[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 26035-26036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10146, CMS-10286, CMS-10308, and CMS-10339]


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: Revision 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 that Part D plan sponsors who deny 
prescription drug coverage must provide a written notice of the denial 
to the enrollee. The written notice must include a statement, in 
understandable language, of the reasons for the denial and a 
description of the appeals process. The Part D denial notice has been 
revised for clarity and includes new optional language for Part D plan 
sponsors to use when explaining their denial rationale. Specifically, 
CMS has added optional language in the denial rationale section of the 
notice to allow plans to populate text explaining that a drug denied 
under Part D may be (or is) covered under a different benefit, such as 
Part B. The instructions have also been changed to guide plans on when 
to use this optional text. CMS solicits feedback on this new addition 
as well as other situations where another benefit may cover a drug 
(i.e. employer group benefits) and what changes to the denial notice 
may be helpful in addressing those situations. CMS also seeks comment 
regarding the potential viability and usefulness of developing a 
combined notice for Part C and Part D, which would allow MA-PD plans 
that deny a drug under Part D to simultaneously issue an approval 
letter under Part B. Form Number: CMS-10146 (OCN 0938-0976). Frequency: 
Occasionally. Affected Public: Private sector (business or other for-
profits). Number of Respondents: 596. Total Annual Responses: 
1,497,929. Total Annual Hours: 374,482. (For policy questions regarding 
this collection contact Caroline L Baker at 410-786-0116. For all other 
issues call 410-786-1326.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved information collection; Title of 
Information Collection: Notice of Research Exception under the Genetic 
Information Nondiscrimination Act; Use: Under the Genetic Information 
Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but 
not require) a genetic test in connection with certain research 
activities so long as such activities comply with specific 
requirements, including: (i) The research complies with 45 CFR part 46 
or equivalent federal regulations and applicable state or local law or 
regulations for the protection of human subjects in research; (ii) the 
request for the participant or beneficiary (or in the case of a minor 
child, the legal guardian of such beneficiary) is made in writing and 
clearly indicates that compliance with the request is voluntary and 
that non-compliance will have no effect on eligibility for benefits or 
premium or contribution amounts; and (iii) no genetic information 
collected or acquired will be used for underwriting purposes. The 
Secretary of Labor or the Secretary of Health and Human Services is 
required to be notified if a group health plan or health insurance 
issuer intends to claim the research exception permitted under Title I 
of GINA. Nonfederal governmental group health plans and issuers solely 
in the

[[Page 26036]]

individual health insurance market or Medigap market will be required 
to file with the Centers for Medicare & Medicaid Services (CMS). The 
Notice of Research Exception under the Genetic Information 
Nondiscrimination Act is a model notice that can be completed by group 
health plans and health insurance issuers and filed with either the 
Department of Labor or CMS to comply with the notification requirement. 
Form Number: CMS-10286 (OCN: 0938-1077); Frequency: On Occasion; 
Affected Public: state, Local, or Tribal Governments, Private Sector; 
Number of Respondents: 2; Number of Responses: 2; Total Annual Hours: 
0.5. (For policy questions regarding this collection, contact Usree 
Bandyopadhyay at 410-786-6650. For all other issues call (410) 786-
1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Parts C and D 
Complaints Resolution Performance Measures. Use: CMS seeks to conduct a 
survey as part of the Part C and D Complaints Resolution Performance 
Measure project. The purpose of the project is to develop and support 
implementation of internal monitoring tools for the Medicare Advantage 
(Part C) and Prescription Drug (Part D) program that represents, from 
the beneficiary's perspective, the way in which plans handle 
complaints. The data collection is necessary because a survey is the 
only way to collect information about the resolution process from the 
beneficiary's perspective. Currently, there is no other data source 
that collects such information for Part C and Part D Medicare plans. 
Form Number: CMS-10308 (OCN 0938-1107). Frequency: Yearly. Affected 
Public: Individuals or households. Number of Respondents: 18,210. Total 
Annual Responses: 18,210. Total Annual Hours: 3,035. (For policy 
questions regarding this collection contact Carolyn Scott at 410-786-
1190. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Pre-Existing 
Health Insurance Plan and Supporting Regulations; Use: On March 23, 
2010, the President signed into law H.R. 3590, the Patient Protection 
and Affordable Care Act (Affordable Care Act), Public Law 111-148. 
Section 1101 of the law establishes a ``temporary high risk health 
insurance pool program'' (which has been named the Pre-Existing 
Condition Insurance Plan, or PCIP) to provide health insurance coverage 
to currently uninsured individuals with pre-existing conditions. The 
law authorizes HHS to carry out the program directly or through 
contracts with states or private, non-profit entities.
    We are requesting an extension of this package because this 
information is needed to assure that PCIP programs are established 
timely and effectively. This request is being made based on regulations 
and guidance that have been issued and contracts which have been 
executed by HHS with states or an entity on their behalf participating 
in the PCIP program. PCIP is also referred to as the temporary 
qualified high risk insurance pool program, as it is called in the 
Affordable Care Act, but we have adopted the term PCIP to better 
describe the program and avoid confusion with the existing state high 
risk pool programs. Form Number: CMS-10339 (OMB: 0938-1100); 
Frequency: Reporting--On occasion; Affected Public: state governments; 
Number of Respondents: 51; Total Annual Responses: 2,652; Total Annual 
Hours: 36,924. (For policy questions regarding this collection contact 
Laura Dash at 410-786-8623. 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 July 2, 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: April 30, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-10522 Filed 5-2-13; 8:45 am]
BILLING CODE 4120-01-P