Alston & Bird Health Care Week in Review - September 2020 #2

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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 Wednesday, HHS announced new guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations when they are made available. Read more about the guidance and other news below.


I. Regulations, Notices & Guidance

  • On September 9, 2020, the Department of Health and Human Services (HHS) issued a request for information entitled, Testing for Coronavirus Disease 2019 (COVID-19) - Surge Capacity. The Office of the Assistant Secretary for Health (OASH) in HHS seeks to obtain information regarding the ability of Clinical Laboratory Improvement Amendments (CLIA)-certified/accredited commercial, academic, medical center, and public health laboratories to feasibly provide additional COVID-19 testing capability if supplementary testing instruments were made available.
  • On September 10, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency. FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. Except as noted in this guidance, this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

Event Notices

  • 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: The Centers for Disease Control and Prevention (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 8, 2020: FDA announced a public meeting entitled, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder.
  • October 26, 2020: CDC announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
  • October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
  • October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
  • 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.
  • November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
  • November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. On November 9, 2020, the committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.

II. Congressional Hearings

U.S. House of Representatives

  • On September 9, 2020, the House Committee on Energy and Commerce held a markup of 38 bills, including 26 health care-related bills. For a description of the bills considered during the markup, the memorandum is available here.

U.S. Senate

  • On September 9, 2020, the Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing entitled, Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health. Witnesses present included: Dr. Francis Collins, MD, PhD, Director, National Institutes of Health (NIH); and VADM Jerome Adams, MD, MPH, Surgeon General of the United States, U.S. Department of Health and Human Services (HHS).

III. Reports, Studies & Analyses

  • On September 9, 2020, the Government Accountability Office (GAO) published a report entitled, Medicaid Information Technology: Effective CMS Oversight and States' Sharing of Claims Processing and Information Retrieval Systems Can Reduce Costs. GAO was asked to assess CMS’s oversight of federal expenditures for MMIS and E&E systems used for Medicaid. This report examines: (1) the amount of federal funds that CMS has provided to state Medicaid programs to support MMIS and E&E systems; (2) the extent to which CMS reviews and approves states’ funding requests for the systems and oversees the use of these funds; and (3) CMS’s and states’ efforts to reduce potential duplication of Medicaid IT systems.
  • On September 9, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Managed Care Rates and Flexibilities: State Options to Respond to COVID-19 Pandemic. This brief provides an overview of how managed care organization (MCO) capitation rates are developed by states and approved by CMS, highlights options available to states to adjust current MCO payment rates and/or risk sharing mechanisms, describes how MCOs pay providers, and outlines state options to direct MCO payments to providers in response to conditions created by the pandemic.

IV. Other Health Policy News

  • On September 8, 2020, HHS, through the Health Resources and Services Administration (HRSA), awarded over $79 million in construction and other capital support for 165 HRSA-funded health centers impacted by Hurricanes Florence and Michael, Typhoon Mangkut, and Super Typhoon Yutu, and wildfires and earthquakes occurring in calendar year 2018, and tornadoes and floods occurring in calendar year 2019. More information about this funding can be found here.
  • On September 9, 2020, HHS, through the Assistant Secretary for Health, issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements. More information about this announcement can be found here.

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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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