Healthcare Compliance Updates 2023 Q2

Prohibition of Gag Clauses

On Thursday, February 23, 2023, the Departments of Labor, Health and Human Services, and the Treasury (collectively, “the Departments”) released FAQ Part 57 on the Prohibition on Gag Clauses on Price and Quality Information in Provider Agreements.

Beginning on December 27, 2020 (the date of enactment of the CAA), ERISA prohibited plans and issuers from entering into an agreement offering access to a network of providers that would directly or indirectly restrict the plan or issuer from providing provider cost or quality of care information; from electronically accessing claims data; and providing an attestation of compliance.

On August 20, 2021, the Departments issued an FAQ stating that the statutory language of section 201 of title II of division BB of the CAA is self-implementing and that the Departments did not expect to issue regulations pertaining to gag clauses at that time. The FAQ clarified that, until any further guidance is issued, plans and issuers are expected to implement the requirements prohibiting gag clauses using a good faith, reasonable interpretation of the statute. The FAQ further stated, however, that the Departments intend to issue guidance explaining how plans and issuers should submit their attestations of compliance, and that the Departments anticipate that they would begin collecting attestations in 2022.

The prohibition on gag clauses on price and quality in provider agreements will apply to network or association of providers, third-party administrators, and other service providers.

The first Gag Clause Prohibition Compliance Attestation is due no later than December 31, 2023, covering 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, covering the period since the last preceding attestation, are due by December 31 of each year thereafter.

Ending of the Public Health Emergency (PHE)

On Monday, January 30, the Biden Administration informed Congress that it intended to end both the public health emergency and national emergency declarations for COVID-19 on May 11.

The information came in the form of a statement of administration policy document, which the White House typically issues in response to legislation under consideration in Congress. This statement was issued in response to legislation dealing with the emergency declarations. It states that:

“The COVID-19 national emergency and public health emergency (PHE) were declared by the Trump Administration in 2020. They are currently set to expire on March 1 and April 11, respectively. At present, the Administration’s plan is to extend the emergency declarations to May 11, and then end both emergencies on that date. This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE.”

As a refresher, the PHE is separate from the national emergency for COVID-19. The public health emergency is declared and periodically renewed by the Secretary of Health and Human Services. The national emergency is declared by the President and is open ended. The testing coverage requirement is tied to the public health emergency while the Timeline Extension Rule is tied to the national emergency.

The text of the statement of administration policy is available here: https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf.

 Ending of the National Emergency

On Monday, April 10, President Biden signed H.J.Res. 7, which terminates the national emergency related to the COVID-19 pandemic under the National Emergencies Act. However, this likely does not impact the end of the Outbreak Period under the Timeline Extension Rule.

The Timeline Extension Rule, and thus the Outbreak Period, is tied to the national emergency declared under the Stafford Act. H.J.Res. 7 does not end the Stafford Act declaration. The Stafford Act declaration is still expected to end May 11, which would keep the end of the Outbreak Period as July 10.

H.J.Res. 7 also does not impact the COVID-19 measures tied to the public health emergency, such as COVID-19 testing coverage requirements. The end of that declaration is controlled by HHS, and they have not given any indication that they will end it before the anticipated May 11 end date.

On March 29, 2023 the Administration released an FAQ document providing guidance on the end of the public health emergency and national emergency for COVID-19. The FAQ document includes information onCOVID-19 testing requirements, coverage of vaccines, and the Timeline Extension Rule’s extended deadlines for COBRA, special enrollments, and group health plan claims and appeals.