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 May 14, 2019, the Centers for Disease Control and Prevention (CDC) issued a request for information entitled, Updating Federal Guidelines Used by Public Health Agencies to Assess and Respond to Potential Cancer Clusters in Communities. This announcement opens a docket for public comment on updating federal guidelines used by public health agencies to assess and respond to potential cancer clusters in communities. The CDC is working with the Agency for Toxic Substances and Disease Registry to develop updated guidelines to ensure that state, tribal, local, and territorial public health agencies and stakeholders have access to information about current scientific tools and approaches to assess and respond to potential cancer clusters. The purpose of this notice is to solicit feedback on best approaches for assessing and responding to potential cancer clusters in communities.
- On May 15, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Product-Specific Guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
- On May 17, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This final rule amends the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans’ negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees. These amendments will improve the regulatory framework to facilitate development of Part C and Part D products that better meet the individual beneficiary’s healthcare needs and reduce out-of-pocket spending for enrollees at the pharmacy and other sites of care.
- May 22, 2019: The Department of Health and Human Services (HHS) announced a public meeting of the Health Information Technology Advisory Committee. The Committee will identify priorities and standards for health information interoperability.
- June 11, 2019: The 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.
- 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.
- There were no health-related hearings this week.
House of Representatives
- On May 15, 2019, the House Ways and Means Committee held a hearing entitled, Economic and Health Consequences of Climate Change. Witnesses present included: Dr. Katherine Marvel, Associate research Scientist, Columbia Engineering Department of Applied Physics and Mathematics; Dr. Ashish Jha, Dean of Global Strategy at Harvard’s T.H. Chan School of Public Health; Roy Wright, President and CEO of the Insurance Institute for Business & Home Safety; Ted Halstead, Chairman and CEO of the Climate Leadership Council; and Rich Powell, Executive Director at ClearPath Action.
- On May 16, 2019, the House Ways and Means Committee held a hearing entitled, Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis. Witnesses present include: Robin Kelly, Congresswoman (D-IL); Jamie Herrera Beutler, Congresswoman (R-WA); Allyson Felix, U.S. Track and Field Olympian; Patrice Harris, President-elect, American Medical Association; Michael Lu, Senior Associate Dean for Academics, Student and Faculty Affairs, Milken Institute School of Public Health, George Washington University; Melanie Rouse, Maternal Mortality Projects Coordinator, Virginia Department of Health, Office of the Chief Medical Examiner; Loren Robinson, Deputy Secretary for Health Promotion and Disease Prevention, Pennsylvania Department of Health; and Lisa Hollier, Immediate Past President and Interim CEO, American College of Obstetricians and Gynecologists.
- On May 16, 2019, the House Oversight and Reform Committee held a hearing entitled, HIV Prevention Drug: Billions in Corporate Profits After Millions in Taxpayer Investments. Witnesses present included: Dr. Robert Grant, Professor of Medicine, University of California; Tim Horton, Director, Medication Access and Pricing, NASTAD; Dr. Aaron Lord, PrEP Patient and Advocate; Daniel O’Day, Chairman and CEO, Gilead Sciences, Inc.; Dr. Rochelle Walensky, Professor of Medicine, Harvard University; and Stephen Ezell, Vice President, Global Innovation Policy, Information Technology and Innovation Foundation.
III. Reports, Studies, & Analyses
- On May 14, 2019, Merritt Hawkins issued a survey entitled, 2019 Physician Inpatient/Outpatient Revenue Survey. The survey shows the net annual inpatient and outpatient revenue generated by physicians in various specialties on behalf of their hospitals. The net average annual revenue generated by all physician specialties was $2,378,727 for their affiliated hospitals.
IV. Other Health Policy News
- On May 17, 2019, CMS announced it will not issue a final National Coverage Determination on CAR T-cell therapy for cancer, but a decision is forthcoming. The announcement is available here.