Transparency in Coverage

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\

\1\ 84 FR 65464 (November 27, 2019).

\2\ 85 FR 72158 (November 12, 2020).

\3\ 85 FR 72158, 72160 (November 12, 2020).

The public disclosures made under the 2020 final rules led to the release of an enormous amount of previously hidden pricing data. However, post-implementation, the Departments received feedback from users of the machine-readable files emphasizing the need to address certain gaps in reporting, shrink file size by reducing duplication and removing unnecessary data, and improve the usability of the files.

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. 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 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.\5\ The Departments plan to begin working to implement the prescription drug file in short order.

\4\ Exec. Order No. 14221, 90 FR 11005 (February 28, 2025).

\5\ 90 FR 23303 (June 2, 2025).

To address statutory requirements and fulfill their responsibility under Executive Order 14221, the Departments proposed to amend certain requirements of the 2020 final rules in the December

23, 2025, Transparency in Coverage proposed rules (the proposed rules).\6\ The proposed rules addressed what the Departments identified as three main barriers to fully achieving the goals of the 2020 final rules: inaccessibility due to the large size of the machine-readable files, data ambiguity due to lack of contextual information alongside the raw data, andareas of misalignment with the Hospital Price Transparency rules \7\ that make comparing data across disclosures challenging. The proposed rules' Executive Summary further discussed the need for price transparency, including how it would benefit employers leveraging the data to lower their health care costs and app developers conducting analyses to offer pricing tools to individuals and employers, in addition to past regulatory and sub-regulatory action (section I.A.).\8\

\6\ 90 FR 60432 (December 23, 2025).

\7\ Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. Price Transparency Requirements for Hospitals To Make Standard Charges Public, 84 FR 65524 (November 27, 2019); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model, 86 FR 63458 (November 16, 2021); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction, 88 FR 81540 (November 22, 2023); Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots, 90 FR 53448 (November 25, 2025).

\8\ 90 FR 60432 (December 23, 2025).

After consideration of public comment to the proposed rules and to address the need for regulatory action, the Departments are finalizing these rules pursuant to the authority under section 2715A of the Public Health Service (PHS) Act, included in 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).\9\ 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).

\9\ Except that under section 2715A of the PHS Act, a plan or coverage that is not offered through the Exchange is only required to submit information to the applicable Secretary and the State insurance commissioner, and to make such information available to the public.

The Departments are also finalizing 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, which added Code section 9819, ERISA section 719, and PHS Act section 2799A-4, requires group health plans and health insurance issuers to offer price comparison guidance by telephone and make a “price comparison tool” available on the plan's or issuer's website.