As Hall Render detailed last month, President Biden announced the need for new COVID-19 vaccination rules. An Emergency Temporary Standard (“ETS”) from the Occupational Safety and Health Administration (“OSHA”) will require vaccinations or weekly testing for employees of employers with 100 or more employees. We also noted that CMS announced its intention to issue an Interim Final Rule in October 2021 that will mandate vaccinations for workers in health care settings that receive Medicare or Medicaid reimbursement as a condition for receiving such funding. CMS observers expect these will take the form of Medicare/Medicaid Conditions of Participation. CMS has expressed an intention that its rule will cover clinical as well as those not directly involved in patient care. The interplay between these rules is key for health care organizations. Many questions remain about the rules and the possible overlap between these agency requirements.
So, what is the status of these rules? While no one can definitively say when they will be formally issued, health care employers should keep their eyes open for news before the end of October. On October 12, 2021, OSHA’s draft rule was received by the Office of Information and Regulatory Affairs (“OIRA”), part of the White House Office of Management and Budget. Neither the White House nor the DOL have publicly committed to how long the review will take. Under a 1993 Executive Order, the OIRA period of review is generally limited to 90 days and the OMB Director may extend that one time for no more than 30 days. If it took that long, the ETS would not be issued until mid-February 2022.
However, the ETS is not expected to take much longer. Based on public statements, the better bet at this point is that the OSHA ETS will surface within the next few weeks. Bloomberg reported on October 18, 2021, that Deputy Labor Secretary Julie Su told a group of business writers last week that “We fully expect to be able to get something out within the next few weeks, but at this point, it’s under review.” On October 7, 2021, President Biden spoke publicly in Illinois and stated there that “The Labor Department is going to shortly issue an emergency rule.” Representatives from OIRA are reportedly taking meetings and have received requests for meetings, from both business leaders (including representatives of the American Hospital Association) and labor leaders. While the White House has not said whether it will await the completion of all such meetings before the rule is issued, one can reasonably conclude that the ETS will appear soon.
An ETS is a process available under federal law when OSHA determines that workers face grave danger due to exposure to toxic substances or agents that are deemed to be toxic or physically harmful. Once OSHA issues an ETS, it publishes it in the Federal Register for subsequent review but it has immediate effect. However, “immediate effect” does not necessarily mean that employers must immediately comply. The agency may give time for employers to begin compliance. In addition, we anticipate litigation to be filed seeking to enjoin enforcement of the OSHA ETS. In fact, many states have their own workplace safety and health plans (referred to as state plans) that OSHA allows to be adopted in satisfaction of federal OSHA requirements. As also reported by Bloomberg on October 19, 2021, Attorneys General in several of these states with their own state plans have vowed to file a lawsuit if the OSHA ETS is enacted, seeking to enjoin the ETS. That could potentially delay enforcement of the OSHA ETS for months.
The timing of CMS’s Interim Final Rule is a little less of a mystery because that office announced on September 9 that this rule would be issued in October. Earlier this month, trade publication McKnight’s Long-Term Care News reported that a CMS spokesperson told them “CMS anticipates issuing this combined regulation in mid to late-October.”
Given the reporting on the status of the OSHA ETS, one can reasonably surmise that it and the CMS Interim Final Rule will arrive around the same time, perhaps before the end of October. Stay tuned.
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Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
