Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On June 4, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Correction. This document corrects technical and typographical errors that appeared in the final rule published in the April 16, 2019 Federal Register titled "Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021".
- On June 5, 2019, CMS issued a notice entitled, Medicare Program; Explanation of Federal Fiscal Year (FY) 2004, 2005, and 2006 Outlier Fixed-Loss Thresholds as Required by Court Rulings. In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004, 2005, and 2006 outlier fixed-loss threshold (FLT) rulemakings, this document provides further explanation of certain methodological choices made in the FLT determinations for those years.
- On June 6, 2019, CMS issued a request for information entitled, Reducing Administrative Burden to Put Patients over Paperwork. This request for information solicits additional public comment on ideas for regulatory, subregulatory, policy, practice and procedural changes that reduce unnecessary administrative burdens for clinicians, providers, patients and their families.
Event Notices
- June 11, 2019: The Food and Drug Administration (FDA) announced a public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The Committee will discuss clinical utility and safety concerns associated with the higher range of opioid analgesic dosing in the outpatient setting.
- June 12, 2019: The HHS announced a public meeting of the Pain Management Best Practices Inter-Agency Task Force. The purpose of the meeting is to discuss payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues.
- June 21, 2019: HHS announced a public meeting entitled, ReImagine HHS Accelerate Clinical Innovation Public Hearing. HHS is interested in how to decrease the overall time for new medical products (drug, medical device, biologic) to go from discovery to widespread patient access and use while maintaining public health standards.
- July 2, 2019: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The meeting will include panel presentations and discussions surrounding emerging antifungals, and provider challenges and educational solutions to influence antibiotic stewardship.
II. Congressional Legislation & Committee Action
U.S. Senate
- On June 4, 2019, the House Foreign Affairs Committee held a hearing entitled, Eradicating Ebola: Lessons Learned and Medical Advancements. Witnesses present included: Admiral Tim Ziemer, Acting Assistant Administrator, United States Agency for International Development; Dr. Robert Redfield, Director, Center for Disease Control and Prevention.
- On June 5, 2019, the Senate Finance Committee held a hearing entitled, Foreign Threats to Taxpayer-Funded Research: Oversight Opportunities and Policy Solutions. Witnesses included: Captain Michael Schmoyer, Assistant Deputy Secretary for National Security, HHS; Lawrence Tabak, Principal Deputy Director, NIH; Les Hollie, Chief of Investigative Operations, HHS Office of Inspector General; Louis Rodi, Deputy Assistant Director, Homeland Security Investigations, Department of Homeland Security; Joe Gray, Gordon Moore Endowed Chair, Department of Biomedical Engineering Director, OHSU Center for Spatial Systems. Oregon Health & Science University.
- On June 5, 2019, the Senate Judiciary Committee held a hearing entitled, The State of Patent Eligibility in America: Part II. The health care-related witnesses included: Jeff Francer, General Counsel, Association for Accessible Medicines; Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Innovation Organization; Natalie Derzko, Of Counsel, Covington & Burling on Behalf of Pharmaceutical Research and Manufacturers of America; Rick Brandon, Associate General Counsel, University of Michigan on Behalf of Association of American Universities and the Association of University Technology Managers; and Kate Ruane, Senior Legislative Counsel, American Civil Liberties Union.
House of Representatives
- On June 4, 2019, the House Energy and Commerce Committee hearing entitled, Investing in America’s Health Care. Witnesses included: Dean Germano, Chief Executive Officer, Shasta Community Health Center; Diana Autin, Executive Co-Director, SPAN Parent Advocacy Network; Aaron Kowalski, President and Chief Executive Office, JDRF; Lisa Cooper, Professor of Medicine, Johns Hopkins University School of Medicine; Thomas Barker, Partner, Co-Chair, Healthcare Practice, Foley Hoag; Mary-Catherine Bohan, Vice President of Outpatient Services, Rutgers University Behavioral Health Care; Michael Waldrum, Chief Executive Office, Vidant Health; Fred Riccardi, President, Medicare Rights Center.
III. Reports, Studies, & Analyses
- On May 31, 2019, the Journal for the American Medical Association issued a study entitled, Trends in Prices of Popular Brand-Name Prescription Drugs in the United States. The report evaluated the prices of 49 top-selling brand-name prescription drugs in the United States, and how the prices have changed over years. The report found that 78 percent of the drugs that have been available since 2012 have seen an increase in insurer and out-of-pocket costs by more than 50 percent. Further, 44 percent have doubled in price since 2012.
IV. Other Health Policy News
- On June 3, 2019, the United States Supreme Court ruled in favor of Disproportionate Share Hospitals (DSH). CMS attempted to cut payment rates for DSH hospitals without providing public comment. The court decided 7-1 that public comment for the payment cut was required. The full opinion is available here.