Employer and other group health plan sponsors, fiduciaries, administrators and insurers should prepare their plans and their administrators to respond appropriately to today’s (3/29/2022) U.S. Food and Drug Administration (“FDA”)’s authorization of a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for certain populations will affect health plan COVID-19 coverage, workplace vaccination mandates or both.
FDA Emergency Use Approval of Second COVID-19 Booster
On March 29, 2022, the FDA amended its e emergency use authorization (“EAU”) for COVID-19 vaccination to add authorization for second COVID-19 booster shots under the following circumstances:
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
- A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
The second booster doses EAU announced March 29 applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. For more information on the FDA COVID-19 Vaccine Approvals, see e.g. ,Comirnaty and Pfizer-BioNTech COVID-19 Vaccine; Spikevax and Moderna COVID-19 Vaccine; COVID-19 Vaccines; Emergency Use Authorization for Vaccines Explained.
Second Booster Authorization Health Plan Implications
Group health plans, their sponsors, fiduciaries, administrators and insurers need to evaluate their existing group health plan language to determine if and when their group health plan will cover second COVID-19 booster doses.
While Federal law currently mandates that all group health plans and group and individual health insurance covered by the Patient Protection & Affordable Care Act (“ACA”) cover FDA-approved initial vaccination and first booster vaccinations administered in accordance with recommendations of the Advisory Committee on Immunization Practices (“ACIP”), the ACIP as of now has not amended its COVID-19 vaccination recommendations to include the FDA second boosters approved by the FDA.
Health plans’ current obligation to cover without cost sharing initial COVID-19 vaccinations and first boosters in accordance with FDA authorizations to covered individuals arises under Section 3203 of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Since January 5, 2021, Section 3203 of the CARES Act has mandated that all group health plans and health insurance issuers subject to the Patient Protection and Affordable Care Act (“ACA”) cover without cost sharing any COVID-19 vaccine with an FDA approved EUA Biologics License Application (“BLA”) consistent with the recommendations of the ACIP. While the CARES Act mandates coverage for ACIP-recommended COVID-19 vaccinations, including vaccines and boosters securing FDA approval subsequent to the effective date of the mandate. As enacted, the CARES Act mandate grows to include COVID-19 vaccinations and booster shots securing FDA approval subsequent to its enactment when recommended by the ACIP. Since the CARES Act only mandates coverage of ACIP recommended vaccines and as of March 29, 2022, the second booster is nt ACIP recommended, the Cares Act does not appear to mandate group health plans and health plan insurers cover the second booster shot approved by the FDA as of March 29, 2022. If in the future the ACIP recommends the booster, coverage by ACA covered group health plans and individual and group health insurance would become mandatory.
As of March 29, 2022, coverage of the second COVID-19 booster with or without cost-sharing also does not appear to be required to comply with the preventive care mandates of §2713 of the Public Health Service Act [PHSA]) enacted as part of the ACA.
The ACA preventive care and other mandates generally apply to individual health insurance coverage, fully insured small- and large-group coverage, and self-insured group plans that are not grandfathered or otherwise exempt.
Where applicable, Section 2713’s preventive care mandate generally requires ACA covered plans to cover without cost sharing specified preventive health services recommended with an A or B rating by the United States Preventive Services Task Force (USPSTF) and any immunization with a recommendation by ACIP adopted by the Centers for Disease Control and Prevention (CDC), for routine use for a given individual. As of now neither agency has adopted a recommendation of the second COVID-19 vaccine booster. Since Section 2713 specifies that its coverage mandates cannot trigger an obligation for covered group health plans to cover a new or revised recommendation any sooner than one year after a new or revised recommendation ispublished, any future adoption by the USPSTF, but not the ACIP, of a recommendation of the second booster shot will not trigger a federal coverage mandate. the ACA preventive care mandate. In contrast, ACA covered health plans would become immediately obligated to cover the second COVID booster if and when the ACIP in the future adds it to its recommendations, as the CARES Act mandate effectively renders moot the one year waiting period applicable for the ACA mandate.
As ACA group health plans and health insurance will become immediately required by the CARES Act to cover the second booster if and when the ACIP amends its COVID recommendations to recommend the second booster, group health plans, their sponsors, fiduciaries, administrators and insurers should monitor the ACIP recommendations for possible changes.
Along with this diligent oversight, most plan sponsors, fiduciaries and administrators should review their existing health plan language to determine if their existing plan language provides the currently mandated coverage as well as if the current language expressly provides or is sufficiently ambiguous to open the door for construction of the plan as authorizing coverage beyond existing applicable mandates. The COVID-19 related operational disruptions and exigencies present when the existing COVID-19 coverage mandates took effect creates a substantial likelihood that many plans contain less than optimal language regarding the COVID-19 vaccine and other mandates. Employer and other health plan sponsors, insurers, fiduciaries and administrators should assess whether tightening up their health plan language for the vaccination and other mandates is advisable to minimize compliance exposure risks, plan administration errors or unnecessary overpayments. Regardless of whether any change in plan language is necessary or advisable, group health plan fiduciaries, sponsors, administrators and insurers should prepare plan administration team members to respond to likely questions from plan members about COVID-19 vaccine and other COVID-related coverage. Health plan and human resources staff should be trained both to provide the appropriate substantive responses and to follow appropriate processes and procedures to contain the spread of fiduciary liability and to minimize the retaliation and other risks.
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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About the Author
A Fellow in the American College of Employee Benefits Counsel repeatedly recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” by LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law and among the “Best Lawyers In Dallas” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other workforce, employee benefits, health care and insurance legal representation, public policy leadership and advocacy, coaching, scholarship and training.
Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, current Chair-Elect of the ABA Tort & Insurance Section (TIPS) Medicine and Law Committee, former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s has worked extensively health and other employee benefit plan, managed care and other health and wellness, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, workforce and vendor performance management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Ms. Stamer also shares her leadership through her extensive involvement in many professional, community and civic organizations including several current leadership roles in various ABA Committees, as a former Joint Committee on Employee Benefits Council Representative, former Society for Human Resources Management Region IV Board Chair and National Consultant’s Board Member; former Editorial Advisory Board Member and author for HR.com, Insurance ThoughtLeaders, BNA CD-Rolm, and Employee Benefits News; former Alliance for Healthcare Excellence Board President, Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, former Board Member and Compliance Chair of the National Kidney Foundation of North Texas. Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. These include hundreds of highly regarded articles and workshops on health and other benefits, workforce, health care and insurance concerns.
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