Department of Health and Human Services November 2006 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled ``One Program Integrity Data Repository (ODR),'' System No. 09- 70-0568. Section 1893 of the Social Security Act (the Act) established the ``Medicare Integrity Program'' that requires CMS to contract with eligible entities to ``review activities of providers of services or other individuals and entities furnishing items and services for which payment may be made under this title'' by utilizing equipment and software technologies. Likewise, section 1893 of the Act requires CMS to establish the Medicare Medicaid Data Match Program (Medi-Medi) in which data from both the Medicare and Medicaid programs are analyzed together to better detect fraud, waste, and abuse existent in these programs. In order to comply with these requirements and enhance our ability to detect fraud, waste, and abuse in Medicare and Medicaid, CMS is proposing to construct the ODR. CMS maintains numerous systems housing Medicare beneficiary Parts A, B, C, and D entitlement, enrollment, and utilization information. Additionally, CMS maintains data on physicians, providers, employer plans, Medicaid recipients and Medicare secondary payers. There are a large number of data sources, extraction tools, and access mechanisms. Users of the data often experience inconsistent, untimely, or duplicated information. The ODR will be an enterprise resource that will provide an integrated view of the data to all of CMS and its partners providing a single authoritative source of information and providing quality and timely data. The ODR will provide an organized structure for reaching the data through a consistent application of access policies, processes and procedures, common services, governance, and framework. The ODR will integrate and load data from various CMS systems consisting of Medicare Parts A, B, C, and D, Medicaid and Retiree Drug Subsidy entitlement, enrollment and utilization data. The ODR will also contain demographic information on Medicaid beneficiaries, Medicare providers and physicians, and employer plans that are receiving a subsidy from CMS for providing creditable drug coverage to their retirees. It is through the integration of this Medicare data with other data; e.g., historic data, Part A and Part B data, and Medicaid data sets provided by state agencies that CMS fraud, waste, and abuse, quality improvement, research, and other analytic activities are maximized. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 FR 58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70-0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09- 70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525, (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70- 0530 (67 FR 48184 (July 23, 2002)); and the Medicaid data sets provided by participating state agencies. The primary purpose of this system is to establish an enterprise resource that will provide a single source of information for all CMS fraud, waste, and abuse activities. 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 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 Quality Improvement Organizations (QIO); (4) assist other insurers for processing individual insurance claims; (5) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new 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 Date section for comment period.

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 the information collection related to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).'' The guidance explains, using a question and answer format, FDA's current thinking on a number of issues related to the regulation of food allergens, including implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

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 an information collection to meet specified requirements for submitting adequate and well-controlled studies to provide substantial evidence of effectiveness for a new animal drug.