Agency Information Collection Activities: Proposed Collection; Comment Request, 903-904 [E9-65]

Download as PDF mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 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 VerDate Nov<24>2008 16:16 Jan 08, 2009 Jkt 217001 (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 https://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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 903 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 E:\FR\FM\09JAN1.SGM 09JAN1 mstockstill on PROD1PC66 with NOTICES 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: https://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: VerDate Nov<24>2008 16:16 Jan 08, 2009 Jkt 217001 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 https://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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 https:// 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: E:\FR\FM\09JAN1.SGM 09JAN1

Agencies

[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 903-904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-65]


-----------------------------------------------------------------------

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 CMS-Hierarchical 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 for-profit 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

[[Page 904]]

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[supreg] 
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: 
https://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 for-profit 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 https://www.cms.hhs.gov/PaperworkReductionActof1995, 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 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 
https://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: 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

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