Health Law Scan

The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS priorities for the coming year. In the FY 2022 HCFAC, DOJ and HHS not only highlighted a series of fraud and abuse enforcement wins, but also indicated increased activity by and with the US Food and Drug Administration (FDA) and the DOJ Consumer Protection Branch (CPB). This increase in activity from these regulatory agencies should be of interest to stakeholders in the pharmaceutical and medical device sectors.

As we at Morgan Lewis pride ourselves on excellent client service, we feel it is our duty to provide critical dispatches from the romantic world of healthcare fraud. Specifically, we want to highlight developments in the District of Massachusetts that may make the prospects of an amicable breakup in a federal civil False Claims Act (FCA) case with Boston federal prosecutors more remote.

Members of our healthcare and life sciences teams recently published an analysis of key insurance, liability, and enforcement considerations for organizations providing vaccine access. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease, what is important for private employers contemplating the administration of closed point-of-delivery vaccination programs to know, and current enforcement trends.

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.

Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021.

We invite you to join us for a webinar series where we discuss our views on the enforcement priorities expected from the incoming Biden-Harris administration.

The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020.

In this LawFlash, our white collar litigation and government investigations team unpacks the fiscal year 2019 False Claims Act (FCA) recovery statistics recently announced by the US Department of Justice.

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services (Allina) with respect to its impact on Medicare payment rules, sharing its Memorandum to the Principal Deputy Administrator & Director of the Center for Medicare dated October 31, 2019 (OGC Memo) with the public.