[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32657-32658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10302, CMS-R-290 and CMS-10437]


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: 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

[[Page 32658]]

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: Annually; 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.)
    2. Type of Information Collection Request: Reinstatement of a 
currently approved collection; Title: Medicare Program: Procedures for 
Making National Coverage Decisions; Use: We revised our April 27, 1999 
(64 FR 22619) notice and published a new notice on September 26, 2003 
(68 FR 55634) that described the process we use to make Medicare 
coverage decisions including decisions regarding whether new technology 
and services can be covered. We have made changes to our internal 
procedures in response to the comments we received following 
publication of the 1999 notice and experience under our new process. 
Over the past several years, we received numerous suggestions to 
further revise our process to continue to make it more open, 
responsive, and understandable to the public. We share the goal of 
increasing public participation in the development of Medicare coverage 
issues. This will assist us in obtaining the information we require to 
make a national coverage determination in a timely manner and ensuring 
that the Medicare program continues to meet the needs of its 
beneficiaries. Form Number: CMS-R-290 (OCN: 0938-0776); Frequency: 
Annual; Affected Public: Private sector: Business or other for-profits; 
Number of Respondents: 200; Total Annual Responses: 200; Total Annual 
Hours: 8,000. (For policy questions regarding this collection contact 
Katherine Tillman at 410-786-9252. For all other issues call 410-786-
1326.)
    1. Type of Information Collection Request: New collection (Request 
for a new control number; Title of Information Collection: Generic 
Social Marketing & Consumer Testing Research; Use: The purpose of this 
submission is to request an Information Collection Request (ICR) 
generic clearance for a program of consumer research aimed at a broad 
audience of those affected by CMS programs including Medicare, 
Medicaid, Children's Health Insurance Program (CHIP), and health 
insurance exchanges. This program extends strategic efforts to reach 
and tailor communications to beneficiaries, caregivers, providers, 
stakeholders, and any other audiences that would support the Agency in 
improving the functioning of the health care system, improve patient 
care and outcomes, and reduce costs without sacrificing quality of 
care. With the clearance, we will create a streamlined and proactive 
process for collection of data and utilizing the feedback on service 
delivery for continuous improvement of communication activities aimed 
at diverse CMS audiences.
    The generic clearance will allow rapid response to inform CMS 
initiatives using a mixture of qualitative and quantitative consumer 
research strategies (including formative research studies and 
methodological tests) to improve communication with key CMS audiences. 
As new information resources and persuasive technologies are developed, 
they can be tested and evaluated for beneficiary response to the 
materials and delivery channels. Results will inform communication 
development and information architecture as well as allow for 
continuous quality improvement. The overall goal is to maximize the 
extent to which consumers have access to useful sources of CMS program 
information in a form that can help them make the most of their 
benefits and options
    The activities under this clearance involve social marketing and 
consumer research using samples of self-selected customers, as well as 
convenience samples, and quota samples, with respondents selected 
either to cover a broad range of customers or to include specific 
characteristics related to certain products or services. All collection 
of information under this clearance will utilize a subset of items 
drawn from a core collection of customizable items referred to as the 
Social Marketing and Consumer Testing Item Bank. This item bank is 
designed to establish a set of pre-approved generic questions that can 
be drawn upon to allow for the rapid turn-around consumer testing 
required for us to communicate more effectively with our audiences. The 
questions in the item bank are divided into two major categories. One 
set focuses on characteristics of individuals and is intended primarily 
for participant screening and for use in structured quantitative on-
line or telephone surveys. The other set is less structured and is 
designed for use in qualitative one-on-one and small group discussions 
or collecting information related to subjective impressions of test 
materials. A Study Initiation Request Form detailing each specific 
study (description, methodology, estimated burden) conducted under this 
clearance will be submitted before any testing is initialed. Results 
will be compiled and disseminated so that future communication can be 
informed by the testing results. We will use the findings to create the 
greatest possible public benefit. Form Number: CMS-10437 (OCN: 0938-
New); Frequency: Yearly; Affected Public: Individuals. Number of 
Respondents: 41,592. Number of Responses: 28,800. Total Annual Hours: 
21,488. (For policy questions regarding this collection contact Julie 
Franklin at 410-786-8126. 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.
    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 July 1, 2013.
    OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, Fax Number: (202) 395-6974, Email: OIRA[email protected].

    Dated: May 28, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-12934 Filed 5-30-13; 8:45 am]
BILLING CODE 4120-01-P