Alston & Bird Healthcare Week in Review

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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

Event Notices

  • 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.
  • June 12, 2019: 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

  • There were no health-related hearings this week.

House of Representatives

  • There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On May 30, 2019, the Biosimilars Forum issued a study entitled, Legislative Options to Save Patients & Taxpayers Billions. The study argues that biosimilar utilization would increase if Medicare Part B were to cover beneficiary out-of-pocket expenses. According to the study, this change could increase the biosimilar market share to 26-46 percent.

IV. Other Health Policy News

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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