,i #aacth ,,congress #ast ,session ,h4 ,r4 #bjhe ,,in ,,the ,,house ,,of ,,representatives ,may #bb1 #bjac ,mr4 ,roskam 7for himself1 ,mr4 ,neal1 ,mr4 ,lance1 ,mr4 ,kind1 ,mr4 ,guthrie1 ,mr4 ,paulsen1 and ,mr4 ,tiberi7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 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 create incentive for innovative diagnostics by improving the process for determining ,medicare payment rates for new tests4 #a4 ,short title ,this ,act may be cited as the ,diagnostic ,innovation ,testing and ,knowledge ,advancement ,act of #bjac4 #b4 ,creating incentives for innovative diagnostics 7a7 ,improvements ,to process for determining fee schedule amounts for new tests 7#a7 ,clarifying factors for rate-setting ,in determining the payment amount under gapfilling procedures 7as described in section #dad4ejh7;b7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation to such section7 for new clinical diagnostic laboratory tests under section #ahcc7;h77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h771 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall take into account1 as applicable and available1 the following factors with respect to such a new test3 7,a7 ,impact on patient care ,the impact of the new test on patient care1 patient management1 or patient treatment4 7,b7 ,technical characteristics ,the technical characteristics of the new test1 and the resources required to develop1 validate1 and perform the new test4 7,c7 ,claims data ,data from claims for which payment is made under part ,b of title ,,xviii of the ,social ,security ,act4 7,d7 ,laboratory charges ,amounts charged by laboratories to self-pay patients for the new test4 7,e7 ,private insurance rates ,amounts paid to laboratories for such new test under private health insurance coverage offered in the group market and the individual market4 7,f7 ,advisory panel recommendations ,the findings and recommendations of the independent advisory panel convened under paragraph 7#b7 with respect to that new test and any comments received during the open meeting of the advisory panel4 7,g7 ,additional factors ,such other factors as the ,secretary may specify4 7#b7 ,input from patients1 clinicians1 and technical experts 7,a7 ,requirement for independent advisory panel ,the ,secretary shall convene an independent advisory panel from which the ,secretary shall request information and recommendations regarding any new test 7as referred to under subparagraph 7,a7 of section #ahcc7;h77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h777 for which payment is made under such section1 including technical1 clinical1 and quality information4 7,b7 ,composition of independent advisory panel ,subject to subparagraph 7,d71 the independent advisory panel shall be comprised of #ai members1 including-- 7i7 #g individuals with expertise and experience with clinical diagnostic laboratory tests including expertise in the technical characteristics of the new test as well as expertise in the requirements to develop1 validate1 and perform the new test2 7ii7 #c representatives of patients1 including a patient representative for rare disorders2 7iii7 #c clinicians who use results of the new test in patient care2 7iv7 #b laboratorians2 7v7 #b individuals with expertise in the area of pharmacoeconomics or health technology assessment2 and 7vi7 #b individuals with expertise on the impact of new tests on quality of patient care1 including genetic counselors4 7,c7 ,terms ,subject to subparagraph 7,d71 a member of the panel shall be appointed to serve a term of #f years1 except with respect to the members first appointed1 whose terms of appointment shall be staggered evenly over #b-year increments4 7,d7 ,temporary appointment of experts ,insofar as the ,secretary determines with respect to a new test that there are an insufficient number of members of the panel with expertise with respect to that specific test1 the ,secretary may appoint individuals who have expertise pertaining to the new test involved to serve on the panel4 7,e7 ,open meetings ,the ,secretary shall receive or review the findings and recommendations of the independent advisory panel with respect to the new tests described in subparagraph 7,a7 involved during a meeting open to the public and provide opportunity for public comment4 7,f7 ,clarification of authority of secretary to consult carriers ,nothing in this section shall be construed as affecting the authority of the ,secretary to consult with appropriate ,medicare administrative contractors4 7#c7 ,justification for payment determinations 7,a7 ,initial justification ,with respect to decisions regarding payments made under the clinical laboratory fee schedule for new clinical diagnostic laboratory tests1 the ,secretary shall publicly provide a justification for the payment basis and payment rate determination1 including a detailed summary of the information submitted to1 or obtained by1 the ,secretary regarding the factors specified in paragraph 7#a71 such that interested stakeholders can readily understand the ,secretary's rationale for the payment basis and rate determinations4 7,b7 ,reconsideration period ,after providing such justification for a payment basis and payment rate determination1 the ,secretary shall provide for a reasonable period of reconsideration to receive any appeal of the determination and to evaluate any additional information received regarding the justification and the factors specified in paragraph 7#a74 7,c7 ,final determination ,after the period of reconsideration the ,secretary shall make a final payment basis and payment rate determination and provide a justification for such final determination explaining what additional information was evaluated during the reconsideration and how such information was taken into account with respect to the final determination4 ,nothing in this paragraph shall be construed as authorizing the ,secretary to reveal proprietary information which is otherwise prohibited from disclosure under law4 7b7 ,process for assignment of temporary codes for diagnostic tests ,the ,secretary shall establish a process for application for the assignment of a temporary national ,,hcpcs code to uniquely identify a diagnostic test until a permanent national ,,hcpcs code is available for assignment to that test4 ,assignments of a temporary national ,,hcpcs code shall occur on a quarterly basis4 ,the ,secretary shall provide public notice through the ,centers for ,medicare ,medicaid ,services ,web site of applications made for such temporary national ,,hcpcs codes4 ,upon assignment of a temporary code under this process1 the ,secretary shall treat such test as a new test for purposes of section #ahcc7;h77#h7 of the ,social ,security ,act4 7c7 ,development of further improvements in rate-,setting processes ,the ,secretary shall analyze the process used for the gapfilling procedure used in determining payment amounts for new clinical diagnostic laboratory tests under section #ahcc7;h77#h7 of the ,social ,security ,act4 ,taking into account the changes made by this section1 the ,secretary shall identify further changes to improve the accuracy and appropriateness of resulting rates and the openness1 transparency1 and predictability of the process4 ,the ,secretary shall examine what and how many entities should perform gapfilling1 under contract or otherwise1 and how to ensure that the process is informed by appropriate expertise and proceeds in a transparent and accountable manner4 ,the ,secretary shall implement improvements in the process1 insofar as these are possible under the law through regulations1 after public notice and opportunity for comment4 ,for changes the ,secretary determines would require a change in law1 the ,secretary shall transmit recommendations to the ,speaker of the ,house and the ,president of the ,senate not later than ,july #a1 #bjad4 7d7 ,definitions ,for purposes of this section3 7#a7 ,new clinical diagnostic laboratory tests ,the term new clinical diagnostic laboratory test means a clinical diagnostic laboratory test-- 7,a7 that is assigned a new or substantially revised code on or after ,january #a1 #bjac2 or 7,b7 for which a temporary national ,,hcpcs code is granted under subsection 7b7 on or after ,january #a1 #bjad4 7#b7 ,self-pay patient ,the term self-pay patient means1 with respect to a health care item or service1 an individual who pays out of pocket for such item or service and who does not have health insurance coverage for such item or service4 7e7 ,effective date 7#a7 ,in general ,subject to paragraph 7#b71 this section shall take effect on the date of enactment of this ,act and shall apply with respect to new clinical diagnostic laboratory tests4 7#b7 ,application of justifications to current rate determinations ,subsection 7a77#c7 shall apply to payment basis and payment rate determinations made on or after ,january #a1 #bjac4