Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency's function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part D Reporting Requirements and Supporting Regulations under 42 CFR section 423.505; Form Number: CMS-10185 (OMB#: 0938-0992); Use: 42 CFR 423.514, requires each Part D Sponsor to have an effective procedure to provide statistics indicating: The cost of its operations, the patterns of utilization of its services, the availability, accessibility, and acceptability of its services, information demonstrating it has a fiscally sound operation and other matters as required by CMS. In addition, § 423.505 of the regulation, establishes a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS. Data collected via Medicare Part D Reporting Requirements will be an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. Refer to the “Revisions from 60-day Comment Period to CY 2008 Part D Reporting Requirements” document to view a list of current changes. Frequency: Reporting—Monthly, Annually, Quarterly and Semi-annually; Affected Public: Business or other for-profit; Number of Respondents: 4,857; Total Annual Responses: 330,276; Total Annual Hours: 287,132.

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: Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The application requirements are codified in Subpart K of 42 CFR 423. 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 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.

The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans applicants. The collected information will be used by CMS to: (1) Insure that applicants meet CMS requirements, and (2) support the determination of contract awards.

Refer to the “High-Level Summary of Changes in Employer/Union Group Waiver Plan Part D Applications” and “High-Level Summary of All Part D Application Revisions from 2008 Solicitation for the 2009 Solicitation” documents to review a list of changes from 2008 to 2009; 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.

3. Type of Information Collection Request: New collection; Title of Information Collection: Data Collection for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration; Use: The NHVBP Demonstration is a CMS “pay-for-performance” initiative to improve the quality of care furnished to Medicare beneficiaries residing in nursing homes. Under this three-year demonstration project, CMS will assess the performance of nursing homes based on selected quality measures, and then make additional payments to those nursing homes that achieve a higher performance based on those measures. In the first year of the demonstration, quality will be assessed based on the following four domains: Staffing, appropriate hospitalizations, outcome measures from the minimum data set (MDS), and survey deficiencies. Additional quality measures may be added in the second and third years of the demonstration as deemed appropriate.

The main purpose of the NHVBP data collection effort is to gather information that will enable CMS to determine which nursing homes will be eligible to receive incentive payments under the NHVBP Demonstration. All measures included in the MDS outcomes, survey deficiency, and appropriate hospitalization domains can be calculated from existing secondary data sources, such as the MDS, annual nursing home certification surveys, and Medicare claims data. However, for the staffing domain, no satisfactory alternative source for these data has been identified. Therefore, CMS will collect payroll-based staffing and resident census information to help assess the quality of care in participating nursing homes. CMS will additionally collect data on two measures, staff immunization status and use of resident care experience surveys, which may be included in the payment determination during the second and third years of the demonstration. Refer to the “Summary of Changes to Data collection for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration” documents to review a list of changed items. Form Number: CMS-10240 (OMB#: 0938-New); Frequency: Reporting: Once; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 1,250; Total Annual Responses: 2,000; Total Annual Hours: 49,170.

4. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage (MA) Applications—Part C; Use: An entity seeking a contract as an MA organization must be able to provide Medicare's basic benefits plus meet the organizational requirements set out in regulations at 42 CFR Part 422. An applicant must demonstrate that it can meet the benefit and other requirements within the specific geographic area it is requesting. The application forms are designed to give CMS the information they need about the health plan to determine compliance with Federal regulations at 42 CFR Part 422 in an efficient manner. The cited regulations outline the MA application process that begins with submission of an application in the form and manner that the Secretary provides. The MA application forms will be used by CMS to determine whether an entity is eligible to enter into a contract to provide services to Medicare beneficiaries. Refer to the “High Level Summary of Key Changes Between The 2008 Part C Applications and The 2009 Part C Applications” and the “High-Level Summary of Changes in Employer/Union-Only Group Waiver Plan MAO Applications” documents to review a list of the changes. Form Number: CMS-10237 and 10214 (OMB#: 0938-0935); Frequency: Reporting: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 241; Total Annual Responses: 241; Total Annual Hours: 5858.

5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Enrollment Application; Form Number: CMS-855 (OMB#: 0938-0685); Use: The primary function of the Medicare enrollment application is to gather information from a provider or supplier that tells us who it is, whether it meets certain qualifications to be a health care provider or supplier, where it practices or renders its services, the identity of the owners of the enrolling entity, and information necessary to establish the correct claims payment. The goal of evaluating and revising the Medicare enrollment applications is to simplify and clarify the information collection without jeopardizing our need to collect specific information.

We are proposing revisions to the CMS-855B to incorporate changes adopted in CMS-1321-FC (71 FR 69624), “Revisions to Payment Policies and Five-Year Review of Relative Value Units Under the Physician Fee Schedule for CY 2007 and Other Changes to Payment Under Part B; Revisions to Ambulance Fee Schedule; Ambulatory Inflation Factor Update for CY 2007.” Specifically, CMS is revising the CMS-855B to:

• Add instructions to Attachment 2 that explain the independent diagnostic testing facility (IDTF) liability insurance requirements in 42 CFR § 410.33(g)(6).
• Require that an IDTF submit copies of its comprehensive liability insurance policy in Section 17.
• List all of the new IDTF standards on a separate page in Attachment 2.
• Remove the supplier type “Voluntary Health/Charitable Agency” from Section 2A.

In addition, we are trying to enhance our ability to identify whether a hospital qualifies as a “specialty hospital.” To this end, we propose to revise the CMS-855A to include a specific box that specialty hospitals must check when completing the application. Instructions explaining the definition of a “specialty hospital” will also be added to the form. We also provide clarification of the term “primary practice location” in the instructions in Section 4 of the CMS-855A. This clarification does not change any data elements on the form. We are also removing the data element “Medicare Year-End Cost Report Date” in Section 2 of the CMS-855A, as this information is no longer needed. Frequency: Recordkeeping and Reporting—On occasion; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 400,000; Total Annual Responses: 400,000; Total Annual Hours: 1,001,503.33.

6. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Home Health Conditions of Participation (CoP) Information Collection Requirements and Supporting Regulations in 42 CFR 484.10, 484.12, 484.16, 484.18, 484.36, 484.48, 484.52; Form Numbers: CMS-R-39 (OMB#: 0938-0365); Use: The information collection requirements contained in this request are part of the requirements classified as the conditions of participation (CoPs) which are based on criteria prescribed in law and are standards designed to ensure that each facility has properly trained staff to provide the appropriate safe physical environment for patients. These particular standards reflect comparable standards developed by industry organizations such as the Joint Commission on Accreditation of Healthcare Organizations, and the Community Health Accreditation Program. The primary users of this information will be State agency surveyors, the regional home health intermediaries, CMS and home health agencies (HHAs) for the purpose of ensuring compliance with Medicare CoPs as well as ensuring the quality of care provided by HHA patients. Frequency: Recordkeeping and Reporting—Annually, On occasion; Affected Public: Business or for-profits, Not-for-profit institutions, and State, Local or Tribal governments; Number of Respondents: 9,354; Total Annual Responses: 9,354; Total Annual Hours: 1,048,483.5.

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 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.

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 November 13, 2007.

OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395-6974.