Healthcare Regulatory Check-Up Newsletter | December 2025 Recap | McDermott Skip to main content

Healthcare Regulatory Check-Up Newsletter | December 2025 Recap

Overview


This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity from December 2025. The end of the year brought a significant number of newly proposed Centers for Medicare & Medicaid Services (CMS) rules and Innovation Center models, as well as several new Office of the Inspector General (OIG) reports and an advisory opinion. We discuss enforcement actions focusing on allegations under the Anti-Kickback Statute (AKS), the False Claims Act (FCA), and other fraud and abuse laws, including allegations related to laboratory testing, wound grafts, and marketing schemes. This issue also discusses recent executive orders related to artificial intelligence (AI) and medical marijuana research.

Read below for an overview of this month’s regulatory and enforcement activity roundup. For a deeper dive, subscribe to the newsletter to get our detailed analysis of all updates.

Click each heading below for a sneak peek of related content.

WOUND GRAFT COMPANY OWNERS SENTENCED FOR $1.2B FRAUD, AGREE TO PAY $309M TO RESOLVE FCA LIABILITY

In a landmark prosecution, the owners of Arizona-based wound graft companies were sentenced to 15.5 and 14 years in prison, respectively, for orchestrating a $1.2 billion healthcare fraud scheme.

PAIN MANAGEMENT DOCTOR, PRACTICE TO PAY $13M+ FOR ALLEGED URINE DRUG TESTING FALSE CLAIMS

A Texas-based pain medicine practice and its physician founder entered into a settlement of more than $13 million to resolve allegations of false claims submissions to federal and state healthcare programs.

HEALTHCARE SOFTWARE CEO SENTENCED FOR $1B TELEMARKETING FRAUD SCHEME

In one of the largest telemarketing Medicare fraud cases ever tried to verdict, the CEO of a marketing and software company was convicted of healthcare fraud, conspiracy to commit healthcare fraud and wire fraud, and related kickback and false statement charges.

ELEVENTH CIRCUIT EVALUATES CONSTITUTIONALITY OF FCA

On December 12, 2025, the US Court of Appeals for the Eleventh Circuit heard oral arguments for an appeal of a district court decision that the qui tam provision of the FCA violates the Appointments Clause of the US Constitution.

FIRST CIRCUIT CLARIFIES FCA MEDICAL NECESSITY STANDARDS

On December 1, 2025, the US Court of Appeals for the First Circuit declined to revive a lawsuit alleging that a laboratory knowingly submitted false Medicare claims by billing for expensive polymerase chain reaction (PCR) tests for urinary tract infections when cheaper and allegedly equally effective bacterial urine culture (BUC) tests were available.

SIXTH CIRCUIT LIMITS FRAUD RESTITUTION PAYMENTS UNDER MVRA

The US Court of Appeals for the Sixth Circuit upheld the convictions of a pharmaceutical sales company cofounder but significantly altered the district court’s calculation of restitution.

CMS ESTABLISHES ORHT, AWARDS INITIAL GRANTS IN $50B PROGRAM

Following the creation of the Rural Health Transformation (RHT) Program, which was tasked with dispensing $50 billion to states in support of rural health over the next five years, CMS established the Office of Rural Health Transformation (ORHT) within its organizational structure.

CMS PROPOSES HOSPITAL BAN ON GENDER-AFFIRMING CARE FOR MINORS

CMS proposed a new condition of participation that would prohibit hospitals from providing certain pharmaceutical or surgical interventions (referred to in the proposed rule as “sex-rejecting procedures”) to transgender and transitioning patients under the age of 18.

CMS INTRODUCES NEW INNOVATION CENTER MODELS

CMS recently announced several new and proposed Innovation Center models: the ACCESS Model, the MAHA ELEVATE Model, the proposed GLOBE and GUARD Models, and the voluntary BALANCE Model.

DHS LIST, PHYSICIAN NONMONETARY COMPENSATION LIMITS UPDATED FOR 2026

CMS issued its new Physician Fee Schedule in November 2025, effective for services starting in January 2026. In the final rule, CMS issued its updated list of designated health services (DHS).

CMS INDEFINITELY SUSPENDS SNF ATTACHMENT DEADLINE

Under a 2023 CMS final rule, skilled nursing facilities (SNFs) are required to provide CMS with extensive managerial, ownership, and control information from additional disclosable parties that provide certain services to or exercise certain controls over SNFs. SNFs must provide this information as part of their Medicare enrollments using the CMS-855A SNF attachment, which was initially released in October 2024. On December 9, 2025, CMS indefinitely suspended the deadline for submitting the SNF attachment.

OIG ISSUES FAVORABLE ADVISORY OPINION ON DISCOUNTS

In Advisory Opinion No. 25-11, a biopharmaceutical manufacturer proposed a system to offer discounts and rebates on its vaccines to various customers, including pharmacies and healthcare organizations.

OIG SOLICITS PROPOSALS FOR NEW AKS SAFE HARBORS

OIG published its annual notification soliciting proposals and recommendations for developing or modifying AKS safe harbors. OIG also seeks suggestions for new special fraud alerts, which have historically served as an important source of subregulatory guidance on key fraud and abuse issues.

OIG AUDIT: MEDICAID AGENCIES MADE MILLIONS IN UNALLOWABLE CAPITATION PAYMENTS

An OIG audit covering July 2021 to June 2022 found $207.5 million in unallowable capitation payments to managed care organizations for deceased enrollees.

OIG AUDIT: ASSISTED LIVING FACILITIES DID NOT COMPLY WITH PROVIDER RELIEF FUND TERMS

An OIG audit of Provider Relief Fund payments to 30 assisted living facilities found that seven facilities claimed $283,000 in unallowable expenses and two inaccurately reported $11 million in lost revenues.

OIG AUDIT: NEW JERSEY SHOULD IMPROVE OVERSIGHT OF NURSING HOME BACKGROUND CHECK COMPLIANCE

An OIG audit assessing compliance with federal requirements during the 2022 calendar year revealed that 11 out of 12 selected New Jersey nursing homes failed to comply with federal background check requirements, affecting 33 out of 120 employees.

LOWER HEALTHCARE COSTS ACT INTRODUCED IN SENATE

On December 8, 2025, Sen. Chuck Shumer (D-NY) introduced S. 3385, which would extend the American Rescue Plan Act of 2021 and the Inflation Reduction Act of 2022 for three years.

HOUSE PASSES LOWER HEALTHCARE PREMIUMS FOR ALL AMERICANS ACT

On December 17, 2025, the US House of Representatives passed H.R. 6703, sending it to the Senate the following day.

FLORIDA OVERPAYMENT STATUTE GOES INTO EFFECT

Effective January 1, 2026, Florida healthcare practitioners and AHCA-licensed facilities are required to refund overpayments made by patients within 30 days after the determination that there has been an overpayment.

ADMINISTRATION RELEASES EXECUTIVE ORDER AND RFI ON AI

On December 11, 2025, President Trump issued an executive order that directs federal agencies to challenge state laws that conflict with national AI policy, asserting federal preemption over state-level regulation.

EXECUTIVE ORDER CALLS FOR EXPANDING RESEARCH INTO MEDICAL MARIJUANA

On December 18, 2025, President Trump signed an executive order that directs federal agencies to support expanded research into medical uses of marijuana and hemp-derived cannabinoids.

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