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Sept 16 -- Advanced Explanation of Benefits (AEOB) and Good Faith Estimate (GFE) for Covered Individuals: Request for Information

This document is a request for information (RFI) to inform DOL, HHS, and the Treasury (collectively, the Departments) and OPM's rulemaking for advanced explanation of benefits (AEOB) and good faith estimate (GFE) requirements of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021 (CAA). This RFI seeks information and recommendations on transferring data from providers and facilities to plans, issuers, and carriers; other policy approaches; and the economic impacts of implementing these requirements.

To be assured consideration, comments must be received by November 15, 2022.
 
On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA), which includes the No Surprises Act, was enacted. The No Surprises Act provides Federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently. Surprise billing occurs when an individual receives an unexpected medical bill from a health care provider or facility, including providers of air ambulance services, after receiving medical services from a provider or facility that, usually unknown to the covered individual, is a nonparticipating provider or facility in the individual's health plan or health insurance coverage.

Public Health Service (PHS) Act section 2799B-6, as added by section 112 of title I of Division BB of the CAA, requires providers and facilities, upon an individual's scheduling of an item or service, or upon an individual's request, to inquire if the individual is enrolled in a group health plan or group or individual health insurance coverage. . . .

Internal Revenue Code (Code) section 9816(f), Employee Retirement Income Security Act of 1974 (ERISA) section 716(f), and PHS Act section 2799A-1(f), as added by section 111 of title I of Division BB of the CAA, require group health plans and health insurance issuers offering group or individual health insurance coverage, upon receiving a GFE regarding an item or service as described in PHS Act section 2799B-6, to send a covered individual, through mail or electronic means, as requested by the covered individual, an advanced explanation of benefits (AEOB) in clear and understandable language. . . .

HHS issued regulations implementing PHS Act section 2799B-6 related to GFEs for uninsured (or self-pay) individuals in interim final rulemaking that was published in the Federal Register on October 7, 2021, but deferred enforcement of the portion of PHS Act section 2799B-6 related to GFEs for covered individuals who are seeking to have a claim submitted to their plan or issuer for scheduled items or services. . . .

Recognizing the complex issues involved in developing regulations to implement Code section 9816(f), ERISA section 716(f), and PHS Act sections 2799A-1(f) and 2799B-6, the Departments and OPM are requesting information from the public on a range of issues to better inform future rulemaking. The Departments and OPM welcome comments from all interested members of the public, including individuals potentially eligible to receive an AEOB, organizations serving or representing the interests of such individuals, health care providers and facilities, group health plans and health insurance issuers, carriers, third-party vendors, states, standards development organizations, and other health programs.

A. Transferring Data From Providers and Facilities to Plans, Issuers, and Carriers
 
As noted previously, the Departments and OPM have not yet established regulatory standards for the transfer of GFE data from providers and facilities to plans, issuers, and carriers. However, as CMS indicated in a blog post on December 8, 2021, the Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard holds potential for supporting interoperability and enabling new entrants and competition throughout the health care industry. FHIR is a standard that was developed specifically to support interoperability and securely facilitate the exchange of health care information between systems. In the time since the FHIR standard was first created, the health care industry has rapidly embraced the standard through substantial investments in industry pilots, specification development, and the deployment of FHIR-based Application Programming Interfaces (APIs) supporting a variety of business needs. Some industry-led FHIR AcceleratorTM programs, such as Da Vinci and CARIN, have created implementation guides (IGs) that CMS has recommended for use in meeting the requirements of the CMS Interoperability and Patient Access final rule for Patient Access and Provider Directory APIs.

In 2021, the Da Vinci FHIR AcceleratorTM program launched a Patient Cost Transparency project dedicated to developing an IG that could be used to exchange AEOB and GFE information. This IG uses a FHIR-based API for exchange of AEOB and GFE data from providers to payers and is currently published as a Standard for Trial Use (STU). The current version of the STU is useable by industry today, and the Patient Cost Transparency workgroup continues to revise and update draft standard versions based on public comments received through the ballot process. The ballot process supports industry consensus on the IG and ensures its usability by all stakeholders—including payers, providers, and vendors—to ultimately serve patients and ensure they have access to the information they need.

The Departments and OPM invite the public to use their expertise and the information in this section to respond to the questions in this RFI in their comments. The input may help inform development of future regulations.

-- What issues should the Departments and OPM consider as they weigh policies to encourage the use of a FHIR-based API for the real-time exchange of AEOB and GFE data? . . .
 
Additionally, the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program consists of specified standards, implementation specifications, and certification criteria that health IT modules, including electronic health records systems, can meet.

-- How could updates to this program support the ability of providers and facilities to exchange GFE information with plans, issuers, and carriers or support alignment between the exchange of GFE information and the other processes providers and facilities may engage in involving the exchange of clinical and administrative data, such as electronic prior authorization?

-- Would the availability of certification criteria under the ONC Health IT Certification Program for use by plans, issuers, and carriers, or health IT developers serving plans, issuers, and carriers, help to enable interoperability of API technology adopted by these entities? . . .

B. Other Policy Considerations

. . . The Departments and OPM request public comment and feedback on the following questions:

-- What unique barriers and challenges do underserved and marginalized communities face in understanding and accessing health care that the Departments and OPM should account for in implementing the AEOB and GFE requirements for covered individuals?

-- What steps should the Departments and OPM consider to help ensure that all covered individuals, particularly those from underserved and marginalized communities, are aware of the opportunity to request AEOBs and GFEs and are able to utilize the information they receive in order to facilitate meaningful decision-making regarding their health care?

-- Code section 9816(f), ERISA section 716(f), and PHS Act sections 2799A-1(f) and 2799B-6 require the AEOB and GFE to be provided in clear and understandable language. What additional approaches should be considered that would facilitate the provision of AEOBs and GFEs that are accessible, linguistically tailored, and at an appropriate literacy level for covered individuals, particularly those from underserved and marginalized communities and those with disabilities or limited English proficiency? Is there any specific language or phrasing that should be used to help mitigate any potential consumer confusion? . . .
 
C. Economic Impacts

The Departments and OPM are interested in understanding the potential economic impacts of implementing requirements related to the AEOB and GFE for covered individuals.

Specifically, the Departments and OPM are interested in estimates of the time and cost burdens on providers and facilities, and separately on plans, issuers, and carriers, for building and maintaining a standards-based API for the real-time exchange of AEOB and GFE data.

The Departments and OPM also seek comment on the extent to which providers, facilities, plans, issuers, and carriers are building and maintaining standards-based APIs for multiple purposes, or already have standards-based APIs in place that they can leverage to implement AEOB and GFE requirements. The Departments and OPM are also interested in how establishing standards-based APIs for these purposes may align with other HHS program requirements to implement standards-based APIs, such as requirements for certain payers covered under the CMS Interoperability and Patient Access final rule to use specific standards to implement the Patient and Provider Access APIs, as well as requirements applicable to health IT developers with health IT modules certified to certain criteria under the ONC Health IT Certification Program that provide standards-based API technology to providers and facilities as part of certified health IT products. In circumstances in which providers, facilities, plans, issuers, and carriers use or plan to use standards-based API technology for multiple purposes, the Departments and OPM are interested in estimates of the time and cost burden specifically related to AEOB and GFE implementation, separated out from the total cost of implementing and using this technology for multiple purposes, to accurately reflect the burden of implementing AEOB and GFE requirements.

-- What would be the costs for purchasing and implementing a standards-based API for the real-time exchange of AEOB and GFE data from a third-party vendor, compared to building standards-based API functionality in-house? What percent of providers, facilities, plans, issuers, and carriers are likely to either purchase and implement the API via a third-party vendor compared to building and implementing the API in-house? How do these costs compare to alternative methods of exchanging AEOB and GFE data, such as through an internet portal or by fax? . . .

FRN: https://www.federalregister.gov/d/2022-19798

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