,,ib  ,union ,calendar ,no4 #ead  #aacth
 ,,congress  #b;d ,session  ,h4 ,r4     
#ebad  ,report ,no4 #aac-fhc  ,,in ,,the
 ,,house ,,of ,,representatives  ,july  
#bh1 #bjad ,mr4 ,olson introduced the   
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,december #bb1 #bjad ,reported with an  
amendment1 committed to the ,committee  
of the ,whole ,house on the ,state of   
the ,union1 and ordered to be printed   
,strike out all after the enacting      
clause and insert the part printed in   
italic ,for text of introduced bill1 see
 copy of bill as introduced on ,july    
#bh1 #bjad  ,a ,,bill  ,to require the  
,secretary of ,health and ,human        
,services to provide for recommendations
 for the development and use of clinical
 data registries for the improvement of 
patient care4  #a4 ,recommendations for 
development and use of clinical data    
registries  7a7 ,in general ,not later  
than one year after the date of the     
enactment of this ,act1 the ,secretary  

of ,health and ,human ,services shall   
make recommendations for the development
 and use1 when appropriate1 of clinical 
data registries that are integrated with
 clinical practice guidelines and best  
practices or standards of care1         
including recommendations designed to   
minimize duplication and burden on those
 operating or reporting to such         
registries1 for the improvement of      
patient care4 ,the ,secretary shall make
 such recommendations available to the  
public by posting them on a public      
,website of the ,department of ,health  
and ,human ,services4  7b7 ,specific    
recommendations ,such recommendations1  
with respect to such registries1 shall  
include the following3  7#a7            
,recommendations for a set of standards 
that1 if adopted by such registries1    
would allow for the bidirectional1      
interoperable exchange of information   
between the electronic health records of
 the reporting clinicians and such      
registries4  7#b7 ,recommendations on   

how clinical registries1 including      
outcomes-based registries1 may be       
developed and then used to evaluate     
various care models and methods1        
including improved clinical care        
coordination1 and the impact of such    
models and methods on the management of 
diseases as measured by appropriate care
 parameters based on clinical practice  
guidelines and best practices 7such as  
,a#a;,c1 blood pressure1 and cholesterol
 levels in the case of diabetes74  7#c7 
,recommendations on how such registries 
should be structured to facilitate--    
7,a7 the recording and reporting of     
post-market data for the purposes of    
monitoring safety and efficacy of       
,,fda-approved devices and drugs2  7,b7 
the reporting of relevant clinical data 
to satisfy attestation requirements for 
coverage of prescribed devices2 and     
7,c7 coverage with evidence development 
policies for devices under the ,medicare
 program 7such as improving patient     
access to safe and effective glucose    

monitoring systems74  7#d7              
,recommendations on how data from such  
registries may be used to inform        
physicians and other health care        
professionals regarding clinical        
practices for the prevention of diseases
 7such as diabetes and the precursor    
conditions of diabetes7 and appropriate 
methods for the dissemination of        
clinical practice support tools and     
other educational resources that may be 
derived from registry data4  7#e7       
,recommendations for how registries can 
be used to promote preventive health    
benefits such as screenings and the     
,medicare annual wellness visits that   
may reduce the risk of chronic diseases 
7such as obesity1 osteoporosis1         
cardiovascular disease1 cancer1 diabetes
 and their complications74  7c7         
,consultation with clinical experts ,the
 ,secretary shall consult with national 
medical specialty societies1 patient    
groups1 technology vendors1 and         
developers and manufacturers of drugs   

and medical devices in the development  
of such recommendations as they relate  
to the diseases that members of such    
societies manage and treat 7such as with
 endocrinologists with respect to       
recommendations relating to diabetes and
 pre-diabetes conditions74  7d7 ,rule of
 construction ,nothing in this section  
may be construed as--  7#a7 authorizing 
the ,secretary of ,health and ,human    
,services to take any action with regard
 to the recommendations made under this 
section 7other than making such         
recommendations available to the public 
in the manner described in subsection   
7a772  7#b7 limiting or interfering with
 the authority of a health care         
practitioner to practice medicine or to 
prescribe or administer a drug or device
 to an individual for a condition or    
disease2 or  7#c7 providing the ,centers
 for ,medicare  ,medicaid ,services with
 authority to limit 7or to encourage    
other individuals or entities to limit7 
coverage under the ,medicare program    

under title ,,xviii of the ,social      
,security ,act for an item or service   
furnished to an individual on account of
 the participation1 or lack of          
participation1 of the individual in a   
registry or other data collection       
system4  ,december #bb1 #bjad ,reported 
with an amendment1 committed to the     
,committee of the ,whole ,house on the  
,state of the ,union1 and ordered to be 
printed