Medicare, Medicaid Institutions Warn: Employees Must Be Immunized | Akerman LLP – Rx Health Law

Medicare and Medicaid-certified establishments will be required to ensure their employees are vaccinated against COVID-19, the Centers for Medicare & Medicaid Services (CMS) announced on September 9, 2021. Healthcare providers with 100 employees or more may also be subject to an upcoming Emergency Temporary Standard (“ETS”) from the Occupational Safety and Health Administration of the United States Department of Labor (“OSHA”) which will also require that employees be vaccinated against COVID-19. These mandates are part of President Biden’s new six-pronged COVID-19 action plan (the “plan”) that he announced last week.

CMS’s immunization mandate

It is important to note that the new requirements will be a condition of participation in Medicare and Medicaid programs and will be published through emergency regulations as an interim final rule with a comment period expected to be published in October 2021. The CMS will accept comments from the public after the rule is published. . The interim final rule will apply to any healthcare facility receiving Medicare or Medicaid reimbursement. The provisional final rule is based on the administration’s announcement on August 18, 2021 of a vaccination requirement for healthcare facilities. This new rule will apply not only to staff in nursing homes, but also to staff in hospitals, dialysis centers, outpatient surgery centers and home health agencies. It will also extend to clinical staff and people providing services through arrangements, as well as volunteers and staff who are not involved in the direct care of patients, residents or clients. CMS expects this new action to protect patients of the 50,000 providers and more than 17 million healthcare workers in facilities that receive Medicare and Medicaid funding.

In the meantime, ahead of the release of the interim final rule, CMS expects Medicare and Medicaid certified facilities “to act in the best interests of patients and staff by complying with new COVID-19 vaccination requirements. “. CMS urges facilities to use all available resources to support employee vaccinations, including employee training and clinics, so that facilities are in compliance when the interim final rule takes effect. CMS also strongly encourages unvaccinated healthcare workers to start the immunization process as soon as possible.


Healthcare providers, including those not subject to CMS requirements, may still need to consider OSHA ETS which will require private employers with 100 or more employees to ensure their employees are either “Fully vaccinated” or provide proof of a negative COVID-19 test at least once a week. OSHA will issue the ETS in the coming weeks, and it will initially be in effect for six months until a final rule is enacted.

In a briefing on September 10, 2021, OSHA officials said that if an employer, including a healthcare provider, is subject to more than one requirement or standard under the plan, employers will have to comply with all requirements and standards. However, OSHA has said its new ETS will comply with other requirements and standards in the plan. OSHA also said during the briefing that guidance will be available for healthcare facilities already subject to the current COVID-19 healthcare ETS. Notably, that the current healthcare HTA allows weekly testing instead of vaccination, while the plan does not appear to allow this option. Therefore, due to the plan, entities covered by the COVID-19 Healthcare ETS may need to revise their OSHA compliance plans.

Regarding the specifics of compliance and the timeline for compliance, during a White House briefing on September 13, 2021, OSHA said ETS will provide the answers. Additionally, OSHA expects to issue a Q&A later this week on general issues such as coverage and information regarding state plans and covered public employees. Additionally, OSHA encourages employers who are not subject to ETS to follow CDC guidelines, including the circumstances in which employees are exposed to people of unknown immunization status.

While a release date for the ETS is unknown, the White House has announced that it is expected to be released in the coming weeks, with an effective date shortly thereafter. OSHA has the authority to issue citations for non-compliance with a penalty of up to $ 14,000 per violation. Also note that employers with collective agreements will still have collective bargaining obligations, and OSHA has indicated that the ETS will not change these obligations more than any other OSHA standard.

And after

Pending the publication of the CMS and OSHA ETS Interim Final Rule, a number of questions remain unanswered for healthcare providers, including:

  • Whether the CMS interim final rule will include a testing option for employees. As mentioned above, contrary to information provided on the OSHA ETS intended for private employers with more than 100 employees, the plan does not indicate whether CMS action will allow regular testing as an alternative to vaccination.
  • Who pays for testing under the OSHA ETS provided for large private employers and, if applicable, under the CMS Interim Final Rule. During the September 10 briefing, OSHA said it had not yet decided who would be required to pay for weekly testing instead of vaccination under the upcoming ETS.
  • The extent to which the practices of physicians are covered by this requirement. The CMS press release contains a hyperlink to the following site for Medicare facilities, which includes “all paid facilities”.
  • How health care providers should check the immunization status of employees. Regarding compliance with the ETS, OSHA said in its briefing that it has yet to decide on the process employers should use to verify employee status immunizations.
  • How this new requirement will affect facilities and providers already struggling with a shortage of healthcare workers during the current surge in COVID-19 cases.

Since the CMS and OSHA ETS Interim Final Rule will be released without notice or a comment period, healthcare facilities participating in Medicare and Medicaid should redouble their efforts to have their workers vaccinated so they can stay safe. comply with it. In the meantime, employers should monitor ongoing developments and new directions and be prepared to pivot accordingly.

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