,i #aadth ,,congress #b;d ,session ,h4 ,r4 #egba ,,in ,,the ,,house ,,of ,,representatives ,july #aa1 #bjaf,ms4 ,jenkins of ,kansas 7for herself and ,mr4 ,kind7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 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 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 #bjaf4 #b4 ,improvements in the ,medicare local coverage determination 7,,lcd7 process for specified ,l,c,ds 7a7 ,,lcd development process ,section #ahfb7l77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is amended by adding at the end the following subparagraph3 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 7iv77 within an area by a fiscal intermediary or carrier that has entered into a contract with the ,secretary under section #ahgd;,a1 such intermediary or carrier 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 section 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 meeting minutes for such 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 section referred to as the final determination7 takes effect-- 7,i7 a response the 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 in the development of the determination 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 ,limitation on determinations across jurisdictions ,notwithstanding any plan under section #ahfb7l77#e77;,a71 in the case of a contract with a fiscal intermediary or carrier under section #ahgd;,a1 such intermediary or carrier may not finalize a specified local coverage determination pursuant to clause 7ii7 with respect to a geographic area that applies1 or has the effect of applying1 outside such area4 ,in the case that such an intermediary or carrier wishes to adopt1 with respect to a specific geographic area a specified local coverage determination developed for a different geographic area1 such intermediary or carrier may not so adopt such determination unless1 prior to so adopting such determination1 such intermediary or carrier independently evaluates and considers the qualifying evidence supporting the determination as applicable to such specific geographic area and makes a local coverage determination for such area in accordance with this subparagraph4 7iv7 ,specified local coverage determination defined ,for purposes of this subparagraph1 the term specified local coverage determination means1 with respect to a geographic area-- 7,i7 a new local coverage determination 7regardless of whether such determination made by a fiscal intermediary or carrier that has entered into a contract with the ,secretary under section #ahgd;,a and is based upon a specified local coverage determination that previously has been made with respect to another geographic area1 or by another such intermediary or carrier72 7,,ii7 a revised local coverage determination for such geographic area that restricts one or more existing coverage criteria for such area 7such as by adding noncovered indications to an existing local coverage determination or by deleting previously covered ,,icd-#i or ,,icd-#aj codes72 7,,iii7 a revised local coverage determination that makes a substantive revision to one or more existing local coverage determinations2 and 7,,iv7 any other local coverage determination specified by the ,secretary pursuant to regulations4 7v7 ,qualifying evidence defined ,for purposes of this subparagraph1 the term qualifying evidence means either of the following3 7,i7 ,scientific evidence published in peer-reviewed medical literature1 such as randomized clinical trials or other studies4 7,,ii7 ,a general consensus of the applicable medical community 7such as a consensus evinced through a recognized standard of practice in such medical community7 that is supported by information provided by a recognized medical authority1 such as a professional medical society4 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 7and1 as applicable1 the limitations under paragraphs 7#h7 and 7#i77 before the colon2 7#b7 in paragraph 7#e71 by inserting 7other than under paragraphs 7#h7 and 7#i77 after this subsection2 7#c7 by redesignating paragraph 7#h7 as paragraph 7#ab72 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 ,for purposes of paragraph 7#b77;,a71 the limitations described in this paragraph are that1 upon the filing of a request by an interested party 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 #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 apply1 or inaccurately applied1 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 a part of the determination 7including1 as applicable1 the entire determination74 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 determination4 7#i7 ,agency evaluation of reconsideration decision ,for purposes of paragraph 7#b77;,a71 the limitations described in this paragraph are that1 in the case that an interested party that filed an applicable request under paragraph 7#h7 with respect to a specified local coverage determination files with the ,secretary1 on a date that is not later than #abj days after the date on which an intermediary or carrier takes an action described under paragraph 7#h77;,d7 with respect to such determination1 an appeal with respect to such decision in such form and manner as the ,secretary may require1 the ,secretary shall1 not later than #cj days after such appeal is filed-- 7,a7 specify which1 if any1 of the statements in subparagraph 7,c7 of paragraph 7#h7 is applicable to the determination2 and 7,b7 based on such specification1 take one of the actions described in subparagraph 7,d7 of such paragraph with respect to the determination4 ,the ,secretary shall apply subparagraph 7,a7 as though the reference to the intermediary or carrier in clause 7vi7 of paragraph 7#h77;,d7 were a reference to the ,secretary4 7#aj7 ,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 #bjah 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 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;,a-- 7i7 a provider of services or supplier that1 in such area1 furnishes1 provides1 or supplies items or services that are subject to such determination2 or 7ii7 an organization that represents such a provider of services or supplier4 7,c7 ,the term qualifying evidence has the meaning given such term by clause 7v7 of section #ahfb7l77#e77;,d74 7,d7 ,the term specified local coverage determination has the meaning given such term by clause 7iv7 of such section4 7#aa7 ,appointment of ,ombudsman 7,a7 ,in general ,the ,secretary shall1 within the ,centers for ,medicare ,medicaid ,services1 appoint a ,medicare ,reviews and ,appeals ,ombudsman 7referred to in this paragraph as the ,ombudsman74 7,b7 ,duties ,the ,ombudsman shall1 with respect to specified local coverage determinations1 carry out the following duties3 7i7 ,provide interested parties 7as defined in paragraph 7#aj77;,b77 with administrative and technical assistance in filing requests under paragraph 7#h7 and appeals under paragraph 7#i74 7ii7 ,make publicly available in a uniform1 consistent1 and easily understood format the following information for each #ab-month period3 7,i7 ,the number of requests filed with fiscal intermediaries and carriers under paragraph 7#h71 and of appeals filed with the ,secretary under paragraph 7#i71 during such period4 7,,ii7 ,with respect to such requests during such period1 the number of times that intermediaries and carriers took1 with respect to the actions described subparagraph 7,a77iv7 of such paragraph1 each such action4 7,,iii7 ,with respect to such appeals during such period1 the number of times that the ,secretary took each such action4 7,,iv7 ,with respect to the numbers made available under subclauses 7,i71 7,,ii71 and 7,,iii71 the number of each such number that is attributable to-- 7aa7 each fiscal intermediary or carrier2 and 7bb7 each interested party 7as defined in paragraph 7#aj77;,b774 7,v7 ,measures of the responsiveness of fiscal intermediaries and carriers with respect to requests filed with such intermediaries and carriers under paragraph 7#h74 7,,vi7 ,recommendations to the ,secretary with respect to ways to improve-- 7aa7 the efficacy and efficiency of the process described in paragraph 7#h72 and 7bb7 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 added 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 ,october #a1 #bjag4