(January 24, 2022): In a 5-4 decision, the US Supreme Court issued a ruling on January 13, 2022 staying the injunctions preventing the implementation of CMS’ Vaccine Mandate in 24 states.[1] As a result, Medicare and Medicaid providers[2] subject to the CMS Vaccine Mandate interim final rule in those states must quickly take steps to come into compliance. Within days after that decision, Texas dismissed its challenge to the mandate ending the injunction in that state also.
The Supreme Court’s majority decision was joined by Justices Roberts, Breyer, Sotomayor, Kagan, and Kavanaugh, with Justices Thomas, Alito, Gorsuch, and Barrett dissenting. The majority concluded that CMS had the authority to issue the vaccine mandate rule under provisions in the Social Security Act that permit the agency to issue rules that “the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services. . ..” The Court went on to give examples of other rules CMS has promulgated that address patient safety including “programs that hospitals must implement to govern the ‘surveillance, prevention, and control of … infectious diseases’” and “conditions of participation that relate to the qualifications and duties of healthcare workers . . ..” The Court majority also rejected the States’ arguments that CMS acted arbitrarily and capriciously in issuing the vaccine mandate rule and concluded that CMS did have good cause to issue an interim final rule rather than going through the full notice of proposed rulemaking/final rule process.
CMS’ Three Guidance Letters on Implementation
1. States Where the Rule Was Not Enjoined
With the Court’s decision and the dismissal of the Texas case, all Medicare and Medicaid providers must come into compliance with CMS’ Vaccine Mandate rule. CMS issued guidance to state surveyors on December 28, 2021, extending the deadline for providers in the 25 states where the rule had not been enjoined. That guidance gave providers until January 27, 2022, to:
- implement necessary policies and procedures to ensure all staff are vaccinated for COVID-19, and
- ensure all staff have received at least one dose of a two-dose vaccine regimen, have a pending request or been granted a medical or religious exemption, or meet CDC requirements meriting a delay in vaccination.
If providers can show they are 80% compliant by January 27, 2022, CMS has instructed surveyors to cite the provider for non-compliance, but that no other enforcement action will be taken.
CMS’ instructions to surveyors went on to extend the second compliance deadline for the Vaccine Mandate rule to February 28, 2022. By that date, all providers must:
- ensure all staff have received the second dose of a two-dose vaccine regimen,[3] or one dose of a single-dose vaccine, been granted an exemption, or meet CDC requirements for delaying vaccination.
If providers are 90% compliant by February 28, 2022, providers may be cited for non-compliance, but no other enforcement action will be taken.
Finally, CMS has said that any provider out of compliance after March 28, 2022, must be 100% compliant with the Vaccine Mandate rule or they risk full enforcement action.
CMS has issued survey guidance for 14 different provider types. The guidance indicates CMS will focus on these areas when it surveys for compliance with the Vaccine Mandate rule:
- COVID-19 vaccination policies and procedures
- Documentation of staff vaccination status
- Contingency plans to mitigate the spread of COVID-19
2. States That Were Part of Supreme Court Decision
CMS issued additional guidance on January 14, 2022, on implementation of the Vaccine Mandate rule in the 24 states that were affected by the Supreme Court’s decision. That guidance mirrors CMS’ December 28, 2021, guidance letter to surveyors, but delays the implementation dates:
- It gives providers in the 24 affected states until February 14, 2022, to implement policies and procedures to ensure all staff are vaccinated for COVID-19, and to ensure all staff have received at least one dose of a two-dose vaccine regimen, have a pending request or been granted a medical or religious exemption, or meet CDC requirements meriting a delay in vaccination.
- Staff should have received the second dose of a two-dose vaccine regimen, or one dose of a single-dose vaccine, been granted an exemption, or meet CDC requirements for delaying vaccination no later than March 14, 2022.
The same enforcement policies will apply. If providers in these states are 80% compliant by February 14, 2022, and 90% compliant by March 14, 2022, they will be cited for non-compliance, but no other enforcement action will be taken. Full enforcement in these states will begin April 14, 2022.
3. Texas
On January 18, 2022, the State of Texas filed a motion to dismiss its claims in Texas v. Becerra. Judge Kacsmaryk with the Northern District of Texas issued an order approving that motion on January 19, 2022, ending the Texas litigation and the current preliminary injunction against implementation of CMS’ Vaccination Mandate rule in Texas. CMS issued guidance to providers in Texas on January 20, 2022, on implementation there. That guidance mirrors CMS’ December 28, 2021, and January 14, 2022, guidance letters, but delays the implementation dates for Texas:
- It gives providers in Texas until February 22, 2022, to implement policies and procedures to ensure all staff are vaccinated for COVID-19, and to ensure all staff have received at least one dose of a two-dose vaccine regimen, have a pending request or been granted a medical or religious exemption, or meet CDC requirements meriting a delay in vaccination.
- Staff should have received the second dose of a two-dose vaccine regimen, or one dose of a single-dose vaccine, been granted an exemption, or meet CDC requirements for delaying vaccination no later than March 21, 2022.
The same enforcement policies will apply. If providers in Texas are 80% compliant by February 21, 2022, and 90% compliant by March 21, 2022, they will be cited for non-compliance, but no other enforcement action will be taken. Full enforcement in Texas will begin April 20, 2022.
All Providers covered by the CMS Vaccine Mandate rule should immediately begin taking steps to come into compliance.
Jennifer Papapanagiotou, MS, JD is a partner with Liles Parker, PLLC, Attorneys and Counselors at Law. Jennifer represents home health and hospice agencies of all sizes around the country in connection with compliance, regulatory, reimbursement and transactional matters. For a complimentary consultation, please call Jennifer at: 1 (800) 475-1906.
- [1] The 24 states covered by the two cases under consideration by the Supreme Court that concern the CMS Vaccine Mandate interim final rule are: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, Ohio, Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.
- [2] Providers subject to the CMS Vaccine Mandate interim final rule include: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal Disease Facilities, Home Health Agencies, Home Infusion Therapy Suppliers, Hospices, Hospitals, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities (PRTFs) Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Medicare Federally Qualified Health Centers, and Long Term Care facilities.
- [3] CMS has indicated in FAQs on its website that it is sufficient for staff to have received the second vaccine dose any time before February 28, 2022. Staff do not have to have completed the 14-day waiting period after the second dose of a two-dose vaccine, or the first dose of a one-dose vaccine, to be considered fully vaccinated for purposes of complying with CMS’ Vaccine Mandate rule. Of note, CMS is not requiring staff to receive booster shots at this time.
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