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.
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 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:
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.
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.
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  that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.
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/
[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 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.
*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.
The last year has seen a flurry of lawsuits and demand letters to health care and other companies, and even a variety of nonprofits, alleging that those entities have websites that are not accessible to those who are blind or have low vision and thus allegedly violate the Americans With Disabilities Act (ADA). The U.S. Department of Health and Human Services’(HHS) Office for Civil Rights (OCR) enforces nondiscrimination and accommodation obligations as to health care entities providing services to Medicare and Medicaid recipients with disabilities. In an ironic twist, the National Federation of the Blind has brought suit in U.S. District Court, District of Massachusetts, alleging that HHS’s sub-agency, the Centers for Medicare and Medicaid Services (CMS) and its CMS subcontractors, have systemically violated the civil rights of blind Medicare recipients.
The purpose of the lawsuit, entitled Figueroa v Burwell (PDF), is stated to be “to require HHS to provide blind individuals meaningful and equally effective access to their Medicare information, as required by Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794” (Rehab Act). (The Rehab Act is the predecessor to, and similar to, the ADA, but applies to the government and federal contractors and financial aid recipients.) The suit notes that CMS is the largest single payor for health care in the country providing coverage to nearly 90 million persons through Medicare, Medicaid and the State Children’s Health Insurance Program.
The suit claims that CMS regularly communicates information to blind persons using inaccessible electronic formats and print. By doing so, the suit alleges, blind beneficiaries have faced loss of benefits and health care disruption. The suit also claims that, in response to Section 504 complaints filed in 2011 and 2012 with the OCR under Section 504 of the Rehab Act, CMS had entered into an agreement entitled the “Commitment to Action to Resolve DREDF Section 504 Complaints.” The Commitment set forth a time period within which CMS was to take specified actions to provide effective communications for individuals with disabilities consistent with Section 504. Pursuant to the agreement, CMS allegedly was required to complete a “Long Term Action Plan” by April 15, 2015, to provide effective cross disability communication access and appropriate auxiliary aids and services to CMS beneficiaries and consumers. The suit alleges that no such action plan was provided.
The suit is a good reminder to health care companies that they should consider whether their websites are accessible to blind and low vision individuals. It is entirely possible that the suit against CMS will cause it, or the OCR, to take an interest in the accessibility of the websites and the auxiliary aids and services used by health care providers who serve Medicare & Medicaid beneficiaries. It is an apt time for health care entities to consider having the accessibility of their websites and auxiliary aids and services reviewed with the assistance of counsel to provide legal advice on ADA and Rehab Act issues and to maximize the potential attorney-client privilege connected to such a review. This is the approach that many entities have taken with us.
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.
With the passage of A.B. 30, California became the first state to require all acute-care hospitals and skilled-nursing facilities to develop and implement comprehensive workplace violence prevention plans. After years of wrangling with California’s Division of Occupational Safety and Health (“Cal OSHA”), the law became effective on April 1, 2018.
This statute was conceived by Cal OSHA, in conjunction with unions such as the California Nurses Association to address the high risk of workplace injuries faced by health care workers daily. Overall, health care workers suffer the greatest number of workplace injuries, with over 650,000 individuals injured each year. Violence in the health care industry, however, is historically underreported; one survey estimated that just 19% of all violent events are reported.
Under the law, affected employers in the health care industry must prepare a workplace violence prevention plan that includes:
- Annual personnel education and training regarding workplace violence;
- A system for responding to and investigating violent or potentially violent incidents; and
- Procedures for annual assessment and evaluation of factors that could help to prevent workplace violence.
Employers must provide annual education and training to all employees at their facility who administer direct patient care, including physicians and temporary employees. This training must include, but not be limited to, information regarding:
- Identifying potentially harmful and violent situations and appropriate responses thereto;
- Reporting violent incidents to law enforcement officials; and
- Resources available to employees coping with the aftermath of a violent incident, such as critical incident stress debriefing and/or employee assistance programs.
Employers’ annual assessment identifying the factors that could possibly minimize the number of incidents of workplace violence should include a review of staffing and staffing patterns; the sufficiency of security systems at the facility; job design, equipment, and facilities; and areas of high security risk including entry and exit points for employees during late-night and early-morning shifts and employee parking lot safety.
Additionally, employers must develop these workplace prevention plans with input from their employees and any applicable collective bargaining agents. Employers are also expressly prohibited from taking punitive or retaliatory action against employees for reporting violent incidents.
Employers, however, should be aware of the dichotomy between interests regulated by Cal OSHA and by the Centers for Medicare and Medicaid Services (CMS). While Cal OSHA creates rules to ensure health care workers have a safe work environment free from harm, CMS creates rules to control aggressive patients in order to protect patients’ rights. These competing interests often create conflicting obligations for health care facilities. With Cal OSHA designating health care as a high risk industry for workplace violence and CMS focusing heavily on patient safety and patient rights, health care facilities must carefully navigate these competing obligations to appropriately protect both their employees and their patients.
Employers with affected health care operations in California should consult counsel for assistance with the development of a legally-compliant violence prevention plan and annual training materials in light of this new regulation.