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Legal Insights and Perspectives for the Healthcare Industry
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.
As reported in As Prescribed, US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards.
Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared earlier this year.