Alston & Bird Health Care Week in Review - February 2021 #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:

This week, the Senate held confirmation hearings on President Biden’s nominee for HHS Secretary, Xavier Becerra. Read more about these hearings and other news below.


I. Regulations, Notices & Guidance

  • On February 22, 2021, the Food and Drug Agency (FDA) issued guidance entitled, Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency. FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, during the COVID-19 public health emergency.
  • On February 22, 2021, FDA issued guidance entitled, Emergency Use Authorization for Vaccines to Prevent COVID-19. FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
  • On February 22, 2021, FDA issued guidance entitled, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests. FDA is issuing this guidance to provide a policy and recommendations on evaluating the potential impact of emerging and future viral mutations of SARS-CoV-2 on COVID-19 tests for the duration of the COVID-19 public health emergency. This guidance describes a policy for test developers to consider the impact of emerging and future variants on their COVID-19 tests during development and post-authorization. Throughout this guidance, references to COVID-19 tests are referring to molecular and antigen tests that detect the SARS-CoV-2 virus and serology tests that detect antibodies to the SARS-CoV-2 virus.
  • On February 23, 2021, the Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion entitled, Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination during the COVID-19 Nationwide Public Health Emergency. This Notification is to inform the public that the HHS is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health (HITECH) Act (“HIPAA Rules”). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with regulatory requirements under the HIPAA Rules against covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.
  • On February 26, 2021, the Departments of Labor, HHS, and the Treasury jointly issued new guidance entitled, FAQS About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 44. The guidance clarifies that health plans and issuers are required to cover COVID-19 diagnostic testing, regardless of whether the individual is experiencing symptoms or has been exposed to COVID-19. The guidance also clarifies that plans and issuers must cover COVID-19 diagnostic testing without cost sharing, prior authorization, or other medical management requirements. Further, the guidance also includes information for providers on reimbursement for COVID-19 testing and vaccinations administered to the uninsured.

Event Notices       

  • March 5, 2021: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 influenza season.
  • March 18, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting entitled, Meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ’s recent accomplishments in Health Systems Research, Practice Improvement, Data and Analytics, and achieving organizational excellence. The agenda will also include a discussion of communication and value of health systems research, an update on PCOR Trust Funds, and a discussion of how AHRQ may advance health equity.
  • March 24-25, 2021: FDA announced a public meeting entitled, Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate.
  • March 31, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Center for Substance Abuse Treatment. The agenda will include consideration of minutes from the SAMHSA CSAT NAC meeting of September 22, 2020; an update on CSAT activities; a discussion with SAMHSA leadership; a discussion about the use of technology in prevention and treatment of substance use disorders; and a discussion on rural and frontier communities.
  • April 15, 2021: FDA announced a public meeting entitled, Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The committee will discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).”

II. Congressional Hearings

U.S. Senate

  •  On February 23, 2021, the Senate HELP Committee held a hearing to consider President Biden’s pick for HHS Secretary, Xavier Becerra. On February 24, 2021, the Senate Finance Committee also held a hearing to question Mr. Becerra. Senators on both committees grilled Mr. Becerra about his health care experience and how he would handle various issues as HHS Secretary. Outside his nomination hearings, Mr. Becerra has met with key Republican senators and has made a point of talking with lawmakers about their home-state issues, saying he could help them as head of the HHS. He has also assured senators that as Secretary he will build upon the existing private sector insurance scheme in the U.S. rather than push for Medicare for All.

U.S. House of Representatives

  • On Tuesday, February 23, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Pathway to Protection: Expanding Availability of COVID-19 Vaccines. Witnesses present included: John Young, Group President, Chief Business Officer, Pfizer; Dr. Stephen Hoge, President, Moderna; Dr. Richard Nettles, Vice President of Medical Affairs, Janssen Pharmaceutical Companies, Johnson & Johnson; Dr. Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca; and John Trizzino, Executive Vice President, Chief Commercial Officer, and Chief Business Officer, Novovax, Inc.
  • On February 24, 2021, the House Committee on Appropriations Subcommittee on the Department of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Ready or Not: U.S. Public Health Infrastructure. Witnesses present included: Dr. Marilyn Bibbs-Freeman, Deputy Director, Division of Consolidated Laboratory Services, Office of the Secretary of Administration, Commonwealth of Virginia; Jennifer Kertanis, Director of Health, Farmington Valley Health District, Connecticut; Dr. Umair Shah, Secretary of Health, State of Washington; and Dr. Kathryn Turner, Deputy State Epidemiologist and Chief, Bureau of Communicable Disease Prevention, Idaho Division of Public Health.
  • On February 26, 2021, the House Committee on Ways and Means Subcommittee on Health held a hearing entitled, The Path Forward on COVID-19 Immunizations. Witnesses present included: Dr. Ashish Jha, Dean of Brown University School of Public Health; Dr. Georges Benjamin, Executive Director of American Public Health Association; Dr. Kimberly Avila Edwards, Director of Advocacy and External Affairs at Ascension Seton; Ann Lewandowski, Executive Director of Wisconsin Immunization Neighborhood; Dr. Reshma Ramachandran, National Clinicians Scholar at Yale School of Medicine; and Dr. Clay Marsh, the West Virginia COVID-19 czar and Vice President and Executive Dean for Health Sciences at West Virginia University.

III. Reports, Studies & Analyses

  • On February 24, 2021, Rand Corporation published a research brief entitled, Private U.S. Health Plans Pay Hospitals 247 Percent of What Medicare Would Pay. Low levels of price transparency make it hard for employers and other purchasers of health care to know how much they pay for hospital care. RAND researchers used information from 49 states and Washington, D.C., to assess hospital prices paid by private health plans. Data sources included $33.8 billion in spending from 3,112 community hospitals—more than half of community hospitals nationwide. Rand researchers found that in 2018, employers and private insurers paid hospitals 247 percent of what Medicare would have paid for the same services at the same facilities.

IV. Other Health Policy News

  • On February 24, 2021, President Biden issued an executive order on America’s supply chains. The order requires a review of the global supply chains in key industries to boost domestic production and to avoid shortages in critical goods during the COVID-19 pandemic. The executive order calls for a 100-day review to assess vulnerabilities and areas for improvement of supply chains for four areas: pharmaceuticals, rare earth minerals, semiconductor chips and large-capacity batteries.

[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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