Department of Health and Human Services December 4, 2006 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending OMB approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Beneficiary Database (MBD),'' System No. 09-70-0536, established at 66 Federal Register (FR) 63392 (December 6, 2001), and modified at 71 FR 11420 (March 7, 2006). The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) authorizes Medicare payment to Part D sponsors (including Medicare Advantage prescription drug plan sponsors) that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 CFR Parts 417, 422 and 423. The MBD will include data necessary to process certain activities associated with the new Part D benefit including, but not limited to, the following activities: (1) Determination of the status of Medicare beneficiaries who are eligible for the Low Income Subsidy Program (LIS) and are deemed to receive certain drug benefits; and (2) auto-assignment/auto- enrollment of beneficiaries as required by the MMA, and regulation, to include all LIS and deemed individuals who are not voluntarily enrolled in a drug plan, will automatically be assigned to a Prescription Drug Plan (PDP) or Medicare Advantage (MA) Prescription Drug Plan (MA-PD). We propose to broaden the scope of the disclosure provisions of this system by adding a new routine use to permit the release of Part D enrollment data maintained in the MBD to support Patient Assistance Programs (PAP) and other groups providing pharmaceutical assistance to the Medicare beneficiary. The new routine use will be published as routine use number 8. Specifically, the new routine use will facilitate the sharing of information between PAPs and Part D plans to meet the MMA provisions for drug utilization reviews, drug medication therapy management, and quality of care that can only be addressed through the cooperation between the PAP and the Part D Plan. Information may be released to these organizations upon a specific request, and only if the requester meets the following requirements. They must (1) Provide an attestation or other qualifying information that they are providing pharmaceutical assistance to Medicare beneficiaries; (2) submit a finder file identifying Medicare beneficiaries receiving pharmaceutical assistance and/or services; (3) safeguard the confidentiality of any CMS data received and prevent unauthorized access; and, (4) complete a written statement attesting to the information recipient's understanding of and willingness to abide by CMS provisions regarding Privacy protections and information security. Recipients of CMS data must complete the Coordination of Benefits PAP Data Sharing Agreement prior to the release of CMS data. The finder file submitted by the PAP must provide the following data elements: (a) First initial of the first name, (b) first 6 letters of the last name, (c) social security number or health insurance claims number, (d) date of birth, and (e) sex. Part D data maintained in the MBD that will be released to a PAP or a group providing pharmaceutical assistance will consist of the verification of Medicare status and the identification of the current Part D Plan selected by the Medicare beneficiary. We will delete published routine use number 8 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 10 and 11 authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which shall refer to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. The primary purpose of this modified system is to provide CMS with a singular, authoritative, database of comprehensive enrollment data on individuals in the Medicare program to support ongoing and expanded program administration, service delivery modalities, and payment coverage options. This collection will contain a complete ``beneficiary insurance profile'' that reflects the individual's Medicare health insurance coverage and Medicare health plan and demonstration enrollment. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or a CMS grantee; (2) assist another Federal or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) support providers and suppliers of services for administration of Title XVIII; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) support Quality Improvement Organizations (QIO); (6) assist other insurers for processing individual insurance claims; (7) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (8) support Patient Assistance Programs and other groups providing pharmaceutical assistance or services to Medicare beneficiaries; (9) support litigation involving the agency; and (10) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for oral use of pyrantel pamoate suspension in horses and ponies as an over-the-counter (OTC) animal drug product for the removal and control of various internal parasites.