On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services organization (MSO) would engage telehealth-based practices and platforms (collectively, Telehealth Companies) to provide telehealth services, including leasing health care professionals and maintaining the telehealth platform. The physician practice would submit claims for the telehealth services under its own private and government payor contracts. This advisory opinion addresses an increasingly common telehealth delivery model aimed at increasing the availability of health plan coverage for telehealth services, particularly in recent years with the rise in popularity of GLP-1 drugs for managing obesity.  

The Center for Medicare and Medicaid Innovation (CMMI) recently announced a new strategic direction during a public webinar and accompanying white paper, outlining its evolving priorities under the current administration. During the May 13, 2025 webinar, Abe Sutton, Director of CMMI and Deputy Administrator for the Centers for Medicare & Medicaid Services (CMS), emphasized CMMI’s continued mission to improve the U.S. health care system and to build on its 15 years of testing alternative payment models. As described in more detail below, however, CMMI’s new strategic direction reflects a shift in focus from CMMI’s approach under the Biden administration even while certain longstanding goals remain the same.

On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million and enter into a Corporate Integrity Agreement to settle allegations of violating the federal anti-kickback statute (AKS) and physician self-referral law (Stark Law) under the False Claims Act (FCA). The alleged conduct at issue revolved around CHS’s plan beginning in 2013 to assist local area physicians in their adoption of the electronic health records (EHR) platform used by CHS and its establishment of PNA to support that goal. For decades, the government has strongly promoted the adoption of interoperable EHR platforms by physician practices (e.g., Meaningful Use payments), given that EHR systems allow for better care coordination, increased efficiency, and improved patient experience. Moreover, as described in more detail below, the Department of Health and Human Services (HHS) adopted an AKS safe harbor and Stark Law exception that allowed certain entities, including hospitals, to donate EHR technology and services to physicians if certain conditions are satisfied. However, CHS’s and PNA’s alleged conduct exceeds what is permissible under the relevant safe harbor and exception.

The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker programs continue to be relatively common in the industry and can play an important role in educating health care professionals on the appropriate uses of companies’ products and on emerging research or development programs. However, two recent enforcement actions by the U.S. Department of Justice (DOJ) highlight the government's ongoing scrutiny of these programs for potential violations of the federal Anti-Kickback Statute (AKS). 

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under Section 330 of the Public Health Service Act (PHSA). The Health Center provides certain social services to individuals (e.g., providing diapers and baby gear to indigent families; assisting crime victims with replacing locks) and proposes to identify individuals in need of primary care services while providing them social services, inform them of available primary care services, and schedule appointments for them to receive such primary care services from the Health Center or a local provider. Noting that the social services would qualify as remuneration that could induce individuals to self-refer to the Health Center, the OIG addressed whether this plan would trigger sanctions under the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements CMP. Ultimately, the OIG approved the proposal based on the Health Center’s inclusion of several safeguards, including the use of an objective criterion for identifying individuals and the inclusion of multiple providers in the referral list.

Our 2025 edition of EnforceMintz reflects on health care enforcement trends, predicts how health care enforcement may evolve, and offers practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

In 2024, DOJ resolved several noteworthy False Claims Act cases against hospitals and health systems, obtaining numerous large recoveries in cases where Stark Law and federal Anti-Kickback Statute violations served as a predicate for FCA claims.

As part of its Modernization Initiative, the Department of Health and Human Services’ Office of Inspector General (OIG) recently published its first industry-segment specific Compliance Program Guidance, which focuses on skilled nursing facilities (SNFs) (SNF ICPG). Since 1998, the OIG has issued voluntary compliance program guidance documents, each tailored to a specific segment of the health care industry and providing important insights on specific risk areas and tips for implementing an effective compliance program.  In April 2023, the OIG announced a long overdue modernization of these compliance program guidance documents and rolled out its General Compliance Program Guidance the following November.  

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically violated the Stark Law from 2014-2021 and “knowingly” submitted claims for hospital procedures in violation of the False Claims Act. The lawsuit was initially brought as a qui tam (whistleblower) lawsuit filed by a former Chief Compliance Officer and a former Chief Financial Officer of Erlanger. While fair market value compensation is a key criterion for most Stark Law exceptions, this lawsuit is one of the few enforcement actions initiated by the DOJ focused on fair market value compensation paid to employed physicians. This blog post covers three key takeaways from the DOJ’s allegations against Erlanger.

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil Monetary Penalties Law (CMPL) with clarifications regarding waiving patients’ cost-sharing amounts pursuant to health care providers’ financial assistance policies. The new FAQs (FAQs #13-16) reiterate the OIG’s longstanding position that hospitals and other health care providers may provide financial assistance to Medicare and Medicaid beneficiaries on the basis of financial need. Of note, the OIG also provides some guidance on the distinction between marketing and advertising to patients as opposed to making patients aware about the availability of financial assistance, and this guidance may be useful in a variety of contexts beyond cost-sharing waivers.