,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #dide  ,,in ,,the ,,house ,,of  
,,representatives  ,october #ca1        
#bjai,mr4 ,griffith 7for himself1 ,mr4  
,welch1 ,mr4 ,bilirakis1 ,mr4 ,soto1 and
 ,mr4 ,larson of ,connecticut7          
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce1 and in addition to the   
,committee on ,ways and ,means1 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  ,a ,,bill  ,to     
amend title ,,xviii of the ,social      
,security ,act to exclude ventilators   
from competitive acquisition programs   
under the ,medicare program for #e      
years1 and for other purposes4  #a4     
,short title ,this ,act may be cited as 
the ,safeguarding ,medicare ,access to  
,respiratory ,therapy ,act of #bjai4    
#b4 ,excluding ventilators and certain  
other respiratory items from competitive

 acquisition programs under the         
,medicare program for #e years ,section 
#ahdg7;a77#b77;,a7 of the ,social       
,security ,act 7#db ,u4,s4,c4           
#aciew-#c7;a77#b77;,a77 is amended by   
inserting excluding ventilators 7whether
 invasive or noninvasive7 and any other 
respiratory covered item 7as defined in 
paragraph 7#ac7 of section #ahcd7;a77   
payable under paragraph 7#c7 of such    
section and furnished on or after       
,january #a1 #bjbj1 and before ,january 
#a1 #bjbe1 before and excluding drugs   
and biologicals44  #c4 ,requiring the   
establishment of updated national       
coverage policies to reflect innovation 
in technology for home mechanical       
ventilator devices under the ,medicare  
program  7a7 ,in ,general ,section      
#ahfi7;f7 of the ,social ,security ,act 
7#db ,u4,s4,c4 #acie;ff7f77 is amended  
by adding at the end the following new  
paragraph3  7#i7 ,technical expert panel
 review and update of national coverage 
determinations for home mechanical      

ventilators and certain other           
respiratory devices  7,a7 ,in general   
,not later than #ij days after the date 
of the enactment of this paragraph1 the 
,secretary 7through use of a contractor 
or otherwise7 shall establish a         
technical expert panel for purposes of  
reviewing national coverage             
determinations with respect to coverage 
under part ,b for home invasive and     
noninvasive ventilators and other       
noninvasive respiratory devices         
7including respiratory devices with     
bi-level pressure capability7 and making
 recommendations for revising such      
determinations4  7,b7 ,review1          
assessment1 and recommendations ,not    
later than #a year after the date the   
technical expert panel described in     
subparagraph 7,a7 is established 7and   
periodically thereafter as the          
,secretary determines appropriate71 the 
technical expert panel shall review     
stakeholder input and clinical          
literature and make recommendations to  

the ,secretary1 with respect to national
 coverage determinations described in   
such paragraph1 relating to--  7i7      
defining home invasive ventilators and  
home noninvasive ventilators2  7ii7     
defining the term respiratory failure   
for purposes of establishing criteria   
for the appropriate use of home invasive
 or noninvasive ventilators2  7iii7     
establishing medical necessity criteria 
for the use of home invasive and        
noninvasive ventilators for individuals 
enrolled under part ,b diagnosed with   
respiratory failure and for such        
individuals not diagnosed with          
respiratory failure2 and  7iv7 any other
 aspects of home ventilators and similar
 devices that the technical expert panel
 determines are appropriate to ensure   
access to medically appropriate devices4
  7,c7 ,membership ,in establishing the 
technical expert panel1 the ,secretary  
shall solicit recommendations from      
interested stakeholders4 ,the technical 
expert panel shall be composed of a     

minimum of #ae individuals with relevant
 expertise and perspectives1 including  
the following3  7i7 ,home invasive and  
noninvasive ventilator patients and     
caregivers4  7ii7 ,experts with relevant
 clinical experience and expertise1     
including researchers in respiratory    
care1 pulmonologists1 nurses1           
respiratory therapists1 and other       
clinicians4  7iii7 ,experts with subject
 matter expertise in reimbursement      
systems and medical necessity           
requirements under this title4  7iv7    
,experts in the supply of devices and   
services for home ventilation therapy4  
7v7 ,experts in the design1 development1
 and manufacturing of home ventilation  
equipment4  7,d7 ,use of the            
recommendations by the secretary  7i7   
,in general ,in consultation with       
stakeholders1 the ,secretary shall1     
based upon the recommendations described
 in subparagraph 7,b71 update national  
coverage determinations for ventilators 
and devices described in paragraph 7#a74

  7ii7 ,timing ,the ,secretary shall    
finalize and implement updated national 
coverage determinations described in    
clause 7i71 taking into account public  
comments made during the determination  
process1 not later than #i months after 
any date on which the ,secretary        
receives recommendations described in   
subparagraph 7,b7 from the technical    
expert panel4  7,e7 ,transparency ,the  
,secretary shall make the minutes of all
 meetings of the technical expert panel 
and all documentation relating to the   
formulation of recommendations described
 in subparagraph 7,b7 available to the  
public through the ,centers for         
,medicare  ,medicaid ,services website4 
4