40064 Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Notices 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: For-Profit PACE 

Study; Use: The Program of All 

Inclusive Care of the Elderly (PACE) 

aims to provide integrated care and 

services to the frail elderly at risk of 

institutionalization to enable them to 

remain in the community. Under the 

Balanced Budget Act of 1997 (BBA), the 

not-for-profit PACE plans were 

established as permanent providers 

under the Medicare and Medicaid 

programs. The BBA also mandated a 

demonstration of for-profit PACE plans. 

This study will estimate the differences 

in quality and access to care between 

the for-profit and not-for-profit PACE 

plans. The data collected in the survey 

will be used to measure the outcomes of 

interest-differences in access to and 

quality of care delivered to PACE 

enrollees. To measure these key 

outcomes, the survey will collect data 

on access to and satisfaction with 

healthcare, personal care, and 

transportation assistance provided by 

the plans. Form Number: CMS–10427 

(OCN: 0938–New); Frequency: Yearly; 

Affected Public: Individuals. Number of 

Respondents: 813. Number of 

Responses: 813. Total Annual Hours: 

447. (For policy questions regarding this 

collection contact Julia Zucco at 410– 

786–6670. For all other issues call 410– 

786–1326.) 

2. Type of Information Collection 

Request: New collection; 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, CMS will create a fast track, 

streamlined, 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 question that can 

be drawn upon to allow for the rapid 

turn-around consumer testing required 

for CMS to communicate more 

effectively with its 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–10427 

(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 Neal Hickson at 

410–786–6737. 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 

Paperwork@cms.hhs.gov, 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 August 6, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: June 29, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–16526 Filed 7–5–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–R–218, CMS– 

10428, CMS–10441, CMS–10261, CMS– 

10338, CMS–10137, CMS–10237 and CMS– 

10003] 

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. 


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1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection. Title of 

Information Collection: HIPAA 

Standards for Electronic Transactions 

and Supporting Regulations in 45 CFR 

Part 162. Use: This information 

collection request has no substantive 

changes since the last OMB approval. 

The adopted transaction standards 

currently in use for electronic 

transactions (Version 4010/4010a) are 

compatible with the ICD–9–CM adopted 

code set that is used to report diagnoses 

and hospital inpatient services. 

However, the ICD–10 codes cannot be 

used with Version 4010/4010a, because 

this version does not have a specific 

qualifier or indicator for reporting 

ICD–10 codes. 

Version 5010 supports the use of the 

ICD–10 code set by making available a 

qualifier to indicate that an ICD–10 code 

is being reported. Like ICD–9, ICD–10 

codes are reported in claim and 

payment transactions, as well as 

eligibility inquiries and responses and 

requests for referrals and authorizations. 

In Version 5010, the number of codes 

required in any given transaction does 

not change. It is possible that a fewer 

number of codes in a given transaction 

may be necessary to report the same 

information reported with ICD–9 codes 

because ICD–10 codes are more specific. 

Form Number: CMS–R–218 (OCN: 

0938–0866). Frequency: Occasionally. 

Affected Public: Private Sector (Business 

or other for-profits, Not-for-profit 

institutions). Number of Respondents: 

696,026. Total Annual Responses: 

696,026. Total Annual Hours: 6,960,260. 

(For policy questions regarding this 

collection contact Gladys Wheeler at 

410–786–0273. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title: PCIP 

Authorization to Share Personal Health 

Information; 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. 

Reapproval of this package is being 

requested as a result of CMS, in its 

administration of the PCIP program, 

serving as a covered entity under the 

Health Insurance Portability and 

Accountability Act (HIPAA). Without a 

valid authorization, the PCIP program is 

unable to disclose information, with 

respect to an applicant or enrollee, 

about the status of an application, 

enrollment, premium billing or claim, to 

individuals of the applicant’s or 

enrollee’s choosing. The HIPAA 

Authorization Form has been modeled 

after CMS’ Medicare HIPAA 

Authorization Form (OMB control 

number 0938–0930) and is used by 

applicants or enrollees to designate 

someone else to communicate with PCIP 

about their protected health information 

(PHI). 

Unless permitted or required by law, 

the Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule (§ 164.508) prohibits CMS’ PCIP 

program (a HIPAA covered entity) from 

disclosing an individual’s protected 

health information without a valid 

authorization. In order to be valid, an 

authorization must include specified 

core elements and statements. 

CMS will make available to PCIP 

applicants and enrollees a standard, 

valid authorization to enable 

beneficiaries to communicate with PCIP 

about their personal health information. 

This is a critical tool because the 

population the PCIP program serves is 

comprised of individuals with preexisting conditions who may be 

incapacitated and need an advocate to 

help them apply for or receive benefits 

from the program. This standard 

authorization will simplify the process 

of requesting information disclosure for 

beneficiaries and minimize the response 

time for the PCIP program. 

Each individual will be asked to 

complete the form which will include 

providing the individual’s name, PCIP 

account number (if known), date of 

birth, what personal health information 

they agree to share, the length of time 

the individual agrees their personal 

health information can be shared, the 

names and addresses of the third party 

the individual wants PCIP to share their 

personal health information with, and 

an attestation that the individual is 

giving PCIP permission to share their 

personal health information with the 

third party listed in the form. This 

completed form will be submitted to the 

PCIP benefits administrator, GEHA, 

which contracts with CMS. 

We estimate that it will take 

approximately 15 minutes per applicant 

to complete and submit a HIPAA 

Authorization Form to the PCIP 

program. 

The federally-run PCIP program 

operates in 23 states plus the District of 

Columbia and receives an average of 

35,000 enrollment applications per year. 

To estimate the number of PCIP 

applicants and enrollees who may 

complete an authorization, we looked at 

the percentage of individuals who 

request an authorization in Medicare as 

a baseline. Medicare estimates 3% of its 

population will submit an authorization 

per year. However, since the PCIP 

program caters to an exclusive 

population comprised of individuals 

who have one or more pre-existing 

conditions, we believe it is likely we 

could receive double the percentage 

estimated by Medicare. Accordingly, 

PCIP estimates 6% (or 2,100) of its 

applicants and enrollees may submit an 

authorization per year. 

Based on the above, it is estimated 

that up to 2,100 applicants and 

enrollees may submit an authorization 

annually. There is no cost to PCIP 

beneficiaries to request, complete, 

submit, or have the authorization form 

processed by PCIP. It should take 

approximately 15 minutes for a 

beneficiary to complete the 

authorization form. 15 minutes 

multiplied by 2,100 beneficiaries equals 

525 hours. Form Number: CMS–10428 

(OCN#: 0938–1161); Frequency: 

Reporting—Once; Affected Public: 

Individuals or households; Number of 

Respondents: 2,100; Total Annual 

Responses: 2,100; Total Annual Hours: 

525. (For policy questions regarding this 

collection contact Geoffrey Cabin at 

410–786–1744. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: New collection; Title: Medicare 

Plan Finder Experiment; Use: The 

mission of the Centers for Medicare & 

Medicaid Services (CMS) is to ensure 

the provision of health care to its 

beneficiaries. Recent legislative 

mandates, including the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003, require CMS 

to provide information to beneficiaries 

about the quality of the Medicare health 

and prescription drug plans. To provide 

that information, all Medicare health 

and prescription drug plans with an 

enrollment of 600 or more are required 

to collect and report data following 

protocols that CMS has established. 

CMS has also contracted with various 

organizations to develop valid and 

reliable quality measures and to 

consider how best to report those 

measures to beneficiaries. 

A primary vehicle for reporting 

quality information to beneficiaries is 

the Medicare Plan Finder, a section of 

the Medicare Web site that is intended 

to help beneficiaries make informed 

choices among health and prescription 

drug plans. The Medicare Plan Finder 


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tool contains a great deal of potentially 

useful information, including extensive 

data on the fixed and variable costs 

associated with being enrolled in plans, 

the benefits and coverage that plans 

offer, and the quality of service that 

plans provide, as revealed by member 

experience data, disenrollment 

statistics, and a variety of measures of 

clinical processes and outcomes. 

One of the key challenges that CMS 

has faced is how to engage beneficiaries 

with the quality information provided 

in the Medicare Plan Finder. Among the 

possible reasons that beneficiaries may 

fail to engage with this information are 

first, that several steps are required for 

a user of the Medicare Plan Finder to 

gain access to comparative plan 

information, and second that once the 

user does reach a data display, the 

amount of information presented is 

voluminous, and can seem 

overwhelming. 

This study will use an experimental 

design to assess the effectiveness of two 

potential enhancements to the Medicare 

Plan Finder tool that may help address 

these barriers to engagement and use of 

quality information. The purpose of this 

experiment is to test the effects of two 

prospective enhancements to the 

Medicare Plan Finder (MPF) Web site. 

We refer to these prospective 

enhancements as the ‘‘Quick Links’’ 

home page and the ‘‘enhanced data 

display.’’ Form Number: CMS–10441 

(OCN#: 0938–New); Frequency: 

Reporting—Once; Affected Public: 

Individuals or Households; Number of 

Respondents: 600; Total Annual 

Responses: 600; Total Annual Hours: 

252. (For policy questions regarding this 

collection contact David Miranda at 

410–786–7819. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title: Part C 

Medicare Advantage Reporting 

Requirements and Supporting 

Regulations in 42 CFR § 422.516(a); Use: 

The Centers for Medicare and Medicaid 

Services (CMS) established reporting 

requirements for Medicare Advantage 

Organizations (MAOs) under the 

authority described in 42 CFR 

§ 422.516(a). It is noted that each MAO 

must have an effective procedure to 

develop, compile, evaluate, and report 

to CMS, to its enrollees, and to the 

general public, at the times and in the 

manner that CMS requires, and while 

safeguarding the confidentiality of the 

doctor-patient relationship, statistics 

and other information with respect to 

the cost of its operations, patterns of 

service utilization, availability, 

accessibility, and acceptability of its 

services, developments in the health 

status of its enrollees, and other matters 

that CMS may require. 

CMS also has oversight authority over 

cost plans which includes establishment 

of reporting requirements. The data 

requirements in this supporting 

statement are specifically relevant to the 

cost plan requirements in section 

1876(c)(1)(C) of the Social Security Act 

which establishes beneficiary 

enrollment and appeal rights. 

CMS initiated new Part C reporting 

requirements with the Office of 

Management and Budget (OMB) 

approval of the ‘‘Information Collection 

Request’’ (ICR) under the Paperwork 

Reduction Act of 1995 (PRA) in 

December, 2008 (OMB# 0938–New; 

CMS–10261). National PACE plans and 

1833 cost plans are excluded from 

reporting all the new Part C Reporting 

Requirements measures. The initial ICR 

involved thirteen measures. Two of 

these thirteen measures have been 

suspended from reporting because the 

information is available elsewhere: 

Measurement #10 Agent Compensation 

Structure and; Measurement #11 Agent 

Training and Testing. One new measure 

was added beginning 2012: Enrollment 

and Disenrollment. The ICR Reference 

number is 201105–0938–008. The OMB 

control number is 0938–1054. 

CMS suspended the ‘‘Benefit 

Utilization’’ measure in late 2011. Thus, 

calendar year 2011 benefit utilization 

data were not reported. This suspension 

remains in effect and will lead to a 

reduction in burden. CMS is requesting 

the suspension of two additional 

measures: ‘‘Procedure Frequency’’ and 

Provider Network Adequacy.’’ The 

suspensions are all due to the fact that 

equivalent data are already being 

collected or are available through other 

sources in CMS. These suspensions will 

lead to a decrease in burden. CMS is 

adding one additional data element to 

its ‘‘grievances’’ measure. The grievance 

measure currently has 10 reporting 

categories. The additional category will 

be ‘‘CMS Issues.’’ This will add a slight 

increase to burden for this measure 

only. Overall, the approval of this ICR 

will lead to an estimated burden 

reduction of 88,730 hours and 

$5,420,095 in costs on an annual basis. 

Form Number: CMS–10261 (OCN#: 

0938–1054); Frequency: Yearly, 

Quarterly; Affected Public: Private 

Sector—Business or other for-profits; 

Number of Respondents: 1,375; Total 

Annual Responses: 6,715; Total Annual 

Hours: 120,190. (For policy questions 

regarding this collection contact Terry 

Lied at 410–786–8973. For all other 

issues call 410–786–1326.) 

5. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title of 

Information Collection: Affordable Care 

Act Internal Claims and Appeals and 

External Review Procedures for Nongrandfathered Group Health Plans and 

Issuers and Individual Market Issuers; 

Use: The Patient Protection and 

Affordable Care Act, Public Law 111– 

148, (the Affordable Care Act) was 

enacted by President Obama on March 

23, 2010. As part of the Act, Congress 

added PHS Act section 2719, which 

provides rules relating to internal claims 

and appeals and external review 

processes. On July 23, 2010, interim 

final regulations (IFR) set forth rules 

implementing PHS Act section 2719 for 

internal claims and appeals and external 

review processes. With respect to 

internal claims and appeals processes 

for group health coverage, PHS Act 

section 2719 and paragraph (b)(2)(i) of 

the interim final regulations provide 

that group health plans and health 

insurance issuers offering group health 

insurance coverage must comply with 

the internal claims and appeals 

processes set forth in 29 CFR 2560.503– 

1 (the DOL claims procedure regulation) 

and update such processes in 

accordance with standards established 

by the Secretary of Labor in paragraph 

(b)(2)(ii) of the regulations. The DOL 

claims procedure regulation requires an 

employee benefit plan to provide thirdparty notices and disclosures to 

participants and beneficiaries of the 

plan. In addition, paragraphs 

(b)(3)(ii)(C) and (b)(2)(ii)(C) of the IFR 

add an additional requirement that nongrandfathered group health plans and 

issuers of non-grandfathered health 

policies provide to the claimant, free of 

charge, any new or additional evidence 

considered, or generated by the plan or 

issuer in connection with the claim. 

Paragraph (b)(3)(i) of the IFR requires 

issuers offering coverage in the 

individual health insurance market to 

also generally comply with the DOL 

claims procedure regulation as updated 

by the Secretary of HHS in paragraph 

(b)(3)(ii) of the IFR for their internal 

claims and appeals processes. 

Furthermore, PHS Act section 2719 

and the IFR provide that nongrandfathered group health plans, 

issuers offering group health insurance 

coverage, and self-insured non-federal 

governmental plans (through the IFR 

amendment dated June 24, 2011) must 

comply either with a State external 

review process or a Federal external 

review process. The IFR provides a basis 

for determining when such plans and 

issuers must comply with an applicable 


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State external review process and when 

they must comply with the Federal 

external review process. Plans and 

issuers that are required to participate in 

the Federal external review process 

must have electronically elected either 

the HHS-administered process or the 

private accredited IRO process as of 

January 1, 2012, or, in the future, at 

such time as the plans and issuers use 

the Federal external review process. 

Plans and issuers must notify HHS as 

soon as possible if any of the above 

information changes at any time after it 

is first submitted. The election 

requirements associated with this ICR 

are articulated through guidance 

published June 22, 2011 at http:// 

cciio.cms.gov/resources/files/ 

hhs_srg_elections_06222011.pdf. The 

election requirements are necessary for 

the Federal external review process to 

provide an independent external review 

as requested by claimants. Form 

Number: CMS–10338 (OCN: 0938– 

1099); Frequency: Occasionally; 

Affected Public: State, Local, Tribal 

Governments; Business or other forprofit; Not-for-profit institutions; 

Number of Respondents: 46,773; 

Number of Responses: 218,657,161; 

Total Annual Hours: 930,267. For policy 

questions regarding this collection, 

contact Colin McVeigh at (301) 492– 

4263. For all other issues call (410) 786– 

1326. 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title: Application 

for New and Expanding Medicare 

Prescription Drug Plans and Medicare 

Advantage Prescription Drug (MA–PD), 

including Cost Plans and Employer 

Group Waiver Plans; Use: The Medicare 

Prescription Drug Benefit program was 

established by section 101 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) and is codified in section 

1860D of the Social Security Act (the 

Act). Section 101 of the MMA amended 

Title XVIII of the Social Security Act by 

redesignating Part D as Part E and 

inserting a new Part D, which 

establishes the voluntary Prescription 

Drug Benefit Program (‘‘Part D’’). The 

MMA was amended on July 15, 2008 by 

the enactment of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA), on 

March 23, 2010 by the enactment of the 

Patient Protection and Affordable Care 

Act and on March 30, 2010 by the 

enactment the Health Care and 

Education Reconciliation Act of 2010 

(collectively the Affordable Care Act). 

Coverage for the prescription drug 

benefit is provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) in 

Subpart 3. The application requirements 

are codified in Subpart K of 42 CFR 423 

entitled ‘‘Application Procedures and 

Contracts with PDP Sponsors.’’ 

Effective January 1, 2006, the Part D 

program established an optional 

prescription drug benefit for individuals 

who are entitled to Medicare Part A or 

enrolled in Part B. In general, coverage 

for the prescription drug benefit is 

provided through PDPs that offer drugonly coverage, or through MA 

organizations that offer integrated 

prescription drug and health care 

coverage (MA–PD plans). PDPs must 

offer a basic drug benefit. Medicare 

Advantage Coordinated Care Plans 

(MA–CCPs) must offer either a basic 

benefit or may offer broader coverage for 

no additional cost. Medicare Advantage 

Private Fee for Service Plans (MA– 

PFFS) may choose to offer a Part D 

benefit. Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group Plans 

may also provide a Part D benefit. If any 

of the contracting organizations meet 

basic requirements, they may also offer 

supplemental benefits through 

enhanced alternative coverage for an 

additional premium. 

Applicants may offer either a PDP or 

MA–PD plan with a service area 

covering the Nation (i.e., offering a plan 

in every region) or covering a limited 

number of regions. MA–PD and Cost 

Plan applicants may offer local plans. 

There are 34 PDP regions and 26 MA 

regions in which PDPs or regional MA– 

PDs may be offered respectively. The 

MMA requires that each region have at 

least two Medicare prescription drug 

plans from which to choose, and at least 

one of those must be a PDP. 

Requirements for contracting with Part 

D Sponsors are defined in Part 423 of 42 

CFR. 

This clearance request is for the 

information collected to ensure 

applicant compliance with CMS 

requirements and to gather data used to 

support determination of contract 

awards. Form Number: CMS–10137 

(OCN: 0938–0936); Frequency: Yearly; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 241; Total Annual 

Responses: 241; Total Annual Hours: 

2,132. (For policy questions regarding 

this collection contact Linda Anders at 

410–786–0459. For all other issues call 

410–786–1326.) 

7. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Part C Medicare 

Advantage and 1876 Cost Plan 

Expansion Application; Use: Collection 

of this information is mandated in Part 

C of the Medicare Prescription Drug, 

Improvement and Modernization Act of 

2003 (MMA) in Subpart K of 42 CFR 422 

entitled ‘‘Contracts with Medicare 

Advantage Organizations.’’ In addition, 

the Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA) 

amended titles XVII and XIX of the 

Social Security Act to improve the 

Medicare program. 

In general, coverage for the 

prescription drug benefit is provided 

through prescription drug plans (PDPs) 

that offer drug-only coverage or through 

Medicare Advantage (MA) organizations 

that offer integrated prescription drug 

and health care products (MA–PD 

plans). PDPs must offer a basic drug 

benefit. Medicare Advantage 

Coordinated Care Plans (MA–CCPs) 

either must offer a basic benefit or may 

offer broader coverage for no additional 

cost. Medicare Advantage Private Fee 

for Service Plans (MA–PFFS) may 

choose to offer enrollees a Part D 

benefit. Employer Group Plans may also 

provide Part D benefits. If any of the 

contracting organizations meet basic 

requirements, they may also offer 

supplemental benefits through 

enhanced alternative coverage for an 

additional premium. 

Organizations wishing to provide 

healthcare services under MA and/or 

MA–PD plans must complete an 

application, file a bid, and receive final 

approval from CMS. Existing MA plans 

may request to expand their contracted 

service area by completing the Service 

Area Expansion (SAE) application. 

Applicants may offer a local MA plan in 

a county, a portion of a county (i.e., a 

partial county) or multiple counties. 

Applicants may offer a MA regional 

plan in one or more of the 26 MA 

regions. 

This clearance request is for the 

information collected to ensure 


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applicant compliance with CMS 

requirements and to gather data used to 

support determination of contract 

awards. Form Number: CMS–10237 

(OCN 0938–0935). Frequency: Yearly. 

Affected Public: Private Sector (Business 

or other for-profits, Not-for-profit 

institutions). Number of Respondents: 

566. Total Annual Responses: 566. Total 

Annual Hours: 22,955. (For policy 

questions regarding this collection 

contact Barbara Gullick at 410–786– 

0563. For all other issues call 410–786– 

1326.) 

8. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Notice of Denial 

of Medical Coverage (or Payment); Use: 

Section 1852(g)(1)(B) of the Social 

Security Act (SSA) requires Medicare 

health plans to provide enrollees with a 

written notice in understandable 

language that explains the plan’s 

reasons for denying a request for a 

service or payment for a service the 

enrollee has already received. The 

written notice must also include a 

description of the applicable appeals 

processes. Regulatory authority for this 

notice is set forth in Subpart M of Part 

422 at 42 CFR 422.568, 422.572, 

417.600(b), and 417.840. 

Section 1932 of the Social Security 

Act (SSA) sets forth requirements for 

Medicaid managed care plans, including 

beneficiary protections related to 

appealing a denial of coverage or 

payment. The Medicaid managed care 

appeals regulations are set forth in 

Subpart F of Part 438 of Title 42 of the 

CFR. Rules on the content of the written 

denial notice can be found at 42 CFR 

§ 438.404. 

This notice combines the existing 

Notice of Denial of Medicare Coverage 

with the Notice of Denial of Payment 

and includes optional language to be 

used in cases where a Medicare health 

plan enrollee also receives full Medicaid 

benefits that are being managed by the 

Medicare health plan. Form Number: 

CMS–10003 (OCN: 0938–0829). 

Frequency: Occasionally. Affected 

Public: Private Sector (Business or other 

for-profits, Not-for-profit institutions). 

Number of Respondents: 665. Total 

Annual Responses: 6,960,410. Total 

Annual Hours: 1,159,604. (For policy 

questions regarding this collection 

contact Gladys Wheeler at 410–786– 

0273. 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 

Paperwork@cms.hhs.gov, 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 September 4, 2012: 

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: June 29, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–16514 Filed 7–5–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0187 Formerly 

Docket No. 2000D–1267] 

Draft Guidance for Industry: 

Recommendations for Donor 

Questioning, Deferral, Reentry, and 

Product Management To Reduce the 

Risk of Transfusion-Transmitted 

Malaria; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance 

document entitled ‘‘Guidance for 

Industry: Recommendations for Donor 

Questioning, Deferral, Reentry and 

Product Management to Reduce the Risk 

of Transfusion-Transmitted Malaria’’ 

dated June 2012. The draft guidance 

document provides blood 

establishments that collect blood and 

blood components with 

recommendations for questioning and 

deferring donors of blood and blood 

components, allowing their reentry, and 

product management to reduce the risk 

of transfusion-transmitted malaria. This 

guidance replaces the draft guidance 

entitled ‘‘Guidance for Industry: 

Recommendations for Donor 

Questioning Regarding Possible 

Exposure to Malaria’’ dated June 2000. 

The draft guidance, when finalized, will 

supersede the FDA memorandum to all 

registered blood establishments entitled 

‘‘Recommendations for Deferral of 

Donors for Malaria Risk’’ dated July 26, 

1994. The recommendations contained 

in the draft guidance are not applicable 

to donors of Source Plasma. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by September 4, 

2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Reisman, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance document entitled 

‘‘Guidance for Industry: 

Recommendations for Donor 

Questioning, Deferral, Reentry and 

Product Management to Reduce the Risk 

of Transfusion-Transmitted Malaria’’ 

dated June 2012. The draft guidance 

document provides blood 

establishments that collect blood and 


TKELLEY on DSK3SPTVN1PROD with NOTICES