31338 Federal Register / Vol. 76, No. 104 / Tuesday, May 31, 2011 / Notices 

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 

§ 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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Federal Register / Vol. 76, No. 104 / Tuesday, May 31, 2011 / Notices 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 forprofits; 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 

Paperwork@cms.hhs.gov, 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10136 and CMS– 

10303] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), 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: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Demonstration Ambulatory Care Quality 

Measure Performance Assessment Tool 

(‘‘PAT’’); Use: This request is to cover a 

modification of an existing, approved 

data collection effort with a new secure 

web based system. This system will also 

provide a platform for developing tools 

to collect clinical quality data for future 

demonstrations and programs. There is 

no increase in burden. In fact, because 

all of the practices submitting data will 

have Electronic Health Records (EHRs), 

it is likely that the originally estimated 

burden will decrease over the coming 

years of the demonstration. CMS is 

requesting an extension of the currently 

approved tool for the collection of 

ambulatory care clinical performance 

measure data. 

The data will be used to continue 

implementation of two Congressionally 

mandated demonstration projects (the 

Physician Group Practice (PGP) 

Demonstration and the Medicare Care 

Management Performance (MCMP) 

Demonstration); also the support data 

collection under the new EHR 

Demonstration. Each of these 

demonstrations, test new payment 

methods for improving the quality and 

efficiency of health care services 

delivered to Medicare fee-for-service 

beneficiaries, especially those with 

chronic conditions that account for a 

disproportionate share of Medicare 

expenditures. In addition, the MCMP 

and EHR demonstration specifically 

encourage the adoption of electronic 

health records systems as a vehicle for 

improving how health care is delivered. 

Form Number: CMS–10136 (OMB# 

0938–0941); Frequency: Yearly; Affected 

Public: Business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 400; Total Annual 

Responses: 400; Total Annual Hours: 

9600. (For policy questions regarding 

this collection contact Jodie Blatt at 

410–786–6921. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information: 

Medicare Gainsharing Demonstration 

Evaluation: Physician Focus Groups; 

Use: The proposed physician focus 

groups are part of the evaluation of the 

Centers for Medicare and Medicaid 

Services (CMS)’s Medicare Physician 

Hospital Collaboration Demonstration. 

The Congress, under Section 646 of the 

Medicare Modernization Act (MMA) of 

2003 permitted CMS to conduct 

demonstrations to test methods for the 

provision of incentives for improving 

the quality and safety of care and 

achieving the efficient allocation of 

resources. The primary goal of the 

demonstration is to evaluate gainsharing 

as means to align physician and hospital 

incentives to improve quality and 

efficiency. This demonstration plans to 

use the physician focus group protocols 

approved by OMB for the DRA 5007 

Gainsharing Demonstration. Form 

Number: CMS–10303 (OMB#: 0938– 

1103); Frequency: Once; Affected 

Public: Private sector, business or other 

for profits; Number of Respondents: 288; 

Total Annual Responses: 144; Total 

Annual Hours: 144 (For policy 

questions regarding this collection 

contact William Buczko at 410–786– 

6593. For all other issues call 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 June 30, 2011. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

oira_submission@omb.eop.gov. 

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