Top News
HELP Committee Convenes Hearing on Healthcare Affordability
The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee convened a field hearing in Louisiana on May 5th titled, “Making Health Care Affordable Again Part 2: Perspectives from Employers, Patients, and Providers.” The hearing highlighted drivers of rising health care costs and potential solutions to improve affordability. Led by Chairman Bill Cassidy (R-LA), the session built upon ongoing efforts to advance policies that lower costs, increase transparency, and strengthen patient choice. Testimony from witnesses underscored the breadth of affordability challenges, including
- how insurance market complexity, rising premiums, and limited plan flexibility constrain consumer choice and drive up out-of-pocket costs;
- the burden on small employers struggling to offer coverage amid escalating premiums and administrative costs;
- the role high treatment costs and insurance barriers have in delaying or limiting access to lifesaving services; and
- how prescription drug pricing and pharmacy benefit manager (PBM) practices increase costs.
As part of a broader initiative to gather real-world input outside of Washington, the hearing considered how affordability challenges impact stakeholders across the health system and aimed to inform future legislative approaches to making healthcare more accessible and cost-effective for Americans.
Administrative Action
CMS Overhauls Prior Authorization
The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) shared an update on the steps the agency has taken to overhaul the prior authorization process, announcing the expansion of electronic prior authorization as part of a broader Health Technology Ecosystem initiative. Building on an earlier pledge with major health plans, CMS is bringing hospitals, physician practices, electronic health records vendors, and digital health developers to the discussion. As of January 1, 2026, impacted payers are required to deliver prior authorization decisions within 72 hours for urgent requests and 7 calendar days for standard requests, with electronic prior authorization interfaces set to go live in January 2027. CMS projects these combined changes will save approximately $15 billion over 10 years.
These reforms come in response to longstanding inefficiencies in the traditional prior authorization process, which has relied heavily on paper forms, fax machines, and phone calls, costing providers an estimated $34,000 and 700 hours per clinician annually. Early results from the initial health plan pledge show that 11% of prior authorizations were eliminated, representing 6.5 million fewer prior authorizations for patients. CMS is also proposing to extend electronic prior authorization to drugs, signaling that this effort is intended to drive broad, lasting change across the entire health care ecosystem.
HHS Aims to Reduce Psychiatric Prescribing
The Department of Health and Human Services (HHS) announced a plan to reduce “psychiatric overprescribing” at a Make America Healthy Again (MAHA) Institute event on the topic. The HHS plan was accompanied by a Dear Colleague letter from the Centers for Medicare and Medicaid Services (CMS), Administration for Children and Families (ACF), Health Resources and Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA) emphasizing clearer guidance for clinicians on when and how to safely reduce or discontinue medications. Taken together, this announcement outlines a shift toward minimizing the use of psychotropic medications, while promoting alternatives such as therapy and other non-drug interventions. The action plan will also include education and outreach, program and policy actions, and research-to-practice efforts. The Administration framed this initiative as a broader policy effort to rebalance mental health treatment with more individualized, evidence-informed care; however, many in the provider and patient-advocate communities have expressed concerns about plans that could make it harder for patients to receive treatment and access medication.
Congressional Psychedelics Advancing Therapies Caucus Urges FDA Commissioner Makary to Advance Evaluation of Novel Therapeutics for Serious Mental Illnesses
Over 30 Representatives representing both parties sent a letter to Food and Drug Administration (FDA) Commissioner Marty Makary to advance its evaluation of rapid-acting novel therapeutics including entactogen and psychedelic-assisted therapies for the treatment of serious mental health conditions. Co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, Representative Jack Bergman (R-MI-01) and Representative Luis Correa (D-CA-46) posed questions to Commissioner Makary on special protocol assessment (SPA) communication and application, methodological standards and interagency coordination, review integrity and subject-matter expertise, and final guidance timeline. Additionally, the Representatives encouraged the FDA to provide further clarity on final guidance on bias, adverse event monitoring, participant safeguards, and the evolving role of psychotherapy in conjunction with a pharmacological intervention. The members of Congress expressed their commitment to ensure veterans and other constituents living with treatment-resistant mental health conditions have access to safe, evidence-based care.
Last month, President Trump issued an Executive Order Accelerating Medical Treatments for Serious Mental Illness. The FDA responded to the directive by announcing a series of regulatory actions to support the development of serotonin-2A agonists and related products, a class of perception-altering psychedelic medications. The FDA announced national priority vouchers for three companies studying psychedelic compounds, allowed an early phase clinical trial for noribogaine hydrochloride, and will release final guidance providing recommendations to sponsors developing psychedelic products. The FDA’s final guidance is expected to be published soon.
FDA Announces New Acting Director for Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA) appointed Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER), the unit responsible for regulating vaccines and other biological products. Szarama, who previously served as deputy director under Vinay Prasad, brings prior experience from both the Centers for Medicare and Medicaid Services and the National Institutes of Health. She succeeds Prasad following his turbulent tenure marked by leadership turnover and political scrutiny, including tensions tied to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and public criticism from conservative stakeholders. In her new role, Szarama will oversee the evaluation of biologics to ensure their safety, effectiveness, and availability. Her appointment signals a continued period of transition across HHS broadly and within FDA leadership specifically, as the agency navigates both scientific priorities and heightened political attention.
Save the Date: 2026 Annual Conference
HealthCare Roundtable 22nd Annual Conference
November 4-6, 2026
The Mayflower Hotel
Washington, D.C.
