[Federal Register Volume 73, Number 154 (Friday, August 8, 2008)]
[Notices]
[Pages 46301-46302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-138, CMS-10147, CMS-10146, CMS-10064, and 
CMS-10225]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Agency: Centers for Medicare & Medicaid Services, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the Agency's function; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Geographic Classification Review Board (MGCRB) Procedures and Criteria 
and Supporting Regulations in 42 CFR, Section 412.256 & 412.230; Use: 
Section 1886(d)(10) of the Social Security Act established the MGCRB, 
an entity that has the authority to accept short-term hospital 
inpatient prospective payment system (IPPS) hospital applications 
requesting geographic reclassification for wage index or standardized 
payment amounts and to issue decisions on these requests. Since it is 
important to ensure the accuracy of the MGCRB decisions and remain 
apprised of potential payment impacts, the regulations note that CMS 
should also receive a copy of any hospital's application to the MGCRB. 
The information submitted by the hospitals is used by CMS staff to 
determine the validity of the hospitals' requests and the discretion 
used by the MGCRB in reviewing and making decisions regarding 
hospitals' requests for geographic reclassification. Since CMS wrote 
the guidelines for the MGCRB, it is essential that CMS staff monitor 
this process. Form Number: CMS-R-138 (OMB 0938-0573); 
Frequency: Yearly; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 300; Total Annual 
Responses: 300; Total Annual Hours: 300.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Coverage and Your Rights; Use: Section 42 CFR 
423.562, requires each Part D plan sponsor to arrange with its network 
pharmacies to post or distribute the Medicare Prescription Drug 
Coverage and Your Rights notice to Part D plan enrollees at each 
pharmacy visit when the enrollee disagrees with the information 
provided by the pharmacist. The purpose of this notice is to provide 
enrollees with information about how to contact their Part D plans to 
request a coverage determination, including a request for an exception 
to the Part D plan's formulary. Form Number: CMS 10147 (OMB 
0938-0975); Frequency: Daily; Affected Public: Business or other for-
profits; Number of Respondents: 40,000; Total Annual Responses: 
30,000,000; Total Annual Hours: 500,000.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Notice of Denial 
of Medicare Prescription Drug Coverage; Use: Section 1860D-4(g)(1) of 
the Social Security Act, requires Part D plan sponsors that deny 
prescription drug coverage to provide a written notice of the denial to 
the enrollee. The written notice must include a statement, in clear 
language, of the reasons for the denial and a description of the 
appeals process. Form Number: CMS 10146 (OMB 0938-0976); 
Frequency: Daily; Affected Public: Business or other for-profits; 
Number of Respondents: 758; Total Annual Responses: 290,344; Total 
Annual Hours: 145,172.
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Minimum Data Set 
(MDS) for Swing Bed Hospitals and Supporting Regulations in 42 CFR 
413.114(a)(2) and 413.343(a); Use: Exercising CMS' authority under 
section 1888(e)(7) of the Social Security Act to determine the most 
appropriate manner in which to implement the Skilled Nursing Facility 
Prospective Payment System (SNF PPS) for swing bed hospitals, CMS 
designed a 2-page MDS instrument for use by swing bed hospitals that 
includes all resident assessment data needed to reimburse swing bed 
hospitals for SNF-level care furnished to Medicare beneficiaries and to 
provide CMS with the basic demographic and utilization data for future 
planning and analysis. Form Number: CMS-10064 (OMB 0938-0872); 
Frequency: Occasionally; Affected Public: Business or other for-
profits, Not-for-profit institutions and State, Local, or Tribal 
Governments; Number of Respondents: 481; Total Annual Responses: 
50,505; Total Annual Hours: 328,283.
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Disclosures to 
Patients by Certain Hospitals and Critical Access Hospitals and 
Supporting Regulations in 42 CFR 489.20; Form Number: CMS-10225 
(OMB: 0938-1035); Use: This information request relates to 
proposed required third party disclosures by certain Medicare-
participating hospitals and critical access hospitals (CAHs) to their 
patients. The policy is contained in the FY 2009 Inpatient Prospective 
Payment System Final Rule. Because this information request is closely 
related to the previously approved collection burden under 0938-01034, 
we have included a discussion of both the approved provisions and the 
new provisions in the supporting statement document.
    In addition to the two existing collections previously approved 
under 0938-1034, we are revising Sec.  489.3 to define a physician-
owned hospital as a hospital in which a physician, or an immediate 
family member of a physician has an ownership or investment interest in 
the hospital. Because of this change to the definition of a physician-
owned hospital, new Sec.  489.20(u)(1) will require that hospitals with 
ownership or investment interests by a physician or immediate family 
member disclose this information to all their patients. Additionally, 
we revised Sec.  489.20(u) by creating Sec.  489.20(u)(1) that requires 
any physician-owned hospital to furnish patients with written notice 
that the hospital is physician-owned and provide the list of physician 
owners (including immediate family members) to the patient at the time 
the patient or someone on the patient's behalf requests it.

[[Page 46302]]

    We also require three new collections which are the primary focus 
of this supporting statement. First, we have added new Sec.  
489.20(u)(2) to require a hospital to require all physicians who are 
members of the hospital's medical staff to agree, as a condition of 
continued medical staff membership or admitting privileges, to disclose 
in writing to all patients they refer to the hospital any ownership or 
investment interest in the hospital held by themselves or by an 
immediate family member. The burden associated with this requirement is 
two-fold and pertains to both hospitals and physicians. First, 
hospitals are required to update by-laws and policies and procedures to 
reflect that as a condition of medical staff membership or admitting 
privileges, physicians must agree to disclose ownership or investment 
interests to patient. In addition, physicians are required to develop 
disclosure notices, distribute them to patients and maintain these 
disclosures in the patients' medical records.
    Finally, we are including new language under Sec.  489.20(v) to 
provide for an exception to the disclosure requirements for a 
physician-owned hospital that does not have at least one referring 
physician who has an ownership or investment interest in the hospital 
(or who has an immediate family member with an ownership or investment 
interest in the hospital), provided that the hospital attests, in 
writing, to that effect and maintains such attestation in its files. 
The burden associated with this requirement is limited to those 
physician-owned hospitals that do not have physician owners who refer 
patients to the hospital.
    The intent of the disclosures is to increase the transparency of 
the hospital's ownership and operations to patients as they make 
decisions about receiving care at the hospital. Frequency: Reporting--
Occasionally; Affected Public: Business or other for-profit; Number of 
Respondents: 2,697; Total Annual Responses: 49,735,828; Total Annual 
Hours: 840,318.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or 
e-mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to [email protected], or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on September 8, 
2008.
    OMB Human Resources and Housing Branch, Attention: OMB Desk 
Officer, New Executive Office Building, Room 10235, Washington, DC 
20503, Fax Number: (202) 395-6974.

    Dated: July 31, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-18361 Filed 8-7-08; 8:45 am]
BILLING CODE 4120-01-P