,,ii #aaith ,,congress #ast ,session ,s4 #agjb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #h1 #bjbe,mrs4 ,capito 7for herself and ,mrs4 ,shaheen7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend titles ,,xviii and ,,xix of the ,social ,security ,act to provide for coverage of prescription digital therapeutics under such titles1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,access to ,prescription ,digital ,therapeutics ,act of #bjbe4 #b4 ,coverage and payment of prescription digital therapeutics under the ,medicare program 7a7 ,prescription digital therapeutic defined ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end the following new subsection3 7nnn7 ,prescription digital therapeutic ,the term prescription digital therapeutic means a product1 device1 internet application1 or other technology that-- 7#a7 is cleared or approved under section #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#b7 has a cleared or approved indication for the prevention1 management1 or treatment of a medical disease1 condition1 or disorder2 7#c7 primarily uses software to achieve its intended result2 and 7#d7 is a device that is exempt from section #ejb7;f77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act under section #hja4aji of title #ba of the ,code of ,federal ,regulations 7or any successor regulation74 4 7b7 ,coverage as medical and other health service ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 in subparagraph 7,,ii71 by striking and at the end2 7#b7 in subparagraph 7,,jj71 by adding and at the end2 and 7#c7 by adding at the end the following new subparagraph3 7,,kk7 prescription digital therapeutics furnished on or after ,january #a1 #bjbf2 4 7c7 ,requirements for prescription digital therapeutics under ,medicare ,part ,b of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 is amended by inserting after section #ahcd;,a the following new section3 #ahcd;,b4 ,requirements for prescription digital therapeutics 7a7 ,payment 7#a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,secretary shall establish a payment methodology for manufacturers of prescription digital therapeutics1 which may consist of a one-time payment or periodic payments1 as determined appropriate by the ,secretary4 7#b7 ,considerations for payment methodology ,for purposes of establishing the payment methodology under paragraph 7#a71 the ,secretary shall consider-- 7,a7 the actual list charge of such prescription digital therapeutic2 7,b7 the weighted median 7calculated by arraying the distribution of all payment rates reported for the most recent period for which such rates were reported under subsection 7c77#a7 for each prescription digital therapeutic weighted by volume for each payor and each manufacturer7 for such prescription digital therapeutic2 7,c7 in the case of a prescription digital therapeutic that requires ongoing use1 the amount for such ongoing use2 and 7,d7 other factors as determined by the ,secretary4 7b7 ,coding 7#a7 ,in general ,not later than #b years after the date of enactment of this section1 the ,secretary shall establish product-specific ,,hcpcs codes for prescription digital therapeutic covered under this title4 7#b7 ,temporary code ,the ,secretary shall adopt temporary product-specific ,,hcpcs codes for purposes of providing payment under this title until a permanent product-specific ,,hcpcs code has been established under paragraph 7#a74 7c7 ,manufacturer reporting 7#a7 ,in general ,beginning on ,january #a1 #bjbf1 each manufacturer of a prescription digital therapeutic covered under this title shall submit to the ,secretary1 at such time and in such manner as specified by the ,secretary1 and annually thereafter1 a report describing-- 7,a7 the payment rate that was paid by each private payor for each prescription digital therapeutic during the period specified by the ,secretary2 7,b7 the volume of such prescription digital therapeutic distributed to each such payor for such period2 and 7,c7 the number of individual users of such prescription digital therapeutic for such period4 7#b7 ,treatment of discounts ,the payment rate reported by a manufacturer in accordance with paragraph 7#a77;,a7 shall reflect all discounts1 rebates1 coupons1 and other price concessions1 including those described in section #ahdg;,a7c77#c74 7#c7 ,civil monetary penalty 7,a7 ,in general ,if the ,secretary determines that a manufacturer has failed to report1 or made a misrepresentation or omission in reporting1 information under this subsection with respect to a prescription digital therapeutic1 the ,secretary may apply a civil money penalty in an amount of up to #aj1jjj per day for each failure to report or each such misrepresentation or omission4 7,b7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this paragraph in the same manner as they apply to a civil money penalty or proceeding under section #aabh;,a7a74 7#d7 ,confidentiality ,information reported under this subsection shall be treated in the same manner in which information disclosed by a manufacturer or a wholesaler of a covered outpatient drug is treated under section #aibg7;b77#c77;,d74 7d7 ,definitions ,for purposes of this section3 7#a7 ,actual list charge ,the term actual list charge means the publicly available payment rate for a prescription digital therapeutic on the first day that such prescription digital therapeutic is available for purchase by a private payor4 7#b7 ,,hcpcs ,the term ,,hcpcs means1 with respect to an item1 the code under the ,healthcare ,common ,procedure ,coding ,system 7,,hcpcs7 7or a successor code7 for such item4 7#c7 ,manufacturer ,the term manufacturer has the meaning given such term by section #hbj4c7o7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 7#d7 ,prescription digital therapeutic ,the term prescription digital therapeutic has the meaning given such term in section #ahfa7nnn74 7#e7 ,private payor ,the term private payor has the meaning given such term in section #ahcd;,a7a77#h74 4 #c4 ,coverage of prescription digital therapeutics under the ,medicaid program ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended-- 7#a7 in paragraph 7#ca71 by striking 2 and and inserting a semicolon2 7#b7 by redesignating paragraph 7#cb7 as paragraph 7#cc72 and 7#c7 by inserting the following paragraph after paragraph 7#ca73 7#cb7 prescription digital therapeutics 7as defined in section #ahfa7nnn772 and 4