Department of Health and Human Services May 25, 2007 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Meeting of the Medicare Coverage Advisory Committee-July 18, 2007
This notice announces a public meeting of the Medicare Evidence Development Coverage Advisory Committee (MedCAC or Committee), formerly the Medicare Coverage Advisory Committee (MCAC). The Committee generally 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 percutaneous transluminal angioplasty (PTA) and stenting of the renal arteries. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Public Meeting in Calendar Year 2007 for New Clinical Laboratory Tests Payment Determinations
This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2008, which will be effective on January 1, 2008. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is performed by the CPT Editorial Panel and will not be discussed at the CMS meeting.
Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-September 5, 6, and 7, 2007
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2007. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2008.
Medicare Program; Approval of Deeming Authority for National Accreditation Organizations to Accredit Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers
This notice announces the 10 national accreditation organizations that have been approved by CMS to accredit durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers seeking to participate in the Medicare program.
Determination of Regulatory Review Period for Purposes of Patent Extension; PREZISTA
The Food and Drug Administration (FDA) has determined the regulatory review period for PREZISTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Exemption of Certain Systems of Records Under the Privacy Act
This proposed rule would exempt the four system of records from subsections (c)(3), (d)(1) through (d)(4), (e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/Incidents Tracking System (``ACTS''), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System (``HITS''), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System (``OPOS''), HHS/CMS, System No. 09-70-0575; and the Fraud Investigation Database (``FID''), HHS/CMS, System No. 09-70- 0527.
Determination of Regulatory Review Period for Purposes of Patent Extension; KDR 401 and 403 PACEMAKERS
The Food and Drug Administration (FDA) has determined the regulatory review period for KDR 401 and 403 PACEMAKERS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims those medical devices.
Proposed Collection; Comment Request; Application for the Pharmacology Research Associate Program
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Application for the Pharmacology Research Associate Program. Type of Information Collection Request: Extension of a currently approved collection, OMB No. 0925-0378, expiration date August 31, 2007. Form Numbers: NIH 2721-1, NIH 2721-2. Need and Use of Information Collection: The Pharmacology Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D., or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. Frequency of Response: Once a year. Affected Public: Individuals or households; Businesses or other for-profit. Type of Respondents: Applicants and Referees. The annual reporting burden is as follows:
Public Meeting of the President's Council on Bioethics on June 28-29, 2007
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-ninth meeting, at which it will (1) take up the topic of the professions and society with a focus on the healing professions; (2) hear and discuss presentations on the topic of ``Health carewho is responsible? The individual, society or both?''; and (3) hear and discuss presentations on nanotechnology and the ethics of applications of nanotechnology in health care and medicine. Subjects discussed at past Council meetings (although not on the agenda for the June 2007 meeting) include: Therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, personalized medicine, criteria for the determination of death, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL-New Drug Applications 21-986 and 22-072
The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCELnew drug applications (NDAs) 21- 986 and 22-072 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYOZYME
The Food and Drug Administration (FDA) has determined the regulatory review period for MYOZYME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey
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 FDA's Health and Diet Survey.
Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability
The Food and Drug Administration (FDA, we) is announcing that it will consider comments submitted through May 29, 2007, for a draft guidance for industry entitled ``Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.'' Although the comment period for the draft guidance ended on April 30, 2007, we will consider comments submitted through May 29, 2007, due to confusion as to the closing date for comments on the draft guidance.
Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes
This proposed rule would clarify the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations; revising the provisions related to appeals of contract determinations and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. This proposed rule would also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities.
Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit
This proposed rule would both codify prior clarifications of our policies associated with the Medicare Prescription Drug Benefit (also known as Medicare Part D) and propose certain clarifications of these policies. These clarifications include the following: Codifying our expectations of Part D sponsors regarding providing adequate access to home infusion pharmacies for infused covered Part D drugs and proposing standards with respect to timeliness of delivery of drugs; codifying our guidance that certain supplies associated with the inhalation of insulin are included in the definition of Part D drug; refining our definition of what may be included in the drug costs Part D sponsors use as the basis for calculating beneficiary cost sharing, reporting drug costs to CMS for the purposes of reinsurance reconciliation and risk sharing, as well submitting bids to CMS; reiterating our previous guidance explaining how we interpret the statutory exclusion from the definition of a Part D drug for any drug when used for the treatment of sexual or erectile dysfunction, unless that drug was used for an FDA-approved purpose other than sexual or erectile dysfunction; and codifying our guidance on plan-to-plan reconciliation and reconciliation to a payer other than the Part D of record. In addition, we are correcting the regulations to ensure that they reflect the appropriate subsidy for partial subsidy individuals subject to a late enrollment penalty. We also propose changes to the retiree drug subsidy regulations, including permitting non-calendar year plans to choose between the current year's or the subsequent year's Part D cost limits in certain circumstances and codifying our previous guidance on aggregating plan options for purposes of meeting the net test for actuarial equivalence.
Medicare Program; Application by the American Diabetes Association (ADA) for Continued Recognition as a National Accreditation Program for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
This proposed notice announces the receipt of an application from the American Diabetes Association (ADA) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. Section 1865(b)(3) of the Social Security Act (the Act) requires that we publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period.
Medicare and Medicaid Programs; Announcement of Applications From Two Hospitals Requesting Waivers for Organ Procurement Service Areas
This notice announces two hospitals' requests for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver for each hospital.
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