DRUGMAKER WINS DEFENSE VERDICT IN KICKBACK AND MEDICAID FRAUD TRIAL

After more than a decade of litigation, on November 7, 2025, a pharmaceutical manufacturer prevailed in a closely watched case involving allegations of kickbacks and Medicaid fraud tied to a hemophilia treatment.

MEDICAL DEVICE COMPANY TO PAY $38.5M TO SETTLE FCA ALLEGATIONS OVER FAULTY KNEE IMPLANT, KICKBACKS

On November 17, 2025, a medical device subsidiary of a global medical and pharmaceutical company agreed to pay $38.5 million to resolve allegations that it violated the FCA by marketing a knee implant that it allegedly knew would fail at a higher than acceptable rate and, as such, was not reasonable and necessary for use during knee replacement surgeries.

SENIOR LIVING OPERATOR COMMITS TO $7M IN STAFFING, FACILITY UPGRADES TO RESOLVE INVESTIGATION

On November 19, 2025, a senior living operator agreed to invest $7 million in staffing and upgrades to resolve an investigation by the Washington State Office of the Attorney General into the operator’s practices at multiple facilities.

BEHAVIORAL HEALTH PROVIDER SUES PLAN OVER EARLY CONTRACT TERMINATION, TELEHEALTH TRANSITION

A behavioral health provider filed suit against a major health plan, alleging violations of state healthcare laws after the plan terminated its provider agreement early and transitioned patients to a telehealth-based model.

CONGRESS EXTENDS KEY MEDICARE TELEHEALTH FLEXIBILITIES INTO 2026, MAKES BEHAVIORAL HEALTH PROVISIONS PERMANENT

Recent federal legislation extended many Medicare telehealth flexibilities originally adopted during the COVID-19 public health emergency (PHE).

MODERNIZATION OF CLIA STANDARDS AND IMPACT ON LABORATORIES

The Centers for Medicare & Medicaid Services (CMS) finalized significant updates to CLIA in late 2024 (the first major overhaul in more than 30 years) with implementation continuing through 2025 and 2026.

CMS FINALIZES 2026 OPPS AND ASC RULE

CMS finalized the calendar year 2026 Outpatient Prospective Payment System (OPPS) and ASC Payment System rule, which includes several important changes that will take effect January 1, 2026.

DC CIRCUIT TESTS AGENCY AUTHORITY OVER 340B PRICING STRUCTURE CHANGES

The US Court of Appeals for the District of Columbia Circuit is considering whether drug manufacturers can unilaterally shift from upfront discounts to a rebate-based system under the federal 340B drug pricing program, or whether they need approval from HHS.

MEDICAID GENEROUS MODEL AIMS TO LOWER DRUG COSTS, EXPAND ACCESS

CMS announced a new initiative called the GENErating cost Reductions for US Medicaid (GENEROUS) model. This voluntary program aims to address high prescription drug costs in the United States.

CMS FINALIZES SECOND ROUND OF MEDICARE DRUG PRICE NEGOTIATIONS

CMS announced the results of its second round of drug price negotiations under the Inflation Reduction Act, furthering efforts to reduce prescription drug costs for Medicare beneficiaries.

OIG FINDS MEDICARE OVERPAID $377M FOR CONTINUOUS GLUCOSE MONITORS

A recent Office of Inspector General (OIG) report determined that Medicare Part B payments for continuous glucose monitors (CGMs) and related supplies significantly exceeded both supplier costs and retail market prices from July 2022 to June 2023.

OIG AUDIT OF SKILLED NURSING FACILITY UNCOVERS $31.2M IN IMPROPER PAYMENTS

OIG audited Medicare Part A skilled nursing claims at a large for-profit New York City skilled nursing facility that participates in both Medicare and Medicaid. In reviewing 2020 – 2021 claims, OIG found that 99 of 100 sampled claims were noncompliant, resulting in $1.1 million in overpayments in the sample and an extrapolated $31.2 million in improper payments.

PENNSYLVANIA’S MEDICAID DRUG REBATE PRACTICES: KEY TAKEAWAYS FROM OIG’S 2025 AUDIT

OIG released its audit of Pennsylvania’s Medicaid drug rebate program, focusing on physician-administered drugs dispensed to enrollees of Medicaid managed care organizations.

INTERSTATE MEDICAL LICENSURE COMPACT EXPANDS IN 2025

The Interstate Medical Licensure Compact continues to grow as a key tool for physician mobility and telehealth access. As of late 2025, the compact includes 42 states, the District of Columbia, and Guam, with recent implementations in Arkansas, North Carolina, and Rhode Island, and legislation introduced in Massachusetts.

NURSE LICENSURE COMPACT UPDATE

The Nurse Licensure Compact continues to grow, now covering 41 states and two US territories, with recent implementations in Connecticut and Pennsylvania.