Government
Healthcare Dive Trendline on Surprise Billing
CMS released first-half 2025 independent dispute resolution (IDR) data: case submissions approached 1.2 million, up about 40% year-over-year, with arbitration entities processing over 1.3 million cases. However, about 20% of cases were non-compliant, and a few private equity-backed suppliers dominated disputes, raising concerns about abuse.
Mid-cap biotechs join Trump’s latest round of drug pricing deals
Nine mid-sized pharmaceutical manufacturers announced Monday an agreement with the White House to participate in a Medicaid demonstration project, aligning prices for certain drugs with payment levels in other countries and increasing domestic U.S. manufacturing, in exchange for tariff exemptions. Details of the agreement were not disclosed, but analysts believe the commercial impact on the companies will be limited.
Monogram Health to pay $2.4M to settle Medicare Advantage upcoding allegations
The U.S. Department of Justice announced on Monday that Monogram Health, a Tennessee-based home care company, has agreed to pay $2.4 million to settle a whistleblower lawsuit alleging that it submitted inaccurate or medically unsupported diagnosis codes from 2021 to 2023, resulting in overpayments to Medicare Advantage plans.
FDA seeks feedback on generative AI regulations
The U.S. Food and Drug Administration (FDA) is seeking input on how to regulate medical devices that incorporate generative artificial intelligence (AI). Its Center for Devices and Radiological Health (CDRH) has approved over 1,000 AI-enabled devices, but most do not use generative AI. On Tuesday, CDRH released a discussion paper proposing a potential regulatory framework and opened a comment period until October 19.
Federal judge vacates Trump admin restrictions on ACA gender-affirming care
U.S. District Judge Nathaniel Gorton ruled that HHS unlawfully revised essential health benefit scope without a required CMS actuary certification. The decision, hailed by California AG Rob Bonta, reinstates ACA cost-sharing protections for gender-affirming care but leaves administrative details unresolved.
Trump nominates policy aide Overton to lead FDA
President Donald Trump on Wednesday nominated Heidi Overton, a top White House policy aide, as the next FDA commissioner, per HHS Secretary Robert F. Kennedy Jr. Overton, a physician with limited drug regulatory experience, would fill a role vacant since Marty Makary's resignation in May. Her nomination comes amid industry calls for stability at the agency.
Survey: Premiums and Out-of-Pocket Costs Top Americans' Healthcare Worries
A new Commonwealth Fund survey reveals that high insurance premiums and out-of-pocket costs are the dominant healthcare concerns for Americans across party lines and coverage types. While most favor federal government action, Republicans lean toward insurers as the solution.