Department of Health and Human Services

CMS has issued a new rule clarifying that its daily Covid-19 reporting via the HHS Teletracking portal is mandatory as a condition of participation in the Medicare program. 42 C.F.R. § 482.42. HHS’s FAQ detailing the hospital reporting requirements can be found here – https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf.  Failure to consistently report throughout the Public Health Emergency

COVID-19 is not the sole focus of the Department of Health and Human Services (“HHS”) these days. On May 15th, the Office of Inspector General (“OIG”) announced that it added to its Work Plan a “Review of Institutions of Higher Education Grantees Receiving National Institutes of Health Awards” to address areas of potential risk at institutions of higher education (“IHE”).
Continue Reading OIG Tags Higher Education Grantees Receiving NIH Awards

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law. Section 3221 of the CARES Act ratified fundamental changes to the Public Health Service Act, codified at 42 U.S.C. § 290dd-2 and associated regulations, which govern the confidentiality requirements of substance use disorder records, commonly known as 42 C.F.R. Part 2, or simply, “Part 2.” Substance use disorder (SUD) records are defined broadly as “[r]ecords of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research.” The changes are significant and align with the increasing movement to align the Part 2 rules with the Health Insurance Portability and Accountability Act (HIPAA). The CARES Act requires the Department of Health and Human Services (HHS) to revise the Part 2 regulations within 12 months to comply with the CARES Act.
Continue Reading CARES Act Changes to Federal Substance Use Privacy Law