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Centers for Medicare and Medicaid Services (CMS) coercion of mandates
CMS issues rules separate from executive orders to enforce mandates. CMS has never previously imposed vaccinations. 86 Fed. Reg. at 61,567
Many health care employees are seeking answers to the failure of their employers to recognize natural immunity and religious and medical exemptions to vaccine mandates. It is all about protecting the flow of money from the federal government to the providers. Most hospitals receive about 60% of their funding from the medicare and medicaid. The prospect of putting that funding at risk terrifies administrators. So they become unwilling to push back on unconstitutional federal behavior. They don’t care about the feelings, health, or religious beliefs of the employees.
For nursing homes, home health agencies and hospice, CMS has stated that it intends to enforce civil monetary penalties, denial of payment and termination from the Medicare and Medicaid program to force vaccine mandates on medical providers. Non-compliant health system face the prospect of not being able to bill for services provided. CMS has said it intends to “work with” noncompliant health care facilities to bring them into compliance.
ANALYSIS OF THE ADMINISTRATIVE PROCEDURES ACT AS APPLIED TO THE CMS VACCINE MANDATE
November 15, 2021
I. The Mandate
The Department of Health and Human Services, Centers for Medicare & Medicaid, on November 5, 2021, published in the Federal Register the Interim final rule with comment period (IFC) entitled “Medicare and Medicaid Programs; Omnibus COVID–19 Health Care Staff Vaccination.”
Covered providers must implement the CMS vaccine mandate in two 30-day phases. (IFC at 61,571). Phase 1 requires that staff receive the first dose of the vaccine or request a medical or religious exemption by December 5, 2021. Phase 2 mandates that non-exempt staff be fully vaccinated by January 4, 2022.
b. Effective Date
The IFC became immediately effective on November 5, 2021—the day it was published. (IFC at 61,555).
c. Comment Period
While there is a “comment period,” it ends on January 4, 2022, the date all persons covered under the IFC must be fully vaccinated or exempt. (IFC at 61,555). The comment period does not stay the effective date of the rule.
“[P]roviders and suppliers that are cited for noncompliance may be subject to enforcement remedies imposed by CMS depending on the level of noncompliance and the remedies available under Federal law (for example, civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement).” (IFC at 61,574).
e. Lack of Notice and Pre-Enactment Comment Period
No notice was published in the Federal Register as mandated by the Administrative Procedures Act, 5 U.S.C. § 533(b). Section 533(b) of the APA also requires that the notice refer to the legal authority under which the rule is proposed. Section 1871(b)(1) of the Social Security Act (of which sections 1102 and 1871 give authority to the Secretary of HHS to make and publish rules and regulations), requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment. (IFC at 61,583).
II. The Administrative Procedures Act and Exceptions
a. The Act (5 U.S.C. 553)
(a) This section applies, according to the provisions thereof, except to the extent that there is involved--
(1) a military or foreign affairs function of the United States; or
(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.
(b) General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include--
(1) a statement of the time, place, and nature of public rule making proceedings;
(2) reference to the legal authority under which the rule is proposed; and
(3) either the terms or substance of the proposed rule or a description of the subjects and issues involved.
Except when notice or hearing is required by statute, this subsection does not apply--
(A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
(c) After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. After consideration of the relevant matter presented, the agency shall incorporate in the rules adopted a concise general statement of their basis and purpose. When rules are required by statute to be made on the record after opportunity for an agency hearing, sections 556 and 557 of this title apply instead of this subsection.
(d) The required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except--
(1) a substantive rule which grants or recognizes an exemption or relieves a restriction;
(2) interpretative rules and statements of policy; or
(3) as otherwise provided by the agency for good cause found and published with the rule.
(e) Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.
b. The “Good Cause” Exception to Section 553 Notice and Comment Requirements
Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive notice and comment procedures if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.
5 U.S.C. 553(b)(B) states : General notice of proposed rule making shall be published in the Federal Register […] Except when notice or hearing is required by statute, this subsection does not apply-- when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
c. HHS Invoked 553(b)(B)
HHS invoked “Section 553(b)(B)” of the APA, stating the following (final paragraph of the substantially lengthier reasoning):
As noted earlier in this section, a combination of factors, including but not limited to failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements, potential harm to patients from unvaccinated healthcare workers, and continuing strain on the health care system and known efficacy and safety of available vaccines, have persuaded us that a vaccine mandate for health care workers is an essential component of the nation’s COVID–19 response. Further, it would endanger the health and safety of patients, and be contrary to the public interest to delay imposing it. Therefore, we believe it would be impracticable and contrary to the public interest for us to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. We find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For those same reasons, as authorized by the Small Business Regulatory Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA), 5 U.S.C. 808(2), we find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA. Therefore, we find there is good cause to waive the CRA’s delay in effective date pursuant to section 808(2) of the CRA.
III. Case Law Cautioning Against the Use of 553(b)(B) with Post-Enactment Comment Period
This exception has been struck down several times in this context.
a. U.S. Steel Corp. v. U.S. E.P.A., 595 F.2d 207, 214–15 (5th Cir.1979)
“The exceptions to section 553 will be narrowly construed and only reluctantly countenanced. This is consistent, of course, with Congress’s clear intent to preserve the statutory purpose of informal rulemaking by making sure those exceptions did not become escape clauses which an agency could utilize at its whim.” Alcaraz v. Block, 746 F.2d 593, 612 (9th Cir.1984), citing Am. Fedn. of Govt. Emp., AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C.Cir.1981), quoting New Jersey, Department of Environmental Protection v. EPA, 626 F.2d 1038, 1045 (D.C.Cir.1980) (citing legislative history of the APA).
In U.S. Steel Corp. v. U.S. E.P.A., 595 F.2d 207, 214–15 (5th Cir.1979), the Fifth Circuit stated, in a challenge to a rule promulgated by the EPA under similar circumstances:
In short the Agency [EPA] has simply failed to show strong enough reason to invoke the s 553(b)(B) exception. This exception [553(b)(B)] should be read narrowly. American Iron and Steel Institute v. EPA, supra, 568 F.2d at 292. It is an important safety valve to be used where delay would do real harm. It should not be used, however, to circumvent the notice and comment requirements whenever an agency finds it inconvenient to follow them.
EPA argues that even if it was obliged to afford opportunity for s 553 notice and comment before making the designations, its failure to do so was cured by its acceptance of comments after the effective date. The argument mixes notions of mootness, harmless error, and minimal injury to petitioners. While the substantial public health interests involved give these arguments some surface appeal, accepting them would lead in the long run to depriving parties affected by agency action of any way to enforce their s 553 rights to pre-promulgation notice and comment.
Essentially the argument is that despite its lack of literal compliance with s 553 the EPA satisfied the intent of s 553 by accepting post-promulgation comments and keeping an open mind about revisions. The EPA overlooks, however, the crucial difference between comments before and after rule promulgation. Section 553 is designed to ensure that affected parties have an opportunity to participate in and influence agency decision making at an early stage, when the agency is more likely to give real consideration to alternative ideas. Other courts have recognized this difference and rejected arguments similar to that asserted here:
Permitting the submission of views after the effective date is no substitute for the right of interested persons to make their views known to the agency in time to influence the rule making process in a meaningful way. . . . “We doubt that persons would bother to submit their views or that the Secretary would seriously consider their suggestions after the regulations are a Fait accompli.”
City of New York v. Diamond, 379 F.Supp. 503, 517 (S.D.N.Y.1974), Quoting Kelly v. Department of Interior, 339 F.Supp. 1095, 1101 (E.D.Cal.1972). Similar conclusions were reached in Maryland v. EPA, 530 F.2d 215, 222 (CA4, 1975), Vacated on other grounds sub nom. EPA v. Brown, 431 U.S. 99, 97 S.Ct. 1635, 52 L.Ed.2d 166 (1977), and Wagner Electric Corp. v. Volpe, 466 F.2d 1013, 1020 (CA3, 1972). The case at hand does not differ from these in any significant way. Were we to allow the EPA to prevail on this point we would make the provisions of s 553 virtually unenforceable. An agency that wished to dispense with pre-promulgation notice and comment could simply do so, invite post-promulgation comment, and republish the regulation before a reviewing court could act.
b. Sixth Circuit Agreement with U.S. Steel Corp.
“[…] [T]the agency's failure to comply with the rulemaking requirements of the Administrative Procedure Act is fatal to the validity of the maintenance amount ceiling rule.” State of Ohio Dept. of Human Services v. U.S. Dept. of Health & Human Services, Health Care Financing Admin., 862 F.2d 1228, 1237 (6th Cir.1988).
This section of the U.S. Steel Corp. v. U.S. E.P.A. opinion was cited and reproduced by the Sixth Circuit in State of Ohio Dept. of Human Services v. U.S. Dept. of Health & Human Services, Health Care Financing Admin., 862 F.2d 1228, 1236 (6th Cir.1988) (stating “Were we to accept the argument that a mere expression of a willingness to receive post-promulgation comments is enough to excuse an agency’s failure to seek and consider comments before promulgation, it “would lead in the long run to depriving parties affected by agency action of any way to enforce their § 553 rights to pre-promulgation notice and comment.”).
IV. Arguments Against HHS’s Reasoning for Invoking the Exception
Notice and comment are essential to proposed rulemaking. The reasons HHS offers for suspending the procedures are at minimum hotly debated. They include the following:
Failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements.
What is a “sufficiently high level of vaccination?”
Why is forced vaccination a legitimate state interest?
Potential harm to patients from unvaccinated healthcare workers.
Bald assertion that there is a risk inherent in being treated by an unvaccinated physician or merely coming into contact with an unvaccinated employee within a healthcare system. Notwithstanding that this ignores the supposed benefits that vaccinated individuals should have, the fact that it has been proven that vaccinated individuals still spread the virus, and the entire year preceding the rollout of the vaccines in which nobody was vaccinated and thus patients were receiving care from unvaccinated hospital employees, this also presumes that the alleged risk of being treated by an unvaccinated physician outweighs the greater national risk of the severe shortage of healthcare workers that the rollout of this Rule presents.
Continuing strain on the health care system and known efficacy and safety of available vaccines.
A greater strain will be put on the healthcare system via resignations occasioned by this Rule.
The VAERS database suggests these vaccines are not safe.
The lack of long term studies firmly suggests there is no “known efficacy.”
“Natural immunity” is not equivalent to receiving the COVID–19 vaccine. Cleveland Clinic study suggests otherwise. Finding that “Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.”