Healthcare Week in Review December 15, 2017

Alston & Bird Healthcare Week in Review, December 15, 2017

I. Regulations, Notices, & Guidance

Event Notices
  • 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 Department of Health and Human Services (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). 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 art 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 24, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council provides advice, information, and recommendations to the Secretary of HHS. The Advisory Council will meet to discuss strategies to combat antibiotic-resistant bacteria.
  • 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.
  • January 30, 2018: The FDA announced a public hearing entitled, Opioid Policy Steering Committee: Prescribing Intervention –Exploring a Strategy for Implementation. The purpose of the hearing is to receive stakeholder input on how the FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing and limit abuse of opioid analgesics.
  • 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.
  • March 19, 2018: The FDA announced a public workshop entitled, Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. The workshop will discuss how individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.

II. Congressional Legislation & Committee Action

U.S. Senate House of Representatives
  • On December 12, 2017, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Examining Concerns of Patient Brokering and Addiction Treatment Fraud. Witnesses present included: Dave Aronberg, State Attorney, 15th Judicial Circuit; Eric Gold, Assistant Attorney General, Health Care Division, Office of the Massachusetts Attorney General; Alan Johnson, Chief Assistant State Attorney, 15th Judicial Circuit; Pete Nielsen, Chief Executive Officer, California Consortium of Addiction Programs and Professionals; Douglas Tieman, President and CEO, Caron Treatment Centers.
  • On December 13, 2017, The House Energy and Commerce Subcommittee on Health held a hearing entitled, Examining the Drug Supply Chain. The witnesses present included: Chip Davis, President and CEO, Association for Accessible Medicines; Tom DiLenge, President, Advocacy, Law, and Public Policy, Biotechnology Innovation Organization; Matt Eyles, Senior Executive Vice President and Chief Operating Officer for Policy and Regulatory Affairs, America’s Health Insurance Plans; Elizabeth Gallenagh, Senior Vice President, Government Affairs and General Counsel, Health Care Distribution Alliance; Gerald Harmon, M.D., Chair, Board of Trustees, American Medical Association; B. Douglas Hoey, CEO, National Community Pharmacists Association; Mark Merritt, President and CEO, Pharmaceutical Care Management Association; David Mitchell, Founder and President, Patients for Affordable Drugs; Tom Nickels, Executive Vice President for Government Relations and Public Policy, American Hospital Association; Lori Reilly, Executive Vice President for Policy, Research and Membership, Pharmaceutical Research and Manufacturers of America
III. Reports, Studies, & Analyses
  1. Other Health Policy News
  • On December 14, 2017, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) held their December meeting. MACPAC’s agenda can be found here.
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