,,ii #aacth ,,congress #b;d ,session ,s4 #bfhi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #cj1 #bjad ,ms4 ,collins 7for herself and ,mrs4 ,shaheen7 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 specify coverage of continuous glucose monitoring devices1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicare ,,cgm ,access ,act of #bjad4 #b4 ,medicare coverage of continuous glucose monitoring devices 7a7 ,in general ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7s77#b7-- 7,a7 in subparagraph 7,,ee71 by striking and at the end2 7,b7 in subparagraph 7,,ff71 by adding and2 and 7,c7 by adding at the end the following new subparagraph3 7,,gg7 continuous glucose monitoring devices 7as defined in subsection 7iii77#a77 furnished to a ,,cgm qualified individual 7as defined in subsection 7iii77#b772 2 and 7#b7 by adding at the end the following new subsection3 7iii7 ,continuous ,glucose ,monitoring ,device2 ,,cgm qualified individual 7#a7 7,a7 ,the term continuous glucose monitoring device means a class ,,iii medical device approved by the ,food and ,drug ,administration that continuously monitors and trends glucose levels in body fluid4 7,b7 ,such term applies to such medical device-- 7i7 as a stand-alone product2 7ii7 when integrated with an insulin pump2 or 7iii7 as an integral component of any other medical device cleared or approved by the ,food and ,drug ,administration1 such as artificial pancreas device systems4 7,c7 ,with respect to a continuous glucose monitoring device that is described in clause 7ii7 or 7iii7 of subparagraph 7,b71 the ,secretary shall treat an insulin pump or other medical device that has a continuous glucose monitoring device as an integrated or integral component as a single medical device4 7,d7 ,such term includes components1 accessories1 and supplies that are necessary and related to the operation of the class ,,iii medical device1 such as sensors1 transmitters1 receivers1 and requisite software4 7#b7 ,the term ,,cgm qualified individual means any of the following3 7,a7 ,an individual with ,type ,i diabetes-- 7i7 who is following an intensive insulin treatment regimen that consists of #c or more insulin injections per day or the use of a subcutaneous insulin infusion pump2 7ii7 subject to paragraph 7#c71 whose attending physician certifies that the individual's condition cannot be safely and effectively managed with self-monitoring of blood glucose2 and 7iii7 who-- 7,i7 has been unable to achieve optimum glycemic control in accordance with evidence-based guidelines2 or 7,,ii7 has experienced hypoglycemia unawareness or frequent hypoglycemic episodes4 7,b7 ,an individual not described in subparagraph 7,a7 who meets such other medical criteria as the ,secretary may specify for the furnishing of a continuous glucose monitoring device based on available medical evidence and taking into account any anticipated pathway to the development of artificial pancreas device systems4 7,c7 ,an individual with diabetes who has been regularly using a continuous glucose monitoring device before becoming entitled to1 or enrolling in1 part ,a1 or enrolling in part ,b1 or both4 7#c7 ,for purposes of a certification by an attending physician described in paragraph 7#b77;,a77ii71 such certification shall not be required more frequently than once every #c years4 4 7b7 ,payment 7#a7 ,in general ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and before 7,z72 and 7,b7 by inserting before the semicolon at the end the following3 1 and 7,,aa7 with respect to continuous glucose monitoring devices under section #ahfa7s77#b77;,,gg771 the amount paid shall be an amount equal to #hj percent of the amount determined under the fee schedule established under section #ahcd7p74 7#b7 ,conforming amendment ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7p7 ,fee schedule for continuous glucose monitoring devices 7#a7 ,establishment 7,a7 ,in general ,with respect to continuous glucose monitoring devices 7as defined in section #ahfa7;iii77#a77 furnished during a year1 the amount of payment under this part for such devices shall be determined under a fee schedule established by the ,secretary in accordance with this subsection4 7,b7 ,clarification of application of fee schedule to devices having ,,cgm as an integral component ,payment shall be calculated and made under the fee schedule established under this subsection for any insulin pump or other medical device that has a continuous glucose monitoring device as an integrated or integral component4 7#b7 ,initial payment rate 7,a7 ,in general ,with respect to each distinct type of continuous glucose monitoring device1 the ,secretary shall establish an initial payment rate under the fee schedule established under this subsection for the first year1 which may be a partial year1 during which payment may be made for such continuous glucose monitoring device under this part4 7,b7 ,data ,with respect to a continuous glucose monitoring device1 the initial payment rate under subparagraph 7,a7 shall-- 7i7 reflect market rates for such device2 and 7ii7 take into account the most recent available data on prices for such device4 7,c7 ,accounting for differences in functionalities among various ,,cgm devices ,for purposes of the initial payment rates established under subparagraph 7,a71 the ,secretary shall establish a new ,,hcpcs code for each distinct type of class ,,iii medical device cleared or approved by the ,food and ,drug ,administration that includes a continuous glucose monitoring device1 such as a medical device described in clause 7ii7 or 7iii7 of section #ahfa7;iii77#a77;,b74 ,such ,,hcpcs codes shall distinguish among the different functionalities of such devices in a manner that reflects the classifications of the ,food and ,drug ,administration in clearing or approving such devices4 7#c7 ,updates to payment rates ,with respect to each year beginning after the year1 or partial year1 referred to in paragraph 7#b77;,a7 during which an initial payment rate is established for a distinct continuous glucose monitoring device1 the ,secretary shall provide for annual updates to the payment rate under the fee schedule established under this subsection for each such device for the preceding year by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period ending with ,june of the preceding year4 7#d7 ,adjustment for geographic variations ,the ,secretary shall provide for adjustments to the payment rates under the fee schedule established under this subsection to take into account geographic variations in the prices of continuous glucose monitoring devices4 4 7c7 ,ensuring beneficiary access to appropriate components ,section #ahdg7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77 is amended by adding at the end the following new paragraph3 7#h7 ,ensuring beneficiary access to appropriate components 7,a7 ,in general ,in carrying out the programs under this section with respect to glucose meters required for continuous glucose monitoring devices 7as defined in section #ahfa7;iii77#a77 that are furnished to ,,cgm qualified individuals 7as defined in section #ahfa7;iii77#b771 the ,secretary shall ensure that such ,,cgm qualified individuals are furnished the brand of diabetic testing supplies 7as defined in subparagraph 7,b77 that function with such continuous glucose monitoring devices1 such as in the case where there is only one brand of glucose meter that is compatible with a particular continuous glucose monitoring device4 7,b7 ,definition ,in this paragraph1 the term diabetic testing supplies means glucose meters and diabetic testing strips4 4 7d7 ,effective date2 ,rulemaking 7#a7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjae4 7#b7 ,rulemaking 7,a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this paragraph referred to as the ,secretary7 shall implement the amendments made by this section through notice and comment rulemaking4 7,b7 ,consultation ,as part of the rulemaking process under subparagraph 7,a71 the ,secretary shall consult with national organizations representing individuals with diabetes1 physicians with relevant clinical expertise in endocrinology1 and other relevant stakeholders to develop clinical criteria for the determination of whether an individual qualifies as having ,type ,i diabetes under section #ahfa7;iii77#b77;,a7 of the ,social ,security ,act1 as added by subsection 7a77#b74 ,not later than #fj days after the date of enactment of this ,act1 the ,secretary shall convene a meeting of those stakeholders to develop consensus recommendations for such clinical criteria4 ,the ,secretary shall take such recommendations into account in implementing the amendments made by this section4