[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]
[[Page 31338]]
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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
[[Page 31339]]
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