I 118th CONGRESS 1st Session H. R. 5396 IN THE HOUSE OF REPRESENTATIVES September 12, 2023 Mr. Bucshon introduced the following bill; which was referred to the Committee on Ways and Means , and in addition to the Committee on Energy and Commerce , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to prohibit Medicare local coverage determinations from restricting access to care, and for other purposes.

1. Short title This Act may be cited as the Coverage Determination Clarity Act of 2023 . 2. Improving access to items and services under medicare local coverage determinations (a) In general Section 1862(l)(5) of the Social Security Act ( 42 U.S.C. 1395y(l)(5) ) is amended— (1) in subparagraph (A), by striking The Secretary and inserting Subject to subparagraph (E), the Secretary ; and (2) by adding at the end the following new subparagraph: (E) Prohibition on limiting access items and services (i) Review of local coverage determinations Beginning in 2024, and annually thereafter, the Secretary shall review each local coverage determination in effect as of the date of such review to determine whether such local coverage determination denies, limits, or conditions the coverage or provision of items or services beyond that provided by a national coverage determination that has determined that such items or services be covered nationally under this title. (ii) Conflict between a national coverage determination and a local coverage determination A local coverage determination denies, limits, or conditions the coverage or provision of items or services for purposes of clause (i) to the extent that such local coverage determination limits access to such items or services by imposing restrictions that do not directly interpret provisions of a national coverage determination that has determined that such items or services be covered nationally under this title. (iii) Revision of local coverage determinations (I) In general If the review conducted by the Secretary under clause (i) determines that a local coverage determination denies, limits, or conditions the coverage or provision of items or services that are approved, cleared, authorized, or licensed under section 505, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, the Secretary shall direct the appropriate Medicare administrative contractor to expeditiously revise such local coverage determination to eliminate the limitation. (II) Timing A Medicare administrative contractor shall publish a revised local determination no later than the date that is 180 days after the date on which the Secretary directs such contractor to revise a local coverage determination under subclause (I). (iv) New local coverage determinations The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to ensure that any such local coverage determination does not deny, limit, or condition the coverage or provision of items or services pursuant to clause (ii) beyond that provided by a national coverage determination that has determined that such items or services be covered nationally under this title. (v) Error verification and corrective actions In verifying any potential errors and taking corrective actions, Medicare administrative contractors, comprehensive error rate testing recovery auditors, and unified program integrity contractors and independent review agencies— (I) shall not deviate from local coverage determination provisions applicable in the region in which such verification or corrective action occurs; and (II) shall provide transparent review by publishing the names of the reviewers and their qualifications in a place and format available to providers. (vi) Reports to congress Beginning in 2025 and each year thereafter, the Secretary shall submit a report to the appropriate committees of Congress on the findings of the review conducted under clause (i) and any local coverage determinations revised pursuant to clause (iii) during the preceding year. . (b) Effective date The amendments made by subsection (a) shall apply with respect to proposed and final local coverage determinations posted on Medicare administrative contractor websites on and after January 1, 2023.