[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15434-15435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10108, CMS-367, CMS-10302, CMS-10179, CMS-R-
234 and CMS-2540]


Agency Information Collection Activities: Proposed Collection; 
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) 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 functions; (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: Medicaid Managed 
Care Regulations for 42 CFR 438.6, 438.8, 438.10, 438.12, 438.50, 
438.56, 438.102, 438.114, 438.202, 438.204, 438.206, 438.207, 438.240, 
438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 
438.604, 437.710, 438.722, 438.724, and 438.810; Use: These information 
collection requirements implement regulations that allow States greater 
flexibility to implement mandatory managed care program, implement new 
beneficiary protections, and eliminate certain requirements viewed by 
State agencies as impediments to the growth of managed care programs. 
Information collected includes information about managed care programs, 
grievances and appeals, enrollment broker contracts, and managed care 
organizational capacity to provide health care services. Form Number: 
CMS-10108 (OMB: 0938-0920); Frequency: Reporting: 
Occasionally; Affected Public: State, Local, or Tribal Government; 
Number of Respondents: 39,114,558; Total Annual Responses: 4,640,344; 
Total Annual Hours: 3,930,093.5. (For policy questions regarding this 
collection contact Angela Garner at 410-786-7062. For all other issues 
call 410-786-1326.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Program Monthly and Quarterly Drug Reporting Format; Use: Section 1927 
of the Social Security Act requires drug manufacturers to enter into 
and have in effect a rebate agreement with the federal government for 
States to receive funding for drugs dispensed to Medicaid 
beneficiaries. The Deficit Reduction Act (DRA) of 2005 modified section 
1927 to require additional reporting requirements beyond the quarterly 
data currently collected. CMS Form 367 identifies the data fields that 
manufacturers must submit to CMS on both a monthly and quarterly basis. 
Form Number: CMS-367 (OMB: 0938-0578); Frequency: Monthly and 
Quarterly; Affected Public: Private Sector: Business or other for-
profits; Number of Respondents: 580; Total Annual Responses: 9,280; 
Total Annual Hours: 137,344. (For policy questions regarding this 
collection contact Samone Angel at 410-786-1123. For all other issues 
call 410-786-1326.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Collection 
Requirements for Compendia for Determination of Medically-accepted 
Indications for Off-label Uses of Drugs and Biologicals in an Anti-
cancer Chemotherapeutic Regimen Use: Congress enacted the Medicare 
Improvement of Patients and Providers Act (MIPPA). Section 182(b) of 
MIPPA amended section 1861(t)(2)(B) of the Social Security Act (42 
U.S.C. 1395x(t)(2)(B)) by adding at the end the following new sentence: 
`On and after January 1, 2010, no compendia may be included on the list 
of compendia under this subparagraph unless the compendia has a 
publicly transparent process for evaluating therapies and for 
identifying potential conflicts of interest.' We believe that the 
implementation of this statutory provision that compendia have a 
``publicly transparent process for evaluating therapies and for 
identifying potential conflicts of interests'' is best accomplished by 
amending 42 CFR 414.930 to include the MIPPA requirements and by 
defining the key components of publicly transparent processes for 
evaluating therapies and for identifying potential conflicts of 
interests.
    All currently listed compendia will be required to comply with 
these provisions, as of January 1, 2010, to remain on the list of 
recognized compendia. In addition, any compendium that is the subject 
of a future request for inclusion on the list of recognized compendia 
will be required to comply with these provisions. No compendium can be 
on the list if it does not fully meet the standard described in section 
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. 
Form Number: CMS-10302 (OMB : 0938-1078); Frequency: 
Reporting, Recordkeeping and Third-party disclosure; Affected Public: 
Business and other for-profits and Not-for-profit institutions; Number 
of Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 
5,135. (For policy questions regarding this collection contact Brijet 
Burton at 410-786-7364. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Requests by Hospitals for an Alternative Cost-to-Charge Ratio. Use: 
Section 1886(d)(5)(A) of the Act provides for additional Medicare 
payments to Inpatient Prospective Payment System (IPPS) hospitals for 
cases that incur

[[Page 15435]]

extraordinarily high costs. To qualify for outlier payments, a case 
must have costs above a predetermined threshold amount (a dollar amount 
by which the estimated cost of a case must exceed the Medicare 
payment). Hospital-specific cost-to-charge ratios are applied to the 
covered charges for a case to determine the estimated cost of the case. 
In general, additional outlier payments for eligible cases are made 
based on a marginal cost factor of 80 percent, i.e. a fixed percentage 
of the costs. Therefore, if the estimated cost of the case exceeds the 
Medicare payment for that discharge plus the outlier threshold, 
generally Medicare will pay the hospital 80 percent of the excess 
amount. The outlier threshold is updated annually at the beginning of 
the Federal Fiscal Year. Form Number: CMS-10179 (OMB : 0938-
1020); Frequency: Occasionally; Affected Public: Private Sector and 
Business or other for-profits, Not-for-profit institutions; Number of 
Respondents: 18; Total Annual Responses: 18 Total Annual Hours: 144. 
(For policy questions regarding this collection contact Michael Treitel 
at 410-786-4552. For all other issues call 410-786-1326.)
    5. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Subpart D--Private Contracts and Supporting Regulations contained in 42 
CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455. Use: 
Section 4507 of Balancing Budget Act (BBA) 1997 amended section 1802 of 
the Social Security Act to permit certain physicians and practitioners 
to opt-out of Medicare and to provide through private contracts 
services that would otherwise be covered by Medicare. Under such 
contracts the mandatory claims submission and limiting charge rules of 
section 1848(g) of the Act would not apply. Subpart D and the 
Supporting Regulations contained in 42 CFR 405.410, 405.430, 405.435, 
405.440, 405.445, and 405.455, counters the effect of certain 
provisions of Medicare law that, absent section 4507 of BBA 1997, 
preclude physicians and practitioners from contracting privately with 
Medicare beneficiaries to pay without regard to Medicare limits. Form 
Number: CMS-R-234 (OMB: 0938-0730); Frequency: Biennially; 
Affected Public: Private Sector and Business or other for-profits; 
Number of Respondents: 26,820; Total Annual Responses: 26,820; Total 
Annual Hours: 7,197. (For policy questions regarding this collection 
contact Fred Grabau at 410-786-0206. For all other issues call 410-786-
1326.)
    6. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Skilled Nursing Facility and Skilled Nursing Facility Health Care 
Complex Cost Report. Use: Providers of services participating in the 
Medicare program are required under sections 1815(a), 1833(e) and 
1861(v)(1)(A) of the Social Security Act (42 USC 1395g) to submit 
annual information to achieve settlement of costs for health care 
services rendered to Medicare beneficiaries. Form Number: CMS-2540 
(OMB: 0938-0463); Frequency: Yearly; Affected Public: Private 
Sector; Number of Respondents: 15,071; Total Annual Responses: 15,071; 
Total Annual Hours: 2,953,916 (For policy questions regarding this 
collection contact Edwin Gill Sr. at 410-786-4525. For all other issues 
call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site 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.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by May 28, 2010:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: March 19, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-7027 Filed 3-26-10; 8:45 am]
BILLING CODE 4120-01-P