March 02, 2023
On February 23, 2023, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively the Departments) jointly issued Affordable Care Act (ACA) FAQs Part 57. The FAQ guidance outlines the requirements related to the gag clause prohibition and attestation of compliance under the Consolidated Appropriations Act, 2021 (CAA ’21).
The CAA ’21 prohibits group health plans and health insurance issuers offering group health coverage from entering into an agreement with health care providers (including an association or network of providers) or third-party administrators (TPAs) that include a “gag clause”. FAQs Part 57 defines a “gag clause” as a contractual term that directly or indirectly restricts a plan or issuer from making provider-specific cost or quality of care information available to other third parties – whether those parties are patients, employer plan sponsors, referring providers, or business associates (Q1). Plans and issuers are also prohibited from contracting away their right to access de-identified claims and encounter information for enrollees and participants (Q2), consistent with applicable privacy regulations under the Health Insurance Portability and Accountability Act (HIPAA), the Genetic Information Nondiscrimination Act (GINA), and the Americans with Disabilities Act (ADA). The prohibition on gag clauses became effective December 27, 2020, the date of enactment of the CAA ’21.
On August 20, 2021, the Departments issued an FAQ – ACA FAQs Part 49 – stating that the statutory language of this provision of the CAA ’21 is self-implementing. The Departments stated that they did not expect to issue regulations pertaining to gag clauses at the time, and until further guidance was issued, plans and issuers were expected to implement the requirements using good faith reasonable interpretation of the statute. The August 2021 FAQ further stated that the Departments intended to issue guidance explaining how plans and issuers should submit their attestations of compliance, with the expectation that the Departments would begin collecting these attestations in 2022.
Guidance – FAQs Part 57
In addition to defining gag clauses, FAQs Part 57 outlines the Gag Clause Prohibition Compliance Attestation requirements. The FAQs describe which entities are, and are not, required to submit attestations (Q8).
Entities required to submit attestations:
- Health insurance issuers offering group health insurance coverage
- Health insurance issuers offering individual health insurance coverage, including student health insurance coverage and individual health insurance coverage issued through an association
- Fully-insured and self-insured group health plans, including ERISA plans, non-Federal governmental plans, and church plans subject to the Internal Revenue Code
Entities not required to attest:
- Plans or issuers offering only excepted benefits
- Issuers offering only short-term, limited-duration insurance (STLDI)
- Medicare and Medicaid plans
- State Children’s Health Insurance Program (CHIP) plans
- The TRICARE program
- The Indian Health Service program
- Basic Health Program Plans
The attestation requirements apply regardless of whether a plan or coverage is considered grandfathered status as defined by the ACA.
Plans and issuers that do not submit their attestation by the deadlines may be subject to enforcement action by the Departments.
For health reimbursement arrangements (HRAs) and other account-based plans – although these are generally considered group health plans that are subject to most requirements, the Departments will not enforce the attestation requirement against plans that consist solely of HRAs or other account-based group health plans. The Departments are of the view that the benefit design of such plans precludes the need to enter into agreements with providers, therefore, making the concepts related to the prohibited gag clauses inapplicable. The Departments expect to issue rules related to a formal exception for HRAs and account based plans, meanwhile an enforcement discretion exception will apply.
The Departments confirm (Q9) that self-insured plans may contract with a service provider such as a third-party administrator (TPA) or pharmacy benefit manager (PBM) to submit the attestation on behalf of the plan. However, the Departments remind self-insured plan sponsors that the legal requirement to provide a timely attestation remains with the plan.
In conjunction with FAQs Part 57, the Departments are launching a website for submitting the compliance attestations. To support plans and issuers submit their attestations, the Departments are issuing instructions, a system user manual, and a Reporting Entity Excel Template. The FAQs include information on how to register for the attestation system (Q12) and direct parties with questions or concerns (Q13) to contact the No Surprises Help Desk, submit a complaint online, contact the applicable state authority, or contact the DOL (for ERISA plans).
Plans and issuers must submit the first Gag Clause Prohibition Compliance Attestation via the online system no later than December 31, 2023 (Q6). This first attestation covers the period beginning December 27, 2020 – or the effective date of the applicable group health plan or health insurance coverage, if later – through the date of attestation. Subsequent attestations will be due annually by December 31 thereafter.
Employer plan sponsors should review the latest FAQ guidance with legal counsel and your TPAs/insurance carriers, PBMs, and other service providers offering access to a network(s) of providers to ensure that contractual arrangements do not contain prohibited gag clauses. Employer plan sponsors should also review the Gag Clause Prohibition Compliance Attestation System and associated resources to prepare for the initial attestation submission due in December 2023.
Business Group on Health will continue to keep members informed of regulatory developments.
- Affordable Care Act FAQs Part 57
- CMS: Gag Clause Prohibition Compliance Attestation System
- CMS: Gag Clause Prohibition Compliance Attestation System Instructions
- CMS: Gag Clause Prohibition Compliance Attestation System User Manual
- CMS: Reporting Entity Excel Template
- CMS: No Surprises Act Resources
If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.
We provide this material for informational purposes only; it is not a substitute for legal advice.
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