On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path…

For those of you who know me, I like to have fun with my Zoom backgrounds – choosing photos of interesting scenery or changing them mid-call to reflect my mood or negotiating strategy. Sitting in front of my computer this year for the first day of the 2022 J.P. Morgan Annual Healthcare Conference (the 40th…

On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. As first announced by President Biden on December 2, 2021, the Biden Administration explained that health plans and health insurance…

On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on  Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”).  Per CMS, the Proposed Rule will reduce out-of-pocket prescription drug costs, improve price transparency and market competition…

In its December Hospital Flash Report, Kaufman Hall identified and reviewed the continued, negative impact of COVID-19 on hospital operating margins. After a dramatic drop in hospital margins during the height of the pandemic in 2020 and early 2021, hospitals experienced a fluctuation of decreasing and increasing margins in the latter-half of the year.…

Scope of practice expansion has been a hot-button issue within medical communities and state legislatures for more than thirty years. The debate is centered on what services advanced practice providers (“APPs”) who hold Master’s Degrees (e.g., Physician Assistants, Nurse Practitioners, Pharmacists, Dental Hygienists, etc.) should or should not be able to furnish in their professional…

The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues.  But, as always at this conference, there are the issues selected by the conference chairs and formally on the agenda – and then there are issues…

Physicians and other providers can take a deep breath as Congress has acted to prevent the trio of Medicare payment cuts that were set to take effect at the beginning of 2022—a 3.75% cut due to scheduled changes in the Medicare Physician Fee Schedule (“PFS”), a 2% cut for Medicare sequestration, and a 4% Statutory…

On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement…