[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16507-16508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-64, CMS-10295, CMS-10302 and CMS-10185]


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.

[[Page 16508]]

    1. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Quarterly 
Medicaid Statement of Expenditures for the Medical Assistance Program. 
Use: Form CMS-64 has been used since January 1980 by Medicaid state 
agencies to report their actual program benefit costs and 
administrative expenses. CMS uses this information to compute the 
federal financial participation for the state's Medicaid program costs. 
Certain schedules of the CMS-64 form are used by states to report 
budget, expenditure and related statistical information required for 
implementation of the Medicaid portion of the State Children's Health 
Insurance Programs, Title XXI of the Social Security Act, established 
by the Balanced Budget Act of 1997. Form Number: CMS-64 (OCN: 0938-
0067). Frequency: Quarterly. Affected Public: State, Local, or Tribal 
Governments. Number of Respondents: 56. Total Annual Responses: 224. 
Total Annual Hours: 16,464. (For policy questions regarding this 
collection contact Abraham John at 410-786-4518. For all other issues 
call 410-786-1326.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Reporting 
Requirements for States Under Transitional Medical Assistance (TMA) 
Provisions. Use: The HHS Secretary is required to submit annual reports 
to Congress with information collected from states in accordance with 
section 5004(d) of the American Recovery and Reinvestment Act of 2009. 
Medicaid agencies in 50 states complete the reports while CMS reviews 
the information to determine if each state has met all of the reporting 
requirements specified under section 5004(d). We are revising this 
package to remove the requirement to report the Medicaid Federal 
Medical Assistance Percentage since it no longer needs to be collected 
from states. Form Number: CMS-10295 (OCN: 0938-1073). Frequency: 
Quarterly. Affected Public: State, Local, or Tribal Governments. Number 
of Respondents: 50. Total Annual Responses: 200. Total Annual Hours: 
400. (For policy questions regarding this collection contact Rhonda 
Simms at 410-786-1200. 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: Section 182(b) of the Medicare 
Improvement of Patients and Providers Act (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 (OCN: 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 
Coachman at 410-786-7364. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements; Use: Title I, Part 423, Sec.  423.514 describes 
CMS' regulatory authority to establish reporting requirements for Part 
D sponsors. It is noted that each Part D plan sponsor must have an 
effective procedure to develop, compile, evaluate, and report to CMS, 
to its enrollees, and to the general public, at the times and in the 
manner that CMS requires, statistics in the following areas: the cost 
of its operations; the patterns of utilization of its services; the 
availability, accessibility, and acceptability of its services; 
information demonstrating that the Part D plan sponsor has a fiscally 
sound operation; and other matters that CMS may require. CMS has 
identified the appropriate data needed to effectively monitor plan 
performance. Changes to the currently approved data collection 
instrument reflect new executive orders, legislation, as well as recent 
changes to Agency policy and guidance. Form Number: CMS-10185 (OCN: 
0938-0992); Frequency: Reporting, Recordkeeping and Third-party 
disclosure; Affected Public: Business and other for-profits; Number of 
Respondents: 690; Total Annual Responses: 8,067; Total Annual Hours: 
12,658. (For policy questions regarding this collection contact Latoyia 
Grant at 410-786-5434. 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 address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or Email 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 14, 2013:
    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 12, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-06038 Filed 3-14-13; 8:45 am]
BILLING CODE 4120-01-P