Articles and Blogs

The U.S. Food and Drug Administration (“FDA”) is seeking public input as it prepares its 2026 report on the risks and benefits to health associated with non-device software functions, including their impact on patient safety and related best practices. Stakeholders have only about one month to submit comments, which are due by August 13,... READ MORE

On April 30, 2026, at the Health Care Compliance Association’s 2026 Compliance Institute, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) introduced its updated Corporate Integrity Agreement (“CIA”) template, using the Kinex Medical Company CIA as its model. The updated template retains the core elements of an effective compliance... READ MORE

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently issued Advisory Opinion 26-15 addressing a subscription-based referral management software platform used during hospital discharge planning. OIG concluded that, under the facts presented, the arrangement could generate prohibited remuneration under the Federal Anti-Kickback Statute (“AKS”) because providers paying subscription fees... READ MORE

National 17 health systems affected by Oracle Health data breach CMS proposes to slash 340B payments to hospitals CMS scraps ‘fast-track’ process for certain Medicaid waivers: 6 things to know CMS unveils 2027 outpatient payment plan: Questions and answers CMS takes aim at 340B, site-neural payments in OPPS proposal CVS, Omnicare reach $440M settlement... READ MORE

The results of the 2026 National Health Care Fraud Takedown (the “Takedown”) were announced on June 23, 2026; the Department of Justice (“DOJ”) charged 455 individuals in connection with alleged health care fraud schemes involving over $6.5 billion in false claims. Ninety of the charged individuals were physicians or other medical professionals. The Takedown,... READ MORE

Earlier this year, Congress enacted Section 6225 of the Consolidated Appropriations Act, 2026 (“CAA”), establishing a new Medicare condition of payment for off-campus hospital outpatient departments beginning January 1, 2028. As discussed in our prior alerts (here and here), the statute generally prohibits Medicare payment for services furnished by an off-campus hospital outpatient department... READ MORE

New York’s Medical Aid in Dying Act (“MAID Act”), introduced in the New York Senate in January 2025 and amended, in part, by the State Assembly in February 2026, will take effect on August 5, 2026, creating a new statutory pathway for qualifying terminally ill adults to request and self-administer medication to end their... READ MORE

On Monday, June 22, 2026, the U.S. Department of Health and Human Services (“HHS”) announced Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clinical research leadership and engagement in the United States. The initiative emphasizes the growth of early-stage clinical research overseas, with HHS acknowledging the threat to “America’s position as a global... READ MORE

National 20 largest healthcare data breaches reported in 2026 so far 4 healthcare laws, rules taking effect July 1 26 states sue CMS over final Medicaid work requirements rule AHA comments on legislation adding reporting requirements for nonprofit hospitals American Hospital Association taps Steve Walsh as next CEO Clinicians’ compensation rose 4.3% across 2025:... READ MORE

Buried in the July 1, 2026, proposed rule for the Home Health Prospective Payment System (“Proposed Rule”), the Centers for Medicare & Medicaid Services (“CMS”) proposed changes to provider enrollment and a provider’s ability to obtain and maintain Medicare billing privileges. Notably, the changes to provider enrollment regulations at 42 CFR Part 424, Subpart... READ MORE