,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #gcab  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,febru>y #i1 #bjbd,ms4
 ,ku/] 7= h]self1 ,mr4 ,bald]son1 & ,ms4
 ,letl[7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committees 
on ,education & ! ,work=ce1 ,ways &     
,means1 & ! ,judici>y1 = a p]iod to be  
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to provide =       
requirem5ts = electronic-prescrib+ =    
controll$ sub/ances "u gr\p heal? plans 
& gr\p & individual heal? insurance     
cov]age4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,electronic ,prescrib+ =    
,controll$ ,sub/ances ,act or ! ,,epcs  
#b4j ,act4  #b4 ,requirem5ts =          
electronic-prescrib+ = controll$        
sub/ances "u gr\p heal? plans & gr\p &  
individual heal? insurance cov]age  7a7 
,public ,heal? ,s]vice ,act am5dm5t     
,section #bgii;,a-#g ( ! ,public ,heal? 

,s]vice ,act 7#db ,u4,s4,c4             
#cjj;gg-#aag7 is am5d$ by add+ at ! end 
! foll[+ new subsection3  7d7           
,requirem5ts = electronic-,prescrib+ =  
controll$ sub/ances  7#a7 ,9 g5]al      
,except z provid$ pursuant to p>agraph  
7#b71 = plan ye>s beg9n+ on or aft]     
,janu>y #a1 #bjbf1 a gr\p heal? plan & a
 heal? insurance issu] (f]+ gr\p or     
individual heal? insurance cov]age1 )   
respect to a p>ticipat+ provid]1 z def9$
 9 section #bgii-a7;a77#c71 %all h 9    
place policies1 subject to p>agraphs    
7#d7 & 7#e71 t require any prescription 
= a s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v     
controll$ sub/ance 7z def9$ by section  
#bjb ( ! ,controll$ ,sub/ances ,act7    
cov]$ by ! plan or cov]age t is         
transmitt$ by su* a p>ticipat+ provid] =
 su* a p>ticipant1 b5efici>y1 or        
enrollee be electronically transmitt$   
consi/5t ) /&>ds e/abli%$ "u p>agraph   
7#c7 ( section #ahfj;,d-#d7;e7 ( !      
,social ,security ,act1 "u an electronic
 prescription drug program t meets      

requirem5ts t are sub/antially simil> 7z
 jo9tly det]m9$ by ! ,secret>y1 !       
,secret>y ( ,labor1 & ! ,secret>y ( !   
,treasury7 to ! requirem5ts ( p>agraph  
7#b7 ( su* section #ahfj;,d-#d7;e74     
7#b7 ,exception = c]ta9 circum/ances ,! 
,secret>y1 ! ,secret>y ( ,labor1 & !    
,secret>y ( ! ,treasury %all jo9tly1    
?r\gh rulemak+1 specify circum/ances &  
processes by :i* ! requirem5t "u        
p>agraph 7#a7 may be waiv$1 ) respect to
 a s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v      
controll$ sub/ance t is a prescription  
drug cov]$ by a gr\p heal? plan or gr\p 
or individual heal? insurance cov]age   
(f]$ by a heal? insurance issu]1 includ+
 9 ! case (-- 7,a7 a prescription issu$ 
:5 ! p>ticipat+ provid] & disp5s+       
ph>macy are ! same entity2  7,b7 a      
prescription issu$ t _c be transmitt$   
electronically "u ! mo/ rec5tly         
implem5t$ v]sion ( ! ,national ,c\ncil =
 ,prescription ,drug ,programs ,,script 
,/&>d2  7,c7 a prescription issu$ by a  
p>ticipat+ provid] :o receiv$ a waiv]   

7:i* may include a waiv] obta9$ pursuant
 to section                             
#ahfj;,d-#d7;e77#g77;,b77iii7 ( !       
,social ,security ,act7 or a r5ewal !re(
 = a p]iod ( "t z det]m9$ by !          
,secret>y1 ! ,secret>y ( ,labor1 & !    
,secret>y ( ! ,treasury1 n to exce$ "o  
ye>1 f ! requirem5t to use electronic   
prescrib+ due to demon/rat$ economic    
h>d%ip1 te*nological limitations t are n
 reasonably )9 ! control ( ! p>ticipat+ 
provid]1 or o!r exceptional circum/ance 
demon/rat$ by ! p>ticipat+ provid]2     
7,d7 a prescription issu$ by a          
p>ticipat+ provid] "u circum/ances 9    
:i*1 not)/&+ ! p>ticipat+ provid]'s     
ability to submit a prescription        
electronically z requir$ by ?is         
subsection1 su* p>ticipat+ provid]      
reasonably det]m9es t x w\ld be         
impractical = ! individual involv$ to   
obta9 sub/ances prescrib$ by electronic 
prescription 9 a timely mann]1 & su*    
delay w\ld adv]sely impact !            
individual's m$ical condition involv$2  

7,e7 a prescription issu$ by a          
p>ticipat+ provid] prescrib+ a drug "u a
 rese>* protocol2  7,f7 a prescription  
issu$ by a p>ticipat+ provid] = a drug =
 :i* ! ,food & ,drug ,adm9i/ration      
requires a prescription to conta9       
elem5ts t are n able to be includ$ 9    
electronic prescrib+1 su* z a drug )    
risk evaluation & mitigation /rategies t
 include elem5ts to assure safe use2    
7,g7 a prescription issu$ = an          
individual :o receives hospice c>e or = 
a resid5t ( a nurs+ facility 7z def9$ 9 
section #aiai7;a7 ( ! ,social ,security 
,act72  7,h7 a prescription issu$ "u    
circum/ances 9 :i* electronic prescrib+ 
is n available due to tempor>y          
te*nological or electrical failure1 z   
specifi$ jo9tly by ! ,secret>y1 !       
,secret>y ( ,labor1 & ! ,secret>y ( !   
,treasury ?r\gh rulemak+2 &  7,i7 a     
prescription issu$ by a p>ticipat+      
provid] all[+ = ! disp5s+ ( a non-pati5t
 specific prescription pursuant to a /&+
 ord]1 approv$ protocol = drug !rapy1   

collaborative drug managem5t1 or        
compreh5sive m$ication managem5t1 9     
response to a public heal? em]g5cy or   
o!r circum/ances "u :i* ! p>ticipat+    
provid] may issue a non-pati5t specific 
prescription4  7#c7 ,rules (            
,con/ruction  7,a7 ,v]ification ,no?+ 9 
?is subsection %all be con/ru$ z requir+
 a disp5s] to v]ify t a p>ticipat+      
provid]1 ) respect to a prescription = a
 s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v        
controll$ sub/ance t is a prescription  
drug cov]$ by a gr\p heal? plan or gr\p 
or individual heal? insurance cov]age   
(f]$ by a heal? insurance issu]1 has a  
waiv] 7or is o!rwise exempt7 "u p>agraph
 7#b7 f ! requirem5t "u p>agraph 7#a74  
7,b7 ,au?ority to disp5se ,no?+ 9 ?is   
subsection %all be con/ru$ z affect+ !  
au?ority ( a gr\p heal? plan or gr\p or 
individual heal? insurance cov]age (f]$ 
by a heal? insurance issu] to cov]1 or !
 au?ority ( a disp5s] to cont9ue to     
disp5se1 a prescription drug if !       
prescription = su* drug is an o!rwise   

valid writt51 oral1 or fax prescription 
t is consi/5t ) applicable law4  7,c7   
,pati5t *oice ,no?+ 9 ?is subsection    
%all be con/ru$ z affect+ ! ability ( an
 individual :o is a p>ticipant1         
b5efici>y1 or enrollee ( a gr\p heal?   
plan or gr\p or individual heal?        
insurance cov]age (f]$ by a heal?       
insurance issu] & :o is prescrib$ a     
s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v         
controll$ sub/ance t is a prescription  
drug cov]$ by ! plan or cov]age to      
designate a p>ticul> disp5s] to disp5se 
a prescrib$ controll$ sub/ance to !     
ext5t consi/5t ) ! requirem5ts "u ?is   
subsection4  7#d7 ,regulations on policy
 requirem5ts ,! ,secret>y1 ! ,secret>y (
 ,labor1 & ! ,secret>y ( ! ,treasury    
%all promulgate regulations specify+    
requirem5ts = ! policies e/abli%$ by    
gr\p heal? plans & heal? insurance      
issu]s "u p>agraph 7#a74 ,su*           
regulations %all include requirem5ts =--
 7,a7 a uni=m process by :i* plans &    
issu]s are requir$ to set ! e-prescrib+ 

requirem5ts2  7,b7 a process by :i*     
plans & issu]s are requir$ to grant     
waiv]s & exceptions to p>ticipat+       
provid]s pursuant to p>agraph 7#b72 &   
7,c7 a me*anism = plans & issu]s to     
recognize waiv]s issu$ to p>ticipat+    
provid]s "u "p ,d ( title ,,xviii ( !   
,social ,security ,act1 pursuant to     
p>agraph 7#b77;,c74  7#e7 ,prohibitions 
,! policies e/abli%$ pursuant to        
p>agraph 7#a7 by a gr\p heal? plan or   
heal? insurance issu] (f]+ gr\p or      
individual heal? insurance cov]age may  
n-- 7,a7 require disp5s]s ( a s*$ule    
,,ii1 ,,iii1 ,,iv1 or ,v controll$      
sub/ance to confirm t ! prescription = !
 controll$ sub/ance 0 electronically    
issu$ by a p>ticipat+ provid] 9         
accordance ) su* policies1 z describ$ 9 
p>agraph 7#a72  7,b7 require disp5s]s ( 
su* controll$ sub/ances to submit       
in=mation or data beyond :at is o!rwise 
requir$ to process a prescription drug  
claim 9 ord] to confirm a p>ticipat+    
provid]'s compliance ) su* policies2    

7,c7 reject1 d5y1 or rec\p reimbursem5t 
= a prescription drug claim bas$ on !   
=mat 9 :i* ! prescription 0 issu$2 or   
7,d7 require a p>ticipat+ provid] to use
 a specific v5dor = electronic prescrib+
 or a specific electronic prescrib+     
product or sy/em4  7#f7 ,atte/ation (   
compliance ,beg9n+ on ,janu>y #a1 #bjbf1
 ea* gr\p heal? plan & heal? insurance  
issu] (f]+ gr\p or individual heal?     
insurance cov]age %all annually submit  
to ! ,secret>y1 ! ,secret>y ( ,labor1 & 
! ,secret>y ( ! ,treasury an atte/ation 
( compliance ) ! requirem5ts ( ?is      
subsection4  7#g7 ,consultation         
requirem5t = rulemak+ ,9 promulgat+     
regulations to c>ry out ?is subsection1 
! ,secret>y1 ! ,secret>y ( ! ,labor1 & !
 ,secret>y ( ! ,treasury %all jo9tly    
consult ) disp5s]s ( controll$          
sub/ances1 ,/ate insurance regulators1  
heal? insurance issu]s (f]+ gr\p or     
individual heal? insurance cov]age1 &   
heal? c>e practition]s4  4  7b7         
,employee ,retirem5t ,income ,security  

,act ( #aigd am5dm5t ,section #gbb ( !  
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #aahek7 is  
am5d$ by add+ at ! end ! foll[+ new     
subsection3  7d7 ,requirem5ts =         
electronic-,prescrib+ = controll$       
sub/ances  7#a7 ,9 g5]al ,except z      
provid$ pursuant to p>agraph 7#b71 =    
plan ye>s beg9n+ on or aft] ,janu>y #a1 
#bjbf1 a gr\p heal? plan & a heal?      
insurance issu] (f]+ gr\p heal?         
insurance cov]age1 ) respect to a       
p>ticipat+ provid]1 z def9$ 9 section   
#gaf7;a77#c71 %all h 9 place policies1  
subject to p>agraphs 7#d7 & 7#e71 t     
require any prescription = a s*$ule     
,,ii1 ,,iii1 ,,iv1 or ,v controll$      
sub/ance 7z def9$ by section #bjb ( !   
,controll$ ,sub/ances ,act7 cov]$ by !  
plan or cov]age t is transmitt$ by su* a
 p>ticipat+ provid] = su* a p>ticipant  
or b5efici>y be electronically          
transmitt$ consi/5t ) /&>ds e/abli%$ "u 
p>agraph 7#c7 ( section #ahfj;,d-#d7;e7 
( ! ,social ,security ,act1 "u an       

electronic prescription drug program t  
meets requirem5ts t are sub/antially    
simil> 7z jo9tly det]m9$ by ! ,secret>y1
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 & ! ,secret>y ( ! ,treasury7 to !      
requirem5ts ( p>agraph 7#b7 ( su*       
section #ahfj;,d-#d7;e74  7#b7          
,exception = c]ta9 circum/ances ,!      
,secret>y1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 & ! ,secret>y ( ! ,treasury  
%all jo9tly1 ?r\gh rulemak+1 specify    
circum/ances & processes by :i* !       
requirem5t "u p>agraph 7#a7 may be      
waiv$1 ) respect to a s*$ule ,,ii1      
,,iii1 ,,iv1 or ,v controll$ sub/ance t 
is a prescription drug cov]$ by a gr\p  
heal? plan or gr\p heal? insurance      
cov]age (f]$ by a heal? insurance issu]1
 includ+ 9 ! case (-- 7,a7 a            
prescription issu$ :5 ! p>ticipat+      
provid] & disp5s+ ph>macy are ! same    
entity2  7,b7 a prescription issu$ t _c 
be transmitt$ electronically "u ! mo/   
rec5tly implem5t$ v]sion ( ! ,national  
,c\ncil = ,prescription ,drug ,programs 

,,script ,/&>d2  7,c7 a prescription    
issu$ by a p>ticipat+ provid] :o receiv$
 a waiv] 7:i* may include a waiv] obta9$
 pursuant to section                    
#ahfj;,d-#d7;e77#g77;,b77iii7 ( !       
,social ,security ,act7 or a r5ewal !re(
 = a p]iod ( "t z det]m9$ by !          
,secret>y1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 & ! ,secret>y ( ! ,treasury1 
n to exce$ "o ye>1 f ! requirem5t to use
 electronic prescrib+ due to demon/rat$ 
economic h>d%ip1 te*nological           
limitations t are n reasonably )9 !     
control ( ! p>ticipat+ provid]1 or o!r  
exceptional circum/ance demon/rat$ by ! 
p>ticipat+ provid]2  7,d7 a prescription
 issu$ by a p>ticipat+ provid] "u       
circum/ances 9 :i*1 not)/&+ ! p>ticipat+
 provid]'s ability to submit a          
prescription electronically z requir$ by
 ?is subsection1 su* p>ticipat+ provid] 
reasonably det]m9es t x w\ld be         
impractical = ! individual involv$ to   
obta9 sub/ances prescrib$ by electronic 
prescription 9 a timely mann]1 & su*    

delay w\ld adv]sely impact !            
individual's m$ical condition involv$2  
7,e7 a prescription issu$ by a          
p>ticipat+ provid] prescrib+ a drug "u a
 rese>* protocol2  7,f7 a prescription  
issu$ by a p>ticipat+ provid] = a drug =
 :i* ! ,food & ,drug ,adm9i/ration      
requires a prescription to conta9       
elem5ts t are n able to be includ$ 9    
electronic prescrib+1 su* z a drug )    
risk evaluation & mitigation /rategies t
 include elem5ts to assure safe use2    
7,g7 a prescription issu$ = an          
individual :o receives hospice c>e or = 
a resid5t ( a nurs+ facility 7z def9$ 9 
section #aiai7;a7 ( ! ,social ,security 
,act72  7,h7 a prescription issu$ "u    
circum/ances 9 :i* electronic prescrib+ 
is n available due to tempor>y          
te*nological or electrical failure1 z   
specifi$ jo9tly by ! ,secret>y1 !       
,secret>y ( ,heal? & ,human ,s]vices1 & 
! ,secret>y ( ! ,treasury ?r\gh         
rulemak+2 &  7,i7 a prescription issu$  
by a p>ticipat+ provid] all[+ = !       

disp5s+ ( a non-pati5t specific         
prescription pursuant to a /&+ ord]1    
approv$ protocol = drug !rapy1          
collaborative drug managem5t1 or        
compreh5sive m$ication managem5t1 9     
response to a public heal? em]g5cy or   
o!r circum/ances "u :i* ! p>ticipat+    
provid] may issue a non-pati5t specific 
prescription4  7#c7 ,rules (            
,con/ruction  7,a7 ,v]ification ,no?+ 9 
?is subsection %all be con/ru$ z requir+
 a disp5s] to v]ify t a p>ticipat+      
provid]1 ) respect to a prescription = a
 s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v        
controll$ sub/ance t is a prescription  
drug cov]$ by a gr\p heal? plan or gr\p 
or individual heal? insurance cov]age   
(f]$ by a heal? insurance issu]1 has a  
waiv] 7or is o!rwise exempt7 "u p>agraph
 7#b7 f ! requirem5t "u p>agraph 7#a74  
7,b7 ,au?ority to disp5se ,no?+ 9 ?is   
subsection %all be con/ru$ z affect+ !  
au?ority ( a gr\p heal? plan or gr\p    
heal? insurance cov]age (f]$ by a heal? 
insurance issu] to cov]1 or ! au?ority (

 a disp5s] to cont9ue to disp5se1 a     
prescription drug if ! prescription =   
su* drug is an o!rwise valid writt51    
oral1 or fax prescription t is consi/5t 
) applicable law4  7,c7 ,pati5t *oice   
,no?+ 9 ?is subsection %all be con/ru$ z
 affect+ ! ability ( an individual :o is
 a p>ticipant or b5efici>y ( a gr\p     
heal? plan or gr\p or individual heal?  
insurance cov]age (f]$ by a heal?       
insurance issu] & :o is prescrib$ a     
s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v         
controll$ sub/ance t is a prescription  
drug cov]$ by ! plan or cov]age to      
designate a p>ticul> disp5s] to disp5se 
a prescrib$ controll$ sub/ance to !     
ext5t consi/5t ) ! requirem5ts "u ?is   
subsection4  7#d7 ,regulations on policy
 requirem5ts ,! ,secret>y1 ! ,secret>y (
 ,heal? & ,human ,s]vices1 & ! ,secret>y
 ( ! ,treasury %all promulgate          
regulations specify+ requirem5ts = !    
policies e/abli%$ by gr\p heal? plans & 
heal? insurance issu]s "u p>agraph 7#a74
 ,su* regulations %all include          

requirem5ts =-- 7,a7 a uni=m process by 
:i* plans & issu]s are requir$ to set ! 
e-prescrib+ requirem5ts2  7,b7 a process
 by :i* plans & issu]s are requir$ to   
grant waiv]s & exceptions to p>ticipat+ 
provid]s pursuant to p>agraph 7#b72 &   
7,c7 a me*anism = plans & issu]s to     
recognize waiv]s issu$ to p>ticipat+    
provid]s "u "p ,d ( title ,,xviii ( !   
,social ,security ,act1 pursuant to     
p>agraph 7#b77;,c74  7#e7 ,prohibitions 
,! policies e/abli%$ pursuant to        
p>agraph 7#a7 by a gr\p heal? plan or   
heal? insurance issu] (f]+ gr\p heal?   
insurance cov]age may n-- 7,a7 require  
disp5s]s ( a s*$ule ,,ii1 ,,iii1 ,,iv1  
or ,v controll$ sub/ance to confirm t ! 
prescription = ! controll$ sub/ance 0   
electronically issu$ by a p>ticipat+    
provid] 9 accordance ) su* policies1 z  
describ$ 9 p>agraph 7#a72  7,b7 require 
disp5s]s ( su* controll$ sub/ances to   
submit in=mation or data beyond :at is  
o!rwise requir$ to process a            
prescription drug claim 9 ord] to       

confirm a p>ticipat+ provid]'s          
compliance ) su* policies2  7,c7 reject1
 d5y1 or rec\p reimbursem5t = a         
prescription drug claim bas$ on ! =mat 9
 :i* ! prescription 0 issu$2 or  7,d7   
require a p>ticipat+ provid] to use a   
specific v5dor = electronic prescrib+ or
 a specific electronic prescrib+ product
 or sy/em4  7#f7 ,atte/ation (          
compliance ,beg9n+ on ,janu>y #a1 #bjbf1
 ea* gr\p heal? plan & heal? insurance  
issu] (f]+ gr\p heal? insurance cov]age 
%all annually submit to ! ,secret>y1 !  
,secret>y ( ,heal? & ,human ,s]vices1 & 
! ,secret>y ( ! ,treasury an atte/ation 
( compliance ) ! requirem5ts ( ?is      
subsection4  7#g7 ,consultation         
requirem5t = rulemak+ ,9 promulgat+     
regulations to c>ry out ?is subsection1 
! ,secret>y1 ! ,secret>y ( ,heal? &     
,human ,s]vices1 & ! ,secret>y ( !      
,treasury %all jo9tly consult ) disp5s]s
 ( controll$ sub/ances1 ,/ate insurance 
regulators1 heal? insurance issu]s (f]+ 
gr\p or individual heal? insurance      

cov]age1 & heal? c>e practition]s4  4   
7c7 ,int]nal ,rev5ue ,code ( #aihf      
am5dm5t ,section #ihbb ( ! ,int]nal     
,rev5ue ,code ( #aihf is am5d$ by add+  
at ! end ! foll[+ new subsection3  7d7  
,requirem5ts = electronic-,prescrib+ =  
controll$ sub/ances  7#a7 ,9 g5]al      
,except z provid$ pursuant to p>agraph  
7#b71 = plan ye>s beg9n+ on or aft]     
,janu>y #a1 #bjbf1 a gr\p heal? plan1 ) 
respect to a p>ticipat+ provid]1 z def9$
 9 section #ihaf7;a77#c71 %all h 9 place
 policies1 subject to p>agraphs 7#d7 &  
7#e71 t require any prescription = a    
s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v         
controll$ sub/ance 7z def9$ by section  
#bjb ( ! ,controll$ ,sub/ances ,act7    
cov]$ by ! plan t is transmitt$ by su* a
 p>ticipat+ provid] = su* a p>ticipant  
or b5efici>y be electronically          
transmitt$ consi/5t ) /&>ds e/abli%$ "u 
p>agraph 7#c7 ( section #ahfj;,d-#d7;e7 
( ! ,social ,security ,act1 "u an       
electronic prescription drug program t  
meets requirem5ts t are sub/antially    

simil> 7z jo9tly det]m9$ by ! ,secret>y1
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 & ! ,secret>y ( ,labor7 to !           
requirem5ts ( p>agraph 7#b7 ( su*       
section #ahfj;,d-#d7;e74  7#b7          
,exception = c]ta9 circum/ances ,!      
,secret>y1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 & ! ,secret>y ( ,labor %all  
jo9tly1 ?r\gh rulemak+1 specify         
circum/ances & processes by :i* !       
requirem5t "u p>agraph 7#a7 may be      
waiv$1 ) respect to a s*$ule ,,ii1      
,,iii1 ,,iv1 or ,v controll$ sub/ance t 
is a prescription drug cov]$ by a gr\p  
heal?1 includ+ 9 ! case (-- 7,a7 a      
prescription issu$ :5 ! p>ticipat+      
provid] & disp5s+ ph>macy are ! same    
entity2  7,b7 a prescription issu$ t _c 
be transmitt$ electronically "u ! mo/   
rec5tly implem5t$ v]sion ( ! ,national  
,c\ncil = ,prescription ,drug ,programs 
,,script ,/&>d2  7,c7 a prescription    
issu$ by a p>ticipat+ provid] :o receiv$
 a waiv] 7:i* may include a waiv] obta9$
 pursuant to section                    

#ahfj;,d-#d7;e77#g77;,b77iii7 ( !       
,social ,security ,act7 or a r5ewal !re(
 = a p]iod ( "t z det]m9$ by !          
,secret>y1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 & ! ,secret>y ( ,labor1 n to 
exce$ "o ye>1 f ! requirem5t to use     
electronic prescrib+ due to demon/rat$  
economic h>d%ip1 te*nological           
limitations t are n reasonably )9 !     
control ( ! p>ticipat+ provid]1 or o!r  
exceptional circum/ance demon/rat$ by ! 
p>ticipat+ provid]2  7,d7 a prescription
 issu$ by a p>ticipat+ provid] "u       
circum/ances 9 :i*1 not)/&+ ! p>ticipat+
 provid]'s ability to submit a          
prescription electronically z requir$ by
 ?is subsection1 su* p>ticipat+ provid] 
reasonably det]m9es t x w\ld be         
impractical = ! individual involv$ to   
obta9 sub/ances prescrib$ by electronic 
prescription 9 a timely mann]1 & su*    
delay w\ld adv]sely impact !            
individual's m$ical condition involv$2  
7,e7 a prescription issu$ by a          
p>ticipat+ provid] prescrib+ a drug "u a

 rese>* protocol2  7,f7 a prescription  
issu$ by a p>ticipat+ provid] = a drug =
 :i* ! ,food & ,drug ,adm9i/ration      
requires a prescription to conta9       
elem5ts t are n able to be includ$ 9    
electronic prescrib+1 su* z a drug )    
risk evaluation & mitigation /rategies t
 include elem5ts to assure safe use2    
7,g7 a prescription issu$ = an          
individual :o receives hospice c>e or = 
a resid5t ( a nurs+ facility 7z def9$ 9 
section #aiai7;a7 ( ! ,social ,security 
,act72  7,h7 a prescription issu$ "u    
circum/ances 9 :i* electronic prescrib+ 
is n available due to tempor>y          
te*nological or electrical failure1 z   
specifi$ jo9tly by ! ,secret>y1 !       
,secret>y ( ,heal? & ,human ,s]vices1 & 
! ,secret>y ( ,labor ?r\gh rulemak+2 &  
7,i7 a prescription issu$ by a          
p>ticipat+ provid] all[+ = ! disp5s+ ( a
 non-pati5t specific prescription       
pursuant to a /&+ ord]1 approv$ protocol
 = drug !rapy1 collaborative drug       
managem5t1 or compreh5sive m$ication    

managem5t1 9 response to a public heal? 
em]g5cy or o!r circum/ances "u :i* !    
p>ticipat+ provid] may issue a          
non-pati5t specific prescription4  7#c7 
,rules ( ,con/ruction  7,a7 ,v]ification
 ,no?+ 9 ?is subsection %all be con/ru$ 
z requir+ a disp5s] to v]ify t a        
p>ticipat+ provid]1 ) respect to a      
prescription = a s*$ule ,,ii1 ,,iii1    
,,iv1 or ,v controll$ sub/ance t is a   
prescription drug cov]$ by a gr\p heal? 
plan1 has a waiv] 7or is o!rwise exempt7
 "u p>agraph 7#b7 f ! requirem5t "u     
p>agraph 7#a74  7,b7 ,au?ority to       
disp5se ,no?+ 9 ?is subsection %all be  
con/ru$ z affect+ ! ability ( a gr\p    
heal? plan to cov]1 or ! ability ( a    
disp5s] to cont9ue to disp5se1 a        
prescription drug if ! prescription =   
su* drug is an o!rwise valid writt51    
oral1 or fax prescription t is consi/5ce
 ) applicable laws & regulations4  7,c7 
,pati5t *oice ,no?+ 9 ?is subsection    
%all be con/ru$ z affect+ ! ability ( an
 individual :o is a p>ticipant or       

b5efici>y ( a gr\p heal? plan & :o is   
prescrib$ a s*$ule ,,ii1 ,,iii1 ,,iv1 or
 ,v controll$ sub/ance t is a           
prescription drug cov]$ by ! plan to    
designate a p>ticul> disp5s] to disp5se 
a prescrib$ controll$ sub/ance to !     
ext5t consi/5t ) ! requirem5ts "u ?is   
subsection4  7#d7 ,regulations on policy
 requirem5ts ,! ,secret>y1 ! ,secret>y (
 ,heal? & ,human ,s]vices1 & ! ,secret>y
 ( ,labor %all promulgate regulations   
specify+ requirem5ts = ! policies       
e/abli%$ by gr\p heal? plans "u p>agraph
 7#a74 ,su* regulations %all include    
requirem5ts =-- 7,a7 a uni=m process by 
:i* plans are requir$ to set !          
e-prescrib+ requirem5ts2  7,b7 a process
 by :i* plans are requir$ to grant      
waiv]s & exceptions to p>ticipat+       
provid]s pursuant to p>agraph 7#b72 &   
7,c7 a me*anism = plans to recognize    
waiv]s issu$ to p>ticipat+ provid]s "u  
"p ,d ( title ,,xviii ( ! ,public ,heal?
 ,s]vice ,act1 pursuant to p>agraph     
7#b77;,c74  7#e7 ,prohibitions ,!       

policies e/abli%$ pursuant to p>agraph  
7#a7 by a gr\p heal? plan may n-- 7,a7  
require disp5s]s ( a s*$ule ,,ii1 ,,iii1
 ,,iv1 or ,v controll$ sub/ance to      
confirm t ! prescription = ! controll$  
sub/ance 0 electronically issu$ by a    
p>ticipat+ provid] 9 accordance ) su*   
policies1 z describ$ 9 p>agraph 7#a72   
7,b7 require disp5s]s ( su* controll$   
sub/ances to submit in=mation or data   
beyond :at is o!rwise requir$ to process
 a prescription drug claim 9 ord] to    
confirm a p>ticipat+ provid]'s          
compliance ) su* policies2  7,c7 reject1
 d5y1 or rec\p reimbursem5t = a         
prescription drug claim bas$ on ! =mat 9
 :i* ! prescription 0 issu$2 or  7,d7   
require a p>ticipat+ provid] to use a   
specific v5dor = electronic prescrib+ or
 a specific electronic prescrib+ product
 or sy/em4  7#f7 ,atte/ation (          
compliance ,beg9n+ on ,janu>y #a1 #bjbf1
 ea* gr\p heal? plan %all annually      
submit to ! ,secret>y1 ! ,secret>y (    
,heal? & ,human ,s]vices1 & ! ,secret>y 

( ,labor an atte/ation ( compliance ) ! 
requirem5ts ( ?is subsection4  7#g7     
,consultation requirem5t = rulemak+ ,9  
promulgat+ regulations to c>ry out ?is  
subsection1 ! ,secret>y1 ! ,secret>y (  
,heal? & ,human ,s]vices1 & ! ,secret>y 
( ,labor %all jo9tly consult ) disp5s]s 
( controll$ sub/ances1 ,/ate insurance  
regulators1 heal? insurance issu]s (f]+ 
gr\p or individual heal? insurance      
cov]age1 & heal? c>e practition]s4  4   
7d7 ,update ( biometric compon5t (      
multifactor au!ntication ,n lat] ?an #a 
ye> aft] ! date ( enactm5t ( ?is ,act1 !
 ,attorney ,g5]al %all f9alize a        
regulation updat+ ! requirem5ts = !     
biometric compon5t ( multifactor        
au!ntication ) respect to electronic    
prescriptions ( controll$ sub/ances1 z  
requir$ "u section #bjjc7;c7 ( !        
,,support = ,pati5ts & ,community ,act  
7,public ,law #aae-bga74