Health-law-columns

As explained in greater detail by our colleague Stuart M. Gerson, the Supreme Court of the United States handed down two major, and quickly decided, rulings on January 13, 2022. After hearing oral arguments only six days earlier, the Court issued two unsigned decisions per curiam. A 5-4 decision in Biden v. Missouri dissolved a preliminary injunction against enforcement of an interim final rule (“Rule”) promulgated by the Centers for Medicare & Medicaid Services (CMS), requiring recipients of federal Medicare and Medicaid funding to ensure that their employees are vaccinated against COVID-19.

Continue Reading Supreme Court Blocks OSHA Vax-or-Test ETS for Large Employers, Allows CMS Health Care Vax Rule

Reversing its prior position, CMS announced on December 28, 2021, that it would begin enforcement of the COVID-19 vaccine requirement, established by the interim final rule, published November 05, 2021, in 25 states and the District of Columbia[1] in a phased approach beginning January 27, 2022. With the announcement CMS issued guidance for surveyors regarding enforcement in S&C Memo QSO 22-07-ALL (“Memo”), describing how CMS will enforce the rule and how facilities that are non-compliant may avoid enforcement action if meeting certain threshold criteria during periods up to 90 days after issuance of the Memo as follows:

Continue Reading CMS Reverses Position and Will Begin Enforcement of Health Care Staff Vaccine Requirement

Health-law-columns

On the evening of Wednesday, December 22, 2021, the Supreme Court of the United States announced that it will hold a special session on January 7, 2022, to hear oral argument in cases concerning whether two Biden administration vaccine mandates should be stayed. One is an interim final rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”); the other is an Emergency Temporary Standard (“ETS”) issued by the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”). The CMS interim final rule, presently stayed in 24 states, would require COVID-19 vaccination for staff employed at Medicare and Medicaid certified providers and suppliers. The OSHA ETS, which requires businesses with 100 or more employees to ensure that workers are vaccinated against the coronavirus or otherwise to undergo weekly COVID-19 testing, was allowed to take effect when a divided panel of the United States Court of Appeals for the Sixth Circuit, to which the consolidated challenges had been assigned by the Judicial Panel on Multidistrict Litigation issued a ruling, on December 17, 2021, lifting a stay that had been previously entered by the Fifth Circuit. Multiple private sector litigants and states immediately challenged the decision.

Continue Reading Rare Hearing by the Supreme Court as to Stays in Vaccine Mandate Cases

As we previously reported, the Centers for Medicare & Medicaid Services’ (CMS’s) interim final rule (the “Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) was effectively stayed nationwide on November 30, 2021, by the U.S. District Court for the Western District of Louisiana (the “Louisiana Court”).  In yet another twist to the ongoing legal battles, the U.S. Court of Appeals for the Fifth Circuit lifted the nationwide stay and held that the Louisiana Court only had authority to block the vaccine mandate in the fourteen plaintiff states that brought suit in that court. Those states are Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.

Due to the litigation in the Eastern District of Missouri, as reported here, enforcement of the vaccine mandate is also blocked in ten other states:  Alaska, Arkansas, Kansas, Iowa, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.  In total, the vaccine mandate under the Rule is now stayed in twenty-four states, but is now in effect in the remaining twenty-six states.

Continue Reading Update: CMS Interim Final Rule Stay Lifted Nationwide, Still in Effect in Twenty-Four Plaintiff States

On December 13, 2021, the Supreme Court of the United States rejected the petition of New York health care workers seeking to stop the State from enforcing regulations requiring covered personnel of hospitals, nursing homes, public health centers, and other health care entities to be fully vaccinated against COVID-19 as a condition of continued employment, subject to narrow exceptions. The Supreme Court’s unsigned order allows the continuing enforcement of the regulations, as litigation of the multiple lawsuits challenging the statewide vaccine mandate for health care workers issued last August continues.

Continue Reading Supreme Court Lets New York’s Vaccine Mandate for Health Care Workers Stand

HEAL-Covid-test

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

Continue Reading CMS Issues Guidance on COVID-19 Testing in the Workplace

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.

Continue Reading Courts Grant Preliminary Injunctions Placing CMS Interim Final Rule on Hold

As featured in #WorkforceWednesday: The Centers for Medicare & Medicaid Services (CMS) issued an interim final rule outlining vaccine requirements for staff at Medicare- and Medicaid-certified providers and suppliers.

Attorney Frank Morris discusses the next steps for health care providers. In addition, covered employers should continue to monitor the recent litigation filed in the Eastern District of Missouri and the Western District of Louisiana seeking to permanently enjoin the CMS interim final rule.

See below for the video and podcast links. Visit https://www.ebglaw.com/insights/cms-vaccine-rule-for-health-care-workers/

Video: YouTube, Vimeo.

Podcast: Apple Podcasts, Google Podcasts, Overcast, Spotify, Stitcher.

[UPDATE, Nov. 30, 2021: The District Court for the Eastern District of Missouri grants injunction for the ten plaintiff states listed in the First Complaint.]

As we previously reported, effective November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (the Rule) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers as a Condition of Participation by January 4, 2022.

On November 10, 2021, a coalition of ten states lodged a complaint in the U.S. District Court for the Eastern District of Missouri (the “First Complaint”), which is subject to appeals in the U.S. Court of Appeals for the Eighth Circuit, seeking to set aside the Rule. On November 17, 2021, the U.S. District Court for the Eastern District of Missouri granted Plaintiff’s Motion to Expedite Briefing — requiring Defendant to file their response to the Plaintiffs’ Motion for Preliminary Injunction by November 22, 2021; and Plaintiffs to file their reply by November 23, 2021.

On November 15, 2021, a coalition of twelve different states filed a similar complaint (the “Second Complaint”) but, perhaps strategically, filed it with the United States District Court for the Western District of Louisiana, Monroe Division.  An appeal of the Louisiana District Court’s decision would go to the U.S. Court of Appeals for the Fifth Circuit, which recently stayed the OSHA vaccination Emergency Temporary Standard (ETS), reported here.

The Complaints

The First Complaint was filed by the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire.  The Second Complaint was lodged by the States of Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana Mississippi, Oklahoma, South Carolina, Utah, and West Virginia.  In total, twenty-two states joined one or the other of the complaints.

Both complaints make similar arguments.  To summarize, the States’ Attorneys General argue that CMS’s statutory authority does not authorize it to impose a vaccine mandate.  They also attack the implementation of the Rule, which was not subject to a notice and comment period as provided by the Administrative Procedure Act.  This period, usually sixty days, generally allows for interested parties to participate in the rulemaking process by submitting written data, views, or arguments before a rule is promulgated.  They further argue that the Rule is arbitrary and capricious because CMS failed to consider relevant factors in implementing the Rule, such as staff shortages, particularly in rural hospitals, alternatives to mandates (e.g., testing), and weighing an individual’s right to refuse medical treatment and failure to consult with the States under the Social Security Act where a rule would impact rural hospitals, among other contentions.

The States also make general arguments with respect to the Federal Government’s power.  First, the States’ Attorneys General argue that the Rule improperly allows for the Federal Government to have authority over states and their citizens, including Medicare state surveyors who review compliance by certified providers.  They also contend that the Rule violates Congress’s Spending Power in that Plaintiffs’ receipt of federal funds is conditioned on compliance with the Rule.

The States seek to set the Rule aside and request permanent injunctions to stop the imposition of the Rule’s vaccine requirements.

What Employers Subject to the Rule Should Do Now

Unless or until there is a stay of the Rule, covered facilities should consider moving forward with preparing the policies and procedures to comply with the Rule, including collecting vaccination information and providing a documented exemption application process based on federal law requirements (i.e., medical and religious accommodations under the Americans with Disabilities Act and Title VII of the Civil Rights Act of 1964). Employers with union represented employees should also consider discussing with the pertinent unions any potential impact the Rule may have on their represented employees.

Taking these steps, as discussed in more detail in our previously reported Insight (the first link above), will help ensure timely compliance in the event that no stay is issued.

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*Kamil Gajda, a Law Clerk – Admission Pending (not admitted to the practice of law) in the firm’s New York office, contributed to the preparation of this post.

On August 26, 2021, the Public Health and Health Planning Council approved an emergency regulation requiring health care personnel to be fully vaccinated against COVID-19. The emergency regulation is effective immediately and will remain in effect for 90 days, subject to review and renewal.

The emergency regulation supersedes the Section 16 Order issued by the New York Department of Health (“DOH”) on August 18, 2021, which mandated the vaccine for personnel at general hospitals and nursing homes.

The emergency regulation expands the mandate to cover personnel at entities beyond general hospitals and nursing homes to also include diagnostic and treatment centers, public health centers, rehabilitation centers, birth centers, adult care facilities, certified home health agencies, hospices, long-term home health care programs, AIDS home care programs, licensed home care service agencies and limited licensed home care service agencies (collectively “Covered Entities”). Under the regulation, covered personnel is defined as: “all persons employed or affiliated with a covered entity, whether paid or unpaid, including but not limited to employees, members of the medical and nursing staff, contract staff, students, and volunteers, who engage in activities such that if they were infected with COVID-19, they could potentially expose other covered personnel, patients or residents to the disease.”

Covered Entities must continuously require personnel to be fully vaccinated against COVID-19. Hospitals and nursing homes must require their current personnel to receive the first dose of the vaccine by September 27, 2021. “Fully vaccinated” for the purpose of this regulation shall be determined by the Department in accordance with applicable federal guidelines and recommendations. All other health care facilities must require their current personnel to receive the first dose of the vaccine by vaccinated by October 7, 2021. Proof of vaccination must be provided and include the manufacturer, lot number(s), date(s) of vaccination, and vaccinator or vaccine clinic site.

Notably, the emergency regulation eliminated the exemption due to a sincerely held religious belief that was included in the proposed emergency regulation and in the Section 16 Order. The emergency regulation provides for a medical exemption so long as it is supported by a certification issued by a licensed physician or certified nurse practitioner opining that the vaccine mandate would be detrimental to the individual’s health based on a pre-existing condition. Covered Entities are required to document the any medical exemptions, including the nature and duration of the medical exemption, and reasonable accommodations provided, in an individual’s medical file, maintained separately from the general personnel file, and ensure that such documentation is immediately available upon request by DOH.

In addition, the emergency regulation requires Covered Entities to develop and implement a policy and procedure to ensure covered personnel are vaccinated for COVID-19 and ensure that such policy and procedure is available to the DOH on request. The emergency regulation also requires Covered Entities, upon the DOH’s request, to report the number and percentage of total covered personnel; the number and percentage that have been vaccinated against COVID-19; and those who have been granted a medical exemption, along with any reasonable accommodation.

Finally, the emergency regulation provides that “[t]he Department may require all personnel, whether vaccinated or unvaccinated, to wear an appropriate face covering for the setting in which such personnel are working in a covered entity. Covered entities shall supply face coverings required by this section at no cost to personnel.”