Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 903 

Information Collection: CY 2010 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP). Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans (PDP) are 

required to submit an actuarial pricing 

‘‘bid’’ for each plan offered to Medicare 

beneficiaries for approval by CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. CMS 

reviews and analyzes the information 

provided on the Bid Pricing Tool. 

Ultimately, CMS decides whether to 

approve the plan pricing (i.e., payment 

and premium) proposed by each 

organization. Form Number: CMS– 

10142 (OMB# 0938–0944); Frequency: 

Yearly; Affected Public: Business or 

other for-profits b. Not-for-profit 

institutions; Number of Respondents: 

550; Total Annual Responses: 6050; 

Total Annual Hours: 42,350. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Internal 

Revenue Service (IRS)/Social Security 

Administration (SSA)/Centers for 

Medicare and Medicaid Services (CMS) 

Data Match and Supporting Regulations 

in 42 CFR 411.20–491.206 Use: 

Medicare Secondary Payer (MSP) is 

essentially the same concept known in 

the private insurance industry as 

coordination of benefits; it refers to 

those situations where Medicare 

assumes a secondary payer role to 

certain types of private insurance for 

covered services provided to a Medicare 

beneficiary. 

Congress sought to reduce the losses 

to the Medicare program by requiring in 

42 U.S.C. 1395y(b)(5) that the Internal 

Revenue Service (IRS), the Social 

Security Administration (SSA), and 

CMS perform an annual data match (the 

IRS/SSA/CMS Data Match, or ‘‘Data 

Match’’ for short). CMS uses the 

information obtained through Data 

Match to contact employers concerning 

possible application of the MSP 

provisions by requesting information 

about specifically identified employees 

(either a Medicare beneficiary or the 

working spouse of a Medicare 

beneficiary). This statutory data match 

and employer information collection 

activity enhances CMS’s ability to 

identify both past and present MSP 

situations. Form Number: CMS–R–137 

(OMB# 0938–0763); Frequency: 

Annually; Affected Public: Business or 

other for-profit, not-for-profit 

institutions, farms, State, Local or Tribal 

Governments; Number of Respondents: 

326,597; Total Annual Responses: 

326,597; Total Annual Hours: 1,900,795. 

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 February 9, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Fax Number: 

(202) 395–6974. 

Dated: December 28, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–52 Filed 1–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10062, CMS– 

10275, and CMS–10137] 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Collection of 

Diagnostic Data from Medicare 

Advantage Organizations for Risk 

Adjusted Payments: Use: CMS requires 

hospital inpatient, hospital outpatient 

and physician diagnostic data from 

Medicare Advantage (MA) organizations 

to continue making payment under the 

risk adjustment methodology as 

required by the Social Security Act, as 

amended by the Balanced Budget Act; 

the Medicare, Medicaid and SCHIP 

Benefits Improvement and Protection 

Act; and the Medicare Prescription Drug 

Benefit, Improvement and 

Modernization Act. CMS will use the 

data to make risk adjusted payment 

under Parts C. MA and MA–PD plans 

will use the data to develop their Parts 

C bids. As required by law, CMS also 

annually publishes the risk adjustment 

factors for plans and other interested 

entities in the Advance Notice of 

Methodological Changes for MA 

Payment Rates (every February) and the 

Announcement of Medicare Advantage 

Payment Rates (every April). Lastly, 

CMS issues monthly reports to each 

individual plan that contains the CMSHierarchical Condition Category (HCC) 

and RxHCC models’ output and the risk 

scores and reimbursements for each 

beneficiary that is enrolled in their plan. 

Form Number: CMS–10062 (OMB# 

0938–0878); Frequency: Quarterly; 

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

Number of Respondents: 852; Total 

Annual Responses: 22,097,070; Total 

Annual Hours: 10,826.1. 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: CAHPS Home 

Health Care Survey: Use: As part of the 

Department of Health and Human 

Services (DHHS) Transparency Initiative 

on Quality Reporting, CMS plans to 

implement a process to measure and 

publicly report home health care patient 

experiences through the CAHPS 

(Consumer Assessment of Healthcare 

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904 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

Providers and Systems) Home Health 

Care Survey. The Home Health Care 

CAHPS survey, as initially discussed in 

the May 4, 2007 Federal Register (72 FR 

25356, 25452), is part of a family of 

CAHPS® surveys that ask patients about 

their health care experiences. The Home 

Health Care CAHPS survey, developed 

by the Agency for Healthcare Research 

and Quality (AHRQ), creates a 

standardized survey for home health 

patients to assess their home health care 

providers and the quality of their home 

health care. Prior to this survey, there 

was no national standard for collecting 

such information that would allow 

comparisons across all home health 

agencies. 

AHRQ conducted a field test to 

determine the length and content of the 

Home Health Care CAHPS Survey. CMS 

has submitted the survey to the National 

Quality Forum (NQF) for consideration 

and approval in their consensus 

process. NQF endorsement represents 

the consensus opinion of many 

healthcare providers, consumer groups, 

professional organizations, purchasers, 

federal agencies, and research and 

quality organizations. The final survey 

has also been submitted to the Office of 

Management and Budget (OMB) for 

their approval under the Paperwork 

Reduction Act (PRA) process. 

The survey captures topics such as 

patients’ interactions with the agency, 

access to care, interactions with home 

health staff, provider care and 

communication, and patient 

characteristics. The survey allows the 

patient to give an overall rating of the 

agency, and asks if the patient would 

recommend the agency to family and 

friends. 

CMS is beginning plans for 

implementation of Home Health Care 

CAHPS Survey. Administration of the 

survey will be conducted by multiple, 

independent survey vendors working 

under contract with home health 

agencies to facilitate data collection and 

reporting. Recruitment and training of 

vendors who wish to be approved to 

collect Home Health Care CAHPS data 

will begin in 2009. Home health 

agencies interested in learning about the 

survey and/or voluntarily participating 

in the survey are encouraged to view the 

Home Health Care CAHPS Web site: 

http://www.homehealthCAHPS.org. 

Information about the project can also 

be obtained by sending an e-mail to 

HHCAHPS@rti.org. 

Home health agency participation in 

the Home Health Care CAHPS Survey is 

currently voluntary. Form Number: 

CMS–10275 (OMB# 0938–New); 

Frequency: Semi-annually, once and 

occasionally; Affected Public: 

Individuals or households; Number of 

Respondents: 2,706,000; Total Annual 

Responses: 2,706,000; Total Annual 

Hours: 541,200. 

3. Type of Information Collection 

Request: Extension 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 Collection of this 

information is mandated in Part D of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and under supporting regulations 

Subpart K of 42 CFR 423 entitled 

‘‘Application Procedures and Contracts 

with PDP Sponsors.’’ 

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. The information will 

be collected under the solicitation of 

proposals from PDP, MA–PD, Cost Plan, 

PACE, and EGWP Plan applicants. The 

collected information will be used by 

CMS to: (1) Ensure that applicants meet 

CMS requirements, (2) support the 

determination of contract awards. Form 

Number: CMS–10137(OMB#: 0938– 

0936); Frequency: Reporting–Once; 

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

Number of Respondents: 455; Total 

Annual Responses: 455; Total Annual 

Hours: 11,890. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s 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 March 10, 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 ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: December 30, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–65 Filed 1–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 9, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

mstockstill on PROD1PC66 with NOTICES