On August 20, 2021, the Departments of Labor, Health and Human Services, and Treasury (“the Departments”) released FAQs clarifying certain requirements for health plans and issuers arising from the Departments Transparency in Coverage final rule (“TiC final rule”) published last November, provisions in the Consolidated Appropriations Act, 2021 (“CAA”), and certain provisions of the Affordable Care Act (“ACA”). The FAQs provide important insights for plans/issuers including announcements regarding the use of enforcement discretion and future rulemaking.
The TiC final rule imposed requirements on plans/issuers beginning January 1, 2022 to make public machine-readable files displaying in-network negotiated provider rates for all covered items and services, out-of-network allowed amounts and billed charges, and in-network prescription drug negotiated rates and historical net prices for prescription drugs. The TiC final rule also required the disclosure of cost-sharing information to enrollees via a price comparison tool. The CAA, signed into law on December 27, 2020, included the No Surprises Act and other provisions that prohibit or limit balance billing in many circumstances, limit patient cost-sharing amounts, create a framework for an independent dispute resolution process, and provide price transparency and reporting requirements.
Enforcement Discretion – The Departments will use enforcement discretion in the following areas:
- The TiC requirement for plans/issuers to publish machine readable files relating to prescription drug pricing pending future rulemaking;
- The TiC requirement to publish machine-readable files of in-network rates and out-of-network allowable amounts and billed charges extended until July 1, 2022;
- The TiC requirement for a health plan or issuer to make a price comparison tool available before plan years that begin January 1, 2023 (and instead will focus on compliance assistance);
- The CAA requirement that providers and facilities provide good faith estimate information for individuals enrolled in a health plan or coverage and seeking to submit a claim for scheduled items or services to their plan or coverage pending further rulemaking;
- The CAA requirement to provide an Advanced Explanation of Benefits (“EOB”) until rulemaking has been undertaken; and
- The CAA requirement to report pharmacy benefit and drug cost information by the first deadline for reporting on December 27, 2021 or the second deadline for reporting on June 1, 2022.
Where states are primary enforcers of the requirements addressed, the Departments encourage the states to implement a similar enforcement approach.
Future Rulemaking – The FAQs announce the Departments’ intention to issue future rulemaking addressing:
- Considering the CAA’s potentially duplicative requirements regarding prescription drug prices, the Departments will consider through notice-and-comment rulemaking whether the machine-readable requirements relating to prescription drugs remain appropriate;
- To determine whether the Internet-based self-service tool requirement in the TiC final rule meets the similar requirements in the CAA;
- To implement a requirement that the information currently required to be available through the online tool or in paper form also be available by telephone;
- How plans/issuers offering complex plan and coverage designs represent information on an ID card to comply with the CAA’s requirements (the guidance provides that good faith, reasonable interpretations should be used by health plans in the meantime);
- The implementation of the good faith estimate requirements for individuals without coverage or that do not plan to have a claim (as the higher priority over individuals with coverage who have other forms of recourse);
- The requirement for plans/issuers to provide an Advanced EOB containing good faith estimates received from providers, including establishing appropriate data transfer standards;
- How plans/issuers should submit their attestations of compliance with the CAA prohibition on gag clauses on price and quality data (which was self-implementing and effective December 27, 2020), and anticipate beginning to collect attestations starting in 2022;
- The CAA’s provider directory requirements, but not before January 1, 2022. Until then, plans/issuers “are expected to implement these provisions using a good faith, reasonable interpretation of the statute,” and the Departments will not deem a plan or issuer out of compliance as long as it imposes only a cost-sharing amount that is not greater than the cost-sharing amount that would be imposed by a participating provider, and counts those cost-sharing amounts toward any deductible or out-of-pocket maximum, when the individual was provided inaccurate information under a provider directory or response protocol;
- The CAA’s continuity of care requirements, but not before January 1, 2022, and will have a prospective effective date; and
- The CAA’s pharmacy benefit and drug cost reporting requirements.
The FAQs also provide practical insights about the Departments’ expectations as health plans and issuers work on compliance with these new requirements, for example:
When analyzing a plan’s or issuer’s efforts to comply with the ID card requirements, the Departments will consider whether the plan’s or issuer’s provision of information on ID cards is reasonably designed and implemented to provide the required information to all participants, beneficiaries, and enrollees entitled to access it on their ID cards. More specifically, the Departments will consider each of the specific data elements included on relevant ID cards; whether any data element required, but not included on the face of an ID card, is made available through information that is provided on the ID card, as well as the mode by which any information absent from the card is made available; the date by which a plan or issuer makes required information available on relevant ID cards; and, for QHP issuers that offer plans through an Exchange, whether the ID card complies with applicable accessibility standards for people with disabilities and people with limited English proficiency under 45 CFR Part 92 and 45 CFR 155.205(c).