RISE summarizes recent regulatory-related headlines and reports.
CMS extends Medicare GLP‑1 Bridge; Delays BALANCE in Part D
The Centers for Medicare & Medicaid Services (CMS) announced this week it will extend the Medicare GLP‑1 Bridge demonstration through December 31, 2027, while delaying implementation of the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model in Medicare Part D for CY 2027.
In a status update sent vie email on Tuesday, CMS said that the Section 402 GLP‑1 Bridge, launching July 1, 2026, will continue to provide eligible Part D beneficiaries access to certain GLP‑1 drugs outside the Part D benefit, allowing CMS and plans to collect additional data and prepare for potential future incorporation under BALANCE.
CMS said it made the decision to extend Medicare GLP‑1 Bridge based on feedback from Part D sponsors. As a result of the delay, Part D sponsors should not indicate BALANCE participation for CY 2027 in HPMS or the Bid Pricing Tool. CMS will continue accepting BALANCE applications from state Medicaid agencies through July 31, with participation start dates between May 1, 2026, and January 1, 2027.
Policy essay calls for expansion of I‑SNPs in long‑term care
An essay published by the Healthcare Policy Working Group of Hoover Institution, a public policy think tank, argues that Institutional Special Needs Plans (I‑SNPs) are underused despite evidence they reduce hospitalizations and improve care for nursing home residents.
I-SNPs are Medicare Advantage plans designed for long-term-care residents that reduce hospitalizations through on-site clinical teams and aligned financial incentives. Although more than 1.2 million Americans live in nursing homes, research finds only 7.6 percent of eligible Medicare beneficiaries are enrolled in I-SNPs. The research team say expanding and improving enrollment channels should be a priority as the population of residents in long-term-care facilities continues to grow.
The authors call on CMS to require skilled nursing facilities to provide eligible beneficiaries with clear information about their Medicare coverage options, including traditional Medicare, Medicare Advantage plans, and I-SNP plans. In addition, they say the agency should modernize the I-SNP program by modifying the quality ratings, marketing rules, and provider network requirements.
ARPA‑H launches $139M initiative to transform behavioral health
The Advanced Research Projects Agency for Health (ARPA-H), an agency within the Department of Health and Human Services (HHS), has announced the first round of research teams funded under Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT), a $139 million initiative aimed at developing objective, FDA‑ready measures to evaluate rapid‑acting behavioral health therapies. The program includes funding for neuromodulation, digital interventions, and psychedelic research, with an emphasis on personalized and predictive mental health care. The initiative will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.
The research teams will help build the first generation of scalable, objective measures of behavioral health, which will be used to help providers offer precise, personalized, data-driven care, accelerate the regulatory approval of effective therapies, reduce the cost of developing interventions for Americans living with conditions such as depression, anxiety, addiction, and post-traumatic stress disorders.
“Today, mental health care too often depends on subjective scales, delayed feedback, and trial-and-error,” said ARPA-H Director Alicia Jackson, Ph.D., in the announcement. “Core to ARPA-H's strategy for addressing behavioral health needs is to be able to definitively understand what works for whom, and when. Through EVIDENT, we are investing in objective, predictive measures that will help clinicians know much sooner whether a therapy is working for an individual patient. These awards are a critical step toward faster relief, fewer failed treatment attempts, and a future where behavioral health care is as measurable and precise as other areas of medicine.”
CMS, FDA unveil RAPID coverage pathway for breakthrough devices
CMS and the Food and Drug Administration (FDA) have announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to speed Medicare access to certain FDA-designated breakthrough devices. Officials said in the announcement that the new pathway will cut red tape and bring predictability to Medicare coverage by aligning FDA approval and CMS coverage decisions earlier in development, potentially reducing Medicare coverage timelines from over a year to as little as two months.
CMS said it will soon publish a proposed procedural notice outlining the RAPID coverage pathway in the Federal Register and the public will have 60 days to provide comments.
HHS halts publication of COVID vaccine effectiveness study
HHS officials blocked publication of a Centers for Disease Control and Prevention (CDC) study showing COVID‑19 vaccines reduced hospitalizations and emergency visits by roughly half, citing methodological concerns, according to the Associated Press. The research was due to appear in the CDC’s flagship publication, Morbidity and Mortality Weekly Report. The decision has drawn criticism from researchers and lawmakers who argue the study design is widely accepted and that political interference risks undermining public health transparency.