,,ii #aafth ,,congress #b;d ,session ,s4 #cecb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ah1 #bjbj,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 coverage of prescription digital therapeutics for the treatment of mental health and substance use disorders under the ,medicare and ,medicaid programs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,prescription ,digital ,therapeutics to ,support ,recovery ,act4 #b4 ,coverage of prescription digital therapeutics under the ,medicare program 7a7 ,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,,gg71 by striking and at the end2 7#b7 in subparagraph 7,,hh71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,,ii7 prescription digital therapeutics as defined in subsection 7kkk74 4 7b7 ,prescription digital therapeutics defined ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end thereof the following new subsection3 7kkk7 ,prescription ,digital ,therapeutics defined 7#a7 ,in general ,the term prescription digital therapeutic means a product1 device1 internet application1 or other technology that-- 7,a7 is approved or cleared by the ,food and ,drug ,administration under a relevant authority 7within the meaning of paragraph 7#b772 7,b7 has an approved indication for the prevention1 management1 or treatment of a mental health or substance use disorder1 including opioid use disorder2 7,c7 uses behavioral treatment or modification to achieve its intended result2 and 7,d7 can only be dispensed pursuant to a prescription4 7#b7 ,relevant authority defined ,for purposes of paragraph 7#a71 the term relevant authority means the following sections of the ,federal ,food1 ,drug1 and ,cosmetic ,act3 7,a7 ,section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k774 7,b7 ,section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e74 4 7c7 ,payment for prescription digital therapeutics ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,payment for prescription digital therapeutics 7#a7 ,separate payment ,the ,secretary shall make a payment 7separate from any payment that may otherwise be made under this title for a related service7 in the amount established pursuant to paragraph 7#c7 for a prescription digital therapeutic 7as defined in section #ahfa7kkk77 that is furnished on or after ,january #a1 #bjba4 7#b7 ,payment recipient ,payment under this subsection shall be made to any provider of services or supplier enrolled under this title that-- 7,a7 prescribes a prescription digital therapeutic 7as defined in such subsection72 7,b7 uses such prescription digital therapeutic as an integral part of a treatment for a related service2 and 7,c7 agrees to accept1 as payment in full1 after the application of any deductible or coinsurance that may be applied under this part1 the amount established pursuant to paragraph 7#c74 7#c7 ,establishment of payment amount 7,a7 ,in general ,the ,secretary shall establish a payment methodology for a prescription digital therapeutic only in accordance with the requirements of this paragraph4 7,b7 ,development of fee schedule ,within #ahj days of the approval or clearance described in section #ahfa7kkk77#a77;,a71 the ,secretary shall develop a proposed fee schedule for each prescription digital therapeutic so approved or cleared4 ,in developing such fee schedule1 the ,secretary may use the gap filling process described on #hd ,federal ,register #fjgbi through #fjgdb and published on ,november #h1 #bjai4 7,c7 ,notice and comment required ,upon the development of the proposed fee schedule described in subparagraph 7,b71 the ,secretary shall publish in the ,federal ,register such proposed fee schedule4 ,section #ahga shall apply to any proposed fee scheduled published pursuant to this subparagraph4 7#d7 ,rule of construction ,for purposes of paragraph 7#a71 a service is related to the use of a prescription digital therapeutic if the service-- 7,a7 is an integral part of the use of the prescription digital therapeutic2 7,b7 is necessary to achieve the full intended result of the prescription digital therapeutic2 and 7,c7 must1 pursuant to the approval or clearance described in section #ahfa7kkk77#a77;,a71 be adjunctive to the use of the prescription digital therapeutic4 4 7d7 ,rule of construction2 effective date 7#a7 ,rule of construction ,no provision of this section1 or the enactment of this section1 shall be construed to imply that1 in the case of an item or service that meets the definition of a prescription digital therapeutic under this section for which coverage or payment under the ,medicare program is already available prior to the date of the enactment of this ,act may not be covered or reimbursed under such program4 7#b7 ,effective date ,the amendments made by this section shall apply to a prescription digital therapeutic dispensed after ,december #ca1 #bjbj4 #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#bi71 by striking 2 and and inserting a semicolon2 7#b7 by redesignating paragraph 7#cj7 as paragraph 7#ca72 and 7#c7 by inserting the following paragraph after paragraph 7#bi73 7#cj7 prescription digital therapeutics 7as defined in section #ahfa7kkk772 and 4