Following closely after the clarifying independent dispute resolution process Final Rule, the four executive branch entities tasked with implementing the provisions of the No Surprises Act, the Office of Personnel Management, the Centers for Medicare & Medicaid Services (CMS), Employee Benefits Security Administration and the Internal Revenue Service have issued a request for information to help the agencies craft the next stage of regulations for the surprise billing law.

The request is the latest effort by agencies to seek stakeholder input on the contours of the regulations implementing the No Surprises Act, this time with a focus on the requirements in the law for providers to issue a good faith estimate (GFE) to plans for services that their covered patients will submit for reimbursement and for insurers to issue an advanced explanation of benefits (AEOB) to their plan participants based on estimated charges relayed to them by providers.

Specifically, the entities are looking for information and recommendations on the process of transferring data from providers and facilities to plans, issuers and carriers to facilitate the GFE and AEOB processes, as well as the economic impacts of implementing these requirements. The notice was added to the Federal Register on Friday, Sept. 16 and comments are due to the agencies by November 15.

Agencies preparing to outline GFE and AEOB requirements

The agencies have previously issued regulations implementing aspects of the No Surprises Act, but those prior rulemakings delayed enforcement of the provisions that related to GFEs and AEOBs  for insured patients. Those deferrals were made in response to stakeholder requests that the agencies develop data transfer standards and to give the industry time to build out the necessary infrastructure to complete these transfers. For more information on past No Surprises Act rules and GFEs in particular, see theses previous posts on the subject.

The No Surprises Act requires providers and facilities to transmit estimates of costs to patients, either directly through a GFE for uninsured patients or indirectly for insured patients through estimated costs transmitted to health care plans and insurers who will then issue an AEOB. The law also requires that health care providers and facilities issue a GFE to health plans and insurers for procedures that the plans’ covered individuals will later submit for reimbursement.

Focus is on interoperability and data security

To facilitate the required transfers of information, necessary for GFEs and AEOBs, CMS has begun to test an approach that could support the level of interoperability that would be required for implementing these data transfers. For purposes of comment, the proposed approach is based on the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard and includes the deployment of an application programming interface (API) that would allow the real-time exchange of AEOB and GFE data. These standards should look familiar to those focused on implementing the interoperability rules promulgated by CMS and office of the National Coordinator for Health Information Technology (ONC) in 2020.

In their request for comment, the agencies have asked interested parties to relay what considerations that they should take into account when weighing whether to go with the FHIR-based API approach. As a primary consideration, the agencies note that HIPAA Privacy and Security Rules apply to the data at issue here, even though this type of pricing data is not included in the type of data covered by HIPAA’s Administrative Simplification requirements, and seek comments on whether the proposed approach sufficiently protects the HIPAA-protected data. In addition to seeking input on what privacy concerns that they should take into account when developing these standards, the agencies also are requesting input on barriers to implementing the standards as well as any flexibilities that could address those barriers and assist in implementation.

Other policy considerations included

The announcement also seeks input on other policy considerations related to GFEs and AEOBs. For example, the agencies are looking for input into how nonparticipating providers that provide nonemergency services apply the GFE requirement and whether there is a possibility that such providers could request consent from patients to waive the law’s protections as part of its GFE transfer.

There are also questions about what notice providers need to give to plans that they seek consent to waive the law’s balance-billing and cost-sharing protections and what would constitute sufficient timing and notice of the waiver.

The notice includes a number of other policy considerations, including questions about the manner in which the AEOB should be presented to patients and how the data that is transmitted should be represented to the patient.

Finally, the agencies seek input on what the economic impact of the implementation of the GFE and AEOB rules will be on the industry, as is common in such RFIs.

Comments are required to be submitted to the agencies by 5 pm on November 15, 2022.

Reed Smith will continue to monitor developments on the No Surprises Act regulations. If you have any questions about this or would like to respond to the RFI, please reach out to the Health Care Lawyers at Reed Smith.