Department of Health and Human Services March 24, 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Hiwot A. Woreta, Duke University Medical Center: Based on the report of an inquiry into admitted fabrication of data conducted by the Duke University Medical Center (DUMC) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Hiwot A. Woreta, former medical student, DUMC, engaged in research misconduct while supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant P30 DK034987. Specifically, PHS found that Ms. Woreta engaged in research misconduct by fabricating data included in Figure 2 of her third year Medical School Thesis at DUMC. These data were also included in a poster presented during the Alpha Omega Alpha Honor Society symposium in May 2004. Ms. Woreta has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on February 24, 2006: (1) To exclude herself 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 that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, 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. Respondent agreed to ensure that a copy of the supervisory plan is also submitted to ORI by the institution. Respondent agreed that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2005 through December 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

This notice requests nominations for consideration for membership on 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 notice also announces a public meeting of the MCAC. The meeting will address the use of non-invasive imaging technologies versus cardiac catheterization in the diagnosis of coronary artery disease. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). Nominations: Deadline and Address: Nominations will be considered if postmarked by April 23, 2006 and mailed to the Executive Secretary (see FOR FURTHER INFORMATION CONTACT). Secretary's Charter: Obtain a copy of the Secretary's Charter for the Medicare Coverage Advisory Committee from Maria Ellis, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: 1-09-06, Baltimore, MD 21244; (410) 786-0309; Maria.Ellis@cms.hhs.gov. This charter is also posted on the following Web site: https://www.cms.hhs.gov/FACA/ downloads/mcaccharter.pdf. Meeting: Date and Location: The public meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, on Thursday, May 18, 2006, from 7:30 a.m. until 4:30 p.m., e.d.t. Presentation and Comments: Interested persons can present data, information, or views orally or in writing on issues pending before the Committee. Please submit written comments to the Executive Secretary by mail or email (see FOR FURTHER INFORMATION CONTACT). Deadline for Written Comments and Presentations: Written comments and presentations for the public meeting must be received by April 24, 2006, 5 p.m., e.d.t. The presentation that will be submitted must be your final presentation; no further changes will be accepted. Deadline for Registration to Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on May 11, 2006. Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or who have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by May 11, 2006 (see FOR FURTHER INFORMATION CONTACT). Web site: You may access up-to-date information on this meeting at https://www.cms.hhs.gov/FACA/02MCAC.asp#TopOfPage.

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2006 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.