On November 5, 2021, the Center for Medicare & Medicaid Services  (CMS) issued an Interim Final Rule (IFR) requiring covered facilities, including Federally Qualified Health Centers (FQHCs), to develop policies and procedures to ensure staff are fully vaccinated or had received an approved medical or religious exemption.

Under the IFR, the required policies and procedures must include:

• A process for ensuring all staff are fully vaccinated and for tracking and documenting vaccination status, including ensuring all staff obtain recommended booster or additional doses;
• Policies and procedures for staff to request exemptions (due to clinical contraindications, based upon Federal antidiscrimination laws, and for temporary delays, as recommended by the CDC due to clinical precautions and considerations) and policies and procedures for the covered facility to respond to exemption requests (including evaluating, tracking and documenting requests); and,
• A process for developing contingency plans for staff who are not yet vaccinated for COVID-19.

As many covered facilities set about implementing the staff vaccine mandate and evaluating exemption requests from staff, the IFR faced multiple legal challenges.  By the time the IFR reached the Supreme Court, covered facilities in 25 states (plus Washington, DC and the territories) were required to implement staff vaccine mandates while in the other 25 states, the mandate was enjoined (i.e., not permitted to move forward).

On January 13^th, in a 5-4 decision, the Supreme Court ruled that CMS has the authority to issue and enforce COVID-19 vaccine requirements for staff in covered facilities that participate in Medicare and Medicaid.

Covered facilities in 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, as well as Washington, DC, and the territories are expected to continue under the timeframes and parameters identified in guidance issued by CMS on December 28^th (available here).  Specifically, CMS provided the following compliance deadlines:

• January 27, 2022:
  • Policies and procedures for ensuring facility staff are vaccinated for COVID-19 must be developed and implemented
  • All staff in covered entities must have at least one dose of COVID-19 vaccine; have a pending request for or have been granted a qualifying exemption; or be identified as having a temporary delay for vaccination, as recommended by the CDC.
• February 28, 2022:
  • All staff in covered entities must either receive the necessary doses to complete a full COVID-19 vaccine series; be granted a qualified exemption; or be identified as having a temporary delay for vaccination, as recommended by the CDC.

Surveying of covered facilities in these states is set to begin on January 27, 2022.

On January 14^th, CMS issued guidance (available here) applicable to covered facilities in the following states where the mandate had been previously enjoined: 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.  Specifically, CMS extended the timeframe for facilities in these states to come into compliance and provided the following compliance deadlines:

• February 14, 2022:
  • Policies and procedures for ensuring facility staff are vaccinated for COVID-19 must be developed and implemented
  • All staff in covered entities must have at least one dose of COVID-19 vaccine; have a pending request for or have been granted a qualifying exemption; or be identified as having a temporary delay for vaccination, as recommended by the CDC.
• March 15, 2022:
  • All staff in covered entities must either receive the necessary doses to complete a full COVID-19 vaccine series; be granted a qualified exemption; or be identified as having a temporary delay for vaccination, as recommended by the CDC.

Surveying of covered facilities in these states is set to begin on February 14, 2022.  CMS instructed surveyors not to take any efforts to implement or enforce the IFR in Texas.

Given the Supreme Court decision, and recent guidance issued by CMS, covered facilities should act quickly to ensure they meet the compliance deadlines based upon their location.