The Centers for Medicare & Medicaid Services has issued guidance and separate compliance deadlines for 24 of the 25 states in which the CMS vaccination mandate was enjoined before last week’s Supreme Court decision lifting the injunctions.

Apart from the deadlines, the new CMS guidance is substantively the same as its December 28 guidance, which applies to covered facilities in states where the mandate had never been enjoined.

The CMS mandate was preliminarily enjoined in 24 states as a result of challenges brought in federal courts in Missouri and Louisiana. The government asked two U.S. Courts of Appeal (Eighth Circuit in the Missouri case, and Fifth Circuit in the Louisiana case) to lift the injunctions. Both appellate courts denied the government’s motions, and the government filed an emergency motion with the U.S. Supreme Court.

On January 13, the U.S. Supreme Court granted the government’s motion and stayed the injunctions in the Missouri and Louisiana cases. (Another case, Texas v. Becerra, in which a preliminary injunction had been issued applying solely in the State of Texas, was not before the Supreme Court.)

The new CMS guidance applies to the 24 states in the Missouri and Louisiana cases that were before the Court, and -- as will be discussed below -- is likely to soon apply in Texas as well.

States covered by the new guidance

The latest CMS guidance, which was issued on Friday, applies 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, Utah, West Virginia, and Wyoming.

The CMS guidance expressly states that it does not apply in Texas because the Texas v. Becerra injunction was still in effect when the guidance was issued. However, after the Supreme Court decision, the State of Texas filed a motion in the federal district court where Texas v. Becerra was pending, and asked the court to dismiss the case. The case was dismissed on Wednesday, and the dismissal also ends the Texas injunction. Accordingly, the CMS is likely to amend its new guidance to add Texas. If so, covered facilities in Texas will be subject to the same deadlines that apply to the other 24 “injunction states.”

Compliance deadlines for “injunction states”

Starting Monday, February 14, federal, state, accreditation, and CMS-contracted surveyors will begin monitoring covered facilities in the 24 (or, perhaps, 25) “injunction states” for full compliance subject to the three-phase rollout plan described below.

Phase 1 (due February 14)

Phase 1 requires covered facilities in the “injunction states” to be able to show the following by Monday, February 14 (actual deadline is Sunday, February 13):

• 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 March 15)

Phase 2 requires covered facilities in the “injunction states” to show the following by Tuesday, March 15:

• 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 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 compliance (due April 14)

Covered facilities in the “injunction states” must be 100 percent compliant with the standard by Thursday, April 14.

The Phase 1, Phase 2, and Phase 3 compliance deadlines for covered facilities in the 25 states where the CMS regulation was never enjoined are January 27, February 28, and March 28, respectively.

Additional CMS documents: Leading employers astray?

CMS has published some documents that were presumably intended to assist covered facilities with compliance, but they appear to be inaccurate or misleading: (1) a state-by-state Implementation Timeline, (2) a summary of the vaccination requirements, and (3) a decision tree for determining whether a facility is covered. Oddly, the documents refer only to Phase 1 and Phase 2, implying that covered facilities must be completely compliant by the Phase 2 deadline. They do not reference Phase 3. This is inconsistent with the CMS guidance issued on December 28 (for states where the CMS rule was not enjoined) and January 14 (for states where the CMS rule was enjoined until the Supreme Court lifted the injunctions). In addition, they indicate that employees must be fully vaccinated by the Phase 2 deadline. But the December 28 and January 14 guidance says that employees have complied when they have received all shots in the applicable vaccine series.

Although these new documents appear to be incorrect, we recommend that covered facilities prepare for the worst and try to become fully compliant and have fully vaccinated employees by the applicable Phase 2 deadline.

The CMS documents also note that the “staff vaccination requirement does not apply to full time telework staff.” Although this is mostly true, the rule expressly notes that any full time telework staff who happen to “occasionally encounter fellow staff . . . who themselves enter a health care facility or site of care for their job responsibilities” should still be vaccinated.

The survey process

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.

Enforcement

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.

Provider-specific guidance

The CMS recently issued 14 provider-specific guidance documents that should be reviewed along with the general guidance. The provider-specific guidance applies in all states.

Ambulatory Surgical Centers

Community Mental Health Centers

Comprehensive Outpatient Rehabilitation Facilities

Critical Access Hospitals

End-Stage Renal Disease Facilities

Home Health Agencies

Home Infusion Therapy

Hospice

Hospitals

Intermediate Care Facility for Individuals with Intellectual Disabilities

Long-Term Care and Skilled Nursing Facility

Outpatient Physical Therapy

Psychiatric Residential Treatment Facility

Rural Health Clinic/Federally Qualified Health Clinic

What’s next for the CMS mandate?

The Supreme Court lifted the injunctions blocking enforcement of the CMS mandate pending final decisions on the merits -- in other words, the Court’s decision is not not a final one declaring the mandate constitutional. However, the Court’s discussion indicates that the mandate is likely to survive. The cases will go back to the Fifth and Eighth Circuits, and the losing parties will have the opportunity to seek Supreme Court review again.

In the meantime, covered facilities in the 24 “injunction states” should immediately take steps to ensure compliance by each phase deadline. And covered facilities in Texas should be on the lookout for amended guidance that applies the same, or slightly different, deadlines to them.