Articles and Blogs

Under the federal Stark Law, hospitals may provide non-monetary compensation to physicians up to an aggregate amount of $429 for calendar year 2021. The dollar limit for “medical staff incidental benefits” (e.g., meals, parking and other items or incidental services that are used on the hospital’s campus) is less than $37 per occurrence. Other... READ MORE

Beginning January 1, 2021, hospitals across the country must publicly post the prices they charge for items and services, including payer-specific negotiated rates. Despite multiple legal challenges and calls for a delay in enforcement due to COVID-19, the Department of Health and Human Services (“HHS”) has remained unwavering in its commitment to move forward... READ MORE

In the closing days of the Trump administration, OIG finalized a controversial rule (the “Final Rule”) to amend the discount safe harbor (“Discount Safe Harbor”) to the federal Anti-Kickback Statute (“AKS”), effectively changing the treatment of prescription drug rebates under the AKS. Beginning January 1, 2022,[1] certain reductions in price or other remuneration from... READ MORE

NATIONAL 27 senators urge inclusion of surprise-billing deal in year-end package 14 pharmaceutical acquisitions in 2020 37 hospital CEO retirements announced in 2020 AHA: 28 recommended actions for Biden in first 100 days AHA asks Biden to extend public health emergency and to be allowed to retain relief funds American Telemedicine Association, HIMSS ask... READ MORE

The First Circuit ruled that an employer would not have acted against a whistleblower ‘but for’ their engaging in conduct the FCA protects. It joined other circuits that have found the FCA’s statutory protections much like other federal employment statutes. Background In this case[1], the Defendant is a medical device company that had several... READ MORE

On December 2, 2020, both the Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) issued final rules amending the Anti‑Kickback Statute safe harbor and Physician Self-Referral Law (Stark) exception for EHR donations (“EHR Donation Rules”), as well as a new safe harbor and exception for... READ MORE

In early December, the Centers for Medicare & Medicaid Services (“CMS”) issued its Calendar Year (“CY”) 2021 Medicare Physician Fee Schedule (“MPFS”) final rule (“Final Rule”). Among many other changes, CMS finalized three key payment policy updates impacting non-physician practitioners (“NPPs”), including: (1) clarification that pharmacists may provide services on an incident-to basis; (2)... READ MORE

On Friday, December 11, the U.S. Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of coronavirus disease 2019 (“COVID-19”) caused by severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”) in individuals 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be... READ MORE

On December 14, 2020, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a final rule amending the Confidentiality of Substance Use Disorder Patient Records regulations at 42 CFR part 2 (“Part 2”), effective January 13, 2021 (“Final Rule”). This Final Rule clarifies when a court can authorize disclosures of confidential communications made... READ MORE

The Centers for Medicare & Medicaid Services (“CMS”) recently announced a new voluntary direct contracting model – the Geographic Direct Contracting Model (the “Model” or “Geo”), which will test whether a geographic-based approach to care delivery and value-based care can improve health outcomes and reduce costs for Medicare beneficiaries across a geographic region. Along... READ MORE