On December 28, the Centers for Medicare & Medicaid Services issued long-awaited guidance regarding how it intends to enforce its Interim Final Rule mandating COVID-19 vaccinations for certain health care workers. The rule, which is currently enjoined in 25 states, requires that most employees (and some non-employees) of covered facilities that receive Medicare or Medicaid funds be fully vaccinated. The new guidance will apply only in the states where the rule has not been enjoined.
The CMS has also issued 14 provider-specific guidance documents that should be reviewed along with the general guidance. (Links are provided below.)
Starting a week from Thursday (January 27), federal, state, accreditation, and CMS-contracted surveyors will begin monitoring for full compliance subject to the three-phase rollout plan described below.
- Phase 1 (due January 27)Phase 1 requires covered facilities to be able to show the following:
- That they have developed and implemented policies and procedures that ensure all staff are vaccinated for COVID-19 (regardless of clinical responsibility or patient contact); and
- That all staff either
- Have received at least one dose of a COVID-19 vaccine
- Have a pending request for a qualifying exemption
- Have been granted a request for a qualifying exemption, or
- Have identified as meriting a temporary delay as recommended by the Centers for Disease Control and Prevention.
All staff at covered facilities must be vaccinated, unless they fall within an exemption or are identified as meriting a temporary delay. If not, the employer will not be considered compliant with the rule. However, enforcement action will not be taken if a facility is more than 80 percent compliant and has a plan to achieve 100 percent compliance within 60 days.
- Phase 2 Compliance (due February 28)Phase 2 requires covered facilities show the following by Monday, February 28 (the actual deadline falls on Saturday, February 26):
- Developed and implemented policies and procedures that ensure all staff are vaccinated for COVID-19 (regardless of clinical responsibility or patient contact); and
- That all staff have either
- Received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multi-dose vaccine series)
- Been granted a qualifying exemption, or
- Been identified as meriting a temporary delay as recommended by the CDC.
All staff must be vaccinated, unless exempted or identified as meriting a temporary delay. Otherwise, the facility will not be considered compliant. A non-compliant facility will not be subject to enforcement action if it is 90 percent compliant and has a plan to achieve 100 percent compliance within 30 days.
- Phase 3 (due March 28)Covered facilities must be 100 percent compliant with the standard by Monday, March 28.
What will the survey process involve?
Generally, the survey process will assess compliance with the rule through observation, interview, and record review. For example, surveyors will ask the facility to provide the following for review:
- COVID-19 vaccination policies and procedures
- List of all staff and their vaccination status
- Contingency plan to mitigate the spread of COVID-19
Surveyors will also review a random sample of records for staff who have been identified as unvaccinated due to clinical contraindications (e.g., severe allergic reaction) or a qualifying exemption. Covered facilities should look to the applicable provider-specific guidance for more details.
How will the CMS enforce compliance?
Depending on the severity of the non-compliance and the type of facility, sanctions can include the following:
- A plan of correction
- Civil monetary penalties
- Denial of payment
- Termination from the Medicare/Medicaid program
Facilities should consult the provider-specific guidance to assess the potential penalties in more detail. For example, the sole enforcement remedy for hospitals and certain acute care and continuing care providers (after being given an opportunity to rectify noncompliance) is termination from the Medicare/Medicaid program.
Where can I get the provider-specific guidance that applies to my facility?
What’s the latest on the legal challenge to the CMS mandate?
As our readers know, the CMS mandate has been enjoined (blocked) in the states of 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. (It remains in force in all the other states.) The government has asked the U.S. Supreme Court to dissolve the injunctions.
On Friday, the U.S. Supreme Court heard oral argument as to whether the CMS exceeded its authority by issuing the vaccine mandate. Although no ruling has been issued, news reports indicate that the justices may vote to uphold the mandate. Accordingly, covered facilities in states where the mandate is in effect should ensure that they are ready to meet the Phase 1 requirements by the January 22 deadline, if not all of the requirements.
Covered facilities in states where the injunctions are still in place should consider having the required policies and procedures prepared in the event that the Supreme Court upholds the CMS mandate and makes it effective nationwide.
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