Medicare Compliance & Reimbursement

Plus: OSHA suspends COVID ETS enforcement … for now.

Legal wrangling back and forth over the feds’ COVID-19 vaccination mandates have left many providers confused about deadlines, enforcement, and legality.

Refresher: The Centers for Medicare & Medicaid Services (CMS) published the Omnibus COVID-19 Health Care Staff Vaccination interim final rule with comment period (IFC) in the Federal Register on Nov. 5. This long-awaited follow-up to CMS’ original vaccination mandate released on Sept. 9 offered implementation guidance on the federal requirements.

In tandem with the IFC, the Occupational Safety & Health Administration (OSHA) issued a new Emergency Temporary Standards (ETS) for protecting workers of large employers from COVID-19. The ETS would require either vaccination or weekly testing for companies with over 100 workers.

Both CMS’ COVID vaccination mandates and the OSHA ETS were immediately met with significant legal challenges across the nation. Read on for the details.

Courts Strike a Blow to CMS Mandates

Ten states filed suit on Nov. 10 against CMS, claiming that the federal government had overreached its authority to dictate what happens in their states, reported the New York Times. On Nov. 15, 12 more states filed suit against the CMS rule, the Associated Press reported. Then both Texas and Florida jumped on the challenge bandwagon and filed their own lawsuits against CMS on Nov. 15 and 17 respectively.

On Nov. 29, Judge Matthew Schelp of the U.S. District Court for the Eastern District of Missouri blocked the IFC in 10 states. “Judge Schelp based his ruling in large part on the argument that CMS lacked authority to implement the vaccine requirement,” notes attorney Suzannah Wilson Overholt with law firm SmithAmundsen LLC. “The ruling has no impact on states that are not parties to the lawsuit,” Wilson Overholt mentions in online legal analysis.

Another stay followed on Nov. 30 by U.S. District Judge Terry Doughty in Louisiana, but it was more comprehensive. “Notably, the scope of the injunction is not limited to states who filed suit,” points out attorney Jennifer Aaron Hataway with law firm Butler Snow in online legal analysis. “Instead, the scope of the injunction is nationwide, except for those states already under a preliminary injunction order issued by the United States District Court for the Eastern District of Missouri on November 29, 2021,” Aaron Hataway adds.

“The order prevents implementation of the interim final rule until the entire case is decided on its merits unless (or until) the decision is reversed by the Fifth Circuit Court of Appeals or the Supreme Court,” explains attorney Jonathon Rabin with Hall Render in online legal analysis.

OSHA ETS Hits a Legal Wall, Too

On Nov. 12, “the Fifth Circuit temporarily stayed OSHA’s implementation of its vaccine ETS. This stay required that OSHA refrain from taking any steps to implement or enforce the ETS,” explain attorneys Drew Howk, Elizabeth Elias, Kevin Stella, and Dana Stutzman with law firm Hall Render in legal analysis.

OSHA swiftly followed the stay by suspending implementation and enforcement of the ETS on Nov. 16 — “thus providing employers covered by the OSHA vaccine ETS some breathing room for now,” observe Howk, Elias, Stella, and Stutzman.

Determine How Your Practice Will Respond

Approximately 10.3 million healthcare workers nationwide are impacted by the court’s injunction of the CMS IFC. With the COVID vaccination mandate deadlines now on hold, providers have a little breathing room to figure out the inoculation route they want to take.

However, the Biden Administration is expected to appeal the injunctions, so you may want to have a back-up plan in place just in case.

“I think providers have some freedom in how they respond,” advises attorney Robert Markette Jr. with Hall Render in Indianapolis. “Providers are, of course, free to continue forward as if the rule was in effect. Many providers (and other employers) mandated vaccines well before federal mandates. In that case, they would just continue as they have been.”

“Covered employers” can certainly “pause their current efforts to comply with the CMS vaccine mandate,” maintain attorneys Katie Ervin Carlson and Alissa Smith with Dorsey & Whitney LLP in the Dorsey Health Law blog. But they “should at a minimum proceed with preparing a policy, religious and medical exemption forms, and an exemption review process” in case “the preliminary injunction is lifted and the mandate is reinstated,” Ervin Carson and Smith point out.

Suspending your vaccination program is always an option, Markette says. But, “if the rule is upheld, providers who stopped following the rule will be out of compliance if the litigation goes beyond January 4 and the deadlines don’t change.”

Watch out: CMS may release more guidance on the IFC as the case works its way through the courts. “I am also hoping to see CMS officially announce it is suspending enforcement of this rule pending the outcome of litigation, the same step OSHA took,” Markette says.

Medicare Compliance & Reimbursement will continue to monitor and report on future rulings.

Resources: Find the final rule in the Federal Register at www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf and QPP resources at https://qpp.cms.gov/resources/resource-library.