IIB 115th CONGRESS 2d Session H. R. 3635 IN THE SENATE OF THE UNITED STATES September 17, 2018 Received; read twice and referred to the Committee on Finance AN ACT To amend title XVIII of the Social Security Act in order to improve the process whereby medicare administrative contractors issue local coverage determinations under the Medicare program, and for other purposes.

1. Short title This Act may be cited as the Local Coverage Determination Clarification Act of 2018 . 2. Improvements in the Medicare local coverage determination (LCD) process for specified LCDs (a) Development process for specified LCDs Section 1862(l)(5)(D) of the Social Security Act ( 42 U.S.C. 1395y(l)(5)(D) ) is amended to read as follows: (D) Process for issuing specified local coverage determinations (i) In general In the case of a specified local coverage determination (as defined in clause (iii)) within an area by a medicare administrative contractor, such medicare administrative contractor must take the following actions with respect to such determination before such determination may take effect: (I) Publish on the public Internet website of the intermediary or carrier a proposed version of the specified local coverage determination (in this subparagraph referred to as a draft determination ), a written rationale for the draft determination, and a description of all evidence relied upon and considered by the intermediary or carrier in the development of the draft determination. (II) Not later than 60 days after the date on which the intermediary or carrier publishes the draft determination in accordance with subclause (I), convene one or more open, public meetings to review the draft determination, receive comments with respect to the draft determination, and secure the advice of an expert panel (such as a carrier advisory committee described in chapter 13 of the Medicare Program Integrity Manual in effect on August 31, 2015) with respect to the draft determination. The intermediary or carrier shall make available means for the public to attend such meetings remotely, such as via teleconference. (III) With respect to each meeting convened pursuant to subclause (II), post on the public Internet website of the intermediary or carrier, not later than 14 days after such meeting is convened, a record of the minutes for such meeting, which may be a recording of the meeting. (IV) Provide a period for submission of written public comment on such draft determination that begins on the date on which all records required to be posted with respect to such draft determination under subclause (III) are so posted and that is not fewer than 30 days in duration. (ii) Finalizing a specified local coverage determination A fiscal intermediary or carrier that has entered into a contract with the Secretary under section 1874A shall, with respect to a specified local coverage determination, post on the public Internet website of the fiscal intermediary or carrier the following information before the specified local coverage determination (in this subparagraph referred to as the final determination ) takes effect— (I) a response to the relevant issues raised at meetings convened pursuant to clause (i)(II) with respect to the draft determination; (II) the rationale for the final determination; (III) in the case that the intermediary or carrier considered qualifying evidence (as defined in clause (v)) that was not described in the written notice provided pursuant to clause (i)(I), a description of such qualifying evidence; and (IV) an effective date for the final determination that is not less than 30 days after the date on which such determination is so posted. (iii) Specified local coverage determination defined For purposes of this subparagraph, the term specified local coverage determination means, with respect to the relevant geographic area— (I) a new local coverage determination; (II) a revised local coverage determination for such geographic area that restricts one or more existing terms of coverage for such area (such as by adding requirement to an existing local coverage determination that results in decreased coverage or by deleting previously covered ICD–9 or ICD–10 codes (for reasons other than routine coding changes)); (III) a revised local coverage determination that makes a substantive revision to one or more existing local coverage determinations; or (IV) any other local coverage determination specified by the Secretary pursuant to regulations. (iv) Qualifying evidence defined For purposes of this subparagraph, the term qualifying evidence means publicly available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements, and clinical guidelines. . (b) LCD reconsideration process Section 1869(f) of the Social Security Act ( 42 U.S.C. 1395ff(f) ) is amended— (1) in paragraph (2)(A), by inserting (including the reconsiderations described in paragraphs (8) and (9)) after local coverage determination ; (2) in paragraph (5), by inserting (except for a reconsideration described in paragraphs (8) and (9)) after the coverage determination ; (3) by redesignating paragraph (8) as paragraph (13); and (4) by inserting after paragraph (7) the following new paragraphs: (8) Carrier or fiscal intermediary reconsideration process for specified local coverage determinations Upon the filing of a request by an interested party (as defined in paragraph (11)(B))with respect to a specified local coverage determination by a fiscal intermediary or carrier that has entered into a contract with the Secretary under section 1874A, the intermediary or carrier shall reconsider such determination in accordance with the following process: (A) Not later than 30 days after such a request is filed with the fiscal intermediary or carrier by the interested party with respect to such determination, the intermediary or carrier shall— (i) determine whether the request is an applicable request; and (ii) in the case that the request is not an applicable request, inform the interested party of the reasons why such request is not an applicable request. (B) In the case that the intermediary or carrier determines under subparagraph (A) that the request described in such subparagraph is an applicable request, the intermediary or carrier shall, not later than 90 days after the date on which the request was filed with the intermediary or carrier, take the actions described in subparagraphs (C), (D), and (E) with respect to the determination. (C) The action described in this subparagraph is the action of specifying whether any of the following statements is applicable to the determination: (i) The determination did not reasonably consider qualifying evidence relevant to such determination. (ii) The determination used language that exceeded the scope of the intended purpose of the determination. (iii) The determination was incorrect in its determination of whether such item or service is reasonable and necessary for the diagnosis or treatment of illness or injury under section 1862(a)(1)(A). (iv) The determination failed to describe, with respect to such an item or service, the clinical conditions to be used for purposes of determining whether such item or service is reasonable and necessary for the diagnosis or treatment of illness or injury under section 1862(a)(1)(A). (v) The determination does not apply with respect to items or services to which it was intended to apply. (vi) The determination is erroneous for another reason that the intermediary or carrier identifies. (D) The action described in this subparagraph, with respect to the determination, is the action of taking, based on the specification under subparagraph (C) of whether any of the statements in such subparagraph applied to such determination, one or more of the following actions: (i) Making no change in the determination. (ii) Rescinding all or a part of the determination. (iii) Modifying the determination to restrict the coverage provided under this title for an item or service that is subject to the determination. (iv) Modifying the determination to expand the coverage provided under this title for an item or service that is subject to the determination. (E) The action described in this subparagraph is the action of making publicly available a written description of the action taken under subparagraph (D) with respect to the determination, including the evidence considered by the medicare administrative contractor. (9) Agency review of reconsideration decision The Secretary shall establish a process to review a medicare administrative contractor’s technical compliance with the requirements, including ensuring that the medicare administrative contractor independently reviewed the evidence involved, of the reconsideration under paragraph (8). (10) Rule of construction Nothing in paragraph (8) may be construed as affecting the right of an aggrieved party to file a complaint under paragraph (2)(A) and receive a determination in accordance with the provisions of such paragraph. An aggrieved party is not required to file a request under paragraph (8) or (9) prior to filing a complaint under paragraph (2). (11) Definitions applicable to paragraphs (8) and (9) For purposes of paragraphs (8) and (9): (A) The term applicable request means a request that is submitted in fiscal year 2019 or a subsequent fiscal year, that is solely with respect to a specified local coverage determination, and that includes a description of the rationale for such request and any information or evidence supporting such request. For purposes of the preceding sentence, the Secretary may not require, as a condition of treating a request with respect to such a determination as an applicable request, that the request contain qualifying evidence that was not considered in the development of such determination. (B) The term interested party means, with respect to a specified local coverage determination within an area by a fiscal intermediary or carrier that has entered into a contract with the Secretary under section 1874A, a beneficiary or stakeholder (including a medical professional society or physician). (C) The term qualifying evidence has the meaning given such term by clause (iv) of section 1862(l)(5)(D). (D) The term specified local coverage determination has the meaning given such term by clause (iii) of such section. (12) Report Not later than December 31 of each year (beginning with 2019), the Secretary shall submit to Congress a report containing the following: (A) The number of requests filed with fiscal intermediaries and carriers under paragraph (8), and the number of appeals filed with the Secretary under paragraph (9), during the 1-year period ending on such date. (B) With respect to such requests filed with such intermediaries and carriers under paragraph (8) during such period, the number of times that intermediaries and carriers took, with respect to the actions described in subparagraphs (C) through (E) of such paragraph, each such action. (C) With respect to such appeals filed with the Secretary under paragraph (9) during such period, the number of times that the Secretary took, with respect to the actions described in subparagraph (D) of paragraph (8), each such action. (D) Recommendations on ways to improve— (i) the efficacy and the efficiency of the process described in paragraph (8); and (ii) communication with individuals entitled to benefits under part A or enrolled under part B, providers of services, and suppliers regarding such process. . 3. Promulgation of regulations; application date The Secretary of Health and Human Services shall promulgate regulations to carry out paragraph (5)(D) of section 1862(l) of the Social Security Act ( 42 U.S.C. 1395y(l) ), as amended by subsection (a), and paragraphs (8) and (9) of section 1869(f) of such Act ( 42 U.S.C. 1395ff(f) ), as inserted by subsection (b), in such a manner as to ensure that the processes described in such paragraphs are fully implemented by January 1, 2020.

Passed the House of Representatives September 12, 2018. Karen L. Haas, Clerk