At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Shortly after our prior blog post discussing the need for healthcare entities to shore up protections against phishing attacks, the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI) released a joint cybersecurity advisory (CSA) to alert members of the healthcare industry of indicators of compromise and tactics, techniques, and procedures used in phishing social engineering campaigns. This recent guidance underscores that phishing attacks have the attention of the FBI and HHS, and that health systems should proactively update their policies, procedures, and security to remain compliant with industry standards.
Phishing, the act of impersonating a person or business to deceive a target into revealing sensitive information, has quickly become the tool of choice for scammers and cybercriminals. In 2023, the Federal Bureau of Investigation’s (FBI’s) Internet Crime Complaint Center noted that there were 298,878 complaints of phishing, a significant increase from the 114,702 cases reported in 2019.
The Boston Bar Association hosted its fifth annual White Collar Crime Conference on May 2, 2024, featuring prosecutors from the US Attorney’s Office for the District of Massachusetts (the Office) and the Office of the Massachusetts Attorney General (the AG’s Office) as well as lawyers from the defense bar.
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.
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.