At the beginning of September, the Biden administration announced a new federal strategy to address the COVID-19 pandemic. A large part of the strategy focuses on “vaccinating the unvaccinated”. To that end, the administration announced a number of new initiatives intended to drive higher vaccination rates through employers:
- New requirement for federal employees to receive the COVID-19 vaccine (no testing opt-out)
- Similar requirement for federal contractors to receive the COVID-19 vaccine (no testing opt-out). The Administration issued additional guidance for this group which provides interesting tea leaves for the following requirements not yet released.
- New requirement for health care providers accepting Medicare and Medicaid payments to mandate COVID-19 vaccines for employees as a Condition of Participation in the program (See CMS statement). This requirement is likely to apply to all facility-based health care workers (hospitals, nursing homes, dialysis facilities, etc.) as well as home care workers and will likely not have a testing opt-out.
- New Emergency Temporary Standard (ETS) issued by the Department of Labor’s Occupational Safety and Health Administration (OSHA) that would require employers with more than 100 employees to mandate either COVID-19 vaccinations or weekly testing for employees
Earlier this month, both the OSHA ETS and a CMS Interim Final Rule have move forward to the Office of Management and Budget (OMB) for review. This status is available through OMB’s Regulatory Review Dashboard.
- CMS: Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415): RIN: 0938-AU75
- OSHA: COVID-19 Vaccination and Testing Emergency Temporary Standard Rulemaking: RIN: 1218-AD42
What it means
- Both regulations can take effect immediately – In both cases, the administration is using regulatory tools that allow the policies to take effect quickly.
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- CMS is using an Interim Final Rule, which takes effect immediately – as opposed to the typical process of issuing a proposed rule with a comment period, followed by a final rule.
- OSHA is using an emergency temporary standard, which allows similar flexibility in implementation.
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- Both regulations will be subject to comment after they take effect
- Both regulations are in the final stages of review – OMB’s review is the final stage of internal review for the executive branch before a policy is cleared for release.
- That doesn’t necessarily make the timing clearer – Regulations can sit at OMB indefinitely, so there is no procedural timeframe for OMB to clear the regulations.
- We expect both regulations this month – The federal response to COVID-19 remains a top priority for the Administration. Don’t expect bureaucracy to tie these regulations up for more than a few weeks.
And other tea leaves:
- The rules are likely to be released together – Both of the regulations landed at OMB within 24 hours.
- There’s likely an effort underway to coordinate the policies – Many health care employers are going to wind up subject to both the CMS rule and the OSHA standard. For those entities, uniformity in the standards and definitions laid out in the respective regulations will be important. Again, based on the fact the rules are travelling in parallel, it looks like the administration has an opportunity to coordinate those pieces.
- Testing? – Given that a pillar of the OSHA ETS will be testing options for employees who do not get vaccinated, the Administration has made several moves to address the widespread and well-known shortages of rapid tests. As the public and federal demand for rapid tests decreased this spring and early summer, many manufacturers ramped down or stopped production. Fast forward to the late summer/fall surge and employers working to implement workplace policies, and that demand spiked. In September, the administration committed $2 billion in purchase orders, and last week they announced another $1 billion. However, it will take some time to get production ramped back up and products back on the shelves. The administration has noted that they aim to triple rapid testing capacity by November, but that has been met with some skepticism.
What’s Next?
These collective rules have the potential for impacting millions of employees, in the health care sector and beyond. Employers have had little information to prepare for these new mandates.
The administration is inching closer to pushing out regulations that will provide substantially more clarity for employers about what shape these mandates will take.
Resources
White House website on COVID-19 strategy – includes brief synopses of each of the pending vaccine rules