Enforcement Update on CMS Vaccine IFR, OSHA Vaccine ETS, and OSHA Healthcare ETS

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While most healthcare providers have been struggling with staffing during the holidays, the Centers for Medicare and Medicaid Services (“CMS”) has been active in providing an enforcement update on the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“IFR”). The Occupational Safety and Health Administration (“OSHA”) has been doing the same with respect to its Vaccination and Testing Emergency Temporary Standard (“Vaccination ETS”) and its now partially expired Occupational Exposure to COVID-19 Emergency Temporary Standard (“Healthcare ETS”).

CMS IFR

On December 29, 2021, CMS issued a guidance memorandum with respect to enforcement of the IFR in those states where it has not been enjoined (i.e., temporarily halted) by court order. The guidance memorandum supersedes the agency’s previous statement that it would not take action to enforce the IFR while it is subject to any court-ordered injunction.

The IFR is presently enjoined in the following states: 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. With the guidance memorandum, CMS will continue to refrain from enforcing the IFR in these states; however, CMS will begin enforcement of the IFR in all other states, districts, and territories where it is applicable.

Under the guidance, CMS stated that all Medicare and Medicaid-certified facilities covered by the IFR in those states where it is not enjoined, must comply with all regulatory requirements or face enforcement remedies, up to and including termination of participation in the Medicare and/or Medicare programs. CMS emphasized that facility staff vaccination rates under 100% (taking into consideration medical and religious exemptions as well as delays in vaccination as recommended by the Centers for Disease Control and Prevention (“CDC”)) constitute non-compliance with the IFR and established the following revised deadlines for compliance:

  • Within 30 days after issuance of the memorandum (on or before January 27, 2022), if a facility demonstrates that:
    • Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient/resident contact are vaccinated for COVID-19; and
    • 100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC, then the facility is compliant under the rule.

If less than 100% of all staff have received at least one dose of COVID-19 vaccine (or have a pending request for, or have been granted a qualifying exemption, or have been identified as having a temporary delay as recommended by the CDC), the facility is non-compliant and will receive a notice of non-compliance.

A facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action; however, CMS cautioned that states should work with their CMS location for cases that exceed these thresholds, yet pose a threat to patient health and safety. Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility (e.g., plans of correction, civil monetary penalties, denial of payment, termination, etc.).

  • Within 60 days after the issuance of the memorandum (on or before February 28, 2022),1 if the facility demonstrates that:
    • Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact, are vaccinated for COVID-19; and
    • 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), or have been granted a qualifying exemption, or have identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule.

If less than 100% of all staff have received at least one dose of a single-dose vaccine, or all doses of a multiple-dose vaccine series (or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC), the facility is non-compliant.

A facility that is above 90% and has a plan to achieve a 100% staff vaccination rate within 30 days would not be subject to additional enforcement action. Again, CMS stated that states should work with their CMS location for cases that exceed these thresholds, yet pose a threat to patient health and safety. Facilities that do not meet the established parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility.

  • Within 90 days after issuance of the memorandum (March 28, 2022), facilities that have not met the 100% standard may be subject to enforcement actions depending on the severity of the deficiency and the type of facility.

Surveys for compliance as part of initial certification, standard recertification or reaccreditation, and complaint surveys will begin on January 27, 2022, which is 30 days following issuance of the memorandum, unless the United States Supreme Court enjoins the IFR. Oral arguments on an emergency motion to stay the IFR are scheduled for January 7, 2022, with a decision on the motion expected sometime thereafter.

OSHA Vaccination ETS

Although facilities in states where the CMS IFR is presently enjoined are, at least temporarily, off the hook for compliance with the IFR, they should start preparing to comply with OSHA’s Vaccination ETS if they have 100 or more employees. Importantly, even in states where the CMS IFR is presently not enjoined and thus is effective, providers will need to comply with those portions of the Vaccination ETS that are not inconsistent with the CMS IFR.

The Vaccination ETS affords employers the option of instituting a mandatory vaccination policy or a policy that permits unvaccinated employees to submit to weekly COVID-19 testing and required masking in the workplace. Also, the Vaccination ETS applies only to employees; not to the broader concept of “staff” specified under the CMS IFR.

While the OSHA Healthcare ETS was in effect, settings where healthcare services and healthcare support services are rendered, were exempt from the Vaccine ETS; however, as discussed below, OSHA allowed most provisions of the Healthcare ETS to expire at midnight on December 21, 2021, thereby subjecting providers that were subject to the OSHA Healthcare ETS to compliance with the provisions of the Vaccination ETS.

A nationwide stay of the OSHA Vaccination ETS was lifted earlier this month by the U.S. Court of Appeals for the 6th Circuit. The states, private parties and trade associations challenging the regulation have moved for an emergency stay in the U.S. Supreme Court, which will hear oral arguments on January 7, 2022. For now, however, the Vaccination ETS is in effect unless and until the U.S. Supreme Court decides otherwise.

OSHA has stated that it is exercising enforcement discretion with respect to the compliance dates of the Vaccination ETS. To provide employers with sufficient time to come into compliance, OSHA will not issue citations for noncompliance with any requirements of the ETS before January 10, 2022, and will not issue citations for noncompliance with the standard’s testing requirements before February 9, 2022, so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard.

OSHA Healthcare ETS

On December 28, 2021, OSHA posted a statement on its Healthcare ETS landing page regarding the status of the Healthcare ETS, and on December 29, 2021, posted a display copy of a request for comments to extend certain portions of the Healthcare ETS. While OSHA has announced that it is withdrawing the non-recordkeeping portions of the Healthcare ETS, it announced that the requirements for maintaining a COVID-19 log of positive COVID-19 cases among employees (regardless of whether those cases are work-related) and reporting work-related COVID-19 inpatient hospitalizations within 24 hours and work-related fatalities within eight hours of learning of such events to OSHA remain in effect (notwithstanding the sunset periods applicable to any ETS).

OSHA also stated that it intends to “work expeditiously” to issue a final standard and to propose rulemaking in the spring with respect to an infectious disease standard. In the interim, OSHA is strongly encouraging all healthcare employers to continue to implement the Healthcare ETS and emphasized that it would “vigorously enforce” the catch-all general duty clause, which states that employers shall furnish to employees employment and a place of employment free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. Specifically, OSHA stated that it will accept compliance with the terms of the Healthcare ETS as satisfying employers’ related obligations under the general duty clause, the respiratory protection standard, and the PPE standard. It did not elaborate on other requirements of the Healthcare ETS, such as employers’ obligations to pay workplace removal protection benefits.

With the promise of vigorous enforcement of the general duty clause, as well as the respiratory protection and PPE standards, but with all non-recordkeeping portions of the Healthcare ETS technically withdrawn, which has the effect of eliminating the exemption under the OSHA Vaccination ETS for employers subject to the Healthcare ETS, OSHA has interjected even more uncertainty into the issue of compliance.  Thus, until the ongoing litigation over all federal vaccination mandates provides further clarity, employers that were subject to the Healthcare ETS, should continue to comply with it, while undertaking steps to comply with the Vaccination ETS as well.

Based on the foregoing analysis, providers should consider the following actions depending on the applicability of the CMS IFR:

CMS IFR Applicability CMS IFR Compliance OSHA Vaccination ETS Compliance (100+ Employees) OSHA Healthcare ETS Compliance
CMS IFR applies but is presently enjoined Not presently required, but preparations should be made for compliance pending outcome of Supreme Court decision Preparations for full compliance by revised deadlines specified by OSHA, pending outcome of Supreme Court decision If Healthcare ETS was applicable to setting, compliance with recordkeeping and reporting compliance required; other provisions recommended, given OSHA enforcement statement.

If Healthcare ETS was not applicable to setting, then N/A.

CMS IFR applies and is not presently enjoined Required according to revised deadlines specified in CMS guidance memorandum Preparations for compliance with provisions of Vaccination ETS not covered by CMS IFR by revised deadlines specified by OSHA, pending outcome of Supreme Court decision If Healthcare ETS was applicable to setting, compliance with recordkeeping and reporting compliance required; other provisions recommended, given OSHA enforcement statement.

If Healthcare ETS was not applicable to setting, then N/A.

CMS IFR does not apply to provider type N/A Preparations for full compliance by revised deadlines specified by OSHA, pending outcome of Supreme Court decision If Healthcare ETS was applicable to setting, compliance with recordkeeping and reporting compliance required; other provisions recommended, given OSHA enforcement statement.

If Healthcare ETS was not applicable to setting, then N/A.

[1] The deadline would be February 26, 2022, but because that date falls on a weekend, CMS will use enforcement discretion to initiate compliance assessments the next business day, which would be February 28, 2022.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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