at risk for sexually transmissible diseases, women who have or have had multiple sexual partners (or if their partner has or has had multiple sexual partners), women who smoke cigarettes, and women 18 years of age and older when provided under the terms and conditions contained in the guidelines adopted by the Deputy Assistant Secretary of Defense, Health Services Financing.</P>
            <P>(x) Other cancer screenings authorized by 10 U.S.C. 1079.</P>

            <P>(xi) Health promotion and disease prevention visits (which may include all of the services provided pursuant to <PRTPAGE P="126"/>§ 199.18(b)(2)) may be provided in connection with immunizations and cancer screening examinations authorized by paragraphs (g)(37)(ii) of this section or (g)(37)(viii) through (x) of this section.</P>
            <P>(38) <E T="03">Chiropractors and naturopaths.</E> Services of chiropractors and naturopaths whether or not such services would be eligible for benefits if rendered by an authorized provider.</P>
            <P>(39) <E T="03">Counseling.</E> Counseling services that are not medically necessary in the treatment of a diagnosed medical condition: For example, educational counseling, vocational counseling, nutritional counseling, and counseling for socioeconomic purposes, diabetic self-education programs, stress management, lifestyle modification, etc. Services provided by a certified marriage and family therapist, pastoral or mental health counselor in the treatment of a mental disorder are covered only as specifically provided in § 199.6. Services provided by alcoholism rehabilitation counselors are covered only when rendered in a CHAMPUS-authorized treatment setting and only when the cost of those services is included in the facility's CHAMPUS-determined allowable cost rate.</P>
            <P>(40) <E T="03">Acupuncture.</E> Acupuncture, whether used as a therapeutic agent or as an anesthetic.</P>
            <P>(41) <E T="03">Hair transplants, wigs, or hairpieces.</E>
            </P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>In accordance with section 744 of the DoD Appropriation Act for 1981 (Pub. L. 96-527), CHAMPUS coverage for wigs or hairpieces is permitted effective December 15, 1980, under the conditions listed below. Continued availability of benefits will depend on the language of the annual DoD Appropriation Acts.</P>
            </NOTE>
            <P>(i) <E T="03">Benefits provided.</E> Benefits may be extended, in accordance with the CHAMPUS-determined allowable charge, for one wig or hairpiece per beneficiary (lifetime maximum) when the attending physician certifies that alopecia has resulted from treatment of a malignant disease and the beneficiary certifies that a wig or hairpiece has not been obtained previously through the U.S. Government (including the Veterans Administration).</P>
            <P>(ii) <E T="03">Exclusions.</E> The wig or hairpiece benefit does not include coverage for the following:</P>
            <P>(A) Alopecia resulting from conditions other than treatment of malignant disease.</P>
            <P>(B) Maintenance, wig or hairpiece supplies, or replacement of the wig or hairpiece.</P>
            <P>(C) Hair transplants or any other surgical procedure involving the attachment of hair or a wig or hairpiece to the scalp.</P>
            <P>(D) Any diagnostic or therapeutic method or supply intended to encourage hair regrowth.</P>
            <P>(42) <E T="03">Education or training.</E> Self-help, academic education or vocational training services and supplies, unless the provisions of § 199.4, paragraph (b)(1)(v) relating to general or special education, apply.</P>
            <P>(43) <E T="03">Exercise/relaxation/comfort devices.</E> Exercise equipment, spas, whirlpools, hot tubs, swimming pools, health club membership or other such charges or items.</P>
            <P>(44) <E T="03">Exercise.</E> General exercise programs, even if recommended by a physician and regardless of whether or not rendered by an authorized provider. In addition, passive exercises and range of motion exercises also are excluded, except when prescribed by a physician and rendered by a physical therapist concurrent to, and as an integral part of, a comprehensive program of physical therapy.</P>
            <P>(45) <E T="03">Audiologist, speech therapist.</E> Services of an audiologist or speech therapist, except when prescribed by a physician and rendered as a part of treatment addressed to the physical defect itself and not to any educational or occupational deficit.</P>
            <P>(46) <E T="03">Vision care.</E> Eye exercises or visual training (orthoptics).</P>
            <P>(47) <E T="03">Eye and hearing examinations.</E> Eye and hearing examinations except as specifically provided in paragraphs (c)(2)(xvi) and (c)(3)(xi) of this section, or except when rendered in connection with medical or surgical treatment of a covered illness or injury.</P>
            <P>(48) <E T="03">Prosthetic devices.</E> Prostheses, except artificial limbs, voice prostheses, eyes, or if an item is inserted surgically in the body as an integral part of a surgical procedure. All dental prostheses are excluded, except for those specially required in connection with otherwise covered orthodontia directly <PRTPAGE P="127"/>related to the surgical correction of a cleft palate anomaly.</P>
            <P>(49) <E T="03">Orthopedic shoes.</E> Orthopedic shoes, arch supports, shoe inserts, and other supportive devices for the feet, including special-ordered, custom-made built-up shoes, or regular shoes later built up.</P>
            <P>(50) <E T="03">Eyeglasses.</E> Eyeglasses, spectacles, contact lenses, or other optical devices, except as specifically provided under paragraph (e)(6) of this section.</P>
            <P>(51) <E T="03">Hearing aids.</E> Hearing aids or other auditory sensory enhancing devices.</P>
            <P>(52) <E T="03">Telephone services.</E> Services or advice rendered by telephone are excluded, except that a diagnostic or monitoring procedure which incorporates electronic transmission of data or remote detection and measurement of a condition, activity, or function (biotelemetry) is not excluded when:</P>
            <P>(i) The procedure without electronic transmission of data or biotelemetry is otherwise an explicit or derived benefit of this section; and</P>
            <P>(ii) The addition of electronic transmission of data or biotelemetry to the procedure is found by the Director, CHAMPUS, or designee, to be medically necessary and appropriate medical care which usually improves the efficiency of the management of a clinical condition in defined circumstances; and</P>
            <P>(iii) That each data transmission or biotelemetry device incorporated into a procedure that is otherwise an explicit or derived benefit of this section, has been classified by the U.S. Food and Drug Administration, either separately or as a part of a system, for use consistent with the defined circumstances in paragraph (g)(52)(ii) of this section.</P>
            <P>(53) <E T="03">Air conditioners, humidifiers, dehumidifiers, and purifiers.</E>
            </P>
            <P>(54) <E T="03">Elevators or chair lifts.</E>
            </P>
            <P>(55) <E T="03">Alterations.</E> Alterations to living spaces or permanent features attached thereto, even when necessary to accommodate installation of covered durable medical equipment or to facilitate entrance or exit.</P>
            <P>(56) <E T="03">Clothing.</E> Items of clothing or shoes, even if required by virtue of an allergy (such as cotton fabric as against synthetic fabric and vegetable-dyed shoes).</P>
            <P>(57) <E T="03">Food, food substitutes.</E> Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care.</P>
            <P>(58) <E T="03">Enuresis.</E> Enuretic devices; enuretic conditioning programs.</P>
            <P>(59) [Reserved]</P>
            <P>(60) <E T="03">Autopsy and postmortem.</E>
            </P>
            <P>(61) <E T="03">Camping.</E> All camping even though organized for a specific therapeutic purpose (such as diabetic camp or a camp for emotionally disturbed children), and even though offered as a part of an otherwise covered treatment plan or offered through a CHAMPUS-approved facility.</P>
            <P>(62) <E T="03">Housekeeper, companion.</E> Housekeeping, homemaker, or attendant services; sitter or companion.</P>
            <P>(63) <E T="03">Noncovered condition, unauthorized provider.</E> All services and supplies (including inpatient institutional costs) related to a noncovered condition or treatment, or provided by an unauthorized provider.</P>
            <P>(64) <E T="03">Comfort or convenience.</E> Personal, comfort, or convenience items such as beauty and barber services, radio, television, and telephone.</P>
            <P>(65) <E T="03">“Stop smoking” programs.</E> Services and supplies related to “stop smoking” regimens.</P>
            <P>(66) <E T="03">Megavitamin psychiatric therapy, orthomolecular psychiatric therapy</E>.</P>
            <P>(67) <E T="03">Transportation.</E> All transportation except by ambulance, as specifically provided under paragraph (d), and except as authorized in paragraph (e)(5) of this section.</P>
            <P>(68) <E T="03">Travel.</E> All travel even though prescribed by a physician and even if its purpose is to obtain medical care, except as specified in paragraph (a)(6) of this section in connection with a CHAMPUS-required physical examination.</P>
            <P>(69) <E T="03">Institutions.</E> Services and supplies provided by other than a hospital, unless the institution has been approved specifically by OCHAMPUS. Nursing homes, intermediate care facilities, halfway houses, homes for the aged, or institutions of similar purpose are excluded from consideration as approved facilities under the Basic Program.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>In order to be approved under CHAMPUS, an institution must, in addition to meeting CHAMPUS standards, provide a <PRTPAGE P="128"/>level of care for which CHAMPUS benefits are payable.</P>
            </NOTE>
            <P>(70)-(71) [Reserved]</P>
            <P>(72) <E T="03">Inpatient mental health services.</E> Effective for care received on or after October 1, 1991, services in excess of 30 days in any fiscal year (or in an admission), in the case of a patient nineteen years of age or older, 45 days in any fiscal year (or in an admission) in the case of a patient under 19 years of age, or 150 days in any fiscal year (or in an admission) in the case of inpatient mental health services provided as residential treatment care, unless coverage for such services is granted by a waiver by the Director, OCHAMPUS, or a designee. In cases involving the day limitations, waivers shall be handled in accordance with paragraphs (b)(8) or (b)(9) of this section. For services prior to October 1, 1991, services in excess of 60 days in any calendar year unless additional coverage is granted by the Director, OCHAMPUS, or a designee.</P>
            <P>(73) <E T="03">Economic interest in connection with mental health admissions.</E> Inpatient mental health services (including both acute care and RTC services) are excluded for care received when a patient is referred to a provider of such services by a physician (or other health care professional with authority to admit) who has an economic interest in the facility to which the patient is referred, unless a waiver is granted. Requests for waiver shall be considered under the same procedure and based on the same criteria as used for obtaining preadmission authorization (or continued stay authorization for emergency admissions), with the only additional requirement being that the economic interest be disclosed as part of the request. The same reconsideration and appeals procedures that apply to day limit waivers shall also apply to decisions regarding requested waivers of the economic interest exclusion. However, a provider may appeal a reconsidered determination that an economic relationship constitutes an economic interest within the scope of the exclusion to the same extent that a provider may appeal determinations under § 199.15(i)(3). This exclusion does not apply to services under the Program for Persons with Disabilities (§ 199.5) or provided as partial hospital care. If a situation arises where a decision is made to exclude CHAMPUS payment solely on the basis of the provider's economic interest, the normal CHAMPUS appeals process will be available.</P>
            <P>(74) <E T="03">Not specifically listed.</E> Services and supplies not specifically listed as a benefit in this part. This exclusion is not intended to preclude extending benefits for those services or supplies specifically determined to be covered within the intent of this part by the Director, OCHAMPUS, or a designee, even though not otherwise listed.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The fact that a physician may prescribe, order, recommend, or approve a service or supply does not, of itself, make it medically necessary or make the charge an allowable expense, even though it is not listed specifically as an exclusion.</P>
            </NOTE>
            <P>(h) <E T="03">Payment and liability for certain potentially excludable services under the Peer Review Organization program</E>—(1) <E T="03">Applicability.</E> This subsection provides special rules that apply only to services retrospectively determined under the Peer Review organization (PRO) program (operated pursuant to § 199.15) to be potentially excludable (in whole or in part) from the basic program under paragraph (g) of this section. Services may be excluded by reason of being not medically necessary (paragraph (g)(1) of this section), at an inappropriate level (paragraph (g)(3) of this section), custodial care (paragraph (g)(7) of this section) or other reason relative to reasonableness, necessity or appropriateness (which services shall throughout the remainder of this subsection, be referred to as “not medically necessary”). (Also throughout the remainder of the subsection, “services” includes items and “provider” includes supplier). This paragraph does not apply to coverage determinations made by OCHAMPUS or the fiscal intermediaries which are not based on medical necessity determinations made under the PRO program.</P>
            <P>(2) <E T="03">Payment for certain potentially excludable expenses.</E> Services determined under the PRO program to be potentially excludable by reason of the exclusions in paragraph (g) of this section for not medically necessary services will not be determined to be excludable if neither the beneficiary to whom the services were provided nor the provider <PRTPAGE P="129"/>(institutional or individual) who furnished the services knew, or could reasonably have been expected to know, that the services were subject to those exclusions. Payment may be made for such services as if the exclusions did not apply.</P>
            <P>(3) <E T="03">Liability for certain excludable services.</E> In any case in which items or services are determined excludable by the PRO program by reason of being not medically necessary and payment may not be made under paragraph (h)(2) of this section because the requirements of paragraph (h)(2) of this section are not met, the beneficiary may not be held liable (and shall be entitled to a full refund from the provider of the amount excluded and any cost share amount already paid) if:</P>
            <P>(i) The beneficiary did not know and could not reasonably have been expected to know that the services were excludable by reason of being not medically necessary; and</P>
            <P>(ii) The provider knew or could reasonably have been expected to know that the items or services were excludable by reason of being not medically necessary.</P>
            <P>(4) <E T="03">Criteria for determining that beneficiary knew or could reasonably have been expected to have known that services were excludable.</E> A beneficiary who receives services excludable by reason of being not medically necessary will be found to have known that the services were excludable if the beneficiary has been given written notice that the services were excludable or that similar or comparable services provided on a previous occasion were excludable and that notice was given by the OCHAMPUS, CHAMPUS PRO or fiscal intermediary, a group or committee responsible for utilization review for the provider, or the provider who provided the services.</P>
            <P>(5) <E T="03">Criteria for determining that provider knew or could reasonably have been expected to have known that services were excludable.</E> An institutional or individual provider will be found to have known or been reasonably expected to have known that services were excludable under this subsection under any one of the following circumstances:</P>
            <P>(i) The PRO or fiscal intermediary had informed the provider that the services provided were excludable or that similar or reasonably comparable services were excludable.</P>
            <P>(ii) The utilization review group or committee for an institutional provider or the beneficiary's attending physician had informed the provider that the services provided were excludable.</P>
            <P>(iii) The provider had informed the beneficiary that the services were excludable.</P>
            <P>(iv) The provider had received written materials, including notices, manual issuances, bulletins, guides, directives or other materials, providing notification of PRO screening criteria specific to the condition of the beneficiary. Attending physicians who are members of the medical staff of an institutional provider will be found to have also received written materials provided to the institutional provider.</P>
            <P>(v) The services that are at issue are the subject of what are generally considered acceptable standards of practice by the local medical community.</P>
            <P>(vi) Preadmission authorization was available but not requested, or concurrent review requirements were not followed.</P>
            <P>(i) <E T="03">Case management program.</E> (1) <E T="03">In general.</E> Case management, as it applies to this program, provides a collaborative process among the case manager, beneficiary, primary caregiver, professional health care providers and funding sources to meet the medical needs of an individual with an extraordinary condition. It is designed to promote quality and cost-effective outcomes through assessment, planning, implementing, monitoring and evaluating the options and services required. Payment for services or supplies limited or not otherwise covered by the basic TRICARE/CHAMPUS program may be authorized when they are provided in accordance with paragraph (i) of this section. Waiver of benefit limits/exclusions may be cost-shared where it is demonstrated that the absence of such services would result in the exacerbation of an existing extraordinary condition, as defined in § 199.2, to the extent that such services are a cost-effective alternative to the basic TRICARE/CHAMPUS program.<PRTPAGE P="130"/>
            </P>
            <P>(2) <E T="03">Applicability of case management program.</E> A CHAMPUS eligible beneficiary may participate in the case management program if he/she has an extraordinary condition, which is disabling and requires extensive utilization of TRICARE resources. The medical or psychological condition must also:</P>
            <P>(i) Be contained in the latest revision of the International Classification of Diseases Clinical Modification, or the Diagnostic and Statistical Manual of Mental Disorders;</P>
            <P>(ii) Meet at least one of the following:</P>
            <P>(A) Demonstrate a prior history of high CHAMPUS costs in the year immediately preceding eligibility for the case management program; or</P>
            <P>(B) Require clinically appropriate services or supplies from multiple providers to address an extraordinary condition; and</P>
            <P>(iii) Can be treated more appropriately and cost effectively at a less intensive level of care.</P>
            <P>(3) <E T="03">Prior authorization required.</E> Services or supplies allowable as a benefit exception under this Section shall be cost-shared only when a beneficiary's entire treatment has received prior authorization through an individual case management program.</P>
            <P>(4) <E T="03">Cost effective requirement.</E> Treatment must be determined to be cost effective by comparison to alternative treatment that would otherwise be required or when compared to existing reimbursement methodology. Treatment must meet the requirements of appropriate medical care as defined in § 199.2.</P>
            <P>(5) <E T="03">Limited waiver of exclusions and limitations.</E> Limited waivers of exclusions and limitations normally applicable to the basic program may be granted for specific services or supplies only when a beneficiary's entire treatment has received prior authorization through the individual case management program described in paragraph (i) of this section. The Director, OCHAMPUS may grant a patient-specific waiver of benefit limits for services or supplies in the following categories, subject to the waiver requirements of this section.</P>
            <P>(i) <E T="03">Durable equipment.</E> The cost of a device or apparatus which does not qualify as Durable Medical Equipment (as defined in § 199.2) or back-up durable medical equipment may be shared when determined by the Director, OCHAMPUS to be cost-effective and clinically appropriate.</P>
            <P>(ii) <E T="03">Custodial care.</E> The cost of services or supplies rendered to a beneficiary that would otherwise be excluded as custodial care (as defined in § 199.2) may be cost-shared for a maximum lifetime period of 365 days when determined by the Director, OCHAMPUS, to be cost effective and clinically appropriate. To qualify for a waiver of benefit limits of custodial care, the patient must meet all eligibility requirements of paragraph (i) of this section, including that the absence of the waived services would result in the exacerbation of an existing extraordinary condition. In addition:</P>
            <P>(A) The proposed treatment must be cost effective and clinically appropriate as determined by the individual case manager. For example, the treatment would be determined to be cost effective by comparison to alternative care that would otherwise be required or when compared to existing reimbursement methodology.</P>
            <P>(B) For patients receiving care at home, there must be a primary caregiver or the patient is capable of self-support.</P>
            <P>(iii) <E T="03">Domiciliary care.</E> The cost of services or supplies rendered to be a beneficiary what would otherwise be excluded as domiciliary care (as defined in § 199.2) may be shared when determined by the Director, OCHAMPUS to be cost effective and clinically appropriate. Waivers for domiciliary care are subject to the same requirements as paragraphs (i)(5)(ii) of this section.</P>
            <P>(iv) <E T="03">In home services.</E> The cost of the following in-home services may be shared when determined by the Director, OCHAMPUS to be cost effective and clinically appropriate: nursing care, physical, occupational, speech therapy, medical social services, intermittent or part-time services of a <PRTPAGE P="131"/>home health aide, beneficiary transportation required for treatment plan implementation, and training for the beneficiary and primary caregiver sufficient to allow them to assume all feasible responsibility for the care of the beneficiary that will facilitate movement of the beneficiary to the least resource-intensive, clinically appropriate setting. (Qualifications for home health aides shall be based on the standards at 42 CFR 848.36.)</P>
            <P>(6) <E T="03">Case management acknowledgment.</E> The beneficiary, or representative, and the primary caregiver shall sign a case management acknowledgment as a prerequisite to prior authorization of case management services. The acknowledgment shall include, in part, all of the following provisions:</P>
            <P>(i) The right to participate fully in the development and ongoing assessment of the treatment;</P>
            <P>(ii) That all health care services for which TRICARE/CHAMPUS cost sharing is sought shall be authorized by the case manager prior to their delivery;</P>
            <P>(iii) That there are limitations in scope and duration of the planned case management treatment, including provisions to transition to other arrangements; and</P>
            <P>(iv) The conditions under which case management services are provided, including the requirement that the services must be cost effective and clinically appropriate;</P>
            <P>(v) That a beneficiary's participation in the case management program shall be discontinued for any of the following reasons:</P>
            <P>(A) The loss of TRICARE/CHAMPUS eligibility;</P>
            <P>(B) A determination that the services or supplies provided are not cost effective or clinically appropriate;</P>
            <P>(C) The beneficiary, or representative, and/or primary caregiver, terminates participation in writing;</P>
            <P>(D) The beneficiary and/or primary caregiver's failure to comply with requirements in this paragraph (i); or</P>
            <P>(E) A determination that the beneficiary's condition no longer meets the requirements of participation as described in paragraph (i) of this section.</P>
            <P>(7) <E T="03">Other administrative requirements.</E> (i) Qualified providers of services or items not covered under the basic program, or who are not otherwise eligible for TRICARE/CHAMPUS authorized status, may be authorized for a time-limited period when such authorization is essential to implement the planned treatment under case management. Such providers must not be excluded or suspended as a CHAMPUS provider, must hold Medicare or state certification or licensure appropriate to the service, and must agree to participate on all claims related to the case management treatment.</P>
            <P>(ii) Retrospective requests for authorization of waiver of benefit limits/exclusions will not be considered. Authorization of waiver of benefit limits/exclusions is allowed only after all other options for services or supplies have been considered and either appropriately utilized or determined to be clinically inappropriate and/or not cost-effective.</P>
            <P>(iii) Experimental or investigational treatment or procedures shall not be cost-shared as an exception to standard benefits under this part.</P>
            <P>(iv) TRICARE/CHAMPUS case management services may be provided by contractors designated by the Director, OCHAMPUS.</P>
            <CITA>[51 FR 24008, July 1, 1986]</CITA>
            <EDNOTE>
              <HD SOURCE="HED">Editorial Notes:</HD>
              <P>For <E T="04">Federal Register</E> citations affecting § 199.4, see the List of CFR Sections Affected in the Finding Aids section of this volume.</P>
            </EDNOTE>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.5</SECTNO>
            <SUBJECT>Program for Persons with Disabilities (PFPWD).</SUBJECT>
            <P>(a) <E T="03">General.</E> This PFPWD provides financial assistance for certain CHAMPUS beneficiaries who are moderately or severely mentally retarded, or seriously physically disabled. The PFPWD is not intended to be a stand alone benefit.</P>
            <P>(1) <E T="03">Purpose.</E> The primary purpose of the PFPWD is to assist in reducing the disabling effects of a PFPWD qualifying condition.</P>
            <P>(2) <E T="03">Benefit source election.</E> A PFPWD beneficiary (or sponsor or guardian acting on behalf of the beneficiary) may elect to use the provisions of either this section, or the provisions of § 199.4, for a specific service or item which is allowable by both sections.</P>
            <P>(i) <E T="03">Election limitation.</E> No amount for authorized, or otherwise allowed, <PRTPAGE P="132"/>PFPWD services or items remaining after the maximum PFPWD benefit dollar amount has been reached in a given month may be cost-shared through the provisions of § 199.4.</P>
            <P>(ii) <E T="03">Election change.</E> A beneficiary (or sponsor or guardian acting on behalf of the beneficiary) shall have the right to request the Director, OCHAMPUS, or designee, to allow PFPWD cost-shared services or items otherwise allowable as a benefit of § 199.4, and which were rendered after the catastrophic loss protection provision applicable to § 199.4 was in effect for a given PFPWD beneficiary's sponsor, to be readjudicated according to the provisions of § 199.4. The Director, OCHAMPUS, or designee, shall allow readjudication when the sponsor's family's CHAMPUS benefit year cost-share liability would be reduced by such readjudication. Such requests are subject to the claims filing deadline provisions of § 199.7. The determination regarding readjudication is conclusive and may not be appealed.</P>
            <P>(3) <E T="03">Application required.</E> A beneficiary shall establish PFPWD eligibility as a prerequisite to authorization or payment of any PFPWD benefits. Subsequent review of the PFPWD qualifying condition to confirm continued eligibility shall be made in accordance with the prognosis for a change in severity such that the condition would not likely continue to be a PFPWD qualifying condition.</P>
            <P>(4) <E T="03">Benefit authorization.</E> To establish whether a requested service or item is a PFPWD benefit, the beneficiary (or sponsor or guardian acting on the behalf of the beneficiary) shall provide such information about how the requested benefit will contribute to confirming, arresting, or reducing the disabling effects of the qualifying condition as the Director, OCHAMPUS, or designee, determines necessary for benefit adjudication.</P>
            <P>(i) <E T="03">Written authorization.</E> The Director, OCHAMPUS, or designee, may require written authorization for any PFPWD category or type of service or item as a prerequisite for adjudication of related claims.</P>
            <P>(ii) <E T="03">Format.</E> An authorization issued by the Director, OCHAMPUS, or designee, shall specify, such description, dates, amounts, requirements, limitations or information as necessary for exact identification of approved benefits and efficient adjudication of resulting claims.</P>
            <P>(iii) <E T="03">Valid period.</E> An authorization for a particular PFPWD service or item shall not exceed six consecutive months.</P>
            <P>(iv) <E T="03">Authorization waiver.</E> The Director, OCHAMPUS, or designee, shall waive the requirement for a written CHAMPUS authorization for rendered PFPWD services or items that, except for the absence of the written CHAMPUS authorization, would be allowable as a PFPWD benefit.</P>
            <P>(v) <E T="03">Public facility use.</E> A PFPWD beneficiary residing within a State, as defined in § 199.2, must demonstrate that a public facility, as defined in § 199.2, funds, except funds administered under a State plan for medical assistance under Title XIX of the Social Security Act (Medicaid) is not available or adequate, as defined in § 199.2, to meet the qualifying condition related need.</P>
            <P>(A) Equipment repair or maintenance for beneficiary owned equipment shall be considered not available when the equipment is a type allowable as a benefit.</P>
            <P>(B) A beneficiary shall not be required to change the provider of public facility funded therapy when public facility funding is depleted during that beneficiary's course of therapy and when such a change is determined by the Director, OCHAMPUS, or designee, to be clinically contraindicated. When contraindicated, other public facilities for the therapy shall not be considered adequate for the beneficiary.</P>
            <P>(5) <E T="03">Public facility use certification.</E> Written certification, in accord with information requirements, formats, and procedures established by the Director, OCHAMPUS, or designee that requested PFPWD services or items cannot be obtained from public facilities because the services or items are not available, or if available, are not adequate, is a prerequisite for PFPWD benefit payment.</P>

            <P>(i) A Military Treatment Facility (MTF) Commander, or designee, may make such certification for a beneficiary residing within a defined geographic area.<PRTPAGE P="133"/>
            </P>
            <P>(ii) An administrator of a public facility, or designee, may make such certification for a beneficiary residing within the service area of that public facility.</P>
            <P>(iii) The domicile of the beneficiary shall be the basis for the determination of public facility availability when the sponsor and beneficiary are separately domiciled due to the sponsor's move to a new permanent duty station or due to legal custody requirements.</P>
            <P>(iv) The Director, OCHAMPUS, or designee, may determine, on a case-by-case basis, that apparent public facility availability for a requested type of service or item can not be substantiated for a specific beneficiary's request for PFPWD benefits and is not available.</P>
            <P>(A) A case-specific determination shall be shall be based upon a written statement by the beneficiary (or sponsor or guardian acting on behalf of the beneficiary) which details the circumstances wherein a specific individual representing a specific public facility refused to provide a public facility use certification, and such other information as the Director, OCHAMPUS, or designee determines to be material to the determination.</P>
            <P>(B) A case-specific determination of public facility availability by the Director, OCHAMPUS, or designee, is conclusive, and is not appealable.</P>
            <P>(6) <E T="03">Equipment.</E> (i) An item of equipment shall not be authorized when such authorization would allow concurrent PFPWD cost-sharing of more than one item of the same type of equipment for the same beneficiary.</P>
            <P>(ii) Reasonable repairs and maintenance shall be allowable for any beneficiary owned equipment otherwise allowable by this section.</P>
            <P>(7) <E T="03">Implementing instructions.</E> The Director, OCHAMPUS, or designee shall issue policies, instructions, procedures, guidelines, standards, and criteria necessary to assure the quality and efficiency of services and items furnished as a PFPWD benefit and to otherwise accomplish the purpose of the PFPWD.</P>
            <P>(i) <E T="03">Other requirements.</E> All provisions of this part, except the provisions of § 199.4, apply to the PFPWD unless otherwise provided by this section.</P>
            <P>(ii) <E T="03">Continuity of eligibility.</E> A CHAMPUS beneficiary who has an outstanding Program for the Handicapped (PFTH) benefit authorization during the 30 calendar day period immediately prior to the effective date of the Program for Persons with Disabilities (PFPWD) shall be deemed to have a PFPWD qualifying condition for the duration of the period during which the beneficiary is otherwise eligible for PFPWD and the beneficiary continues to meet the applicable PFTH qualifying condition criteria.</P>
            <P>(b) <E T="03">Eligibility</E>—(1) <E T="03">Spouse or child.</E> PFPWD benefits are limited to a CHAMPUS eligible child or spouse, but not a former spouse, except as provided in paragraph (b)(1)(ii) of this section, of:</P>
            <P>(i) <E T="03">Active duty sponsor.</E> An active duty member of one of the Uniformed Services as determined in accordance with the provisions of § 199.3; or</P>
            <P>(ii) <E T="03">Former member sponsor.</E> After November 13, 1986, a former member of a Uniformed Service, when the qualifying condition is the result of, or has been exacerbated by, an injury or illness resulting from physical or emotional abuse; or</P>
            <P>(iii) <E T="03">Deceased sponsor.</E> A CHAMPUS beneficiary remains eligible for benefits under the PFPWD:</P>
            <P>(A) For a period of one calendar year from the date an active duty sponsor dies; or</P>
            <P>(B) Through midnight of the beneficiary's twenty-first birthday when the beneficiary is receiving PFPWD benefits at the time the active duty sponsor dies and the sponsor was eligible, at the time of death, for receipt of hostile-fire pay or died as a result of a disease or injury incurred while eligible for such pay.</P>
            <P>(2) <E T="03">Loss of PFPWD eligibility.</E> Eligibility for PFPWD benefits ceases as of 12.:01 a.m. of the day following the day that:</P>
            <P>(i) The sponsor ceases to be an active duty member for any reason other than death; or</P>
            <P>(ii) Eligibility based upon the abused dependent provisions of paragraph (b)(1) of this section expires; or</P>

            <P>(iii) Eligibility based upon the deceased sponsor provisions of paragraph (b)(1) of this section expires; or<PRTPAGE P="134"/>
            </P>
            <P>(iv) The Director, OCHAMPUS, or designee, determines that the beneficiary no longer has a qualifying condition.</P>
            <P>(3) <E T="03">Qualifying condition</E>—(i) <E T="03">Mental retardation.</E> A diagnosis of moderate or severe mental retardation made in accordance with the criteria of the current edition of the “Diagnostic and Statistical Manual of Mental Disorders” published by the American Psychiatric Association is a PFPWD qualifying condition.</P>
            <P>(ii)<E T="03">Serious physical disability</E>. A serious physical disability as defined in § 199.2, is a PFPWD qualifying condition.</P>
            <P>(iii) <E T="03">Infant/toddler.</E> For CHAMPUS beneficiaries under the age of three years with a diagnosed neuromuscular developmental condition or Down syndrome, or other condition that can to a reasonable medical probability be expected to precede a diagnosis of moderate or severe mental retardation or be characterized as a serious physical disability before the age of seven, the Director, OCHAMPUS, or designee, shall establish criteria for PFPWD eligibility in lieu of the requirements of paragraph (b)(3)(i) or paragraph (b)(3)(ii) of this section.</P>
            <P>(iv) <E T="03">Multiple disabilities.</E> The cumulative disabling effect shall be used in the adjudication of a qualifying condition determination when an applicant has two or more disabilities involving separate body systems.</P>
            <P>(c) <E T="03">Benefit.</E> Items or services which the Director, OCHAMPUS, or designee, has determined to be intrinsic to the following benefit categories and has determined to be capable of confirming, arresting, or reducing the severity of the disabling effects of a qualifying condition, generally or in a specific case, and which are not otherwise excluded by this PFPWD, may be allowed.</P>
            <P>(1) <E T="03">Diagnostic procedures</E> to establish a qualifying condition diagnosis or to measure the extent of functional loss.</P>
            <P>(2) <E T="03">Treatment</E> through the use of such medical, habilitative, or rehabilitative methods, techniques, therapies and equipment which otherwise meet the requirements of this PFPWD. Treatment includes, but is not limited to, prosthetic devices, orthopedic braces, and orthopedic appliances. Otherwise allowable treatment may be rendered in-home, or as inpatient or outpatient care as appropriate.</P>
            <P>(3) <E T="03">Training</E> when required to allow the use of an assistive technology device or to acquire skills which are expected to assist the beneficiary to reduce the disabling effects of a qualifying condition and for parents (or guardian) and siblings of a PFPWD beneficiary when required as an integral part of the management of the qualifying condition.</P>
            <P>(4) <E T="03">Special education instruction,</E> other than training specifically designed to accommodate the disabling effects of a qualifying condition.</P>
            <P>(5) <E T="03">Institutional care</E> within a State, as defined in § 199.2, when the severity of the qualifying condition requires protective custody or training in a residential environment.</P>
            <P>(6) <E T="03">Transportation</E> when required to convey the PFPWD beneficiary to or from a facility or institution to receive otherwise allowable services or items. Transportation for a medical attendant may be approved when medically necessary for the safe transport of the PFPWD eligible beneficiary.</P>
            <P>(7) <E T="03">Adjunct services</E>—(i) <E T="03">Assistive services.</E> Services of a qualified interpreter or translator for PFPWD beneficiaries who are deaf, readers for PFPWD beneficiaries who are blind, and personal assistants for PFPWD beneficiaries with other types of qualifying conditions, when such services are not directly related to the rendering or delivery of service or item otherwise an allowable PFPWD benefit.</P>
            <P>(ii) <E T="03">Equipment adaptation.</E> The allowable equipment purchase shall encompass such services and structural modification to the equipment as necessary to make the equipment serviceable for a particular disability.</P>
            <P>(iii) <E T="03">Equipment maintenance.</E> Reasonable repairs and maintenance for that portion of the useful life of beneficiary owned equipment that is concurrent with the beneficiary's PFPWD eligibility.</P>
            <P>(d) <E T="03">Exclusions—</E>(1) <E T="03">Inpatient acute care</E> for medical or surgical treatment of an acute illness, or of an acute exacerbation of the qualifying condition, is excluded.<PRTPAGE P="135"/>
            </P>
            <P>(2) <E T="03">Structural alterations</E> to living space and permanent fixtures attached thereto, including alterations necessary to accommodate installation of equipment, or to facilitate entrance or exit, are excluded.</P>
            <P>(3) <E T="03">Homemaker, sitter, or companion services,</E> except as institutional care of adjunct services, which predominantly provide assistance with daily living activities or accomplish household chores or provide companionship or provide supervision or observation, or any combination of these functions, are excluded.</P>
            <P>(4) <E T="03">Dental care or orthodontic treatment</E> is excluded.</P>
            <P>(5) <E T="03">Nondomestic travel</E> which originates or terminates outside of a State, as defined in § 199.2, is excluded.</P>
            <P>(6) <E T="03">Deluxe travel accommodation</E> price differential between the price for a type of accommodation which provides services or features which exceed the requirements of the beneficiary's condition for safe transport and the price for a type of accommodation without those deluxe features, is excluded.</P>
            <P>(7) <E T="03">Equipment.</E> Exclusions for durable medical equipment at § 199.4(d)(3)(ii)(D) apply to all PFPWD allowable equipment.</P>
            <P>(8) <E T="03">Medical devices.</E> Prosthetic devices and medical equipment which do not meet the benefit requirements of § 199.4 are excluded.</P>
            <P>(9) <E T="03">No obligation to pay.</E> Services or items for which the beneficiary or sponsor has no legal obligation to pay, or for which no charge would be made if the beneficiary was not eligible for the CHAMPUS, are excluded.</P>
            <P>(10) <E T="03">Public facility or Federal government.</E> Services or items paid for, or eligible for payment, directly or indirectly by a Public Facility, as defined in § 199.2, or by the Federal government, other than the Department of Defense, are excluded, except when such services or items are eligible for payment under a State plan for medical assistance under Title XIX of the Social Security Act (Medicaid).</P>
            <P>(11) <E T="03">Study, grant, or research programs.</E> Services and items provided as a part of a scientific clinical study, grant, or research program are excluded.</P>
            <P>(12) <E T="03">Unproven drugs, devices, and medical treatments or procedures.</E>  Services and items whose safety and efficacy have not been established as described in § 199.4 are unproven and cannot be cost-shared by CHAMPUS.</P>
            <P>(13) <E T="03">Immediate family or household.</E>  Services or items provided or prescribed by a member of the beneficiary's immediate family, or a person living in the beneficiary's or sponsor's household, are excluded.</P>
            <P>(14) <E T="03">Court or agency ordered care.</E> Services or items ordered by a court or other government agency that are not otherwise a legitimate PFPWD benefit are excluded.</P>
            <P>(15) <E T="03">Excursions.</E> Additional or special charges for excursions, other than otherwise allowable transportation, are excluded even though part of a program offered by an approved provider.</P>
            <P>(16) <E T="03">Drugs and medicines.</E> Drugs and medicines which do not meet the benefit requirements of § 199.4 are excluded.</P>
            <P>(17) <E T="03">Therapeutic absences.</E> Therapeutic absences from an inpatient facility are excluded.</P>
            <P>(e) <E T="03">Cost-share liability—</E>(1) <E T="03">No deductible.</E>  PFPWD benefits are not subject to a deductible amount.</P>
            <P>(2)(i) <E T="03">Sponsor cost-share liability.</E> Regardless of the number of PFPWD eligible family members, the sponsor's cost share for allowed PFPWD benefits in a given month is according to the following table:</P>
            <GPOTABLE CDEF="s25,7" COLS="2" OPTS="L2,i1">
              <BOXHD>
                <CHED H="1">Member's pay grade</CHED>
                <CHED H="1">Monthly share</CHED>
              </BOXHD>
              <ROW>
                <ENT I="01">E-1 through E-5</ENT>
                <ENT>$25</ENT>
              </ROW>
              <ROW>
                <ENT I="01">E-6</ENT>
                <ENT>30</ENT>
              </ROW>
              <ROW>
                <ENT I="01">E-7 and O-1</ENT>
                <ENT>35</ENT>
              </ROW>
              <ROW>
                <ENT I="01">E-8 and O-2</ENT>
                <ENT>40</ENT>
              </ROW>
              <ROW>
                <ENT I="01">E-9, W-1, W-2, and O-3</ENT>
                <ENT>45</ENT>
              </ROW>
              <ROW>
                <ENT I="01">W-3, W-4, and O-4</ENT>
                <ENT>50</ENT>
              </ROW>
              <ROW>
                <ENT I="01">W-5 and O-5</ENT>
                <ENT>65</ENT>
              </ROW>
              <ROW>
                <ENT I="01">O-6</ENT>
                <ENT>75</ENT>
              </ROW>
              <ROW>
                <ENT I="01">O-7</ENT>
                <ENT>100</ENT>
              </ROW>
              <ROW>
                <ENT I="01">O-8</ENT>
                <ENT>150</ENT>
              </ROW>
              <ROW>
                <ENT I="01">O-9</ENT>
                <ENT>200</ENT>
              </ROW>
              <ROW>
                <ENT I="01">O-10</ENT>
                <ENT>250</ENT>
              </ROW>
            </GPOTABLE>

            <P>(ii) The sponsor's cost-share will be applied, up to the amount given in the table in paragraph (e)(2)(i), to the first allowed charges in any given month. The government's share will be paid, up to the maximum amount(s) specified in paragraphs (e)(3) and (e)(4) of this section for allowed charges after the sponsor's cost-share has been applied.<PRTPAGE P="136"/>
            </P>
            <P>(3) <E T="03">Government cost-share liability: member who sponsors one PFPWD beneficiary.</E> The total government share of the cost of all PFPWD benefits provided in a given month to a beneficiary who is the sponsor's only PFPWD eligible family member may not exceed $1,000 after application of the allowable payment methodology. Any amount remaining after the Government's maximum share has been reached is the responsibility of the active duty sponsor.</P>
            <P>(4) <E T="03">Government cost-share liability: member who sponsors more than one PFPWD beneficiary.</E> The total government share of the cost of all PFPWD allowable benefits provided in a given month to a beneficiary  who is one of two or more PFPWD eligible family members of the same sponsor shall be determined as follows:</P>
            <P>(i) <E T="03">Maximum benefit limit determination for the first PFPWD eligible beneficiary.</E> The $1,000 maximum monthly government PFPWD benefit amount shall apply only to the beneficiary incurring the least amount of allowable PFPWD expense in a given month, after application of the allowable payment methodology. If two or more PFPWD eligible beneficiaries have the same amount of allowable PFPWD expenses in a given month, the $1,000 maximum benefit in that month shall apply to only one PFPWD eligible beneficiary.</P>
            <P>(ii) <E T="03">Maximum benefit limit determination for the remaining PFPWD eligible beneficiaries.</E> After application of the Government's cost-share specified in paragraph (e)(4)(i) of this section, the government shall cost-share the entire remaining amount for all allowable services and items received in that month by the remaining PFPWD eligible beneficiaries.</P>
            <P>(f) <E T="03">Benefit payment</E>—(1) <E T="03">Equipment.</E> The allowable amount for equipment shall be calculated in the same manner as durable medical equipment allowable through § 199.4.</P>
            <P>(2) <E T="03">Transportation.</E> The allowable amount for transportation is limited to the actual cost of the standard published fare plus any standard surcharge made to accommodate any person with a similar disability or to the actual cost of specialized medical transportation when nonspecialized transport cannot accommodate the beneficiary's disability related needs, or when specialized transport is more economical than nonspecialized transport. When transport is by private vehicle, the allowable amount is limited to the Federal government employee mileage reimbursement rate in effect on the trip date.</P>
            <P>(3) <E T="03">Proration of equipment expense.</E> The PFPWD beneficiary (or sponsor or guardian acting on the beneficiary's behalf) may, only at the time of the request for authorization of equipment, specify that the allowable cost of the equipment be prorated. Equipment expense proration permits the allowable cost of an item of PFPWD authorized equipment to be apportioned so that no portion of the allowable cost exceeds the monthly benefit limit and allows each apportioned amount to be separately authorized as a benefit during subsequent contiguous months.</P>
            <P>(i) <E T="03">Maximum period.</E> The maximum number of contiguous months during which a prorated amount may be authorized for cost-share shall be the lesser of:</P>
            <P>(A) The number of months calculated by dividing the initial allowable cost for the item of equipment by $1,000 and doubling the resulting quotient; or</P>
            <P>(B) The number of months of useful equipment life for the requesting beneficiary, as determined by the Director, OCHAMPUS, or designee.</P>
            <P>(ii) <E T="03">Cost-share.</E> A cost-share is applicable in any month in which a prorated amount is authorized, subject to the cost-share provisions for a sponsor with two or more PFPWD eligible beneficiaries.</P>
            <P>(iii) <E T="03">Termination.</E> Prorated payments shall be terminated as of the first day of the month following the death of a beneficiary or as of the effective date of a beneficiary's loss of PFPWD eligibility for any other reason.</P>
            <P>(4) <E T="03">For-profit institutional care provider.</E> Institutional care provided by a for-profit entity may be allowed only when the care for a specific PFPWD beneficiary:</P>
            <P>(i) Is contracted for by a public facility, as defined in § 199.2, as a part of a publicly funded long-term inpatient care program; and</P>

            <P>(ii) Is provided based upon the PFPWD beneficiary's being eligible for <PRTPAGE P="137"/>the publicly funded program which has contracted for the care; and</P>
            <P>(iii) Is authorized by the public facility as a part of a publicly funded program; and</P>
            <P>(iv) Would cause a cost-share liability in the absence of CHAMPUS eligibility; and</P>
            <P>(v) Produces a PFPWD beneficiary cost-share liability that does not exceed the maximum charge by the provider to the public facility for the contracted level of care.</P>
            <P>(g) <E T="03">Implementing instructions.</E> The Director, OCHAMPUS, or a designee, shall issue CHAMPUS policies, instructions, procedures, guidelines, standards, and criteria as may be necessary to implement the intent of this section.</P>
            <CITA>[62 FR 35093, June 30, 1997, as amended at 62 FR 42904, Aug. 11, 1997]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.6</SECTNO>
            <SUBJECT>Authorized providers.</SUBJECT>
            <P>(a) <E T="03">General.</E> This section sets forth general policies and procedures that are the basis for the CHAMPUS cost-sharing of medical services and supplies provided by institutions, individuals, or other types of providers. Providers seeking payment from the Federal Government through programs such as CHAMPUS have a duty to familiarize themselves with, and comply with, the program requirements.</P>
            <P>(1) <E T="03">Listing of provider does not guarantee payment of benefits.</E> The fact that a type of provider is listed in this section is not to be construed to mean that CHAMPUS will automatically pay a claim for services or supplies provided by such a provider. The provider who actually furnishes the service(s) must, in fact, meet all licensing and other requirements established by this part to be an authorized provider; the provider must not be the subject of sanction under § 199.9; and, cost-sharing of the services must not otherwise be prohibited by this part. In addition, the patient must in fact be an eligible beneficiary and the services or supplies billed must be authorized and medically necessary, regardless of the standing of the provider.</P>
            <P>(2) <E T="03">Outside the United States or emergency situations within the United States.</E> Outside the United States or within the United States and Puerto Rico in emergency situations, the Director, OCHAMPUS, or a designee, after review of the facts, may provide payment to or on behalf of a beneficiary who receives otherwise covered services or supplies from a provider of service that does not meet the standards described in this part.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Only the Secretary of Defense, the Secretary of Health and Human Services, or the Secretary of Transportation, or their designees, may authorize (in emergency situations) payment to civilian facilities in the United States that are not in compliance with title VI of the Civil Rights Act of 1964. For the purpose of the Civil Rights Act only, the United States includes the 50 states, the District of Columbia, Puerto Rico, Virgin Islands, American Samoa, Guam, Wake Island, Canal Zone, and the territories and possessions of the United States.</P>
            </NOTE>
            <P>(3) <E T="03">Dual Compensation/Conflict of Interest.</E> Title 5, United States Code, section 5536 prohibits medical personnel who are active duty Uniformed Service members or civilian employees of the Government from receiving additional Government compensation above their normal pay and allowances for medical care furnished. In addition, Uniformed Service members and civilian employees of the Government are generally prohibited by law and agency regulations and policies from participating in apparent or actual conflict of interest situations in which a potential for personal gain exists or in which there is an appearance of impropriety or incompatibility with the performance of their official duties or responsibilities. The Departments of Defense, Health and Human Services, and Transportation have a responsibility, when disbursing appropriated funds in the payment of CHAMPUS benefits, to ensure that the laws and regulations are not violated. Therefore, active duty Uniformed Service members (including a reserve member while on active duty and civilian employees of the United States Government shall not be authorized to be CHAMPUS providers. While individual employees of the Government may be able to demonstrate that the furnishing of care to CHAMPUS beneficiaries may not be incompatible with their official duties and responsibilities, the processing of millions of CHAMPUS claims each year does not enable Program administrators to efficiently review the status <PRTPAGE P="138"/>of the provider on each claim to ensure that no conflict of interest or dual compensation situation exists. The problem is further complicated given the numerous interagency agreements (for example, resource sharing arrangements between the Department of Defense and the Veterans Administration in the provision of health care) and other unique arrangements which exist at individual treatment facilities around the country. While an individual provider may be prevented from being an authorized CHAMPUS provider even though no conflict of interest or dual compensation situation exists, it is essential for CHAMPUS to have an easily administered, uniform rule which will ensure compliance with the existing laws and regulations. Therefore, a provider who is an active duty Uniformed Service member or civilian employee of the Government shall not be an authorized CHAMPUS provider. In addition, a provider shall certify on each CHAMPUS claim that he/she is not an active duty Uniformed Service member or civilian employee of the Government.</P>
            <P>(4) [Reserved]</P>
            <P>(5) <E T="03">Utilization review and quality assurance.</E> Providers approved as authorized CHAMPUS providers have certain obligations to provide services and supplies under CHAMPUS which are (i) furnished at the appropriate level and only when and to the extent medically necessary under the criteria of this part; (ii) of a quality that meets professionally recognized standards of health care; and, (iii) supported by adequate medical documentation as may be reasonably required under this part by the Director, OCHAMPUS, or designee, to evidence the medical necessity and quality of services furnished, as well as the appropriateness of the level of care. Therefore, the authorization of CHAMPUS benefits is contingent upon the services and supplies furnished by any provider being subject to pre-payment or post-payment utilization and quality assurance review under professionally recognized standards, norms, and criteria, as well as any standards or criteria issued by the Director, OCHAMPUS, or a designee, pursuant to this part. (Refer to §§ 199.4, 199.5, and 199.7 of this part.)</P>
            <P>(6) <E T="03">Exclusion of beneficiary liability.</E> In connection with certain utilization review, quality assurance and preauthorization requirements of section 199.4 of this part, providers may not hold patients liable for payment for certain services for which CHAMPUS payment is disallowed. With respect to such services, providers may not seek payment from the patient or the patient's family. Any such effort to seek payment is a basis for termination of the provider's authorized status.</P>
            <P>(7) <E T="03">Provider required.</E> In order to be considered for benefits, all services and supplies shall be rendered by, prescribed by, or furnished at the direction of, or on the order of a CHAMPUS-authorized provider practicing within the scope of his or her license.</P>
            <P>(8) <E T="03">Participating providers.</E> A CHAMPUS-authorized provider is a participating provider, as defined in § 199.2 under the following circumstances:</P>
            <P>(i) <E T="03">Mandatory participation.</E> (A) All Medicare-participating hospitals must be CHAMPUS participating providers for all inpatient CHAMPUS claims.</P>
            <P>(B) Hospitals that are not Medicare-participating but are subject to the CHAMPUS-DRG-based payment methodology or the CHAMPUS mental health payment methodology as established by § 199.14(a), must enter into a participation agreement with CHAMPUS for all inpatient claims in order to be a CHAMPUS-authorized provider.</P>
            <P>(C) Corporate services providers authorized as CHAMPUS providers under the provisions of paragraph (f) of this section must enter into a participation agreement as provided by the Director, OCHAMPUS, or designee.</P>
            <P>(ii) <E T="03">Voluntary participation</E>—(A) <E T="03">Total claims participation: The participating provider program.</E> A CHAMPUS-authorized provider that is not required to participate by this part may become a participating provider by entering into an agreement or memorandum of understanding (MOU) with the Director, OCHAMPUS, or designee, which includes, but is not limited to, the provisions of paragraph (a)(13) of this section. The Director, OCHAMPUS, or <PRTPAGE P="139"/>designee, may include in a participating provider agreement/MOU provisions that establish between CHAMPUS and a class, category, type, or specific provider, uniform procedures and conditions which encourage provider participation while improving beneficiary access to benefits and contributing to CHAMPUS efficiency. Such provisions shall be otherwise allowed by this part or by DoD Directive or DoD Instruction specifically pertaining to CHAMPUS claims participation. Participating provider program provisions may be incorporated into an agreement/MOU to establish a specific CHAMPUS-provider relationship, such as a preferred provider arrangement.</P>
            <P>(B) <E T="03">Claim-specific participation</E>. A CHAMPUS-authorized provider that is not required to participate and that has not entered into a participation agreement pursuant to paragraph (a)(8)(ii)(A) of this section may elect to be a participating provider on a claim-by-claim basis by indicating “accept assignment” on each claim form for which participation is elected.</P>
            <P>(9) <E T="03">Limitation to authorized institutional provider designation.</E> Authorized institutional provider status granted to a specific institutional provider applicant does not extend to any institution-affiliated provider, as defined in § 199.2, of that specific applicant.</P>
            <P>(10) <E T="03">Authorized provider</E>. A hospital or institutional provider, physician, or other individual professional provider, or other provider of services or supplies specifically authorized in this chapter to provide benefits under CHAMPUS. In addition, to be an authorized CHAMPUS provider, any hospital which is a CHAMPUS participating provider under paragraph (a)(7) of this section, shall be a participating provider for all care, services, or supplies furnished to an active duty member of the uniformed services for which the active duty member is entitled under 10 U.S.C. 1074(c). As a participating provider for active duty members, the CHAMPUS authorized hospital shall provide such care, services, and supplies in accordance with the payment rules of § 199.16 of this part. The failure of any CHAMPUS participating hospital to be a participating provider for any active duty member subjects the hospital to termination of the hospital's status as a CHAMPUS authorized provider for failure to meet the qualifications established by this part.</P>
            <P>(11) <E T="03">Balance billing limits.</E>
            </P>
            <P>(i) <E T="03">In general.</E> Individual providers who are not Participating Providers may not balance bill a beneficiary an amount which exceeds the applicable balance billing limit. The balance billing limit shall be the same percentage as the Medicare limiting charge percentage for nonparticipating physicians.</P>
            <P>(ii) <E T="03">Waiver.</E> The balance billing limit may be waived by the Director, OCHAMPUS on a case-by-case basis if requested by a CHAMPUS beneficiary. A decision by the Director, OCHAMPUS to waive or not waive the limit in any particular case is not subject to the appeal and hearing procedures of § 199.10.</P>
            <P>(iii) <E T="03">Compliance.</E> Failure to comply with the balance billing limit shall be considered abuse and/or fraud and grounds of exclusion or suspension of the provider under § 199.9.</P>
            <P>(12) <E T="03">Medical records.</E> CHAMPUS-authorized provider organizations and individuals providing clinical services shall maintain adequate clinical records to substantiate that specific care was actually furnished, was medically necessary, and appropriate, and identify(ies) the individual(s) who provided the care. This applies whether the care is inpatient or outpatient. The minimum requirements for medical record documentation are set forth by all of the following:</P>
            <P>(i) The cognizant state licensing authority;</P>
            <P>(ii) The Joint Commission on Accreditation of Healthcare Organizations, or the appropriate Qualified Accreditation Organization as defined in § 199.2;</P>
            <P>(iii) Standards of practice established by national medical organizations; and</P>
            <P>(iv) This part.</P>
            <P>(13) <E T="03">Participation agreements.</E> A participation agreement otherwise required by this part shall include, in part, all of the following provisions requiring that the provider shall:</P>
            <P>(i) Not charge a beneficiary for the following:</P>

            <P>(A) Services for which the provider is entitled to payment from CHAMPUS;<PRTPAGE P="140"/>
            </P>
            <P>(B) Services for which the beneficiary would be entitled to have CHAMPUS payment made had the provider complied with certain procedural requirements.</P>
            <P>(C) Services not medically necessary and appropriate for the clinical management of the presenting illness, injury, disorder or maternity;</P>
            <P>(D) Services for which a beneficiary would be entitled to payment but for a reduction or denial in payment as a result of quality review; and</P>
            <P>(E) Services rendered during a period in which the provider was not in compliance with one or more conditions of authorization;</P>
            <P>(ii) Comply with the applicable provisions of this part and related CHAMPUS administrative policy;</P>
            <P>(iii) Accept the CHAMPUS determined allowable payment combined with the cost-share, deductible, and other health insurance amounts payable by, or on behalf of, the beneficiary, as full payment for CHAMPUS allowed services;</P>
            <P>(iv) Collect from the CHAMPUS beneficiary those amounts that the beneficiary has a liability to pay for the CHAMPUS deductible and cost-share;</P>
            <P>(v) Permit access by the Director, OCHAMPUS, or designee, to the clinical record of any CHAMPUS beneficiary, to the financial and organizational records of the provider, and to reports of evaluations and inspections conducted by state, private agencies or organizations;</P>
            <P>(vi) Provide the Director, OCHAMPUS, or designee, prompt written notification of the provider's employment of an individual who, at any time during the twelve months preceding such employment, was employed in a managerial, accounting, auditing, or similar capacity by an agency or organization which is responsible, directly or indirectly for decisions regarding Department of Defense payments to the provider;</P>
            <P>(vii) Cooperate fully with a designated utilization and clinical quality management organization which has a contract with the Department of Defense for the geographic area in which the provider renders services;</P>
            <P>(viii) Obtain written authorization before rendering designated services or items for which CHAMPUS cost-share may be expected;</P>
            <P>(ix) Maintain clinical and other records related to individuals for whom CHAMPUS payment was made for services rendered by the provider, or otherwise under arrangement, for a period of 60 months from the date of service;</P>
            <P>(x) Maintain contemporaneous clinical records that substantiate the clinical rationale for each course of treatment, periodic evaluation of the efficacy of treatment, and the outcome at completion or discontinuation of treatment;</P>
            <P>(xi) Refer CHAMPUS beneficiaries only to providers with which the referring provider does not have an economic interest, as defined in § 199.2; and</P>
            <P>(xii) Limit services furnished under arrangement to those for which receipt of payment by the CHAMPUS authorized provider discharges the payment liability of the beneficiary.</P>
            <P>(14) <E T="03">Implementing instructions.</E> The Director, OCHAMPUS, or a designee, shall issue CHAMPUS policies, instructions, procedures, and guidelines, as may be necesssary to implement the intent of this section.</P>
            <P>(15) <E T="03">Exclusion.</E> Regardless of any provision in this section, a provider who is suspended, excluded, or terminated under § 199.9 of this part is specifically excluded as an authorized CHAMPUS provider.</P>
            <P>(b) <E T="03">Institutional providers</E>—(1) <E T="03">General.</E> Institutional providers are those providers who bill for services in the name of an organizational entity (such as hospital and skilled nursing facility), rather than in the name of a person. The term “institutional provider” does not include professional corporations or associations qualifying as a domestic corporation under § 301.7701-5 of the Internal Revenue Service Regulations nor does it include other corporations that provide principally professional services. Institutional providers may provide medical services and supplies on either an inpatient or outpatient basis.</P>
            <P>(i) <E T="03">Preauthorization.</E> Preauthorization may be required by the Director, OCHAMPUS for any health care service for which payment is sought under CHAMPUS. (See §§ 199.4 and 199.15 for <PRTPAGE P="141"/>further information on preauthorization requirements.)</P>
            <P>(ii) Billing practices.</P>
            <P>(A) Each institutional billing, including those institutions subject to the CHAMPUS DRG-based reimbursement method or a CHAMPUS-determined all-inclusive rate reimbursement method, must be itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits.</P>
            <P>(B) Institutional claims subject to the CHAMPUS DRG-based reimbursement method or a CHAMPUS-determined all-inclusive rate reimbursement method, may be submitted only after the beneficiary has been discharged or transferred from the institutional provider's facility or program.</P>
            <P>(C) Institutional claims for Residential Treatment Centers and all other institutional providers, except those listed in (B) above, should be submitted to the appropriate CHAMPUS fiscal intermediary at least every 30 days.</P>
            <P>(2) <E T="03">Nondiscrimination policy.</E> Except as provided below, payment may not be made for inpatient or outpatient care provided and billed by an institutional provider found by the Federal Government to practice discrimination in the admission of patients to its services on the basis of race, color, or national origin. Reimbursement may not be made to a beneficiary who pays for care provided by such a facility and submits a claim for reimbursement. In the following circumstances, the Secretary of Defense, or a designee, may authorize payment for care obtained in an ineligible facility:</P>
            <P>(i) <E T="03">Emergency care.</E> Emergency inpatient or outpatient care.</P>
            <P>(ii) <E T="03">Care rendered before finding of a violation.</E> Care initiated before a finding of a violation and which continues after such violation when it is determined that a change in the treatment facility would be detrimental to the health of the patient, and the attending physician so certifies.</P>
            <P>(iii) <E T="03">Other facility not available.</E> Care provided in an ineligible facility because an eligible facility is not available within a reasonable distance.</P>
            <P>(3) <E T="03">Procedures for qualifying as a CHAMPUS-approved institutional provider.</E> General and special hospitals otherwise meeting the qualifications outlined in paragraphs (b)(4) (i), (ii), and (iii), of this section are not required to request CHAMPUS approval formally.</P>
            <P>(i) <E T="03">JCAH accreditation status.</E> Each CHAMPUS fiscal intermediary shall keep informed as to the current JCAH accreditation status of all hospitals and skilled nursing facilities in its area; and the provider's status under Medicare, particularly with regard to compliance with title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d(1)). The Director, OCHAMPUS, or a designee, shall specifically approve all other authorized institutional providers providing services to CHAMPUS beneficiaries. At the discretion of the Director, OCHAMPUS, any facility that is certified and participating as a provider of services under title XVIII of the Social Security Act (Medicare), may be deemed to meet CHAMPUS requirements. The facility must be providing a type and level of service that is authorized by this part.</P>
            <P>(ii) <E T="03">Required to comply with criteria.</E> Facilities seeking CHAMPUS approval will be expected to comply with appropriate criteria set forth in paragraph (b)(4) of this section. They also are required to complete and submit CHAMPUS Form 200, “Required Information, Facility Determination Instructions,” and provide such additional information as may be requested by OCHAMPUS. An onsite evaluation, either scheduled or unscheduled, may be conducted at the discretion of the Director, OCHAMPUS, or a designee. The final determination regarding approval, reapproval, or disapproval of a facility will be provided in writing to the facility and the appropriate CHAMPUS fiscal intermediary.</P>
            <P>(iii) <E T="03">Notice of peer review rights</E>. All health care facilities subject to the DRG-based payment system shall provide CHAMPUS beneficiaries, upon admission, with information about peer review including their appeal rights. The notices shall be in a form specified by the Director, OCHAMPUS.</P>
            <P>(iv) <E T="03">Surveying of facilities.</E> The surveying of newly established institutional providers and the periodic resurveying of all authorized institutional providers is a continuing process conducted by OCHAMPUS.<PRTPAGE P="142"/>
            </P>
            <P>(v) <E T="03">Institutions not in compliance with CHAMPUS standards.</E> If a determination is made that an institution is not in compliance with one or more of the standards applicable to its specific category of institution, CHAMPUS shall take immediate steps to bring about compliance or terminate the approval as an authorized institution in accordance with § 199.9(f)(2).</P>
            <P>(vi) <E T="03">Participation agreements required for some hospitals which are not Medicare-participating.</E> Notwithstanding the provisions of this paragraph (B)(3), a hospital which is subject to the CHAMPUS DRG-based payment system but which is not a Medicare-particpating hospital must request and sign an agreement with OCHAMPUS. By signing the agreement, the hospital agrees to participate on all CHAMPUS inpatient claims and accept the requirements for a participating provider as contained in paragraph (a)(8) of § 199.6. Failure to sign such an agreement shall disqualify such hospital as a CHAMPUS-approved institutional provider.</P>
            <P>(4) <E T="03">Categories of institutional providers.</E> The following categories of institutional providers may be reimbursed by CHAMPUS for services provided CHAMPUS beneficiaries subject to any and all definitions, conditions, limitation, and exclusions specified or enumerated in this part.</P>
            <P>(i) <E T="03">Hospitals, acute care, general and special.</E> An institution that provides inpatient services, that also may provide outpatient services (including clinical and ambulatory surgical services), and that:</P>
            <P>(A) Is engaged primarily in providing to inpatients, by or under the supervision of physicians, diagnostic and therapeutic services for the medical or surgical diagnosis and treatment of illness, injury, or bodily malfunction (including maternity).</P>
            <P>(B) Maintains clinical records on all inpatients (and outpatients if the facility operates an outpatient department or emergency room).</P>
            <P>(C) Has bylaws in effect with respect to its operations and medical staff.</P>
            <P>(D) Has a requirement that every patient be under the care of a physician.</P>
            <P>(E) Provides 24-hour nursing service rendered or supervised by a registered professional nurse, and has a licensed practical nurse or registered professional nurse on duty at all times.</P>
            <P>(F) Has in effect a hospital utilization review plan that is operational and functioning.</P>
            <P>(G) In the case of an institution in a state in which state or applicable local law provides for the licensing of hospitals, the hospital:</P>
            <P>(<E T="03">1</E>  ) Is licensed pursuant to such law, or</P>
            <P>(<E T="03">2</E>  ) Is approved by the agency of such state or locality responsible for licensing hospitals as meeting the standards established for such licensing.</P>
            <P>(H) Has in effect an operating plan and budget.</P>
            <P>(I) Is accredited by the JCAH or meets such other requirements as the Secretary of Health and Human Services, the Secretary of Transportation, or the Secretary of Defense finds necessary in the interest of the health and safety of patients who are admitted to and furnished services in the institution.</P>
            <P>(ii) <E T="03">Liver transplantation centers.</E> (A) CHAMPUS shall provide coverage for liver transplantation procedures performed only by experienced transplant surgeons at centers complying with the provisions outlined in paragraph (b)(4)(i) of this section and meeting the following criteria:</P>
            <P>(<E T="03">1</E>) The center is a tertiary care facility affiliated with an academic health center. The center must have accredited programs in graduate medical education related to the function of liver transplantation such as internal medicine, pediatrics, surgery, and anesthesiology;</P>
            <P>(<E T="03">2</E>) The center has an active solid organ transplantation program (involving liver transplants as well as other organs);</P>
            <P>(<E T="03">3</E>) The transplantation center must have at least a 50 percent one-year survival rate for ten cases. At the time CHAMPUS approval is requested, the transplant center must provide evidence that at least ten liver transplants have been performed at the center and that at least 50 percent of those transplanted patients have survived one year following surgery. A 50 percent one-year survival rate for all subsequent liver transplantations must be <PRTPAGE P="143"/>maintained for continued CHAMPUS approval;</P>
            <P>(<E T="03">4</E>) The center has allocated sufficient operating room, recovery room, laboratory, and blood bank support and a sufficient number of intensive care and general surgical beds and specialized staff for these areas;</P>
            <P>(<E T="03">5</E>) The center participates in a donor procurement program and network;</P>
            <P>(<E T="03">6</E>) The center systematically collects and shares data on its transplant program;</P>
            <P>(<E T="03">7</E>) The center has an interdisciplinary body to determine the suitability of candidates for transplantation on an equitable basis;</P>
            <P>(<E T="03">8</E>) The transplantation surgeon is specifically trained for liver grafting and must assemble and train a team to function whenever a donor liver is available;</P>
            <P>(<E T="03">9</E>) The transplantation center must have on staff board eligible or board certified physicians and other experts in the field of hepatology, pediatrics, infectious disease, nephrology with dialysis capability, pulmonary medicine with respiratory therapy support, pathology, immunology, and anesthesiology to complement a qualified transplantation team;</P>
            <P>(<E T="03">10</E>) The transplantation center has the assistance of appropriate microbiology, clinical chemistry, and radiology support;</P>
            <P>(<E T="03">11</E>) The transplantation center has blood bank support to accommodate normal demands and the transplant procedure; and</P>
            <P>(<E T="03">12</E>) The transplantation center includes the availability of psychiatric and social services support for patients and family.</P>
            <P>(B) In order to receive approval as a CHAMPUS authorized liver transplant center, a center must submit a request to the Director, CHAMPUS, or a designee. The CHAMPUS authorized liver transplant center shall agree to the following:</P>
            <P>(<E T="03">1</E>) Bill for all services and supplies related to the liver transplantation performed by its staff and bill also for services rendered by the donor hospital following declaration of brain death and after all existing legal requirements for excision of the donor organ have been met; and</P>
            <P>(<E T="03">2</E>) The center shall agree to submit all charges on the basis of fully itemized bills. This means that each service and supply and the charge for each is individually identified.</P>
            <P>(iii) <E T="03">Heart transplantation centers.</E> (A) CHAMPUS shall provide coverage for heart transplantation procedures performed only by experienced transplant surgeons at centers complying with provisions outlined in paragraph (b)(4)(i) of this section and meeting the following criteria:</P>
            <P>(<E T="03">1</E>) The center has experts in the fields of cardiology, cardiovascular surgery, anesthesiology, immunology, infectious disease, nursing, social services and organ procurement to complement the transplant team;</P>
            <P>(<E T="03">2</E>) The center has an active cardiovascular medical and surgical program as evidenced by a minimum of 500 cardiac catheterizations and coronary arteriograms and 250 open heart procedures per year;</P>
            <P>(<E T="03">3</E>) The center has an anesthesia team that is available at all times;</P>
            <P>(<E T="03">4</E>) The center has infectious disease services with both the professional skills and the laboratory resources that are needed to discover, identify, and manage a whole range of organisms;</P>
            <P>(<E T="03">5</E>) The center has a nursing service team trained in the hemodynamic support of the patient and in managing immunosuppressed patients;</P>
            <P>(<E T="03">6</E>) The center has pathology resources that are available for studying and reporting the pathological responses of transplantation;</P>
            <P>(<E T="03">7</E>) The center has legal counsel familiar with transplantation laws and regulations;</P>
            <P>(<E T="03">8</E>) The commitment of the transplant center must be at all levels and broadly evident throughout the facility;</P>
            <P>(<E T="03">9</E>) Responsible team members must be board certified or board eligible in their respective disciplines;</P>
            <P>(<E T="03">10</E>) Component teams must be integrated into a comprehensive transplant team with clearly defined leadership and responsibility;</P>
            <P>(<E T="03">11</E>) The center has adequate social service resources;<PRTPAGE P="144"/>
            </P>
            <P>(<E T="03">12</E>) The transplant center must comply with applicable State transplant laws and regulations;</P>
            <P>(<E T="03">13</E>) The transplant center must safeguard the rights and privacy of patients;</P>
            <P>(<E T="03">14</E>) The transplant center must have adequate patient management plans and protocols;</P>
            <P>(<E T="03">15</E>) The center participates in a donor procurement program and network;</P>
            <P>(<E T="03">16</E>) The center systematically collects and shares data on its transplant program;</P>
            <P>(<E T="03">17</E>) The center has an interdisciplinary body to determine the suitability of candidates for transplantation on an equitable basis;</P>
            <P>(<E T="03">18</E>) The center has extensive blood bank support;</P>
            <P>(<E T="03">19</E>) The center must have an established heart transplantation program with documented evidence of 12 or more heart transplants in each of the two consecutive preceding 12-month periods prior to application and 12 heart transplants prior to that; and</P>
            <P>(<E T="03">20</E>) The center must demonstrate actuarial survival rates of 73 percent for one year and 65 percent for two years for patients who have had heart transplants since January 1, 1982, at that facility.</P>
            <P>(B) CHAMPUS approval will lapse if either the number of heart transplants falls below 8 in 12 months or if the one-year survival rate falls below 60 percent for a consecutive 24-month period.</P>
            <P>(C) CHAMPUS-approval may also be extended for a heart transplant center that meets other certification or accreditation standards provided the standards are equivalent to or exceed the criteria listed above and have been approved by the Director, OCHAMPUS.</P>
            <P>(D) In order to receive approval as a CHAMPUS heart transplant center, a facility must submit a request to the Director, OCHAMPUS, or a designee. The CHAMPUS-authorized heart transplant center shall agree to the following:</P>
            <P>(<E T="03">1</E>) Bill for all services and supplies related to the heart transplantation performed by its staff and bill also for services rendered by the donor hospital following declaration of brain death;</P>
            <P>(<E T="03">2</E>) Submit all charges on the basis of fully itemized bills. Each service and supply must be individually identified and the first claim submitted for the heart transplantation must include a copy of the admission history and physical examination; and</P>
            <P>(<E T="03">3</E>) Report any significant decrease in the experience level or survival rates and loss of key members of the transplant team to the Director, OCHAMPUS.</P>
            <P>(iv) <E T="03">Hospitals, psychiatric.</E> A psychiatric hospital is an institution which is engaged primarily in providing services to inpatients for the diagnosis and treatment of mental disorders.</P>
            <P>(A) There are two major categories of psychiatric hospitals:</P>
            <P>(<E T="03">1</E>  ) The private psychiatric hospital category includes both proprietary and the not-for-profit nongovernmental institutions.</P>
            <P>(<E T="03">2</E>  ) The second category is those psychiatric hospitals that are controlled, financed, and operated by departments or agencies of the local, state, or Federal Government and always are operated on a not-for-profit basis.</P>
            <P>(B) In order for the services of a psychiatric hospital to be covered, the hospital shall comply with the provisions outlined in paragraph (b)(4)(i) of this section. All psychiatric hospitals shall be accredited under the JCAHO Accreditation Manual for Hospitals (AMH) standards in order for their services to be cost-shared under CHAMPUS. In the case of those psychiatric hospitals that are not JCAHO-accredited because they have not been in operation a sufficient period of time to be eligible to request an accreditation survey by the JCAHO, the Director, OCHAMPUS, or a designee, may grant temporary approval if the hospital is certified and participating under Title XVIII of the Social Security Act (Medicare, Part A). This temporary approval expires 12 months from the date on which the psychiatric hospital first becomes eligible to request an accreditation survey by the JCAHO.</P>

            <P>(C) Factors to be considered in determining whether CHAMPUS will cost-share care provided in a psychiatric hospital include, but are not limited to, the following considerations:<PRTPAGE P="145"/>
            </P>
            <P>(<E T="03">1</E> ) Is the prognosis of the patient such that care provided will lead to resolution or remission of the mental illness to the degree that the patient is of no danger to others, can perform routine daily activities, and can be expected to function reasonably outside the inpatient setting?</P>
            <P>(<E T="03">2</E> ) Can the services being provided be provided more economically in another facility or on an outpatient basis?</P>
            <P>(<E T="03">3</E> ) Are the charges reasonable?</P>
            <P>(<E T="03">4</E> ) Is the care primarily custodial or domiciliary? (Custodial or domiciliary care of the permanently mentally ill or retarded is not a benefit under the Basic Program.)</P>
            <P>(D) Although psychiatric hospitals are accredited under the JCAHO AMH standards, their medical records must be maintained in accordance with the JCAHO Consolidated Standard Manual for Child, Adolescent, and Adult Psychiatric, Alcoholism, and Drug Abuse Facilities and Facilities Serving the Mentally Retarded, along with the requirements set forth in § 199.7(b)(3). The hospital is responsible for assuring that patient services and all treatment are accurately documented and completed in a timely manner.</P>
            <P>(v) <E T="03">Hospitals, long-term (tuberculosis, chronic care, or rehabilitation)</E>. To be considered a long-term hospital, an institution for patients that have tuberculosis or chronic diseases must be an institution (or distinct part of an institution) primarily engaged in providing by or under the supervision of a physician appropriate medical or surgical services for the diagnosis and active treatment of the illness or condition in which the institution specializes.</P>
            <P>(A) In order for the service of long-term hospitals to be covered, the hospital must comply with the provisions outlined in paragraph (b)(4)(i) of this section. In addition, in order for services provided by such hospitals to be covered by CHAMPUS, they must be primarily for the treatment of the presenting illness.</P>
            <P>(B) Custodial or domiciliary care is not coverable under CHAMPUS, even if rendered in an otherwise authorized long-term hospital.</P>
            <P>(C) The controlling factor in determining whether a beneficiary's stay in a long-term hospital is coverable by CHAMPUS is the level of professional care, supervision, and skilled nursing care that the beneficiary requires, in addition to the diagnosis, type of condition, or degree of functional limitations. The type and level of medical services required or rendered is controlling for purposes of extending CHAMPUS benefits; not the type of provider or condition of the beneficiary.</P>
            <P>(vi) <E T="03">Skilled nursing facility.</E> A skilled nursing facility is an institution (or a distinct part of an institution) that is engaged primarily in providing to inpatients medically necessary skilled nursing care, which is other than a nursing home or intermediate facility, and which:</P>
            <P>(A) Has policies that are developed with the advice of (and with provisions for review on a periodic basis by) a group of professionals, including one or more physicians and one or more registered nurses, to govern the skilled nursing care and related medical services it provides.</P>
            <P>(B) Has a physician, a registered nurse, or a medical staff responsible for the execution of such policies.</P>
            <P>(C) Has a requirement that the medical care of each patient must be under the supervision of a physician, and provides for having a physician available to furnish necessary medical care in case of an emergency.</P>
            <P>(D) Maintains clinical records on all patients.</P>
            <P>(E) Provides 24-hour skilled nursing service that is sufficient to meet nursing needs in accordance with the policies developed as provided in paragraph (b)(4)(iv)(A) of this section, and has at least one registered professional nurse employed full-time.</P>
            <P>(F) Provides appropriate methods and procedures for the dispensing and administering of drugs and biologicals.</P>
            <P>(G) Has in effect a utilization review plan that is operational and functioning.</P>
            <P>(H) In the case of an institution in a state in which state or applicable local law provides for the licensing of this type facility, the institution:</P>
            <P>(<E T="03">1</E> ) Is licensed pursuant to such law, or<PRTPAGE P="146"/>
            </P>
            <P>(<E T="03">2</E> ) Is approved by the agency of such state or locality responsible for licensing such institutions as meeting the standards established for such licensing.</P>
            <P>(I) Has in effect an operating plan and budget.</P>
            <P>(J) Meets such provisions of the most current edition of the Life Safety Code <SU>8</SU>
              <FTREF/> as are applicable to nursing facilities; except that if the Secretary of Health and Human Services has waived, for such periods, as deemed appropriate, specific provisions of such code which, if rigidly applied, would result in unreasonable hardship upon a nursing facility.</P>
            <FTNT>
              <P>
                <SU>8</SU> Compiled and published by the National Fire Protection Association, Batterymarch Park, Quincy, Massachusetts 02269.</P>
            </FTNT>
            <P>(vii) <E T="03">Residential treatment centers.</E> This paragraph (b)(4)(vii) establishes standards and requirements for residential treatment centers (RTCs).</P>
            <P>(A) <E T="03">Organization and administration.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Definition.</E> A Residential Treatment Center (RTC) is a facility or a distinct part of a facility that provides to beneficiaries under 21 years of age a medically supervised, interdisciplinary program of mental health treatment. An RTC is appropriate for patients whose predominant symptom presentation is essentially stabilized, although not resolved, and who have persistent dysfunction in major life areas. The extent and pervasiveness of the patient's problems require a protected and highly structured therapeutic environment. Residential treatment is differentiated from:</P>
            <P>(<E T="03">i</E>) Acute psychiatric care, which requires medical treatment and 24-hour availability of a full range of diagnostic and therapeutic services to establish and implement an effective plan of care which will reverse life-threatening and/or severely incapacitating symptoms;</P>
            <P>(<E T="03">ii</E>) Partial hospitalization, which provides a less than 24-hour-per-day, seven-day-per-week treatment program for patients who continue to exhibit psychiatric problems but can function with support in some of the major life areas;</P>
            <P>(<E T="03">iii</E>) A group home, which is a professionally directed living arrangement with the availability of psychiatric consultation and treatment for patients with significant family dysfunction and/or chronic but stable psychiatric disturbances;</P>
            <P>(<E T="03">iv</E>) Therapeutic school, which is an educational program supplemented by psychological and psychiatric services;</P>
            <P>(<E T="03">v</E>) Facilities that treat patients with a primary diagnosis of chemical abuse or dependence; and</P>
            <P>(<E T="03">vi</E>) Facilities providing care for patients with a primary diagnosis of mental retardation or developmental disability.</P>
            <P>(<E T="03">2</E>) Eligibility.</P>
            <P>(<E T="03">i</E>) Every RTC must be certified pursuant to CHAMPUS certification standards. Such standards shall incorporate the basic standards set forth in paragraphs (b)(4)(vii) (A) through (D) of this section, and shall include such additional elaborative criteria and standards as the Director, OCHAMPUS determines are necessary to implement the basic standards.</P>
            <P>(<E T="03">ii</E>) To be eligible for CHAMPUS certification, the facility is required to be licensed and fully operational for six months (with a minimum average daily census of 30 percent of total bed capacity) and operate in substantial compliance with state and federal regulations.</P>
            <P>(<E T="03">iii</E>) The facility is currently accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) under the current edition of the Manual for Mental Health, Chemical Dependency, and Mental Retardation/Developmental Disabilities Services which is available from JCAHO, P.O. Box 75751, Chicago, IL 60675.</P>
            <P>(<E T="03">iv</E>) The facility has a written participation agreement with OCHAMPUS. The RTC is not a CHAMPUS-authorized provider and CHAMPUS benefits are not paid for services provided until the date upon which a participation agreement is signed by the Director, OCHAMPUS.</P>
            <P>(<E T="03">3</E>) <E T="03">Governing body.</E>
            </P>
            <P>(<E T="03">i</E>) The RTC shall have a governing body which is responsible for the policies, bylaws, and activities of the facility. If the RTC is owned by a partnership or single owner, the partners or <PRTPAGE P="147"/>single owner are regarded as the governing body. The facility will provide an up-to-date list of names, addresses, telephone numbers and titles of the members of the governing body.</P>
            <P>(<E T="03">ii</E>) The governing body ensures appropriate and adequate services for all patients and oversees continuing development and improvement of care. Where business relationships exist between the governing body and facility, appropriate conflict-of-interest policies are in place.</P>
            <P>(<E T="03">iii</E>) Board members are fully informed about facility services and the governing body conducts annual review of its performance in meeting purposes, responsibilities, goals and objectives.</P>
            <P>(<E T="03">4</E>) <E T="03">Chief executive officer.</E> The chief executive officer, appointed by and subject to the direction of the governing body, shall assume overall administrative responsibility for the operation of the facility according to governing body policies. The chief executive officer shall have five years’ administrative experience in the field of mental health. On October 1, 1997, the CEO shall possess a degree in business administration, public health, hospital administration, nursing, social work, or psychology, or meeting similar educational requirements as prescribed by the Director, OCHAMPUS.</P>
            <P>(<E T="03">5</E>) <E T="03">Clinical Director.</E> The clinical director, appointed by the governing body, shall be a psychiatrist or doctoral level psychologist who meets applicable CHAMPUS requirements for individual professional providers and is licensed to practice in the state where the residential treatment center is located. The clinical director shall possess requisite education and experience, credentials applicable under state practice and licensing laws appropriate to the professional discipline, and a minimum of five years’ clinical experience in the treatment of children and adolescents. The clinical director shall be responsible for planning, development, implementation, and monitoring of all clinical activities.</P>
            <P>(<E T="03">6</E>) <E T="03">Medical director.</E> The medical director, appointed by the governing body, shall be licensed to practice medicine in the state where the residential treatment center is located and shall possess requisite education and experience, including graduation from an accredited school of medicine or osteopathy, an approved residency in psychiatry and a minimum of five years clinical experience in the treatment of children and adolescents. The Medical Director shall be responsible for the planning, development, implementation, and monitoring of all activities relating to medical treatment of patients. If qualified, the Medical Director may also serve as Clinical Director.</P>
            <P>(<E T="03">7</E>) <E T="03">Medical or professional staff organization.</E> The governing body shall establish a medical or professional staff organization to assure effective implementation of clinical privileging, professional conduct rules, and other activities directly affecting patient care.</P>
            <P>(<E T="03">8</E>) <E T="03">Personnel policies and records.</E> The RTC shall maintain written personnel policies, updated job descriptions and personnel records to assure the selection of qualified personnel and successful job performance of those personnel.</P>
            <P>(<E T="03">9</E>) <E T="03">Staff development.</E>  The facility shall provide appropriate training and development programs for administrative, professional support, and direct care staff.</P>
            <P>(<E T="03">10</E>) <E T="03">Fiscal accountability.</E> The RTC shall assure fiscal accountability to applicable government authorities and patients.</P>
            <P>(<E T="03">11</E>) <E T="03">Designated teaching facilities.</E> Students, residents, interns or fellows providing direct clinical care are under the supervision of a qualified staff member approved by an accredited university. The teaching program is approved by the Director, OCHAMPUS.</P>
            <P>(<E T="03">12</E>) <E T="03">Emergency reports and records.</E> The facility notifies OCHAMPUS of any serious occurrence involving CHAMPUS beneficiaries.</P>
            <P>(B) <E T="03">Treatment services.</E>
            </P>
            <P>(<E T="03">1</E>) Staff composition.</P>
            <P>(<E T="03">i</E>) The RTC shall follow written plans which assure that medical and clinical patient needs will be appropriately addressed 24 hours a day, seven days a week by a sufficient number of fully qualified (including license, registration or certification requirements, educational attainment, and professional experience) health care professionals and support staff in the <PRTPAGE P="148"/>respective disciplines. Clinicians providing individual, group, and family therapy meet CHAMPUS requirements as qualified mental health providers and operate within the scope of their licenses. The ultimate authority for planning, development, implementation, and monitoring of all clinical activities is vested in a psychiatrist or doctoral level psychologist. The management of medical care is vested in a physician.</P>
            <P>(<E T="03">ii</E>) The RTC shall ensure adequate coverage by fully qualified staff during all hours of operation, including physician availability, other professional staff coverage, and support staff in the respective disciplines.</P>
            <P>(<E T="03">2</E>) <E T="03">Staff qualifications.</E> The RTC will have a sufficient number of qualified mental health providers, administrative, and support staff to address patients’ clinical needs and to coordinate the services provided. RTCs which employ individuals with master's or doctoral level degrees in a mental health discipline who do not meet the licensure, certification and experience requirements for a qualified mental health provider but are actively working toward licensure or certification, may provide services within the all-inclusive per diem rate, provided the individual works under the clinical supervision of a fully qualified mental health provider employed by the RTC. All other program services shall be provided by trained, licensed staff.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient rights.</E>
            </P>
            <P>(<E T="03">i</E>) The RTC shall provide adequate protection for all patient rights, including rights provided by law, privacy, personnel rights, safety, confidentiality, informed consent, grievances, and personal dignity.</P>
            <P>(<E T="03">ii</E>) The facility has a written policy regarding patient abuse and neglect.</P>
            <P>(<E T="03">iii</E>) Facility marketing and advertising meets professional standards.</P>
            <P>(<E T="03">4</E>) <E T="03">Behavioral management.</E> The RTC shall adhere to a comprehensive, written plan of behavioral management, developed by the clinical director and the medical or professional staff and approved by the governing body, including strictly limited procedures to assure that the restraint or seclusion are used only in extraordinary circumstances, are carefully monitored, and are fully documented. Only trained and clinically privileged RNs or qualified mental health professionals may be responsible for the implementation of seclusion and restraint procedures in an emergency situation.</P>
            <P>(<E T="03">5</E>) <E T="03">Admission process.</E> The RTC shall maintain written policies and procedures to ensure that, prior to an admission, a determination is made, and approved pursuant to CHAMPUS preauthorization requirements, that the admission is medically and/or psychologically necessary and the program is appropriate to meet the patient's needs. Medical and/or psychological necessity determinations shall be rendered by qualified mental health professionals who meet CHAMPUS requirements for individual professional providers and who are permitted by law and by the facility to refer patients for admission.</P>
            <P>(<E T="03">6</E>) <E T="03">Assessments.</E> The professional staff of the RTC shall complete a current multidisciplinary assessment which includes, but is not limited to physical, psychological, developmental, family, educational, social, spiritual and skills assessment of each patient admitted. Unless otherwise specified, all required clinical assessments are completed prior to development of the multidisciplinary treatment plan.</P>
            <P>(<E T="03">7</E>) <E T="03">Clinical formulation.</E> A qualified mental health professional of the RTC will complete a clinical formulation on all patients. The clinical formulation will be reviewed and approved by the responsible individual professional provider and will incorporate significant findings from each of the multidisciplinary assessments. It will provide the basis for development of an interdisciplinary treatment plan.</P>
            <P>(<E T="03">8</E>) <E T="03">Treatment planning.</E> A qualified mental health professional shall be responsible for the development, supervision, implementation, and assessment of a written, individualized, interdisciplinary plan of treatment, which shall be completed within 10 days of admission and shall include individual, measurable, and observable goals for incremental progress and discharge. A preliminary treatment plan is completed within 24 hours of admission and includes at least an admission <PRTPAGE P="149"/>note and orders written by the admitting mental health professional. The master treatment plan is reviewed and revised at least every 30 days, or when major changes occur in treatment.</P>
            <P>(<E T="03">9</E>) <E T="03">Discharge and transition planning.</E> The RTC shall maintain a transition planning process to address adequately the anticipated needs of the patient prior to the time of discharge. The planning involves determining necessary modifications in the treatment plan, facilitating the termination of treatment, and identifying resources to maintain therapeutic stability following discharge.</P>
            <P>(<E T="03">10</E>) <E T="03">Clinical documentation.</E> Clinical records shall be maintained on each patient to plan care and treatment and provide ongoing evaluation of the patient's progress. All care is documented and each clinical record contains at least the following: demographic data, consent forms, pertinent legal documents, all treatment plans and patient assessments, consultation and laboratory reports, physician orders, progress notes, and a discharge summary. All documentation will adhere to applicable provisions of the JCAHO and requirements set forth in § 199.7(b)(3). Anappropriately qualified records administrator or technician will supervise and maintain the quality of the records. These requirements are in addition to other records requirements of this part, and documentation requirements of the Joint Commission on Accreditation of Healthcare Organizations.</P>
            <P>(<E T="03">11</E>) <E T="03">Progress notes.</E> RTC's shall document the course of treatment for patients and families using progress notes which provide information to review, analyze, and modify the treatment plans. Progress notes are legible, contemporaneous, sequential, signed and dated and adhere to applicable provisions of the Manual of Mental Health, Chemical Dependency, and Mental Retardation/Development Disabilities Services and requirements set forth in § 199.7(b)(3).</P>
            <P>(<E T="03">12</E>) <E T="03">Therapeutic services.</E>
            </P>
            <P>(<E T="03">i</E>) Individual, group, and family psychotherapy are provided to all patients, consistent with each patient's treatment plan, by qualified mental health providers.</P>
            <P>(<E T="03">ii</E>) A range of therapeutic activities, directed and staffed by qualified personnel, are offered to help patients meet the goals of the treatment plan.</P>
            <P>(<E T="03">iii</E>) Therapeutic educational services are provided or arranged that are appropriate to the patients educational and therapeutic needs.</P>
            <P>(<E T="03">13</E>) <E T="03">Ancillary services.</E> A full range of ancillary services is provided. Emergency services include policies and procedures for handling emergencies with qualified personnel and written agreements with each facility providing the service. Other ancillary services include physical health, pharmacy and dietary services.</P>
            <P>(C) <E T="03">Standards for physical plant and environment.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Physical environment.</E> The buildings and grounds of the RTC shall be maintained so as to avoid health and safety hazards, be supportive of the services provided to patients, and promote patient comfort, dignity, privacy, personal hygiene, and personal safety.</P>
            <P>(<E T="03">2</E>) <E T="03">Physical plant safety.</E> The RTC shall be of permanent construction and maintained in a manner that protects the lives and ensures the physical safety of patients, staff, and visitors, including conformity with all applicable building, fire, health, and safety codes.</P>
            <P>(<E T="03">3</E>) <E T="03">Disaster planning.</E> The RTC shall maintain and rehearse written plan for taking care of casualities and handling other consequences arising from internal and external disasters.</P>
            <P>(D) <E T="03">Standards for evaluation system.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Quality assessment and improvement.</E> The RTC shall develop and implement a comprehensive quality assurance and quality improvement program that monitors the quality, efficiency, appropriateness, and effectiveness of the care, treatments, and services it provides for patients and their families, primarily utilizing explicit clinical indicators to evaluate all functions of the RTC and contribute to an ongoing process of program improvement. The clinical director is responsible for developing and implementing quality assessment and improvement activities throughout the facility.</P>
            <P>(<E T="03">2</E>) <E T="03">Utilization review.</E> The RTC shall implement a utilization review process, pursuant to a written plan approved by <PRTPAGE P="150"/>the professional staff, the administration, and the governing body, that assesses the appropriateness of admission, continued stay, and timeliness of discharge as part of an effort to provide quality patient care in a cost-effective manner. Findings of the utilization review process are used as a basis for revising the plan of operation, including a review of staff qualifications and staff composition.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient records review.</E> The RTC shall implement a process, including monthly reviews of a representative sample of patient records, to determine the completeness and accuracy of the patient records and the timeliness and pertinence of record entries, particularly with regard to regular recording of progress/non-progress in treatment.</P>
            <P>(<E T="03">4</E>) <E T="03">Drug utilization review.</E> The RTC shall implement a comprehensive process for the monitoring and evaluating of the prophylactic, therapeutic, and empiric use of drugs to assure that medications are provided appropriately, safely, and effectively.</P>
            <P>(<E T="03">5</E>) <E T="03">Risk management.</E> The RTC shall implement a comprehensive risk management program, fully coordinated with other aspects of the quality assurance and quality improvement program, to prevent and control risks to patients and staff and costs associated with clinical aspects of patient care and safety.</P>
            <P>(<E T="03">6</E>) <E T="03">Infection control.</E> The RTC shall implement a comprehensive system for the surveillance, prevention, control, and reporting of infections acquired or brought into the facility.</P>
            <P>(<E T="03">7</E>) <E T="03">Safety.</E> The RTC shall implement an effective program to assure a safe environment for patients, staff, and visitors, including an incident report system, a continuous safety surveillance system, and an active multidisciplinary safety committee.</P>
            <P>(<E T="03">8</E>) <E T="03">Facility evaluation.</E> The RTC annually evaluates accomplishment of the goals and objectives of each clinical program and service of the RTC and reports findings and recommendations to the governing body.</P>
            <P>(E) <E T="03">Participation agreement requirements.</E> In addition to other requirements set forth in paragraph (b)(4)(vii), of this section in order for the services of an RTC to be authorized, the RTC shall have entered into a Participation Agreement with OCHAMPUS. The period of a participation agreement shall be specified in the agreement, and will generally be for not more than five years. Participation agreements entered into prior April 6, 1995 must be renewed not later than October 1, 1995. In addition to review of a facility's application and supporting documentation, an on-site inspection by OCHAMPUS authorized personnel may be required prior to signing a Participation Agreement. Retroactive approval is not given. In addition, the Participation Agreement shall include provisions that the RTC shall, at a minimum:</P>
            <P>(<E T="03">1</E>) Render residential treatment center impatient services to eligible CHAMPUS beneficiaries in need of such services, in accordance with the participation agreement and CHAMPUS regulation;</P>
            <P>(<E T="03">2</E>) Accept payment for its services based upon the methodology provided in § 199.14(f) or such other method as determined by the Director, OCHAMPUS;</P>
            <P>(<E T="03">3</E>) Accept the CHAMPUS all-inclusive per diem rate as payment in full and collect from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability, as defined in § 199.4, and charges for services and supplies that are not a benefit of CHAMPUS;</P>
            <P>(<E T="03">4</E>) Make all reasonable efforts acceptable to the Director, OCHAMPUS, to collect those amounts, which represents the beneficiary's liability, as defined in § 199.4;</P>
            <P>(<E T="03">5</E>) Comply with the provisions of § 199.8, and submit claims first to all health insurance coverage to which the beneficiary is entitled that is primary to CHAMPUS;</P>
            <P>(<E T="03">6</E>) Submit claims for services provided to CHAMPUS beneficiaries at least 30 days (except to the extent a delay is necessitated by efforts to first collect from other health insurance). If claims are not submitted at least every 30 days, the RTC agrees not to bill the beneficiary or the beneficiary's family for any amounts disallowed by CHAMPUS;</P>
            <P>(<E T="03">7</E>) Certify that:<PRTPAGE P="151"/>
            </P>
            <P>(<E T="03">i</E>) It is and will remain in compliance with the provisions of paragraph (b)(4)(vii) of this section establishing standards for Residential Treatment Centers;</P>
            <P>(<E T="03">ii</E>) It has conducted a self assessment of the facility's compliance with the CHAMPUS Standards for Residential Treatment Centers Serving Children and Adolescents with Mental Disorders, as issued by the Director, OCHAMPUS and notified the Director, OCHAMPUS of any matter regarding which the facility is not in compliance with such standards; and</P>
            <P>(<E T="03">iii</E>) It will maintain compliance with the CHAMPUS Standards for Residential Treatment Centers Serving Children and Adolescents with Mental Disorders, as issued by the Director, OCHAMPUS, except for any such standards regarding which the facility notifies the Director, OCHAMPUS that it is not in compliance.</P>
            <P>(<E T="03">8</E>) Designate an individual who will act as liaison for CHAMPUS inquiries. The RTC shall inform OCHAMPUS in writing of the designated individual;</P>
            <P>(<E T="03">9</E>) Furnish OCHAMPUS, as requested by OCHAMPUS, with cost data certified by an independent accounting firm or other agency as authorized by the Director, OCHAMPUS;</P>
            <P>(<E T="03">10</E>) Comply with all requirements of this section applicable to institutional providers generally concerning preauthorization, concurrent care review, claims processing, beneficiary liability, double coverage, utilization and quality review and other matters;</P>
            <P>(<E T="03">11</E>) Grant the Director, OCHAMPUS, or designee, the right to conduct quality assurance audits or accounting audits with full access to patients and records (including records relating to patients who are not CHAMPUS beneficiaries) to determine the quality and cost-effectiveness of care rendered. The audits may be conducted on a scheduled or unscheduled (unannounced) basis. This right to audit/review includes, but is not limited to:</P>
            <P>(<E T="03">i</E>) Examination of fiscal and all other records of the RTC which would confirm compliance with the participation agreement and designation as an authorized CHAMPUS RTC provider;</P>
            <P>(<E T="03">ii</E>) Conducting such audits of RTC records including clinical, financial, and census records, as may be necessary to determine the nature of the services being provided, and the basis for charges and claims against the United States for services provided CHAMPUS beneficiaries;</P>
            <P>(<E T="03">iii</E>) Examining reports of evaluations and inspections conducted by federal, state and local government, and private agencies and organizations;</P>
            <P>(<E T="03">iv</E>) Conducting on-site inspections of the facilities of the RTC and interviewing employees, members of the staff, contractors, board members, volunteers, and patients, as required;</P>
            <P>(<E T="03">v</E>) Audits conducted by the United States General Accounting Office.</P>
            <P>(F) <E T="03">Other requirements applicable to RTCs.</E>
            </P>
            <P>(<E T="03">1</E>) Even though an RTC may qualify as a CHAMPUS-authorized provider and may have entered into a participation agreement with CHAMPUS, payment by CHAMPUS for particular services provided is contingent upon the RTC also meeting all conditions set forth in § 199.4 especially all requirements of paragraph (b)(4) of that section.</P>
            <P>(<E T="03">2</E>) The RTC shall provide inpatient services to CHAMPUS beneficiaries in the same manner it provides inpatient services to all other patients. The RTC may not discriminate against CHAMPUS beneficiaries in any manner, including admission practices, placement in special or separate wings or rooms, or provisions of special or limited treatment.</P>
            <P>(<E T="03">3</E>) The RTC shall assure that all certifications and information provided to the Director, OCHAMPUS incident to the process of obtaining and retaining authorized provider status is accurate and that it has no material errors or omissions. In the case of any misrepresentations, whether by inaccurate information being provided or material facts withheld, authorized status will be denied or terminated, and the RTC will be ineligible for consideration for authorized provider status for a two year period.</P>
            <P>(viii) <E T="03">Christian Science sanatoriums</E>. The services obtained in Christian Science sanatoriums are covered by CHAMPUS as inpatient care. To qualify for coverage, the sanatorium either must be operated by, or be listed and <PRTPAGE P="152"/>certified by the First Church of Christ, Scientist.</P>
            <P>(ix) <E T="03">Infirmaries.</E> Infirmaries are facilities operated by student health departments of colleges and universities to provide inpatient or outpatient care to enrolled students. Charges for care provided by such facilities will not be cost-shared by CHAMPUS if the student would not be charged in the absence of CHAMPUS, or if student is covered by a mandatory student health insurance plan, in which enrollment is required as a part of the student's school registration and the charges by the college or university include a premium for the student health insurance coverage. CHAMPUS will cost-share only if enrollment in the student health program or health insurance plan is voluntary.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>An infirmary in a boarding school also may qualify under this provision, subject to review and approval by the Director, OCHAMPUS or a designee.</P>
            </NOTE>
            <P>(x) <E T="03">Other special institution providers.</E> (A) <E T="03">General.</E> (<E T="03">1</E> ) Care provided by certain special institutional providers (on either an inpatient or outpatient basis), may be cost-shared by CHAMPUS under specified circumstances and only if the provider is specifically identified in paragraph (b)(4)(x) of this section.</P>
            <P>(<E T="03">i</E> ) The course of treatment is prescribed by a doctor of medicine or osteopathy.</P>
            <P>(<E T="03">ii</E> ) The patient is under the supervision of a physician during the entire course of the inpatient admission or the outpatient treatment.</P>
            <P>(<E T="03">iii</E> ) The type and level of care and service rendered by the institution are otherwise authorized by this part.</P>
            <P>(<E T="03">iv</E> ) The facility meets all licensing or other certification requirements that are extant in the jurisdiction in which the facility is located geographically.</P>
            <P>(<E T="03">v</E> ) Is other than a nursing home, intermediate care facility, home for the aged, halfway house, or other similar institution.</P>
            <P>(<E T="03">vi</E> ) Is accredited by the JCAH or other CHAMPUS-approved accreditation organization, if an appropriate accreditation program for the given type of facility is available. As future accreditation programs are developed to cover emerging specialized treatment programs, such accreditation will be a prerequisite to coverage by CHAMPUS for services provided by such facilities.</P>
            <P>(<E T="03">2</E>) To ensure that CHAMPUS beneficiaries are provided quality care at a reasonable cost when treated by a special institutional provider, the Director, OCHAMPUS may:</P>
            <P>(<E T="03">i</E>) Require prior approval of all admissions to special institutional providers.</P>
            <P>(<E T="03">ii</E>) Set appropriate standards for special institutional providers in addition to or in the absence of JCAHO accreditation.</P>
            <P>(<E T="03">iii</E> ) Monitor facility operations and treatment programs on a continuing basis and conduct onsite inspections on a scheduled and unscheduled basis.</P>
            <P>(<E T="03">iv</E> ) Negotiate agreements of participation.</P>
            <P>(<E T="03">v</E> ) Terminate approval of a case when it is ascertained that a departure from the facts upon which the admission was based originally has occurred.</P>
            <P>(<E T="03">vi</E>) Declare a special institutional provider not eligible for CHAMPUS payment if that facility has been found to have engaged in fraudulent or deceptive practices.</P>
            <P>(<E T="03">3</E>) In general, the following disclaimers apply to treatment by special institutional providers:</P>
            <P>(<E T="03">i</E> ) Just because one period or episode of treatment by a facility has been covered by CHAMPUS may not be construed to mean that later episodes of care by the same or similar facility will be covered automatically.</P>
            <P>(<E T="03">ii</E> ) The fact that one case has been authorized for treatment by a specific facility or similar type of facility may not be construed to mean that similar cases or later periods of treatment will be extended CHAMPUS benefits automatically.</P>
            <P>(B) <E T="03">Types of providers.</E> The following is a list of facilities that have been designated specifically as special institutional providers.</P>
            <P>(<E T="03">1</E> ) <E T="03">Free-standing ambulatory surgical centers.</E> Care provided by freestanding ambulatory surgical centers may be cost-shared by CHAMPUS under the following circumstances:</P>
            <P>(<E T="03">i</E> ) The treatment is prescribed and supervised by a physician.<PRTPAGE P="153"/>
            </P>
            <P>(<E T="03">ii</E> ) The type and level of care and services rendered by the center are otherwise authorized by this part.</P>
            <P>(<E T="03">iii</E> ) The center meets all licensing or other certification requirements of the jurisdiction in which the facility is located.</P>
            <P>(<E T="03">iv</E> ) The center is accredited by the JCAH, the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), or such other standards as authorized by the Director, OCHAMPUS.</P>
            <P>(<E T="03">v</E>) A childbirth procedure provided by a CHAMPUS-approved free-standing ambulatory surgical center shall not be cost-shared by the CHAMPUS unless the surgical center is also a CHAMPUS-approved birthing center institutional provider as established by the birthing center provider certification requirement of this Regulation.</P>
            <P>(<E T="03">2</E> )[Reserved]</P>
            <P>(xi) <E T="03">Birthing centers.</E> A birthing center is a freestanding or institution-affiliated outpatient maternity care program which principally provides a planned course of outpatient prenatal care and outpatient childbirth service limited to low-risk pregnancies; excludes care for high-risk pregnancies; limits childbirth to the use of natural childbirth procedures; and provides immediate newborn care.</P>
            <P>(A) <E T="03">Certification requirements.</E> A birthing center which meets the following criteria may be designated as an authorized CHAMPUS institutional provider:</P>
            <P>(<E T="03">1</E>) The predominant type of service and level of care rendered by the center is otherwise authorized by this part.</P>
            <P>(<E T="03">2</E>) The center is licensed to operate as a birthing center where such license is available, or is specifically licensed as a type of ambulatory health care facility where birthing center specific license is not available, and meets all applicable licensing or certification requirements that are extant in the state, county, municipality, or other political jurisdiction in which the center is located.</P>
            <P>(<E T="03">3</E>) The center is accredited by a nationally recognized accreditation organization whose standards and procedures have been determined to be acceptable by the Director, OCHAMPUS, or a designee.</P>
            <P>(<E T="03">4</E>) The center complies with the CHAMPUS birthing center standards set forth in this part.</P>
            <P>(<E T="03">5</E>) The center has entered into a participation agreement with OCHAMPUS in which the center agrees, in part, to:</P>
            <P>(<E T="03">i</E>) Participate in CHAMPUS and accept payment for maternity services based upon the reimbursement methodology for birthing centers;</P>
            <P>(<E T="03">ii</E>) Collect from the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability under the participation agreement and the reimbursement methodology for birthing centers, and the amounts for services and supplies that are not a benefit of the CHAMPUS;</P>
            <P>(<E T="03">iii</E>) Permit access by the Director, OCHAMPUS, or a designee, to the clinical record of any CHAMPUS beneficiary, to the financial and organizational records of the center, and to reports of evaluations and inspections conducted by state or private agencies or organizations;</P>
            <P>(<E T="03">iv</E>) Submit claims first to all health benefit and insurance plans primary to the CHAMPUS to which the beneficiary is entitled and to comply with the double coverage provisions of this part;</P>
            <P>(<E T="03">v</E>) Notify CHAMPUS in writing within 7 days of the emergency transport of any CHAMPUS beneficiary from the center to an acute care hospital or of the death of any CHAMPUS beneficiary in the center.</P>
            <P>(<E T="03">6</E>) A birthing center shall not be a CHAMPUS-authorized institutional provider and CHAMPUS benefits shall not be paid for any service provided by a birthing center before the date the participation agreement is signed by the Director, OCHAMPUS, or a designee.</P>
            <P>(B) <E T="03">CHAMPUS birthing center standards.</E> (<E T="03">1</E>) <E T="03">Environment:</E> The center has a safe and sanitary environment, properly constructed, equipped, and maintained to protect health and safety and meets the applicable provisions of the “Life Safety Code” of the National Fire Protection Association.</P>
            <P>(<E T="03">2</E>) <E T="03">Policies and procedures:</E> The center has written administrative, fiscal, personnel and clinical policies and procedures which collectively promote the provision of high-quality maternity <PRTPAGE P="154"/>care and childbirth services in an orderly, effective, and safe physical and organizational environment.</P>
            <P>(<E T="03">3</E>) <E T="03">Informed consent:</E> Each CHAMPUS beneficiary admitted to the center will be informed in writing at the time of admission of the nature and scope of the center's program and of the possible risks associated with maternity care and childbirth in the center.</P>
            <P>(<E T="03">4</E>) <E T="03">Beneficiary care:</E> Each woman admitted will be cared for by or under the direct supervision of a specific physician or a specific certified nurse-midwife who is otherwise eligible as a CHAMPUS individual professional provider.</P>
            <P>(<E T="03">5</E>) <E T="03">Medical direction:</E> The center has written memoranda of understanding (MOU) for routine consultation and emergency care with an obstetrician-gynecologist who is certified or is eligible for certification by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology and with a pediatrician who is certified or eligible for certification by the American Board of Pediatrics or by the American Osteopathic Board of Pediatrics, each of whom have admitting privileges to at least one backup hospital. In lieu of a required MOU, the center may employ a physician with the required qualifications. Each MOU must be renewed annually.</P>
            <P>(<E T="03">6</E>) <E T="03">Admission and emergency care criteria and procedures.</E> The center has written clinical criteria and administrative procedures, which are reviewed and approved annually by a physician related to the center as required by paragraph (b)(4)(xi)(B)(<E T="03">5</E>) above, for the exclusion of a woman with a high-risk pregnancy from center care and for management of maternal and neonatal emergencies.</P>
            <P>(<E T="03">7</E>) <E T="03">Emergency treatment.</E> The center has a written memorandum of understanding (MOU) with at least one backup hospital which documents that the hospital will accept and treat any woman or newborn transferred from the center who is in need of emergency obstetrical or neonatal medical care. In lieu of this MOU with a hospital, a birthing center may have an MOU with a physician, who otherwise meets the requirements as a CHAMPUS individual professional provider, and who has admitting privileges to a backup hospital capable of providing care for critical maternal and neonatal patients as demonstrated by a letter from that hospital certifying the scope and expected duration of the admitting privileges granted by the hospital to the physician. The MOU must be reviewed annually.</P>
            <P>(<E T="03">8</E>) <E T="03">Emergency medical transportation.</E> The center has a written memorandum of understanding (MOU) with at least one ambulance service which documents that the ambulance service is routinely staffed by qualified personnel who are capable of the management of critical maternal and neonatal patients during transport and which specifies the estimated transport time to each backup hospital with which the center has arranged for emergency treatment as required in paragraph (b)(4)(xi)(B)(<E T="03">7</E>) above. Each MOU must be renewed annually.</P>
            <P>(<E T="03">9</E>) <E T="03">Professional staff.</E> The center's professional staff is legally and professionally qualified for the performance of their professional responsibilities.</P>
            <P>(<E T="03">10</E>) <E T="03">Medical records.</E> The center maintains full and complete written documentation of the services rendered to each woman admitted and each newborn delivered. A copy of the informed consent document required by paragraph (b)(4)(xi)(B)(<E T="03">3</E>), above, which contains the original signature of the CHAMPUS beneficiary, signed and dated at the time of admission, must be maintained in the medical record of each CHAMPUS beneficiary admitted.</P>
            <P>(<E T="03">11</E>) <E T="03">Quality assurance.</E> The center has an organized program for quality assurance which includes, but is not limited to, written procedures for regularly scheduled evaluation of each type of service provided, of each mother or newborn transferred to a hospital, and of each death within the facility.</P>
            <P>(<E T="03">12</E>) <E T="03">Governance and administration.</E> The center has a govening body legally responsible for overall operation and maintenance of the center and a full-time employee who has authority and responsibility for the day-to-day operation of the center.</P>
            <P>(xii) <E T="03">Psychiatric partial hospitalization programs.</E> Paragraph (b)(4)(xii) of this <PRTPAGE P="155"/>section establishes standards and requirements for psychiatric partial hospitalization programs.</P>
            <P>(A) <E T="03">Organization and administration.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Definition.</E> Partial hospitalization is defined as a time-limited, ambulatory, active treatment program that offers therapeutically intensive, coordinated, and structured clinical services within a stable therapeutic milieu. Partial hospitalization programs serve patients who exhibit psychiatric symptoms, disturbances of conduct, and decompensating conditions affecting mental health.</P>
            <P>(<E T="03">2</E>) <E T="03">Eligibility.</E>
            </P>
            <P>(<E T="03">i</E>) Every psychiatric partial hospitalization program must be certified pursuant to CHAMPUS certification standards. Such standards shall incorporate the basic standards set forth in paragraphs (b)(4)(xii) (A) through (D) of this section, and shall include such additional elaborative criteria and standards as the Director, OCHAMPUS determines are necessary to implement the basic standards. Each psychiatric partial hospitalization program must be either a distinct part of an otherwise authorized institutional provider or a freestanding program.</P>
            <P>(<E T="03">ii</E>) To be eligible for CHAMPUS certification, the facility is required to be licensed and fully operational for a period of at least six months (with a minimum patient census of at least 30 percent of bed capacity) and operate in substantial compliance with state and federal regulations.</P>
            <P>(<E T="03">iii</E>) The facility is currently accredited by the Joint Commission on Accreditation of Healthcare Organizations under the current edition of the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation/Developmental Disabilities Services.</P>
            <P>(<E T="03">iv</E>) The facility has a written participation agreement with OCHAMPUS. On October 1, 1995, the PHP is not a CHAMPUS-authorized provider and CHAMPUS benefits are not paid for services provided until the date upon which a participation agreement is signed by the Director, OCHAMPUS. Partial hospitalization is capable of providing an interdisciplinary program of medical and therapeutic services a minimum of three hours per day, five days per week, and may include full- or half-day, evening, and weekend treatment programs.</P>
            <P>(<E T="03">3</E>) <E T="03">Governing body.</E>
            </P>
            <P>(<E T="03">i</E>) The PHP shall have a governing body which is responsible for the policies, bylaws, and activities of the facilities. If the PHP is owned by a partnership or single owner, the partners or single owner are regarded as the governing body. The facility will provide an up-to-date list of names, addresses, telephone numbers, and titles of the members of the governing body.</P>
            <P>(<E T="03">ii</E>) The governing body ensures appropriate and adequate services for all patients and oversees continuing development and improvement of care. Where business relationships exist between the governing body and facility, appropriate conflict-of-interest policies are in place.</P>
            <P>(<E T="03">iii</E>) Board members are fully informed about facility services and the governing body conducts annual review of its performance in meeting purposes, responsibilities, goals and objectives.</P>
            <P>(<E T="03">4</E>) <E T="03">Chief executive officer.</E> The Chief Executive Officer, appointed by and subject to the direction of the governing body, shall assume overall administrative responsibility for the operation of the facility according to governing body policies. The chief executive officer shall have five years’ administrative experience in the field of mental health. On October 1, 1997, the CEO shall possess a degree in business administration, public health, hospital administration, nursing, social work, or psychology, or meet similar educational requirements as prescribed by the Director, OCHAMPUS.</P>
            <P>(<E T="03">5</E>) <E T="03">Clinical Director.</E> The clinical director, appointed by the governing body, shall be a psychiatrist or doctoral level psychologist who meets applicable CHAMPUS requirements for individual professional providers and is licensed to practice in the state where the PHP is located. The clinical director shall possess requisite education and experience, credentials applicable under state practice and licensing laws appropriate to the professional discipline, and a minimum of five years’ clinical experience in the treatment of mental disorders specific to the ages and disabilities of the patients served. <PRTPAGE P="156"/>The clinical director shall be responsible for planning, development, implementation, and monitoring of all clinical activities.</P>
            <P>(<E T="03">6</E>) <E T="03">Medical director.</E> The medical director, appointed by the governing body, shall be licensed to practice medicine in the state where the residential treatment center is located and shall possess requisite education and experience, including graduation from an accredited school of medicine or osteopathy, an approved residency in psychiatry and a minimum of five years clinical experience in the treatment of mental disorders specific to the ages and disabilities of the patients served. The Medical Director shall be responsible for the planning, development, implementation, and monitoring of all activities relating to medical treatment of patients. If qualified, the Medical Director may also serve as Clinical Director.</P>
            <P>(<E T="03">7</E>) <E T="03">Medical or professional staff organization.</E> The governing body shall establish a medical or professional staff organization to assure effective implementation of clinical privileging, professional conduct rules, and other activities directly affecting patient care.</P>
            <P>(<E T="03">8</E>) <E T="03">Personnel policies and records.</E> The PHP shall maintain written personnel policies, updated job descriptions, personnel records to assure the selection of qualified personnel and successful job performance of those personnel.</P>
            <P>(<E T="03">9</E>) <E T="03">Staff development.</E> The facility shall provide appropriate training and development programs for administrative, professional support, and direct care staff.</P>
            <P>(<E T="03">10</E>) <E T="03">Fiscal accountability.</E> The PHP shall assure fiscal accountability to applicable government authorities and patients.</P>
            <P>(<E T="03">11</E>) <E T="03">Designated teaching facilities.</E> Students, residents, interns, or fellows providing direct clinical care are under the supervision of a qualified staff member approved by an accredited university. The teaching program is approved by the Director, OCHAMPUS.</P>
            <P>(<E T="03">12</E>) <E T="03">Emergency reports and records.</E> The facility notifies OCHAMPUS of any serious occurrence involving CHAMPUS beneficiaries.</P>
            <P>(B) <E T="03">Treatment services.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Staff composition.</E>
            </P>
            <P>(<E T="03">i</E>) The PHP shall ensure that patient care needs will be appropriately addressed during all hours of operation by a sufficient number of fully qualified (including license, registration or certification requirements, educational attainment, and professional experience) health care professionals. Clinicians providing individual, group, and family therapy meet CHAMPUS requirements as qualified mental health providers, and operate within the scope of their licenses. The ultimate authority for managing care is vested in a psychiatrist or licensed doctor level psychologist. The management of medical care is vested in a physician.</P>
            <P>(<E T="03">ii</E>) The PHP shall establish and follow written plans to assure adequate staff coverage during all hours of operation, including physician availability, other professional staff coverage, and support staff in the respective disciplines.</P>
            <P>(<E T="03">2</E>) <E T="03">Staff qualifications.</E> The PHP will have a sufficient number of qualified mental health providers, administrative, and support staff to address patients’ clinical needs and to coordinate the services provided. PHPs which employ individuals with master's or doctoral level degrees in a mental health discipline who do not meet the licensure, certification and experience requirements for a qualified mental health provider but are actively working toward licensure or certification, may provide services within the all-inclusive per diem rate, provided the individual works under the clinical supervision of a fully qualified mental health provider employed by the PHP. All other program services shall be provided by trained, licensed staff.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient rights.</E>
            </P>
            <P>(<E T="03">i</E>) The PHP shall provide adequate protection for all patient rights, including rights provided by law, privacy, personal rights, safety, confidentiality, informed consent, grievances, and personal dignity.</P>
            <P>(<E T="03">ii</E>) The facility has a written policy regarding patient abuse and neglect.</P>
            <P>(<E T="03">iii</E>) Facility marketing and advertising meets professional standards.</P>
            <P>(<E T="03">4</E>) <E T="03">Behavioral management.</E> The PHP shall adhere to a comprehensive, written plan of behavior management, developed by the clinical director and the <PRTPAGE P="157"/>medical or professional staff and approved by the governing body, including strictly limited procedures to assure that restraint or seclusion are used only in extraordinary circumstances, are carefully monitored, and are fully documented. Only trained and clinically privileged RNs or qualified mental health professionals may be responsible for implementation of seclusion and restraint procedures in an emergency situation.</P>
            <P>(<E T="03">5</E>) <E T="03">Admission process.</E> The PHP shall maintain written policies and procedures to ensure that prior to an admission, a determination is made, and approved pursuant to CHAMPUS preauthorization requirements, that the admission is medically and/or psychologically necessary and the program is appropriate to meet the patient's needs. Medical and/or psychological necessity determinations shall be rendered by qualified mental health professionals who meet CHAMPUS requirements for individual professional providers and who are permitted by law and by the facility to refer patients for admission.</P>
            <P>(<E T="03">6</E>) <E T="03">Assessments.</E> The professional staff of the PHP shall complete a multidisciplinary assessment which includes, but is not limited to physical health, psychological health, physiological, developmental, family, educational, spiritual, and skills assessment of each patient admitted. Unless otherwise specified, all required clinical assessment are completed prior to development of the interdisciplinary treatment plan.</P>
            <P>(<E T="03">7</E>) <E T="03">Clinical formulation.</E> A qualified mental health provider of the PHP will complete a clinical formulation on all patients. The clinical formulation will be reviewed and approved by the responsible individual professional provider and will incorporate significant findings from each of the multidisciplinary assessments. It will provide the basis for development of an interdisciplinary treatment plan.</P>
            <P>(<E T="03">8</E>) <E T="03">Treatment planning.</E> A qualified mental health professional with admitting privileges shall be responsible for the development, supervision, implementation, and assessment of a written, individualized, interdisciplinary plan of treatment, which shall be completed by the fifth day following admission to a full-day PHP, or by the seventh day following admission to a half-day PHP, and shall include measurable and observable goals for incremental progress and discharge. The treatment plan shall undergo review at least every two weeks, or when major changes occur in treatment.</P>
            <P>(<E T="03">9</E>) <E T="03">Discharge and transition planning.</E> The PHP shall develop an individualized transition plan which addresses anticipated needs of the patient at discharge. The transition plan involves determining necessary modifications in the treatment plan, facilitating the termination of treatment, and identifying resources for maintaining therapeutic stability following discharge.</P>
            <P>(<E T="03">10</E>) <E T="03">Clinical documentation.</E> Clinical records shall be maintained on each patient to plan care and treatment and provide ongoing evaluation of the patient's progress. All care is documented and each clinical record contains at least the following: demographic data, consent forms, pertinent legal documents, all treatment plans and patient assessments, consultation and laboratory reports, physician orders, progress notes, and a discharge summary. All documentation will adhere to applicable provisions of the JCAHO and requirements set forth in § 199.7(b)(3). An appropriately qualified records administrator or technician will supervise and maintain the quality of the records. These requirements are in addition to other records requirements of this part, and documentation requirements of the Joint Commission on Accreditation of Health Care Organization.</P>
            <P>(<E T="03">11</E>) <E T="03">Progress notes.</E> PHPs shall document the course of treatment for patients and families using progress notes which provide information to review, analyze, and modify the treatment plans. Progress notes are legible, contemporaneous, sequential, signed and dated and adhere to applicable provisions of the Manual for Mental Health, Chemical Dependency, and Mental Retardation/Developmental Disabilities Services and requirements set forth in section 199.7(b)(3).</P>
            <P>(<E T="03">12</E>) <E T="03">Therapeutic services.</E>
            </P>
            <P>(<E T="03">i</E>) Individual, group, and family therapy are provided to all patients, consistent with each patient's treatment <PRTPAGE P="158"/>plan by qualified mental health providers.</P>
            <P>(<E T="03">ii</E>) A range of therapeutic activities, directed and staffed by qualified personnel, are offered to help patients meet the goals of the treatment plan.</P>
            <P>(<E T="03">iii</E>) Educational services are provided or arranged that are appropriate to the patient's needs.</P>
            <P>(<E T="03">13</E>) <E T="03">Ancillary services.</E> A full range of ancillary services are provided. Emergency services include policies and procedures for handling emergencies with qualified personnel and written agreements with each facility providing these services. Other ancillary services include physical health, pharmacy and dietary services.</P>
            <P>(C) <E T="03">Standards for physical plant and environment.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Physical environment.</E> The buildings and grounds of the PHP shall be maintained so as to avoid health and safety hazards, be supportive of the services provided to patients, and promote patient comfort, dignity, privacy, personal hygiene, and personal safety.</P>
            <P>(<E T="03">2</E>) <E T="03">Physical plant safety.</E> The PHP shall be of permanent construction and maintained in a manner that protects the lives and ensures the physical safety of patients, staff, and visitors, including conformity with all applicable building, fire, health, and safety codes.</P>
            <P>(<E T="03">3</E>) <E T="03">Disaster planning.</E> The PHP shall maintain and rehearse written plans for taking care of casualities and handling other consequences arising from internal and external disasters.</P>
            <P>(D) <E T="03">Standards for evaluation system.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Quality assessment and improvement.</E> The PHP shall develop and implement a comprehensive quality assurance and quality improvement program that monitors the quality, efficiency, appropriateness, and effectiveness of care, treatments, and services the PHP provides for patients and their families. Explicit clinical indicators shall be used to be used to evaluate all functions of the PHP and contribute to an ongoing process of program improvement. The clinical director is responsible for developing and implementing quality assessment and improvement activities throughout the facility.</P>
            <P>(<E T="03">2</E>) <E T="03">Utilization review.</E> The PHP shall implement a utilization review process, pursuant to a written plan approved by the professional staff, the administration and the governing body, that assesses distribution of services, clinical necessity of treatment, appropriateness of admission, continued stay, and timeliness of discharge, as part of an overall effort to provide quality patient care in a cost-effective manner. Findings of the utilization review process are used as a basis for revising the plan of operation, including a review of staff qualifications and staff composition.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient records.</E> The PHP shall implement a process, including regular monthly reviews of a representative sample of patient records, to determine completeness, accuracy, timeliness of entries, appropriate signatures, and pertinence of clinical entries. Conclusions, recommendations, actions taken, and the results of actions are monitored and reported.</P>
            <P>(<E T="03">4</E>) <E T="03">Drug utilization review.</E> The PHP shall implement a comprehensive process for the monitoring and evaluating of the prophylactic, therapeutic, and empiric use of drugs to assure that medications are provided appropriately, safely, and effectively.</P>
            <P>(<E T="03">5</E>) <E T="03">Risk management.</E> The PHP shall implement a comprehensive risk management program, fully coordinated with other aspects of the quality assurance and quality improvement program, to prevent and control risks to patients and staff, and to minimize costs associated with clinical aspects of patient care and safety.</P>
            <P>(<E T="03">6</E>) <E T="03">Infection control.</E> The PHP shall implement a comprehensive system for the surveillance, prevention, control, and reporting of infections acquired or brought into the facility.</P>
            <P>(<E T="03">7</E>) <E T="03">Safety.</E> The PHP shall implement an effective program to assure a safe environment for patients, staff, and visitors, including an incident reporting system, disaster training and safety education, a continuous safety surveillance system, and an active multidisciplinary safety committee.</P>
            <P>(<E T="03">8</E>) <E T="03">Facility evaluation.</E> The PHP annually evaluates accomplishment of the goals and objectives of each clinical program component or facility service of the PHP and reports findings and recommendations to the governing body.<PRTPAGE P="159"/>
            </P>
            <P>(E) <E T="03">Participation agreement requirements.</E> In addition to other requirements set forth in paragraph (b)(4)(xii) of this section, in order for the services of a PHP to be authorized, the PHP shall have entered into a Participation Agreement with OCHAMPUS. The period of a Participation Agreement shall be specified in the agreement, and will generally be for not more than five years. On October 1, 1995, the PHP shall not be considered to be a CHAMPUS authorized provider and CHAMPUS payments shall not be made for services provided by the PHP until the date the participation agreement is signed by the Director, OCHAMPUS. In addition to review of a facility's application and supporting documentation, an on-site inspection by OCHAMPUS authorized personnel may be required prior to signing a participation agreement. The Participation Agreement shall include at least the following requirements:</P>
            <P>(<E T="03">1</E>) Render partial hospitalization program services to eligible CHAMPUS beneficiaries in need of such services, in accordance with the participation agreement and CHAMPUS regulation.</P>
            <P>(<E T="03">2</E>) Accept payment for its services based upon the methodology provided in § 199.14, or such other method as determined by the Director, OCHAMPUS;</P>
            <P>(<E T="03">3</E>) Accept the CHAMPUS all-inclusive per diem rate as payment in full and collect from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability, as defined in § 199.4, and charges for services and supplies that are not a benefit of CHAMPUS;</P>
            <P>(<E T="03">4</E>) Make all reasonable efforts acceptable to the Director, OCHAMPUS, to collect those amounts, which represent the beneficiary's liability, as defined in § 199.4;</P>
            <P>(<E T="03">5</E>) Comply with the provisions of § 199.8, and submit claims first to all health insurance coverage to which the beneficiary is entitled that is primary to CHAMPUS;</P>
            <P>(<E T="03">6</E>) Submit claims for services provided to CHAMPUS beneficiaries at least every 30 days (except to the extent a delay is necessitated by efforts to first collect from other health insurance). If claims are not submitted at least every 30 days, the PHP agrees not to bill the beneficiary or the beneficiary's family for any amounts disallowed by CHAMPUS;</P>
            <P>(<E T="03">7</E>) Certify that:</P>
            <P>(<E T="03">i</E>) It is and will remain in compliance with the provisions of paragraph (b)(4)(xii) of this section establishing standards for psychiatric partial hospitalization programs;</P>
            <P>(<E T="03">ii</E>) It has conducted a self assessment of the facility's compliance with the CHAMPUS Standards for Psychiatric Partial Hospitalization Programs, as issued by the Director, OCHAMPUS, and notified the Director, OCHAMPUS of any matter regarding which the facility is not in compliance with such standards; and</P>
            <P>(<E T="03">iii</E>) It will maintain compliance with the CHAMPUS Standards for Psychiatric Partial Hospitalization Programs, as issued by the Director, OCHAMPUS, except for any such standards regarding which the facility notifies the Director, OCHAMPUS that it is not in compliance.</P>
            <P>(<E T="03">8</E>) Designate an individual who will act as liaison for CHAMPUS inquiries. The PHP shall inform OCHAMPUS in writing of the designated individual;</P>
            <P>(<E T="03">9</E>) Furnish OCHAMPUS with cost data, as requested by OCHAMPUS, certified by an independent accounting firm or other agency as authorized by the Director, OCHAMPUS;</P>
            <P>(<E T="03">10</E>) Comply with all requirements of this section applicable to institutional providers generally concerning preauthorization, concurrent care review, claims processing, beneficiary liability, double coverage, utilization and quality review and other matters;</P>
            <P>(<E T="03">11</E>) Grant the Director, OCHAMPUS, or designee, the right to conduct quality assurance audits or accounting audits with full access to patients and records (including records relating to patients who are not CHAMPUS beneficiaries) to determine the quality and cost-effectiveness of care rendered. The audits may be conducted on a scheduled or unscheduled (unannounced) basis. This right to audit/review includes, but is not limited to:</P>
            <P>(<E T="03">i</E>) Examination of fiscal and all other records of the PHP which would confirm compliance with the participation <PRTPAGE P="160"/>agreement and designation as an authorized CHAMPUS PHP provider;</P>
            <P>(<E T="03">ii</E>) Conducting such audits of PHP records including clinical, financial, and census records, as may be necessary to determine the nature of the services being provided, and the basis for charges and claims against the United States for services provided CHAMPUS beneficiaries;</P>
            <P>(<E T="03">iii</E>) Examining reports of evaluations and inspections conducted by federal, state and local government, and private agencies and organizations;</P>
            <P>(<E T="03">iv</E>) Conducting on-site inspections of the facilities of the PHP and interreviewing employees, members of the staff, contractors, board members, volunteers, and patients, as required;</P>
            <P>(<E T="03">v</E>) Audits conducted by the United States General Account Office.</P>
            <P>(F) <E T="03">Other requirements applicable to PHPs.</E>
            </P>
            <P>(<E T="03">1</E>) Even though a PHP may qualify as a CHAMPUS-authorized provider and may have entered into a participation agreement with CHAMPUS, payment by CHAMPUS for particular services provided is contingent upon the PHP also meeting all conditions set forth in section 199.4 of this part.</P>
            <P>(<E T="03">2</E>) The PHP shall provide patient services to CHAMPUS beneficiaries in the same manner it provides inpatient services to all other patients. The PHP may not discriminate against CHAMPUS beneficiaries in any manner, including admission practices, placement in special or separate wings or rooms, or provisions of special or limited treatment.</P>
            <P>(<E T="03">3</E>) The PHP shall assure that all certifications and information provided to the Director, OCHAMPUS incident to the process of obtaining and retaining authorized provider status is accurate and that is has no material errors or omissions. In the case of any misrepresentations, whether by inaccurate information being provided or material facts withheld, authorized provider status will be denied or terminated, and the PHP will be ineligible for consideration for authorized provider status for a two year period.</P>
            <P>(xiii) <E T="03">Hospice programs.</E> Hospice programs must be Medicare approved and meet all Medicare conditions of participation (42 CFR part 418) in relation to CHAMPUS patients in order to receive payment under the CHAMPUS program. A hospice program may be found to be out of compliance with a particular Medicare condition of participation and still participate in the CHAMPUS as long as the hospice is allowed continued participation in Medicare while the condition of noncompliance is being corrected. The hospice program can be either a public agency or private organization (or a subdivision thereof) which:</P>
            <P>(A) Is primarily engaged in providing the care and services described under § 199.4(e)(19) and makes such services available on a 24-hour basis.</P>
            <P>(B) Provides bereavement counseling for the immediate family or terminally ill individuals.</P>
            <P>(C) Provides for such care and services in individuals’ homes, on an outpatient basis, and on a short-term inpatient basis, directly or under arrangements made by the hospice program, except that the agency or organization must:</P>
            <P>(<E T="03">1</E>) Ensure that substantially all the core services are routinely provided directly by hospice employees.</P>
            <P>(<E T="03">2</E>) Maintain professional management responsibility for all services which are not directly furnished to the patient, regardless of the location or facility in which the services are rendered.</P>
            <P>(<E T="03">3</E>) Provide assurances that the aggregate number of days of inpatient care provided in any 12-month period does not exceed 20 percent of the aggregate number of days of hospice care during the same period.</P>
            <P>(<E T="03">4</E>) Have an interdisciplinary group composed of the following personnel who provide the care and services described under § 199.4(e)(19) and who establish the policies governing the provision of such care/services:</P>
            <P>(<E T="03">i</E>) A physician;</P>
            <P>(<E T="03">ii</E>) A registered professional nurse;</P>
            <P>(<E T="03">iii</E>) A social worker; and</P>
            <P>(<E T="03">iv</E>) A pastoral or other counselor.</P>
            <P>(<E T="03">5</E>) Maintain central clinical records on all patients.</P>
            <P>(<E T="03">6</E>) Utilize volunteers.</P>
            <P>(<E T="03">7</E>) The hospice and all hospice employees must be licensed in accordance with applicable Federal, State and local laws and regulations.<PRTPAGE P="161"/>
            </P>
            <P>(<E T="03">8</E>) The hospice must enter into an agreement with CHAMPUS in order to be qualified to participate and to be eligible for payment under the program. In this agreement the hospice and CHAMPUS agree that the hospice will:</P>
            <P>(<E T="03">i</E>) Not charge the beneficiary or any other person for items or services for which the beneficiary is entitled to have payment made under the CHAMPUS hospice benefit.</P>
            <P>(<E T="03">ii</E>) Be allowed to charge the beneficiary for items or services requested by the beneficiary in addition to those that are covered under the CHAMPUS hospice benefit.</P>
            <P>(<E T="03">9</E>) Meet such other requirements as the Secretary of Defense may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization.</P>
            <P>(xiv) <E T="03">Substance use disorder rehabilitation facilities.</E> Paragraph (b)(4)(xiv) of this section establishes standards and requirements for substance use order rehabilitation facilities (SUDRF). This includes both inpatient rehabilitation centers for the treatment of substance use disorders and partial hospitalization centers for the treatment of substance use disorders.</P>
            <P>(A) <E T="03">Organization and administration.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Definition of inpatient rehabilitation center.</E> An inpatient rehabilitation center is a facility, or distinct part of a facility, that provides medically monitored, interdisciplinary addiction-focused treatment to beneficiaries who have psychoactive substance use disorders. Qualified health care professionals provide 24-hour, seven-day-per-week, medically monitored assessment, treatment, and evaluation. An inpatient rehabilitation center is appropriate for patients whose addiction-related symptoms, or concomitant physical and emotional/behavioral problems reflect persistent dysfunction in several major life areas. Inpatient rehabilitation is differentiated from:</P>
            <P>(<E T="03">i</E>) Acute psychoactive substance use treatment and from treatment of acute biomedical/emotional/behavioral problems; which problems are either life-threatening and/or severely incapacitating and often occur within the context of a discrete episode of addiction-related biomedical or psychiatric dysfunction;</P>
            <P>(<E T="03">ii</E>) A partial hospitalization center, which serves patients who exhibit emotional/behavioral dysfunction but who can function in the community for defined periods of time with support in one or more of the major life areas;</P>
            <P>(<E T="03">iii</E>) A group home, sober-living environment, halfway house, or three-quarter way house;</P>
            <P>(<E T="03">iv</E>) Therapeutic schools, which are educational programs supplemented by addiction-focused services;</P>
            <P>(<E T="03">v</E>) Facilities that treat patients with primary psychiatric diagnoses other than psychoactive substance use or dependence; and</P>
            <P>(<E T="03">vi</E>) Facilities that care for patients with the primary diagnosis of mental retardation or developmental disability.</P>
            <P>(<E T="03">2</E>) <E T="03">Definition of partial hospitalization center for the treatment of substance use disorders.</E> A partial hospitalization center for the treatment of substance use disorders is an addiction-focused service that provides active treatment to adolescents between the ages of 13 and 18 or adults aged 18 and over. Partial hospitalization is a generic term for day, evening, or weekend programs that treat patients with psychoactive substance use disorders according to a comprehensive, individualized, integrated schedule of care. A partial hospitalization center is organized, interdisciplinary, and medically monitored. Partial hospitalization is appropriate for those whose addiction-related symptoms or concomitant physical and emotional/behavioral problems can be managed outside the hospital environment for defined periods of time with support in one or more of the major life areas.</P>
            <P>(<E T="03">3</E>) <E T="03">Eligibility.</E>
            </P>
            <P>(<E T="03">i</E>) Every inpatient rehabilitation center and partial hospitalization center for the treatment of substance use disorders must be certified pursuant to CHAMPUS certification standards. Such standards shall incorporate the basic standards set forth in paragraphs (b)(4)(xiv) (A) through (D) of this section, and shall include such additional elaborative criteria and standards as the Director, OCHAMPUS determines <PRTPAGE P="162"/>are necessary to implement the basic standards.</P>
            <P>(<E T="03">ii</E>) To be eligible for CHAMPUS certification, the SUDRF is required to be licensed and fully operational (with a minimum patient census of the lesser of: six patients or 30 percent of bed capacity) for a period of at least six months and operate in substantial compliance with state and federal regulations.</P>
            <P>(<E T="03">iii</E>) The SUDRF is currently accredited by the Joint Commission on Accreditation of Healthcare Organizations under the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation/Developmental Disabilities Services, or by the Commission on Accreditation of Rehabilitation Facilities as an alcoholism and other drug dependency rehabilitation program under the Standards Manual for Organizations Serving People with Disabilities, or other designated standards approved by the Director, OCHAMPUS.</P>
            <P>(<E T="03">iv</E>) The SUDRF has a written participation agreement with OCHAMPUS. On October 1, 1995, the SUDRF is not considered a CHAMPUS-authorized provider, and CHAMPUS benefits are not paid for services provided until the date upon which a participation agreement is signed by the Director, OCHAMPUS.</P>
            <P>(<E T="03">4</E>) <E T="03">Governing body.</E>
            </P>
            <P>(<E T="03">i</E>) The SUDRF shall have a governing body which is responsible for the policies, bylaws, and activities of the facility. If the SUDRF is owned by a partnership or single owner, the partners or single owner are regarded as the governing body. The facility will provide an up-to-date list of names, addresses, telephone numbers and titles of the members of the governing body.</P>
            <P>(<E T="03">ii</E>) The governing body ensures appropriate and adequate services for all patients and oversees continuing development and improvement of care. Where business relationships exist between the governing body and facility, appropriate conflict-of-interest policies are in place.</P>
            <P>(<E T="03">iii</E>) Board members are fully informed about facility services and the governing body conducts annual reviews of its performance in meeting purposes, responsibilities, goals and objectives.</P>
            <P>(<E T="03">5</E>) <E T="03">Chief executive officer</E>. The chief executive officer, appointed by and subject to the direction of the governing body, shall assume overall administrative responsibility for the operation of the facility according to governing body policies. The chief executive officer shall have five years’ administrative experience in the field of mental health or addictions. On October 1, 1997 the CEO shall possess a degree in business administration, public health, hospital administration, nursing, social work, or psychology, or meet similar educational requirements as prescribed by the Director, OCHAMPUS.</P>
            <P>(<E T="03">6</E>) <E T="03">Clinical Director.</E> The clinical director, appointed by the governing body, shall be a qualified psychiatrist or doctoral level psychologist who meets applicable CHAMPUS requirements for individual professional providers and is licensed to practice in the state where the SUDRF is located. The clinical director shall possess requisite education and experience, including credentials applicable under state practice and licensing laws appropriate to the professional discipline. The clinical director shall satisfy at least one of the following requirements: certification by the American Society of Addiction Medicine; one year or 1,000 hours of experience in the treatment of psychoactive substance use disorders; or is a psychiatrist or doctoral level psychologist with experience in the treatment of substance use disorders. The clinical director shall be responsible for planning, development, implementation, and monitoring of all clinical activities.</P>
            <P>(<E T="03">7</E>) <E T="03">Medical director.</E> The medical director, appointed by the governing body, shall be licensed to practice medicine in the state where the center is located and shall possess requisite education including graduation from an accredited school of medicine or osteopathy. The medical director shall satisfy at least one of the following requirements: certification by the American Society of Addiction Medicine; one year or 1,000 hours of experience in <PRTPAGE P="163"/>the treatment of psychoactive substance use disorders; or is a psychiatrist with experience in the treatment of substance use disorders. The medical director shall be responsible for the planning, development, implementation, and monitoring of all activities relating to medical treatment of patients. If qualified, the Medical Director may also serve as Clinical Director.</P>
            <P>(<E T="03">8</E>) <E T="03">Medical or professional staff organization.</E> The governing body shall establish a medical or professional staff organization to assure effective implementation of clinical privileging, professional conduct rules, and other activities directly affecting patient care.</P>
            <P>(<E T="03">9</E>) <E T="03">Personnel policies and records.</E> The SUDRF shall maintain written personnel policies, updated job descriptions, personnel records to assure the selection of qualified personnel and successful job performance of those personnel.</P>
            <P>(<E T="03">10</E>) <E T="03">Staff development.</E> The SUDRF shall provide appropriate training and development programs for administrative, support, and direct care staff.</P>
            <P>(<E T="03">11</E>) <E T="03">Fiscal accountability.</E> The SUDRF shall assure fiscal accountability to applicable government authorities and patients.</P>
            <P>(<E T="03">12</E>) <E T="03">Designated teaching facilities.</E> Students, residents, interns, or fellows providing direct clinical care are under the supervision of a qualified staff member approved by an accredited university or approved training program. The teaching program is approved by the Director, OCHAMPUS.</P>
            <P>(<E T="03">13</E>) <E T="03">Emergency reports and records.</E> The facility notifies OCHAMPUS of any serious occurrence involving CHAMPUS beneficiaries.</P>
            <P>(B) <E T="03">Treatment services.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Staff composition.</E>
            </P>
            <P>(<E T="03">i</E>) The SUDRF shall follow written plans which assure that medical and clinical patient needs will be appropriately addressed during all hours of operation by a sufficient number of fully qualified (including license, registration or certification requirements, educational attainment, and professional experience) health care professionals and support staff in the respective disciplines. Clinicians providing individual, group and family therapy meet CHAMPUS requirements as qualified mental health providers and operate within the scope of their licenses. The ultimate authority for planning, development, implementation, and monitoring of all clinical activities is vested in a psychiatrist or doctoral level clinical psychologist. The management of medical care is vested in a physician.</P>
            <P>(<E T="03">ii</E>) The SUDRF shall establish and follow written plans to assure adequate staff coverage during all hours of operation of the center, including physician availability and other professional staff coverage 24 hours per day, seven days per week for an inpatient rehabilitation center and during all hours of operation for a partial hospitalization center.</P>
            <P>(<E T="03">2</E>) <E T="03">Staff qualifications.</E> Within the scope of its programs and services, the SUDRF has a sufficient number of professional, administrative, and support staff to address the medical and clinical needs of patients and to coordinate the services provided. SUDRFs that employ individuals with master's or doctoral level degrees in a mental health discipline who do not meet the licensure, certification and experience requirements for a qualified mental health provider but are actively working toward licensure or certification, may provide services within the DRG, provided the individual works under the clinical supervision of a fully qualified mental health provider employed by the SUDRF.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient rights.</E>
            </P>
            <P>(<E T="03">i</E>) The SUDRF shall provide adequate protection for all patient rights, safety, confidentiality, informed consent, grievances, and personal dignity.</P>
            <P>(<E T="03">ii</E>) The SUDRF has a written policy regarding patient abuse and neglect.</P>
            <P>(<E T="03">iii</E>) SUDRF marketing and advertising meets professional standards.</P>
            <P>(<E T="03">4</E>) <E T="03">Behavioral management.</E> When a SUDRF uses a behavioral management program, the center shall adhere to a comprehensive, written plan of behavioral management, developed by the clinical director and the medical or professional staff and approved by the governing body. It shall be based on positive reinforcement methods and, except for infrequent use of temporary physical holds or time outs, does not <PRTPAGE P="164"/>include the use of restraint or seclusion. Only trained and clinically privileged RNs or qualified mental health professionals may be responsible for the implementation of seclusion and restraint in an emergency situation.</P>
            <P>(<E T="03">5</E>) <E T="03">Admission process</E>. The SUDRF shall maintain written policies and procedures to ensure that, prior to an admission, a determination is made, and approved pursuant to CHAMPUS preauthorization requirements, that the admission is medically and/or psychologically necessary and the program is appropriate to meet the patient's needs. Medical and/or psychological necessity determinations shall be rendered by qualified mental health professionals who meet CHAMPUS requirements for individual professional providers and who are permitted by law and by the facility to refer patients for admission.</P>
            <P>(<E T="03">6</E>) <E T="03">Assessment.</E> The professional staff of the SUDRF shall provide a complete, multidisciplinary assessment of each patient which includes, but is not limited to, medical history, physical health, nursing needs, alcohol and drug history, emotional and behavioral factors, age-appropriate social circumstances, psychological condition, education status, and skills. Unless otherwise specified, all required clinical assessments are completed prior to development of the multidisciplinary treatment plan.</P>
            <P>(<E T="03">7</E>) <E T="03">Clinical formulation.</E> A qualified mental health care professional of the SUDRF will complete a clinical formulation on all patients. The clinical formulation will be reviewed and approved by the responsible individual professional provider and will incorporate significant findings from each of the multidisciplinary assessments. It will provide the basis for development of an interdisciplinary treatment plan.</P>
            <P>(<E T="03">8</E>) <E T="03">Treatment planning.</E> A qualified health care professional with admitting privileges shall be responsible for the development, supervision, implementation, and assessment of a written, individualized, and interdisciplinary plan of treatment, which shall be completed within 10 days of admission to an inpatient rehabilitation center or by the fifth day following admission to full day partial hospitalization center, and by the seventh day of treatment for half day partial hospitalization. The treatment plan shall include individual, measurable, and observable goals for incremental progress towards the treatment plan objectives and goals and discharge. A preliminary treatment plan is completed within 24 hours of admission and includes at least a physician's admission note and orders. The master treatment plan is regularly reviewed for effectiveness and revised when major changes occur in treatment.</P>
            <P>(<E T="03">9</E>) <E T="03">Discharge and transition planning.</E> The SUDRF shall maintain a transition planning process to address adequately the anticipated needs of the patient prior to the time of discharge.</P>
            <P>(<E T="03">10</E>) <E T="03">Clinical documentation.</E> Clinical records shall be maintained on each patient to plan care and treatment and provide ongoing evaluation of the patient's progress. All care is documented and each clinical record contains at least the following: demographic data, consent forms, pertinent legal documents, all treatment plans and patient assessments, consultation and laboratory reports, physician orders, progress notes, and a discharge summary. All documentation will adhere to applicable provisions of the JCAHO and requirements set forth in § 199.7(b)(3). An appropriately qualified records administrator or technician will supervise and maintain the quality of the records. These requirements are in addition to other records requirements of this part, and provisions of the JCAHO Manual for Mental Health, Chemical Dependency, and Mental Retardation/Developmental Disabilities Services.</P>
            <P>(<E T="03">11</E>) <E T="03">Progress notes.</E> Timely and complete progress notes shall be maintained to document the course of treatment for the patient and family.</P>
            <P>(<E T="03">12</E>) <E T="03">Therapeutic services.</E>
            </P>
            <P>(<E T="03">i</E>) Individual, group, and family psychotherapy and addiction counseling services are provided to all patients, consistent with each patient's treatment plan by qualified mental health providers.</P>
            <P>(<E T="03">ii</E>) A range of therapeutic activities, directed and staffed by qualified personnel, are offered to help patients meet the goals of the treatment plan.<PRTPAGE P="165"/>
            </P>
            <P>(<E T="03">iii</E>) Therapeutic educational services are provided or arranged that are appropriate to the patient's educational and therapeutic needs.</P>
            <P>(<E T="03">13</E>) <E T="03">Ancillary services.</E> A full range of ancillary services is provided. Emergency services include policies and procedures for handling emergencies with qualified personnel and written agreements with each facility providing the service. Other ancillary services include physical health, pharmacy and dietary services.</P>
            <P>(C) <E T="03">Standards for physical plant and environment.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Physical environment.</E> The buildings and grounds of the SUDRF shall be maintained so as to avoid health and safety hazards, be supportive of the services provided to patients, and promote patient comfort, dignity, privacy, personal hygiene, and personal safety.</P>
            <P>(<E T="03">2</E>) <E T="03">Physical plant safety.</E> The SUDRF shall be maintained in a manner that protects the lives and ensures the physical safety of patients, staff, and visitors, including conformity with all applicable building, fire, health, and safety codes.</P>
            <P>(<E T="03">3</E>) <E T="03">Disaster planning.</E> The SUDRF shall maintain and rehearse written plans for taking care of casualties and handling other consequences arising from internal or external disasters.</P>
            <P>(D) <E T="03">Standards for evaluation system.</E>
            </P>
            <P>(<E T="03">1</E>) <E T="03">Quality assessment and improvement.</E> The SUDRF develop and implement a comprehensive quality assurance and quality improvement program that monitors the quality, efficiency, appropriateness, and effectiveness of the care, treatments, and services it provides for patients and their families, utilizing clinical indicators of effectiveness to contribute to an ongoing process of program improvement. The clinical director is responsible for developing and implementing quality assessment and improvement activities throughout the facility.</P>
            <P>(<E T="03">2</E>) <E T="03">Utilization review.</E> The SUDRF shall implement a utilization review process, pursuant to a written plan approved by the professional staff, the administration, and the governing body, that assesses the appropriateness of admissions, continued stay, and timeliness of discharge as part of an effort to provide quality patient care in a cost-effective manner. Findings of the utilization review process are used as a basis for revising the plan of operation, including a review of staff qualifications and staff composition.</P>
            <P>(<E T="03">3</E>) <E T="03">Patient records review.</E> The center shall implement a process, including monthly reviews of a representative sample of patient records, to determine the completeness and accuracy of the patient records and the timeliness and pertinence of record entries, particularly with regard to regular recording of progress/non-progress in treatment plan.</P>
            <P>(<E T="03">4</E>) <E T="03">Drug utilization review.</E> An inpatient rehabilitation center and, when applicable, a partial hospitalization center, shall implement a comprehensive process for the monitoring and evaluating of the prophylactic, therapeutic, and empiric use of drugs to assure that medications are provided appropriately, safely, and effectively.</P>
            <P>(<E T="03">5</E>) <E T="03">Risk management.</E> The SUDRF shall implement a comprehensive risk management program, fully coordinated with other aspects of the quality assurance and quality improvement program, to prevent and control risks to patients and staff and costs associated with clinical aspects of patient care and safety.</P>
            <P>(<E T="03">6</E>) <E T="03">Infection control.</E> The SUDRF shall implement a comprehensive system for the surveillance, prevention, control, and reporting of infections acquired or brought into the facility.</P>
            <P>(<E T="03">7</E>) <E T="03">Safety.</E> The SUDRF shall implement an effective program to assure a safe environment for patients, staff, and visitors.</P>
            <P>(<E T="03">8</E>) <E T="03">Facility evaluation.</E> The SUDRF annually evaluates accomplishment of the goals and objectives of each clinical program and service of the SUDRF and reports findings and recommendations to the governing body.</P>
            <P>(<E T="03">E</E>) <E T="03">Participation agreement requirements.</E> In addition to other requirements set forth in paragraph (b)(4)(xiv) of this section, in order for the services of an inpatient rehabilitation center or partial hospitalization center for the treatment of substance abuse disorders to be authorized, the center shall have entered into a Participation Agreement with OCHAMPUS. The period of a <PRTPAGE P="166"/>Participation Agreement shall be specified in the agreement, and will generally be for not more than five years. On October 1, 1995, the SUDRF shall not be considered to be a CHAMPUS authorized provider and CHAMPUS payments shall not be made for services provided by the SUDRF until the date the participation agreement is signed by the Director, OCHAMPUS. In addition to review of the SUDRFS application and supporting documentation, an on-site visit by OCHAMPUS representatives may be part of the authorization process. In addition, such a Participation Agreement may not be signed until an SUDRF has been licensed and operational for at least six months. The Participation Agreement shall include at least the following requirements:</P>
            <P>(<E T="03">1</E>) Render applicable services to eligible CHAMPUS beneficiaries in need of such services, in accordance with the participation agreement and CHAMPUS regulation;</P>
            <P>(<E T="03">2</E>) Accept payment for its services based upon the methodology provided in § 199.14, or such other method as determined by the Director, OCHAMPUS;</P>
            <P>(<E T="03">3</E>) Accept the CHAMPUS-determined rate as payment in full and collect from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability, as defined in § 199.4, and charges for services and supplies that are not a benefit of CHAMPUS;</P>
            <P>(<E T="03">4</E>) Make all reasonable efforts acceptable to the Director, OCHAMPUS, to collect those amounts which represent the beneficiary's liability, as defined in § 199.4;</P>
            <P>(<E T="03">5</E>) Comply with the provisions of § 199.8, and submit claims first to all health insurance coverage to which the beneficiary is entitled that is primary to CHAMPUS;</P>
            <P>(<E T="03">6</E>) Furnish OCHAMPUS with cost data, as requested by OCHAMPUS, certified to by an independent accounting firm or other agency as authorized by the Director, OCHAMPUS;</P>
            <P>(<E T="03">7</E>) Certify that:</P>
            <P>(<E T="03">i</E>) It is and will remain in compliance with the provisions of paragraph (b)(4)(xiv) of the section establishing standards for substance use disorder rehabilitation facilities;</P>
            <P>(<E T="03">ii</E>) It has conducted a self assessment of the SUDRF'S compliance with the CHAMPUS Standards for Substance Use Disorder Rehabilitation Facilities, as issued by the Director, OCHAMPUS, and notified the Director, OCHAMPUS of any matter regarding which the facility is not in compliance with such standards; and</P>
            <P>(<E T="03">iii</E>) It will maintain compliance with the CHAMPUS Standards for Substance Use Disorder Rehabilitation Facilities, as issued by the Director, OCHAMPUS, except for any such standards regarding which the facility notifies the Director, OCHAMPUS that it is not in compliance.</P>
            <P>(<E T="03">8</E>) Grant the Director, OCHAMPUS, or designee, the right to conduct quality assurance audits or accounting audits with full access to patients and records (including records relating to patients who are not CHAMPUS beneficiaries) to determine the quality and cost effectiveness of care rendered. The audits may be conducted on a scheduled or unscheduled (unannounced) basis. This right to audit/review included, but is not limited to:</P>
            <P>(<E T="03">i</E>) Examination of fiscal and all other records of the center which would confirm compliance with the participation agreement and designation as an authorized CHAMPUS provider;</P>
            <P>(<E T="03">ii</E>) Conducting such audits of center records including clinical, financial, and census records, as may be necessary to determine the nature of the services being provided, and the basis for charges and claims against the United States for services provided CHAMPUS beneficiaries;</P>
            <P>(<E T="03">iii</E>) Examining reports of evaluations and inspection conducted by federal, state and local government, and private agencies and organizations;</P>
            <P>(<E T="03">iv</E>) Conducting on-site inspections of the facilities of the SUDRF and interviewing employees, members of the staff, contractors, board members, volunteers, and patients, as required.</P>
            <P>(<E T="03">v</E>) Audits conducted by the United States General Accounting Office.</P>
            <P>(F) <E T="03">Other requirements applicable to substance use disorder rehabilitation facilities.</E>
              <PRTPAGE P="167"/>
            </P>
            <P>(<E T="03">1</E>) Even though a SUDRF may qualify as a CHAMPUS-authorized provider and may have entered into a participation agreement with CHAMPUS, payment by CHAMPUS for particular services provided is contingent upon the SUDRF also meeting all conditions set forth in § 199.4.</P>
            <P>(<E T="03">2</E>) The center shall provide inpatient services to CHAMPUS beneficiaries in the same manner it provides services to all other patients. The center may not discriminate against CHAMPUS beneficiaries in any manner, including admission practices, placement in special or separate wings or rooms, or provisions of special or limited treatment.</P>
            <P>(<E T="03">3</E>) The substance use disorder facility shall assure that all certifications and information provided to the Director, OCHAMPUS incident to the process of obtaining and retaining authorized provider status is accurate and that it has no material errors or omissions. In the case of any misrepresentations, whether by inaccurate information being provided or material facts withheld, authorized provider status will be denied or terminated, and the facility will be ineligible for consideration forauthorized provider status for a two year period.</P>
            <P>(c) <E T="03">Individual professional providers of care</E>—(1) <E T="03">General</E>—(i) <E T="03">Purpose.</E> This individual professional provider class is established to accommodate individuals who are recognized by 10 U.S.C. 1079(a) as authorized to assess or diagnose illness, injury, or bodily malfunction as a prerequisite for CHAMPUS cost-share of otherwise allowable related preventive or treatment services or supplies, and to accommodate such other qualified individuals who the Director, OCHAMPUS, or designee, may authorize to render otherwise allowable services essential to the efficient implementation of a plan-of-care established and managed by a 10 U.S.C. 1079(a) authorized professional.</P>
            <P>(ii) <E T="03">Professional corporation affiliation or association membership permitted.</E> Paragraph (c) of this section applies to those individual health care professionals who have formed a professional corporation or association pursuant to applicable state laws. Such a professional corporation or association may file claims on behalf of a CHAMPUS-authorized individual professional provider and be the payee for any payment resulting from such claims when the CHAMPUS-authorized individual certifies to the Director, OCHAMPUS, or designee, in writing that the professional corporation or association is acting on the authorized individual's behalf.</P>
            <P>(iii) <E T="03">Scope of practice limitation.</E> For CHAMPUS cost-sharing to be authorized, otherwise allowable services provided by a CHAMPUS-authorized individual professional provider shall be within the scope of the individual's license as regulated by the applicable state practice act of the state where the individual rendered the service to the CHAMPUS beneficiary or shall be within the scope of the test which was the basis for the individual's qualifying certification.</P>
            <P>(iv) <E T="03">Employee status exclusion.</E> An individual employed directly, or indirectly by contract, by an individual or entity to render professional services otherwise allowable by this part is excluded from provider status as established by this paragraph (c) for the duration of each employment.</P>
            <P>(v) <E T="03">Training status exclusion.</E> Individual health care professionals who are allowed to render health care services only under direct and ongoing supervision as training to be credited towards earning a clinical academic degree or other clinical credential required for the individual to practice independently are excluded from provider status as established by this paragraph (c) for the duration of such training.</P>
            <P>(2) <E T="03">Conditions of authorization</E>—(i) <E T="03">Professional license requirement.</E> The individual must be currently licensed to render professional health care services in each state in which the individual renders services to CHAMPUS beneficiaries. Such license is required when a specific state provides, but does not require, license for a specific category of individual professional provider. The license must be at full clinical practice level to meet this requirement. A temporary license at the full clinical practice level is acceptable.</P>
            <P>(ii) <E T="03">Professional certification requirement.</E> When a state does not license a <PRTPAGE P="168"/>specific category of individual professional, certification by a Qualified Accreditation Organization, as defined in § 199.2, is required. Certification must be at full clinical practice level. A temporary certification at the full clinical practice level is acceptable.</P>
            <P>(iii) <E T="03">Education, training and experience requirement.</E> The Director, OCHAMPUS, or designee, may establish for each category or type of provider allowed by this paragraph (c) specific education, training, and experience requirements as necessary to promote the delivery of services by fully qualified individuals.</P>
            <P>(iv) <E T="03">Physician referral and supervision.</E> When physician referral and supervision is a prerequisite for CHAMPUS cost-sharing of the services of a provider authorized under this paragraph (c), such referral and supervision means that the physicians must actually see the patient to evaluate and diagnose the condition to be treated prior to referring the beneficiary to another provider and that the referring physician provides ongoing oversight of the course of referral related treatment throughout the period during which the beneficiary is being treated in response to the referral. Written contemporaneous documentation of the referring physician's basis for referral and ongoing communication between the referring and treating provider regarding the oversight of the treatment rendered as a result of the referral must meet all requirements for medical records established by this part. Referring physician supervision does not require physical location on the premises of the treating provider or at the site of treatment.</P>
            <P>(3) <E T="03">Types of providers.</E> Subject to the standards of participation provisions of this part, the following individual professional providers of medical care are authorized to provide services to CHAMPUS beneficiaries:</P>
            <P>(i) <E T="03">Physicians.</E> (A) Doctors of Medicine (M.D.).</P>
            <P>(B) Doctors of Osteopathy (D.O.).</P>
            <P>(ii) <E T="03">Dentists.</E> Except for covered oral surgery as specified in § 199.4(e) of this part, all otherwise covered services rendered by dentists require preauthorization.</P>
            <P>(A) Doctors of Dental Medicine (D.M.D.).</P>
            <P>(B) Doctors of Dental Surgery (D.D.S.).</P>
            <P>(iii) <E T="03">Other allied health professionals.</E> The services of the following individual professional providers of care are coverable on a fee-for-service basis provided such services are otherwise authorized in this or other sections of this part.</P>
            <P>(A) <E T="03">Clinical psychologist</E>. For purposes of CHAMPUS, a clinical psychologist is an individual who is licensed or certified by the state for the independent practice of psychology and:</P>
            <P>(<E T="03">1</E>) Possesses a doctoral degree in psychology from a regionally accredited university; and</P>
            <P>(<E T="03">2</E>) Has has 2 years of supervised clinical experience in psychological health services of which at least 1 year is post-doctoral and 1 year (may be the post-doctoral year) is in an organized psychological health service training program; or</P>
            <P>(<E T="03">3</E>) As an alternative to paragraphs (c)(3)(iii)(A)(<E T="03">1</E>) and (<E T="03">2</E>) of this section is listed in the National Register of Health Service Providers in Psychology.</P>
            <P>(B) <E T="03">Doctors of Optometry.</E>
            </P>
            <P>(C) <E T="03">Doctors of Podiatry or Surgical Chiropody.</E>
            </P>
            <P>(D) <E T="03">Certified nurse midwives.</E>
            </P>
            <P>(<E T="03">1</E> ) A certified nurse midwife may provide covered care independent of physician referral and supervision, provided the nurse midwife is:</P>
            <P>(<E T="03">i</E> ) Licensed, when required, by the local licensing agency for the jurisdiction in which the care is provided; and</P>
            <P>(<E T="03">ii</E> ) Certified by the American College of Nurse Midwives. To receive certification, a candidate must be a registered nurse who has completed successfully an educational program approved by the American College of Nurse Midwives, and passed the American College of Nurse Midwives National Certification Examination.</P>
            <P>(<E T="03">2</E> ) The services of a registered nurse who is not a certified nurse midwife may be authorized only when the patient has been referred for care by a licensed physician and a licensed physican provides continuing supervision of the course of care. A lay midwife who is neither a certified nurse midwife nor a registered nurse is not a <PRTPAGE P="169"/>CHAMPUS-authorized provider, regardless of whether the services rendered may otherwise be covered.</P>
            <P>(E) <E T="03">Certified nurse practitioner.</E> Within the scope of applicable licensure or certification requirements, a certified nurse practitioner may provide covered care independent of physician referral and supervision, provided the nurse practitioner is:</P>
            <P>(<E T="03">1</E> ) A licensed, registered nurse; and</P>
            <P>(<E T="03">2</E> ) Specifically licensed or certified as a nurse practitioner by the state in which the care was provided, if the state offers such specific licensure or certification; or</P>
            <P>(<E T="03">3</E> ) Certified as a nurse practitioner (certified nurse) by a professional organization offering certification in the speciality of practice, if the state does not offer specific licensure or certification for nurse practitioners.</P>
            <P>(F) <E T="03">Certified Clinical Social Worker.</E> A clinical social worker may provide covered services independent of physician referral and supervision, provided the clinical social worker:</P>
            <P>(<E T="03">1</E> ) Is licensed or certified as a clinical social worker by the jurisdiction where practicing; or, if the jurisdiction does not provide for licensure or certification of clinical social workers, is certified by a national professional organization offering certification of clinical social workers; and</P>
            <P>(<E T="03">2</E> ) Has at least a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education; and</P>
            <P>(<E T="03">3</E> ) Has had a minimum of 2 years or 3,000 hours of post-master's degree supervised clinical social work practice under the supervision of a master's level social worker in an appropriate clinical setting, as determined by the Director, OCHAMPUS, or a designee.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Patients’ organic medical problems must receive appropriate concurrent management by a physician.</P>
            </NOTE>
            <P>(G) <E T="03">Certified psychiatric nurse specialist.</E> A certified psychiatric nurse specialist may provide covered care independent of physician referral and supervision. For purposes of CHAMPUS, a certified psychiatric nurse specialist is an individual who:</P>
            <P>(<E T="03">1</E>) Is a licensed, registered nurse; and</P>
            <P>(<E T="03">2</E>) Has at least a master's degree in nursing from a regionally accredited institution with a specialization in psychiatric and mental health nursing; and</P>
            <P>(<E T="03">3</E> ) Has had at least 2 years of post-master's degree practice in the field of psychiatric and mental health nursing, including an average of 8 hours of direct patient contact per week; or</P>
            <P>(<E T="03">4</E> ) Is listed in a CHAMPUS-recognized, professionally sanctioned listing of clinical specialists in psychiatric and mental health nursing.</P>
            <P>(H) <E T="03">Certified physician assistant.</E> A physician assistant may provide care under general supervision of a physician (see § 199.14(g)(1)(iii) of this part for limitations on reimbursement). For purposes of CHAMPUS, a physician assistant must meet the applicable state requirements governing the qualifications of physician assistants and at least one of the following conditions:</P>
            <P>(<E T="03">1</E>) Is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians, or</P>
            <P>(<E T="03">2</E>) Has satisfactorily completed a program for preparing physician assistants that:</P>
            <P>(<E T="03">i</E>) Was at least 1 academic year in length;</P>
            <P>(<E T="03">ii</E>) Consisted of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction directed toward preparing students to deliver health care; and</P>
            <P>(<E T="03">iii</E>) Was accredited by the American Medical Association's Committee on Allied Health Education and Accreditation; or</P>
            <P>(<E T="03">3</E>) Has satisfactorily completed a formal educational program for preparing program physician assistants that does not meet the requirement of paragraph (c)(3)(iii)(H)(<E T="03">2</E>) of this section and had been assisting primary care physicians for a minimum of 12 months during the 18-month period immediately preceding January 1, 1987.</P>
            <P>(I) <E T="03">Other individual paramedical providers.</E> The services of the following individual professional providers of care to be considered for benefits on a fee-for-service basis may be provided only if the beneficiary is referred by a physician for the treatment of a medically-diagnosed condition and a physician must also provide continuing and ongoing oversight and supervision of the <PRTPAGE P="170"/>program or episode of treatment provided by these individual para-medical providers.</P>
            <P>(<E T="03">1</E> ) Licensed registered nurses.</P>
            <P>(<E T="03">2</E> ) Licensed registered physical therapists and occupational therapists.</P>
            <P>(<E T="03">3</E> ) Licensed registered physical therapists.</P>
            <P>(<E T="03">4</E> ) Audiologists.</P>
            <P>(<E T="03">5</E> ) Speech therapists (speech pathologists).</P>
            <P>(iv) <E T="03">Extramedical individual providers.</E> Extramedical individual providers are those who do counseling or nonmedical therapy and whose training and therapeutic concepts are outside the medical field. The services of extramedical individual professionals are coverable following the CHAMPUS determined allowable charge methodology provided such services are otherwise authorized in this or other sections of the regulation.</P>
            <P>(A) <E T="03">Certified marriage and family therapists.</E> For the purposes of CHAMPUS, a certified marriage and family therapist is an individual who meets the following requirements:</P>
            <P>(<E T="03">1</E>) Recognized graduate professional education with the minimum of an earned master's degree from a regionally accredited educational institution in an appropriate behavioral science field, mental health discipline; and</P>
            <P>(<E T="03">2</E>) The following experience:</P>
            <P>(<E T="03">i</E>) Either 200 hours of approved supervision in the practice of marriage and family counseling, ordinarily to be completed in a 2- to 3-year period, of which at least 100 hours must be in individual supervision. This supervision will occur preferably with more than one supervisor and should include a continuous process of supervision with at least three cases; and</P>
            <P>(<E T="03">ii</E>) 1,000 hours of clinical experience in the practice of marriage and family counseling under approved supervision, involving at least 50 different cases; or</P>
            <P>(<E T="03">iii</E>) 150 hours of approved supervision in the practice of psychotherapy, ordinarily to be completed in a 2- to 3-year period, of which at least 50 hours must be individual supervision; plus at least 50 hours of approved individual supervision in the practice of marriage and family counseling, ordinarily to be completed within a period of not less than 1 nor more than 2 years; and</P>
            <P>(<E T="03">iv</E>) 750 hours of clinical experience in the practice of psychotherapy under approved supervision involving at least 30 cases; plus at least 250 hours of clinical practice in marriage and family counseling under approved supervision, involving at least 20 cases; and</P>
            <P>(<E T="03">3</E>) Is licensed or certified to practice as a marriage and family therapist by the jurisdiction where practicing (see paragraph (c)(3)(iv)(D) of this section for more specific information regarding licensure); and</P>
            <P>(<E T="03">4</E>) Agrees that a patients’ organic medical problems must receive appropriate concurrent management by a physician.</P>
            <P>(<E T="03">5</E>) Agrees to accept the CHAMPUS determined allowable charge as payment in full, except for applicable deductibles and cost-shares, and hold CHAMPUS beneficiaries harmless for noncovered care (i.e., may not bill a beneficiary for noncovered care, and may not balance bill a beneficiary for amounts above the allowable charge). The certified marriage and family therapist must enter into a participation agreement with the Office of CHAMPUS within which the certified marriage and family therapist agrees to all provisions specified above.</P>
            <P>(<E T="03">6</E>) As of the effective date of termination, the certified marriage and family therapist will no longer be recognized as an authorized provider under CHAMPUS. Subsequent to termination, the certified marriage and family therapist may only be reinstated as an authorized CHAMPUS extramedical provider by entering into a new participation agreement as a certified marriage and family therapist.</P>
            <P>(B) <E T="03">Pastoral counselors.</E> For the purposes of CHAMPUS, a pastoral counselor is an individual who meets the following requirements:</P>
            <P>(<E T="03">1</E>) Recognized graduate professional education with the minimum of an earned master's degree from a regionally accredited educational institution in an appropriate behavioral science field, mental health discipline; and</P>
            <P>(<E T="03">2</E>) The following experience:</P>
            <P>(<E T="03">i</E>) Either 200 hours of approved supervision in the practice of pastoral counseling, ordinarily to be completed in a 2- to 3-year period, of which at least 100 <PRTPAGE P="171"/>hours must be in individual supervision. This supervision will occur preferably with more than one supervisor and should include a continuous process of supervision with at least three cases; and</P>
            <P>(<E T="03">ii</E>) 1,000 hours of clinical experience in the practice of pastoral counseling under approved supervision, involving at least 50 different cases; or</P>
            <P>(<E T="03">iii</E>) 150 hours of approved supervision in the practice of psychotherapy, ordinarily to be completed in a 2- to 3-year period, of which at least 50 hours must be individual supervision; plus at least 50 hours of approved individual supervision in the practice of pastoral counseling, ordinarily to be completed within a period of not less than 1 nor more than 2 years; and</P>
            <P>(<E T="03">iv</E>) 750 hours of clinical experience in the practice of psychotherapy under approved supervision involving at least 30 cases; plus at least 250 hours of clinical practice in pastoral counseling under approved supervision, involving at least 20 cases; and</P>
            <P>(<E T="03">3</E>) Is licensed or certified to practice as a pastoral counselor by the jurisdiction where practicing (see paragraph (c)(3)(iv)(D) of this section for more specific information regarding licensure); and</P>
            <P>(<E T="03">4</E>) The services of a pastoral counselor meeting the above requirements are coverable following the CHAMPUS determined allowable charge methdology, under the following specified conditions:</P>
            <P>(<E T="03">i</E>) The CHAMPUS beneficiary must be referred for therapy by a physician; and</P>
            <P>(<E T="03">ii</E>) A physician is providing ongoing oversight and supervision of the therapy being provided; and</P>
            <P>(<E T="03">iii</E>) The pastoral counselor must certify on each claim for reimbursement that a written communication has been made or will be made to the referring physician of the results of the treatment. Such communication will be made at the end of the treatment, or more frequently, as required by the referring physician (refer to § 199.7).</P>
            <P>(<E T="03">5</E>) Because of the similarity of the requirements for licensure, certification, experience, and education, a pastoral counselor may elect to be authorized under CHAMPUS as a certified marriage and family therapist, and as such, be subject to all previously defined criteria for the certified marriage and family therapist category, to include acceptance of the CHAMPUS determined allowable charge as payment in full, except for applicable deductibles and cost-shares (i.e., balance billing of a beneficiary above the allowable charge is prohibited; may not bill beneficiary for noncovered care). The pastoral counselor must also agree to enter into the same participation agreement as a certified marriage and family therapist with the Office of CHAMPUS within which the pastoral counselor agrees to all provisions including licensure, national association membership and conditions upon termination, outlined above for certified marriage and family therapist.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>No dual status will be recognized by the Office of CHAMPUS. Pastoral counselors must elect to become one of the categories of extramedical CHAMPUS provides specified above. Once authorized as either a pastoral counselor, or a certified marriage and family therapist, claims review and reimbursement will be in accordance with the criteria established for the elected provider category.</P>
            </NOTE>
            <P>(C) <E T="03">Mental health counselor.</E> For the purposes of CHAMPUS, a mental health counselor is an individual who meets the following requirements:</P>
            <P>(<E T="03">1</E>) Minimum of a master's degree in mental health counseling or allied mental health field from a regionally accredited institution; and</P>
            <P>(<E T="03">2</E>) Two years of post-masters experience which includes 3000 hours of clinical work and 100 hours of face-to-face supervision; and</P>
            <P>(<E T="03">3</E>) Is licensed or certified to practice as a mental health counselor by the jurisdiction where practicing (see paragraph (c)(3)(iv)(D) of this section for more specific information); and</P>
            <P>(<E T="03">4</E>) May only be reimbursed when:</P>
            <P>(<E T="03">i</E>) The CHAMPUS beneficiary is referred for therapy by a physician; and</P>
            <P>(<E T="03">ii</E>) A physician is providing ongoing oversight and supervision of the therapy being provided; and</P>
            <P>(<E T="03">iii</E>) The mental health counselor certifies on each claim for reimbursement that a written communication has been made or will be made to the referring physician of the results of the treatment. Such communication will be made at the end of the treatment, or <PRTPAGE P="172"/>more frequently, as required by the referring physician (refer to § 199.7).</P>
            <P>(D) The following additional information applies to each of the above categories of extramedical individual providers:</P>
            <P>(<E T="03">1</E>) These providers must also be licensed or certified to practice as a certified marriage and family therapist, pastoral counselor or mental health counselor by the jurisdiction where practicing. In jurisdictions that do not provide for licensure or certification, the provider must be certified by or eligible for full clinical membership in the appropriate national professional association that sets standards for the specific profession.</P>
            <P>(<E T="03">2</E>) Grace period for therapists or counselors in states where licensure/certification is optional. CHAMPUS is providing a grace period for those therapists or counselors who did not obtain optional licensure/certification in their jurisdiction, not realizing it was a CHAMPUS requirement for authorization. The exemption by state law for pastoral counselors may have misled this group into thinking licensure was not required. The same situation may have occurred with the other therapist or counselor categories where licensure was either not mandated by the state or was provided under a more general category such as “professional counselors.” This grace period pertains only to the licensure/certification requirement, applies only to therapists or counselors who are already approved as of October 29, 1990, and only in those areas where the licensure/certification is optional. Any therapist or counselor who is not licensed/certified in the state in which he/she is practicing by August 1, 1991, will be terminated under the provisions of § 199.9. This grace period does not change any of the other existing requirements which remain in effect. During this grace period, membership or proof of eligibility for full clinical membership in a recognized professional association is required for those therapists or counselors who are not licensed or certified by the state. The following organizations are recognized for therapists or counselors at the level indicated: Full clinical member of the American Association of Marriage and Family Therapy; membership at the fellow or diplomate level of the American Association of Pastoral Counselors; and membership in the National Academy of Certified Clinical Mental Health Counselors. Acceptable proof of eligibility for membership is a letter from the appropriate certifying organization. This opportunity for delayed certification/licensure is limited to the counselor or therapist category only as the language in all of the other provider categories has been consistent and unmodified from the time each of the other provider categories were added. The grace period does not apply in those states where licensure is mandatory.</P>
            <P>(E) <E T="03">Christian Science practitioners and Christian Science nurses.</E> CHAMPUS cost-shares the services of Christian Science practitioners and nurses. In order to bill as such, practitioners or nurses must be listed or be eligible for listing in the Christian Science Journal <SU>1</SU>
              <FTREF/> at the time the service is provided.</P>
            <FTNT>
              <P>
                <SU>1</SU> Copies of this journal can be obtained through the Christian Science Publishing Company, 1 Norway Street, Boston, MA 02115-3122 or the Christian Science Publishing Society, P.O. Box 11369, Des Moines, IA 50340.</P>
            </FTNT>
            <P>(d) <E T="03">Other providers.</E> Certain medical supplies and services of an ancillary or supplemental nature are coverable by CHAMPUS, subject to certain controls. This category of provider includes the following:</P>
            <P>(1) <E T="03">Independent laboratory.</E> Laboratory services of independent laboratories may be cost-shared if the laboratory is approved for participation under Medicare and certified by the Medicare Bureau, Health Care Financing Administration.</P>
            <P>(2) <E T="03">Suppliers of portable x-ray services.</E> Such suppliers must meet the conditions of coverage of the Medicare program, set forth in the Medicare regulations, or the Medicaid program in that state in which the covered service is provided.</P>
            <P>(3) <E T="03">Pharmacies.</E> Pharmacies must meet the applicable requirements of state law in the state in which the pharmacy is located.</P>
            <P>(4) <E T="03">Ambulance companies.</E> Such companies must meet the requirements of <PRTPAGE P="173"/>state and local laws in the jurisdiction in which the ambulance firm is licensed.</P>
            <P>(5) <E T="03">Medical equipment firms, medical supply firms.</E> As determined by the Director, OCHAMPUS, or a designee.</P>
            <P>(6) <E T="03">Mammography suppliers.</E> Mammography services may be cost-shared only if the supplier is certified by Medicare for participation as a mammography supplier, or is certified by the American College of Radiology as having met its mammography supplier standards.</P>
            <P>(e) <E T="03">Program for Persons with Disabilities Providers</E>.—(1) <E T="03">General</E>. (i) Services and items cost-shared through § 199.5 must be rendered by a CHAMPUS-authorized provider.</P>
            <P>(ii) A Program for the Handicapped (PFTH) provider with CHAMPUS-authorized status on the effective date for the Program for Persons with Disabilities (PFPWD) shall be deemed to be a CHAMPUS-authorized PFPWD provider until all outstanding PFTH benefit authorizations for services or items being rendered by the provider expire.</P>
            <P>(2) <E T="03">PFPWD provider categories</E>.—(i) <E T="03">PFPWD inpatient care provider</E>. A provider of residential institutional care which is otherwise a PFPWD benefit shall be:</P>
            <P>(A) A not-for-profit entity or a public facility, as defined in § 199.2; and</P>
            <P>(B) Located within a State, as defined in § 199.2; and</P>
            <P>(C) Be certified as eligible for Medicaid payment in accordance with a State plan for medical assistance under Title XIX of the Social Security Act (Medicaid) as a Medicaid Nursing Facility, or Intermediate Care Facility for the Mentally Retarded, or be a CHAMPUS-authorized Institutional Provider as defined in paragraph (b) of this section, or be approved by a State educational agency as a training institution.</P>
            <P>(ii) <E T="03">PFPWD outpatient care provider</E>. A provider of PFPWD outpatient, ambulatory, or in-home services shall be:</P>
            <P>(A) A CHAMPUS-authorized provider of services as defined in this section; or</P>
            <P>(B) An individual, corporation, foundation, or public entity that predominantly renders services of a type uniquely allowable as a PFPWD benefit and not otherwise allowable as a benefit of § 199.4, that meets all applicable licensing or other regulatory requirements that are extant in the state, county, municipality, or other political jurisdiction in which the PFPWD service is rendered.</P>
            <P>(iii) <E T="03">PFPWD vendor</E>. A provider of an allowable PFPWD item, supply, equipment, orthotic, or device shall be deemed to be a CHAMPUS-authorized vendor for the provision of the specific item, supply, equipment, orthotic, or device when the vendor supplies such information as the Director, OCHAMPUS, or designee, determines necessary to adjudicate a specific claim.</P>
            <P>(3) <E T="03">PFPWD provider exclusion or suspension</E>. A provider of PFPWD services or items may be excluded or suspended for a pattern of discrimination on the basis of disability. Such exclusion or suspension shall be accomplished according to the provisions of § 199.9.</P>
            <P>(f) <E T="03">Corporate services providers</E>—(1) <E T="03">General</E>. (i) This corporate services provider class is established to accommodate individuals who would meet the criteria for status as a CHAMPUS authorized individual professional provider as established by paragraph (c) of this section but for the fact that they are employed directly or contractually by a corporation or foundation that provides principally professional services which are within the scope of the CHAMPUS benefit.</P>
            <P>(ii) Payment for otherwise allowable services may be made to a CHAMPUS-authorized corporate services provider subject to the applicable requirements, exclusions and limitations of this part.</P>
            <P>(iii) The Director, OCHAMPUS, or designee, may create discrete types within any allowable category of provider established by this paragraph (f) to improve the efficiency of CHAMPUS management.</P>
            <P>(iv) The Director, OCHAMPUS, or designee, may require, as a condition of authorization, that a specific category or type of provider established by this paragraph (f):</P>

            <P>(A) Maintain certain accreditation in addition to or in lieu of the requirement of paragraph (f)(2)(v) of this section;<PRTPAGE P="174"/>
            </P>
            <P>(B) Cooperate fully with a designated utilization and clinical quality management organization which has a contract with the Department of Defense for the geographic area in which the provider does business;</P>
            <P>(C) Render services for which direct or indirect payment is expected to be made by CHAMPUS only after obtaining CHAMPUS written authorization; and</P>
            <P>(D) Maintain Medicare approval for payment when the Director, OCHAMPUS, or designee, determines that a category, or type, of provider established by this paragraph (f) is substantially comparable to a provider or supplier for which Medicare has regulatory conditions of participation or conditions of coverage.</P>
            <P>(v) Otherwise allowable services may be rendered at the authorized corporate services provider's place of business, or in the beneficiary's home under such circumstances as the Director, OCHAMPUS, or designee, determines to be necessary for the efficient delivery of such in-home services.</P>
            <P>(vi) The Director, OCHAMPUS, or designee, may limit the term of a participation agreement for any category or type of provider established by this paragraph (f).</P>
            <P>(vii) Corporate services providers shall be assigned to only one of the following allowable categories based upon the predominate type of procedure rendered by the organization;</P>
            <P>(A) Medical treatment procedures;</P>
            <P>(B) Surgical treatment procedures;</P>
            <P>(C) Maternity management procedures;</P>
            <P>(D) Rehabilitation and/or habilitation procedures; or</P>
            <P>(E) Diagnostic technical procedures.</P>
            <P>(viii) The Director, OCHAMPUS, or designee, shall determine the appropriate procedural category of a qualified organization and may change the category based upon the provider's CHAMPUS claim characteristics. The category determination of the Director, OCHAMPUS, designee, is conclusive and may not be appealed.</P>
            <P>(2) <E T="03">Conditions of authorization.</E> An applicant must meet the following conditions to be eligible for authorization as a CHAMPUS corporate services provider:</P>
            <P>(i) Be a corporation or a foundation, but not a professional corporation or professional association; and</P>
            <P>(ii) Be institution-affiliated or freestanding as defined in § 199.2; and</P>
            <P>(iii) Provide:</P>
            <P>(A) Services and related supplies of a type rendered by CHAMPUS individual professional providers or diagnostic technical services and related supplies of a type which requires direct patient contact and a technologist who is licensed by the state in which the procedure is rendered or who is certified by a Qualified Accreditation Organization as defined in § 199.2; and</P>
            <P>(B) A level of care which does not necessitate that the beneficiary be provided with on-site sleeping accommodations and food in conjunction with the delivery of services; and</P>
            <P>(iv) Complies with all applicable organizational and individual licensing or certification requirements that are extant in the state, county, municipality, or other political jurisdiction in which the provider renders services; and</P>
            <P>(v) Be approved for Medicare payment when determined to be substantially comparable under the provisions of paragraph (f)(1)(iv)(D) of this section or, when Medicare approved status is not required, be accredited by a qualified accreditation organization, as defined in § 199.2; and</P>
            <P>(vi) Has entered into a participation agreement approved by the Director, OCHAMPUS, or designee, which at least complies with the minimum participation agreement requirements of this section.</P>
            <P>(3) <E T="03">Transfer of participation agreement.</E> In order to provide continuity of care for beneficiaries when there is a change of provider ownership, the provider agreement is automatically assigned to the new owner, subject to all the terms and conditions under which the original agreement was made.</P>

            <P>(i) The merger of the provider corporation or foundation into another corporation or foundation, or the consolidation of two or more corporations or foundations resulting in the creation of a new corporation or foundation, constitutes a change of ownership.<PRTPAGE P="175"/>
            </P>
            <P>(ii) Transfer of corporate stock or the merger of another corporation or foundation into the provider corporation or foundation does not constitute change of ownership.</P>
            <P>(iii) The surviving corporation or foundation shall notify the Director, OCHAMPUS, or designee, in writing of the change of ownership promptly after the effective date of the transfer or change in ownership.</P>
            <P>(4) <E T="03">Pricing and payment methodology:</E> The pricing and payment of procedures rendered by a provider authorized under this paragraph (f) shall be limited to those methods for pricing and payment allowed by this part which the Director, OCHAMPUS, or designee, determines contribute to the efficient management of CHAMPUS.</P>
            <P>(5) <E T="03">Termination of participation agreement.</E> A provider may terminate a participation agreement upon 45 days written notice to the Director, OCHAMPUS, or designee, and to the public.</P>
            <CITA>[51 FR 24008, July 1, 1986]</CITA>
            <EDNOTE>
              <HD SOURCE="HED">Editorial Note:</HD>
              <P>For <E T="04">Federal Register</E> citations affecting § 199.6, see the List of Sections Affected in the Finding Aids section of this volume.</P>
            </EDNOTE>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.7</SECTNO>
            <SUBJECT>Claims submission, review, and payment.</SUBJECT>
            <P>(a) <E T="03">General.</E> The Director, OCHAMPUS, or a designee, is responsible for ensuring that benefits under CHAMPUS are paid only to the extent described in this part. Before benefits can be paid, an appropriate claim must be submitted that includes sufficient information as to beneficiary identification, the medical services and supplies provided, and double coverage information, to permit proper, accurate, and timely adjudication of the claim by the CHAMPUS contractor or OCHAMPUS. Providers must be able to document that the care or service shown on the claim was rendered. This section sets forth minimum medical record requirements for verification of services. Subject to such definitions, conditions, limitations, exclusions, and requirements as may be set forth in this part, the following are the CHAMPUS claim filing requirements:</P>
            <P>(1) <E T="03">CHAMPUS identification card required.</E> A patient shall present his or her applicable CHAMPUS identification card (that is, Uniformed Services identification card) to the authorized provider of care that identifies the patient as an eligible CHAMPUS beneficiary (refer to § 199.3 of this part).</P>
            <P>(2) <E T="03">Claim required</E>. No benefit may be extended under the Basic Program or Program for Persons with Disabilities (PFPWD) without the submission of a complete and properly executed appropriate claim form.</P>
            <P>(3) <E T="03">Responsibility for perfecting claim.</E> It is the responsibility of the CHAMPUS beneficiary or sponsor or the authorized provider acting on behalf of the CHAMPUS beneficiary to perfect a claim for submission to the appropriate CHAMPUS fiscal intermediary. Neither a CHAMPUS fiscal intermediary nor OCHAMPUS is authorized to prepare a claim on behalf of a CHAMPUS beneficiary.</P>
            <P>(4) <E T="03">Obtaining appropriate claim form.</E> CHAMPUS provides specific CHAMPUS forms appropriate for making a claim for benefits for various types of medical services and supplies (such as hospital, physician, or prescription drugs). Claim forms may be obtained from the appropriate CHAMPUS fiscal intermediary who processes claims for the beneficiary's state of residence, from the Director, OCHAMPUS, or a designee, or from CHAMPUS health benefits advisors (HBAs) located at all Uniformed Services medical facilities.</P>
            <P>(5) <E T="03">Prepayment not required.</E> A CHAMPUS beneficiary or sponsor is not required to pay for the medical services or supplies before submitting a claim for benefits.</P>
            <P>(6) <E T="03">Deductible certificate.</E> If the fiscal year outpatient deductible, as defined in § 199.4(f)(2) has been met by a beneficiary or a family through the submission of a claim or claims to a CHAMPUS fiscal intermediary in a geographic location different from the location where a current claim is being submitted, the beneficiary or sponsor must obtain a deductible certificate from the CHAMPUS fiscal intermediary where the applicable individual or family fiscal year deductible was met. Such deductible certificate must be attached to the current claim being submitted for benefits. Failure to obtain a deductible certificate under <PRTPAGE P="176"/>such circumstances will result in a second individual or family fiscal year deductible being applied. However, this second deductible may be reimbursed once appropriate documentation, as described in this paragraph is supplied to the CHAMPUS fiscal intermediary applying the second deductible (refer to § 199.4 (f)(2)(i)(F)).</P>
            <P>(7) <E T="03">Nonavailability Statement (DD Form 1251).</E> In some geographic locations or under certain circumstances, it is necessary for a CHAMPUS beneficiary to determine whether the required medical care can be provided through a Uniformed Services facility. If the required medical care cannot be provided by the Uniformed Services facility, a Nonavailability Statement will be issued. When requried (except for emergencies), this Nonavailability Statement must be issued before medical care is obtained from civilian sources. Failure to secure such a statement will waive the beneficiary's rights to benefits under CHAMPUS, subject to appeal to the appropriate hospital commander (or higher medical authority).</P>
            <P>(i) <E T="03">Rules applicable to issuance of Nonavailability Statement.</E> The ASD(HA) has issued DoD Instruction 6015.19 that contains rules for the issuance of Nonavailability Statements. Such rules may change depending on the current situations.</P>
            <P>(ii) <E T="03">Beneficiary responsibility.</E> The beneficiary shall ascertain whether or not he or she resides in a geographic area that requires obtaining a Nonavailability Statement. Information concerning current rules may be obtained from the CHAMPUS fiscal intermediary concerned, a CHAMPUS HBA or the Director, OCHAMPUS, or a designee.</P>
            <P>(iii) <E T="03">Rules in effect at time civilian care is provided apply.</E> The applicable rules regarding Nonavailability Statements in effect at the time the civilian care is rendered apply in determining whether a Nonavailability Statement is required.</P>
            <P>(iv) <E T="03">Nonavailability Statement must be filed with applicable claim.</E> When a claim is submitted for CHAMPUS benefits that includes services for which a Nonavailability Statement is required, such statement must be submitted along with the claim form.</P>
            <P>(b) <E T="03">Information required to adjudicate a CHAMPUS claim.</E> Claims received that are not completed fully and that do not provide the following minimum information may be returned. If enough space is not available on the appropriate claim form, the required information must be attached separately and include the patient's name and address, be dated, and signed.</P>
            <P>(1) <E T="03">Patient's identification information.</E> The following patient identification information must be completed on every CHAMPUS claim form submitted for benefits before a claim will be adjudicated and processed:</P>
            <P>(i) <E T="03">Patient's full name.</E>
            </P>
            <P>(ii) <E T="03">Patient's residence address.</E>
            </P>
            <P>(iii) <E T="03">Patient's date of birth.</E>
            </P>
            <P>(iv) <E T="03">Patient's relationship to sponsor.</E>
            </P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>If name of patient is different from sponsor, explain (for example, stepchild or illegitimate child).</P>
            </NOTE>
            <P>(v) <E T="03">Patient's identification number (from DD Form 1173).</E>
            </P>
            <P>(vi) <E T="03">Patient's identification card effective date and expiration date (from DD Form 1173).</E>
            </P>
            <P>(vii) <E T="03">Sponsor's full name.</E>
            </P>
            <P>(viii) <E T="03">Sponsor's service or social security number.</E>
            </P>
            <P>(ix) <E T="03">Sponsor's grade.</E>
            </P>
            <P>(x) <E T="03">Sponsor's organization and duty station.</E> Home port for ships; home address for retiree.</P>
            <P>(xi) <E T="03">Sponsor's branch of service or deceased or retiree's former branch of service.</E>
            </P>
            <P>(xii) <E T="03">Sponsor's current status.</E> Active duty, retired, or deceased.</P>
            <P>(2) <E T="03">Patient treatment information.</E> The following patient treatment information routinely is required relative to the medical services and supplies for which a claim for benefits is being made before a claim will be adjudicated and processed:</P>
            <P>(i) <E T="03">Diagnosis.</E> All applicable diagnoses are required; standard nomenclature is acceptable. In the absence of a diagnosis, a narrative description of the definitive set of symptoms for which the medical care was rendered must be provided.</P>
            <P>(ii) <E T="03">Source of care.</E> Full name of source of care (such as hospital or physician) providing the specific medical services being claimed.<PRTPAGE P="177"/>
            </P>
            <P>(iii) <E T="03">Full address of source of care.</E> This address must be where the care actually was provided, not a billing address.</P>
            <P>(iv) <E T="03">Attending physician.</E> Name of attending physician (or other authorized individual professional provider).</P>
            <P>(v) <E T="03">Referring physician.</E> Name and address of ordering, prescribing, or referring physician.</P>
            <P>(vi) <E T="03">Status of patient.</E> Status of patient at the time the medical services and supplies were rendered (that is, inpatient or outpatient).</P>
            <P>(vii) <E T="03">Dates of service.</E> Specific and inclusive dates of service.</P>
            <P>(viii) <E T="03">Inpatient stay.</E> Source and dates of related inpatient stay (if applicable).</P>
            <P>(ix) <E T="03">Physicians or other authorized individual professional providers.</E> The claims must give the name of the individual actually rendering the care, along with the individual's professional status (e.g., M.D., Ph.D., R.N., etc.) and provider number, if the individual signing the claim is not the provider who actually rendered the service. The following information must also be included:</P>
            <P>(A) Date each service was rendered.</P>
            <P>(B) Procedure code or narrative description of each procedure or service for each date of service.</P>
            <P>(C) Individual charge for each item of service or each supply for each date.</P>
            <P>(D) Detailed description of any unusual complicating circumstances related to the medical care provided that the physician or other individual professional provider may choose to submit separately.</P>
            <P>(x) <E T="03">Hospitals or other authorized institutional providers.</E> For care provided by hospitals (or other authorized institutional providers), the following information also must be provided before a claim will be adjudicated and processed:</P>
            <P>(A) An itemized billing showing each item of service or supply provided for each day covered by the claim.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The Director, OCHAMPUS, or a designee, may approve, in writing, an alternative billing procedure for RTCs or other special institutions, in which case the itemized billing requirement may be waived. The particular facility will be aware of such approved alternate billing procedure.</P>
            </NOTE>
            <P>(B) Any absences from a hospital or other authorized institution during a period for which inpatient benefits are being claimed must be identified specifically as to date or dates and provide details on the purpose of the absence. Failure to provide such information will result in denial of benefits and, in an ongoing case, termination of benefits for the inpatient stay at least back to the date of the absence.</P>
            <P>(C) For hospitals subject to the CHAMPUS DRG-based payment system (see paragraph (a)(1)(ii)(D) of § 199.14), the following information is also required:</P>
            <P>(<E T="03">1</E>) The principal diagnosis (the diagnosis established, after study, to be chiefly responsible for causing the patient's admission to the hospital).</P>
            <P>(<E T="03">2</E>) All secondary diagnoses.</P>
            <P>(<E T="03">3</E>) All significant procedures performed.</P>
            <P>(<E T="03">4</E>) The discharge status of the beneficiary.</P>
            <P>(<E T="03">5</E>) The hospital's Medicare provider number.</P>
            <P>(<E T="03">6</E>) The source of the admission.</P>
            <P>(D) Claims submitted by hospitals (or other authorized institutional providers) must include the name of the individual actually rendering the care, along with the individual's professional status (e.g., M.D., Ph.D., R.N., etc.).</P>
            <P>(xi) <E T="03">Prescription drugs and medicines (and insulin).</E> For prescription drugs and medicines (and insulin, whether or not a prescription is required) receipted bills must be attached and the following additional information provided:</P>
            <P>(A) Name of drug.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>When the physician or pharmacist so requests, the name of the drugs may be submitted to the CHAMPUS fiscal intermediary directly by the physician or pharmacist.</P>
            </NOTE>
            <P>(B) Strength of drug.</P>
            <P>(C) Name and address of pharmacy where drug was purchased.</P>
            <P>(D) Prescription number of drug being claimed.</P>
            <P>(xii) <E T="03">Other authorized providers</E>. For items from other authorized providers (such as medical supplies), an explanation as to the medical need must be attached to the appropriate claim form. For purchases of durable equipment under the PFPWD, it is necessary also to attach a copy of the preauthorization.</P>
            <P>(xiii) <E T="03">Nonparticipating providers.</E> When the beneficiary or sponsor submits the <PRTPAGE P="178"/>claim to the CHAMPUS fiscal intermediary (that is, the provider elects not to participate), an itemized bill from the provider to the beneficiary or sponsor must be attached to the CHAMPUS claim form.</P>
            <P>(3) <E T="03">Medical records/medical documentation.</E> Medical records are of vital importance in the care and treatment of the patient. Medical records serve as a basis for planning of patient care and for the ongoing evaluation of the patient's treatment and progress. Accurate and timely completion of orders, notes, etc., enable different members of a health care team and subsequent health care providers to have access to relevant data concerning the patient. Appropriate medical records must be maintained in order to accommodate utilization review and to substantiate that billed services were actually rendered.</P>
            <P>(i) All care rendered and billed must be appropriately documented in writing. Failure to document the care billed will result in the claim or specific services on the claim being denied CHAMPUS cost-sharing.</P>
            <P>(ii) A pattern of failure to adequately document medical care will result in episodes of care being denied CHAMPUS cost-sharing.</P>
            <P>(iii) Cursory notes of a generalized nature that do not identify the specific treatment and the patient's response to the treatment are not acceptable.</P>
            <P>(iv) The documentation of medical records must be legible and prepared as soon as possible after the care is rendered. Entries should be made when the treatment described is given or the observations to be documented are made. The following are documentation requirements and specific time frames for entry into the medical records:</P>
            <P>(A) General requirements for acute medical/surgical services:</P>
            <P>(<E T="03">1</E>) Admission evaluation report within 24 hours of admission.</P>
            <P>(<E T="03">2</E>) Completed history and physical examination report within 72 hours of admission.</P>
            <P>(<E T="03">3</E>) Registered nursing notes at the end of each shift.</P>
            <P>(<E T="03">4</E>) Daily physician notes.</P>
            <P>(B) Requirements specific to mental health services:</P>
            <P>(<E T="03">1</E>) Psychiatric admission evaluation report within 24 hours of admission.</P>
            <P>(<E T="03">2</E>) History and physical examination within 24 hours of admission; complete report documented within 72 hours for acute and residential programs and within 3 working days for partial programs.</P>
            <P>(<E T="03">3</E>) Individual and family therapy notes within 24 hours of procedure for acute, detoxification and Residential Treatment Center (RTC) programs and within 48 hours for partial programs.</P>
            <P>(<E T="03">4</E>) Preliminary treatment plan within 24 hours of admission.</P>
            <P>(<E T="03">5</E>) Master treatment plan within 5 calendar days of admission for acute care, 10 days for RTC care, 5 days for full-day partial programs and within 7 days for half-day partial programs.</P>
            <P>(<E T="03">6</E>) Family assessment report within 72 hours of admission for acute care and 7 days for RTC and partial programs.</P>
            <P>(<E T="03">7</E>) Nursing assessment report within 24 hours of admission.</P>
            <P>(<E T="03">8</E>) Nursing notes at the end of each shift for acute and detoxification programs; every ten visits for partial hospitalization; and at least once a week for RTCs.</P>
            <P>(<E T="03">9</E>) Daily physician notes for intensive treatment, detoxification, and rapid stabilization programs; twice per week for acute programs; and once per week for RTC and partial programs.</P>
            <P>(<E T="03">10</E>) Group therapy notes once per week.</P>
            <P>(<E T="03">11</E>) Ancillary service notes once per week.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>A pattern of failure to meet the above criteria may result in provider sanctions prescribed under § 199.9.</P>
            </NOTE>
            <P>(4) <E T="03">Double coverage information.</E> When the CHAMPUS beneficiary is eligible for medical benefits coverage through another plan, insurance, or program, either private or Government, the following information must be provided:</P>
            <P>(i) <E T="03">Name of other coverage.</E> Full name and address of double coverage plan, insurance, or program (such as Blue Cross, Medicare, commercial insurance, and state program).</P>
            <P>(ii) <E T="03">Source of double coverage</E>. Source of double coverage (such as employment, including retirement, private purchase, membership in a group, and law).<PRTPAGE P="179"/>
            </P>
            <P>(iii) <E T="03">Employer information</E>. If source of double coverage is employment, give name and address of employer.</P>
            <P>(iv) <E T="03">Identification number</E>. Identification number or group number of other coverage.</P>
            <P>(5) <E T="03">Right to additional information</E>. (i) As a condition precedent to the cost-sharing of benefits under this part or pursuant to a review or audit, whether the review or audit is prospective, concurrent, or retroactive, OCHAMPUS or CHAMPUS contractors may request, and shall be entitled to receive, information from a physician or hospital or other person, institution, or organization (including a local, state, or Federal Government agency) providing services or supplies to the beneficiary for whom claims or requests for approval for benefits are submitted. Such information and records may relate to the attendance, testing, monitoring, examination, diagnosis, treatment, or services and supplies furnished to a beneficiary and, as such, shall be necessary for the accurate and efficient administration of CHAMPUS benefits. This may include requests for copies of all medical records or documentation related to the episode of care. In addition, before a determination on a request for preauthorization or claim of benefits is made, a beneficiary, or sponsor, shall provide additional information relevant to the requested determination, when necessary. The recipient of such information shall hold such records confidential except when:</P>
            <P>(A) Disclosure of such information is authorized specifically by the beneficiary;</P>
            <P>(B) Disclosure is necessary to permit authorized governmental officials to investigate and prosecute criminal actions; or</P>
            <P>(C) Disclosure is authorized or required specifically under the terms of DoD Directive 5400.7 and 5400.11, the Freedom of Information Act, and the Privacy Act (refer to paragraph (m) of § 199.1 of this part).</P>

            <P>(ii) For the purposes of determining the applicability of and implementing the provisions of §§ 199.8 and 199.9, or any provision of similar purpose of any other medical benefits coverage or entitlement, OCHAMPUS or CHAMPUS fiscal intermediaries, without consent or notice to any beneficiary or sponsor, may release to or obtain from any insurance company or other organization, governmental agency, provider, or person, any information with respect to any beneficiary when such release constitutes a routine use duly published in the <E T="04">Federal Register</E> in accordance with the Privacy Act.</P>
            <P>(iii) Before a beneficiary's claim of benefits is adjudicated, the beneficiary or the provider(s) must furnish to CHAMPUS that information which is necessary to make the benefit determination. Failure to provide the requested information will result in denial of the claim. A beneficiary, by submitting a CHAMPUS claim(s) (either a participating or nonparticipating claim), is deemed to have given consent to the release of any and all medical records or documentation pertaining to the claims and the episode of care.</P>
            <P>(c) <E T="03">Signature on CHAMPUS Claim Form—</E>(1) <E T="03">Beneficiary signature</E>. CHAMPUS claim forms must be signed by the beneficiary except under the conditions identified in paragraph (c)(1)(v) of this section. The parent or guardian may sign for any beneficiary under 18 years.</P>
            <P>(i) <E T="03">Certification of identity</E>. This signature certifies that the patient identification information provided is correct.</P>
            <P>(ii) <E T="03">Certification of medical care provided</E>. This signature certifies that the specific medical care for which benefits are being claimed actually were rendered to the beneficiary on the dates indicated.</P>
            <P>(iii) <E T="03">Authorization to obtain or release information</E>. Before requesting additional information necessary to process a claim or releasing medical information, the signature of the beneficiary who is 18 years old or older must be recorded on or obtained on the CHAMPUS claim form or on a separate release form. The signature of the beneficiary, parent, or guardian will be requested when the beneficiary is under 18 years.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>If the care was rendered to a minor and a custodial parent or legal guardian requests information prior to the minor turning 18 years of age, medical records may still be released pursuant to the signature of the parent or guardian, and claims information <PRTPAGE P="180"/>may still be released to the parent or guardian in response to the request, even though the beneficiary has turned 18 between the time of the request and the response. However, any follow-up request or subsequent request from the parent or guardian, after the beneficiary turns 18 years of age, will necessitate the authorization of the beneficiary (or the beneficiary's legal guardian as appointed by a cognizant court), before records and information can be released to the parent or guardian. </P>
            </NOTE>
            <P>(iv) <E T="03">Certification of accuracy and authorization to release double coverage information</E>. This signature certifies to the accuracy of the double coverage information and authorizes the release of any information related to double coverage. (Refer to § 199.8 of this part).</P>
            <P>(v) <E T="03">Exceptions to beneficiary signature requirement</E>. (A) Except as required by paragraph (c)(1)(iii) of this section, the signature of a spouse, parent, or guardian will be accepted on a claim submitted for a beneficiary who is 18 years old or older.</P>
            <P>(B) When the institutional provider obtains the signature of the beneficiary (or the signature of the parent or guardian when the beneficiary is under 18 years) on a CHAMPUS claim form at admission, the following participating claims may be submitted without the beneficiary's signature.</P>
            <P>(<E T="03">1</E> ) Claims for laboratory and diagnostic tests and test interpretations from radiologists, pathologists, neurologists, and cardiologists.</P>
            <P>(<E T="03">2</E> ) Claims from anesthesiologists.</P>
            <P>(C) Claims filed by providers using CHAMPUS-approved signature-on-file and claims submission procedures.</P>
            <P>(2) <E T="03">Provider's signature.</E> A participating provider (see paragraph (a)(8) of § 199.6) is required to sign the CHAMPUS claim form.</P>
            <P>(i) <E T="03">Certification</E>. A participating provider's signature on a CHAMPUS claim form:</P>
            <P>(A) Certifies that the specific medical care listed on the claim form was, in fact, rendered to the specific beneficiary for which benefits are being claimed, on the specific date or dates indicated, at the level indicated and by the provider signing the claim unless the claim otherwise indicates another individual provided the care. For example, if the claim is signed by a psychiatrist and the care billed was rendered by a psychologist or licensed social worker, the claim must indicate both the name and profession of the individual who rendered the care.</P>
            <P>(B) Certifies that the provider has agreed to participate (providing this agreement has been indicated on the claim form) and that the CHAMPUS-determined allowable charge or cost will constitute the full charge or cost for the medical care listed on the specific claim form; and further agrees to accept the amount paid by CHAMPUS or the CHAMPUS payment combined with the cost-shared amount paid by, or on behalf of the beneficiary, as full payment for the covered medical services or supplies.</P>
            <P>(<E T="03">1</E> ) Thus, neither CHAMPUS nor the sponsor is responsible for any additional charges, whether or not the CHAMPUS-determined charge or cost is less than the billed amount.</P>
            <P>(<E T="03">2</E> ) Any provider who signs and submits a CHAMPUS claim form and then violates this agreement by billing the beneficiary or sponsor for any difference between the CHAMPUS-determined charge or cost and the amount billed is acting in bad faith and is subject to penalties including withdrawal of CHAMPUS approval as a CHAMPUS provider by administrative action of the Director, OCHAMPUS, or a designee, and possible legal action on the part of CHAMPUS, either directly or as a part of a beneficiary action, to recover monies improperly obtained from CHAMPUS beneficiaries or sponsors (refer to § 199.6 of this part.)</P>
            <P>(ii) <E T="03">Physician or other authorized individual professional provider.</E> A physician or other authorized individual professional provider is liable for any signature submitted on his or her behalf. Further, a facsimile signature is not acceptable unless such facsimile signature is on file with, and has been authorized specifically by, the CHAMPUS fiscal intermediary serving the state where the physician or other authorized individual professional provider practices.</P>
            <P>(iii) <E T="03">Hospital or other authorized institutional provider.</E> The provider signature on a claim form for institutional services must be that of an authorized representative of the hospital or other authorized institutional provider, <PRTPAGE P="181"/>whose signature is on file with and approved by the appropriate CHAMPUS fiscal intermediary.</P>
            <P>(d) <E T="03">Claims filing deadline.</E> For all services provided on or after January 1, 1993, to be considered for benefits, all claims submitted for benefits must, except as provided in paragraph (d)(2) of this section, be filed with the appropriate CHAMPUS contractor no later than one year after the services are provided. Unless the requirement is waived, failure to file a claim within this deadline waives all rights to benefits for such services or supplies.</P>
            <P>(1) <E T="03">Claims returned for additional information.</E> When a claim is submitted initially within the claim filing time limit, but is returned in whole or in part for additional information to be considered for benefits, the returned claim, along with the requested information, must be resubmitted and received by the appropriate CHAMPUS contractor no later than the later of:</P>
            <P>(i) One year after the services are provided; or</P>
            <P>(ii) 90 days from the date the claim was returned to the provider or beneficiary.</P>
            <P>(2) <E T="03">Exception to claims filing deadline.</E> The Director, OCHAMPUS, or a designee, may grant exceptions to the claims filing deadline requirements.</P>
            <P>(i) <E T="03">Types of exception</E>. (A) <E T="03">Retroactive eligibility.</E> Retroactive CHAMPUS eligibility determinations.</P>
            <P>(B) <E T="03">Administrative error.</E> Administrative error (that is, misrepresentation, mistake, or other accountable action) of an officer or employee of OCHAMPUS (including OCHAMPUSEUR) or a CHAMPUS fiscal intermediary, performing functions under CHAMPUS and acting within the scope of that official's authority.</P>
            <P>(C) <E T="03">Mental incompetency.</E> Mental incompetency of the beneficiary or guardian or sponsor, in the case of a minor child (which includes inability to communicate, even if it is the result of a physical disability).</P>
            <P>(D) <E T="03">Delays by other health insurance.</E> When not attributable to the beneficiary, delays in adjudication by other health insurance companies when double coverage coordination is required before the CHAMPUS benefit determination.</P>
            <P>(E) <E T="03">Other waiver authority.</E> The Director, OCHAMPUS may waive the claims filing deadline in other circumstances in which the Director determines that the waiver is necessary in order to ensure adequate access for CHAMPUS beneficiaries to health care services.</P>
            <P>(ii) <E T="03">Request for exception to claims filing deadline.</E> Beneficiaries who wish to request an exception to the claims filing deadline may submit such a request to the CHAMPUS fiscal intermediary having jurisdiction over the location in which the service was rendered, or as otherwise designated by the Director, OCHAMPUS.</P>
            <P>(A) Such requests for an exception must include a complete explanation of the circumstances of the late filing, together with all available documentation supporting the request, and the specific claim denied for late filing.</P>
            <P>(B) Each request for an exception to the claims filing deadline is reviewed individually and considered on its own merits.</P>
            <P>(e) <E T="03">Other claims filing requirements.</E> Notwithstanding the claims filing deadline described in paragraph (d) of this section, to lessen any potential adverse impact on a CHAMPUS beneficiary or sponsor that could result from a retroactive denial, the following additional claims filing procedures are recommended or required.</P>
            <P>(1) <E T="03">Continuing care.</E> Except for claims subject to the CHAMPUS DRG-based payment system, whenever medical services and supplies are being rendered on a continuing basis, an appropriate claim or claims should be submitted every 30 days (monthly) whether submitted directly by the beneficiary or sponsor or by the provider on behalf of the beneficiary. Such claims may be submitted more frequently if the beneficiary or provider so elects. The Director, OCHAMPUS, or a designee, also may require more frequent claims submission based on dollars. Examples of care that may be rendered on a continuing basis are outpatient physical therapy, private duty (special) nursing, or inpatient stays. For claims subject to the CHAMPUS DRG-based payment system, claims may be submitted only after the beneficiary has been discharged or transferred from the hospital.<PRTPAGE P="182"/>
            </P>
            <P>(2) <E T="03">Inpatient mental health services.</E> Under most circumstances, the 60-day inpatient mental health limit applies to the first 60 days of care paid in a calendar year. The patient will be notified when the first 30 days of inpatient mental health benefits have been paid. The beneficiary is responsible for assuring that all claims for care are submitted sequentially and on a regular basis. Once payment has been made for care determined to be medically appropriate and a program benefit, the decision will not be reopened solely on the basis that previous inpatient mental health care had been rendered but not yet billed during the same calendar year by a different provider.</P>
            <P>(3) <E T="03">Claims involving the services of marriage and family counselors, pastoral counselors, and mental health counselors.</E> CHAMPUS requires that marriage and family counselors, pastoral counselors, and mental health counselors make a written report to the referrring physician concerning the CHAMPUS beneficiary's progress. Therefore, each claim for reimbursement for services of marriage and family counselors, pastoral counselors, and mental health counselors must include certification to the effect that a written communication has been made or will be made to the referring physician at the end of treatment, or more frequently, as required by the referring physician.</P>
            <P>(f) <E T="03">Preauthorization.</E> When specifically required in other sections of this part, preauthorization requires the following:</P>
            <P>(1) <E T="03">Preauthorization must be granted before benefits can be extended.</E> In those situations requiring preauthorization, the request for such preauthorization shall be submitted and approved before benefits may be extended, except as provided in § 199.4(a)(11). If a claim for services or supplies is submitted without the required preauthorization, no benefits shall be paid, unless the Director, OCHAMPUS, or a designee, has granted an exception to the requirement for preauthorization.</P>
            <P>(i) <E T="03">Specifically preauthorized services.</E> An approved preauthorization specifies the exact services or supplies for which authorization is being given. In a preauthorization situation, benefits cannot be extended for services or supplies provided beyond the specific authorization.</P>
            <P>(ii) <E T="03">Time limit on preauthorization.</E> Approved preauthorizations are valid for specific periods of time, appropriate for the circumstances presented and specified at the time of the preauthorization is approved. In general, preauthorization are valid for 30 days. If the preauthorized service or supplies are not obtained or commenced within the specified time limit, a new preauthorization is required before benefits may be extended.</P>
            <P>(2) <E T="03">Treatment plan</E>. Each preauthorization request shall be accompanied by a proposed medical treatment plan (for inpatient stays under the Basic Program) which shall include generally a diagnosis; a detailed summary of complete history and physical; a detailed statement of the problem; the proposed treatment modality, including anticipated length of time the proposed modality will be required; any available test results; consultant's reports; and the prognosis. When the preauthorization request involves transfer from a hospital to another inpatient facility, medical records related to the inpatient stay also must be provided.</P>
            <P>(3) <E T="03">Claims for services and supplies that have been preauthorized.</E> Whenever a claim is submitted for benefits under CHAMPUS involving preauthorized services and supplies, the date of the approved preauthorization must be indicated on the claim form and a copy of the written preauthorization must be attached to the appropriate CHAMPUS claim.</P>
            <P>(4) <E T="03">Advance payment prohibited</E>. No CHAMPUS payment shall be made for otherwise authorized services or items not yet rendered or delivered to the beneficiary.</P>
            <P>(g) <E T="03">Claims review</E>. It is the responsibility of the CHAMPUS fiscal intermediary (or OCHAMPUS, including OCHAMPUSEUR) to review each CHAMPUS claim submitted for benefit consideration to ensure compliance with all applicable definitions, conditions, limitations, or exclusions specified or enumerated in this part. It is also required that before any CHAMPUS benefits may be extended, <PRTPAGE P="183"/>claims for medical services and supplies will be subject to utilization review and quality assurance standards, norms, and criteria issued by the Director, OCHAMPUS, or a designee (see paragraph (a)(1)(v) of § 199.14 for review standards for claims subject to the CHAMPUS DRG-based payment system).</P>
            <P>(h) <E T="03">Benefit payments.</E> CHAMPUS benefit payments are made either directly to the beneficiary or sponsor or to the provider, depending on the manner in which the CHAMPUS claim is submitted.</P>
            <P>(1) <E T="03">Benefit payments made to beneficiary or sponsor.</E> When the CHAMPUS beneficiary or sponsor signs and submits a specific claim form directly to the appropriate CHAMPUS fiscal intermediary (or OCHAMPUS, including OCHAMPUSEUR), any CHAMPUS benefit payments due as a result of that specific claim submission will be made in the name of, and mailed to, the beneficiary or sponsor. In such circumstances, the beneficiary or sponsor is responsible to the provider for any amounts billed.</P>
            <P>(2) <E T="03">Benefit payments made to participating provider.</E> When the authorized provider elects to participate by signing a CHAMPUS claim form, indicating participation in the appropriate space on the claim form, and submitting a specific claim on behalf of the beneficiary to the appropriate CHAMPUS fiscal intermediary, any CHAMPUS benefit payments due as a result of that claim submission will be made in the name of and mailed to the participating provider. Thus, by signing the claim form, the authorized provider agrees to abide by the CHAMPUS-determined allowable charge or cost, whether or not lower than the amount billed. Therefore, the beneficiary or sponsor is responsible only for any required deductible amount and any cost-sharing portion of the CHAMPUS-determined allowable charge or cost as may be required under the terms and conditions set forth in §§ 199.4 and 199.5 of this part.</P>
            <P>(3) <E T="03">CEOB.</E> When a CHAMPUS claim is adjudicated, a CEOB is sent to the beneficiary or sponsor. A copy of the CEOB also is sent to the provider if the claim was submitted on a participating basis. The CEOB form provides, at a minimum, the following information:</P>
            <P>(i) Name and address of beneficiary.</P>
            <P>(ii) Name and address of provider.</P>
            <P>(iii) Services or supplies covered by claim for which CEOB applies.</P>
            <P>(iv) Dates services or supplies provided.</P>
            <P>(v) Amount billed; CHAMPUS-determined allowable charge or cost; and amount of CHAMPUS payment.</P>
            <P>(vi) To whom payment, if any, was made.</P>
            <P>(vii) Reasons for any denial.</P>
            <P>(viii) Recourse available to beneficiary for review of claim decision (refer to § 199.10 of this part).</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>The Director, OCHAMPUS, or a designee, may authorize a CHAMPUS fiscal intermediary to waive a CEOB to protect the privacy of a CHAMPUS beneficiary.</P>
            </NOTE>
            <P>(4) <E T="03">Benefit under $1.</E> If the CHAMPUS benefit is determined to be under $1, payment is waived.</P>
            <P>(i) <E T="03">Erroneous payments and recoupment</E>—(1) <E T="03">Erroneous payments.</E> Erroneous payments are expenditures of government funds that are not authorized by law or this part. Such payments are to be recouped under the provisions of § 199.11 of this part.</P>
            <P>(2) <E T="03">Claims denials resulting from clarification or change in law or Regulation.</E> In those instances where claims review results in a finding of denial of benefits previously allowed but currently denied due to a clarification or interpretation of law or this part, or due to a change in this part, no recoupment action need be taken to recover funds expended prior to the effective date of such clarification, interpretation, or change.</P>
            <P>(3) <E T="03">Fraudulent billing.</E> Claims that are submitted to CHAMPUS that include a billing for services, supplies, or equipment not furnished, or used by, CHAMPUS beneficiaries will be denied in their entirety, regardless of the relative amount of the fraudulent billing compared to the total billings. Claims that have been CHAMPUS cost-shared that are retroactively audited or reviewed and are found to include fraudulent billings may be denied in part or in total based on the discretion of the Director, OCHAMPUS, or a designee.</P>
            <P>(j) <E T="03">General assignment of benefits not recognized.</E> CHAMPUS does not recognize any general assignment of <PRTPAGE P="184"/>CHAMPUS benefits to another person. All CHAMPUS benefits are payable as described in this and other Sections of this part.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 52 FR 33007, Sept. 1, 1987; 53 FR 5373, Feb. 24, 1988; 54 FR 25246, June 14, 1989; 56 FR 28487, June 21, 1991; 56 FR 59878, Nov. 26, 1991; 58 FR 35408, July 1, 1993; 58 FR 51238, Oct. 1, 1993; 58 FR 58961, Nov. 5, 1993; 62 FR 35097, June 30, 1997; 63 FR 48446, Sept. 10, 1998]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.8</SECTNO>
            <SUBJECT>Double coverage.</SUBJECT>
            <P>(a) <E T="03">Introduction.</E> In enacting CHAMPUS legislation, Congress clearly has intended that CHAMPUS be the secondary payer to all health benefit and insurance plans. 10 U.S.C. 1079(j)(1) specifically provides:
            </P>
            <EXTRACT>

              <P>“A benefit may not be paid under a plan [CHAMPUS] covered by this section in the case of a person enrolled in any other insurance, medical service, or health plan to the extent that the benefit also is a benefit under other plans, except in the case of a plan [Medicaid] administered under title 19 of the Social Security Act (42 U.S.C. 1306 <E T="03">et seq.).”</E>
              </P>
            </EXTRACT>
            
            <FP>The above provision is made applicable specifically to retired members, dependents, and survivors by 10 U.S.C. 1086(d). The underlying intent, in addition to preventing waste of Federal resources, is to ensure that CHAMPUS beneficiaries receive maximum benefits while ensuring that the combined payments of CHAMPUS and other health benefit and insurance plans do not exceed the total charges.</FP>
            <P>(b) <E T="03">Double coverage plan.</E> A double coverage plan is one of the following:</P>
            <P>(1) <E T="03">Insurance plan.</E> An insurance plan is any plan or program that is designed to provide compensation or coverage for expenses incurred by a beneficiary for medical services and supplies. It includes plans or programs for which the beneficiary pays a premium to an issuing agent as well as those plans or programs to which the beneficiary is entitled as a result of employment or membership in, or association with, an organization or group.</P>
            <P>(2) <E T="03">Medical service or health plan.</E> A medical service or health plan is any plan or program of an organized health care group, corporation, or other entity for the provision of health care to an individual from plan providers, both professional and institutional. It includes plans or programs for which the beneficiary pays a premium to an issuing agent as well as those plans or programs to which the beneficiary is entitled as a result of employment or membership in, or association with, an organization or group.</P>
            <P>(3) <E T="03">Exceptions.</E> Double coverage plans do not include:</P>
            <P>(i) Plans administered under title XIX of the Social Security Act (Medicaid);</P>
            <P>(ii) Coverage specifically designed to supplement CHAMPUS benefits (a health insurance policy or other health benefit plan that meets the definition and criteria under supplemental insurance plan as set forth in § 199.2(b));</P>
            <P>(iii) Entitlement to receive care from Uniformed Services medical care facilities;</P>
            <P>(iv) Certain Federal Government programs, as prescribed by the Director, OCHAMPUS, that are designed to provide benefits to a distinct beneficiary population and for which entitlement does not derive from either premium payment of monetary contribution (for example, the Indian Health Service); or   </P>
            <P>(v) State Victims of Crime Compensation Programs.</P>
            <P>(c) <E T="03">Application of double coverage provisions.</E> CHAMPUS claims submitted for otherwise covered services or supplies and which involve double coverage shall be adjudicated as follows:</P>
            <P>(1) <E T="03">CHAMPUS always last pay.</E> For any claim that involves a double coverage plan as defined above, CHAMPUS shall be last pay. That is, CHAMPUS benefits may not be extended until all other double coverage plans have adjudicated the claim.</P>
            <P>(2) <E T="03">Waiver of benefits.</E> A CHAMPUS beneficiary may not elect to waive benefits under a double coverage plan and use CHAMPUS. Whenever double coverage exists, the provisions of this Section shall be applied.</P>
            <P>(3) <E T="03">Last pay limitations.</E> CHAMPUS may not pay more as a secondary payer than it would have in the absence of other coverages. Application of double coverage provisions does not extend or add to the CHAMPUS benefits as otherwise set forth in this and other Sections of this part.<PRTPAGE P="185"/>
            </P>
            <P>(d) <E T="03">Special considerations.</E> (1) <E T="03">CHAMPUS and Medicare.</E> In any double coverage situation involving Medicare, Medicare is always the primary payer. When Part A, “Hospital Insurance,” of Medicare is involved, the Medicare “lifetime reserve” benefit must be used before CHAMPUS benefits may be extended.</P>
            <P>(2) <E T="03">CHAMPUS and Medicaid.</E> Medicaid is not a double coverage plan. In any double coverage situation involving Medicaid, CHAMPUS is always the primary payer.</P>
            <P>(3) <E T="03">CHAMPUS and Worker's Compensation.</E> CHAMPUS benefits are not payable for a work-related illness or injury that is covered under a worker's compensation program.</P>
            <P>(4) <E T="03">Program for persons with disabilities (PFPWD).</E> A PFPWD eligible beneficiary (or sponsor or guardian acting on behalf of the beneficiary) does not have the option of waiving the full use of public facilities which are determined by the Director, OCHAMPUS, or designee, to be available and adequate to meet a disability related need for which a PFPWD benefit was requested. Benefits eligible for payment under a State plan for medical assistance under Title XIX of the Social Security Act (Medicaid) are never considered to be available in the adjudication of PFPWD benefits.</P>
            <P>(e) <E T="03">Implementing instructions.</E> The Director, OCHAMPUS, or a designee, shall issue such instructions, procedures, or guidelines, as necessary, to implement the intent of this section.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 62 FR 35097, June 30, 1997; 62 FR 54384, Oct. 20, 1997; 63 FR 59232, Nov. 3, 1998]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.9</SECTNO>
            <SUBJECT>Administrative remedies for fraud, abuse, and conflict of interest.</SUBJECT>
            <P>(a) <E T="03">General.</E> (1) This section sets forth provisions for invoking administrative remedies under CHAMPUS in situations involving fraud, abuse, or conflict of interest. The remedies impact institutional providers, professional providers, and beneficiaries (including parents, guardians, or other representatives of beneficiaries), and cover situations involving criminal fraud, civil fraud, administrative determinations of conflicts of interest or dual compensation, and administrative determinations of fraud or abuse. The administrative actions, remedies, and procedures may differ based upon whether the initial findings were made by a court of law, another agency, or the Director, OCHAMPUS (or designee).</P>
            <P>(2) This section also sets forth provisions for invoking administrative remedies in situations requiring administrative action to enforce provisions of law, regulation, and policy in the administration of CHAMPUS and to ensure quality of care for CHAMPUS beneficiaries. Examples of such situations may include a case in which it is discovered that a provider fails to meet requirements under this part to be an authorized CHAMPUS provider; a case in which the provider ceases to be qualified as a CHAMPUS provider because of suspension or revocation of the provider's license by a local licensing authority; or a case in which a provider meets the minimum requirements under this part but, nonetheless, it is determined that it is in the best interest of the CHAMPUS or CHAMPUS beneficiaries that the provider should not be an authorized CHAMPUS provider.</P>
            <P>(3) The administrative remedies set forth in this section are in addition to, and not in lieu of, any other remedies or sanctions authorized by law or regulation. For example, administrative action under this section may be taken in a particular case even if the same case will be or has been processed under the administrative procedures established by the Department of Defense to implement the Program Fraud Civil Remedies Act.</P>
            <P>(4) Providers seeking payment from the Federal Government through programs such as CHAMPUS have a duty to familiarize themselves with, and comply with, the program requirements.</P>

            <P>(5) CHAMPUS contractors and peer review organizations have a responsibility to apply provisions of this regulation in the discharge of their duties, and to report all known situations involving fraud, abuse, or conflict of interest. Failure to report known situations involving fraud, abuse, or conflict <PRTPAGE P="186"/>of interest will result in the withholding of administrative payments or other contractual remedies as determined by the Director, OCHAMPUS, or a designee.</P>
            <P>(b) <E T="03">Abuse.</E> The term “abuse” generally describes incidents and practices which may directly or indirectly cause financial loss to the Government under CHAMPUS or to CHAMPUS beneficiaries. For the definition of abuse, see § 199.2 of this part. The type of abuse to which CHAMPUS is most vulnerable is the CHAMPUS claim involving the overutilization of medical and health care services. To avoid abuse situations, providers have certain obligations to provide services and supplies under CHAMPUS which are: Furnished at the appropriate level and only when and to the extent medically necessary as determined under the provisions of this part; of a quality that meets professionally recognized standards of health care; and, supported by adequate medical documentation as may reasonably be required under this part by the Director, OCHAMPUS, or a designee, to evidence the medical necessity and quality of services furnished, as well as the appropriateness of the level of care. A provider's failure to comply with these obligations can result in sanctions being imposed by the Director, OCHAMPUS, or a designee, under this section. Even when administrative remedies are not initiated under this section, abuse situations under CHAMPUS are a sufficient basis for denying all or any part of CHAMPUS cost-sharing of individual claims. The types of abuse or possible abuse situations under CHAMPUS include, but are not limited, to the following:</P>
            <P>(1) A pattern of waiver of beneficiary (patient) cost-share or deductible.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>In a case of a legitimate bad debt write-off of patient cost-share or deductible, the provider's record should include documentation as to what efforts were made to collect the debt, when the debt was written off, why the debt was written off, and the amount of the debt written off.</P>
            </NOTE>
            <P>(2) Improper billing practices. Examples include, charging CHAMPUS beneficiaries rates for services and supplies that are in excess of those charges routinely charged by the provider to the general public, commercial health insurance carriers, or other federal health benefit entitlement programs for the same or similar services. (This includes dual fee schedules—one for CHAMPUS beneficiaries and one for other patients or third-party payers. This also includes billing other third-party payers the same as CHAMPUS is billed but accepting less than the billed amount as reimbursement. However, a formal discount arrangement such as through a preferred provider organization, may not necessarily constitute an improper billing practice.)</P>
            <P>(3) A pattern of claims for services which are not medically necessary or, if medically necessary, not to the extent rendered. For example, a battery of diagnostic tests are given when, based on the diagnosis, fewer tests were needed.</P>
            <P>(4) Care of inferior quality. For example, consistently furnishing medical or mental health services that do not meet accepted standards of care.</P>
            <P>(5) Failure to maintain adequate medical or financial records.</P>
            <P>(6) Refusal to furnish or allow the Government (for example, OCHAMPUS) or Government contractors access to records related to CHAMPUS claims.</P>
            <P>(7) Billing substantially in excess of customary or reasonable charges unless it is determined by OCHAMPUS that the excess charges are justified by unusual circumstances or medical complications requiring additional time, effort, or expense in localities when it is accepted medical practice to make an extra charge in such cases.</P>

            <P>(8) Unauthorized use of the term “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)” in private business. While the use of the term “CHAMPUS” is not prohibited by federal statute, misrepresentation or deception by use of the term “CHAMPUS” to imply an official connection with the Government or to defraud CHAMPUS beneficiaries may be a violation of federal statute. Regardless of whether the actual use of the term “CHAMPUS” may be actionable under federal statute, the unauthorized or deceptive use of the term “CHAMPUS” in private business will be considered abuse for purposes of this Section.<PRTPAGE P="187"/>
            </P>
            <P>(c) <E T="03">Fraud.</E> For the definition of fraud, see § 199.2 of this part. Examples of situations which, for the purpose of this part, are presumed to be fraud include, but are not limited to:</P>
            <P>(1) Submitting CHAMPUS claims (including billings by providers when the claim is submitted by the beneficiary) for services, supplies, or equipment not furnished to, or used by, CHAMPUS beneficiaries. For example, billing or claiming services when the provider was on call (other than an authorized standby charge) and did not provide any specific medical care to the beneficiary; providing services to an ineligible person and billing or submitting a claim for the services in the name of an eligible CHAMPUS beneficiary; billing or submitting a CHAMPUS claim for an office visit for a missed appointment; or billing or submitting a CHAMPUS claim for individual psychotherapy when a medical visit was the only service provided.</P>
            <P>(2) Billing or submitting a CHAMPUS claim for costs for noncovered or nonchargeable services, supplies, or equipment disguised as covered items. Some examples are: (i) Billings or CHAMPUS claims for services which would be covered except for the frequency or duration of the services, such as billing or submitting a claim for two one-hour psychotherapy sessions furnished on separate days when the actual service furnished was a two-hour therapy session on a single day, (ii) spreading the billing or claims for services over a time period that reduces the apparent frequency to a level that may be cost-shared by CHAMPUS, (iii) charging to CHAMPUS, directly or indirectly, costs not incurred or not reasonably allowable to the services billed or claimed under CHAMPUS, for example, costs attributable to nonprogram activities, other enterprises, or the personal expenses of principals, or (iv) billing or submitting claim on a fee-for-service basis when in fact a personal service to a specific patient was not performed and the service rendered is part of the overall management of, for example, the laboratory or x-ray department.</P>
            <P>(3) Breach of a provider participation agreement which results in the beneficiary (including parent, guardian, or other representative) being billed for amounts which exceed the CHAMPUS-determined allowable charge or cost.</P>
            <P>(4) Billings or CHAMPUS claims for supplies or equipment which are clearly unsuitable for the patient's needs or are so lacking in quality or sufficiency for the purpose as to be virtually worthless.</P>
            <P>(5) Billings or CHAMPUS claims which involve flagrant and persistent overutilization of services without proper regard for results, the patient's ailments, condition, medical needs, or the physician's orders.</P>
            <P>(6) Misrepresentations of dates, frequency, duration, or description of services rendered, or of the identity of the recipient of the services or the individual who rendered the services.</P>
            <P>(7) Submitting falsified or altered CHAMPUS claims or medical or mental health patient records which misrepresent the type, frequency, or duration of services or supplies or misrepresent the name(s) of the individual(s) who provided the services or supplies.</P>
            <P>(8) Duplicate billings or CHAMPUS claims. This includes billing or submitting CHAMPUS claims more than once for the same services, billing or submitting claims both to CHAMPUS and the beneficiary for the same services, or billing or submitting claims both to CHAMPUS and other third-parties (such as other health insurance or government agencies) for the same services, without making full disclosure of material facts or immediate, voluntary repayment or notification to CHAMPUS upon receipt of payments which combined exceed the CHAMPUS-determined allowable charge of the services involved.</P>
            <P>(9) Misrepresentation by a provider of his or her credentials or concealing information or business practices which bear on the provider's qualifications for authorized CHAMPUS provider status. For example, a provider representing that he or she has a qualifying doctorate in clinical psychology when the degree is not from a regionally accredited university.</P>

            <P>(10) Reciprocal billing. Billing or claiming services which were furnished by another provider or furnished by the billing provider in a capacity other than as billed or claimed. For example, practices such as the following: (i) One <PRTPAGE P="188"/>provider performing services for another provider and the latter bills as though he had actually performed the services (e.g., a weekend fill-in); (ii) providing service as an institutional employee and billing as a professional provider for the services; (iii) billing for professional services when the services were provided by another individual who was an institutional employee; (iv) billing for professional services at a higher provider profile than would be paid for the person actually furnishing the services, (for example, bills reflecting that an M.D. or Ph.D. performed the services when services were actually furnished by a licensed social worker, psychiatric nurse, or marriage and family counselor); or (v) an authorized provider billing for services which were actually furnished by an unauthorized or sanctioned provider.</P>
            <P>(11) Submitting CHAMPUS claims at a rate higher than a rate established between CHAMPUS and the provider, if such a rate has been established. For example, billing or claiming a rate in excess of the provider's most favored rate limitation specified in a residential treatment center agreement.</P>
            <P>(12) Arrangements by providers with employees, independent contractors, suppliers, or others which appear to be designed primarily to overcharge the CHAMPUS through various means (such as commissions, fee-splitting, and kickbacks) used to divert or conceal improper or unnecessary costs or profits.</P>
            <P>(13) Agreements or arrangements between the supplier and recipient (recipient could be either a provider or beneficiary, including the parent, guardian, or other representative of the beneficiary) that result in billings or claims which include unnecessary costs or charges to CHAMPUS.</P>
            <P>(d) <E T="03">Conflict of Interest.</E> (1) Conflict of interest includes any situation where an active duty member of the Uniformed Services (including a reserve member while on active duty, active duty for training, or inactive duty training) or civilian employee of the United States Government, through an official federal position has the apparent or actual opportunity to exert, directly or indirectly, any influence on the referral of CHAMPUS beneficiaries to himself/herself or others with some potential for personal gain or the appearance of impropriety. Although individuals under contract to the Uniformed Services are not considered “employees,” such individuals are subject to conflict of interest provisions by express terms of their contracts and, for purposes of this part, may be considered to be involved in conflict of interest situations as a result of their contract positions. In any situation involving potential conflict of interest of a Uniformed Service employee, the Director, OCHAMPUS, or a designee, may refer the case to the Uniformed Service concerned for appropriate review and action. If such a referral is made, a report of the results of findings and action taken shall be made to the Director, OCHAMPUS, by the Uniformed Service having jurisdiction within 90 days of receiving the referral.</P>
            <P>(2) CHAMPUS cost-sharing shall be denied on any claim where a conflict of interest situation is found to exist. This denial of cost-sharing applies whether the claim is submitted by the individual who provided the care, the institutional provider in which the care was furnished, or the beneficiary.</P>
            <P>(e) <E T="03">Dual Compensation.</E> (1) Federal law (5 U.S.C. 5536) prohibits active duty members of the Uniformed Services or employees (including part-time or intermittent) appointed in the civil service of the United States Government from receiving additional compensation from the Government above their normal pay and allowances. This prohibition applies to CHAMPUS payments for care furnished to CHAMPUS beneficiaries by active duty members of the Uniformed Services or civilian employees of the Government.</P>
            <P>(2) CHAMPUS cost-sharing of a claim shall be denied where the services or supplies were provided by an active duty member of the Uniformed Services or a civilian employee of the Government. This denial of CHAMPUS payment applies whether the claim for reimbursement is filed by the individual who provided the care, the institutional provider in which the care was furnished, or by the beneficiary.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>

              <P>Physicians of the National Health Service Corps (NHSC) may be assigned to <PRTPAGE P="189"/>areas where there is a shortage of medical providers. Although these physicians would be prohibited from accepting CHAMPUS payments as individuals if they are employees of the United States Government, the private organizations to which they may be assigned may be eligible for payment, as determined by the Director, OCHAMPUS, or a designee.</P>
            </NOTE>
            <P>(3) The prohibition against dual compensation does not apply to individuals under contract to the Uniformed Services or the Government.</P>
            <P>(f) <E T="03">Administrative Remedies.</E> Administrative remedies available under CHAMPUS in this section are set forth below.</P>
            <P>(1) <E T="03">Provider exclusion or suspension.</E> The Director, OCHAMPUS, or a designee, shall have the authority to exclude or suspend an otherwise authorized CHAMPUS provider from the program based on any criminal conviction or civil judgment involving fraud by the provider; fraud or abuse under CHAMPUS by the provider; exclusion or suspension of the provider by another agency of the Federal Government, a state, or local licensing authority; participation in a conflict of interest situation by the provider; or, when it is in the best interests of the program or CHAMPUS beneficiaries to exclude or suspend a provider under CHAMPUS. In all cases, the exclusion or suspension of a provider shall be effective 15 calendar days from the date on the written initial determination issued under paragraph (h)(2) of this section.</P>
            <P>(i) <E T="03">Criminal conviction or civil judgment involving fraud by a provider—</E>(A) <E T="03">Criminal conviction involving CHAMPUS fraud.</E> A provider convicted by a Federal, state, foreign, or other court of competent jurisdiction of a crime involving CHAMPUS fraud, whether the crime is a felony or misdemeanor, shall be excluded or suspended from CHAMPUS for a period of time as determined by the Director, OCHAMPUS, or a designee. The CHAMPUS exclusion or suspension applies whether or not the provider, as a result of the conviction, receives probation or the sentence is suspended or deferred, and whether or not the conviction or sentence is under appeal.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Under the above paragraph (f)(1)(i)(A) of this section, an entity may be excluded or suspended from CHAMPUS whenever the entity is found to have a person, convicted of a crime involving CHAMPUS fraud, who has a direct or indirect ownership or control interest (see § 199.2) of 5 percent or more in the entity, or is an officer, director, agent or managing employee of the entity. The entity will have an opportunity to provide evidence to show that the ownership or control relationship has ceased. While an entity will not be excluded or suspended from CHAMPUS for employing a provider who has been sanctioned under this Section, the entity will be denied CHAMPUS payment for any services furnished by the sanctioned employee. As an authorized CHAMPUS provider, the entity is responsible for ensuring that all CHAMPUS claims involve services furnished to CHAMPUS beneficiaries by employees who meet all requirements under CHAMPUS for provider status.</P>
            </NOTE>
            <P>(B) <E T="03">Criminal conviction involving fraud of other Federal programs.</E> Any provider convicted by a Federal, state, or other court of competent jurisdiction of a crime involving another Federal health care or benefit program (such as plans administered under titles XVIII and XIX of the Social Security Act, Federal Workmen's Compensation, and the Federal Employees Program (FEP) for employee health insurance), whether the crime is a felony or misdemeanor, shall be excluded from CHAMPUS for a period of time as determined by the Director, OCHAMPUS, or a designee. The CHAMPUS exclusion or suspension applies whether or not the provider, as a result of the conviction, receives probation or the sentence is suspended or deferred, and whether or not the conviction or sentence is under appeal.</P>
            <P>(C) <E T="03">Criminal conviction involving fraud of non-Federal programs.</E> Any provider convicted by a Federal, state, foreign, or other court of competent jurisdiction of a crime involving any non-Federal health benefit program or private insurance involving health benefits may be excluded or suspended from CHAMPUS for a period of time as determined by the Director, OCHAMPUS, or a designee.</P>
            <P>(D) <E T="03">Civil fraud involving CHAMPUS.</E> If a judgment involving civil fraud has been entered (whether or not it is appealed) against a provider in a civil action involving CHAMPUS benefits (whether or not other Federal programs are involved), the provider shall be excluded or suspended from CHAMPUS for a period determined by <PRTPAGE P="190"/>the Director, OCHAMPUS, or a designee.</P>
            <P>(E) <E T="03">Civil fraud involving other programs.</E> If a judgment involving civil fraud has been entered against a provider (whether or not it has been appealed) in a civil action involving other public or private health care programs or health insurance, the provider may be excluded or suspended for a period of time determined by the Director, OCHAMPUS, or a designee.</P>
            <P>(ii) <E T="03">Administrative determination of fraud or abuse under CHAMPUS.</E> If the Director, OCHAMPUS, or a designee, determines that a provider has committed fraud or abuse as defined in this part, the provider shall be excluded or suspended from CHAMPUS for a period of time determined by the Director, OCHAMPUS, or designee.</P>
            <P>(iii) <E T="03">Administrative determination that the provider has been excluded or suspended by another agency of the Federal Government, a state, or local licensing authority.</E> Any provider who is excluded or suspended by any other Federal health care program (for example, Medicare), shall be excluded or suspended under CHAMPUS. A provider who has his/her credentials revoked through a Veterans Administration or Military Department credentials review process and who is excluded, suspended, terminated, retired, or separated, shall also be excluded or suspended under CHAMPUS. The period of time of exclusion or suspension shall be determined by the Director, OCHAMPUS, or a designee, pursuant to paragraph (g) of this section.</P>
            <P>(iv) <E T="03">Administrative determination that the provider has participated in a conflict of interest situation.</E> The Director, OCHAMPUS, or a designee, may exclude or suspend any provider who has knowingly been involved in a conflict of interest situation under CHAMPUS. The period of time of exclusion or suspension shall be determined by the Director, OCHAMPUS, or a designee, pursuant to paragraph (g) of this section. For purposes of this administrative determination, it will be presumed that a CHAMPUS provider knowingly participated in a conflict of interest situation if the provider employs, in the treatment of a CHAMPUS beneficiary (resulting in a CHAMPUS claim), any medical personnel who are active duty members of the Uniformed Services or civilian employees of the Government. The burden of proof to rebut this presumption rests with the CHAMPUS provider. Two exceptions will be recognized to the presumption that a conflict of interest exists. First, indirect CHAMPUS payments may be made to private organizations to which physicians of the National Health Service Corps (NHSC) are assigned. Second, any off-duty Government medical personnel employed in an emergency room of an acute care hospital will be presumed not to have had the opportunity to exert, directly or indirectly, any influence on the referral of CHAMPUS beneficiaries; therefore, CHAMPUS payments may be made to the employing hospital <E T="03">provided</E> the medical care was not furnished directly by the off-duty Government medical personnel in violation of dual compensation provisions.</P>
            <P>(v) <E T="03">Administrative determination that it is in the best interests of the CHAMPUS or CHAMPUS beneficiaries to exclude or suspend a provider</E>—(A) <E T="03">Unethical or improper practices or unprofessional conduct.</E> (<E T="03">1</E>) In most instances, unethical or improper practices or unprofessional conduct by a provider will be program abuse and subject the provider to exclusion or suspension for abuse. However, in some cases such practices and conduct may provide an independent basis for exclusion or suspension of the provider by the Director, OCHAMPUS, or a designee.</P>
            <P>(<E T="03">2</E>) Such exclusions or suspensions may be based on findings or recommendations of state licensure boards, boards of quality assurance, other regulatory agencies, state medical societies, peer review organizations, or other professional associations.</P>
            <P>(B) <E T="03">In any other case in which the Director, OCHAMPUS (or designee), determines that exclusion or suspension of a provider is in the best interests of CHAMPUS or CHAMPUS beneficiaries.</E> The Director, OCHAMPUS, or a designee, may exclude or suspend any provider if it is determined that the authorization of that particular provider <PRTPAGE P="191"/>under CHAMPUS poses an unreasonable potential for fraud, abuse, or professional misconduct. Any documented misconduct by the provider reflecting on the business or professional competence or integrity of the provider may be considered. Situations in which the Director, OCHAMPUS, or a designee, may take administrative action under this Section to protect CHAMPUS or CHAMPUS beneficiaries include, but are not limited to, a case in which it is determined that a provider poses an unreasonable potential cost to the Government to monitor the provider for fraud or abuse and to avoid the issuance of erroneous payments; or that the provider poses an unreasonable potential harm to the financial or health status of CHAMPUS beneficiaries; or that the provider poses any other unreasonable threat to the interests of CHAMPUS or CHAMPUS beneficiaries. One example of such circumstances involves a provider who, for his/her entire practice or for most of his/her practice, provides or bills for tratment that is not a CHAMPUS benefit, resulting in CHAMPUS frequently and repeatedly denying claims as non-covered services. This may occur when a professional provider furnishes sex therapy (a therapy which may be recognized by the provider's licensing authority but which is excluded from CHAMPUS coverage) and repeatedly submits CHAMPUS claims for the services.</P>
            <P>(2) <E T="03">Provider termination.</E> The Director, OCHAMPUS, or a designee, shall terminate the provider status of any provider determined not to meet the qualifications established by this part to be an authorized CHAMPUS provider.</P>
            <P>(i) <E T="03">Effective date of termination.</E> Except as provided in paragraph (g)(2)(ii) of this section, the termination shall be retroactive to the date on which the provider did not meet the requirements of this part.</P>
            <P>(A) The retroactive effective date of termination shall not be limited due to the passage of time, erroneous payment of claims, or any other events which may be cited as a basis for CHAMPUS recognition of the provider notwithstanding the fact that the provider does not meet program qualifications. Unless specific provision is made in this part to “grandfather” or authorize a provider who does not otherwise meet the qualifications established by this part, all unqualified providers shall be terminated.</P>
            <P>(B) Any claims cost-shared or paid under CHAMPUS for services or supplies furnished by the provider on or after the effective date of termination, even when the effective date is retroactive, shall be deemed an erroneous payment unless specific exception is provided in this part. All erroneous payments are subject to collection under § 199.11 of this part.</P>

            <P>(C) If an institution is terminated as an authorized CHAMPUS provider, the institution shall immediately give written notice of the termination to any CHAMPUS beneficiary (or their parent, guardian, or other representative) admitted to, or receiving care at, the institution on or after the effective date of the termination. In addition, when an institution is terminated with an effective date of termination after the date of the initial determination terminating the provider, any beneficiary admitted to the institution prior to the effective date of termination (or their parent, guardian, or other representative) shall be notified by the Director, OCHAMPUS, or a designee, by certified mail of the termination, and that CHAMPUS cost-sharing of the beneficiary's care in the institution will cease as of the effective date of the termination. However, any beneficiary admitted to the institution prior to any grace period extended to the institution under paragraph (f)(2)(ii)(A) of this section shall be advised that, if the beneficiary's care otherwise qualifies for CHAMPUS coverage, CHAMPUS cost-sharing of the care in the institution will continue in order to provide a reasonable period of transition of care; however the transitional period of CHAMPUS cost-sharing shall not exceed the last day of the month following the month in which the institution's status as a CHAMPUS provider is terminated. (This authorized CHAMPUS cost-sharing of the inpatient care received during the transition period is an exception to the general rule that CHAMPUS payment for care furnished after the effective date of termination of the provider's status <PRTPAGE P="192"/>shall be deemed to be an erroneous payment.) If a major violation under paragraph (f)(2)(ii)(B) of this section is involved, in order to ensure immediate action is taken to transfer beneficiaries to an approved provider, CHAMPUS cost-sharing shall not be authorized after the effective date of termination of the provider's status.</P>
            <P>(ii) <E T="03">Institutions not in compliance with CHAMPUS standards.</E> If it is determined that an institution is not in compliance with one or more of the standards applicable to its specific category of institution under this part, the Director, OCHAMPUS, or a designee, shall take immediate steps to bring about compliance or terminate the status of the provider as an authorized CHAMPUS provider.</P>
            <P>(A) <E T="03">Minor violations.</E> An institution determined to be in violation of one or more of the standards shall be advised by certified mail of the nature of the discrepancy or discrepancies and will be given a grace period of 30 days to effect appropriate corrections. The grace period may be extended at the discretion of the Director, OCHAMPUS, or a designee, but in no event shall the extension exceed 90 days.</P>
            <P>(<E T="03">1</E>) CHAMPUS will not cost-share a claim for any beneficiary admitted during the grace period.</P>
            <P>(<E T="03">2</E>) Any beneficiary admitted to the institution prior to the grace period (or the beneficiary's parent, guardian, or other representative) will be notified by the Director, OCHAMPUS, or a designee, in writing, of the minor violations and the grace period granted the institution to correct the violations. The beneficiary will also be advised that, if the beneficiary's care otherwise meets all requirements for CHAMPUS coverage, CHAMPUS cost-sharing will continue during the grace period.</P>
            <P>(<E T="03">3</E>) If the institution submits written notice before the end of the grace period that corrective action has been taken <E T="03">and</E> if the Director, OCHAMPUS, or a designee, determines that the corrective action has eliminated the minor violations, the provider will be advised that the institution is restored to full status as an authorized CHAMPUS provider as of 12:01 a.m. on the day written notice of correction was received by the Director, OCHAMPUS, or a designee, or the day on which acceptable corrective action was completed in the judgment of the Director, OCHAMPUS, or a designee. Any beneficiary admitted to the institution prior to the grace period will be notified by the Director, OCHAMPUS, or a designee, of the corrective action and that the provider continues to be an authorized CHAMPUS provider. CHAMPUS cost-sharing for any beneficiary admitted to the institution during the grace period shall be allowed only for care received after 12:01 a.m. on the day written notice of correction was received by the Director, OCHAMPUS, or a designee, or the day on which acceptable corrective action was completed in the judgment of the Director, OCHAMPUS, or a designee.</P>
            <P>(<E T="03">4</E>) If the institution has failed to give notification in writing before the end of the grace period that corrective action has been completed <E T="03">or,</E> in the judgment of the Director, OCHAMPUS, or a designee, the institution has not completed acceptable corrective action during the grace period, the Director, OCHAMPUS, or a designee, may initiate action to terminate the provider as an authorized CHAMPUS provider.</P>
            <P>(B) <E T="03">Major violations.</E> If the Director, OCHAMPUS, or a designee, determines that an institution is in violation of standards detrimental to life, safety, or health, or substantially in violation of approved treatment programs, immediate action shall be taken to terminate the institution as an authorized CHAMPUS provider. The institution shall be notified by telegram, certified mail, or express mail of the termination under this subparagraph, effective on receipt of the notice. The notice shall include a brief statement of the nature of violations resulting in the termination and advise the institution that an initial determination formalizing the administrative action of termination will be issued pursuant to paragraph (h)(3)(ii) of this section within 15 days.</P>
            <P>(3) <E T="03">Beneficiary sanctions.</E> (i) With entitlement to CHAMPUS benefits based on public law, an eligible beneficiary will not be suspended or excluded from CHAMPUS. However, the Director, OCHAMPUS, or a designee, may take <PRTPAGE P="193"/>action deemed appropriate and reasonable to protect the Government from those beneficiaries (including sponsors, parents, guardians, or representatives of beneficiaries) who have submitted false claims.</P>
            <P>(ii) Pursuant to § 199.11 of this part, the Director, OCHAMPUS, or a designee, may recover erroneous payments on claims involving fraud or false or misleading statements. Remedies for recovery of the erroneous payments include the use of offset against future CHAMPUS payments.</P>
            <P>(iii) Under policies adopted by the Director, OCHAMPUS, or a designee, individuals who, based on reliable information, have previously submitted fraudulent or false CHAMPUS claims, may be required to comply with any procedures (e.g., partial or total pre-payment audit or review, restriction to a designated primary care provider, etc.) which the Director, OCHAMPUS, or a designee, deems appropriate to ensure that their future medical care and CHAMPUS claims (including the medical care and CHAMPUS claims submitted by or for members of their family) are valid.</P>
            <P>(g) <E T="03">Period of exclusion, suspension, or termination</E>—(1) <E T="03">Exclusions or suspensions.</E> Except as otherwise required by paragraph (g)(1)(i) of this section, the Director, OCHAMPUS, or a designee, shall determine the period of exclusion or suspension for a provider using the factors set forth in paragraph (g)(1)(ii) of this section.</P>
            <P>(i) <E T="03">Exclusion or suspension of a provider based on the provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority.</E> If the administrative action under CHAMPUS is based <E T="03">solely</E> on the provider's exclusion or suspension by another agency, state, or local licensing authority, the period of exclusion or suspension under CHAMPUS shall be for the same length of time of exclusion or suspension imposed by the other agency, state, or local licensing authority. The provider may request reinstatement as an authorized CHAMPUS provider if reinstatement is achieved under the other program prior to the end of the period of exclusion or suspension. If the administrative action under CHAMPUS is not based <E T="03">solely</E> on the provider's exclusion or suspension by another agency, state, or local licensing authority, the minimum period of exclusion or suspension shall be for the same period of exclusion or suspension imposed by the other agency, state, or local licensing authority.</P>
            <P>(ii) <E T="03">Factors to be considered in determining the period of exclusion or suspension of providers under CHAMPUS.</E> In determining the period of exclusion or suspension of a provider, the Director, OCHAMPUS, or a designee, may consider any or all of the following:</P>
            <P>(A) When the case concerns all or any part of the same issues which have been the subject of criminal conviction or civil judgment involving fraud by a provider:</P>
            <P>(<E T="03">1</E>) The period(s) of sentence, probation, and other sanction imposed by court order against the provider may be presumed reasonable and adopted as the administrative period of exclusion or suspension under CHAMPUS, unless aggravating or mitigating factors exist.</P>
            <P>(<E T="03">2</E>) If any aggravating factors exist, then cause exists for the Director, OCHAMPUS, or a designee, to consider the factors set forth in paragraph (g)(1)(ii)(B) of this section, in imposing a period of administrative exclusion or suspension in excess of the period(s) of sentence, probation, and/or other sanctions imposed by court order. Examples of aggravating factors include, but are not limited to:</P>
            <P>(<E T="03">i</E>) An administrative determination by the Director, OCHAMPUS, or a designee, that the basis for administrative exclusion or suspension includes an act(s) of fraud or abuse under CHAMPUS in addition to, or unrelated to, an act(s) of fraud included in the court conviction or civil judgment.</P>
            <P>(<E T="03">ii</E>) The fraudulent act(s) involved in the criminal conviction or civil judgment, or similar acts, were committed over a significant period of time; that is, one year or more.</P>
            <P>(<E T="03">iii</E>) The act(s) of fraud or abuse had an adverse physical, mental, or financial impact on one or more CHAMPUS beneficiaries.</P>
            <P>(<E T="03">iv</E>) The loss or potential loss to CHAMPUS is over $5,000. The entire amount of loss or potential loss to <PRTPAGE P="194"/>CHAMPUS due to acts of fraud and abuse will be considered, in addition to the amount of loss involved in the court conviction or civil judgment, regardless of whether full or partial restitution has been made to CHAMPUS.</P>
            <P>(<E T="03">v</E>) The provider has a prior court record, criminal or civil, or administrative record or finding of fraud or abuse.</P>
            <P>(<E T="03">3</E>) If any mitigating factors exist, then cause may exist for the Director, OCHAMPUS, or a designee, to reduce a period of administrative exclusion or suspension from any period(s) imposed by court conviction or civil judgment. Only the existence of either of the following two factors may be considered in mitigation:</P>
            <P>(<E T="03">i</E>) The criminal conviction or civil judgment only involved three or fewer misdemeanor offenses, and the total of the estimated losses incurred (including any loss from act(s) not involved in the conviction or judgment) is less than $1,000, regardless of whether full or partial restitution has been made.</P>
            <P>(<E T="03">ii</E>) The criminal or civil court proceedings establish that the provider had a mental, emotional or physical condition, prior to or contemporaneous with the commission of the act(s), that reduced the provider's criminal or civil culpability.</P>
            <P>(B) The Director, OCHAMPUS, or a designee, may consider the following factors in determining a reasonable period of exclusion or suspension of a provider under CHAMPUS:</P>
            <P>(<E T="03">1</E>) The nature of the claims and the circumstances under which they were presented;</P>
            <P>(<E T="03">2</E>) The degree of culpability;</P>
            <P>(<E T="03">3</E>) History of prior offenses (including whether claims were submitted while the provider was either excluded or suspended pursuant to prior administrative action);</P>
            <P>(<E T="03">4</E>) Number of claims involved;</P>
            <P>(<E T="03">5</E>) Dollar amount of claims involved;</P>
            <P>(<E T="03">6</E>) Whether, if a crime was involved, it was a felony or misdemeanor;</P>
            <P>(<E T="03">7</E>) If patients were injured financially, mentally, or physically; the number of patients; and the seriousness of the injury(ies);</P>
            <P>(<E T="03">8</E>) The previous record of the provider under CHAMPUS;</P>
            <P>(<E T="03">9</E>) Whether restitution has been made or arrangements for repayment accepted by the Government;</P>
            <P>(<E T="03">10</E>) Whether the provider has resolved the conflict of interest situations or implemented procedures acceptable to the Director, OCHAMPUS, or a designee, which will prevent conflict of interest in the future; and,</P>
            <P>(<E T="03">11</E>) Such other factors as may be deemed appropriate.</P>
            <P>(2) <E T="03">Terminations.</E> When a provider's status as an authorized CHAMPUS provider is ended, other than through exclusion or suspension, the termination is based on a finding that the provider does not meet the qualifications to be an authorized provider, as set forth in this part. Therefore, the period of termination in all cases will be indefinite and will end only after the provider has successfully met the established qualifications for authorized provider status under CHAMPUS and has been reinstated under CHAMPUS. Except as otherwise provided in this subparagraph, the following guidelines control the termination of authorized CHAMPUS provider status for a provider whose license to practice (or, in the case of an institutional provider, to operate) has been temporarily or permanently suspended or revoked by the jurisdiction issuing the license.</P>
            <P>(i) Termination of the provider under CHAMPUS shall continue even if the provider obtains a license to practice in a second jurisdiction during the period of suspension or revocation of the provider's license by the original licensing jurisdiction. A provider who has licenses to practice in two or more jurisdictions and has one or more license(s) suspended or revoked will also be terminated as a CHAMPUS provider.</P>
            <P>(A) Professional providers shall remain terminated from the CHAMPUS until the jurisdiction(s) suspending or revoking the provider's license(s) to practice restores it or removes the impediment to restoration.</P>

            <P>(B) Institutional providers shall remain terminated under CHAMPUS until their license is restored. In the event the facility is sold, transferred, or reorganized as a new legal entity, and a license issued under a new name or to a different legal entity, the new <PRTPAGE P="195"/>entity must submit an application to be an authorized CHAMPUS provider.</P>
            <P>(ii) If the CHAMPUS provider status is terminated due to the loss of the provider's license, the effective date shall be retroactive to the date the provider lost the license; however, in the case of a professional provider who has licenses in two or more jurisdictions and submitted claims from a jurisdiction from which he/she had a valid license, the effective date of the termination will be 15 calendar days from the date of the written initial determination of termination for purposes of claims from the jurisdiction in which the provider still has a valid license.</P>
            <P>(h) <E T="03">Procedures for initiating and implementing the administrative remedies</E>—(1) <E T="03">Temporary suspension of claims processing.</E> (i) In general, temporary suspension of claims processing may be invoked to protect the interests of the Government for a period reasonably necessary to complete investigation or appropriate criminal, civil, and administrative proceedings. The temporary suspension only delays the ultimate payment of otherwise appropriate claims. When claims processing involving a participating provider is temporarily suspended, the participation agreement remains in full force and the provider cannot repudiate the agreement because of the delay in the final disposition of the claim(s). Once it has been determined appropriate to end the temporary suspension of claims processing, CHAMPUS claims which were the subject of the suspension and which are otherwise determined to be in compliance with the requirements of law and regulation, will be processed to completion and payment <E T="03">unless</E> such action is deemed inappropriate as a result of criminal, civil, or administrative remedies ultimately invoked in the case.</P>
            <P>(ii) When adequate evidence exists to determine that a provider or beneficiary is submitting fraudulent or false claims or claims involving practices that may be fraud or abuse as defined by this part, the Director, OCHAMPUS, or a designee, may suspend CHAMPUS claims processing (in whole or in part) for claims submitted by the beneficiary or any CHAMPUS claims involving care furnished by the provider. The temporary suspension of claims processing for care furnished by a provider may be invoked against all such claims, whether or not the claims are submitted by the beneficiary or by the provider as a participating CHAMPUS provider. In cases involving a provider, notice of the suspension of claims processing may also be given to the beneficiary community either directly or indirectly through notice to appropriate military facilities, health benefit advisors, and the information or news media.</P>
            <P>(A) Adequate evidence is any information sufficient to support the reasonable belief that a particular act or omission has occurred.</P>
            <P>(B) Indictment or any other initiation of criminal charges, filing of a complaint for civil fraud, issuance of an administrative complaint under the Program Fraud Civil Remedies Act, or issuance of an initial determination under this part for submitting fraudulent or false claims or claims involving practices that may be fraud or abuse as defined by this part, shall constitute adequate evidence for invoking temporary suspension of claims processing.</P>
            <P>(iii) The Director, OCHAMPUS, or a designee, may suspend CHAMPUS claims processing without first notifying the provider or beneficiary of the intent to suspend payments. Following a decision to invoke a temporary suspension, however, the Director, OCHAMPUS, or a designee, shall issue written notice advising the provider or beneficiary that:</P>
            <P>(A) A temporary suspension of claims processing has been ordered and a statement of the basis of the decision to suspend payment. Unless the suspension is based on any of the actions set forth in paragraph (h)(1)(ii)(B) of this section, the notice shall describe the suspected acts or omissions in terms sufficient to place the provider or beneficiary on notice without disclosing the Government's evidence.</P>
            <P>(B) Within 30 days (or, upon written request received by OCHAMPUS during the 30 days and for good cause shown, within 60 days) from the date of the notice, the provider or beneficiary may:</P>
            <P>(<E T="03">1</E>) Submit to the Director, OCHAMPUS, or a designee, in writing, <PRTPAGE P="196"/>information (including documentary evidence) and argument in opposition to the suspension, provided the additional specific information raises a genuine dispute over the material facts, or</P>
            <P>(<E T="03">2</E>) Submit a written request to present in person evidence or argument to the Director, OCHAMPUS, or a designee. All such presentations shall be made at the Office of Civilian Health and Medical Program of the Uniformed Services (OCHAMPUS) in Aurora, Colorado, at the provider's or beneficiary's own expense.</P>
            <P>(C) Additional proceedings to determine disputed material facts may be conducted unless:</P>
            <P>(<E T="03">1</E>) The suspension is based on any of the actions set forth in paragraph (h)(1)(ii)(B) of this section, or,</P>
            <P>(<E T="03">2</E>) A determination is made, on the basis of the advice of the responsible Government official (e.g., an official of the Department of Justice, the designated Reviewing Official under the Program Fraud Civil Remedies Act, etc.), that the substantial interests of the Government in pending or contemplated legal or administrative proceedings based on the same facts as the suspension would be prejudiced.</P>
            <P>(iv) If the beneficiary or provider submits, either in writing or in person, additional information or argument in opposition to the suspension, the Director, OCHAMPUS, or a designee, shall issue a suspending official's decision which modifies, terminates, or leaves in force the suspension of claims processing. However, a decision to terminate or modify the suspension shall be without prejudice to the subsequent imposition of suspension of claims processing, imposition of sanctions under this § 199.9, the recovery of erroneous payments under § 199.11 of this part, or any other administrative or legal action authorized by law or regulation. The suspending official's decision shall be in writing as follows:</P>
            <P>(A) A written decision based on all the information in the administrative record, including any submission by the beneficiary or provider, shall be final in a case:</P>
            <P>(<E T="03">1</E>) Based on any of the actions set forth in paragraph (h)(1)(ii)(B) of this section,</P>
            <P>(<E T="03">2</E>) In which the beneficiary's or provider's submission does not raise a genuine dispute over material facts, or</P>
            <P>(<E T="03">3</E>) In which additional proceedings to determine disputed material facts have been denied on the basis of advice of a responsible Government official that the substantial interests of the Government in pending or contemplated legal or administrative proceedings would be prejudiced.</P>
            <P>(B) In a case in which additional proceedings are necessary as to disputed material facts, the suspending official's decision shall advise the beneficiary or provider that the case has been referred for handling as a hearing under § 199.10 of this part.</P>
            <P>(v) A suspension of claims processing may be modified or terminated for reasons such as:</P>
            <P>(A) Newly discovered evidence;</P>
            <P>(B) Elimination of any of the causes for which the suspension was invoked; or</P>
            <P>(C) Other reasons the Director, OCHAMPUS, or a designee, deems appropriate.</P>
            <P>(vi) A suspension of claims processing shall be for a temporary period pending the completion of investigation and any ensuing legal or administrative proceedings, unless sooner terminated by the Director, OCHAMPUS, or a designee, or as provided in this subparagraph.</P>
            <P>(A) If legal or administrative proceedings are not initiated within 12 months after the date of the suspension notice, the suspension shall be terminated unless the Government official responsible for initiation of the legal or administrative action requests its extension, in which case it may be extended for an additional 6 months. In no event may a suspension extend beyond 18 months, unless legal or administrative proceedings have been initiated during that period.</P>

            <P>(B) The Director, OCHAMPUS, or a designee, shall notify the Government official responsible for initiation of the legal or administrative action of the proposed termination of the suspension, at least 30 days before the 12-month period expires, to give the official an opportunity to request an extension.<PRTPAGE P="197"/>
            </P>
            <P>(2) <E T="03">Notice of proposed administrative sanction.</E> (i) A provider shall be notified in writing of the proposed action to exclude, suspend, or terminate the provider's status as an authorized CHAMPUS provider.</P>
            <P>(A) The notice shall state which sanction will be taken and the effective date of that sanction as determined in accordance with the provisions of this part.</P>
            <P>(B) The notice shall inform the provider of the situation(s), circumstance(s), or action(s) which form the basis for the proposed sanction and reference the paragraph of this part under which the administrative action is being taken.</P>
            <P>(C) The notice will be sent to the provider's last known business or office address (or home address if there is no known business address.)</P>
            <P>(D) The notice shall offer the provider an opportunity to respond within 30 days (or, upon written request received by OCHAMPUS during the 30 days and for good cause shown, within 60 days) from the date on the notice with either:</P>
            <P>(<E T="03">1</E>) Documentary evidence and written argument contesting the proposed action; or,</P>
            <P>(<E T="03">2</E>) A written request to present in person evidence or argument to the Director, OCHAMPUS, or a designee. All such presentations shall be made at the Office of the Civilian Health and Medical Program of the Uniformed Services (OCHAMPUS) in Aurora, Colorado, at the provider's own expense.</P>
            <P>(3) <E T="03">Initial determination.</E> (i) If, after the provider has exhausted, or failed to comply with, the procedures specified in paragraph (h)(2) of this section, the Director, OCHAMPUS, or a designee, decides to invoke an administrative remedy of exclusion, suspension, or termination of a provider under CHAMPUS, written notice of the decision will be sent to the provider by certified mail. Except in those cases where the sanction has a retroactive effective date, the written notice shall be dated no later than 15 days before the decision becomes effective. For terminations under paragraph (f)(2)(ii)(B) of this section, the initial determination may be issued without first implementing or exhausting the procedures specified in paragraph (h)(2) of this section.</P>
            <P>(ii) The initial determination shall include:</P>
            <P>(A) A statement of the sanction being invoked;</P>
            <P>(B) A statement of the effective date of the sanction;</P>
            <P>(C) A statement of the facts, circumstances, or actions which form the basis for the sanction and a discussion of any information submitted by the provider relevant to the sanction;</P>
            <P>(D) A statement of the factors considered in determining the period of sanction;</P>
            <P>(E) The earliest date on which a request for reinstatement under CHAMPUS will be accepted;</P>
            <P>(F) The requirements and procedures for reinstatement; and,</P>
            <P>(G) Notice of the available hearing upon request of the sanctioned provider.</P>
            <P>(4) <E T="03">Reinstatement procedures</E>—(i) <E T="03">Restitution.</E> (A) There is no entitlement under CHAMPUS for payment (cost-sharing) of any claim that involves either criminal or civil fraud as defined by law, or fraud or abuse or conflict of interest as defined by this part. In addition, except as specifically provided in this part, there is no entitlement under CHAMPUS for payment (cost-sharing) of any claim for services or supplies furnished by a provider who does not meet the requirements to be an authorized CHAMPUS provider. In any of the situations described above, CHAMPUS payment shall be denied whether the claim is submitted by the provider as a participating claim or by the beneficiary for reimbursement. If an erroneous payment has been issued in any such case, collection of the payment will be processed under § 199.11 of this part.</P>

            <P>(B) If the Government has made erroneous payments to a provider because of claims involving fraud, abuse, or conflicts of interest, restitution of the erroneous payments shall be made before a request for reinstatement as a CHAMPUS authorized provider will be considered. Without restitution or resolution of the debt under § 199.11 of this part, a provider shall not be reinstated as an authorized CHAMPUS provider. <PRTPAGE P="198"/>This is not an appealable issue under § 199.10 of this part.</P>
            <P>(C) For purposes of authorization as a CHAMPUS provider, a provider who is excluded or suspended under this § 199.9 and who submits participating claims for services furnished on or after the effective date of the exclusion or suspension is considered to have forfeited or waived any right or entitlement to bill the beneficiary for the care involved in the claims. Similarly, because a provider is expected to know the CHAMPUS requirements for qualification as an authorized provider, any participating provider who fails to meet the qualification requirements for CHAMPUS is considered to have forfeited or waived any right or entitlement to bill the beneficiary for the care involved in the CHAMPUS claims. If, in either situtation, the provider bills the beneficiary, restitution to the beneficiary may be required by the Director, OCHAMPUS, or a designee, as a condition for consideration of reinstatement as a CHAMPUS authorized provider.</P>
            <P>(ii) <E T="03">Terminated providers.</E> A terminated provider who subsequently achieves the minimum qualifications to be an authorized CHAMPUS provider or who has had his/her license reinstated or the impediment to reinstatement removed by the appropriate licensing jurisdiction may submit a written request for reinstatement under CHAMPUS to the Director, OCHAMPUS, or a designee. If restitution or proper reinstatement of license is not at issue, the Director, OCHAMPUS, or a designee, will process the request for reinstatement under the procedures established for initial requests for authorized CHAMPUS provider status.</P>
            <P>(iii) <E T="03">Providers (other than entities) excluded or suspended under CHAMPUS.</E> (A) A provider excluded or suspended from CHAMPUS (other than an entity excluded under § 199.9(f)(1)(i)) may seek reinstatement by submitting a written request to the Director, OCHAMPUS, or a designee, any time after the date specified in the notice of exclusion or suspension or any earlier date specified in an appeal decision issued in the provider's appeal under § 199.10 of this part. The request for reinstatement shall include:</P>
            <P>(<E T="03">1</E>) Documentation sufficient to establish the provider's qualifications under this part to be a CHAMPUS authorized provider;</P>
            <P>(<E T="03">2</E>) A statement from the provider setting forth the reasons why the provider should be reinstated, accompanied by written statements from professional associates, peer review bodies, and/or probation officers (if appropriate), attesting to their belief that the violations that led to exclusion or suspension will not be repeated.</P>
            <P>(B) A provider entity excluded from CHAMPUS under § 199.9(f)(1)(i) may seek reinstatement by submitting a written request to the Director, OCHAMPUS, or a designee, with documentation sufficient to establish the provider's qualifications under this part to be a CHAMPUS authorized provider and either:</P>
            <P>(<E T="03">1</E>) Documentation showing the CHAMPUS reinstatement of the excluded individual provider whose conviction led to the CHAMPUS exclusion or suspension of the provider entity; <E T="03">or</E>
            </P>
            <P>(<E T="03">2</E>) Documentation acceptable to the Director, OCHAMPUS, or a designee, that shows that the individual whose conviction led to the entity's exclusion:</P>
            <P>(<E T="03">i</E>) Has reduced his or her ownership or control interest in the entity below 5 percent; or</P>
            <P>(<E T="03">ii</E>) Is no longer an officer, director, agent or managing employee of the entity; or</P>
            <P>(<E T="03">iii</E>) Continues to maintain a 5 percent or more ownership or control interest in such entity, and that the entity due to circumstances beyond its control, is unable to obtain a divestiture.
            </P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>Under paragraph (h)(4)(iii)(B)(<E T="03">2</E>) of this section, the request for reinstatement may be submitted any time prior to the date specified in the notice of exclusion or suspension or an earlier date specified in the appeal decision issued under § 199.10 of this part.</P>
            </NOTE>
            
            <P>(iv) <E T="03">Action on request for reinstatement.</E> In order to reinstate a provider as a CHAMPUS authorized provider, the Director, OCHAMPUS, or a designee, must determine that:<PRTPAGE P="199"/>
            </P>
            <P>(A) The provider meets all requirements under this part to be an authorized CHAMPUS provider;</P>
            <P>(B) No additional criminal, civil, or administrative action has been taken or is being considered which could subject the provider to exclusion, suspension, or termination under this section;</P>

            <P>(C) In the case of a provider entity, verification has been made of the divestiture or termination of the owner, controlling party, officer, director, agent or managing employee whose conviction led to the entity's exclusion, <E T="03">or</E> that the provider entity should be reinstated because the entity, due to circumstances beyond its control, cannot obtain a divestiture of the 5 percent or more ownership or controlling interest by the convicted party.</P>
            <P>(v) <E T="03">Notice of action on request for reinstatement—</E>(A) <E T="03">Notice of approval of request.</E> If the Director, OCHAMPUS, or a designee, approves the request for reinstatement, he or she will:</P>
            <P>(<E T="03">1</E>) Give written notice to the sanctioned party specifying the date when the authorized provider status under CHAMPUS may resume; and</P>
            <P>(<E T="03">2</E>) Give notice to those agencies and groups that were originally notified, in accordance with § 199.9(k), of the imposition of the sanction. General notice may also be given to beneficiaries and other parties as deemed appropriate by the Director, OCHAMPUS, or a designee.</P>
            <P>(B) <E T="03">Notice of denial of request.</E> If the Director, OCHAMPUS, or a designee, does not approve the request for reinstatement, written notice will be given to the provider. If established procedures for processing initial requests for authorized provider status are used to review the request for reinstatement, the established procedures may be used to provide the notice that the provider does not meet requirements of this part for such status. If the provider continues to be excluded, suspended, or terminated under the provisions of this section, the procedures set forth in this paragraph (h) may be followed in denying the provider's request for reinstatement.</P>
            <P>(5) <E T="03">Reversed or vacated convictions or civil judgments involving CHAMPUS fraud.</E> (i) If a CHAMPUS provider is excluded or suspended <E T="03">solely</E> on the basis of a criminal conviction or civil judgment involving a CHAMPUS fraud and the conviction or judgment is reversed or vacated on appeal, CHAMPUS will void the exclusion of a provider. Such action will not preclude the initiation of additional independent administrative action under this section or any other administrative remedy based on the same facts or events which were the subject of the criminal conviction or civil judgment.</P>
            <P>(ii) If an exclusion is voided under paragraph (h)(5)(i) of this section, CHAMPUS will make payment, either to the provider or the beneficiary (if the claim was not a participating claim) for otherwise authorized services under CHAMPUS that are furnished or performed during the period of exclusion.</P>

            <P>(iii) CHAMPUS will also void the exclusion of any entity that was excluded under § 199.9(f)(1)(i) based <E T="03">solely</E> on an individual's conviction that has been reversed or vacated on appeal.</P>
            <P>(iv) When CHAMPUS voids the exclusion of a provider or an entity, notice will be given to the agencies and others that were originally notified, in accordance with § 199.9(k).</P>
            <P>(i) <E T="03">Evidence required for determinations to invoke administrative remedies—</E>(1) <E T="03">General.</E> Any relevant evidence may be used by the Director, OCHAMPUS, or a designee, if it is the type of evidence on which reasonable persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule that might make improper the admission of such evidence over objection in civil or criminal courts.</P>
            <P>(2) <E T="03">Types of evidence.</E> The types of evidence which the Director, OCHAMPUS, or a designee, may rely on in reaching a determination to invoke administrative remedies under this section include but are not limited to the following:</P>

            <P>(i) Results of audits conducted by or on behalf of the Government. Such audits can include the results of 100 percent review of claims and related records or a statistically valid sample audit of the claims or records. A statistical sampling shall constitute <E T="03">prima facie</E> evidence of the number and <PRTPAGE P="200"/>amount of claims and the instances of fraud, abuse, or conflict of interest.</P>
            <P>(ii) Reports, including sanction reports, from various sources including a peer review organization (PRO) for the area served by the provider; state or local licensing or certification authorities; peer or medical review consultants of the Government, including consultants for Government contractors; state or local professional societies; or other sources deemed appropriate by the Director, OCHAMPUS, or a designee.</P>
            <P>(iii) Orders or documents issued by Federal, state, foreign, or other courts of competent jurisdiction which issue findings and/or criminal convictions or civil judgments involving the provider, and administrative rulings, findings, or determinations by any agency of the Federal Government, a state, or local licensing or certification authority regarding the provider's status with that agency or authority.</P>
            <P>(j) <E T="03">Suspending Administrative Action.</E> (1) All or any administrative action may be suspended by the Director, OCHAMPUS, or a designee, pending action in the case by the Department of Defense—Inspector General, Defense Criminal Investigative Service, or the Department of Justice (including the responsible United States Attorney). However, action by the Department of Defense—Inspector General or the Department of Justice, including investigation, criminal prosecution, or civil litigation, does not preclude administrative action by OCHAMPUS.</P>
            <P>(2) The normal OCHAMPUS procedure is to suspend action on the administrative process pending an investigation by the Department of Defense—Inspector General or final disposition by the Department of Justice.</P>
            <P>(3) Though OCHAMPUS administrative action is taken independently of any action by the Department of Defense-Inspector General or by the Department of Justice, once a case is forwarded to the Department of Defense-Inspector General or the Department of Justice for legal action (criminal or civil), administrative action may be held in abeyance.</P>
            <P>(4) In some instances there may be dual jurisdiction between agencies; as in, for example, the joint regulations issued by the Department of Justice and the Government Accounting Office regarding debt collection.</P>
            <P>(k) <E T="03">Notice to Other Agencies.</E> (1) When CHAMPUS excludes, suspends, or terminates a provider, the Director, OCHAMPUS, or a designee, will notify other appropriate agencies (for example, the Department of Health and Human Services and the state licensing agency that issued the provider's license to practice) that the individual has been excluded, suspended, or terminated as an authorized provider under CHAMPUS. An exclusion, suspension, or termination action is considered a public record. Such notice can include the notices and determinations sent to the suspended provider and other public documents such as testimony given at a hearing or exhibits or depositions given in a lawsuit or hearing. Notice may also be given to Uniformed Services Military Treatment Facilities, Health Benefit Advisors, beneficiaries and sponsors, the news media, and institutional providers if inpatient care was involved.</P>
            <P>(2) If CHAMPUS has temporarily suspended claims processing, notice of such action normally will be given to the affected provider and Uniformed Services Medical Treatment Facilities, Health Benefits Advisors, beneficiaries, and sponsors. Notice may also be given to any information or news media and any other individual, professional provider, or institutional provider, as deemed appropriate. However, since a “temporary suspension of claims processing” is by definition not a final or formal agency action, the basis for the action generally will not be disclosed. It is noted that the basis for the action can be a result of questions arising from routine audits to investigation of possible criminal violations.</P>
            <P>(l) <E T="03">Compromise, Settlement, and Resolution Authority.</E> (1) In lieu of invoking any remedy provided by this Section, the Director, OCHAMPUS, or a designee, may elect to enter into an agreement with the provider intended to correct the situation within an established time period and subject to any remedies deemed appropriate by the Director, OCHAMPUS, or a designee.</P>

            <P>(2) When it is in the best interest of CHAMPUS, the Director, OCHAMPUS, <PRTPAGE P="201"/>has the discretionary authority to waive an action or enter into compromise or settlement of administrative actions taken under this § 199.9.</P>
            <P>(m) <E T="03">Government-wide effect of exclusion or suspension from CHAMPUS.</E> As provided by section 2455 of the Federal Acquisition Streamlining Act of 1994, Pub. L. 103-355, October 13  1994, and Executive Order 12549, “Debarment and Suspension from Federal Financial and Nonfinancial Assistance Programs,” February 18, 1986, any health care provider excluded or suspended from CHAMPUS under this section shall, as a general rule, also be debarred, suspended, or otherwise excluded from all other programs and activities involving Federal financial assistance. Among the other programs for which this debarment, suspension, or exclusion shall operate are the Medicare and Medicaid programs. This debarment, suspension, or termination requirement is subject to limited exceptions in the regulations governing the respective Federal programs affected. (Note: Other regulations related to this government-wide exclusion or suspension authority are 32 CFR Part 25 and 45 CFR Part 76.)</P>
            <CITA>[54 FR 25246, June 14, 1989, as amended at 63 FR 48445, Sept. 10, 1998]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.10</SECTNO>
            <SUBJECT>Appeal and hearing procedures.</SUBJECT>
            <P>(a) <E T="03">General.</E> This Section sets forth the policies and procedures for appealing decisions made by OCHAMPUS, OCHAMPUSEUR, and CHAMPUS contractors adversely affecting the rights and liabilities of CHAMPUS beneficiaries, CHAMPUS participating providers, and providers denied the status of authorized provider under CHAMPUS. An appeal under CHAMPUS is an administrative review of program determinations made under the provisions of law and regulation. An appeal cannot challenge the propriety, equity, or legality of any provision of law or regulation.</P>
            <P>(1) <E T="03">Initial determination.</E> (i) <E T="03">Notice of initial determination and right to appeal.</E> (A) OCHAMPUS, OCHAMPUSEUR, and CHAMPUS contractors shall mail notices of initial determinations to the affected provider or CHAMPUS beneficiary (or representative) at the last known address. For beneficiaries who are under 18 years of age or who are incompetent, a notice issued to the parent, guardian, or other representative, under established CHAMPUS procedures, constitutes notice to the beneficiary.</P>
            <P>(B) CHAMPUS contractors and OCHAMPUSEUR shall notify a provider of an initial determination on a claim only if the provider participated in the claim. (See § 199.7 of this part.)</P>
            <P>(C) CHAMPUS peer review organizations shall notify providers and fiscal intermediaries of a denial determination on a claim.</P>
            <P>(D) Notice of an initial determination on a claim processed by a CHAMPUS contractor or OCHAMPUSEUR normally will be made on a CHAMPUS Explanation of Benefits (CEOB) form.</P>
            <P>(E) Each notice of an initial determination on a request for benefit authorization, a request by a provider for approval as an authorized CHAMPUS provider, or a decsion to disqualify or exclude a provider as an authorized provider under CHAMPUS shall state the reason for the determination and the underlying facts supporting the determination.</P>
            <P>(F) In any case when the initial determination is adverse to the beneficiary or participating provider, or to the provider seeking approval as an authorized CHAMPUS provider, the notice shall include a statement of the beneficiary's or provider's right to appeal the determination. The procedure for filing the appeal also shall be explained.</P>
            <P>(ii) <E T="03">Effect of initial determination.</E> The initial determination is final unless appealed in accordance with this chapter, or unless the initial determination is reopened by OCHAMPUS, the CHAMPUS contractor, or the CHAMPUS peer review organization.</P>
            <P>(2) <E T="03">Participation in an appeal.</E> Participation in an appeal is limited to any party to the initial determination, including CHAMPUS, and authorized representatives of the parties. Any party to the initial determination, except CHAMPUS, may appeal an adverse determination. The appealing party is the party who actually files the appeal.<PRTPAGE P="202"/>
            </P>
            <P>(i) <E T="03">Parties to the initial determination.</E> For purposes of the CHAMPUS appeals and hearing procedures, the following are not parties to an initial determination and are not entitled to administrative review under this section.</P>
            <P>(A) A provider disqualified or excluded as an authorized provider under CHAMPUS based on a determination of abuse or fraudulent practices or procedures under another Federal or federally funded program is not a party to the CHAMPUS action and may not appeal under this section.</P>
            <P>(B) A beneficiary who has an interest in receiving care or has received care from a particular provider cannot be an appealing party regarding the exclusion, suspension, or termination of the provider under § 199.9 of this part.</P>
            <P>(C) A sponsor or parent of a beneficiary under 18 years of age or guardian or an incompetent beneficiary is not a party to the initial determination and may not serve as the appealing party, although such persons may represent the appealing party in an appeal.</P>
            <P>(D) A third party, such as an insurance company, is not a party to the initial determination and is not entitled to appeal even though it may have an indirect interest in the initial determination.</P>
            <P>(E) A nonparticipating provider is not a party to the initial determination and may not appeal.</P>
            <P>(ii) <E T="03">Representative.</E> Any party to the initial determination may appoint a representative to act on behalf of the party in connection with an appeal. Generally, the parent of a minor beneficiary and the legally appointed guardian of an incompetent beneficiary shall be presumed to have been appointed representative without specific designation by the beneficiary. The custodial parent or legal guardian (appointed by a cognizant court) of a minor beneficiary may initiate an appeal based on the above presumption. However, should a minor beneficiary turn 18 years of age during the course of an appeal, then any further requests to appeal on behalf of the beneficiary must be from the beneficiary or pursuant to the written authorization of the beneficiary appointing a representative. For example, if the beneficiary is 17 years of age and the sponsor (who is a custodial parent) requests a formal review, absent written objection by the minor beneficiary, the sponsor is presumed to be acting on behalf of the minor beneficiary. Following the issuance of the formal review, the sponsor requests a hearing; however if, at the time of the request for a hearing, the beneficiary is 18 years of age or older, the request must either be by the beneficiary or the beneficiary must appoint a representative. The sponsor, in this example, could not pursue the request for hearing without being appointed by the beneficiary as the beneficiary's representative.</P>
            <P>(A) The representative shall have the same authority as the party to the appeal and notice given to the representative shall constitute notice required to be given to the party under this part.</P>
            <P>(B) To avoid possible conflicts of interest, an officer or employee of the United States, such as an employee or member of a Uniformed Service, including an employee or staff member of a Uniformed Service legal office, or a CHAMPUS advisor, subject to the exceptions in 18 U.S.C. 205, is not eligible to serve as a representative. An exception usually is made for an employee or member of a Uniformed Service who represents an immediate family member. In addition, the Director, OCHAMPUS, or designee, may appoint an officer or employee of the United States as the CHAMPUS representative at a hearing.</P>
            <P>(3) <E T="03">Burden of proof.</E> The burden of proof is on the appealing party to establish affirmatively by substantial evidence the appealing party's entitlement under law and this part to the authorization of CHAMPUS benefits, approval of authorized CHAMPUS provider status, or removal of sanctions imposed under § 199.9 of this part. If a presumption exists under the provisions of this part or information constitutes <E T="03">prima facie</E> evidence under the provisions of this part, the appealing party must produce evidence reasonably sufficient to rebut the presumption or <E T="03">prima facie</E> evidence as part of the appealing party's burden of proof. CHAMPUS shall not pay any part of the cost or fee, including attorney fees, <PRTPAGE P="203"/>associated with producing or submitting evidence in support of an appeal.</P>
            <P>(4) <E T="03">Evidence in appeal and hearing cases.</E> Any relevant evidence may be used in the administrative appeal and hearing process if it is the type of evidence on which reasonable persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule that might make improper the admission of such evidence over objection in civil or criminal courts.</P>
            <P>(5) <E T="03">Late filing.</E> If a request for reconsideration, formal review, or hearings is filed after the time permitted in this section, written notice shall be issued denying the request. Late filing may be permitted only if the appealing party reasonably can demonstrate to the satisfaction of the Director, OCHAMPUS, or a designee, that the timely filing of the request was not feasible due to extraordinary circumstances over which the appealing party had no practical control. Each request for an exception to the filing requirement will be considered on its own merits. The decision of the Director, OCHAMPUS, or a designee, on the request for an exception to the filing requirement shall be final.</P>
            <P>(6) <E T="03">Appealable issue.</E> An appealable issue is required in order for an adverse determination to be appealed under the provisions of this section. Examples of issues that are not appealable under this section include:</P>
            <P>(i) A dispute regarding a requirement of the law or regulation.</P>
            <P>(ii) The amount of the CHAMPUS-determined allowable cost or charge, since the methodology for determining allowable costs or charges is established by this part.</P>
            <P>(iii) The establishment of diagnosis-related groups (DRGs), or the methodology for the classification of inpatient discharges within the DRGs, or the weighting factors that reflect the relative hospital resources used with respect to discharges within each DRG, since each of these is established by this part.</P>
            <P>(iv) Certain other issues on the basis that the authority for the initial determination is not vested in CHAMPUS. Such issues include but are not limited to the following examples:</P>
            <P>(A) Determination of a person's eligibility as a CHAMPUS beneficiary is the responsibility of the appropriate Uniformed Service. Although OCHAMPUS, OCHAMPUSEUR, and CHAMPUS contractors must make determinations concerning a beneficiary's eligibility in order to ensure proper disbursement of appropriated funds on each CHAMPUS claim processed, ultimate responsibility for resolving a beneficiary's eligibility rests with the Uniformed Services. Accordingly, disputed question of fact concerning a beneficiary's eligibility will not be considered an appealable issue under the provisions of this section, but shall be resolved in accordance with § 199.3 of this part.</P>
            <P>(B) Similarly, decisions relating to the issuance of a Nonavailability Statement (DD Form 1251) in each case are made by the Uniformed Services. Disputes over the need for a Nonavailability Statement or a refusal to issue a Nonavailability Statement are not appealable under this section. The one exception is when a dispute arises over whether the facts of the case demonstrate a medical emergency for which a Nonavailability Statement is not required. Denial of payment in this one situation is an appealable issue.</P>

            <P>(C) Any sanction, including the period of the sanction, imposed under § 199.9 of this part which is based solely on a provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority is not appealable under this section. The provider must exhaust administrative appeal rights offered by the other agency that made the initial determination to exclude or suspend the provider. Similarly, any sanction imposed under § 199.9 which is based solely on a criminal conviction or civil judgment against the provider is not appealable under this section. If the sanction imposed under § 199.9 is not based solely on the provider's criminal conviction or civil judgment or on the provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority, that portion of the CHAMPUS administrative determination which is in addition to the criminal conviction/civil judgment or exclusion/suspension <PRTPAGE P="204"/>by the other agency may be appealed under this section.</P>
            <P>(v) A decision by the Director, OCHAMPUS, or a designee, as a suspending official when the decision is final under the provisions of § 199.9(h)(1)(iv)(A).</P>
            <P>(7) <E T="03">Amount in dispute.</E> An amount in dispute is required for an adverse determination to be appealed under the provisions of this section, except as set forth below.</P>
            <P>(i) The amount in dispute is calculated as the amount of money CHAMPUS would pay if the services and supplies involved in dispute were determined to be authorized CHAMPUS benefits. Examples of amounts of money that are excluded by the Regulation from CHAMPUS payments for authorized benefits include, but are not limited to:</P>
            <P>(A) Amounts in excess of the CHAMPUS-determined allowable charge or cost.</P>
            <P>(B) The beneficiary's CHAMPUS deductible and cost-share amounts.</P>
            <P>(C) Amounts that the CHAMPUS beneficiary, or parent, guardian, or other responsible person has no legal obligation to pay.</P>
            <P>(D) Amounts excluded under the provisions of § 199.8 of this part.</P>
            <P>(ii) The amount of dispute for appeals involving a denial of a request for authorization in advance of obtaining care shall be the estimated allowable charge or cost for the services requested.</P>
            <P>(iii) There is no requirement for an amount in dispute when the appealable issue involves a denial of a provider's request for approval as an authorized CHAMPUS provider or the determination to exclude, suspend, or terminate a provider's authorized CHAMPUS provider status.</P>
            <P>(iv) Individual claims may be combined to meet the required amount in dispute if all of the following exist:</P>
            <P>(A) The claims involve the same beneficiary.</P>
            <P>(B) The claims involve the same issue.</P>
            <P>(C) At least one of the claims so combined has had a reconsideration decision issued by OCHAMPUSEUR, a CHAMPUS contractor, or a CHAMPUS peer review organization.</P>
            <NOTE>
              <HD SOURCE="HED">Note:</HD>
              <P>A request for administrative review under this appeal process which involves a dispute regarding a requirement of law or regulation (paragraph (a)(6)(i) of this section) or does not involve a sufficient amount in dispute (paragraph (a)(7) of this section) may not be rejected at the reconsideration level of appeal. However, an appeal shall involve an appealable issue and sufficient amount in dispute under these paragraphs to be granted a formal review or hearing.</P>
            </NOTE>
            <P>(8) <E T="03">Levels of appeal.</E> The sequence and procedures of a CHAMPUS appeal vary, depending on whether the initial determination was made by OCHAMPUS, OCHAMPUSEUR, a CHAMPUS contractor, or a CHAMPUS peer review organization.</P>
            <P>(i) <E T="03">Appeal levels for initial determination made by OCHAMPUSEUR, CHAMPUS contractor, or CHAMPUS peer review organization</E>. (A) Reconsideration by OCHAMPUSEUR, CHAMPUS contractor, or CHAMPUS peer review organization.</P>
            <P>(B) Formal review by OCHAMPUS (except for CHAMPUS peer review organization reconsiderations).</P>
            <P>(C) Hearing.</P>
            <P>(ii) <E T="03">Appeal levels for initial determination made by OCHAMPUS.</E> (A) Reconsideration by OCHAMPUSEUR or CHAMPUS contractor.</P>
            <P>(A) Formal review by OCHAMPUS <E T="03">except</E> (<E T="03">1</E>) initial determinations involving the suspension of claims processing where the Director, OCHAMPUS, or a designee, determines that additional proceedings are necessary as to disputed material facts and the suspending official's decision is not final under the provisions of § 199.9(h) (1)(iv)(A) or (<E T="03">2</E>) initial determinations involving the sanctioning (exclusion, suspension, or termination) of CHAMPUS providers. Initial determinations involving these matters shall be appealed directly to the hearing level.</P>
            <P>(B) Hearing.</P>
            <P>(9) <E T="03">Appeal decision.</E> An appeal decision at any level may address all pertinent issues which arise under the appeal or are otherwise presented by the information in the case record (for example, the entire episode of care in the appeal), and shall not be limited to addressing the specific issue appealed by a party. In the case of sanctions imposed under § 199.9, the final decision <PRTPAGE P="205"/>may affirm, increase or reduce the sanction period imposed by CHAMPUS, or otherwise modify or reverse the imposition of the sanction.</P>
            <P>(b) <E T="03">Reconsideration.</E> Any part to the initial determination made by OCHAMPUSEUR, the CHAMPUS contractor, or a CHAMPUS peer review organization may request a reconsideration.</P>
            <P>(1) <E T="03">Requesting a reconsideration</E>—(i) <E T="03">Written request required.</E> The request must be in writing, shall state the specific matter in dispute, and shall include a copy of the notice of initial determination (such as the CEOB form) made by OCHAMPUSEUR, the CHAMPUS contractor, or the CHAMPUS peer review organization.</P>
            <P>(ii) <E T="03">Where to file.</E> The request shall be submitted to the office that made the initial determination (i.e., OCHAMPUSEUR, the CHAMPUS contractor, or the CHAMPUS peer review organization) or any other CHAMPUS contractor designated in the notice of initial determination.</P>
            <P>(iii) <E T="03">Allowed time to file.</E> The request must be mailed within 90 days after the date of the notice of initial determination.</P>
            <P>(iv) <E T="03">Official filing date.</E> A request for a reconsideration shall be deemed filed on the date it is mailed and postmarked. If the request does not have a postmark, it shall be deemed filed on the date received by OCHAMPUSEUR, the CHAMPUS contractor or the CHAMPUS peer review organization.</P>
            <P>(2) <E T="03">The reconsideration process.</E> The purpose of the reconsideration is to determine whether the initial determination was made in accordance with law, regulation, policies, and guidelines in effect at the time the care was provided or requested, or at the time of the initial determination and/or reconsideration decision involving a provider request for approval as an authorized provider under CHAMPUS. The reconsideration is performed by a member of the OCHAMPUSEUR, CHAMPUS contractor, or CHAMPUS peer review organization staff who was not involved in making the initial determination and is a thorough and independent reveiw of the case. The reconsideration is based on the information submitted that led to the initial determination, plus any additional information that the appealing party may submit or OCHAMPUSEUR, the CHAMPUS contractor, or CHAMPUS peer review organization may obtain.</P>
            <P>(3) <E T="03">Timeliness of reconsideration determination.</E> OCHAMPUSEUR, the CHAMPUS contractor, or CHAMPUS peer review organization normally shall issue its reconsideration determination no later than 60 days from the date of receipt of the request for reconsideration by OCHAMPUSEUR, the CHAMPUS contractor, or the CHAMPUS peer review organization.</P>
            <P>(4) <E T="03">Notice of reconsideration determination.</E> OCHAMPUSEUR, the CHAMPUS contractor, or the CHAMPUS peer review organization shall issue a written notice of the reconsideration determination to the appealing party at his or her last known address. The notice of the reconsideration must contain the following elements:</P>
            <P>(i) A statement of the issues or issue under appeal.</P>
            <P>(ii) The provisions of law, regulation, policies, and guidelines that apply to the issue or issues under appeal.</P>
            <P>(iii) A discussion of the original and additional information that is relevant to the issue or issues under appeal.</P>
            <P>(iv) Whether the reconsideration upholds the initial determination or reverses it, in whole or in part, and the rationale for the action.</P>
            <P>(v) A statement of the right to appeal further in any case when the reconsideration determination is less than fully favorable to the appealing party and the amount in dispute is $50 or more.</P>
            <P>(5) <E T="03">Effect of reconsideration determination.</E> The reconsideration determination is final if either of the following exist:</P>
            <P>(i) The amount in dispute is less than $50.</P>
            <P>(ii) Appeal rights have been offered, but a request for formal review is not received by OCHAMPUS within 60 days of the date of the notice of the reconsideration determination.</P>
            <P>(c) <E T="03">Formal review.</E> Except as explained in this paragraph, any party to an initial determination made by OCHAMPUS, or a reconsideration determination made by the CHAMPUS <PRTPAGE P="206"/>contractor may request a formal review by OCHAMPUS if the party is dissatisfied with the initial or reconsideration determination unless the initial or reconsideration determination</P>
            <P>(1) Is final under paragraph (b)(5) of this section;</P>
            <P>(2) Involves the sanctioning of a provider by the exclusion, suspension or termination of authorized provider status;</P>
            <P>(3) Involves a written decision issued pursuant to § 199.9, paragraph (h)(l)(iv)(A) regarding the temporary suspension of claims processing; or</P>
            <P>(4) Involves a reconsideration determination by a CHAMPUS peer review organization. A hearing, but not a formal review level of appeal, may be available to a party to an initial determination involving the sanctioning of a provider or to a party to a written decision involving a temporary suspension of claims processing. A beneficiary (or an authorized representative of a beneficiary), but not a provider, may request a hearing, but not a formal review, of a reconsideration determination made by a CHAMPUS peer review organization.</P>
            <P>(d) <E T="03">Hearing.</E> Any party to the initial determination may request a hearing if the party is dissatisfied with the formal review determination and the formal review determination is not final under the provisions of paragraph (c)(5), of this section, <E T="03">or</E> the initial determination involves the sanctioning of a provider under § 199.9 of this part and involves an appealable issue.</P>
            <P>(1) <E T="03">Requesting a hearing</E>—(i) <E T="03">Written request required.</E> The request shall be in writing, state the specific matter in dispute, include a copy of the appropriate initial determination or formal review determination being appealed, and include any additional information or documents not submitted previously.</P>
            <P>(ii) <E T="03">Where to file.</E> The request shall be submitted to the Chief, Appeals and Hearings, OCHAMPUS, Aurora, Colorado 80045-6900.</P>
            <P>(iii) <E T="03">Allowed time to file.</E> The request shall be mailed within 60 days after the date of the notice of the initial determination or formal review determination being appealed.</P>
            <P>(iv) <E T="03">Official filing date.</E> A request for hearing shall be deemed filed on the date it is mailed and postmarked. If a request for hearing does not have a postmark, it shall be deemed filed on the day received by OCHAMPUS.</P>
            <P>(2) <E T="03">Hearing process.</E> A hearing is an administrative proceeding in which facts relevant to the appealable issue(s) in the case are presented and evaluated in relation to applicable law, regulation, policies, and guidelines in effect at the time the care in dispute was provided or requested; at the time of the initial determination, formal review determination, or hearing decision involving a provider request for approval under CHAMPUS as an authorized provider; or at the time of the act or event which is the basis for the imposition of sanctions under this part. A hearing, except for an appeal involving a provider sanction, generally shall be conducted as a nonadversary, administrative proceeding. However, an authorized party to any hearing, including CHAMPUS, may submit additional evidence or testimony relevant to the appealable issue(s) and may appoint a representative, including legal counsel, to participate in the hearing process.</P>
            <P>(3) <E T="03">Timeliness of hearing.</E> (i) Except as otherwise provided in this section, within 60 days following receipt of a request for hearing, the Director, OCHAMPUS, or a designee, normally will appoint a hearing officer to hear the appeal. Copies of all records in the possession of OCHAMPUS that are pertinent to the matter to be heard or that formed the basis of the formal review determination shall be provided to the hearing officer and, upon request, to the appealing party.</P>
            <P>(ii) The hearing officer, except as otherwise provided in this Section, normally shall have 60 days from the date of written notice of assignment to review the file, schedule and hold the hearing, and issue a recommended decision to the Director, OCHAMPUS, or designee.</P>

            <P>(iii) The Director, OCHAMPUS, or designee, may delay the case assignment to the hearing officer if additional information is needed that cannot be obtained and included in the record within the time period specified <PRTPAGE P="207"/>above. The appealing party will be notified in writing of the delay resulting from the request for additional information. The Director, OCHAMPUS, or a designee, in such circumstances, will assign the case to a hearing officer within 30 days of receipt of all such additional information, or within 60 days of receipt of the request for hearing, whichever shall occur last.</P>
            <P>(iv) The hearing officer may delay submitting the recommended decision if, at the close of the hearing, any party to the hearing requests that the record remain open for submission of additional information. In such circumstances, the hearing officer will have 30 days following receipt of all such additional information including comments from the other parties to the hearing concerning the additional information to submit the recommended decision to the Director, OCHAMPUS, or a designee.</P>
            <P>(4) <E T="03">Representation at a hearing.</E> Any party to the hearing may appoint a representative to act on behalf of the party at the hearing, unless such person currently is disqualified or suspended from acting in another Federal administrative proceeding, or unless otherwise prohibited by law, this part, or any other DoD regulation (see paragraph (a)(2)(ii) of this section). A hearing officer may refuse to allow any person to represent a party at the hearing when such person engages in unethical, disruptive, or contemptuous conduct, or intentionally fails to comply with proper instructions or requests of the hearing officer, or the provisions of this part. The representative shall have the same authority as the appealing party and notice given to the representative shall constitute notice required to be given to the appealing party.</P>
            <P>(5) <E T="03">Consolidation of proceedings.</E> The Director, OCHAMPUS, or a designee, may consolidate any number of proceedings for hearing when the facts and circumstances are similar and no substantial right of an appealing party will be prejudiced.</P>
            <P>(6) <E T="03">Authority of the hearing officer.</E> The hearing officer in exercising the authority to conduct a hearing under this part will be bound by 10 U.S.C. chapter 55 and this part. The hearing officer in addressing substantive, appealable issues shall be bound by policy manuals, instructions, procedures, and other guidelines issued by the ASD(HA), or a designee, or by the Director, OCHAMPUS, or a designee, in effect for the period in which the matter in dispute arose. A hearing officer may not establish or amend policy, procedures, instructions, or guidelines. However, the hearing officer may recommend reconsideration of the policy, procedures, instructions or guidelines by the ASD(HA), or a designee, when the final decision is issued in the case.</P>
            <P>(7) <E T="03">Disqualification of hearing officer.</E> A hearing officer voluntarily shall disqualify himself or herself and withdraw from any proceeding in which the hearing officer cannot give fair or impartial hearing, or in which there is a conflict of interest. A party to the hearing may request the disqualification of a hearing officer by filing a statement detailing the reasons the party believes that a fair and impartial hearing cannot be given or that a conflict of interest exists. Such request immediately shall be sent by the appealing party or the hearing officer to the Director, OCHAMPUS, or a designee, who shall investigate the allegations and advise the complaining party of the decision in writing. A copy of such decision also shall be mailed to all other parties to the hearing. If the Director, OCHAMPUS, or a designee, reassigns the case to another hearing officer, no investigation shall be required.</P>
            <P>(8) <E T="03">Notice and scheduling of hearing.</E> The hearing officer shall issue by certified mail, when practicable, a written notice to the parties to the hearing of the time and place for the hearing. Such notice shall be mailed at least 15 days before the scheduled date of the hearing. The notice shall contain sufficient information about the hearing procedure, including the party's right to representation, to allow for effective preparation. The notice also shall advise the appealing party of the right to request a copy of the record before the hearing. Additionally, the notice shall advise the appealing party of his or her responsibility to furnish the hearing officer, no later than 7 days before the scheduled date of the hearing, a list of all witnesses who will testify and a <PRTPAGE P="208"/>copy of all additional information to be presented at the hearing. The time and place of the hearing shall be determined by the hearing officer, who shall select a reasonable time and location mutually convenient to the appealing party and OCHAMPUS.</P>
            <P>(9) <E T="03">Dismissal of request for hearing.</E> (i) <E T="03">By application of appealing party.</E> A request for hearing may be dismissed by the Director, OCHAMPUS, or a designee, at any time before the mailing of the final decision, upon the application of the appealing party. A request for dismissal must be in writing and filed with the Chief, Appeals and Hearings, OCHAMPUS, or the hearing officer. When dismissal is requested, the formal review determination in the case shall be deemed final, unless the dismissal is vacated in accordance with paragraph (d)(9)(v) of this section.</P>
            <P>(ii) <E T="03">By stipulation of the parties to the hearing.</E> A request for a hearing may be dismissed by the Director, OCHAMPUS, or a designee, at any time before to the mailing of notice of the final decision under a stipulation agreement between the appealing party and OCHAMPUS. When dismissal is entered under a stipulation, the formal review decision shall be deemed final, unless the dismissal is vacated in accordance with paragraph (d)(9)(v) of this section.</P>
            <P>(iii) <E T="03">By abandonment.</E> The Director, OCHAMPUS, or a designee, may dismiss a request for hearing upon abandonment by the appealing party.</P>
            <P>(A) An appealing party shall be deemed to have abandoned a request for hearing, other than when personal appearance is waived in accordance with § 199.10(d)(11)(xii), if neither the appealing party nor an appointed representative appears at the time and place fixed for the hearing and if, within 10 days after the mailing of a notice by certified mail to the appealing party by the hearing officer to show cause, such party does not show good and sufficient cause for such failure to appear and failure to notify the hearing officer before the time fixed for hearing that an appearance could not be made.</P>
            <P>(B) An appealing party shall be deemed to have abandoned a request for hearing if, before assignment of the case to the hearing officer, OCHAMPUS is unable to locate either the appealing party or an appointed representative.</P>
            <P>(C) An appealing party shall be deemed to have abandoned a request for hearing if the appealing party fails to prosecute the appeal. Failure to prosecute the appeal includes, but is not limited to, an appealing party's failure to provide information reasonably requested by OCHAMPUS or the hearing officer for consideration in the appeal.</P>
            <P>(D) If the Director, OCHAMPUS, or a designee, dismisses the request for hearing because of abandonment, the formal review determination in the case shall be deemed to be final, unless the dismissal is vacated in accordance with paragraph (d)(9)(v) of this section.</P>
            <P>(iv) <E T="03">For cause.</E> The Director, OCHAMPUS, or a designee, may dismiss for cause a request for hearing either entirely or as to any stated issue. If the Director, OCHAMPUS, or a designee, dismisses a hearing request for cause, the formal review determination in the case shall be deemed to be final, unless the dismissal is vacated in accordance with paragraph (d)(9)(v) of this section. A dismissal for cause may be issued under any of the following circumstances:</P>
            <P>(A) When the appealing party requesting the hearing is not a proper party under paragraph (a)(2)(i) of this section, or does not otherwise have a right to participate in a hearing.</P>
            <P>(B) When the appealing party who filed the hearing request dies, and there is no information before the Director, OCHAMPUS, or a designee, showing that a party to the initial determination who is not an appealing party may be prejudiced by the formal review determination.</P>
            <P>(C) When the issue is not appealable (see § 199.10(a)(6)).</P>
            <P>(D) When the amount in dispute is less than $300 (see § 199.10(a)(7)).</P>
            <P>(E) When all appealable issues have been resolved in favor of the appealing party.</P>
            <P>(v) <E T="03">Vacation of dismissal.</E> Dismissal of a request for hearing may be vacated by the Director, OCHAMPUS, or a designee, upon written request of the appealing party, if the request is received <PRTPAGE P="209"/>within 6 months of the date of the notice of dismissal mailed to the last known address of the party requesting the hearing.</P>
            <P>(10) <E T="03">Preparation for hearing</E>. (i) <E T="03">Prehearing statement of contentions.</E> The hearing officer may on reasonable notice require a party to the hearing to submit a written statement of contentions and reasons. The written statement shall be provided to all parties to the hearing before the hearing takes place.</P>
            <P>(ii) <E T="03">Discovery.</E> Upon the written request of a party to the initial determination (including OCHAMPUS) and for good cause shown, the hearing officer will allow that party to inspect and copy all documents, unless privileged, relevant to issues in the proceeding that are in the possession or control of the other party participating in the appeal. The written request shall state clearly what information and documents are required for inspection and the relevance of the documents to the issues in the proceeding. Depositions, interrogatories, requests for admissions, and other forms of prehearing discovery are generally not authorized and the Department of Defense does not have subpoena authority for purposes of administrative hearings under this Section. If the hearing officer finds that good cause exists for taking a deposition or interrogatory, the expense shall be assessed to the requesting party, with copies furnished to the hearing officer and the other party or parties to the hearing.</P>
            <P>(iii) <E T="03">Witnesses and evidence.</E> All parties to a hearing are responsible for producing, at each party's expense, meaning without reimbursement of payment by CHAMPUS, witnesses and other evidence in their own behalf, and for furnishing copies of any such documentary evidence to the hearing officer and other party or parties to the hearing. The Department of Defense is not authorized to subpoena witnesses or records. The hearing officer may issue invitations and requests to individuals to appear and testify without cost to the Government, so that the full facts in the case may be presented.</P>
            <P>(11) <E T="03">Conduct of hearing.</E> (i) <E T="03">Right to open hearing.</E> Because of the personal nature of the matters to be considered, hearings normally shall be closed to the public. However, the appealing party may request an open hearing. If this occurs, the hearing shall be open except when protection of other legitimate Government purposes dictates closing certain portions of the hearing.</P>
            <P>(ii) <E T="03">Right to examine parties to the hearing and their witnesses.</E> Each party to the hearing shall have the right to produce and examine witnesses, to introduce exhibits, to question opposing witnesses on any matter relevant to the issue even though the matter was not covered in the direct examination, to impeach any witness regardless of which party to the hearing first called the witness to testify, and to rebut any evidence presented. Except for those witnesses employed by OCHAMPUS at the time of the hearing, or records in the possession of OCHAMPUS, a party to a hearing shall be responsible, that is to say no payment or reimbursement shall be made by CHAMPUS for the cost or fee associated with producing witnesses or other evidence in the party's own behalf, or for furnishing copies of documentary evidence to the hearing officer and other party or parties to the hearing.</P>
            <P>(iii) <E T="03">Taking of evidence.</E> The hearing officer shall control the taking of evidence in a manner best suited ascertain the facts and safeguard the rights of the parties to the hearing. Before taking evidence, the hearing officer shall identify and state the issues in dispute on the record and the order in which evidence will be recieved.</P>
            <P>(iv) <E T="03">Questioning and admission of evidence.</E> A hearing officer may question any witness and shall admit any relevant evidence. Evidence that is irrelevant or unduly repetitious shall be excluded.</P>
            <P>(v) <E T="03">Relevant evidence.</E> Any relevant evidence shall be admitted, unless unduly repetitious, if it is the type of evidence on which responsible persons are accustomed to rely in the conduct of serious affairs, regardless of the existence of any common law or statutory rule that might make improper the admission of such evidence over objection in civil or criminal actions.</P>
            <P>(vi) <E T="03">CHAMPUS determination first.</E> The basis of the CHAMPUS determinations <PRTPAGE P="210"/>shall be presented to the hearing officer first. The appealing party shall then be given the opportunity to establish affirmatively why this determination is held to be in error.</P>
            <P>(vii) <E T="03">Testimony.</E> Testimony shall be taken only on oath, affirmation, or penalty of perjury.</P>
            <P>(viii) <E T="03">Oral argument and briefs.</E> At the request of any party to the hearing made before the close of the hearing, the hearing officer shall grant oral argument. If written argument is requested, it shall be granted, and the parties to the hearing shall be advised as to the time and manner within which such argument is to be filed. The hearing officer may require any party to the hearing to submit written memoranda pertaining to any or all issues raised in the hearing.</P>
            <P>(ix) <E T="03">Continuance of hearing.</E> A hearing officer may continue a hearing to another time or place on his or her own motion or, upon showing of good cause, at the request of any party. Written notice of the time and place of the continued hearing, except as otherwise provided here, shall be in accordance with this part. When a continuance is ordered during a hearing, oral notice of the time and place of the continued hearing may be given to each party to the hearing who is present at the hearing.</P>
            <P>(x) <E T="03">Continuance for additional evidence.</E> If the hearing officer determines, after a hearing has begun, that additional evidence is necessary for the proper determination of the case, the following procedures may be invoked:</P>
            <P>(A) <E T="03">Continue hearing.</E> The hearing may be continued to a later date in accordance with § 199.10(d)(11)(ix), above.</P>
            <P>(B) <E T="03">Closed hearing.</E> The hearing may be closed, but the record held open in order to permit the introduction of additional evidence. Any evidence submitted after the close of the hearing shall be made available to all parties to the hearing, and all parties to the hearing shall have the opportunity for comment. The hearing officer may reopen the hearing if any portion of the additional evidence makes further hearing desirable. Notice thereof shall be given in accordance with paragraph (d)(8) of this section.</P>
            <P>(xi) <E T="03">Transcript of hearing.</E> A verbatim taped record of the hearing shall be made and shall become a permanent part of the record. Upon request, the appealing party shall be furnished a duplicate copy of the tape. A typed transcript of the testimony will be made only when determined to be necessary by OCHAMPUS. If a typed transcript is made, the appealing party shall be furnished a copy without charge. Corrections shall be allowed in the typed transcript by the hearing officer solely for the purpose of conforming the transcript to the actual testimony.</P>
            <P>(xii) <E T="03">Waiver of right to appear and present evidence.</E> If all parties waive their right to appear before the hearing officer for presenting evidence and contentions personally or by representation, it will not be necessary for the hearing officer to give notice of, or to conduct a formal hearing. A waiver of the right to appear must be in writing and filed with the hearing officer or the Chief, Appeals and Hearings, OCHAMPUS. Such waiver may be withdrawn by the party by written notice received by the hearing officer or Chief, Appeals and Hearings, no later than 7 days before the scheduled hearing or the mailing of notice of the final decision, whichever occurs first. For purposes of this Section, failure of a party to appear personally or by representation after filing written notice of waiver, will not be cause for finding of abandonment and the hearing officer shall make the recommended decision on the basis of all evidence of record.</P>
            <P>(12) <E T="03">Recommended decision.</E> At the conclusion of the hearing and after the record has been closed, the matter shall be taken under consideration by the hearing officer. Within the time frames previously set forth in this Section, the hearing officer shall submit to the Director, OCHAMPUS, or a designee, a written recommended decision containing a statement of findings and a statement of reasons based on the evidence adduced at the hearing and otherwise included in the hearing record.</P>
            <P>(i) <E T="03">Statement of findings.</E> A statement of findings is a clear and concise statement of fact evidenced in the record or conclusions that readily can be deduced from the evidence of record. <PRTPAGE P="211"/>Each finding must be supported by substantial evidence that is defined as such evidence as a reasonable mind can accept as adequate to support a conclusion.</P>
            <P>(ii) <E T="03">Statement of reasons.</E> A reason is a clear and concise statement of law, regulation, policies, or guidelines relating to the statement of findings that provides the basis for the recommended decision.</P>
            <P>(e) <E T="03">Final decision.</E> (1) <E T="03">Director, OCHAMPUS.</E> The recommended decision shall be reviewed by the Director, OCHAMPUS, or a designee, who shall adopt or reject the recommended decision or refer the recommended decision for review by the Assistant Secretary of Defense (Health Affairs). The Director, OCHAMPUS, or designee, normally will take action with regard to the recommended decision within 90 days of receipt of the recommended decision or receipt of the revised recommended decision following a remand order to the Hearing Officer.</P>
            <P>(i) <E T="03">Final action.</E> If the Director, OCHAMPUS, or a designee, concurs in the recommended decision, no further agency action is required and the recommended decision, as adopted by the Director, OCHAMPUS, is the final agency decision in the appeal. In the case of rejection, the Director, OCHAMPUS, or a designee, shall state the reason for disagreement with the recommended decision and the underlying facts supporting such disagreement. In these circumstances, the Director, OCHAMPUS, or a designee, may have a final decision prepared based on the record, or may remand the matter to the Hearing Officer for appropriate action. In the latter instance, the Hearing Officer shall take appropriate action and submit a new recommended decision within 60 days of receipt of the remand order. The decision by the Director, OCHAMPUS, or a designee, concerning a case arising under the procedures of this section, shall be the final agency decision and the final decision shall be sent by certified mail to the appealing party or parties. A final agency decision under paragraph (e)(1) of this section will not be relied on, used, or cited as precedent by the Department of Defense in the administration of CHAMPUS.</P>
            <P>(ii) <E T="03">Referral for review by ASD(HA).</E> The Director, OCHAMPUS, or a designee, may refer a hearing case to the Assistant Secretary of Defense (Health Affairs) when the hearing involves the resolution of CHAMPUS policy and issuance of a final decision which may be relied on, used, or cited as precedent in the administration of CHAMPUS. In such a circumstance, the Director, OCHAMPUS, or a designee, shall forward the recommended decision, together with the recommendation of the Director, OCHAMPUS, or a designee, regarding disposition of the hearing case.</P>
            <P>(2) <E T="03">ASD(HA).</E> The ASD(HA), or a designee, after reviewing a case arising under the procedures of this section may issue a final decision based on the record in the hearing case or remand the case to the Director, OCHAMPUS, or a designee, for appropriate action. A decision issued by the ASD(HA), or a designee, shall be the final agency decision in the appeal and a copy of the final decision shall be sent by certified mail to the appealing party or parties. A final decision of the ASD(HA), or a designee, issued under this paragraph (e)(2) may be relied on, used, or cited as precedent in the administration of CHAMPUS.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 52 FR 33007, Sept. 1, 1987; 54 FR 25255, June 14, 1989; 55 FR 43341, Nov. 16, 1990; 56 FR 59880, Nov. 26, 1991]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.11</SECTNO>
            <SUBJECT>Overpayments recovery.</SUBJECT>
            <P>(a) <E T="03">General.</E> Actions to recover overpayments arise when the government has a right to recover money or property from an individual, partnership, association, corporation, governmental body or other legal entity, foreign or domestic, except an instrumentality of the United States because of an erroneous payment of benefits under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). A claim against several joint debtors arising from a single incident or transaction is considered to be one claim. It is the purpose of this Section to prescribe procedures for investigation, determination, assertion, collection, compromise, waiver and termination of claims in favor of the United States for <PRTPAGE P="212"/>erroneous benefits payments arising out of administration of CHAMPUS.</P>
            <P>(b) <E T="03">Authority</E>. (1) <E T="03">Federal statutory authority.</E> The Federal Claims Collection Act provides the basic authority under which claims may be asserted pursuant to this section. It is implemented by joint regulations issued by the Department of Justice and the General Accounting Office, 4 CFR parts 101-105. Thereunder, the heads of federal agencies or their designees are required to attempt collection of all claims of the United States for money or property arising out of the activities of their respective agencies. These officials may, with respect to claims that do not exceed $20,000, exclusive of interest, and in conformity with the standards promulgated in the joint regulations, compromise, suspend, or terminate collection action on such claims. Section 743 of the National Defense Authorization Act for Fiscal Year 1996 (Public Law 104-106) authorizes the waiver (see paragraph (g)(3) of this section) of collection of overpayments otherwise due from a person after the termination of the person's CHAMPUS eligibility, because the person became eligible for Medicare Part A by reason of disability or end-stage renal disease.</P>
            <P>(2) <E T="03">Other authority.</E> Occasionally, federal claims may arise which are grounded, at least in part, in authority other than the federal statute referenced above. These include, but are not limited to, claims arising under:</P>
            <P>(i) State worker's compensation laws.</P>
            <P>(ii) State hospital lien laws.</P>
            <P>(iii) State no-fault automobile statutes.</P>
            <P>(iv) Contract rights under terms of insurance policies.</P>
            <P>(c) <E T="03">Policy.</E> The governmental policy of avoiding unnecessary litigation in the collection of claims by the United States for money or property necessitates aggressive agency collection action. The Director, OCHAMPUS, or a designee, will insure that CHAMPUS claims asserting personnel are adequately supported to take timely and effective action. Claims arising out of any incident which has or probably will generate a claim in favor of the government will not be compromised nor will collection action be terminated by any person not authorized to take final action on the government's claim. By the Act of July 18, 1966 (28 U.S.C. 2415-2418), Congress established a statute of limitation applicable to the government in areas where previously neither limitations nor laches were available as a defense. Claims falling within the provisions of this statute will be processed expeditiously to the Department of Justice or the General Accounting Office, as appropriate, without attempting administrative collection action if such action cannot be accomplished in sufficient time to preclude the running of the statute of limitations.</P>
            <P>(d) <E T="03">Appealability.</E> This section describes the procedures to be followed in the recovery and collection of federal claims in favor of the United States arising from the operation of the CHAMPUS. Actions taken under this section are not initial determinations for the purpose of the appeal procedures of § 199.10 of this part. However, the proper exercise of the right to appeal benefit or provider status determinations under the procedures set forth in § 199.10 may affect the processing of federal claims arising under this section. Those appeal procedures afford a CHAMPUS beneficiary or participating provider an opportunity for administrative appellate review in cases in which benefits have been denied and in which there is a significant factual dispute. For example, a fiscal intermediary may erroneously make payment for services which are excluded as CHAMPUS benefits because they are determined to be not medically necessary. In that event recoupment action will be initiated by the fiscal intermediary at the same time the fiscal intermediary will offer an administrative appeal as provided in § 199.10 of this part on the medical necessity issue raised by the adverse benefit determination. The recoupment action and the administrative appeal are separate actions. However, in an appropriate case, the pendency of the appeal may provide a basis for the suspension of collection in the recoupment. Obviously, if the appeal is resolved entirely in favor of the appealing party, that would provide a basis for the termination of collection action in the recoupment case.<PRTPAGE P="213"/>
            </P>
            <P>(e) <E T="03">Delegation.</E> Subject to the limitations imposed by law or contained in this section, the authority to assert, settle, compromise or to suspend or terminate collection action on claims arising under the Federal Claims Collection Act has been delegated to the Director, OCHAMPUS, or a designee.</P>
            <P>(f) <E T="03">Recoupment of erroneous payments.</E> (1) <E T="03">Erroneous payments.</E> Erroneous payments are expenditures of government funds which are not authorized by law or this part. Examples which are sometimes encountered in the administration of the CHAMPUS include mathematical errors, payment for care provided to an ineligible person, payment for care which is not an authorized benefit, payment for duplicate claims, inaccurate application of the deductible or co-payment, or payment for services which were not medically necessary. Claims in favor of the government arising as the result of the filing of false CHAMPUS claims or other fraud fall under the direct cognizance of the Department of Justice. Consequently, the procedures in this section apply to such claims only when specifically authorized or directed by the Department of Justice. (See 32 CFR 101.3.)</P>
            <P>(2) <E T="03">Scope.</E> (i) <E T="03">General.</E> Paragraph (f) of this section and the paragraphs following contain requirements and procedures for the assertion, collection or compromise of, and the suspension or termination of collection action on claims for erroneous payments against a sponsor, beneficiary, provider, physician or other supplier of services under the CHAMPUS. These provisions are adopted pursuant to the Federal Claims Collection Act (31 U.S.C. 3701 <E T="03">et seq.,</E> as amended by the Debt Collection Act of 1982, Pub. L. 97-365), which requires each agency of the U.S. Government (pursuant to regulations jointly promulgated by the Attorney General and the Comptroller General) to attempt collection of federal claims in favor of the United States arising out of the activities of the agency, and 5 U.S.C. 5514, which provides for installment deduction for indebtedness to the United States, implemented by regulations issued by the Office of Personnel Management, 5 CFR part 550, and the Department of Defense, 32 CFR part 90. Paragraph (f) of this section also includes government-wide collections by salary offset under 5 U.S.C. 5514.</P>
            <P>(ii) <E T="03">Debtor defined.</E> As used herein, “debtor” means a sponsor, beneficiary, provider, physician, other supplier of services or supplies, or any other person who has for any reason been erroneously paid under the CHAMPUS. It includes an individual, partnership, corporation, professional corporation or association, estate, trust or any other legal entity.</P>
            <P>(iii) <E T="03">Delinquency defined.</E> As used herein, a debt is considered “delinquent” if it has not been paid by the date specified in the initial demand for payment (that is, the initial written notification) or applicable contractual agreement, unless other satisfactory payment arrangements have been made by that date. A debt is also considered delinquent if at any time after entering into a repayment agreement, the debtor fails to satisfy any obligations under that agreement.</P>
            <P>(3) <E T="03">Other health insurance claims.</E> Claims arising from erroneous CHAMPUS payments in situations where the beneficiary has entitlement to insurance, medical service, health and medical plan, or other government program, except in the case of a plan administered under Title XIX of the Social Security Act (42 U.S.C. 1396 <E T="03">et seq.</E>), through employment, by law, through membership in an organization, or as a student, or through the purchase of a private insurance or health plan, shall be recouped under one of the following procedures:</P>
            <P>(i) Where the other health insurance plan has not already made benefit payments to the beneficiary or provider, a claim for direct reimbursement will be asserted against the plan, pursuant to the fiscal intermediary's coordination of benefit procedures.</P>
            <P>(ii) If the other health insurance plan has made its benefit payment prior to receiving the CHAMPUS request for reimbursement, the recoupment procedures set forth in paragraph (f) of this section will be followed.</P>
            <P>(4) <E T="03">Claims denials due to clarification or change.</E> In those instances where claim review results in the denial of benefits previously provided but now denied due <PRTPAGE P="214"/>to a change, clarification or interpretation of the public law or this part, no recoupment action need be taken to recover funds expended prior to the effective date of such change, clarification, or interpretation.</P>
            <P>(5) <E T="03">Good faith payment.</E> (i) The Department of Defense, through the Defense Enrollment Eligibility Reporting System (DEERS), is responsible for establishing and maintaining a file listing persons eligible to receive benefits under CHAMPUS. However, it is the responsibility of the Uniformed Services to provide eligible CHAMPUS beneficiaries with accurate and appropriate means of identification. When sources of civilian medical care exercise reasonable care and precaution in identifying persons claiming to be eligible CHAMPUS beneficiaries and furnish otherwise covered services and supplies to such persons in good faith, CHAMPUS benefits may be paid subject to prior approval by the Director, OCHAMPUS, or a designee, notwithstanding the fact that the person receiving the services and supplies is subsequently determined to be ineligible for benefits. Good faith payments will not be authorized for services and supplies provided by a civilian source of medical care as the result of its own careless identification procedures.</P>
            <P>(ii) When it is determined that a person was not a CHAMPUS beneficiary, the CHAMPUS fiscal intermediary and the civilian source of medical care are expected to make all reasonable efforts to obtain payment or recoup the amount of the good faith payment from the person who erroneously claimed to be a CHAMPUS beneficiary. Recoupments of good faith payments initiated by the CHAMPUS fiscal intermediary will be processed pursuant to the provisions of paragraph (f) of this section.</P>
            <P>(6) <E T="03">Recoupment procedures.</E> (i) <E T="03">Initial action.</E> When an erroneous payment is discovered, the CHAMPUS fiscal intermediary normally will be required to take the initial action to effect recoupment. Such action will be in accordance with the provisions of this part and the fiscal intermediary's CHAMPUS contract and will include demands for refund or an offset against any other CHAMPUS payment becoming due the debtor. When the efforts of the CHAMPUS fiscal intermediary to effect recoupment are not successful within a reasonable time, recoupment cases will be referred to the General Counsel, OCHAMPUS, for further action in accordance with the provisions of paragraph (f) of this section. All requests to debtors for refund or notices of intent to offset shall be in writing.</P>
            <P>(ii) <E T="03">Demand for payment.</E> The CHAMPUS fiscal intermediary and OCHAMPUS normally shall make a total of at least three progressively stronger written demands upon the debtor in terms which inform the debtor of the consequences of his or her failure to cooperate. The initial written demand shall inform the debtor of the basis for and the amount of the indebtedness. The initial written demand shall also inform the debtor of the following: The debtor's right to inspect and copy all records pertaining to the debt; his or her right to request an administrative review by the fiscal intermediary; that interest on the debt at the current rate as determined by the Director, OCHAMPUS, or a designee, will begin to accrue on the date of the initial demand notification; that such interest shall be waived on the debt, or any portion thereof, which is paid within 30 days of the date of the initial demand notification; that payment of the indebtedness is due within 30 days of the date of the initial demand notification; and that administrative costs and penalties will be charged pursuant to 4 CFR 102.13. The debtor also shall be informed that collection by offset against current or subsequent claims may be taken. All debtors will be offered an opportunity to enter into a written agreement to repay the indebtedness. The fiscal intermediary demand letters must be dated the same day as they are mailed. Two written demands, at 30-day intervals, normally will be made by the CHAMPUS fiscal intermediary unless a response to the first demand indicates that further demand would be futile or unless prompt suit or attachment is required in anticipation of the departure of the debtor, of his removal or transfer of assets, or the running of the statute of limitations. There should be no undue time <PRTPAGE P="215"/>lag in responding to any communication received from the debtor. Responses should be made within 30 days whenever feasible. If these initial efforts at collection are not productive or if immediate legal action on the claim appears necessary, the claim either will be referred promptly by the CHAMPUS fiscal intermediary to the General Counsel, OCHAMPUS, or the CHAMPUS fiscal intermediary will prepare a final notice informing the debtor that the debt is to be offset in whole or in part. When a case is referred to OCHAMPUS, the Office of General Counsel will normally prepare a third written demand unless from the record such demand appears futile or otherwise inappropriate.</P>
            <P>(iii) <E T="03">Collection by administrative offset.</E> Collections by offset will be undertaken administratively on claims which are liquidated or certain in amount in every instance in which this is feasible. No collection by offset may be undertaken unless a demand for payment containing all of the procedural safeguards described in paragraph (f)(6)(ii) of this section, has been sent to the debtor. The determinations of indebtedness made for recoupment of erroneous CHAMPUS payments rarely involve issues of credibility of veracity. Erroneous CHAMPUS payments most frequently arise from claims submitted by individuals ineligible for CHAMPUS benefits; from claims submitted for services or supplies not covered by CHAMPUS; from claims in which there have been other insurance payments which reduce the CHAMPUS liability and from claims from participating providers in which payment is initially erroneously made to the beneficiary. While these recoupment claims normally involve the resolution of factual questions, these resolution nearly always require only reference to the documentary evidence compiled in the investigation and processing of the claim. The appeals system described in § 199.10 of this part affords a CHAMPUS beneficiary or participating provider an opportunity for an administrative appellate review, including, under certain circumstances, the right to oral hearing before a hearing officer. Further, there is no statutory provision for the waiver of indebtedness arising from erroneous CHAMPUS payments, other than the provisions of the Federal Claims Collection Act which allow for the compromise of claims or the termination of collection action under certain circumstances specified in paragraph (g) of this section. Consequently, the pre-offset oral hearing requirements of the Federal Claims Collection Standards (4 CFR 102.3) do not apply to the recoupment of erroneous CHAMPUS payments. CHAMPUS fiscal intermediaries may take administrative action to offset erroneous payments against other current CHAMPUS payments owing a debtor. Payments on the claims of a debtor pending at or filed subsequent to the time collection action is initiated should be suspended pending the outcome of the collection action so that these funds will be available for offset. All or any part of a debt may be offset depending upon the amount available for offset. Only the case in which no possibility of offset arises within 60 days of the initiation of collection action and on which other collection efforts have been unsuccessful or in which the debtor seeks relief from the indebtedness will be referred to the General Counsel, OCHAMPUS, by the CHAMPUS fiscal intermediary. Offset, under the provisions of 31 U.S.C. 3716, is not to be used with respect to debts owed by any state or local government. Any requests for offset that are received from other agencies shall be forwarded to the General Counsel, OCHAMPUS, for processing, as will orders for garnishment issued by courts of competent jurisdiction.</P>
            <P>(iv) <E T="03">Collection of installments.</E> CHAMPUS recoupment claims should be collected in one lump sum whenever possible. However, if the debtor is financially unable to pay the debt in one lump sum, payment may be accepted in regular installments by the CHAMPUS fiscal intermediary or the General Counsel, OCHAMPUS. Installment payments normally will be required on at least a monthly basis and their size will bear a reasonable relation to the size of the debt and the debtor's ability to pay. A CHAMPUS fiscal intermediary should not enter into installment agreements which extend beyond 24 months. OCHAMPUS installment <PRTPAGE P="216"/>agreements normally should liquidate the government's claim within 3 years. Installment payments of less than $50 per month normally will be accepted only if justifiable on grounds of financial hardship or some other reasonable cause. Any installment agreement with a debtor in which the total amount of the deferred installments will exceed $750 should normally include an executed promissory note.</P>
            <P>(v) <E T="03">Interest, penalties, and administrative costs.</E> Interest shall be charged on CHAMPUS recoupment debts and debts collected in installments in accordance with 4 CFR 102.13 and instructions issued by the Director, OCHAMPUS, or a designee. Interest shall accrue from the date on which the initial demand is mailed to the debtor. The rate of interest assessed shall be the rate of the current value of funds to the United States Treasury (that is, the Treasury tax and loan account rate). The rate of interest, as initially assessed shall remain fixed for the duration of the indebtedness, except that where the debtor has defaulted on a repayment agreement and seeks to enter into a new agreement, a new interest rate may be set which reflects the current value of funds to the Treasury at the time the new agreement is executed. The collection of interest on the debt or any portion of the debt, which is paid within 30 days after the date on which interest began to accrue, shall be waived. The agency may extend this 30-day period, on a case-by-case basis, if it reasonably determines that such action is appropriate. Also, the collection of interest, penalties, and administrative costs may be waived in whole or in part as a part of the compromise of a debt as provided in paragraph (g) of this section. In addition, the Director, OCHAMPUS, or a designee, may waive in whole or in part, the collection of interest, penalties, or administrative costs assessed herein, if he or she determines that collection of these charges would be against equity and good conscience or not in the best interests of the United States. Some situations in which such a waiver may be appropriate include:</P>
            <P>(A) Waiver of interest consistent with 4 CFR 104.2(c)(2) in connection with a suspension of collection action pending a CHAMPUS appeal under § 199.10 of this part where there is a substantial issue of fact in dispute.</P>
            <P>(B) Waiver of interest where the original debt arose through no fault or lack of good faith on the part of the debtor and the collection of interest would impose a financial hardship or burden on the debtor. Some examples in which such a waiver may be appropriate include: a debt arising when a CHAMPUS beneficiary, who is unaware of the loss of eligibility for CHAMPUS because he or she has become eligible for Medicare, continues to file and be paid for CHAMPUS claims, resulting in erroneous CHAMPUS payments; a debt arising when a CHAMPUS beneficiary in good faith files and is paid a CHAMPUS claim for medical services or supplies which are later determined not to be benefits of CHAMPUS; and a debt arising when a CHAMPUS beneficiary is overpaid as the result of a calculation error on the part of a fiscal intermediary or OCHAMPUS.</P>
            <P>(C) Waiver of interest where there has been an agreement to repay a debt in installments, there is no indication of fault or lack of good faith on the part of the debtor, and the amount of interest is so large in relation to the size of the installments that the debtor can reasonably afford to pay, that it is likely the debt will never be repaid in full.</P>

            <FP>When a debt is paid in installments, the installment payments first will be applied to the payment of outstanding penalty and administrative cost charges, second to accrued interest and then to principal. Administrative costs incurred as the result of a debt becoming delinquent (as defined in paragraph (f)(2)(iii) of this section) shall be assessed against a debtor. These administrative costs represent the additional costs incurred in processing and handling the debt because it became delinquent. The calculation of administrative costs should be based upon cost analysis establishing an average of actual additional costs incurred in processing and handling claims against other debtors in similar stages of delinquency. A penalty charge, not exceeding six percent a year shall be assessed on any portion of a debt that is delinquent for more than 90 days. This <PRTPAGE P="217"/>charge, which need not be calculated until the 91st day of delinquency, shall accrue from the date that the debt became delinquent.</FP>
            <P>(vi) <E T="03">Referral to other federal agencies for administrative offset.</E> As appropriate and in accordance with 4 CFR part 1023, agencies will be requested to initiate administrative offset to collect CHAMPUS debts. When a debtor is employed by the U.S. Government, or is a member or retired member of the Uniformed Service, and collection by offset against other CHAMPUS payments due the debtor cannot be accomplished, and there have been no positive responses to a demand for payment within 60 days, the Director, OCHAMPUS, or a designee, may contact the agency holding funds payable to the debtor for payment by allotment or otherwise by salary offset from current disposable pay in accordance with 37 U.S.C. 1007 or 5 U.S.C. 5514 as implemented by 32 CFR part 90 and 5 CFR part 550. Where applicable, the request for recovery of erroneous CHAMPUS payments shall be submitted to the debtor's paying agency in accordance with 5 CFR 550.1106. Before contacting the paying agency, the Director, OCHAMPUS, or a designee, will provide the debtor written notification of the agency's intent to collect the debt by means of salary offset, authorized by 5 U.S.C. 5514. The notification will include, as a minimum:</P>
            <P>(A) The agency's determination that a debt is owed, including the origin, nature, and the amount of the debt;</P>
            <P>(B) The date by which payment is to be made, which will normally be 30 days from the date the demand letter is mailed;</P>
            <P>(C) The amount, frequency, proposed beginning date and duration of the intended deductions, which will be determined in accordance with the provisions of 5 CFR 550.1104 or 32 CFR part 90, as appropriate. Ordinarily, the size of installment deductions must bear a reasonable relationship to the size of the debt and the employee's ability to pay (4 CFR 102.11). However, the amount deducted for any period must not exceed 15 percent of the disposable pay from which the deduction is made unless the debtor has agreed in writing to the deduction of a greater amount. Debts must be collected in one lump-sum whenever possible. However, if the employee is financially unable to pay in one lump-sum, or the amount of the debt exceeds 15 percent of current disposable pay for an officially established pay interval, collection must be made in installments. Such installment deductions must be made to effect collection within the period of anticipated active duty or employment. If the debtor retires or resigns or if his or her employment or period of active duty ends before collection of the debt is completed, offset from subsequent payments of any kind due the employee from the paying agency as of the date of separation shall be made to the extent necessary to liquidate the debt pursuant to 31 U.S.C. 3716 as implemented by 5 CFR part 550 and 32 CFR part 90. If possible, the installment payments should be sufficient in size and frequency to liquidate the government's claim in not more than 3 years. Installment payments of less than $50 per month should be accepted only with reasonable justification. An employee's involuntary payment of all or any portion of a debt being collected under 5 U.S.C. 5514 will not be construed as a waiver of any rights the debtor may have under that statute or any other provisions of contract or law, unless there are statutory or contractual provisions to the contrary.</P>
            <P>(D) An explanation of interest, penalties, and administrative costs, including a statement that such assessments must be made unless excused in accordance with the Federal Claims Collection Standards;</P>
            <P>(E) Advice that the debtor may inspect and copy government records relating to the debt or, if debtor or his or her representative cannot personally inspect the records, to request and receive a copy of such records. Requests for copies of the records relating to the debt shall be made no later than 10 days from the receipt by the debtor of the notice of indebtedness.</P>

            <P>(F) An opportunity for a review by the agency of its determination regarding the existence or the amount of the debt, or when a repayment schedule is established other than by written agreement, concerning the terms of the repayment schedule. The debtor shall be advised that a challenge to either <PRTPAGE P="218"/>the existence of the debt, the amount of the debt, or the repayment schedule, must be made within 30 days of the receipt by the debtor of the notice of indebtedness or within 45 days after receipt of the records relating to the debt, if such records are requested by the debtor. A request for waiver or reconsideration should be accompanied by supporting documents indicating why the debtor believes he is not so indebted, or by a financial affidavit supporting his request for an alternative repayment schedule;</P>
            <P>(G) Notice that the timely filing of a petition for review will stay the commencement of collection proceedings;</P>
            <P>(H) Notice that a final decision on the review (if one is requested) will be issued at the earliest practical date, but not later than 60 days after the filing of the petition requesting the review unless the employee requests, and the agency grants, a delay in the proceedings;</P>
            <P>(I) The opportunity, if it has not been previously provided, to enter into a written agreement to establish a schedule for repayment of the debt in lieu of offset. The agreement will be signed by both the debtor and the agency's representative and will be kept in the agency's files;</P>
            <P>(J) Notice that any knowingly false or frivolous statements, representations, or evidence may subject the debtor to:</P>
            <P>(<E T="03">1</E>) Disciplinary procedures appropriate under chapter 75 of Title 5 U.S. Code, 5 CFR part 752, or any other applicable statutes or regulations;</P>
            <P>(<E T="03">2</E>) Penalties under the False Claims Act, 31 U.S.C. 3729-3731, or any other applicable authority, or</P>
            <P>(<E T="03">3</E>) Criminal penalties under 18 U.S.C. 286, 287, 1001 and 1002, or any other applicable authority;</P>
            <P>(K) Where applicable, notice of the debtor's right to appeal, under § 199.10 of this part;</P>
            <P>(L) That amounts paid on or deducted for the debt which are later waived or found not owed to the United States will promptly be refunded to the debtor. Refunds do not bear interest unless required or permitted by law or contract;</P>
            <P>(M) The specific address to which all correspondence regarding the debt shall be directed. Unless otherwise prohibited by law, moneys which are due and payable to a debtor from the Civil Service Retirement and Disability Fund may be administratively offset in reasonable amounts in order to collect in one full payment or a minimal number of payments debts owed to the United States by the debtor. The General Counsel, OCHAMPUS, may forward requests for offset of debts arising from the operation of CHAMPUS to the appropriate officials of the Office of Personnel Management. These requests shall comply with the provisions of 4 CFR 102.4 and 5 CFR part 550.</P>
            <P>(vii) <E T="03">Referral to debt collection agencies.</E> Pursuant to the provisions of the Federal Claims Collection Standards (4 CFR 102.6), the Director, OCHAMPUS, or a designee, is authorized to enter into contracts for collection services, including contracts with private collection agencies for the purpose of supplementing and strengthening the collection efforts of the Department of Defense in recouping erroneous CHAMPUS payments. Such contracts will supplement but not replace the basic collection program described herein. The authority to resolve disputes, compromise claims, terminate collection action and initiate legal action may not be delegated in such contracts but will be retained by the Director, OCHAMPUS, or a designee. Individuals or firms that enter into contracts for collection services pursuant to this paragraph are subject to the Privacy Act of 1974, as amended, 5 U.S.C. 552a, federal and state laws and regulations pertaining to debt collection practices, including the Fair Debt Collection Practices Act, 15 U.S.C. 1692. Debt collection contractors shall be required to account strictly for all amounts collected and must agree to provide any data contained in their files relating to 4 CFR 105.2(a) (1), (2) and (3). Contracts for commercial collection services must comply with 32 CFR part 90.</P>
            <P>(viii) <E T="03">Referrals to consumer reporting agencies.</E> The Director, OCHAMPUS, or a designee, is authorized to provide for the reporting of delinquent debts to consumer reporting agencies. Delinquent debts are those which are not paid or for which satisfactory payment <PRTPAGE P="219"/>arrangements are not made by the due date specified in the initial notification of indebtedness, or those for which the debtor has entered into a written payment agreement and installment payments are past due 30 days or longer. These referrals may be made only after publication of a “routine use” for the disclosures involved as required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a. Procedures developed for such referrals must also insure that an accounting of the disclosures is kept which is available to the debtor; that the consumer reporting agencies are provided with corrections and annotations of disagreements by the debtor; and that reasonable efforts are made to assure that the information to be reported is accurate, complete, timely and relevant. When requested by a consumer reporting agency, verification of information disclosed will promptly be provided. Once a claim has been reviewed and determined to be valid, a complete explanation of the claim will be given the debtor. When the claim is overdue, the individual will be notified in writing that payment is overdue; that within 60 days, disclosure of the claim shall be made to a consumer reporting agency unless satisfactory payment arrangements are made or unless the debtor requests an administrative review and demonstrates some basis on which the debt is legitimately disputed; and of the specific information to be disclosed to the consumer reporting agency. The information to be disclosed to the consumer reporting agency will be limited to information necessary to establish the identity of the debtor, including name, address and taxpayer identification number; the amount, status and history of the claim; and the agency or program under which the claim arose. Reasonable action will be taken to locate an individual for whom a current address is not available.</P>
            <P>(ix) <E T="03">Use and disclosure of mailing addresses.</E> In attempting to locate a debtor in the collection of a debt under this section, the Director, OCHAMPUS, or a designee, may send a written request to the Secretary of the Treasury, or a designee, for current address information from records of the Internal Revenue Service. These requests will comply with the provisions of 26 U.S.C. 6103(p)(4) and applicable regulations of the Internal Revenue Service. Disclosure of a mailing address so obtained may be made pursuant to 4 CFR 102.18(b) and 31 U.S.C. 3711.</P>
            <P>(g) <E T="03">Compromise, waiver, suspension or termination of collection actions arising under the Federal Claims Collection Act.</E> (1) <E T="03">Basic considerations.</E> Federal claims against the debtor and in favor of the United States arising out of the administration of the CHAMPUS may be compromised or collection action taken thereon may be suspended or terminated in compliance with the Federal Claims Collection Act, 31 U.S.C. 3711(a)(2) as implemented by the Federal Claims Collection Standards, 4 CFR parts 101 through 105.</P>
            <P>(2) <E T="03">Authority.</E> CHAMPUS fiscal intermediaries are not authorized to compromise or to suspend or terminate collection action on federal CHAMPUS claims. Only the Director, OCHAMPUS, or a designee, and Uniformed Service claims officers acting under the provisions of their own regulations, are so authorized.</P>
            <P>(3) <E T="03">Waiver of collection of erroneous payments due from certain persons unaware of loss of CHAMPUS eligibility.</E>
            </P>
            <P>(i) The Director, OCHAMPUS may waive collection of payments otherwise due from certain persons as a result of health benefits received under this part after the termination of the person's eligibility for such benefits. Waiver may be granted if collection of such payments would be against equity and good conscience and not in the best interest of the United States. These criteria are met by a finding that there is no indication of fraud, misrepresentation, fault, or lack of good faith on the part of the person who received the erroneous payment or any other person having an interest in obtaining such waiver.</P>
            <P>(ii) <E T="03">Persons eligible for waiver.</E> The following persons are eligible for waiver:</P>
            <P>(A) A person who:</P>
            <P>(1) Is entitled to Medicare Part A by reason of disability or end stage renal disease;</P>

            <P>(2) In the absence of such entitlement, would have been eligible for CHAMPUS under 10 U.S.C. 1086; and<PRTPAGE P="220"/>
            </P>
            <P>(3) At the time of the receipt of such benefits, was under age 65.</P>
            <P>(B) Any participating provider of care who received direct payment for care provided to a person described in paragraph (g)(ii)(A) of this section pursuant to an assignment of benefits from such person.</P>
            <P>(iii) The authority to waive collection of payments under this section shall apply with regard to health benefits provided during the period beginning January 1, 1967, and ending on the later of: the termination date of any special enrollment period for Medicare Part B provided specifically for such persons; or July 1, 1996.</P>
            <P>(4) <E T="03">Basis for compromise.</E> A claim may be compromised hereunder if the government cannot collect the full amount if:</P>
            <P>(i) The debtor or the estate of a debtor does not have the present or prospective ability to pay the full amount within a reasonable time;</P>
            <P>(ii) The debtor refuses to pay the claim in full and the government is unable to enforce collection of the full amount within a reasonable time by enforced collection proceedings;</P>

            <P>(iii) There is real doubt concerning the government's ability to prove its case in court for the full amount claimed either because of the legal issues involved or a <E T="03">bona fide</E> dispute as to the facts; or</P>
            <P>(iv) The cost of collecting the claim does not justify enforced collection of the full amount.</P>
            <P>(5) <E T="03">Basis for suspension.</E> Collection action may be suspended for either of the following reasons if future collection action may be sufficiently productive to justify periodic review and action on the claim giving consideration to its size and the amount which may be realized thereon:</P>
            <P>(i) The debtor cannot be located; or</P>
            <P>(ii) The debtor is unable to make payments on the government's claim or effect a compromise at the time, but the debtor's future prospects justify retention of the claim for periodic review and action and:</P>
            <P>(A) The applicable statute of limitations has been tolled or started running anew; or</P>
            <P>(B) Future collection action can be effected by offset, notwithstanding the statute of limitations with due regard to the 10-year limitation prescribed by 31 U.S.C. 3716(c)(1); or</P>
            <P>(C) The debtor agrees to pay interest on the amount of the debt on which collection action will be temporarily suspended, and such temporary suspension is likely to enhance the debtor's ability to fully pay the principal amount of the debt with interest at a later date.</P>
            <P>(iii) Consideration may be given by the Director, OCHAMPUS, or a designee, to suspend collection action pending action on a request for a review of the government's claim against the debtor or pending an administrative review under § 199.10 of this part of any CHAMPUS claim or claims directly involved in the government's claim against the debtor. Suspension under this paragraph will be based upon appropriate consideration, on a case-by-case basis as to whether:</P>
            <P>(A) There is a reasonable possibility that the debt (in whole or in part) will be found not owing from the debtor;</P>
            <P>(B) The Government's interest would be protected if suspension were granted by reasonable assurance that the debt would be recovered if the debtor does not prevail; and</P>
            <P>(C) Collection of the debt will cause undue hardship.</P>
            <P>(6) <E T="03">Basis for termination.</E> Collection action may be terminated for one or more of the following reasons:</P>
            <P>(i) The United States cannot collect or enforce collection of any significant sum from the debtor having due regard to the judicial remedies available to the government, the debtor's future financial prospects and the exemptions available to the debtor under state and federal law;</P>
            <P>(ii) The debtor cannot be located, and either:</P>
            <P>(A) There is no security remaining to be liquidated, or</P>
            <P>(B) The applicable statute of limitations has run and the prospects of collecting by offset, notwithstanding the bar of the statute of limitations, are too remote to justify retention of the claim;</P>
            <P>(iii) The cost of further collection action is likely to exceed any recovery;</P>

            <P>(iv) It is determined that the claim is legally without merit; or<PRTPAGE P="221"/>
            </P>
            <P>(v) Evidence necessary to prove the claim cannot be produced or the necessary witnesses are unavailable and efforts to induce voluntary payment are unavailing.</P>
            <P>(7) <E T="03">Factors considered.</E> In determining whether a claim will be compromised, or collection action terminated or suspended, the responsible CHAMPUS collection authority will consider the following factors:</P>
            <P>(i) Age and health of the debtor, present and potential income, inheritance prospects, possible concealment or improper transfer of assets and the availability of assets or income which may be realized upon by enforced collection proceedings;</P>
            <P>(ii) Applicability of exemptions available to a debtor under state or federal law;</P>
            <P>(iii) Uncertainty as to the price which collateral or other property may bring at forced sale; or</P>
            <P>(iv) The probability of proving the claim in court, the probability of full or partial recovery, the availability of necessary evidence and related pragmatic considerations.</P>
            <P>(8) <E T="03">Amount of compromise</E>. The amount acceptable in compromise will be reasonable in relation to the amount that can be recovered by enforced collection proceedings. Consideration shall be given to the following:</P>
            <P>(i) The exemptions available to the debtor under state and federal law;</P>
            <P>(ii) The time necessary to collect the debt;</P>
            <P>(iii) The litigative probabilities involved; and</P>
            <P>(iv) The administrative and litigative costs of collection where the cost of collecting the claim is a basis for compromise.</P>
            <P>(9) <E T="03">Payment of compromised claims</E>. (i) <E T="03">Time and manner</E>. Compromised claims are to be paid in one lump sum if possible. However, if payment of a compromise is necessary, a legally enforceable compromise agreement must be obtained. Payment of the amount that CHAMPUS has agreed to accept as a compromise in full settlement of a CHAMPUS claim must be made within the time and in the manner prescribed in the compromise agreement. Any such compromised claim is not settled until the full payment of the compromised amount has been made within the time and the manner prescribed. Compromise agreements must provide for the reinstatement of the prior indebtedness, less sums paid thereon, and acceleration of the balance due upon default in the payment of any installment.</P>
            <P>(ii) <E T="03">Failure to pay the compromised amount</E>. Failure of any debtor to make payment as provided in the compromise agreement will have the effect of reinstating the full amount of the original claim, less any amounts paid prior to the default.</P>
            <P>(10) <E T="03">Effect of compromise, waiver, suspension or termination of collection action.</E> Pursuant to the Internal Revenue Code, 26 U.S.C. 6041, compromises and terminations of undisputed debts not discharged in a Title 11 bankruptcy case and totaling $600 or more for the year will be reported to the Internal Revenue Service in the manner prescribed for inclusion in the debtor's gross income for that year. Any action taken under paragraph (g) of this section regarding the compromise of a federal claim, or waiver or suspension or termination of collection action on a federal claim is not an initial determination for purposes of the appeal procedures § 199.10.</P>
            <P>(h) <E T="03">Referrals for collection</E>. (1) <E T="03">Prompt referral.</E> Federal claims of $600 or more on which collection action has been taken in accordance with the provisions of this section and which cannot be collected or compromised or on which collection action cannot be suspended or terminated, as provided herein, will be promptly referred by the Director, OCHAMPUS, or a designee, to the Department of Justice for litigation in accordance with 4 CFR part 105. Such referrals will be made as early as possible consistent with aggressive collection action by CHAMPUS fiscal intermediaries and OCHAMPUS and well within the period for bringing a timely suit against the debtor. Ordinarily referrals will be made within one year of the OCHAMPUS final determination of the fact and the amount of the debt.</P>
            <P>(2) <E T="03">Report of prior collection actions.</E> The Director, OCHAMPUS, or a designee, will prepare a Claims Collection Litigation Report (CCLR) for each case <PRTPAGE P="222"/>referred for collection under the provisions of this section. The CCLR shall also be used when a claim is referred to the Department of Justice in order to obtain approval of that Department with respect to compromise, suspension, or termination when such approval is required by 4 CFR 103.1(b) and 104.1(b). The CCLR will include, as a minimum, the following:</P>
            <P>(i) A checklist or brief summary of the actions previously taken to collect or compromise the claim. If any of the required administrative collection actions have been omitted, the reason for its omission must be provided.</P>
            <P>(ii) The current address or the debtor, or the same and address of the agent for a corporation upon whom service may be made. Reasonable and appropriate steps will be taken to locate missing parties in all cases. Referrals to the Department of Justice for the institution of foreclosure or other proceedings, in which the current address of any party is unknown, will be accompanied by a listing of the prior known addresses of such party and a statement of the steps taken to locate that party.</P>
            <P>(iii) Reasonably current credit data indicating that there is a reasonable prospect of effecting enforced collection from the debtor, having due regard for the exemptions available to the debtor under state and federal law and the judicial remedies available to the government. Such credit data may take the form of a commercial credit report; an agency investigative report showing the debtor's assets, liabilities, income, and expenses; the individual debtor's own financial statement executed under penalty of perjury reflecting the debtor's assets, liabilities, income, and expenses; or an audited balance sheet of a corporate debtor. Such credit data may be omitted if a surety bond is available in an amount sufficient to satisfy the claim in full; the forced sale value of any security available for application to the government's claim is sufficient to satisfy the claim in full; the debtor is in bankruptcy or receivership; the debtor's liability to the government is fully covered by insurance, in which case such information as can be developed concerning the identity and address of the insurer and the type and amount of insurance coverage will be furnished; or the nature of the debtor is such that credit data is not normally available or cannot reasonably be obtained, for example, a unit of state or local government.</P>
            <P>(3) <E T="03">Preservation of evidence.</E> The Director, OCHAMPUS, or a designee, will take such action as is necessary to ensure that all files, records and exhibits on claims referred hereunder are properly preserved.</P>
            <P>(i) Claims Involving Indications of Fraud, Filing of False Claims or Misrepresentation.</P>
            <P>Any case in which there is an indication of fraud, filing of false claims or misrepresentation will be promptly referred to the Director, OCHAMPUS, or a designee, for processing. The Director, OCHAMPUS, or a designee, will investigate and evaluate the case and either refer the case to the appropriate investigative law enforcement agency or return the claim for other appropriate administrative action, including collection action under this section. Payment on all CHAMPUS beneficiary or provider claims in which fraud, filing false claims or misrepresentation is suspected will be suspended until payment or denial of the claim is authorized by the Director, OCHAMPUS, or a designee. Collection action on all federal claims in which a suspicion of fraud, misrepresentation or filing false claims arises will be suspended pending referral to the appropriate law enforcement agencies by the Director, OCHAMPUS, or a designee. Only the Department of Justice has authority to compromise or terminate collection action on such claims.</P>
            <CITA>[51 FR 24008, July 1, 1986, as amended at 62 FR 35097, June 30, 1997; 63 FR 27678, May 20, 1998]</CITA>
          </SECTION>
          <SECTION>
            <SECTNO>§ 199.12</SECTNO>
            <SUBJECT>Third party recoveries.</SUBJECT>
            <P>(a) <E T="03">General.</E> This section deals with the right of the United States to recover the costs of medical care furnished or paid for on behalf of CHAMPUS beneficiaries from third parties. These third parties may be individuals, or entities who are liable for tort damages to the injured CHAMPUS beneficiary or a liability insurance carrier covering the individual or entity. <PRTPAGE P="223"/>These third parties may also include other entities who are primarily responsible to pay for the medical care provided to the injured beneficiary by reason of an insurance policy, workers’ compensation law or other source of primary payment.</P>
            <P>(b) <E T="03">Authority</E>. (1) <E T="03">Federal statutory authority.</E> The Federal Medical Care Recovery Act (42 U.S.C. 2651-2653) provides the basis under which claims may be asserted or other actions taken under this Section. The Federal Medical Care Recovery Act is a statute enacted to authorize the recovery of the reasonable value of medical care furnished or paid for by the United States to a person who is injured or suffers a disease under circumstances creating tort liability in a third party. This Act is implemented by Executive Order 11060 and an Attorney General regulation, 28 CFR part 43.</P>
            <P>(2) <E T="03">Other authority.</E> Third party recoveries may arise in whole or in part under authorities other than the Medical Care Recovery Act. These include, but are not limited to:</P>
            <P>(i) State Workers’ Compensation Laws</P>
            <P>(ii) State hospital lien laws</P>
            <P>(iii) State no-fault or uninsured motorist statutes</P>
            <P>(iv) Contract rights under terms of insurance policies.</P>
            <P>(c) <E T="03">Policy.</E> CHAMPUS third party recovery claims can be complex and difficult to administer because they often involve recovery potential from multiple sources. It is essential that all persons responsible for taking action under this section have adequate training and support in this area. The Director, OCHAMPUS, or a designee, will insure that CHAMPUS personnel (including fiscal intermediary personnel) responsible for taking any action under this section are adequately trained and supported to take timely and effective action. Responsibility for taking third party recovery action at various times can rest with either fiscal intermediary personnel, OCHAMPUS employees, or uniformed service claims asserting authorities. For this reason close coordination between those responsible for any action under this section is essential. Care must also be taken to insure that appropriate action to assert any third party recovery right is taken in sufficient time to preclude the running of any applicable statute of limitations or other bar to the government's right to recover.</P>
            <P>(d) <E T="03">Appealability.</E> This section describes the procedures to be followed in the assertion and collection of third party recovery claims in favor of the United States arising from the operation of CHAMPUS. Actions taken under this section are not initial determinations for the purpose of the appeal procedures of § 199.10 of this part. However, the proper exercise of the right to appeal benefit or provider status determinations under the procedures set forth in § 199.10 may affect the processing of federal claims arising under this section. Those appeal procedures afford a CHAMPUS beneficiary or participating provider an opportunity for administrative appellate review in cases in which benefits have been denied and in which there is a significant factual dispute. For example, a fiscal intermediary may deny payment for services which are determined to be excluded as CHAMPUS benefits because they are found to be not medically necessary. In that event the fiscal intermediary will offer an administrative appeal as provided in § 199.10 of this part on the medical necessity issue raised by the adverse benefit determination. If the care in question results from an accidental injury and if the appeal results in a reversal of the initial determination to deny the benefit, a third party recovery claim may arise as a result of the appeal decision to pay the benefit. However, in no case is the decision to initiate such a claim itself appealable under § 199.10 of this part.</P>
            <P>(e) <E T="03">Federal Medical Care Recovery Act Claims.</E> (1) <E T="03">General.</E> The Federal Medical Care Recovery Act (FMCRA) (42 U.S.C. 2651-2653) provides that in any case in which the United States is authorized or required by law to furnish or pay for hospital, medical, surgical or dental care and treatment to a person who is injured or suffers a disease under circumstances creating tort liability in some third person to pay damages for that care, the United States has a right to recover from the third person the <PRTPAGE P="224"/>reasonable value of the care and treatment furnished or to be furnished.</P>
            <P>(2) <E T="03">Obligations of persons receiving treatment.</E> To insure the expeditious and efficient processing of Federal Medical Care Recovery Act claims, any person furnished care and treatment under CHAMPUS, his or her guardian, personal representative, counsel, estate, dependents or survivors shall be required:</P>
            <P>(i) To provide complete information regarding the circumstances surrounding an injury as a condition precedent to the processing of a CHAMPUS claim involving possible third-party liability.</P>
            <P>(ii) To assign in writing to the United States his or her claim or cause of action against the third person to the extent of the reasonable value of the care and treatment furnished, or to be furnished, or any portion thereof;</P>
            <P>(iii) To furnish such additional information as may be requested concerning the circumstances giving rise to the injury or disease for which care and treatment are being given and concerning any action instituted or to be instituted by or against a third person;</P>
            <P>(iv) To notify the responsible recovery judge advocate, the CHAMPUS fiscal intermediary or General Counsel, OCHAMPUS, or other officer who is representing the interests of the government at the time, of a settlement with, or an offer of settlement from a third person; and,</P>
            <P>(v) To cooperate in the prosecution of all claims and actions by the United States against such third person.</P>
            <P>(3) <E T="03">Responsibility for recovery.</E> The Director, OCHAMPUS, or a designee, is responsible for insuring that CHAMPUS claims arising under the Federal Medical Care Recovery Act are properly referred to and coordinated with the Uniformed Services. Generally, federal claims arising under this statute will be processed as follows:</P>
            <P>(i) <E T="03">Identification and referral of Federal Medical Care Recovery Act claims.</E> (A) <E T="03">CHAMPUS fiscal intermediaries.</E> In most cases where medical care is provided by civilian providers and payment for such care has been made by a CHAMPUS fiscal intermediary, initial identification of potential third-party liability will be by the CHAMPUS fiscal intermediary. In such cases, the CHAMPUS fiscal intermediary is responsible for conducting a preliminary investi