#aaeth ,,congress #b;d ,session ,h4 ,r4 #cfce ,,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 program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,local ,coverage ,determination ,clarification ,act of #bjah4 #b4 ,improvements in the ,medicare local coverage determination 7,,lcd7 process for specified ,l,c,ds 7a7 ,development process for specified ,l,c,ds ,section #ahfb7l77#e77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77;,d77 is amended to read as follows3 7,d7 ,process for issuing specified local coverage determinations 7i7 ,in general ,in the case of a specified local coverage determination 7as defined in clause 7iii77 within an area by a medicare administrative contractor1 such medicare administrative contractor must take the following actions with respect to such determination before such determination may take effect3 7,i7 ,publish on the public ,internet website of the intermediary or carrier a proposed version of the specified local coverage determination 7in this subparagraph referred to as a draft determination71 a written rationale for the draft determination1 and a description of all evidence relied upon and considered by the intermediary or carrier in the development of the draft determination4 7,,ii7 ,not later than #fj days after the date on which the intermediary or carrier publishes the draft determination in accordance with subclause 7,i71 convene one or more open1 public meetings to review the draft determination1 receive comments with respect to the draft determination1 and secure the advice of an expert panel 7such as a carrier advisory committee described in chapter #ac of the ,medicare ,program ,integrity ,manual in effect on ,august #ca1 #bjae7 with respect to the draft determination4 ,the intermediary or carrier shall make available means for the public to attend such meetings remotely1 such as via teleconference4 7,,iii7 ,with respect to each meeting convened pursuant to subclause 7,,ii71 post on the public ,internet website of the intermediary or carrier1 not later than #ad days after such meeting is convened1 a record of the minutes for such meeting1 which may be a recording of the meeting4 7,,iv7 ,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 7,,iii7 are so posted and that is not fewer than #cj days in duration4 7ii7 ,finalizing a specified local coverage determination ,a fiscal intermediary or carrier that has entered into a contract with the ,secretary under section #ahgd;,a shall1 with respect to a specified local coverage determination1 post on the public ,internet website of the fiscal intermediary or carrier the following information before the specified local coverage determination 7in this subparagraph referred to as the final determination7 takes effect-- 7,i7 a response to the relevant issues raised at meetings convened pursuant to clause 7i77,,ii7 with respect to the draft determination2 7,,ii7 the rationale for the final determination2 7,,iii7 in the case that the intermediary or carrier considered qualifying evidence 7as defined in clause 7v77 that was not described in the written notice provided pursuant to clause 7i77,i71 a description of such qualifying evidence2 and 7,,iv7 an effective date for the final determination that is not less than #cj days after the date on which such determination is so posted4 7iii7 ,specified local coverage determination defined ,for purposes of this subparagraph1 the term specified local coverage determination means1 with respect to the relevant geographic area-- 7,i7 a new local coverage determination2 7,,ii7 a revised local coverage determination for such geographic area that restricts one or more existing terms of coverage for such area 7such as by adding requirement to an existing local coverage determination that results in decreased coverage or by deleting previously covered ,,icd-#i or ,,icd-#aj codes 7for reasons other than routine coding changes772 7,,iii7 a revised local coverage determination that makes a substantive revision to one or more existing local coverage determinations2 or 7,,iv7 any other local coverage determination specified by the ,secretary pursuant to regulations4 7iv7 ,qualifying evidence defined ,for purposes of this subparagraph1 the term qualifying evidence means publicly available evidence of general acceptance by the medical community1 such as published original research in peer-reviewed medical journals1 systematic reviews and meta-analyses1 evidence-based consensus statements1 and clinical guidelines4 4 7b7 ,,lcd reconsideration process ,section #ahfi7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ff7f77 is amended-- 7#a7 in paragraph 7#b77;,a71 by inserting 7including the reconsiderations described in paragraphs 7#h7 and 7#i77 after local coverage determination2 7#b7 in paragraph 7#e71 by inserting 7except for a reconsideration described in paragraphs 7#h7 and 7#i77 after the coverage determination2 7#c7 by redesignating paragraph 7#h7 as paragraph 7#ac72 and 7#d7 by inserting after paragraph 7#g7 the following new paragraphs3 7#h7 ,carrier or fiscal intermediary reconsideration process for specified local coverage determinations ,upon the filing of a request by an interested party 7as defined in paragraph 7#aa77;,b77with respect to a specified local coverage determination by a fiscal intermediary or carrier that has entered into a contract with the ,secretary under section #ahgd;,a1 the intermediary or carrier shall reconsider such determination in accordance with the following process3 7,a7 ,not later than #cj days after such a request is filed with the fiscal intermediary or carrier by the interested party with respect to such determination1 the intermediary or carrier shall-- 7i7 determine whether the request is an applicable request2 and 7ii7 in the case that the request is not an applicable request1 inform the interested party of the reasons why such request is not an applicable request4 7,b7 ,in the case that the intermediary or carrier determines under subparagraph 7,a7 that the request described in such subparagraph is an applicable request1 the intermediary or carrier shall1 not later than #ij days after the date on which the request was filed with the intermediary or carrier1 take the actions described in subparagraphs 7,c71 7,d71 and 7,e7 with respect to the determination4 7,c7 ,the action described in this subparagraph is the action of specifying whether any of the following statements is applicable to the determination3 7i7 ,the determination did not reasonably consider qualifying evidence relevant to such determination4 7ii7 ,the determination used language that exceeded the scope of the intended purpose of the determination4 7iii7 ,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 #ahfb7;a77#a77;,a74 7iv7 ,the determination failed to describe1 with respect to such an item or service1 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 #ahfb7;a77#a77;,a74 7v7 ,the determination does not apply with respect to items or services to which it was intended to apply4 7vi7 ,the determination is erroneous for another reason that the intermediary or carrier identifies4 7,d7 ,the action described in this subparagraph1 with respect to the determination1 is the action of taking1 based on the specification under subparagraph 7,c7 of whether any of the statements in such subparagraph applied to such determination1 one or more of the following actions3 7i7 ,making no change in the determination4 7ii7 ,rescinding all or a part of the determination4 7iii7 ,modifying the determination to restrict the coverage provided under this title for an item or service that is subject to the determination4 7iv7 ,modifying the determination to expand the coverage provided under this title for an item or service that is subject to the determination4 7,e7 ,the action described in this subparagraph is the action of making publicly available a written description of the action taken under subparagraph 7,d7 with respect to the determination1 including the evidence considered by the medicare administrative contractor4 7#i7 ,agency review of reconsideration decision ,the ,secretary shall establish a process to review a medicare administrative contractor's technical compliance with the requirements1 including ensuring that the medicare administrative contractor independently reviewed the evidence involved1 of the reconsideration under paragraph 7#h74 7#aj7 ,rule of construction ,nothing in paragraph 7#h7 may be construed as affecting the right of an aggrieved party to file a complaint under paragraph 7#b77;,a7 and receive a determination in accordance with the provisions of such paragraph4 ,an aggrieved party is not required to file a request under paragraph 7#h7 or 7#i7 prior to filing a complaint under paragraph 7#b74 7#aa7 ,definitions applicable to paragraphs 7#h7 and 7#i7 ,for purposes of paragraphs 7#h7 and 7#i73 7,a7 ,the term applicable request means a request that is submitted in fiscal year #bjai or a subsequent fiscal year1 that is solely with respect to a specified local coverage determination1 and that includes a description of the rationale for such request and any information or evidence supporting such request4 ,for purposes of the preceding sentence1 the ,secretary may not require1 as a condition of treating a request with respect to such a determination as an applicable request1 that the request contain qualifying evidence that was not considered in the development of such determination4 7,b7 ,the term interested party means1 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 #ahgd;,a1 a beneficiary or stakeholder 7including a medical professional society or physician74 7,c7 ,the term qualifying evidence has the meaning given such term by clause 7iv7 of section #ahfb7l77#e77;,d74 7,d7 ,the term specified local coverage determination has the meaning given such term by clause 7iii7 of such section4 7#ab7 ,report ,not later than ,december #ca of each year 7beginning with #bjai71 the ,secretary shall submit to ,congress a report containing the following3 7,a7 ,the number of requests filed with fiscal intermediaries and carriers under paragraph 7#h71 and the number of appeals filed with the ,secretary under paragraph 7#i71 during the #a-year period ending on such date4 7,b7 ,with respect to such requests filed with such intermediaries and carriers under paragraph 7#h7 during such period1 the number of times that intermediaries and carriers took1 with respect to the actions described in subparagraphs 7,c7 through 7,e7 of such paragraph1 each such action4 7,c7 ,with respect to such appeals filed with the ,secretary under paragraph 7#i7 during such period1 the number of times that the ,secretary took1 with respect to the actions described in subparagraph 7,d7 of paragraph 7#h71 each such action4 7,d7 ,recommendations on ways to improve-- 7i7 the efficacy and the efficiency of the process described in paragraph 7#h72 and 7ii7 communication with individuals entitled to benefits under part ,a or enrolled under part ,b1 providers of services1 and suppliers regarding such process4 4 #c4 ,promulgation of regulations2 application date ,the ,secretary of ,health and ,human ,services shall promulgate regulations to carry out paragraph 7#e77;,d7 of section #ahfb7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l771 as amended by subsection 7a71 and paragraphs 7#h7 and 7#i7 of section #ahfi7;f7 of such ,act 7#db ,u4,s4,c4 #acie;ff7f771 as inserted by subsection 7b71 in such a manner as to ensure that the processes described in such paragraphs are fully implemented by ,january #a1 #bjbj4 ,passed the ,house of ,representatives ,september #ab1 #bjah4;,clerk4