,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #caab  ,,in ,,the ,,house ,,of  
,,representatives  ,september #ag1      
#bjac,mr4 ,thompson of ,pennsylvania    
7for himself and ,mr4 ,thompson of      
,california7 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 modify the
 designation of accreditation           
organizations for orthotics and         
prosthetics1 to apply accreditation and 
licensure requirements to suppliers of  
such devices and items for purposes of  
payment under the ,medicare program1 and
 to modify the payment rules for such   
devices and items under such program to 
account for practitioner qualifications 

and complexity of care1 and for other   
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,medicare ,orthotics
 and ,prosthetics ,improvement ,act of  
#bjac4  #b4 ,modification of            
requirements applicable under medicare  
to designation of accreditation         
organizations for suppliers of orthotics
 and prosthetics  7a7 ,in general       
,section #ahcd7;a77#bj77;,b7 of the     
,social ,security ,act 7#db ,u4,s4,c4   
#aciem7a77#bj77;,b77 is amended-- 7#a7  
by striking organizations4--,not later  
than and inserting3 organizations4-- 7i7
 ,in general ,subject to clause 7ii71   
not later than  2 and  7#b7 by adding   
after clause 7i71 as added by paragraph 
7#a71 the following new clauses3  7ii7  
,special requirements for accreditation 
of suppliers of orthotics and           
prosthetics ,for purposes of applying   
quality standards under subparagraph    
7,a7 for suppliers 7other than suppliers
 described in clause 7iii77 of items and
 services described in subparagraph     

7,d77ii71 the ,secretary shall designate
 and approve an independent             
accreditation organization under clause 
7i7 only if such organization is a      
,board or program described in          
subsection 7h77#a77;,f77iv74 ,not later 
than ,january #a1 #bjad1 the ,secretary 
shall ensure that at least one          
independent accreditation organization  
is designated and approved in accordance
 with this clause4  7iii7 ,exception    
,suppliers described in this clause are 
physicians1 occupational therapists1 or 
physical therapists who are licensed or 
otherwise regulated by the ,state in    
which they are practicing and who       
receive payment under this title1       
including regulations promulgated       
pursuant to this subsection4  4  7b7    
,effective date ,an organization must   
satisfy the requirement of section      
#ahcd7;a77#bj77;,b77ii71 as added by    
subsection 7a77#b71 not later than      
,january #a1 #bjad1 regardless of       
whether such organization is designated 

or approved as an independent           
accreditation organization before1 on1  
or after the date of the enactment of   
this ,act4  #c4 ,application of existing
 accreditation and licensure            
requirements to certain prosthetics and 
custom-fabricated or custom-fitted      
orthotics  7a7 ,in general ,section     
#ahcd7;h77#a77;,f7 of the ,social       
,security ,act 7#db ,u4,s4,c4           
#aciem7h77#a77;,f77 is amended-- 7#a7 in
 the heading1 by inserting or           
custom-fitted after custom-fabricated2  
7#b7 in clause 7i71 by striking an item 
of custom-fabricated orthotics described
 in clause 7ii7 or for an item of       
prosthetics unless such item is and     
inserting an item of orthotics or       
prosthetics1 including an item of       
custom-fabricated orthotics described in
 clause 7ii71 unless such item is2  7#c7
 in clause 7ii77,,ii71 by striking a    
list of items to which this subparagraph
 applies and inserting a list of items  
for purposes of clause 7i72  7#d7 in    

clause 7iii77,,iii71 by striking to     
provide or manage the provision of      
prosthetics and custom-designed or      
-fabricated orthotics and inserting to  
provide or manage the provision of      
orthotics and prosthetics 7and          
custom-designed or -fabricated          
orthotics1 in the case of an item       
described in clause 7ii772 and  7#e7 by 
adding at the end the following new     
clause3  7v7 ,exemption of off-the-shelf
 orthotics included in a competitive    
acquisition program ,this subparagraph  
shall not apply to an item of orthotics 
described in paragraph 7#b77;,c7 of     
section #ahdg7;a7 furnished on or after 
,january #a1 #bjad1 that is included in 
a competitive acquisition program in a  
competitive acquisition area under such 
section4  4  7b7 ,effective date ,the   
amendments made by subsection 7a7 shall 
apply to orthotics and prosthetics      
furnished on or after ,january #a1      
#bjad4  #d4 ,eligibility for medicare   
payment for orthotics and prosthetics   

based on supplier qualifications and    
complexity of care ,section #ahcd7;h7 of
 the ,social ,security ,act 7#db        
,u4,s4,c4 #aciem7h77 is amended-- 7#a7  
in paragraph 7#a77;,f77iii71 in the     
matter preceding subclause 7,i71 by     
striking other individual who and       
inserting other individual who1 with    
respect to a category of orthotics and  
prosthetics care described in clause    
7i71 7ii71 7iii71 7iv71 or 7v7 of       
paragraph 7#e77;,c7 furnished on or     
after ,january #a1 #bjad1 and subject to
 paragraph 7#e77;,a71 satisfies all     
applicable criteria of the supplier     
qualification designation for such      
category described in the respective    
clause1 and who2  7#b7 in paragraph     
7#a77;,f77iv71 by inserting before the  
period the following3 and1 with respect 
to a category of orthotics and          
prosthetics care described in clause    
7i71 7ii71 7iii71 7iv71 or 7v7 of       
paragraph 7#e77;,c7 furnished on or     
after ,january #a1 #bjad1 and subject to

 paragraph 7#e77;,a71 satisfies all     
applicable criteria of the provider     
qualification designation for such      
category described in the respective    
clause2 and  7#c7 by adding at the end  
the following new paragraph3  7#e7      
,eligibility for payment based on       
supplier qualifications and complexity  
of care  7,a7 ,considerations for       
eligibility for payments  7i7 ,in       
general ,in applying clauses 7iii7 and  
7iv7 of paragraph 7#a77;,f7 for purposes
 of determining whether payment may be  
made under this subsection for orthotics
 and prosthetics furnished on or after  
,january #a1 #bjad1 the ,secretary shall
 take into account the complexity of the
 respective item and1 subject to clauses
 7ii71 7iii71 and 7iv71 the             
qualifications of the individual or     
entity furnishing and fabricating such  
respective item in accordance with this 
paragraph4  7ii7 ,individual and        
entities exempted from supplier         
qualification designation criteria ,with

 respect to an item of orthotics or     
prosthetics described in clause 7ii71   
7iii71 7iv7 or 7v7 of subparagraph 7,c71
 any criteria for the supplier          
qualification designations under such   
respective clause1 including application
 of subparagraph 7,d71 shall not apply  
to physicians1 occupational therapists1 
or physical therapists who are licensed 
or otherwise regulated by the ,state in 
which they are practicing and who       
receive payment under this title1       
including regulations promulgated       
pursuant to this subsection1 for the    
provision of orthotics and prosthetics4 
7iii7 ,suppliers medicare-eligible prior
 to ,january #a1 #bjad1 exempted ,in the
 case of a qualified supplier who is    
eligible to receive payment under this  
title before ,january #a1 #bjad-- 7,i7  
with respect to an item of orthotics or 
prosthetics described in clause 7i7 of  
subparagraph 7,c71 any criteria for the 
provider qualification designations     
under such clause1 including application

 of subparagraph 7,d71 shall not apply  
to such supplier1 respectively1 for the 
furnishing or fabrication of such an    
item so described2 and  7,,ii7 with     
respect to an item of orthotics or      
prosthetics described in clause 7ii71   
7iii71 or 7iv7 of subparagraph 7,c71 any
 criteria for the supplier qualification
 designations under the respective      
clause 7or a subsequent clause of such  
subparagraph71 including application of 
subparagraph 7,d71 shall not apply to   
such supplier1 respectively1 for the    
furnishing or fabrication of such an    
item described in such respective 7or   
such subsequent7 clause4  7iv7 ,delayed 
application of certain supplier         
qualification designation criteria ,the 
supplier qualification designations     
under clauses 7i71 7ii71 and 7iii7 of   
subparagraph 7,c71 including the        
application of subparagraph 7,d7 to such
 clauses1 shall not be taken into       
account with respect to payment made    
under this subsection for orthotics and 

prosthetics furnished before ,january   
#a1 #bjae4  7v7 ,modifications ,the     
,secretary shall1 in consultation with  
the ,boards and programs described in   
paragraph 7#a77;,f77iv71 periodically   
review the criteria for the supplier    
qualification designation under         
subparagraph 7,c77i77,,iii7 and may     
implement by regulation any             
modifications to such criteria1 as      
determined appropriate in accordance    
with such consultation4 ,any such       
modification shall take effect no       
earlier than ,january #a1 #bjaf4  7,b7  
,assignment of billing codes ,for       
purposes of subparagraph 7,a71 the      
,secretary1 in consultation with        
representatives of the fields of        
occupational therapy1 physical therapy1 
orthotics1 and prosthetics shall utilize
 and incorporate the set of ,l-codes    
listed1 as of the date of the enactment 
of this paragraph1 in the ,centers for  
,medicare  ,medicaid ,services document 
entitled ,transmittal #fef 7,,cms ,pub4 

#ajj-jd1 ,change ,request #ciei1 ,august
 #ai1 #bjje74 ,transmittal #fef shall be
 the controlling source of category1    
product1 and code assignments for the   
orthotics and prosthetics care described
 in each of clauses 7i7 through 7v7 of  
subparagraph 7,c7 using the supplier    
qualification designation for each      
,,hcpcs code as stated in such document4
 ,in the case that ,transmittal #fef is 
updated1 reissued1 or replaced by a     
subsequent document1 the previous       
sentence shall be applied with respect  
to the most recent update1 reissuance1  
or replacement of such document4  7,c7  
,categories of orthotic and prosthetic  
care described  7i7 ,custom-fabricated  
limb prosthetics category ,the category 
of orthotic and prosthetic care         
described in this clause is a category  
for artificial legs and arms1 including 
replacements 7as described in section   
#ahfa7s77#i77 that are made from        
detailed measurements1 images1 or models
 in accordance with a prescription and  

that can only be utilized by a specific 
intended patient and for which payment  
is made under this part4 ,the supplier  
qualification designation for the       
category shall reflect each of the      
following1 in accordance with           
subparagraph 7,d73 7,i7 ,the category of
 care involves the highest level of     
complexity with substantial clinical    
risk4  7,,ii7 ,the category of care     
requires a supplier who satisfies any of
 the education requirements described in
 subclause 7,,iii71 has completed a     
prosthetic residency accredited by the  
,national ,commission on ,orthotic and  
,prosthetic ,education 7,,ncope71 and is
 certified or licensed in prosthetics to
 ensure the comprehensive provision of  
prosthetic care4  7,,iii7 ,the category 
of care requires a supplier who has     
completed any of the following education
 requirements3 7aa7 ,a bachelor's degree
 or master's degree in prosthetics as   
offered by educational institutions     
accredited by the ,commission on        

,accreditation of ,allied ,health       
,education ,programs4  7bb7 ,a          
bachelor's degree1 plus a certificate in
 prosthetics as offered by educational  
institutions accredited by the          
,commission on ,accreditation of ,allied
 ,health ,education ,programs4  7cc7 ,a 
foreign degree determined by the ,world 
,education ,service to be equivalent to 
an educational program in prosthetics   
accredited by the ,commission on        
,accreditation of ,allied ,health       
,education ,programs4  7ii7             
,custom-fabricated orthotics category   
,the category of orthotics and          
prosthetics care described in this      
clause is a category for                
custom-fabricated orthotics that are    
made from detailed measurements1 images1
 or models in accordance with a         
prescription and that can only be       
utilized by a specific intended patient4
 ,the supplier qualification designation
 for the category shall reflect the     
following1 in accordance with           

subparagraph 7,d73 7,i7 ,the category of
 care involves the highest level of     
complexity with substantial clinical    
risk4  7,,ii7 ,the category of care     
requires a supplier who satisfies any of
 the education requirements described in
 clause 7i77,,iii7 7except that for     
purposes of this subclause such clause  
shall be applied by substituting the    
term orthotics each place the term      
prosthetics is used71 has completed an  
orthotic residency accredited by the    
,national ,commission on ,orthotic and  
,prosthetic ,education1 and is certified
 or licensed in orthotics to ensure the 
appropriate provision of orthotic care4 
7iii7 ,custom-fitted high orthotics     
category ,the category of orthotic care 
described in this clause is a category  
for prefabricated orthotics that are    
manufactured with no specific patient in
 mind1 but that are appropriately sized1
 adapted1 modified1 and configured 7with
 the required tools and equipment7 to a 
specific patient in accordance with a   

prescription4 ,the supplier             
qualification designation for the       
category shall reflect the following1 in
 accordance with subparagraph 7,d73 7,i7
 ,the category of care involves moderate
 to high complexity with substantial    
clinical risk4  7,,ii7 ,the category of 
care requires a practitioner who        
either-- 7aa7 satisfies any of the      
education requirements described in     
clause 7i77,,iii71 except that for      
purposes of this subclause such clause  
shall be applied by substituting the    
term orthotics each place the term      
prosthetics is used2 or  7bb7 is        
certified or licensed in orthotics to   
ensure the appropriate provision of     
orthotic care within the practitioner's 
normal scope of practice4  7iv7         
,custom-fitted low orthotics category   
,the category of orthotics and          
prosthetics care described in this      
clause is a category for prefabricated  
orthotics that are manufactured with no 
specific patient in mind1 but that are  

appropriately sized and adjusted to a   
specific patient in accordance with a   
prescription4 ,the supplier             
qualification designation for the       
category shall reflect the following3   
7,i7 ,the category of care involves a   
low level of complexity and low clinical
 risk4  7,,ii7 ,the category of care    
requires a supplier that is certified or
 licensed within a limited scope of     
practice to ensure appropriate provision
 of orthotic care4 ,the supplier's      
education and training shall ensure that
 basic clinical knowledge and technical 
expertise is available to confirm       
successful fit and device compliance    
with the prescription4  7v7             
,off-the-shelf ,the category of orthotic
 care described in this clause is       
described in section #ahdg7;a77#b77;,c74
 ,the supplier qualification designation
 for the category shall reflect that no 
formal credentialing1 clinical          
education1 or technical training is     
required to dispense such items4  7,d7  

,care based on sound clinical judgment  
and technical expertise ,care described 
in clauses 7i71 7ii71 and 7iii7 of      
subparagraph 7,c7 shall be based on     
sound clinical judgment and technical   
expertise based on the supplier's       
education and clinical training1 in     
order to allow the practitioner to      
determine-- 7i7 with respect to care    
described in clause 7i7 or 7ii7 of      
subparagraph 7,c71 the device parameters
 and design1 fabrication process1 and   
functional purpose specific to the needs
 of the patient to maximize optimal     
clinical outcomes2 and  7ii7 with       
respect to care described in clause     
7iii7 of such subparagraph1 the         
appropriate device relative to the      
diagnosis and specific to the needs of  
the patient to maximize optimal clinical
 outcomes4  4  #e4 ,consultation ,in    
implementing the provisions of1 and     
amendments made by1 this ,act1 the      
,secretary of ,health and ,human        
,services shall consult with appropriate

 experts in orthotics and prosthetics1  
including suppliers that furnish items  
within the categories of orthotic and   
prosthetic care described in paragraph  
7#e77;,c7 of section #ahcd7;h7 of the   
,social ,security ,act 7#db ,u4,s4,c4   
#aciem7h771 as added by section #d4  #f4
 ,reports  7a7 ,report on enforcing new 
licensing and accreditation requirements
 ,not later than #ah months after the   
date of the enactment of this ,act1 the 
,secretary of ,health and ,human        
,services shall submit to ,congress a   
report on the steps taken by the        
,department of ,health and ,human       
,services to ensure that the ,state     
licensure and accreditation requirements
 under section #ahcd7;h77#a77;,f7 of the
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciem7h77#a77;,f771 as amended by      
section #c1 are enforced4 ,such report  
shall include a determination of the    
extent to which payments for orthotics  
and prosthetics under the ,medicare     
program under title ,,xviii of such ,act

 are made only to those suppliers that  
meet the relevant accreditation and     
licensure requirements under such       
section and a determination of whether  
additional steps are needed4  7b7       
,report on fraud and abuse ,not later   
than #cj months after the date of the   
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall   
submit to ,congress a report on the     
effect of the requirements under        
subsection 7a77#bj77;,b77ii7 of section 
#ahcd of the ,social ,security ,act 7#db
 ,u4,s4,c4 #aciem71 as added by section 
#b1 and subsection 7h77#a77;,f7 of such 
section1 as amended by section #c1 on   
the occurrence of fraud and abuse under 
the ,medicare program under title       
,,xviii of such ,act1 with respect to   
orthotics and prosthetics for which     
payment is made under such program4  #g4
 ,reduction in medicare spending  7a7   
,projection of cumulative effect on     
spending ,not later than ,december #ca1 
#bjad1 the ,secretary of ,health and    

,human ,services 7in this section       
referred to as the ,secretary71 acting  
through the ,chief ,actuary of the      
,centers for ,medicare  ,medicaid       
,services 7in this section referred to  
as the ,chief ,actuary71 shall submit to
 ,congress1 and have published in the   
,federal ,register1 a projection of the 
effect on cumulative ,federal spending  
under part ,b of title ,,xviii of the   
,social ,security ,act for the period of
 years #bjad through #bjah as a result  
of the implementation of the provisions 
of1 and amendments made by1 this ,act4  
7b7 ,strengthening standards applicable 
if savings not achieved  7#a7 ,in       
general ,subject to paragraph 7#b71 if  
the ,chief ,actuary projects under      
subsection 7a7 that the implementation  
of the provisions of1 and amendments    
made by1 this ,act will not result in a 
cumulative reduction in spending under  
such part of at least #bej1jjj1jjj for  
the period of years #bjad through #bjah 
7using a #bjac baseline71 the ,secretary

 shall1 in accordance with the ,chief   
,actuary's projection1 issue an interim 
final regulation 7to take effect for    
#bjae and subsequent years7 with a      
period for public comment on such       
regulation after the date of publication
 to strengthen the licensure1           
accreditation1 and quality standards    
applicable to suppliers of orthotics and
 prosthetics under title ,,xviii of the 
,social ,security ,act1 including such  
standards described in subsections      
7a77#bj7 and 7h77#a77;,f7 of section    
#ahcd of such ,act 7#db ,u4,s4,c4       
#aciem71 as amended by this ,act1 in    
order to produce such cumulative        
reduction by ,december #ca1 #bjah4  7#b7
 ,exception ,the interim final          
regulation issued under paragraph 7#a7  
shall not apply to a qualified physical 
therapist or qualified occupational     
therapist 7as described in section      
#ahcd7;h77#a77;,f77iii7 of the ,social  
,security ,act 7#db ,u4,s4,c4           
#aciem7h77#a77;,f77iii7774  #h4 ,no     

effect on payment basis for orthotics   
and prosthetics or competitive bidding  
programs ,nothing in the provisions of1 
or amendments made by1 this ,act shall  
have any effect on-- 7#a7 the           
determination of the payment basis for  
orthotics and prosthetics under section 
#ahcd7;h7 of the ,social ,security ,act 
7#db ,u4,s4,c4 #aciem7h772 or  7#b7 the 
implementation of competitive           
acquisition programs under section #ahdg
 of such ,act 7#db ,u4,s4,c4 #aciew-#c71
 including such implementation with     
respect to off-the-shelf orthotics      
described in subsection 7a77#b77;,c7 of 
that section1 that are included in a    
competitive acquisition program in a    
competitive acquisition area under that 
section4