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 March 5, 2019, the Food and Drug Administration (FDA) issued a final order entitled, Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception. The FDA is classifying the software application for contraception into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software application for contraception’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
- On March 6, 2019, the FDA issued a notice entitled, Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. The FDA is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and FDA’s Dockets Management Staff.
- On March 7, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) entitled, Patient Protection and Affordable Care Act; Increasing Consumer Choice through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. The RFI solicits comment from interested parties on how to eliminate barriers to and enhance health insurance issuers’ ability to sell individual health insurance coverage across state lines, primarily pursuant to Health Care Choice Compacts. This RFI was written in connection with Executive Order 13813, “Promoting Healthcare Choice and Competition Across the United States,” which directs the Administration, including the Department of Health and Human Services (HHS), to the extent consistent with law, to facilitate the purchase of health insurance coverage across state lines. HHS is committed to increasing health insurance coverage options under Title I of the Patient Protection and Affordable Care Act.
- March 11, 2019: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The PTAC meeting will include deliberation and voting on proposals for physician-focused payment models submitted by individuals and stakeholder entities.
- March 13-15, 2019: HHS announced a public meeting for all new public requests for revisions to the Healthcare Common Procedure Coding System coding and payment determinations.
- April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
- 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.
- April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
II. Congressional Legislation & Committee Action
- On March 5, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Vaccines Save Lives: What is Driving Preventable Disease Outbreaks? Witnesses present included: John Wiesman, Secretary of Health, Washington State Department of Health; Saad Omer, William Foege Professor of Global Health, Emory University; Jonathan McCullers, Professor and Chair, Department of Pediatrics, University of Tennessee Health Science Center; Jon Bayle, President and CEO, Immune Deficiency Foundation; and Ethan Lindenberger, Student, Norwalk High School.
- On March 6, 2019, the Senate Committee on Aging held a hearing entitled, The Complex Web of Prescription Drug Prices, Part I: Patients Struggling with Rising Costs. Witnesses present included: Michelle Dehetre, Lewiston, ME; Pamela Holt, Granger, IN; Donnette Smith, Huntsville, AL; Sheldon Armus, Boynton Beach, FL; and Barbara Cisek, Rural Ridge, PA.
- On March 6, 2019, the Senate Finance Committee held a hearing entitled, Not Forgotten: Protecting Americans from Abuse and Neglect in Nursing Homes. Witnesses present included: Patricia Blank, Daughter of Nursing Home Neglect Victim; Maya Fischer, Daughter of Nursing Home Abuse Victim; David Grabowski, Professor, Harvard Medical School; David Gifford, Senior Vice President, Quality and Regulatory Affairs, American Health Care Association; Kate Goodrich, Director, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services; Antoinette Bacon, Associate Deputy General, United States Department of Justice; and Keesha Mitchell, Section Chief, Health Care Fraud Section, Ohio Attorney General Office.
- On March 7, 2019, the Senate Committee on Aging held a hearing entitled, The Complex Web of Prescription Drug Prices, Part II: Untangling the Web and Paths Forward. Witnesses present included: Lisa Gill, Deputy Editor, Consumer Reports; Pooja Babbrah, Practice Lead, Point-of-Care Partners; Stacie Dusetzina, Associate Professor of Health Policy, Vanderbilt University; and Jane Horvath, Principal, Horvath Health Policy.
House of Representatives
- On March 6, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Strengthening Our Health Care System: Legislation to Lower Consumer Costs and Expand Access. Witnesses included: Peter Lee, Executive Director, Covered California; Audrey Gasteier, Chief of Policy, Massachusetts Health Connector; and J.P. Wieske, Vice President, State Affairs, Council for Affordable Health Coverage
- On March 7, 2019, the House Ways & Means Health Subcommittee held a hearing entitled, Promoting Competition to Lower Medicare Drug Prices. Witnesses included: Robin Feldman, Director of the Institute for Innovation Law, UC Hastings School of Law; Ameet Sarpatwari, Assistant Director of the Program on Regulation, Therapeutics, and Law (PORTAL), Harvard Medical School; Amy Kapcynski, Co-Director of the Global Health Justice Partnership, Yale Law School; Frederick Isasi, Executive Director, Families USA; and Douglas Holtz-Eakin, American Action Forum.
- On March 7, 2019, the House Judiciary Committee held a hearing entitled, Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets. Witnesses included: Fiona Morton, Professor, Yale School of Management; Martin Gaynor, Professor, Carnegie Mellon University; Michael Kades, Director of Markets and Competition Policy, Washington Center for Equitable Growth; and Craig Garthwaite, Professor, Northwestern University.
- On March 7, 2019, the House Oversight Committee held a hearing entitled, Trump Administration’s Response to the Drug Crisis. Witnesses present included: James Carroll, Director, Office of National Drug Control Policy, Mike McDaniel, Director, Houston High Intensity Drug Trafficking Area; and Triana McNiel, Acting Director, Strategic Issues, Government Accountability Office.
- On March 7, 2019, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Addressing the Public Health Emergency of Gun Violence. Witnesses present included: John Lott, President, Crime Prevention Research Center; Andrew Morral, Senior Behavioral Scientist, RAND Corporation; Ronald Steward, Director of Trauma Programs, American College of Surgeons Committee on Trauma; and Daniel Webster, Director, Johns Hopkins Center for Gun Policy and Research.
III. Reports, Studies, & Analyses
- On March 7, 2019, the Government Accountability Office (GAO) issued a report entitled, Preliminary Observations on the 2019 National Drug Control Strategy. The Office of the National Drug Control Policy issued the 2019 National Drug Control Strategy on January 31, 2019. This report includes initial observations on the strategy.
IV. Other Health Policy News