,,ii #aaith ,,congress #ast ,session ,s4 #bgfa ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #aj1 #bjbe,mr4 ,tillis 7for himself and ,mr4 ,warnock7 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 provide long-term stability for ,medicare beneficiary access to clinical diagnostic laboratory tests by improving the accuracy of1 and feasibility of data collection for1 the private payor-based fee schedule payment rates applied under the ,medicare program for such tests1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,reforming and ,enhancing ,sustainable ,updates to ,laboratory ,testing ,services ,act of #bjbe or the ,,results ,act4 #b4 ,improving the accuracy and data collection feasibility of the private payor-based ,medicare payment rates for clinical diagnostic laboratory tests 7a7 ,acquiring data for widely available non-,advanced diagnostic laboratory tests from a qualifying comprehensive claims database of an independent national nonprofit entity ,section #ahcd;,a7a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking requirements4--,subject to subparagraph 7,b7 and inserting requirements4-- 7i7 ,in general ,subject to subparagraph 7,b7 and except as provided for in clause 7ii7 2 7ii7 in clause 7i71 as added by clause 7i7 of this subparagraph-- 7,i7 by striking paragraph 7#b7 and inserting paragraph 7#b77;,a72 7,,ii7 by inserting 1 in accordance with the provisions of this section1 before report to the ,secretary2 7,,iii7 by striking applicable information 7as defined in paragraph 7#c77 for a data collection period 7as defined in paragraph 7#d77 and inserting applicable information 7as defined in paragraph 7#c77-- 7,i7 for a data collection period 7as defined in paragraph 7#d77 beginning before ,january #a1 #bjbg1 2 7,,iv7 by striking the period at the end and inserting 2 and2 and 7,v7 by adding at the end the following new subclause3 7,,ii7 for a data collection period beginning on or after ,january #a1 #bjbg1 for each clinical diagnostic laboratory test for which final payment is made under this part to the laboratory during such period4 2 and 7iii7 by adding at the end the following new clause2 7ii7 ,collection and submission of data 7,i7 ,in general ,with respect to data collection periods for reporting periods beginning on or after ,january #a1 #bjbh1 and for purposes of this section1 in the case of a widely available non-,,adlt clinical diagnostic laboratory test 7as defined in paragraph 7#b77;,e771 the ,secretary shall collect and use applicable information from a qualifying comprehensive claims database 7as defined in paragraph 7#b77;,c77 of a qualifying independent claims data entity 7as defined in paragraph 7#b77;,d77 with which the ,secretary has in effect a contract under subclause 7,,ii7 for each such test furnished during the respective data collection period and for which final payment is made under this part during the year in which such data collection period occurs4 7,,ii7 ,contract with qualifying independent claims data entity for access to applicable information ,as soon as practicable after the date of enactment of this clause1 the ,secretary shall identify and enter into a contract with a qualifying independent claims data entity for the purpose of1 with respect to widely available non-,,adlt clinical diagnostic laboratory tests furnished during a data collection period1 such entity reporting to the ,secretary applicable information from a qualifying comprehensive claims database of the entity for such tests for which final payment is made under this part during the year in which such data collection period occurs and for which there is applicable information within such database for such period4 4 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i71 by striking #bjbe and inserting #bjbg2 7ii7 in clause 7ii71 by striking beginning ,january #a1 #bjbf1 and ending ,march #ca1 #bjbf and inserting beginning ,january #a1 #bjbh1 and ending ,march #ca1 #bjbh2 and 7iii7 in clause 7iii71 by striking three years and inserting #d years2 and 7#b7 in paragraph 7#b7-- 7,a7 by striking ,definition of applicable laboratory4--,in this section1 the term applicable laboratory means and inserting ,definitions4--,in this section3 7,a7 ,applicable laboratory 7i7 ,reporting periods before #bjbh ,with respect to reporting periods beginning before ,january #a1 #bjbh1 the term applicable laboratory means 2 7,b7 in subparagraph 7,a71 as inserted by subparagraph 7,a7 of this paragraph-- 7i7 in clause 7i71 in the second sentence1 by striking paragraph and inserting clause2 and 7ii7 by adding at the end the following new clause3 7ii7 ,reporting periods beginning during #bjbh and subsequent years ,with respect to reporting periods beginning on or after ,january #a1 #bjbh1 the term applicable laboratory shall have the meaning given such term in section #dad4ejb of title #db1 ,code of ,federal ,regulations1 as in effect on ,may #a1 #bjbe1 except without application of paragraph 7#c7 of such section4 2 and 7,c7 by adding at the end the following new subparagraphs3 7,b7 ,non-widely available non-,,adlt clinical diagnostic laboratory test ,the term non-widely available non-,,adlt clinical diagnostic laboratory test means1 with respect to a reporting period1 a clinical diagnostic laboratory test that is not an advanced diagnostic laboratory test and that is not described in subparagraph 7,e74 7,c7 ,qualifying independent claims data entity ,the term qualifying independent claims data entity means an entity that satisfies each of the following criteria3 7i7 ,the entity is a national nonprofit organization that is not affiliated with any ,government agency1 insurance issuer1 group health plan1 provider of services or supplier1 or other organization in the health care sector4 7ii7 ,the entity collects data and maintains a qualifying comprehensive claims database 7as defined in subparagraph 7,d774 7iii7 ,the entity is certified by the ,secretary to be a qualified entity 7as defined in paragraph 7#b7 of section #ahgd7;e77 with respect to having access to data described in paragraph 7#c7 of such section4 7iv7 ,the entity1 with respect to all data included in the qualifying comprehensive claims database of the entity1 complies with all applicable ,federal and ,state privacy and security requirements1 including ,,hipaa privacy and security law 7as defined in section #cjji of the ,public ,health ,service ,act74 7v7 ,the entity applies quality assurance processes to validate all data that is included in the qualifying comprehensive claims database of the entity1 including comprehensive statistical testing4 7,d7 ,qualifying comprehensive claims database ,the term qualifying comprehensive claims database means an independent database of private payor claims data1 which-- 7i7 includes at least #ej1jjj1jjj1jjj claims from more than #ej private payors and claims administrators2 7ii7 is a statistically significant repository of claims data that is representative for all #ej ,states and the ,district of ,columbia2 7iii7 includes only data that is validated by quality assurance processes1 including comprehensive statistical testing2 7iv7 complies with all applicable ,federal and ,state privacy and security requirements1 as described in subparagraph 7,c77iv72 7v7 provides for version control of claims to enable the collation and submission1 for purposes of this section1 of only claims representative of final payment amounts2 and 7vi7 includes claims data with respect to widely available non-,,adlt clinical diagnostic laboratory tests4 7,e7 ,widely available non-,,adlt clinical diagnostic laboratory test ,the term widely available non-,,adlt clinical diagnostic laboratory test means1 with respect to a reporting period1 a clinical diagnostic laboratory test that is not an advanced diagnostic laboratory test and for which1 during the first #f months of the year immediately preceding the data collection period for such reporting period1 the number of providers of services and suppliers receiving payments under this section 7as determined by the ,secretary using the national provider identifier of the provider of services or supplier on the claim submitted for payment under this part for such test7 exceeds #ajj4 2 7#c7 in paragraph 7#e7-- 7,a7 by inserting final after ,the2 and 7,b7 by inserting or from a qualifying comprehensive claims database pursuant to paragraph 7#a77;,a77ii7 after reported by a laboratory under this subsection2 7#d7 in paragraph 7#f7-- 7,a7 by inserting 7or1 with respect to a widely available non-,,adlt clinical diagnostic laboratory test1 the qualifying comprehensive claims database of the qualifying independent claims data entity with a contract under paragraph 7#a77;,a77ii77 after ,in the case where an applicable laboratory2 7,b7 by striking payment rate each place it appears and inserting final payment rate2 7,c7 by inserting 7and such different payment rates do not relate to the same claim7 after for the same payor for the same test2 and 7,d7 by inserting or qualifying independent claims data entity1 as applicable1 after the applicable laboratory2 7#e7 in paragraph 7#i77;,a71 by inserting required to be reported by such laboratory after in reporting information2 7#f7 in paragraph 7#aj7-- 7,a7 by striking by a laboratory after information disclosed2 and 7,b7 by inserting by a laboratory or the qualifying independent claims data entity with a contract under paragraph 7#a77;,a77ii7 after under this subsection2 and 7#g7 in paragraph 7#ab7-- 7,a7 by striking ,regulations4--,not later than ,june #cj1 #bjae1 and inserting ,regulations4-- 7,a7 ,for data collection periods before #bjbg ,not later than ,june #cj1 #bjae1 for data collection periods beginning before ,january #a1 #bjbg1 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,for data collection periods beginning with #bjbg ,not later than ,december #ca1 #bjbf1 the ,secretary shall establish through notice and comment rulemaking parameters for data collection periods beginning on or after ,january #a1 #bjbg4 4 7b7 ,incorporating data collection improvements into private payor-,based ,medicare payment rates for clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests 7#a7 ,calculation of weighted median of private payor-based rates ,section #ahcd;,a7b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#b77 is amended-- 7,a7 by inserting and1 in the case of widely available non-,,adlt clinical diagnostic laboratory tests1 with respect to data collection periods for reporting periods beginning on or after ,january #a1 #bjbh1 for each such test furnished by an applicable laboratory with respect to which there is applicable information made available to the ,secretary pursuant to paragraph 7#a77;,a77ii7 of such subsection after under subsection 7a7 for a data collection period2 and 7,b7 by inserting final before payment rates reported4 7#b7 ,default adjustment in cases of widely available non-,,adlt clinical diagnostic laboratory tests for periods for which there is no contract with a qualifying independent claims entity or no applicable information in the qualifying comprehensive claims database ,section #ahcd;,a7b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77 is amended-- 7,a7 in paragraph 7#a77;,a71 by striking paragraph 7#c7 and inserting paragraphs 7#c7 and 7#f72 and 7,b7 by adding at the end the following new paragraph3 7#f7 ,default payment for widely available non-,,adlt clinical diagnostic laboratory tests for periods for which there is no contract with an independent entity or with respect to which there is no data 7,a7 ,in general ,with respect to data collection periods for reporting periods beginning on or after ,january #a1 #bjbh1 in the case of a widely available non-,,adlt clinical diagnostic laboratory test with respect to which subsection 7c7 does not apply1 if a circumstance described in subparagraph 7,b7 applies with respect to such a reporting period and such a clinical diagnostic laboratory test1 payment for such test under this section for a year beginning during the qualified rate period described in subparagraph 7,c71 shall be equal to the amount of payment for such clinical diagnostic laboratory test under this section for the previous year1 increased by the percentage increase in the ,consumer ,price ,index for all urban consumers 7all items2 ,united ,states city average7 over the previous year4 7,b7 ,circumstances described ,for purposes of subparagraph 7,a71 with respect to a data collection period and a widely available non-,,adlt clinical diagnostic laboratory test1 the circumstances described in this subparagraph are if the ,secretary-- 7i7 is not able to enter into a contract under subsection 7a77#a77;,a77ii7 with a qualifying independent claims data entity with respect to such data collection period2 or 7ii7 determines that there is no applicable information with respect to such clinical diagnostic laboratory test and data collection period in the qualifying comprehensive claims database of such qualifying independent claims data entity4 7,c7 ,qualified rate period described ,for purposes of subparagraph 7,a71 the qualified rate period1 with respect to a data collection period and a widely available non-,,adlt clinical diagnostic test to which a circumstance described in subparagraph 7,b7 applies1 is the period-- 7i7 beginning on the first day of the second year following the first data collection period with respect to which such circumstance applies with respect to such test2 and 7ii7 ending with the last day of the year following the first data collection period with respect to which such circumstance no longer applies with respect to such test4 4 7#c7 ,payment in cases in which there is no reported applicable information for non-widely available non-,a,d,l,ts ,section #ahcd;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a71 is amended-- 7,a7 in subsection 7b71 as amended by paragraph 7#b7-- 7i7 in paragraph 7#a77;,a71 by striking paragraphs 7#c7 and 7#f7 and inserting paragraphs 7#c71 7#f71 and 7#g72 and 7ii7 by adding at the end the following new paragraph3 7#g7 ,payment for non-widely available non-,,adlt clinical diagnostic laboratory tests for which there is no applicable information 7,a7 ,in general ,for determining payment under this subsection for a year in the case of a non-widely available non-,,adlt clinical diagnostic laboratory test with respect to which subsection 7c7 does not apply1 if the ,secretary determines that no applicable information has been reported under subsection 7a77#a77;,a77i7 by any applicable laboratory for such test with respect to the most recent data collection period 7beginning with data collection periods for reporting periods beginning on or after ,january #a1 #bjbh71 payment for such test under this section for such year shall be determined as follows3 7i7 ,in the case that a process described in subparagraph 7,b7 was not applied pursuant to this subparagraph for determining payment for such test for a previous year with respect to such data collection period1 payment for such test and year shall be determined using such a process4 7ii7 ,in the case that a process described in subparagraph 7,b7 was applied pursuant to this subparagraph for determining payment for such test for a previous year with respect to such data collection period1 payment for such test and year shall be equal to the amount of payment for such test under this section for the previous year4 7,b7 ,process described ,for purposes of subparagraph 7,a71 a process described in this subparagraph1 with respect to a non-widely available non-,,adlt clinical diagnostic laboratory test for which there is no reported data 7as described in such subparagraph7 with respect to a data collection period1 is-- 7i7 cross-walking 7as described in section #dad4ejh7;a7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 to the most appropriate clinical diagnostic laboratory test under the fee schedule under this section during that period2 or 7ii7 if no other clinical diagnostic laboratory test is comparable to the test for which there is no reported applicable information1 according to the gapfilling process described in subsection 7c77#b74 2 and 7,b7 in subsection 7c77#c71 by inserting or subsection 7b77#g7 after under this subsection4 7#d7 ,publicly available explanation of payment rates ,section #ahcd;,a7b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b771 as amended by paragraphs 7#b7 and 7#c77;,a71 is amended by adding at the end the following new paragraph3 7#h7 ,explanation of payment rates ,in the case of a clinical diagnostic laboratory test for which payment is made under this subsection1 the ,secretary shall make available to the public an explanation of the payment rate for such test1 including any supporting data as may be necessary for a laboratory to assess the accuracy of the calculations4 4 7#e7 ,technical correction clarifying period of application of market rates ,section #ahcd;,a7b77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#d77;,a77 is amended by striking until the year following and inserting through the year following4 7c7 ,additional improvements ,to ensure updated1 accurate market-,based data for clinical diagnostic laboratory tests 7#a7 ,updates to applicable information to better reflect final payment rates ,section #ahcd;,a7a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#c77 is amended-- 7,a7 in the heading1 by inserting and final payment rate after information2 7,b7 in subparagraph 7,a7-- 7i7 in the heading1 by striking ,in general and inserting ,data collection periods before ,january #a1 #bjbg2 and 7ii7 in the matter preceding clause 7i7-- 7,i7 by striking subparagraph 7,b7 and inserting subparagraph 7,c72 and 7,,ii7 by inserting beginning before ,january #a1 #bjbg after for a data collection period2 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 7,d7 by inserting after subparagraph 7,a7 the following new subparagraph3 7,b7 ,subsequent data collection periods ,in this section1 subject to subparagraph 7,c71 for a data collection period beginning on or after ,january #a1 #bjbg1 the term applicable information means-- 7i7 with respect to a widely available non-,,adlt clinical diagnostic laboratory test furnished during such period-- 7,i7 the final payment rate 7as determined in accordance with paragraph 7#e7 and defined in subparagraph 7,d77 that was paid by each private payor for the test during the year in which such period occurs2 and 7,,ii7 the volume1 for each such payor1 of such test for which final payment was made during such year2 and 7ii7 with respect to a non-widely available non-,,adlt clinical diagnostic laboratory test or an advanced diagnostic laboratory test-- 7,i7 the final payment rate 7as determined in accordance with paragraph 7#e7 and defined in subparagraph 7,d77 that was paid by each private payor for the test during the data collection period2 and 7,,ii7 the volume1 for each such payor1 of such test for which final payment was made during such period4 2 and 7,e7 by inserting after subparagraph 7,c71 the following new subparagraph3 7,d7 ,final payment rate ,in this section1 for a data collection period beginning on or after ,january #a1 #bjbg1 the term final payment rate-- 7i7 means-- 7,i7 with respect to a widely available non-,,adlt clinical diagnostic laboratory test furnished during a data collection period1 the last payment made for a test during the year in which the data collection period occurs2 and 7,,ii7 with respect to a non-widely available non-,,adlt clinical diagnostic laboratory test or an advanced diagnostic laboratory test paid during a data collection period1 the last payment made during the data collection period2 and 7ii7 does not include-- 7,i7 denied payments2 7,,ii7 payments under appeal or under review by the private payor2 7,,iii7 payments made in error2 or 7,,iv7 payments that are recouped by the private payor4 4 7#b7 ,updating data collection periods ,section #ahcd;,a7a77#d77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#d77;,b77 is amended-- 7,a7 by striking ,january #a1 #bjai and inserting ,january #a1 #bjbg2 7,b7 by striking ,june #cj1 #bjai and inserting ,june #cj1 #bjbg2 and 7,c7 by adding at the end the following new sentence3 ,in the case of the reporting period after the reporting period described in paragraph 7#a77;,b77ii7 and each subsequent reporting period with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests1 the term data collection period means the #f-month period beginning ,january #ast of the year preceding the year during which such reporting period begins44 7#c7 ,ensuring data is market-based by excluding rates of ,medicaid managed care organizations ,section #ahcd;,a7a77#h77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#h77;,c77 is amended by striking ,a medicaid managed care organization and inserting ,with respect to data collection periods for reporting periods beginning before ,january #a1 #bjbh1 a medicaid managed care organization44 7#d7 ,modifications to limits on payment reductions ,section #ahcd;,a7b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#c77 is amended-- 7,a7 in subparagraph 7,a71 by striking each of #bjag through #bjbh and inserting #bjag and each subsequent year2 7,b7 in subparagraph 7,b7-- 7i7 in clause 7ii71 by striking #bjbe and inserting #bjbh2 and 7ii7 in clause 7iii71 by striking for each of #bjbf through #bjbh1 #ae percent and inserting for #bjbi and each subsequent year1 #e percent2 and 7,c7 in subparagraph 7,c77ii71 by inserting laboratory after advanced diagnostic4 7#e7 ,sunsetting review limitations ,section #ahcd;,a7h77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;h77#a77 is amended by inserting before ,january #a1 #bjbi before the period at the end4