Alston & Bird Healthcare Week in Review

by Alston & Bird

I. Regulations, Notices, & Guidance

Event Notices
  • December 4-5, 2017: The NIH announced meetings of the Eunice Kennedy Shriver National Institute of Child Health and Human Development committee of the National Advisory Board on Medical Rehabilitation Research. The meetings will cover a variety updates and reports conducted regarding rehabilitation research.
  • December 5, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The purpose of the meeting is receive an update on progress relevant to the Action Plan for the Muscular Dystrophies.
  • December 5, 2017: The Federal Advisory Committee on Minority Health announced it will hold a meeting conducted via telephone conference call. The topics to be discussed during the teleconference include finalizing recommendations regarding improving access and quality of data related to the opioid usage and health disparities. The finalized recommendations will be given to the Deputy Assistant Secretary for Minority Health.
  • December 5-6, 2017: The NIH announced it will host a public workshop about Methods for Evaluating Experiments in Obesity. The workshop seeks to discuss, among other things, population-based data sources that have been used in studies for obesity prevention and control.
  • December 7, 2017: The HHS announced a public meeting of the National Preparedness and Response Science Board (NPRSB). Pursuant to the Public Health Service Act, the NPRSB can provide advice and guidance to the HHS Secretary and/or the Assistant Secretary for Preparedness and Response (ASPR) on other matters related to public health emergencies. The meeting will deliberate and vote on the future of the NPRSB Work Group Draft Letter to the ASPR.
  • December 7-8, 2017:  The NIH announced the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC is a federally chartered external advisory group composed of scientists from the public and private sector. The BSC will provide input to the NTP on programmatic activities and issues. The meeting is open to the public.
  • December 7-8, 2017: The NIH announced a public meeting of the Sleep Disorders Research Advisory Board. The meeting will evaluate sleep and circadian research activities and discuss plans for the proposed revision of the NIH Sleep Disorders Research Plan and potential opportunities for the inter-agency coordination activities.
  • December 8, 2017: The Health resources and Services Administration (HRSA) announced a meeting for the Advisory Commission on Childhood Vaccines (ACCV).  The ACCV agenda items include a review of petitions to add injuries to the vaccine injury table, and updates from the Department of Justice, CDC, and FDA.
  • December 11, 2017: The Center for Disease Control and Prevention (CDC) announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussion on 1) update on preliminary tuberculosis funding formula; 2) update on whole genome sequencing data sharing plan; and 3) an update on the three-month Isoniazid/Rifapentine regime guidelines.
  • December 11, 2017: The HHS announced the next meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objections for 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure.
  • December 11-12, 2017: The FDA announced a public workshop entitled, Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward; Public Workshop; Request for Comments. The workshop will host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products.
  • December 15, 2017: The FDA announced a public workshop entitled, Medical Gas Regulation Workshop I.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
  • December 18, 2017: The FDA announced a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA may be used to inform regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act.
  • December 18-20, 2017: The HHS announced the next meeting of the Physician-Focused Payment Model Technical Advisory Committee which will be held in Washington, D.C. The meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
  • January 9-10, 2018: The HHS announced a meeting of the National Committee on Vital and Health Statistics. Committee members will discuss several health data policy topics and begin work outlined in their 2018 work plan. In addition, an environmental scan report will be reviewed and discussed by the Committee as part of the Health Information Privacy and Security Beyond HIPAA project.
  • January 10, 2018: The FDA announced a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to the agency on FDA’s regulatory issues. The meeting will be open to the public.
  • January 11-12, 2018: The CDC announced a public meeting for the Board of Scientific Counselors (BSC) and the National Center for Health Statistics (BSC, NCHS). The meeting will provide an update on the National Health and Nutrition Examination Survey Reports and activities; provide an update on the Division of Health Care Statistics Reports and Activities; provide an update on vital statistics activities; and an update on the international activities of the NCHS.
  • January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
  • January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
  • January 25, 2018: The FDA announced a public hearing on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including appropriate use and labeling.
  • February 13, 2018: The CMS announced a Town Hall meeting to discuss Fiscal Year (FY) 2019 applications for add-on payments for new medical services and technologies under the Hospital Inpatient Prospective Payment System (IPPS). Interested parties are invited to the meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
  • February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.

II. Congressional Legislation & Committee Actionh

U.S. Senate   House of Representatives
  • On November 28, 2017, the House Oversight and Government Reform Committee held a hearing entitled, Combating the Opioid Crisis. The witnesses present included: The Honorable Chris Christie, Governor of New Jersey; Richard Baum, Acting Director, Office of National Drug Control Policy; Lean Wen, M.D., Health Commissioner, Baltimore, MD; Caleb Alexander, M.D., Johns Hopkins Bloomberg School of Public Health, Center for Drug Safety and Effectiveness.
  • On November 29, 2017, the House Committee on Veterans Affairs’ Subcommittee on Oversight and Investigations held a hearing entitled, Examining the VA’s Failure to Address Provider Quality and Safety Concerns. The witnesses present included: Gerald Cox, M.D., M.H.A., Acting Deputy Secretary, Health for Organizational Excellence (HOE), U.S. Department of Veterans Affairs; Humayun Chaudhry, D.O., M.S., M.A.C.P., M.A.C.O.I., President and Chief Executive Officer (CEO), Federation of State Medical Boards (FSMB); and Randall Williamson, Director of Health Care, U.S. Government Accountability Office (GAO).
  • On November 30, 2017, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Implementing the 21st Century Cures Act: An Update from FDA and NIH. The witnesses present included: The Honorable Francis Collins, M.D., Director, National Institutes of Health and the Honorable Scott Gottlieb, M.D., Commissioned, Food and Drug Administration.
III. Reports, Studies, & Analyses

Iv. Other Health Policy News

  • On November 27, 2017, the Center for Consumer Information and Insurance Oversight (CCIIO) issued a letter entitled, 2019 Draft Letter to Issuers in the Federally-facilitated Exchanges. The letter provides updates on operational and technical guidance for the 2019 plan year for issuers offering Qualified Health Plans (QHPs), including stand-alone dental plans in the Federally-facilitated Exchanges (FFEs) or the Federally-facilitated Small Business Health Options Programs (FF-SHOPs).

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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