E9-20127. 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: Revision of the currently approved collection.

Title of Information Collection: Collection of Drug Event Data From Contracted Part D Providers for Payment.

Use: In December 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 referred to as the Medicare Modernization Act (MMA). The Medicare Prescription Drug Benefit program (Part D) was established by section 101 of the MMA and is codified in section 1860D-1 through 1860 D-41 of the Social Security Act. Effective January 1, 2006, the Part D program establishes an optional prescription drug benefit for individuals who are entitled to Medicare Part A and/or enrolled in Part B. Part D plans have flexibility in terms of benefit design. This flexibility includes, but is not limited to, authority to establish a formulary that limits coverage to specific drugs within each therapeutic class of drugs, and the ability to have a cost-sharing structure other than the statutorily defined structure (subject to certain actuarial tests). Coverage under the new prescription drug benefit is provided predominately through private at-risk prescription drug plans that offer drug-only coverage (PDPs), Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans) or through Cost Plans that offer prescription drug benefits.

The transmission of the data will be in an electronic format. The information users will be Pharmacy Benefit Managers (PBM), third party administrators and pharmacies and the PDPs, MA-PDs, Fallbacks and other plans that offer coverage of outpatient prescription drugs under the Medicare Part D benefit to Medicare beneficiaries. The data is used primarily for payment, and is used for claim validation as well as for other legislated functions such as quality monitoring, program integrity and oversight.

Form Number: CMS-10174 (OMB#: 0938-0982).

Frequency: Reporting—Monthly.

Affected Public: Business or other for-profits and not-for-profit institutions.

Number of Respondents: 747.

Total Annual Responses: 947,881,770.

Total Annual Hours: 1896.

(For policy questions regarding this collection contact Bobbie Knickman at 410-786-4161. For all other issues call 410-786-1326.)

2. 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.)

3. Type of Information Collection Request: Extension of a currently approved collection.

Title of Information Collection: External Quality Review Protocols.

Use: The results of Medicare reviews, Medicare accreditation services, and Medicaid external quality reviews will be used by States in assessing the quality of care provided to Medicaid beneficiaries by managed care organizations and to provide information on the quality of care provided to the general public upon request.

Form Number: CMS-R-305 (OMB#: 0938-0786).

Frequency: Reporting—Yearly.

Affected Public: State, Local or Tribal Governments.

Number of Respondents: 40.

Total Annual Responses: 40.

Total Annual Hours: 520,000.

(For policy questions regarding this collection contact Gary B. Jackson at 410-786-1218. 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 E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to [e-mail], or call the Reports Clearance Office on [phone].

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 September 21, 2009:

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: [phone], E-mail: [e-mail].

Dated: August 14, 2009.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.