If you’re leaning toward pausing your vaccination requirement process, be ready to crank it back up on a dime, legal experts stress. Medicare’s sweeping COVID vaccination rule is now on ice, and that’s leaving uncertain home health and hospice agencies out in the cold. Follow the legal experts’ advice to navigate the confusion. After the Biden administration issued two vaccine regulations on Nov. 5 — one from the Centers for Medicare & Medicaid Services and one from the Occupational Safety and Health Administration — states and state coalitions mounted legal challenges to them in federal courts across the country. OSHA ETS: First, “on November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit granted a motion to stay OSHA’s COVID-19 Vaccination and Testing Emergency Temporary Standard,” OSHA says in a prominent notice on its website. That regulation would require employers with 100 or more employees to require vaccination or COVID-19 testing. “The court ordered that OSHA ‘take no steps to implement or enforce’ the ETS ‘until further court order.’ The U.S. Court of Appeals for the Sixth Circuit now has jurisdiction over ETS challenges and [the Department of Labor] has filed a motion to lift the stay,” according to OSHA. CMS Rule: Second, 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. The feds and the states will be duking it out for some weeks to come, experts predict (see story, p. 348). That means providers won’t receive a final answer on whether the Medicare rule or the OSHA ETS are in effect until well after their Phase 1 Dec. 6 due date, and maybe even after the Phase 2 Jan. 4 due date. “The Louisiana court’s decision has left many facilities covered by the CMS Interim Final Rule asking, now what do we do?” note attorneys Matthew Thome and Andrew Phillips with law firm von Briesen & Roper in Milwaukee. Heed advice from the experts to determine how you want to navigate this legally tricky area. First, check your area-specific laws on this front. “These rulings do not affect any state or local regulations that may currently be in effect,” point out attorneys J. Michael Grubbs, Scott Witlin, and Laura Seng with law firm Barnes & Thornburg in online analysis. In other words, if “you are in a state with a state-level mandate, then none of this concerns you,” advises attorney Robert Markette Jr. with Hall Render in Indianapolis. Go ahead with making sure you are in compliance with your state or local requirements. If you don’t have employee vaccination requirements on the state or local level, then “providers have some freedom in how they respond,” Markette tells AAPC. But that freedom generally boils down to two main options, legal experts offer. Option 1. Proceed With A Vaccination Mandate “Many providers (and other employers) mandated vaccines well before federal mandates,” Markette points out. “In that case, they would just continue as they have been.” Agencies won’t see the same uncertainty imposing their own requirements that CMS is experiencing. After all, “legal challenges brought to mandates imposed by employers have failed,” notes Washington, D.C.-based healthcare attorney Elizabeth Hogue. In the absence of CMS rules, you would have the opportunity to craft your vaccination requirement as you see fit, provided it follows laws for exemptions such as the Americans with Disabilities Act, experts allow. “But agencies that decide to proceed probably ought to just follow the CMS regulation,” Markette recommends. “That way, if it is later upheld, they are already in compliance.” Don’t overlook: Also check and make sure any vaccination requirements you implement comply with collective bargaining agreements you have in place with employees, advises attorney Brad Bennett with law firm Bricker & Eckler in Columbus, Ohio. Both Hogue and the National Association for Home Care & Hospice endorse staying the course on requiring vaccinations. “We believe it is incumbent upon providers to operate in good faith throughout [the legal actions] to achieve compliance,” NAHC says in a Dec. 2 release. “A good faith compliance effort will be the best protection a provider can have against any enforcement action.” That may be especially important in the unlikely event that the original Dec. 6 compliance deadline for Phase 1 is ultimately held in place. “HHAs and hospices should still diligently work toward coming into compliance with the Interim Final Rule,” agrees attorney Will Vail with law firm Polsinelli. “We are advising NAHC members to continue to undertake, in good faith, all necessary measures to be compliant with Phase 1 and Phase 2 requirements of the rule except for any steps that would have been taken with staff that are not vaccinated or subject to an exception,” the trade group says. “We further advise providers to document any barriers to compliance,” NAHC adds. NAHC's “except for any steps that would have been taken with staff that are not vaccinated” is a crucial point. Agencies can choose whether to follow through on dismissing or just not scheduling such staff, or can keep them scheduled until the rule finally gets cleared — if it does. Hogue urges agencies to look at the big picture. “Now that the Omicron variant has been identified here in the United States, it is more important than ever to keep safety top of mind,” she stresses. Plus, it’s “important to move ahead because it’s clear that vaccine mandates work,” Hogue tells AAPC. “Providers and others that implemented mandates have already seen compliance rates in the high nineties in terms of percentages. They have lost very few staff members.” But that’s not what many providers are expecting, Markette relates. “Contrary to CMS’ position in the comments to the IFC, many of my clients are anticipating losing as much as 10 percent of their staff to mandates,” he reports. That’s a big reason agencies would consider the other option. Another reason is agencies’ “belief that proper infection control was an effective way to protect patients and staff,” Markette adds. Ultimately, “many providers I work with are not going to proceed, because they want to put off the issue of staff quitting,” Markette reports. Option 2: Pause Any Vaccination Requirements Agencies’ other option is to “suspend efforts to comply” with the CMS IFC, Markette notes. If you want to go this route and you have “formally adopted a policy, I would formally suspend it,” he recommends. “Then notify staff that, due to recent court developments, the vaccine mandate is suspended.” This will mean they are not removing those staff from the schedule who are not vaccinated by Dec. 6 or Jan. 4. “Covered employers … who do not wish to proceed with a voluntary vaccine mandate may pause their current efforts to comply with the CMS vaccine mandate,” allow attorneys Katie Ervin Carlson and Alissa Smith with Dorsey & Whitney in Des Moines. But they “should at a minimum proceed with preparing a policy, religious and medical exemption forms, and an exemption review process so that employers are ready to proceed within any established deadlines if the preliminary injunction is lifted and the mandate is reinstated,” Ervin Carlson and Smith say in online analysis. In other words, “be prepared to pivot, pending appeal rulings and further updates,” urge attorneys Michael Bertoncini and Sarah Skubas with law firm Jackson Lewis. “The injunctions issued by the courts in Missouri and Louisiana may stick, but they also could be reversed,” Vail tells AAPC. “And if reversed, providers may not have much time to come into compliance.” Incidentally, “this is the same recommendation we have given to large employers covered by the Occupational Safety and Health Administration’s COVID-19 Vaccination and Testing Emergency Temporary Standard (OSHA ETS),” Ervin Carlson and Smith note. In fact, Markette recommends not only having the exemption forms and processes in place, but also continuing to operate the whole exemption process. “That way, if the regulation is ultimately upheld, the agency will have already addressed exemptions,” he says. “Although they would accept and resolve exemption requests, employees would be allowed to continue working until the CMS mandate is resolved,” Markette clarifies. NAHC supports this option only “should the Administration take steps to directly suspend implementation and enforcement of the rule pending the outcome of the litigation, as has occurred with the OSHA ETS,” it says in its release. “We encourage the Administration to take such a step to provide needed clarity to all health providers subject to the rule,” the trade group adds. Bottom line: “We believe the best action at this stage is for the Administration to formally issue a policy that it will not implement or enforce the rule until all litigation is resolved,” NAHC President Bill Dombi tells AAPC. NAHC would also like to see CMS issue some other critical information. “We remain very concerned that CMS has issued no guidance on how providers should address any workforce shortages triggered by the rule in event that such leads to insufficient staff to care for existing patients or any new patient admissions,” the trade group says. Note: Stay tuned for further legal and regulatory developments on the COVID-19 vaccination requirement.