Providers are getting whiplash from the twists and turns of the mandate’s legal journey. If you thought you were set to not have to worry about Medicare’s COVID-19 vaccination mandate for staff until the U.S. Supreme Court likely takes it up in the New Year, you may need to think again. Recap: After the Centers for Medicare & Medicaid Services issued a vaccine mandate regulation on Nov. 5, states and state coalitions mounted legal challenges to them in federal courts across the country. On Nov. 29, the U.S. District Court for the Eastern District of Missouri issued a preliminary injunction covering 10 states, blocking the CMS interim final rule with comment period (IFC) that would require employee COVID vaccination for 21 types of Medicare health care providers — including HHAs and hospices. Then on Nov. 30, the U.S. District Court for the Western District of Louisiana granted a nationwide preliminary injunction on the matter. Accordingly, CMS issued a memo telling state surveyors to step down on enforcing the mandate while the legal battle plays out. Legal experts told AAPC that home health and hospice agencies should still prepare for the requirement, but have options on how to enforce the mandate — if at all — for the time being (see HCW, Vol. XXX, No. 44). Now “the Fifth Circuit Court of Appeals issued its opinion partially upholding and partially reversing the district court’s injunction,” note attorneys Taylor Appling and Kara Schoonover with law firm Foley & Lardner in online legal analysis. The government is likely to win its bid to limit the nationwide injunction, Appling and Schoonover say. “In other words, although the CMS Rule is still halted in the 14 states that brought the lawsuit in Louisiana, and in the 10 states that are part of the Missouri lawsuit, for everywhere else, the injunction is lifted,” they explain. For agencies in those 26 states (see box below), the question is what to do about enforcement now. “If you are in the states in which the injunction is lifted, I think things just got very unclear,” warns attorney Robert Markette Jr. with Hall Render in Indianapolis. CMS’ survey memo that announced its decision to suspend enforcement of the mandate states, “while these preliminary injunctions are in effect, surveyors must not survey providers for compliance with the requirements,” Markette points out. “At the time they issued this, the injunctions were nationwide. That is no longer the case,” he stresses. “This may mean that mandate is 'back on’ in those states that are no longer subject to the injunction.” “We are all awaiting guidance from CMS on when enforcement in the non-enjoined states will start back up — if at all,” Appling and Schoonover observe. Remember, the Phase 1 deadline to get all staff (except for those with valid exemptions) the first dose of the vaccine was Dec. 6. “For consistency and because these cases will likely move through the courts quickly, CMS may continue to suspend enforcement," Markette predicts. But perhaps not.
“If CMS decides to enforce the rule now, do the deadlines change?” Markette asks. Even for providers that are ready to jump back into immediate compliance mode, the original Dec. 6 and Jan. 4 deadlines are shot due to the enforcement suspension. Another complicating factor is a Dec. 13 decision from the U.S. Court of Appeals for the Eighth Circuit. The court denied the Biden administration’s appeal to stay the Eastern District of Missouri’s injunction. “The Eighth Circuit’s denial also means that the federal government can now ask the U.S. Supreme Court [to stay] the Missouri district court’s preliminary injunction, setting up a high court showdown over whether the CMS vaccine mandate should go into effect,” says partner attorney Sean Marotta with Hogan Lovells in an American Hospital Association (AHA) blog update on the mandate. The bottom line is that a compliance mess is brewing. The mandate is turning into a game of red light, green light, the Foley attorneys rue. And “several covered entities have locations across state lines and may be forced to implement, and to comply with a hodgepodge of various federal, state, and local rules,” they worry. Wait for word: Providers probably don’t have to worry about implementation until they officially hear from CMS. “A reasonable interpretation of CMS’ December 2, 2021 instructions is that there should be no survey activity (even in states where the injunction is lifted) until after receipt of further guidance from CMS,” Appling and Schoonover judge. “Starting to enforce in some states now and others later creates a patchwork amongst Medicare providers,” Markette protests. “Hopefully, CMS will make an official announcement that it will continue to suspend enforcement. If not, CMS needs to clarify how the delay caused by the injunction impacts compliance deadlines for providers in states that were, but no longer are, under the mandate,” he tells AAPC. Either way, providers should be ready to turn on a dime. “Covered entities — in all states — should continue to be ready to put in place the policies and procedures necessary to comply with the CMS vaccination mandate,” Appling and Schoonover advise. Meanwhile: Stay tuned for CMS guidance, legal developments, and more. Note: The CMS memo is at www.cms.gov/files/document/qso-22-04-all.pdf.