[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