Agencies are seeking input on bona fide discretion rules

Follow up closely after clarification of the independent dispute resolution process Final ruleissued the four executive entities tasked with implementing the provisions of the No Surprises Act, the Office of Personnel Management, the Centers for Medicare and Medicaid Services (CMS), the Employee Benefits Security Administration, and the Internal Revenue Service. Request for information To assist agencies in drafting the next stage of regulations for the Surprise Billing Act.

The request is the latest effort by the agencies to solicit stakeholder input on the features of regulations implementing the No Surprises Act, this time focusing on the requirements in law for providers to issue a good faith estimate (GFE) for service plans that their covered patients will present for compensation and for insurers to issue an advanced explanation of benefits (AEOB) to participants in their plan based on the estimated fees carried forward to them by the service providers.

Specifically, entities seek information and recommendations regarding the process of transferring data from service providers and facilities to plans, exporters and carriers to facilitate GFE and AEOB operations, as well as the economic implications of implementing these requirements. The notice was added to the Federal Register on Friday, September 16, and comments are due to be sent to the agencies by November 15.

Agencies preparing to determine GFE and AEOB requirements

Agencies previously issued implementing regulations for aspects of the No Surprises Act, but those earlier rules delayed enforcement of provisions regarding GFEs and AEOBs for insured patients. These postponements were made in response to stakeholders’ requests that agencies set data transfer standards and give the industry time to build the infrastructure needed to complete these transfers. For more information on the previous rules of the No Surprises Act and the Public Fiscal Regulations in particular, see theses previous posts about this subject.

The No Surprises Act requires providers and facilities to pass on cost estimates to patients, either directly through the GFE for uninsured patients or indirectly for insured patients through the estimated costs transferred to health care plans and insurance companies that will then issue an AEOB. The law also requires that health care providers and facilities issue a GFE to health plans and insurers for actions that covered individuals will later file for compensation.

The focus is on interoperability and data security

To facilitate the required information transfers, required for GFEs and AEOBs, CMS has begun testing an approach that can support the level of interoperability required to perform these data transfers. For comment purposes, the proposed approach is based on the Health Care Interoperability Resource (FHIR) Fast Health Level 7 and includes API deployment that allows for real-time exchange of AEOB and GFE data. These standards should sound familiar to those focused on implementing interoperability rules issued by CMS and the Office of the National Health Information Technology Coordinator (ONC) in 2020.

In its request for comment, the agencies asked interested parties to convey considerations they should take into account when evaluating whether to follow an API based FHIR approach. As a primary consideration, agencies note that HIPAA privacy and security rules apply to the data in question here, although this type of pricing data is not included in the type of data covered by HIPAA’s administrative simplification requirements, and solicited comments on whether the proposed approach adequately protects the data. HIPAA protected. In addition to seeking input on privacy concerns that they should take into account when developing these standards, agencies are also seeking input on barriers to implementation of standards as well as any flexibilities that can address these barriers and assist with implementation.

Other policy considerations included

The announcement also seeks input on other policy considerations related to GFEs and AEOBs. For example, agencies are seeking input on how non-participating providers providing non-emergency services enforce GFE requirements and whether providers may require patients’ consent to waive law protection as part of a GFE transfer.

There are also questions about what notice providers need to provide for plans they seek to waive the balance billing and cost-sharing protection required by law and what might constitute adequate timing and notice for the exemption.

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

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

Comments must be submitted to agencies by 5 PM on November 15, 2022.

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