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Legal Insights and Perspectives for the Healthcare Industry
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Our healthcare team recently published a LawFlash on a significant victory in the US Court of Appeals for the Fifth Circuit for The University of Texas MD Anderson Cancer Center. The case involved an appeal of a proposed civil money penalty (CMP) related to a Health Insurance Portability and Accountability Act data breach enforcement action brought by the US Department of Health and Human Services' Office for Civil Rights (OCR).
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 US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act).
Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.
Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
HHS recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI), in an apparent effort to combat prescription drug shortages and price spikes.
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.”
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.