,,ib ,union ,calendar ,no4 #hja #aahth ,,congress #b;d ,session ,h4 ,r4 #afia ,report ,no4 #aah-ieb1 ,part ,i ,,in ,,the ,,house ,,of ,,representatives ,march #bb1 #bjbc ,mr4 ,wenstrup 7for himself1 ,ms4 ,del,bene1 ,mr4 ,bilirakis1 ,mr4 ,crdenas1 ,mr4 ,moore of ,utah1 ,ms4 ,sewell1 ,mr4 ,guthrie1 and ,ms4 ,eshoo7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,december #bd1 #bjbd ,additional sponsors3 ,mr4 ,joyce of ,pennsylvania1 ,ms4 ,kuster1 ,mr4 ,crenshaw1 ,mr4 ,kilmer1 ,mrs4 ,miller of ,west ,virginia1 ,ms4 ,craig1 ,mrs4 ,steel1 ,ms4 ,dean of ,pennsylvania1 ,mr4 ,bacon1 ,mr4 ,peters1 ,mr4 ,balderson1 ,mr4 ,auchincloss1 ,mr4 ,curtis1 ,ms4 ,houlahan1 ,mr4 ,bucshon1 ,mr4 ,fitzpatrick1 ,mr4 ,yakym1 ,ms4 ,lofgren1 ,ms4 ,schrier1 ,mrs4 ,trahan1 ,mr4 ,lieu1 ,mr4 ,mc,govern1 ,mr4 ,boyle of ,pennsylvania1 ,ms4 ,wild1 ,mr4 ,bera1 ,mr4 ,correa1 ,ms4 ,porter1 ,mr4 ,swalwell1 ,mr4 ,ciscomani1 ,mr4 ,ferguson1 ,mr4 ,carey1 ,mr4 ,simpson1 ,mrs4 ,kim of ,california1 ,mr4 ,pappas1 ,mr4 ,burgess1 ,mrs4 ,miller-,meeks1 ,ms4 ,scanlon1 ,mr4 ,panetta1 ,mr4 ,dunn of ,florida1 ,mr4 ,mullin1 ,ms4 ,ross1 ,mr4 ,kelly of ,pennsylvania1 ,ms4 ,de,gette1 ,ms4 ,lee of ,florida1 ,mr4 ,gottheimer1 ,mr4 ,phillips1 ,ms4 ,tenney1 ,mr4 ,barr1 ,mr4 ,kean of ,new ,jersey1 ,mr4 ,neguse1 ,mr4 ,pence1 ,mrs4 ,fischbach1 ,mr4 ,mast1 ,mr4 ,johnson of ,ohio1 ,mr4 ,langworthy1 ,ms4 ,van ,duyne1 ,ms4 ,pettersen1 ,mr4 ,finstad1 ,mr4 ,la,hood1 ,mr4 ,schneider1 ,mr4 ,owens1 ,mr4 ,smucker1 ,mr4 ,thompson of ,pennsylvania1 ,ms4 ,caraveo1 ,mr4 ,rutherford1 ,mr4 ,crow1 ,mr4 ,westerman1 ,mr4 ,armstrong1 ,mr4 ,cohen1 ,mr4 ,soto1 ,mr4 ,carter of ,georgia1 ,mr4 ,nickel1 ,mr4 ,obernolte1 ,mr4 ,smith of ,nebraska1 ,mr4 ,james1 ,ms4 ,maloy1 ,ms4 ,barragn1 ,mr4 ,davis of ,north ,carolina1 ,ms4 ,slotkin1 ,mr4 ,davis of ,illinois1 ,ms4 ,strickland1 and ,ms4 ,stevens ,december #bd1 #bjbd ,reported from the ,committee on ,ways and ,means with an amendment ,strike out all after the enacting clause and insert the part printed in italic ,december #bd1 #bjbd ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed ,for text of introduced bill1 see copy of bill as introduced on ,march #bb1 #bjbc ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to ensure prompt coverage of breakthrough devices under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,patient ,access to ,critical ,breakthrough ,products ,act of #bjbd4 #b4 ,ensuring prompt coverage of breakthrough devices under the ,medicare program 7a7 ,ensuring coverage through a transitional coverage period 7#a7 ,in general ,section #ahfb7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a77 is amended-- 7,a7 in subparagraph 7,o71 by striking and at the end2 7,b7 in subparagraph 7,p71 by adding and at the end2 and 7,c7 by inserting after subparagraph 7,p7 the following new subparagraph3 7,q7 in the case of a breakthrough device 7as defined in section #ahfa7nnn77 furnished during the transitional coverage period 7as so defined7 with respect to such device1 which is not furnished in accordance with the ,food and ,drug ,administration-approved labeling for such device or that the ,secretary determines1 based on a review of clinical data1 presents an undue risk of harm that outweighs the potential clinical benefits for individuals entitled to benefits under part ,a or enrolled under part ,b2 4 7#b7 ,definitions ,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 ,breakthrough device 7#a7 ,in general ,the term breakthrough device means a device so designated by the ,secretary under section #ahii;,c4 7#b7 ,transitional coverage period ,the term transitional coverage period means1 with respect to a breakthrough device1 the #d-year period that begins on the date that such device is so designated by the ,secretary under section #ahii;,c4 4 7#c7 ,breakthrough device determinations ,part ,e of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq47 is amended by adding at the end the following new section3 #ahii;,c4 ,designation of breakthrough devices 7a7 ,in general ,beginning #ah months after the date of the enactment of this section1 upon application of a manufacturer of a device 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that is cleared1 classified1 or approved under section #eaj7k71 #eac7;f77#b71 or #eae of such ,act on or after the date of the enactment of this section1 the ,secretary shall designate such device as a breakthrough device if the ,secretary determines that such device meets the criteria specified in subsection 7b74 7b7 ,criteria ,for purposes of subsection 7a71 the criteria specified in this subsection are1 with respect to a device1 the following3 7#a7 ,the device is provided with priority review pursuant to section #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#b7 ,in the case such device is cleared under section #eaj7k7 of such ,act1 such device is so cleared based on clinical trial information from an applicable device clinical trial 7as such terms are defined in section #djb7;j7 of such ,act7 that enrolled individuals entitled to benefits under part ,a or enrolled under part ,b4 7#c7 ,the device is not a clinical diagnostic laboratory test4 7c7 ,determination process 7#a7 ,in general ,the ,secretary shall make a determination with respect to a device that is the subject of an application described in subsection 7a7 not later than #f months after such application is submitted to the ,secretary4 7#b7 ,explanation required in case of determination that device does not meet criteria for designation ,in the case that the ,secretary determines that a device that is the subject of an application described in subsection 7a7 does not meet the criteria specified in subsection 7b71 the ,secretary shall notify the manufacturer of such device of such determination and include in such notification an explanation identifying the specific criterion or criteria that such device failed to meet4 7d7 ,reports ,the ,secretary shall submit to ,congress on an annual basis a report specifying-- 7#a7 the number of applications received under this section during such year2 7#b7 the number of devices designated as breakthrough devices under this section during such year2 and 7#c7 the number of applications for a designation for a device under this section with respect to which the ,secretary determined that such device did not meet the criteria specified in subsection 7b7 during such year4 4 7b7 ,ensuring issuance of national coverage determination during transition period ,section #ahfb7l77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#b77 is amended by adding at the end the following new flush sentence3 ,in the case of a request for a national coverage determination with respect to a breakthrough device 7as defined in section #ahfa7nnn771 the ,secretary shall ensure that a final decision is made on such request prior to the end of the transitional coverage period 7as so defined7 for such device if such request was submitted to the ,secretary before the date that is #i months 7or #ab months1 in the case such request is a request to which subparagraph 7,b7 applies7 before the last day of such period4 4 7c7 ,funding ,in addition to amounts otherwise available1 there are appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any monies in the ,treasury not otherwise appropriated1 #aj1jjj1jjj for each of fiscal years #bjbe through #bjcj1 to remain available until expended1 to carry out the amendments made by this section4 ,december #bd1 #bjbd ,reported from the ,committee on ,ways and ,means with an amendment ,december #bd1 #bjbd ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed