On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.

Continue Reading U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

On January 13, 2022, the United States Supreme Court granted emergency relief to the petitions of numerous states, businesses, and non-governmental organizations by staying the implementation and enforcement of the federal Occupational Safety and Health Administration’s (“OSHA”) COVID-19 Emergency Temporary Standard (“ETS”).  Under the original ETS, private employers with 100 or more employees were required to implement a mandatory vaccination or weekly testing/face covering policy, which constituted a drastic change in policy for many employers and contradicted many state requirements.  Although the U.S. Court of Appeals for the Sixth Circuit has yet to ultimately decide on the merits whether the ETS can stand, the stay by the Supreme Court indicates how the Court may ultimately view the ETS and OSHA’s authority to require vaccinations and weekly testing.  Nonetheless, the ETS is not dead yet, so employers should continue to monitor the appeal process and OSHA’s response to the stay.

Continue Reading U.S. Supreme Court Stays Implementation of OSHA’s COVID-19 ETS Requiring Vaccination or Weekly Testing Policy

Thursday, January 13 was the last day of the virtual J.P. Morgan Annual Healthcare Conference for 2022. And since the conference was virtual, what better topic to start us off today than a consideration of the new Virtual-First trend that surfaced in 2021. We’ll follow that with a dive onto the couch to consider the conference’s mental health offerings and where the behavioral health sector is heading.

Continue Reading Day Four Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

Have you been working out recently? We hope so, for today, Day Three of the 40th Annual J.P. Morgan Healthcare Conference, was definitely a day for heavy lifting.  Got a challenge that seems overwhelming? A problem that’s big enough to totally scare other folks? Do you eat triathlons for lunch? Well, then you’re going to like the Day Three companies. Let’s talk about fixing the huge American diabetes problem, providing better healthcare for Medicaid and dual eligible beneficiaries, and helping people beat cancer.  All that, plus a COVID-19 thought exercise…

Continue Reading Day Three Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

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 back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements. The transition periods, which would begin (in most cases) 180 days after the end of the public health emergency (PHE), would allow manufacturers, healthcare facilities, and other stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements. Manufacturers who do not wish to continue distribution post-PHE could keep business as usual through the end of the 180-day transition period. Comments on the draft guidance are due on March 23, 2022.  The guidance for EUA devices can be found here, and for devices marketed under COVID-19 enforcement policies, here.

Continue Reading FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

The phrase “whole person health” kept echoing through the virtual hallways during the second day of the 40th Annual J.P. Morgan Healthcare Conference. Looking at the whole person – not just separate organs or body systems – may seem obvious and commonsense, but it’s not how our (well planned, highly logical) healthcare system currently is structured.

Continue Reading Day Two Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

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 annual!), I was lamenting the bland, boring backgrounds of the presenters who were using low-quality stock shots or empty office views until I realized that I was looking at the wrong thing. I really had to look at the shadows and not the backgrounds. There are a LOT of shadows over this year’s J.P. Morgan Conference – COVID-19, the jittery stock market, the future of Medicare Advantage and recent industry changes.

Continue Reading Day One Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

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 issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. The Administration directed the Tri-Agencies to issue guidance by January 15, 2022 detailing how to effectuate this expanded coverage of COVID-19 diagnostic testing. Yesterday, the Tri-Agencies published FAQ 51 which requires health plans and health insurance issuers to cover no less than 8 tests per 30-day period per individual beneficiary beginning January 15, 2022.

Continue Reading Tri-Agencies Release Guidance on Coverage of OTC COVID-19 Tests

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 under the Part D program, strengthen consumer protections to ensure Medicare Advantage (“MA”) and Part D beneficiaries have accurate and accessible information about their health plan choices and benefits, strengthen CMS oversight of MA and Part D plans, and improve the integration of Medicare and Medicaid programs for individuals enrolled in dual eligible special needs plans (“D-SNPs”). CMS failed to mention that the Proposed Rule will also result in additional administrative burdens and increased costs for MA organizations (“MAOs”) and Part D sponsors.

Continue Reading CMS’s Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

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. Overall, hospital margins remain significantly narrower than they were in 2019, before the pandemic. As a result, the industry may see an increase in hospital transactions in 2022 to offset the operational and financial hardships that continue to burden the health care system, as described in greater detail below.

Continue Reading COVID-19 Impacts and Outcomes on Hospital Margins in 2021: Increased Activity in Hospital Transactions in 2022?

Today HHS published the Notice of Benefit and Payment Parameters for 2023 proposed rule in the Federal Register. The annual rulemaking details changes to qualified health plans (“QHPs”), QHP issuers, and the ACA’s exchanges including:


Continue Reading Back to the Future: 2023 Payment Rule Would Revert Nondiscrimination and Guaranteed Availability Provisions to Pre-Trump Forms, Returns Standardized Plan Options