Request for Information Regarding the Prescription Drug Machine-Readable File Requirement in the Transparency in Coverage Final Rule

DEPARTMENT OF THE TREASURY <SUBAGY>Internal Revenue Service</SUBAGY> <CFR>26 CFR Part 54</CFR> <RIN>RIN 1545-BR51</RIN> DEPARTMENT OF LABOR <SUBAGY>Employee Benefits Security Administration</SUBAGY> <CFR>29 CFR Part 2590</CFR> <RIN>RIN 1210-AC30</RIN> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>45 CFR Part 147</CFR> <DEPDOC>[CMS-9882-NC]</DEPDOC> <RIN>RIN 0938-AV64</RIN> <SUBJECT>Request for Information Regarding the Prescription Drug Machine-Readable File Requirement in the Transparency in Coverage Final Rule</SUBJECT> <HD SOURCE="HED">AGENCIES:</HD> 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. <HD SOURCE="HED">ACTION:</HD> Request for information. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document is a request for information (RFI) regarding the prescription drug machine-readable file disclosure requirements in the Transparency in Coverage final rules. The Departments of Labor, Health and Human Services (HHS), and the Treasury (the Departments) are issuing this RFI to gather input regarding implementation of the prescription drug machine-readable file disclosure requirements under the Transparency in Coverage final rules, including what modifications to the disclosure requirements or additional technical implementation guidance might be necessary to better ensure the accurate and timely completion of the prescription drug file. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below by July 2, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Written comments may be submitted to the address specified below. Any comment that is submitted will be shared among the Departments. 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. All 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 1210-AC30. The Departments cannot accept comments by facsimile (FAX) transmission. Comments must be submitted in one of the following two ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to <E T="03">https://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. By mail. You may mail written comments to the following address ONLY: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, <E T="03">Attention:</E> 1210-AC30. Please allow sufficient time for mailed comments to be received before the close of the comment period. <E T="03">Inspection of Public Comments:</E> 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 comments are posted on the following website as soon as possible after they have been received: <E T="03">https://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Alexander Krupnick, Internal Revenue Service, Department of the Treasury, at (202) 317-5500. Elizabeth Schumacher, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335. Kendra May, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (301) 448-3996. <E T="03">Customer Service Information:</E> Individuals interested in obtaining information from the Department of Labor (DOL) concerning private sector employment-based health coverage laws may submit a question at askEBSA.dol.gov, call the Employee Benefits Security Administration (EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the DOL's website ( <E T="03">www.dol.gov/agencies/ebsa</E> ). In addition, information from HHS on private health insurance coverage and nonfederal governmental group health plans can be found on the Centers for Medicare & Medicaid Services (CMS) website ( <E T="03">www.cms.gov/cciio</E> ), and information on healthcare reform can be found at <E T="03">www.HealthCare.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> The Departments are soliciting information from the public to inform future rulemaking or guidance on prescription drug price transparency. As discussed below, in 2020 the Departments issued the Transparency in Coverage final rules (TiC final rules)  <SU>1</SU> <FTREF/> requiring group health plans and health insurance issuers offering group or individual health insurance coverage to make available to the public, among other things, certain information relating to prescription drug expenditures. <FTNT> <SU>1</SU>  85 FR 72158 (Nov. 12, 2020). </FTNT> The Departments previously deferred enforcement of the provisions of the TiC final rules relating to prescription drug expenditures in published guidance, as discussed below. <SU>2</SU> <FTREF/> However, transparency in healthcare pricing is a priority, and the Departments intend to implement disclosure requirements related to prescription drug expenditures and effectuate the goals of greater price transparency including transparency related to prescription drug pricing. In addition, President Trump issued an Executive Order to prioritize improving existing price transparency requirements and ensuring that patients have the information they need to make well-informed decisions about their healthcare. <SU>3</SU> <FTREF/> Accordingly, the Departments now seek the public's feedback on ways to effectively implement or amend the disclosure requirements related to prescription drug expenditures in the TiC final rules. <FTNT> <SU>2</SU>   <E T="03">See</E> FAQs About Affordable Care Act Implementation Part 61 (FAQs Part 61) (Sept. 27, 2023), available at <E T="03">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-61.pdf</E> and <E T="03">https://www.cms.gov/files/document/faqs-about-affordable-care-act-implementation-part-61.pdf;</E> FAQs About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 49 (FAQs Part 49), Q1 (Aug. 20, 2021), available at <E T="03">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/affordable-care-act-faqs-49-2021.pdf</E> and <E T="03">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-49.pdf.</E> </FTNT> <FTNT> <SU>3</SU>   <E T="03">See</E> Executive Order 14221, “Making America Healthy Again by Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information,” 90 FR 11005 (Feb. 28, 2025). Executive Order 14221 was issued on February 25, 2025, and was published in the <E T="04">Federal Register</E> on February 28, 2025. </FTNT> <HD SOURCE="HD2">A. Statutory Background, Executive Order 13877, and the TiC Final Rules</HD> 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) (collectively, PPACA) reorganized, amended, and added to the provisions of part A of title XXVII of the Public Health Service (PHS) Act relating to health coverage requirements for group health plans and health insurance issuers in the group and individual markets. <SU>4</SU> <FTREF/> <FTNT> <SU>4</SU>  The PPACA also added section 715 to the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815 to the Internal Revenue Code (Code) to incorporate the provisions of part A of title XXVII of the PHS Act, PHS Act sections 2701 through 2728, making them applicable to group health plans and health insurance issuers providing coverage in connection with group health plans. </FTNT> Section 2715A of the PHS Act, incorporated into section 715 of the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815 to the Internal Revenue Code (Code), provides that group health plans and health insurance issuers offering group or individual health insurance coverage must comply with section 1311(e)(3) of the PPACA, <SU>5</SU> <FTREF/> which 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 PPACA). A plan or coverage that is not offered through an Exchange and that is subject to section 2715A of the PHS Act is required to submit the information required to the Secretary of HHS and the relevant state's insurance commissioner, and to make that information available to the public. Together these statutory provisions require the majority of private health plans to disseminate comprehensive information to provide transparency in coverage. <SU>6</SU> <FTREF/> <FTNT> <SU>5</SU>  Paragraph (A) of section 1311(e)(3) of the PPACA requires a plan seeking certification as a QHP to make the following information available to the public and submit it to state insurance regulators, the Secretary of HHS, and the Exchange (1) Claims paym ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 45k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━