[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Proposed Rules]
[Pages 60432-60518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23693]
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Vol. 90
Tuesday,
No. 244
December 23, 2025
Part IV
Department of the Treasury
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Internal Revenue Service
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26 CFR Part 54
Department of Labor
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Employee Benefits Security Administration
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29 CFR Part 2590
Department of Health and Human Services
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45 CFR Part 147
Transparency in Coverage; Proposed Rule
Federal Register / Vol. 90 , No. 244 / Tuesday, December 23, 2025 /
Proposed Rules
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG-107111-25]
RIN 1545-BQ55
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC30
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS-9882-P]
RIN 0938-AV64
Transparency in Coverage
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Proposed rule.
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SUMMARY: These proposed rules set forth proposed requirements that
would amend the regulations under the Public Health Service Act, the
Employee Retirement Income Security Act of 1974, and the Internal
Revenue Code regarding price transparency reporting requirements for
non-grandfathered group health plans and health insurance issuers
offering non-grandfathered group and individual health insurance
coverage. Specifically, these proposed rules would improve the
standardization, accuracy, and accessibility of public pricing
disclosures in line with the goals of the Executive Order 14221. With
respect to the in-network rate and out-of-network allowed amount
machine-readable files, these proposed rules would achieve these goals
by adding new contextual files and additional data elements like
product type, network name, and enrollment counts; changing the
reporting level for aggregation of data; removing in-network rates for
unlikely provider-to-service mappings; increasing the reporting period
and lowering the claims threshold for out-of-network historical data;
and reducing the reporting cadence. These proposed rules would also
improve the findability of all of the publicly disclosed machine-
readable files required under the Transparency in Coverage rules,
including the prescription drug file, by requiring a text file and
footer with website URLs and contact information for the files. These
proposed rules would also require pricing information that is made
available through an online consumer tool and paper (upon request), to
also be made available by phone, and establish that the satisfaction of
such requirement also satisfies the requirements of section 114 of the
No Surprises Act (including for grandfathered group health plans and
health insurance issuers offering grandfathered group and individual
health insurance coverage that are not otherwise subject to these
proposed rules).
DATES: To be assured consideration, comments must be received at one of
the addresses provided below by February 23, 2026.
ADDRESSES: Written comments may be submitted to the addresses specified
below. Any comment that is submitted will be shared among the
Department of the Treasury, the Department of Labor, the Department of
Health and Human Services (the Departments), and the Office of
Personnel Management. Please do not submit duplicates.
Comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. Comments are posted on the internet
exactly as received and can be retrieved by most internet search
engines. No deletions, modifications, or redactions will be made to the
comments received, as they are public records. Comments may be
submitted anonymously.
In commenting, please refer to file code CMS-9882-P. Because of
staff and resource limitations, the Departments cannot accept comments
by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-9882-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-9882-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Kendra May or Jeremy Rotner, Centers
for Medicare and Medicaid Services, (301) 492-4293.
Elizabeth Schumacher or Sharon Aguirre, Employee Benefits Security
Administration, (202) 693-8335.
Alexander Krupnick, Internal Revenue Service, Department of the
Treasury, (202) 317-5500.
Individuals interested in obtaining information from the Department
of Labor (DOL) concerning employment-based health coverage laws may
call the Employee Benefits Security Administration (EBSA) Toll-Free
Hotline at 1-866-444-EBSA (3272) or visit the DOL's website
(www.dol.gov/agencies/ebsa). In addition, information from the
Department of Health and Human Services (HHS) on private health
insurance coverage and coverage provided by non-Federal governmental
group health plans can be found on the Centers for Medicare & Medicaid
Services (CMS) website (http://www.cms.gov/marketplace), information on
health care reform can be found at http://www.healthcare.gov, and
information on surprise medical bills can be found at http://www.cms.gov/nosurprises.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. The Departments post all
comments received before the close of the comment period on the
following website as soon as possible after they have been received:
http://www.regulations.gov. Follow the search instructions on that
website to view public comments. The Departments will not post on
Regulations.gov public comments that make threats to individuals or
institutions or suggest that the commenter will take actions to harm an
individual. The Departments continue to encourage individuals not to
submit duplicative comments. The
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Departments will post acceptable comments from multiple unique
commenters even if the content is identical or nearly identical to
other comments. The Departments encourage commenters to include
supporting facts, research, and evidence in their comments. When doing
so, commenters are encouraged to provide citations to the materials
referenced, including active hyperlinks. Likewise, commenters who
reference materials that have not been published are encouraged to
upload relevant data collection instruments, data sets, and detailed
findings as a part of their comment. Providing such citations and
documentation will assist the Departments in analyzing the comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this rule may be found at https://www.regulations.gov/.
I. Executive Summary
A. Purpose
The Departments of Labor, Health and Human Services (HHS), and the
Treasury (collectively, the Departments) issued proposed requirements
in the 2019 Transparency in Coverage proposed rules (2019 proposed
rules) \1\ and finalized the rules in 2020 (the 2020 final rules).\2\
The rules aimed to provide consumers with price and benefit information
that would enable them to better evaluate health care options and make
cost-conscious decisions; reduce surprises in consumers' out-of-pocket
costs for health care services; create a competitive dynamic that would
begin to narrow price differences for the same services in the same
health care markets; foster innovation by providing industry the
information necessary to support informed, price-conscious consumers in
the health care market; and, over time, potentially lower overall
health care costs.\3\
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\1\ 84 FR 65464 (November 27, 2019).
\2\ 85 FR 72158 (November 12, 2020).
\3\ 85 FR 72158, 72160 (November 12, 2020).
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The public disclosures made pursuant to the 2020 final rules led to
the release of an enormous amount of previously hidden pricing data.
However, post-implementation, the Departments continue to receive
feedback from users of the machine-readable files emphasizing the need
to address certain gaps in reporting and shrink file size by reducing
duplication and removing unnecessary data. Since the finalization of
the 2020 final rules, the Departments have also received feedback from
many interested parties about the myriad ways in which plans and
issuers contract with providers for items and services that impact the
usability of the data disclosed under the rules.
On February 25, 2025, President Trump issued Executive Order 14221,
``Making America Healthy Again by Empowering Patients With Clear,
Accurate, and Actionable Healthcare Pricing Information'' (Executive
Order 14221).\4\ Among other things, Executive Order 14221 directs the
Departments to take all necessary and appropriate action, including
issuing proposed regulatory action to promote more transparency in
health care pricing information. In line with the goals of Executive
Order 14221, the Departments propose several amendments to the 2020
final rules to improve the standardization, accuracy, and accessibility
of pricing information.
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\4\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
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Based on internal assessment and external feedback from interested
parties, the Departments have identified three main barriers to fully
achieving the goals of the 2020 final rules: inaccessibility due to the
size of the machine-readable files, ambiguity regarding some of the
data disclosures due to a lack of contextual information alongside the
raw data, and misalignment with the ``2019 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'' rule \5\ (2019 Hospital Price Transparency
rule) that makes comparing data across disclosures challenging.
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\5\ 84 FR 65524 (November 27, 2019).
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The Departments understand that the large size of many of the
required machine-readable files, particularly the in-network rate
machine-readable file (In-network Rate File), is the most prominent
challenge with working with the machine-readable files. Academics and
researchers,\6\ data engineers,\7\ health plans and health insurance
issuers,\8\ and members of Congress \9\ have stated that these large
file sizes create several problems for file users seeking to open and
analyze the files, as well as for health plans and health insurance
issuers reporting that amount of data. For file users, the amount of
data to sift through monthly requires significant resources and time.
Smaller datasets are easier to analyze and cheaper to maintain. For
plans and issuers, large files have large data storage, maintenance,
and bandwidth costs. The amount of data being generated monthly can
also lead to increased errors in the files, making it difficult for
plans and issuers to ensure they are compliant with the disclosure
requirements and for file users to be confident in the integrity of the
data being reported. Reducing the collective burden from large file
sizes and making it easier for all users to work with the data in the
machine-readable files are among the driving goals of these proposed
rules.
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\6\ Christopher Whaley, Neeraj Radhakrishnan, Michael Richards,
Kosali Simon, et al., Understanding Health Care Price Variation:
Evidence from Transparency-in-Coverage Data, 3 Health Affairs
Scholar 2 (2025), https://doi.org/10.1093/haschl/qxaf011;
Michael E. Chernew, Sabrina Corlette, Kelly Davenport,
Fran[ccedil]ois de Brantes, et al., Transparency in Coverage:
Recommendations for Improving Access to and Usability of Health Plan
Price Data (2022), Georgetown University, https://georgetown.app.box.com/s/1ezsggz1c7smsaexkr8rght15sokgusl.
\7\ Adam Geitgey, A Petabyte of Health Insurance Prices per
Month, Turquoise Health (July 11, 2023), https://blog.turquoise.health/a-petabyte-of-health-insurance-rates-a-month/.
\8\ United Health Care, Transparency in coverage, https://transparency-in-coverage.uhc.com/ (last visited Dec. 8, 2025).
(``Files are in a JSON format and may contain millions of lines of
data and be up to 1 terabyte (TB) in size. Please consider your
system's capacity and memory when downloading these files.'')
\9\ Maggie Hassan & Michael Braun, Letter to CMS Administrator
Chiquita Brooks-LaSure (Mar. 6, 2023), https://www.hassan.senate.gov/imo/media/doc/tic.pdf.
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With the 2020 final rules, the Departments expected the public
disclosure of pricing information related to health care items and
services to help both uninsured and insured individuals in their health
care and health coverage purchasing decisions. As stated in the
preamble to the 2020 final rules, research indicates that having access
to pricing information can increase consumers' overall satisfaction and
provide opportunities for education and engagement on health care
pricing.\10\
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\10\ 85 FR 72158 (November 21, 2020).
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Price transparency enables consumers to evaluate health care
options and make cost-conscious decisions, allowing for the possibility
of a competitive dynamic that may narrow price dispersion for the same
items and services in the same health care markets and put downward
pressure on prices and potentially lower overall health care costs.\11\
Since the publication of the 2020 final rules, researchers have
continued to analyze price transparency in health care with the benefit
of access to the data provided largely by the machine-readable files.
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\11\ 85 FR 72158, 72159 (November 12, 2020).
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Some researchers have identified significant potential cost-savings
across the health insurance landscape through greater use of the
machine-readable file data.\12\ Recent discussions extol the potential
benefits of price transparency, echoing the reasons the Departments
emphasized in the 2020 final rules. These include effects on the demand
for health care by ``guiding patients to lower-priced providers'' and
to the supply side by ``promot[ing] price competition among
providers,'' \13\ as well as benefits to employers to ``redesign health
benefits and inform purchasing decisions.'' \14\ One analysis
emphasized a range of benefits, from ``optimizing current contracts''
to ``increasing the accuracy of performance assumptions, market
analysis, and strategic value.'' \15\ Early analyses of the potential
financial and economic impacts of the 2020 final rules show promise for
fulfilling the goals the Departments articulated in the 2020 final
rules of ``facilitating a market-driven heath care system by giving
consumers of health care services data that will enable consumers to
make fully informed, cost-conscious decisions when choosing health
care.'' \16\
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\12\ Stephen T. Parente, Estimating the Impact of New Health
Price Transparency Policies, 60 The Journal of Health Care
Organization, Provision, and Financing (Feb. 17, 2023);
David N. Bernstein & John R. Crowe, Price Transparency in United
States' Health Care: A Narrative Policy Review of the Current State
and Way Forward, 61 Inquiry (2024).
\13\ Juan Carvajal, Christopher Ody, & Christopher Whaley, The
Relationship Between Pricing Transparency and Price Competition in
the US Health Care Industry (Nov. 5, 2024), https://www.analysisgroup.com/globalassets/insights/publishing/2024_aba_article_relationship_between_pricing_transparency.pdf.
\14\ Christopher Whaley & Austin Frakt, If Patients Don't Use
Available Health Service Pricing Information, Is Transparency Still
Important?, 24 AMA Journal of Ethics 995 (Nov. 2022.
\15\ Sarun Charumilind, Shubham Singhal, Oleg Bestsennyy, Erica
Coe, et al., How Price Transparency Could Affect US Healthcare
Markets), McKinsey (Apr. 2, 2024), https://www.mckinsey.com/industries/healthcare/our-insights/how-price-transparency-could-affect-us-healthcare-markets.
\16\ 85 FR 72158, 72171 (November 12, 2020).
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While the machine-readable file requirements of the 2020 final
rules and the 2019 Hospital Price Transparency rule do not require the
exact same disclosures, they have similar goals and some overlapping
data. Therefore, it can be useful to review studies of hospital
machine-readable files for lessons learned and outcomes that may
translate to the plan and issuer machine-readable file disclosures. One
study using hospital data found that ``choosing plans from the largest
insurer in the local market is more likely to result in lower
negotiated rates than from other plans,'' which can lead to reduced
costs for the ``growing number of self-insured employers engaged in
direct contracts with hospitals.'' \17\ One county government used
hospital data in this manner to reduce its health costs by over 40
percent.\18\ Tools allowing comparison of the hospital data recently
began populating the internet. The Departments are also aware of app
developers conducting similar analyses of the data from plan and issuer
disclosures and offering them to consumers (both individuals and
employers). The Departments expect that continued analyses and
development of consumer-facing tools and services will result in
similar savings opportunities achieved from studying the hospital
machine-readable files.
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\17\ Yang Wang, Michael E. Chernew, Leemore S. Dafny, Maximilian
J. Pany, et al., Do Insurers with Greater Market Power Negotiate
Consistently Lower Prices for Hospital Care? Evidence From Hospital
Price Transparency Data, 29 Medical Care Research & Review (Aug. 18,
2023).
\18\ Sara Hansard, One County Combed Hospital Data to Slash
Health Plan Costs 43 Percent (Feb. 6, 2023), Bloomberg, https://news.bloomberglaw.com/health-law-and-business/employer-health-plan-eyes-43-savings-from-payment-data-audits.
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However, the success of these analyses and the effectiveness of
consumer-facing tools depend on the usability of the machine-readable
files. Large file sizes, lack of clarity, and data of limited use
hamper efforts to build tools that can be brought to market. These
proposed changes, if finalized, would contribute to making the files
easier to digest and analyze, reduce challenges for existing tool
developers, and open the market to additional tool and app developers.
The Departments seek to address the limitations of the machine-
readable files through these proposed rules as well as through updates
to the machine-readable file form and manner requirements as detailed
in technical implementation guidance. As a first step towards
addressing these limitations, on May 22, 2025, the Departments
announced in FAQs Part 70 the intention to release schema version 2.0
(Schema 2.0), which will implement revised technical requirements for
the In-network Rate File and out-of-network allowed amounts and billed
charges machine-readable file (Allowed Amount File).\19\ However, the
Departments also recognize that more substantive requirements are
needed to clarify the data being published and to give users more
confidence in the data. Feedback from interested parties demonstrates
that, while the raw data from the machine-readable files presents
valuable information and opportunities for analysis, additional
contextual information is needed to supplement the in-network rates and
out-of-network allowed amounts and billed charges disclosed in the
machine-readable files. Additional contextual information would allow
users to understand changes in pricing over time, promote more accurate
reporting, and make pricing information more meaningful and accessible
overall. Therefore, the Departments are issuing these proposed rules as
a next step to addressing these concerns.
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\19\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, Frequently Asked
Questions About Affordable Care Act Implementation Part 70 (May 22,
2025), https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-70.
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The disclosure requirements under the Transparency in Coverage
rules represent just one prong in a multipronged approach to promote
greater transparency and understanding of costs and pricing in the
health care and the health insurance market. The 2020 final rules must
be viewed within the context of other regulatory and statutory changes,
such as the Hospital Price Transparency initiative, as well as Title I
of Division BB of the Consolidated Appropriations Act, 2021 (CAA), also
known as the No Surprises Act, and its consumer protections against
surprise billing, its requirements for a good faith estimate, advanced
explanation of benefits, and more accurate provider directories. With
respect to the Hospital Price Transparency and the Transparency in
Coverage initiatives in particular, section 3(b) of Executive Order
14221 instructed the Departments to ``issue updated guidance or
proposed regulatory action ensuring pricing information is standardized
and easily comparable across hospitals and health plans.'' \20\ The
Departments received encouraging feedback that ``commercial prices
disclosed in the TiC [Transparency in Coverage] data are mostly
comparable to those disclosed by hospitals in compliance with the
hospital price transparency rule and to Marketscan [sic] claims data.''
\21\
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However, other interested parties have noted that, despite the
consistency of the raw data across hospital and plan and issuer
machine-readable files, there are other challenges in comparing the
information between the two sets of machine-readable files.\22\
Therefore, the Departments intend in these proposed rules, along with
Schema 2.0, to help align the Hospital Price Transparency reporting
requirements and the 2020 final rules, as well as to fulfill the
directive under Executive Order 14221.
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\20\ Exec. Order No. 14221, 90 FR 11005, 11006 (February 28,
2025).
\21\ Yang Wang, Michael Meiselbach, Gerard Anderson & Ge Bai,
Hospital Pricing Information Consistent Between Transparency-In-
Coverage Data and Other Commercial Data Sources, 42 Health Affairs
(2023), https://www.healthaffairs.org/content/forefront/hospital-pricing-information-consistent-between-transparency-coverage-data-and-other. Information on MarketScan data can be found at https://www.merative.com/documents/merative-marketscan-research-databases.
\22\ Nikki Tong, Price Transparency Proposal Leaves Room for
Improvement, Experts Say, Fierce Healthcare (Aug. 1, 2023), https://www.fiercehealthcare.com/providers/price-transparency-proposal-leaves-room-improvement; Jing Jiang, Mengqi Jiang & Ge Bai,
Enforcing Hospital Price Transparency: Lessons from CMS Actions,
Health Affairs Forefront (Dec. 3, 2024), https://www.healthaffairs.org/content/forefront/enforcing-hospital-price-transparency-lessons-cms-actions.
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Additionally, to better inform a response to Executive Order 14221,
on June 2, 2025, the Departments published a Request for Information
(RFI) seeking the public's input on ways to effectively implement or
amend the prescription drug machine-readable file requirement in the
2020 final rules.\23\
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\23\ 90 FR 23303 (June 2, 2025).
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Building off of the 2020 final rules, the Departments propose these
rules pursuant to the authority under Section 2715A of the Public
Health Service (PHS) Act, incorporated into section 715 of the Employee
Retirement Income Security Act (ERISA) and section 9815 of the Internal
Revenue Code (Code), which provide that non-grandfathered group health
plans and health insurance issuers offering non-grandfathered group or
individual health insurance coverage must comply with section
1311(e)(3) of the Patient Protection and Affordable Care Act
(Affordable Care Act). This section of the Affordable Care Act
addresses transparency in health coverage and imposes certain reporting
and disclosure requirements on health plans that are seeking
certification as qualified health plans (QHPs) that may be offered on
an Exchange (as defined by section 1311(b)(1) of the Affordable Care
Act).
The Departments also propose these rules pursuant to the authority
under the No Surprises Act, which amended chapter 100 of the Code, Part
7 of ERISA, and title XXVII of the PHS Act. Among other protections,
the No Surprises Act provides Federal protections against surprise
billing by limiting out-of-network cost sharing and prohibiting balance
billing in many of the circumstances in which surprise bills most
frequently arise. Section 114 of the No Surprises Act added Code
section 9819, ERISA section 719, and PHS Act section 2799A-4, which
require plans and issuers to offer price comparison guidance by
telephone and make a ``price comparison tool'' available on the plan's
or issuer's website.
B. Summary of the Major Provisions
1. Transparency in Coverage--Definitions
The 2020 final rules include definitions at 26 CFR 54.9815-
2715A1(a)(2); 29 CFR 2590.715-2715A1(a)(2); and 45 CFR 147.210(a)(2).
These proposed rules, if finalized, would add a definition of the term
health insurance market for purposes of amendments to 26 CFR 54.9815-
2715A3(b)(1)(ii), 29 CFR 2590.715-2715A3(b)(1)(ii), and 45 CFR
147.212(b)(1)(ii) that would require group health plans and health
insurance issuers offering group or individual health insurance
coverage to make an out-of-network allowed amount machine-readable file
available for each health insurance market in which the plan or issuer
offers a plan or coverage. Under 26 CFR 54.9815-2715A1 and 45 CFR
147.210, the Departments propose to redesignate paragraphs (a)(2)(xi)
through (xxii) as paragraphs (a)(2)(xii) through (xxiii), respectively,
and add a new paragraph (a)(2)(xi) with the new definition. Under 29
CFR 2590.715-2715A1, the Departments propose to redesignate paragraphs
(a)(2)(x) through (xxi) as paragraphs (a)(2)(xi) through (xxii) and add
a new paragraph (a)(2)(x) with the new definition.
2. Transparency in Coverage--Required Disclosures to Participants,
Beneficiaries, or Enrollees
The 2020 final rules at 26 CFR 54.9815-2715A2; 29 CFR 2590.715-
2715A2; and 45 CFR 147.211 require non-grandfathered group health plans
and health insurance issuers offering non-grandfathered coverage in the
group and individual markets to make cost-sharing information available
to participants, beneficiaries, and enrollees through an internet-based
self-service tool (self-service tool), and in paper form, upon request.
The Departments propose to amend paragraph (b)(1)(vii)(A) of this
section to require the disclaimer, described in that paragraph, to
state that the cost-sharing information does not account for potential
additional amounts in situations where applicable State and Federal law
allow out-of-network providers to balance bill participants,
beneficiaries, and enrollees. This proposed amendment reflects the
existence of the Federal balance billing protections set forth in the
No Surprises Act, which was not in effect when (b)(1)(vii)(A) was
finalized in the 2020 final rules. The Departments also propose to
clarify that the disclaimer is not required if the State in which the
item or service was furnished prohibits all out-of-network providers
from balance billing for all items and services payable by the plan or
issuer.
In addition, the Departments propose to add a new paragraph at
(b)(2)(iii) under this section to require plans and issuers to make
available to participants, beneficiaries, and enrollees the cost-
sharing estimates and other disclosures required under paragraph (b)(1)
via a telephone number to implement requirements under section 9819 of
the Code, section 719 of ERISA, and PHS Act Section 2799A-4, as added
by section 114 of the No Surprises Act.\24\ The Departments propose to
require a telephone number through which a consumer may seek customer
assistance which would be required to be the same number that Code
section 9816(e), ERISA section 716(e), and PHS Act section 2799A-1(e),
as added by section 107 of the No Surprises Act requires be indicated
on any physical or electronic plan or insurance identification card
issued to a participant, beneficiary, or enrollee. The Departments also
propose to redesignate paragraph (b)(2)(ii)(D) as new paragraph
(b)(2)(iv) and amend redesignated paragraph (b)(2)(iv) to remove phone
as an alternative means by which a participant, beneficiary, or
enrollee can request the disclosures required under paragraph (b)(1).
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\24\ 42 U.S.C. 300gg-111(e)(3); 29 U.S.C. 1185e(e)(3); 26 U.S.C.
9819. U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs about Affordable
Care Act and Consolidated Appropriations Act, 2021 Implementation
Part 49 (August 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf.
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The Departments also propose to add a new paragraph (c)(7) stating
that plans and issuers satisfy the requirements set forth in Code
section 9819, ERISA section 719, and PHS Act section 2799A-4 regarding
the price comparison tool by providing the information to participants,
beneficiaries, and enrollees set forth in paragraph (b)(1) as amended
in accordance with the method and format requirements set forth in
paragraph (b)(2), as amended.\25\
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\25\ While PHS Act section 2715A does not apply to grandfathered
health plans and health insurance issuers offering grandfathered
individual and group health insurance coverage, section 9819 of the
Code, section 719 of ERISA, and section 2799A-4 of the PHS Act do
apply to grandfathered health plans and issuers offering
grandfathered health insurance coverage.
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3. Transparency in Coverage--Requirements for Public Disclosure
The Transparency in Coverage final rules at 26 CFR 54.9815-2715A3;
29 CFR 2590.715-2715A3; and 45 CFR 147.212 require non-grandfathered
group health plans and health insurance issuers offering non-
grandfathered group and individual health insurance coverage to
disclose on a public website, in the format of machine-readable files,
information regarding in-network provider rates for covered items and
services, out-of-network allowed amounts and billed charges for covered
items and services, and negotiated rates and historical net prices for
covered prescription drugs.
The Departments propose a number of amendments that would apply to
the disclosure of information required under paragraphs (b)(1) and
(b)(2). First, the Departments propose to amend the introductory
paragraph of (b) to reference new requirements for the public
disclosure of contextual information and to redesignate paragraphs
(b)(2) through (b)(3) as paragraphs (b)(3) through (b)(4),
respectively, and add a new paragraph (b)(2) describing the proposed
contextual information disclosure requirements for the In-network Rate
File. The Departments also propose to add two new paragraphs,
(b)(2)(iv) and (b)(3)(iii), to help users more easily locate the public
disclosures made pursuant to these proposed rules by requiring plans
and issuers to post a plain text file in a .txt format (Text File) in
the root folder of the plan or issuer's website and a specific internet
domain as a link in the footer on the home page of the plan's or
issuer's website. The Departments are also considering a standardized
file format for all machine-readable files. The Departments also
propose to amend the required information at redesignated paragraph
(b)(1)(i)(B) and paragraph (b)(1)(ii)(A) to remove the requirement to
report a specific number of digits of the Health Insurance Oversight
System (HIOS) identifier (ID) that are required for each coverage
option and to add a requirement to disclose the product type associated
with the plan or policy in the In-network Rate Files and the Allowed
Amount Files. The Departments also propose to amend the special rules
to prevent unnecessary duplication in current paragraph (b)(4) by
redesignating paragraph (b)(4)(i) as paragraph (b)(5)(i), redesignating
paragraph (b)(4)(ii) as paragraph (b)(5)(ii), redesignating paragraph
(b)(4)(iii) as paragraph (b)(5)(iv), and adding paragraph (b)(5)(iii).
In new paragraph (b)(5)(iii), the Departments propose to permit self-
insured group health plans under certain circumstances to allow another
party, such as a service provider, with which they have an agreement as
described in paragraph (b)(5)(ii), to make available in a single In-
network Rate File as required under paragraph (b)(1)(i), the
information required under paragraph (b)(1)(i) for more than one plan,
insurance policy, or contract (including those offered by different
plan sponsors with which the other party has an agreement) and across
different health insurance markets. The Departments also propose to
amend newly redesignated paragraph (b)(5)(iv) to permit self-insured
group health plans under certain circumstances to allow another party
with which they have an agreement to aggregate the Allowed Amount Files
required under paragraph (b)(1)(ii) for more than one self-insured
group health plan, including those offered by different plan sponsors.
Finally, the Departments propose to amend newly redesignated
paragraph (b)(4) by adding new paragraphs to specify the timing
requirements for each machine-readable file required as proposed under
these rules. As related to the public disclosures generally, proposed
paragraph (b)(4)(i) would amend the required reporting frequency for
the In-network Rate and Allowed Amount Files under paragraphs (b)(1)(i)
and (b)(1)(ii) from monthly to quarterly but would not propose any
changes to the monthly reporting frequency for the prescription drug
file required under paragraph (b)(1)(iii). Newly redesignated paragraph
(b)(4)(vi) proposes to require the Text File proposed under new
paragraph (b)(2)(iv) to be posted beginning on the first day of the
calendar-year quarter following the applicability date under paragraph
(c)(1) and updated and posted as soon as practicable but no later than
7 calendar days following a change in any of the information required
under redesignated paragraph b)(2)(iv).
The amendments contained in these proposed rules generally modify
requirements related to the In-network Rate Files and the Allowed
Amount Files. However, several proposed amendments would amend
requirements related to the prescription drug machine-readable files,
specifically: the requirement that plans and issuers must include a
Text File in the root folder of a plan's or issuer's website as
described in proposed paragraphs (b)(2)(iv) (section III.C.7.d. of this
preamble) and the requirements related to the method and format for
disclosing information to the public as described in proposed
redesignated paragraph (b)(3) (section III.C.9. of this preamble). The
Departments note in each applicable section when a proposal would
modify requirements related to the prescription drug machine-readable
files.
4. Public Disclosure of In-Network Rates
With respect to the disclosure of in-network rates specifically, to
reduce duplicate in-network rate data, the Departments propose 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 maintained or contracted
by the plan or issuer. As part of this proposal, the Departments
propose to redesignate paragraphs (b)(1)(i)(A) through (C) as
paragraphs (b)(1)(i)(B) through (D), respectively, and add a new
paragraph (b)(1)(i)(A) requiring each In-network Rate File to include
the common provider network name for which negotiated rate information
is included in that file.
The Departments also propose to amend redesignated paragraph
(b)(1)(i)(D)(1) to require in-network rates to be reflected as a dollar
amount except for contractual arrangements under which plans and
issuers agree to pay an in-network provider a percentage of billed
charges and are not able to assign a dollar amount to an item or
service prior to a bill being generated. The Departments also propose
to add new paragraph (b)(1)(i)(E), requiring each In-network Rate File
to include current enrollment totals, as of the date the file is
posted, for each plan or coverage option offered by a plan or issuer
that uses that file's provider network.
The Departments also propose in new paragraph (b)(1)(i)(F) to
require plans and issuers to exclude any provider and their negotiated
rate (provider-rate combination) for an item or service, if the
provider is unlikely to be reimbursed for the 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 also propose to amend newly redesignated paragraph
(b)(1)(i)(D)(2) to account for this proposed required exclusion.
The Departments also propose to require plans and issuers to post
several contextual machine-readable files under new paragraph (b)(2)
that would help file users better understand the public
[[Page 60437]]
disclosures required in the In-network Rate Files under paragraph
(b)(1)(i). This proposal would mean plans and issuers would be required
to prepare new contextual files for each In-network Rate File prepared
pursuant to these proposed rules. In particular, the Departments
propose to require a change-log file (``Change-log File'') at new
paragraph (b)(2)(i), which would identify any changes made to the
required information described in paragraph (b)(1)(i) in the In-network
Rate File since the last posted In-network Rate File.
The Departments also propose to require a utilization file
(``Utilization File'') at new paragraph (b)(2)(ii), which would
document, for the 12-month period that ends 6 months prior to the
publication date of each Utilization File, all items and services
covered under the plans or policies represented in the In-network Rate
File prepared pursuant to proposed amended paragraph (b)(1)(i) for
which a claim has been submitted and reimbursed. The Utilization File
would also include each in-network provider identified by the National
Provider Identifier (NPI), Tax Identification Number (TIN), and Place
of Service Code who was reimbursed, in whole or in part, for a claim
for each covered item or service included in such file.
The Departments also propose to require plans and issuers to
publish a taxonomy file (``Taxonomy File'') at new paragraph
(b)(2)(iii) which would include their internal provider taxonomy that
matches items and services (represented by a billing code) with
provider specialties (represented by specialty codes that are derived
from the Health Care Provider Taxonomy \26\ code set established by the
National Uniform Claim Committee (NUCC)) 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.
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\26\ National Uniform Claim Committee, Health Care Provider
Taxonomy, https://www.nucc.org/index.php/code-sets-mainmenu-41/provider-taxonomy-mainmenu-40 (last visited Dec. 8, 2025).
---------------------------------------------------------------------------
Finally, the Departments propose to add timing requirements for the
proposed new contextual files under redesignated paragraph (b)(4). With
respect to the contextual files that related to the In-network Rate
Files under paragraph (b)(1)(i), under proposed paragraph (b)(4)(iii),
the Change-log File proposed at paragraph (b)(2)(i) would be required
to be posted beginning on the first day of the calendar-year quarter
following the date on which the first In-network Rate File is required
to be posted under paragraph (b)(4)(i), and updated and posted
quarterly whether or not there are changes to that file since it was
last posted. Under proposed paragraph (b)(4)(iv), the Utilization File
proposed at paragraph (b)(2)(ii) would be required to be posted
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) and updated annually after
the initial posting. Lastly, under proposed paragraph (b)(4)(v), the
Taxonomy File proposed at paragraph (b)(2)(iii) would be required to be
posted beginning on the first day of the calendar-year quarter
following the applicability date under paragraph (c)(1) and updated and
posted quarterly if changes to the internal provider taxonomy impact
the information required in the machine-readable file required under
paragraph (b)(1)(i).
5. Public Disclosure of Out-of-Network Allowed Amounts
The Departments propose to make several amendments to 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 increase the amount of historical claims data
available in the Allowed Amount Files. These amendments would require
plans and issuers to report out-of-network allowed amounts and billed
charges at the health insurance market level, rather than the plan or
policy level, lower the threshold for including claims in the Allowed
Amount File from 20 to 11 different claims per item or service, and
increase the reporting period from 90 days to 6 months and the lookback
period from 180 days to 9 months.
6. Severability
The 2020 final rules included severability clauses to emphasize the
Departments' intent that, to the extent a reviewing court holds that
any provision of the final rules is unlawful, the remaining rules
should take effect and be given the maximum effect permitted by law.
The 2020 final rules provide that any provision held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, or stayed pending further agency action, shall be
severable from the relevant section and shall not affect the remainder
thereof or the application of the provision to persons not similarly
situated or to dissimilar circumstances. The Departments are not
modifying this language in the 2020 final rules and clarify that these
clauses continue to apply and would extend to the amendments proposed
in these rules, if finalized.
7. Technical Amendments
The Departments propose a series of technical amendments to the way
group health plans and health insurance issuers offering group or
individual health insurance coverage are referenced in 26 CFR 54.9815-
2715A2 and 54.9815-2715A3, 29 CFR 2590.715-2715A2 and 2590.715-2715A3,
and 45 CFR 147.211 and 147.212. In the 2020 final rules, the
Departments generally adopted the convention of referring to those
entities using the terms ``group health plan'' and ``health insurance
issuer'' throughout the regulations, except that where the Departments
refer to those entities more than once in the same paragraph, the terms
``plan'' and ``issuer'' are used after the initial instance. However,
that convention was not applied evenly.
Therefore, in the internet-based self-service tool disclosure
requirements in 26 CFR 54.9815-2715A2, 29 CFR 2590.715-2715A2, and 45
CFR 147.211, the Departments propose technical amendments to paragraphs
(b)(1)(i)(A), (b)(1)(i)(B), (b)(2)(ii), (b)(3)(i), and (b)(3)(ii) that
would bring the terms used to describe those entities in line with that
convention. In the machine-readable file disclosure requirements in 26
CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212, the
Departments propose amendments to redesignated paragraph (b)(1)(i)(D),
(b)(5)(i), and (b)(5)(ii) that would bring the terms used to describe
those entities in line with that convention. These paragraphs are
otherwise unchanged. These proposed changes are technical in nature and
would not affect the rights or obligations of any plan, issuer, or
other entity.
C. Summary of Costs and Benefits
[[Page 60438]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.047
[[Page 60439]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.048
[[Page 60440]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.049
II. Background
A. Executive Orders
On June 24, 2019, President Trump issued Executive Order 13877,
``Improving Price and Quality Transparency in American Healthcare to
Put Patients First.'' \27\ Executive Order 13877 sought to improve
transparency in health care and empower patients to make fully informed
decisions about their health care. As Executive Order 13877 noted,
``patients often lack both access to useful price and quality
information and the incentives to find low-cost, high-quality care.''
The lack of this information is widely understood to be one of the root
problems causing dysfunction within America's health care system,
``generally leav[ing] patients and taxpayers worse off than would a
more transparent system.''
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\27\ Exec. Order No. 13877, 84 FR 30849 (June 27, 2019).
---------------------------------------------------------------------------
Executive Order 13877 directed the Departments to take action that
would combat this issue by making meaningful price and quality
information more broadly available to more Americans, thereby
increasing competition, innovation, and value in the health care
system. Specifically, section 3(b) of Executive Order 13877 directed
the Secretaries of the Departments to issue an advance notice of
proposed rulemaking, consistent with applicable law, soliciting comment
on a proposal to require health care providers, health insurance
issuers, and self-insured group health plans to provide or facilitate
access to information about expected out-of-pocket costs for items or
services to patients before they receive care.
To fulfill their responsibility under Executive Order 13877, the
Departments proposed \28\ and subsequently finalized the Transparency
in Coverage rules in the 2020 final rules.\29\ The 2020 final rules
published by the Departments on November 12, 2020, implemented section
2715A of the PHS Act, which requires group health plans and health
insurance issuers offering group or individual health insurance
coverage to comply with section 1311(e)(3) of the Affordable Care Act.
As described more fully elsewhere in this preamble, these provisions
address transparency in health coverage and require plans and issuers
to make certain information available to the public.
---------------------------------------------------------------------------
\28\ 84 FR 65464 (November 27, 2019).
\29\ 85 FR 72158 (November 12, 2020).
---------------------------------------------------------------------------
On February 25, 2025, President Trump issued Executive Order
14221,\30\ ``Making America Healthy Again by Empowering Patients With
Clear, Accurate, and Actionable Healthcare Pricing Information.''
Executive Order 14221 stated that ``[m]aking America healthy again will
require empowering individuals with the best information possible to
inform their life and healthcare choices'' with the goal to ``make more
meaningful price information available to patients to support a more
competitive, innovative, affordable, and higher quality healthcare
system.'' To that end, the Executive Order directs the Departments to
``promote universal access to clear and accurate healthcare prices[;] .
. . to improve existing price transparency requirements; increase
enforcement of price transparency requirements; and identify
opportunities to further empower patients with meaningful price
information, potentially including through the expansion of existing
price transparency requirements.'' \31\
---------------------------------------------------------------------------
\30\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
\31\ Id.
---------------------------------------------------------------------------
Section 3 of Executive Order 14221 directs the Secretaries of the
Departments to rapidly implement and enforce the health care price
transparency regulations issued pursuant to Executive Order 13877,\32\
[[Page 60441]]
including action to: ``(a) require the disclosure of the actual prices
of items and services, not estimates; (b) issue updated guidance or
proposed regulatory action ensuring pricing information is standardized
and easily comparable across hospitals and health plans; and (c) issue
guidance or proposed regulatory action updating enforcement policies
designed to ensure compliance with the transparent reporting of
complete, accurate, and meaningful data.'' \33\ In line with these
directives, the Departments are publishing these proposed rules with
amendments to the regulations issued under the 2020 final rules.\34\
---------------------------------------------------------------------------
\32\ Exec. Order No. 13877, 84 FR 30849 (June 27, 2019).
\33\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
\34\ 85 FR 72158 (November 12, 2020).
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B. Statutory Background and Enactment of the Affordable Care Act and
the No Surprises Act
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010, and the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30,
2010 (collectively the Affordable Care Act). As relevant here, the
Affordable Care Act reorganized, amended, and added to the provisions
of part A of title XXVII of the PHS Act relating to health coverage
requirements for group health plans and health insurance issuers. The
term group health plan includes both insured and self-insured group
health plans.
The Affordable Care Act also added section 715 to ERISA and section
9815 to the Code to incorporate the provisions of part A of title XXVII
of the PHS Act, PHS Act sections 2701 through 2728, into ERISA and the
Code, making them applicable to group health plans and health insurance
issuers providing coverage in connection with group health plans.
Section 2715A of the PHS Act, incorporated into section 715 of
ERISA and section 9815 of the Code, provides that plans and issuers
must comply with section 1311(e)(3) of the Affordable Care Act, which
addresses transparency in health coverage and imposes certain reporting
and disclosure requirements for health plans that are seeking
certification as QHPs that may be offered on an Exchange. A plan or
coverage that is not offered through an Exchange (as defined by section
1311(b)(1) of the Affordable Care Act) is required to submit the
information required to the relevant Secretary and the relevant State's
insurance commissioner, and to make that information available to the
public.
The 2020 final rules require non-grandfathered health plans and
health insurance issuers offering non-grandfathered group or individual
health insurance coverage to disclose cost-sharing information for all
covered items and services to participants, beneficiaries, and
enrollees through an internet-based self-service tool or, if requested
by the individual, on paper. These provisions of the 2020 final rules
implement paragraph (C) of section 1311(e)(3) of the Affordable Care
Act.
The 2020 final rules also require non-grandfathered plans and
health insurance issuers offering non-grandfathered group or individual
health insurance coverage to disclose on a public website three
separate machine-readable files containing certain information
regarding health care pricing under the plan or coverage. The machine-
readable file disclosure requirements are intended to make health care
pricing information accessible and useful to consumers and other
interested parties (including employers, and other purchasers of health
care),\35\ support efforts to lower health care costs by driving
competition,\36\ and to supplement State transparency efforts.\37\
These provisions of the 2020 final rules requiring plans and issuers to
disclose in-network negotiated rates, out-of-network allowed amounts
and the associated billed charges, and negotiated rates and historical
net prices for prescription drugs implement paragraph (A) of section
1311(e)(3) of the Affordable Care Act. In particular, the provisions
requiring the disclosure of out-of-network allowed amounts specifically
implement the requirement in section 1311(e)(3)(A)(vii) of the
Affordable Care Act to provide information on ``payments with respect
to any out-of-network coverage.'' In addition, the Secretary of HHS
determined that requiring disclosure of payment information on in-
network rates and prescription drugs is appropriate under section
1311(e)(3)(A)(ix) of the Affordable Care Act.
---------------------------------------------------------------------------
\35\ 85 FR 72158, 72160-61 (November 12, 2020).
\36\ 85 FR 72158, 72161-62 (November 12, 2020).
\37\ 85 FR 72158, 72162-63 (November 12, 2020).
---------------------------------------------------------------------------
The No Surprises Act added new provisions applicable to plans and
issuers in Subchapter B of chapter 100 of the Code, Part 7 of ERISA,
and Parts D and E of title XXVII of the PHS Act. As relevant here, the
No Surprises Act added new sections 9816(a)-(b) and 9817(a) of the
Code, sections 716(a)-(b) and 717(a) of ERISA, and sections 2799A-1,
2799A-2, 2799B-1, 2799B-2, 2799B-3, and 2799B-5 of the PHS Act, which
protect participants, beneficiaries, and enrollees in group health
plans and group and individual health insurance coverage from balance
bills by prohibiting nonparticipating providers, facilities, and
providers of air ambulance services from billing or holding liable
individuals for an amount that exceeds in-network cost sharing
determined in accordance with the No Surprises Act's cost-sharing
limitations in circumstances where the cost-sharing limitations apply.
The No Surprises Act also added new section 9816(e) of the Code,
section 716(e) of ERISA, and sections 2799A-1(e) of the PHS Act, which
contain requirements for applicable group health plans or issuers to
include certain information, in clear writing, on any physical or
electronic plan or insurance identification card issued to the
participants or beneficiaries in the plan or coverage. This information
includes any deductible applicable to such plan or coverage, any out-
of-pocket maximum limitation applicable to such plan or coverage, and a
telephone number and internet website address through which such
individual may seek consumer assistance information.
Further, section 114 of the No Surprises Act added section 2799A-4
of the PHS Act, section 9819 of the Code, and section 719 of ERISA,
which require plans and issuers to: offer price comparison guidance by
telephone and make available on the internet website of the plan or
issuer a price comparison tool that (to the extent practicable) allows
an individual enrolled under such plan or coverage, with respect to
such plan year, such geographic region, and participating providers
with respect to such plan or coverage, to compare the amount of cost
sharing that the individual would be responsible for paying under such
plan or coverage with respect to the furnishing of a specific item or
service by any such provider.
C. Statutory Background for Enforcement With Regards to the Affordable
Care Act and the CAA of 2021
The enforcement responsibilities of HHS and the States with respect
to oversight of health insurance issuer compliance with the Federal
insurance market reforms are set forth in the PHS Act. Pursuant to
section 2723(a)(1) of the PHS Act, as amended by the No Surprises Act,
states have primary enforcement authority over health insurance issuers
regarding the provisions of Parts A and D of title XXVII of the PHS
Act. Under this framework, HHS has enforcement
[[Page 60442]]
authority over issuers in a State if the Secretary of HHS makes a
determination that the State is failing to substantially enforce a
provision (or provisions) of Part A or D of title XXVII of the PHS
Act.\38\
---------------------------------------------------------------------------
\38\ See section 2723(a)(2) and (b)(1)(A) of the PHS Act; 45 CFR
150.203.
---------------------------------------------------------------------------
The Departments of Labor and the Treasury generally have primary
enforcement authority over private sector employment-based group health
plans. The Internal Revenue Service (IRS) has jurisdiction over certain
church plans. HHS also has primary enforcement authority over non-
Federal governmental plans, such as those sponsored by state and local
government employers.\39\
---------------------------------------------------------------------------
\39\ Section 2723(b)(1)(B) of the PHS Act.
---------------------------------------------------------------------------
The Departments will generally use existing processes to ensure
compliance with the Code, ERISA, and PHS Act requirements that apply to
group health plans and health insurance issuers. HHS's enforcement
procedures related to the PHS Act Federal insurance market reforms are
set forth in section 2723 of the PHS Act and 45 CFR 150.101 et seq.,
including bases for initiating investigations, performing market
conduct examinations, and imposing civil money penalties. Section 504
of ERISA provides DOL with investigatory authority to determine whether
any person has violated or is about to violate any provision of ERISA
or any regulation or order thereunder.
D. Consultation With and Input From Interested Parties
The Departments have been in regular consultation with interested
parties since publishing the 2019 proposed rules. In addition to the
thousands of comments received on the 2019 proposed rules, following
the publication of the 2020 final rules, the Departments continued to
engage in consultation with interested parties and collaboration about
implementation of the 2020 final rules through technical implementation
discussions on GitHub (an online hosting platform for development and
source code management that permits version control), webinars, emails,
and an inquiry management system, as well as other informal compliance
assistance efforts and meetings with interested parties. This period of
collaboration with interested parties led to the finalization of an
initial technical format for disclosures (Schema 1.0) that was
finalized on March 1, 2022, and became applicable on July 1, 2022. The
Departments also regularly review news articles and research
publications discussing the 2020 final rules and have received written
and verbal recommendations from plans and issuers, data engineers, and
researchers and academics.\40\
---------------------------------------------------------------------------
\40\ Supra note 8, 9, 10, and 11.
---------------------------------------------------------------------------
On May 22, 2025, the Departments released FAQs Part 70 on Schema
2.0, which states the Departments' intention to issue revised technical
reporting requirements for the In-network Rate File and Allowed Amount
File for group health plans and health insurance issuers, and the
applicability date for implementation.\41\ FAQs Part 70 requested
interested parties to provide feedback through GitHub on how best to
address the revised technical reporting requirements. These
improvements respond to feedback from interested parties and are
designed to reduce unnecessary or duplicative data fields and make cost
information easier for consumers to understand and use.
---------------------------------------------------------------------------
\41\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs About Affordable
Care Act Implementation Part 70 (May 22, 2025), https://www.cms.gov/files/document/aca-faqs-part-70.pdf and https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-70.
---------------------------------------------------------------------------
Additionally, on June 2, 2025, the Departments issued an RFI \42\
regarding the prescription drug machine-readable file requirement
seeking comment and recommendations on the prescription drug price
disclosure requirements. More specifically, the RFI requested comments
and recommendations to help inform implementation of the prescription
drug file disclosure requirements, including information on existing
prescription drug file data elements, the ability of health plans to
access necessary data for reporting, as well as state approaches and
innovation.\43\
---------------------------------------------------------------------------
\42\ See 90 FR 23303 (June 2, 2025).
\43\ Id.
---------------------------------------------------------------------------
The Departments considered all public input received as they
developed the policies in these proposed rules, with the exception of
prescription drug RFI comments. However, the Departments received these
prescription drug RFI comments and are separately taking them into
consideration to evaluate how to implement the Transparency in Coverage
prescription drug disclosure requirements in technical implementation
guidance or future rulemaking.
III. Provisions of the Proposed Regulations
A. Definitions
The Departments propose to define the term health insurance market
for purposes of proposed amendments to the Allowed Amount File
provision at 26 CFR 54.9815-2715A3(b)(1)(ii), 29 CFR 2590.715-
2715A3(b)(1)(ii), and 45 CFR 147.212(b)(1)(ii) (discussed in more
detail in section III.C.6. of this preamble), which would require group
health plans and health insurance issuers offering group or individual
health insurance coverage to make an out-of-network allowed amount
machine-readable file available for each health insurance market in
which plans and issuers offer a plan or coverage. Establishing a
standardized definition of the term health insurance market for this
purpose would promote consistent data organization across plans and
issuers in these market-level Allowed Amount Files.
The Departments propose to redesignate paragraphs (a)(2)(xi)
through (xxii) as paragraphs (a)(2)(xii) through (xxiii) under 26 CFR
54.9815-2715A1 and 45 CFR 147.210, respectively, and add a new
paragraph (a)(2)(xi) with the new definition. The Departments also
propose to redesignate paragraphs (a)(2)(x) through (xxi) as paragraphs
(a)(2)(xi) through (xxii) under 29 CFR 2590.715-2715A1, and to add a
new paragraph (a)(2)(x) with the new definition. Under this proposal,
health insurance market would mean, irrespective of the State, one of
the following:
The individual market, as defined in 45 CFR 144.103 (other
than short-term, limited-duration insurance or individual health
insurance coverage that consists solely of excepted benefits).
The large group market, as defined in 45 CFR 144.103
(other than coverage that consists solely of excepted benefits).
The small group market, as defined in 45 CFR 144.103
(other than coverage that consists solely of excepted benefits).
For purposes of self-insured group health plans (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), all self-insured group
health plans maintained by the plan sponsor.
For consistency, this definition would largely align with the
definition of the term ``insurance market'' for the purposes of the
methodology for calculating the qualifying payment amount (QPA) at 26
CFR 54.9816-6(a)(8), 29 CFR 2590.716-6(a)(8), and 45 CFR 149.140(a)(8).
As background, Code section 9816(a)(3)(E), ERISA section 716(a)(3)(E),
and PHS Act 2799A-1(a)(3)(E), as added by section 103 of the
[[Page 60443]]
No Surprises Act, generally defines the QPA as ``the median of the
contracted rates recognized by the plan or issuer, respectively
(determined with respect to all such plans of such sponsor or all such
coverage offered by such issuer that are offered within the same
insurance market (specified in subclause (I), (II), (III), or (IV) of
clause (iv)) as the plan or coverage) . . . under such plans or
coverage, respectively, on January 31, 2019,'' subject to other
criteria and increased for inflation. Paragraph (a)(3)(E)(iv)(III) of
the Code and ERISA and paragraph (a)(3)(E)(iv)(IV) of the PHS Act,
provide that in the case of a self-insured group health plan, a health
insurance market is ``other self-insured group health plans.''
When interpreting the definition of QPA for purposes of
establishing a methodology for calculating the QPA, the Departments
defined ``insurance market'' with respect to self-insured group health
plans to include, ``at the option of the plan sponsor, all self-insured
group health plans administered by the same entity (including a third
party administrator (TPA) contracted by the plan), to the extent
otherwise permitted by law, that is responsible for calculating the
qualifying payment amount on behalf of the plan.'' \44\ In other words,
the interim final rules permitted plan sponsors to use either rates
from only their own plans or rates from all plans administered by their
TPA to calculate QPAs. However, this language has been vacated by the
United States District Court for the Eastern District of Texas on the
basis that the No Surprises Act specifies that QPAs must be calculated
using the rates of ``all such plans of such sponsor.'' \45\ Therefore,
the United States District Court for the Eastern District of Texas
interpreted the No Surprises Act to restrict aggregation in that manner
for the purpose of calculating the QPA.
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\44\ 86 FR 36954 (July 13, 2021).
\45\ Texas Medical Association, a trade association representing
more than 56,000 Texas physicians and medical students; Dr. Adam
Corley, a Tyler, Texas physician; Tyler Regional Hospital, LLC, a
hospital in Tyler, Texas; LifeNet, Inc.; East Texas Air One, LLC;
Rocky Mountain Holdings, LLC; and Air Methods Corporation v. United
States Department of Health & Human Services, U.S. Department of
Labor, U.S. Department of the Treasury, and the Office of Personnel
Management, No. 6:22-cv-450-JDK (E.D. Tex. August 24, 2023) (TMA
III) (vacating portions of 26 CFR 54.9816-6T(a)(8)(iv), 29 CFR
2590.716-6(a)(8)(iv), and 45 CFR 149.140(a)(8)(iv). The Department
of Justice did not appeal the vacatur of this specific provision and
it remains in place. See also FAQs About Affordable Care Act and
Consolidated Act, 2021 Implementation Part 71 (July 30, 2025).
https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-71 (until the Fifth Circuit issues its
en banc decision, extending enforcement relief for plans and issuers
that use a QPA calculated using a good faith, reasonable
interpretation of the methodology in place before the district court
decision, for items and services furnished before February 1, 2026).
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In contrast, the language of PHS Act section 2715A neither requires
nor prohibits disclosure of information described in the Affordable
Care Act section 1311(e)(3) to be aggregated by any specific market.
Therefore, in order to avoid confusion between the insurance market
applicable to the Allowed Amount File and the insurance market
applicable to the definition of QPA, which is subject to the holding of
TMA III, the Departments propose to use the term ``health insurance
market,'' rather than ``insurance market,'' for purposes of organizing
the Allowed Amount File. The Departments note that to the extent self-
insured group health plans use an entity to administer the plan, the
aggregation rules described in proposed 26 CFR 54.9815-
2715A3(b)(5)(iv), 29 CFR 2590.715-2715A3(b)(5)(iv), and 45 CFR
147.212(b)(5)(iv) would allow the entity to aggregate out-of-network
allowed amounts for more than one plan offered by a self-insured group
health plan sponsor the entity administers, including those offered by
self-insured group health plan sponsors. For clarity, the Departments
also propose to include cross-references to the market-wide definitions
in 45 CFR 144.103 where applicable.
The Departments understand that the term health insurance market is
not generally used to refer to self-insured group health plans.
However, for purposes of uniformity in the definition, to facilitate a
more streamlined and uniformed disclosure of Allowed Amount File, and
for ease of reference, the Departments propose that for purposes of
self-insured group health plans (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) of this subchapter, and plans that consist
solely of excepted benefits), health insurance market would mean all
self-insured group health plans maintained by the plan sponsor.
The Departments seek comment on this proposed definition.
B. Requirements for Disclosing Cost-Sharing Information to
Participants, Beneficiaries, and Enrollees
1. Disclaimer on Balance Billing
The Departments propose to amend the balance billing protection
notice that plans and issuers are currently required to include along
with the required cost-sharing information to participants,
beneficiaries, and enrollees under 26 CFR 54.9815-2715A2(b)(1)(vii)(A),
29 CFR 2590.715-2715A2(b)(1)(vii)(A), and 45 CFR 147.211(b)(1)(vii)(A).
These proposed amendments would require a statement that the cost-
sharing information in the self-service tool does not account for
potential additional amounts in situations where applicable State and
Federal law allow out-of-network providers to bill participants,
beneficiaries, or enrollees for the difference between a provider's
billed charges and the sum of the amount collected from the plan or
issuer and the amount collected from the participant, beneficiary, or
enrollee in the form of a copayment, coinsurance, or deductible amount
(the difference referred to as balance billing). These changes are
being proposed to reflect the existence of the Federal balance billing
protections set forth in the No Surprises Act, which were not yet
enacted when the current disclaimer language was finalized in the 2020
final rules. This statement would not be required if the State in which
the item or service was furnished prohibits all out-of-network
providers from balance billing for all items and services payable by
the group health plan or health insurance issuer.
Currently, under paragraph (b)(1) of this section, plans and
issuers must disclose certain cost-sharing information to participants,
beneficiaries, and enrollees, including, under paragraph (b)(1)(i), an
estimate of the participant's, beneficiary's, or enrollee's cost-
sharing liability for a requested covered item or service from a
particular provider or providers. Paragraph (b)(1)(iv) requires, in
part, that if the request is for cost-sharing information for an out-
of-network provider, the plan or issuer must disclose an out-of-network
allowed amount or any other rate that the group health plan or health
insurance issuer will pay for the requested covered item or service. As
discussed in the 2020 final rules,\46\ because cost estimates cannot
account for potential balance billing by an out-of-network provider,
current rules under paragraph (b)(1)(vii) require plans and issuers to
include a notice with a number of statements, including, under
paragraph (b)(1)(vii)(A), that out-of-network providers may bill
participants, beneficiaries, or enrollees for the difference between a
provider's billed charges and the sum of the amount collected from the
plan or issuer and the amount collected from the participant,
beneficiary, or enrollee in the form of a
[[Page 60444]]
copayment or coinsurance amount (the difference often referred to as
balance billing) and that these estimates do not account for those
potential additional amounts. Because there were existing State laws
prohibiting balance billing to some extent, as discussed in the 2020
final rules,\47\ the current rules only require this statement if
balance billing is permitted under State law.
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\46\ 85 FR 72158, 72201 (November 12, 2020).
\47\ 85 FR 72158, 72201 (November 12, 2020).
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Shortly after the 2020 final rules were published, the CAA, 2021,
which included the No Surprises Act, was signed into law on December
27, 2020. The No Surprises Act added provisions that apply to group
health plans and health insurance issuers offering group or individual
health insurance coverage, including certain limitations on cost
sharing for emergency services and for non-emergency services provided
by nonparticipating providers with respect to visits to certain
participating health care facilities.\48\ The No Surprises Act also
added certain limitations on cost sharing for air ambulance services
provided by out-of-network air ambulance providers.\49\ Additionally,
the No Surprises Act added that cost-sharing payments for emergency
services, non-emergency services furnished by a nonparticipating
provider in a participating health care facility, and air ambulance
services furnished by a nonparticipating provider must be counted
toward any in-network deductible or out-of-pocket maximums applied
under the plan or coverage (including the annual limitation on cost
sharing under section 2707(b) of the PHS Act) (as applicable),
respectively (and these in-network deductibles and out-of-pocket
maximums must be applied) in the same manner as if such cost-sharing
payments were made with respect to services furnished by a
participating provider or facility.\50\
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\48\ Codified in Code section 9816, ERISA section 716, and PHS
Act section 2799A-1.
\49\ Codified in Code section 9817, ERISA section 717, and PHS
Act section 2799A-2.
\50\ Codified in Code sections 9816 and 9817, ERISA sections 716
and 717, and PHS Act sections 2799A-1 and 2799A-2.
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In addition to the new provisions applicable to plans and issuers,
the No Surprises Act added a new Part E to title XXVII of the PHS Act
establishing requirements applicable to health care providers,
facilities, and providers of air ambulance services. Specifically, the
No Surprises Act added new PHS Act sections 2799B-1, 2799B-2, 2799B-3,
and 2799B-5, which protect participants, beneficiaries, and enrollees
in group health plans and group and individual health insurance
coverage offered by health insurance issuers from balance bills by
generally prohibiting nonparticipating providers, facilities, and
providers of air ambulance services from billing or holding liable
individuals for an amount that exceeds in-network cost sharing
determined in accordance with the No Surprises Act's cost-sharing
limitations in circumstances where the cost-sharing limitations apply.
Given that after the passage of the No Surprises Act, all
participants, beneficiaries, and enrollees of group health plans and
group and individual health insurance coverage are now protected from
certain balance billing under Federal law, the Departments propose to
amend the balance billing protection notice provision under paragraph
(b)(1)(vii)(A) to require a statement that the cost-sharing information
provided pursuant to paragraph (b)(1)(i) does not account for potential
additional amounts in situations where applicable State and Federal law
allow out-of-network providers to bill participants, beneficiaries, or
enrollees, for the difference between a provider's billed charges and
the sum of the amount collected from the plan or issuer and from the
participant, beneficiary, or enrollee in the form of a copayment,
coinsurance, or deductible amount (the difference referred to as
balance billing). Because there are circumstances under which
participants, beneficiaries, and enrollees can be balance billed under
current Federal law and State balance billing laws, the Departments
propose to clarify that this disclaimer is not required only if the
State in which the item or service is to be furnished prohibits all
out-of-network providers from balance billing for all items and
services payable by the group health plan or health insurance issuer.
The Departments understand that no States currently categorically
prohibit balance billing under all circumstances. Therefore, requiring
plans and issuers in States without such categorical prohibitions to
include this disclaimer would provide an additional layer of
transparency for consumers. It would also maintain flexibility for
plans and issuers to not include the notice if the State in which the
plan or issuer is disclosing cost-sharing information to a participant,
beneficiary, or enrollee does, subsequent to the finalization of these
proposed rules, pass a law to which all providers are subject that
prohibits balance billing for all items and services payable by the
plan or issuer.
The Departments seek comment on this proposal.
2. New Required Method and Format for Disclosing Information to
Participants, Beneficiaries, or Enrollees
The Departments propose to add new 26 CFR 54.9815-
2715A2(b)(2)(iii), 29 CFR 2590.715-2715A2(b)(2)(iii), and 45 CFR
147.211(b)(2)(iii) to require plans and issuers to make available to
participants, beneficiaries, and enrollees, at their request, the cost-
sharing estimates and other disclosures required under 26 CFR 54.9815-
2715A2(b)(1), 29 CFR 2590.715-2715A2(b)(1), and 45 CFR 147.211(b)(1)
via a phone number. Under this proposal, the information required via a
phone number would be required to be accurate at the time of the
request and provided at the time of the request. Plans and issuers
would be required to use the same telephone number that Code section
9816(e), ERISA section 716(e), and PHS Act section 2799A-1(e), as added
by section 107 of the No Surprises Act,\51\ require be indicated on any
physical or electronic plan or insurance identification (ID) card
issued to participants, beneficiaries, and enrollees for obtaining
customer assistance. The Departments also propose to redesignate
paragraph (b)(2)(ii)(D) as new paragraph (b)(2)(iv) and amend paragraph
(b)(2)(iv) to remove phone as an example of an alternative means for
providing the disclosures by which a participant, beneficiary, or
enrollee may request the disclosures required described in paragraph
(b)(1) because providing the disclosures by a phone number would be
required, as specified previously. If this new requirement is finalized
as proposed, plans and issuers would be required to make available
cost-sharing estimates via the internet-based self-service tool, a
phone number, and paper upon request.
---------------------------------------------------------------------------
\51\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs about Affordable
Care Act and Consolidated Appropriations Act, 2021 Implementation
Part 49 (August 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf.
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The 2020 final rules at paragraph (b)(2) allow plans and issuers to
satisfy the disclosure requirements of paragraph (b)(1) through a self-
service tool, via paper, or through an alternative means such as phone
or email, provided the participant, beneficiary, or enrollee agrees
that disclosure through such means is sufficient to satisfy the request
and the request is fulfilled at least as rapidly as required for the
paper method. However, disclosure by such alternative means is not
required.
[[Page 60445]]
While the Departments have determined that the No Surprises Act's
price comparison tool (codified at Code section 9819, ERISA section
719, and the PHS Act section 2799A-4) and self-service tool required
under the 2020 final rules are largely duplicative, as discussed in
more detail in section III.B.3. of this preamble, the requirements of
Code section 9819, ERISA section 719, and the PHS Act section 2799A-4
expand the requirements for the disclosure of cost-sharing information
in the 2020 final rules in one prominent way. Specifically, Code
section 9819, ERISA section 719, and the PHS Act section 2799A-4
require group health plans and health insurance issuers offering group
or individual health insurance coverage to ``offer price comparison
guidance by telephone.''
The Departments intend for these proposed rules to satisfy the
requirements of the No Surprises Act to require price comparison
guidance via a telephone number, as set forth in Code section 9819,
ERISA section 719, and PHS Act section 2799A-4. Further, implementing
this requirement would respond to feedback the Departments have
received from participants, beneficiaries, and enrollees since the
publication of the 2020 final rules, indicating a limited ability to
receive cost-sharing information over the phone when requested from
plans and issuers. Requiring plans and issuers to provide cost-sharing
information in this way would further promote the price transparency
goals of providing accurate, real-time pricing to consumers, and making
that information accessible to more consumers.
To achieve these goals, these proposed rules add paragraph
(b)(2)(iii), proposing to require plans and issuers to make available
to participants, beneficiaries, and enrollees the cost-sharing
estimates and other disclosures required under paragraph (b)(1), via
phone, at the time requested and accurate at the time of their request.
In addition, at paragraph (b)(2)(iii), the Departments propose to
allow plans and issuers to limit the number of providers with respect
to which cost-sharing information for covered items and services is
provided to no fewer than 20 providers per day and, to require plans
and issuers to disclose the applicable provider-per-day limit to the
participant, beneficiary, or enrollee when the request for information
is made. A similar 20 provider limit currently applies with respect to
paper requests at 26 CFR 54.9815-2715A2(b)(2)(ii), 29 CFR 2590.715-
2715A2(b)(2)(ii), and 45 CFR 147.211(b)(2)(ii). In the 2020 final
rules, the Departments determined based on comments that ``limiting
paper request to 20 providers per request is a reasonable approach to
balancing the burdens on plans and issuers with the benefits of
providing consumers with enough information to be able to compare cost
and provider options.'' \52\ The Departments have determined that the
process by which plans and issuers would generate information
responsive to requests for receiving cost-sharing information over the
phone should be similar to the process for generating such information
to deliver via paper, given the practicalities of generating a response
on paper and over the phone. Therefore, the Departments propose to
adopt the limitations for paper disclosure at 26 CFR 54.9815-
2715A2(b)(2)(ii), 29 CFR 2590.715-2715A2(b)(2)(ii), and 45 CFR
147.211(b)(2)(ii) for phone disclosure such that plans and issuers may
limit the number of providers with respect to which cost-sharing
information for covered items and services is provided to no fewer than
20 providers per day and, plans and issuers would be required to
disclose the applicable provider-per-day limit to the participant,
beneficiary, or enrollee when the request for information is made. This
proposal is intended to balance the added burden to plans and issuers
of this additional method of delivery with ensuring that participants,
beneficiaries, and enrollees that opt to receive cost-sharing
information over the phone have access to the same information as those
that request such information via the paper method. The Departments
note that nothing in these proposed rules precludes a participant,
beneficiary, or enrollee from obtaining cost-sharing information from
more than one method, consistent with the requirements for each method.
Similarly, for consistency with the requirements for the paper method
of delivery under the 2020 final rules, the Departments also propose to
require plans and issuers to satisfy requests for cost-sharing
information over the phone at the time of the phone call in order to
ensure that participants, beneficiaries, and enrollees receive
information as quickly as possible.
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\52\ 85 FR 72158, 72207 (November 12, 2020).
---------------------------------------------------------------------------
Accordingly, the Departments propose to require plans and issuers
to make available to participants, beneficiaries, and enrollees the
cost-sharing estimates and other disclosures described in paragraph
(b)(1) via phone at the time of the request and accurate at the time of
the request, and in accordance with the method and format requirements
in paragraphs (b)(2)(i)(A) through (C).
The Departments are also proposing to require health plans and
health insurance issuers to make cost-sharing estimates and other
disclosures available over the phone at a number designated on the ID
card for individuals to seek assistance. Code section 9816(e), ERISA
section 716(e), and PHS Act section 2799A-1(e) (insurance ID card
requirements), as added by section 107 of the No Surprises Act,
separately require plans and issuers to include in clear writing, on
any physical or electronic plan or insurance identification card issued
to participants, beneficiaries, or enrollees, certain information
including a phone number and website address for individuals to seek
consumer assistance. Therefore, plans and issuers are already required
to have a phone number designated on any physical or electronic plan or
insurance identification card and, under this proposal, plans and
issuers should make available cost-sharing estimates and other
disclosures at the request of the participant or beneficiary via such
phone number, if finalized. These provisions apply with respect to plan
years (in the individual market, policy years) beginning on or after
January 1, 2022.\53\ The Departments expect that requiring plans and
issuers to use an existing phone number would allow them to leverage
existing workflows and would make it easier for participants,
beneficiaries, and enrollees to obtain the cost information they are
seeking.
---------------------------------------------------------------------------
\53\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs About Affordable
Care Act and Consolidated Appropriations Act, 2021 Implementation
Part 49 (Aug. 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf. FAQ Part 49 provided that, pending any
implementing rulemaking, the Departments would not deem a plan or
issuer to be out of compliance with ID card requirements where a
plan or issuer includes on any ID card, among other things, a
telephone number and website address for individuals to seek
consumer assistance and access additional applicable deductibles and
maximum out-of-pocket limits.
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The Departments request comment on whether this proposal should
include phone service standards to ensure that consumers have access to
timely and reliable information. In particular, the Departments request
comment on what such standards should include and what parameters
should be applied to each criterion. The Departments also request
comment on whether there are other relevant Federal, State, or local
[[Page 60446]]
standards for phone service quality or any industry practices that the
Departments should consider.
3. Compliance With PHS Act Section 2799A-4, ERISA Section 719, and Code
Section 9819
The Departments propose to add new 26 CFR 54.9815-2715A2(c)(7), 29
CFR 2590.715-2715A2(c)(7), and 45 CFR 147.211(c)(7) stating that a plan
or issuer satisfies the requirements of Code section 9819, ERISA
section 719, and the PHS Act section 2799A-4, as added by section 114
of the No Surprises Act by providing the information required under
paragraph (b)(1) of this section to participants, beneficiaries, and
enrollees in accordance with the method and format requirements
specified in paragraph (b)(2) of this section.
The 2020 final rules added 26 CFR 54.9815-2715A2(b)(1) and (b)(2),
29 CFR 2590.715-2715A2(b)(1) and (b)(2), and 45 CFR 147.211(b)(1) and
(b)(2), which created a comprehensive set of requirements for plan and
issuer disclosure of cost-sharing information through an internet-based
self-service tool, and in paper form, upon request.\54\ Paragraph
(b)(1) of the 2020 final rules requires the disclosure of cost-sharing
information, which is accurate at the time the request is made, with
respect to a participant's, beneficiary's, or enrollee's cost-sharing
liability for covered items and services, and which must reflect any
cost-sharing reductions the enrollee would receive.
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\54\ 26 CFR 54.9815-2715A2(b)(1) and (2), 29 CFR
2590.2715A2(b)(1) and (2), and 45 CFR 147.211(b)(1) and (2).
---------------------------------------------------------------------------
Under paragraph (b)(2) of the 2020 final rules, disclosures must be
made available through a self-service tool on an internet website that
provides real-time responses based on cost-sharing information that is
accurate at the time of the request, in plain language, without a fee,
or in paper form, at the user's request. This paragraph requires
certain functionality to make searching using the self-service tool
easier, including searching by billing code or descriptive term, and
refining and reordering search results based on geographic proximity of
in-network providers, and the amount of the participant's,
beneficiary's, or enrollee's estimated cost-sharing liability for the
covered item or service, to the extent the search for cost-sharing
information for covered items or services returns multiple results.\55\
---------------------------------------------------------------------------
\55\ 26 CFR 54.9815-2715A2(b)(2)(i), 29 CFR
2590.2715A2(b)(2)(i), and 45 CFR 147.211(b)(2)(i).
---------------------------------------------------------------------------
Code section 9819, ERISA section 719, and PHS Act section 2799A-4,
as added by section 114 of the No Surprises Act, require plans and
issuers to offer price comparison guidance by telephone and make
available on the plan's or issuer's website a ``price comparison tool''
that allows individuals enrolled under such plan or coverage offered by
the plan or issuer to compare the amount of cost sharing that the
individual would be responsible for paying for an item or service
furnished by an in-network provider (hereinafter ``No Surprises Act
price comparison tool''). This requirement was applicable with respect
to plan years (and in the individual market, policy years) beginning on
or after January 1, 2022.
The Departments announced on August 20, 2021, in FAQs Part 49 that
the price comparison methods required by the No Surprises Act price
comparison tool are largely duplicative of the self-service tool
component of the 2020 final rules except that the information under the
No Surprises Act price comparison tool must also be provided over the
telephone upon request.\56\ Therefore, the Departments indicated they
intended to propose rulemaking requiring that the same pricing
information that is available through the self-service tool or in paper
form, as described in the 2020 final rules, must also be provided over
the phone upon request. The Departments also announced that, as an
exercise of enforcement discretion, they would defer enforcement of the
requirement that plans and issuers make available a price comparison
tool by internet website, in paper form, or telephone pursuant to the
No Surprises Act until plan years (or in the individual market, policy
years) beginning on or after January 1, 2023, to align the enforcement
date of the No Surprises Act price comparison disclosure requirements
with the enforcement date of the self-service tool described in the
2020 final rules.
---------------------------------------------------------------------------
\56\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs About Affordable
Care Act and Consolidated Appropriations Act, 2021 Implementation
Part 49 (Aug. 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf.
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Further, the Departments announced their intention to propose
rulemaking and seek public comment regarding whether compliance with
the self-service tool requirements of the 2020 final rules should
satisfy the analogous requirements set forth Code section 9819, ERISA
section 719, and PHS Act section 2799A-4. Plans and issuers have built
and developed tools to comply with the requirements of the 2020 final
rules and have anticipated, since the release of FAQs Part 49, that the
Departments would propose in a future rulemaking that plans and issuers
satisfy the No Surprises Act price comparison tool requirement by
providing the required disclosures to participants, beneficiaries, and
enrollees through the self-service tool as required in paragraphs
(b)(1) and (2) of the 2020 final rules. Given this, the Departments
have determined that requiring plans and issuers to build a second
self-service tool would impose significant unnecessary burden and cause
considerable confusion for consumers on the purposes of the two tools.
Thus, it is appropriate that compliance with the self-service tool
described in the 2020 final rules and as amended in these proposed
rules should satisfy compliance with the No Surprises Act price
comparison tool requirements.
Therefore, as discussed in section II.B.2. of this preamble, to
align with the No Surprises Act price comparison tool requirements the
Departments propose to require in new paragraph (b)(2)(iii) that plans
and issuers make available to participants, beneficiaries, and
enrollees the cost-sharing information and other disclosures required
under paragraph (b)(1) via the same telephone number that Code section
9816(e), ERISA section 716(e), and PHS Act section 2799A-1(e), as added
by section 107 of the No Surprises Act, requires be indicated on any
physical or electronic plan or insurance identification card issued to
a participant, beneficiary, or enrollee for obtaining customer
assistance. The Departments also propose at new paragraph (c)(7) that a
group plan or health insurance issuer satisfies the requirements of
Code section 9819, ERISA section 719, and PHS Act section 2799A-4 by
providing the information required in paragraph (b)(1) to participants,
beneficiaries, and enrollees in accordance with the method and format
requirements specified in paragraph (b)(2).
The Departments acknowledge that, while PHS Act section 2715A does
not apply to grandfathered health plans and health insurance issuers
offering grandfathered individual and group health insurance coverage,
Code section 9819, ERISA section 719, and PHS Act section 2799A-4 do.
The Departments have also stated that the requirements of PHS Act
section 2715A are largely duplicative to those of Code section 9819,
ERISA section 719, and PHS Act section 2799A-4, except that the former
does not require information to be disclosed by phone. Therefore, if
this rule is finalized, grandfathered health plans and issuers offering
grandfathered
[[Page 60447]]
health insurance coverage may comply with the requirements of PHS Act
2715A, as codified in 26 CFR 54.9815-2715A2, 29 CFR 2590.716-2715A2 and
45 CFR 147.211, to satisfy the requirements of Code section 9819, ERISA
section 719, and PHS Act section 2799A-4. The Departments request
comments on whether any additional provisions are necessary to assist
grandfathered health plans and health insurance issuers in complying
with the requirements of 26 CFR 54.9815-2715A2, 29 CFR 2590.716-2715A2
and 45 CFR 147.211. The Departments seek comment on all aspects of this
proposal.
4. Applicability
The Departments propose to revise 26 CFR 54.9815-2715A2(c)(1), 29
CFR 2590.715-2715A2(c)(1), and 45 CFR 147.211(c)(1) to state that the
proposed amendments to (b)(1)(vii)(A), and new paragraphs (b)(2)(iii),
(b)(2)(iv), and (c)(7) of this section would apply for plan years (in
the individual market, policy years) beginning on or after January 1,
2027. Until such time, the current provisions of paragraph (b) of this
section continue to apply.
With respect to proposed provisions at new paragraph (b)(2)(iii),
the Departments understand that most plans and issuers already have in
place a consumer assistance telephone number for participants,
beneficiaries, and enrollees to receive benefit information pursuant to
Code section 9816(e), ERISA section 716(e), and PHS Act section 2799A-
1(e), as added by section 107 of the No Surprises Act, and as clarified
in previously issued guidance.\57\ Because plans and issuers can
leverage the operations of an existing consumer assistance phone
number, the Departments have determined that the proposed applicability
date appropriately balances the need for improved access to cost-
sharing estimates for consumers who wish to access this information
over the phone with the time necessary for plans and issuers to make
the administrative and operational changes to implement this proposal.
Similarly, because most plans are already required to disclose the
balance billing disclosures under the 2020 final rules, the Departments
have determined that the proposed applicability date for new paragraph
(b)(1)(vii)(A) that would amend the balance billing disclosure is
appropriate and reasonable.
---------------------------------------------------------------------------
\57\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs About Affordable
Care Act and Consolidated Appropriations Act, 2021 Implementation
Part 49 (Aug. 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/affordable-care-act-faqs-49-2021.pdf.
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The Departments propose to make new paragraph (c)(7) applicable for
plan years (in the individual market, policy years) beginning on or
after January 1, 2027. The Departments selected this date because once
plans and issuers are required to provide cost-sharing information by
phone on the same date pursuant to proposed new paragraph (b)(2)(iii),
it would be reasonable for the Departments to consider a plan or
issuer's compliance with paragraphs (b)(1) and (2) to constitute
compliance with the No Surprises Act price comparison tool as required
by Code section 9819, ERISA section 719, and PHS Act section 2799A-4.
The Departments seek comment on this proposed applicability date
for these proposed provisions.
C. Requirements for Public Disclosure of In-Network Rates and
Historical Allowed Amount Data for Covered Items and Services From In-
and Out-of-Network Providers
1. Provider Network-Level Reporting for the In-Network Rate Files
The current In-network Rate File provision at 26 CFR 54.9815-
2715A3(b)(1)(i), 29 CFR 2590.715-2715A3(b)(1)(i), and 45 CFR
147.212(b)(1)(i) requires plans and issuers to make available on a
public website a machine-readable file that discloses in-network
provider rates for covered items and services, with the exception of
prescription drugs that are subject to a fee-for-service reimbursement
arrangement. The Departments propose to amend the introductory language
of paragraph (b)(1)(i) to require plans and issuers to make available
an In-network Rate File for each provider network maintained or
contracted by the group health plan or health insurance issuer. This
proposed change is intended to reduce the size and total number of In-
network Rate Files, allow file users to more efficiently aggregate and
analyze the data, and align reporting more closely to how data is
typically reported by hospitals pursuant to the Hospital 2019 and 2023
Price Transparency rules \58\ under 45 CFR part 180.
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\58\ 84 FR 65524 (November 17, 2019) and 88 FR 81540 (November
22, 2023).
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a. Reducing File Size
As discussed in section I.A. of this preamble, file size is the
most common concern that the Departments have heard from interested
parties regarding the current In-network Rate Files. These files are
often very large, making them challenging for users to download,
analyze, and store.\59\ In-network Rate File sizes often represent many
terabytes of data a month for a single issuer,\60\ and many exceed most
local storage and processing capabilities.\61\ Additionally, each
issuer may have hundreds of separate files for each plan or coverage it
offers, making aggregation and analysis highly resource intensive.\62\
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\59\ See Fred Diamond, Payers' Price Transparency Data Still Not
User-Friendly, Say Researchers (Feb. 7, 2023), https://www.fiercehealthcare.com/payers/health-insurance-plans-price-transparency-data-still-not-user-friendly-say-researchers; See
alsoDavid Muhlestein, Improving Price Transparency Data:
Recommendations From Practice, Health Affairs. (Mar. 19, 2025),
https://www.healthaffairs.org/content/forefront/improving-price-transparency-data-recommendations-practice.
\60\ See David Muhlestein, Improving Price Transparency Data:
Recommendations from Practice, Health Affairs (Mar. 19, 2025),
https://www.healthaffairs.org/content/forefront/improving-price-transparency-data-recommendations-practice.
\61\ See Aileen Y. Choi, Karen Manthe-Cohen, & Robert J. Rosso,
Technical Challenges with Private Health Insurance Price
Transparency Data, Congressional Research Service (June 13, 2025),
https://www.congress.gov/crs-product/R48570.
\62\ See Aileen Y. Choi, Karen Manthe-Cohen, & Robert J. Rosso,
Technical Challenges with Private Health Insurance Price
Transparency Data, Congressional Research Service (June 13, 2025),
https://www.congress.gov/crs-product/R48570.
---------------------------------------------------------------------------
The Departments have determined that the size of the In-network
Rate File can be highly dependent on how it is organized. It is very
common for multiple plans offered by the same issuer or administered by
the same service provider to leverage the same provider networks with
the same negotiated rates.\63\ This means that when plans and issuers
organize In-network Rate Files by plan ID, they often repeat the same
negotiated rates across multiple plan files, which leads to significant
duplicative data throughout the In-network Rate Files. The Departments
have received consistent feedback about the challenges related to file
size, and some of that feedback has suggested that the disclosure
requirements be amended to organize In-network Rate Files by provider
network, whereby each file would contain all rates negotiated by the
reporting entity for that provider network, rather than having a file
for each plan ID.\64\
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\63\ See Lester Adler, Michael Fiedler, & Benjamin Ippolito,
Assessing Recent Health Care Proposals from the House Committee on
Energy and Commerce (May 25, 2023), https://www.brookings.edu/articles/assessing-recent-health-care-proposals-from-the-house-committee-on-energy-and-commerce.
\64\ See Mark Robben, Learnings from MRF Land, Serif Health
(Mar. 31, 2023), https://www.serifhealth.com/blog/learnings-from-mrf-land; Georgetown University, Transparency in Coverage:
Recommendations for Improving Access to and Usability of Health Plan
Price Data (Jan. 9, 2023), https://georgetown.app.box.com/s/1ezsggz1c7smsaexkr8rght15sokgusl.
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[[Page 60448]]
Currently, the technical implementation guidance for the In-network
Rate File allows plans and issuers flexibility to leverage a Table of
Contents File to combine common negotiated rates across multiple In-
network Rate Files, rather than publishing negotiated rates
individually for each plan ID. This allows issuers to avoid duplicating
prices within and across plans by linking the files for each plan that
uses a given provider network to an underlying file of in-network
prices.\65\ Interested parties report that this reduces the total
amount of data that must be analyzed to estimate market-level
prices.\66\ Many plans and issuers currently leverage this
optimization. The Departments conducted an internal analysis in 2024
that sampled In-network Rate Files market wide and found that 83
percent of issuers sampled were leveraging a Table of Contents to
organize their files.
---------------------------------------------------------------------------
\65\ See Lester Adler, Michael Fiedler, & Benjamin Ippolito,
Assessing Recent Health Care Proposals from the House Committee on
Energy and Commerce (May 25, 2023), https://www.brookings.edu/articles/assessing-recent-health-care-proposals-from-the-house-committee-on-energy-and-commerce.
\66\ Id.
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The Departments agree that where multiple plans share the same
negotiated rates under an umbrella provider network, organizing the In-
network Rate Files by provider network would decrease the size of the
files, often significantly while still maintaining data integrity.
Therefore, to standardize this method of organizing files across all
plans and issuers, the Departments propose to amend the introductory
language of paragraph (b)(1)(i) to require plans and issuers to make an
In-network Rate File available for each provider network maintained or
contracted by the plan or issuer. This approach would also reduce the
total number of In-network Rate Files because there are far more plans
and policies available than there are distinct, separately managed
provider networks.\67\
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\67\ See Jianhui Zhu, Yuting Zhang, & Daniel Polsky, Networks in
ACA Marketplaces Are Narrower for Mental Health Care Than for
Primary Care, 36 Health Affairs 9 (Sept. 2017). (Researchers found
that, using 2016 HealthCare.gov data, 531unique provider networks
were used by 281 different issuers, covering 5,022 qualified health
plans in the Federally-facilitated Marketplaces).
---------------------------------------------------------------------------
To make it easier for file users to determine in advance of
downloading a provider network-level In-network Rate File whether it
contains data of interest to them, the Departments propose to
redesignate paragraphs (b)(1)(i)(A) through (C) as paragraphs
(b)(1)(i)(B) through (D), respectively, and add a new paragraph
(b)(1)(i)(A) requiring each In-network Rate File to include the common
provider network name for which negotiated rate information is
included. The Departments seek comment on whether there is another term
or code, in addition to or instead of the common provider network name,
that would help producers or file users identify specific provider
networks. The Departments expect plans and issuers to define what
constitutes a separate provider network according to their current
business practices. The Departments solicit comments on whether
additional limitations on what constitutes a separate provider network
should be required.
In order to maintain the connection of rates to plans under this
proposal, as further discussed in section III.C.2. of this preamble,
the Departments also propose to amend redesignated paragraph
(b)(1)(i)(B) to require plans and issuers to identify, for each
provider network for which the plan or issuer must publish an In-
network Rate File, each of the plan's or issuer's coverage options that
use that network. This would allow file users to cross reference the
rates for a particular plan or policy of interest to its in-network
rates.
The Departments also propose conforming amendments to redesignated
paragraphs (b)(1)(i)(C) and (D). Specifically, the Departments propose
to amend redesignated paragraph (b)(1)(i)(C) to specify that each In-
network Rate File must include a billing code and a plain language
description for each covered item or service included in the file,
rather than under each coverage option offered by plans and
issuers.\68\ The Departments propose to amend redesignated paragraph
(b)(1)(i)(D) to specify that all applicable rates must be included for
each covered item or service included in the file, rather than for all
items or services the plan or issuer covers, since not all applicable
rates for items or services the plan or issuer covers are negotiated
under a given provider network. Since plans and issuers would be
required to make an In-network Rate File available for each provider
network they maintain or contract with, they would ultimately still be
required to disclose all applicable rates for items or services they
cover, but those rates may not all be reported in every In-network Rate
File organized by provider network.
---------------------------------------------------------------------------
\68\ ``Plain language'' means ``written and presented in a
manner calculated to be understood by the average participant,
beneficiary, or enrollee'' under current 26 CFR 54.9815-
2715A1(a)(2)(xx), 29 CFR 2590.715-2715A1(a)(2)(xix), and 45 CFR
147.210(a)(2)(xx) (redesignated as 26 CFR 54.9815-2715A1(a)(2)(xxi),
29 CFR 2590.715-2715A1(a)(2)(xx), and 45 CFR 147.210(a)(2)(xxi)
under these proposed rules).
---------------------------------------------------------------------------
The Departments are also proposing special aggregation rules for
self-insured group health plans, which is described in more detail in
section III.C.11. of this preamble.
b. Other Improvements for File Users
The Departments have determined that, overall, provider network-
level files would simplify data aggregation and analysis for
researchers and other groups interested in analyzing specific provider
networks, which is important to facilitate consumer's plan selection
decisions. For example, the Departments understand that organizing In-
network Rate Files by network would make it easier for employers and
plan sponsors to analyze the negotiated rates of different networks to
make informed decisions about which plans to offer their employees,
potentially favoring networks with more competitive pricing, in
addition to opening the door for employers to bring health care
purchasing decisions in house through direct contracting with provider
groups.\69\ This proposal may be of particular benefit to smaller
employers, who have historically had less leverage to negotiate
directly with providers due to lower patient volume, by empowering them
with access to network-level pricing data for negotiations.
---------------------------------------------------------------------------
\69\ See Samuel Haitoff, Jay Puthumana, Abhishek Dama, Yang
Wang, et al., Employer-Provider Direct Contracting: Practice and
Policy, Health Affairs Forefront (Apr. 1, 2025), https://www.healthaffairs.org/content/forefront/employer-provider-direct-contracting-practice-and-policy; See also Cynthia A. Fisher & Arthur
B. Laffer, Healthcare Price Transparency and Competition: How Real
Price Transparency Can Reduce American Healthcare Costs More Than $1
Trillion Annually and Extend Life Expectancy (Oct. 2023), https://static1.squarespace.com/static/60065b8fc8cd610112ab89a7/t/652f0429f8ca6d62668bb43d/1697580073561/PRA_Fisher-Laffer+Healthcare+Price+Transparency+Paper_FINAL.pdf; See also
Christopher Whaley, Geetika Sachdev, Michael Bartlett, & Ge Bai,
It's Time for Employers to Bring Health Care Decisions In-House,
Health Affairs Forefront (Sept. 22, 2022), https://www.healthaffairs.org/content/forefront/s-time-employers-bring-health-care-decisions-in-house.
---------------------------------------------------------------------------
Similarly, organizing in-network rate information by provider
network would help service providers advise clients on network
selection and cost management strategies. Likewise, researchers,
academics, and policymakers would be better positioned to analyze
pricing variations across different providers, specialties, and
geographic areas within the same provider network and between
[[Page 60449]]
different networks that may inform policy interventions aimed at cost
containment and market regulations.
The Departments understand that State insurance regulators may also
be able to use network-level data to inform and improve rate review
processes, optimize public option plans, and potentially guide
antitrust enforcement.\70\ Currently, State regulators may review unit
cost and utilization trends submitted by issuers as part of their rate
review process. Access to more consumable provider rates by network and
product type in the In-network Rate Files may make it easier for
regulators to validate unit cost trends, and to use those trends to
assess the reasonableness of premium increases. Also, the reduction of
duplicative data in the In-network Rate Files may make it easier for
States to monitor rates to identify collusive behaviors, as well as
help establish benchmarks for negotiations with providers as part of
State oversight activities related to coverage programs.
---------------------------------------------------------------------------
\70\ Colorado's State law mandates insurers provide in-network
allowed amounts data tailored for State-specific analyses. See
Colorado Rev. Statutes Sec. 10-16-168(4); Medical Group Management
Association, Unlocking the Potential of Healthcare Price
Transparency Data (Dec. 5, 2024), https://www.mgma.com/articles/unlocking-the-potential-of-healthcare-price-transparency-data
(noting that Colorado uses price transparency data ``to inform rate
reviews, optimize [its] public option plans, and potentially guide
antitrust enforcement,'' according to Colorado Insurance
Commissioner Michael Conway); See also Sabrina Corlette, The Health
Plan Price Transparency Files Are a Mess: States Can Help Make Them
Better, Health Affairs Forefront (May 5, 2023), https://chirblog.org/the-health-plan-price-transparency-data-files-are-a-mess-states-can-help-make-them-better.
---------------------------------------------------------------------------
c. Better Alignment With Hospital Price Transparency Reporting
Organizing in-network rates by provider network would also promote
standardization and streamlined comparison of pricing information
across hospitals and health plans, consistent with Executive Order
14221.\71\ As discussed in section I.A. of this preamble, many
interested parties have called for better alignment among Federal price
transparency requirements to avoid consumer confusion and duplication
of effort.\72\
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\71\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
\72\ See American Hospital Association, Fact Sheet: Hospital
Price Transparency (Feb. 24, 2023), https://www.aha.org/fact-sheets/2023-02-24-fact-sheet-hospital-price-transparency.
---------------------------------------------------------------------------
Currently, the Hospital Price Transparency machine-readable files
required under 45 CFR part 180 generally disclose rates at the provider
network level.\73\ By contrast, rates disclosed pursuant to the 2020
final rules are currently disclosed at the more granular plan or policy
level, which presents complications for data matching. For example, a
single set of Hospital Price Transparency rates negotiated between a
plan and a hospital system could appear multiple times, under several
different plan names, in an issuer's current In-network Rate Files,
without any reference to the provider network name in the Hospital
Price Transparency file. Standardization of price disclosures for
providers, plans, issuers, and procedures at the same level would allow
for more accurate comparisons between the different types of
transparency files.
---------------------------------------------------------------------------
\73\ 45 CFR 180.50.
---------------------------------------------------------------------------
The Departments seek comment on all aspects of these proposals.
2. HIOS Identifier and Product Type
The Departments propose to amend the identifying coverage
information that plans and issuers must disclose in the In-network Rate
Files at redesignated 26 CFR 54.9815-2715A3(b)(1)(i)(B), 29 CFR
2590.715-2715A3(b)(1)(i)(B), and 45 CFR 147.212(b)(1)(i)(B), and in the
Allowed Amount Files at 26 CFR 54.9815-2715A3(b)(1)(ii)(A), 29 CFR
2590.715-2715A3(b)(1)(ii)(A), and 45 CFR 147.212 (b)(1)(ii)(A).
Specifically, the Departments propose to remove the requirement for
plans and issuers to report the 14-digit Health Insurance Oversight
System (HIOS) identifier (ID) or, if the 14-digit HIOS ID is not
available, the 5-digit HIOS ID, and instead require them to report the
HIOS identifier associated with each coverage option for which data is
being reported in a form and manner as specified in guidance issued by
the Departments. The Departments also propose to add a requirement for
plans and issuers to report the product type (for example, Health
Maintenance Organization (HMO) or Preferred Provider Organization
(PPO)) associated with the coverage option for which data is being
reported.
The 2020 final rules require plans and issuers to include their 14-
digit HIOS ID in the In-network Rate File and Allowed Amount File
unless the plan or issuer does not have a 14-digit HIOS ID available,
in which case the plan or issuer must include the HIOS ID at the 5-
digit issuer level.\74\ If a plan or issuer does not have a HIOS ID, it
must use its Employer Identification Number (EIN). The Departments
received significant comments on GitHub about requiring the 14-digit
HIOS ID,\75\ stating that this requirement would result in an enormous
amount of redundant data because provider rates are not established
based on distinct plan designs, but rather they are applied across
multiple plan offerings. The Departments have determined that the
number of HIOS digits that plans and issuers must report is a technical
implementation detail that should be removed from regulation and set
forth in technical implementation guidance to better maintain the
Departments' flexibility to determine appropriate technical reporting
requirements and to make refinements in response to changes in
technology or health care industry business practice. This is in line
with the Departments' general approach as described in the preamble to
the 2020 final rules, to provide specific technical direction in
separate technical implementation guidance, rather than in rulemaking,
in order to keep pace with and respond to technological
developments.\76\ The Departments propose to amend the reporting
requirements to specify that for each applicable coverage option
offered by a group health plan or health insurance issuer, the plan or
issuer must report the name and the HIOS identifier, or, if no HIOS
identifier is available, the EIN.
---------------------------------------------------------------------------
\74\ The 14-digit HIOS ID is comprised of the following: (1)
issuer's ID number (first 5 digits, for example, 12345), (2)
issuer's State abbreviation (next 2 digits, for example, WA); (3)
issuer's three-digit Product ID (next 3 digits, for example, 001);
and (4) a four-digit sequence number that is the ``Component ID''
(last 4 digits, for example, 0001). Thus, HIOS ID at the 14-digit
level would be 12345WA0010001, 10 digits would be 12345WA001, 7
digits would be 12345WA, and 5 digits would be 12345.
\75\ See GitHub Users, GitHub Discussion: Updating to allow for
reporting at the 10-digit HIOS level vs the 14-digit level #447,
GitHub, https://github.com/CMSgov/price-transparency-guide/pull/447#issuecomment-1102946004 (last updated Apr. 19, 2022); See also
GitHub Users, GitHub Discussion: In-Network-Rates File: Schema and
Definition of Plan Name and HIOS/EIN #44, GitHub, https://github.com/CMSgov/price-transparency-guide/discussions/44#discussioncomment-645647 (last updated Mar. 28, 2022).
\76\ 85 FR 72158, 72221 (November 12, 2020).
---------------------------------------------------------------------------
In addition to the HIOS digit amendment, the Departments propose to
amend redesignated paragraph (b)(1)(i)(B) and amend paragraph
(b)(1)(ii)(A) to newly require plans and issuers to report the product
type for each applicable coverage option offered by a plan or issuer in
the In-network Rate File and Allowed Amount File, respectively. The
Departments have received feedback that requiring plans and issuers to
disclose health plan product types (for example, HMO, PPO) would
promote more meaningful transparency around the health care pricing
information disclosed in the In-
[[Page 60450]]
network Rate and Allowed Amount Files. The Departments agree with this
feedback, as product types dictate the fundamental relationship between
the payer and the provider regarding patient access and volume, which
are key leverage points in contract negotiations over rates. For
example, in instances where HMOs may have narrow networks, providers
contracting with such HMOs are likely to see increased patient volume,
which may encourage such providers to contract at a lower rate with the
HMO than they might with a PPO that is less likely to result in higher
patient volume. Product types also dictate the fundamental relationship
between payer and patient, with differences, for example, related to
patient choice, cost-sharing responsibilities, and accessibility.
Additionally, the Departments have heard from interested parties
that although negotiated rates under a provider network are typically
consistent across plans and policies with respect to a specific item or
service and a specific provider, these rates may differ based on
product type. As such, interested parties have stated that requiring
plans and issuers to include the product type for each applicable
coverage option offered by the plan or issuer in the In-network Rate
File would allow users to account for those differences.
In addition to providing context on how prospective rates differ,
the Departments have determined that adding a product type to the
Allowed Amount Files would allow file users to compare how historical
provider reimbursements differ based on product type. Disclosing
product type data in the Allowed Amount Files would enable more
accurate and actionable comparisons for employers, researchers, and
regulators so they can understand true market pricing for specific
product types. In addition, not only could users of these data make
comparisons of allowed amounts across different product types for a
specific service for a single payer, they could also make comparisons
for the same service based on product type across different payers. For
example, an employer or plan sponsor offering a PPO plan could
benchmark their out-of-network costs specifically against other PPO
plans in the market, rather than a generalized average that includes
potentially lower-cost HMOs, and they could use this information to
make future plan coverage determinations. Furthermore, with allowed
amounts tied to product type, employers and plan sponsors would better
understand the actual tradeoffs in plan design--that is, not just
premiums and network access, but also how much the plan will pay when
employees go out-of-network. One study on out-of-network behavioral
health care in employer-sponsored coverage observed that balance
billing was higher for HMO enrollees versus non-HMO enrollees.\77\ With
the inclusion of data on plan type, employers could use historical
allowed amounts segmented by plan type to evaluate the level of
financial protection offered for out-of-network services.
---------------------------------------------------------------------------
\77\ See Sarah A. Friedman, Hao Xu, Fernando Azocar & Susan L.
Ettner, Quantifying Balance Billing for Out-of-Network Behavioral
Health Care in Employer-Sponsored Insurance, 73 Psychiatric Services
1019 (2022).
---------------------------------------------------------------------------
The Departments acknowledge that product type is often used in the
fully insured market, typically to comply with laws that apply to
insured products. The Departments also acknowledge that the definitions
of these product types may differ from State to State and seek comment
on whether that would present difficulties for plans and issuers in
determining which product type to indicate. The Departments also seek
comment on whether possible inconsistency between State definitions of
certain product types would cause confusion among file users. Under
ERISA, self-insured plans are not currently required to be identified
by product type and these traditional classifications may not
necessarily apply or otherwise accurately describe a self-insured
benefit arrangement. As such, the Departments seek comment on whether
self-insured plans generally identify benefit package options by
product type, whether there is any existing nomenclature that self-
insured plans could use to accurately identify the type of benefit
arrangement being offered, and whether it is practical to extend this
requirement to self-insured plans.
3. Percentage-of-Billed-Charges Arrangements
The Departments propose to amend redesignated 26 CFR 54.9815-
2715A3(b)(1)(i)(D)(1), 29 CFR 2590.715-2715A3(b)(1)(i)(D)(1), and 45
CFR 147.212(b)(1)(i)(D)(1) (redesignated from paragraph (b)(1)(i)(C)(1)
as discussed in section III.C.1. of this preamble) of the In-network
Rate Files provision to require that in-network rates must be reflected
as a dollar amount except for contractual arrangements under which a
plan or issuer agrees to pay an in-network provider a percentage of
billed charges and is not able to assign a dollar amount to an item or
service prior to a bill being generated. In such circumstances, plans
and issuers must report a percentage number, in lieu of a dollar
amount, in the form and manner as specified in guidance issued by the
Departments.
Paragraph (b)(1)(i)(C) of the current In-network Rate File
provision requires plans and issuers to publish all applicable rates,
which may include one or more of the following: negotiated rates,
underlying fee schedule rates, or derived amounts for all covered items
and services in the In-network Rate File. The Departments specified in
the preamble to the 2020 final rules that the In-network Rate File
requirement applies to plans and issuers regardless of the type of
payment model or models under which they provide reimbursement.\78\
---------------------------------------------------------------------------
\78\ 85 FR 72158, 72226 (November 12, 2020).
---------------------------------------------------------------------------
Under the 2020 final rules, paragraph (b)(1)(i)(C)(1) of the In-
network Rate File provision requires that rates must be reflected in
the In-network Rate File as dollar amounts and if the rate is subject
to change based upon participant, beneficiary, or enrollee-specific
characteristics, that these dollar amounts should be reflected as the
base negotiated rate applicable to the item or service prior to
adjustments for participant, beneficiary, or enrollee-specific
characteristics. While there are alternative reimbursement arrangements
that do not have a dollar amount associated with particular items and
services before the item or service is furnished, a dollar amount can
still be determined in some instances under these arrangements.
Accordingly, in the preamble to the 2020 final rules, the Departments
provided a list of alternative reimbursement arrangements and
summarized general reporting expectations for these arrangements, while
acknowledging that the list was not exhaustive, as there may be other
alternative reimbursement or contracting arrangements in use.\79\
Specifically, the Departments summarized the general reporting
expectations, including for bundled payment arrangements and capitation
arrangements (including sole capitation arrangements and partial
capitation arrangements), reference-based pricing without a defined
network, reference-based pricing with a defined network, and value-
based purchasing. For example, the preamble to the 2020 final rules
clarified that for payment arrangements under which adjustments are
made after care is provided, the plan or issuer should disclose the
base negotiated rate before adjustments are applied.\80\
---------------------------------------------------------------------------
\79\ Id.
\80\ 85 FR 72158, 72228 (November 12, 2020).
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[[Page 60451]]
After the 2020 final rules were issued, interested parties used
GitHub \81\ and other forums to raise to the Departments' attention
alternative payment arrangements under which reporting a current and
accurate dollar amount for items and services in the In-network Rate
File before the item or service is furnished may not be possible and
requested guidance from the Departments on how to meet the disclosure
requirements for such arrangements. Specifically, interested parties
questioned the Departments on how to report dollar amounts for
negotiated rates that result from certain ``percentage-of-billed-
charges'' contract arrangements, under which a dollar amount can be
determined only retrospectively because the agreement between the plan
or issuer and the in-network provider states that the plan or issuer
will pay a fixed percentage of the billed charges. It is the
Departments' understanding that these types of arrangements are not
uncommon for certain types of items or services (such as low-volume
procedures or high-cost, outlier inpatient care).
---------------------------------------------------------------------------
\81\ GitHub Users, GitHub Discussion: If negotiated rate is
based on percentage of charge--then how would this be reported in
the in-network file? #23, GitHub, https://github.com/CMSgov/price-transparency-guide/discussions/23 (last updated Apr. 15, 2022);
GitHub Users, GitHub Discussion: Percentage of Billed Charges #315,
GitHub,https://github.com/CMSgov/price-transparency-guide/discussions/315 (last visited Dec. 8, 2025); GitHub Users, GitHub
Discussion: Using Claims History for In-Network File when unable to
extract rates (that is percent of billed charges) #197, GitHub,
https://github.com/CMSgov/price-transparency-guide/discussions/197
(last updated Sep. 30, 2022).
---------------------------------------------------------------------------
On April 19, 2022, the Departments issued FAQs Part 53 \82\ to
provide an enforcement safe harbor for satisfying the reporting
requirements for plans and issuers that use an alternative payment
arrangement that does not permit them to derive with accuracy specific
dollar amounts contracted for covered items and services in advance of
the provision of that item or service, or that otherwise cannot
disclose specific dollar amounts according to the file formatting
requirements as provided in the Departments' technical implementation
guidance through GitHub. This guidance further advised that for
contractual arrangements under which a plan or issuer agrees to pay an
in-network provider a percentage of billed charges and is not able to
assign a dollar amount to an item or service prior to a bill being
generated, plans and issuers may report a percentage number, in lieu of
a dollar amount.
---------------------------------------------------------------------------
\82\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs about Affordable
Care Act Implementation Part 53 (April 19, 2022), https://www.cms.gov/files/document/faqs-part-53.pdf and https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-53.
---------------------------------------------------------------------------
On September 27, 2023, the Departments clarified in FAQs Part 61
\83\ that whether a plan or issuer is able to comply with the
requirement to disclose certain rates as dollar amounts is a fact-
specific determination and that the Departments would exercise
enforcement discretion with respect to this requirement on a case-by-
case basis, without any categorical ``safe harbor.'' The Departments
instructed plans and issuers that are unable to determine dollar
amounts for the applicable rate element to continue to follow the
existing technical implementation guidance on GitHub.
---------------------------------------------------------------------------
\83\ U.S. Department of Labor, U.S. Department of Health & Human
Services & U.S. Department of the Treasury, FAQs about Affordable
Care Act Implementation Part 61 (September 27, 2023), https://www.cms.gov/files/document/faqs-about-affordable-care-act-implementation-part-61.pdf and https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-61.
---------------------------------------------------------------------------
Since issuing the guidance in 2023, the Departments have continued
to receive feedback from interested parties that arrangements where a
dollar amount is unable to be determined in advance are not uncommon
and should be reflected in the data. Therefore, the Departments propose
to amend redesignated 26 CFR 54.9815-2715A3(b)(1)(i)(D)(1), 29 CFR
2590.715-2715A3(b)(1)(i)(D)(1), and 45 CFR 147.212(b)(1)(i)(D)(1) to
state that applicable rates must be reflected as dollar amounts, with
respect to each covered item or service that is furnished by an in-
network provider, except for contractual arrangements under which a
group health plan or health insurance issuer agrees to pay an in-
network provider a percentage of billed charges and is not able to
assign a dollar amount to an item or service prior to a bill being
generated. In these instances, plans and issuers must report a
percentage number, in lieu of a dollar amount, in a form and manner as
specified in guidance issued by the Departments.
While the Departments recognize the importance of allowing plans
and issuers to disclose non-dollar amount rates when a dollar amount is
unknown in advance, the Departments reiterate that plans and issuers
must disclose rates as a dollar amount whenever a dollar amount can be
calculated in advance, including when a negotiated base rate can be
calculated prior to adjustments. Further, the Departments emphasize
that this proposed change, if finalized, would permit plans and issuers
to disclose an applicable rate in a non-dollar amount only in instances
where the applicable rate is a percentage of billed charges and expect
that plans and issuers report all other applicable rates as dollar
amounts consistent with the form and manner specified in guidance
issued by the Departments.
The Departments seek comment on this proposal.
4. Enrollment Totals
The Departments propose to add new 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) requiring plans and issuers to include in each In-
network Rate File, current numerical enrollment totals, as of the date
the file is posted, for each coverage option offered by a plan or
issuer represented in the In-network Rate File. Such numerical
enrollment totals must include the number of participants,
beneficiaries, and enrollees (including all dependents) in the coverage
option offered by a plan or issuer.
Affordable Care Act sections 1311(e)(3)(A)(iii) and (iv) require
health plans seeking certification as a qualified health plan to submit
to the Exchange, the Secretary, the State insurance commissioner, and
make available to the public, accurate and timely disclosure of data on
enrollment and disenrollment. PHS Act section 2715A, incorporated into
ERISA section 715 and Code section 9815, gives the Departments the
statutory authority to require a plan or coverage that is not offered
through an Exchange to submit the information required under Affordable
Care Act section 1311(e)(3) to the Secretary and the relevant State's
insurance commissioner, and to make that information available to the
public. However, the 2020 final rules do not require the disclosure of
enrollment data.
Since the publication of the 2020 final rules, the Departments have
received feedback from interested parties on the importance of
additional data elements that would allow users to weigh different
plans and coverage options to understand their relative influence on
the overall landscape of pricing in health insurance, such as plan
enrollment numbers, in line with the goals stated in the 2020 final
rules.\84\ The Departments understand that requiring the reporting of
plan enrollment counts would enable file users to develop analytical
models that prioritize negotiated rates for health care
[[Page 60452]]
items and services based on the number of individuals covered by the
corresponding plan or coverage, thereby focusing analysis on prices
with the broadest impact on the insured population. Plans with higher
enrollments may have a larger impact on negotiated rates, due to
relative market power, approximate size of the overall market, and
other factors. Additionally, this contextual information would expand
opportunities to conduct analysis and compare rates across ``like''
plans. The Departments understand, based on feedback from interested
parties, that enrollment data would be particularly useful in analyzing
the small group and individual markets, where small differences may
have pronounced impacts on trends and patterns. The Departments are
specifying that the numerical enrollment totals must include the number
of participants, beneficiaries, and enrollees (including all
dependents) to distinguish from other reporting requirements plans and
issuers are required to comply with.
---------------------------------------------------------------------------
\84\ 85 FR 72158, 72161 (November 12, 2020); See Gary Claxton,
Lynne Cotter, & Shameek Rakshit, Challenges with Effective Price
Transparency Analyses, Peterson-KFF Health System Tracker (Feb. 25,
2025), https://www.healthsystemtracker.org/brief/challenges-with-effective-price-transparency-analyses/.
---------------------------------------------------------------------------
Therefore, the Departments have determined that requiring
disclosure of this additional data in the In-network Rate File would
provide important context to the health care pricing information and
propose to require in new paragraph (b)(1)(i)(E) that plans and issuers
are required to disclose enrollment totals for each coverage option
they offer represented in the In-network Rate File. These proposed
rules would require that plans and issuers include enrollment totals as
of the date the In-network Rate File is posted. The Departments seek
comment on the feasibility of including the enrollment total as of the
date the file is posted and whether an enrollment total on a different
specified date would be more feasible for file producers and more
useful to the data users. The Departments also solicit comment on this
proposal in general.
5. Excluded Provider Information
The Departments propose to add new 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) to the In-network Rate Files provision that would
require plans and issuers to exclude from each In-network Rate File a
provider and their 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 the item or service based on the
scope of the provider's license or area of specialty. The Departments
further propose that plans and issuers must make such a determination
using their internal provider taxonomy that is typically used during
the claims adjudication process. The Departments have determined that
excluding provider-rate combinations that are not likely to result in a
reimbursement is necessary to limit unnecessary information that
inflates file size and limits the accessibility of the data in the In-
network Rate File.
These proposed rules at paragraph (b)(1)(i)(F) would require plans
and issuers to use their internal provider taxonomy that is typically
used during the claims adjudication process to determine which
provider-rate combinations to exclude from the In-network Rate File.
The internal provider taxonomy is part of the claims adjudication
workflow, in which the plan or issuer assesses whether the billed item
or service (represented by a billing code) aligns with the specialty of
the rendering provider (represented by a provider taxonomy code). If
the specialty does not meet the plan or issuer's requirements for that
item or service, the claim may be denied. For example, the Departments
expect that a plan or issuer's internal provider taxonomy would be
unlikely to reimburse a claim submitted for a heart surgery submitted
from a podiatrist because the billing code associated with a heart
surgery would not match with a taxonomy code for a podiatrist.
The Departments understand that it is standard business practice
for the internal provider taxonomy maintained by a plan or issuer to
identify provider specialties using a standardized code set established
by the National Uniform Claim Committee (NUCC).\85\ The NUCC maintains
standard provider taxonomy codes, which are used to define a provider's
area of specialty.\86\ Provider taxonomy codes are ten characters in
length structured into three distinct ``levels'' including provider
grouping, classification, and area of specialization.\87\ The
Departments understand that when a provider submits a claim for
reimbursement to a plan or issuer, the provider must include their NUCC
code and the billing code for the item or service along with certain
other information. The Departments understand that plans and issuers
then compare the NUCC provider taxonomy code and billing code included
from the claim against their internal provider taxonomy mappings to
determine if the claim can proceed through the next step of the payment
adjudication process.
---------------------------------------------------------------------------
\85\ The NUCC establishes and maintains standard provider
taxonomy codes, which are used to define a provider's area of
specialty. Provider taxonomy codes are ten characters in length
structured into three distinct ``levels'' including provider
grouping, classification, and area of specialization. See National
Uniform Claim Committee, Health Care Provider Taxonomy, https://www.nucc.org/index.php/code-sets-mainmenu-41/provider-taxonomy-mainmenu-40 (last visited Dec. 8, 2025).
\86\ See National Uniform Claim Committee, Health Care Provider
Taxonomy, https://www.nucc.org/index.php/code-sets-mainmenu-41/provider-taxonomy-mainmenu-40 (last visited Dec. 8, 2025).
\87\ See National Uniform Claim Committee, Health Care Provider
Taxonomy, https://www.nucc.org/index.php/code-sets-mainmenu-41/provider-taxonomy-mainmenu-40 (last visited Dec. 8, 2025).
---------------------------------------------------------------------------
The Departments have observed that several third-party data
aggregation vendors successfully demonstrated various methods to
efficiently filter existing machine-readable file content by utilizing
NUCC provider taxonomy codes, demonstrating these codes can help
determine whether a provider is likely going to be eligible for
reimbursement for a specific service or procedure.\88\ Therefore, the
Departments have determined this may be a viable approach to excluding
certain provider-rate combinations.
---------------------------------------------------------------------------
\88\ See Sameer Mukhi, Zombie Hunting: Filtering Approaches for
Price Transparency Data, Serif Health Blog (Sept. 20, 2024), https://www.serifhealth.com/blog/zombie-hunting-filtering-approaches-for-price-transparency-data/; Matt Najarian, Clinically Implausible
Rates Are Getting the Boot, Turquoise Health Blog (Aug. 30, 2023),
https://blog.turquoise.health/clinically-implausible-rates-are-getting-the-boot/.
---------------------------------------------------------------------------
The 2020 final rules at 26 CFR 54.9815-2715A3(b)(1)(i)(C)(1), 29
CFR 2590.715-2715A3(b)(1)(i)(C)(1), and 45 CFR 147.212(b)(1)(i)(C)(1)
require plans and issuers to disclose all applicable rates for in-
network providers, including negotiated rates, underlying fee schedule
rates, or derived amounts, to the extent they may be used for purposes
of determining provider reimbursement or cost-sharing for in-network
providers. The 2020 final rules do not specify any exclusions to this
requirement. As a result, the Departments have observed and have
received feedback that In-network Rate Files often include negotiated
rates for providers for items and services that those providers would
not likely be reimbursed for because the items and services are outside
their specialty (for example, a mental health provider billing for knee
replacement).\89\ The Departments understand that plans and issuers
frequently negotiate applicable rates at the provider organization
level (such as large multi-specialty physician groups or integrated
health systems) for every provider who is a member of that
organization, regardless of whether that
[[Page 60453]]
provider would be likely to be reimbursed for that item or service.
---------------------------------------------------------------------------
\89\ See Sameer Mukhi, Zombie Hunting: Filtering Approaches for
Price Transparency Data, Serf Health Blog (Sept. 20, 2024), https://www.serifhealth.com/blog/zombie-hunting-filtering-approaches-for-price-transparency-data/.
---------------------------------------------------------------------------
Under the 2020 final rules, these rates are required to be
disclosed. As a result, the Departments and interested parties have
observed that there are many provider-rate combinations that are not
meaningful for transparency purposes and impose unnecessary burden on
both producers and users of the In-network Rate File. This
overinclusion leads to significant file sizes, where In-network Rate
Files are consistently enlarged by the inclusion of these unlikely
provider-rate combinations. One early examination found that plans and
issuers were posting approximately a petabyte (PB) \90\ of information
each month, in part due to the inclusion of what it refers to as
``clinically implausible rates.'' \91\ In September 2024, the
Departments analyzed a subset of In-network Rate Files and discovered
that 73 percent of hematologists' negotiated rates were for 500 billing
codes for services for which they would be unlikely to be reimbursed
for. Another researcher reported that 96.5 percent of rates reported in
the In-network Rate Files were for services with respect to providers
who would be unlikely to be reimbursed for those services based on
their specialty.\92\ The Departments understand from feedback from
interested parties that excessive file size creates network bandwidth
and data storage problems for file producers and users alike, including
significant costs associated with hosting, downloading, or analyzing
significant amounts of data.
---------------------------------------------------------------------------
\90\ One petabyte (PB) is a unit of digital information equal to
1,000 terabytes (TB) in the decimal system (or 1,000,000 gigabytes
(GB)). In binary terms, which is sometimes used in computing, 1 PB
equals 1,024 terabytes.
\91\ Adam Geitgey, A Petabyte of Health Insurance Prices Per
Month, Turquoise Health Blog (July 11, 2023), https://blog.turquoise.health/a-petabyte-of-health-insurance-rates-a-month/.
\92\ See David Muhlestein, Improving Price Transparency Data:
Recommendations From Practice, Health Affairs Forefront (Mar. 19,
2025), https://www.healthaffairs.org/content/forefront/improving-price-transparency-data-recommendations-practice.
---------------------------------------------------------------------------
In addition, the Departments understand that excess data of limited
use poses an unnecessary barrier to analyzing these files for users
seeking to understand health care price variation, and to carrying out
research on pricing data.\93\ For example, one researcher identified a
negotiated rate for a Caesarean section (C-section) for a neurological
institute that was almost ten times the median rate for a C-section in
that geographic region.\94\ The researcher identified that the
neurological institute must share the same rate for a C-section with
all the providers in their parent organization per their contract even
though neurologists would be unlikely to be reimbursed for a C-
section.\95\ These rates may distort patterns, averages, and medians
when conducting market-wide analyses, leading to an inaccurate
understanding of health care prices.\96\
---------------------------------------------------------------------------
\93\ See Gary Claxton, Lynne Cotter, & Shameek Rakshit,
Challenges with Effective Price Transparency Analyses, Peterson-KFF
Health System Tracker (Feb. 25, 2025), https://www.healthsystemtracker.org/brief/challenges-with-effective-price-transparency-analyses/; See also David Muhlestein, Improving Price
Transparency Data: Recommendations From Practice, Health Affairs
Forefront (Mar. 19, 2025), https://www.healthaffairs.org/content/forefront/improving-price-transparency-data-recommendations-practice.
\94\ See Adam Stein, Beyond the Trillion Prices: Pricing C-
Sections in America, D01thUb Blog (Oct. 13, 2022), https://www.dolthub.com/blog/2022-10-03-c-sections/.
\95\ Id.
\96\ See James Hines, Zombie Rates: A Data-Driven Approach to
Healthcare Price Transparency, Gigasheet Blog (Jan. 27, 2025),
https://www.gigasheet.com/post/price-transparency-zombie-rates.
---------------------------------------------------------------------------
The Departments recognize that the 2020 final rules specifying that
plans and issuers disclose all negotiated rates for all covered items
and services for all in-network providers have led to the disclosure of
rates beyond what was intended by the Departments. The Departments have
determined that excluding provider-rate combinations for services that
providers are unlikely to perform or be reimbursed for--because they
fall outside their specialty--would significantly reduce the size of
the In-network Rate Files. This significant decrease in file size would
also reduce the storage space and computer processing resources needed
to generate, store, and analyze In-network Rate Files, reducing burden
for file producers and users alike.
Therefore, the Departments propose to revise the content
requirements for the In-network Rate File to require plans and issuers
to exclude provider-rate combinations for an item or service if the
provider would be unlikely to be reimbursed for the item or service
given the provider's area of specialty, according to the plan's or
issuer's internal provider taxonomy that is typically used during the
claims adjudication process.
In order for users of the In-network Rate Files to understand how
plans and issuers constructed the files according to this new proposed
requirement, the Departments also propose 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), to require plans and issuers to publish a taxonomy
machine-readable file. As discussed in more detail in section III.C.7.
of this preamble, this new machine-readable file would disclose the
mapping of billing codes to internal provider taxonomy codes, providing
transparency into how plans and issuers determined which provider-rate
combinations for covered items and services have been excluded from the
In-network Rate Files based on the plan's or issuer's taxonomy rules.
The Departments seek comment on all aspects of this proposal. The
Departments are particularly interested in feedback from interested
parties on whether there are plans or issuers that do not map provider
specialties to billing codes within their claims adjudication process
or use different code sets, and whether there could be a way to
standardize the provider specialty mapping to billing code process. The
Departments are also interested in whether there are alternative
approaches to excluding any provider that has a rate for an item or
service that interested parties consider to not be a meaningful rate.
While the Departments have included a discussion of some potential
alternatives in section VI.D.2. of this preamble, the Departments are
interested in feedback from interested parties on the relative burdens
and benefits of alternative approaches to both producers and file
users. The Departments are also interested in any concerns that parties
may have with a proposal to require plans and issuers to make such
exclusions at all. For instance, do file users have concerns about
plans and issuers intentionally or inadvertently over-excluding
provider-rate combinations from the In-network Rate File? Additionally,
do file users recommend alternative approaches to best achieve the
goals of transparency as set out in the 2020 final rules? For example,
are there alternative approaches that will help meet the Departments'
goals of limiting unnecessary information that inflates file size,
without limiting the accessibility of the data, and promoting
meaningful transparency of in-network rate pricing information?
6. Out-of-Network Allowed Amount Machine-Readable File
The Departments propose to make several amendments to the Allowed
Amount File provision at 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 increase the
amount of historical out-of-network claims data disclosed in the files,
including a proposal to lower the threshold for including claims from
20 to 11 different
[[Page 60454]]
claims per item or service, a proposal to increase the reporting period
from 90 days to 6 months, a proposal to increase the lookback period
from 180 days to 9 months, and a proposal to require reporting at the
health insurance market level, rather than the plan or policy level.
Lastly, the Departments propose to remove the phrase ``and provider''
from paragraph (b)(1)(ii)(C) to clarify that the claims threshold
pertains to the number of claims for an item or service overall for the
file, not the number of claims for an item or service from a particular
provider.
The 2020 final rules at paragraph (b)(1)(ii)(C) require plans and
issuers to disclose on a public website a machine-readable file that
includes, among other things, each unique out-of-network allowed amount
with respect to covered items or services furnished by a particular
out-of-network provider during the 90-day time period that begins 180
days prior to the publication date of the Allowed Amount File. In
addition, plans and issuers must omit such data in relation to a
particular item or service and provider when including it would require
the plan or issuer to report payment of out-of-network allowed amounts
in connection with fewer than 20 different claims for payments for an
item or service under a single plan or coverage.\97\ Current rules at
paragraph (b)(4)(iii) also permit, but do not require, plans and
issuers to satisfy the public disclosure requirements of paragraph
(b)(1)(ii) by making available out-of-network allowed amount data that
has been aggregated to include information from more than one plan or
policy, under certain circumstances.
---------------------------------------------------------------------------
\97\ 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).
---------------------------------------------------------------------------
a. Reducing the Claims Threshold
Initially, the Departments established the 20-claims threshold to
limit the possibility that individual participants, beneficiaries, and
enrollees may be identified through the public disclosure of historical
allowed amount data. In the 2019 proposed rules, the Departments
proposed to require plans and issuers to omit out-of-network allowed
amounts from the Allowed Amount File in relation to a particular item
or service and provider when including this data would require the plan
or issuer to report payment of out-of-network allowed amounts in
connection with fewer than 10 different claims for payments.\98\ The
Departments requested comment on whether a higher minimum claims
threshold, such as a threshold of 20 claims, would better mitigate
privacy concerns and minimize complexity in complying with Federal or
State privacy laws without compromising the integrity of the compiled
information.\99\ As discussed in the 2020 final rules, some commenters
expressed concerns about maintaining Health Insurance Portability and
Accountability Act (HIPAA) protections on the Allowed Amount File due
to the small number of claims associated with specific items and
services for out-of-network providers.\100\ Several commenters stated
that the threshold of 10 different claims to require public disclosure
of unique historical allowed amounts would be too low to protect
consumers' protected health information. Based on commenters' concerns,
the Departments determined that increasing the claims threshold from 10
to 20 claims in the 2020 final rules would better balance the policy
goal of transparency with the need to protect participants,
beneficiaries, and enrollees from the possibility of being re-
identified through the data included in the Allowed Amount File.\101\
---------------------------------------------------------------------------
\98\ 84 FR 65464, 65481 (November 27, 2019).
\99\ Id.
\100\ 85 FR 72158, 72233 (November 12, 2020).
\101\ Id.
---------------------------------------------------------------------------
The Departments clarified in technical implementation guidance that
while a plan or issuer with fewer than 20 claims for a particular item
or service must omit information on payment of out-of-network allowed
amounts for that item or service, the Allowed Amount File must still be
produced pursuant to paragraph (b)(1)(ii)(C); however, information in
the file would be minimal due to the lack of information to
report.\102\ The Departments reasoned that the file must be created so
that file users know that the plan or issuer does not have any claims
that meet the 20-claims threshold, and that maintenance of such files
would be minimal.\103\
---------------------------------------------------------------------------
\102\ Centers for Medicare & Medicaid Services. Technical
Clarifications Question 23: After we compile all our allowed amounts
and billed charges for the Allowed Amount file, how do we adjust the
file to make sure we have taken into account the 20-claim
threshold?, https://www.cms.gov/priorities/healthplan-price-transparency/overview/resources/technical-clarification (last
visited Dec. 8, 2025).
\103\ Centers for Medicare & Medicaid Services. Technical
Clarifications Question 15: If a plan does not meet the 20-claim
threshold for any of its allowed amounts, must a file be produced?,
https://www.cms.gov/priorities/healthplan-price-transparency/overview/resources/technical-clarification (last visited Dec. 8,
2025).
---------------------------------------------------------------------------
Since the publication of the 2020 final rules, however, the
Departments have received feedback and observed that many plans and
issuers produce Allowed Amount Files with limited to no out-of-network
claims data, which the Departments have determined is due in part to
the 20-claims threshold. Given the limited data available, file users
are unable to perform meaningful analyses using out-of-network
data.\104\ This is because there are too many ``gaps'' in out-of-
network data in the file, which occur whenever there are fewer than 20
claims for a specific out-of-network item or service for a given plan.
---------------------------------------------------------------------------
\104\ Matthew Robben, Learnings from MRF Land, Serif Health Blog
(Mar. 31, 2023), https://www.serifhealth.com/blog/learnings-from-mrf-land.
---------------------------------------------------------------------------
Out-of-network price transparency data is vital for employers,
researchers, and regulators to analyze health care spending, benchmark
costs, and inform future policy decisions. This data offers new insight
into actual health care expenditures, including a window into the price
of an item or service in the context of an arms-length transaction
between a provider and a plan or issuer who have not negotiated the
rate, and where there is therefore no discount associated with the
advantage to a provider of being ``in network.'' \105\ Employers and
plan sponsors can use this data to benchmark costs, refine benefit
designs, and negotiate more effectively with administrators. Health
care providers and service providers can use it to estimate what they
might be reimbursed and what their patients or their participants,
beneficiaries, or enrollees, respectively, might be charged for out-of-
network care.\106\
---------------------------------------------------------------------------
\105\ Zack Cooper, Hao Nguyen, Nathan Shekita & Fiona Scott
Morton, Out-of-Network Billing and Negotiated Payments for Hospital-
Based Physicians, 39 Health Affairs 24 (2020) (published Dec. 16,
2019), https://www.healthaffairs.org/doi/10.1377/hlthaff.2019.00507.
\106\ Rebecca Hodes, Demystifying ``Allowed Amounts'' in Out-of-
Network Billing, Mentaya Blog (Apr. 1, 2025), https://www.mentaya.com/blog/demystifying-allowed-amounts-in-out-of-network-billing.
---------------------------------------------------------------------------
Therefore, to increase the volume of allowed amount data available,
the Departments propose to amend paragraph (b)(1)(ii)(C) to lower the
minimum claims threshold for a particular item or service under a
single plan or coverage to 11 different claims for a particular item or
service in a single health insurance market. The proposed 11-claims
threshold would align with the CMS cell suppression policy, which sets
minimum thresholds for the display of CMS data by researchers or other
custodians of CMS data sets, such as Limited Data Set (LDS) files.\107\
The policy stipulates that
[[Page 60455]]
no cell (such as admittances, discharges, patients, services, etc.)
containing a value of 1 to 10 can be reported directly.\108\ This
policy is a safeguard designed to prevent the identification of
individual Medicare or Medicaid beneficiaries when CMS data is shared
publicly \109\ and helps ensure compliance with Federal privacy laws,
such as HIPAA, by reducing the risk of re-identification of individuals
from aggregated data.
---------------------------------------------------------------------------
\107\ Centers for Medicare & Medicaid Services, Limited Data Set
(LDS) Files, https://www.cms.gov/data-research/files-for-order/data-disclosures-and-data-use-agreements-duas/limited-data-set-lds (last
modified July 7, 2025); Research Data Assistance Center (ResDAC),
CMS Cell Size Suppression Policy (Jan. 26, 2024), https://resdac.org/articles/cms-cell-size-suppression-policy.
\108\ Id.
\109\ Id.
---------------------------------------------------------------------------
The Departments have determined that the proposed 11-claims
threshold, combined with the proposal to require reporting by health
insurance market type discussed later in this section of the preamble,
would provide sufficient protection against the disclosure of sensitive
patient information. Under the proposal to require reporting by health
insurance market type, data disclosed in the Allowed Amount Files would
not be directly associated with a single plan or policy when two or
more plans or policies are aggregated into one file (as discussed in
more detail later in this section of the preamble). Instead, the data
would be aggregated to a broader health insurance market type (such as
``individual market'' or ``large group market''). For example, a unique
allowed amount and billed charge for a given item or service furnished
by a given provider might be associated with ``Large Group Market
offered by Insurer A,'' rather than ``Insurer A's Employer X Gold PPO
Plan.'' This high-level aggregation would provide a strong shield for
patient privacy.
Additionally, the Departments also note that, as specified in
current paragraph (b)(1)(ii)(C), disclosure of such information would
not be required if doing so would violate applicable health information
privacy laws. This is consistent with paragraph (c)(3), which specifies
that, among other things, nothing in 26 CFR 54.9815-2715A3, 29 CFR
2590.715-2715A3, or 45 CFR 147.212 alters or otherwise affects a plan's
or issuer's duty to comply with requirements under other applicable
State or Federal laws, including those governing the privacy or
security of information required to be disclosed under this section.
As such, the Departments have determined that lowering the claims
threshold in this way would strike a better balance between protecting
sensitive health information and allowing for a more comprehensive and
useful dataset to support the end goals of price transparency.
Lastly, the Departments propose to delete ``and provider'' from the
parenthetical language in (b)(1)(ii)(C) to more clearly specify that
the claims threshold pertains to the number of claims for an item or
service overall for the file, not the number of claims for an item or
service from a particular provider. This change would reflect the
Departments' current policy (other than the proposed changes to this
paragraph discussed elsewhere in this section of the preamble), and is
proposed as a technical clarification.\110\ The parenthetical in
paragraph (b)(1)(ii)(C) would be revised to specify that a plan or
issuer must omit out-of-network allowed amount and billed charge data
in relation to a particular item or service if including it would
require the plan or issuer to report payment of out-of-network allowed
amounts in connection with fewer than 11 different claims for payment
of that item or service in a single health insurance market. The
Departments seek comment on this proposal.
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\110\ Centers for Medicare & Medicaid Services. Technical
Clarifications Question 23: After we compile all our allowed amounts
and billed charges for the Allowed Amount file, how do we adjust the
file to make sure we have taken into account the 20-claim
threshold?, https://www.cms.gov/priorities/healthplan-price-transparency/overview/resources/technical-clarification (last
visited Dec. 8, 2025).
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b. Increasing the Reporting Period
The Departments also propose to amend paragraph (b)(1)(ii)(C) to
specify that plans and issuers would be required to include in the
Allowed Amount File allowed amounts and billed charges with respect to
covered items or services furnished by out-of-network providers during
the 6-month time period that begins 9 months prior to the publication
date of the file. This amendment would increase the reporting period
from 90 days to 6 months and increase the lookback period from 180 days
to 9 months. In the preamble to the 2020 final rules, the Departments
noted that they would monitor the implementation of the lookback period
for the Allowed Amount Files and may revisit it if the 90-day reporting
period and 180-day lookback period failed to yield sufficient out-of-
network data on allowed amounts.\111\ By approximately doubling the
reporting period from 90 days to 6 months and shifting the lookback
period from 180 days to 9 months, the Departments expect that more out-
of-network claims for items and services would meet the required
threshold for reporting requirements, meaning there would be more data
to populate the Allowed Amount Files.
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\111\ 85 FR 72158, 72230 (November 12, 2020).
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The Departments welcome comment on all aspects of this proposal.
The Departments are also particularly interested in feedback on the
impact of the proposed amendment to the required reporting cadence
(proposed to be quarterly as discussed in section III.C.10. of this
preamble) on the proposed changes to the lookback period. For example,
since the proposed quarterly reporting period would require reporting 6
months' worth of data every 3 months, the Departments seek comment on
whether a potential duplication of out-of-network allowed amounts
across multiple files would present any difficulties for the analysis
of the data, such as calculating averages or annual amounts.
c. Aggregating Data by Requiring Reporting by Market Type
Lastly, the Departments propose to amend the introductory language
in paragraph (b)(1)(ii) to require plans and issuers to aggregate their
allowed amount reporting at the health insurance market level (as
defined in proposed new 26 CFR 54.9815-2715A1(a)(2)(xi), 29 CFR
2590.715-2715A1(a)(2)(x), and 45 CFR 147.210(a)(2)(xi) and discussed in
section III.A. of this preamble). Specifically, under paragraph
(b)(1)(ii), plans and issuers would be required to make available an
Allowed Amount File for each health insurance market in which a plan or
coverage is offered. The Departments also propose to make conforming
amendments in paragraphs (b)(1)(ii)(A) through (C) to indicate that
each Allowed Amount File for a given health insurance market must
include information aggregated across the coverage options offered by
the plan or issuer in that market, rather than all coverage options
offered by the plan or issuer.
The Departments have received feedback from interested parties
indicating that aggregating health insurance out-of-network claims by
health insurance market type--specifically (1) individual market, (2)
large group market, (3) small group market, and (4) self-insured group
health plans maintained by the same plan sponsor--provides a structured
approach to organizing and analyzing claims data. Interested parties
suggested that this categorization would be useful because pricing
dynamics and reimbursement rates tend to vary by
[[Page 60456]]
market segments.\112\ Therefore, the Departments expect that organizing
out-of-network allowed amounts in this way would facilitate a more
comprehensive assessment of the volume and characteristics of out-of-
network claims and enhance the data's utility for users by aligning it
with the distinct pricing structures and regulatory environments of
each market type. It would also make comparing allowed amounts for
plans and policies within the same market easier for file users.
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\112\ There is evidence of consistent alignment within market
types and significant divergence between market types when comparing
allowed amounts relative to a common benchmark (Medicare). This
pattern holds even for in-network prices. Out-of-network allowed
amounts often derive from similar underlying cost structures.
Caroline Hanson, Ian McCarthy, Eamon Molloy & Karen Stockley,
Providers Paid Substantially Less by Marketplace Nongroup Insurers
Than by Employer Small-Group Plans, 2021, 43 Health Affairs 1672
(Dec. 20, 2024), https://www.healthaffairs.org/doi/10.1377/hlthaff.2024.00913.
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If this proposed amendment is finalized, the Departments also
anticipate a significant reduction in the overall number of Allowed
Amount Files (since these would be reported at the market level, rather
than at the plan level), even as those data files become more
populated. Additionally, this approach would further protect patient
privacy, as discussed earlier in this section of the preamble, because
data aggregated across two or more plans or policies would not be
directly associated with a single plan or policy.
On the other hand, the Departments acknowledge that requiring
market-level aggregation may limit or eliminate the ability of file
users to map specific allowed amounts and billed charges to an
individual plan or policy. However, plans and issuers would still be
required under paragraph (b)(1)(ii)(A) to disclose information about
the plans or policies whose allowed amounts are included in each file.
Therefore, file users would be able to determine which plans or
policies have allowed amounts included in the Allowed Amount File, even
if they would be unable to match a specific out-of-network allowed
amount to a particular plan or policy. The Departments have determined
that the advantages of having more populated Allowed Amount Files at
the market level would outweigh the drawbacks of missing plan-level
data. The Departments seek comment on what additional information might
be limited or lost by aggregating allowed amount and billed charges
data by health insurance market type, and the potential importance of
that information to price transparency. The Departments also invite
comments more broadly on the proposal to require reporting of out-of-
network allowed amount data by health insurance market type.
Lastly, the Departments are also proposing special aggregation
rules for self-insured group health plans, which are described in more
detail in section III.C.11. of this preamble. The Departments request
comment on all aspects of these proposals. For a discussion of the
Departments' proposal to amend paragraph (b)(1)(ii)(A) related to
disclosing HIOS IDs and product types in Allowed Amount Files, see
section III.C.2. of this preamble.
7. Contextual Files: Change-log, Utilization, Taxonomy, and Text
The Departments propose to require plans and issuers to publicly
disclose, through machine-readable files, additional contextual
information that would help file users better understand the public
disclosures required under paragraph (b)(1)(i). These files, which
include a Change-log File, Utilization File, and Taxonomy File would
contain information about the data within the In-network Rate and
Allowed Amount Files. The Departments also propose to require a
contextual machine-readable file to help users find the In-Network
Rate, Allowed Amount, and prescription drug machine-readable files
required under paragraph (b)(1) and new paragraph (b)(2) of this
section, which the Departments are proposing to identify as a Text
File.\113\ In particular, the Departments propose to amend 26 CFR
54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212 to
redesignate paragraphs (b)(2) through (4) as paragraphs (b)(3) through
(5), respectively, and to add new paragraph (b)(2) to require
contextual files. Specifically, the Departments propose to add new
paragraphs (b)(2)(i) through (iv) requiring: a Change-log File at
paragraph (b)(2)(i), a Utilization File at paragraph (b)(2)(ii), a
Taxonomy File at paragraph (b)(2)(iii), and a Text File at paragraph
(b)(2)(iv).
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\113\ As previously mentioned, several proposed amendments would
amend requirements related to the prescription drug machine-readable
files, specifically: the requirement that plans and issuers must
include a plain text file in a .txt format in the root folder of a
plan's or issuer's website as describe in proposed paragraphs
(b)(2)(iv) of 26 CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45
CFR 147.212 (section III.C.7.d of this preamble) and the
requirements related to the method and format for disclosing
information to the public as described in proposed paragraph (b)(3)
of 26 CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212
(section III.C.9 of this preamble).
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The 2020 final rules at 26 CFR 54.9815-2715A3(b), 29 CFR 2590.715-
2715A3(b), and 45 CFR 147.212(b) require plans and issuers to make
available on a public internet website the disclosure of health care
pricing information in machine-readable files, in accordance with
specific manner and format requirements. In particular, the Departments
require plans and issuers to disclose in-network provider rates, out-
of-network allowed amounts and the associated billed charges and
negotiated rates and historic net prices for prescription drugs. In the
2020 final rules, the Departments recognized the necessity of public
disclosure of health care pricing information due to the variation in
health care prices across the health care industry and the complexity
of health insurance and health plan coverage.\114\
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\114\ The 2020 final rules stated that ``many consumers do not
fully comprehend the basics of health coverage, much less the more
complex facets of the health care system that can affect an
individual's out-of-pocket cost for items and services, including:
Its specialized billing codes and payment processes; the various
specialized terms used in plan and coverage contracts and related
documents (such as copayment and coinsurance); and the various
billing and payment structures plans and issuers use to compensate
providers and assign cost-sharing liability to individuals (for
example, bundled payment arrangements).'' 85 FR 72158, 72210
(November 12, 2020).
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While price disclosures required in the 2020 final rules
contributed to a broader understanding of the data that drives plan and
issuer payments for health care items and services, the intervening
years demonstrated that additional context is necessary to promote a
fuller understanding of health care industry pricing dynamics. These
proposed additional files would help make the data disclosures of the
machine-readable files required under paragraph (b)(1) more meaningful
and accessible, which would promote greater transparency in health care
pricing information. Under this proposal, plans and issuers would be
required to prepare a Change-log File, a Utilization File, and a
Taxonomy File for each In-network Rate File prepared pursuant to these
proposed rules, and a single Text File to facilitate locating the other
machine-readable files required under these proposed rules. Each
Change-log File would reflect changes in data from one In-network Rate
File (under these proposed rules, prepared for a specific provider
network) to the publishing of the next In-network Rate File; each
Utilization File would reflect utilized covered items and services
under the plans and policies represented in one In-network Rate File;
and each Taxonomy File would represent the mapping of billing codes to
internal provider taxonomy codes used as part of the claims
adjudication
[[Page 60457]]
process for the plans and policies represented in the In-network Rate
File. Each Text File would direct users to the location of the machine-
readable files required under paragraphs (b)(1) and (2) and provide
contact information for an individual who can address inquiries and
issues related to the required machine-readable files. To ensure this
data can be imported and read by a computer system directly, without
reliance on proprietary software, and to promote standardization, these
contextual files would also need to be machine-readable, in the form
and manner as specified in guidance pursuant to proposed re-designated
paragraph (b)(3)(i).
a. Change-log File
The Departments propose to require, in new 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 plans and issuers must make available, in a
machine-readable format, a Change-log File for each In-network Rate
File, that identifies any changes made to the required information in
the In-network Rate File since the immediately preceding published In-
network Rate File. The proposed Change-log File would be required to be
publicly posted in the form as specified in guidance issued by the
Departments, consistent with redesignated and amended paragraph (b)(3)
and discussed in section III.C.9. of this preamble. It would be
required to be posted in accordance with the timing requirements
proposed at redesignated paragraph (b)(4)(iii) and discussed in section
III.C.10. of this preamble. Specifically, it would be required to be
posted on the first day of the calendar-year quarter following the date
on which the first In-network Rate File would be required to be posted
under proposed paragraph (b)(4)(i).\115\ The purpose of the proposed
Change-log File would be to assist all file users in identifying
changes to the required information in the In-network Rate File from
one reporting period to the next. Pursuant to the proposed requirement
to publish the In-network Rate File described at (b)(1)(i) quarterly,
the updated Change-log File would also be required to be published
quarterly, indicating whether or not there were changes.
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\115\ See Table 2 for an example.
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The total amount of information contained in every plan's and
issuer's set of machine-readable files is extremely large,\116\
creating challenges for file users of all backgrounds in ingesting and
analyzing the information. Therefore, rather than downloading and
analyzing each set of newly posted files to determine if there have
been any changes to the required information in a plan's or issuer's
In-network Rate File, file users would only need to look at the Change-
log File to determine which new files they need to examine. These
proposed rules would create efficiencies for file users by reducing the
amount of required data storage for file users and save time by
eliminating the need to review data that has not changed. This would
also allow researchers and other interested parties to more easily
track changes over time.
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\116\ Gary Claxton, Lynne Cotter, & Shameek Rakshit, Challenges
with Effective Price Transparency Analyses, Peterson-KFF Health
System Tracker (Feb. 25, 2025), https://www.healthsystemtracker.org/brief/challenges-with-effective-price-transparency-analyses/.
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The Departments seek comment on how the Change-log File can be most
effective, including what machine-readable file format it should be
required to be published. The Departments also seek comment on if any
specific information should be required to be included, and if so, what
information should be required to be included in the Change-log File.
For example, the Departments are interested in feedback from interested
parties on whether the Change-log File should only identify the
information in the file that has changed between one reporting to the
next or if it should also identify how the specific information has
changed since the last reporting. The Departments also seek comment on
whether there are particular data elements that, when changed, should
not be captured in the Change-log File so as to maximize the usefulness
of the reporting. The Departments expect that plans and issuers would
likely incur a burden from having to create this new file and develop a
system for identifying changes, therefore the Departments are
interested in the minimal level of change information necessary to
create the desired efficiencies. For instance, the Departments assume
that identifying changes to rate information from one In-network Rate
File to the next is critical to the usefulness of the Change-log File
but are less certain of the relative benefits and drawbacks of
requiring plans and issuers to identify less material changes, such as
minor changes to the plain language description for each billing code.
The Departments also seek comment on the specific burdens to plans and
issuers for the different possibilities for a Change-log File.
b. Utilization File
The Departments propose to require at new paragraphs 26 CFR
54.9815-2715A3(b)(2)(ii), 29 CFR 2590.715-2715A3(b)(2)(ii), and 45 CFR
147.212(b)(2)(ii), that plans and issuers must make available in a
machine-readable format an annual Utilization File for each In-network
Rate File specified under paragraph (b)(1)(i), that includes, for the
12-month period that ends 6 months prior to the publication of each
Utilization File: items and services covered under the plans or
policies included in the files prepared as specified in proposed
amended paragraph (b)(1)(i) for which a claim has been submitted and
reimbursed, in whole or in part, and each in-network provider
identified by the National Provider Identifier (NPI), Tax
Identification Number (TIN), and Place of Service Code who was
reimbursed, in whole or in part, for a claim for each covered item or
service included as specified in paragraph (b)(2)(ii)(A) of this
section. The Utilization File would be required to be published in the
form and manner specified in proposed redesignated paragraph (b)(3) and
discussed in section III.C.9. of this preamble and in accordance with
the timing requirements proposed at redesignated paragraph (b)(4)(iv)
and discussed in section III.C.10. of this preamble. Specifically, it
would be required to be updated and posted annually beginning on the
first day of the calendar-year quarter following the applicability date
under paragraph (c)(1). Plans and issuers would be required to update
and post the Utilization File in accordance with the timing
requirements proposed at redesignated paragraph (b)(4)(iv) and
discussed in section III.C.10. of this preamble.
The Departments have determined that the Utilization File would
provide important insights, both as a stand-alone dataset, as well as
in combination with the In-network Rate File. On its own, the
Utilization File would reveal which providers are actively serving
enrollees and delivering covered items and services within a plan's or
issuer's network. If a provider appears in a plan's or issuer's In-
network Rate File but does not appear in the plan's or issuer's
Utilization File, then users may reasonably conclude that that
provider, despite having a negotiated rate, has had no recent
interactions with that plan's or issuer's participants, beneficiaries,
or enrollees. This type of analytical approach to the Utilization File
would provide empirical evidence regarding which providers are actively
providing
[[Page 60458]]
covered items and services to participants, beneficiaries, or enrollees
and billing for items or services within a plan's network, as opposed
to relying on static provider directories, which can be over-inclusive
when describing providers' availability. In turn, the Utilization File
could aid consumers in understanding whether certain providers are
actually available (whether they are actively seeking new patients or
have the capacity to accept new patients) to provide covered items and
services to participants, beneficiaries, and enrollees under certain
plans.
Extending this type of analysis to all providers for a plan or
issuer's network could provide important insights into network
adequacy. For example, a plan's In-network Rate File might include many
providers who, in theory, deliver a wide range of services in a
particular geographic area. However, if the Utilization File reveals
that those providers are not actually delivering those services, then
this could indicate whether health plans are offering a sufficient and
accessible network of providers for the services their members use.
The Utilization File could also provide insights into the types of
services performed by specific providers, by indicating whether those
providers perform more routine procedures within their field of
expertise or instead concentrate on rarer or more complex procedures.
This type of analysis performed with the Utilization File could reveal
whether networks in specific geographic areas have larger pools of
providers performing certain procedures, thereby offering valuable
insights into regional provider availability and specialization. Such
insights into provider specialization would not be evident from the In-
network Rate File alone, since that file lists negotiated rates for all
services, regardless of whether a specific provider actually performs
them.
The Departments have determined that taken together, these examples
of analyses that could be performed with the Utilization File suggest
that this file would become a valuable transparency resource for
researchers, regulators, consumer-facing decision-tool makers, and
other interested parties, who could help consumers benefit from a more
accurate picture of provider service patterns, along with the
information published in the In-network Rate Files. Some organizations
that currently use the In-network Rate Files already combine the data
in those files with utilization data from other sources to conduct
these types of analyses.\117\ But by requiring plans and issuers to
generate and publish Utilization Files, this pairing of in-network
rates to actual utilization would become more widely and consistently
available to users of the Transparency in Coverage pricing data.
Finally, the Utilization Files would act as an important qualifier to
the data disclosed in the In-network Rate Files, by providing a strong
indication of the degree to which negotiated rates are used by
providers to deliver actual services to health plan enrollees.
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\117\ Sameer Mukhi, Zombie Hunting: Filtering Approaches for
Price Transparency Data, Serf Health Blog (Sept. 20, 2024), https://www.serifhealth.com/blog/zombie-hunting-filtering-approaches-for-price-transparency-data/.
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Under this proposed requirement, plans and issuers would not be
required to disclose the number of times that any given provider
submitted a claim for any particular item or service, but rather only
that a given provider submitted and was reimbursed, partially or in
whole, for at least one claim for a covered item or service during the
reporting period. The Departments have determined this appropriately
balances the need for additional transparency around which in-network
providers are actively providing a covered item or service with the
burden on plans and issuers associated with extracting data from a
claims data repository. The Departments recognize that because plans
and issuers would not be required to disclose the number of items and
services performed by specific providers, the Utilization File would be
limited in its ability to address some research questions that might be
of interest to some interested parties. As such, the Departments
request comment on whether the inclusion of the volume of items and
services performed by an in-network provider would be a valuable
addition to the Utilization File. The Departments also request comment
on whether additional data elements, such as metrics analyzing a plan
or overall percentage of providers with zero utilization for the
lookback period should be included in order to make it easier for file
users to examine provider network adequacy. The Departments also
request comment on the burden to plans and issuers to produce a
Utilization File with claims volume and any additional metrics included
in the files, as well as comments on how to mitigate these concerns.
The Departments are also proposing 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), to require the Utilization File to include data for
the 12-month period that ends 6 months prior to the publication date of
each Utilization File, to allow for enough time for plans and issuers
to complete the claims processing lifecycle including pre-claim
submission, pre-claim payment, and payment determination and
collection.\118\ This figure is obtained from research suggesting that
claims that take the longest to resolve can take up to 75 days to reach
payment determination.\119\ While 75 days is considerably shorter than
6 months, due to the lack of available metrics on the time it takes
payers to complete payment to providers, the Departments propose a
longer lookback period to ensure the Utilization File captures all
applicable payments.
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\118\ FinThrive, Understanding the Claims Lifecycle: A Step-by-
Step Guide (Nov. 26, 2024), https://finthrive.com/blog/understanding-the-claims-lifecycle-a-step-by-step-guide.
\119\ Rajiv Chandawarkar, Prakash Nadkarni, Elizabeth Barmash,
Stephany Thomas, et al., Revenue Cycle Management: The Art and the
Science, 12 Plastic and Reconstructive Surgery Global Open 7 (July
2, 2024).
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The Departments request comment on this lookback period.
c. Taxonomy File
The Departments propose at 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), to
require plans and issuers to make available, in a machine-readable
format, 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 as
established by the NUCC) 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. Under these proposed rules and as
discussed in section III.C.5. of this preamble, plans and issuers would
be required to use their internal provider taxonomy to determine
whether to exclude certain provider-rate combinations from the In-
Network Rate file because they are unlikely to result in reimbursement,
and therefore do not provide useful information to users of the In-
network Rate File. The Taxonomy File would be required to include the
plan or issuer's internal provider taxonomy mappings and would be
required to be published in the form and manner specified in proposed
redesignated paragraph (b)(3) and discussed in section III.C.9. of this
preamble. Additionally, and as discussed in section III.C.10. of this
preamble, the Departments propose to
[[Page 60459]]
add paragraph (b)(4)(v) to require plans and issuers to post an updated
Taxonomy File quarterly beginning on the first day of the calendar-year
quarter following the applicability date under paragraph (c)(1). If
there are no changes to the taxonomy that affect the information
required in the machine-readable file required under (b)(1)(i) in a
subsequent quarter, the posted Taxonomy File would not be required to
be updated for that quarter.
The Taxonomy File would provide transparency into how plans and
issuers determine whether to exclude certain provider-rate combinations
from an In-network Rate File. As explained in section III.C.5. of this
preamble, the Departments are proposing to require plans and issuers to
exclude from each In-network Rate File a provider-rate combination for
an item or service, if the provider would be unlikely to be reimbursed
for the item or service given that provider's area of specialty,
according to the plan's or issuer's internal provider taxonomy. This is
because rates for such items and services generally do not provide
useful information to users of the In-network Rate File, and excluding
them would improve the reliability of the data reported and
significantly reduce the file size.
The Departments have determined that it is necessary to give plans
and issuers specific guidance for how to exclude provider-rate
combinations for items and services for which the provider would not
likely be reimbursed given their practice area of specialty, rather
than leaving it to each plan and issuer to determine how to exclude
such information. Accordingly, the Departments have determined that
plans and issuers should be required to post their internal provider
taxonomy mappings in the Taxonomy File.
Requiring plans and issuers to create a separate provider Taxonomy
File that discloses their internal provider taxonomy would provide
valuable data for file users about the data included in the In-network
Rate File. The Taxonomy File would disclose the mapping rules already
used by plans and issuers for their claims adjudication process,
ensuring that the mapping rules could be available to file users to
understand how plans and issuers determined which provider-rate
combinations to include in the In-network Rate Files and which to
exclude.
In addition to providing critical contextual information to
understand the data in the In-network Rate File, the proposed
requirement for plans and issuers to provide a Taxonomy File would also
offer researchers and other file users potentially valuable insights
into the degree of standardization in mapping used by plans and
issuers, and how this varies across different market types.
Furthermore, the Taxonomy File would offer new information to
potentially guide future rate negotiations between plans and issuers
and providers, particularly concerning the scope of reimbursable
services by provider type to include in contract discussions.
The Departments solicit comment on the Taxonomy File proposal,
including whether there are other provider taxonomy code sets commonly
used by plans and issuers other than the ones established by the NUCC
or if there are other commonly used processes for plans and issuers to
determine which providers should be reimbursed for which types of items
and services, based on specialty, and which providers should not. The
Departments also seek comment on how frequently plans and issuers
update their internal taxonomy used during the claims adjudication
process.
d. Text File
The Departments also propose to add paragraphs 26 CFR 54.9815-
2715A3(b)(2)(iv), 29 CFR 2590.715-2715A3(b)(2)(iv), and 45 CFR
147.212(b)(2)(iv), requiring plans and issuers to post a plain text
file in .txt format (Text File) in the root folder (the top-level
directory on an electronic file system) of a plan's or issuer's website
that includes: (1) the source page URL for the internet website that
hosts machine-readable files required under paragraphs (b)(1) and (2);
(2) a direct link to the URL for the machine-readable files required
under paragraphs (b)(1) and (2); and (3) point-of-contact information
including an up-to-date name, title, and email address for an
individual who can address inquiries and issues related to the machine-
readable files required under paragraphs (b)(1) and (2).\120\ This
contact information must be prominently displayed on the same website
where the machine-readable files are made available and be kept updated
per the requirements in paragraph (b)(4)(vi) of this section. This
information would allow users to more easily locate the plan's or
issuer's machine-readable files, increasing both automated and non-
automated access to the machine-readable files. Additionally, and as
discussed in section III.C.10. of this preamble, the Departments
propose to add paragraph (b)(4)(vi) to require plans and issuers to
post a Text File beginning on the first day of the calendar-year
quarter following the applicability date under paragraph (c)(1) and
subsequently update the Text File as soon as practicable but not later
than 7 calendar days following a change in any of the information
required under paragraph (b)(2)(iv) of this section.
---------------------------------------------------------------------------
\120\ As previously mentioned, proposed paragraph (b)(2)(iv)
(relating to the proposed requirement to include a plain text file
in a .txt format in the root folder of a plan's or issuer's website)
and (b)(3) (relating to the method and format for disclosing
information to the public) of 26 CFR 54.9815-2715A3, 29 CFR
2590.715-2715A3, and 45 CFR 147.212 applies to the prescription drug
machine-readable files.
---------------------------------------------------------------------------
The Departments have observed and received feedback from interested
parties that locating the files on a plan's or issuer's website can be
difficult. To assist the public, CMS provided guidance on how to locate
machine-readable files on the Transparency in Coverage website.\121\
However, in considering how to improve both automated and non-automated
access to the machine-readable files, the Departments have determined
it is appropriate to require a standardized Text File at a consistent
location (specifically, the root folder of the plan's or issuer's
website), which would provide a direct link to the machine-readable
files as opposed to the current approach of having to locate the
correct web page within the website. If a plan or issuer does not have
a website, they can satisfy this requirement by entering into a written
agreement under which another party (such as a TPA) posts the Text File
in the root folder on its public website on behalf of the plan or
issuer pursuant to proposed paragraph (b)(3)(iv).
---------------------------------------------------------------------------
\121\ Centers for Medicare & Medicaid Services, Use of Pricing
Information Published Under the Transparency in Coverage Final Rule,
https://www.cms.gov/priorities/healthplan-price-transparency/overview/use-pricing-information-published-under-transparency-coverage-final-rule (last modified Aug. 14, 2025).
---------------------------------------------------------------------------
Further, the Departments also received feedback regarding the
difficulty of contacting plans and issuers to alert them to problems
with their machine-readable files or to ask for additional information
or clarifying context. Contact information for someone at the plan or
issuer who is familiar with the details of the machine-readable files
would allow the public to reach out for assistance with accessing or
utilizing the machine-readable files.
Therefore, the Departments propose to require the Text File to
include plan or issuer point-of-contact information, who could help in
verifying the contents of the machine-readable files and respond to
requests for assistance related to accessing and utilizing the machine-
[[Page 60460]]
readable files. The Departments also propose to require that the point-
of-contact information be posted prominently on the same web page where
the machine-readable files are located to further reduce the difficulty
file users have faced in reaching out to plans and issuers for
assistance. Under this proposal, and consistent with the flexibility
described in redesignated 26 CFR 54.9815-2715A3(b)(3)(iv), 29 CFR
2590.715-2715A3(b)(3)(iv), and 45 CFR 147.212(b)(3)(iv), nothing would
prevent a group health plan or health insurance issuer who contracts
with a service provider to provide the machine-readable files on their
behalf from listing the service provider as a point-of-contact.
The Departments considered whether frequent changes to the host
website could negate the benefit to automated access as well as impose
burden in creating and maintaining this Text File. The Departments have
determined that the benefits outweigh the drawbacks for having a plan
or issuer ensure that the public website on which it chooses to host
the machine-readable file includes a Text File in the root folder that
includes a direct link to the machine-readable files to establish and
maintain automated access.
The Departments also propose these new requirements in accordance
with Executive Order 14221 Section 3(b), which directs the Departments
to ``issue updated guidance or proposed regulatory action ensuring
pricing information is standardized and easily comparable across
hospitals and health plans.'' \122\ CMS added new requirements to the
2019 Hospital Price Transparency rule \123\ in the 2023 Hospital Price
Transparency rule.\124\ The 2023 Hospital Price Transparency rule,\125\
which went into effect on January 1, 2024, requires certain hospitals
to include a Text File in the root folder of the hospital's public
website that includes a direct link to the hospital's machine-readable
file containing standard charge information and a link in the footer on
its website that links directly to the publicly available web page that
hosts the link to the machine-readable file. In proposing to adopt a
similar requirement, the Departments would align this requirement with
the 2023 Hospital Price Transparency rule \126\ requirement to improve
machine-readable file accessibility for the public. Based on feedback
on this similar provision for the 2023 Hospital Price Transparency
rule,\127\ the Departments have determined this would be a relatively
simple, low burden change, and that the increased benefits to the
public outweigh the costs.
---------------------------------------------------------------------------
\122\ Centers for Medicare & Medicaid Services, Use of Pricing
Information Published Under the Transparency in Coverage Final Rule,
https://www.cms.gov/priorities/healthplan-price-transparency/overview/use-pricing-information-published-under-transparency-coverage-final-rule (last modified Aug. 14, 2025).
\123\ 84 FR 65524 (November 17, 2019).
\124\ 88 FR 81540 (November 22, 2023).
\125\ Id.
\126\ 88 FR 81540, 82112 (November 22, 2023).
\127\ 88 FR 81540 (November 22, 2023).
---------------------------------------------------------------------------
The Departments request comment on all aspects of this proposal,
and in particular on whether the Departments should issue guidance
regarding whether any standards are required to ensure that the
identified point-of-contact for plans and issuers is responsive to
inquiries submitted by file users (such as a timeline to respond to
inquiries or designated hours of availability for phone contact, and,
if so, the recommended timeline and designated hours) or whether
additional forms of contact (such as a physical address) are necessary.
8. File Format
The 2020 final rules at 26 CFR 54.9815-2715A3(b)(2), 29 CFR
2590.715-2715A3(b)(2), and 45 CFR 147.212(b)(2) (which the Departments
are proposing to redesignate as paragraph (b)(3) per section III.C.9.
of this preamble) state that the machine-readable files described in
paragraph (b) must be available in the form and manner as specified in
guidance issued by the Departments and must be publicly available and
accessible free of charge and without conditions.
In the 2020 final rules, the Departments clarified that this meant
all machine-readable files must conform to a non-proprietary, open-
standards format that is platform-independent and made available to the
public without restrictions that would impede the re-use of the
information.\128\
---------------------------------------------------------------------------
\128\ 85 FR 72158, 72242 (November 12, 2020).
---------------------------------------------------------------------------
The Departments are not including in these proposed rules any
changes to the required format for disclosing information under
paragraph (b). The Departments are, however, considering whether to
indicate in either rulemaking or technical implementation guidance that
the machine-readable files required under paragraph (b) must be
published in a single, non-proprietary, open-standards format, and, if
so, naming either JavaScript Object Notation (JSON) or Comma Separate
Value(s) (CSV) as that single format in technical implementation
guidance. As such, the Departments seek input from interested parties
on such potential future rulemaking or technical implementation
guidance.
In the 2019 proposed rules, the Departments requested comment on
whether the final rules should require a single, specific non-
proprietary format for the machine-readable files, specifically JSON
files.\129\ The Departments noted that this format generally is easily
downloadable, and it could simplify the ability of file users to access
the data. The Departments received a comment in support of requiring
JSON as the standardized file format for the required machine-readable
files. However, in the 2020 final rules, the Departments acknowledged
that their internal technical experts agreed that the speed of
technology developments weighs heavily in favor of maintaining
flexibility to adopt a suitable file format as a non-substantive,
operational requirement that will be identified in the relevant
implementation guidance for the required machine-readable files.\130\
In addition to maintaining the Departments' flexibility, the
Departments indicated in the 2020 final rules that being overly
prescriptive regarding the file type would impose an unnecessary cost
on issuers and service providers despite the advantages of JSON.\131\
Therefore, the Departments did not require in the 2020 final rules one,
specific non-proprietary open format. The Departments did, however,
indicate that they would provide additional guidance regarding the file
format in future technical implementation guidance.\132\
---------------------------------------------------------------------------
\129\ 84 FR 65464, 65481 (November 27, 2019).
\130\ 85 FR 72158, 72242 (November 12, 2020).
\131\ 85 FR 72158, 72272 (November 12, 2020).
\132\ Id.
---------------------------------------------------------------------------
When first developing machine-readable file guidance, the
Departments considered various file formats that could satisfy the
goals of the final rules, including hierarchical, tabular, and columnar
formats. The technical implementation guidance hosted on GitHub
includes a repository set of schemas describing the data formats
(encoded as JSON, Extensible Markup Language (XML), and CSV). The
technical implementation guidance was also published as part of the
Paperwork Reduction Act (PRA) package developed for the Information
Collection Requests (ICRs) included in the 2020 final rules.\133\ To
help plans and issuers understand the machine-readable file
requirements, the Departments built a
[[Page 60461]]
JSON schema on the Transparency in Coverage GitHub site and provided
samples in JSON and XML formats.
---------------------------------------------------------------------------
\133\ Transparency in Pricing Information (CMS-10715), OMB
control number 0938-1429 (October 14, 2021), https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202410-0938-006.
---------------------------------------------------------------------------
After more than 3 years since the publication of the 2020 final
rules' machine-readable file requirements, the Departments have had
time to analyze the landscape of plan and issuer file format use in
published machine-readable files and have considered feedback from
interested parties on the viability, benefits, and drawbacks of various
file formats. Given that, based on internal analysis, over 90 percent
of plans and issuers have chosen one format (that is, JSON), that
initial flexibility regarding file type may no longer be needed, and to
advance the goals in section 3(b) of Executive Order 13877 \134\ to
ensure pricing information is standardized and easily comparable across
health plans, the Departments are now considering indicating in either
rulemaking or technical implementation guidance that the machine-
readable files required under paragraph (b)(1) must be published in a
standard non-proprietary open format, as well as specifying the
particular file format through technical implementation guidance.
---------------------------------------------------------------------------
\134\ See Exec. Order No. 13877, 84 FR 30849 (June 27, 2019).
---------------------------------------------------------------------------
The Departments have received feedback in support of specifying
either JSON or CSV formats. Both JSON and CSV formats have benefits and
drawbacks, and each serves different audiences. JSON is a widely
adopted industry standard that allows the machine-readable file data to
be accessible to various users and adaptable to various use-cases. In
the 2020 final rules, the Departments noted that the machine-readable
files' primary benefit to health care consumers will be the
availability of web-based tools and mobile applications developed for
consumer use by third-party developers, aggregation, and analysis
conducted by researchers, and oversight efforts by regulators. The
required machine-readable files will be optimal for ingestion, data
aggregation, and data analysis, all of which are functions performed by
third-party internet-based developers, researchers, and regulators who
use large data sets in a manner that will lead to benefits for
consumers.'' \135\ In the 3 years since the publication of the machine-
readable file requirements, the Departments have observed the creation
of a number of web-based tools developed for consumer use by third-
party developers. These developers provided feedback on the benefits
and drawbacks of various file formats but largely indicated a
preference for using JSON due to its flexibility and adaptability.
---------------------------------------------------------------------------
\135\ 85 FR 72158, 72240 (November 12, 2020).
---------------------------------------------------------------------------
It is the Departments' understanding that JSON's suitability for
the broad, high-volume disclosures required pursuant to the
Transparency in Coverage rules stems in part from its ability to
effectively handle different stages of the process by which raw data is
transformed into more user-friendly outputs. This data process, known
as Extract, Transform, and Load (ETL), begins with raw data gathered
(``extracted'') from a range of sources; then cleaned and standardized
(``transformed'') into a selected format; and then loaded into a
repository or database for subsequent uses (and ultimately, for
downstream analysis). Different file formats are best suited for
different stages of the ETL process. An optimal file format for the
machine-readable files would accurately represent the data's underlying
relationships through the file format's organizational structure,
ensure efficient storage and processing of the data, and make the data
accessible to a variety of users with diverse use cases. As applied to
the machine-readable files, JSON's strength is its capacity to handle
all stages of the ETL process. It is also lightweight and effective for
the extraction step from raw data, and it is highly flexible for both
the initial transformation step and subsequent transformation of
machine-readable file data by downstream users. The widespread use of
JSON for the machine-readable files is expected given the advantages of
JSON in the data extraction stage, and in efficiently representing the
underlying complex relationships in machine-readable file data.
Additionally, JSON is widely adopted by industry and government as a
common means of data exchanges, and enjoys native support for most
programming languages, meaning that these languages and tools already
``speak'' JSON, limiting the time and effort required to work with
JSON-formatted files.
The Departments have also received feedback that many file users,
especially researchers, prefer to work with the machine-readable file
data in CSV format due to its relative simplicity and accessibility,
and that they migrate the data from JSON to CSV in order to conduct
analyses. For example, CSV files can include a header row specifying
the titles of each subsequent column in the file for visual simplicity.
CSV files are highly portable and can be loaded into commonly used
tools that do not require engineering capability such as Microsoft
Excel and may be a more familiar format to a wider audience than JSON.
The Departments recognize that both of these file formats have
limitations. A JSON format requires users to have some data engineering
sophistication to interact with the machine-readable files directly--
capabilities and resources that many individuals and organizations may
not have. Additionally, working with JSON may require more computing
resources than some other formats to process. Other file formats may
have attributes that suit the needs of certain users of the machine-
readable files better than JSON does. However, the drawback with using
CSV or any row-based tabular flat file structure for machine-readable
file publishing and consumption of the amount of data that is being
generated pursuant to the Transparency in Coverage requirements is that
it makes it challenging for a file user with a standard personal
computer to load and work with it effectively. For example, those
opening large CSV machine-readable files in Microsoft Excel will
encounter the software's limitations in how many rows of data can be
opened and will often crash the program.\136\ Most significantly, the
flat structure of CSV files would force publishers to create numerous
columns where the same data values would be repeated up to millions of
times per file, which is both inefficient and impractical given current
file size concerns by interested parties.
---------------------------------------------------------------------------
\136\ The average file size from the files sampled during the
Departments' two environmental scans was 5 GB. Excel's limit is
1,048,576 rows by 16,384 columns. See https://support.microsoft.com/en-us/office/excel-specifications-and-limits-1672b34d-7043-467e-8e27-269d656771c3.
---------------------------------------------------------------------------
As explained, the Departments are now strongly considering
specifying a single, non-proprietary open format in technical
implementation guidance. Specifying the file format in technical
implementation guidance would reduce flexibility for plans and issuers
in selecting alternate file formats but would further standardize
reporting of critical health care pricing information. The Departments
are of the view that specifying a single format presents an important
part of fully realizing the goals of price transparency and Executive
Orders 13877 and 14221.\137\ The Departments seek comment on specifying
a single, non-proprietary open-source format for the machine-readable
files and on the relevant benefits and burdens associated with the CSV
and JSON formats. The Departments also seek comment on the
[[Page 60462]]
Departments' position that specifying a single format in technical
implementation guidance, as opposed to regulation, is advisable to
maintain maximum flexibility to change formats more quickly to keep
pace with technological changes.
---------------------------------------------------------------------------
\137\ See Exec. Order No. 13877, 84 FR 30849 (June 27, 2019);
See also Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
---------------------------------------------------------------------------
Additionally, in recognition of the developments of electronic data
transfer systems since the publication of the 2020 final rules and in
anticipation of future developments of new technologies, the
Departments are revisiting the request for comment made in the 2019
proposed rules regarding a requirement that plans and issuers provide
rate information through a publicly accessible API that would comply
with standards defined by the Departments.\138\ In light of the
publication of the CMS Interoperability and Prior Authorization Final
Rule,\139\ the Departments seek comment on whether the required
information in paragraphs (b)(1) and (2) should be required to be
disclosed through an electronic data transfer technology, such as a
publicly accessible API, as well as what standards should apply. The
Departments also seek comment on whether the use of a standards-based
API would benefit consumers, developers of consumer-facing
applications, and other entities seeking to access this data.
---------------------------------------------------------------------------
\138\ See 84 FR 65464, 65483 (November 27, 2019).
\139\ See 89 FR 8758 (February 24, 2024).
---------------------------------------------------------------------------
9. Required Method and Format for Disclosing Information to the Public
As discussed in section III.C.7. of this preamble, the Departments
propose to redesignate paragraphs (b)(2) through (3) of 26 CFR 54.9815-
2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212 as paragraphs (b)(3)
and (4), respectively. The Departments propose to add paragraph (iii)
to redesignated paragraph (b)(3) to require that the source page URL
for the internet website that hosts the machine-readable files required
by paragraph (b)(1) and new paragraph (b)(2) must be included as a link
in the footer on the home page of the group health plan's or health
insurance issuer's website, as well as any page of the website that
features a footer, that is labeled ``Price Transparency'' or
``Transparency in Coverage'' and links directly to the publicly
available web page that hosts the link to the machine-readable
files.\140\ Additionally, in redesignating paragraph (b)(2) as
paragraph (b)(3), the Departments propose to make three changes: first,
the Departments propose to divide the existing language in paragraph
(b)(2) into two paragraphs at redesignated paragraphs (b)(3)(i) and
(ii); second, the Departments propose to indicate that the machine-
readable files in paragraphs (b)(1) and (2) (instead of paragraph (b)
generally as currently written) must be available in a form and manner
as specified in guidance issued by the Departments; and third, the
Departments propose to amend redesignated paragraph (b)(3)(ii) to
ensure that the machine-readable files remain publicly accessible to
automated scripts and web crawlers as well as human users and that
blocking server configurations or firewalls cannot be used to impede
access. The Departments also propose to add paragraph (iv) at
redesignated 26 CFR 54.9815-2715A3(b)(3), 29 CFR 2590.715-2715A3(b)(3),
and 45 CFR 147.212(b)(3), allowing a group health plan or health
insurance issuer to satisfy the disclosure requirements of paragraph
(b)(3)(iii) by entering into a written agreement under which another
party posts the machine-readable files on its public website on behalf
of the plan or issuer. However, if the files are posted on a service
provider's website and the plan or issuer maintains a public website
but chooses not to host the files separately on its own public website,
it must provide a link on its own public website to the location where
the files are made publicly available. This requirement applies to a
public website maintained by the plan or issuer and does not apply to a
public website maintained by an employer or plan sponsor.
---------------------------------------------------------------------------
\140\ As previously mentioned, proposed paragraph (b)(3)
(relating to the method and format for disclosing information to the
public) of 26 CFR 54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR
147.212 applies to the prescription drug machine-readable files.
---------------------------------------------------------------------------
The 2020 final rules at 26 CFR 54.9815-2715A3(b)(2), 29 CFR
2590.715-2715A3(b)(2), and 45 CFR 147.212(b)(2) require plans and
issuers to make the machine-readable files described in paragraph (b)
of that section available and accessible to any person on a public
website in a form and manner as specified in guidance issued by the
Departments. In the 2020 final rules, the Departments finalized the
proposal to allow plans and issuers flexibility to publish the files in
the locations of their choosing based upon their knowledge of their
website traffic and the places on their website where the machine-
readable files would be readily accessible by the intended users.\141\
As discussed in section III.C.7. of this preamble, the Departments have
observed and received feedback from interested parties that locating
the files on a plan's or issuer's website can be difficult and that
there are occasional obstacles to automated and human access.
---------------------------------------------------------------------------
\141\ 85 FR 72158, 72242 (November 12, 2020).
---------------------------------------------------------------------------
Therefore, the Departments have determined that they should require
the addition of standardized hyperlinks in the footer of a plan's or
issuer's website home page, as well as any other page on their website
that features a footer, in order to aid file users in the automated and
non-automated retrieval of machine-readable files by creating a
predictable navigation path to internal web pages that host the
machine-readable files posted pursuant to the Transparency in Coverage
requirements. Additionally, the Departments propose to amend the
existing requirement that the machine-readable files described in
paragraphs (b)(1) and (2) must be publicly available and accessible to
any person free of charge and without conditions, to specify that they
must be publicly available and accessible to any person, automated
scripts, or web crawlers free of charge and without conditions such as
establishment of a user account, password, submission of personally
identifiable information or other credentials, or blocking server
configurations or firewalls to access the file. Requiring the machine-
readable files to be available to both human and automated users more
directly aligns with the purpose of the files being machine-readable.
Examples of conditions include a ``captcha,'' \142\ a 403 error,\143\
or limits on the number of downloads allowed by a user or at a time.
---------------------------------------------------------------------------
\142\ See IBM, What is a CAPTCHA?, https://www.ibm.com/think/topics/captcha (last visited Dec. 8, 2025). (``CAPTCHA stands for
`completely automated public Turing test to tell computers and
humans apart.' It refers to various authentication methods that
validate users as humans, not bots, by presenting a challenge that
is simple for humans but difficult for machines.'')
\143\ See Mozilla, 403 Error, https://developer.mozilla.org/en-US/docs/Web/HTTP/Reference/Status/403 (last updated July 4, 2025).
(``The HTTP 403 Forbidden client error response status code
indicates that the server understood the request but refused to
process it.'')
---------------------------------------------------------------------------
Once a human user or automated web crawler arrives at the website
of the plan or issuer, they would be able to identify the specific
location of the files. The Departments have determined that making this
information more easily accessible to automated searches and data
aggregation would help third parties to develop tools that further
assist the public in understanding this information and capturing it in
a meaningful way for making informed health care decisions. Moreover,
the Departments have determined that this requirement would be simple
for plans and issuers to implement, because plans
[[Page 60463]]
and issuers commonly link to other information in their website footer.
In addition, using a standardized label for the link in the footer
would make the location of the machine-readable files easier to
identify by individual consumers manually searching for such files.
Both this proposed requirement and the proposed contextual machine-
readable Text File as discussed in section III.C.7.d. of this preamble,
are intended to improve both automated and manual location of the
machine-readable files on a plan's or issuer's website. While the Text
File will enhance automated searching more so than manual searching,
the footer links would assist manual searching more so than automated
searching as individuals are likely to first examine a footer for web
page navigation. Thus, these proposed requirements would complement
each other and improve overall accessibility.
Additionally, for a plan or issuer that does not have a public
website, the Departments have determined that it would be overly
burdensome to require such plan or issuer to create and maintain a
website to satisfy this requirement. Therefore, the Departments also
propose to add paragraph (iv) at redesignated 26 CFR 54.9815-
2715A3(b)(3), 29 CFR 2590.715-2715A3(b)(3), and 45 CFR 147.212(b)(3),
in line with guidance issued on April 19, 2022 in FAQs Part 55,\144\
but extended to apply to issuers, such that any plan or issuer may
satisfy the disclosure requirements of paragraph (b)(3)(iii) by
entering into a written agreement under which another party posts the
machine-readable files on its public website on behalf of the plan or
issuer. Additionally, if the files are hosted on a service provider's
website, and the plan or issuer does maintain a public website and
chooses not to also post the files separately on its own public
website, it must provide a link on its own public website to the
location where the files are made publicly available. This requirement
applies to a public website maintained by the plan or issuer and does
not apply to a public website maintained by an employer or plan
sponsor. This proposed new paragraph also moves part of current 26 CFR
54.9815-2715A3(b)(4)(iii), 29 CFR 2590.715-2715A3(b)(4)(iii), and 45
CFR 147.212(b)(4)(iii) addressing plans or issuers who do not have a
website to new paragraph (b)(3)(iv) for clarity and alignment with
other proposed changes.
---------------------------------------------------------------------------
\144\ See U.S. Department of Labor, U.S. Department of Health &
Human Services & U.S. Department of the Treasury, FAQs about
Affordable Care Act and Consolidated Appropriations Act, 2021
Implementation Part 55 (Aug. 19, 2022), https://www.cms.gov/files/document/faqs-part-55.pdf and https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-55.
---------------------------------------------------------------------------
The Departments recognize that many employer-sponsored ERISA plans
do not currently maintain a separate dedicated internet page for their
group health plans or have an internet website at all. This proposed
new paragraph would codify FAQs Part 55 \145\ and extend it to apply to
issuers, and recognize the hardship for impacted group health plans,
especially for smaller employers. The Departments are proposing this
extension to issuers because they were not covered under the guidance
in FAQs Part 55 and this would make the requirements consistent across
all entities subject to the requirements of paragraph (b)(3)(iii).
---------------------------------------------------------------------------
\145\ U.S. Department of Labor, U.S. Department of Health &
Human Services & U.S. Department of the Treasury, FAQs about
Affordable Care Act and Consolidated Appropriations Act, 2021
Implementation Part 55 (Aug 19, 2022), https://www.cms.gov/files/document/faqs-part-55.pdf and https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-55.
---------------------------------------------------------------------------
The Departments also propose to amend paragraph (b)(3)(i) at
redesignated 26 CFR 54.9815-2715A3(b)(3), 29 CFR 2590.715-2715A3(b)(3),
and 45 CFR 147.212(b)(3) to require that the proposed method and format
requirements for disclosing information to the public would apply to
both the machine-readable files under paragraph (b)(1) and the
contextual machine-readable files under new paragraph (b)(2).
Finally, as with the public disclosure requirements in the 2020
final rules, the Departments intend to continue to issue form and
manner requirements for the machine-readable files specified in
technical guidance in the form of sample file schemas and data
attributes on GitHub.\146\ The technical guidance for the machine-
readable files, in the form of schemas,\147\ will be updated when
appropriate as the Departments receive feedback from the community and
interested parties. Additionally, guidance on applicability timelines
for new schema requirements and implementation of policy requirements
will continue to be posted in the form of Frequently Asked
Questions.\148\ Table 2 summarizes the technical guidance documents
that the Departments expect to publish pursuant to the finalization of
these proposed rules. The Departments encourage interested parties to
submit all questions and issues on GitHub, as it enables a centralized
response and helps to efficiently identify and address common concerns
across interested parties.
---------------------------------------------------------------------------
\146\ Centers for Medicare & Medicaid Services, Price
Transparency Guide, https://github.com/CMSgov/price-transparency-guide (last updated Oct. 1, 2025).
\147\ Centers for Medicare & Medicaid Services, Schema Examples,
https://github.com/CMSgov/price-transparency-guide/tree/master/examples (last updated Oct. 1, 2025).
\148\ Centers for Medicare & Medicaid Services, Affordable Care
Act Frequently Asked Questions, https://www.cms.gov/marketplace/resources/fact-sheets-faqs#Affordable_Care_Act (last updated July
30, 2025); U.S. Department of Labor, Affordable Care Act
Implementation Frequently Asked Questions, https://www.dol.gov/agencies/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/aca-implementation-faqs (last updated July
30, 2025).
[GRAPHIC] [TIFF OMITTED] TP23DE25.050
[[Page 60464]]
The Departments seek comment on these proposals.
10. Timing
Under 26 CFR 54.9815-2715A3(b)(4), 29 CFR 2590.715-2715A3(b)(4),
and 45 CFR 147.212(b)(4) (proposed to be redesignated from paragraph
(b)(3), as discussed in section III.C.7. of this preamble), the
Departments propose to add new paragraphs to specify timing
requirements for each machine-readable file that would be required
under these proposed rules. With respect to the In-network Rate Files
and Allowed Amount Files under paragraph (b)(1)(i) and (ii), the
Departments propose to amend the publication frequency under new
paragraph (b)(4)(i), from a requirement to post monthly to quarterly.
The Departments also propose to add disclosure timing requirements
for the new contextual machine-readable files that would be required
under proposed new paragraph (b)(2) at new paragraphs (b)(4)(iii)
through (vi) under redesignated paragraph (b)(4). The Departments note
that the first machine-readable files prepared based upon these
proposed rules would be required to be disclosed according to the
applicability date as proposed at paragraph (c)(1) and discussed in
section III.C.12. of this preamble, which is 12 months after the
publication of the final rules. These proposed rules also specify the
timing for each machine-readable file to be updated thereafter and
example dates are shown in Table 3.
In particular, the Departments propose to amend redesignated
paragraph (b)(4)(i) to require plans and issuers to update and post the
In-network Rate and Allowed Amount Files required under paragraphs
(b)(1)(i) and (ii), respectively, quarterly rather than monthly and
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1). The Departments have
received feedback from both producers and users of the machine-readable
files recommending reducing the reporting frequency to quarterly, to
help lower data storage and hosting costs, decrease bandwidth needs,
and reduce ongoing maintenance expenses. The Departments have received
feedback that a reduced reporting cadence may also provide more time to
analyze the data,\149\ as some file users have informed the Departments
that they have difficulty keeping up with the pace of downloading and
ingesting the file data monthly.
---------------------------------------------------------------------------
\149\ See Michael Chernew, Sabrina Corlette, Kevin Davenport,
Fran[ccedil]ois de Brantes, et al., Transparency in Coverage:
Recommendations for Improving Access to and Usability of Health Plan
Price Data (2022), Georgetown University, https://georgetown.app.box.com/s/1ezsggz1c7smsaexkr8rght15sokgusl.
---------------------------------------------------------------------------
With respect to In-network Rate File data, interested parties have
indicated that negotiated rates between issuers and health care
organizations (for example, hospital systems)--in contrast to
individual providers--tend to change slowly over time because contracts
generally last a year or more, with some multi-year contracts lasting 2
to 5 years. As such, the Departments have determined negotiated rates
between health care organizations and issuers should not significantly
change from month to month, so the proposed quarterly reporting cadence
would not meaningfully affect the accuracy of reported rates in the In-
network Rate File for these entities.
The Departments acknowledge that the accuracy of rates at the
individual provider level are more likely to be affected by the
proposed quarterly reporting cadence, though not significantly. The
Departments understand that individual providers can regularly move in
and out of relationships with the institutions that employ them (for
example, hospital systems, group medical practices); \150\ thus,
reported rates at the individual provider level may be less accurate
with a change from monthly to quarterly reporting. More specifically,
the turnover of individual providers within the roster of a large
provider organization (like specialist physicians associated with a
hospital system) means that the reporting of negotiated rates that
``flow down'' to the individual providers might become increasingly out
of date, given a longer cadence for the reporting requirement. One
recent study that quantified physician turnover rates due to
retirements and shifts in practice affiliations suggested an annual
turnover rate of 7.6 percent in 2018.\151\ Given that this relatively
low annual percentage would translate to an even smaller quarterly
turnover rate, the Departments have determined that under the proposed
change in reporting cadence, negotiated rates for individual providers
would likely become only somewhat less accurate because there would be
more providers who terminate employment with their parent organizations
during the extended reporting interval.
---------------------------------------------------------------------------
\150\ Cf. Code section 9820(a)(2), ERISA section 720(a)(2), and
PHS Act section 2799A-5(a)(2) (requiring plans and issuers to verify
and update their provider directory database not less frequently
than once every 90 days, and to remove providers and facilities
which have the plan or issuer has been unable to verify).
\151\ Amelia M. Bond, Lawrence P. Casalino, Ming Tai-Seale,
Matthew A. Unruh, et al., Physician Turnover in the United States,
175 Annals of Internal Medicine 896, 903 (2023).
---------------------------------------------------------------------------
Notwithstanding the potential for some of the data in the files to
be less accurate, particularly with respect to individual providers,
the Departments expect the benefits of quarterly reporting to outweigh
these potential limitations, given that for the majority of use cases
for the In-network Rate Files, the proposed change in reporting cadence
would have only minimal impact on the ability to use the data for
reasonable analytic purposes and would significantly reduce burdens
both on producers and file users. For example, for a file user that
analyzes aggregated rates between plans or issuers and health care
organizations and compares reimbursement for orthopedic services in the
same geographic market between two issuers, the impact of individual
providers (who all share the same rates) moving in and out of health
care systems would be immaterial.
The Departments request comment on the benefits, drawbacks, and
potential impact of the proposed change in reporting cadence for the
In-network Rate Files.
The Departments have also determined there would be no loss in data
value by changing the reporting cadence from monthly to quarterly for
the Allowed Amount File under paragraph (b)(1)(ii) since the data
represents a historical snapshot that would continue to be captured in
its entirety. The Departments seek comment on the potential impact of
the proposed change in reporting cadence for the Allowed Amount File.
The Departments are not proposing to change the monthly reporting
cadence for the prescription drug machine-readable file under paragraph
(b)(1)(iii) in proposed paragraph (b)(4)(ii).
With respect to the proposals to require new contextual files under
new paragraph (b)(2), the Departments intend for them to be updated at
a frequency at which they will be maximally useful and provide the most
context to the In-network Rate File and Allowed Amount File. The
Departments have determined that since the Change-log File serves as a
reference to an In-network Rate File, it should be posted at the same
time as the In-network Rate File to show what has changed from an In-
network Rate File since it was last updated. Therefore, the Departments
propose to require at proposed paragraph (b)(4)(iii) that plans and
issuers update the Change-log File under proposed paragraph (b)(2)(i)
on
[[Page 60465]]
the same day as each In-network Rate File described in (b)(1)(i) is
required to be updated, except for the first In-network Rate File for
which there would be no changes to report. This would mean the plan or
issuer would be required to post their first Change-log File beginning
on the first day of the calendar-year quarter following the date on
which the first In-network Rate File would be required to be posted
under paragraph (b)(4)(i).\152\ The Departments propose to require that
if there are no changes to an In-network Rate File since it was updated
last, a Change-log File would still be required to be posted at that
time indicating there are no changes for that quarter.
---------------------------------------------------------------------------
\152\ See Table 3 for an example.
---------------------------------------------------------------------------
The Departments also propose to require at proposed paragraph
(b)(4)(iv) that the Utilization File described in proposed new
paragraph (b)(2)(ii) be updated and posted every 12 months after the
initial posting. The Utilization File would be required to be initially
posted on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) and annually on the same date
thereafter. The Departments have determined that an annual cadence for
this file is sufficient to illustrate provider reimbursement for
corresponding items and services and appropriately balances the benefit
of having recent historical data with the burden on plans and issuers
to extract data from their claims systems annually.
The Departments also propose to require at proposed paragraph
(b)(4)(v) that plans and issuers update the Taxonomy File prepared
pursuant to proposed paragraph (b)(2)(iii) and post such file beginning
on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1). This would help to ensure
file users have all necessary information to assess the data disclosed
through the In-network Rate Files as described under paragraph
(b)(1)(i) and to provide clarity around what data was excluded from the
In-network Rate Files pursuant to the new proposed requirement to
exclude certain information under new paragraph (b)(1)(i)(F). If there
are no changes to the taxonomy that impact the information required to
be included in the In-network Rate File from one quarter to the next,
the posted Taxonomy File would not be required to be updated.
The Departments also propose in new paragraph (b)(4)(vi) to require
that the Text File required under proposed paragraph (b)(2)(iv) of this
section be initially posted on the first day of the calendar-year
quarter following the applicability date under paragraph (c)(1) and
updated and posted as soon as practicable but no later than 7 calendar
days following a change in any of the information required under
paragraph (b)(2)(iv). The Departments request comment on all aspects of
these proposed timing requirements. In particular, the Departments
request comment on whether the proposed requirement that plans and
issuers update the Text File as soon as practicable but not later than
7 calendar days following a change in any of the information required
under paragraph (b)(2)(iv) of this section provides sufficient time for
plans and issuers to make the required update.
[GRAPHIC] [TIFF OMITTED] TP23DE25.051
The Departments seek comment on these proposed timing requirements.
11. Special Rules To Prevent Unnecessary Duplication
The Departments propose in 26 CFR 54.9815-2715A3, 29 CFR 2590.715-
2715A3, and 45 CFR 147.212 to redesignate paragraph (b)(4)(i) as
paragraph (b)(5)(i) and redesignate paragraph (b)(4)(ii) as paragraph
[[Page 60466]]
(b)(5)(ii)--each without any substantive changes to the existing policy
in the 2020 final rules. The Departments also propose to redesignate
and amend paragraph (b)(4)(iii), which permits aggregation of out-of-
network allowed amounts in certain circumstances, as paragraph
(b)(5)(iv) and to add new paragraph (b)(5)(iii) to include similar
permissions with respect to in-network rates.
In new paragraph (b)(5)(iii), the Departments propose, under
certain conditions, to allow self-insured group health plans to permit
another party (pursuant to a contract) to make available in a single
In-network Rate File, the information required under paragraph
(b)(1)(i) for multiple plans, insurance policies, and contracts,
including those offered by different plan sponsors with which the other
party contracts and across markets that share the same provider
network.\153\ Similarly, in redesignated paragraph (b)(5)(iv), the
Departments propose amendments that would allow, under certain
conditions, self-insured group health plans to permit another party
(pursuant to a contract) to make available in a single Allowed Amount
File the information required under paragraph (b)(1)(ii) for more than
one self-insured group health plan, including those offered by
different plan sponsors with which the other party contracts. The
Departments also propose two amendments to redesignated paragraph
(b)(5)(iv) to account for proposed amendments to the Allowed Amount
File requirements in paragraph (b)(1)(ii): (1) to require that the
minimum claims threshold apply across multiple self-insured group
health plans whose information is included in a single Allowed Amount
File, as described in proposed paragraph (b)(5)(iv), rather than for
each such individual self-insured group health plan, and (2) to revise
the minimum claims threshold to 11-claims in accordance with proposed
paragraph (b)(1)(ii)(C). Lastly, the Departments propose amendments to
better organize and streamline requirements in redesignated paragraph
(b)(5)(iv) which do not affect any substantive rights or obligations.
---------------------------------------------------------------------------
\153\ For the purposes of this section III.C.11, the term
``health insurance market'' refers to the definition in proposed 25
CFR 54.9815-2715A1, 29 CFR 2590.715.2715A1, and 45 CFR 147.210 as
described in section III.A of these proposed rules.
---------------------------------------------------------------------------
a. Special Rule for Self-Insured Group Health Plans With Respect to the
Disclosure of In-Network Rate Files
In new paragraph (b)(5)(iii), the Departments propose to permit In-
network Rate Files, which for self-insured group health plans under the
proposed amendments to paragraph (b)(1)(i) would have been required to
be made available at the plan sponsor level, to instead be made
available at the service provider level for each provider network used
by the self-insured group health plan. This In-network Rate File could
include such information for more than one self-insured group health
plan with which the other party has an agreement, as well as other
policies and contracts offered by the other party acting as a health
insurance issuer, that uses the same provider network. This In-network
Rate File may also include the relevant information from plans or
coverage in different health insurance markets, as described below.
As discussed in section III.C.1 of this preamble, the Departments
propose to amend paragraph (b)(1)(i) to require plans and issuers to
make an In-network Rate File available for each provider network
maintained or contracted by the plan or issuer. This organization by
provider network would reduce file size and the overall number of files
and make more meaningful information available to file users. Under
this proposal, each self-insured group health plan would be required to
make available an In-network Rate File for each provider network it
maintains. For self-insured group health plans that are administered by
the same service provider and use the same provider network, this
approach would require duplicate In-network Rate Files that include the
same negotiated rates under the same provider network for each self-
insured group health plan using that network. Therefore, to further the
goals of reducing duplicative rates and simplifying analysis for file
users, the Departments propose in paragraph (b)(5)(iii) to permit and
encourage self-insured group health plans to allow another party with
which they contract, such as a service provider, to make available an
In-network Rate File for each provider network used by more than one
self-insured plan.
Further, the Departments propose that these In-network Rate Files
may include information about plans, insurance policies, and contracts
across health insurance markets, since a service provider may use the
same provider network for multiple self-insured group health plans it
administers and also for multiple fully-insured group health plans or
individual health insurance coverage it offers as a health insurance
issuer. Such a service provider, when acting as a health insurance
issuer, would already be required under the Departments' proposed
amendments to paragraph (b)(1)(i) to disclose an In-network Rate File
for that provider network that includes negotiated rate information for
the fully-insured group health plans it offers across the small group
and large group markets, as well as any individual policies it offers
in the individual market, to the extent those plans or policies use
that same provider network. Under new paragraph (b)(5)(iii), a self-
insured group health plan could permit its service provider to include
plans and coverage offered in different health insurance markets in the
same In-network Rate File, to the extent they use the same provider
network. If this In-network Rate File includes the required rates for
individual and group health insurance coverage offered by the issuer,
the issuer would also be considered to comply with the Departments'
proposed amendments to paragraph (b)(1)(i).
The Departments also propose to add new paragraphs (b)(5)(iii)(A)
and (B) to include two conditions on the applicability of the special
rule for self-insured group health plans with respect to the disclosure
of the In-network Rate File. In new paragraph (b)(5)(iii)(A), the
Departments propose that a self-insured group health plan may only
avail itself of the special rule described in (b)(5)(iii) if each In-
network Rate File made available for a provider network includes
information for all covered items and services under each plan,
insurance policy, or contract that uses the same provider network for
which the In-network Rate File is made available, consistent with the
requirements for disclosing rate information under proposed (b)(1)(i).
In new paragraph (b)(5)(iii)(B), the Departments propose that a
self-insured group health plan may only use the special rule described
in (b)(5)(iii) if each proposed Change-log, Utilization, and Taxonomy
File (all of which must be made available for each In-network Rate
File, as discussed in section III.C.7. of this preamble, under proposed
new paragraphs (b)(2)(i), (ii) and (iii), respectively), include data
from the same plans, insurance policies, or contracts (including those
offered by different plan sponsors and across different health
insurance markets, if applicable) that are represented in the
corresponding In-network Rate File. This is because, as discussed in
section III.C.7. of this preamble, for the Change-log, Utilization, and
Taxonomy Files to be meaningful, they must directly correspond to the
disclosures in the In-network Rate Files for which they are made
available. Under this proposal, a self-insured group health plan that
contracts with another party that takes
[[Page 60467]]
advantage of the special rule would not be permitted to publish (either
itself or by contracting with another party) the corresponding Change-
log, Utilization, and Taxonomy Files only with respect to its own
plans.
b. Special Rule for Self-Insured Group Health Plans With Respect to the
Disclosure of Out-of-Network Allowed Amount Files
As described above, the Departments propose in 26 CFR 54.9815-
2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212 to redesignate
paragraph (b)(4)(iii) as paragraph (b)(5)(iv), and to amend
redesignated paragraph (b)(5)(iv) to state that a self-insured group
health plan may permit another party with which it contracts, such as a
service provider, to include the required allowed amount and billed
charge information in a single Allowed Amount File for more than one
self-insured group health plan, including those offered by different
plan sponsors with which the other party contracts, provided certain
conditions are met.
For improved readability, the Departments propose to move the
condition currently described in paragraph (b)(4)(iii) (related to
application of the claims threshold to the Allowed Amount File) into
new paragraph (b)(5)(iv) and to amend it to align with the Departments'
proposed revisions to the claims threshold in paragraph (b)(1)(ii).
Under paragraph (b)(4)(iii) of the 2020 final rules, group health
plans and health insurance issuers are currently permitted to satisfy
the Allowed Amount File disclosure requirements in paragraph (b)(1)(ii)
by contracting with an issuer, service provider, or other party to make
available out-of-network allowed amount data that has been aggregated
to include information from more than one plan, policy, or contract
(provided that the claims threshold described in paragraph
(b)(1)(ii)(C) is met independently for each item or service and for
each plan or coverage included in an aggregated Allowed Amount File).
These plans, policies, or contracts may be across multiple health
insurance markets.
As discussed in section III.C.6 of this preamble, the Departments
now propose to amend paragraph (b)(1)(ii) to require all plans and
issuers to aggregate out-of-network allowed amount data across the
plans or coverage they offer in each health insurance market. For
example, an issuer offering six plans in the small group market and
four in the individual market would be required to make available two
Allowed Amount Files: one that aggregates allowed amounts across the
issuer's six small group market plans and another that aggregates
allowed amounts across its four individual market plans.
Therefore, if proposed (b)(1)(ii) were finalized and current
paragraph (b)(4)(iii) were retained, plans and issuers would be
required to aggregate out-of-network allowed amount data across the
plans or coverage they offer in each health insurance market, and, if a
plan or issuer contracts with an issuer, service provider or other
party to satisfy the disclosure requirement of (b)(1)(ii), such party
would additionally be permitted to aggregate allowed amount data across
the plans or coverage in different health insurance markets. Permitting
plans and issuers to aggregate data within a health insurance market
and then again across multiple different health insurance markets would
undermine the Departments' goal of improving data useability of the
Allowed Amount Files as discussed in section III.C.6 of this preamble.
As discussed in section III.A. of this preamble, the Departments
propose to add new paragraphs 26 CFR 54.9815-2715A1(a)(2)(xi), 29 CFR
2590.715-2715A1(a)(2)(x), and 45 CFR 147.210(a)(2)(xi) to define health
insurance markets for purposes of the proposed amendments to the
Allowed Amount File at proposed paragraph (b)(1)(ii). If finalized as
proposed, for purposes of self-insured group health plans (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) of this subchapter,
and plans that consist solely of excepted benefits), health insurance
market would be defined as all self-insured group health plans
maintained by the plan sponsor. Therefore, proposed paragraph
(b)(1)(ii) would require self-insured group health plans to aggregate
out-of-network allowed amount data across the plans offered by the same
plan sponsor (that is, in the same health insurance market), but would
not permit aggregation across more than one plan sponsor. The
Departments have determined that allowing aggregation of allowed amount
data only across self-insured group health plans offered by different
plan sponsors maintains the market division grouping necessary to make
the data more actionable for research and analysis as discussed in
section III.C.6 of this preamble. As such, proposed paragraph
(b)(5)(iv) states that a self-insured group health plan that enters
into an agreement with another party described in paragraph (b)(5)(ii)
may permit such other party to make available the information required
under paragraph (b)(1)(ii) in a single out-of-network allowed amount
file for more than one self-insured group health plan, including those
offered by different plan sponsors with which the other party
contracts. This would mean that a self-insured group health plan may
permit their service provider or other party with which they contract
to include their required allowed amount and billed charges information
in a single Allowed Amount File along with allowed amount and billed
charges information from more than one self-insured group health plan,
including those offered by different plan sponsors (that is, in
different health insurance markets). Therefore, the Departments propose
to limit the application of redesignated paragraph (b)(5)(iv) to self-
insured group health plans; allowed amounts and billed charges from
fully-insured group health plans or individual market coverage must not
be included.
In addition, in new paragraph (b)(5)(iv), the Departments propose
that a self-insured group health plan may not take advantage of the
special rule under paragraph (b)(5)(iv) unless the proposed 11-claim
threshold applies across all plans included in the Allowed Amount File.
Under current paragraph (b)(1)(ii)(C), plans and issuers must apply the
minimum claims threshold by evaluating the number of different claims
for payments under a single plan or coverage. Under current paragraph
(b)(4)(iii), when allowed amount data is aggregated at the service
provider level, rather than reported by plan, policy, or contract, the
minimum claims threshold is applied the same way: it must be met
independently for each item or service and for each plan, insurance
policy, or coverage included in an aggregated Allowed Amount File.\154\
---------------------------------------------------------------------------
\154\ 26 CFR 54.9815-2715A1(b)(4)(iii), 29 CFR 2590.715-
2715A1(b)(4)(iii), and 45 CFR 147.212(b)(4)(iii).
---------------------------------------------------------------------------
The Departments finalized this requirement in the 2020 final rules
because if the threshold were applied to the aggregated claims data at
the service provider level, rather than for each plan or coverage as is
required under current paragraph (b)(1)(ii)(C), the Departments
determined that the goal of the minimum claims threshold could be
undermined.\155\ The Departments gave the following example in the 2020
rules: ``Plan A has 20 claims for Service X, while Plan B only has six
claims for Service X. In aggregate, the plans meet the 20-claim
threshold with 26 total claims for Service X. However, individually,
only Plan A has met the
[[Page 60468]]
minimum claim threshold.'' \156\ If the claims threshold were applied
to the aggregated data set, data for Service X would be required to be
included from both Plan A and Plan B. The Departments determined that
``allowing Plan B data to be included in the file for Service X would
undermine the minimum claim threshold, increasing risk that individual
patients' claims histories could be identified.'' \157\
---------------------------------------------------------------------------
\155\ 85 FR 72158, 72246 (November. 12, 2020).
\156\ Id.
\157\ Id.
---------------------------------------------------------------------------
As discussed in section III.C.6. of this preamble, the Departments
now propose in paragraph (b)(1)(ii)(C) to lower the claims threshold
from 20 to 11 and apply it at the health insurance market level, rather
than the individual plan or policy level. That is, plans and issuers
would be required to exclude claims data for an item or service if
there are fewer than 11 claims for that item or service in an Allowed
Amount File, regardless of how many plans, insurance policies, or
contracts are represented in the file.
For consistency in the application of the claims threshold, the
Departments propose in new paragraph (b)(5)(iv) that in order for a
self-insured group health plan to take advantage of the special rule
under paragraph (b)(5)(iv), the proposed 11-claim threshold must be
applied to the aggregated data set. Applying the threshold to
aggregated data, especially when aggregated across multiple self-
insured group health plans offered by different plan sponsors, would
likely increase the amount of allowed amount data available because
more services would likely exceed the 11-claim threshold.
Notwithstanding, and as discussed in more detail in section III.C.6. of
this preamble, the Departments expect this approach would result in
maintaining appropriate patient privacy protections.
Finally, the Departments propose to revise the paragraph heading
for redesignated paragraph (b)(5)(iv) to better describe the proposed
requirements in this paragraph.
c. Better Organizing Existing Requirements
Current paragraph (b)(4)(iii), redesignated as paragraph
(b)(5)(iv), also provides that nothing in 26 CFR 54.9815-2715A3, 29 CFR
2590.715-2715A3, and 45 CFR 147.212 prevents the Allowed Amount File
from being hosted on a third-party website or prevents a plan
administrator or issuer from contracting with a service provider to
post the file, but that if a plan or issuer chooses not to also host
the file separately on its own website, it must provide a link on its
own public website to the location where the file is made publicly
available. The Departments have determined that this provision more
logically belongs in redesignated paragraph (b)(3) concerning the
method and format for disclosing information to the public. As such,
the Departments propose to move it to new paragraph (b)(3)(iv) with
proposed amendments that are discussed in section III.C.9. of this
preamble.
The Departments seek comment on these proposals.
12. Applicability
The Departments propose to require under paragraph (c)(1)that the
proposed amendments to the provisions of paragraph (b) of 26 CFR
54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212 apply 12
months following the date of publication of the final regulations in
the Federal Register. The Departments are proposing this applicability
date to ensure that all plans and issuers begin following the updated
set of technical requirements at the same time. Until such time, the
current provisions of paragraph (b) continue to apply.
Based on initial implementation experience, the Departments have
determined that the proposed applicability date appropriately balances
the need for achieving increased usability of the machine-readable file
data in a timely manner with the time necessary for both file
developers and other users to collaborate with the Departments on
GitHub and for plans and issuers to make the operational and systems
changes to implement these proposals.
The Departments seek comment on this proposed applicability date,
including whether 12 months following publication of final regulations
provides enough time for plans and issuers to comply with the amended
provisions of paragraph (b) and whether there are particular challenges
in complying with such applicability date compared to an applicability
date based on plan or policy year.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), the Departments
are required to provide notice in the Federal Register and solicit
comment before a collection of information request (ICR) is submitted
to OMB for review and approval. These proposed rules contain ICRs that
are subject to review by OMB. A description of these provisions is
given in sections IV.C. and D. of this preamble with an estimate of the
annual burden, summarized in Tables 35 and 36.
To evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the PRA requires that the Departments
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of an agency, including whether
the information shall have practical utility.
The accuracy of the Departments' estimate of the
information collection burden, including the validity of the
methodology and assumptions used.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
A. Allocation of Total Burden Hours to the Departments of Health and
Human Services, Labor, and the Treasury
Based on their respective jurisdiction over issuers and third-party
administrators (TPAs), HHS is estimated to account for 50 percent of
the total burden, while the Departments of Labor and the Treasury would
each account for 25 percent. Tables 4 and 5 present each Department's
share of the total on-going and one-time estimated burden hours needed
to implement the proposed requirements.
[[Page 60469]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.052
[GRAPHIC] [TIFF OMITTED] TP23DE25.053
B. Wage Estimates
To estimate wages, the Departments used data from the Contract
Awarded Labor Category (CALC) database tool \158\ to calculate average
labor costs associated with the burden and equivalent costs of the
information collection requirements (ICRs). The CALC tool was developed
to assist acquisition professionals with market research and price
analysis of labor categories under multiple U.S. General Services
Administration (GSA) and Veterans Administration (VA) contracts. While
the Departments recognize that various methods exist for estimating
fringe benefits and overhead costs, the CALC database was selected
because, unlike Bureau of Labor Statistics (BLS) data, which is
valuable for identifying broad labor market trends, the CALC tool is
specifically designed to support market research for government
procurement. It provides cost estimates for specific labor categories
based on actual contract rates. More importantly, CALC data reflects
fully burdened hourly rates, including both base pay and benefits,
whereas BLS data reflects only base wages. The Departments determined
that CALC's occupation-specific data better aligns with the skill sets
and job functions necessary for implementing the requirements in these
proposed rules and therefore provides a more suitable basis for
estimating labor costs. Table 6 presents the fully burdened mean hourly
wage and occupations used in the Departments' estimates.
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\158\ U.S. General Services Administration, Pricing Intelligence
Suite, CALC information and wage rates, https://buy.gsa.gov/pricing/
(last visited Dec. 8, 2025).
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[[Page 60470]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.054
C. ICRs Regarding Requirements for Disclosures to Participants,
Beneficiaries, or Enrollees Under 26 CFR 54.9815-2715A2, 29 CFR
2590.715-2715A2, and 45 CFR 147.211
As discussed previously in this preamble, the Departments propose
several amendments to the 2020 final rules to improve price
transparency and strengthen consumer protections for participants,
beneficiaries, and enrollees. First, the Departments propose revising
the disclaimer required under paragraph (b)(1)(vii)(A) to clarify that
the cost-sharing information does not account for potential additional
amounts in situations where applicable State and Federal law allow out-
of-network providers to balance bill participants, beneficiaries, and
enrollees. These revisions reflect the Federal balance billing
protections introduced by the No Surprises Act, which were not in
effect when the original provision was finalized. These proposed
revisions aim to ensure that participants, beneficiaries, and enrollees
understand that cost-sharing estimates disclosed through their plan's
or issuer's self-service tool may not account for additional amounts
owed to out-of-network providers.
In addition, the Departments propose adding a new paragraph
(b)(2)(iii) requiring plans and issuers to make cost-sharing
information available by telephone, consistent with requirements under
the No Surprises Act. The Departments propose to require a telephone
number for consumer assistance that Code section 9816(e), ERISA section
716(e), and PHS Act section 2799A-1(e), as added by section 107 of the
No Surprises Act, requires be indicated on any physical or electronic
plan or insurance identification card issued to a participant,
beneficiary, or enrollee. The proposal further states that, to reduce
unnecessary administrative burden and prevent consumer confusion,
providing the information as specified in paragraph (b)(1) and in the
method and format as specified in paragraph (b)(2), as amended by these
proposed rules, would satisfy the price comparison tool requirements
under section 114 of the No Surprises Act. The requirements in these
proposed rules apply to non-grandfathered group health plans and health
insurance issuers offering non-grandfathered coverage in the group and
individual markets.
As discussed in section VI.C.3. of this preamble, the Departments
assume that self-insured group health plans would depend on TPAs,
including issuers providing administrative services only and non-issuer
TPAs, to implement these proposed updates, including the new phone
disclosure requirement. 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.\159\ For those self-insured plans that choose to
develop their own internet-based self-service tools (and which are
included in the total count of issuers and TPAs used to estimate
burden), the Departments assume that they would incur costs and burdens
similar to those estimated for issuers and TPAs. Accordingly, the
Departments use issuers and TPAs as the unit of analysis for estimating
the cost of proposed changes. The Departments also assume that issuers
and TPAs have already developed internet-based self-service tools,
originally required for plan or policy years beginning on or after
January 1, 2023, and would only need to modify these existing systems
to comply with the proposed provisions. The Departments acknowledge
that some interactive voice response (IVR) programming work may be
necessary, but the Departments expect the associated cost would be
minimal. The Departments welcome comment on these assumptions.
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\159\ Louise Norris, What is Self-Insured Health Insurance? Most
Very Large Employers Self-Insure, Verywell Health (November 9,
2024), https://www.verywellhealth.com/what-is-self-insured-health-insurance-and-how-is-it-regulated-4688567.
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As also noted in section VI.C.3. of this preamble, the Departments
estimate that approximately 1,375 issuers \160\ and 205 TPAs \161\ (a
total of 1,580 entities) would implement the proposed requirements. The
Departments acknowledge that actual costs may vary depending on factors
such as the volume of providers and items or services for which cost-
sharing information must be disclosed, and whether plans (or TPAs on
behalf of plans) and issuers already have tools that fully or partially
meet the proposed requirements or can be readily adapted. The
Departments welcome comment on the assumptions and inputs used to
develop these burden and cost estimates.
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\160\ 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 2023 reporting year. Centers for Medicare & Medicaid
Services, Medical Loss Ratio Data and System Resources (December 23,
2024), https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.
\161\ Non-issuer TPAs based on data derived from the 2016
Benefit Year reinsurance program contributions.
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The Departments also assume that plans (or TPAs on behalf of plans)
have
[[Page 60471]]
already built self-service tools and would only be required to revise
the disclaimer stating that out-of-network providers may engage in
balance billing, subject to applicable State and Federal laws. Although
these updates build on existing infrastructure, they would require a
one-time cost for minor technical modifications including editing
disclosure text, testing for quality assurance, and implementing the
update. The Departments estimate that, on average, each issuer or TPA
would require 10 minutes (approximately 0.17 hours) of a Senior
Application Developer's time (at $143 per hour) to update the
disclosure. As shown in Table 7, across all 1,580 issuers and TPAs, the
total one-time burden is estimated at 263 hours, with an associated
cost of approximately $37,657.
[GRAPHIC] [TIFF OMITTED] TP23DE25.055
a. High Impact for Providing Cost-Sharing Information Via Phone
Under a scenario with increased call volume and duration (that is,
high impact), the Departments anticipate that requiring cost-sharing
information to also be accessible by phone, could increase call volume
and call duration to the plan's or issuer's customer support line. This
anticipated increase is driven by participants, beneficiaries, and
enrollees who may prefer verbal assistance, have limited digital access
or literacy, or need help interpreting complex pricing information.
Accordingly, the Departments estimate that for each issuer or TPA,
it would require 10 minutes \162\ for a customer service representative
(at $40 per hour) to speak with each consumer and provide the requested
information and complete post-call documentation. Assuming, as a high
impact scenario estimate, there would be 7.8 million calls
annually,\163\ each issuer or TPA would receive approximately 4,937
calls per year, resulting in an estimated annual burden of 823
hours,\164\ with an estimated associated cost of $32,911. As shown in
Table 8, the Departments estimate that for all 1,580 issuers and TPAs,
the estimated total ongoing annual burden would be approximately
1,300,000 hours, with an estimated associated cost of $52 million
annually.
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\162\ According to a 2012 report by the Healthcare Financial
Management Association, the average handle time for call centers
generally ranges from 7 to 8 minutes. For purposes of this analysis,
the Departments assume an additional 2 minutes would be needed for
call documentation, resulting in an average handle time of 9 to 10
minutes. Accordingly, the Departments use 9 minutes as the lower
bound and 10 minutes as the upper bound to estimate the potential
impact of increased call times under the proposed disclosure
requirements. Healthcare Financial Management Association, Ask the
Expert: Setting Industry Standards for Call Center Activities (Oct.
25, 2012), https://www.hfma.org/revenue-cycle/kpis/7256/.
\163\ According to data from the Congressional Research Service,
the total insured population in private/commercial insurance,
including employer-sponsored and individual market coverage, is
projected to be approximately 156 million in 2023 (of the estimated
304 million insured individuals in 2023, approximately 148 million
are covered by public programs, including Medicare, Medicaid, VA
Care, and TRICARE. The remaining 156 million are covered under
private/commercial insurance, including both employer-sponsored and
individual market plans). The Departments estimate 5 percent of
total calls would be shopping-related calls per year under the high-
call time scenario. This estimate is informed by a KFF study
(https://www.kff.org/affordable-care-act/kff-survey-of-consumer-experiences-with-health-insurance/) in which 57 percent of adults
contacted their insurance in 2023, with under 31percent asking about
out-of-pocket expenses--a subset of which could reasonably be
considered shopping related calls. Considering that consumers
contact plans via phone, online, in-person, or in writing, it was
estimated that 25 percent of these contacts were by phone. Of these
phone contacts, 10-20 percent of the 31 percent asking about out-of-
pocket expenses were assumed to be shopping calls, resulting in an
estimated range of 2.5 percent to 5 percent of total calls being
shopping-related. Using the upper bound of 5 percent for the high-
call time scenario, this results in approximately 7.8 million
shopping-related calls per year. Congressional Research Service,
U.S. Health Care Coverage and Spending (Feb. 19, 2025), https://www.congress.gov/crs-product/IF10830.
\164\ This calculation distributes the total workload across all
1,580 issuers and TPAs. At the industry level, there are 7,800,000
high-call time calls per year, with an average handle time of 10
minutes per call, resulting in 78,000,000 total minutes (1,300,000
hours). To compute the per-entity workload, the total calls are
divided by the number of issuers and TPAs: 7,800,000/1,580 [ap]
4,937 calls per entity per year. Multiplying the per-entity calls by
the 10-minute average handle time gives 49,370 minutes annually per
entity, which converts to approximately 823 hours (49,370/60).
[GRAPHIC] [TIFF OMITTED] TP23DE25.056
b. Lower Impact Estimate for Providing Cost-Sharing Information Via
Phone
[[Page 60472]]
Under a scenario with less call volume and duration (that is,
lower-impact scenario), the Departments assume that a smaller subset of
participants, beneficiaries, and enrollees would opt to request pricing
information by phone. In this scenario, the Departments estimate that
for each issuer or TPA it would take 9 minutes for a customer service
representative (at $40 per hour) to speak with consumers and provide
the requested information and complete post-call documentation.
Assuming 3.9 million calls annually,\165\ each issuer or TPA would
receive approximately 2,468 calls per year, resulting in an estimated
annual burden of 370 hours \166\ with an estimated associated cost of
$14,810 per issuer or TPA. As shown in Table 9, across all 1,580
issuers and TPAs, the estimated total ongoing burden would be
approximately 585,000 hours, with a total annual cost of approximately
$23.4 million.
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\165\ According to data from the Congressional Research Service,
the total insured population in private/commercial insurance,
including employer-sponsored and individual market coverage, is
projected to be approximately 156 million in 2023 (of the estimated
304 million insured individuals in 2023, approximately 148 million
are covered by public programs, including Medicare, Medicaid, VA
Care, and TRICARE. The remaining 156 million are covered under
private/commercial insurance, including both employer-sponsored and
individual market plans). The Departments estimate that 2.5 percent
of total calls would be shopping-related calls per year under the
low-call time scenario. This estimate is informed by a KFF study
(https://www.kff.org/affordable-care-act/kff-survey-of-consumer-experiences-with-health-insurance/) in which 57 percent of adults
contacted their insurance in 2023, with under 31 percent asking
about out-of-pocket expenses--a subset of which could reasonably be
considered shopping related calls. Considering that consumers
contact plans via phone, online, in-person, or in writing, it was
estimated that 25 percent of these contacts were by phone. Of these
phone contacts, 10-20 percent of the 31percent asking about out-of-
pocket expenses were assumed to be shopping calls, resulting in an
estimated range of 2.5 percent to 5 percent of total calls being
shopping-related. Using the lower bound of 2.5 percent for the low-
call time scenario, this results in approximately 3.9 million
shopping-related calls per year. Congressional Research Service,
U.S. Health Care Coverage and Spending (Feb. 19, 2025), https://www.congress.gov/crs-product/IF10830.
\166\ This calculation distributes the total workload across all
1,580 issuers and TPAs. At the industry level, there are 3,900,000
high-volume calls per year, with an average handle time of 9 minutes
per call, resulting in 35,100,000 total minutes (585,000 hours). To
compute the per-entity workload, the total calls are divided by the
number of issuers and TPAs: 3,900,000/1,580 [ap] 2,468 calls per
entity per year. Multiplying the per-entity calls by the 9 minute
average handle time gives 22,212 minutes annually per entity, which
converts to approximately 370 hours (22,212/60).
[GRAPHIC] [TIFF OMITTED] TP23DE25.057
Plans (or TPAs on behalf of plans) and issuers would also incur a
one-time burden and cost to train customer service representatives and
their supervisors on the proposed phone requirement. The Departments
assume this requirement would not necessitate hiring additional full-
time staff. Instead, the Departments expect issuers and TPAs to rely on
existing customer service representatives and supervisors for this
task. For each issuer or TPA, the Departments estimate that one
training specialist would spend 8 hours (at $104 per hour) to train 20
customer service representatives (totaling 160 hours at $40 per hour)
and two supervisors (totaling 16 hours at $91 per hour) on how to
respond to participants, beneficiaries, and enrollees seeking pricing
information by phone. This results in a one-time burden of 184 hours
per issuer or TPA, with an estimated associated cost of $8,688. As
shown in Table 10, for all 1,580 issuers and TPAs, the total estimated
one-time training hour burden would be 290,720 hours, with a
corresponding cost of approximately $13,727,040.
[GRAPHIC] [TIFF OMITTED] TP23DE25.058
The Departments anticipate that, in the future, ongoing training
costs associated with the proposed phone requirements would be
incorporated into existing onboarding programs for new employees and
included in the regular annual training provided to current staff.
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
D. ICRs Regarding Requirements for Public Disclosure Under 26 CFR
54.9815-2715A3, 29 CFR 2590.715-2715A3, and 45 CFR 147.212
The Departments are proposing updates to the 2020 final rules to
improve the accessibility, clarity, and usefulness of the public
disclosures through machine-readable files. The proposed changes aim to
help users better locate machine-readable files, revise the content and
format of disclosures, and modify the publication frequency for certain
files. For In-network Rate Files, the proposal would
[[Page 60473]]
require plans and issuers to create a separate file for each provider
network, allow rates to be expressed as a percentage of billed charges
when appropriate, associate enrollment totals for each plan or coverage
option, disclose provider network product types, and exclude providers
unlikely to be reimbursed based on their scope of practice. For Allowed
Amount Files, the proposals include requiring 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. In addition, these
proposed rules would require plans and issuers to post several
contextual machine-readable files: a Change-log File, a Utilization
File, a Taxonomy File, and a Text File, each with specific update and
posting requirements. These changes are intended to strengthen
transparency and improve the usefulness of publicly available pricing
information.
As discussed in section VI.C.3. of this preamble, the Departments
assume that self-insured group health plans would depend on TPAs,
including issuers providing administrative services only and non-issuer
TPAs, to implement these proposed updates, noting that some self-
insured plans may choose to comply individually, likely incurring a
similar hour burden.
The Departments recognize that some proposed 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, new
file creation such as Taxonomy, Change-log, and Utilization Files, and
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. The Departments seek public comment on additional costs or
implementation challenges that may not be fully captured in this
assessment.
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 (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 propose 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 associated with the
plan or policy being reported. The Departments also propose 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 including across different health insurance
markets.
Under the current technical reporting requirements, plans and
issuers publish an In-network Rate File for each plan or coverage they
offer. As a result, the scope of the existing disclosure is at the
individual plan or policy level, rather than at the broader provider
network level. Current technical implementation guidance gives plans
and issuers flexibility in how they structure their In-network Rate
File to associate providers with negotiated rates. As a result, some
plans or issuers may already be using network-based aggregation to both
optimize the size of their output files as well as allow for greater
file reuse across multiple plans. As discussed in section III.C.1. of
this preamble, the Departments understand that many plans and issuers
already leverage a Table of Contents to organize their files, an
approach that would allow them to combine common negotiated rates
across multiple In-network Rate Files, rather than publishing
negotiated rates individually for each plan ID. However, the
Departments assume that few have fully implemented that second step to
organize files by provider networks with common negotiated rates across
multiple In-network Rate Files, and many have not adopted it at all.
For burden estimation, the Departments make the assumption that no
plans or issuers have adapted their In-network Rate File processes to
align with this proposed 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 proposal.
To implement this proposed provision, plans (or TPAs on behalf of
plans) and issuers would 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 that
associates each coverage option to 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
will be incremental and build on the current process.
The proposed provision would also require, under newly proposed
paragraph (b)(1)(i)(A), that each In-network Rate File be associated
with its common provider network name. In practice, this means plans
(or TPAs on behalf of plans) and issuers would need to add a new data
element and identify the source of the common provider network names
within their systems of record so these can be incorporated into the
automated process for generating the required information for the In-
network Rate Files. However, the Departments assume that plans (or TPAs
on behalf of plans) and issuers would already have identified and
captured these common provider network names as part of the related
proposal to organize the In-network Rate Files by provider network. As
a result, the Departments expect that any burden associated with
disclosing this new data element is accounted for in the burden
estimate for organizing these files by provider network, with no
additional burden anticipated. The Departments seek comment on this
assumption.
The Departments estimate that issuers and TPAs would 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 discrete provider networks
and crosswalk those networks to relevant plans or policies. As shown in
Table 11, the Departments estimate that, on average, each issuer or TPA
would require 16 hours from a Project Manager or Team Lead (at $153 per
hour), 80 hours from a Technical Architect/Sr. Developer (at $149 per
hour), 80 hours from a Senior Application Developer (at $143 per hour),
and 16 hours from a
[[Page 60474]]
Business Analyst (at $120 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 $27,728. For all
1,580 issuers and TPAs, as shown in Table 12, the Departments estimate
a total one-time burden of 303,360 hours with an estimated associated
cost of $43,810,240.
[GRAPHIC] [TIFF OMITTED] TP23DE25.059
[GRAPHIC] [TIFF OMITTED] TP23DE25.060
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
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)(B) and (b)(1)(ii)(A), 29 CFR 2590.715-
2715A3(b)(1)(i)(B), and (b)(1)(ii)(A), and 45 CFR 147.212(b)(1)(i)(B)
and (b)(1)(ii)(A))
The Departments propose to amend redesignated paragraphs 26 CFR
54.9815-2715A3(b)(1)(i)(B) and (b)(1)(ii)(A), 29 CFR 2590.715-
2715A3(b)(1)(i)(B), and (b)(1)(ii)(A), and 45 CFR 147.212(b)(1)(i)(B)
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 have determined that product type data is readily
available to most plans and issuers and that this proposed requirement
would only involve a one-time system update to include the product type
variable in the machine-readable files. The assumptions account 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 would, on average, require 8
hours from a Project Manager or Team Lead (at $153 per hour), 8 hours
from a Senior Application Developer (at $143 per hour), 8 hours from a
Technical Architect/Sr. Developer (at $149 per hour), and 8 hours from
a Business Analyst (at $120 per hour) to make the system updates and
implement the requirements proposed in these rules. As shown in Table
13, this results in a total estimated burden of 32 hours, with an
associated estimated cost of $4,520 per issuer or TPA. As shown in
Table 14, for all 1,580 issuers TPAs, the Departments estimate a total
one-time burden of 50,560 hours with an associated total cost of
approximately $7,141,600.
[[Page 60475]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.061
[GRAPHIC] [TIFF OMITTED] TP23DE25.062
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
3. ICRs Regarding Requirements To Report Dollar Amounts Except for Only
``Percentage-of-Billed-Charges'' Payments (26 CFR 54.9815-
2715A3(b)(1)(i)(D)(1), 29 CFR 2590.715-2715A3(b)(1)(i)(D)(1), and 45
CFR 147.212(b)(1)(i)(D)(1))
The Departments propose to amend 26 CFR 54.9815-
2715A3(b)(1)(i)(D)(1), 29 CFR 2590.715-2715A3(b)(1)(i)(D)(1), and 45
CFR 147.212(b)(1)(i)(D)(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. 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 proposal codifies an exception for situations in which
the Departments have indicated they are unlikely to pursue enforcement
action, the Departments have determined that many systems would already
be compliant, as plans and issuers should already be reporting dollar
amounts for rates except in certain ``percentage-of-billed charges''
arrangements. The Departments are also of the view that most plans and
issuers have already incurred a one-time cost to make this adjustment
and would incur no additional implementation costs or burden to update
the In-network Rate Files. However, for those plans and issuers that
may not have made this alteration to their In-network Rate Files, the
Departments estimate a one-time burden and cost to meet the
requirements of this proposed provision. For a low-end estimate, the
Departments assume that 20 percent of plans (or TPAs on behalf of the
plan) and issuers would need to make this one-time modification to
their In-network Rate Files, while for a high-end estimate, it's
assumed that all plans (or TPAs on behalf of the plan) and issuers
would need to make this adjustment to their In-network Rate Files.
The Departments estimate, on average, each affected issuer or TPA
would require 8 hours from a Project Manager or Team Lead (at $153 per
hour), 8 hours from a Technical Architect/Sr. Developer (at $149 per
hour), 8 hours of work from a Senior Application Developer (at $143 per
hour), and 8 hours from a Business Analyst (at $120 per hour) to review
their In-network Rate File generation code to determine if there are
any instances where a non-dollar amount would appear in the file and
then make the necessary coding adjustments and validate the changes,
resulting in an estimated burden of 32 hours, with an estimated
associated cost of $4,520 per issuer or TPA, as shown in Table 15. The
Departments estimate that, under the low-end scenario, affected issuers
and TPAs would incur a total one-time burden of 10,112 hours with an
associated total cost of approximately $1,428,320. Under the high-end
scenario, for all issuers and TPAs, the total one-time burden would be
50,560 hours with an associated total cost of approximately $7,141,600,
as shown in Table 16.
[[Page 60476]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.063
[GRAPHIC] [TIFF OMITTED] TP23DE25.064
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
4. ICRs Regarding Requirements To Report Required Enrollment Data (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))
The Departments propose adding 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) requiring 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.
The Departments recognize that each plan or issuer would report a
different number of coverage options, so the estimates reflect a
presumed average. These estimates include the preparatory work needed
for plans (or TPAs on behalf of plans) and issuers to understand the
requirement, identify data sources (enrollment data may be stored
across multiple systems), assess current systems, and agree on
necessary system changes.
To implement this provision, plans (or TPAs on behalf of plans) and
issuers would incur a one-time cost to update their systems to automate
the retrieval and reporting of the required enrollment data.
Furthermore, the Departments expect this work to be coordinated with
efforts to comply with the proposed amendments under section IV.D.1. of
this preamble, which requires listing each plan associated with a
network.
Accordingly, the Departments estimate a one-time burden and cost
for issuers and TPAs to update their systems to include a field for
current enrollment totals and to automate ongoing data extraction. On
average, each issuer or TPA would require 8 hours from a Project
Manager or Team Lead (at $153 per hour), 8 hours from a Technical
Architect/Sr. Developer (at $149 per hour), 8 hours from a Senior
Application Developer (at $143 per hour), and 8 hours from a Business
Analyst (at $120 per hour) to complete this work. As shown in Table 17,
this results in a total estimated burden of 32 hours per issuer or TPA,
with an associated cost of approximately $4,520. For all 1,580 issuers
and TPAs, as shown in Table 18, the Departments estimate a total one-
time burden of 50,560 hours and a total cost of approximately
$7,141,600.
[[Page 60477]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.065
[GRAPHIC] [TIFF OMITTED] TP23DE25.066
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
5. ICRs Regarding Requirements To Exclude Certain Providers From In-
Network Rate Files (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))
The Departments propose 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.
In addition, the Departments propose 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 an
additional machine-readable file, called 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
would increase transparency by showing how decisions to exclude certain
provider-rate combinations from the In-network Rate File were
determined.
This proposed provision would require plans and issuers to perform
two specific updates: (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 the taxonomy 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 would include (1)
extracting and adapting the claims adjudication logic built off the
internal provider taxonomy that determines whether a provider is
authorized to bill for a particular service 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 the
provider-rate combinations for those that are not eligible to submit
claims for specific services.
Additionally, posting a Taxonomy File would 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. 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 would require 48 hours from a Project
Manager or Team Lead (at $153 per hour), 48 hours from a Technical
Architect/Sr. Developer (at $149 per hour), 48 hours from a Senior
Application Developer (at $143 per hour), and 48 hours from a Business
Analyst (at $120 per hour). As shown in
[[Page 60478]]
Table 19, this results in a total estimated burden of 192 hours per
issuer or TPA, with an associated cost of approximately $27,120. For
all 1,580 issuers and TPAs, as shown in Table 20, the Departments
estimate a total one-time burden of 303,360 hours and a total cost of
approximately $42,849,600.
[GRAPHIC] [TIFF OMITTED] TP23DE25.067
[GRAPHIC] [TIFF OMITTED] TP23DE25.068
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
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 propose 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, lowering the current threshold from 20 to 11 to expand the
data available.
The Departments assume this requirement would 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.
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
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 propose 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 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 assume extending the reporting period from 90 days
to 6 months would not create additional burden for plans and issuers,
who the Departments assume currently have automated systems in
production to report out-of-network allowed amounts. This change 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 Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
[[Page 60479]]
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 propose 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,
(3) large group market, and (4) plans in self-insured group markets.
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 propose 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 of the view that this proposal would 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 would require modifying the output so that, rather
than producing a separate Allowed Amount File for each plan or policy,
plans and issuers would 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.\167\
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\167\ 26 CFR 54.9801-2, 29 CFR 2590.701-2, and 45 CFR 144.103,
as applicable.
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The Departments estimate that plans (or TPAs on behalf of plans)
and issuers would 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 would
require 16 hours from a Project Manager or Team Lead (at $153 per
hour), 16 hours from a Technical Architect/Sr. Developer (at $149 per
hour), 16 hours of work from a Senior Application Developer (at $143
per hour), and 16 hours from a Business Analyst (at $120 per hour) to
complete this work. As shown in Table 21, this results in a total
estimated burden of 64 hours per issuer or TPA, with an associated cost
of approximately $9,040. For all 1,580 issuers and TPAs, as shown in
Table 22, the Departments estimate a total one-time burden of 101,120
hours and a total cost of approximately $14,283,200.
[GRAPHIC] [TIFF OMITTED] TP23DE25.069
[GRAPHIC] [TIFF OMITTED] TP23DE25.070
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
[[Page 60480]]
9. ICRs Regarding Requirements To Add a Change-Log File Related to the
In-Network Rate File Disclosures (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 propose adding 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.
Under this proposal, each plan or issuer would be required to
publish a Change-log File each quarter, identifying any changes made to
the In-network Rate File for each provider network maintained or
contracted by that plan or issuer compared to the file in the preceding
quarter. If there are no changes made to the machine-readable file
since that previous file's posting, a Change-log File must still be
posted indicating there are no changes.
This proposed requirement does not currently specify the required
level of detail for the Change-log File, such as whether it should
include high-level summaries or detailed information about changes to
specific data points. As noted in section III.C.7.a. of this preamble,
the Departments are seeking comment on which data elements should be
included and on the overall design of the Change-log File. Due to the
nature of the proposed provision, the Departments have made certain
assumptions based on current information available to estimate the
burden hours and cost of this proposed provision.
The Departments assume that plans and issuers would develop an
automated system to track changes in the required data fields and
report specific detailed information, such as the exact dollar amount
of an applicable rate change. The Departments estimate that each issuer
and TPA would incur a one-time burden and cost to develop and implement
the to the proposed provision including to identify data sources for
each field, write code to detect changes from the previous file,
generate the Change-log File, and conduct testing and quality control
before establishing a process to make the file available to the public.
Once these systems are in place, creating the Change-log File is
expected to be automated.
On average, each plan (or a TPA on behalf of the plan) or issuer
would require 50 hours from a Project Manager or Team Lead (at $153 per
hour), 220 hours from a Technical Architect/Sr. Developer (at $149 per
hour), 220 hours from a Senior Application Developer (at $143 per
hour), 50 hours from a Business Analyst (at $120 per hour), and 36
hours from a DevOps Engineer (at $181 per hour) to complete this work.
As shown in Table 23, this results in a total estimated burden of 576
hours per issuer or TPA, with an associated cost of approximately
$84,406. For all 1,580 issuers and TPAs, as shown in Table 24, the
Departments estimate a total one-time burden of 910,080 hours and a
total cost of approximately $133,361,480.
[GRAPHIC] [TIFF OMITTED] TP23DE25.071
[GRAPHIC] [TIFF OMITTED] TP23DE25.072
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
10. ICRs Regarding Requirements To Implement the Disclosures Required
for the Utilization File (26 CFR 54.9815-2715A3(b)(2)(ii), 29 CFR
2590.715-2715A3(b)(2)(ii), and 45 CFR 147.212(b)(2)(ii)).
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), the Departments propose
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 from in-network providers and identify
each provider who submitted claims for each item or service. The
[[Page 60481]]
Departments propose that the Utilization File 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.
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 would require issuers to
programmatically generate a list of each unique combination of provider
NPI, TIN, and place of service 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 would 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 would
be lower than those originally estimated in the 2020 final rules for
the development and implementation of the Allowed Amount File.
Given the differences in the two files and past experience with the
Allowed Amount File, the Departments estimate a one-time cost and
burden for plans (or TPAs on behalf of plans) and issuers to develop,
implement, and operate the Utilization File to meet the requirements of
these proposed rules. On average, each issuer or TPA would require 364
hours from a Scrum Master (at $105 per hour), 546 hours from a
Technical Architect/Sr. Developer (at $149 per hour), 1,456 hours of
work from a Senior Application Developer (at $143 per hour), 364 hours
from a Business Analyst (at $120 per hour), and 182 hours from a DevOps
Engineer (at $181per hour). As shown in Table 25, this results in a
total estimated burden of 2,912 hours per issuer or TPA, with an
associated cost of approximately $404,404. For all 1,580 issuers and
TPAs, as shown in Table 26, the Departments estimate a total one-time
burden of 4,600,960 hours and a total cost of approximately
$638,958,320.
[GRAPHIC] [TIFF OMITTED] TP23DE25.073
[GRAPHIC] [TIFF OMITTED] TP23DE25.074
In addition to the one-time burden and cost estimated in Tables 25
and 26, plans (or TPAs on behalf of plans) and issuers would incur
ongoing annual burden and cost to update the Utilization File. The
Departments estimate that, on average, each issuer or TPA would
annually require 6 hours from a Scrum Master (at $105 per hour), 16
hours of work from a Senior Application Developer (at $143 per hour),
and 16 hours from DevOps Engineer (at $181 per hour) to make the
required updates. As shown in Table 27, this results in a total
estimated annual burden of 38 hours per issuer or TPA, with an
associated cost of approximately $5,814. For all 1,580 issuers and
TPAs, as shown in Table 28, the Departments estimate a total ongoing
annual burden of 60,040 hours and a total cost of approximately
$9,186,120. The 3-year average costs and burden for this proposal are
presented in Table 29.
[[Page 60482]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.075
[GRAPHIC] [TIFF OMITTED] TP23DE25.076
[GRAPHIC] [TIFF OMITTED] TP23DE25.077
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
11. ICRs Regarding Requirements To Add a Text File, Identify Point-of-
Contact 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)(iv), 29 CFR 2590.715-2715A3(b)(2)(iv), and
45 CFR 147.212(b)(2)(iv))
The Departments propose to add new 26 CFR 54.9815-2715A3(b)(2)(iv),
29 CFR 2590.715-2715A3(b)(2)(iv), and 45 CFR 147.212(b)(2)(iv), 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 2023 Hospital
Price Transparency rule \168\ 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.
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\168\ 88 FR 81540 (November 22, 2023).
---------------------------------------------------------------------------
The Departments anticipate plans (or a TPA on behalf of plans) and
issuers would 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 would
identify a point-of-contact for the file that would be available to
address inquiries and issues related to the required machine-readable
files and include this point-of-contact in the Text Files. The point-
of-contact identified would need to set up a mechanism to receive and
respond to inquiries and issues, such an email box or online feedback
form.
The Departments estimate a one-time burden and cost for plans (or
TPAs on
[[Page 60483]]
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 would require 8 hours of work from a Senior Application Developer
(at $143 per hour), 8 hours from a Project Manager or Team Lead (at
$153 per hour), and 8 hours from a Business Analyst (at $120 per hour).
As shown in Table 30, this results in a total estimated burden of 24
hours per entity, with an associated cost of approximately $3,328.
Across all 1,580 issuers and TPAs, the Departments estimate a total
one-time burden of 37,920 hours and a combined cost of approximately
$5,258,240, as presented in Table 31.
[GRAPHIC] [TIFF OMITTED] TP23DE25.078
[GRAPHIC] [TIFF OMITTED] TP23DE25.079
In addition to the one-time costs estimated in Tables 30 and 31,
plans (or TPAs on behalf of plans) and issuers would 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
would establish a team to triage, review, and respond to the inquiries.
The Departments estimate that, on average each year, each issuer or TPA
would receive approximately 30 inquiries. Addressing each inquiry is
estimated to require 10 minutes of work per inquiry from an Attorney
III (totaling 300 minutes for 30 inquiries at $143 per hour), 20
minutes per inquiry from a Senior Application Developer (totaling 600
minutes for 30 inquiries at $143 per hour), and 30 minutes per inquiry
from a Project Manager/Team Lead (totaling 900 minutes for 30 inquiries
at $153 per hour). As shown in Table 32, this results in a total
estimated annual burden of 30 hours per issuer or TPA, with an
associated cost of approximately $4,440 for each issuer or TPA. As
shown in Table 33, the Departments estimate a total ongoing annual
burden of 47,400 hours and a total cost of approximately $7,015,200 for
all 1,580 issuers and TPAs. The 3-year average burden hours and costs
for this proposal are presented in Table 34.
[GRAPHIC] [TIFF OMITTED] TP23DE25.080
[[Page 60484]]
[GRAPHIC] [TIFF OMITTED] TP23DE25.081
[GRAPHIC] [TIFF OMITTED] TP23DE25.082
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
12. 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 propose 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 must 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 anticipate that the burden associated with this
proposed requirement would be minimal, as it would involve only basic
website modifications.
The Departments request comment on the estimated cost and burden
hours presented in this analysis, including any additional costs or
challenges that commenters may identify.
E. Submission of PRA Related Comments
The burden associated with the Transparency in Coverage disclosure
requirements for HHS is currently approved under OMB control number
0938-1429 (CMS-10715, Transparency in Coverage).\169\ HHS plans to
revise this information collection request to include the additional
burden resulting from the proposed requirements. For the Departments of
Labor and the Treasury, the related burden was submitted to OMB as
Request for Common Form (RCF) submissions. Once OMB approves the RCF
submissions, both DOL and Treasury will update and submit their
respective information collection requests to reflect the proposed
changes. The Departments have submitted a copy of these proposed rules
to OMB for its review of the rule's information collection and
recordkeeping requirements. These requirements are not effective until
they have been approved by the OMB.
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\169\ Transparency in Pricing Information (CMS-10715), OMB
control number 0938-1429 (October 14, 2021), https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202410-0938-006.
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To obtain copies of the supporting statement and any related forms
for the proposed collections for control number 0938-1429, please visit
CMS's website at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing. To obtain copies
of the supporting statement for control number 0938-1429, please go to
https://www.RegInfo.gov or email the request to [email protected] and
reference control number 0938-1429.
The Departments invite public comment on these potential
information collection requirements. Commenters may send their views on
the Department's PRA analysis in the same way they send comments in
response to these proposed rules (for example, through the
www.regulations.gov website), including as part of a comment responding
to the broader proposed rules.
F. Summary of Ongoing and One-Time Burden Estimates for the Proposed
Requirements
As shown in Tables 35 and 36, the Departments estimate that these
proposed requirements would result in an ongoing burden of
approximately 1.4 million hours annually, at a cost of $68.2 million
per year for all plans (or TPAs on behalf of plans) and issuers. In
addition, these proposed requirements are expected to impose one-time
implementation costs, totaling approximately 6.7 million hours and
$913.7 million across all plans (TPAs on behalf of plans) and issuers.
Together, this represents a first-year burden of roughly 7.8 million
hours and $982 million in associated costs. In subsequent years, the
burden is estimated at about 1.4 million hours and $68.2 million per
year.
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V. Response to Comments
Because of the large number of public comments the Departments
normally receive on Federal Register documents, we are not able to
acknowledge or respond to them individually. The Departments will
consider all comments we receive by the date and time specified in the
DATES section of this preamble, and, when the Departments proceed with
a subsequent document, the Departments will respond to the comments in
the preamble to that document.
VI. Regulatory Impact Analysis
A. Statement of Need
These proposed rules would amend and strengthen the existing
regulations under sections 1311(e)(3) and 2715A of the PHS Act and be
incorporated into section 715 of ERISA and section 9815 to the Code to
enhance price transparency reporting requirements for non-grandfathered
group health plans and health insurance issuers offering non-
grandfathered group and individual health insurance coverage.
Consistent with the goals of Executive Order 14221, these proposed
rules aim to provide patients with clear, accurate, and actionable
pricing information.\170\
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\170\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).
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More broadly, these proposed rules seek to improve the quality,
accuracy, and usability of publicly available pricing disclosures and
cost-sharing information for participants, beneficiaries, and
enrollees. They also address new Federal protections under the No
Surprises Act and reduce duplicative reporting requirements.
By making pricing data more meaningful and accessible, these
changes are intended to help participants, beneficiaries, and enrollees
better understand their potential costs, support more informed
decision-making, and promote greater competition among health care
providers and insurers.
B. Overall Impact
The Departments have examined the impacts of these proposed rules
as required by Executive Order 12866, ``Regulatory Planning and
Review;'' \171\ Executive Order 13132, ``Federalism;'' \172\ Executive
Order 13563, ``Improving Regulation and Regulatory Review''; \173\
Executive Order 14192, ``Unleashing Prosperity Through Deregulation'';
\174\ the Regulatory Flexibility Act (RFA); \175\ section 1102(b) of
the Social Security Act; and section 202 of the Unfunded Mandates
Reform
[[Page 60489]]
Act of 1995 (March 22, 1995, Pub. L. 104-4).
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\171\ Exec. Order No. 12866, 58 FR 51735 (September 30, 1993).
\172\ Exec. Order No. 13132, 64 FR 43255 (August 4, 1999).
\173\ Exec. Order No. 13563, 76 FR 3821 (January 18, 2011).
\174\ Exec. Order No. 14192, 90 FR 9065 (January 31, 2025).
\175\ Regulatory Flexibility Act, Public Law 96-354, 94 Stat.
1164 (September 19, 1980).
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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 regulatory impact analysis (RIA) must be prepared for a
regulatory action that is significant under Executive Order 12866. A
``significant regulatory action'' is also subject to review by the
Office of Management and Budget (OMB). The Departments have concluded
that this rule is likely to have economic impacts of $100 million or
more in at least 1 year. 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
incorporated into this RIA.
C. Affected Entities
This section of the preamble summarizes the number of plans,
issuers, and participant, beneficiaries and enrollees that would be
affected by these proposed rules.
1. Group Health Plans
These proposed rules would affect ERISA-covered group health plans
and non-Federal governmental group health plans. The Departments
estimate there are approximately 2,600,000 ERISA-covered group health
plans, of which approximately 119,000 are self-insured and 1,500,000
are fully funded.\176\ The Departments also estimate that these
proposed rules would affect 90,900 non-Federal governmental group
health plans.\177\ Of these plans, approximately 35.7 percent \178\ (or
32,400) are self-insured,\179\ and 64.3 percent (or 58,400) are fully
funded.\180\
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\176\ There are 2,627,159 ERISA-covered group health plans, of
which 119,485 are self-insured and 1,476,575 are fully funded.
(Based on the 2023 Medical Expenditure Panel Survey Insurance
Component (MEPS-IC) and the 2021 County Business Patterns from the
Census Bureau. Agency for Healthcare Research and Quality, 2023
Medical Expenditure Panel Survey Insurance Component (MEPS-IC),
https://meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp
(last visited Dec. 8, 2025); U.S. Census Bureau, 2021 County
Business Patterns, https://www.census.gov/programs-surveys/cbp/data.html (last visited Dec. 8, 2025).
\177\ 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/tables/2022/econ/gus/2022-governments.html (last
visited Dec. 8, 2025).
\178\ 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.
\179\ 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.
\180\ 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.
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2. Participants, Beneficiaries, and Enrollees
The Departments estimate that there are 135.5 million participants
in ERISA-covered group health plans, of which 78.9 million are in self-
insured plans and 56.6 million are in fully funded plans.\181\ There
are also approximately 44.5 million participants in non-Federal
governmental group health plans, of which 22.8 million are in self-
insured plans and 21.5 million are in fully funded plans.\182\ In
addition, roughly 46 million individuals are covered by private direct-
purchase health insurance.\183\
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\181\ Employee Benefits Security Administration, Health
Insurance Coverage Bulletin: Abstract of Auxiliary Data for the
March 2023 Annual Social and Economic Supplement to the Current
Population Survey (August 30, 2024), https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2023.pdf.
\182\ Id.
\183\ Congressional Research Service, U.S. Health Care Coverage
and Spending, https://sgp.fas.org/crs/misc/IF10830.pdf (last updated
Feb. 19, 2025).
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3. Issuers and TPAs
Finally, the Departments estimate that these proposed rules would
affect 205 TPAs \184\ and 1,375 issuers.\185\ The Departments assume
that fully-insured group health plans would rely on health insurance
issuers. In contrast, self-insured group health plans would depend on
TPAs, including issuers providing administrative services only and non-
issuer TPAs, to implement the proposed 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.\186\ The Departments use the term TPA in this section of
the preamble to refer to any other party with which a self-insured
group health plan has an agreement to provide services to meet the
proposed requirements in these proposed rules.
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\184\ 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, 2023 Medical Loss Ratio Data, https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources
(last updated Dec. 23, 2024).
\185\ 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 2023 reporting year. Centers for Medicare & Medicaid
Services, Medical Loss Ratio Data and System Resources, https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr (last updated Dec.
23, 2024).
\186\ Louise Norris, What is Self-Insured Health Insurance? Most
Very Large Employers Self-Insure, Verywell Health (November 9,
2024), https://www.verywellhealth.com/what-is-self-insured-health-insurance-and-how-is-it-regulated-4688567.
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D. Detailed Economic Analysis
1. Impact Estimates of the Transparency in Coverage Provisions and
Accounting Table
Consistent with Executive Order 12866 and OMB Circular A-4,\187\
Table 37 depicts an accounting statement summarizing the Departments'
assessment of the benefits, costs, and transfers associated with these
proposed
[[Page 60490]]
regulatory actions. The Departments are unable to quantify all of the
benefits and costs associated with these proposed rules due to data
limitations and uncertainty about how plans, issuers, and other
interested parties may respond to these proposed requirements.
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\187\ 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.
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Since the implementation of the 2020 final rules, many plans and
issuers have experienced higher-than-anticipated costs associated with
generating,
[[Page 60493]]
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 seek to
address them in these proposed rules by requiring more efficient
disclosure formats, clarifying data reporting structures and reducing
duplicative data. While the Departments are unable to quantify the
extent of the underestimation in the 2020 final rules, they seek
comment on which particular burden estimates were underestimated and
what data sources can be relied upon to demonstrate the impact.
The following sections outline a more detailed accounting of the
quantified and non-quantified benefits and costs associated with these
proposed rules.
2. Proposed Requirements for Disclosures to Participants,
Beneficiaries, or Enrollees Under 45 CFR 147.211
a. Benefits
The following paragraphs describe the benefits of the proposed
revisions 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 disclaimer related to
balance-billing consistent with balance billing protections under the
No Surprises Act.
(1) Informed Consumer
These proposed amendments would 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 phone number found on
any physical or electronic plan or insurance identification (ID) card
issued to participants, beneficiaries, and enrollees for which a
consumer may seek customer assistance would ensure 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 would be empowered to make cost-conscious decisions about
their health care. In addition, the proposed amendments to the
currently required notice on balance billing would 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, as well
as to ensure that plans and issuers are including this notice unless
the plans or policies are offered in States that categorically prohibit
balance billing.
(2) Timely Payment of Medical Bills
The proposed amended requirements are designed to make the cost-
sharing information disclosed pursuant to these proposed rules more
accessible to more 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 of the
information 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 would 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.\188\ 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 $20.5million in 2017, after implementing an automated cost-
estimation tool that provided transparent pricing before care.\189\
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.\190\ 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.
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\188\ Beth Kutscher, Consumers demand price transparency, but at
what cost?, Modern Healthcare (June 2015), https://www.modernhealthcare.com/article/20150623/NEWS/150629957/consumers-demand-price-transparency-but-at-what-cost.
\189\ Christopher Cheney, Cost estimation drives huge increase
in POS collections, HealthLeaders (Feb. 1, 2018), https://www.healthleadersmedia.com/finance/cost-estimation-drives-huge-increase-pos-collections.
\190\ Sze-jung Wu, Gosia Sylwestrzak, Christine 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.
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(3) Increased Competition Among Providers
The proposed amendments in these proposed 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 proposed rules would ensure broader
access to pricing information. In addition, a clearer notice about
potential balance billing by out-of-network providers would 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 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.\191\ The study also found that price
variations between hospital and non-hospital facilities for MRI scans
decreased by 30percent. 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.\192\ These findings
[[Page 60494]]
support the Departments' view 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.
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\191\ Sze-jung Wu, Gosia Sylwestrzak, Christine 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.
\192\ 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).
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The Departments acknowledge that, while price transparency may
promote competition and reduce costs, some studies indicate it may lead
to price convergence, where lower-cost providers raise prices toward
the market average.\193\ This can occur when providers observe that
competitors charge substantially more for the same service and adjust
their own prices upward to capture additional revenue, potentially
reducing consumer savings.
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\193\ Sunita Desai, Laura A. Hatfield, Andrew L. Hicks, Michael
E. Chernew, et al., Association Between Availability of a Price
Transparency Tool and Outpatient Spending, 315 JAMA 1874, 1881
(2016); Noah Tong, Transparency has led to uniformity in healthcare
costs--but not necessarily lower prices: White paper, Fierce
Healthcare (Oct. 23, 2024), https://www.fiercehealthcare.com/providers/transparency-leading-uniformity-healthcare-costs-not-necessarily-lower-prices-study.
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(4) Reduced Deadweight Loss 194
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\194\ 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 healthcare, 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.
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Through Improved Access to Cost-Sharing Information by Phone
The Departments anticipate that requiring plans and issuers to
provide cost-sharing information by phone would help 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,\195\ and 22 percent of these adults report
never going online at all.\196\ By improving access to real-time,
personalized cost-sharing data for these populations, this proposed
requirement could enable more consumers to compare prices and select
lower-cost providers. This shift in behavior could reduce overpayment
for services and better align spending with consumers' willingness to
pay, thereby decreasing the deadweight loss that results from
information asymmetry.
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\195\ Michelle Faverio, Share of Those 65 and Older who are Tech
Users has Grown in the Past Decade (Jan. 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.
\196\ Andrew Perrin & Sara Atske, 7 percent of Americans Don't
Use the internet. Who are They?, Pew Research Center (Apr. 2, 2021),
https://www.pewresearch.org/short-reads/2021/04/02/7-of-americans-dont-use-the-internet-who-are-they.
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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.\197\ The Departments recognize the potential for
meaningful economic benefits and welcome comment and data that could
inform a more robust estimate of the reduction in deadweight loss
associated with these proposed provisions.
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\197\ Yiquan Gu & Tobias Wenzel, Transparency, price-dependent
demand and product variety, 110 Economics Letters 216, 219 (2011).
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b. Costs
Section IV.C. of this preamble outlines the quantified costs
associated with updating cost-sharing disclosures to reflect Federal
balance billing protections, as described in 26 CFR 54.9815-
2715A2(b)(1)(vii)(A), 29 CFR 2590.715-2715A2(b)(1)(vii)(A), and 45 CFR
147.211(b)(1)(vii)(A). The Departments assume that plans and issuers
have already developed self-service tools and would only need to revise
the disclaimer to state that out-of-network providers may engage in
balance billing, subject to applicable State and Federal laws. Although
these updates build on existing infrastructure, the Departments
estimate that all plans (or TPAs on behalf of plans) and issuers would
incur a one-time cost for minor technical modifications, with a total
burden of 263 hours and an associated cost of approximately $37,657.
Section IV. of this preamble also outlines the quantified costs
associated with providing the cost-sharing information, as described in
26 CFR 54.9815-2715A2(b)(1), 29 CFR 2590.715-2715A2(b)(1), and 45 CFR
147.211(b)(1), over the phone, as proposed in new paragraph 26 CFR
54.9815-2715A2(b)(2)(iii), 29 CFR 2590.715-2715A2(b)(2)(iii), and 45
CFR 147.211(b)(2)(iii). As discussed in more detail in section IV.C. of
this preamble, the Departments have provided both lower impact and
higher impact cost estimates to account for varying call times. The
Departments estimate that all plans (or TPAs on behalf plans) and
issuers would incur a total, low-range, annual ongoing time burden of
585,000 hours with an associated estimated cost of $23,400,000, and a
total, high-range, burden of 1,300,000 hours with and associated
estimated cost of $52,000,000, to provide pricing information by phone.
The Departments have determined that plans and issuers would
leverage their existing customer service call center infrastructure to
provide cost-sharing information over the phone in order to reduce or
eliminate any one-time burden and cost. While the Departments have
determined many plans (or TPAs on behalf of plans) and issuers already
provide some level of real-time phone-based cost-sharing information,
they recognize that some plans and issuers may be required to alter
existing or develop new infrastructure and could incur one-time burden
and cost in order to meet the proposed requirements.
The Departments also anticipate that providing phone-based access
would increase call duration and require plans (or TPAs on behalf of
plans) and issuers to train customer service representatives and
supervisors, resulting in a one-time burden of 290,720 hours and an
estimated total cost of approximately $13,727,040.
The Departments assume that most self-insured group health plans
would rely on TPAs to fulfill these newly proposed requirements and
that TPAs typically serve multiple clients, allowing for economies of
scale, which could result in a lower burden and cost. Additionally, the
Departments acknowledge that plans and issuers might choose to upgrade
their communication systems voluntarily, such as adding mobile call
features or real-time texting, which could result in additional burden
or cost reductions.
The Departments recognize that expanding access to personalized
pricing data, particularly via phone, may increase the risk of
potential exposure of personal health information (PHI) and personally
identifiable information (PII). As with internet-based disclosures,
additional investments in security infrastructure, staff training on
data protection, and consumer privacy tools may be necessary to
mitigate the risk of unauthorized access or breaches. Between 2009 and
2024, there were 6,759 health care data breaches involving 500 or more
records reported to the Department of Health and Human Services Office
for Civil Rights, compromising the data of over 846 million individuals
(an average of more than 2.6 per member of the U.S population).
Notably, in 2024 alone, nearly 277 million individuals were affected,
with an average of over
[[Page 60495]]
758,000 records breached daily.\198\ As a result, complying with these
provisions may necessitate additional safeguards to protect PHI and PII
during phone-based interactions.
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\198\ Steve Adler, Healthcare Data Breach Statistics, The HIPAA
Journal (Sept. 30, 2025), https://www.hipaajournal.com/healthcare-data-breach-statistics/.
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The Departments seek comment on these burden and cost estimates,
including assumptions on disclosures to reflect Federal balance billing
protections, call duration, customer service staffing, and the extent
to which plans (or TPAs on behalf of plans) and issuers are already
equipped to provide real-time cost-sharing information by phone.
While not quantified in this analysis, the Departments acknowledge
that State regulators may incur administrative costs to review,
monitor, or enforce compliance with these additional requirements. The
Departments seek comment on any potential State-level impacts and any
other burdens and costs that could be incurred by entities that would
be affected by the provision of these proposals.
3. Proposed Requirements for Public Disclosure Under 26 54.9815-2715A3,
29 CFR 2590.715-2715A3, and 45 CFR 147.212
The following paragraphs describe the quantified and non-quantified
benefits of the proposed requirements to disclose information related
to in-network rates and historical out-of-network allowed amounts
through machine-readable files.
a. Quantified Benefits
(1) Reduced Data Cleaning and Integration Costs for Third-Party
Developers and Other File Users
The Departments have determined that by reducing the complexity and
inconsistency of data that currently require extensive data processing
and reconciliation, these proposed rules would make machine-readable
data both easier to locate and easier to process for third-party
developers and other file users, such as academics, researchers, data
engineers, and plans and issuers. These proposed rules would do this by
requiring plans and issuers to publish contextual files including a
Change-log File, Taxonomy File, and a Utilization File; report at the
network rather than the plan or policy level; exclude providers that
have in-network rates for items or services for which they are unlikely
to be reimbursed; add enrollment numbers, common network names, and
product types; and standardize file locations with a Text File and
footer links. The Departments anticipate that much of the burden
currently involved in cleaning and processing the machine-readable
files would be eliminated, since the files would contain more accurate
data in smaller sizes. This would reduce the time and resources third-
party developers and other file users spend removing duplicative and
irrelevant data, which in turn would decrease the computational
resources required for data cleaning and integration, further reducing
overall costs.
In particular, the Departments estimate that the proposed
provisions to require network-level reporting, add enrollment numbers,
and specify product types would meaningfully reduce data cleaning and
integration costs for approximately 300 third-party developers and
other file users,\199\ including research shops and consultancies.
Specifically, network-level reporting is expected to save about 40
hours per quarterly reporting cycle, or 160 hours annually. Providing
enrollment data directly in the files would remove the need for third-
party sourcing and integration, saving another 40 hours each year,
while the inclusion of product types would save an estimated 20 hours
per quarterly cycle, or 80 hours annually. Together, these provisions
would reduce about 280 hours of analyst time per year for each third-
party developer or other file user. Using an average hourly wage of
$120 for a Business Analyst,\200\ the total estimated annual labor
savings across all 300 third-party developers and other file users
would be approximately $10.1 million.\201\
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\199\ This estimate is based on discussions with a sample of
third-party developers and other file users. From these discussions,
the Departments estimated a total of approximately 300 third-party
developers and other file users consuming the public disclosures
associated with these rules.
\200\ U.S. General Services Administration, Pricing Intelligence
Suite, CALC information and wage rates, https://buy.gsa.gov/pricing/
(last visited Dec. 8, 2025).
\201\ The total estimated annual labor savings is calculated by
multiplying the 280 hours saved per third-party developer or other
file user by the 300 affected users and the average hourly wage of
$120 (280 x 300 x $120 = $10.1 million).
---------------------------------------------------------------------------
In addition, by requiring plans and issuers to exclude provider-
rate combinations for items and services for which a provider would be
unlikely to be reimbursed, the Departments estimate a substantial
reduction in the data volume that would be disclosed, compared to
current volumes, leading to lower computational costs when processing
the files. Assuming industry-wide disclosures currently total roughly
1,000,000 gigabytes (GB), equivalent to 1 PB \202\ in size per month,
the proposed exclusion of these provider-rate combinations would reduce
file sizes by about 70 percent \203\ to a new estimated size of 300,000
GBs. While most actual savings would be associated with algorithms that
are processing the data, which would reflect much higher actual
computation savings, an absolute baseline can still be established.
---------------------------------------------------------------------------
\202\ Christopher Whaley, Neeraj Radhakrishnan, Michael
Richards, Kosali Simon, et al., Understanding Health Care Price
Variation: Evidence from Transparency-in-Coverage Data, 3 Health
Affairs Scholar 2 (2025), https://doi.org/10.1093/haschl/qxaf011.
\203\ This estimate is based on internal analysis of existing
data and stakeholder feedback. External sources, such as Serif
Health, report rates exceeding 80 percent. Salman Mukhi, Zombie
Hunting: Filtering Approaches for Price Transparency Data (Sep. 20,
2024), https://www.serifhealth.com/blog/zombie-hunting-filtering-approaches-for-price-transparency-data.
---------------------------------------------------------------------------
Assuming an average compute cost of $0.015 per GB RAM-hour for
general purpose usage,\204\ the baseline monthly compute cost for 1 PB
is estimated at roughly $334 \205\ with an annual cost of $4,008. With
a 70 percent reduction in file size, monthly compute costs would
decrease to approximately $100, yielding a monthly savings of $234,
which corresponds to an estimated annual savings of approximately
$2,808 per third-party developer or other file user. Across 300 third-
party developers and other file users, this equates to total annual
savings of approximately $842,400.
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\204\ Amazon Web Services, Amazon EC2 On-Demand Pricing, https://aws.amazon.com/ec2/pricing/on-demand (last accessed Oct. 1, 2025).
\205\ This is calculated using AWS t4g.xlarge throughput of 720
GB/hour and 16 GB of RAM. Total hours = Total data/Throughput =
1,000,000GB/720GB per hour [ap] 1,388.89 hours; GB-RAM-hours = RAM x
Hours = 16GB x 1,388.89 hours [ap] 22,222 GB-RAM-hours; Total cost =
GB-RAM-hours x Price per GB-RAM-hour = 22,222 x $0.015 [ap] $333.33.
---------------------------------------------------------------------------
These proposed rules would also shift the reporting frequency from
monthly to quarterly for In-network Rate and Allowed Amount Files,
reducing the total computational needs accordingly. This change reduces
total annual downloads from 3,600 (300 third-party developers and users
x 12 months) to 1,200 (300 third-party developers and users x 4
months), or an average of 100 downloads per month to be processed.
Under quarterly reporting, the estimated annual industry-wide
computational costs for the optimized files would be $120,000.\206\
Relative to the monthly baseline, this cadence change combined with the
file-size reduction yield $1,082,400 in total annual compute savings.
Of this amount, approximately
[[Page 60496]]
$842,400 of compute savings is attributable to file-size optimization,
while an additional $240,000 results from the reduction in reporting
frequency.
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\206\ Total computational costs for new files (300,000 GB)
processed quarterly are calculated as $100 x 1,200 downloads per
year = $120,000.
---------------------------------------------------------------------------
The Departments have determined that together these proposed
provisions would result in total annual savings of roughly $11.2
million ($10.1 million in labor savings plus $1.1 million in industry-
wide storage cost savings from the shift to quarterly reporting) for
third-party developers and other users of price transparency data,
while supporting the intended goal of making price data more usable and
actionable.
The Departments seek comment on the estimated potential cost and
time savings from streamlining and standardizing the machine-readable
files, and on whether these proposed provisions would effectively
result in reduced data processing burdens and costs for users.
(2) Reduced Storage Costs for Plans, Issuers, Third-Party Developers,
and Other Files Users
The proposed provisions would lead to reduced storage costs for
plans, issuers, third-party developers, and other users by
significantly decreasing the total volume of data needed to generate,
store, and make available for download. These proposals would minimize
data duplication and reduce both the number and size of the machine-
readable files by changing the reporting cadence for both the In-
network Rate File and the Allowed Amount File from monthly to
quarterly, requiring reporting of negotiated rates at the network level
rather than the plan or policy level, and excluding provider-rate
combinations in the In-network Rate File for certain items and
services.
The Departments have determined that these changes could lower
ongoing storage, backup, and processing costs for the In-network Rate
File, making it easier and more cost-effective for third-party users to
download and build and manage consumer-facing price comparison tools
based on the machine-readable data. Further, the Departments anticipate
some users would opt not to download and store all of the new In-
network Rate Files, given the Change-log File would identify changes in
data from one In-network Rate File to the next, further decreasing data
storage and processing costs.
Researchers have estimated that the combined monthly file sizes
across industry for the In-network Rate Files are over 1 PB. The
Departments estimate that the proposed changes would reduce file sizes
by approximately 70 percent, lowering the monthly data volume from
about 1,000,000 GB to approximately 300,000 GB.
Using Amazon Web Services (AWS) S3 pricing as a benchmark, $0.023
per GB for the first 50 TB, $0.022 per GB for the next 450 TB, and
$0.021 per GB beyond that,\207\ storing 1 PB worth of data would result
in an estimated baseline monthly storage cost of roughly $22,583 with
an annual cost of approximately $270,996. With a 70 percent reduction
in file size, monthly storage costs would decrease to approximately
$6,651 ($79,812 annually), yielding a monthly savings of $15,932 and an
estimated annual savings of approximately $191,184. These cost savings
would apply for all plans and issuers.
---------------------------------------------------------------------------
\207\ Amazon Web Services, Amazon S3 pricing, https://aws.amazon.com/s3/pricing/ (last accessed Oct. 1, 2025).
---------------------------------------------------------------------------
Assuming 300 third-party developers and other file users download
the files each month, total annual storage costs under current file
size assumptions would be approximately $81,298,800.\208\ With the 70
percent file-size reduction, the annual cost for all 300 third-party
developers and other file users would drop to $23,943,600.\209\ This
results in an annual storage savings of roughly $57,355,200 \210\ for
the 300 third-party developers and other files users based on file-size
optimizations.
---------------------------------------------------------------------------
\208\ This is calculated by multiplying the current yearly cost
to download multiplied by the number of third-party developers and
other file users: $270,996 x 300 = $81,298,800.
\209\ This figure is calculated by multiplying the annual cost
per user after the file-size reduction ($79,812) by the number of
third-party developers and other file users (300): $79,812 x 300 =
$23,943,600.
\210\ Annual storage savings of $57,355,200 is calculated by
subtracting the total annual cost after file-size reduction
($23,943,600) from the total annual cost under current file-size
assumptions ($81,298,800): $81,298,800-$23,943,600 = $57,355,200.
---------------------------------------------------------------------------
However, because these proposed rules also shift the reporting
frequency from monthly to quarterly, total storage needs and
corresponding savings would be reduced accordingly. Under quarterly
reporting, annual industry-wide storage cost for the reduced file size
for the In-network Rate Files savings is estimated at $7,981,200.\211\
Relative to the monthly baseline, this cadence change combined with the
file-size reduction yield about $73,317,600 in total annual
savings.\212\ Of this amount, approximately $57,355,200 in storage
savings can be attributed to file-size optimization, while an
additional $15,962,400 can be attributed to the reduction in reporting
frequency.
---------------------------------------------------------------------------
\211\ This is calculated by multiplying the reduced monthly
storage cost ($6,651) by 4 quarterly reports and 300 third-party
developers and other files: $6,651 x 4 x 300 = $7,981,200.
\212\ This is calculated by subtracting the total storage costs
for the new, quarterly file downloads ($7,981,200) from the total
storage costs for the current monthly downloads ($81,298,800):
$81,298,800-$7,981,200 = $73,317,600.
---------------------------------------------------------------------------
The Departments seek comment on the assumptions made and the
estimated storage cost savings for plans and issuers, third-party
developers, and other users from reducing data volume.
(3) Reduced Network Egress Costs for Plans and Issuers
In addition to the estimated savings from reduced storage
requirements, the Departments anticipate that the proposed provisions
would also lead to a reduction of bandwidth network costs for plans and
issuers needed with making their machine-readable files available for
download.
Using the estimates developed and discussed in the preceding
section for the In-network Rate File, and applying AWS egress costs,
which are fees for data transferred from AWS to the public internet, as
a benchmark--the first 100 GB are free, followed by $0.09 per GB for
the first 50 TB, $0.085 per GB for the next 40 TB, $0.07 per GB for the
next 100 TB, and $0.05 per GB for any amount exceeding 150 TB.\213\ The
Departments estimate a monthly tiered egress cost of transferring 1 PB
data would be approximately $53,800 with an estimated annual cost of
roughly $645,600. With a 70 percent reduction in file size to 300,000
GB, monthly data transfer egress costs would decrease to about $18,795,
with estimated annual costs of approximately $225,600. This would yield
a monthly savings of $35,005 and annual cost savings of approximately
$420,060 for all plans and issuers. These cost estimates assume a
single data transfer, or download, each month.
---------------------------------------------------------------------------
\213\ Amazon Web Services, Amazon EC2 On-Demand Pricing, https://aws.amazon.com/ec2/pricing/on-demand/ (last accessed Oct. 1, 2025).
---------------------------------------------------------------------------
Because files would not be downloaded just once, the Departments
would also estimate the number of users that would download the entire
data set each month. Assuming 300 third-party developers and other file
users download the files each month, total annual egress costs under
current file size assumption would be nearly $194 million.\214\ With
the optimized file size estimates, the costs would be reduced
[[Page 60497]]
by about $68 million annually,\215\ yielding total industry-wide
savings of $126 million annually.\216\
---------------------------------------------------------------------------
\214\ At current file sizes, data transfer cost estimates are
approximately $53,800 per month for 1 PB data. The Departments
assume that 300 third-party developers and other file users each
download one file per month (12 annually), resulting in 3,600 total
downloads per year. Based on a cost of $53,800 per download, the
estimated annual cost is approximately $193,680,000 ($53,800 x
3,600).
\215\ This is calculated as follows: Estimated size data
transfer cost estimates for optimized files are $18,795 per month
for transferring 300,000 GB. The Departments assume that 300 third-
party developers and other file users each download one file per
month (3,600 downloads each year). At this rate, the total annual
cost is estimated at $67,662,000 ($18,795 x 3,600).
\216\ Estimated annual size data transfer cost savings are
calculated by subtracting the total annual cost for the optimized
300TB files ($67,662,000) from the total annual cost for the
original 1PB files ($193,680,000): $193,680,000-$67,662,000 =
$126,018,000.
---------------------------------------------------------------------------
Similar to reduced storage costs for plans and issuers discussed in
section VI.D.3.a.(2). of this preamble, these proposed rules would also
shift the reporting frequency from monthly to quarterly, which reduces
total egress needs and corresponding savings. This change reduces total
annual downloads from 3,600 (300 third-party developers and other file
users x 12 months) to 1,200 (300 third-party developers and other file
users x 4 months), or an average of 100 downloads per month. Under
quarterly reporting, annual industry-wide egress costs for the
optimized files would be about $22.6 million.\217\ Relative to the
monthly baseline, this cadence change combined with the file-size
reduction would yield about $171 million in total annual savings.\218\
Of this amount, approximately $126 million egress savings would be
attributable to file-size optimization, while an additional $45 million
would result from the reduction in reporting frequency.
---------------------------------------------------------------------------
\217\ Total network costs for transferring new files (300,000
GB) on a quarterly basis are calculated by multiplying the monthly
cost per file transfer ($18,795) by the total annual downloads
(1,200): $18,795 x 1,200 downloads per year = $22,554,000.
\218\ Total network cost savings are calculated by subtracting
the total annual network costs for the new files downloaded
quarterly ($22,554,000) from the total annual costs for the current
monthly downloads ($193,680,000): $193,680,000-$22,554,000 =
$171,126,000.
---------------------------------------------------------------------------
The Departments seek comment on the assumptions made and
anticipated egress cost savings for plans and issuers from reducing
data volume and reporting cadence.
(4) Reduced Time Locating the Files for Third-party Developers and
Other File Users
The Departments' proposal to require plans and issuers to include a
standardized Text File and place a direct link to the files in the
website footer would make it easier for third-party developers and
other file users, who currently face challenges navigating plan or
issuer websites to find their machine-readable files, to more
efficiently locate and access the data needed for their applications
and analyses.
The time savings from locating files primarily stem from the
proposed requirement that plans and issuers include a standardized Text
File that includes, among other things, the source page URL for the
internet website that hosts the machine-readable files, and a footer
link in certain prominent locations that links directly to the web page
that hosts the link to the machine-readable files. Additionally, the
proposed change from monthly to quarterly reporting would reduce the
number of times a file user would need to locate the In-network Rate
and Allowed Amount Files to find updated information. Together, the
Departments estimate that these changes would save about 10 hours \219\
of labor quarterly (or 40 hours annually) for each third-party
developer or file user, reflecting the reduced need to manually track
down and verify file locations. Using an average hourly wage of $120
for a Business Analyst,\220\ the Departments estimate that total annual
labor savings for all third-party developers and other file users would
amount to approximately $1.4 million.\221\ The Departments seek comment
on the assumptions and estimated burden and cost savings from making
the machine-readable files easier to locate through standardized links.
---------------------------------------------------------------------------
\219\ The estimated 10 hours saved annually per organization is
based on the assumption that, for each update, organizations review
the prior month's links to locate files, and only a subset of those
files requires additional effort to determine their posting
location.
\220\ U.S. General Services Administration, Pricing Intelligence
Suite, CALC information and wage rates, https://buy.gsa.gov/pricing/
(last visited Dec. 8, 2025).
\221\ The total annual labor savings estimate is derived as
follows: each of the approximately 300 third-party developers and
other file users is estimated to save 10 hours of labor per
quarterly reporting cycle as a result of the proposed standardized
Text file and footer link, which facilitate easier file location.
With four reporting cycles per year, this equates to 40 hours saved
annually per third-party developer or other file user. Applying an
average hourly wage for a Business Analyst of $120 results in an
estimated annual savings of approximately $4,800 per third-party
developer or other file user (40 hours x $120). When aggregated
across the estimated 300 third-party developers and other file
users, the total annual labor savings amount to approximately
$1,440,000.
---------------------------------------------------------------------------
The Departments have determined that the provisions of these
proposed rules would help reduce administrative complexity and advance
the objective of making price transparency data more accessible,
efficient, and actionable for participants, beneficiaries, and
enrollees.
As shown in Table 38, the proposed provisions are estimated to
generate total annual benefits of approximately $257 million for plans,
issuers, third-party developers, and other users.
[GRAPHIC] [TIFF OMITTED] TP23DE25.089
[[Page 60498]]
b. Non-Quantified Benefits
(1) Stronger Market Leverage for Plans and Issuers
By requiring more streamlined, meaningful, and clear disclosure of
in-network rates and detailed out-of-network data, the provisions in
these proposed rules would better enable plans and issuers to compare
their in-network rates and out-of-network coverage with those of
competitors. The addition of contextual files, including the Taxonomy
File, Utilization File, and Change-log File, would enhance the
practical value of this data, helping plans and issuers see not just
raw prices but also provider specialties, actual in-network
utilization, and historical changes in rate information. This would
support plans and issuers in identifying gaps, trends, and outliers
within their own networks and relative to the market. This enhanced
transparency might strengthen their ability to negotiate lower
reimbursement rates with providers based on knowing what those
providers have negotiated with other payers that are similarly situated
within the market for the same items or services with other plans and
issuers that are similarly situated within the market. However, as
noted in section VI.D.2.a.(3). of this preamble, the Departments also
recognize the potential for this information to drive rates up if
providers learn they are being paid less than other providers and use
that information to seek higher negotiated rates.
By enhancing the transparency of out-of-network allowed amounts and
historic billed charges, these provisions might facilitate broader
adoption of private health insurance market reference-based pricing
strategies. Specifically, the proposed requirements related to the
Allowed Amount File would provide the public with clearer information
on what out-of-network providers charge. This additional transparency
could help plans and issuers, and other consumers, better identify
lower-cost providers and benchmark reasonable prices, ultimately
supporting strategies where participants, beneficiaries, or enrollees
pay the difference when selecting higher-cost providers in
circumstances where they have a meaningful choice among providers.
Plans and issuers may use such reference-based pricing structures to
guide participants, beneficiaries, and enrollees toward lower-cost
providers. While the Departments recognize that reference-based pricing
may not apply uniformly (for example, some plans offer exemptions based
on clinical need or geographic limitations), it has generally led to
cost reductions. For instance, combining price transparency with
reference pricing has led to significant shifts in consumer choice of
facility, resulting in a 27 percent reduction in the average price paid
per laboratory test and a 13 percent reduction in the average price
paid per imaging test.\222\
---------------------------------------------------------------------------
\222\ Christopher Whaley, Timothy Brown, & James Robinson,
Consumer responses to price transparency alone versus price
transparency combined with reference pricing, 5 American Journal of
Health Economics 227, 249 (2019).
---------------------------------------------------------------------------
(2) Enhanced Regulatory Oversight and Inform Policymaking
The Departments expect that State and Federal regulators could gain
efficiencies and increased insights from the data reporting pursuant to
the amended disclosure requirements in these proposed rules. The
proposals would give regulators access to more streamlined, usable, and
actionable in-network rate and out-of-network data, which may support
more informed oversight of premium rate filings by enabling more
effective monitoring of market trends and price variations. The
proposals may also help States monitor rates to identify collusive
behaviors, as well as help establish benchmarks for negotiations with
providers as part of State oversight activities related to coverage
programs, ultimately strengthening regulatory oversight and promoting
more competitive markets.
(3) Increased Understanding and Empowered Consumers
These proposals aim to empower participants, beneficiaries, and
enrollees by increasing transparency around what plans and issuers
reimburse providers for covered items and services. By providing access
to clearer, more streamlined, and more specific in-network rates,
historical out-of-network allowed amounts, and billed charges, file
users and ultimately health care consumers might be better equipped to
understand how their choices of coverage and providers affect their
costs. This transparency may support more informed consumer decision-
making when comparing plans or selecting providers. Adding supporting
contextual information to accompany the data is expected to enhance
overall usability for third-party developers and other file users. As
stated in the preamble to the 2020 final rules, the Departments
expected third-party developers and other innovators to use the
machine-readable file data to create ``easy-to-use internet-based tools
and mobile applications that will present information to laypersons in
easy-to-understand, plain language that is sufficiently concise and
well-organized,'' \223\ which would allow ``consumers to consider price
as a factor when making meaningful comparisons between different
coverage options and providers.'' \224\ The Departments are encouraged
by the consumer-facing tools that have been built since implementation
of the 2020 final rules and look forward to additional growth in this
space following implementation of the enhancements in these proposed
rules.
---------------------------------------------------------------------------
\223\ 85 FR 72169 (November 12, 2020).
\224\ 85 FR 72210 (November 12, 2020).
---------------------------------------------------------------------------
c. Costs
This section of the preamble provides both quantitative and
qualitative discussion of the costs associated with the Departments'
proposed revisions to the requirements that plans and issuers make
information regarding in-network negotiated rates and out-of-network
allowed amounts available through machine-readable files on a public
website. The Department request comment and data on how to better
quantify these costs.
Section IV.D. of this preamble outlines the quantified costs
associated with requirements for public disclosure of in-network rates
and allowed amount data for covered items and services from in- and
out-of-network providers, as described under 26 CFR 54.9815-2715A3, 29
CFR 2590.715-2715A3, and 45 CFR 147.212.
For In-network Rate Files, this proposal would require plans and
issuers to create a separate file for each provider network, allow
rates to be expressed as a percentage of billed charges when
appropriate, include enrollment totals for each plan or coverage
option, disclose provider network product types, and exclude providers
unlikely to be reimbursed based on their scope of practice. The
Departments estimate that all plans (or TPAs on behalf of plans) and
issuers would incur a one-time burden of 717,952 hours on the low end
and 758,400 hours on the high end, with associated costs of
approximately $102,371,360 and $108,084,640, respectively. While these
proposals would involve a one-time cost to modify existing processes,
the Departments expect that, once these updates are implemented, the
ongoing burden related to including product type, excluding certain
providers, reporting dollar amounts (except for ``percentage-of-billed-
charges'' payments), including enrollment data, organizing files by
provider network, and allowing service
[[Page 60499]]
providers to organize files across multiple self-insured plans would be
minimal, beyond current costs for monitoring and maintaining these
processes.
For Allowed Amount Files, the proposal includes requiring 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.
The Departments estimate that all plans (or TPAs on behalf of plans)
and issuers would incur a one-time burden of 101,120 hours, with
associated costs of approximately $14,283,200. While lowering the
claims threshold to 11 is expected to require only minor system
adjustments, the Departments anticipate minimal ongoing costs for
maintaining and monitoring compliance. Similarly, extending the
lookback period is not expected to impose a significant additional
burden, as automated systems are already in place to report out-of-
network allowed amounts for the 90-day reporting period beginning 180
days before publication. Ongoing costs for aggregating out-of-network
Allowed Amount Files by market type are also expected to be minimal.
In addition, these proposed rules would require plans and issuers
to post several contextual machine-readable files: a Change-log File, a
Utilization File, a Taxonomy File, and a Text File, each with specific
update and posting requirements. The Departments estimate a one-time
burden of 5,548,960 hours for plans (or TPAs on behalf of plans) and
issuers, with associated costs of approximately $777,578,040 to add and
implement these files, with an ongoing annual burden of 60,040 hours
(costing approximately $9,186,120) to update the Utilization File and
47,400 hours (costing approximately $7,015,200) to address point-of-
contact inquiries to improve discoverability and accessibility of the
machine-readable files. The Change-log File is expected to be fully
automated, and the Departments anticipate only minimal system
maintenance beyond the initial generation and posting of the file.
Similarly, once the initial setup for adding a Text File is complete,
ongoing updates are expected to require minimal effort. The Departments
also assume that including a link to the internet domain hosting the
machine-readable files on the website footer would result in minimal
additional burden.
(1) Non-Quantified Costs for Public Disclosure of In-Network Provider
Rates
The proposed provisions are expected to introduce meaningful
improvements to the quality, clarity, and usability of In-network Rate
Files, such as requiring files to be organized by provider network
rather than by plan or policy, allowing for percentage-of-billed
charges reporting when the dollar amount is not known in advance,
adding contextual files like Taxonomy, Utilization, and Change-log
files, and excluding certain provider-rate combinations if it is
unlikely that a provider would be reimbursed for an item or service
given that provider's area of specialty. While these improvements aim
to help file users, tool developers, and regulators better navigate and
interpret rate data, they may also create non-quantified operational
and market-level costs for plans and issuers.
Specifically, plans and issuers could face additional
administrative and compliance costs from producing and maintaining
stricter standardized machine-readable files. This may involve internal
quality reviews, greater coordination across business units, as well as
potential redesign of existing automated processes to create network-
specific files and incorporate new required data fields.
There is also a risk that improving the transparency of negotiated
rates may cause some providers to raise their prices if they discover
they are paid less than their peers. This response could contribute to
price convergence rather than sustained downward pressure on costs, an
effect observed in some transparency studies, where high prices fall
slightly but lower prices rise, ultimately reducing overall savings.
For instance, one study found that although price transparency has
helped narrow price variation in health care, it has not consistently
lowered overall prices. According to the study, the highest prices fell
by 6.3 percent, while the lowest prices rose by 3.4 percent, and mid-
range prices decreased only slightly by 1.1 percent.\225\ While the
study does not address the effect on average prices, these findings
suggest that transparency can pressure high-cost providers to reduce
prices but may also lead lower-cost providers to increase prices. A
2020 study also suggests that price transparency could facilitate
tactical collusion, resulting in higher prices in markets that are not
perfectly competitive, such as health care. In these markets, there are
fewer sellers and higher barriers to entry for new competitors.\226\
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\225\ Forrest Xiao, The Healthcare Cost Conundrum: Prices are
Stabilizing. Why are Expenses Still Rising?, Turquoise Health (Oct.
31, 2024), https://blog.turquoise.health/the-healthcare-cost-conundrum/.
\226\ Robert F. Graboyes & Jessica McBirney, Price Transparency
in Healthcare: Apply With Caution, Mercatus Center, George Mason
University (2020), https://www.mercatus.org/system/files/graboyes-price-transparency-mercatus-research-v1.pdf.
---------------------------------------------------------------------------
Another potential cost stemming from increased transparency due to
improvements in In-network Rate Files is the impact on a plan's or
issuer's ability or incentive to develop and maintain a robust provider
network. A provider network consists of health care providers that have
entered into agreements with plans or issuers to deliver care at a
negotiated rate, which the provider accepts as full payment. Plans and
issuers often prefer their participants, beneficiaries, and enrollees
to use in-network providers, as these providers meet the health plan's
quality standards and agree to lower rates in exchange for the patient
volume they will receive by being part of the network.\227\ Some plans
and issuers use narrow networks, which include a more limited group of
providers. While these networks offer fewer in-network options to
participants, beneficiaries and enrollees, they often result in lower
monthly premiums and reduced out-of-pocket costs.\228\ The Departments
recognize that publicly disclosing negotiated rates may reduce the
incentive for providers to enter into such contractual agreements,
particularly in narrow networks, if they know those rates will be made
public or they are being offered lower than market rates. This could,
in turn, limit network options available to plans and issuers.
---------------------------------------------------------------------------
\227\ Elizabeth Davis, Health insurance provider network
overview, Verywell Health (Feb. 9, 2025), https://www.verywellhealth.com/health-insurance-provider-network-1738750.
\228\ Tracy Anderman, What to know about narrow network health
insurance plans, Consumer Reports (Nov. 23, 2018), https://www.consumerreports.org/health-insurance/what-to-know-about-narrow-network-health-insurance-plans.
---------------------------------------------------------------------------
Smaller issuers may be disproportionately affected by the improved
transparency of negotiated rates, as they may be unable to match the
higher rates that larger issuers can offer. In turn, smaller issuers
may be forced to contract only with lower-cost providers, potentially
leading to narrower networks and affecting participant, beneficiary,
and enrollee access to care. Such network constraints may also make it
more difficult for these issuers to fully comply with network adequacy
standards described at 45 CFR 156.230 or applicable State standards.
Ultimately, while the purpose of
[[Page 60500]]
improving price transparency is to empower participants, beneficiaries,
and enrollees and enhance market efficiency, the Departments
acknowledge that these proposed provisions could, in some cases, reduce
the ability or incentive of plans and issuers, especially smaller ones,
to build and maintain robust networks that satisfy quality and access
requirements.
(2) Non-Quantified Costs for Public Disclosure of Out-of-Network
Allowed Amounts
The Departments recognize the potential costs arising from the
proposed expansion of data in the Allowed Amount Files. These may
include the increased complexity and administrative burden of managing
and reporting a larger volume of data over extended reporting and
lookback periods, as well as at the broader health insurance market
level rather than at the plan or policy level. Additionally, to account
for the expanded handling of detailed claims data, plans and issuers
might face additional expenses for enhanced cybersecurity measures and
compliance with data privacy regulations. These potential costs are
difficult to quantify given current data limitations, but the
Departments acknowledge that they represent important considerations
associated with implementing these proposed provisions.
The Departments seek comment and data on the potential magnitude of
these non-quantified costs, including legal, operational, and network
impacts, and how they may affect plan and issuer implementation and
that may assist the Departments' estimate on any related additional
burden and cost.
4. Summary of Transfers
The requirements of these proposed rules, as discussed in section
III. of this preamble, require plans and issuers to enhance the
accuracy and usability of pricing information through improved machine-
readable files, expand cost-sharing disclosure methods (including phone
access), and streamline reporting requirements. As a result of the
proposed requirements, the Departments expect various transfers,
discussed in this section of the preamble, to occur between plans and
issuers; providers; participants, beneficiaries, and enrollees; and the
Federal government. While the precise magnitude of these transfers is
difficult to quantify due to varying market conditions and consumer
behaviors, the directional effects and distributional impacts can be
analyzed conceptually.
a. Transfer From Higher-Cost to Lower-Cost Providers
If participants, beneficiaries, and enrollees gain easier access to
pricing information through enhanced machine-readable files and phone-
based cost-sharing estimates, some consumers might switch from higher-
cost to lower-cost providers for comparable services. This transfer
occurs as consumer cost preferences result in shifts from providers who
charge what consumers feel are above-market rates, to those offering
what the consumer feels to be more competitive pricing. The magnitude
of this transfer would depend on several factors: the degree of price
variation between providers, consumer price sensitivity, and the
consumer's relationships between those providers.
Some evidence shows that in competitive markets, price ranges may
narrow as lower-cost providers raise their prices to align with higher-
cost competitors, potentially increasing costs.\229\ Disclosing
negotiated rates can enable providers to match each other's prices,
which may further limit cost reductions or even lead to higher overall
prices despite the increased transparency.\230\ However, in some
instances, increased transparency could lead higher-cost providers to
face new pressure to lower costs, potentially decreasing costs.\231\
The Departments acknowledge that this transfer may be partially offset
by potential price convergence effects, where lower-cost providers may
increase their prices toward market averages once pricing becomes more
transparent. However, the net effect is expected to favor more
efficient providers and create competitive pressure for cost reduction
across the market.
---------------------------------------------------------------------------
\229\ Forrest Xiao, The Healthcare Cost Conundrum: Prices are
Stabilizing. Why are Expenses Still Rising?, Turquoise Health (Oct.
31, 2024), https://blog.turquoise.health/the-healthcare-cost-conundrum/.
\230\ David N. Bernstein & Jonathan R. Crowe, Price Transparency
in United States' Health Care: A Narrative Policy Review of the
Current State and Way Forward, 61 INQUIRY: The Journal of Health
Care Organization, Provision, and Financing (2024).
\231\ Yanzhi Feng, Price Transparency in Healthcare: Bargaining
Incentives and Patient Responses, 102 Journal of Health Economics
(2025).
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b. Transfer From Providers to Consumers Through Reduced Out-of-Pocket
Spending
If consumers use enhanced pricing information to select lower-cost
providers, their out-of-pocket expenses for health care services are
expected to decrease, representing a transfer from the provider to the
consumer. This transfer is facilitated by the proposed requirement to
make cost-sharing information available by phone, which might
particularly benefit populations who face barriers to using online
tools, including older adults, individuals with disabilities, and those
with limited internet access. By expanding access to personalized
pricing information, these consumers might make more cost-conscious
health care decisions, resulting in lower deductibles, copayments, and
coinsurance amounts. The magnitude of this transfer could vary
significantly based on individual utilization patterns, plan design,
and the availability of lower-cost alternatives within their provider
networks. This shift is consistent with empirical findings that greater
price transparency can help consumers make more cost-effective choices
and encourage market competition.\232\
---------------------------------------------------------------------------
\232\ Zachary Y. Brown, Equilibrium Effects of Health Care Price
Information, 101 Review of Economics and Statistics 4 (2019);
Christopher Whaley, Zachary Brown, & John C. Robinson, Consumer
Responses to Price Transparency Alone Versus Price Transparency
Combined with Reference Pricing, 5 American Journal of Health
Economics 227 (2019).
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c. Transfer From Plans and Issuers to Participants, Beneficiaries, and
Enrollees Through Potential Premium Reductions
If enhanced price transparency leads to systematic shifts toward
lower-cost providers and overall reductions in health care spending,
plans and issuers may experience lower claims costs, which could
eventually translate to reduced premiums for participants,
beneficiaries, and enrollees. That is, as plans and issuers experience
lower medical costs due to participant, beneficiary, and enrollee price
shopping, competitive pressure may lead to premium reductions to
attract and retain enrollees. However, the magnitude of this transfer
would depend on several factors, including the degree of competition
across different market segments and geographic areas (for example,
urban vs. rural markets) and the rate in which consumer utilization
patterns change.
d. Transfer From Premium Tax Credit (PTC) Eligible Consumers to Federal
Government Through Reduced PTC
If enhanced price transparency leads to lower premiums in the
individual insurance market, consumers eligible for PTCs would receive
smaller subsidy amounts, resulting in a transfer from consumers to the
Federal government. This transfer would occur if, through the use of
transparency tools, premiums in the individual market declined
[[Page 60501]]
(including the second lowest-cost silver benchmark plan) and thus
resulted in a reduction in Federal spending through reduced PTC
amounts. The magnitude of this transfer would depend on the extent to
which price transparency leads to substantial competitive pressure,
overall premium reductions, and the number of PTC-eligible consumers
affected. For subsidized consumers, the net effect may be largely
neutral, since their required premium contributions are based on income
rather than plan cost; however, if they choose a lower-cost plan as
premiums decrease, they could experience a net benefit. On the other
hand, unsubsidized consumers would generally see a positive impact from
any premium reductions.
e. Transfer From Federal Government to Consumers Through Increased PTCs
If the costs associated with enhanced transparency requirements
contribute to premium increases, for example, through price
convergence, this could result in higher PTC payments to eligible
consumers, representing a transfer from the Federal government to
consumers. This transfer could also occur if the costs of implementing
enhanced machine-readable file requirements, phone-based cost-sharing
tools, and other transparency measures result in increased premiums.
The magnitude and direction of this transfer is uncertain due to the
variation in market responses; however, these proposed rules are
designed to reduce administrative burden and streamline reporting
requirements and thus reduce premiums and overall costs.
The Departments acknowledge uncertainty in both the magnitude and
timing of these potential transfers. Market responses to price
transparency efforts might vary widely based on local competitive
conditions, consumer behavior patterns, provider networks, and the
specific design of transparency tools. This analysis focuses on
directional effects and distributional considerations rather than
precise quantification, given the limited empirical evidence on the
specific transparency enhancements proposed in this rule, and evidence
indicates that, while transparency may create competitive pressure and
encourage cost reductions, the net effects on prices and transfers
remain uncertain.\233\ Price transparency can influence consumer
decision-making, potentially encouraging shifts toward lower-cost
providers; \234\ however, in markets that are not perfectly
competitive, it can sometimes lead to price alignment or collusion,
which may increase prices rather than lower them.\235\
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\233\ Harold A. Pollack, Necessity for and Limitations of Price
Transparency in American Health Care, 24 AMA Journal of Ethics E1069
(Nov. 2022).
\234\ McKinsey & Company, Consumer Decision Making in
Healthcare: The Role of Information Transparency (July, 2020),
https://www.mckinsey.com/~/media/McKinsey/Industries/
Healthcare%20Systems%20and%20Services/Our%20Insights/
Consumer%20decision%20making%20in%20healthcare/Consumer-decision-
making-in-healthcare-The-role-of-information-transparency.pdf.
\235\ Robert F. Graboyes & James McBirney, Price Transparency in
Healthcare: Apply with Caution, Mercatus Center, George Mason
University (2020), https://www.mercatus.org/system/files/graboyes-price-transparency-mercatus-research-v1.pdf.
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The Departments seek comment on the potential transfers described
previously, including any potential transfers from higher-cost
providers to participants, beneficiaries, and enrollees and issuers
resulting from improved price transparency, as well as any possible
impacts resulting from the potential for provider collusions and price
convergence.
5. Uncertainty Analysis
The Departments recognize that the assumptions underlying the
estimated costs and benefits described in sections VI.D.2.b. and
VI.D.3.a. of this preamble involve a degree of uncertainty. Differences
in plan and issuer size, internal systems, and workflows may affect the
resources required to implement the proposed requirements. The quality,
structure, and reporting practices of existing files could also shape
the extent of savings realized by third-party developers and other
users. In addition, labor costs, technical implementation needs, and
the pace of adopting new practices are likely to vary across the
industry. External factors, such as market behavior, regulatory
changes, or shifts in the number of file users, may further influence
the overall impacts. The Departments seek comment on these assumptions
and uncertainties, and welcome data or information that could improve
the accuracy of the estimates or help identify ways to address
potential variability.
6. Regulatory Review Cost Estimation
To comply with these proposed rules, affected entities must first
review and understand the regulatory requirements. While plans and
issuers are ultimately responsible for meeting these proposed
requirements, the Departments expect, as assumed elsewhere, that the
burden of compliance would fall primarily on issuers and TPAs, with
only the largest self-insured plans likely to assume this
responsibility directly. While the Departments do not have specific
data on how many large self-insured plans will opt to comply
independently, such plans would likely incur similar costs and burdens
as issuers and TPAs in developing compliant tools and reviewing these
proposed rules. Therefore, for purposes of estimating regulatory review
costs, the Departments assume that a total of 1,580 issuers and TPAs
would take on these responsibilities.
Additionally, the Departments expect States to review these
proposed rules to prepare for oversight and enforcement duties. If
these proposed rules impose administrative costs on private entities,
such as the time required to review and interpret these proposed rules,
the Departments should estimate the costs associated with regulatory
review. Given the difficulty in precisely determining how many entities
will undertake such a review, the Departments assume that all plans (or
TPAs on behalf of plans) and issuers, and States would need to review
these proposed rules in order to comply.
The Departments acknowledge that this assumption may overstate or
understate actual costs, as not all entities may conduct an in-depth
review, and some may rely on external counsel or consultants.
Nonetheless, the Departments have determined that using the total
number of plans, issuers, and States provides a reasonable basis for
estimating the regulatory review burden.
Using data from the Bureau of Labor Statistics' Occupational
Employment and Wage Statistics,\236\ the Departments assume that
issuers and TPAs would rely on a Computer and Information Systems
Manager (Code 11-3021) and a Lawyer (Code 23-1011) to review and
interpret these proposed rules. For States, a Compliance Officer (Code
13-1041) is assumed to perform this task. Assuming an average reading
speed of 200 words per minute and using BLS median wage data (including
a 100 percent increase to account for the cost of fringe benefits and
other indirect costs), the Departments estimate that each issuer or TPA
would require approximately 2.9 hours of review by a Computer and
Information Systems Manager (at $164.62/hour) and 5.8 hours by a Lawyer
(at $145.34/hour). Based on these assumptions, the combined labor cost
for all 1,580 issuers and TPAs is approximately $2,068,200.
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\236\ U.S. Bureau of Labor Statistics, National Occupational
Employment and Wage Estimates (May 2024), https://www.bls.gov/oes/current/oes_stru.htm.
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[[Page 60502]]
For States, it is estimated that a Compliance Officer would need
approximately 4.6 hours (at $75.40/hour) to review these proposed
rules, resulting in a total cost of $22,111 across all 50 States and
the District of Columbia. Accordingly, the total combined estimated
cost of regulatory review for all plans and issuers, and State DOIs is
approximately $2,090,311.
E. Alternatives Considered
1. Disclosure of Claims Volume
The Departments considered adding a new content element under the
In-network Rate File requirements at 26 CFR 54.9815-2715A3(b)(1), 29
CFR 2590.715-2715A3(b)(1), and 45 CFR 147.212(b)(1) requiring
disclosure of claims volume for each negotiated rate for each provider
for each item and service as an additional or alternative method of
providing contextual plan and coverage usage information. The
Departments also considered requiring the Utilization File 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) to disclose the number of times that any given
provider submitted a claim for any particular item or service. Claims
volume could inform which providers are associated with high-volume
services and the respective negotiated rates as well as help indicate
the degree to which negotiated rates are used by providers to deliver
actual services to health plan enrollees. However, the Departments are
concerned that this additional information may impose a significant
burden for plans and issuers, who would need to pull claims data for
each item and service for each provider that has a negotiated rate for
such item and service and update the claims count. Claims data most
likely resides in different systems from contract data and would need
to be imported and kept up to date in the In-network Rate File
according to the cadence in which the In-network Rate File must be
updated, potentially making the production of In-network Rate Files, as
well as the annual Utilization File, much more burdensome. Further,
this level of querying is complex and potentially always changing based
on the frequency of provider groups changing (which providers are
included in the TIN/NPI combination) and claims activity associated
with such providers for such items and services, making the burden not
only significant but ongoing. Lastly, current In-network Rate Files
contain contract data which is prospective in nature and claims data is
retrospective. The mixing of types of data within a file may introduce
potential data confusion. Therefore, the Departments are not proposing
to require disclosure of claims-related information in the In-network
Rate File or the Utilization File. The Departments seek comment on the
relative benefits and burdens interested parties might anticipate with
requiring claims-related information.
2. Excluded Information
As an alternative to the proposal to require plans and issuers to
exclude from each In-network Rate File a provider and their negotiated
rate (provider-rate combination) for an item or service, if it is
unlikely that such provider would be reimbursed for the 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 considered two alternative approaches. The
first approach involved running each combination of provider and
service as a mock claim and only including in the In-network Rate File
those claims that passed validation edits for appropriateness of that
provider to perform the service. This is different from the proposed
process described in section III.C.5. of this preamble because it would
require plans and issuers to process each potential provider-rate
combination through its claims adjudication, rather than relying on its
internal mapping of billing codes to exclude providers. This method
establishes a clear standard and provides meaningful information,
resulting in smaller In-network Rate Files that are far more accessible
and manageable. However, there are significant drawbacks to this
approach. Plans and issuers would face a high initial and ongoing
administrative and financial burden, as they would need to run every
provider through the claims adjudication system for every item or
service with a negotiated rate, repeating this process quarterly. This
method imposes the greatest engineering burden among the options
considered, as it may require setting up and maintaining parallel
adjudication systems specifically for this task, separate from
production adjudication systems. The Departments considered the
administrative burden associated with this approach to be a significant
deterrent to proposing this approach as a viable option.
Second, the Departments explored the idea of requiring plans and
issuers to create In-network Rate Files with negotiated rates based
solely on historic claims data, identifying providers who have
submitted claims for specific items or services. This approach has
several advantages. It would establish a clear standard, provide
meaningful information, and ensure that negotiated rates are disclosed
only for providers who have actually submitted claims for those items
and services over the course of a particular period of time. However,
the proposal also presented significant drawbacks. First, this approach
would lack a mechanism to monitor over-filtering by plans and issuers,
potentially excluding relevant providers. Also, mixing prospective and
retrospective data within the In-network Rate File could confuse users
about which services are available under current contracts versus
historical activity. Finally, the approach might require exceptions for
new providers who have not yet submitted claims, making it difficult
for users to distinguish between active providers and those who are
unlikely to offer specific services. As a result, the Departments
determined this approach was overly complex as compared with the
proposed approach of utilizing the taxonomy data discussed.
3. Data Retention
The Departments received feedback from interested parties
recommending that plans and issuers be required to retain the
Transparency in Coverage data required pursuant to 26 CFR 54.9815-
2715A3(b), 29 CFR 2590.715-2715A3(b), 45 CFR 147.212(b) on a public
website for 7 years. They argue their recommendation on the fact that,
because plans and issuers are currently only required to post their
machine-readable files monthly, most plans and issuers replace the
files on their website each month, making the prior month's files
unavailable, and consequently making it difficult for file consumers
like researchers and academics to analyze pricing trends over time,
verify historical rates, or assess the evolution of provider-plan
relationships.
The Departments considered data retention standards of 7 years, as
well as shorter durations, but are not proposing any data retention
requirements at this time due to the significant cost and burden the
Departments have determined it would incur on plans and issuers.
Specifically, storing, maintaining, and making 7 years of machine-
readable files publicly available would be costly, and the benefits,
such as enabling longitudinal analysis of contractual data and
historical price benchmarking, are relatively marginal especially if
other proposals in these proposed rules are finalized. In particular,
the recommendation would necessitate
[[Page 60503]]
robust additional data storage capacity--moving beyond transient
monthly files to a vast archive capable of accommodating potential
petabytes of historical records. Concurrently, significant network
bandwidth allocations would be required to handle the consistent
monthly influx of new data, as well as the eventual high-volume demands
of researchers or other entities accessing and downloading years' worth
of historical files. Furthermore, the ongoing maintenance and
organization of the datasets would require ensuring data integrity over
time, implementing efficient indexing and cataloging of systems for
easy discoverability. Without careful engineering planning and
dedicated resources, the archived files risk becoming digital
landfills, undermining the transparency they are intended to provide.
The Departments' proposed change from a requirement to post updated
In-network Rate and Allowed Amount Files every month to quarterly in
redesignated 26 CFR 54.9815-2715A3(b)(4)(i), 29 CFR 2590.715-
2715A3(b)(4)(i), and 45 CFR 147.212(b)(4)(i) and described in section
III.C.10. of this preamble would reduce the number of files required to
be retained by users for future reference and thus the associated costs
of doing so. Similarly, a quarterly cadence should ease the difficulty
some users have when downloading and collecting the file data monthly,
thus expanding access to more users without losing any data. The
Departments also expect that the proposed requirement for plans and
issuers to produce a quarterly Change-log File in new 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 described in section III.C.7.a. of this preamble
may help users more easily catalog and assess data changes over time,
limiting the need to access all the data in prior files.
The Departments, however, seek comment on the relative burdens and
benefits of requiring files to be publicly posted for a specific period
of time. The Departments are particularly interested in whether
interested parties believe that public retention of prior files would
continue to be valuable if combined with the other changes in these
proposed rules. The Departments are also interested in views from
interested parties on what would be a sufficient amount of retention
time that would still provide value for file users without imposing an
undue burden on plans and issuers.
4. Deemed Compliance With PHS Act Section 2799A-4, ERISA Section 719,
and Code Section 9819
The Departments indicated in FAQs Part 49 on August 20, 2021 \237\
that, because the price comparison methods required by the No Surprises
Act (codified in Code section 9819, ERISA section 719, and PHS Act
section 2799A-4) are largely duplicative of the self-service tool
described in the 2020 final rules, the Departments intended to propose
rulemaking and seek public comment regarding whether compliance with
the self-service tool requirements of the 2020 final rules satisfies
the analogous requirements set forth in Code section 9819, ERISA
section 719, and PHS Act section 2799A-4. The Departments recognized
that plans and issuers had already been working to implement the self-
service tool requirement of the 2020 final rules.
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\237\ U.S. Department of Labor, U.S. Department of Health &
Human Services & U.S. Department of the Treasury, FAQs about
Affordable Care Act Implementation Part 49 (Aug. 20, 2021), https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf.
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The Departments considered requiring plans to develop a separate
cost comparison tool to fulfill the requirements of the No Surprises
Act, however, such a proposal would likely impose significant costs on
plans and issuers for having to build an entirely new technical
infrastructure, with little additional benefits for participants,
beneficiaries, and enrollees, given that the provisions of the No
Surprises Act largely duplicate the requirements of the Transparency in
Coverage rules. Additionally, there would be great potential for public
confusion, as participants, beneficiaries, and enrollees would be
unsure of which tool use, whether they had different purposes, and the
potential for search results to be different. The Departments have
received feedback from plans and issuers that their participants,
beneficiaries, and enrollees expressed similar concerns of confusion as
the plan and issuer transitioned from a legacy self-service tool to a
tool that satisfied the requirements of the 2020 final rules. For these
reasons, the Departments are not proposing to require an additional
self-service tool.
F. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) \238\ requires agencies to
prepare an initial regulatory flexibility analysis to describe the
impact of a proposed rule on small entities, unless the head of the
agency can certify that the rule will not have a significant economic
impact on a substantial number of small entities. The Departments have
determined that the costs calculated in these proposed rules do not
rise to the level of significance under the RFA. The Departments have
prepared the following justification for this determination.
---------------------------------------------------------------------------
\238\ 5 U.S.C. 601, et seq.
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1. Proposed Rules
These proposed amendments aim to improve the accessibility,
standardization, and utility of pricing data disclosures by refining
certain requirements and aligning regulatory text with the No Surprises
Act and Executive Order 14221. Key changes include clarifying the
balance billing disclaimer to reflect Federal protections, requiring
that cost-sharing information to also be made available by phone, and
enhancing the format and usability of machine-readable files by
reducing duplication and file size.
2. Affected Entities
The RFA generally defines a ``small entity'' as (1) a proprietary
firm meeting the size standards of the Small Business Administration
(SBA), (2) a not-for-profit organization that is not dominant in its
field, or (3) a small government jurisdiction with a population of less
than 50,000. States and individuals are not included in the definition
of ``small entity.'' The Departments use a change in revenues of more
than 3 to 5 percent as its measure of significant economic impact on a
substantial number of small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdiction.
a. Group Health Plans
As discussed in section VI.C.1. of this preamble, these proposed
rules would affect ERISA-covered group health plans and non-Federal
governmental group health plans. The Department estimates that there
are approximately 2,500,000 ERISA-covered group health plans with less
than 100 employees, of which 1,400,000 are fully funded.\239\ For
purposes of the RFA, the Department of Labor continues to consider a
small entity to be an employee benefit plan
[[Page 60504]]
with fewer than 100 participants.\240\ Further, while some large
employers may have small plans, in general, most small plans are
maintained by small employers. Thus, the Departments have determined
that assessing the impact of these proposed rules on small plans is an
appropriate substitute for evaluating the effect on small entities. The
definition of small entity considered appropriate for this purpose
differs, however, from a definition of small business that is based on
size standards issued by the SBA (13 CFR 121.201) pursuant to the Small
Business Act (15 U.S.C. 631, et seq.). Therefore, the Departments
invite comments on the appropriateness of the size standard used in
evaluating the impact of these proposed rules on small entities.
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\239\ There are 2,454,996 ERISA-covered group health plans with
less than 100 employees, of which 1,423,897 are fully insured.
Agency for Healthcare Research and Quality, 2023 Medical Expenditure
Panel Survey Insurance Component (MEPS-IC), https://meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp (last visited Dec. 8,
2025); U.S. Census Bureau, 2021 County Business Patterns, https://www.census.gov/programs-surveys/cbp/data.html (last visited Dec. 8,
2025).
\240\ The Department of Labor consulted with the Small Business
Administration Office of Advocacy in making this determination, as
required by 5 U.S.C. 603(c) and 13 CFR 121.903(c) in a memo dated
June 4, 2020.
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The Department also estimates there are approximately 90,900 non-
Federal governmental group health plans.\241\ Of these plans,
approximately 35.7 percent \242\ (or 32,400) are self-insured,\243\ and
64.3 percent (or 58,400) are fully insured.\244\ Furthermore,
approximately 93.4 percent of group health plans have less than 100
employees.\245\ Therefore, the Department estimates there are
approximately 84,900 non-Federal governmental health plans with less
than 100 employees, of which 30,300 are self-insured \246\ and 54,600
are fully funded.\247\
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\241\ 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/tables/2022/econ/gus/2022-governments.html (last
visited Dec. 8, 2025).
\242\ Agency for Healthcare Research and Quality, Medical
Expenditure Panel Survey--Insurance Component, Table III.A.2.a.
(2023), https://datatools.ahrq.gov/meps-ic/?tab=private-sector-national&dash=19 (last visited Dec. 8, 2025).
\243\ 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.
\244\ 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.
\245\ Based on the 2023 Medical Expenditure Panel Survey
Insurance Component (MEPS-IC) and the 2021 County Business Patterns
from the Census Bureau. Agency for Healthcare Research and Quality,
2023 Medical Expenditure Panel Survey Insurance Component (MEPS-IC),
https://meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp
(last visited Dec. 8, 2025); U.S. Census Bureau, 2021 County
Business Patterns, https://www.census.gov/programs-surveys/cbp/data.html (last visited Dec. 8, 2025).
\246\ This estimate is calculated as follow: 32,447 self-
insured, non-Federal governmental group health plans x 93.4 percent
= 30,300 self-insured, non-Federal governmental group health plans
with less than 100 employees.
\247\ This estimate is calculated as follow: 58,440 fully
funded, non-Federal governmental group health plans x 93.4 percent =
54,582 fully funded, non-Federal governmental group health plans
with less than 100 employees.
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b. Participants and Enrollees
The Departments estimate that there are 35.6 million participants
in ERISA-covered group health plans with also 100 employees, of which
5.6 million are in self-insured plans and 30.1 million are in fully
funded plans.\248\ There are also approximately 2.2 million
participants in non-Federal governmental group health plans with less
than 100 employees, of which one million are in self-insured plans and
1.2 million are in fully insured plans.\249\
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\248\ Employee Benefits Security Administration, Health
Insurance Coverage Bulletin: Abstract of Auxiliary Data for the
March 2023 Annual Social and Economic Supplement to the Current
Population Survey (Aug. 30, 2024), https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2023.pdf.
\249\ Id.
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c. Issuers and TPAs
For purposes of the RFA, the Departments have determined that
health insurance companies are generally classified under the North
American Industry Classification System (NAICS) code 524114 (Direct
Health and Medical Insurance Carriers). According to SBA size
standards,\250\ entities with average annual receipts of $47 million or
less are considered small entities within this classification.
Alternatively, some may fall under NAICS code 621491 (HMO Medical
Centers), which has a size standard of $44.5 million or less.\251\
---------------------------------------------------------------------------
\250\ U.S. Small Business Administration, Table of Size
Standards (2023), https://www.sba.gov/document/support--table-size-standards (last updated Dec. 26, 2024).
\251\ Id.
---------------------------------------------------------------------------
Based on data from Medical Loss Ratio (MLR) annual report
submissions for the 2023 reporting year, approximately 84 out of 479
(18 percent) issuers of health insurance coverage nationwide had total
premium revenues of $47 million or less.\252\ The Departments also
estimate, based on MLR data, that over 80 percent of these small
companies belong to larger holding groups, and many, if not all, of
these small companies, are likely to have non-health lines of business
that would result in their revenues exceeding $47 million. The
Departments have determined that the same assumptions also apply to
TPAs that would be affected by these proposed rules.\253\ However, it
should be noted that at least 76 percent of these small companies
belong to larger holding groups that may not be small, and many, if not
all, of these companies are likely to have non-health lines of business
that would result in their revenues exceeding $47 million.
---------------------------------------------------------------------------
\252\ Based on internal calculations. Centers for Medicare &
Medicaid Services, Medical Loss Ratio Data and System Resources
(2023), https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources (last modified Dec. 23, 2024).
\253\ The Departments have determined that most TPAs are or are
affiliated with issuers.
---------------------------------------------------------------------------
3. Cost of These Proposed Rules
Using a threshold approach, if the total costs of these proposed
rules were spread evenly across all 1,375 issuers and 205 TPAs, the
high-end per-entity costs would be approximately $578,298 in one-time
first-year costs and $43,165 in ongoing annual costs, which would also
be incurred in the first year.\254\ Although the Departments are not
able to apply the 3 to 5 percent change in revenues standard as a
measure of significant economic impact on a substantial number of small
entities due to limited data, as discussed in section VI.F.3. of this
preamble, it is notable that over 80 percent of issuers and at least 76
percent of TPAs classified as small businesses are affiliated with
larger holding groups that may not themselves qualify as small. Based
on this information, the Departments anticipate that the costs
associated with these proposed rules do not rise to the level of
significance under the RFA. Therefore, the Departments conclude that an
initial regulatory flexibility analysis is not required for such firms.
The Departments seek comment on the assumptions and methodology
underlying this analysis, including whether alternative data or
approaches could better assess the impact on small plans and issuers,
and on potential ways to reduce burden while meeting the objectives of
these proposed rules.
---------------------------------------------------------------------------
\254\ The per-entity costs are estimated at $578,298 for the
first year and $43,165 on an ongoing annual basis. These figures are
derived by dividing the total estimated first-year cost of
$913,710,577 and the total estimated ongoing annual cost of
$68,201,320 by the total number of affected entities (1,375 issuers
+ 205 TPAs = 1,580).
---------------------------------------------------------------------------
Although ERISA-covered plans are often small entities, the
Departments have determined that these plans would rely on the larger
health insurance issuers and TPAs to comply with these proposed rules.
Nevertheless, these plans may still experience increased
[[Page 60505]]
costs due to the requirements, as the costs associated with
implementation are likely to be passed on to them. However, the
Departments are not of the view that the additional costs rise to the
level of a significant economic impact. In addition, although the
requirements of this proposal do not directly apply to providers,
providers may experience a loss in revenue as a result of the demands
of price-sensitive consumers and plans, as well as a potential
unwillingness among smaller issuers to continue paying higher rates
than those of larger issuers for the same items and services.
The Departments acknowledge that it may be likely that a number of
small entities might enter into contracts with other entities in order
to meet the requirements in these proposed rules, perhaps allowing for
the development of economies of scale. However, due to limited
information about how small entities may choose to meet these
requirements and the potential costs associated with such contractual
arrangements, the Departments seek comment on ways that these proposed
rules could impose additional costs and burdens on small entities and
how many such entities would likely enter into contracts to meet these
proposed requirements.
Finally, section 1102(b) of the Social Security Act (SSA) (42
U.S.C. 1302) requires agencies to prepare a regulatory impact analysis
if a rule is expected to have a significant impact on the operations of
a substantial number of small rural hospitals. This analysis must align
with the provisions of section 603 of the RFA. For purposes of section
1102(b) of the SSA, the Departments define a small rural hospital as a
hospital that is located outside of a metropolitan statistical area
with fewer than 100 beds. While these proposed rules are not
anticipated to directly regulate small rural hospitals, the Departments
acknowledge that the transparency requirement may have indirect effects
on these facilities through potential changes in negotiated rates and
patient cost-sharing, behaviors that could impact hospital revenues,
particularly given that rural providers typically operate with thinner
profit margins than their urban counterparts. However, the Departments
recognize that rural hospitals may also face lower levels of
competition and any indirect effects that result from these proposed
rules may have a lower impact, in some areas. Therefore, the
Departments have determined that while there may be indirect effects,
these do not rise to the level of a significant impact on the
operations of a substantial number of small rural hospitals.
4. Duplicate, Overlapping, or Relevant Federal Rules
There are no duplicate, overlapping, or relevant Federal rules.
G. Unfunded Mandates Reform Act (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires agencies to assess anticipated costs and benefits before
issuing any rule that may result in expenditures of $100 million or
more in any one year (in 1995 dollars), adjusted annually for
inflation. For 2025, this threshold is approximately $187 million.
These proposed rules include disclosure requirements that may impact
private sector entities, such as health insurance issuers offering
coverage in the individual and group health insurance markets and TPAs
administering group health plans. In addition, States, local, or Tribal
governments may incur costs related to enforcement of certain
provisions. The Departments expect the total burden on States, local,
or Tribal governments and the private sector to exceed the UMRA
threshold. The regulatory impact analysis proceeding this section of
the preamble constitutes the assessment of anticipated costs and
benefits required by UMRA.
H. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule that imposes
substantial direct costs on State and local governments, preempts State
law, or otherwise has federalism implications. Federal agencies issuing
regulations that have federalism implications must consult with States
and local officials and describe the extent of their consultation and
the nature of the concerns of States and local officials in the
preamble to the regulation.
In the Departments' view, these proposed rules may have federalism
implications, because it would have direct effects on the States, the
relationship between the Federal Government and States, or on the
distribution of power and responsibilities among various levels of
government relating to the disclosure of health insurance coverage
information to consumers.
Under these proposed rules, all group health plans and health
insurance issuers, including self-insured, non-Federal governmental
group health plans as defined in section 2791 of the PHS Act, would be
required to enhance the accessibility and transparency of cost-sharing
and pricing information for a participant, beneficiary, or enrollee (or
an authorized representative on behalf of such individual).
Specifically, plans and issuers would need to update disclaimers to
reflect Federal balance billing protections, make cost-sharing
estimates available by phone, and clarify how to meet the requirements
for price comparison tools. These proposed rules would also require
improvements to the format and accessibility of machine-readable files,
expansion of required data elements, and adjustments to posting
frequency and structure to ensure pricing data is more usable and
understandable for consumers. Federal standards developed under section
2715A of the PHS Act preempt any related States' standards that require
pricing information to be disclosed to the participant, beneficiary, or
enrollee, or otherwise publicly disclosed, to the extent the State
disclosure requirements would provide less information to the consumer
or the public than what is required under these proposed rules.
The Departments have determined that these proposed rules may have
federalism implications based on the required disclosure of pricing
information, as they are aware of at least 25 States that have passed
some form of price transparency legislation, such as all-payer claims
databases, consumer-facing price comparison tools, and the right to
shop programs, with varying requirements regarding the scope and level
of disclosure.\255\ While some States provide prices for individual
services, others report aggregated costs across providers or over time
to reflect the cost of an episode of care. The methods of sharing this
information also vary. For instance, California requires uninsured
patients to receive price estimates upon request, whereas other States
use websites or software applications to enable consumers to compare
prices across providers. Only seven States have published pricing
information of issuers on consumer-facing public websites.\256\
Therefore, these proposed rules may require plans and issuers to
disclose more detailed pricing information than some State laws
currently mandate.
---------------------------------------------------------------------------
\255\ National Conference of State Legislatures, Health Costs,
Coverage and Delivery State Legislation Data Base, https://www.ncsl.org/health/health-costs-coverage-and-delivery-state-legislation (last updated Sep 26, 2025).
\256\ Melanie Evans, One State's Effort to Publicize Hospital
Prices Brings Mixed Results, Wall Street Journal (June 26, 2019),
https://www.wsj.com/articles/one-states-effort-to-publicize-hospital-prices-brings-mixed-results-11561555562.
---------------------------------------------------------------------------
In general, through section 514, ERISA supersedes State laws to the
[[Page 60506]]
extent that they relate to any covered employee benefit plan but
preserves State laws that regulate insurance, banking, or securities.
Furthermore, the preemption provisions of section 731 of ERISA and
section 2724 of the PHS Act (implemented in 29 CFR 2590.731(a) and 45
CFR 146.143(a)) apply so that the provisions of Part 7 of ERISA and
chapter XXVII of the PHS Act (including the amendments made by the
Affordable Care Act) are not to be ``construed to supersede any
provision of State law which establishes, implements, or continues in
effect any standard or requirement solely relating to issuers in
connection with group health insurance coverage except to the extent
that such standard or requirement prevents the application of a
`requirement' of a Federal standard.'' The conference report
accompanying HIPAA indicates that this preemption is intended to be the
``narrowest'' preemption of State laws.\257\ States may therefore
continue to apply State law requirements to issuers so long as such
requirements do not prevent the application of the Affordable Care Act
requirements that are the subject of this rulemaking. Accordingly,
States have significant latitude to impose requirements on issuers that
are more restrictive than the Federal law.
---------------------------------------------------------------------------
\257\ U.S. Department of Labor, U.S. Department of Health &
Human Services & U.S. Department of the Treasury, FAQs about
Affordable Care Act Implementation Part 54 (July 28, 2022), https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.
---------------------------------------------------------------------------
In compliance with the requirement of Executive Order 13132, which
requires agencies to examine closely any policies that may have
federalism implications or limit the policy making discretion of the
States, the Departments have engaged in efforts to consult with and
work cooperatively with affected States. These efforts have included
participation in conference calls and events hosted by the NAIC, as
well as direct engagement with State insurance officials. The
Departments intend to act in a similar fashion in enforcing the
Affordable Care Act, including the provisions of section 2715A of the
PHS Act. While drafting these proposed rules, the Departments attempted
to balance the States' interests in regulating issuers with the goal of
enhancing price transparency nationwide. By doing so, the Departments
have determined that they have complied with the requirements of
Executive Order 13132.
The Departments request comment on any potential effects these
proposed rules may have on States. The Departments also request comment
regarding any duplicative burdens that may exist between State and
Federal requirements and ways such duplicative burdens can be
addressed, if applicable.
In accordance with the requirements set forth in section 8(a) of
Executive Order 13132, and by the signatures affixed to these proposed
rules, the Departments certify that the Department of the Treasury,
Employee Benefits Security Administration, and the CMS have complied
with the requirements of Executive Order 13132 for the attached
proposed rules in a meaningful and timely manner.
I. Executive Order 14192, ``Unleashing Prosperity Through
Deregulation''
Executive Order 14192, titled ``Unleashing Prosperity Through
Deregulation,'' was issued on January 31, 2025. Section 3(a) of
Executive Order 14192 requires an agency, unless prohibited by law, to
identify at least ten existing regulations to be repealed when the
agency issues a new regulation. In furtherance of this requirement,
section 3(c) of Executive Order 14192 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with
prior regulations. A significant regulatory action (as defined in
section 3(f) of Executive Order 12866) that would impose total costs
greater than zero is considered an Executive Order 14192 regulatory
action. This proposed rule, if finalized as proposed, is, therefore,
expected to be an Executive Order 14192 regulatory action. Details on
the estimated costs appear in the preceding analysis.
List of Subjects
26 CFR Part 54
Excise taxes, Health care, Pensions, Reporting and recordkeeping
requirements.
29 CFR Part 2590
Child support, Employee benefit plans, Health care, Health
insurance, Infants and children, Maternal and child health, Penalties,
Pensions, Privacy, Reporting and recordkeeping requirements.
45 CFR Part 147
Aged, Citizenship and naturalization, Civil rights, Health care,
Health insurance, Individuals with disabilities, Intergovernmental
relations, Reporting and recordkeeping requirements, Sex
discrimination.
Frank J. Bisignano,
Chief Executive Officer, Internal Revenue Service.
Daniel Aronowitz,
Assistant Secretary, Employee Benefits Security Administration.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
For the reasons set forth in the preamble, the Department of the
Treasury proposes to amend 26 CFR part 54 as set forth below:
PART 54--PENSION EXCISE TAXES
0
1. The authority citation for part 54 continues to read in part as
follows:
Authority: 26 U.S.C. 7805, unless otherwise noted.
* * * * *
Sections 54.9815-2715A1, 54.9815-2715A2, and 54.9815-2715A3 are
also issued under 26 U.S.C. 9833;
* * * * *
0
2. Section 54.9815-2715A1 is amended by:
0
a. Redesignating paragraphs (a)(2)(xi) through (xxii) as paragraphs
(a)(2)(xii) through (xxiii); and
0
b. Adding new paragraph (a)(2)(xi).
The addition reads as follows:
Sec. 54.9815-2715A1 Transparency in coverage--definitions.
(a) * * *
(2) * * *
(xi) Health insurance market means, irrespective of the State, one
of the following:
(A) The individual market, as defined in 45 CFR 144.103 (other than
short-term, limited-duration insurance or individual health insurance
coverage that consists solely of excepted benefits).
(B) The large group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(C) The small group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(D) For purposes of self-insured group health plans (other than
account-based plans, as defined in Sec. 54.9815-2711(d)(6)(i), and
plans that consist solely of excepted benefits), all self-insured group
health plans maintained by the plan sponsor.
* * * * *
0
3. Section 54.9815-2715A2 is amended by--
[[Page 60507]]
0
a. Revising paragraphs (b)(1)(i)(A) and (B), (b)(1)(vii)(A), and
(b)(2)(ii) introductory text;
0
b. Redesignating paragraph (b)(2)(ii)(D) as paragraph (b)(2)(iv);
0
c. Adding paragraph (b)(2)(iii);
0
d. Revising newly redesignated paragraph (b)(2)(iv);
0
e. Revising paragraphs (b)(3)(i) and (ii);
0
f. Revising paragraph (c)(1); and
0
g. Adding paragraph (c)(7).
The revisions and additions read as follows:
Sec. 54.9815-2715A2 Transparency in coverage--required disclosures to
participants and beneficiaries.
* * * * *
(b) * * *
(1) * * *
(i) * * *
(A) If the request for cost-sharing information relates to items
and services that are provided within a bundled payment arrangement,
and the bundled payment arrangement includes items or services that
have a separate cost-sharing liability, the group health plan or health
insurance issuer must provide estimates of the cost-sharing liability
for the requested covered item or service, as well as an estimate of
the cost-sharing liability for each of the items and services in the
bundled payment arrangement that have separate cost-sharing
liabilities. While plans and issuers are not required to provide
estimates of cost-sharing liability for a bundled payment arrangement
where the cost-sharing is imposed separately for each item and service
included in the bundled payment arrangement, nothing prohibits plans or
issuers from providing estimates for multiple items and services in
situations where such estimates could be relevant to participants or
beneficiaries, as long as the plan or issuer also discloses information
about the relevant items or services individually, as required in
paragraph (b)(1)(v) of this section.
(B) For requested items and services that are recommended
preventive services under section 2713 of the Public Health Service Act
(PHS Act), if the group health plan or health insurance issuer cannot
determine whether the request is for preventive or non-preventive
purposes, the plan or issuer must display the cost-sharing liability
that applies for non-preventive purposes. As an alternative, a plan or
issuer may allow a participant or beneficiary to request cost-sharing
information for the specific preventive or non-preventive item or
service by including terms such as ``preventive,'' ``non-preventive,''
or ``diagnostic'' as a means to request the most accurate cost-sharing
information.
* * * * *
(vii) * * *
(A) A statement that the cost-sharing information provided pursuant
to this paragraph (b)(1) does not account for potential additional
amounts in situations where applicable State or Federal law allow out-
of-network providers to bill participants or beneficiaries for the
difference between a provider's billed charges and the sum of the
amount collected from the group health plan or health insurance issuer
and from the participants or beneficiaries in the form of a copayment,
coinsurance, or deductible amount (the difference referred to as
balance billing). This statement is not required if the State in which
the item or service was furnished prohibits all out-of-network
providers from balance billing for all items and services payable by
the plan or issuer.
* * * * *
(2) * * *
(ii) Paper method. Information provided under this paragraph (b)
must be made available in plain language, without a fee, in paper form
at the request of the participant or beneficiary. In responding to such
a request, the group health plan or health insurance issuer may limit
the number of providers with respect to which cost-sharing information
for covered items and services is provided to no fewer than 20
providers per request. The plan or issuer is required to:
* * * * *
(iii) Phone method. Information provided under this paragraph (b)
must be made available at the request of the participant or beneficiary
via a telephone number through which a consumer may seek customer
assistance that Code section 9816(e) requires be indicated on any
physical or electronic plan or insurance identification card issued to
a participant, beneficiary, or enrollee. Such information must be
accurate at the time of the request and must be provided at the time of
the request. In responding to such a request, the group health plan or
health insurance issuer may limit the number of providers with respect
to which cost-sharing information for covered items and services is
provided to no fewer than 20 providers per day. The plan or issuer is
required to:
(A) Disclose the applicable provider-per-day limit; and
(B) Provide the cost-sharing information, in accordance with the
requirements in paragraphs (b)(2)(i)(A) through (C) of this section.
(iv) Alternative method. In circumstances where participants and
beneficiaries request disclosure other than by the internet-based self-
service tool, paper, or phone (for example, by email) group health
plans and health insurance issuers may provide the disclosure through
alternative means and satisfy the requirements of this section,
provided the participant or beneficiary agrees that such disclosure
through such means is sufficient to satisfy the request and the plan or
issuer meets the timing requirements established under paragraph
(b)(2)(ii)(C) of this section for paper method disclosure.
(3) * * *
(i) Special rule for insured group health plans. To the extent
coverage under a group health plan consists of group health insurance
coverage, the plan satisfies the requirements of this paragraph (b) if
the plan requires the health insurance issuer offering the coverage to
provide the information required by this paragraph (b) in compliance
with this section pursuant to a written agreement. Accordingly, if an
issuer and a plan sponsor enter into a written agreement under which
the issuer agrees to provide the information required under this
paragraph (b) in compliance with this section, and the issuer fails to
do so, then the issuer, but not the plan, violates the transparency
disclosure requirements of this paragraph (b).
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a pharmacy benefit manager or other third-party) provides the
information required by this paragraph (b) in compliance with this
section. Notwithstanding the preceding sentence, if a plan or issuer
chooses to enter into such an agreement and the party with which it
contracts fails to provide the information in compliance with this
paragraph (b), the plan or issuer violates the transparency disclosure
requirements of this paragraph (b).
(c) * * *
(1)(i) The provisions of this section apply for plan years (in the
individual market, for policy years) beginning on or after January 1,
2023 with respect to the 500 items and services to be posted on a
publicly available website, and with respect to all covered items and
services, for plan years (in the individual market, for policy years)
beginning on or after January 1, 2024.
(ii) Notwithstanding paragraph (c)(1)(i) of this section,
paragraphs
[[Page 60508]]
(b)(1)(vii)(A), (b)(2)(iii) and (iv), and (c)(7) of this section apply
for plan years (in the individual market, for policy years) beginning
on or after January 1, 2027. Until such time, the current provisions of
paragraph (b) of this section continue to apply.
* * * * *
(7) A group health plan or health insurance issuer that provides to
the participant or beneficiary the information required under paragraph
(b)(1) of this section, in accordance with the method and format
requirements set forth in paragraph (b)(2) of this section, satisfies
the requirements set forth in Code section 9819, ERISA section 719, and
PHS Act section 2799A-4.
* * * * *
0
4. Section Sec. 54.9815-2715A3 is amended by--
0
a. Revising paragraph (b) heading and introductory text;
0
b. Revising paragraphs (b)(1)(i) and (ii);
0
c. Redesignating paragraphs (b)(2) and (3) as paragraphs (b)(3) and
(4), respectively;
0
d. Adding new paragraph (b)(2);
0
e. Revising newly redesignated paragraphs (b)(3) and (4);
0
f. Redesignating paragraphs (b)(4)(i) and (ii) as paragraphs (b)(5)(i)
and (ii), respectively;
0
g. Revising newly redesignated paragraphs (b)(5)(i) and (ii);
0
h. Redesignating paragraph (b)(4)(iii) as paragraph (b)(5)(iv);
0
i. Adding new paragraph (b)(5)(iii);
0
j. Revising newly redesignated paragraph (b)(5)(iv); and
0
k. Revising paragraph (c)(1).
The revisions and additions read as follows:
Sec. 54.9815-2715A3 Transparency in coverage--requirements for public
disclosure.
* * * * *
(b) Requirements for public disclosure of in-network provider rates
for covered items and services, out-of-network allowed amounts and
billed charges for covered items and services, negotiated rates and
historical net prices for covered prescription drugs, and contextual
information. A group health plan or health insurance issuer must make
available on an internet website the information required under
paragraphs (b)(1) and (2) of this section in machine-readable files, in
accordance with the method and format requirements described in
paragraph (b)(3) of this section, and that are updated as required
under paragraph (b)(4) of this section.
(1) * * *
(i) An in-network rate machine-readable file for each provider
network maintained or contracted by a group health plan or health
insurance issuer that includes the required information under this
paragraph (b)(1)(i) for all covered items and services under each
coverage option offered by the plan or issuer that uses such provider
network, except for prescription drugs that are subject to a fee-for-
service reimbursement arrangement, which must be reported in the
prescription drug machine-readable file pursuant to paragraph
(b)(1)(iii) of this section. Each in-network rate machine-readable file
must include:
(A) The common provider network name;
(B) For each coverage option offered by a group health plan or
health insurance issuer that uses such provider network, the name; the
Health Insurance Oversight System (HIOS) identifier, or, if no HIOS
identifier is available, the Employer Identification Number (EIN); and
the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(C) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for each billing code for each
covered item or service included in the machine-readable file;
(D) For each covered item or service included in the machine-
readable file, all applicable rates, which may include one or more of
the following: Negotiated rates, underlying fee schedule rates, or
derived amounts. If a group health plan or health insurance issuer does
not use negotiated rates for provider reimbursement, then the plan or
issuer should disclose derived amounts to the extent these amounts are
already calculated in the normal course of business. If the plan or
issuer uses underlying fee schedule rates for calculating cost sharing,
then the plan or issuer should include the underlying fee schedule
rates in addition to the negotiated rate or derived amount. Applicable
rates, including for both individual items and services and items and
services in a bundled payment arrangement, must be:
(1) Reflected as dollar amounts, with respect to each covered item
or service that is furnished by an in-network provider. If the
negotiated rate is subject to change based upon participant or
beneficiary-specific characteristics, these dollar amounts should be
reflected as the base negotiated rate applicable to the item or service
prior to adjustments for participant or beneficiary-specific
characteristics. For contractual arrangements under which a group
health plan or health insurance issuer agrees to pay an in-network
provider a percentage of billed charges and is not able to assign a
dollar amount to an item or service prior to a bill being generated,
plans and issuers must report a percentage number, in lieu of a dollar
amount, in a form and manner as specified in guidance issued by the
Department of the Treasury, the Department of Labor, and the Department
of Health and Human Services.
(2) Associated with the National Provider Identifier (NPI), Tax
Identification Number (TIN), and Place of Service Code for each in-
network provider, except those specified in paragraph (b)(1)(i)(F) of
this section;
(3) Associated with the last date of the contract term or
expiration date for each provider-specific applicable rate that applies
to each covered item or service; and
(4) Indicated with a notation where a reimbursement arrangement
other than a standard fee-for-service model (such as capitation or a
bundled payment arrangement) applies.
(E) Current numerical enrollment totals, as of the date the file is
posted, for each coverage option offered by a group health plan or
health insurance issuer that uses such provider network. Such numerical
enrollment totals must include the number of participants and
beneficiaries (including all dependents) in the coverage option offered
by a plan or issuer.
(F) A group health plan or health insurance issuer must exclude
from each file under paragraph (b)(1)(i) of this section a provider and
their negotiated rate (provider-rate combination) for an item or
service if the plan or issuer determines it is unlikely that the
provider would be reimbursed for the 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.
(ii) For each health insurance market, as defined in Sec. 54.9815-
2715A1(a)(2)(xi), in which a group health plan or health insurance
issuer offers a plan or coverage, an out-of-network allowed amount
machine-readable file, including:
(A) For each coverage option offered by a group health plan or
health insurance issuer in such health insurance market, the name and
the HIOS identifier, or, if no HIOS identifier is available, the EIN;
and the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(B) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for
[[Page 60509]]
each billing code for each covered item or service under any coverage
option offered by a group health plan or health insurance issuer in
such health insurance market; and
(C) Aggregated unique out-of-network allowed amounts and billed
charges with respect to each covered item or service under any coverage
option offered by a group health plan or health insurance issuer in
such health insurance market furnished by out-of-network providers
during the 6-month time period that begins 9 months prior to the
publication date of the machine-readable file (except that a plan or
issuer must omit such data in relation to a particular item or service
when compliance with this paragraph (b)(1)(ii)(C) would require the
plan or issuer to report payment of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of that item
or service in a single health insurance market). Consistent with
paragraph (c)(3) of this section, nothing in this paragraph
(b)(1)(ii)(C) requires the disclosure of information that would violate
any applicable health information privacy law. Each unique out-of-
network allowed amount must be:
(1) Reflected as a dollar amount, with respect to each covered item
or service that is furnished by an out-of-network provider; and
(2) Associated with the NPI, TIN, and Place of Service Code for
each out-of-network provider.
* * * * *
(2) Required contextual files. A group health plan or health
insurance issuer must make available in a machine-readable format:
(i) A change-log file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that identifies
any changes made to the required information described in paragraph
(b)(1)(i) of this section since the immediately preceding published in-
network rate machine-readable file.
(ii) A utilization file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that includes,
for the 12-month period that ends 6 months prior to the publication
date of each utilization file:
(A) Items and services covered under the plans or policies included
in the files prepared as specified in paragraph (b)(1)(i) of this
section for which a claim has been submitted and reimbursed, in whole
or in part; and
(B) Each in-network provider identified by the NPI, TIN, and Place
of Service Code who was reimbursed, in whole or in part, for a claim
for each covered item or service included as specified in paragraph
(b)(2)(ii)(A) of this section.
(iii) A taxonomy file, for each in-network rate machine-readable
file prepared as specified in paragraph (b)(1)(i) of this section,
which includes the group health plan's or health insurance issuer's
internal provider taxonomy that matches items and services (represented
by a billing code) 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)) 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.. Plans and issuers must use their internal provider taxonomy
to determine whether to exclude certain provider-rate combinations from
the in-network rate machine-readable file as specified in paragraph
(b)(1)(i)(F) of this section.
(iv) A plain text file in a .txt format in the root folder (that
is, the top-level directory on an electronic file system) of a group
health plan's or health insurance issuer's website that includes:
(A) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section;
(B) A direct link to the URL for the machine-readable files
required under paragraphs (b)(1) and (2) of this section; and
(C) Point-of-contact information, including an up-to-date name,
title, and email address for an individual who can address inquiries
and issues related to the machine-readable files required under
paragraphs (b)(1) and (2) of this section. This contact information
must be prominently displayed on the same website where the machine-
readable files are made available and be kept updated per the
requirements in paragraph (b)(4)(vi) of this section.
(3) Required method and format for disclosing information to the
public. (i) The machine-readable files described in paragraphs (b)(1)
and (2) of this section must be available in a form and manner as
specified in guidance issued by the Department of the Treasury, the
Department of Labor, and the Department of Health and Human Services.
(ii) The machine-readable files must be publicly available and
accessible to any person, automated scripts, or web crawlers free of
charge and without conditions, such as establishment of a user account,
password, submission of personally identifiable information or other
credentials, or blocking server configurations or firewalls to access
the file.
(iii) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section must be included as a link in the footer on the home page of
the group health plan's or health insurance issuer's website, as well
as any page of the website that features a footer, that is labeled
``Price Transparency'' or ``Transparency in Coverage'' and links
directly to the publicly available web page that hosts the link to the
machine-readable files.
(iv) The group health plan or health insurance issuer may satisfy
the requirements of paragraph (b)(3)(iii) of this section by entering
into a written agreement under which another party (such as a third-
party administrator) posts the machine-readable files on its public
website on behalf of the plan or issuer, including if the plan or
issuer does not have a website. However, if the files are posted on a
service provider's website, and the plan or issuer maintains a public
website but chooses not to host the files separately on its own public
website, it must provide a link on its own public website to the
location where the files are made publicly available.
(4) Timing. A group health plan or health insurance issuer must
update the machine-readable files in accordance with the following
timeframes and clearly indicate the date that the files were most
recently updated:
(i) The in-network rate and out-of-network allowed amount machine-
readable files required by paragraphs (b)(1)(i) and (ii) of this
section must be updated and posted quarterly beginning on the first day
of the calendar-year quarter following the applicability date under
paragraph (c)(1) of this section;
(ii) The prescription drug machine-readable file required by
paragraph (b)(1)(iii) of this section must be updated monthly;
(iii) The change-log machine-readable file required by paragraph
(b)(2)(i) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
date on which the first in-network rate machine-readable file is
required to be posted under paragraph (b)(4)(i) of this section in
accordance with the applicability date of the amendments to paragraph
(b)(1) of this section as specified in paragraph (c)(1) of this
section. If there are no changes to the in-network rate machine-
readable file described in paragraph (b)(1)(i) of this section since
the last such file was
[[Page 60510]]
updated, a change-log machine-readable file must still be updated and
posted quarterly indicating there are no changes;
(iv) The utilization machine-readable file required under paragraph
(b)(2)(ii) of this section must be updated and posted annually
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section;
(v) The taxonomy machine-readable file required under paragraph
(b)(2)(iii) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section. If there are
no changes to the taxonomy that affect the information required in the
machine-readable file required under paragraph (b)(1)(i) of this
section in a subsequent quarter, the posted taxonomy file is not
required to updated that quarter; and
(vi) The text file required by paragraph (b)(2)(iv) of this section
must be posted beginning on the first day of the calendar-year quarter
following the applicability date under paragraph (c)(1) of this section
and subsequently updated and posted as soon as practicable but no later
than 7 calendar days following a change in any of the information
required under paragraph (b)(2)(iv) of this section.
(5) Special rules to prevent unnecessary duplication--(i) Special
rule for insured group health plans. To the extent coverage under a
group health plan consists of group health insurance coverage, the plan
satisfies the requirements of this paragraph (b) if the plan requires
the health insurance issuer offering the coverage to provide the
information pursuant to a written agreement. Accordingly, if an issuer
and a plan sponsor enter into a written agreement under which the
issuer agrees to provide the information required under this paragraph
(b) in compliance with this section, and the issuer fails to do so,
then the issuer, but not the plan, violates the transparency disclosure
requirements of this paragraph (b).
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a third-party administrator or health care claims clearinghouse) will
provide the information required by this paragraph (b) in compliance
with this section. Notwithstanding the preceding sentence, if a plan or
issuer chooses to enter into such an agreement and the party with which
it contracts fails to provide the information in compliance with this
paragraph (b), the plan or issuer violates the transparency disclosure
requirements of this paragraph (b).
(iii) Special rule for self-insured group health plans with respect
to the disclosure of in-network rate machine-readable files. A self-
insured group health plan that enters into an agreement with another
party described in paragraph (b)(5)(ii) of this section may permit such
other party to make available in a single in-network rate machine
readable file as required under paragraph (b)(1)(i) of this section the
information required under paragraph (b)(1)(i) for each provider
network used by more than one plan, insurance policy, or contract
(including those offered by different plan sponsors with which the
other party has an agreement)and across different health insurance
markets, provided that--
(A) Each in-network rate machine-readable file made available for a
provider network includes the required information under paragraph
(b)(1)(i) of this section for all covered items and services under each
plan, insurance policy, or contract that uses the same provider network
for which the in-network rate machine-readable file is made available;
and
(B) Each of the self-insured group health plan's change-log,
utilization, and taxonomy machine-readable files include the
information required under paragraphs (b)(2)(i), (ii), and (iii) of
this section, respectively, for the same plans, insurance policies, or
contracts (including those offered by different plan sponsors and
across different health insurance markets, if applicable) represented
in the corresponding in-network rate machine-readable files specified
in paragraph (b)(1)(i) of this section.
(iv) Special rule for self-insured group health plans with respect
to the disclosure of out-of-network allowed amount machine-readable
files. A self-insured group health plan that enters into an agreement
with another party described in paragraph (b)(5)(ii) of this section
may permit such other party to make available the information required
under paragraph (b)(1)(ii) of this section in a single out-of-network
allowed amount file for more than one self-insured group health plan
(including those offered by different plan sponsors with which the
other party has an agreement), provided that the out-of-network allowed
amount and billed charge data described in paragraph (b)(1)(ii)(C) of
this section in relation to a particular item or service is omitted if
it would require disclosure of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of such item
or service across all of the plans (including those offered by
different plan sponsors) included in the out-of-network machine-
readable file.
(c) * * *
(1)(i) Beginning on or after January 2, 2022, the requirements of
this section apply for plan years (in the individual market, for policy
years).
(ii) Notwithstanding paragraph (c)(1)(i) of this section, paragraph
(b)(1) of this section applies on [DATE 12 MONTHS AFTER PUBLICATION OF
FINAL REGULATIONS IN THE FEDERAL REGISTER]. Until such time, the
current provisions of paragraph (b) of this section continue to apply.
* * * * *
DEPARTMENT OF LABOR
Employee Benefits Security Administration
For the reasons stated in the preamble, the Department of Labor
proposes to amend 29 CFR part 2590 as set forth below:
PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS
0
5. The authority citation for part 2590 continues to read as follows:
Authority: 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-
1183, 1181 note, 1185, 1185a-n, 1191, 1191a, 1191b, and 1191c; sec.
101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-
200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-
343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148,
124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029;
Division M, Pub. L. 113-235, 128 Stat. 2130; Pub. L. 116-260, 134
Stat. 1182; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9,
2012).
0
6. Section 2590.715-2715A1 is amended by--
0
a. Redesignating paragraphs (a)(2)(x) through (xxi) as paragraphs
(a)(2)(xi) through (xxii); and
0
b. Adding new paragraph (a)(2)(x).
The addition reads as follows:
Sec. 2590.715-2715A1 Transparency in coverage--definitions.
(a) * * *
(2) * * *
(x) Health insurance market means, irrespective of the State, one
of the following:
(A) The individual market, as defined in 45 CFR 144.103 (other than
short-term, limited-duration insurance or individual health insurance
coverage that consists solely of excepted benefits).
[[Page 60511]]
(B) The large group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(C) The small group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(D) For purposes of self-insured group health plans (other than
account-based plans, as defined in Sec. 2590.715-2711(d)(6)(i), and
plans that consist solely of excepted benefits), all self-insured group
health plans maintained by the plan sponsor.
* * * * *
0
7. Section 2590.715-2715A2 is amended by--
0
a. Revising paragraphs (b)(1)(i)(A) and (B), (b)(1)(vii)(A), and
(b)(2)(ii) introductory text;
0
b. Redesignating paragraph (b)(2)(ii)(D) as paragraph (b)(2)(iv);
0
c. Adding paragraph (b)(2)(iii);
0
d. Revising newly redesignated paragraph (b)(2)(iv);
0
e. Revising paragraphs (b)(3)(i) and (ii);
0
f. Revising paragraph (c)(1); and
0
g. Adding paragraph (c)(7).
The revisions and additions read as follows:
Sec. 2590.715-2715A2 Transparency in coverage--required disclosures
to participants and beneficiaries.
* * * * *
(b) * * *
(1) * * *
(i) * * *
(A) If the request for cost-sharing information relates to items
and services that are provided within a bundled payment arrangement,
and the bundled payment arrangement includes items or services that
have a separate cost-sharing liability, the group health plan or health
insurance issuer must provide estimates of the cost-sharing liability
for the requested covered item or service, as well as an estimate of
the cost-sharing liability for each of the items and services in the
bundled payment arrangement that have separate cost-sharing
liabilities. While plans and issuers are not required to provide
estimates of cost-sharing liability for a bundled payment arrangement
where the cost-sharing is imposed separately for each item and service
included in the bundled payment arrangement, nothing prohibits plans or
issuers from providing estimates for multiple items and services in
situations where such estimates could be relevant to participants or
beneficiaries, as long as the plan or issuer also discloses information
about the relevant items or services individually, as required in
paragraph (b)(1)(v) of this section.
(B) For requested items and services that are recommended
preventive services under section 2713 of the Public Health Service Act
(PHS Act), if the group health plan or health insurance issuer cannot
determine whether the request is for preventive or non-preventive
purposes, the plan or issuer must display the cost-sharing liability
that applies for non-preventive purposes. As an alternative, a plan or
issuer may allow a participant or beneficiary to request cost-sharing
information for the specific preventive or non-preventive item or
service by including terms such as ``preventive,'' ``non-preventive,''
or ``diagnostic'' as a means to request the most accurate cost-sharing
information.
* * * * *
(vii) * * *
(A) A statement that the cost-sharing information provided pursuant
to this paragraph (b)(1) does not account for potential additional
amounts in situations where applicable State or Federal law allow out-
of-network providers to bill participants or beneficiaries for the
difference between a provider's billed charges and the sum of the
amount collected from the group health plan or health insurance issuer
and from the participants or beneficiaries in the form of a copayment,
coinsurance, or deductible amount (the difference referred to as
balance billing). This statement is not required if the State in which
the item or service was furnished prohibits all out-of-network
providers from balance billing for all items and services payable by
the plan or issuer;
* * * * *
(2) * * *
(ii) Paper method. Information provided under this paragraph (b)
must be made available in plain language, without a fee, in paper form
at the request of the participant or beneficiary. In responding to such
a request, the group health plan or health insurance issuer may limit
the number of providers with respect to which cost-sharing information
for covered items and services is provided to no fewer than 20
providers per request. The plan or issuer is required to:
* * * * *
(iii) Phone method. Information provided under this paragraph (b)
must be made available at the request of the participant or beneficiary
via a telephone number through which a consumer may seek customer
assistance that ERISA section 716(e) requires be indicated on any
physical or electronic plan or insurance identification card issued to
a participant, beneficiary, or enrollee. Such information must be
accurate at the time of the request and must be provided at the time of
the request. In responding to such a request, the group health plan or
health insurance issuer may limit the number of providers with respect
to which cost-sharing information for covered items and services is
provided to no fewer than 20 providers per day. The plan or issuer is
required to:
(A) Disclose the applicable provider-per-day limit; and
(B) Provide the cost-sharing information, in accordance with the
requirements in paragraphs (b)(2)(i)(A) through (C) of this section.
(iv) Alternative method. In circumstances where participants and
beneficiaries request disclosure other than by the internet-based self-
service tool, paper, or phone (for example, by email) group health
plans and health insurance issuers may provide the disclosure through
alternative means and satisfy the requirements of this section,
provided the participant or beneficiary agrees that such disclosure
through such means is sufficient to satisfy the request and the plan or
issuer meets the timing requirements established under paragraph
(b)(2)(ii)(C) of this section for paper method disclosure.
(3) * * *
(i) Special rule for insured group health plans. To the extent
coverage under a group health plan consists of group health insurance
coverage, the plan satisfies the requirements of this paragraph (b) if
the plan requires the health insurance issuer offering the coverage to
provide the information required by this paragraph (b) in compliance
with this section pursuant to a written agreement. Accordingly, if an
issuer and a plan sponsor enter into a written agreement under which
the issuer agrees to provide the information required under this
paragraph (b) in compliance with this section, and the issuer fails to
do so, then the issuer, but not the plan, violates the transparency
disclosure requirements of this paragraph (b).
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a pharmacy benefit manager or other third-party) provides the
information required by this paragraph (b) in compliance with this
section. Notwithstanding the preceding sentence, if a plan or issuer
chooses to enter into such an agreement and the party with which it
contracts fails to provide the information in
[[Page 60512]]
compliance with this paragraph (b), the plan or issuer violates the
transparency disclosure requirements of this paragraph (b).
(c) * * *
(1)(i) The provisions of this section apply for plan years (in the
individual market, for policy years) beginning on or after January 1,
2023 with respect to the 500 items and services to be posted on a
publicly available website, and with respect to all covered items and
services, for plan years (in the individual market, for policy years)
beginning on or after January 1, 2024.
(ii) Notwithstanding paragraph (c)(1)(i) of this section,
paragraphs (b)(1)(vii)(A), (b)(2)(iii) and (iv), and (c)(7) of this
section apply for plan years (in the individual market, for policy
years) beginning on or after January 1, 2027. Until such time, the
current provisions of paragraph (b) of this section continue to apply.
* * * * *
(7) A group health plan or health insurance issuer that provides to
the participant or beneficiary the information required under paragraph
(b)(1) of this section, in accordance with the method and format
requirements set forth in paragraph (b)(2) of this section, satisfies
the requirements set forth in Code section 9819, ERISA section 719, and
PHS Act section 2799A-4.
* * * * *
0
8. Section 2590.715-2715A3 is amended by--
0
a. Revising paragraph (b) heading and introductory text;
0
b. Revising paragraphs (b)(1)(i) and (ii);
0
c. Redesignating paragraphs (b)(2) and (3) as paragraphs (b)(3) and
(4), respectively;
0
d. Adding new paragraph (b)(2);
0
e. Revising newly redesignated paragraphs (b)(3) and (4);
0
f. Redesignating paragraphs (b)(4)(i) and (ii) as paragraphs (b)(5)(i)
and (ii), respectively;
0
g. Revising newly redesignated paragraphs (b)(5)(i) and (ii);
0
h. Redesignating paragraph (b)(4)(iii) as paragraph (b)(5)(iv);
0
i. Adding new paragraph (b)(5)(iii);
0
j. Revising newly redesignated paragraph (b)(5)(iv); and
0
k. Revising paragraph (c)(1).
The revisions and additions read as follows:
Sec. 2590.715-2715A3 Transparency in coverage--requirements for
public disclosure.
* * * * *
(b) Requirements for public disclosure of in-network provider rates
for covered items and services, out-of-network allowed amounts and
billed charges for covered items and services, negotiated rates and
historical net prices for covered prescription drugs, and contextual
information. A group health plan or health insurance issuer must make
available on an internet website the information required under
paragraphs (b)(1) and (2) of this section in machine-readable files, in
accordance with the method and format requirements described in
paragraph (b)(3) of this section, and that are updated as required
under paragraph (b)(4) of this section.
(1) * * *
(i) An in-network rate machine-readable file for each provider
network maintained or contracted by a group health plan or health
insurance issuer that includes the required information under this
paragraph (b)(1)(i) for all covered items and services under each
coverage option offered by the plan or issuer that uses such provider
network, except for prescription drugs that are subject to a fee-for-
service reimbursement arrangement, which must be reported in the
prescription drug machine-readable file pursuant to paragraph
(b)(1)(iii) of this section. Each in-network rate machine-readable file
must include:
(A) The common provider network name;
(B) For each coverage option offered by a group health plan or
health insurance issuer that uses such provider network, the name; the
Health Insurance Oversight System (HIOS) identifier, or, if no HIOS
identifier is available, the Employer Identification Number (EIN); and
the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(C) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for each billing code for each
covered item or service included in the machine-readable file;
(D) For each covered item or service included in the machine-
readable file, all applicable rates, which may include one or more of
the following: Negotiated rates, underlying fee schedule rates, or
derived amounts. If a group health plan or health insurance issuer does
not use negotiated rates for provider reimbursement, then the plan or
issuer should disclose derived amounts to the extent these amounts are
already calculated in the normal course of business. If the plan or
issuer uses underlying fee schedule rates for calculating cost sharing,
then the plan or issuer should include the underlying fee schedule
rates in addition to the negotiated rate or derived amount. Applicable
rates, including for both individual items and services and items and
services in a bundled payment arrangement, must be:
(1) Reflected as dollar amounts, with respect to each covered item
or service that is furnished by an in-network provider. If the
negotiated rate is subject to change based upon participant or
beneficiary-specific characteristics, these dollar amounts should be
reflected as the base negotiated rate applicable to the item or service
prior to adjustments for participant or beneficiary-specific
characteristics. For contractual arrangements under which a group
health plan or health insurance issuer agrees to pay an in-network
provider a percentage of billed charges and is not able to assign a
dollar amount to an item or service prior to a bill being generated,
plans and issuers must report a percentage number, in lieu of a dollar
amount, in a form and manner as specified in guidance issued by the
Department of the Treasury, the Department of Labor, and the Department
of Health and Human Services.
(2) Associated with the National Provider Identifier (NPI), Tax
Identification Number (TIN), and Place of Service Code for each in-
network provider, except those specified in paragraph (b)(1)(i)(F) of
this section;
(3) Associated with the last date of the contract term or
expiration date for each provider-specific applicable rate that applies
to each covered item or service; and
(4) Indicated with a notation where a reimbursement arrangement
other than a standard fee-for-service model (such as capitation or a
bundled payment arrangement) applies.
(E) Current numerical enrollment totals, as of the date the file is
posted, for each coverage option offered by a group health plan or
health insurance issuer that uses such provider network. Such numerical
enrollment totals must include the number of participants and
beneficiaries (including all dependents) in the coverage option offered
by a plan or issuer.
(F) A group health plan or health insurance issuer must exclude
from each file under paragraph (b)(1)(i) of this section a provider and
their negotiated rate (provider-rate combination) for an item or
service if the plan or issuer determines it is unlikely that the
provider would be reimbursed for the 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.
[[Page 60513]]
(ii) For each health insurance market, as defined in Sec.
2590.715-2715A1(a)(2)(x), in which a group health plan or health
insurance issuer offers a plan or coverage, an out-of-network allowed
amount machine-readable file, including:
(A) For each coverage option offered by a group health plan or
health insurance issuer in such health insurance market, the name and
the HIOS identifier, or, if no HIOS identifier is available, the EIN;
and the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(B) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for each billing code for each
covered item or service under any coverage option offered by a group
health plan or health insurance issuer in such health insurance market;
and
(C) Aggregated unique out-of-network allowed amounts and billed
charges with respect to each covered item or service under any coverage
option offered by a group health plan or health insurance issuer in
such health insurance market furnished by out-of-network providers
during the 6-month time period that begins 9 months prior to the
publication date of the machine-readable file (except that a plan or
issuer must omit such data in relation to a particular item or service
when compliance with this paragraph (b)(1)(ii)(C) would require the
plan or issuer to report payment of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of that item
or service in a single health insurance market). Consistent with
paragraph (c)(3) of this section, nothing in this paragraph
(b)(1)(ii)(C) requires the disclosure of information that would violate
any applicable health information privacy law. Each unique out-of-
network allowed amount must be:
(1) Reflected as a dollar amount, with respect to each covered item
or service that is furnished by an out-of-network provider; and
(2) Associated with the NPI, TIN, and Place of Service Code for
each out-of-network provider.
* * * * *
(2) Required contextual files. A group health plan or health
insurance issuer must make available in a machine-readable format:
(i) A change-log file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that identifies
any changes made to the required information described in paragraph
(b)(1)(i) of this section since the immediately preceding published in-
network rate machine-readable file.
(ii) A utilization file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that includes,
for the 12-month period that ends 6 months prior to the publication
date of each utilization file:
(A) Items and services covered under the plans or policies included
in the files prepared as specified in paragraph (b)(1)(i) of this
section for which a claim has been submitted and reimbursed, in whole
or in part; and
(B) Each in-network provider identified by the NPI, TIN, and Place
of Service Code who was reimbursed, in whole or in part, for a claim
for each covered item or service included as specified in paragraph
(b)(2)(ii)(A) of this section.
(iii) A taxonomy file, for each in-network rate machine-readable
file prepared as specified in paragraph (b)(1)(i) of this section,
which includes the group health plan's or health insurance issuer's
internal provider taxonomy that matches items and services (represented
by a billing code) 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)) 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.. Plans and issuers must use their internal provider taxonomy
to determine whether to exclude certain provider-rate combinations from
the in-network rate machine-readable file as specified in paragraph
(b)(1)(i)(F) of this section.
(iv) A plain text file in a .txt format in the root folder (that
is, the top-level directory on an electronic file system) of a group
health plan's or health insurance issuer's website that includes:
(A) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section;
(B) A direct link to the URL for the machine-readable files
required under paragraphs (b)(1) and (2) of this section; and
(C) Point-of-contact information, including an up-to-date name,
title, and email address for an individual who can address inquiries
and issues related to the machine-readable files required under
paragraphs (b)(1) and (2) of this section. This contact information
must be prominently displayed on the same website where the machine-
readable files are made available and be kept updated per the
requirements in paragraph (b)(4)(vi) of this section.
(3) Required method and format for disclosing information to the
public. (i) The machine-readable files described in paragraphs (b)(1)
and (2) of this section must be available in a form and manner as
specified in guidance issued by the Department of the Treasury, the
Department of Labor, and the Department of Health and Human Services.
(ii) The machine-readable files must be publicly available and
accessible to any person, automated scripts, or web crawlers free of
charge and without conditions, such as establishment of a user account,
password, submission of personally identifiable information or other
credentials, or blocking server configurations or firewalls to access
the file.
(iii) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section must be included as a link in the footer on the home page of
the group health plan's or health insurance issuer's website, as well
as any page of the website that features a footer, that is labeled
``Price Transparency'' or ``Transparency in Coverage'' and links
directly to the publicly available web page that hosts the link to the
machine-readable files.
(iv) The group health plan or health insurance issuer may satisfy
the requirements of paragraph (b)(3)(iii) of this section by entering
into a written agreement under which another party (such as a third-
party administrator) posts the machine-readable files on its public
website on behalf of the plan or issuer, including if the plan or
issuer does not have a website. However, if the files are posted on a
service provider's website, and the plan or issuer maintains a public
website but chooses not to host the files separately on its own public
website, it must provide a link on its own public website to the
location where the files are made publicly available.
(4) Timing. A group health plan or health insurance issuer must
update the machine-readable files in accordance with the following
timeframes and clearly indicate the date that the files were most
recently updated:
(i) The in-network rate and out-of-network allowed amount machine-
readable files required by paragraphs (b)(1)(i) and (ii) of this
section must be updated and posted quarterly beginning on the first day
of the calendar-year quarter following the applicability date under
paragraph (c)(1) of this section;
[[Page 60514]]
(ii) The prescription drug machine-readable file required by
paragraph (b)(1)(iii) of this section must be updated monthly;
(iii) The change-log machine-readable file required by paragraph
(b)(2)(i) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
date on which the first in-network rate machine-readable file is
required to be posted under paragraph (b)(4)(i) of this section in
accordance with the applicability date of the amendments to paragraph
(b)(1) of this section as specified in paragraph (c)(1) of this
section. If there are no changes to the in-network rate machine-
readable file described in paragraph (b)(1)(i) of this section since
the last such file was updated, a change-log machine-readable file must
still be updated and posted quarterly indicating there are no changes;
(iv) The utilization machine-readable file required under paragraph
(b)(2)(ii) of this section must be updated and posted annually
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section;
(v) The taxonomy machine-readable file required under paragraph
(b)(2)(iii) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section. If there are
no changes to the taxonomy that affect the information required in the
machine-readable file required under paragraph (b)(1)(i) of this
section in a subsequent quarter, the posted taxonomy file is not
required to updated that quarter; and
(vi) The text file required by paragraph (b)(2)(iv) of this section
must be posted beginning on the first day of the calendar-year quarter
following the applicability date under paragraph (c)(1) of this section
and subsequently updated and posted as soon as practicable but no later
than 7 calendar days following a change in any of the information
required under paragraph (b)(2)(iv) of this section.
(5) Special rules to prevent unnecessary duplication--(i) Special
rule for insured group health plans. To the extent coverage under a
group health plan consists of group health insurance coverage, the plan
satisfies the requirements of this paragraph (b) if the plan requires
the health insurance issuer offering the coverage to provide the
information pursuant to a written agreement. Accordingly, if an issuer
and a plan sponsor enter into a written agreement under which the
issuer agrees to provide the information required under this paragraph
(b) in compliance with this section, and the issuer fails to do so,
then the issuer, but not the plan, violates the transparency disclosure
requirements of this paragraph (b).
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a third-party administrator or health care claims clearinghouse) will
provide the information required by this paragraph (b) in compliance
with this section. Notwithstanding the preceding sentence, if a plan or
issuer chooses to enter into such an agreement and the party with which
it contracts fails to provide the information in compliance with this
paragraph (b), the plan or issuer violates the transparency disclosure
requirements of this paragraph (b).
(iii) Special rule for self-insured group health plans with respect
to the disclosure of in-network rate machine-readable files. A self-
insured group health plan that enters into an agreement with another
party described in paragraph (b)(5)(ii) of this section may permit such
other party to make available in a single in-network rate machine-
readable file as required under paragraph (b)(1)(i) of this section the
information required under paragraph (b)(1)(i)for each provider network
used by more than one plan, insurance policy, or contract (including
those offered by different plan sponsors with which the other party has
an agreement) and across different health insurance markets, provided
that--
(A) Each in-network rate machine-readable file made available for a
provider network includes the required information under paragraph
(b)(1)(i) of this section for all covered items and services under each
plan, insurance policy, or contract that uses the same provider network
for which the in-network rate machine-readable file is made available;
and
(B) Each of the self-insured group health plan's change-log,
utilization, and taxonomy machine-readable files include the
information required under paragraphs (b)(2)(i), (ii), and (iii) of
this section, respectively, for the same plans, insurance policies, or
contracts (including those offered by different plan sponsors and
across different health insurance markets, if applicable) represented
in the corresponding in-network rate machine-readable files specified
in paragraph (b)(1)(i) of this section.
(iv) Special rule for self-insured group health plans with respect
to the disclosure of out-of-network allowed amount machine-readable
files. A self-insured group health plan that enters into an agreement
with another party described in paragraph (b)(5)(ii) of this section
may permit such other party to make available the information required
under paragraph (b)(1)(ii) of this section in a single out-of-network
allowed amount file for more than one self-insured group health plan
(including those offered by different plan sponsors with which the
other party has an agreement), provided that the out-of-network allowed
amount and billed charge data described in paragraph (b)(1)(ii)(C) of
this section in relation to a particular item or service is omitted if
it would require disclosure of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of such item
or service across all of the plans (including those offered by
different plan sponsors) included in the out-of-network machine-
readable file.
(c) * * *
(1)(i) Beginning on or after January 2, 2022, the requirements of
this section apply for plan years (in the individual market, for policy
years).
(ii) Notwithstanding paragraph (c)(1)(i) of this section, paragraph
(b)(1) of this section applies on [DATE 12 MONTHS AFTER PUBLICATION OF
FINAL REGULATIONS IN THE FEDERAL REGISTER]. Until such time, the
current provisions of paragraph (b) of this section continue to apply.
* * * * *
DEPARTMENT OF HEALTH AND HUMAN SERVICES
For the reasons stated in the preamble, the Department of Health
and Human Services proposes to amend 45 CFR part 147 as set forth
below:
PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND
INDIVIDUAL HEALTH INSURANCE MARKETS
0
9. The authority citation for part 147 is revised to read as follows:
Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, 300gg-
92, and 300gg-114, as amended.
0
10. Section 147.210 is amended by--
0
a. Redesignating paragraphs (a)(2)(xi) through (xxii) as paragraphs
(a)(2)(xii) through (xxiii), respectively; and
0
b. Adding new paragraph (a)(2)(xi).
The addition reads as follows:
[[Page 60515]]
Sec. 147.210 Transparency in coverage--definitions.
(a) * * *
(2) * * *
(xi) Health insurance market means, irrespective of the State, one
of the following:
(A) The individual market, as defined in 45 CFR 144.103 (other than
short-term, limited-duration insurance or individual health insurance
coverage that consists solely of excepted benefits).
(B) The large group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(C) The small group market, as defined in 45 CFR 144.103 (other
than coverage that consists solely of excepted benefits).
(D) For purposes of self-insured group health plans (other than
account-based plans, as defined in Sec. 147.126(d)(6)(i), and plans
that consist solely of excepted benefits), all self-insured group
health plans maintained by the plan sponsor.
* * * * *
0
11. Section 147.211 is amended by--
0
a. Revising paragraphs (b)(1)(i)(A) and (B), (b)(1)(vii)(A), and
(b)(2)(ii) introductory text;
0
b. Redesignating paragraph (b)(2)(ii)(D) as paragraph (b)(2)(iv);
0
c. Adding paragraph (b)(2)(iii);
0
d. Revising newly redesignated paragraph (b)(2)(iv);
0
e. Revising paragraphs (b)(3)(i) and (ii);
0
f. Revising paragraph (c)(1); and
0
g. Adding paragraph (c)(7).
The revisions and additions read as follows:
Sec. 147.211 Transparency in coverage--required disclosures to
participants, beneficiaries, or enrollees.
* * * * *
(b) * * *
(1) * * *
(i) * * *
(A) If the request for cost-sharing information relates to items
and services that are provided within a bundled payment arrangement,
and the bundled payment arrangement includes items or services that
have a separate cost-sharing liability, the group health plan or health
insurance issuer must provide estimates of the cost-sharing liability
for the requested covered item or service, as well as an estimate of
the cost-sharing liability for each of the items and services in the
bundled payment arrangement that have separate cost-sharing
liabilities. While plans and issuers are not required to provide
estimates of cost-sharing liability for a bundled payment arrangement
where the cost-sharing is imposed separately for each item and service
included in the bundled payment arrangement, nothing prohibits plans or
issuers from providing estimates for multiple items and services in
situations where such estimates could be relevant to participants or
beneficiaries, as long as the plan or issuer also discloses information
about the relevant items or services individually, as required in
paragraph (b)(1)(v) of this section.
(B) For requested items and services that are recommended
preventive services under section 2713 of the Public Health Service Act
(PHS Act), if the group health plan or health insurance issuer cannot
determine whether the request is for preventive or non-preventive
purposes, the plan or issuer must display the cost-sharing liability
that applies for non-preventive purposes. As an alternative, a plan or
issuer may allow a participant, beneficiary, or enrollee to request
cost-sharing information for the specific preventive or non-preventive
item or service by including terms such as ``preventive,'' ``non-
preventive,'' or ``diagnostic'' as a means to request the most accurate
cost-sharing information.
* * * * *
(vii) * * *
(A) A statement that the cost-sharing information provided pursuant
to this paragraph (b)(1) does not account for potential additional
amounts in situations where applicable State or Federal law allow out-
of-network providers to bill participants, beneficiaries, or enrollees
for the difference between a provider's billed charges and the sum of
the amount collected from the group health plan or health insurance
issuer and from the participants, beneficiaries, or enrollees in the
form of a copayment, coinsurance, or deductible amount (the difference
referred to as balance billing). This statement is not required if the
State in which the item or service was furnished prohibits all out-of-
network providers from balance billing for all items and services
payable by the plan or issuer;
* * * * *
(2) * * *
(ii) Paper method. Information provided under this paragraph (b)
must be made available in plain language, without a fee, in paper form
at the request of the participant, beneficiary, or enrollee. In
responding to such a request, the group health plan or health insurance
issuer may limit the number of providers with respect to which cost-
sharing information for covered items and services is provided to no
fewer than 20 providers per request. The plan or issuer is required to:
* * * * *
(iii) Phone method. Information provided under this paragraph (b)
must be made available at the request of the participant, beneficiary,
or enrollee via a telephone number through which a consumer may seek
customer assistance that PHS Act section 2799A-1(e) required be
indicated on any physical or electronic plan or insurance
identification card issued to a participant, beneficiary, or enrollee.
Such information must be accurate at the time of the request and must
be provided at the time of the request. In responding to such a
request, the group health plan or health insurance issuer may limit the
number of providers with respect to which cost-sharing information for
covered items and services is provided to no fewer than 20 providers
per day. The plan or issuer is required to:
(A) Disclose the applicable provider-per-day limit; and
(B) Provide the cost-sharing information, in accordance with the
requirements in paragraphs (b)(2)(i)(A) through (C) of this section.
(iv) Alternative method. In circumstances where participants,
beneficiaries, and enrollees request disclosure other than by the
internet-based self-service tool, paper, or phone (for example, by
email) group health plans and health insurance issuers may provide the
disclosure through alternative means and satisfy the requirements of
this section, provided the participant, beneficiary, or enrollee agrees
that such disclosure through such means is sufficient to satisfy the
request and the plan or issuer meets the timing requirements
established under paragraph (b)(2)(ii)(C) of this section for paper
method disclosure.
(3) * * *
(i) Special rule for insured group health plans. To the extent
coverage under a group health plan consists of group health insurance
coverage, the plan satisfies the requirements of this paragraph (b) if
the plan requires the health insurance issuer offering the coverage to
provide the information required by this paragraph (b) in compliance
with this section pursuant to a written agreement. Accordingly, if an
issuer and a plan sponsor enter into a written agreement under which
the issuer agrees to provide the information required under this
paragraph (b) in compliance with this section, and the issuer fails to
do so, then the issuer, but not the plan, violates the transparency
disclosure requirements of this paragraph (b).
[[Page 60516]]
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a pharmacy benefit manager or other third-party) provides the
information required by this paragraph (b) in compliance with this
section. Notwithstanding the preceding sentence, if a plan or issuer
chooses to enter into such an agreement and the party with which it
contracts fails to provide the information in compliance with this
paragraph (b), the plan or issuer violates the transparency disclosure
requirements of this paragraph (b).
(c) * * *
(1)(i) The provisions of this section apply for plan years (in the
individual market, for policy years) beginning on or after January 1,
2023 with respect to the 500 items and services to be posted on a
publicly available website, and with respect to all covered items and
services, for plan years (in the individual market, for policy years)
beginning on or after January 1, 2024.
(ii) Notwithstanding paragraph (c)(1)(i) of this section,
paragraphs (b)(1)(vii)(A), (b)(2)(iii) and (iv), and (c)(7) of this
section apply for plan years (in the individual market, for policy
years) beginning on or after January 1, 2027. Until such time, the
current provisions of paragraph (b) of this section continue to apply.
* * * * *
(7) A group health plan or health insurance issuer that provides to
the participant, beneficiary or enrollee the information required under
paragraph (b)(1) of this section, in accordance with the method and
format requirements set forth in paragraph (b)(2) of this section,
satisfies the requirements set forth in Code section 9819, ERISA
section 719, and PHS Act section 2799A-4.
* * * * *
0
12. Section 147.212 is amended by--
0
a. Revising paragraph (b) heading and introductory text;
0
b. Revising paragraphs (b)(1)(i) and (ii);
0
c. Redesignating paragraphs (b)(2) and (3) as paragraphs (b)(3) and
(4), respectively;
0
d. Adding new paragraph (b)(2);
0
e. Revising newly redesignated paragraphs (b)(3) and (4);
0
f. Redesignating paragraphs (b)(4)(i) and (ii) as paragraphs (b)(5)(i)
and (ii), respectively;
0
g. Revising newly redesignated paragraphs (b)(5)(i) and (ii);
0
h. Redesignating paragraph (b)(4)(iii) as paragraph (b)(5)(iv);
0
i. Adding new paragraph (b)(5)(iii);
0
j. Revising newly redesignated paragraph (b)(5)(iv); and
0
k. Revising paragraph (c)(1).
The revisions and additions read as follows:
147.212 Transparency in coverage--requirements for public disclosure.
* * * * *
(b) Requirements for public disclosure of in-network provider rates
for covered items and services, out-of-network allowed amounts and
billed charges for covered items and services, negotiated rates and
historical net prices for covered prescription drugs, and contextual
information. A group health plan or health insurance issuer must make
available on an internet website the information required under
paragraphs (b)(1) and (2) of this section in machine-readable files, in
accordance with the method and format requirements described in
paragraph (b)(3) of this section, and that are updated as required
under paragraph (b)(4) of this section.
(1) * * *
(i) An in-network rate machine-readable file for each provider
network maintained or contracted by a group health plan or health
insurance issuer that includes the required information under this
paragraph (b)(1)(i) for all covered items and services under each
coverage option offered by the plan or issuer that uses such provider
network, except for prescription drugs that are subject to a fee-for-
service reimbursement arrangement, which must be reported in the
prescription drug machine-readable file pursuant to paragraph
(b)(1)(iii) of this section. Each in-network rate machine-readable file
must include:
(A) The common provider network name;
(B) For each coverage option offered by a group health plan or
health insurance issuer that uses such provider network, the name; the
Health Insurance Oversight System (HIOS) identifier, or, if no HIOS
identifier is available, the Employer Identification Number (EIN); and
the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(C) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for each billing code for each
covered item or service included in the machine-readable file;
(D) For each covered item or service included in the machine-
readable file, all applicable rates, which may include one or more of
the following: Negotiated rates, underlying fee schedule rates, or
derived amounts. If a group health plan or health insurance issuer does
not use negotiated rates for provider reimbursement, then the plan or
issuer should disclose derived amounts to the extent these amounts are
already calculated in the normal course of business. If the plan or
issuer uses underlying fee schedule rates for calculating cost sharing,
then the plan or issuer should include the underlying fee schedule
rates in addition to the negotiated rate or derived amount. Applicable
rates, including for both individual items and services and items and
services in a bundled payment arrangement, must be:
(1) Reflected as dollar amounts, with respect to each covered item
or service that is furnished by an in-network provider. If the
negotiated rate is subject to change based upon participant,
beneficiary, or enrollee-specific characteristics, these dollar amounts
should be reflected as the base negotiated rate applicable to the item
or service prior to adjustments for participant, beneficiary, or
enrollee-specific characteristics. For contractual arrangements under
which a group health plan or health insurance issuer agrees to pay an
in-network provider a percentage of billed charges and is not able to
assign a dollar amount to an item or service prior to a bill being
generated, plans and issuers must report a percentage number, in lieu
of a dollar amount, in a form and manner as specified in guidance
issued by the Department of the Treasury, the Department of Labor, and
the Department of Health and Human Services.
(2) Associated with the National Provider Identifier (NPI), Tax
Identification Number (TIN), and Place of Service Code for each in-
network provider, except those specified in paragraph (b)(1)(i)(F) of
this section;
(3) Associated with the last date of the contract term or
expiration date for each provider-specific applicable rate that applies
to each covered item or service; and
(4) Indicated with a notation where a reimbursement arrangement
other than a standard fee-for-service model (such as capitation or a
bundled payment arrangement) applies.
(E) Current numerical enrollment totals, as of the date the file is
posted, for each coverage option offered by a group health plan or
health insurance issuer that uses such provider network. Such numerical
enrollment totals must include the number of participants,
beneficiaries, and enrollees (including all dependents) in the coverage
option offered by a plan or issuer.
[[Page 60517]]
(F) A group health plan or health insurance issuer must exclude
from each file under paragraph (b)(1)(i) of this section a provider and
their negotiated rate (provider-rate combination) for an item or
service if the plan or issuer determines it is unlikely that the
provider would be reimbursed for the 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.
(ii) For each health insurance market, as defined in Sec.
147.210(a)(2)(xi), in which a group health plan or health insurance
issuer offers a plan or coverage, an out-of-network allowed amount
machine-readable file, including:
(A) For each coverage option offered by a group health plan or
health insurance issuer in such health insurance market, the name and
the HIOS identifier, or, if no HIOS identifier is available, the EIN;
and the product type (for example, Health Maintenance Organization,
Preferred Provider Organization);
(B) A billing code, which in the case of prescription drugs must be
an NDC, and a plain language description for each billing code for each
covered item or service under any coverage option offered by a group
health plan or health insurance issuer in such health insurance market;
and
(C) Aggregated unique out-of-network allowed amounts and billed
charges with respect to each covered item or service under any coverage
option offered by a group health plan or health insurance issuer in
such health insurance market furnished by out-of-network providers
during the 6-month time period that begins 9 months prior to the
publication date of the machine-readable file (except that a plan or
issuer must omit such data in relation to a particular item or service
when compliance with this paragraph (b)(1)(ii)(C) would require the
plan or issuer to report payment of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of that item
or service in a single health insurance market). Consistent with
paragraph (c)(3) of this section, nothing in this paragraph
(b)(1)(ii)(C) requires the disclosure of information that would violate
any applicable health information privacy law. Each unique out-of-
network allowed amount must be:
(1) Reflected as a dollar amount, with respect to each covered item
or service that is furnished by an out-of-network provider; and
(2) Associated with the NPI, TIN, and Place of Service Code for
each out-of-network provider.
* * * * *
(2) Required contextual files. A group health plan or health
insurance issuer must make available in a machine-readable format:
(i) A change-log file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that identifies
any changes made to the required information described in paragraph
(b)(1)(i) of this section since the immediately preceding published in-
network rate machine-readable file.
(ii) A utilization file, for each in-network rate machine-readable
file specified in paragraph (b)(1)(i) of this section, that includes,
for the 12-month period that ends 6 months prior to the publication
date of each utilization file:
(A) Items and services covered under the plans or policies included
in the files prepared as specified in paragraph (b)(1)(i) of this
section for which a claim has been submitted and reimbursed, in whole
or in part; and
(B) Each in-network provider identified by the NPI, TIN, and Place
of Service Code who was reimbursed, in whole or in part, for a claim
for each covered item or service included as specified in paragraph
(b)(2)(ii)(A) of this section.
(iii) A taxonomy file, for each in-network rate machine-readable
file prepared as specified in paragraph (b)(1)(i) of this section,
which includes the group health plan's or health insurance issuer's
internal provider taxonomy that matches items and services (represented
by a billing code) 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)) 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. Plans and issuers must use their internal provider taxonomy
to determine whether to exclude certain provider-rate combinations from
the in-network rate machine-readable file as specified in paragraph
(b)(1)(i)(F) of this section. (iv) A plain text file in a .txt format
in the root folder (that is, the top-level directory on an electronic
file system) of a group health plan's or health insurance issuer's
website that includes:
(A) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section;
(B) A direct link to the URL for the machine-readable files
required under paragraphs (b)(1) and (2) of this section; and
(C) Point-of-contact information, including an up-to-date name,
title, and email address for an individual who can address inquiries
and issues related to the machine-readable files required under
paragraphs (b)(1) and (2) of this section. This contact information
must be prominently displayed on the same website where the machine-
readable files are made available and be kept updated per the
requirements in paragraph (b)(4)(vi) of this section.
(3) Required method and format for disclosing information to the
public. (i) The machine-readable files described in paragraphs (b)(1)
and (2) of this section must be available in a form and manner as
specified in guidance issued by the Department of the Treasury, the
Department of Labor, and the Department of Health and Human Services.
(ii) The machine-readable files must be publicly available and
accessible to any person, automated scripts, or web crawlers free of
charge and without conditions, such as establishment of a user account,
password, submission of personally identifiable information or other
credentials, or blocking server configurations or firewalls to access
the file.
(iii) The source page URL for the internet website that hosts the
machine-readable files required under paragraphs (b)(1) and (2) of this
section must be included as a link in the footer on the home page of
the group health plan's or health insurance issuer's website, as well
as any page of the website that features a footer, that is labeled
``Price Transparency'' or ``Transparency in Coverage'' and links
directly to the publicly available web page that hosts the link to the
machine-readable files.
(iv) The group health plan or health insurance issuer may satisfy
the requirements of paragraph (b)(3)(iii) of this section by entering
into a written agreement under which another party (such as a third-
party administrator) posts the machine-readable files on its public
website on behalf of the plan or issuer, including if the plan or
issuer does not have a website. However, if the files are posted on a
service provider's website, and the plan or issuer maintains a public
website but chooses not to host the files separately on its own public
website, it must provide a link on its own public website to the
location where the files are made publicly available.
(4) Timing. A group health plan or health insurance issuer must
update the
[[Page 60518]]
machine-readable files in accordance with the following timeframes and
clearly indicate the date that the files were most recently updated:
(i) The in-network rate and out-of-network allowed amount machine-
readable files required by paragraphs (b)(1)(i) and (ii) of this
section must be updated and posted quarterly beginning on the first day
of the calendar-year quarter following the applicability date under
paragraph (c)(1) of this section;
(ii) The prescription drug machine-readable file required by
paragraph (b)(1)(iii) of this section must be updated monthly;
(iii) The change-log machine-readable file required by paragraph
(b)(2)(i) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
date on which the first in-network rate machine-readable file is
required to be posted under paragraph (b)(4)(i) of this section in
accordance with the applicability date of the amendments to paragraph
(b)(1) of this section as specified in paragraph (c)(1) of this
section. If there are no changes to the in-network rate machine-
readable file described in paragraph (b)(1)(i) of this section since
the last such file was updated, a change-log machine-readable file must
still be updated and posted quarterly indicating there are no changes;
(iv) The utilization machine-readable file required under paragraph
(b)(2)(ii) of this section must be updated and posted annually
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section;
(v) The taxonomy machine-readable file required under paragraph
(b)(2)(iii) of this section must be updated and posted quarterly
beginning on the first day of the calendar-year quarter following the
applicability date under paragraph (c)(1) of this section. If there are
no changes to the taxonomy that affect the information required in the
machine-readable file required under paragraph (b)(1)(i) of this
section in a subsequent quarter, the posted taxonomy file is not
required to updated that quarter; and
(vi) The text file required by paragraph (b)(2)(iv) of this section
must be posted beginning on the first day of the calendar-year quarter
following the applicability date under paragraph (c)(1) of this section
and subsequently updated and posted as soon as practicable but no later
than 7 calendar days following a change in any of the information
required under paragraph (b)(2)(iv) of this section.
(5) Special rules to prevent unnecessary duplication--(i) Special
rule for insured group health plans. To the extent coverage under a
group health plan consists of group health insurance coverage, the plan
satisfies the requirements of this paragraph (b) if the plan requires
the health insurance issuer offering the coverage to provide the
information pursuant to a written agreement. Accordingly, if an issuer
and a plan sponsor enter into a written agreement under which the
issuer agrees to provide the information required under this paragraph
(b) in compliance with this section, and the issuer fails to do so,
then the issuer, but not the plan, violates the transparency disclosure
requirements of this paragraph (b).
(ii) Other contractual arrangements. A group health plan or health
insurance issuer may satisfy the requirements under this paragraph (b)
by entering into a written agreement under which another party (such as
a third-party administrator or health care claims clearinghouse) will
provide the information required by this paragraph (b) in compliance
with this section. Notwithstanding the preceding sentence, if a plan or
issuer chooses to enter into such an agreement and the party with which
it contracts fails to provide the information in compliance with this
paragraph (b), the plan or issuer violates the transparency disclosure
requirements of this paragraph (b).
(iii) Special rule for self-insured group health plans with respect
to the disclosure of in-network rate machine-readable files. A self-
insured group health plan that enters into an agreement with another
party described in paragraph (b)(5)(ii) of this section may permit such
other party to make available in a single in-network rate machine-
readable file as required under paragraph (b)(1)(i) of this section the
information required under paragraph (b)(1)(i) for each provider
network used by more than one plan, insurance policy, or
contract(including those offered by different plan sponsors with which
the other party has an agreement) and across different health insurance
markets, provided that--
(A) Each in-network rate machine-readable file made available for a
provider network includes the required information under paragraph
(b)(1)(i) of this section for all covered items and services under each
plan, insurance policy, or contract that uses the same provider network
for which the in-network rate machine-readable file is made available;
and
(B) Each of the self-insured group health plan's change-log,
utilization, and taxonomy machine-readable files include the
information required under paragraphs (b)(2)(i), (ii), and (iii) of
this section, respectively, for the same plans, insurance policies, or
contracts (including those offered by different plan sponsors and
across different health insurance markets, if applicable) represented
in the corresponding in-network rate machine-readable files specified
in paragraph (b)(1)(i) of this section.
(iv) Special rule for self-insured group health plans with respect
to the disclosure of out-of-network allowed amount machine-readable
files. A self-insured group health plan that enters into an agreement
with another party described in paragraph (b)(5)(ii) of this section
may permit such other party to make available the information required
under paragraph (b)(1)(ii) of this section in a single out-of-network
allowed amount file for more than one self-insured group health plan
(including those offered by different plan sponsors with which the
other party has an agreement), provided that the out-of-network allowed
amount and billed charge data described in paragraph (b)(1)(ii)(C) of
this section in relation to a particular item or service is omitted if
it would require disclosure of out-of-network allowed amounts in
connection with fewer than 11 different claims for payment of such item
or service across all of the plans (including those offered by
different plan sponsors) included in the out-of-network machine-
readable file.
(c) * * *
(1)(i) Beginning on or after January 2, 2022, the requirements of
this section apply for plan years (in the individual market, for policy
years).
(ii) Notwithstanding paragraph (c)(1)(i) of this section, paragraph
(b)(1) of this section applies on [DATE 12 MONTHS AFTER PUBLICATION OF
FINAL REGULATIONS IN THE FEDERAL REGISTER]. Until such time, the
current provisions of paragraph (b) of this section continue to apply.
* * * * *
[FR Doc. 2025-23693 Filed 12-19-25; 4:15 pm]
BILLING CODE 4831-GV-P; 4150-29-P; 4120-01-P]