backU.S. Supreme Court Halts Implementation of the OSHA Vaccination Mandate but Greenlights CMS’s Healthcare Vaccination Rule – On January 13, 2022, the U.S. Supreme Court issued two per curium orders related to Federal COVID-19 vaccination requirements, one addressing the Occupational Safety and Health Administration’s (OSHA) vaccination mandate (OSHA Order), and the other addressing CMS’s interim final rule (IFR) related to vaccination requirements for healthcare workers (CMS Order). In the OSHA Order, a six-Justice majority granted a preliminary injunction halting implementation of OSHA’s vaccination mandate that requires all businesses with 100 or more employees to enact a COVID-19 vaccination mandate or have workers submit to weekly tests. In the CMS Order, a five-Justice majority gave the green light for CMS to implement the IFR in states where it was previously enjoined, which requires healthcare facilities that accept money from Medicare and Medicaid to ensure that their staff are vaccinated against COVID–19. The IFR offers medical and religious exemptions, as well as an exemption for full-time teleworkers. On January 14, 2022, in the aftermath of the Court’s ruling, CMS issued guidance requiring full vaccination compliance by March 15, 2022 for healthcare facilities in 24 states where the IFR was previously enjoined.
The OSHA Order and the CMS Order each stem from consolidated cases that the Supreme Court fast tracked for review in December 2021 and heard oral argument for on January 7, 2022. In the OSHA cases, coalitions of states and trade groups sought to enjoin the mandate from taking effect after the Sixth Circuit gave the go-ahead for implementation. On the CMS side, the IFR that was scheduled to take effect immediately was blocked by injunctions issued by district courts in both the Fifth and Eighth Circuits, prompting the Biden administration to file emergency requests to stay those injunctions and allow the CMS rule to take effect pending full review of the district court orders by the respective Courts of Appeals.
In the OSHA Order, the Court supported its decision to enjoin implementation of the mandate by explaining that, “permitting OSHA to regulate the hazards of daily life - simply because most Americans have jobs and face those same risks while on the clock - would significantly expand OSHA's regulatory authority without clear congressional authorization.” In the dissent authored by Justice Breyer, he contended that the majority’s decision “stymies the federal government’s ability to counter the unparalleled threat that COVID-19 poses to our nation’s workers.”
In the CMS Order, the Court, “agree[d] with the Government that the Secretary’s rule falls within the authorities that Congress has conferred upon him.” In elaborating on this, the Court explained, “Congress has authorized the Secretary to impose conditions on the receipt of Medicaid and Medicare funds that ‘the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services.’” And “[t]he rule thus fits neatly within the language of the statute.” In addition, the Court found that CMS acted within its authority in making a “good cause” determination under the Administrative Procedure Act that it could bypass notice-and-comment rulemaking in issuing the IFR.
In dissent, Justice Thomas disagreed that the Government made a strong showing of statutory authority to impose the rule, and that, “[t]o the extent the rule has any connection to the management of Medicare and Medicaid, it is at most a ‘tangential’ one.” In a separate dissent, Justice Alito also disagreed that CMS could forego notice-and-comment rulemaking on such an important and consequential decision without allowing for and taking into account public input first.
In terms of next steps, the CMS cases will be remanded back to the Fifth and Eighth Circuits to consider the merits of a granting a preliminary injunction against the CMS vaccine rule. But given the substantive reasoning and import of the Supreme Court’s opinion, those courts would seem to have no choice but to deny the motions and allow CMS to continue forward with implementing the rule. And in fact, just one day after the ruling, CMS issued guidance requiring that healthcare facilities in the two-dozen states previously covered by the injunctions comply with the full vaccination requirements by March 15, 2022. This guidance does not apply to Texas where an injunction is currently still in place. For the other 25 states and the District of Columbia where no injunction was in place, the deadline for full compliance with the vaccine mandate is February 28, 2022.
A copy of the OSHA Order is available here. A copy of the CMS Order is available here. CMS’s guidance regarding compliance with the IFR is available here.
Reporters, Amy L. O’Neill, Sacramento, +1 916 321 4812, aoneill@kslaw.com, Chris Kenny, Washington, D.C., +1 202 626 9253, ckenny@kslaw.com and Nikesh Jindal, Washington, D.C., +1 202 383 8933, njindal@kslaw.com.
CMS Proposal Regarding Medicare Coverage of Monoclonal Antibodies for Treatment of Alzheimer’s Disease is Open for Public Comment – On January 11, 2022, CMS released a proposed National Coverage Determination memorandum which sets forth the conditions under which Medicare would cover the use of monoclonal antibodies that target amyloid treatment for Alzheimer’s disease. Potential Medicare coverage of the monoclonal antibody treatment has been controversial due to the high cost of the treatment and data from the FDA approval process that showed limited effectiveness of the treatment. If approved, certain FDA-approved drugs would be covered for people with Medicare if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days. CMS will announce a decision by April 11, 2022.
If the proposal is finalized, CMS will review clinical trial submissions to determine whether they meet the specific criteria set forth in the proposal to allow for Medicare coverage. If CMS approves a clinical trial for coverage, it would be posted to the CMS Coverage website, available here. National Institutes of Health-sponsored trials would be covered under the proposed National Coverage Determination as well. Medicare patients participating in these approved trials would be eligible to receive coverage of the drug, and various related services and costs.
CMS promulgated the evidence-based proposal after agency experts analyzed publicly available evidence and feedback from stakeholders. CMS Administrator, Chiquita Brooks-LaSure was quoted saying, “[t]hroughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.” There is an opportunity for 30 days to provide feedback before the proposal becomes final. Public comments can be submitted here.
The proposal utilizes an evidence-based analysis CMS started in July 2021 to examine whether Medicare will establish a national policy for the proposed coverage of monoclonal antibodies meant to treat Alzheimer’s disease. There was already a national coverage analysis comment period in 2021, in which two listening sessions occurred. Each session had over 360 attendees. In addition, 131 public comments were reviewed and more than 250 peer-reviewed documents. This is part of the process established by Congress to decide whether a medical item or service should be covered nationally by Medicare.
Whether Medicare covers the treatment has been controversial due to its high price and data from FDA that shows limited effectiveness of the treatment. Under current Medicare policy, because there is no National Coverage Determination, Medicare contractors may cover the drug as medically necessary on a case-by-case basis. CMS’s proposal to cover the treatment only in the context of an approved clinical trial is seen as an attempt by the agency to set more strict parameters that would limit coverage. The proposed National Coverage Determination decision memorandum is available here.
Reporter, Dominic Nunneri, Los Angeles, +1 213 443 4329, dnunneri@kslaw.com.
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King & Spalding Webinar – Annual Healthcare Fraud Enforcement Update: What Does 2022 Hold? – On February 1, 2022, at 1:00 PM ET, King & Spalding will be hosting a roundtable webinar exploring the evolving healthcare fraud enforcement pattens from 2021 and focusing on what to expect from the government and whistleblowers in 2022.
Topics for discussion will include:
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Department of Justice and Office of Inspector General False Claims Act (FCA) enforcement initiatives impacting providers, including the Deputy Attorney General’s speech on individual accountability and focus on pandemic issues;
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Specific FCA enforcement trends, including post-acute care, Medicare Part C, pursuit of private equity investors, the Provider Relief Fund, and the focus on the Anti-Kickback Statute;
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FCA procedural updates, such as the False Claims Amendments Act of 2021; and
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Thoughts on strategies for risk assessment and proactive compliance steps to mitigate risk.
The presenters include Amy Boring, Ethan Davis, Stephanie Johnson and Michael Paulhus. To register for the event, click here.