LEGISLATIVE UPDATES
This Week: Health-Related Hearings Will be Held in the House and Senate
In the U.S. House of Representatives this week, two health-related hearings are scheduled in the House Committee on Energy and Commerce on June 7 and 9, 2023. A markup is scheduled for June 6, 2023, in the House Committee on Education and the Workforce that will address five bills, including the Telehealth Benefit Expansion for Workers Act. On June 7, 2023, the House Committee on Ways and Means is anticipated to hold a markup of bills impacting high-deductible health plans and the use of health savings accounts. In the U.S. Senate, the Committee on Finance will hold a hearing on June 8, 2023, regarding healthcare consolidation and ownership, and the Committee on Health, Education, Labor, and Pensions (HELP) will explore youth mental health crises.
President Biden Signs Debt Limit Bill – What It Means for Healthcare
Congress reached a bipartisan, bicameral deal to suspend the debt ceiling into 2025. On June 3, 2023, President Joe Biden signed the bill into law, preventing the United States from reaching its debt limit. The Fiscal Responsibility Act raises the debt limit into 2025, implements a 3 percent cap on military spending increases in the fiscal year (FY) 2024, caps nondefense federal spending at $704 billion for the next two years and provides $45 billion for a new program expanding coverage for veterans exposed to toxic burn pits. It will also end a three-year freeze on student loan payments, speed up large-scale energy and infrastructure projects, and raises the age by which nondisabled, low-income adults without dependents are required to work to be eligible for Temporary Assistance to Needy Families (TANF) program and the Supplemental Nutrition Assistance Program (SNAP) and establishes a new administrative Pay-As-You-Go (PAYGO) requirement for executive branch rules that would increase direct spending.
The law does not include Medicaid work requirements, but it claws back almost $30 billion of unspent COVID- 19 relief funds from many programs and agencies, including Centers for Medicare & Medicaid Services (CMS), National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The Congressional Budget Office (CBO) analysis notes the law would rescind funds that had been provided to 87 budget accounts during the 2020-2022 period as part of the federal response to the coronavirus pandemic and public health emergency. Those include reductions in funding designated as an emergency requirement and reductions in funding not so designated. Most of the reductions would come from the Public Health and Social Service Emergency Fund, totaling nearly $10 billion. However, any "priority" efforts like funding for research into next-generation COVID-19 vaccines, long COVID research and efforts to improve the pharmaceutical supply chain are exempted from returning their funds, which will amount to around $5 billion.
REGULATORY UPDATES
CMS Withdraws COVID-19 Healthcare Facility Vaccination Requirements
CMS issued a final rule on May 31, 2023, which, in part, withdraws the COVID-19 healthcare staff vaccination requirements established in a November 2021 interim final rule. The November 2021 rule required most Medicare- and Medicaid-certified providers and suppliers to ensure COVID-19 vaccination of staff. This rule largely did not apply to physician offices. Although CMS is withdrawing the staff vaccination provisions, the agency intends to encourage ongoing COVID-19 vaccination through its quality reporting and value-based incentive programs.
CMS Announces Plan to Ensure Availability of New Alzheimer's Drugs
CMS Administrator Chiquita Brooks-LaSure announced on June 1, 2023, how beneficiaries could obtain Medicare coverage for drugs that target amyloid plaque in the brain (slow the progression of Alzheimer's disease) for enrollees who meet coverage criteria. The agency noted that if the U.S. Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover the drugs in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product on June 9, 2023, with a decision on traditional approval possible within weeks. Broader Medicare coverage would begin on the same day that FDA grants traditional approval.
New MEDPAC Members
The U.S. Government Accountability Office (GAO) announced the appointment of three new members to the Medicare Payment Advisory Commission (MedPAC), as well as the reappointment of three current members, one of whom will continue to serve as chair. The newly appointed members, whose terms began in May 2023 and will expire in April 2026, are R. Tamara Konetzka, Ph.D., and Brian Miller, M.D., MBA, MPH. Gina Upchurch, RPh, MPH, was also appointed. She is serving the remaining term for a member who resigned, and her term will expire in 2024. The reappointed members, whose terms will expire in April 2026, are Michael Chernew, Ph.D., Betty Rambur, Ph.D., R.N. – both fellows of the American Academy of Nursing (FAAN) – and Wayne Riley, M.D., MPH, MBA.
President Biden's Pick to Lead the CDC
As previously reported in Health Dose, President Joe Biden plans to appoint former North Carolina health secretary Mandy Cohen as CDC Director, replacing Rochelle Walensky, who will step down at the end of June 2023. In 2008, Cohen worked with Surgeon General Vivek Murthy to co-found Doctors for Obama. Cohen has also worked at the U.S. Department of Veterans Affairs (VA) on women's health and previously worked on HIV issues in South Africa. Cohen previously served as COO and chief of staff at CMS under the Obama Administration and served as North Carolina's health secretary for nearly five years, helping steer the state's COVID-19 response in 2020 and 2021. Currently, Cohen serves as an executive at a private-sector firm that aims to improve primary care health practices. Biden's formal announcement of Cohen as CDC director is expected shortly after her paperwork is finalized.
RSV Vaccine Approval
The FDA approved Pfizer's vaccine against the respiratory syncytial virus (RSV) for adults ages 60 and older on May 31, 2023, marking the second approval an RSV vaccine has received from the agency following its approval of GlaxoSmithKline's (GSK) vaccine on May 3, 2023. Pfizer has also asked the FDA to approve its RSV vaccine for pregnant individuals that offers protection to their fetuses. The FDA will decide whether to approve this vaccine by August 2023. The CDC Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults.
