By Eric J. Conn and Beeta B. Lashkari

Per our update last month, on December 8, 2022, OSHA delivered to the White House’s Office of Management and Budget (OMB) a proposed final rule for “Occupational Exposure to COVID-19 in Healthcare Settings.”  On behalf of our Employers COVID-19 Prevention Coalition, we secured three stakeholder meetings with the Office of Information and Regulatory Affairs (OIRA) within OMB for the three industry segments in the coalition most likely to be affected by the rule:

• • Construction / Maintenance:  Tuesday, January 3^rd
  • Retailers / Retail Pharmacies:  Wednesday, January 4^th
  • Manufacturers w/ Medical Clinics:  Thursday, January 5^th

Below is a report out from those meetings with OIRA and a discussion about what we think is going to happen next and when.

The meetings were hosted by a Deputy Branch Chief at OIRA with participation by representatives from OMB/OIRA, DOL, DOL’s Office of the Solicitor, SBA’s Office of Advocacy, as well as OSHA’s Directorate of Standards and Guidance, Office of Engineering Safety, Office of Physical Hazards, Office of Chemical Hazards, and Office of Regulatory Analysis.

On behalf of our Employers COVID-19 Prevention Coalition, we had representatives from the National Electrical Contractors Association (NECA) for the Construction / Maintenance industry segment, the Retail Industry Leaders Association and the National Association of Chain Drug Stores for the Retail Pharmacy industry segment, and the American Chemistry Council for Manufacturers with On-site Medical Clinics.

Here are the official records on OIRA’s website about our meetings:

At each meeting, OMB confirmed that the government participants cannot discuss the contents of the draft rule that they are reviewing or their opinions of it, but may ask clarifying questions to us stakeholders to ensure they understand our perspective.  They were intended as and very much were just “listening sessions,” with the stakeholders doing the talking.  The meetings were then handed over to us.

We introduced our coalition and confirmed that OIRA received our written materials, including written comments regarding issues facing: (1) retailers and retail pharmacies; (2) addressing embedded medical clinics and emergency response teams for manufacturers and other industrial worksites; and (3) addressing construction issues at healthcare workplaces.  We then discussed our greatest concerns and top priorities about the rule, and opened up for questions.  Below is a summary of the points we presented at each meeting and questions we fielded.

At each meeting, we expressed two critical messages:

1. 1. Litigation Risk:  Unlike the ETS which generally exempted our industry segments and was the only significant OSHA rule in recent history that was not challenged in court, if the permanent rule is scoped too broadly, it will almost certainly be challenged, and presumably the litigants will find a favorable judicial venue and seek a judicial stay of the entire rule pending outcome of the challenges.
   2. Politics:  Scoping this rule too broadly also will likely have negative political impacts on this Administration.  Rather than a regulatory victory, a broadly scoped COVID rule would feel and look more like the failed Vaccinate-or-Test ETS, which OSHA withdrew after legal challenges all the way to the Supreme Court.  Politically, it will be polarizing (even at the worker level), and risks creating serious negative backlash for the Administration at a time when the Administration is attempting to move beyond the pandemic and focus its priorities elsewhere.  The Administration should take a “win” with a properly scoped rule, rather than risk a “loss” by overreaching.

Retail / Retail Pharmacies

Our main positions included:

• • The retail pharmacy industry has played an instrumental role in the fight against coronavirus since its inception.  Pharmacies have administered close to 300 million COVID-19 vaccinations to date.  Pharmacists and pharmacy staff are vaccinated.  And, retail pharmacies have become a bedrock of the nation’s COVID-19 testing program.
  • We request that OSHA expand the exemption included in the ETS that excludes coverage for the dispensing of pharmaceuticals in non-hospital settings, to expressly exclude all retail pharmacy activities from coverage of the standard.  At the very least, and it truly would be too little, OSHA should not disturb the other existing exemption for ambulatory care settings where known or suspected COVID-19 cases are screened and barred from entry.
  • The healthcare related services provided in the retail pharmacy setting do not pose sufficient risk to trigger coverage under OSHA’s hospital-oriented standard, including the administration of COVID-19 vaccines and the provision of COVID-19 testing.  These activities simply do not pose a risk of exposure to COVID-19 at a level anywhere approaching the risk posed to healthcare workers in hospitals.  Indeed, SCOTUS spoke in its decision of the Vaccination and Testing ETS, essentially stating that regulation of COVID-19 is only appropriate where there is a unique risk of exposure due to the work environment and/or activities.  Accordingly, applying the entire breadth of the COVID-19 hospital standard, with its requirements that were designed for long-term, acute care, in-patient services to severely ill patients, is not appropriate.
    • • Infection rates by job function tracked by the industry reported fewer infections among their pharmacy staff than the general employee population.  Indeed, data shows that infection rates among pharmacy staff are lower than those in the pharmacies’ surrounding communities.
      • The vast majority of pharmacists (anecdotally, upwards of 90%), and a similarly disproportionately high percentage of other pharmacy staff, are fully vaccinated and/or boosted.
      • There is nothing inherently risky about providing vaccinations.
        • • First, the CDC has made crystal clear that people with suspected or confirmed COVID-19 should not get vaccinated until they complete their applicable isolation/quarantine periods.
          • Second, it takes only approximately 5 minutes for the entire immunization process (including answering any questions, preparing the bandage, the administration of the shot, and excusing the patient from the room).
          • Third, the CDC has issued very thoughtful, tailored infection-control guidance for pharmacies to follow for administering vaccines.
      • We appreciate that, unlike the population who present themselves for vaccination, the universe of customers who seek COVID-19 testing may include a higher percentage of individual infected with COVID-19.  Notwithstanding, the risk presented to pharmacy staff administering testing, does not come close to approaching the infection risk presented to healthcare workers providing extended direct patient care in hospital settings to severely ill COVID-19 patients.
        • • First, the entire time it takes, from start to finish, to administer a COVID-19 test, is less than 1 minute, and closer to 30 seconds.
          • Second, the tester is protected by the PPE and other protective equipment recommended by the CDC, including, at minimum, gloves and a surgical mask, typically, in addition to a face shield or goggles.
  • OSHA should not take any action that disincentivizes or hampers this vital industry from continuing its efforts, which are essential components of the effort to continue to move the country successfully through endemics/pandemics related to COVID-19.
  • At a minimum, the permanent COVID-19 standard for healthcare should preserve the non-ambulatory care screening exemption that had been included in the ETS.  There is no scientific basis for removal of the ambulatory care screening exemption.  While certainly the omicron variant (and subvariants) was shown to be more transmissible, there does not appear to be any evidence to suggest that it caused more asymptomatic or pre-symptomatic cases.

Manufacturers w/ Medical Clinics

Our main positions included:

• • We urge OSHA to preserve the screening exemption that OSHA included in its ETS for COVID-19 in its permanent COVID-19 standard.
  • There is a critical distinction between the universe of “patients” serviced by healthcare personnel working in embedded clinics, from those serviced by healthcare personnel working in hospitals.  While nurses, doctors, and emergency technicians working in embedded clinics in manufacturing facilities may be professionally equivalent to their hospital counterparts, there is a fundamental difference between the clientele treated.  Hospitals are designed to accept COVID-19 patients and thus draw people with COVID-19 in; embedded clinics are not designed this way and thus do not draw people with COVID-19 in.
  • The screening exemption is effective in excluding suspected and confirmed cases out of embedded medical clinics.
    • • Screening and barring data show that far fewer employees in medical clinics (where screening and barring was required) contracted COVID-19 than employees at the same facility outside the medical clinics (where screening and barring might not have been required or, more often the case, was subject to perhaps less scrutiny).
        • • For example, one employer reported that, for one of its sectors, which has about 25,000 employees (of which, there are about 15 total staff in health services), from March 2020 to April 2022, it had approximately 4,000 total positive COVID-19 employee cases (confirmed by test or health care provider), with zero total medical personnel who contracted COVID-19 from the workplace.  This is despite almost 7,000 total visits to the medical clinics during this time period.  The employer has refused entry due to a failed screening almost twenty times.
          • Additionally, in speaking with one doctor who is a contractor for one of the largest sites of a major manufacturer, the doctor reported that there have been zero work-related COVID-19 cases among his medical staff in 4,310 encounters at his two embedded medical facilities since OSHA issued the Healthcare ETS in June 2021.  Indeed, the doctor reported that he has “stacks and stacks” of completed screening checklists, and that, despite many employee clinical visits, he believes no COVID-19 cases came through his clinic.  The site has not had any health professional have a positive case due to a workplace exposure.
          • Another employer reported that, at one site, it too has had zero work-related cases of COVID-19 among the staff in its medical unit.
  • We understand that OSHA also may believe it is warranted in eliminating the screening exemption in part because of the less stringent legal standard for Section 6(b) rulemaking compared to emergency rulemaking conducted under Section 6(c) of the OSH Act.  However, it is not at all clear that OSHA would have legal authority under the significant risk standard to impose compliance with the permanent healthcare COVID-19 standard on embedded medical clinics in non-healthcare settings.  Medical clinics are very different from hospital settings.
    • • Generally, medical clinics provide essentially two types of services: (1) routine, regulatory compliance occupational health services, like respirator fit testing, and (2) triage of workplace emergencies.
      • In many instances, medical clinics are staffed by registered nurses, not doctors, and the services provided are typically limited to first aid and emergencies in the workplace.  Additionally, employee visits tend to be quick – employees are “in and out,” unlike many hospital emergency room or certainly other hospital visits.
      • Many employers require their employees to report to them before even coming to work (by calling from home) if they test positive or are diagnosed with COVID-19 or, in many cases, otherwise suspect they have COVID-19.  This is an initial filter for excluding any confirmed cases from entering on-site medical clinics.
      • Unlike a hospital or urgent care center, our embedded medical clinics are not available for use by the general population.
  • It could be technologically and economically infeasible and certainly unnecessarily time-consuming and operationally challenging to apply certain requirements of the Healthcare ETS, which acts as the proposed permanent standard, to on-site medical clinics (e.g., physical distancing, standard and transmission-based precautions such as special handling/laundering of work clothes, etc.).
  • There is no new scientific evidence that was not available to OSHA at the time it promulgated the ETS to suggest that the screening exemption should be eliminated.  While certainly the omicron variant (and sub-variants) was shown to be more transmissible than previous variants – though, thankfully, as we are generally seeing with the new variants, less severe in outcome  – there does not appear to be any scientific evidence to suggest that it caused more asymptomatic or pre-symptomatic cases.  In fact, in describing the omicron variant, as it was on the rise in December 2021, the CDC used language to suggest that there is nothing particular or unique about omicron in terms of the number of asymptomatic cases.

Construction / Maintenance

Our main positions included:

• • The construction industry was not involved with the initial promulgation of the proposed rule.  The proposal was not reviewed by the OSHA Advisory Committee for Construction Safety and Health (ACCSH) for any recommendations and comments to OSHA on how this would impact the construction industry.
  • When OSHA finally held a meeting of ACCSH on June 15, 2022, ACCSH recommended to the agency that OSHA rely on existing language in its general industry standards (29 CFR 1910) related to the performance of maintenance activities, and not create a specific COVID-19 rule for construction in healthcare in its construction standards (29 CFR 1926).  We support that approach.
  • Employers that engage in construction activities in hospitals, long-term care facilities and other settings covered by the ETS, do not face risks of exposure to COVID-19 that even approach the risk that healthcare employees potentially face in these settings.
  • Construction activities in health care settings already have infection control measures in place that protect against COVID-19.  The requirements and recommendations of the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC), The Joint Commission, and the Center for Medicare and Medicaid Services (CMS) are carried forward into the contracts between healthcare companies and their contractors.
  • There are areas where the requirements and recommendations of HICPAC, The Joint Commission, and/or CMS may differ with OSHA’s standard, or where OSHA’s standard does not make sense for the construction industry – such as compliance with standard and transmission-based precautions (e.g., special handling/laundering of work clothes).  Adherence to such requirements would create confusion for the industry, but, more importantly, would be unnecessary.
  • It would be technologically infeasible and operationally challenging and burdensome to apply many of the requirements of the ETS, that likely will be carried into the permanent COVID-19 standard, to construction activities occurring in healthcare settings (e.g., physical distancing, physical barriers, facemasks).
  • If OSHA determines that construction activities in healthcare settings should be covered, which, again, we, nor the ACCSH committee, don’t think it should, we recommend OSHA limit application of the full requirements of the standard to construction employers and simply impose a requirement to coordinate with healthcare employers covered by the standard prior to conducting work at a covered facility.

Timing and Next Steps

As of January 14^th, the last stakeholder meeting that appears to have been scheduled on OIRA’s EO 12866 Meetings calendar was conducted earlier this week — Tuesday, January 17^th.  The meeting was requested by LeadingAge, which is a community of nonprofit aging services providers serving older adults.  That was the 13^th meeting OIRA has taken over approximately five weeks (though, part of that was the holiday season).  No other meetings for the standard appear on the calendar.

We attempted to schedule another OIRA meeting for late January on behalf of third party operators of medical clinics at industrial sites, but OMB denied the meeting request.  The agency’s purported reason for denying the request is that it has already taken multiple meetings from our coalition, but it could also be a sign that OMB is preparing to clear the rule.  We are preparing as though that is the case.

As a reminder, during the first COVID-19 emergency rulemaking, OIRA took more than 50 stakeholder meetings over eight weeks, and the end result was a final rule that was quite different from the proposed final rule that we understand OSHA had first delivered to OMB.  Our Coalition for that rulemaking participated in five stakeholder meetings, and got additional written comments into the hands of OMB and OSHA through that process.  Technically, OMB has 12 weeks to review and either approve the rule or return it to OSHA for more work; however, we do not expect OMB will take the full 12 weeks.  In fact, given that OSHA lists issuance of the “Occupational Exposure to COVID-19 in Healthcare Settings” standard as occurring in December 2022 (obviously, that is now overdue) in DOL’s just-released Fall 2022 Regulatory Agenda, and that the agencies likely want to take advantage of the winter surge of COVID-19 cases that we are now experiencing as political cover for issuing the rule at all, we think issuance of the rule is imminent.