30574 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

Office, Economic Recovery, Fatherhood and 

Healthy Families, Inter-religious Dialogue 

and Cooperation, Environment and Climate 

Change and Global Poverty and 

Development. 

For Further Information Contact: Mara 

Vanderslice, 202–205–2419, 

mara.vanderslice@hhs.gov. 

Dated: June 22, 2009. 

Mara Vanderslice, 

Special Assistant. 

[FR Doc. E9–15185 Filed 6–25–09; 8:45 am] 

BILLING CODE 4154–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10237, CMS– 

10137, CMS–10285, CMS–R–38, CMS–R–70, 

CMS–10287, CMS–10080 and CMS–846–849, 

854, 10125, 10126, and 10269] 

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: Medicare 

Advantage Applications–Part C; Use: 

Under section 1851(a)(1) of the Social 

Security Act, every individual entitled 

to Medicare Part A and enrolled under 

Part B, except for most individuals with 

end-stage renal disease (ESRD), could 

elect to receive benefits either through 

the Original Medicare Program or an 

M+C plan, if one was offered where he 

or she lived. The Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (MMA) Pub. L. 108–173 was 

enacted on December 8, 2003. The 

MMA established the Medicare 

Prescription Drug Benefit Program (Part 

D) and made revisions to the provisions 

of Medicare Part C, governing what is 

now called the Medicare Advantage 

(MA) program (formerly 

Medicare+Choice). 

Coverage for the prescription drug 

benefit is provided through contracted 

prescription drug plans or through 

Medicare Advantage (MA) plans that 

offer integrated prescription drug and 

health care coverage (MA–PD plans). 

Cost plans that are required 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 MA and 

MA–PD plans must complete an 

application, negotiate rates and receive 

final approval from CMS. Certain 

existing MA plans may also expand 

their contracted area by completing the 

Service Area Expansion (SAE) 

application. Health plans must meet 

regulatory requirements to enter into a 

contract with CMS in order to provide 

health benefits to Medicare 

beneficiaries. The revised MA 

applications are the collection 

receptacles required. Refer to the 

supporting document ‘‘High-Level 

Summary of All Part C Application 

Revisions from 2010 Version of Part C 

Application to 2011 Version’’ for a list 

of changes: Form Number: CMS–10237 

(OMB#: 0938–0935); Frequency: 

Reporting—Yearly; Affected Public: 

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

Respondents: 291; Total Annual 

Responses: 291; Total Annual Hours: 

9,547. (For policy questions regarding 

this collection contact Letticia Ramsey 

at 410–786–5262. For all other issues 

call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Application for 

Prescription Drug Plans (PDP); 

Application for Medicare Advantage 

Prescription Drug (MA–PD); 

Application for Cost Plans to Offer 

Qualified Prescription Drug Coverage; 

Application for Employer Group Waiver 

Plans to Offer Prescription Drug 

Coverage; Service Area Expansion 

Application for Prescription Drug 

Coverage; 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). 

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. Refer to supporting 

document ‘‘Summary of Substantive 

and Technical Changes for All Part D 

Application Revisions from 2010 

Version of Part D application to 2011 

Draft Version’’: Form Number: CMS– 

10137 (OMB#: 0938–0936); Frequency: 

Reporting—Once; Affected Public: 

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

Respondents: 453; Total Annual 

Responses: 453; Total Annual Hours: 

11,919. (For policy questions regarding 

this collection contact Marla Rothouse 

at 410–786–8063. For all other issues 

call 410–786–1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Request for 

Expedited Review of Denial of Premium 

Assistance; Use: The American 

Recovery and Reinvestment Act of 2009 

provides for premium assistance and 

expanded eligibility for health benefits 

under both the Consolidated Omnibus 

Budget Reconciliation Act of 1986, 

commonly called COBRA, and 

comparable State continuation coverage 

programs. This premium assistance is 

not paid directly to the covered 

employee or the qualified beneficiary, 

but instead is in the form of a tax credit 

for the health plan, the employer, or the 

insurer. ‘‘Assistance eligible 

individuals’’ pay only 35% of their 

continuation coverage premiums to the 

plan and the remaining 65% is paid 

through the tax credit. 

If an individual requests treatment as 

an assistance eligible individual and the 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30575 

employee’s group health plan, 

employer, or insurer denies him or her 

the reduced premium assistance, the 

Secretary of Health and Human Services 

must provide for expedited review of 

the denial upon application to the 

Secretary in the form and manner the 

Secretary provides. The Secretary is 

required to make a determination within 

15 business days after receipt of an 

individual’s application for review. 

The Request for Review If You Have 

Been Denied Premium Assistance (the 

‘‘application’’) is the form that will be 

used by individuals to file their 

expedited review appeals. Each 

individual must complete all 

information requested on the 

application in order for CMS to begin 

reviewing his or her case. An 

application cannot be reviewed if 

sufficient information is not provided. 

Refer to the supporting document 

‘‘Crosswalk of Changes Between Request 

for Expedited Review of Denial of 

Premium Assistance (4/09) and Request 

for Review if You Have Been Denied 

Premium Assistance (6/09)’’ for a list of 

changes: Form Number: CMS–10285 

(OMB#: 0938–1062); Frequency: 

Reporting—Once; Affected Public: 

Individuals and households; Number of 

Respondents: 12,000; Total Annual 

Responses: 12,000; Total Annual Hours: 

12,000. (For policy questions regarding 

this collection contact Jim Mayhew at 

410–786–9244. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Conditions of 

Certification for Rural Health Clinics 

and Supporting Regulations in 42 CFR 

491.9, 491.10, 491.11; Use: The Rural 

Health Clinic (RHC) conditions of 

certification are based on criteria 

prescribed in law and are designed to 

ensure that each facility has a properly 

trained staff to provide appropriate care 

and to assure a safe physical 

environment for patients. The Centers 

for Medicare and Medicaid Services 

(CMS) uses these conditions of 

participation to certify RHCs wishing to 

participate in the Medicare program. 

These requirements are similar in intent 

to standards developed by industry 

organizations such as the Joint 

Commission on Accreditation of 

Hospitals, and the National League of 

Nursing/American Public Association 

and merely reflect accepted standards of 

management and care to which rural 

health clinics must adhere. Form 

Number: CMS–R–38 (OMB#: 0938– 

0334); Frequency: Recordkeeping and 

Reporting—Annually and upon initial 

application for Medicare approval; 

Affected Public: Business or other forprofits; Number of Respondents: 3,937; 

Total Annual Responses: 3,937; Total 

Annual Hours: 18,932. (For policy 

questions regarding this collection 

contact Mary Collins at 410–786–3189. 

For all other issues call 410–786–1326.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements in HSQ–110, 

Acquisition, Protection and Disclosure 

of Peer Review Organization 

Information and Supporting Regulations 

in 42 CFR, Sections 480.104, 480.105, 

480.116, and 480.134; Use: The Peer 

Review Improvement Act of 1982 

authorizes quality improvement 

organizations (QIOs), formally known as 

peer review organizations (PROs), to 

acquire information necessary to fulfill 

their duties and functions and places 

limits on disclosure of the information. 

The QIOs are required to provide 

notices to the affected parties when 

disclosing information about them. 

These requirements serve to protect the 

rights of the affected parties. The 

information provided in these notices is 

used by the patients, practitioners and 

providers to: obtain access to the data 

maintained and collected on them by 

the QIOs; add additional data or make 

changes to existing QIO data; and reflect 

in the QIO’s record the reasons for the 

QIO’s disagreeing with an individual’s 

or provider’s request for amendment. 

Form Number: CMS–R–70 (OMB#: 

0938–0426); Frequency: Reporting—On 

occasion; Affected Public: Business or 

other for-profits; Number of 

Respondents: 362; Total Annual 

Responses: 3729; Total Annual Hours: 

60,919. (For policy questions regarding 

this collection contact Tom Kessler at 

410–786–1991. For all other issues call 

410–786–1326.) 

6. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Medicare 

Quality of Care Complaint Form; Use: In 

accordance with Section 1154(a)(14) of 

the Social Security Act, Quality 

Improvement Organizations (QIOs) are 

required to conduct appropriate reviews 

of all written complaints submitted by 

beneficiaries concerning the quality of 

care received. The Medicare Quality of 

Care Complaint Form will be used by 

Medicare beneficiaries to submit quality 

of care complaints. This form will 

establish a standard form for all 

beneficiaries to utilize and ensure 

pertinent information is obtained by 

QIOs to effectively process these 

complaints. Form Number: CMS–10287 

(OMB#: 0938–New); Frequency: 

Reporting—On occasion; Affected 

Public: Individuals or Households; 

Number of Respondents: 3,500; Total 

Annual Responses: 3,500; Total Annual 

Hours: 583. (For policy questions 

regarding this collection contact Tom 

Kessler at 410–786–1991. For all other 

issues call 410–786–1326.) 

7. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Publication 

Usage Survey; Use: The Publication 

Usage survey was developed to gather 

information from people who request or 

access Medicare publications, to ensure 

comprehension, usability, and use of the 

publications. CMS is seeking 

understanding about whether 

publications have been effective in 

informing members of the Medicare 

audience regarding policy and benefits. 

Included in the survey are questions 

regarding the satisfaction of publication 

users with specific publications and 

whether the information they received 

informed them about the Medicare 

program. Information gathered in this 

survey will be used only for purposes of 

targeting and improving 

communications with Medicare 

beneficiaries, caregivers, partners, and 

community organizations. Form 

Number: CMS–10080 (OMB#: 0938– 

0892); Frequency: Reporting—On 

occasion; Affected Public: Individuals or 

Households; Number of Respondents: 

3,800; Total Annual Responses: 3,800; 

Total Annual Hours: 950. (For policy 

questions regarding this collection 

contact Renee Clarke at 410–786–0006. 

For all other issues call 410–786–1326.) 

8. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Durable Medical 

Equipment Medicare Administrative 

Contractors (MAC), Certificates of 

Medical Necessity; Use: The certificate 

of medical necessity (CMN) collects 

information required to help determine 

the medical necessity of certain items. 

CMS requires CMNs where there may be 

a vulnerability to the Medicare program. 

Each initial claim for these items must 

have an associated CMN for the 

beneficiary. Suppliers (those who bill 

for the items) complete the 

administrative information (e.g., 

patient’s name and address, items 

ordered, etc.) on each CMN. The 1994 

Amendments to the Social Security Act 

require that the supplier also provide a 

narrative description of the items 

ordered and all related accessories, their 

charge for each of these items, and the 

Medicare fee schedule allowance (where 

applicable). The supplier then sends the 

CMN to the treating physician or other 

clinicians (e.g., physician assistant, 

30576 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

LPN, etc.) who completes questions 

pertaining to the beneficiary’s medical 

condition and signs the CMN. The 

physician or other clinician returns the 

CMN to the supplier who has the option 

to maintain a copy and then submits the 

CMN (paper or electronic) to CMS, 

along with a claim for reimbursement. 

Due to a technical oversight on the 

part of CMS, an important question on 

CMN Form 10269 was omitted from the 

last OMB submission that would allow 

claims with an apnea-hypopnea index 

(AHI) or respiratory disturbance index 

(RDI) greater than or equal to 5 without 

symptoms for Criterion 2 be paid for by 

the Medicare program. The omission of 

the following question ‘‘Does the patient 

have documented evidence of at least 

one of the following: Excessive daytime 

sleepiness, impaired cognition, mood 

disorders, insomnia, hypertension, 

ischemic heart disease or history of 

stroke’’ could cause improper payment 

of claims without regards as to whether 

the patient has signs or symptoms in 

support of meeting the applicable 

coverage criteria for PAP devices. We 

are resubmitting this information 

collection request to have the revised 

CMN Form 10269 approved. None of the 

other CMN forms have changed. 

Form Number: CMS–846–849, 854, 

10125, 10126, 10269 (OMB# 0938– 

0679); Frequency: Occasionally; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 59,200; Total 

Annual Responses: 6,480,000; Total 

Annual Hours: 1,296,000. (For policy 

questions regarding this collection 

contact Doris Jackson at (410) 786–4459. 

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.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 August 25, 2009: 

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 18, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–15193 Filed 6–25–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–R–205 and CMS– 

R–206] 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements Referenced in 

HIPAA title I for the Individual Market, 

Supporting Regulations at 45 CFR 148 

(148.120, 148.122, 148.124, 148.126, 

and 148.128), Forms and Instructions; 

Use: The provisions of title I of the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

amend the Public Health Service Act 

(PHS Act) and are designed to make it 

easier for people to get access to health 

care coverage; to reduce the limitations 

that can be put on the coverage; and to 

make it more difficult for issuers to 

terminate the coverage. The information 

collection requirements will ensure that 

issuers in the individual market comply 

with HIPAA title I, provide individuals 

with certificates of creditable coverage 

necessary to demonstrate prior 

creditable coverage and file 

documentation with CMS for review in 

a Federal direct enforcement state. 

Requirements must also ensure states’ 

flexibility to implement state alternative 

mechanisms. Form Number: CMS–R– 

205 (OMB#: 0938–0703); Frequency: 

Reporting—Yearly and Occasionally; 

Affected Public: Business or other Forprofit and Not-for-profit institutions; 

Number of Respondents: 2,042; Total 

Annual Responses: 2,979,801; Total 

Annual Hours: 856,384. (For policy 

questions regarding this collection 

contact Louis Blank at 410–786–5511. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Information 

Collection Requirements in HIPAA title 

I for the Group Market, Supporting 

Regulations 45 CFR 146 (146.111, 

146.115, 146.117, 146.150, 146.152, 

146.160 and 146.180) Forms and 

Instructions; Use: The provisions of title 

I of the Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) are 

designed to make it easier for people to 

get access to health care coverage and to 

reduce the limitations that can be put on 

the coverage. This collection pertains to 

notices issued by group health 

insurance issuers and self-funded nonFederal governmental plans as required 

by 45 CFR 146. These notices are 

triggered by the issuance of certificates 

of creditable coverage; notification of 

preexisting condition exclusions; 

notification of special enrollment rights; 

and State review of issuers’ filings of 

group market products or similar 

Federal review in cases in which a State 

is not enforcing a HIPAA group market 

provision. Form Number: CMS–R–206 

(OMB#: 0938–0702); Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector; Business or other Forprofit and Not-for-profit institutions, 

and State, Local, or Tribal Governments; 

Number of Respondents: 8,050; Total 

Annual Responses: 37,002,217; Total 

Annual Hours: 2,920,012. (For policy 

questions regarding this collection 

contact Louis Blank at 410–786–5511. 

For all other issues call 410–786–1326.) 

To be assured consideration, 

comments and recommendations for the