,,ii #aagth ,,congress #b;d ,session ,s4 #dddi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bb1 #bjbb,mr4 ,burr 7for himself and ,mr4 ,brown7 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 improve the accuracy of market-based ,medicare payment for clinical diagnostic laboratory services1 to reduce administrative burdens in the collection of data1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,saving ,access to ,laboratory ,services ,act4 #b4 ,modification of requirements for medicare clinical diagnostic laboratory tests 7a7 ,use of statistical sampling for widely available clinical diagnostic laboratory tests 7#a7 ,in general ,section #ahcd;,a7a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#a77 is amended-- 7,a7 in subparagraph 7,a71 by striking ,subject to subparagraph 7,b7 and inserting ,subject to subparagraphs 7,b7 and 7,c72 and 7,b7 by adding at the end the following new subparagraph3 7,c7 ,use of statistical sampling for widely available clinical diagnostic laboratory tests 7i7 ,in general ,subject to clause 7ii71 with respect to data collection periods for reporting periods beginning on or after ,january #a1 #bjbf1 in the case of a widely available clinical diagnostic laboratory test 7as defined in clause 7iii771 in lieu of requiring the reporting of applicable information from each applicable laboratory1 the ,secretary shall require the collection and reporting of applicable information from a statistically valid sample of applicable laboratories for each such widely available clinical diagnostic laboratory test4 7ii7 ,requirements for statistical sampling 7,i7 ,in general ,the ,secretary1 in consultation with stakeholders1 shall develop a methodology for a statistically valid sample under clause 7i71 using the maximal brewer selection method1 as described in the ,june #bjba ,medicare ,payment ,access ,commission ,report to the ,congress1 to establish the payment amount for a widely available clinical diagnostic laboratory test under paragraph 7#b7 of subsection 7b7 for each applicable ,,hcpcs code for a widely available clinical diagnostic laboratory test4 7,,ii7 ,representative sampling ,the methodology under subclause 7,i7 for a statistically valid sample under clause 7i7 shall1 for each applicable ,,hcpcs code for a widely available clinical diagnostic laboratory test-- 7aa7 provide for a sample that allows for the payment amounts established under paragraph 7#b7 of subsection 7b7 for such a test to be representative of rates paid by private payors to applicable laboratories receiving payment under this section1 including independent laboratories1 hospital laboratories1 hospital outreach laboratories1 and physician office laboratories that furnish the widely available clinical diagnostic laboratory test2 7bb7 include applicable information 7as defined in paragraph 7#c77 with respect to such widely available clinical diagnostic laboratory test from such different types of applicable laboratories2 and 7cc7 be of sufficient size to accurately and proportionally represent the range of private payor payment rates received by each such type of applicable laboratory weighted according to the utilization rates of each type of applicable laboratory for the widely available clinical diagnostic laboratory test during the first #f months of the calendar year immediately preceding the data collection period applicable to the sample to be collected4 7,,iii7 ,least burdensome data collection and reporting processes ,the methodology developed by the ,secretary shall be designed to reduce administrative burdens of data collection and reporting on applicable laboratories and the ,centers for ,medicare ,medicaid ,services to the greatest extent practicable4 7,,iv7 ,publication of list of widely available clinical diagnostic laboratory tests and notification to applicable laboratories required to report applicable information ,not later than ,september #cj of the year immediately preceding each data collection period 7as defined in paragraph 7#d771 the ,secretary shall publish in the ,federal ,register a list of widely available clinical diagnostic laboratory tests and shall directly notify applicable laboratories required to report applicable information under this subsection4 7iii7 ,definition of widely available clinical diagnostic laboratory test ,in this subparagraph1 the term widely available clinical diagnostic laboratory test means a clinical diagnostic laboratory test that meets both of the following criteria during the first #f months of the calendar year immediately preceding the data collection period applicable to the sample to be collected3 7,i7 ,payment rate ,the payment amount determined for the clinical diagnostic laboratory test under this section is less than #a1jjj per test4 7,,ii7 ,number of laboratories performing the test ,the number of applicable laboratories receiving payments under this section for the clinical diagnostic laboratory test 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 4 7#b7 ,delays to revised reporting periods and reporting period frequency 7,a7 ,in general ,section #ahcd;,a7a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#a77;,b77 is amended-- 7i7 in clause 7i71 by striking ,december #ca1 #bjbb and inserting ,december #ca1 #bjbd2 7ii7 in clause 7ii71 by striking beginning ,january #a1 #bjbc1 and ending ,march #ca1 #bjbc and inserting beginning ,january #a1 #bjbf1 and ending ,march #ca1 #bjbf2 and 7iii7 in clause 7iii7 by striking every three years and inserting every four years4 7,b7 ,conforming change to definition of data collection period ,section #ahcd;,a7a77#d77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#d77;,b77 is amended by striking ,january #a1 #bjai1 and ending ,june #cj1 #bjai and inserting ,january #a1 #bjbe1 and ending ,june #cj1 #bjbe4 7b7 ,elimination of majority of ,medicare revenues test ,the first sentence of section #ahcd;,a7a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#b77 is amended by striking ,in this section and all that follows through the period and inserting the following3 ,notwithstanding determinations of applicable laboratories made prior to ,january #a1 #bjbd1 the term applicable laboratory means a laboratory that receives at least #ab1ejj in payments under this section during the first #f months of the calendar year immediately preceding the applicable data collection period44 7c7 ,modifications to applicable information reported 7#a7 ,medicaid managed care rates ,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 #bjbf1 a medicaid managed care organization 7as defined in section #aijc7m774 7#b7 ,authority to exclude manual remittances ,section #ahcd;,a7a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#c77 is amended-- 7,a7 in subparagraph 7,a71 by striking subject to subparagraph 7,b71 and inserting subject to subparagraphs 7,b7 and 7,c72 and 7,b7 by adding at the end the following new subparagraph3 7,c7 ,exclusion of manual remittances ,an applicable laboratory for which less than #aj percent of its total paid claims during a data collection period are paid by private payors by means other than an electronic standard transaction 7as defined in section #afb4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulation77 may exclude from the definition of applicable information under this paragraph payments made by private payors that are not made through an electronic standard transaction4 4 7d7 ,modification to limits on payment reductions2 imposition of annual cap on payment increases 7#a7 ,payment reduction limits ,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 for each of #bjag through #bjbe and inserting for #bjag and each succeeding year2 and 7,b7 in subparagraph 7,b7-- 7i7 in clause 7ii71 by striking and at the end2 and 7ii7 by striking clause 7iii7 and inserting the following3 7iii7 for #bjbc1 #j percent2 7iv7 for #bjbd1 #b4e percent2 and 7v7 for #bjbe and each subsequent year1 #e percent4 4 7#b7 ,annual cap on payment rate increases ,section #ahcd;,a7b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#c771 as amended by paragraph 7#a71 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 by striking test for #bjag and each succeeding year-- and inserting test-- 7i7 for #bjag and each succeeding year 2 7ii7 in clause 7i71 as added by clause 7i7 of this subparagraph1 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following new clause3 7ii7 for #bjbc and each succeeding year1 shall not result in an increase in payments for a clinical diagnostic laboratory test for the year of greater than the applicable percent 7as defined in subparagraph 7,d77 of the amount of payment for the test for the preceding year4 2 7,b7 in subparagraph 7,b71 in the matter preceding clause 7i71 by striking ,in this paragraph and inserting ,in clause 7i7 of subparagraph 7,a72 and 7,c7 by adding at the end the following new subparagraph3 7,d7 ,definition of applicable percent for purposes of annual cap on payment increases ,in clause 7ii7 of subparagraph 7,a71 the term applicable percent means the following3 7i7 ,widely available clinical diagnostic laboratory tests ,with respect to a widely available clinical diagnostic laboratory test-- 7,i7 for #bjbc1 #b4e percent2 7,,ii7 for #bjbd1 #b4e percent2 7,,iii7 for #bjbe1 #c4ge percent2 7,,iv7 for #bjbf1 #c4ge percent2 and 7,v7 for #bjbg and each subsequent year1 #e percent4 7ii7 ,other clinical diagnostic laboratory tests ,with respect to a clinical diagnostic laboratory test not described in clause 7i71 #e percent4 4 7#c7 ,conforming amendment ,section #ahcd;,a7b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#c77 is amended in the heading by striking reductions and inserting medicare payment changes4 7e7 ,regulations 7#a7 ,not later than ,december #ca1 #bjbc1 the ,secretary of ,health and ,human ,services shall implement the amendments made by this section 7other than subsection 7d77 through notice and comment rulemaking4 7#b7 ,the ,secretary of ,health and ,human ,services may implement the amendments made by subsection 7d7 through interim final rulemaking1 program instruction1 or otherwise4