DOJ can pursue alternate theory in FCA case after First Circuit ruling on but-for causation

On August 4, 2025, the US District Court for the District of Massachusetts ruled that the government may proceed with an alternative theory in its FCA kickback case against Regeneron Pharmaceuticals Inc., allowing prosecutors another opportunity to seek a pretrial victory following a US Court of Appeals for the First Circuit decision that marked a “critical shift” in the legal landscape.

Behavioral medicine provider will pay $2.75 million to resolve alleged false claims for psychotherapy services

A California behavioral medicine provider agreed to pay $2.75 million to resolve allegations that it violated the FCA by submitting false claims to government healthcare payors for certain psychotherapy services.

State attorneys general challenge federal actions on gender-affirming care

A coalition of state attorneys general argued in a suit filed on August 1, 2025, that the Trump administration has improperly “weaponized” federal laws against drug misbranding, false claims, and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care.

HHS, CMS form Healthcare Advisory Committee

HHS and CMS announced the formation of a new Healthcare Advisory Committee tasked with providing strategic recommendations to improve care delivery and financing across Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.

CMS increases oversight of citizenship verification in Medicaid, CHIP

CMS launched a nationwide initiative aimed at ensuring that all Medicaid and CHIP enrollees meet citizenship or immigration eligibility requirements, with the stated goal of protecting program integrity and safeguarding taxpayer funds.

OIG issues favorable AO on physician-owner compensation arrangement based on small entity safe harbor

OIG issued a favorable advisory opinion (AO No. 25-09) regarding a physician investment arrangement in a privately held medical device company, determining that the arrangement met all eight elements of the small entity investment safe harbor under 42 C.F.R. § 1001.952(a)(2) of the AKS.

OIG reviews billing for remote patient monitoring in Medicare

OIG issued a report examining the growth of remote patient monitoring (RPM) practices in Medicare and recommending actions that CMS could take to monitor such practices and prevent fraud, waste, and abuse.

OIG to audit diagnosis codes for MAO compliance

OIG announced its intention to audit certain diagnoses submitted by Medicare Advantage Organizations (MAOs) to evaluate whether diagnosis codes, submitted for use in CMS’s risk-adjustment program, complied with federal substantiation requirements. The audit will reportedly focus on diagnoses that are more likely to be submitted without supporting medical records that document the condition via an appropriate face-to-face encounter.

OIG to issue white paper on DMEPOS fraud, waste, and abuse

OIG announced its intention to publish a white paper discussing fraud, waste, and abuse in the Medicare program related to durable medical equipment, prosthetic devices, prosthetics, orthotics, and supplies (DMEPOS). Expected in fiscal year 2026, the white paper will reportedly provide background on DMEPOS fraud in Medicare, describe program vulnerabilities, and enumerate potential actions that CMS could take to safeguard program integrity.

OIG continues to audit Medicare global surgery payment accuracy

Existing Medicare policy bundles payments for services furnished by providers for surgeries, including services provided before, during, and after the actual procedure, into a single payment. Pursuant to the Medicare Access and CHIP Reauthorization Act of 2015, CMS is required to gather information to assist in improving the accuracy of global surgery valuation. OIG has begun auditing CMS’s collection of this claim information from providers and previously audited the accuracy of information that CMS gathers to value global surgery payment policy. To continue this work, OIG issued a new report comparing the number of postoperative procedures reported by practitioners to the number of procedures estimated in CMS’s valuation of global surgery fees.

New Jersey expands criminal patient brokering law

On August 11, 2025, amendments to New Jersey’s patient brokering statute were signed into law. The amendments expanded New Jersey’s existing patient brokering statute to include clinical laboratories and recovery residences and to more explicitly parallel the federal Eliminating Kickbacks in Recovery Act (EKRA).

FDA begins real-time adverse event data reporting

On August 22, 2025, the FDA began publishing daily data from the FDA Adverse Event Reporting System (FAERS), which collects reports of adverse events, medication errors, and product quality issues related to prescription drugs and therapeutic biologics.

FDA launches PreCheck program to strengthen US drug manufacturing

FDA also announced the launch of the FDA PreCheck program, a new initiative designed to bolster domestic pharmaceutical manufacturing and reduce the United States’ reliance on foreign drug production.