Yesterday, the Centers for Medicare and Medicaid Services issued an Interim Final Rule with Comment Period (“IFC”) that effectively imposes a vaccine mandate on many healthcare providers. Here’s a link to that rule: CMS Vaccine Mandate. CMS also issued a set of Frequently Asked Questions regarding the mandate, which can be found here: CMS Mandate FAQ’s This rule is expected to cover more than 17 million workers at approximately 76,000 healthcare facilities around the country.
Here are the highlights.
1. Who’s covered?
The IFC primarily applies to healthcare facilities, not individual physicians’ offices. Nevertheless, other healthcare providers (including physicians’ offices) remain subject to the Emergency Temporary Standard issued by OSHA in June. Here’s a link to OSHA’s ETS web page: OSHA Healthcare ETS Page.
CMS generally categorizes entities covered by the new IFC as: (1) residential congregate care facilities; (2) acute care settings; (3) outpatient clinical care and service; and, (4) home-based care. Here is a complete list of the categories of affected entities and their C.F.R. sections:
- Ambulatory Surgical Centers (ASCs) (§ 416.51)
- Hospices (§ 418.60)
- Psychiatric residential treatment facilities (PRTFs) (§ 441.151)
- Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430)
- Home Health Agencies (HHAs) (§ 484.70)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70)
- Critical Access Hospitals (CAHs) (§ 485.640)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725)
- Community Mental Health Centers (CMHCs) (§ 485.904)
- Home Infusion Therapy (HIT) suppliers (§ 486.525)
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8)
- End-Stage Renal Disease (ESRD) Facilities (§ 494.30)
Employees who provide services 100% remote or who have no direct contact with patients or other staff are not require to be vaccinated. The IFC also recognizes that exemptions must be granted for medical and religious reasons.
Physicians with admitting privileges at acute care hospitals will be covered by the vaccine requirement.
The IFC requires adoption of policies that apply to all facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients: Facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.
2. What’s required?
Facilities must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. By December 5, 2021, staff must receive at least the first dose of the vaccine. If they don’t, they cannot provide any care, treatment or other services for the facility or its patients. By January 4, 2021, staff must have completed or received their second vaccine dose.
Those policies and procedures must include, at a minimum, the following components:
(i) A process for ensuring all staff (with the exception of those who are exempted or medically-delayed) have received within 30 days, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine, prior to staff providing any care, treatment, or other services for the center and/or its patients;
(ii) A process for ensuring that all staff are full vaccinated within 60 days;
(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19 (as discussed below there is no “test out” exception like there is for OSHA;
(iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff;
(v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;
(vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law;
(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the center has granted, an exemption from the staff COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains:
(A) All information specifying which of the authorized or licensed COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending that the staff member be exempted from the center’s COVID-19 vaccination requirements based on the recognized clinical contraindications;
(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and
(x) Contingency plans for staff who are not fully vaccinated for COVID-19.
3. A simple doctor’s note is not enough for a medical exemption.
Please pay attention to the process for obtaining a medical exemption. Many private-sector employers are accepting doctor’s notes as sufficient evidence of the need to grant a medical exemption to the vaccine mandate. CMS is impose much more stringent measures. A detailed, signed statement on the contraindications for vaccination for the particular employee is required.
4. There is no “test out” exception under this rule.
The OSHA standard released on November 4, 2021 gives employers an option: (1) they can adopt policies mandating vaccinations for all employees; or (2) they can adopt policies allowing employees to decline the vaccination if they engage in weekly testing and mask wearing. There is no such exception for under the CMS rule.
On the evening of November 3, 2021, the White House arranged a telephone conference between the press and “Senior Administration Officials” but directed the press not to release details until November 4. A transcript of that call can be found here: Background Press Call on Vaccinations. When asked about a “test out” provision, one official said: “There is not a testing option. We have a higher bar for healthcare workers, given their critical role in ensuring the health and safety of their patients. And so, it’s either vaccination or an exemption under the rules outlined.”
5. Enforcement / Consequences
CMS’s rule is a Condition of Participation for Medicare and Medicare. As a result, failure to comply with the rule can potentially lead to monetary penalties and even termination from participation. Nevertheless, CMS’s list of FAQ’s includes says that the “goal is to bring health care facilities into compliance. Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.”
Facilities can expect surveyors to review compliance and issue citations for noncompliance. CMS discusses the three types of citations as follows:
“Immediate Jeopardy” citations indicate a serious scope of non-compliance, failure of the provider to address deficiencies, and close interaction with patients of unvaccinated staff. Termination of the provider type will occur within 23-days following the citation if not immediately addressed.
“Condition” level citations indicate substantial non-compliance that needs to be addressed to avoid termination.
“Standard” level citations indicate minor non-compliance where (with respect to this rule) almost all staff are vaccinated, the provider has a reasonable policy in place to educate staff on the vaccinations, and the provider has procedures for tracking and monitoring vaccination rates. CMS generally allows for continued operation subject to the facility’s agreement to a CMS-approved plan of correction.
6. CMS Mandate? OSHA Mandate? Both?
It’s not clear whether these facilities are supposed to also comply with the OSHA vaccine mandate for employers with 100+ employees. Here’s my discussion of that mandate: OSHA Vaccine Mandate Blog The OSHA mandate says that it does not apply for employees who are subject to OSHA’s earlier Healthcare ETS. But, it is silent on whether the CMS mandate pre-empts the OSHA mandate.
Nevertheless, during the phone call with “Senior Administration Officials” on Wednesday evening, an official speaking for CMS said: “For Medicare- and Medicaid-certified providers, these vaccination regulations supersede all others, including state regulations and those issued by OSHA.“