On December 28, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination (the “Guidance”). The Guidance provides direction to surveyors on assessing compliance with CMS’s November 5, 2021 Interim Final Rule (the “IFR”), which established COVID-19 vaccination requirements for staff of Medicare- and Medicaid-certified providers and suppliers. The Guidance currently applies to providers and suppliers in all states and U.S. territories except 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, Texas, Utah, West Virginia and Wyoming (collectively, the “Excepted States”). The Guidance directs surveyors in the Excepted States to refrain from undertaking any efforts to implement or enforce the IFR.
The Guidance provides updated compliance dates for providers and suppliers subject to the IFR and also outlines survey processes for each type of provider/supplier. Further, the Guidance includes instructions for surveyors with respect to citing levels of deficiencies for non-compliance with the IFR.
The Guidance includes separate (albeit similar) surveyor guidance for each type of provider or supplier subject to the IFR. Federal, state, accreditation organization and CMS-contracted surveyors will begin surveying for compliance with the Guidance as part of initial certification, standard recertification or reaccreditation, and complaint surveys beginning on January 27, 2022.
Excepted States
At present, providers in the Excepted States remain subject to the injunctions issued by Missouri and Louisiana federal district courts as a result of litigation filed by the Excepted States. The Fifth and Eighth Circuit Courts of Appeal declined CMS’s request to stay those injunctions for the Excepted States pending rulings on the merits of the appeals. As a result, the Biden Administration has asked the Supreme Court of the United States to stay the lower court injunctions pending more complete reviews by the respective Circuit Courts. The Supreme Court has scheduled a special hearing on January 7, 2022 to consider arguments on whether to stay implementation of the lower court injunctions for the Excepted States.
Compliance Dates
The Guidance provides that beginning January 27, 2022 (30 days after release of the Guidance), providers and suppliers must demonstrate that they have developed and implemented policies and procedures for ensuring all staff subject to the IFR are vaccinated for COVID-19. In addition, the provider must demonstrate that 100% of its staff have received at least one dose of a COVID‑19 vaccine, or: (i) have a pending request for a qualifying exemption; (ii) have been granted a qualifying exemption; or (iii) have been identified as requiring a temporary delay in vaccination as recommended by the CDC. A provider whose staff vaccination rate is above 80% and has a plan to achieve a 100% vaccination rate within 60 days of the survey would not be subject to additional enforcement action.
Beginning February 28, 2022 (60 days after release of the Guidance), providers and suppliers must demonstrate that they have developed and implemented policies and procedures for ensuring all staff subject to the IFR are vaccinated for COVID-19. In addition, the provider must demonstrate that 100% of staff have received the doses necessary to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), have been granted a qualifying exemption or have been identified as needing a temporary delay in vaccination as recommended by the CDC. A provider whose staff vaccination rate is above 90% and has a plan to achieve a 100% vaccination rate within 60 days of survey would not be subject to additional enforcement action.
Beginning March 28, 2022 (90 days after issuance of the Guidance), providers that fail to maintain compliance with the 100% standard may be subject to enforcement action.
Required Policies and Procedures and Survey Process
The Guidance provides additional detail on the content of the policies and procedures required by the IFR, and also contains specific instructions for the survey process. For example, during the survey entrance process, surveyors are instructed to ask for copies of the required policies and procedures, as well as a list of all staff and their vaccine status. Surveyors are instructed to review required policies and vaccine status lists, and to interview a sample of staff and contractors, both vaccinated and unvaccinated.
Level of Deficiency and Plans of Correction
Where surveyors identify non-compliance with the IFR compliance dates discussed above, the Guidance sets forth instructions on the appropriate level of citation (i.e., Immediate Jeopardy, Condition Level or Standard Level), and sets forth the elements of acceptable plans of correction. Not surprisingly, citation levels are determined largely (although not entirely) on staff vaccination levels. Surveyors are permitted to lower the citation level or enforcement action if they identify that, prior to the survey, the provider made a good-faith effort to comply with the IFR. The Guidance provides that in order to meet the “good faith effort” standard, the provider must have taken aggressive steps toward achieving compliance with the staff vaccination requirement, and/or the provider must demonstrate that it has no or limited access to the vaccine, and has documented attempts to access to the vaccine.
Practical Takeaways
All Medicare and Medicaid providers and suppliers subject to the IFR should carefully review the Guidance attachment applicable to their provider/supplier type, and should begin finalizing the policies and procedures required by the IFR. In states and territories not included within the Excepted States, providers and suppliers should continue their efforts to: (i) ensure staff have at least one dose of a COVID-19 vaccine or have submitted a request for exemption or temporary vaccination delay by January 27, 2022; and (ii) ensure that staff have completed their vaccine series, have an approved exemption or have a documented need for temporary vaccination delay by February 28, 2022. Such providers should also familiarize themselves with the survey processes in order to ensure that they can promptly comply with surveyor requests. Although providers in Excepted States will likely be granted additional time to comply with the IFR in the event the Supreme Court lifts the injunction on enforcement of the IFR, providers in Excepted States should still review the Guidance with an eye towards prompt compliance if and when required.
For more information on the Guidance or other vaccine mandate questions, please contact:
- Jennifer Skeels at (317) 977-1497 or jskeels@hallrender.com;
- Elizabeth Elias at (317) 977-1468 or eelias@hallrender.com;
- Brian Jent at (317) 977-1402 or bjent@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
