by David M. Traskey, Vanessa A. Giunta | Jul 30, 2025
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
by Stacey L. Gulick, Kathleen M. Brown | Jul 29, 2025
On July 23, 2025, the United States Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $250,000 settlement with the Specialty Surgery Center of Central New York (the “Surgery Center”) as a result of a ransomware attack involving the PYSA ransomware variant, which is known to target the healthcare industry.
by Andrew E. Blustein, Robert A. Del Giorno, David M. Traskey | Jul 21, 2025
Traditionally, the Centers for Medicare & Medicaid Services (CMS) has relied on a “pay and chase” approach to recover monies CMS believes it may have paid to providers erroneously. CMS relies on this approach not only for collecting routine overpayments, but also when it believes evidence of fraud, waste, or abuse exists. More recently, CMS has used this approach to target providers who render medically reasonable and necessary services to patients in certain areas that CMS deems to be vulnerable to fraud such as skin and tissue substitutes, among others.
by Kimberly Kempton-Serra | Jul 11, 2025
Ambulatory care facilities in New Jersey are currently subject to an annual “assessment” by the Department of Health equal to approximately 3% of gross revenue, not to exceed $350,000 annually per facility. However, the recently enacted Healthcare Finance Enhancement Act reduces the assessment rate to 2.5% but also removes the $350,000 cap starting in Fiscal Year 2026.
by Kimberly Kempton-Serra | Jul 9, 2025
Governor Murphy recently signed the Fiscal Year 2026 Budget into law, simultaneously with numerous other bills, including the “Healthcare Finance Enhancement Act”. The Act subjects surgical practices that are required to become licensed as ASCs to the “ambulatory care facility assessment” starting in Fiscal Year 2026.
