Transparency in Coverage

In the proposed rules, the Departments proposed updates to the 2020 final rules intended to improve the accessibility, clarity, and usefulness of the public disclosures through machine-readable files. The proposed changes included requirements related to the content, format, organization, and publication frequency of the machine-readable files, as well as additional contextual and technical requirements intended to improve file usability and reduce operational complexity for file users.

The Departments received numerous comments on these proposals. As discussed in greater detail in section III.C. of this preamble, the Departments are finalizing many of the provisions as proposed or with modifications after considering public comments, while declining to finalize certain other proposed requirements.

For In-network Rate Files, these final rules require such files to be organized by provider network while also requiring reporting of a common provider network name and provider network identifier. These final rules also allow rates to be expressed as a percentage of billed charges when a dollar amount cannot be derived in advance as well as exclude providers unlikely to be reimbursed based on their scope of practice. The Departments are not finalizing the proposed requirement to report enrollment data due to operational, implementation, and data reliability concerns raised by commenters.

In addition, these final rules require plans and issuers to post several contextual machine-readable files: a Utilization File, a Taxonomy File, and a Text File, each with corresponding timing requirements. The Departments are finalizing these requirements with modifications to certain provisions, including modifying the Utilization File reporting period to align with the prior plan or policy year to avoid combining utilization data across reporting periods and modifying the Text File requirement to allow plans and issuers to include a monitored email address for inquiries related to the machine-readable files. However, the Departments are not finalizing the proposed Change-log File requirement due to concerns regarding the operational burden and implementation complexity associated with maintaining and publishing detailed records of file updates and revisions.

For the Allowed Amount Files, these final rules require data reporting at the market level instead of the individual plan level, lowering the claims threshold from 20 to 11, extending the reporting period from 90 days to 6 months, and increasing the lookback period from 180 days to 9 months to enhance the robustness of historical data.

Finally, these final rules also modify the technical requirements applicable to the machine-readable files by requiring files to be made available in a single, non-proprietary, open-standards format to improve accessibility and standardization across files. In addition, the Departments are finalizing a modified applicability timeline. While the proposed rules generally proposed that all requirements would become applicable 12 months after publication

of the final rules, these final rules instead adopt a phased applicability approach under which all requirements become applicable 5 months after publication of these final rules, except for the requirements regarding the Taxonomy File, Utilization File, Text File, and “findability” link requirement, which become applicable 11 months after publication.

Collectively, these changes are intended to strengthen transparency and improve the usefulness of publicly available pricing information and reduce unnecessary operational burden by streamlining certain reporting requirements and modifying or not finalizing requirements that commenters indicated could be overly complex or resource-intensive to implement.

As discussed in section V.C.3. of this preamble, the Departments assume that self-insured group health plans will depend on TPAs, including issuers providing administrative services only and non-issuer TPAs, to implement these updates, noting that some self-insured plans may choose to comply individually, likely incurring a similar hour burden.

The Departments recognize that some requirements may be integrated into existing operational processes, potentially reducing implementation burdens, though the Departments acknowledge that the extent of integration varies significantly across different requirements. Marginal modifications may include adjusting reporting thresholds from 20 to 11 claims, extending lookback and reporting periods, and adding website footer links, while higher-burden implementations likely include network-level file reorganization, creation of new contextual files (such as Taxonomy and Utilization Files), and implementation of provider-rate combination exclusion logic. Although some activities may align with routine system updates and maintenance cycles, the Departments provide detailed burden estimates for requirements involving substantial system modifications or new operational processes in sections IV.B.1. through 15. of this preamble. 1. ICRs Regarding Requirements To Organize Files by Provider Network, Allow Service Providers or Other Parties To Organize by Provider Network Across Multiple Self-Insured Group Health Plans, and Include a Common Provider Network Name and Provider Network Identifier (26 CFR 54.9815-2715A3(b)(1)(i) and (b)(5)(iii), 29 CFR 2590.715- 2715A3(b)(1)(i) and (b)(5)(iii), and 45 CFR 147.212(b)(1)(i) and (b)(5)(iii))

The Departments proposed to amend 26 CFR 54.9815-2715A3(b)(1)(i), 29 CFR 2590.715-2715A3(b)(1)(i), and 45 CFR 147.212(b)(1)(i) to require plans and issuers to make an In-network Rate File available for each provider network they maintain or contract with and that is associated with the plan or policy being reported. The Departments also proposed to add new 26 CFR 54.9815-2715A3(b)(5)(iii), 29 CFR 2590.715- 2715A3(b)(5)(iii), and 45 CFR 147.212(b)(5)(iii) to permit In-network Rate Files to be made available by provider network for multiple plans administered by service providers or other parties, including those offered by different plan sponsors and across different health insurance markets.

In response to public comments, the Departments are finalizing this requirement with a modification to add a new paragraph (b)(1)(i)(B) requiring plans and issuers to disclose a provider network identifier in addition to the common provider network name. As discussed in more detail in section III.C.1. of this preamble, the Departments agree with commenters who stated that requiring plans and issuers to report only a common provider network name might not be sufficient for file users to reliably identify, distinguish, and cross-reference provider networks across files and coverage options. This requirement as finalized will reduce ambiguity and enable file users to distinguish between provider networks with the same or similar names. The Departments expect that any associated burden will be minimal because plans and issuers already use provider network identifiers for internal tracking purposes.

As noted in the proposed rules, the Departments still maintain that the size of the In-network Rate File can be highly dependent on how it is organized. Where multiple plans share the same negotiated rates under an umbrella provider network, organizing the In-network Rate Files by provider network rather than by each individual plan or policy would, in most cases, decrease the size of the files, often significantly, while still maintaining data integrity.\136\ Several commenters also agreed that this approach could reduce the total number of In-network Rate Files because there are far more plans and policies offered than there are distinct, separately managed provider networks.\137\ The Departments have determined that, taken together, these reductions can ease processing burden on both file producers and file users and increase usability for employers and purchasers.

\136\ 90 FR 60432, 60448 (December 23, 2025).

\137\ See Jane M. Zhu, Yuehan Zhang, & Daniel Polsky, Networks in ACA Marketplaces Are Narrower for Mental Health Care Than for Primary Care, 36 Health Affairs 9 (September 5, 2017), https://www.healthaffairs.org/doi/10.1377/hlthaff.2017.0325 (finding, based on 2016 HealthCare.gov data, 531 unique provider networks were used by 281 different issuers, covering 5,022 qualified health plans in the Federally-facilitated Marketplaces).

As discussed in section III.C.1. of this preamble, the Departments understand that many plans and issuers already leverage a Table of Contents File to organize their files, an approach that allows them to combine common negotiated rates across multiple In-network Rate Files, rather than publishing negotiated rates individually for each plan identifier. However, the Departments assume that few have fully implemented use of the Table of Contents File, and many have not adopted it at all.

For burden estimation, the Departments assume that no plans or issuers have adapted their In-network Rate File processes to align with this provision. While this may overstate the implementation burden for some, it provides a reasonable upper bound, ensuring the estimates cover the substantial and complex changes that most plans or issuers may need to make to comply with this requirement.

To implement this provision, plans (or TPAs on behalf of plans) and issuers will need to modify their In-network Rate File processes to produce files aggregated at the provider network level rather than the plan level, and to generate a crosswalk Table of Contents File that associates each coverage option with the corresponding provider network the plan or issuer maintains or contracts with. The implementation will involve a meaningful, one-time recoding effort to revise existing In- network Rate File processes. However, because the underlying data used to build the In-network Rate Files will not change, these revisions are expected to be incremental and build on the current process.

This finalized provision also requires, under new paragraphs (b)(1)(i)(A) and (b)(1)(i)(B), that each In-network Rate

File be associated with its common provider network name and the corresponding unique provider network identifier. In practice, this means plans (or TPAs on behalf of plans) and issuers will need to add new data elements and identify the source of the common provider network names within their systems of record so these can be included into the automated process for generating the required information for the Table of Contents and In-network Rate Files. However, the Departments assume that plans (or TPAs on behalf of plans) and issuers already have identified and captured these common provider network names and provider network identifiers as part of the related requirement to organize the In-network Rate Files by provider network. As a result, the Departments expect that any burden associated with disclosing these new data elements is accounted for in the burden estimate for organizing these files by provider network, with no additional burden anticipated.

The Departments estimate that issuers and TPAs will incur a one- time cost and burden to modify a plan's or issuer's current process for generating In-network Rate Files to disclose a discrete provider network name and the corresponding unique provider network identifier, and crosswalk those networks to applicable plans or policies. As shown in Table 8, the Departments estimate that, on average, each issuer or TPA will require 16 hours from a Project Manager or Team Lead (at $149.23 per hour), 80 hours from a Technical Architect (at $193.30 per hour), 80 hours from a Senior Application Developer (at $182.76 per hour), and 16 hours from a Business Analyst (at $112.01 per hour) to modify the plan's or issuer's current process, resulting in a one-time burden for each issuer or TPA of 192 hours with an estimated associated cost of $34,265. For all 1,508 issuers and TPAs, as shown in Table 9, the Departments estimate a total one-time burden of 289,536 hours, with an estimated associated cost of $51,671,077. [GRAPHIC] [TIFF OMITTED] TR06OC26.029

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The Departments expect any additional ongoing burden with this requirement to be minimal, as it will involve only limited coding updates to account for and validate changes in the relationships reflected in the source files.

The Departments requested comment on the estimated cost and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on these estimates. 2. ICRs Regarding Requirements To Include Product Type in Both In- Network Rate and Allowed Amount Files (26 CFR 54.9815- 2715A3(b)(1)(i)(C) and (b)(1)(ii)(A), 29 CFR 2590.715- 2715A3(b)(1)(i)(C), and (b)(1)(ii)(A), and 45 CFR 147.212(b)(1)(i)(C) and (b)(1)(ii)(A))

The Departments proposed to amend redesignated paragraphs 26 CFR 54.9815-2715A3(b)(1)(i)(C) and (b)(1)(ii)(A), 29 CFR 2590.715- 2715A3(b)(1)(i)(C), and (b)(1)(ii)(A), and 45 CFR 147.212(b)(1)(i)(C) and (b)(1)(ii)(A) to require plans and issuers to report the product type (for example, HMO or PPO) associated with each coverage option in both the In-network Rate File and the Allowed Amount File. Currently, there is no requirement for plans and issuers to include a product type in their machine-readable files. The only identifier currently required is the HIOS ID or the EIN when a HIOS ID is not available.

The Departments are finalizing this requirement as proposed. The Departments have determined that product type data is readily available to

most plans and issuers and that this requirement will only involve a one-time system update to include the product type variable in the machine-readable files. The estimate accounts for time and effort to access the data sources from which to populate the product type variable within the machine-readable files.

The Departments estimate a one-time cost and burden for plans (or TPAs on behalf of plans) and issuers to implement the required system automation updates. Each issuer or TPA, on average, will require 8 hours from a Project Manager or Team Lead (at $149.23 per hour), 8 hours from a Senior Application Developer (at $182.76 per hour), 8 hours from a Technical Architect (at $193.30 per hour), and 8 hours from a Business Analyst (at $112.01 per hour) to make the system updates and implement the requirements finalized in these rules. As shown in Table 10, this results in a total estimated one-time burden of 32 hours, with an associated estimated cost of $5,098 per issuer or TPA. As shown in Table 11, for all 1,508 issuers and TPAs, the Departments estimate a total one-time burden of 48,256 hours with an associated total cost of approximately $7,688,387. [GRAPHIC] [TIFF OMITTED] TR06OC26.031

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The Departments expect any additional ongoing burden with this requirement to be minimal.

The Departments requested comment on the estimated cost and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on these estimates. 3. ICRs Regarding Requirements To Report Dollar Amounts Except for Only “Percentage-of-Billed-Charges” Payments (26 CFR 54.9815- 2715A3(b)(1)(i)(E)(1), 29 CFR 2590.715-2715A3(b)(1)(i)(E)(1), and 45 CFR 147.212(b)(1)(i)(E)(1))

The Departments proposed to amend redesignated 26 CFR 54.9815- 2715A3(b)(1)(i)(E)(1), 29 CFR 2590.715-2715A3(b)(1)(i)(E)(1), and 45 CFR 147.212(b)(1)(i)(E)(1) to clarify that plans and issuers are required to report in-network rates as a dollar amount, except when the contractual arrangement specifies payment as a percentage of billed charges and it is not possible to determine a dollar amount before the bill is generated. In those cases, the plan or issuer would instead be required to report the applicable percentage.

The Departments are finalizing this requirement as proposed. This requirement is intended to improve data quality by ensuring plans and issuers consistently use a percentage when the contract bases payment on a percentage of billed charges and plans and issuers cannot calculate a dollar amount in advance.

Since this requirement codifies an exception that permits reporting a percentage instead of a dollar amount when reflecting percentage-of- billed charges arrangements, the Departments expect that many plans and issuers may already be compliant with this requirement. However, because the Departments cannot determine the extent to which plans and issuers have already included any necessary modifications to their In- network Rate Files, the Departments estimate a one-time burden and cost associated with complying with this requirement.

For a low-end estimate, the Departments assume that 20 percent of plans (or TPAs on behalf of the plan) and issuers will need to make this one-time modification to their In-network Rate Files, while for a high-end estimate, it is assumed that all plans (or TPAs on behalf of the plan) and issuers will need to make this adjustment to their In- network Rate Files.

The Departments estimate, on average, each affected issuer or TPA will require 8 hours from a Project Manager or Team Lead (at $149.23 per hour), 8 hours from a Technical Architect (at $193.30 per hour), 8 hours of work from a Senior Application Developer (at $182.76 per hour), and 8 hours from a Business Analyst (at $112.01 per hour) to review their In-network Rate File generation code to determine if there are any instances where a non-dollar amount appears in the file and then make the necessary coding adjustments and validate the changes, resulting in an estimated one-time burden of 32 hours,

with an estimated associated cost of $5,098 per issuer or TPA, as shown in Table 12.

The Departments estimate that, under the low-end scenario, affected issuers and TPAs will incur a total one-time burden of 9,651 hours with an associated total cost of approximately $1,537,677. Under the high- end scenario, for all issuers and TPAs, the total one-time burden will be 48,256 hours with an associated total cost of approximately $7,688,387, as shown in Table 13. [GRAPHIC] [TIFF OMITTED] TR06OC26.034

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The Departments expect any additional ongoing costs related to the requirement that plans and issuers report in-network rates as a dollar amount, except when the contractual arrangement specifies payment as a percentage of billed charges and it is not possible to determine a dollar amount before the bill is generated, to be minimal.

The Departments requested comment on the estimated costs and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on these estimates. 4. ICRs Regarding Requirements To Report Required Enrollment Data

The Departments proposed to add a new provision at 26 CFR 54.9815- 2715A3(b)(1)(i)(E), 29 CFR 2590.715-2715A3(b)(1)(i)(E), and 45 CFR 147.212(b)(1)(i)(E) that would require plans and issuers to include the current enrollment totals (number of individuals) for each coverage option associated with the applicable In-network Rate File, as of the date the file is posted.

Due to operational, implementation, data reliability, and business vulnerability concerns raised by commenters, as discussed in section III.C.4. of this preamble, the Departments are not finalizing the proposed requirement to report enrollment data. Accordingly, the corresponding burden estimates from the proposed rules are not included in the final burden estimates of these final rules. 5. ICRs Regarding Requirements To Exclude Certain Providers From In- Network Rate Files and To Publish a Taxonomy File (26 CFR 54.9815- 2715A3(b)(1)(i)(F), 29 CFR 2590.715-2715A3(b)(1)(i)(F) and 45 CFR 147.212(b)(1)(i)(F), and 26 CFR 54.9815-2715A3(b)(2)(ii), 29 CFR 2590.715-2715A3(b)(2)(ii), and 45 CFR 147.212(b)(2)(ii))

In the proposed rules, the Departments proposed to amend the paragraph on required information under 26 CFR 54.9815-2715A3(b)(1)(i), 29 CFR 2590.715-2715A3(b)(1)(i), and 45 CFR 147.212(b)(1)(i) to increase access to and improve the usability of the data reported in the In-network Rate File, by adding new paragraph (b)(1)(i)(F). This new paragraph would require plans and issuers to exclude from their In- network Rate Files a provider's negotiated rate (provider-rate

combination) for an item or service if the plan or issuer determines it is unlikely that such provider would be reimbursed for such item or service given that provider's area of specialty according to the plan's or issuer's internal provider taxonomy used during the claims adjudication process. The Departments are finalizing this requirement with a modification of requiring plans and issuers to exclude provider- rate combinations that are unlikely given the provider's specialty according to the plan's or issuer's internal provider taxonomy or other internal rules used during the claims adjudication process.

In addition, the Departments proposed to add at 26 CFR 54.9815- 2715A3(b)(2)(iii), 29 CFR 2590.715-2715A3(b)(2)(iii), and 45 CFR 147.212(b)(2)(iii) to require plans and issuers to publish a contextual machine-readable file, referred to as a Taxonomy File, that includes the plan or issuer's internal provider taxonomy, which maps items and services (represented by a billing code) to provider specialties (represented by specialty code) to determine if the plan or issuer should deny reimbursement for an item or service because it was not furnished by a provider in an appropriate specialty. This new file is intended to increase transparency by showing how decisions to exclude certain provider-rate combinations from the In-network Rate File were determined. The Departments are finalizing the Taxonomy File requirement as proposed with three modifications: first, adding that plans and issuers must base the Taxonomy File on their internal provider taxonomy or other internal rules used during the claims adjudication process to determine if the plan or issuer should deny reimbursement for an item or service based on the provider's specialty; second, specifying that the information provided in the Taxonomy File, regardless of whether it is based on an internal taxonomy or other internal rules, must be expressed as pairings of items and services (represented by billing codes) with provider specialties (represented by specialty codes which are derived from the Health Care Provider Taxonomy code set established by the National Uniform Claim Committee (NUCC)); and third, a technical modification renumbering the paragraph as 26 CFR 54.9815-2715A3(b)(2)(ii), 29 CFR 2590.715-2715A3(b)(2)(ii), and 45 CFR 147.212(b)(2)(ii).

Taken together, these provisions require plans and issuers to perform two specific tasks: (1) update their current programmatic code to exclude certain provider-rate combinations from the existing In- network Rate Files, and (2) create and publish a new Taxonomy File.

The Departments have determined that: (1) plans (or TPAs on behalf of plans) and issuers already maintain a complete listing of their in- network providers along with the specialties of those providers; (2) plans and issuers possess an internal provider taxonomy, or other internal rules, needed to map provider specialties to the appropriate billing codes; and (3) plans and issuers have implemented similar logic within their claims adjudication systems to pend or deny claims that fall outside a provider's scope of practice, for example, if a claim for brain surgery is submitted by a provider whose specialty does not align with that procedure.

Given this, the additional burden and cost required to automate the exclusion of certain provider-rate combinations is expected to include: (1) extracting and adapting the claims adjudication logic built off the plans' and issuers' internal provider taxonomy, or other internal rules, that determine whether a provider is authorized to bill for a particular service given the provider's specialty, for use in generating the In-network Rate File; (2) implementing an automated process to extract the in-network provider list along with their specialties from the plan's or issuer's system of record; and (3) modifying the programmatic logic of the In-network Rate File generation software to exclude provider-rate combinations for those that are not eligible to submit claims for specific services.

Additionally, posting a Taxonomy File will require plans (or TPAs on behalf of plans) and issuers to list each taxonomy code they use and specify the associated service codes (for example, CPT codes). These mappings are typically stored in a reference table used by issuer claims adjudication systems. Plans (or TPAs on behalf of plans) and issuers that use other internal rules during their claims adjudication process to determine whether to deny reimbursement for an item or services given the provider's specialty will need to map those rules to a taxonomy that matches specialty codes with billing codes. The Taxonomy File must be produced separately, in addition to each In- network Rate File.

To update the programmatic code to exclude certain provider-rate combinations from the existing In-network Rate File and to create and publish a new Taxonomy File, the Departments estimate a one-time cost and burden for plans (or TPAs on behalf of plans) and issuers. On average, each issuer or TPA will require 48 hours from a Project Manager or Team Lead (at $149.23 per hour), 48 hours from a Technical Architect (at $193.30 per hour), 48 hours from a Senior Application Developer (at $182.76 per hour), and 48 hours from a Business Analyst (at $112.01 per hour). As shown in Table 14, this results in a total estimated one-time burden of 192 hours per issuer or TPA, with an associated cost of approximately $30,590. For all 1,508 issuers and TPAs, as shown in Table 15, the Departments estimate a total one-time burden of 289,536 hours and a total cost of approximately $46,130,323.

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The Departments expect ongoing maintenance costs for the In-network Rate Files to include support for minor changes to the programming logic used to generate these files to be minimal.

The Departments requested comment on the estimated cost and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. A commenter noted that the ongoing costs associated with Taxonomy Files are not accounted for. The Departments acknowledge this comment but expect that any additional ongoing costs associated with maintaining Taxonomy Files will be minimal because the files are expected to rely primarily on existing data, mappings, code sets, and other internal rules that plans (or TPAs on behalf of plans) and issuers maintain and periodically update as part of their normal claims adjudication and operational processes. These existing resources may include listings of in-network providers and their specialties and internal provider taxonomies or other internal rules used to map provider specialties to appropriate billing codes, as well as similar programming logic used within claims adjudication systems to identify claims for items and services that may fall outside a provider's scope of practice. 6. ICRs Regarding Requirements To Lower Claims Reporting Threshold in the Allowed Amount File From 20 to 11 Claims (26 CFR 54.9815- 2715A3(b)(1)(ii)(C), 29 CFR 2590.715-2715A3(b)(1)(ii)(C), and 45 CFR 147.212(b)(1)(ii)(C))

The Departments proposed to amend 26 CFR 54.9815- 2715A3(b)(1)(ii)(C), 29 CFR 2590.715-2715A3(b)(1)(ii)(C), and 45 CFR 147.212(b)(1)(ii)(C) to require plans and issuers to include data in the Allowed Amount File for items and services provided under a single plan or coverage when there are 11 or more unique claims for that item or service in a single health insurance market, lowering the current threshold from 20 to 11 to expand the data available.

The Departments are finalizing this requirement as proposed. The Departments assume this requirement will not create additional burden for plans and issuers. Existing systems are currently designed to report out-of-network allowed amounts when there are more than 20 claims for a covered item or service within a relevant 90-day period. Lowering the threshold to 11 claims is expected to require only marginal system variable adjustments, with any associated costs absorbed into the routine system maintenance activities that plans (or TPAs on behalf of plans) and issuers already perform in the normal course of business. The change constitutes a standard simple administrative update, rather than a system redesign, and therefore does not necessitate additional infrastructure, a dedicated project budget, or significant developer time. The adjustment can be implemented by existing IT personnel as part of their routine operational duties, with no disruption and minimal costs.

A commenter expressed concern that lowering the claims threshold would significantly increase operational burden by expanding data volume, file size, and processing complexity, and would require additional validation, monitoring, and system adjustments. The Departments acknowledge this concern but have determined that, although the change may increase the data volume and file size for some plans and issuers, it is not expected to materially affect processing complexity given that the underlying processes for validation, monitoring, and file generation remain unchanged. Thus, the Departments have determined that this modification will only affect the threshold for inclusion, rather than the structure or logic of the files, and therefore expect any associated burden to be minimal.

7. ICRs Regarding Expansion of Reporting and Lookback Periods for Allowed Amount Files From 90 Days to 6 Months and 180 Days to 9 Months (26 CFR 54.9815-2715A3(b)(1)(ii)(C), 29 CFR 2590.715- 2715A3(b)(1)(ii)(C), and 45 CFR 147.212(b)(1)(ii)(C))

The Departments proposed to amend 26 CFR 54.9815- 2715A3(b)(1)(ii)(C), 29 CFR 2590.715-2715A,3(b)(1)(ii)(C), and 45 CFR 147.212(b)(1)(ii)(C) to expand the data included in the Allowed Amount Files by requiring plans and issuers to report on items and services furnished by out-of-network providers over a 6-month reporting period starting 9 months before the file's publication date, replacing the current 90-day reporting period that begins 180 days prior to the file's publication date.

The Departments are finalizing this requirement as proposed. The Departments assume that extending the reporting period from 90 days to 6 months and the lookback period from 180 days to 9 months will not create additional burden for plans and issuers, as they currently have automated systems in production to report out-of-network allowed amounts. Implementing this change is expected to require only minimal system modifications to accommodate the updated reporting and lookback periods, with any associated costs absorbed into the routine system maintenance activities that plans (or TPAs on behalf of plans) and issuers already perform in the normal course of business.

As such, this change constitutes a standard simple administrative update, rather than a system redesign, and therefore does not necessitate additional infrastructure, a dedicated project budget, or significant developer time.

The Departments requested comment on the discussion of potential costs and burden associated with this proposed requirement, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on this aspect of the proposal. 8. ICRs Regarding Requirements To Aggregate Allowed Amount Files by Market Type and Allow Service Providers or Other Parties To Aggregate by Market Type Across Multiple Self-Insured Group Health Plans (26 CFR 54.9815-2715A3(b)(1)(ii), 29 CFR 2590.715-2715A3(b)(1)(ii), and 45 CFR 147.212(b)(1)(ii)) and Permit Such Aggregation at the TPA Level (26 CFR 54.9815-2715A3(b)(5)(iv), 29 CFR 2590.715-2715A3(b)(5)(iv), and 45 CFR 147.212(b)(5)(iv))

The Departments proposed to amend 26 CFR 54.9815-2715A3(b)(1)(ii), 29 CFR 2590.715-2715A3(b)(1)(ii), and 45 CFR 147.212(b)(1)(ii) to require plans and issuers to aggregate out-of-network data reporting by health insurance market, specifically by grouping plan-level data into one of four categories: (1) small group market, (2) individual market (other than short-term, limited-duration insurance or individual health insurance coverage that consists solely of excepted benefits, as defined in 45 CFR 148.220), (3) large group market, and (4) all self- insured group health plans maintained by the plan sponsor (other than account-based plans, as defined in 26 CFR 54.9815-2711(d)(6)(i), 29 CFR 2590.715-2711(d)(6)(i), and 45 CFR 147.126(d)(6)(i), and plans that consist solely of excepted benefits, as defined in 26 CFR 54.9831-1(c), 29 CFR 2590.732(c), and 45 CFR 146.145(b)). Under current technical reporting requirements, plans and issuers may, but are not required to, aggregate data across multiple plans or policies to meet public disclosure requirements for the Allowed Amount Files. The Departments also proposed to amend redesignated 26 CFR 54.9815-2715A3(b)(5)(iv), 29 CFR 2590.715-2715A3(b)(5)(iv), and 45 CFR 147.212(b)(5)(iv) to permit Allowed Amount Files to be aggregated by market type at the service provider level, rather than the plan level, for more than one self- insured group health plan, including those offered by different plan sponsors.

The Departments are finalizing these requirements as proposed. The Departments have determined that this requirement will not require plans (or TPAs on behalf of plans) and issuers to make substantial changes to how they currently generate Allowed Amount Files. Instead, it requires modifying the output so that, rather than producing a separate Allowed Amount File for each plan or policy, plans and issuers will aggregate data into a single file for each applicable market category. The four market categories, small group, large group, individual, and plans in self-insured group markets, are already well established under existing market-wide regulations, and plans and issuers can use existing data elements in their systems to classify each plan appropriately.\138\

\138\ 26 CFR 54.9801-2, 29 CFR 2590.701-2, and 45 CFR 144.103, as applicable.

The Departments estimate that plans (or TPAs on behalf of plans) and issuers will incur a one-time cost and burden to modify and update their existing Allowed Amount File processes to produce output files aggregated by market segment. On average, each issuer or TPA will require 16 hours from a Project Manager or Team Lead (at $149.23 per hour), 16 hours from a Technical Architect (at $193.30 per hour), 16 hours of work from a Senior Application Developer (at $182.76 per hour), and 16 hours from a Business Analyst (at $112.01 per hour) to complete this work. As shown in Table 16, this results in a total estimated one-time burden of 64 hours per issuer or TPA, with an associated cost of approximately $10,197. For all 1,508 issuers and TPAs, as shown in Table 17, the Departments estimate a total one-time burden of 96,512 hours and a total cost of approximately $15,376,774.

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The Departments expect any additional ongoing costs related to aggregating Allowed Amount Files by market type, including allowing service providers or other parties to aggregate data across multiple self-insured group health plans to be minimal.

The Departments requested comment on the estimated costs and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on these estimates. 9. ICRs Regarding Requirements To Add a Change-Log File Related to the In-Network Rate File Disclosures

The Departments proposed to add a new provision under 26 CFR 54.9815-2715A3(b)(2)(i), 29 CFR 2590.715-2715A3(b)(2)(i), and 45 CFR 147.212(b)(2)(i) that would require plans and issuers to publish a Change-log File on a quarterly basis, on the same day the In-network Rate File is published, identifying all changes made since the previous version.

After consideration of the comments received, as discussed in section III.C.8.a. of this preamble, and further evaluation of the operational complexity and burden associated with this requirement, including the significant burden identified by commenters, the Departments are not finalizing the proposed requirement for plans and issuers to publish a Change-log File. Accordingly, the corresponding burden estimates from the proposed rules are not included in the final burden estimates of these final rules. 10. ICRs Regarding Requirements To Implement the Disclosures Required for the Utilization File (26 CFR 54.9815-2715A3(b)(2)(i), 29 CFR 2590.715-2715A3(b)(2)(i), and 45 CFR 147.212(b)(2)(i)).

The Departments proposed to add a new provision at 26 CFR 54.9815- 2715A3(b)(2)(ii), 29 CFR 2590.715-2715A3(b)(2)(ii), and 45 CFR 147.212(b)(2)(ii) requiring a Utilization File which would require plans and issuers to list all items and services for which a claim has been submitted and reimbursed, in whole or in part by in-network providers and identify each provider who submitted claims for each item or service. The Departments also proposed that the Utilization File to include information from the 12-month period that ends 6 months prior to the publication of the Utilization File and be updated every 12 months.

In response to public comments, as discussed in section III.C.8.b. of this preamble, the Departments are finalizing this requirement with the modification of the Utilization File as new paragraph 26 CFR 54.9815-2715A3(b)(2)(i), 29 CFR 2590.715-2715A3(b)(2)(i), and 45 CFR 147.212(b)(2)(i) and by modifying the lookback period to include data from the previous plan or policy year, rather than the 12-month period ending 6 months prior to publication, to prevent files from including utilization data across plan or policy years. The Departments have determined that this modification does not materially affect the underlying assumptions used to estimate burden for this ICR and that any associated burden will be minimal.

The Departments assume that data for the new Utilization File is readily accessible to all plans and issuers through their existing claims databases. Posting a Utilization File requires plans and issuers to programmatically generate a list of each unique combination of provider NPI, TIN, and Place of Service Code from their claims database for in-network providers reimbursed for any covered item or service during a specified period. In addition to the one-time burden and cost associated with the initial coding effort to create the Utilization File, plans and issuers will incur annual ongoing operational burden and cost to produce the annual Utilization File, validate the data, store the Utilization File, and post

it to the designated public access location.

Because the process for generating the Utilization File is similar to the logic used for creating the Allowed Amount File, and existing programmatic logic could serve as a starting point for the creation of the Utilization File, the Departments assume the burden and cost will be lower than those originally estimated in the 2020 final rules for the development and implementation of the Allowed Amount File.

A few commenters noted that the burden associated with the Utilization File is overstated. They explained that the requirement represents an incremental extension of existing claims-based workflows and is significantly less complex than the original Allowed Amount File. They further emphasized that the Utilization File does not necessitate a new system and is updated annually rather than monthly.

The Departments thank the commenters for their insight and agree with their assessment that the burden associated with the Utilization File was overstated. A commenter recommended revising the estimated hours and costs downward. After reviewing the initial estimate based on commenters' input, the Departments acknowledge that certain previously estimated burden hours, particularly for roles such as for a Senior Application Developer and Technical Architect, were higher than necessary to implement the Utilization File. Accordingly, the Departments have revised the Utilization File burden estimate to better align with the estimates for the other newly required contextual files and updates to existing machine-readable files. As a result, the Departments have reduced the estimated one-time burden hours and costs downward to more accurately reflect the expected implementation burden.

Under the revised estimate, each issuer or TPA, on average, will require 80 hours from a Scrum Master (at $141.16 per hour), 160 hours from a Technical Architect (at $193.30 per hour), a total of 320 hours of work from two Senior Application Developers (at $182.76 per hour), 80 hours from a Business Analyst (at $112.01 per hour), and 40 hours from a DevOps Engineer III (at $160.20 per hour) to develop and complete the Utilization File. As shown in Table 18, this results in a total estimated burden of 680 hours per issuer or TPA, with an associated cost of approximately $116,073. For all 1,508 issuers and TPAs, as shown in Table 19, the Departments estimate a total one-time burden of 1,025,440 hours and a total cost of approximately $175,037,782. [GRAPHIC] [TIFF OMITTED] TR06OC26.040

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In addition to the one-time burden and cost estimated in Tables 18 and 19, plans (or TPAs on behalf of plans) and issuers will incur ongoing annual burden and cost to update the Utilization File. The Departments estimate that, on average, each issuer or TPA will annually require 6 hours from a Scrum Master (at $141.16 per hour), 16 hours of work from a Senior Application Developer (at $182.76 per hour), and 16 hours from DevOps Engineer III (at $160.20 per hour) to make the required updates. As shown in Table 20, this results in a total estimated annual burden of 38 hours per issuer or TPA, with an associated cost of approximately $6,334. For all 1,508 issuers and TPAs, as shown in Table 21, the Departments estimate a total ongoing annual burden of 57,304 hours and a total cost of approximately $9,552,155. The 3-year average costs and burden for this requirement are presented in Table 22.

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The Departments did not receive any comments on the estimated ongoing hours and costs for this provision. 11. ICRs Regarding Requirements To Add a Text File and Identify Point- of-Contact Information for Inquiries To Improve Discoverability and Accessibility of Machine-Readable Files, and Respond to Machine- Readable File Inquiries (26 CFR 54.9815-2715A3(b)(2)(iii), 29 CFR 2590.715-2715A3(b)(2)(iii), and 45 CFR 147.212(b)(2)(iii))

The Departments proposed to add new 26 CFR 54.9815- 2715A3(b)(2)(iii), 29 CFR 2590.715-2715A3(b)(2)(iii), and 45 CFR 147.212(b)(2)(iii), which would establish a new requirement for plans and issuers to improve the accessibility of their machine-readable files. Under this proposal, plans (or TPAs on behalf of plans) and issuers would be required to generate a Text File that includes the URL of the page hosting the machine-readable files, a direct link to the machine-readable files themselves, and contact information, for the individual at the plan, issuer, or TPA that is responsible for the machine-readable files. This Text File would be required to be placed in the root folder of the public website domain selected to host the machine-readable files, without regard to the website's page structure. This proposed new requirement would align with similar provisions under the Hospital Price Transparency rules \139\ at 45 CFR 180.50(d)(6) and is intended to enhance the discoverability, usability, and consistency of pricing information for participants, beneficiaries, and enrollees, third-party developers, researchers, and regulators.

\139\ Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. Price Transparency Requirements for Hospitals To Make Standard Charges Public, 84 FR 65524 (November 27, 2019); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model, 86 FR 63458 (November 16, 2021); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction, 88 FR 81540 (November 22, 2023); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots, 90 FR 53448 (November 25, 2025).

As discussed in section III.C.8.d. of this preamble, the Departments are

finalizing this requirement with modifications to clarify that plans and issuers must provide a monitored email address for an individual or group responsible for receiving and responding to inquiries and issues related to the machine-readable files, in lieu of requiring the point- of-contact information to include a specific named individual with their title. The Departments have determined that this modification does not materially affect the burden estimate as plans and issuers may use an existing email address or establish a new dedicated inbox.

The Departments anticipate plans (or a TPA on behalf of plans) and issuers will incur a one-time development burden to update their systems to support the automated generation and publication of the required Text File. In addition to setting up the ability to produce the Text File, plans (or TPAs on behalf of plans) and issuers must identify point-of-contact information for the individual or group who will be available to address inquiries and issues related to the required machine-readable files and include this point-of-contact information in the Text Files. The plan or issuer will need to set up a mechanism to receive and respond to inquiries and issues, such an email box or online feedback form, on behalf of the identified point of contact.

The Departments estimate a one-time burden and cost for plans (or TPAs on behalf of plans) and issuers to develop, test, and implement the automation necessary to generate and post the required Text File in the root folder of their public website as well as set up a mechanism to receive and respond to inquiries and issues. On average, each issuer or TPA will require 8 hours of work from a Senior Application Developer (at $182.76), 8 hours from a Business Analyst (at $112.01 per hour), and 8 hours from a Project Manager or Team Lead (at $149.23 per hour). As shown in Table 23, this results in a total estimated one-time burden of 24 hours per entity, with an associated cost of approximately $3,552. Across all 1,508 issuers and TPAs, the Departments estimate a total one-time burden of 36,192 hours and a combined cost of approximately $5,356,416, as presented in Table 24. [GRAPHIC] [TIFF OMITTED] TR06OC26.045

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In addition to the one-time costs estimated in Tables 23 and 24, plans (or TPAs on behalf of plans) and issuers will incur ongoing annual burden and cost to respond to inquiries and issues on the machine-readable files. The Departments assume that each issuer and TPA will establish a team to triage, review, and respond to the inquiries. The Departments estimate that, on average each year, each issuer or TPA will receive approximately 30 inquiries. Addressing each inquiry is estimated to require 10 minutes of work per inquiry from an Attorney III (totaling 5 hours for 30 inquiries at $178.25 per hour), 20 minutes per inquiry from a Senior Application Developer (totaling 10 hours for 30 inquiries at $182.76), and 30 minutes per inquiry from a Project Manager/Team Lead (totaling 15 hours for 30 inquiries at $149.23 per hour). As shown in Table 25, this results in a total estimated annual burden of 30 hours per issuer or TPA, with an associated cost of approximately $4,957 for each issuer or TPA. As shown in Table 26, the Departments estimate a total ongoing annual burden of 45,240 hours and a total cost of approximately $7,475,608 for all 1,508 issuers and TPAs. The 3-year average burden hours and costs for this requirement are presented in Table 27.

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The Departments requested comment on the estimated cost and burden hours presented in this ICR, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on these estimates. 12. ICRs Regarding Requirements To Publish Machine-Readable Files in a Single Non-Proprietary, Open-Standards Format (26 CFR 54.9815- 2715A1(b)(3)(i), 29 CFR 2590.715-2715A1(b)(3)(i), and 45 CFR 147.212(b)(3)(i))

The Departments are finalizing an amendment to 26 CFR 54.9815- 2715A1(b)(3)(i), 29 CFR 2590.715-2715A1(b)(3)(i), and 45 CFR 147.212(b)(3)(i) to require, unless otherwise specified in 26 CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212, plans and issuers to make machine-readable files available in a single non- proprietary, open-standards format, in a form and manner specified in technical implementation guidance. This requirement, which was discussed in the preamble of the proposed rules, along with a request for comment, builds on the 2020 final rules, which require machine- readable files to be publicly available in a non-proprietary, open format but did not mandate a single standardized format.

As discussed in section III.C.9. of this preamble, after considering public comments, the Departments have determined that greater standardization will improve usability, reduce data processing complexity, and enhance comparability across machine-readable files. The Departments explained that earlier technical guidance had contemplated multiple formats, including JSON, XML, and CSV, but that file developers had largely converged on JSON. Since implementation of the 2020 final rules, the Departments have observed that most plans and issuers are already using JSON, with internal analysis indicating that more than 90 percent currently use that format. The Departments have determined that requiring a single format will promote consistency, facilitate more efficient data use by developers and researchers, and reduce variation in file structure. Although some plans and issuers may incur transition costs to align with the specified format, the Departments expect the overall total costs to be limited given current industry practices and anticipate that standardization will reduce ongoing operational complexity over time.

As further discussed in section III.C.9. of this preamble, the Departments have determined that specifying the format in guidance, rather than regulation, provides flexibility to adapt to future technological developments while maintaining a consistent standard for publication. While the Departments will specify the required file format through guidance, the Departments currently intend to specify JSON as the required

format for the In-network Rate File, Allowed Amount File, Utilization File, and Taxonomy File, because it best supports the structure and exchange of Transparency in Coverage data. The Text File, as described in section III.C.8.d. of this preamble, must be published in .txt format, which is also a single, non-proprietary, open standard format.

Consistent with the Departments' findings, industry reports also indicate that JSON adoption exceeds 95 percent.\140\ Accordingly, the Departments estimate one-time burden and costs only for the approximately 5-10 percent of plans and issuers expected to update their current machine-readable files to the JSON format. Based on this expectation, the Departments estimate the following one-time burden for this requirement.

\140\ Carol Skenes, New year, renewed efforts, Turquoise Health (January 5, 2026), available at https://turquoise.health/resources/blog/new-year-renewed-efforts-for-understanding-the-cost-of-care.

On average, each issuer or plan (or TPA on behalf of a plan) will require 20 hours from a Project Manager/Team Lead ($149.23 per hour), 20 hours from a Scrum Master (at $141.16 per hour), 60 hours from a Technical Architect (at $193.30 per hour), 60 hours of work from a Senior Application Developer (at $182.76 per hour), 5 hours from a Business Analyst (at $112.01 per hour), and 5 hours from a DevOps Engineer III (at $160.20 per hour). As shown in Table 28, this results in a one-time estimated burden of 170 hours for each issuer or TPA, with an associated cost of approximately $29,732.

For the 151 affected issuers and TPAs \141\ as shown in Table 29, the Departments estimate a total one-time burden of 25,636 hours and a total cost of approximately $4,483,653.

\141\ The estimate of 151 affected issuers and TPAs is calculated as 10 percent of 1,508 issuers and TPAs (1,508 x 0.10 [ap] 151). [GRAPHIC] [TIFF OMITTED] TR06OC26.050

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The Departments do not anticipate any ongoing costs associated with this requirement because, once implemented, plans and issuers are expected to maintain compliance using existing processes and systems without incurring additional recurring burden. 13. ICRs Regarding Requirements To Add a Price Transparency Footer Link on Website Directing Users to the Location of the Machine-Readable Files (26 CFR 54.9815-2715A3(b)(3)(iii), 29 CFR 2590.715- 2715A3(b)(3)(iii), and 45 CFR 147.212(b)(3)(iii))

The Departments proposed to add a new requirement at 26 CFR 54.9815-2715A3(b)(3)(iii), 29 CFR 2590.715-2715A3(b)(3)(iii), and 45 CFR 147.212(b)(3)(iii) to improve user access to machine-readable files published under paragraphs (b)(1) and (2). Specifically, plans and issuers would be required to include a link to the internet domain where the machine-readable files are hosted on the footer of their website. This link would be required to appear on the home page and on any other page that includes a footer and must be labeled as “Price Transparency” or “Transparency in Coverage.”

The Departments are finalizing this requirement as proposed. The Departments anticipate that the burden associated with this requirement will be minimal, as it will involve only basic website modifications.

The Departments requested comment on the discussion of potential costs and burden associated with this ICR in the proposed rules, including any additional costs or challenges that may not have been identified. The Departments did not receive any comments on this discussion. 14. ICRs Regarding Requirements To Attest to Machine-Readable Files (26 CFR 54.9815-2715A3(b)(1)(iv), 29 CFR 2590.715-2715A3(b)(1)(iv), and 45 CFR 147.212(b)(1)(iv))

As discussed in section III.C.7. of this preamble, the Departments are finalizing a requirement for group health plans and health insurance issuers to attest, to the best of their knowledge and belief, the accuracy and completeness of the information contained in their machine-readable files. The attestation requirement is intended to enhance confidence in the disclosures and further align the Transparency in Coverage requirements with the Hospital Price Transparency framework.

Specifically, the Departments are finalizing provisions at 26 CFR 54.9815-2715A3(b)(1)(iv), 29 CFR 2590.715-2715A3(b)(1)(iv), and 45 CFR 147.212(b)(1)(iv), which establish a new requirement for group health plans and health insurance issuers to include an attestation and related identifying information within each machine-readable file required under paragraphs (b)(1)(i) through (iii) and (b)(2)(i) and (ii) of these sections. Under these provisions, plans and issuers must attest that, to the best of their knowledge and belief, the machine- readable file includes all applicable information required under 26 CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212, and that the information encoded in the file is true, accurate, and complete as of the date of the file. Plans and issuers must also encode the name of the chief executive officer, president, or other senior official designated to oversee the encoding of true, accurate, and complete data.

As discussed in section III.C.7. of this preamble and pursuant to the special rules to prevent unnecessary duplication in paragraph (b)(5), plans and issuers may satisfy the attestation requirements of paragraphs (b)(1)(iv)(A) and (B) through a written agreement with another party, such as a TPA, that prepares and publishes the machine- readable files on their behalf. Under such an arrangement, the TPA may make the attestation required under paragraph (b)(1)(iv)(A) and encode the name of its chief executive officer, president, or other designated senior official responsible for overseeing the truthfulness, accuracy, and completeness of the information contained in the machine-readable files.

The Departments anticipate that plans (or TPAs on behalf of plans) and issuers will incur a one-time burden to modify their existing machine-readable file generation processes to include the required attestation statement and the name of the designated senior official. Plans and issuers will also need to establish internal procedures for reviewing the machine-readable files and confirming that the required information has been included prior to publication.

To account for these activities, the Departments estimate a one- time burden and cost for plans (or TPAs on behalf of plans) and issuers to develop internal processes and procedures and the operational changes necessary to comply with the attestation requirement. Specifically, the Departments estimate that each issuer or TPA will require, on average, 16 hours of work from a Business Analyst (at $112.01 per hour), 8 hours from an Operations Manager (at $121.54 per hour), and 2 hours from a Chief Executive (at $290.93 per hour) to develop and update the necessary processes and procedures, review the updates, and review and attest to the accuracy and completeness of the information included in the machine-readable files. As shown in Table 30, this results in a total estimated one-time burden of 26 hours per entity, with an associated cost of approximately $3,346. Across all 1,508 affected issuers and TPAs, the Departments estimate a total one- time burden of 39,208 hours and a combined cost of approximately $5,046,281, as presented in Table 31. [GRAPHIC] [TIFF OMITTED] TR06OC26.052

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In addition to the one-time implementation burden, the Departments estimate an ongoing annual burden associated with maintaining compliance with the attestation requirement. Specifically, each issuer or TPA is expected to require, on average, 8 hours of work from a Business Analyst ($112.01 per

hour), 4 hours from an Operations Manager ($121.54 per hour), and 2 hours from a Chief Executive ($290.93 per hour) to review machine- readable files, make updates to internal procedures, periodically review the attestation information to ensure it remains accurate and current, validate information, and complete the annual attestation. As shown in Table 32, this results in an estimated ongoing annual burden of 14 hours per entity, with an associated cost of approximately $1,964 per issuer or TPA. Across all 1,508 affected issuers and TPAs, the Departments estimate a total ongoing annual burden of 21,112 hours and a combined annual cost of approximately $2,961,863 million, as presented in Table 33. The 3-year average costs and burden for this requirement are presented in Table 34. [GRAPHIC] [TIFF OMITTED] TR06OC26.054

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15. ICRs Regarding Requirements for Phased Implementation of New and Amended Machine-Readable File Requirements (26 CFR 54.9815- 2715A3(c)(1)(ii)-(iii), 29 CFR 2590.715-2715A3(c)(1)(ii)-(iii), and 45 CFR 147.212(c)(1)(ii)-(iii))

In the proposed rules, the Departments proposed that the amendments to the Transparency in Coverage machine-readable file requirements would apply beginning 12 months after publication of these final rules in the Federal Register and sought comment on whether this timeframe would provide sufficient implementation time.

As discussed in section III.C.13. of this preamble, and after considering public comments, the Departments are finalizing a phased implementation approach. Under this approach, certain requirements become applicable 5 months after publication of these final rules in the Federal Register (Phase 1), while other requirements become applicable 11 months after publication (Phase 2). The Departments have determined that this phased approach appropriately balances commenter requests for accelerated implementation of requirements with the time necessary to implement newly established contextual files and related technical changes.

Phase 1 includes requirements related to excluded providers, provider network-level reporting, reporting of common provider network name and network identifier, reporting of percentage of billed charges, aggregation of Allowed Amount File data by market type with a lower claims threshold and longer reporting period, inclusion of product type and HIOS identifiers, quarterly reporting, and adoption of a single file format. Phase 2 includes the Taxonomy File and Utilization File for the In-network Rate File, as well as the

Text File and the “findability” link requirement applicable to both files.

The two phases have different applicability dates, which may create an overlap period during which plans and issuers must simultaneously implement Phase 1 requirements while continuing to prepare for Phase 2 requirements. Maintaining these concurrent implementation workstreams is expected to increase coordination across planning, systems development, file creation and testing, operational coordination, and other implementation activities. Accordingly, the overlap period may require plans and issuers to allocate additional staff and technical resources across multiple implementation timelines, which could increase administrative and operational costs during the transition period.

The Departments do not have detailed information regarding the staffing structures, operational processes, or resource allocation practices of affected plans and issuers and therefore cannot precisely estimate the incremental burden associated with these concurrent implementation efforts. For purposes of this analysis, the Departments assume a conservative 20 percent increase in labor hours and associated labor costs relative to total first-year implementation burden for activities occurring during the overlap period. This assumption is intended to account for the additional coordination, project management, testing, and operational effort required to support overlapping implementation timelines.

Accordingly, the Departments estimate that plans and issuers will incur approximately 435,259 hours, with associated costs of approximately $66,624,563, during the first year of implementation.\142\ The Departments do not anticipate that the phased approach will impact ongoing costs. Ongoing costs are primarily driven by recurring reporting, data maintenance, and file updates, which are not expected to be duplicated as a result of overlapping implementation timelines. Rather, the phased approach affects the timing and sequencing of one-time implementation activities without increasing the overall magnitude of ongoing burden.

\142\ The estimated 435,259 hours and associated costs of $66,624,563 reflect a 20 percent adjustment to the high-end total first-year implementation burden estimates for the requirements in these final rules described in section IV.B.1 through 14., which total 2,176,295 total labor hours and $333,122,817 in associated costs.

The Departments have examined the impacts of these final rules as required by Executive Order 12866, “Regulatory Planning and Review;” \145\ Executive Order 13132, “Federalism;” \146\ Executive Order 13563, “Improving Regulation and Regulatory Review”; \147\ Executive Order 14192, “Unleashing Prosperity Through Deregulation”; \148\ the Regulatory Flexibility Act (RFA); \149\ section 1102(b) of the Social Security Act; section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. L. 104-4); and the Congressional Review Act (5 U.S.C. 804(2)).

\145\ Exec. Order No. 12866, 58 FR 51735 (September 30, 1993).

\146\ Exec. Order No. 13132, 64 FR 43255 (August 4, 1999).

\147\ Exec. Order No. 13563, 76 FR 3821 (January 18, 2011).

\148\ Exec. Order No. 14192, 90 FR 9065 (January 31, 2025).

\149\ Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (Sep. 19, 1980).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select those regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; and distributive impacts).

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as any regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, or the President's priorities, or the principles set forth in this Executive order. A “significant regulatory action” is subject to review by OMB. An RIA must be prepared for a regulatory action that is significant under Executive Order 12866. Based on the Departments' estimates, OMB's Office of Information and Regulatory Affairs (OIRA) has determined these rules are significant under section 3(f)(1) of Executive Order 12866, and an RIA has been prepared. In addition, under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act), OIRA has determined that this rule is a major rule as defined under 5 U.S.C. 804(2). The Departments have provided an assessment of the potential costs, benefits, and transfers associated with this rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB. Additionally, tax regulatory actions issued by the U.S. Department of the Treasury are subject to the requirements of section 6 of Executive Order 12866 pursuant to the Memorandum of Agreement (MOA) (July 4, 2025) between the Treasury Department and OMB regarding review of tax regulations. As such, the Treasury portions of this rule were also reviewed by OMB and are also included into this RIA.

These final rules will affect ERISA-covered group health plans and non-Federal governmental group health plans, and certain church plans subject to the applicable provisions of the Internal Revenue Code. However, because the Departments do not have sufficient data to estimate the number of church plans, they are not included in the quantitative estimates presented in this section.

The Departments estimate there are approximately 2,765,373 ERISA- covered group health plans.\151\ The Departments also estimate that these final rules are expected to affect 90,900 non-Federal governmental group health plans.\152\ Of these plans, approximately 35.7 percent \153\ (or 32,400) are self-insured,\154\ and 64.3 percent (or 58,400) are fully funded.\155\

\151\ Based on the 2024 Medical Expenditure Panel Survey Insurance Component (MEPS-IC) and the 2022 County Business Patterns from the Census Bureau, EBSA estimates there are 2,765,373 ERISA- covered group health plans.

\152\ Based on data from the 2022 Census of Governments, there are 90,887 State and local entities. The Departments assume there is one plan per entity on average. Therefore, the Departments estimate that there are 90,887 non-Federal governmental plans. U.S. Census Bureau, 2022 Census of Governments, Organization Tables, https://www.census.gov/data/CEs/2022/econ/gus/2022-governments.html (last visited Dec. 8, 2025).

\153\ Agency for Healthcare Research and Quality, Medical Expenditure Panel Survey--Insurance Component, Table III.A.2.a. (2023), https://www.meps.ahrq.gov/data_stats/summ_tables/insr/national/series_3/2023/ic23_iiia_g.pdf.

\154\ This estimate is calculated as follows: 90,887 non-Federal group health plans x 35.7 percent = 32,447 self-insured, non-Federal governmental group health plans.

\155\ This estimate is calculated as follows: 90,887 non-Federal group health plans x 64.3 percent = 58,440 fully insured, non- Federal governmental group health plans.

Finally, the Departments estimate that these final rules will affect 205 TPAs \160\ and 1,303 issuers.\161\ The Departments assume that fully-insured group health plans will rely on health insurance issuers, and self-insured group health plans will depend on TPAs, including issuers providing administrative services only and non-issuer TPAs, to implement the final updates to cost-sharing disclosures to participants, beneficiaries, and enrollees, as well as to implement the amended public disclosure requirements. This assumption is based on the Departments' understanding that most self-insured group health plans already rely on TPAs to perform core administrative functions, such as enrollment and claims processing.\162\ The Departments use the term TPA in this section of this preamble to refer to any other party with which a self-insured group health plan has an agreement to provide services to meet the requirements in these final rules.

\160\ An “issuer/State combination” refers to a health insurance issuer and the State in which it offers coverage, such that the same issuer operating in multiple States is treated as separate issuer/State combinations. Centers for Medicare & Medicaid Services, 2024 Medical Loss Ratio Data, https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources (last updated Mar. 13, 2026).

\161\ The Departments' estimate of the number of health insurance companies and the number of issuers (issuer/State combinations) is based on medical loss ratio reports submitted by issuers for the 2024 reporting year. Centers for Medicare & Medicaid Services, Medical Loss Ratio Data and System Resources (last updated Mar. 3, 2026), https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.

\162\ Louise Norris, What is Self-Insured Health Insurance? Most Very Large Employers Self-Insure, Verywell Health (November 6, 2025), https://www.verywellhealth.com/what-is-self-insured-health-insurance-and-how-is-it-regulated-4688567.

Consistent with Executive Order 12866 and OMB Circular A-4,\163\ Table 41 depicts an accounting statement summarizing the Departments' assessment of the benefits, costs, cost savings and transfers associated with these final regulatory actions. The Departments are unable to quantify all of the benefits and costs associated with these final rules due to data limitations and uncertainty about how plans, issuers, and other interested parties may respond to these final requirements. The Departments do not anticipate that these final rules will result in new or additional administrative costs to the Departments. The accounting table separately reports gross annualized monetized costs and annualized monetized cost savings, which are combined to calculate the net annualized monetized costs/cost savings.\164\

\163\ Office of Management and Budget, Circular A-4: Regulatory Analysis (2003), https://trumpwhitehouse.archives.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf.

\164\ Unless otherwise specified, all costs estimates in section V. of this preamble were developed using an IGCE framework. The IGCE framework provides a structured approach for estimating the resources necessary to implement and maintain regulatory requirements by identifying the anticipated activities, appropriate labor categories, level of effort, and operational and technical resources associated with each requirement. The Departments used this framework to develop reasonable assumptions regarding the personnel and hours necessary for plans and issuers to complete each information collection activity, taking into account the nature and complexity of the required tasks. Additional information regarding IGCE tools and resources is available through the U.S. General Services Administration. See U.S. General Services Administration, IGCE (Independent Government Cost Estimate), https://buy.gsa.gov/pricing/ (last visited August 13, 2026).

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\165\ For purposes of the accounting table and Executive Order 14192, negative values reflect reductions in costs with respect to monetized cost savings.

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Since the implementation of the 2020 final rules, many group health plans and health insurance issuers have experienced higher-than- anticipated costs associated with generating, storing, and updating very large and complex machine-readable files. The Departments acknowledge these burdens, as well as the underestimation of such burdens in the 2020 final rules and have taken steps in these final rules to mitigate these burdens by requiring more efficient disclosure formats, clarifying data reporting structures and reducing duplicative data. In the proposed rules, the Departments sought comment on which burden estimates may have been underestimated and what data sources could be relied upon to better assess implementation impacts; however, the Departments did not receive comments specifically addressing those issues. 2. Requirements for Disclosures to Participants, Beneficiaries, and Enrollees Under 26 CFR 54.9815-2715A2, 29 CFR 2590.715-2715A2, and 45 CFR 147.211 a. Non-Quantified Benefits

The following paragraphs describe the non-quantified benefits of the amendments, finalized in these rules, to the requirement that plans and issuers disclose certain cost-sharing information to participants, beneficiaries, and enrollees through an internet-based self-service tool, including making pricing information available by phone, and amending the statement related to balance billing consistent with balance billing protections under the No Surprises Act. (1) Informed Consumer

These final rules will enhance consumer access to critical cost- sharing information by expanding the available delivery methods and clarifying their scope. Requiring group health plans and issuers to provide cost-sharing estimates by phone using a telephone number found on any physical or electronic plan or insurance identification card issued to participants, beneficiaries, and enrollees ensures broader accessibility for all participants, beneficiaries, and enrollees, including those who prefer or rely on verbal communication due to visual impairments, limited literacy, or other challenges. By expanding access to this information, more participants, beneficiaries, and enrollees may be empowered to make cost-conscious decisions about their health care. This conclusion is consistent with a recent study indicating that transparent and accessible health care cost information empowers patients and providers to make more informed decisions and promotes consumer-driven health.\166\ Although the study evaluated price transparency tools generally rather than telephone disclosures specifically, its findings underscore the importance of ensuring that pricing information is readily accessible to consumers.

\166\ Niki Nourmohammadi & Gelareh Sadigh, Patients, Practice, and Price Transparency: The Impact of Disclosing Healthcare Costs on Consumer Decision-Making, 107 Clinical Imaging 110064 (2024), https://doi.org/10.1016/j.clinimag.2023.110064.

In addition, the amendments adopted in these final rules to the currently required statement on balance billing will provide individuals with clearer information about the potential for out-of- network providers to charge additional amounts not reflected in the cost-sharing information provided to the individual, including the fact that there are protections against balance bills under Federal law. The amendments will also ensure that plans and issuers include this statement unless the plans or policies are offered in States that categorically prohibit balance billing. (2) Timely Payment of Medical Bills

The amendments adopted in these final rules are designed to make cost-sharing information more accessible to participants, beneficiaries, and enrollees, and easier for participants, beneficiaries, and enrollees to understand and anticipate their health care costs. More transparency around potential health care costs by providing a new method for delivery via the phone and clearer information about potential balance billing and out-of-pocket costs is expected to increase participants', beneficiaries', and enrollees' overall awareness of their potential health care costs.

The Departments have determined that this increased transparency and awareness will help participants, beneficiaries, and enrollees better anticipate expenses and lead to more consistent and timely payment of medical bills. A TransUnion survey reported that 79 percent of individuals would be more likely to pay their medical bills promptly if they had out-of-pocket costs estimates before obtaining care.\167\ Additionally, recent reports from hospital systems show that when patients receive clear, upfront cost estimates, they are more likely to make payments at the time of service. For example, the Surgery Center of Oklahoma achieved a 22-fold increase in point-of-service collections, from about $900,000 in 2007 to $20.5 million in 2017, after implementing an automated cost-estimation tool that provided transparent pricing before care.\168\ Similarly, a Florida-based

hospital system that adopted real-time price estimates experienced a nearly 30 percent increase in point-of-service collections over 2 years.\169\ This suggests that making cost-sharing information disclosures more accessible and understandable can support patients' financial planning, promote more timely payment of medical bills, and provide financial benefits for hospitals and other health care providers.

\167\ Beth Kutscher, Consumers demand price transparency, but at what cost?, Modern Healthcare (June 23, 2015), https://www.modernhealthcare.com/article/20150623/NEWS/150629957/consumers-demand-price-transparency-but-at-what-cost.

\168\ Christopher Cheney, Cost estimation drives huge increase in POS collections, HealthLeaders (February 1, 2018), https://www.healthleadersmedia.com/finance/cost-estimation-drives-huge-increase-pos-collections.

\169\ Sze-jung Wu, Gosia Sylwestrzak, Christiane Shah, & Andrea DeVries, Price transparency for MRIs increased use of less costly providers and triggered provider competition, 33 Health Affairs 1391, 1398 (2014), https://www.healthaffairs.org/doi/10.1377/hlthaff.2014.0168.

(3) Increased Competition Among Providers

The amendments finalized in these rules aim to empower consumers to make cost-conscious choices among health care providers by improving the accessibility and clarity of cost-sharing information for participants, beneficiaries, and enrollees. By requiring plans and issuers to provide cost-sharing estimates over the phone, in addition to online and in paper form, these final rules will ensure broader access to pricing information. In addition, a clearer statement about potential balance billing by out-of-network providers will further enhance transparency and give individuals a more complete picture of the potential financial obligations associated with different providers.

Evidence suggests that price transparency can lead to reduced health care costs and increased market pressure on higher-cost providers. Studies have shown that when consumers receive pricing information, particularly in combination with incentives such as lower cost-sharing, cash rewards, or premium reductions, they are more likely to choose lower-cost options. For example, a price transparency initiative that allowed consumers to compare magnetic resonance imaging (MRI) prices across facilities resulted in nearly a 19 percent average cost reduction per scan (approximately $220 in savings per scan) and decreased use of higher-cost hospital settings.\170\ The study also found that price variations between hospital and non-hospital facilities for MRI scans decreased by 30 percent. This reduction was mainly driven by consumers switching to lower-cost options and competitive price adjustments by higher-cost facilities. Another study found that disclosure of negotiated prices stimulated provider competition and led to lower prices for shoppable services.\171\ These findings support the Departments' determination that greater transparency can drive competition, encourage cost-conscious decision- making, reduce price disparities across the health care system, and potentially contribute to lowering overall health care costs.

\170\ Id.

\171\ Angela Zhang, Khic-Houy Prang, Nancy Devlin, Anthony Scott, et al., The impact of price transparency on consumers and providers: A scoping review, 124 Health Policy 819, 825 (2020).

Recent evidence on price convergence suggests that, to the extent convergence occurs, reductions in higher negotiated rates may exceed increases in lower negotiated rates. One analysis of negotiated rates for 37 common health care services at 234 unique hospitals across the 10 largest U.S. metropolitan areas found that higher-priced negotiated rates declined by 6.3 percent annually, while lower-priced negotiated rates increased by 3.4 percent annually, resulting in lower overall negotiated prices.\172\

\172\ Turquoise Health, Is Price Transparency Helping? (October 25, 2024), https://s3.us-west-1.amazonaws.com/assets.turquoise.health/case_studies/Is+Price+Transparency+Helping+-+White+Paper+by+Turquoise+Health.pdf.

As discussed in greater detail in section V.D.4.e. of this preamble, the empirical literature suggests that price transparency may reduce overall health care costs, although the effects may vary depending on market conditions, provider responses, consumer behavior, and how price transparency requirements are implemented. Additionally, upward price adjustments among lower-priced providers and changes in provider contracting behavior may still occur in certain markets. The Departments also recognize that although increased transparency may provide participants, beneficiaries, and enrollees with more information to compare prices across providers, individuals may not always change providers based on cost information alone. Other factors such as existing provider relationships, continuity of care, or provider availability may affect how consumers select their providers. (4) Reduced Deadweight Loss \173\ Through Improved Access to Cost- Sharing Information by Phone

\173\ Deadweight loss refers to the economic inefficiency that arises when the consumption of a service deviates from the socially optimal level due to inaccurate pricing or insufficient information. In health care, lack of price transparency can lead patients to make suboptimal choices, either overpaying or postponing care, thereby decreasing overall economic welfare for both consumers and providers.

The Departments anticipate that requiring plans and issuers to provide cost-sharing information by phone helps reduce information asymmetry in health care markets, particularly for individuals who are less likely to use online tools, have limited internet access or feel less comfortable accessing or interpreting information over the internet. For example, according to the Pew Research Center, while 75 percent of those 65 and older use the internet generally, less than 61 percent own a smartphone,\174\ and 22 percent of these adults report never going online at all.\175\ By improving access to real-time, personalized cost-sharing data for these populations, this requirement is expected to enable more consumers to compare prices and select lower-cost providers. This shift in behavior is expected to reduce overpayment for services and better align spending with consumers' willingness to pay, thereby decreasing the deadweight loss that results from information asymmetry.

\174\ Michelle Faverio, Share of Those 65 and Older who are Tech Users has Grown in the Past Decade (January 13, 2022), Pew Research Center, https://www.pewresearch.org/short-reads/2022/01/13/share-of-those-65-and-older-who-are-tech-users-has-grown-in-the-past-decade. The share of those 65 and older who are tech users have improved at a rapid clip over the past decade and will continue to improve as more utilize online tools and resources.

\175\ Andrew Perrin & Sara Atske, 7 percent of Americans Don't Use the internet. Who are They?, Pew Research Center (April 2, 2021), https://www.pewresearch.org/short-reads/2021/04/02/7-of-americans-dont-use-the-internet-who-are-they.

Although quantifying these efficiency gains presents methodological challenges, economic literature supports the notion that improved price transparency can lead to behavioral changes and welfare improvements.\176\ The Departments recognize the potential for meaningful economic benefits and requested comment on these benefits; however, no comments were received.

\176\ Yiquan Gu & Tobias Wenzel, Transparency, price-dependent demand and product variety, 110 Economics Letters 216, 219 (Mar. 2011).