Alston & Bird Health Care Week in Review, March 26, 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 passed a bill to further delay Medicare cuts through December 31, 2021. Read more about this legislation and other news below.

I. Regulations, Notices & Guidance

There were no relevant regulations published in the Federal Register this week.

Event Notices    

• 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: The Food and Drug Administration (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.
• June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

II. Congressional Hearings

U.S. Senate

• On March 23, 2021, the Senate Committee on Health, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security held a hearing entitled, Why Does the US Pay the Highest Prices in the World for Prescription Drugs? Witnesses present included: Dr. Aaron Kesselheim, Professor of Medicine, Brigham and Women’s Hospital and Harvard Medical School; Dr. Nav Persaud, Canada Research Chair in Health Justice, University of Toronto; Elia Spates, Patient; and Alex Brill, Resident Fellow, American Enterprise Institute (AEI).
• On March 25, 2021, the Senate HELP Committee hearing entitled, Examining Our COVID-19 Response: Improving Health Equity and Outcomes by Addressing Health Disparities. Witnesses present included: Dr. Consuelo Wilkins, Vice President for Health Equity, Vanderbilt University Medical Center; Abigail Echo-Hawk (Pawnee), Executive Vice President, Seattle Indian Health Board; Taryn Mackenzie Williams, Managing Director, Poverty to Prosperity, Center for American Progress; and Gene Woods, President and CEO, Atrium Health.

U.S. House of Representatives

• On March 22, 2021, the House Committee on Energy and Commerce held a legislative hearing entitled, LIFT America: Revitalizing our Nation's Infrastructure and Economy. Witnesses present included: The Honorable Ernest Moniz, President and CEO, Energy Futures Initiatives, Former Secretary, U.S. Department of Energy; Dr. Tom Frieden, President and CEO, Resolve to Save Lives, Former Director, CDC; The Honorable Michael O’Reilly, Principal, MPORielly Consulting, LLC, Former Commissioner, Federal Communications Commission (FCC); and the Honorable Tom Wheeler, Visiting Fellow, Brookings Institution, Senior Fellow, Harvard Kennedy School, Former Chairman, Federal Communications Commission.
• On March 23, 2021, the House Committee on Appropriations Subcommittee on The Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Addressing the Maternal Health Crisis. Witnesses present included: Ms. Lisa Asare, Assistant Commissioner, Division of Family Health Services, New Jersey Department of Health; Dr. Wendy Gordon, Associate Professor and Chair of the Department of Midwifery, Bastyr University; Dr. Carol Sakala, Director for Maternal Health, National Partnership for Women and Families; and Ms. Stacey D. Stewart, President and CEO, March of Dimes.
• On March 23, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a legislative hearing entitled, Building on the ACA: Legislation to Expand Health Coverage and Lower Costs. Witnesses present included: Katie Keith, Associate Research Professor, Georgetown University; Dean Cameron, Director, Idaho Department of Insurance; Cindy Mann, Partner, Manatt, Phelps & Phillips, LLP; Marni Jameson Carey, Executive Director, Association of Independent Doctors; and Laura LeBrun Hatcher, Board Vice President, Little Lobbyists.
• On March 25, 2021, the House Committee on Ways and Means Subcommittee on Oversight held a hearing entitled, Examining Private Equity’s Expanded Role in the U.S. Health Care System. Witnesses present included: Sabrina Howell, Ph.D., Assistant Professor of Finance, New York University Stern School of Business (NYU); Milly Silva, Executive Vice President, Service Employees International Union (SEIU), United Healthcare Workers East; Terris King, Sc.D., CEO, King Enterprise Group, LLC; Ernest Tosh, J.D., Trial Attorney, Tosh Law Firm, PLLC; and Grace Colucci, Voices for Seniors (VFS).

III. Reports, Studies & Analyses

• On March 23, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, How Have Health Care Utilization and Spending Changed So Far During the Coronavirus Pandemic? This issue brief summarizes what is known so far about how health costs and utilization have changed during the pandemic. The analysis finds that the drop in health spending in 2020 reflects a decrease in utilization for non-COVID medical care; particularly early in the pandemic, it appears many people delayed or went without medical care they otherwise would have received. Although healthcare use picked up toward the end of the year, it was not enough to compensate for the missed care earlier in the year.
• On March 24, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report entitled, Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery. This review provides a national snapshot, from the perspective of front-line hospital administrators, on how responding to the COVID-19 pandemic has affected their capacity to care for patients, staff, and communities.
• On March 25, 2021, KFF published an issue brief entitled, Moving the Needle on Prescription Drug Costs: Using the Innovation Center and Other Demonstration Authority. This brief focuses on two pathways through which the Biden Administration could use its executive authority to implement policy changes related to prescription drug costs. The first pathway would use the authority provided under the Affordable Care Act (ACA) through the Center for Medicare and Medicaid Innovation (CMMI, or Innovation Center). The second pathway would use authority that was established soon after Medicare was enacted—known as Section 402 demonstration authority—to implement Medicare demonstrations to test new ways of delivering health care and paying health care providers.

IV. Other Health Policy News

• On March 23, 2021, President Biden announced that the Centers for Medicare & Medicaid Services (CMS) is extending access to the Special Enrollment Period (SEP) until August 15—giving consumers additional time to take advantage of new savings through the American Rescue Plan Act of 2021. This action provides new and current enrollees an additional three months to enroll or re-evaluate their coverage needs with increased tax credits available to reduce premiums.
• On March 24, 2021, CMS released an updated data snapshot detailing the impact of COVID-19 on Medicare beneficiaries, particularly among underserved beneficiaries including racial and ethnic minorities, adults 85 years old and older, and people with certain pre-existing conditions. More information about the updated data snapshot can be found here.
• On March 25, 2021 the Senate passed H.R. 1868, a bill to postpone the 2 percent Medicare cuts scheduled to go into effect April 1. The bill will extend the moratorium on the Medicare sequester cuts by 9 months, until December 31. The Senate cleared the legislation by a vote of 90-2. The House passed its version of the bill last week, but it will need to vote again on the amended measure before President Biden can sign the bill into law.

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