OSHA, CDC, and the CMS Mandate – This, That, and the Other Thing for Healthcare

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In June of 2021, OSHA issued an ETS which required a variety of actions for healthcare providers. This included continuing personal protective equipment programs such as masking, specific respiratory protection standards (including fit testing) for personnel “providing care to persons who are suspected or confirmed to have COVID-19,” enhanced recordkeeping requirements which required not only the continued utilization of the 300 log but also a separate COVID-19 log for employees who may have contracted COVID other than in the workplace, and paid leave to obtain vaccines or when placed on leave from work due to COVID exposure or illness.

That ETS expired in December of 2021 with no new permanent rule yet being enacted. However, OSHA, while being tied up in the defense of the vaccine mandates, is not ignoring healthcare standards. Although a new rule has not yet been published, OSHA has clearly stated in its December 27, 2021, “Statement on the Status of the OSHA COVID-19 Healthcare ETS” that it intends to create a rule relating to these items. OSHA states that it will “vigorously enforce the general duty clause and its general standards, including the personal protective equipment (PPE) and respiratory protection standards to help protect healthcare employees from the hazard of COVID-19.”

The announcement further states that the enhanced recordkeeping requirements, including the separate COVID-19 log “remain in effect.” If you, as a healthcare employer, for any reason ceased keeping your COVID-19 log or accidentally never started, a form setting forth the information expected by OSHA is available on OSHA.gov in the COVID-19 section. Also, see this October article - OSHA 300 Logs and the Emergency Temporary Standard.

However, the OSHA statement further indicates that they are withdrawing the “non-recordkeeping” components. This leads employers to the question of paid leave. Under the current statements by OSHA, paid leave for vaccines or quarantine which was part of the OSHA ETS, is no longer required. Therefore, employers who enacted special leave banks for vaccines or time off for COVID are no longer required to offer this type of leave. If employees were “going negative” because OSHA allowed employers to require that they use their own PTO, that is also no longer necessary. Leave issues could be impacted by other rules and regulations as this area evolves daily in terms of what the various agencies expect.

To summarize, continue:

  • Your 300 and separate COVID-19 logs as those requirements under 29 CFR 1910.502 continue to remain in effect.
  • PPE including facemasks, strict cleaning, and other measures you have taken as well as the respiratory protection program you have in place to meet OSHA’s clearly stated expectations under the general duty clause.
  • COVID mitigation efforts and keep your COVID mitigation plans current. OSHA has stated that they will be watching.
  • To encourage vaccination to show good compliance with not only OSHA but CMS expectations. However, at the current time, you can discontinue the additional paid leave or secondary paid leave programs for both vaccinations and COVID illness.

Healthcare Staffing and Chronic Shortages

For years, the healthcare industry has known there are chronic staffing shortages exacerbated by a wide array of economic factors. Given the nature of healthcare and daily media coverage of staff burnout, various public agencies have begun to focus more specifically on healthcare staffing shortages. Iowa Governor Kim Reynolds, as well as the state legislature, has stated that they will be proposing various incentives, legislation, and other programs to help alleviate medical staffing issues. This is a matter that we will continue to monitor over the course of the legislative session as proposals on day one sometimes don’t look precisely like what happens at the end of the session.

However, on December 23, 2021, the CDC set forth its “Strategies to Mitigate Healthcare Personnel Staffing Shortages.” This included changes to the work restrictions for employees exposed to COVID-19 and their return to work. If you currently have conventional staffing, an employee is vaccinated, their work restrictions are for 10 days or 7 days with a negative test if asymptomatic. If asymptomatic or mildly symptomatic with improving symptoms there are more limited restrictions if you have also received a booster and for those who have previously had a vaccination.

This can all be found at www.CDC.gov with a chart regarding various issues. However, the CDC has different expectations if you are in a contingent staffing shortage or a staffing crisis. In a contingency staffing situation, where the employee is boosted and fully asymptomatic, there are no work restrictions with an exposure.

Contingent Staffing

What is contingent or crisis staffing? The CDC does not provide a comprehensive definition. It does provide some guidance in its expectations in the section entitled “Contingency Capacity Strategies to Mitigate Staffing Shortages.” In this section, the CDC indicates that its expectations for healthcare facilities that are in a contingent or crisis situation would include the cancellation of “all nonessential procedures and visits.” This appears to indicate that a healthcare facility asserting the contingent status in order to bring people back early from asymptomatic exposures would be required to cancel all elective procedures.

This section goes on to state that healthcare facilities should attempt to address other social factors such as transportation or housing which may affect staffing, identify state-specific emergency waivers, including changes to licensure requirements, and postpone elective time off from work while commensurately still considering the mental health needs and caretaker responsibilities of staff. Essentially an almost impossible balance for healthcare entities.

Additionally, in the “Crisis Capacity Strategy used to Mitigate Staffing Shortages,” section the CDC makes it clear that bringing even mildly symptomatic people back to work is a “last resort.” The CDC further suggests the transfer of patients to other facilities with adequate staffing and a range of other potential “solutions.”

While the CDC did not provide a definition, these expectations and strategies for mitigating staffing shortages do provide some guidelines as to what governing agencies such as CMS, DHS, and others might review to determine whether utilization of the contingent or crisis staffing category under the CDC guidelines is appropriate.

As a healthcare employer, you need to be able to document why these categories are used to utilize various liability safe harbors in the Iowa Code regarding the transmission of COVID-19, as well as meet your obligations under OSHA, CMS, and other rules. Canceling elective procedures and limiting PTO are two methods cited by CDC.

CMS and Vaccines (Iowa Version)

On January 13, 2022, the United States Supreme Court issued rulings regarding various lawsuits against the Department of Health and Human Services concerning the CMS regulation for vaccine mandates. The Supreme Court, in part, agrees “with the government that the Secretary’s rule falls within the authorities that Congress has conferred upon him.”

In other words, CMS has the right to make a rule of this type relating to safety within healthcare institutions that receive funding from CMS. Further stating, “After all, ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: First, do no harm.”

The opinion from the Supreme Court goes on to state that healthcare workers are ordinarily required to be vaccinated for a variety of things such as Hepatitis B, influenza, measles, mumps, and rubella noting also that the vaccine mandate in healthcare was supported by a wide array of healthcare providers including the American Medical Association, American Public Health Association, and others. Based on this order, the preliminary injunction prohibiting enforcement of the CMS regulation which applied to Iowa is removed pending further Court action in the Eighth Circuit (Iowa is in the Eighth Circuit).

Basically, the CMS rule mandating vaccines and its ability to enforce that rule, including penalties, can move forward unless further litigation changes that ruling.

Given the various delays in implementation of the rule, deadlines for 8th Circuit states like Iowa, Indiana, and Kanas vary from the national law.

  • Phase I: First dose, data collection, or an exemption is in-process - February 14, 2022
  • Phase II: Completion of the process - March 15, 2022
  • Phase III: End of any grace period and enforcement deadline - April 14, 2022

Note that CMS issued guidance on December 28 regarding how the interim final rule will be enforced outside of the 8th Circuit which includes:

  • Phase I: Initial vaccines or exemption process by January 22, 2022
  • Phase II: Completion of vaccine doses or receiving a qualifying exemption or a temporary delay by February 28, 2022
  • Phase III: 100% percent compliant by March 28, 2022

Given the structure of the Supreme Court’s opinion, it seems likely the CMS requirements are likely to survive other challenges. Remember that the CMS regulation required a variety of things including encouraging vaccinations, the provision of vaccine programs, recordkeeping, and that an exemption process must be CMS-compliant.

While CMS did not provide much guidance in terms of religious exemptions, its specific regulations are very specific about what is an acceptable medical exemption. Medical exemptions appear to be extremely limited.

Some key questions involve the issue of testing. While CMS is clear that testing is not mandated under this rule (there may be other testing rules applicable to your facility) it is listed as one part of possible reasonable accommodation. It seems that while CMS is not mandating testing it does expect heightened safety measures. If your entity is not testing, you must be able to document what you are doing - standard masking as usual does not appear to be enough. CMS has also been very specific that its rule preempts state law (except in Texas).

Booster vaccines are not required although they are “advised” in some circumstances. This may change as the process is ongoing.

100+ Employees and the OSHA ETS

At the same time the Supreme Court issued its ruling on the CMS regulations, it also continued the stay on the enforcement of the OSHA ETS relating to companies with employers of 100 or more. Just like with the CMS regulations, the content of the opinion by the Supreme Court and the breakdown of the votes on removing the stay of enforcement appears to indicate that further litigation attempting to support or keep the OSHA mandate in effect is unlikely to be successful.

However, if you are a facility that is not covered by the CMS requirements, but you have 100 or more employees, keep in mind that OSHA has broad authority under the general duty clause to enforce safety requirements. OSHA has signaled it is likely to issue other directives which although it may not require vaccinations can require a number of other mitigating actions by the employer. As noted above, OSHA has signaled that certain components of the original ETS regarding PPE and recordkeeping remain in effect.

The Big Picture

Continue to monitor what the various agencies and governmental groups are doing. Encourage vaccination, complete recordkeeping documentation, and move through your exemption process where appropriate. Update your mitigation plan and be clear about your risk assessment. Remember to note the CMS is also anticipating that employees will receive booster vaccines as well as your corresponding documentation. It will be critical to demonstrate your compliance with CMS expectations by updating your COVID mitigation plan and keeping documentation regarding your vaccine “encouragement” efforts.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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