[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3635 Referred in Senate (RFS)]

<DOC>
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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Local Coverage Determination 
Clarification Act of 2018''.

SEC. 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.''.

SEC. 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.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.