The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule survived its initial trip to the U.S. Supreme Court on January 13 with a per curiam decision that stayed injunctions placed on the rule by federal district courts in December.

The Supreme Court took the rare action of holding oral argument and then issuing a full opinion (with dissents) on the emergency stay application that had been brought by the Centers for Medicare & Medicaid Services, asking the Court to allow the agency to enforce the rule while it challenges to its validity continue in the lower federal courts.

The Court was definitive that the rule as published falls within the authority of the Secretary of Health and Human Services to promulgate based on the statutory authority conferred by Congress through the Social Security Act (SSA). Specifically, the court found that the various statutory provisions within the SSA allow the Secretary to impose conditions of participation on the receipt of Medicare and Medicaid funds that are necessary in the interest of the health and safety of individuals who furnish services reimbursable under those programs and the federal program beneficiaries that they serve.

However, the Court’s opinion still leaves some questions unanswered about whether the rule will be enforceable in Texas and whether eventually some facilities may be exempted.

Questions remain for Texas

CMS had asked for stays of two preliminary injunctions entered in legal challenges brought by 24 states in the U.S. District Courts for the Western District of Louisiana and the Eastern District of Missouri. The Supreme Court’s decision stays those preliminary injunctions pending review by the respective federal appeals courts. It makes the rule enforceable across covered health care entities—i.e., those certified providers and suppliers subject to the Rule—nationwide, with the exception of Texas.

Initially the U.S. District Court for the Northern District of Texas declined to enter an injunction in the case because the federal court in Louisiana had issued a nationwide injunction that covered the field. However, the U.S. Court of Appeals for the Fifth Circuit limited that nationwide injunction to only those 14 states involved in the Louisiana case. Texas, despite residing within the Fifth Circuit and subject to the dictates of that appeals court, was not one of the states enjoined by the Fifth Circuit’s order.

In response to the Fifth Circuit’s narrowing of the injunction, the federal judge in Texas reopened the state’s motion for a preliminary injunction and granted that motion for the duration of the case. The Supreme Court’s per curiam decision makes no mention of the Texas case and specifically orders a stay of only the Missouri and Louisiana injunctions as those were the only two orders before the Court.

On January 14, the CMS appealed the Texas injunction to the Fifth Circuit and asked the district court to stay the injunction, the same relief that was granted with regard to the other injunctions by the Supreme Court. It its brief supporting the motion, the CMS identified how the Supreme Court’s ruling addresses every reason that the federal judge had originally given for imposing the injunction in the Texas challenge in the first place.

The district court has ordered Texas to respond to the CMS motion by Tuesday afternoon, January 18 and will likely rule on the request shortly thereafter. However, until the district court or the Fifth Circuit act, the injunction remains in place in Texas. The CMS issued guidance on January 14 telling survey agencies to begin enforcing the rule everywhere except Texas.

Deadlines extended for challenger states

As originally written the rule has a two-phase compliance structure with staff at impacted facilities required to receive a first dose of vaccine by December 5, 2021 and a second dose by January 4, 2022.

Because of the nationwide injunction that was entered in the Louisiana case, the CMS had initially delayed the compliance dates for the rule. In guidance published December 28, 2021, after the nationwide injunction was narrowed by the Fifth Circuit, the CMS reset those deadlines for the 25 non-challenger states plus the District of Columbia and the U.S. Territories, none of whom were covered by an injunction. Among those states are California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin. The new compliance deadline for those states plus the District of Columbia and the territories are January 27, 2022 for staff to receive the first dose of the vaccine and February 28, 2022 for staff to receive the second dose.

Even after the Supreme Court’s opinion, those deadlines still apply for the non-challenger areas. However, given that the 24 states that were covered by injunctions reviewed by the Supreme Court have only recently been placed under the rule, the CMS gave facilities in those states a little more time to comply. Under the new guidance, the facilities in Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming have until February 14 to have their staff receive their first dose of vaccine and until March 15 to be fully compliant.

As noted above, Texas is still under an injunction so there is no compliance date for facilities in that state. Florida is the only other state to have challenged the rule, having filed its own case in the U.S District Court for the Northern District of Florida. However, that both the district court and the U.S. Court of Appeals for the Eleventh Circuit have refused to enter an injunction on the rule in that challenge. As a result, Florida remains in the group of 25 states that must begin compliance with the rule by January 27, 2022.

Dissent noted statutory differences

One other wrinkle was presented by the Supreme Court’s action that could have some bearing on the outcome of the challenges to the rules. In his dissenting opinion, Justice Clarence Thomas identified statutory provisions defining five of the impacted facility types as not including the “health and safety” language the Court relied on to anchor its claims that Congress conferred authority on the CMS to promulgate the rule.

According to the dissent, these five types of facilities include:

  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Inpatient Psychiatric Hospital Services for Individuals Under Age 21
  • End-Stage Renal Disease (ESRD) Facilities
  • Home Infusion Therapy (HIT) suppliers
  • Critical Access Hospitals (CAHs)

The per curiam opinion addressed the statutory difficulty from Justice Thomas in a way that could lead to some problems down the line as the federal appeals courts work through the merits of the claims against the rule. In a footnote the court addressed the dissent by saying: “[E]mployees at these facilities—which include end-stage renal disease clinics and home infusion therapy suppliers—represent less than 3% of the workers covered by the rule.”

Additionally the Court noted that “We see no reason to let the infusion-clinic tail wag the hospital dog, especially because the rule has an express severability provision.”

It is that last statement about the severability provisions of the rule that could lead to trouble in the future. If the lower courts decide that Justice Thomas is right about the statutory provisions and decide to exclude those five provider types from the rule, the majority of the court, including Justice Brett Kavanaugh and Chief Justice John Roberts, could be convinced to sever those provider types from the rule and leave the rest of the rule intact.

How the lower courts handle this and what the Supreme Court has to say when the merits of the case invariably end up on its docket will settle the issue. However, as of this writing, providers in the 21 enumerated categories of the rule who are resident in the 49 states, D.C. and the U.S. territories must be ready for enforcement of the rule by state survey agencies.

For a more detailed review of what enforcement and compliance will look like, please see our prior coverage of the rule.