Category Archives: COVID-19

CMS Health Care Vaccine Mandate Allowed by U.S. Supreme Court

Contributed by Suzannah Overholt, January 13, 2022

Ending months of uncertainty, today the Supreme Court issued its decision allowing CMS to enforce its vaccine mandate for healthcare workers. The Court’s decision stays the injunctions entered by federal courts in Missouri and Louisiana. CMS may now enforce the rule nationwide. Before today’s decision, the CMS rule could only be enforced in 26 states. 

As a refresher on what the CMS rule requires, see our previous summary of the rule. Further guidance should be issued by CMS before compliance is required. We will continue to keep you updated.

In another opinion issued today, the Court decided that OSHA’s “shot or test” rule for large employers may not be enforced. Read more about this decision on our blog.

OSHA’s Emergency COVID-19 Vaccination and Testing Standard Blocked

Contributed by Matthew Horn, January 13, 2022

In a 6-3 decision just released, the Supreme Court blocked OSHA’s Emergency COVID-19 Vaccination and Testing Standard (“ETS”) from taking effect, which required employers with one hundred or more employees to conduct weekly testing of all unvaccinated employees, amongst other things. 

While procedurally, the ruling merely reinstituted the stay of the ETS, the ruling signaled the final outcome for the ETS, finding more broadly that the ETS went beyond OSHA’s authority. The Court stated: “[a]lthough Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.”

Moving forward, we will continue to keep you advised as to all relevant updates relating to the ETS—and any revised ETS that OSHA attempts to issue in light of the ruling.

Biden’s Insurance Plan Mandate to Cover At-Home COVID-19 Tests, But Not for Employment Purposes

Contributed by Kelly Haab-Tallitsch and Sara Zorich, January 13, 2022

President Biden announced on January 10th that the Biden-Harris Administration is requiring insurance companies and group health plans to cover the cost of over-the-counter (OTC), at-home COVID-19 tests. Beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) will be able to have those test costs covered by their plan or insurance. Insurance companies and health plans are required to cover 8 free over-the-counter at-home tests per covered individual per month.

In the Department of Labor(DOL) FAQs issued January 10, 2022, Q1 states, “This FAQ does not modify previous guidance** addressing coverage for purposes not primarily intended for individualized diagnosis or treatment of COVID-19, including the guidance that states that plans and issuers are not required to provide coverage of testing (including an OTC COVID-19 test) that is for employment purposes.” 

Additionally, Q4 provides that plans and issuers can take reasonable steps to ensure an OTC COVID-19 test was purchased for the individual’s own personal use, including requiring an attestation that the test was purchased for personal use and not for employment use.  

** The previous guidance referenced above is the DOL FAQs issued in February 2021 that states plans and issuers are required to cover COVID-19 diagnostic testing of asymptomatic individuals when the purpose of the testing is for individualized diagnosis or treatment of COVID-19, but not for public health surveillance or employment purposes.

The Bottom Line: While we are waiting to find out how insurance companies will handle this, we expect they will take steps to exclude tests for employment now, even if they hadn’t so far. Unfortunately employers shouldn’t rely on this to help with out of pocket testing costs.

Save the date! Complimentary Webcast January 10, 2022: COVID-19 Testing: What Employers Need to Know

While employers continue to review their COVID-19 protocols under various government vaccine mandates (including OSHA’s ETS) as well as their own policies and practices and customer requirements, testing continues to be a confusing topic for many. From the types of testing that can be relied on to satisfy such obligations to whether an employer must pay for such testing, there is a tremendous amount of uncertainty for employers trying to navigate their processes and policies related to employee testing. Additionally, testing capacity and supply is also a growing concern. 

Please join Jeff Risch and Sara Zorich on January 10 for a one hour webcast at Noon CT for a practical discussion on what is required of employers in adopting a testing program and how to efficiently and effectively comply with the onslaught of new obligations concerning the same in today’s environment.

OSHA’S COVID-19 Vaccine Mandate is Back on!

Contributed by Sara Zorich and Jeff Risch, December 20, 2021

Filling syringe with medicine from vial, closeup

On December 17, 2021, in a 2-1 decision, the 6th Circuit Court of Appeals dissolved the stay of OSHA’s Emergency Temporary Standard (ETS) previously ordered by the 5th Circuit Court of Appeals. Therefore, OSHA’s ETS mandating workplace vaccination and testing on all private employers with 100 or more employees is back on. While the 6th Circuit did not address timing issues, the day after the decision was released, OSHA announced that it will not issue citations for noncompliance with any requirements of the ETS before January 10, 2022 and will not issue citations for noncompliance with the standard’s testing requirements before February 9, 2022 — so long as an employer is exercising reasonable, good faith efforts to come into compliance.

As you may recall, soon after the ETS was published back on November 5, 2021, the 5th Circuit issued a scathing opinion staying the enforcement of the ETS – which had essentially implemented a January 4, 2022 deadline for the “get the shot or test” requirement.  In the week that followed, legal challenges were brought in every other Circuit Court of Appeals across the country. On November 16, 2021, the matter was assigned through a lottery system to the 6th Circuit. With the 6th Circuit’s decision now in place, the matter has now moved to the U.S. Supreme Court for possible review. The Supreme Court does not have to take on the merits of the matter and could simply allow the 6th Circuit’s decision to stand as is.   

So, what should private employers with 100+ employees do now? 

By January 10, 2022, you will need to implement the following:

  1. Finalize and publish your COVID-19 vaccine policy to all employees (this includes clear messaging that anyone who tests positive for COVID -19 or is diagnosed shall immediately provide notice to their employer and shall refrain from entering the workplace until they meet criteria set by the CDC).
  2. Distribute and publish to all employees the following notices:
    1. Workers’ Rights under the COVID-19 Vaccination and Testing ETS
    2. Information for Employees on Penalties for False Statements and Records
  3. Finalize your Vaccination Roster — obtaining proof of and confirming who is fully vaccinated and who is not — in a confidential manner.
  4. Provide Paid Leave for anyone obtaining the vaccine (note: boosters do NOT count) (up to 4 hours per shot).
  5. Permit a “reasonable amount of time” (i.e. up to 2 days) of paid leave for the recovery from any ill-effects of any vaccination dose.
  6. Mandate that face coverings must be worn by anyone who is not fully vaccinated at all times (unless isolated in an office with four walls and a ceiling).

Then, by February 9, 2022, you will need to: A) require all employees to be fully vaccinated (note: boosters are NOT relevant under the current ETS); and/or B) require all unvaccinated employees to submit to weekly testing.  Under the ETS, employees who are exclusively working remotely or predominately working outside are not subject to these requirements. 

Note, employers must review state and local vaccine requirements and laws when preparing their vaccine policy.  Many state and local laws have been enacted since the original ETS was issued and these laws/regulations might be more stringent, contain different deadlines than the OSHA mandate or may place restrictions on employers who issue a mandatory vaccination policy.

SmithAmundsen’s Labor & Employment, Healthcare and OSHA practices will continue to monitor these developments. 

CMS Vaccine Mandate – On Again (Sort Of)?

Contributed by Suzannah Wilson Overholt, December 16, 2021

syringe and vial bottle with covid 19 vaccine

In the ongoing saga of the federal government’s attempts to impose vaccine mandates on certain sectors, on Wednesday, December 15, the United States Court of Appeals for the Fifth Circuit concluded that the nationwide injunction issued by a Louisiana District Court was overbroad and could only apply to the 14 states that were plaintiffs in the lawsuit. The court stayed the injunction for the 26 states that were not parties to the lawsuit before it or covered by the 10-state injunction issued by the Eastern District of Missouri on November 29. Therefore, the CMS vaccine mandate for healthcare workers is now enjoined in 24 states but could be enforced in 26 states. 

What this means is that the CMS mandate IS NOT in effect for the following 24 states: 

  • Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire (due to injunction issued in Missouri); and
  • Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky and Ohio (due to Fifth Circuit opinion).

The 26 states in which the CMS mandate could be enforced are as follows:

  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Hawaii
  • Illinois
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Nevada
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • Oregon
  • Pennsylvania
  • Rhode Island
  • Tennessee
  • Texas
  • Vermont
  • Virginia
  • Washington
  • Wisconsin

What remains to be seen is when (or whether) CMS will now enforce the mandate in these 26 states. On December 2, CMS instructed state surveyors not to survey providers for compliance with the CMS vaccine mandate requirements, which equated to not enforcing the mandate.  CMS will now need to change its instructions for enforcement efforts to begin – and that has not occurred yet.

Because of the ongoing uncertainty, entities covered by the CMS mandate should continue to be ready to comply with it. However, further guidance should be issued by CMS before compliance is required. We will continue to keep you updated.

Federal Contractors’ Alert: COVID-19 Vaccination Mandate Is Halted — For Now

Contributed by Heather Bailey, December 7, 2021

Judge’s gavel

In September President Biden’s Executive Order 14042 was blessed by the Safer Federal Workforce Task Force requiring certain federal contractors to have all of their contract and related workers vaccinated against COVID-19 by the new deadline date of January 4, 2022 (it was previously set for December 8, 2021 but with the OSHA and CMS mandates, the federal contractors’ date was extended). Just like President Biden’s Orders to get both healthcare workers and employees who work for companies with 100 or more employees vaccinated, the federal contractor vaccination mandate is being fought hard in the court system by several states and organizations. 

Today, U.S. District Court Judge R. Stan Baker in the Southern District of Georgia put a nationwide halt on the federal contractor vaccination mandate, as various states and organizations are arguing that the President is exceeding his authority under the U.S. Constitution, and that Congress never granted him this authority. The case is captioned: The State of Georgia et al v. Biden et al, Case No. 1:21-CV-00163.  Here, the judge granted the preliminary injunction to stop the enforcement of mandatory vaccination requirements on federal contractors.

What do you do now? There is nothing stopping a federal contractor from keeping pace and rolling out their vaccination policies and requiring workers to get COVID-19 vaccinations. However, if you are in the same boat as many other federal contractors and such a mandate and the requirements are causing you heart burn and stretching resources you do not have, you can put a stay on your roll out to see what happens next during this lawsuit since the lawsuit has halted any enforcement on the mandate as of now. 

Stay tuned for updates as this case progresses.

CMS Vaccine Mandate Enjoined Nationwide

Contributed by Suzannah Wilson Overholt, December 1, 2021

gavel and scales of justice

On Tuesday, November 30, Louisiana federal district Judge Doughty issued a nationwide injunction against implementation of Centers for Medicare & Medicaid Services’ (CMS) vaccine mandate for health care workers. Judge Doughty’s decision was issued just a day after Missouri federal district Judge Schelp issued a preliminary injunction against the mandate in 10 states. Unlike the Missouri decision, the Louisiana court issued a nationwide injunction due to that court’s conclusion that there was a need for uniformity and protection of unvaccinated healthcare workers. In reaching its decision, the court relied heavily on the Fifth Circuit’s injunction against the OSHA vaccine or test mandate, which we discussed in an earlier blog.

First, the court agreed that plaintiffs were likely to prevail on all of their arguments against the vaccine mandate.  The court concluded that CMS issued the vaccine mandate without following statutorily required processes for notice and comment and rejected CMS’ argument that it met the good cause exception that would exempt it from those requirements. Next, the court found that the mandate was beyond the authority of CMS, concluding that such a sweeping requirement should have at least been issued by Congress, not a federal agency, and questioned whether even Congress would have authority to issue the mandate. 

The court also concluded that the CMS mandate is likely contrary to law because the federal government did not consult with appropriate state agencies regarding the mandate, improperly dictated hiring and firing policies with respect to unvaccinated employees, and did not conduct a regulatory impact analysis for rural hospitals given the mandate’s likely significant impact on rural hospitals.  

In addition, the court agreed that the CMS mandate was likely arbitrary and capricious because it ignores patient well-being and instead focuses on the health of healthcare providers. Plaintiffs maintained that increasing individual vaccine rates would harm patient well-being by causing staff shortages and the federal government failed to consider or arbitrarily rejected alternatives to the mandate, such as daily or weekly COVID testing, wearing masks, natural immunity and/or social distancing. The court found that CMS had not provided any evidence of why it rejected these alternatives or why it departed from its earlier position of not requiring vaccines.  Finally, the court found that the mandate likely violates the states’ police powers and improperly delegates authority to CMS. 

The court next concluded that the states had shown irreparable injury by not being able to enforce their laws that were preempted by the mandate, incurring costs associated with the mandate, by having their police power encroached, and by having substantial burdens placed on the liberty interests of their citizens. Granting the injunction was in the public interest because it would maintain the liberty of individuals who do not want to take the COVID-19 vaccine.  We will keep you updated regarding the status of this issue. In the interim, health care entities who were subject to the CMS rule should be prepared to comply with the rule if the injunction is lifted.  Our prior post discusses the requirements of the rule.

OSHA Suspends Emergency COVID-19 Vaccination and Testing Standard

Contributed by guest author Matthew Horn, November 18, 2021

In September, the Biden Administration directed OSHA to issue an Emergency Temporary Standard (“ETS”) requiring employers with one hundred or more employees to ensure their employees are either fully vaccinated or tested for COVID-19 on a weekly basis.  That promised ETS was published on November 5, 2021, and linked here are OSHA’s summary of the ETS and the FAQ’s relating to the ETS.   

One week later, on November 12, 2021, the 5th Circuit Court of Appeals issuing a scathing opinion staying the enforcement of the ETS.  In the week that followed, legal challenges were brought in every other Circuit Court of Appeals across the country.  On November 16, 2021, the matter was assigned through a lottery to the 6th Circuit Court of Appeals, which has jurisdiction over Michigan, Ohio, Kentucky, and Tennessee.  If the 6th Circuit upholds the stay of the ETS—which seems more likely than not—then the ETS will remain stayed while the issue proceeds to the U.S. Supreme Court.  If the 6th Circuit lifts the stay of the ETS, then the ETS could potentially go into effect while the issue proceeds to the U.S. Supreme Court. 

On November 17, 2021, OSHA formally acknowledged that it had suspended all activities related to the implementation and enforcement of the ETS.  However, OSHA and the Biden Administration have vowed to continue the fight and implement the ETS if/when allowed, so at this juncture, we continue to recommend that employers plan and prepare for the potential implementation of the ETS—namely, preparing the required policies and compiling a roster of employees who have been vaccinated (and those who have not).  

For a more thorough discussion of the ETS, the pending legal challenges, and our recommendation moving forward, please see our recent webinar on these issues. We will continue to keep you advised as to the status of the ETS and the related legal challenges. 

CMS Releases Interim Final Rule Requiring COVID-19 Vaccination for Employees and Suppliers

Contributed by Suzannah Wilson Overholt, November 4, 2021

Studio macro of a stethoscope and digital tablet with shallow DOF evenly matched abstract on wood table background

Today the Centers for Medicare & Medicaid Services (CMS) released its interim final rule requiring all employees and certain suppliers of most Medicare and Medicaid certified providers to be fully vaccinated against COVID-19 unless they receive an exemption due to a disability, medical condition or sincerely held religious belief (the “Rule”) (the text of the regulations starts on page 171 of the CMS publication). The Rule is effective upon official publication, which is targeted as November 5.

Covered Health Care Entities

The Rule applies to the following types of CMS regulated facilities:

  • Ambulatory Surgical Centers (ASCs)
  • Hospices
  • Psychiatric residential treatment facilities (PRTFs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities)
  • Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
  • Home Health Agencies (HHAs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
  • Community Mental Health Centers (CMHCs) offering partial hospitalization services
  • Home Infusion Therapy (HIT) suppliers
  • Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
  • End-Stage Renal Disease (ESRD) Facilities

The Rule does not directly apply to other health care entities not regulated by CMS. Such entities may still be subject to other State or Federal COVID-19 vaccination requirements, such as those issued by OSHA for certain employers.  Our discussion of the OSHA Rule may be found in our previous blog post.

Key Dates (assuming the Rule is published November 5)

  • December 5, 2021 (30 days from publication): Staff must have received the first dose, or only dose as applicable, of a COVID-19 vaccine, or have requested or been granted an exemption to the vaccination requirement. 
  • January 4, 2022 (60 days from publication): The primary vaccination series must be completed and staff must be fully vaccinated, except for staff granted exemptions or those staff for whom vaccination must be temporarily delayed due to clinical precautions and considerations. Staff who have completed the primary series for the vaccine by this date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination.

Covered Employees Vendors

The vaccine requirement applies to the following, regardless of clinical responsibility or patient contact:

  • Employees;
  • Licensed practitioners;
  • Students, trainees, and volunteers; and
  • Individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. 

Individuals who provide services 100% remotely, e.g. fully remote telehealth or payroll services, are not subject to the vaccination requirement.  Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (e.g. annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (e.g. accounting services).

Definition of “Fully Vaccinated”

“Fully vaccinated” means two weeks or more has elapsed since completion of a primary vaccination series. “Completion of a primary vaccination series” means the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. COVID-19 vaccine doses from different manufacturers may be combined. Providers and suppliers must have a process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

Unvaccinated Staff

All applicable providers and suppliers must follow nationally recognized infection prevention and control guidelines to mitigate the transmission and spread of COVID-19 and implement additional precautions for all staff who are not fully vaccinated for COVID-19. The CDC infection control guidance can be found on the CDC website.

Documentation Requirements

Providers and suppliers must track and securely document the vaccination status of each staff member. Vaccine exemption requests and outcomes must also be documented. All vaccine documentation must be kept confidential and stored separately from the personnel files. Examples of acceptable forms of proof of vaccination include:

  • CDC COVID-19 vaccination record card (or photo of the card),
  • Documentation of vaccination from a health care provider or electronic health record, or
  • State immunization record.

Exemptions

Providers and suppliers must establish and implement a process by which staff may request an exemption from COVID-19 vaccination requirements based on recognized medical conditions or religious beliefs. The Rule directs providers and suppliers to the CDC guidance regarding contraindications. Our previous discussion regarding medical and religious exemptions can be found in a previous blog post.

Now is the time for affected providers to implement vaccination and exemption policies. We will continue to provide updates on this important issue.