Health Law Scan

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. This announcement essentially walks back FDA’s enforcement approach regarding “marketed unapproved drugs,” allowing them to continue to be sold consistent with the 2006 FDA policy. Although the incoming Biden administration may ultimately decide to reinstitute the UDI program, unapproved drugs may be excluded from coverage by Medicare and Medicaid and by private health plans that follow federal plan coverage standards.

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 rule changes will transform fraud and abuse compliance and accelerate what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

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.” The full list of providers eligible for PRF Phase 3 Payment application is listed on the HHS website, and HHS confirmed that these providers may apply “regardless of whether they accept Medicaid or Medicare.” (Read the announcement for more information.)

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. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future grants under Section 330(e) of the Public Health Service Act on Federally Qualified Health Centers establishing practices that ensure the 340B discount they receive on insulin and injectable epinephrine is passed through to low-income patients who lack insurance or have high copays or deductibles. The HHS secretary has discretion to set the standard for eligible patients.

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 order contains four specific directives:

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. In response to the pandemic, the US Department of Health and Human Services (HHS) has expanded the Public Readiness and Emergency Preparedness (PREP) Act’s immunity protection.