Alston & Bird Health Care Week in Review, March 19, 2021

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 Thursday, the U.S. Senate confirmed California Attorney General Xavier Becerra as HHS Secretary. Read more about this and other news below.

I. Regulations, Notices & Guidance

• On March 18, 2021, the Department of Health and Human Services (HHS) issued a notice delaying the effective date of the final rule entitled, Securing Updated and Necessary Statutory Evaluations Timely. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule requires HHS to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of significant regulations. If a given regulation is subject to the RFA, HHS must review the regulation every ten years to determine whether the regulation is still needed and whether it is having appropriate impacts. Regulations will expire if HHS does not assess and, if required, review them in a timely manner. The effective date for this rule is proposed to be delayed for one year, until March 22, 2022.
• On March 18, 2021, HHS issued a notice delaying the effective date of certain amendments in the final rule entitled, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. This rule amends the safe harbor regulation concerning discounts for prescription pharmaceutical products. Amending this regulation changes the definition of certain conduct that is protected from liability under the Federal anti-kickback statute of the Social Security Act (the Act). New regulatory text in the amendment revises the discount safe harbor. By excluding from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D or pharmacy benefit managers (PBMs) under contract with them, HHS modifies the existing discount safe harbor in particular contexts. Existing safe harbors otherwise remain unchanged. Safe harbors are also created for two additional types of arrangements. The first protects certain point-of-sale reductions in price on prescription pharmaceutical products, and the second protects certain PBM service fees. The effective date of these amendments has been further delayed until January 1, 2023.
• On March 19, 2021, HHS issued a notice delaying the effective date of the final rule entitled, Implementation of Executive Order on Access to Affordable Lifesaving Medications. This final rule implements an Executive Order requiring entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and that also participate in the 340B Drug Pricing Program must establish practices to provide access to insulin and injectable epinephrine to low-income health center patients at the price the health center purchased these two drugs through the 340B Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements. The effective date for this rule has been further delayed until July 20, 2021.

Event Notices 

• March 24-25, 2021: The Food and Drug Administration (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 26, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to discuss equitable vaccine access and acceptance.
• 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 6, 2021: FDA announced a public meeting entitled, Meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc.
• 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).”
• May 5, 2021: 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 dengue vaccine and rabies vaccines. No recommendation votes are scheduled.
• May 18-19, 2021: FDA announced a public meeting entitled, Potential Medication Error Risks with Investigational Drug Container Labels. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.

II. Congressional Hearings

U.S. Senate

• On March 16, 2021, the Senate Finance Committee held a hearing entitled, Made in America: Effect of the U.S. Tax Code on Domestic Manufacturing. Witnesses present included: George Davis, EVP and CFO, Intel Corporation; Mr. Jonathan Jennings, Vice President, Ford Motor Company; Mr. Jay Timmons, President and CEO, National Association of Manufacturers; Dr. Michelle Hanlon, Professor, Sloan School of Management, MIT; and Mr. Donnie Blatt, District Director, Union Steelworkers.
• On March 17, 2021, the Senate Finance Committee held a hearing entitled, A National Tragedy: COVID-19 in the Nation’s Nursing Homes. Witnesses present included: Adelina Ramos, Certified Nursing Assistant, SEIU District 1199 New England; Denise Bottcher, State Director, American Association of Retired Persons (AARP) Louisiana; Quiteka Moten, MPH, CDP, State Long-Term Care Ombudsman, State of Tennessee; Dr. R. Tamara Konetzka, Ph.D., Louis Block Professor of Public Health Sciences, Department of Public Health Sciences, The University of Chicago; John Dicken, Director, Health Care, U.S. Government Accountability Office (GAO); and Dr. David Gifford, MD, MPH, Chief Medical Officer, American Health Care Association (AHCA).
• On March 18, 2021, the Senate Aging Committee held a hearing entitled, COVID-19 One Year Later: Addressing Health Care Needs for At-Risk Americans. Witnesses present included: Dr. Anand Iyer, Assistant Professor, Division of Pulmonary, Allergy And Critical Care Medicine, University of Alabama at Birmingham; Dr. Amy Houtrow, Professor and Vice Chair, Department of Physical Medicine and Rehabilitation for Pediatric Rehabilitation Medicine, University of Pittsburgh School of Medicine; Anthony Jackson, Senior Vice President and Chief Operating Officer, Roper Saint Francis Healthcare; and Sandra Harris, Volunteer State President, AARP Massachusetts.
• On March 18, 2021, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Examining Our COVID-19 Response: An Update from Federal Officials. Witnesses present included: Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); Dr. David Kessler, Chief Science Officer, COVID Response, HHS; Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA; and Dr. Rochelle Walensky, Director, CDC.

U.S. House of Representatives

• On March 16, 2021, the House Committee on Appropriations Subcommittee on the Department of Homeland Security held a hearing entitled, The Role of FEMA and Emergency Management in COVID-19 Response. Witnesses present included: George Davis, EVP and CFO, Intel Corporation; Mr. Jonathan Jennings, Vice President, Ford Motor Company; Mr. Jay Timmons, President and CEO, National Association of Manufacturers; Dr. Michelle Hanlon, Professor, Sloan School of Management, MIT; and Mr. Donnie Blatt, District Director, Union Steelworkers.
• On March 17, 2021, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations. Witnesses present included: Dr. Rochelle Walensky, Director, CDC; Dr. Anthony Fauci, Director, NIH; and Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA.

III. Reports, Studies & Analyses

• On March 16, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, One Year into the Pandemic: Implications of COVID-19 for Social Determinants of Health. Even as the COVID-19 vaccine roll-out is accelerating across the country, the public health and economic effects of the pandemic continue to affect the well-being of many Americans. The American Rescue Plan Act of 2021 includes additional funding not only to address the public health crisis of the pandemic, but also to provide economic support to many low-income people struggling to make ends meet. Millions have lost jobs or income in the past year, making it difficult to pay expenses including basic needs like food and housing. These challenges will ultimately affect people’s health and well-being, as they influence social determinants of health. This brief provides an overview of social determinants of health and a look at how adults are faring across an array of measures one year into the pandemic.
• On March 16, 2021, RAND Corporation published a report entitled, RAND Technical Expert Panel Medicare Advantage (MA) and Part D Contract Star Ratings, November 19, 2020 Meeting. On November 19, 2020, the RAND Corporation convened a Technical Expert Panel (TEP) web meeting to gather input about stratified reporting of performance and approaches to reduce disparities in Medicare Advantage (MA) and Part D Contracts. This meeting summary includes a list of meeting attendees, summary of the meeting and discussions during the meeting, as well as analytic ideas that surfaced during discussions. The summary is organized by discussion topic, which maps to the content of the presentation.

IV. Other Health Policy News

• On March 15, 2021, the Centers for Medicare & Medicaid Services (CMS) announced it is increasing the Medicare payment amount for administering the COVID-19 vaccine. This new and higher payment rate will support important actions taken by providers that are designed to increase the number of vaccines they can furnish each day, including establishing new or growing existing vaccination sites, conducting patient outreach and education, and hiring additional staff. More information about this decision can be found here.
• On March 17, 2021, HHS announced it will invest $10 billion from the American Rescue Plan of 2021 to ramp up screening testing to help schools reopen, $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings. These measures are part of the Biden Administration’s strategy to increase COVID-19 testing nationwide as vaccinations increase. More information about these efforts can be found here.
• On March 17, 2021, HHS announced it is investing $150 million to increase access to COVID-19 monoclonal antibody therapeutic treatments for patients in vulnerable communities across the country. More information about the announcement can be found here.
• On March 18, 2021, the U.S. Senate voted to confirm California Attorney General Xavier Becerra as the next Secretary of HHS. The Senate voted 50-49 to confirm Mr. Becerra. Senator Susan Collins (R-ME) was the only Republican to vote in Mr. Becerra’s favor.

Click here to view the members of our Health Care Legislative & Public Policy team.