This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between May 21 and June 20, 2022. Key updates include a case in which a California-based rheumatologist agreed to pay approximately $1 million to settle allegations that he violated the False Claims Act (FCA) by charging Medicare for drugs not approved by the United States Food and Drug Administration (FDA) and associated services related to the treatment of osteoarthritis pain. The Supreme Court of the United States also overturned Medicare payment cuts applicable to 340B drugs in 2018 and 2019, finding that the US Department of Health and Human Services (HHS) failed to carry out a required survey of hospital drug acquisition costs before implementing the cuts.
In addition to examining recent Office of Inspector General (OIG) advisory opinions, we provide an update on the No Surprises Act and the first fines issued against hospitals for noncompliance with the price transparency rules that took effect in January 2021. Finally, we take a look at recent Centers for Medicare & Medicaid Services (CMS) activity, including its recommendations for Medicare Part B premium reexamination and a comment notice regarding the self-referral disclosure protocol.
STAY CURRENT ON THE 340B LITIGATION THAT MAY IMPACT YOUR BUSINESS
McDermott+Consulting has launched a 340B Litigation Tracking Tool, a real-time resource following the 40+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for important case developments. This tracker, available 24/7 and regularly monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape. Learn more here.