President Biden issued an Executive Order on September 9, 2021 (the “EO”) that will lead to required COVID-19 vaccinations for workers in most health care facilities that receive Medicare or Medicaid funds.  This covers approximately 50,000 health care providers across the country.

The EO also triggers COVID-19 vaccination requirements for many of these health care providers’ HIPAA business associates, if the contracts are entered into, renewed, or extended on or after October 15, 2021.

As per the EO, the Safer Federal Workforce Task Force will issue further guidance by September 24, 2021, including language that affected covered entities and business associates must incorporate into their contracts and subcontracts.  The EO contains few exceptions:

This order shall not apply to:
(i)    grants;
(ii)   contracts, contract-like instruments, or agreements with Indian Tribes under the Indian Self-Determination and Education Assistance Act (Public Law 93-638), as amended;
(iii)  contracts or subcontracts whose value is equal to or less than the simplified acquisition threshold, as that term is defined in section 2.101 of the Federal Acquisition Regulation;
(iv)   employees who perform work outside the United States or its outlying areas, as those terms are defined in section 2.101 of the Federal Acquisition Regulation; or
(v)    subcontracts solely for the provision of products.

Many covered entity health care providers have been implementing worker vaccination mandates for some time, and have grappled in recent months with the breadth and scope of COVID-19 vaccination mandates affecting workers, volunteers, vendors, and other individuals who enter their facilities.  Business associates who provide services to these health care providers are less likely to have developed policies and procedures dealing with workforce and subcontractor vaccination requirements.  The EO should serve as a wake-up call to business associates who may face a COVID-19 employee and subcontractor vaccination requirement in the near future.