CMS Vaccine Mandate Upheld by US Supreme Court: Are There Any Limits on the Types of Conditions CMS Can Impose on Providers?

Despite its determination that the Occupational Safety and Health Administration (OSHA) did not have the authority to impose a vaccine mandate for employers with more than 100 employees, the Supreme Court did not surprise many when it upheld an interim CMS rule mandating that providers participating in the Medicare and/or Medicaid program require vaccines for its on-site personnel. The Per Curiam decision, with dissents from four of the justices, was issued January 13, 2022, in Biden v. Missouri (consolidated with Becerra v. Louisiana).

Provider participation in the Medicare program is technically voluntary, but practically compelled as it is the largest payer of health care services. Because CMS funds the program, the Secretary of the Department of Health and Human Services (HHS) has the power to make the rules and impose conditions upon those it pays for health care services as the Secretary finds necessary in the interest of the health and safety of patients.

Through the rulemaking process, the Secretary has issued over time “conditions of participation” for hospitals, skilled nursing facilities, ambulatory surgery centers, outpatient rehabilitation, and other types of providers. The vaccine mandate for health care workers was the most recent condition imposed by the Secretary on November 5, 2021, in the interim final rule published in the Federal Register.

While the opinion of the court explains its rationale and finding that the vaccine mandate rule was within the scope of authority of the Secretary and procedurally correct in its issuance, it concludes with a suggestion that there may not be any limitation on the type of “health and safety” conditions it may impose:
 

“[T]he rule does not run afoul of the directive in [42 USC] § 1395 that federal officials may not ‘exercise 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. That reading of section 1395 would mean that nearly every condition of participation the Secretary has long insisted upon is unlawful.”
 

Unfortunately, there is no discussion by the court on what the distinction should be between rules that pass muster or run afoul of section 1395. Typically, conditions of participation outline the nature and scope of services required and set standards, while providing the facility flexibility in setting its own policies and procedures to uphold those standards. For example, one of the hospital HHS conditions of participation relates to the development of infection prevention and control programs. The HHS regulations state the conditions of participation that a hospital needs to meet, but do not go into specifically how a hospital meets the condition (except in the case of COVID vaccinations for its employees). 

The question left open is whether the Secretary can issue precise conditions as to “how” (i.e., the manner in which) a hospital or other health care provider operates. For example, can the Secretary go beyond the current condition that a hospital has sufficient 24-hour nursing services and impose a new requirement mandating a specific nurse-to-patient staffing ratio? Perhaps there will be a future case when the Supreme Court will clarify if there are limits on the type of health and safety conditions that the Secretary may impose.