NOTE FROM ROBIN: This was originally a legal bulletin that went to our subscribers on Friday, January 14.

After operating in limbo for a little over two months, Medicare/Medicaid certified facilities across the country now know one thing for certain—the Centers for Medicare & Medicaid Services Interim Final Rule mandating health care worker vaccinations is here to stay. 

In a 5 to 4 vote, the Supreme Court of the United States lifted the stay imposed in half of the states on enforcing the CMS vaccine mandate. More specifically, the Supreme Court found the following:

• CMS did not exceed its authority by making mandatory vaccination a condition of participation in the Medicare/Medicaid programs.
• The CMS vaccine mandate was not arbitrary and capricious, as its analysis and explanation demonstrates the agency “acted within a zone of reasonableness.”
• The “winter flu season” and potential for increased “COVID-19 infections, hospitalizations, and deaths” is the “something specific” that is required to establish good cause and forgo notice and comment.
• CMS was not required to consult with the appropriate State agencies before issuing the vaccine mandate.
• CMS was not required to prepare a regulatory impact analysis discussing the effect of the vaccine mandate on small rural hospitals.
• The mandate did not “run afoul” of Section 1395, which prohibits federal officials from “exercis[ing] any supervision or control over the . . . manner in which medical services are provided, or over the selection [or] tenure of any officer or employee of” any facility.

The Court said the “global pandemic [does] not allow a federal agency to exercise power that Congress has not conferred upon it. At the same time, such unprecedented circumstances provide no grounds for limiting the exercise of authorities the agency has long been recognized to have.”

In addition, the Court emphasized the need to promote and protect patient health and safety and that the “fundamental principle of the medical profession” is “first, do no harm.” The Court said that it would be contrary to these principles if unvaccinated health care workers were to contract COVID-19 and transmit it to the very patients they have a duty to protect.

Chief Justice John Roberts and Justice Brett Kavanaugh, both of whom helped to defeat the vaccination-or-test mandate issued by the Occupational Safety and Health Administration, joined Justices Stephen Breyer, Elena Kagan, and Sonia Sotomayor to create a majority upholding the CMS mandate. Justices Samuel Alito, Amy Coney Barrett, Neil Gorsuch, and Clarence Thomas dissented.

What do covered Medicare/Medicaid certified facilities need to know?

The CMS vaccine mandate now applies nationwide. At this time, there is no indication that the CMS will extend its current Phase 1, 2, and 3 deadlines in states where the mandate had not been enjoined, although we will let you know if that changes. Until further notice, covered facilities in those states should prepare to meet the January 27, February 28, and March 28 deadlines detailed here.

• We expect that CMS will shortly release a timeline for compliance by covered facilities in states where the mandate had been enjoined (Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Missouri, Mississippi, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming).  In the meantime, facilities in those states should begin developing and putting into place policies and procedures that ensure all staff working in Medicare/Medicaid-certified facilities be vaccinated unless they are exempted or identified as meriting a temporary delay as recommended by the Centers for Disease Control and Prevention.

• In addition to the CMS mandate, covered facilities should review applicable state and local laws to determine whether there are any additional requirements health care facilities must follow or implement (e.g., mandatory boosters).

• It is possible that the CMS mandate will be found not to apply to (1) Intermediate Care Facilities for Individuals with Intellectual Disabilities, (2) Inpatient Psychiatric Hospital Services for Individuals under Age 21, (3) Home Fusion Therapy, (4) End-Stage Renal Disease Clinics, or (5) Critical Access Hospitals following its review on the merits by the lower courts.
  
  In upholding the CMS rule, the Court relied on statutory language giving CMS the right to take action that it “finds necessary in the interest of the health and safety of individuals who are furnished services.” That language does not appear in the statutes governing these five types of facilities. Although the Court said that the language could be read into the statutes, it would not  “let the infusion-clinic tail wag the hospital dog, especially because the rule has an express severability provision.”
  
  Thus, it is possible that these five types of facilities may have a valid challenge to the CMS vaccine mandate. But for now, they must comply with the vaccine mandate to avoid enforcement action.

Noncompliance with the CMS mandate can result in a plan of correction, civil monetary penalties, denial of Medicare/Medicaid payments, or termination from the Medicare/Medicaid program.