[Federal Register Volume 76, Number 104 (Tuesday, May 31, 2011)]
[Notices]
[Pages 31338-31339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13328]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10147, CMS-10396 and CMS-R-246]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.
    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: Standardized 
Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare 
Prescription Drug Coverage and Your Rights) Use: This is a request for 
approval of changes to a currently approved collection under 42 CFR 
423.562(a)(3). This regulatory provision has recently been modified to 
eliminate the previously available option of posting the standardized 
notice at the pharmacy. Revised 423.562(a)(3) and an associated 
regulatory provision at Sec.  423.128(b)(7)(iii) require the pharmacy 
to provide the Part D enrollee with a printed copy of this standardized 
notice if the prescription cannot be filled.
    The purpose of this notice is to provide enrollees with information 
about how to contact their Part D plans to request a coverage 
determination, including a request for an exception to the Part D 
plan's formulary. The notice reminds enrollees about certain rights and 
protections related to their Medicare prescription drug benefits, 
including the right to receive a written explanation from the drug plan 
about why a prescription drug is not covered. A Part D plan sponsor's 
network pharmacies are in the best position to notify enrollees about 
how to contact their Part D plan if the prescription cannot be filled.
    As noted in a final rule published April 15, 2011 (76 FR 21432), 
the option of posting this notice at the pharmacy has been eliminated. 
If a prescription cannot be filled, the pharmacy must provide the 
enrollee with a printed copy of this notice. Form Number: CMS-10147 
(OCN: 0938-0975) Frequency: Yearly; Affected Public: Private Sector--
Business or other For-profits; Number of Respondents: 42,000; Number of 
Responses: 37,087,402; Total Annual Hours: 617,876. (For policy 
questions regarding this collection, contact Kathryn McCann Smith at 
410-786-7623. For all other issues call (410) 786-1326.)
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Medication Therapy Management Program 
Improvements--Standardized Format. Use: The Medicare Modernization Act 
of 2003 (MMA) under title 42 CFR part 423, subpart D, established the 
requirements that Part D sponsors must meet with regard to medication 
therapy management (MTM) programs. Beginning in 2010, sponsors must 
offer an interactive, person-to-person comprehensive medication review 
(CMR) by a pharmacist or other qualified provider at least annually. A 
CMR is a review of a beneficiary's medications, including prescription 
and over-the-counter (OTC) medications, herbal therapies, and dietary 
supplements, which is intended to aid in assessing medication therapy 
and optimizing patient outcomes. Sponsors must summarize the CMR and 
provide an individualized written or printed summary to the 
beneficiary. The burden associated with the time and effort necessary 
for Part D sponsors to conduct CMRs with written summaries was 
estimated previously under OMB Control Number 0938-0964 as 937,500 
hours with total labor cost of $112.5 million.
    The Affordable Care Act (ACA) under Section 10328 specifies that 
the Secretary, in consultation with relevant stakeholders, develop a 
standardized format for the action plan and written or printed summary 
that are given to beneficiaries as a result of their CMRs. The 
standardized format will replace whatever formats Part D sponsors are 
using for their written CMR summaries and action plans prior to 2013. 
Beginning in January, 2013, Part D sponsors will collect information 
required by the new standardized format, and provide that information 
to Medicare beneficiaries after their CMRs on forms that comply with 
the requirements specified by CMS for the standardized format. The use 
of the standardized format will increase the burden associated with 
providing the CMRs with written summaries and action plans as described 
in this submission. The use of the standardized format will support a 
uniform and consistent level of MTMP communications with beneficiaries, 
improve the ability of beneficiaries to understand and manage their 
medications safely and effectively, and support improved healthcare 
outcomes and lower overall healthcare costs. The final standardized 
format will be posted in the 2013 Call Letter for implementation by 
Part D sponsors in January 2013. Form Number: CMS-10396 (OCN: 0938-New) 
Frequency: Yearly; Affected Public: Private sector--business or other 
for-profits; Number of Respondents: 673; Number of Responses: 
1,875,000; Total Annual Hours: 1,179,894. (For policy questions 
regarding this collection, contact Gary Wirth at 410-786-3997. For all 
other issues call (410) 786-1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage, Medicare Part D and Medicare Fee For Service Consumer 
Assessment of Healthcare Providers and Systems Survey. Use: CMS has 
fielded the MA Consumer Assessment of Health Care Providers and Systems 
(CAHPS) Survey annually since 1998, the Medicare FFS CAHPS Survey 
annually since 2000, and the MA DP and Stand Alone PDP CAHPS survey 
annually since 2006. The Medicare CAHPS is a national survey of health 
and prescription drug plans conducted at the contract level for MA, MA 
PD and Stand Alone PDP plans and at the state level for Medicare fee-
for-service. Medicare CAHPS provides data to permit preparation of plan 
performance measures to assist Medicare beneficiaries in their 
selection of a health plan, prescription drug plan or both, and help 
policymakers and others assist the Medicare program and Medicare plans 
design and monitor patient-centered quality improvement initiatives. 
The 2009 Call letter for MA and MA PD plans requires these plans to 
contract with private vendors from a list selected by CMS to conduct 
the 2011 Medicare CAHPS survey for their plan at the contract level and 
provide the collected data to CMS for analyses and preparation of CAHPS 
measures for

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use in consumer and plan reports and for quality improvement purposes 
for MA, MA PD, and Stand Alone PDP plans. CMS will continue to collect 
the Medicare FFS CAHPS data from surveys at the state and some sub-
state levels. This revision to a currently approved collection is to 
add questions focusing on care coordination. Form Number: CMS-R-246 
(OCN: 0938-0732) Frequency: Yearly; Affected Public: Private sector--
business or other for-profits; Number of Respondents: 598,200; Number 
of Responses: 598,200; Total Annual Hours: 216,555. (For policy 
questions regarding this collection, contact Sarah Gaillot at 410-786-
4637. 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.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage 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 at 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 August 1, 2011:
    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: May 25, 2011.
Michelle Shortt,
 Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2011-13328 Filed 5-27-11; 8:45 am]
BILLING CODE 4120-01-P