General Publications February 8, 2019

Alston & Bird Healthcare Week in Review, February 8, 2019

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

  • On February 4, 2019, the Food and Drug Administration (FDA) issued guidance entitled, The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and Food and Drug Administration Staff; Availability. The FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • On February 6, 2019, the FDA issued guidance entitled, Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment. This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive-compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films. This guidance finalizes the draft guidance entitled “Opioid Dependence: Developing Depot Buprenorphine Products for Treatment” issued in April 2018.
  • On February 8, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicaid Program: Final FY 2017 and Preliminary FY 2019 Disproportionate Share Hospital Allotments, and Final FY 2017 and Preliminary FY 2019 Institutions for Mental Diseases Disproportionate Share Hospital Limits. This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2017 and the preliminary federal share DSH allotments for FY 2019. This notice also announces the final FY 2017 and the preliminary FY 2019 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states’ FY DSH allotments.

Event Notices   

  • February 20, 2019: The Health Information Technology Advisory Committee announced a public meeting. The Committee will develop recommendations to the National Coordinator on interoperability.
  • February 27, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment National Advisory Council (NAC). The NAC will discuss recovery housing and expanding access to medication-assisted treatment.
  • March 8, 2019: The FDA announced a public meeting of the Microbiology Devices Panel. The panel will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV).
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.

II. Congressional Legislation & Committee Action

U.S. Senate

  • On February 5, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, How Primary Care Affects Health Care Costs and Outcomes. Witnesses present included: Josh Umbehr, M.D., Atlas MD; Sapna Kripalani, M.D., Assistant Professor of Clinical Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center; Katherine Bennett, M.D., Assistant Professor of Medicine, Division of Gerontology and Geriatric Medicine, University of Washington School of Medicine; and Tracy Watts, Senior Partner, National Leader for U.S. Healthcare Reform, Mercer.

House of Representatives

  • On February 6, 2019, the House Appropriations Committee held a hearing entitled, Impact of the Administration’s Policies Affecting the Affordable Care Act. Witnesses included: Aviva Aaron-Dine, Vice President for Health Policy, Center on Budget and Policy Priorities; Ed Haislmaier, Senior Research Fellow, The Heritage Foundation; Peter Morley, Patient Advocate; Joshua Peck, Co-Founder, Get America Covered.
  • On February 6, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Texas v. US: The Republican Lawsuit and Its Impacts on Americans with Pre-Existing Conditions. Witnesses present included: Christen Linke Young, Fellow, USC-Brookings Schaeffer, Initiative for Health Policy; Avik Roy, President, The Foundation for Research on Equal Opportunity; Elena Hung, Co-Founder, Little Lobbyists; Thomas Miller, Resident Fellow, American Enterprise Institute; and Simon Lazarus, Constitutional Lawyer and Writer.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On February 5, 2019, President Trump announced in his State of the Union Address to “eliminate the HIV epidemic in the United States within 10 years.” Department of Health and Human Services Secretary Azar announced that President Trump’s initiative will reduce new infections by 75 percent in the next five years and by 90 percent in the next ten years.
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