Legal Analysis for the OSHA & CMS Vaccine Requirement Regulations

National Federation of Independent Business v. Department of Labor & Ohio v. Department of Labor

Biden v. Missouri and Becerra v. Louisiana

Blog prepared exclusively for the Arizona Public Health Association

Jennifer L. Piatt, J.D.

On January 13, 2022, the Supreme Court of the United States issued two opinions addressing federal COVID-19 vaccination requirements. In National Federation of Independent Business v. Department of Labor and Ohio v. Department of Labor (“The OSHA Cases”), the Court blocked enforcement of the Occupational Safety and Health Administration (OSHA) COVID-19 Emergency Temporary Standard (ETS) for certain U.S. workplaces.

In Biden v. Missouri and Becerra v. Louisiana (“The CMS Cases”), the Court allowed a Centers for Medicare and Medicaid Services (CMS) rule to take effect requiring providers to ensure that staff are vaccinated against COVID-19. The Court’s decisions turn on the Justices’ interpretations of federal agency powers.

The OSHA Cases: On November 5, 2021, OSHA promulgated the ETS, generally requiring workplaces with more than 100 employees to implement employee COVID-19 vaccine-or-test policies. The ETS faced instantaneous opposition in courts across the nation by several states, businesses, and other organizations. On December 17, the Sixth Circuit rejected preliminary challenges to the ETS, finding in part that OSHA had clear authority to “protect workers against infectious diseases.”

The Supreme Court disagreed. In blocking enforcement of the ETS, the Court reasoned that the Secretary of Labor, through OSHA, does not have the authority to issue “broad public health measures.” Rather, under the Occupational Safety and Health (OSH) Act, the Secretary may regulate “occupation-specific risks” and set “workplace safety standards.”

The Secretary may not “regulate the hazards of daily life,”—public health threats which are not unique to the workplace. The Court left a small amount of room for a narrower standard addressing “special danger[s]” COVID-19 might pose in a particular working environment. In a blistering dissent, Justices Breyer, Sotomayor, and Kagan criticized the majority for placing limitations on OSHA’s authority that do not appear in statute.

The CMS Cases. CMS promulgated its own rule requiring COVID-19 vaccination of program participant staff on November 5, 2021, causing a similar flood of nationwide litigation. After several inconsistent lower court rulings, the Supreme Court allowed the CMS COVID-19 vaccine mandate to take effect, concluding that the Secretary of Health and Human Services was plainly authorized to issue it.

The Secretary can set requirements necessary for the “health and safety of individuals” receiving program services, and the CMS vaccine mandate clearly falls within the scope of that authority. Vaccine requirements in healthcare settings are common, they help keep patients safe, and CMS routinely imposes conditions of participation for receipt of funds. Justices Thomas, Alito, Gorsuch, and Barrett dissented, arguing CMS does not have the authority to issue a vaccine mandate.

The Court’s decisions are not the end of the road—in theory, they simply indicate whether the rules can or cannot be enforced while federal courts consider the legal challenges to them.

The ETS (ASHA Rule) has been blocked pending further litigation, while the CMS mandate can take effect. Still, with a clear 5-4 vote supporting the CMS mandate, and a clear 6-3 vote against the OSHA ETS, lower courts may be inclined to follow these interpretations.

Jennifer L. Piatt, J.D., LL.M., is a Research Scholar, Center for Public Health Law and Policy, Sandra Day O’Connor College of Law, Arizona State University.

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Which Entities & Employees are Covered Under the CMS Vaccine Requirement?

Now that the CMS vaccine requirement is settled law (probably) who does it apply to? Here is CMS’ Guidance Memo with the details. The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types:

Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal Disease Facilities, Home Health Agencies, Home Infusion Therapy Suppliers, Hospices, Hospitals, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities, Programs for All-Inclusive Care for the Elderly Organizations, Rural Health Clinics/Medicare Federally Qualified Health Centers, and Long Term Care facilities.

Test Positivity Reaches 60% with 175,000 COVID Cases Reported Last Week in Arizona: Ducey & Herrington Remain At Large

View the Full Epidemiology & Hospital Occupancy Report

Arizona is experiencing historic levels of community transmission attributable to the newly dominant Omicron variant.  Test positivity is insanely high (60%) reminding us that test capacity, accessibility, and/or uptake is wholly inadequate. Arizona, like much of the United States, is in the midst of another large pandemic wave. Expect transmission to peak in late January with very large numbers of hospitalizations continuing into February. The greatest burden on our health care system will shift towards emergency departments and general wards and away from our ICU facilities.

As of January 9th, new cases were being diagnosed at a rate of 1494 cases per 100K residents per week. Given the experience of eastern states, we can expect this rate to likely peak in the ballpark of 3000 cases per 100K residents per week before the end of the month. Given it is now January 15th, rates are considerably higher as your read this in the moment. For example, the ADHS Dashboard recorded a whopping 24,964 cases on January 15th which is roughly equivalent to 175,000 per week!

Mask mandates were needed at municipal and county levels to reduce transmission, blunt the worst of the Omicron wave, and relieve overwhelmed hospitals. Now, hospitals will just have to grin and bear it.

COVID-19 hospital occupancy is once again increasing and should continue to do so throughout January. Hospitals should prepare for >30% occupancy in general wards and in the ICU. Access to care will continue to be further restricted in the face of staff shortages owing to infections among healthcare workers. However, healthcare workers have told to “suck it up, Buttercup” and work even if COVID-19 positive.

January, and perhaps early February, will be hospital’s most difficult month with the tail of the Delta wave, below average but still meaningful seasonal influenza, and a large Omicron surge.

Weekly COVID-19 deaths have now reached 500 per week and should remain at or below this level as the tail end of the Delta wave recedes. So far, 25068 Arizonans have lost their lives to COVID-19.

Editorial Note: I’ll spare you any editorial notes this week. At this point, one just has to throw their hands up and say- well, if these circumstances won’t convince Ducey & Herrington to do anything, nothing will.

U.S. Supreme Court Upholds CMS’ Vaccine Requirement; Strikes Down OSHA’s Vaccinate or Test Rule

The Supreme Court just stopped enforcement of OSHA’s emergency rule that would have required employers with more than 100 staff to require that their team be vaccinated or undergo periodic testing. The court said that OSHA doesn’t have the authority to impose the vaccine or test requirement. In the unsigned opinion called National Federation of Independent Business v. OSHA the court wrote that:

Although 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.

The vote on the OSHA provision was 6-3 with the usual cast of characters voting exactly as you would expect.

However, the court upheld CMS’ new requirement that people employed at health care facilities that receive federal Medicare and Medicaid be vaccinated. That measure will now take effect this month and will covers about 10 million workers nationally, about 200,000 workers in AZ.

In that case, called Biden v. Missouri the 5-4 court majority held that CMS does have the authority to implement the vaccine requirement. The majority wrote that:

The challenges posed by a global pandemic do not allow a federal agency to exercise power that Congress has not conferred upon it. At the same time, such unprecedented circumstances provide no grounds for limiting the exercise of authorities the agency has long been recognized to have.

Dissenting were Thomas, Alito, Gorsuch and Barrett.

Masking, Ventilation, & Air Filtration Effectively Reduce Classroom Transmission of COVID

Yesterday I gave a talk for the Arizona Association of School Business Officials about COVID. During the talk I discussed a few evidence-based interventions that lower transmission of COVID in schools, including universal masking, ventilation and air filtration. After the talk, a few of the attendees asked me for the study I was referencing during my talk called SARS-CoV-2 aerosol transmission in schools: the effectiveness of different interventions.

I thought I’d post this blog so everybody could find that study easier. Here are the Results and Conclusions of the study:

Results

The most effective single intervention was natural ventilation through the full opening of six windows all day during the winter (14-fold decrease in cumulative dose), followed by the universal use of surgical face masks (8-fold decrease). In the spring/summer, natural ventilation was only effective (≥ 2-fold decrease) when windows were fully open all day. In the winter, partly opening two windows all day or fully opening six windows at the end of each class was effective as well (≥ 2-fold decrease).

One HEPA filter was as effective as two windows partly open all day during the winter (2.5-fold decrease) while two filters were more effective (4-fold decrease). Combined interventions (i.e., natural ventilation, masks, and HEPA filtration) were the most effective (≥ 30-fold decrease). Combined interventions remained highly effective in the presence of a super-spreader.

Conclusions

Natural ventilation, face masks, and HEPA filtration are effective interventions to reduce SARS-CoV-2 aerosol transmission. These measures should be combined and complemented by additional interventions (e.g., physical distancing, hygiene, testing, contact tracing, and vaccination) to maximize benefit.

Arizona Legislative Session Begins: AzPHA Starts Taking Positions on Bills

We’re off to the races for the 2nd Regular Session of the 55th Legislature.  Over 100 bills have already been pre-filed. So far, there are several repeat themes from the 2021 session on election procedure, school choice, and education issues, and restricting public health and healthcare mandates. We’ve already signed up in opposition to a few of those.

AzPHA will be activating our public health policy committee meetings starting next Friday, January 21. I made the appointments in our member Basecamp. I’ll have more details in next Sunday’s member policy update.

The House Health Committee has some new faces, including Representative Beverly Pingerelli (R-LD21) and former Health Committee member Rep. Pamela Powers Hannley (D-LD9), as well as a new Vice-Chair in Rep. Steve Kaiser (R-LD15). The Senate Health Committee also has one new member in recently appointed Senator Raquel Terán (D-LD30).

Senate Health Committee

Committee Members (5R 3D)

Member Position
Nancy Barto (R) Chairman
Rosanna Gabaldon (D) Member
Sally Ann Gonzales (D) Member
Tyler Pace (R) Vice-Chairman
Wendy Rogers (R) Member
Thomas Shope (R) Member
Raquel Terán (D) Member
Kelly Townsend (R) Member

Senate Health Committee will meet on Wednesdays in SHR1 (time TBD)

Here’s the roster of Senators with their contact information: Senate Member Roster

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House Health Committee

Committee Members (5R 4D)

Member Position
Kelli Butler (D) Member
Joseph Chaplik (R) Member
Alma Hernandez (D) Member
Steve Kaiser (R) Vice-Chairman
Joanne Osborne (R) Chairman
Beverly Pingerelli (R) Member
Pamela Powers Hannley (D) Member
Amish Shah (D) Member
Justin Wilmeth (R) Member

House Health Committee will meet on Mondays in HHR4 (time TBD)

Here’s the roster of House members with their contact information: House Member Roster

Supreme Court Hears Oral Arguments on the CMS and OSHA Vaccine Mandates: Decision Expected this Week

Will Ducey Sabotage the Effort?

The U.S. Supreme Court heard oral arguments last week about whether CMS and OSHA used proper procedures and were acting within their statutory authority when they promulgated their vaccine mandates. The CMS mandate applies to healthcare workers while the OSHA mandate applies to workers at places of employment with over 100 employees.

Due to rulings issued by different circuit courts, the CMS mandate is currently enforceable in half the country (we’re in a circuit court area where the mandate is currently not enforceable). CMS announced on December 28 it would begin enforcing the mandate in 25 states (but not in AZ).

Hopefully the US Supreme Court rules in favor of the mandates in short order. Because our governor and state health director are unwilling to use any of their public health emergency authority for anything useful- we’re stuck with grabbing interventions wherever we can from the federal government.

Editorial Note: CMS will be able to enforce their own vaccine requirement as they have contractual authority over the covered entities (they accept CMS money for the services they provide). OSHA will need to rely on states to enforce the provisions (if upheld). In Arizona, the state OSHA agency is within the Arizona Industrial Commission – in the Division of Occupational Safety and Health (under a delegation agreement with OSHA).

The Commission is packed with Ducey appointees who will likely follow the direction of Governor Ducey and not enforce the vaccine mandate on businesses. When that occurs, OSHA should revoke Arizona’s delegation agreement for their unwillingness to comply with their contractual obligations.

Arizona Healthcare Providers Cry Out for Help

Arizona hospitals and healthcare workers are in world of hurt from both the demand and the supply side of the ledger. On the demand side- we are having a continued increase of unvaccinated persons presenting needing care for their COVID19 infection.

This is, of course, exacerbated by the fact that the governor and state health director are unwilling to use any of their public health emergency authority to implement any evidence-based public health measures like universal indoor mask mandates, vaccine status checks at bars, restaurants, and nightclubs, etc. They’re also hostile to any mitigation in schools – which leads to additional community spread.

Complicating the problem is that nurses, respiratory therapists, and other providers are increasingly calling in sick because of family illnesses- breakthrough or otherwise. Additionally, temporary and traveling nurse agencies are actively recruiting hospital nursing staff and then turning around and hiring out those nurses at a higher rate (and paying the nurses more than they were getting at their former employer). This has been a huge problem that is continuing to get worse.

Stephanie Innes at the Arizona Republic had a good story last week ‘Enough is enough’: AZ health care workers want action against omicron that highlights the struggles hospitals and healthcare providers are having – emphasizing a call to action from over 1000 healthcare workers urging Ducey and Herrington to exercise some authority to help.

It feels like an act of desperation though…  because neither have any interest whatsoever in even temporarily implementing the evidence-based measures that would reduce suffering and save lives.

COVID-19 In Arizona: The Crescendo Begins While Ducey & Herrington Sit on Their Hands

Read Dr. Gerald’s Weekly COVID Epidemiology & Hospital Occupancy Report

From Dr. Gerald today:

Good morning, all:

Today, I am reminded of the M*A*S*H* episode, Preventative Medicine, where Hawkeye performs an appendectomy on Lieutenant Colonel Lacy, a commander whose unit suffered more causalities than any other in theatre. Of course, the Colonel’s appendix was perfectly normal. Hawkeye, through frustration, violated his Hippocratic Oath to ‘do no harm’ in order to serve a greater good by operating on the commander and getting him off the battlefield.
Why am I reminded of this now? Well, Arizona’s leaders are recklessly pursuing a “new normal” strategy on the eve of Arizona’s largest SARS-CoV-2 outbreak of the pandemic. As I type this, we are setting new records for viral transmission; yet, our state, county, and institutional leaders are maintaining their laissez-faire stance. Sadly, the outcome will be more death and disability than necessary, more death and disability than others in similar circumstances will experience.
I struggle to understand why our leaders are willing to take such great risks, to take such strong stands to avoid the costs necessary to protect those entrusted to their care. Have our leaders lost any sense of noblesse oblige? Must every decision be transactional where no sacrifice is too small to be avoided? Our current stance only make sense when transactional gains are concentrated among the privileged and the harms spread diffusely among the disadvantaged.
My public health colleagues have argued for more aggressive action. We have provided ample warning of the potential and likely consequences. Our leaders have failed to head these warnings. Assuredly, not all of us are going to die. In fact, most of us will be just fine. But why should we accept such a high requirement before acting? Are 30,000 Arizonan deaths not enough? How many more are we willing to throw on the pyre for the appearance of ‘normalcy?’
As always, I welcome suggestions or corrections.
Joe

Looking to Make a Career Move in 2022?  Looking for New Members for Your Team?

The Arizona Public Health Association’s Career Center might be the ticket you’re looking for to find the right opportunity or candidate.

Looking for a Job?

One of your AzPHA member benefits is access to our career center, where you can find a multitude of jobs in the public health, healthcare, laboratory sciences and many other fields. Simply visit the site from time to time and check out what’s out there. You can also set up an account as a ‘Job Seeker” under that navigation tab at the top of the site.

There’s also a job center resource room to help you make your resume stand out, interview tips, and pointers to use social to help your search. You can also upload your resume to get more visibility by setting up the free job seeker account.

I’m in the process of priming the pump with more jobs at our organizational members’ workplaces, so be sure to check back from time to time to check what’s out there.

Interested in Posting a Job?

If you’re interested in posting a job on our site, simply create an employer account. We have several product categories depending on what your needs are, including Basic Posting, Passive Job Seeker Package, and Enhanced Posting- ranging from $99 to $199.

The $199 package includes getting your job emailed to to over 27,000 people, a 30 day posting period. Your job will be highlighted and will stay near top of list on job board too. There are additional package deals for posting multiple jobs.

If your employer is an organizational member of AzPHA I can create some time-limited free coupons that you can use to post some jobs. To get one of those coupons contact me at willhumble@azpha.org.

Happy New Year!

Pearl Tang, MD Bequeaths Major Gift to the Arizona Public Health Association

Longtime AzPHA member Pearl Tang, MD passed away last summer at the age of 99. We were notified recently that Dr. Tang bequeathed $50,000 to the Arizona Public Health Association in her will. What a tremendous gift.

Dr. Tang was a public health pioneer and powerhouse. She cared for so many and helped save lives. Her strength of character and personality helped her achieve many accomplishments. She was such an amazing person.

She routinely attended the quarterly AzPHA retiree lunches that are organized by Barbara Burkholder. Dr. Tang was a member of AzPHA for as long as our computer records go.

Before Dr. Tang started her public health career, she left her home in Shanghai, China, and in 1947 married a Chinese-speaking American, Thomas Tang, whom she had met in 1945 while he was stationed in Shanghai during his World War II service. This brought her to Arizona, his home. By this time she had completed her medical training in Shanghai and her residency in obstetrics and gynecology in Quebec City, Canada.

While waiting acceptance by Arizona medical examiners of her foreign credentials she studied and received an MS degree from the University of Arizona in microbiology (1950), after which she was hired by the US Public Health Service to conduct a study of diarrhea diseases. During this yearlong study she identified for the first time the pathogenic E. Coli, a result of national importance.

She and her lawyer husband successfully challenged the Medical Board to allow her to take her qualifying exams, which she passed in 1951.

As a locally recognized physician she was hired to be in charge of the hospital on the San Carlos Indian Reservation. This brought her in contact with the Indian Health Service and other services in rural Arizona.

Dr. Tang was hired part time by the Maricopa County Health Department to develop an immunization program for children in urban and rural parts of the county where she encountered the substandard living conditions and lack of available clean water common among her patients.

This turned into full time work in the well-baby clinics. Working with the staff of public health nurses using statistics collected in each area she instituted prevention education through in-home visits. She then facilitated the establishment of prenatal care clinics in the areas of high infant mortality.

When she was the Chief of Maternal and Child Health for the county she used teamwork, volunteers and federal funds through the 60s and 70s to significantly reduced the infant mortality rates.

For the rest of Pearl’s career until she retired in 1982 she continued to plan, develop, find funding and advocate among the policy making elected officials for new programs. Among them were uterine cancer screening, free dental clinics for children, school health, nutrition, family planning and health care in the Head Start programs.

Because she represents the basic public health values of trained science-based decision making, observant community-based program development and support and a creative spirit and sense of adventure, Pearl’s public health career is a model acknowledged and admired by her public health community.

She was recognized with our Senator Andy Nichols Honor Award in 1969 and given a Lifetime membership in AzPHA in 2012. We posthumously recognized her lifetime work, awarding her our 2021 Elsie Eyer Commitment to Underserved People Award. She received the Diana Gregory Outreach Services Lifetime Achievement Award in 2015. 

Here’s a tribute to her during Women’s History Month a couple of months before her passing Pearl Tang, pioneering Arizona doctor, is a name everyone should know and an article in the Arizona Republic about her live and passing Pearl Tang, first Asian female doctor in Arizona.

The AzPHA Board of Directors will be making decisions about how to use Dr. Tang’s incredible gift to improve public health outcomes in the coming months.