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

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Bariatric Surgery System (MBSS), System No. 09-70-0570.'' National coverage determinations (NCDs) are determinations made by the Secretary of HHS with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) section 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,'' section 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that bariatric surgery is reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the MBSS criteria set forth in the decision memorandum and are consistent with the trials discussed. Bariatric surgery is reasonable and necessary only when facilities performing the surgery have full accreditation based on standards equivalent to or exceeding the CMS minimum standards. Collection of data elements related to bariatric surgery allows that determination to be made. The purpose of this system is to provide reimbursement for bariatric surgery, and assist in the collection of data on patients receiving bariatric surgery, for a data collection process to assure patient safety and protection, and to determine that the bariatric surgery is reasonable and necessary. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain Federally-funded 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 proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Food and Drug Administration (FDA) published a notice in the Federal Register of December 14, 2005 (70 FR 74020) announcing the availability of a guidance document entitled, ``Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.'' The guidance document provided guidance to FDA and the food industry about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006, effective date for the trans fat labeling final rule, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule. This is to notify all interested persons of an addendum to that guidance.

The U.S. Department of Health and Human Services invites suggestions from interested organizations and knowledgeable individuals regarding the highest priorities for research, demonstration, and evaluation projects to support and improve the Medicare, Medicaid, and State Children Health Insurance (SCHIP) programs. The research and other activities undertaken and authorized by the above-captioned or above referenced statutory provision may address: 1. The outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and 2. Strategies for improving the efficiency and effectiveness of such programs, including the ways in which such items and services are organized, managed, and delivered under such programs. The statute: a. Requires the establishment of a priority setting process for identifying the most important topics to address, b. Establishes a timetable for development of an initial priority list and completion of the research; and c. Requires ongoing consultation with relevant stakeholders. To review the text of section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, please visit Section 1013. Research on Outcomes of Health Care Items and Services (PDF 21.7 KB) or https://www.medicare.gov/medicarereform/108s1013.htm (text). Current priority conditions being studied focus on topics particularly relevant to Medicare beneficiaries. The next set of priority conditions will be expanded to include conditions relevant to the Medicaid and SCHIP programs. The current priority conditions are: Arthritis and non-traumatic joint disorders. Cancer. Chronic obstructive pulmonary disease and asthma. Dementia including Alzheimer's disease. Depression and other mood disorders. Diabetes mellitus. Ischemic heart disease. Peptic ulcer disease and dyspepsia. Pneumonia. Stroke and hypertension.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled ``Recommended Approaches to Integration of Genetic Toxicology Study Results.'' This guidance is intended to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in genetic toxicology assays during drug development. The guidance provides recommendations on how to proceed with clinical studies while ensuring the safety of study participants when results in genotoxicity studies suggest a potential cancer or genetic hazard.

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (92) entitled ``Impurities in New Veterinary Drug Substances (Revision)'' VICH GL10(R). This draft revised guidance, which updates a final guidance on the same topic for which a Notice of Availability was published in the Federal Register of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state.

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Hans E. Geisler, M.D., Saint Vincent Hospital and Health Care Center: Based on the report of an inquiry and investigation conducted by Saint Vincent Hospital (SVH) in Indianapolis, Indiana, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Hans E. Geisler, M.D., former Staff Physician and Principal Investigator for SVH's studies under the Gynecologic Oncology Group (GOG), engaged in scientific misconduct by soliciting a pathologist to falsify the originally correct tissue-type on the pathology report (omentum) as being another type (ovary) and submitting the falsified report to the GOG group member at the University of Iowa, in order to justify enrollment of a patient in GOG clinical protocol 182. The questioned research was supported by National Institutes of Health (NIH) funds to the University of Iowa through the American Society for Obstetrics and Gynecology under National Cancer Institute (NCI), National Institutes of Health (NIH), cooperative agreement U10 CA27469. Dr. Geisler has entered into a Voluntary Exclusion Agreement (Agreement ) in which he has voluntarily agreed, for a period of three (3) years, beginning on December 2, 2005: (1) To exclude himself from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant; and (2) That any institution which uses the Respondent in any capacity on PHS-supported research, or that submits an application for PHS support for a research project on which the Respondent's participation is proposed or submits a report of PHS-funded research in which the Respondent's participation is continuing, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution. A copy of the supervisory plan must also be submitted to ORI by the institution. Respondent agrees that he will not participate in any PHS- supported research until such a supervision plan is submitted to ORI. Respondent disagrees with the ORI finding set forth herein but executes this Agreement to avoid further proceedings and bring this matter to a close. The execution of this Agreement shall not be deemed an admission to the charge of scientific misconduct by the Respondent.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Translational Research Working Group (TRWG), a broad panel including advocates, researchers from academia, industry representatives, and government officials, was established in early 2005 to evaluate the status of the National Cancer Institute's (NCI) intramural and extramural investment in translational research in order to develop recommendations on ways to coordinate and optimally integrate activities. The TRWG is also charged with developing implementation strategies that will enable the scientific community and NCI leadership to appropriately prioritize its translational research opportunities. Recommendations will be made to the National Cancer Advisory Board by early 2007. To assist in its future planning efforts, TRWG is asking public stakeholders in the translational research enterprise for feedback on some of the key questions facing the panel and insights on how to proceed.