[Federal Register Volume 62, Number 91 (Monday, May 12, 1997)] [Notices] [Pages 25957-25964] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-12262] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration [BPO-148-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances; Fourth Quarter 1996 AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during October, November, and December of 1996 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness [[Page 25958]] of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame. FOR FURTHER INFORMATION CONTACT: Bridget Wilhite, (410) 786-5248 (For Medicare instruction information) Pat Prete, (410) 786-3246 (For Medicaid instruction information) Sharon Hippler, (410) 786-4633 (For Food and Drug Administration- approved investigational device exemption information) Cathy Johnson, (410) 786-5241 (For all other information) SUPPLEMENTARY INFORMATION: I. Program Issuances The Health Care Financing Administration (HCFA) is responsible for administering the Medicare and Medicaid programs, which pay for health care and related services for 38 million Medicare beneficiaries and 36 million Medicaid recipients. Administration of these programs involves (1) Providing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public, and (2) effective communications with regional offices, State governments, State Medicaid Agencies, State Survey Agencies, various providers of health care, fiscal intermediaries and carriers that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted the Secretary under sections 1102, 1871, and 1902 and related provisions of the Social Security Act (the Act) and also issue various manuals, memoranda, and statements necessary to administer the programs efficiently. Section 1871(c)(1) of the Act requires that we publish in the Federal Register at least every 3 months a list of all Medicare manual instructions, interpretive rules, and guidelines of general applicability not issued as regulations. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the 3-month time frame. Since the publication of our quarterly listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid issuances to our quarterly listings. Accordingly, we list in this notice Medicaid issuances and Medicaid substantive and interpretive regulations published during October through December 1996. II. How to Use the Addenda This notice is organized so that a reader may review the subjects of all manual issuances, memoranda, substantive and interpretive regulations, or Food and Drug Administration-approved investigational device exemptions published during the time frame to determine whether any are of particular interest. We expect it to be used in concert with previously published notices. Most notably, those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the notice published March 31, 1993 (58 FR 16837), and those desiring information on the Medicare Coverage Issues Manual may wish to review the August 21, 1989 publication (54 FR 34555). To aid the reader, we have organized and divided this current listing into five addenda. Addendum I lists the publication dates of the most recent quarterly listings of program issuances. Addendum II identifies previous Federal Register documents that contain a description of all previously published HCFA Medicare and Medicaid manuals and memoranda. Addendum III of this notice lists, for each of our manuals or Program Memoranda, a HCFA transmittal number unique to that instruction and its subject matter. A transmittal may consist of a single instruction or many. Often it is necessary to use information in a transmittal in conjunction with information currently in the manuals. Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the date published, the Federal Register citation, the parts of the Code of Federal Regulations (CFR) that have changed (if applicable), the agency file code number, the title of the regulation, the ending date of the comment period (if applicable), and the effective date (if applicable). On September 19, 1995, we published a final rule (60 FR 48417) establishing in regulations at 42 CFR 405.201 et seq. that certain devices with an investigational device exemption approved by the Food and Drug Administration and certain services related to those devices may be covered under Medicare. That final rule states that we will announce in this quarterly notice all investigational device exemption categorizations, using the investigational device exemption numbers the Food and Drug Administration assigns. Addendum V includes listings of the Food and Drug Administration-approved investigational device exemption numbers that have been approved or revised during the quarter covered by this notice. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B, and identified by the investigational device exemption number). III. How to Obtain Listed Material A. Manuals An individual or organization interested in routinely receiving any manual and revisions to it may purchase a subscription to that manual. Those wishing to subscribe should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630. In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, all manuals are available at the following Internet address: http//www.hcfa.gov/pubforms/progman.htm. B. Regulations and Notices Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, [[Page 25959]] Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.access.gpo.gov/su__docs/, by using local WAIS client software, or by telnet to swais.access.gpo.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required). C. Rulings We publish Rulings on an infrequent basis. Interested individuals can obtain copies from the nearest HCFA Regional Office or review them at the nearest regional depository library. We have, on occasion, published Rulings in the Federal Register. In addition, we anticipate that Rulings, beginning with those released in 1995, will soon be available online, through the HCFA Home Page. D. HCFA's Compact Disk-Read Only Memory (CD-ROM) Our laws, regulations, and manuals are also available on CD-ROM, which may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD- ROM disk:Titles XI, XVIII, and XIX of the Act. HCFA-related regulations. HCFA manuals and monthly revisions. HCFA program memoranda. The titles of the Compilation of the Social Security Laws are current as of January 1, 1995. The remaining portions of CD-ROM are updated on a monthly basis. Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re- visit this issue in the near future, and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM. Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk. IV. How to Review Listed Material Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1400 designated libraries throughout the United States. Interested parties may examine the documents at any one of the FDLs. Some may have arrangements to transfer material to a local library not designated as an FDL. To locate the nearest FDL, contact any library. In addition, individuals may contact regional depository libraries, which receive and retain at least one copy of most Federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. Superintendent of Documents numbers for each HCFA publication are shown in Addendum III, along with the HCFA publication and transmittal numbers. To help FDLs locate the instruction, use the Superintendent of Documents number, plus the HCFA transmittal number. For example, to find the Intermediary Manual, Part 2--Fiscal Administration (HCFA Pub. 13-2) transmittal entitled ``Beneficiary Services,'' use the Superintendent of Documents No. HE 22.8/6-2 and the HCFA transmittal number 408. V. General Information It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. Copies can be purchased or reviewed as noted above. Questions concerning Medicare items in Addendum III may be addressed to Bridget Wilhite, Bureau of Program Operations, Issuances Staff, Health Care Financing Administration, N2-05-03, 7500 Security Boulevard, Baltimore, 21244-1850, Telephone (410) 786-5248. Questions concerning Medicaid items in Addendum III may be addressed to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-3246. Questions concerning Food and Drug Administration-approved investigational device exemptions may be addressed to Sharon Hippler, Bureau of Policy Development, Office of Chronic Care and Insurance Policy, Health Care Financing Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633. Questions concerning all other information may be addressed to Cathy Johnson, Bureau of Policy Development, Office of Regulations, Health Care Financing Administration, C5-12-16, 7500 Security Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-5241. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare-- Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: April 18, 1997. Gary Kavanagh, Acting Director, Bureau of Program Operations. Addendum I This addendum lists the publication dates of the most recent quarterly listings of program issuances. November 15, 1995 (60 FR 57435) April 8, 1996 (61 FR 15491) June 26, 1996 (61 FR 33119) December 18, 1996 (61 FR 66676) April 21, 1997 (62 FR 19328) Addendum II--Description of Manuals, Memoranda, and HCFA Rulings An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the Medicare Coverage Issues Manual was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468. [[Page 25960]] Addendum III.--Medicare and Medicaid Manual Instructions [October Through December 1996] ------------------------------------------------------------------------ Trans. No. Manual/Subject/Publication No. ------------------------------------------------------------------------ Intermediary Manual Part 2--Fiscal Administration (HCFA Pub. 13-2) (Superintendent of Documents No. HE 22.8/6-2) ------------------------------------------------------------------------ 408 o Beneficiary Services. Provider Services. ------------------------------------------------------------------------ Intermediary Manual Part 3--Claims Process (HCFA Pub. 13-3) (Superintendent of Documents No. HE 22.8/6) ------------------------------------------------------------------------ 1689 o Outpatient Observation Services. Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers. Hospital Outpatient Partial Hospitalization Services. Billing for Hospital Outpatient Services Furnished By Clinical Social Workers. 1690 o HCPCS for Hospital Outpatient Radiology Services and Other Diagnostic Procedures. Radiology HCPCS Codes Subject to the Payment Limit. Other Diagnostic Services HCPCS Codes Subject to the Payment Limit. 1691 o Mammography Screening. 1692 o Outpatient Therapeutic Services. Drugs and Biologicals. 1693 o Rural Health Clinics--General. Federally Qualified Health Centers. 1694 o Outpatient Therapeutic Services. Drugs and Biologicals. 1695 o Beneficiary Address Change. ------------------------------------------------------------------------ Carriers Manual Part 2--Program Administration (HCFA Pub. 14-2) (Superintendent of Documents No. HE 22.8/7-3) ------------------------------------------------------------------------ 134 o Beneficiary Services. Provider Services. ------------------------------------------------------------------------ Carriers Manual Part 3--Claims Process (HCFA Pub. 14-3) (Superintendent of Documents No. HE 22.8/7) ------------------------------------------------------------------------ 1552 o Paper Remittance Notice. Paper Remittance Notice Requirements. Use of Standard Codes on the Paper Remittance Notice. Paper Remittance Notice Abbreviations. Participation Program and Billing Limitations. 1553 o Incident to Physician's Professional Services. Commonly Furnished in Physician's Offices. Services and Supplies. 1554 o Correct Coding Initiative. ------------------------------------------------------------------------ Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of Documents No. HE 22.8/6-5) ------------------------------------------------------------------------ A-96-8 o Medicare's Partial Hospitalization Benefit- Eligibility and Scope of Services A-96-9 o Home Health Agency Cost Limits--Correction to the Budget Neutrality Factor. A-96-10 o Change in Hospice Payment Rates. A-96-11 o Home Health Agency Cost Limits--Revised Correction to the Budget Neutrality Factor. ------------------------------------------------------------------------ Program Memorandum Carriers (HCFA Pub. 60B) (Superintendent of Documents No. HE 22.8/6-5) ------------------------------------------------------------------------ B-96-3 o Coverage of Epoetin Alfa for HIV/AIDS and Cancer Patients Undergoing Chemotherapy. ------------------------------------------------------------------------ [[Page 25961]] Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B) (Superintendent of Documents No. HE 22.8/6-5) ------------------------------------------------------------------------ AB-96-10 o Current Status of Medicare Program Memorandums and Letters Issued Before Calendar Year 1996. AB-96-11 o Nonpayment of Viral Load Testing (Roche Diagnostic Amplicor Test). ------------------------------------------------------------------------ Program Memorandum Medicaid State Agencies (HCFA Pub. 17) (Superintendent of Documents No. HE 22.8/6-5) ------------------------------------------------------------------------ 96-1 o Current Status of Medicaid Program Memorandums and Action Transmittals Issued Before Calendar Year 1996. ------------------------------------------------------------------------ Peer Review Organization Manual (HCFA Pub. 19) (Superintendent of Documents No. HE 22.8/8-15) ------------------------------------------------------------------------ 63 o Consumer Representative Hospital Manual (HCFA Pub. 10) Superintendent of Documents No. HE 22.8/2) ------------------------------------------------------------------------ 701 o Outpatient Observation Services. Billing for Hospital Outpatient Partial Hospitalization Services. Billing for Hospital Outpatient Services Furnished by Clinical Social Workers. 702 o HCPCS for Hospital Outpatient Radiology and Other Diagnostic Procedures. Radiology HCPCS Codes Subject to the Payment Limit. Other Diagnostic Services HCPCS Codes Subject to the Payment Limit. 703 o Billing for Mammography Screening. ------------------------------------------------------------------------ Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents No. HE 22.8/5) ------------------------------------------------------------------------ 281 o Billing for Ambulance Services. HCPCS Reporting Requirement. ------------------------------------------------------------------------ Skilled Nursing Facility Manual (HCFA Pub. 12) (Superintendent of Documents No. HE 22.8/3) ------------------------------------------------------------------------ 346 o Billing for Mammography Screening. 347 o Billing for Ambulance Services. ------------------------------------------------------------------------ HCPCS Reporting Requirement Medicare Rural Health Clinic and Federally Qualified Health Centers Manual (HCFA Pub. 27) (Superintendent of Documents No. HE 22.8/19:985) ------------------------------------------------------------------------ 24 o Billing for Mammography Screening by Rural Health Clinics and Federally Qualified Health Centers. ------------------------------------------------------------------------ Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation Facility Manual (HCFA Pub. 9) (Superintendent of Documents No. HE 22.8/9) ------------------------------------------------------------------------ 128 o Billing Instructions for Partial Hospitalization Services Provided in Community Mental Health Centers. ------------------------------------------------------------------------ Coverage Issues Manual (HCFA Pub. 6) Superintendent of Documents No. HE 22.8/14) ------------------------------------------------------------------------ 90 o Antigens Prepared for Sublingual Administration. ------------------------------------------------------------------------ [[Page 25962]] Provider Reimbursement Manual Part 1--(HCFA Pub. 15-1) (Superintendent of Documents No. HE 22.8/4) ------------------------------------------------------------------------ 397 o Travel Expense. ------------------------------------------------------------------------ Provider Reimbursement Manual Part II--Provider Cost Reporting Forms and Instructions (HCFA Pub. 15-II-AC) (Superintendent of Documents No. HE 22.8/4) ------------------------------------------------------------------------ 4 o Independent Rural Health Clinic/Federally Qualified Health Center Statistical Data and Certification Statement. Determination of Total Payment. ------------------------------------------------------------------------ Provider Reimbursement Manual Part II--Provider Cost Reporting Forms and Instructions (HCFA Pub. 15-II- AJ) (Superintendent of Documents No. HE 22.8/4) ------------------------------------------------------------------------ 1 o Hospital and Hospital Health Care Complex Cost Report--Form HCFA 2552-96. 2 o Form HCFA-2552-96 Worksheet. ------------------------------------------------------------------------ State Buy-In Manual (HCFA Pub. 24) (Superintendent of Documents No. HE 22.8/11) ------------------------------------------------------------------------ 1 o Describe the Policies and Procedures Governing the Enrollment of Individuals in the Part A and Part B State Buy-In Program. ------------------------------------------------------------------------ State Medicaid Manual--Part 6 Payment for Services (HCFA Pub. 45-6) (Superintendent of Documents No. HE 22.8/10) ------------------------------------------------------------------------ 32 o Upper Limits for Prescription Drugs. ------------------------------------------------------------------------ Medicare/Medicaid Sanction--Reinstatement Report (HCFA Pub. 69) ------------------------------------------------------------------------ 96-9 o Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers. Excluded/Reinstated--August 1996. 96-10 o Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers. Excluded/Reinstated--September 1996. 96-11 o Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers. Excluded/Reinstated--October 1996. 96-12 o Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers. Excluded/Reinstated--November 1996. ------------------------------------------------------------------------ Medicare Coverage Issues Manual For the Medicare Coverage Issues Manual instruction that was published during the quarter covered by this notice, we give the transmittal number, the title of the section, and a brief synopsis of the revisions. The full text of these revisions is available at the following Internet address: http://www.hcfa.gov/pubforms/pub6/ pub6toc.htm Transmittal No. 90 New Implementing Instruction--Effective Date: 11/17/96 Section 45-28, Antigens Prepared for Sublingual Administration.-- This section is added to provide a national determination that antigens, which are to be administered sublingually, are not covered by Medicare. Addendum IV.--Regulation Documents Published in the Federal Register -------------------------------------------------------------------------------------------------------------------------------------------------------- End of Publication date FR vol. 61 page CFR part(s) File code* Regulation title comment Effective date period -------------------------------------------------------------------------------------------------------------------------------------------------------- 10/01/96................ 51295-51298 ........................ BPD-874-N Medicare Program; Update ........... 10/01/96 of Ambulatory Surgical Center Payment Rates Effective for Services on or After October 1, 1996. [[Page 25963]] 10/01/96................ 51217 412, 413, 489........... BPD-847-N Medicare Program; Notice ........... 10/01/96 of Effective Date for Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1997 Rates. 10/03/96................ 51611-51617 413..................... BPD-805-F Medicare and Medicaid ........... 1/04/96 Programs; New Payment Methodology for Routine Extended Care Services Provided in a Swing-Bed Hospital. 10/23/96................ 55002-55009 ........................ OACT-052-N Medicare Program; ........... 01/01/97 Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1, 1997. 11/04/96................ 56691-56693 ........................ OACT-053-N Medicare Program; Part A ........... 01/01/97 Premium for 1997 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. 11/04/96................ 56690-56691 ........................ OACT-054-N Medicare Program; ........... 01/01/97 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 1997. 11/08/96................ 57876-57878 ........................ BPD-879-NC Medicare and Medicaid 01/07/97 ................. Programs; Announcement of Additional Application From Hospital Requesting Waivers for Organ Procurement Service Area and Technical Correction. 11/13/97................ 58140-58143 431..................... MB-092-F Medicaid and Aid to ........... 11/13/96 Families With Dependent Children; Certain Provisions of the National Voter Registration Act of 1993. 11/18/96................ 58631 413..................... BPD-805-CN Medicare and Medicaid ........... 11/04/96 Programs; New Payment Methodology for Routine Extended Care Services Provided in a Swing-Bed Hospital; Correction. 11/19/96................ 58885 ........................ ORD-093-N New and Pending ........... ................. Demonstration Project Proposals Submitted Pursuant to Section 1115(a) of the Social Security Act: September 1996. 11/19/96................ 58885-58886 ........................ OPL-012-CN Medicare Program; ........... ................. December 16, 1996 Meeting of the Practicing Physicians Advisory Council. 11/21/96................ 59198 440..................... MB-102-F Medicaid Program; Family ........... 11/10/94 Planning Services and Supplies for Individuals of Child- Bearing Age. 11/22/96................ 59490-59716 410, 415................ BPD-852-FC Medicare Program; 01/21/97 01/01/97 Revisions to Payment Policies and Five-Year Review of and Adjustments to the Relative Value Units Under the Physician Fee Schedule for Calendar Year 1997. 11/22/96................ 59717-59724 ........................ BPD-853-FN Medicare Program; ........... 10/01/96-01/01/97 Physician Fee Schedule Update for Calendar Year 1997 and Physician Volume Performance Standard Rates of Increase for Federal Fiscal Year 1997. 12/02/96................ 63740-63749 401, 403, 405, 411, 413, BPO-118-FC Medicare Program; 01/31/97 01/02/97 447, 493. Changes Concerning Suspension of Medicare Payments, and Determinations of Allowable Interest Expenses. 12/09/96................ 64914-64918 ........................ ORD-094-N New and Pending ........... ................. Demonstration Project Proposals Submitted Pursuant to Section 1115(a) of the Social Security Act: October 1996. 12/18/96................ 66676 ........................ OPL-013-N Medicare Program; ........... ................. Request for Nominations for Members for the Practicing Physicians Advisory Council. 12/18/96................ 66676-66687 ........................ BPO-140-N Medicare and Medicaid ........... ................. Programs; Quarterly Listing of Program Issuances and Coverage Decisions--Second Quarter 1996. [[Page 25964]] 12/19/96................ 66919-66923 412, 413, 489........... BPD-847-FCN Medicare Program; ........... 10/01/96 Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1997 Rates; Corrections. 12/19/96................ 67041-67047 ........................ BPD-849-FN Medicare Program; ........... 12/19/96 through Recognition of the 12/19/02 Ambulatory Surgical Center Standards of the Joint Commission on the Accreditation of Healthcare Organizations and the Accreditation Association for Ambulatory Health Care. 12/30/96................ 68697-68698 ........................ BPD-886-N Department of Health and 02/03/97 ................. Human Services, Health Care Financing Administration; Department of Labor, Pension and Welfare Benefits Administration; and Department of the Treasury, Office of Tax Policy and Internal Revenue Services (the Agencies); Health Insurance Portability. 12/31/96................ 69034 401, 405................ BPD-869-CN Medicare Program; Waiver ........... 10/21/96 of Recovery of Overpayments. 12/31/96................ 69034-69050 417, 434................ OMC-010-F Medicare and Medicaid ........... 01/01/97 Programs; Requirements for Physician Incentive Plans in Prepaid Health Care Organizations. -------------------------------------------------------------------------------------------------------------------------------------------------------- Addendum V--Categorization of Food and Drug Administration-Approved Investigational Device Exemptions Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. Also, under the new categorization process to assist HCFA, the Food and Drug Administration assigns each device with a Food and Drug Administration-approved investigational device exemption to one of two categories. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328). The following information presents the device number, category (in this case, A), and criterion code. G960164 A2 G960186 A2 G960190 A1 G960200 A1 G960203 A2 G960213 A1 The following information presents the device number category (in this case, B), and criterion code. G940148 B2 G940193 B2 G950094 B1 G960065 Be G960072 B4 G960106 B5 G960115 Be G960134 B4 G960144 B4 G960166 Be G960183 B2 G960187 B1 G960189 B2 G960191 Be G960197 Be G960198 B2 G960199 B2 G960201 Be G960202 B4 G960204 Be G960205 B4 G960206 B2 G960210 B4 G960211 B4 G960212 B4 G960215 B2 G960217 B4 G960219 Be G960221 B2 G960223 B1 G960224 B2 G960225 B4 G960226 B2 G960227 B2 G960229 B1 G960232 B4 G960236 Be G960238 B4 G960239 B1 G960242 B4Q This quarter we are listing previously published IDE numbers that have changed reimbursement category. They are: G870181 from A2 to B2 G880210 from A2 to B4 G890210 from A2 to B2 G900143 from A2 to B4 G900246 from A2 to B2 G910064 from A2 to B4 G910078 from A2 to B4 G910170 from A2 to B4 G910197 from A2 to B4 G910202 from A2 to B4 G920142 from B2 to B4 G920143 from A2 to B4 G930017 from B2 to A2 G930054 from A2 to B4 G930115 from A2 to B4 G930190 from A2 to B4 G930192 from A2 to B4 G940084 from A2 to B2 G940088 from A2 to B4 G950083 from A2 to B2 G950168 from A2 to B4 G950175 from A2 to B4 G960060 from A1 to A2 G960113 from A2 to B4 [FR Doc. 97-12262 Filed 5-9-97; 8:45 am] BILLING CODE 4120-01-P