,,ii  #aafth ,,congress  #b;d ,session  
,s4 #ciad  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #h1      
#bjbj,ms4 ,mc,sally 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 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 #bjbj4  
#b4 ,coverage and payment for           
breakthrough devices under the ,medicare
 program  7a7 ,in general ,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       
,coverage of breakthrough devices  7a7  
,breakthrough devices  7#a7 ,in general 
,for purposes of this section1 the term 
breakthrough device means a medical     

device that is a device 7as defined in  
section #bja of the ,federal ,food1     
,drug1 and ,cosmetic ,act7 and that is--
 7,a7 provided with review priority by  
the ,secretary under subsection 7d77#e7 
of section #eae of such ,act2 and  7,b7 
approved or cleared pursuant to section 
#eaj7k71 #eac7;f71 or #eae of such ,act 
for use in treating an indication on or 
after ,july #a1 #bjai4  ,such term also 
includes a breakthrough device that is a
 specified breakthrough device 7as      
defined in subsection 7e77#a77;,b77     
approved or cleared pursuant to section 
#eaj7k71 #eac7;f71 or #eae of such ,act 
for use in treating an indication on or 
after ,december #a1 #bjah4  7#b7        
,limitation on number of #eaj7k7 devices
 ,with respect to a #e-year period1 in  
no case may more than five medical      
devices described in paragraph 7#a7 that
 are classified under section #eaj7k7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act be covered and paid for  
under this title by reason of this      

section during each such #e-year period4
  7b7 ,coverage  7#a7 ,transitional     
coverage  7,a7 ,in general ,during the  
transitional coverage period 7as defined
 in subparagraph 7,b77 a breakthrough   
device shall be-- 7i7 deemed to be      
reasonable and necessary for purposes of
 section #ahfb7;a77#a77;,a72  7ii7      
deemed to be a medical or other health  
service for purposes of section         
#ahfa7s72  7iii7 deemed to be approved  
for an additional payment under section 
#ahhf7;d77#e77,k7 7other than with      
respect to the cost criterion under     
clause 7ii77,i7 of such section72  7iv7 
deemed to be approved for pass-through  
payment under section #ahcc7t77#f7 and  
section #ahcc7;i7 7other than with      
respect to the cost criterion under     
section #ahcc7t77#f77;,a77iv772 and  7v7
 insofar as such breakthrough device may
 be furnished in a setting for which    
payment is made under an applicable     
payment system described in             
subparagraphs 7,d7 through 7,l7 of      

subsection 7c77#d71 deemed eligible for 
an additional payment or payment        
adjustment1 as the case may be1 pursuant
 to subsection 7d77#c7 when furnished in
 a setting for which payment is made    
under such an applicable payment system 
during such transitional coverage       
period4  7,b7 ,transitional coverage    
period defined ,as used in this section1
 the term transitional coverage period  
means1 with respect to a breakthrough   
device1 the period that-- 7i7 begins on 
the date of the approval under section  
#eae of the ,federal ,food1 ,drug1 and  
,cosmetic ,act or of the clearance under
 section #eaj7k7 of such ,act1 as       
applicable1 of such device by the       
,secretary for the indication described 
in subsection 7a77#a72 and  7ii7 ends on
 the last day of the #c-year period that
 begins on the date that the ,secretary1
 pursuant to subsection 7c77#b71 updates
 the relevant applicable payment system 
7as defined in subsection 7c77#d77 to   
recognize the unique temporary or       

permanent code or codes assigned under  
subsection 7c77#a7 to such breakthrough 
device1 except as provided in           
subsections 7d77#a77;,b7 and            
7d77#b77;,b74  7,c7 ,data used to meet  
the ,,ntap and pass-through cost        
criteria ,in determining whether a      
breakthrough device qualifies for an    
additional payment under section        
#ahhf7;d77#e77,k7 or for pass-through   
payment under section #ahcc7t77#f7 or   
section #ahcc7;i71 the ,secretary shall 
use the most recently available data and
 information on the costs of such       
breakthrough device1 which may include  
list prices and invoice prices charged  
for such breakthrough device4  7#b7     
,process for regular coverage ,for      
purposes of the application of section  
#ahfb7;a77#a77;,a7 to a breakthrough    
device furnished after the transitional 
coverage period 7as defined in paragraph
 7#a77;,b77 for such device1 the        
,secretary shall establish a process for
 the coverage of such breakthrough      

devices under this title after such     
period as follows3 7,a7 ,identification 
of additional evidence  7i7 ,in general 
,with respect to a breakthrough device1 
not later than #a year after the date of
 the approval of such device under      
section #eae of the ,federal ,food1     
,drug1 and ,cosmetic ,act or of the     
clearance of such device under section  
#eaj7k7 of such ,act1 as applicable1 the
 ,secretary shall identify whether any  
additional data or evidence is required 
with respect to any indications for such
 device for purposes of the application 
of such section #ahfb7;a77#a77;,a7 to   
such device for such indications4  7ii7 
,non-duplication of data requests ,in   
carrying out clause 7i7 with respect to 
a breakthrough device1 the ,secretary   
shall ensure that data or evidence      
identified-- 7,i7 does not duplicate    
data required to be collected by the    
,food and ,drug ,administration with    
respect to such breakthrough device2    
7,,ii7 minimizes the administrative     

burdens of data collection and reporting
 on providers of services1 suppliers1   
and manufacturers of breakthrough       
devices2 and  7,,iii7 is not otherwise  
unnecessary or redundant4  7,b7         
,proposal for coverage after the        
transitional coverage period ,not later 
than #b years after the date of the     
approval or clearance of a breakthrough 
device by the ,food and ,drug           
,administration1 the ,secretary shall   
develop a proposal for coverage under   
this title of such breakthrough device  
for such indications as the ,secretary  
determines to be appropriate1 based on  
the data and evidence collected under   
subparagraph 7,a71 for such devices     
furnished after the transitional        
coverage period under paragraph 7#a7 for
 such device4 ,if the ,secretary does   
not1 on a date that is before the end of
 such #b-year period1 take action to    
modify the indications for which        
coverage of a breakthrough device may be
 provided under this title after such   

period1 for purposes of section         
#ahfb7;a77#a77;,a7 coverage under this  
title of such breakthrough device shall 
be made for all indications for which   
such device is approved under section   
#eae of the ,federal ,food1 ,drug1 and  
,cosmetic ,act or cleared under section 
#eaj7k7 of such ,act4  7#c7 ,rules of   
construction ,nothing in this section   
shall be construed to-- 7,a7 affect the 
ability of the manufacturer of a        
breakthrough device to seek approval for
 pass-through payment status under      
section #ahcc7t77#f7 or to seek approval
 for an additional payment under section
 #ahhf7;d77#e77,k7 insofar as such      
breakthrough device does not qualify for
 transitional coverage under paragraph  
7#a72 or  7,b7 affect the application   
and approval process for pass-through   
payment status under section            
#ahcc7t77#f7 or for an additional       
payment under section #ahhf7;d77#e77,k7 
in the case of a medical device that is 
not approved by the ,food and ,drug     

,administration as a breakthrough       
device4  7c7 ,coding  7#a7 ,prompt      
assignment ,not later than three months 
after the date of approval or clearance 
of a breakthrough device by the ,food   
and ,drug ,administration1 subject to   
subsection 7b77#a77;,b71 the ,secretary 
shall assign a unique temporary or      
permanent code or codes for purposes of 
coverage and payment for such           
breakthrough device under the applicable
 payment systems 7described in paragraph
 7#d774  7#b7 ,updates  7,a7 ,,ipps ,the
 ,secretary shall provide for semiannual
 updates under the applicable payment   
system described in paragraph 7#d77;,a7 
7relating to the inpatient hospital     
prospective payment system7 to recognize
 the code or codes assigned under       
paragraph 7#a74  7,b7 ,,opps ,the       
,secretary shall provide for quarterly  
updates under the applicable payment    
system described in paragraph 7#d77;,b7 
7relating to the outpatient hospital    
prospective payment system7 to recognize

 the code or codes assigned under       
paragraph 7#a74  7,c7 ,other payment    
systems ,the ,secretary shall provide   
for semiannual or quarterly updates1 as 
the case may be1 under the applicable   
payment systems described in            
subparagraphs 7,c7 through 7,l7 of      
paragraph 7#d7 to recognize the code or 
codes assigned under paragraph 7#a74    
7#c7 ,transparency ,the process for the 
assignment of a code or codes under this
 subsection shall provide for public    
notice and a meaningful opportunity for 
public comment from affected parties4   
7#d7 ,applicable payment systems        
described ,for purposes of this         
subsection1 the term applicable payment 
systems means-- 7,a7 with respect to    
inpatient hospital services1 the        
prospective payment system for inpatient
 hospital services established under    
section #ahhf7;d72  7,b7 with respect to
 outpatient hospital services1 the      
prospective payment system for covered  
,,opd services established under section

 #ahcc7t72  7,c7 with respect to        
ambulatory surgical center services1 the
 fee schedule for such services         
established under section #ahcc7;i72    
7,d7 with respect to physicians'        
services1 the physician fee schedules   
established under section #ahdh2  7,e7  
with respect to covered items of durable
 medical equipment1 the applicable fee  
schedules established under section     
#ahcd2  7,f7 with respect to diagnostic 
laboratory tests1 the payment amounts   
under section #ahcd;,a and the fee      
schedules establish under section #ahdh1
 as the case may be2  7,g7 with respect 
to renal dialysis services furnished by 
a provider of services or a renal       
dialysis facility1 the single payment   
system established under section        
#ahha7;b77#ad72  7,h7 with respect to   
inpatient hospital services furnished by
 rehabilitation facilities1 the         
prospective payment system established  
under section #ahhf7;j72  7,i7 with     
respect to inpatient hospital services  

furnished by long-term care hospitals1  
the prospective payment system under    
section #ahhf7m72  7,j7 with respect to 
inpatient hospital services furnished by
 psychiatric hospitals and psychiatric  
units1 the prospective payment system   
under section #ahhf7s72  7,k7 with      
respect to home health services1 the    
prospective payment system under section
 #ahie2 and  7,l7 with respect to items 
and services1 or a provider of services 
or supplier1 not described in           
subparagraphs 7,a7 through 7,k71 the    
payment system established under this   
title for such items and services when  
furnished by such provider of services  
or supplier4  7d7 ,payment  7#a7        
,inpatient ,hospital ,prospective       
,payment ,system3 ,deemed eligibility   
for breakthrough payment ,the ,secretary
 shall deem each breakthrough device as 
approved for an additional payment under
 section #ahhf7;d77#e77,k7 for the      
#c-year period that begins-- 7,a7 except
 as provided in subparagraph 7,b71 on   

the date that the ,secretary1 pursuant  
to subsection 7c77#b77;,a71 updates the 
payment system under section #ahhf7;d7  
to recognize the unique temporary or    
permanent code or codes assigned under  
subsection 7c77#a7 to such breakthrough 
device2 or  7,b7 in the case of a device
 that has not received approval or      
clearance as a breakthrough device by   
the ,food and ,drug ,administration     
before such payment system is updated   
under subsection 7c77#b77;,a7 to        
recognize the unique temporary or       
permanent code or codes assigned under  
subsection 7c77#a7 to such device1 on   
the date of such approval or clearance4 
,nothing in this paragraph shall be     
construed to affect the authority of the
 ,secretary to use claims data to       
establish new diagnosis or procedure    
codes for breakthrough devices or to    
identify appropriate diagnosis-related  
groups for the assignment of            
breakthrough devices under annual       
rulemaking to carry out section         

#ahhf7;d77#e77,k74  7#b7 ,outpatient    
,prospective ,payment ,system3 ,deemed  
eligibility for pass-through payment    
,the ,secretary shall deem each         
breakthrough device as approved for     
pass-through payment under section      
#ahcc7t77#f7 7including for purposes of 
section #ahcc7;i77#b77;,d77 during the  
#c-year period that begins-- 7,a7 except
 as provided in subparagraph 7,b71 on   
the date that the ,secretary1 pursuant  
to subsection 7c77#b77;,b71 updates the 
payment system under section #ahcc7t7 to
 recognize the unique temporary or      
permanent code or codes assigned under  
subsection 7c77#a7 to such breakthrough 
device2 or  7,b7 in the case of a device
 that has not received approval or      
clearance as a breakthrough device by   
the ,food and ,drug ,administration     
before such payment system is updated   
under subsection 7c77#b77;,b7 to        
recognize the unique temporary or       
permanent code or codes assigned under  
subsection 7c77#a7 to such device1 on   

the date of such approval or clearance4 
,nothing in this paragraph shall be     
construed to affect the authority of the
 ,secretary to use claims data to       
establish new ambulatory payment        
classification groups for breakthrough  
devices or to revise such groups to take
 into account breakthrough devices under
 annual rulemaking to carry out section 
#ahcc7t74  7#c7 ,other payment systems  
7,a7 ,in general ,in the case of a      
breakthrough device that is furnished   
and for which payment may be made under 
the payment system established under    
section #ahcd1 #ahcd;,a1 #ahdh1         
#ahha7;b77#ad71 #ahhf7;j71 #ahhf7m71    
#ahhf7s71 or #ahie1 or any other        
provision of this title 7other than     
sections #ahcc7;i71 #ahcc7t71 and       
#ahhf7;d771 the ,secretary shall provide
 for an additional payment for such     
breakthrough device under such          
applicable payment system or an         
adjustment to such applicable payment   
system1 as the case may be4 ,the payment

 basis for such additional payment or   
adjustment1 as the case may be1 shall   
equal an amount that the ,secretary     
determines covers the costs of such     
breakthrough device4  7,b7 ,cost        
information ,in determining the costs of
 a breakthrough device for purposes of  
determining an additional payment or    
payment adjustment under subparagraph   
7,a71 the ,secretary shall use the most 
recently available data and information 
on the costs of such breakthrough       
device1 which may include list prices   
and invoice prices charged for such     
breakthrough device4  7,c7 ,rule of     
construction ,nothing in this paragraph 
shall be construed to affect the        
authority of the ,secretary to use      
claims data to establish new or modify  
existing ambulatory payment             
classification groups1 diagnosis-related
 groups1 level ,,ii ,,hcpcs codes1 or   
such other groups or codes as the       
,secretary may establish under the      
annual rulemaking authority under the   

provisions referred to in subparagraph  
7,a74  7,d7 ,clinical diagnostic        
laboratory tests ,an additional payment 
or payment adjustment under subparagraph
 7,a7 for a breakthrough device under   
the applicable payment system           
established in section #ahcd;,a may be  
in the form of an increase to the amount
 determined for the breakthrough device 
using cross-walking under section       
#ahcd;,a7c77#a77;,a71 an extension of   
the initial period of payment applicable
 to advance diagnostic laboratory tests 
under section #ahcd;,a7d77#a77;,a71 and 
in such other form or manner as the     
,secretary determines reflects the costs
 for such breakthrough device under the 
relevant provisions of section #ahcd;,a4
  7#d7 ,payment for breakthrough devices
 after the transitional coverage period 
,payment for a breakthrough device that 
is furnished after the conclusion of the
 transitional coverage period under     
subsection 7b77#a7 for such device shall
 be made pursuant to the applicable     

payment system involved1 taking into    
account the additional evidence and data
 collected under subsection 7b77#b74    
7e7 ,special rules for certain          
breakthrough devices  7#a7 ,coverage of 
specified breakthrough devices  7,a7 ,in
 general ,subject to the succeeding     
provisions of this subsection and       
notwithstanding any other provision of  
law1 the ,secretary shall provide for   
coverage and payment pursuant to this   
section of a specified breakthrough     
device 7as defined in subparagraph      
7,b774  7,b7 ,specified breakthrough    
device defined ,in this section1 the    
term specified breakthrough device means
 a breakthrough device with respect to  
which no ,medicare benefit category     
exists4  7#b7 ,period of transitional   
coverage  7,a7 ,in general ,subject to  
subparagraph 7,c71 the provisions of    
subsection 7b77#a7 7relating to the     
transitional coverage period and payment
 for breakthrough devices1 including the
 use of the most recently available data

 and information on costs7 shall apply  
to a specified breakthrough device in   
the same manner as such provisions apply
 to a breakthrough device4 ,the         
,secretary may use methodologies under  
existing payment systems established    
under this title1 may provide for       
appropriate adjustments to such         
methodologies1 or may establish a new   
payment methodology under this title1 to
 provide for payment for a specified    
breakthrough device to ensure the       
payment basis for such payment covers   
costs of the specified breakthrough     
device4  7,b7 ,report  7i7 ,in general  
,with respect to each specified         
breakthrough device1 the ,secretary     
shall submit to ,congress a report on   
the coverage of and payment for such    
specified breakthrough device under this
 section that includes the following    
information3 7,i7 ,the manner in which  
coverage is provided and payment is made
 for the specified breakthrough device1 
including how such device was classified

 7such as an item of durable medical    
equipment or otherwise7 and the payment 
methodology the ,secretary applied with 
respect to such device4  7,,ii7 ,the    
impact of the availability of the       
specified breakthrough device to        
,medicare beneficiaries1 including      
impacts on the quality of patient care1 
patient outcomes1 and patient           
experience4  7,,iii7 ,the impact of the 
availability of the specified           
breakthrough device to ,medicare        
beneficiaries on program expenditures   
under this title4  7,,iv7 ,such other   
information as the ,secretary determines
 to be appropriate4  7ii7 ,deadline     
7,i7 ,in general ,except as provided in 
subclause 7,,ii71 the ,secretary shall  
submit a report required under this     
subparagraph no later than the end of   
the transitional period of coverage and 
payment applicable to such specified    
breakthrough device4  7,,ii7 ,extension 
to generate additional data ,if the     
,secretary determines that additional   

data or evidence is required to complete
 a report required under this           
subparagraph with respect to a specified
 breakthrough device1 the deadline under
 this clause may be extended for an     
additional two years4  7,c7 ,additional 
period of transitional coverage to      
develop additional data ,insofar as the 
,secretary determines that additional   
data or evidence is required to complete
 a report required under subparagraph   
7,b7 with respect to a specified        
breakthrough device1 the transitional   
coverage period of coverage and payment 
for such device shall be extended by the
 lesser of-- 7i7 two years2 or  7ii7 the
 amount of additional time required for 
the submission of the report with       
respect to such device4  7#c7 ,coverage 
and payment after the transitional      
period ,the ,secretary may continue to  
provide for coverage of and payment for 
a specified breakthrough device after   
the end of the transitional period of   
coverage and payment for breakthrough   

devices through the national coverage   
determination process if the ,secretary 
determines that the specified           
breakthrough device-- 7,a7 improves the 
quality of care and patient outcomes2   
7,b7 improves the delivery of care2 or  
7,c7 reduces spending under this title  
without reducing the quality of care4  4
  7b7 ,study of limit on #eaj7k7        
breakthrough devices  7#a7 ,study ,the  
,secretary of ,health and ,human        
,services shall conduct a study on the  
effect of the limit under section       
#ahii;,c7a77#b7 of the ,social ,security
 ,act1 as added by subsection 7a71 on   
the number of devices cleared under     
section #eaj7k7 of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj7k77 that are breakthrough devices 
for purposes of such section #ahii;,c4  
7#b7 ,matters examined ,in conducting   
the study described in paragraph 7#a71  
the ,secretary shall-- 7,a7 determine   
the number of medical devices cleared   
under such section #eaj7k7 during the   

#e-year period beginning on the date of 
the enactment of this ,act2  7,b7       
determine the number of such devices    
that were not included as breakthrough  
devices for purposes of such section    
#ahii;,c by reason of the limitation    
under subsection 7a77#b7 of such        
section2 and  7,c7 examine the impact of
 such limitation on access to such      
devices for individuals entitled to     
benefits under part ,a or enrolled in   
part ,b of title ,,xviii of the ,social 
,security ,act 7#db ,u4,s4,c4 #acie et  
seq47 or both4  7#c7 ,report ,not later 
than #f years after the date of the     
enactment of this ,act1 the ,secretary  
shall submit to ,congress a report on   
the study conducted under this          
subsection and shall include such       
recommendations for legislative or      
administrative changes as the ,secretary
 determines to be appropriate4  7c7     
,clarification regarding certain        
payments  7#a7 ,,ipps new technology    
payment ,section #ahhf7;d77#e77,k7 of   

the ,social ,security ,act 7#db         
,u4,s4,c4 #acieww7d77#e77,k77 is amended
 by adding at the end the following new 
clause3  7x7 ,during the period with    
respect to which a new medical service  
or technology is eligible for an        
additional payment under this subsection
 by reason of this subparagraph1 any    
local coverage determination 7as defined
 in section #ahfi7;f77#b77;,b77 that    
would affect the coverage of1 or the    
additional payment under this subsection
 for1 such new medical service or       
technology shall have no force or effect
 in law or regulation4  4  7#b7 ,,opps  
pass-through payment ,section           
#ahcc7t77#f7 of the ,social ,security   
,act 7#db ,u4,s4,c4 #aciel7t77#f77 is   
amended by adding at the end the        
following new subparagraph3  7,k7       
,prohibition on use of local coverage   
determinations to affect coverage of and
 payment for pass-through products      
,during the period with respect to which
 a drug1 biological1 or medical device  

is eligible for an additional payment   
under this paragraph1 any local coverage
 determination 7as defined in section   
#ahfi7;f77#b77;,b77 that would affect   
the coverage of1 or the additional      
payment under this paragraph for1 such  
drug1 biological1 or medical device     
shall have no force or effect in law or 
regulation4  4  7#c7 ,effective date    
,this subsection1 and the amendments    
made by this subsection1 shall apply    
with respect to items and services      
furnished on or after the date of the   
enactment of this ,act1 including any   
such item or service that is eligible on
 such date for an additional payment    
under section #ahhf7;d7 of the ,social  
,security ,act 7#db ,u4,s4,c4           
#acieww7d77 by reason of paragraph      
7#e77,k7 of such section or under       
section #ahcc7t77#f7 of such ,act 7#db  
,u4,s4,c4 #acieww7t77#f771 or that would
 have been so eligible on such date but 
for a local coverage determination that 
limits or denies coverage of and such   

additional payment for the item or      
service4  7d7 ,conforming amendments    
7#a7 ,inpatient ,prospective ,payment   
,system ,section #ahhf7;d77#e77,k7 of   
the ,social ,security ,act 7#db         
,u4,s4,c4 #acieww7d77#e77,k771 as       
amended by subsection 7c77#a71 is       
amended by adding at the end the        
following new clause3  7xi7 ,effective  
for discharges occurring on or after    
,october #a1 #bjbj1 in the case of a new
 medical service or technology that is a
 breakthrough device 7as defined in     
section #ahii;,c7a771 the additional    
payment established for such            
breakthrough device under this          
subparagraph shall be made for the      
#c-year period applicable to such       
breakthrough device under section       
#ahii;,c7d77#a74 ,in determining the    
amount of the additional payment for a  
breakthrough device under this          
subparagraph during such #c-year period1
 the ,secretary shall apply section     
#dab4hh7;b7 of title #db1 ,code of      

,federal ,regulations 7or any successor 
regulation71 as if the reference to #ej 
percent in such section were a reference
 to #hj percent4  4  7#b7 ,outpatient   
,prospective ,payment ,system ,section  
#ahcc7t77#f77;,c7 of such ,act 7#db     
,u4,s4,c4 #aciel7t77#f77;,c77 is amended
 by adding at the end the following new 
clause3  7iii7 ,special rule for        
breakthrough devices ,notwithstanding   
clause 7i7 or 7ii71 or any other        
provision of this paragraph to the      
contrary1 in the case of a breakthrough 
device 7as defined in section           
#ahii;,c7a77 that is furnished on or    
after ,january #a1 #bjba1 payment under 
this paragraph for such breakthrough    
device shall be made for the #c-year    
period applicable to such breakthrough  
device under section #ahii;,c7d77#b74   
,the provisions of this clause shall    
also apply for purposes of transitional 
pass-through payment under section      
#ahcc7;i77#b77;,d74  4  7#c7            
,competitive bidding program ,section   

#ahdg7;a7 of such ,act 7#db ,u4,s4,c4   
#aciew-#c7;a77 is amended-- 7,a7 in     
paragraph 7#b77;,a7-- 7i7 by striking   
and excluding drugs and inserting       
excluding drugs2 and  7ii7 by inserting 
before the period at the end the        
following3 1 and excluding breakthrough 
devices 7as defined in section          
#ahii;,c7a772 and  7,b7 in paragraph    
7#g71 by adding at the end the following
 new subparagraph3  7,c7 ,breakthrough  
devices ,a breakthrough device described
 in paragraph 7#b77;,a7 that is         
furnished during the transitional       
coverage period 7as defined in section  
#ahii;,c7b77#a77;,b77 applicable to such
 device under section #ahii;,c4  4  7e7 
,effective date ,this section1 and the  
amendments made by this section1 shall  
take effect on the date of the enactment
 of this ,act and1 unless otherwise     
specified in this section 7or in an     
amendment made by this section71 shall  
apply to breakthrough devices 7as       
defined in section #ahii;,c7a7 of the   

,social ,security ,act1 as added by     
subsection 7a771 approved or cleared on 
or after ,july #a1 #bjai1 or1 in the    
case of a specified breakthrough device 
7as defined in such section as so       
added71 approved or cleared on or after 
,december #a1 #bjah4