The Department of Health and Human Services, Office of Inspector General (OIG) recently released an advisory opinion (Advisory Opinion 25-08) concluding that a proposed arrangement between a medical device company and third-party software vendor could violate the Anti-Kickback Statute (AKS)
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Medicare Changes as a Result of 2025 Reconciliation Law Could Be Substantial
This is the second in a series of blog posts designed to provide a deeper dive into the provisions of the 2025 Reconciliation Law (Informally called the One Big Beautiful Bill Act). An earlier installment discussed the impact of the
OIG Green-Lights Travel Assistance for Pediatric Gene Therapy
The Department of Health and Human Services Office of Inspector General (OIG) has issued an advisory opinion, concluding that it would not impose monetary sanctions on a pharmaceutical manufacturer’s program to cover travel, lodging, and related expenses for families
Reconciliation Bill Blocks Funding For Family Planning Services, Reproductive Health, and Related Medical Care
This is the first in a series of blog posts designed to provide a deeper dive into the provisions of the 2025 Reconciliation Law (Informally called the One Big Beautiful Bill Act). This installment discusses the impact of the law
OIG Advisory Opinion Supports Plan to Reimburse for Needle Stick Injuries
In an advisory opinion released June 30th, the U.S. Department of Health and Human Services Office of Inspector General (OIG) confirmed that it would not seek to impose monetary sanctions on a medical device manufacturer for its efforts to reimburse
Federal Court Vacates 2024 Reproductive Health Privacy Rule
Late on Wednesday June 18, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas issued an order vacating almost the entirety of HHS’s 2024amendments to the HIPAA Privacy Rule that created special protections for
New Oregon Law Targets MSO Involvement in Medical Practices
On June 9, 2025, Oregon updated its Corporate Practice of Medicine (“CPOM”) doctrine by passing SB 951, to, among other things, prohibit workarounds to the doctrine by management services organizations (MSOs) and their owners and employees. According to one of
Florida judge once again rules against constitutionality of False Claims Act relators
Judge Kathryn Kimball Mizelle in the Middle District of Florida has once again ruled that the qui tam relator provisions of the False Claims Act (FCA) violated the Appointments Clause of the U.S. Constitution. In a May 29, 2025 order
California Senate Passes Bill Regulating Pharmacy Benefit Managers
The California Senate has approved SB 41, a bill now under consideration in the Assembly, that would impose new licensing, transparency, and pricing regulations on pharmacy benefit managers (PBMs). Proponents argue the legislation would curb anti-competitive practices, enhance transparency,
Breaking down the Health Care Impacts of the One Big [Reconciliation] Bill
After 28 hours of deliberation including a marathon Rules Committee meeting that saw more than 500 proposed Democratic amendments, the House of Representatives, early in the morning of May 22, passed the One Big Beautiful Bill Act (H.R. 1) (the