,,ii #aaith ,,congress #b;d ,session ,s4 #edge ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bc1 #bjbf,mr4 ,lujn 7for himself and ,mr4 ,cotton7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to ensure timely review of local coverage determination requests under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,timely ,access to ,coverage ,decisions ,act4 #b4 ,ensuring timely review of local coverage determination requests under the ,medicare program 7a7 ,in general ,section #ahfb7l77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is amended by adding at the end the following new subparagraph3 7,e7 ,timeframe for decisions on requests for local coverage determinations 7i7 ,in general ,the ,secretary shall require each ,medicare administrative contractor that receives a formal ,,lcd request on or after the date that is #ij days after the date of enactment of this subparagraph to determine whether such request is a complete request or an incomplete request not later than #fj days after such contractor receives such request4 7ii7 ,notification with respect to incomplete requests ,in the case that a ,medicare administrative contractor makes a determination described in clause 7i7 with respect to a formal ,,lcd request that such request is incomplete1 such contractor shall1 not later than #fj days after the date on which such contractor received such request1 transmit to the entity that submitted such request a written notification of such determination that includes a specification of each item of additional information needed to make such request complete4 7iii7 ,decision timeline for complete requests ,in the case that a ,medicare administrative contractor makes a determination described in clause 7i7 with respect to a formal ,,lcd request that such request is complete1 such contractor shall1 not later than #a year after the date on which such contractor received such request1 take the actions described in clauses 7i7 and 7ii7 of subparagraph 7,d74 7iv7 ,formal ,,lcd request defined ,in this subparagraph1 the term formal ,,lcd request means a document that identifies itself as a formal request for a local coverage determination4 4 7b7 ,reconsideration requests ,section #ahfb7l77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e771 as amended by subsection 7a71 is further amended by adding at the end the following new subparagraphs3 7,f7 ,timeframe for decisions on reconsideration requests for local coverage determinations 7i7 ,in general ,the ,secretary shall require each ,medicare administrative contractor that receives a formal reconsideration request on or after the date that is #ij days after the date of enactment of this subparagraph to determine whether such request is a complete request or an incomplete request not later than #fj days after such contractor receives such request4 7ii7 ,notification with respect to incomplete requests ,in the case that a ,medicare administrative contractor makes a determination described in clause 7i7 with respect to a formal reconsideration request that such request is incomplete1 such contractor shall1 not later than #fj days after the date on which such contractor received such request1 transmit to the entity that submitted such request a written notification of such determination that includes a specification of each item of additional information needed to make such request complete4 7iii7 ,decision timeline for complete requests ,in the case that a ,medicare administrative contractor makes a determination described in clause 7i7 with respect to a formal reconsideration request that such request is complete1 such contractor shall1 not later than #a year after the date on which such contractor received such request1 take the actions described in clauses 7i7 and 7ii7 of subparagraph 7,d74 7iv7 ,definitions ,in this subparagraph3 7,i7 ,formal reconsideration request ,the term formal reconsideration request means1 with respect to a ,medicare administrative contractor1 a document that-- 7aa7 identifies itself as a formal request for reconsideration of part or all of a finalized local coverage determination made by such contractor with respect to a geographic area2 and 7bb7 is submitted by an interested party4 7,,ii7 ,interested party ,the term interested party means1 with respect to a local coverage determination made by a ,medicare administrative contractor with respect to a geographic area-- 7aa7 an individual entitled to benefits under part ,a or enrolled under part ,b who resides in1 or receives items or services in1 such area2 7bb7 a provider of services or supplier that1 in such area1 furnishes1 provides1 or supplies items or services that are subject to such determination2 or 7cc7 any entity that the ,secretary determines to be an interested party in such area4 7,g7 ,agency review of reconsideration decision ,upon the request of an interested party 7as defined in subparagraph 7,f77iv771 the ,secretary shall review the final determination 7as defined in subparagraph 7,d77ii77 made by a ,medicare administrative contractor following a complete formal reconsideration request made under subparagraph 7,f74 ,such review shall include an analysis of whether-- 7i7 the determination did not apply1 or inaccurately interpreted1 qualifying evidence 7as defined in subparagraph 7,d77iv77 relevant to such determination2 7ii7 the determination used language that exceeded the scope of the intended purpose of the determination2 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;,a72 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;,a72 7v7 the determination does not apply with respect to items or services to which it was intended to apply2 or 7vi7 the determination conflicts with any other law1 rule1 regulation1 or national coverage determination1 as determined by the ,secretary4 4 7c7 ,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 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 ,centers for ,medicare ,medicaid ,services commonly referred to as the ,medicare ,coverage ,database 7or a successor website7 and on the public internet website of the ,medicare administrative contractor a proposed version of the specified local coverage determination 7in this subparagraph referred to as a draft determination71 any related coding or billing information1 a written rationale for the draft determination1 and a description of all evidence relied upon and considered by the contractor in the development of the draft determination4 7,,ii7 ,not later than #fj days after the date on which the ,medicare administrative contractor publishes the draft determination in accordance with subclause 7,i7-- 7aa7 convene one or more open1 public meetings to review the draft determination1 and1 with respect to each such meeting1 make available means for the public to attend such meeting remotely1 and make the planned agenda for such meeting publicly accessible at least #ad days in advance2 7bb7 receive comments with respect to the draft determination2 and 7cc7 secure the advice of an expert panel1 which shall include-- 7,,aa7 #a or more physicians2 7,,bb7 #a or more members of the ,contractor ,advisory ,committee 7as described in chapter #ac of the ,medicare ,program ,integrity ,manual1 as in effect on ,february #ab1 #bjai72 and 7,,cc7 #a or more entities advocating on behalf of one or more individuals entitled to benefits under part ,a or enrolled under part ,b4 7,,iii7 ,with respect to each meeting convened pursuant to subclause 7,,ii77aa71 post on the public internet website of the contractor1 not later than #ad days after such meeting is convened1 a record of such meeting1 which may include a video or audio 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 7,i7 ,in general ,subject to subclause 7,,ii71 a ,medicare administrative contractor that has entered into a contract with the ,secretary under section #ahgd;,a shall1 before a specified local coverage determination 7in this subparagraph referred to as the final determination7 takes effect1 post on the ,medicare ,coverage ,database and the public internet website of the contractor the following information3 7aa7 ,a response to public comments received and the relevant issues raised at meetings convened pursuant to clause 7i77,,ii77aa7 with respect to the draft determination4 7bb7 ,the full text of all such public comments received4 7cc7 ,the rationale for the final determination4 7dd7 ,in the case that the ,medicare administrative contractor considered qualifying evidence 7as defined in clause 7iv77 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 evidence4 7ee7 ,an effective date for the final determination that is not less than #de days after the date on which such determination is so posted4 7,,ii7 ,logical outgrowth requirement ,notwithstanding subclause 7,i71 a final determination may not take effect unless such determination is a logical outgrowth of the draft determination published under clause 7i74 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 that makes a substantive revision to one or more existing local coverage determinations 7such as by imposing new requirements with respect to coverage of the relevant item or service or by changing any coding or billing information related to such determination72 or 7,,iii7 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 7d7 ,effective date ,this section1 and the amendments made by this section1 shall apply beginning on the date that is #a year after the date of the enactment of this section4