Department of Health and Human Services January 2005 – 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.

This Federal Register notice sets forth the Supplemental Compliance Program Guidance (CPG) for Hospitals developed by the Office of Inspector General (OIG). Through this notice, the OIG is supplementing its prior compliance program guidance for hospitals issued in 1998. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas, taking into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance. The supplemental CPG provides voluntary guidelines to assist hospitals and hospital systems in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.

This notice announces the first public meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. Notice of this meeting is required by the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Board will provide advice and recommendations with respect to the establishment and operation of the demonstration mandated by section 623(e) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This notice also announces the appointment of eleven individuals to serve as members of the Advisory Board, including one individual to serve as co-chairperson, and one additional co-chairperson, who is employed by CMS.

The National Institutes of Health (NIH) proposes to amend the existing regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.

This notice announces the implementation of a demonstration mandated under Section 651 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), which will expand coverage of chiropractic services under Medicare beyond the current coverage for manipulation to correct a neuromusculoskeletal condition. Chiropractors will be permitted to bill Medicare for diagnostic and other services that a chiropractor is legally authorized to perform by the State or jurisdiction in which such treatment is provided. The demonstration will be conducted in four sites, two urban and two rural; one site in each area type must be a health professional shortage area (HPSA). Any chiropractor that provides services in these geographic areas will be able to participate in the demonstration. Any beneficiary enrolled under Medicare Part B, and served by chiropractors practicing in these sites would be eligible to receive services. Physician approval would not be required for these services. The statute requires that the demonstration be budget neutral. We anticipate that the demonstration will begin in April 2005 and operate for two years.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns usual care of chronic wounds. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This final rule implements the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit. The new voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Although this final rule specifies most of the requirements for implementing the new prescription drug program, readers should note that we are also issuing a closely related rule that concerns Medicare Advantage organizations, which, if they offer coordinated care plans, must offer at least one plan that combines medical coverage under Parts A and B with prescription drug coverage. Readers should also note that separate CMS guidance on many operational details appears or will soon appear on the CMS website, such as materials on formulary review criteria, risk plan and fallback plan solicitations, bid instructions, solvency standards and pricing tools, plan benefit packages. The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Generally, coverage for the prescription drug benefit will be provided under private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare. PDPs must offer a basic prescription drug benefit. MA-PDs must offer either a basic benefit or broader coverage for no additional cost. If this required level of coverage is offered, MA-PDs or PDPs, but not fallback PDPs may also offer supplemental benefits through enhanced alternative coverage for an additional premium. All organizations offering drug plans will have flexibility in the design of the prescription drug benefit. Consistent with the MMA, this final rule also provides for subsidy payments to sponsors of qualified retiree prescription drug plans to encourage retention of employer-sponsored benefits. We are implementing the drug benefit in a way that permits and encourages a range of options for Medicare beneficiaries to augment the standard Medicare coverage. These options include facilitating additional coverage through employer plans, MA-PD plans and high-option PDPs, and through charity organizations and State pharmaceutical assistance programs. See sections II.C, II.J, and II.P, and II.R of this preamble for further details on these issues. The proposed rule identified options and alternatives to the provisions we proposed and we strongly encouraged comments and ideas on our approach and on alternatives to help us design the Medicare Prescription Drug Benefit Program to operate as effectively and efficiently as possible in meeting the needs of Medicare beneficiaries.

By designation of the Administration for Children and Families, a member of the Departmental Appeals Board has been appointed as the presiding officer for an appeal of the Administration for Children and Families' (ACF) disapproval of an amendment to the plan of the New York State Office of Children and Family Services for implementing title IV-E of the Social Security Act (Foster Care and Adoption Assistance). The purpose of this notice is to give interested parties an opportunity to participate. Requests To Participate: Requests to participate as a party or as amicus curiae must be submitted to the Departmental Appeals Board in the form specified at 45 CFR 213.15 by February 11, 2005. Within that time, those persons, groups, or organizations seeking participation as parties or amici may file petitions or request extensions of time for submitting petitions to participate, and may also contact the Board to obtain copies of the briefs that the parties have filed.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses'' (DHHS Reference E-137-1991/0- US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders'' (DHHS Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' (DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein Molecules'' (DHHS Reference E- 128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of business in Heidelberg, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory will be worldwide and the field of use may be limited to therapeutics for the treatment of Multiple Sclerosis.

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 the availability of a draft guidance for industry entitled ``Nonclinical Safety Evaluation of Drug Combinations.'' The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.