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 8, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Regulation to Require Drug Pricing Transparency. This final rule revises the Federal Health Insurance Programs for the Aged and Disabled by amending regulations for the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC or list price) of that drug or biological product. This rule is intended to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize their out-of-pocket (OOP) costs.
- On May 8, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics. This draft guidance is intended to encourage sponsors and applicants who are using real-world data to generate real-world evidence (RWE) as part of their regulatory submissions to provide certain information to FDA so that FDA can internally track the submissions. The purpose of the guidance is to provide instructions on how to document RWE in a submission.
- On May 10, 2019, the FDA issued guidance entitled, Considerations in Demonstrating Interchangeability with a Reference Product. This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009.
- May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
- 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.
- On May 7, 2019, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers, Part II. Witnesses included: Don Rucker, National Coordinator for Health Information, HHS and Kate Goodrich, Director and Center for Medicare and Medicaid Services Chief Medical Officer, HHS.
- On May 7, 2019, the Senate Judiciary Committee held a hearing entitled, Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition. Witnesses present included: Mr. Joshua D. Baker, Director, South Carolina Department of Health and Human Services; Mr. David Mitchell, President and Founder, Patients for Affordable Drugs; Mr. James Stansel, Executive Vice President and General Counsel, Pharmaceutical Research and Manufacturers of America; Professor Michael Carrier, Distinguished Professor Of Law, Rutgers Law School; and Professor David S. Olson, Associate Professor, Boston College Law School.
- On May 8, 2019, the Senate Finance Committee held a hearing entitled, Medicare Physician Payment Reform After Two Years: Examining MACRA Implementation and the Road Ahead. Witnesses present included: Barbara McAneny, M.D., President, American Medical Association; John Cullen, M.D., President, American Academy of Family Physicians; Frank Opelka, M.D., Medical Director for Quality and Health Policy, American College of Surgeons; Scott Hines, M.D., Director, American Medical Group Association; and Matthew Fiedler, Ph.D., Fellow USC-Brookings Schaeffer Initiative For Health Policy, Brookings Institution.
House of Representatives
- On May 8, 2019, the House Appropriations Committee held a markup entitled, FY 2020 Labor, Health and Human Services, Education, and Related Agencies legislation. The Committee advanced the legislation by a vote of 30 to 23.
- On May 9, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering Prescription Drug Prices: Deconstructing the Drug Supply Chain. Witnesses present included: Justin McCarthy, Senior Vice President, Patient & Health Impact Group, Pfizer; Kave Niksefat, Vice President, Value and Access, Amgen; Jeffrey Hessekiel, Executive Vice President & General Counsel, Exelixis; Amy Bricker, Senior Vice President, Supply Chain, Express Scripts; Brent Eberle, Chief Pharmacy Officer, Navitus Health Solutions; Estay Greene, Vice President of Pharmacy Services, Blue Cross Blue Shield of North Carolina; Lynn Eshenbacher, Chief Pharmacy Officer, Ascension; Jack Resneck, M.D., Chair, Board of Trustees, American Medical Association; Richard Ashworth, President of Pharmacy, Walgreens; and Leigh Purvis, Director of Health Services Research, AARP.
- On May 9, 2019, the House Committee on Oversight and Reform held a hearing entitled, the Trump Administration’s Response to the Drug Crisis, Part II. Witnesses present included: James Carroll, Director, Office of National Drug Control Policy; Wayne Ivey, Sheriff, Brevard County, Florida; Triana McNeil, Acting Director, Homeland Security and Justice, Government Accountability Office; and Karyl Rattay, Director, Delaware Division of Public Health.
III. Reports, Studies, & Analyses
- On May 7, 2019, Health Affairs issued a report entitled, Using External Reference Pricing in Medicare Part D to Reduce Drug Price Differentials with Other Countries. The study reviewed price differentials among the U.S. and the United Kingdom, Japan, and Ontario for single-source brand-name drugs that have been on the market for three years. The authors found that the prices averaged three to four times higher in the U.S. after rebates were considered. The report stated that the estimated savings from international reference pricing to Medicare Part D could total $72.9 billion.
IV. Other Health Policy News
- On May 9, 2019, President Trump announced that he wants Congress to pass legislation protecting patients from receiving surprise medical bills after they visit an out-of-network hospital. The President’s remarks are available here.