Alston & Bird Health Care Week in Review - August 2020 #4

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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.


Week in Review Highlight of the Week:

On Tuesday, CMS issued another interim rule with comment period (IFC) intended to help health care professionals respond to the COVID-19 pandemic. Read more about the IFC and other news below.


I. Regulations, Notices & Guidance

  • On August 26, 2020, the Food and Drug Administration (FDA) issued a guidance entitled, Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. The guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The draft guidance includes study design recommendations regarding the patient population.
  • On August 27, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (IFC) entitled, Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. This IFC revises regulations in an effort to strengthen CMS’ ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital Conditions of Participation for tracking the incidence and impact of COVID-19 to assist public health officials in surveillance efforts, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services in a manner and form, and timing and frequency, as described by the Secretary during the public health emergency.

Event Notices

  • August 31, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting entitled, Meeting of the Advisory Panel on Hospital Outpatient Payment. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as CMS prepares the annual updates for the hospital outpatient prospective payment system.
  • September 8-9, 2020: FDA announced a public meeting entitled, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss the classification of several medical devices.
  • September 14, 2020: HHS announced a public meeting entitled, Meeting of the National Committee on Vital and Health Statistics. The National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Privacy, Confidentiality, and Security, will explore the privacy, confidentiality, and security considerations for data collection and use during a public health emergency, in light of the nationwide COVID-19 pandemic.
  • September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
  • September 22, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
  • September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.
  • October 2, 2020: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
  • October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.

II. Congressional Hearings

There were no health-related congressional events this week.

III. Reports, Studies & Analyses

IV. Other Health Policy News

  • The Medicare Payment and Access Commission (MedPAC) will hold its September meeting next week. MedPAC’s meeting agenda is available here.

[View source.]

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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