Louisiana v. Becerra, 3:21-CV-03970
| Decision Date | 30 November 2021 |
| Docket Number | 3:21-CV-03970 |
| Parties | STATE OF LOUISIANA ET AL v. XAVIER BECERRA ET AL |
| Court | United States District Courts. 5th Circuit. United States District Courts. 5th Circuit. Western District of Louisiana |
KAYLA D. MCCLUSKY MAG. JUDGE
MEMORANDUM RULING
The issue before this Court is whether the Plaintiff States[1] are entitled to a preliminary injunction against the Government Defendants[2] as a result of a COVID-19 CMS vaccine mandate ("CMS Mandate") implemented by the Government Defendants on November 5, 2021. 86 Fed.Reg 61555-01. The CMS Mandate requires the staff of twenty-one types of Medicare and Medicaid healthcare providers to receive one vaccine by December 6, 2021, and to receive the second vaccine by January 4, 2022. Failure to comply with the CMS Mandate may result in penalties up to and including "termination of the Medicare/Medicaid Provider Agreement." 86 Fed.Reg. at 61574.
According to the CMS, the CMS Mandate regulates over 10.3 million health care workers in the United States. Id. at 61603. Of those 10.3 million, 2.4 million health care workers are currently unvaccinated. Id. at 61607.
Implicit in determining whether a preliminary injunction should be granted is determining whether the Government Defendants have the statutory and/or constitutional authority to implement the CMS Mandate. Finding that the Government Defendants do not have the authority to implement the CMS Mandate, this Court GRANTS Plaintiff States' Motion for Preliminary Injunction [Doc No. 2] and IMMEDIATELY ENJOINS and RESTRAINS the Government Defendants from implementing the CMS Mandate.
This case is about COVID-19 vaccine mandates. The CMS Mandate requires over 10.3 million healthcare workers to be fully vaccinated with one of the COVID-19 vaccines in two months. The first of two COVID-19 vaccines is required by December 6, 2021, and the second by January 4, 2022. The factual statements made herein should be considered as findings of fact and legal conclusions should be considered conclusions of law. This Court's job is to examine the appropriate statutes and/or constitutional authority for the Government Defendants to issue the specific CMS Mandate discussed herein. The opinion expressed hereto is legal, not political or personal.
On March 13, 2020, President Trump declared the COVID-19 pandemic a national emergency. On March 11, 2020, the World Health Organization ("WHO") declared COVID-19 a global pandemic.
On December 11, 2020, the U.S. Food and Drug Administration ("FDA") issued an Emergency Use Authorization ("EUA") for the Pfizer-BioNTech vaccine. The FDA issued an EUA for the Moderna COVID-19 vaccine on December 18, 2020, and issued an EUA for the Janssen COVID-19 vaccine on February 27, 2021.[3] The Pfizer-BioNTech COVID-19 vaccine received FDA approval on August 23, 2021 for individuals sixteen years of age and older.[4] On November 19, 2021, the FDA authorized Pfizer-BioNTech and Moderna COVID-19 boosters for all adults ages eighteen and older.[5]
The first cases of COVID-19 in the United States were recorded in January 2020.[6] Cases began surging thereafter with the highest surge from October 2020 to February 2021. The seven-day average for cases in the United States recorded a high on January 12, 2021, at 250, 512 cases. For the last ninety days, the seven-day average has declined from 164, 374 on September 2, 2021, to 94, 335 on November 23, 2021.[7]
In response to the pandemic, CMS issued six previous rules with regard to COVID-19. These rules were issued on April 6, 2020, May 8, 2020, September 2, 2020, November 6, 2020, May 13, 2021, and June 21, 2021. 86 Fed.Reg. at 61561. These previous actions dealt with revision of regulations, data reporting, and infection control requirements to protect healthcare workers from exposure to COVID-19. The June 21, 2021, Healthcare Emergency Temporary Standard ("ETS") required healthcare workers to develop a plan for each workplace, which included patient screening, protective equipment, aerosol procedures, physical distancing, physical barriers, cleaning and disinfecting, ventilation, health screening, training, recordkeeping, and reporting. Id.
On November 5, 2021, CMS issued the disputed Interim Final Rule ("IFR"), which contained the requirements for mandating COVID-19 vaccines. The IFR was described by CMS as "revises the requirements that Medicare and Medicaid certified providers and suppliers must meet to participate in the Medicare and Medicaid Programs."
The Mandate was effective on November 5, 2021, and established COVID-19 vaccination requirements for staff, and this included Medicare and Medicaid - certified providers and suppliers. The Mandate implemented the COVID-19 vaccinations in two phases. The first vaccine is to be required by December 6, 2021, and the second vaccine is to be required by January 4, 2022. The CMS Mandate went into effect immediately; there was no notice and comment under the Administrative Procedures Act 5 U.S.C. 553.
The mandate applies to the employees of Medicare and Medicaid providers and suppliers listed. 86 Fed.Reg. at 61556. CMS claimed authority to issue the mandate pursuant to §§ 1102, 1863, and 1871 of the Social Security Act. 86 Fed.Reg. at 61560, 61567. The reasoning for the mandate was: "In light of our responsibility to protect the health and safety of individuals providing and receiving care and services from the Medicare and Medicaid certified providers and suppliers, and CMS's broad authority to establish health and safety regulations, we are compelled to require staff vaccinations for COVID-19 in these settings." 86 Fed.Reg. 61560.
CMS indicated its mandate was "complementary to the OSHA ETS", [8] which also requires mandatory vaccinations. (Occupational Safety and Health Administration ("OSHA")). CMS admittedly has not previously required any vaccinations. 86 Fed.Reg. 61567. The mandate discussed the potential effect of health care workers choosing to leave their jobs rather than be vaccinated but concluded[9] there was insufficient evidence to quantify and compare adverse impacts on patient and residential care associated with temporary staffing losses. 86 Fed.Reg. at 61569.
Like the OSHA mandate, [10] the CMS mandate is described as a "common set of provisions for each applicable provider and supplier as there are no substantive regulatory differences across settings." 86 Fed.Reg. at 61570.
The CMS mandate also requires that the medical providers and suppliers "track and securely document" the vaccination status of each staff member, including storing staff members' medical records showing proof of vaccination. 86 Fed.Reg. 61572. The CMS mandate allows exemptions that are based upon existing Federal law. The mandate specifically states that it "preempts" the applicability of any state or local law providing for exemptions. 86 Fed.Reg. 61572.
In not inviting notice and comment pursuant to the Administrative Procedures Act, 5 U.S.C. 553, CMS found "good cause" that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest based upon the reasons set out at 86 Fed.Reg. 61583 to 61585.
President-Elect Biden initially did not think vaccines should be mandatory[11]. On September 9, 2021, President Biden changed his mind announcing his intention to impose a national mandate[12].
Both the OSHA Mandate and the CMS Mandate were imposed approximately two months later on November 5, 2021.
Medicare is a federal program that pays for healthcare for the elderly. Medicaid is a cooperative state-funded program that helps States finance medical care for their poor and disabled citizens. The Secretary of Health and Human Resources is charged through the Social Security Act with administrative responsibilities related to maintaining the Medicare and Medicaid Programs. 42 U.S.C. 301, et al.
The Social Security Act also delegates to the Secretary certain rule-making authority. As relevant here, 42 U.S.C. 1302(a) gives the Secretary the authority to make and publish rules and regulations that may be necessary to the efficient administration of the functions with which the Secretary is charged.
The Government Defendants maintain this Court does not have jurisdiction to hear the Plaintiff States' claims based upon the Medicare Act's channeling requirement, 42 U.S.C. 405(g) as incorporated by 42 U.S.C. 1395ii. The Government Defendants argue that Medicare and Medicaid's exclusive review scheme bars pre-enforcement challenges. The Government Defendants further claim the Plaintiff States are required to go through the statute's administrative review scheme and have an administrative hearing before filing suit in district court. Plaintiff States' claims arise under both the Medicare and Medicaid statutes, the United States Constitution, the Administrative Procedure Act, and the Congressional Review Act.
The Government Defendants cite Shalala v. Illinois Council on Long Term Care, Inc., 529 U.S. 1 (2000) for the proposition that any "arising under" jurisdictional claims must undergo the SSA's administrative process and that Congress made the review exclusive.
However both 42 U.S.C. 405(g) and 42 U.S.C. 1395ii do not apply in this case. 42 U.S.C. 405(h) states that the SSA administrative process only applies to actions "to recover on any claim arising under this subchapter." The "subchapter" refers to claims for benefits under the SSA. It does not apply to a claim for declaratory and injunctive relief as to the authority of CMS to make regulations. Plaintiff States are neither "institutions" nor "agencies" who are "dissatisfied" with the...
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