,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #dfig  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #c1 #bjaf ,ms4   
,e/y 7= h]self1 ,mr4 ,co/ello (         
,p5nsylvania1 & ,mr4 ,knight7 introduc$ 
! foll[+ bill2 :i* 0 ref]r$ to !        
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committees on ,ways &    
,means & ! ,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 =       
increas$ ,f$]al ov]sight ( prescription 
opioid treatm5t & assi/ance to ,/ates 9 
r$uc+ opioid addiction1 div]sion1 &     
dea?s4  #a4 ,%ort title ,?is ,act may be
 cit$ z ! ,prev5t ,drug ,addiction ,act 
( #bjaf4  #b4 ,consum] education        
campaign ,"p ,a ( title ,v ( ! ,public  
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bij;aa et seq47 is am5d$ by add+ at !  
end ! foll[+3  #ejf;,c4 ,consum]        
education campaign  7a7 ,9 g5]al ,!     
,adm9i/rator %all aw>d grants to ,/ates 

& nonpr(it entities = ! purpose (       
conduct+ culturally s5sitive consum]    
education ab\t opioid addiction1 includ+
 me?adone addiction4 ,su* education %all
 include in=mation on ! dang]s ( opioid 
addiction1 h[ to prev5t opioid addiction
 includ+ ?r\gh safe disposal (          
prescription m$ications & o!r safety    
precautions1 & detection ( e>ly w>n+    
signs ( addiction4  7b7 ,eligibility ,to
 be eligible to receive a grant "u      
subsection 7a71 an entity %all-- 7#a7 be
 a ,/ate or nonpr(it entity2 &  7#b7    
submit to ! ,adm9i/rator an application 
at su* "t1 9 su* mann]1 & conta9+ su*   
in=mation z ! ,adm9i/rator may require4 
7c7 ,priority ,9 aw>d+ grants "u ?is    
section1 ! ,adm9i/rator %all give       
priority to applicants t are ,/ates or  
communities ) a high incid5ce (         
addiction to me?adone & o!r opioids1 &  
opioid-relat$ dea?s4  7d7 ,evaluations  
,! ,adm9i/rator %all develop a process  
to evaluate ! effectiv5ess ( activities 
c>ri$ out by grantees "u ?is section at 

r$uc+ addiction to me?adone & o!r       
opioids4  7e7 ,au?orization (           
appropriations ,!re is au?oriz$ to be   
appropriat$ to c>ry out ?is section     
#ae1jjj1jjj = ea* ( fiscal ye>s #bjag   
?r\gh #bjba4  4  #c4 ,practition]       
education  7a7 ,education requirem5ts   
7#a7 ,regi/ration consid]ation ,section 
#cjc7;f7 ( ! ,controll$ ,sub/ances ,act 
7#ba ,u4,s4,c4 #hbc7;f77 is am5d$ by    
ins]t+ aft] p>agraph 7#e7 ! foll[+3     
7#f7 ,! applicant's compliance ) ! tra9+
 requirem5ts describ$ 9 subsection      
7g77#c7 dur+ any previ\s p]iod 9 :i* !  
applicant has be5 subject to su* tra9+  
requirem5ts4  4  7#b7 ,tra9+ requirem5ts
 ,section #cjc7;g7 ( ! ,controll$       
,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77
 is am5d$ by add+ at ! end ! foll[+3    
7#c7  7,a7 ,to be regi/]$ to prescribe  
or o!rwise disp5se me?adone or o!r      
opioids1 a practition] describ$ 9       
p>agraph 7#a7 %all comply ) ! #ab-;h\r  
tra9+ requirem5t ( subp>agraph 7,b7 at  
lea/ once dur+ ea* #c-ye> p]iod4  7,b7  

,! tra9+ requirem5t ( ?is subp>agraph is
 t ! practition] has complet$ n less ?an
 #ab h\rs ( tra9+ 7?r\gh classroom      
situations1 sem9>s at pr(essional       
society meet+s1 electronic              
communications1 or o!rwise7 ) respect   
to--  7i7 ! treatm5t & managem5t (      
opioid-dep5d5t pati5ts2  7ii7 pa9       
managem5t treatm5t guidel9es2 &  7iii7  
e>ly detection ( opioid addiction1      
includ+ ?r\gh su* me?ods z ,scre5+1     
,brief ,int]v5tion1 & ,ref]ral to       
,treatm5t 7,,sbirt71  t is provid$ by ! 
,am]ican ,society ( ,addiction ,m$ic9e1 
! ,am]ican ,academy ( ,addiction        
,psy*iatry1 ! ,am]ican ,m$ical          
,association1 ! ,am]ican ,o/eopa?ic     
,association1 ! ,am]ican ,psy*iatric    
,association1 ! ,am]ican ,academy ( ,pa9
 ,managem5t1 ! ,am]ican ,pa9 ,society1 !
 ,am]ican ,academy ( ,pa9 ,m$ic9e1 !    
,am]ican ,bo>d ( ,pa9 ,m$ic9e1 !        
,am]ican ,society ( ,int]v5tional ,pa9  
,physicians1 or any o!r organization t !
 ,secret>y det]m9es is appropriate =    

purposes ( ?is subp>agraph4  4  7b7     
,requirem5ts = p>ticipation 9 opioid    
treatm5t programs ,effective ,july #a1  
#bjag1 a physician practic+ 9 an opioid 
treatm5t program %all comply ) !        
requirem5ts ( section #cjc7;g77#c7 ( !  
,controll$ ,sub/ances ,act 7z add$ by   
subsection 7a77 ) respect to requir$    
m9imum tra9+ at lea/ once dur+ ea*      
#c-ye> p]iod4  7c7 ,def9ition ,9 ?is    
section1 ! t]m opioid treatm5t program  
has ! mean+ giv5 su* t]m 9 section #h4b 
( title #db1 ,code ( ,f$]al ,regulations
 7or any successor regulation74  7d7    
,fund+ ,! ,drug ,en=cem5t ,adm9i/ration 
%all fund ! en=cem5t ( ! requirem5ts    
specifi$ 9 section #cjc7;g77#c7 ( !     
,controll$ ,sub/ances ,act 7z add$ by   
subsection 7a77 ?r\gh ! use ( a portion 
( ! lic5s+ fees paid by controll$       
sub/ance prescrib]s "u ! ,controll$     
,sub/ances ,act 7#ba ,u4,s4,c4 #hja et  
seq474  #d4 ,op]ation ( opioid treatm5t 
programs ,section #cjc ( ! ,controll$   
,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is 

am5d$ by add+ at ! end ! foll[+3  7i7   
7#a7 ,an opioid treatm5t program t is   
regi/]$ "u ?is section1 & t closes =    
bus9ess on any weekday or week5d day1   
includ+ a ,f$]al or ,/ate holiday1 %all 
comply ) ! requirem5ts ( ?is subsection4
  7#b7 ,! program %all make acceptable  
arrangem5ts = ea* pati5t :o is re/rict$1
 by ,f$]al regulation or guidel9e or by 
! det]m9ation ( ! program m$ical        
director1 f hav+ a take-home dose ( a   
controll$ sub/ance relat$ to ! treatm5t 
involv$1 to receive a dose ( t sub/ance 
"u appropriate sup]vision dur+ !        
closure4  7#c7 ,! ,adm9i/rator ( !      
,sub/ance ,abuse & ,m5tal ,heal?        
,s]vices ,adm9i/ration %all issue a     
notice t ref]5ces regulations on        
acceptable arrangem5ts "u ?is           
subsection1 or %all promulgate          
regulations on su* acceptable           
arrangem5ts4  4  #e4 ,mortality report+ 
,"p ,a ( title ,v ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bij;aa et  
seq471 z am5d$ by section #c1 is fur!r  

am5d$ by add+ at ! end ! foll[+3        
#ejf;,d4 ,mortality report+  7a7 ,model 
,opioid ,treatm5t ,program ,mortality   
,report  7#a7 ,9 g5]al ,n lat] ?an ,july
 #a1 #bjag1 ! ,secret>y1 act+ ?r\gh !   
,adm9i/rator1 %all require t a ,model   
,opioid ,treatm5t ,program ,mortality   
,report be complet$ & submitt$ to !     
,adm9i/rator = ea* individual :o dies   
:ile receiv+ treatm5t 9 an opioid       
treatm5t program4  7#b7 ,requirem5t (   
,/ates t receive fund+ = ! ,controll$   
,sub/ance ,monitor+ ,program ,z a       
condition = receiv+ funds "u section    
#cii,o1 ea* ,/ate %all require t any    
individual :o signs a dea? c]tificate   
:]e an opioid drug is detect$ 9 ! body (
 ! deceas$1 or :]e su* drug is o!rwise  
associat$ ) ! dea?1 report su* dea? to !
 ,adm9i/rator by submitt+ a ,model      
,opioid ,treatm5t ,program ,mortality   
,report describ$ 9 p>agraph 7#c74 ,su*  
report %all be submitt$ to !            
,adm9i/rator on or be=e ! lat] (--  7,a7
 #ij days aft] ! date ( sign+ ! dea?    

c]tificate2 or  7,b7 z soon z           
practicable aft] ! date on :i* !        
necess>y po/mortem & toxicology reports 
become available to su* individual1 z   
requir$ by ! ,secret>y4  7#c7           
,developm5t ,! ,adm9i/rator1 9          
consultation ) ,/ate & local m$ical     
exam9]s1 prescrib+ physicians1          
hospitals1 & any o!r organization t !   
,adm9i/rator det]m9es appropriate1 %all 
develop a ,model ,opioid ,treatm5t      
,program ,mortality ,report to be us$ "u
 p>agraphs 7#a7 & 7#b74  7b7 ,national  
,opioid ,dea? ,regi/ry  7#a7 ,9 g5]al ,n
 lat] ?an ,july #a1 #bjag1 !            
,adm9i/rator %all e/abli% & implem5t1   
?r\gh ! ,national ,c5t] = ,heal?        
,/ati/ics1 a ,national ,opioid ,dea?    
,regi/ry 7ref]r$ to 9 ?is subsection z !
 ,regi/ry7 to track opioid-relat$ dea?s 
& in=mation relat$ to su* dea?s4  7#b7  
,consultation ,9 e/abli%+ ! uni=m       
report+ crit]ia = ! ,regi/ry1 !         
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion %all consult ) !          

,adm9i/rator1 ,/ate & local m$ical      
exam9]s1 prescrib+ physicians1          
hospitals1 & any o!r organization t !   
,director det]m9es is appropriate =     
purposes ( ?is subsection4  7#c7        
,requirem5ts ,! regi/ry %all be design$ 
z a uni=m report+ sy/em = opioid-relat$ 
dea?s & %all require ! report+ (        
in=mation ) respect to su* dea?s1       
includ+--  7,a7 ! p>ticul> drug         
=mulation us$ at ! "t ( dea?2  7,b7 !   
dosage level2  7,c7 a description ( !   
circum/ances surr\nd+ ! dea? 9 relation 
to ! recomm5d$ dosage involv$2  7,d7 a  
disclosure ( :e!r ! m$ication involv$ c 
be trac$ back to a physician's          
prescription2  7,e7 a disclosure ( :e!r 
! individual 0 9 an opioid treatm5t     
program at ! "t ( dea?2  7,f7 ! age &   
sex ( ! individual2 &  7,g7 o!r         
nonp]sonal in=mation su* z t includ$ 9  
fil$ ,national ,association ( ,m$ical   
,exam9]s ,p$iatric ,toxicology ,regi/ry 
case reports z requir$ "u ! privacy /&>d
 = ! de-id5tification ( heal? in=mation 

pursuant to ! regulations conta9$ 9 "p  
#afd ( title #de1 ,code ( ,f$]al        
,regulations4  7#d7 ,au?orization ,!re  
is au?oriz$ to be appropriat$ #e1jjj1jjj
 = ea* ( fiscal ye>s #bjag ?r\gh #bjba  
to c>ry out ?is subsection4  7c7 ,report
 on ,regi/ry in=mation ,n lat] ?an !    
,janu>y #a ( ! fir/ fiscal ye> beg9n+ #b
 ye>s aft] ! date ( enactm5t ( ?is      
section1 & ea* ,janu>y #a !reaft]1 !    
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion %all submit to ! ,secret>y
 a report1 bas$ on in=mation conta9$ 9 !
 ,regi/ry describ$ 9 subsection 7b71    
conc]n+ ! numb] ( me?adone-relat$ dea?s 
9 ! ,unit$ ,/ates = ! ye> = :i* ! report
 is submitt$4  4  #f4 ,developm5t (     
prescription drug addiction prev5tion & 
treatm5t quality measures across ea*    
relevant provid] sett+ ,subp>t ,i ( "p  
,d ( title ,,ix ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#ca  
et seq47 is am5d$ by add+ at ! end !    
foll[+3  #icb4 ,developm5t (            
prescription drug addiction prev5tion & 

treatm5t quality measures across ea*    
relevant provid] sett+  7a7 ,9 g5]al ,! 
,secret>y1 act+ ?r\gh ! ,director ( !   
,ag5cy = ,heal?c>e ,rese>* & ,quality & 
9 consultation ) ! ,director ( ! ,c5t]s 
= ,disease ,control & ,prev5tion1 !     
,adm9i/rator ( ! ,sub/ance ,abuse &     
,m5tal ,heal? ,s]vices ,adm9i/ration1 & 
! ,director ( ! ,c5t]s = ,m$ic>e        
,m$icaid ,s]vices1 %all require !       
developm5t & application ( specific     
prescription drug addiction prev5tion & 
treatm5t quality measures = ea* relevant
 heal? c>e provid] sett+1 z id5tifi$ by 
! ,director4  7b7 ,dissem9ation ,n lat] 
?an ,april #a1 #bjag1 ! ,secret>y %all  
dissem9ate ! quality measure requirem5ts
 develop$ "u subsection 7a7 to all      
affect$ provid]s4  7c7 ,types ( measures
 ,quality measures develop$ "u ?is      
section may be /ructure-ori5t$ 7su* z ! 
requir$ pres5ce ( a hospital-bas$       
treatm5t program71 process-ori5t$ 7su* z
 requir+ pati5ts to be in=m$ ( !        
addictive qualities ( ! m$ication be+   

prescrib$71 or outcome-ori5t$ 7su* z    
assess+ family satisfaction ) c>e74  4  
#g4 ,programs to prev5t prescription    
drug addiction "u ,m$ic>e "p ,d  7a7    
,drug managem5t program = at-,risk      
b5efici>ies  7#a7 ,9 g5]al ,section     
#ahfj;,d-#d7;c7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#aj7;c77 is  
am5d$ by add+ at ! end ! foll[+3  7#d7  
,drug managem5t program = at-risk       
b5efici>ies  7,a7 ,au?ority to e/abli%  
,a ,,pdp sponsor may e/abli% a drug     
managem5t program = at-risk b5efici>ies 
"u :i*1 subject to subp>agraph 7,b71 !  
,,pdp sponsor may1 9 ! case ( an at-risk
 b5efici>y = prescription drug addiction
 :o is an enrollee 9 a prescription drug
 plan ( su* ,,pdp sponsor1 limit su*    
b5efici>y's access to cov]age =         
addictive drugs "u su* plan to addictive
 drugs t are prescrib$ = su* b5efici>y  
by a prescrib] select$ "u subp>agraph   
7,d71 & disp5s$ = su* b5efici>y by a    
ph>macy select$ "u su* subp>agraph4     
7,b7 ,requirem5t = notices  7i7 ,9 g5]al

 ,a ,,pdp sponsor may n limit ! access (
 an at-risk b5efici>y = prescription    
drug addiction to cov]age = addictive   
drugs "u a prescription drug plan until 
su* sponsor--  7,i7 provides to !       
b5efici>y an initial notice describ$ 9  
clause 7ii7 & a second notice describ$ 9
 clause 7iii72 &  7,,ii7 v]ifies ) !    
provid]s ( ! b5efici>y t ! b5efici>y is 
an at-risk b5efici>y = prescription drug
 addiction4  7ii7 ,initial notice ,an   
initial notice describ$ 9 ?is clause is 
a notice t provides to ! b5efici>y--    
7,i7 notice t ! ,,pdp sponsor has       
id5tifi$ ! b5efici>y z pot5tially be+ an
 at-risk b5efici>y = prescription drug  
addiction2  7,,ii7 in=mation describ+   
all ,/ate & ,f$]al public heal? res\rces
 t are design$ to address prescription  
drug addiction to :i* ! b5efici>y has   
access1 includ+ m5tal heal? s]vices &   
o!r c\nsel+ s]vices2  7,,iii7 notice (1 
& in=mation ab\t1 ! "r ( ! b5efici>y to 
appeal su* id5tification "u subsection  
7h7 & ! option ( an automatic escalation

 to ext]nal review2  7,,iv7 a reque/ = !
 b5efici>y to submit to ! ,,pdp sponsor 
pref]5ces = :i* prescrib]s & ph>macies !
 b5efici>y w\ld pref] ! ,,pdp sponsor to
 select "u subp>agraph 7,d7 9 ! case t !
 b5efici>y is id5tifi$ z an at-risk     
b5efici>y = prescription drug addiction 
z describ$ 9 clause 7iii77,i72  7,v7 an 
explanation ( ! mean+ & consequ5ces ( ! 
id5tification ( ! b5efici>y z pot5tially
 be+ an at-risk b5efici>y = prescription
 drug addiction1 includ+ an explanation 
( ! drug managem5t program e/abli%$ by !
 ,,pdp sponsor pursuant to subp>agraph  
7,a72  7,,vi7 cle> in/ructions t expla9 
h[ ! b5efici>y c contact ! ,,pdp sponsor
 9 ord] to submit to ! ,,pdp sponsor !  
pref]5ces describ$ 9 subclause 7,,iv7 & 
any o!r communications relat+ to ! drug 
managem5t program = at-risk b5efici>ies 
e/abli%$ by ! ,,pdp sponsor2 &  7,,vii7 
contact in=mation = o!r organizations t 
c provide ! b5efici>y ) assi/ance reg>d+
 su* drug managem5t program 7simil> to !
 in=mation provid$ by ! ,secret>y 9 o!r 

/&>diz$ notices provid$ to "p ,d        
eligible individuals enroll$ 9          
prescription drug plans "u ?is "p74     
7iii7 ,second notice ,a second notice   
describ$ 9 ?is clause is a notice t     
provides to ! b5efici>y notice-- 7,i7 t 
! ,,pdp sponsor has id5tifi$ ! b5efici>y
 z an at-risk b5efici>y = prescription  
drug addiction2  7,,ii7 t su* b5efici>y 
is subject to ! requirem5ts ( ! drug    
managem5t program = at-risk b5efici>ies 
e/abli%$ by su* ,,pdp sponsor = su*     
plan2  7,,iii7 ( ! prescrib] & ph>macy  
select$ = su* individual "u subp>agraph 
7,d72  7,,iv7 (1 & in=mation ab\t1 !    
b5efici>y's "r to appeal su*            
id5tification "u subsection 7h7 & !     
option ( an automatic escalation to     
ext]nal review2  7,v7 t ! b5efici>y c1 9
 ! case t ! b5efici>y has n previ\sly   
submitt$ to ! ,,pdp sponsor pref]5ces = 
:i* prescrib]s & ph>macies ! b5efici>y  
w\ld pref] ! ,,pdp sponsor select "u    
subp>agraph 7,d71 submit su* pref]5ces  
to ! ,,pdp sponsor2 &  7,,vi7 t includes

 cle> in/ructions t expla9 h[ !         
b5efici>y c contact ! ,,pdp sponsor4    
7iv7 ,tim+ ( notices  7,i7 ,9 g5]al     
,subject to subclause 7,,ii71 a second  
notice describ$ 9 clause 7iii7 %all be  
provid$ to ! b5efici>y on a date t is n 
less ?an #fj days aft] an initial notice
 describ$ 9 clause 7ii7 is provid$ to ! 
b5efici>y4  7,,ii7 ,exception ,9 ! case 
t ! ,,pdp sponsor1 9 conjunction ) !    
,secret>y1 det]m9es t conc]ns id5tifi$  
?r\gh rulemak+ by ! ,secret>y reg>d+ !  
heal? or safety ( ! b5efici>y or reg>d+ 
significant drug div]sion activities    
require ! ,,pdp sponsor to provide a    
second notice describ$ 9 clause 7iii7 to
 ! b5efici>y on a date t is e>li] ?an ! 
date describ$ 9 subclause 7,,ii71 !     
,,pdp sponsor may provide su* second    
notice on su* e>li] date4  7,c7 ,at-risk
 b5efici>y = prescription drug addiction
  7i7 ,9 g5]al ,= purposes ( ?is        
p>agraph1 ! t]m at-risk b5efici>y =     
prescription drug addiction means a "p  
,d eligible individual :o is n an       

exempt$ individual describ$ 9 clause    
7ii7 &-- 7,i7 :o is id5tifi$ ?r\gh ! use
 ( guidel9es develop$ by ! ,secret>y 9  
consultation ) ,,pdp sponsors & o!r     
/akehold]s describ$ 9 section           
#aj7;f77#b77;,a7 ( ! ,prev5t ,drug      
,addiction ,act ( #bjaf2 or  7,,ii7 )   
respect to :om ! ,,pdp sponsor ( a      
prescription drug plan1 ^u enroll+ su*  
individual 9 su* plan1 receiv$ notice f 
! ,secret>y t su* individual 0 id5tifi$ 
"u ?is p>agraph to be an at-risk        
b5efici>y = prescription drug addiction 
"u ! prescription drug plan 9 :i* su*   
individual 0 mo/ rec5tly previ\sly      
enroll$ & su* id5tification has n be5   
t]m9at$ "u subp>agraph 7,f74  7ii7      
,exempt$ individual describ$ ,an exempt$
 individual describ$ 9 ?is clause is an 
individual :o-- 7,i7 receives hospice   
c>e "u ?is title2 or  7,,ii7 ! ,secret>y
 elects to treat z an exempt$ individual
 = purposes ( clause 7i74  7,d7         
,selection ( prescrib]s  7i7 ,9 g5]al ,)
 respect to ea* at-risk b5efici>y =     

prescription drug addiction enroll$ 9 a 
prescription drug plan (f]$ by su*      
sponsor1 a ,,pdp sponsor %all1 bas$ on !
 pref]5ces submitt$ to ! ,,pdp sponsor  
by ! b5efici>y pursuant to clauses      
7ii77,,iv7 & 7iii77,v7 ( subp>agraph    
7,b71 select--  7,i7 "o or m individuals
 :o are au?oriz$ to prescribe addictive 
drugs 7ref]r$ to 9 ?is p>agraph z       
prescrib]s7 :o may write prescriptions =
 su* drugs = su* b5efici>y2 &  7,,ii7 "o
 or m ph>macies t may disp5se su* drugs 
to su* b5efici>y4  7ii7 ,reasonable     
access ,9 mak+ ! selection "u ?is       
subp>agraph1 a ,,pdp sponsor %all ensure
 t ! b5efici>y cont9ues to h reasonable 
access to drugs describ$ 9 subp>agraph  
7,g71 tak+ into acc\nt geographic       
location1 b5efici>y pref]5ce1           
af=dability1 & reasonable travel "t4    
7iii7 ,b5efici>y pref]5ces  7,i7 ,9     
g5]al ,if an at-risk b5efici>y =        
prescription drug addiction submits     
pref]5ces = :i* 9-network prescrib]s &  
ph>macies ! b5efici>y w\ld pref] ! ,,pdp

 sponsor select 9 response to a notice  
"u subp>agraph 7,b71 ! ,,pdp sponsor    
%all--  7aa7 review su* pref]5ces2  7bb7
 select or *ange ! selection ( a        
prescrib] or ph>macy = ! b5efici>y bas$ 
on su* pref]5ces2 &  7cc7 in=m !        
b5efici>y ( su* selection or *ange (    
selection4  7,,ii7 ,exception ,9 ! case 
t ! ,,pdp sponsor det]m9es t a *ange to 
! selection ( a prescrib] or ph>macy "u 
item 7bb7 by ! ,,pdp sponsor is         
contribut+ or w\ld contribute to        
prescription drug addiction or drug     
div]sion by ! b5efici>y1 ! ,,pdp sponsor
 may *ange ! selection ( a prescrib] or 
ph>macy = ! b5efici>y )\t reg>d to !    
pref]5ces ( ! b5efici>y describ$ 9      
subclause 7,i74  7iv7 ,confirmation     
,be=e select+ a prescrib] or ph>macy "u 
?is subp>agraph1 a ,,pdp sponsor mu/    
reque/ & receive confirmation f !       
prescrib] or ph>macy ackn[l$g+ & accept+
 t ! b5efici>y involv$ is 9 ! drug      
managem5t program = at-risk b5efici>ies4
  7,e7 ,t]m9ations & appeals ,!         

id5tification ( an individual z an      
at-risk b5efici>y = prescription drug   
addiction "u ?is p>agraph1 a cov]age    
det]m9ation made "u a drug managem5t    
program = at-risk b5efici>ies1 & !      
selection ( a prescrib] or ph>macy "u   
subp>agraph 7,d7 ) respect to su*       
individual %all be subject to           
reconsid]ation & appeal "u subsection   
7h7 & ! option ( an automatic escalation
 to ext]nal review to ! ext5t provid$ by
 ! ,secret>y4  7,f7 ,t]m9ation (        
id5tification  7i7 ,9 g5]al ,! ,secret>y
 %all develop /&>ds = ! t]m9ation (     
id5tification ( an individual z an      
at-risk b5efici>y = prescription drug   
addiction "u ?is p>agraph4 ,"u su* /&>ds
 su* id5tification %all t]m9ate z ( !   
e>li] (--  7,i7 ! date ! individual     
demon/rates t ! individual is no long]  
likely1 9 ! abs5ce ( ! re/rictions "u   
?is p>agraph1 to be an at-risk b5efici>y
 = prescription drug addiction describ$ 
9 subp>agraph 7,c77i72 or  7,,ii7 ! end 
( su* maximum p]iod ( id5tification z ! 

,secret>y may specify4  7ii7 ,rule (    
con/ruction ,no?+ 9 clause 7i7 %all be  
con/ru$ z prev5t+ a plan f id5tify+ an  
individual z an at-risk b5efici>y =     
prescription drug addiction "u          
subp>agraph 7,c77i7 aft] su* t]m9ation  
on ! basis ( additional in=mation on    
drug use occurr+ aft] ! date ( notice ( 
su* t]m9ation4  7,g7 ,addictive drug ,= 
purposes ( ?is subsection1 ! t]m        
addictive drug means a drug t is det]m9$
 by ! ,secret>y to be addictive or      
frequ5tly div]t$ & t is--  7i7 a        
,controll$ ,drug ,sub/ance 9 ,s*$ule    
,,cii-,,civ2  7ii7 )9 ! same class or   
category ( drugs z a ,controll$ ,drug   
,sub/ance 9 ,s*$ule ,,cii-,,civ2 or     
7iii7 )9 ano!r class or category ( drugs
 t ! ,secret>y det]m9es1 9 consultation 
) ! ,inspector ,g5]al ( ! ,dep>tm5t (   
,heal? & ,human ,s]vices1 is at high    
risk = div]sion or addiction4  7,h7     
,data disclosure ,9 ! case ( an at-risk 
b5efici>y = prescription drug addiction 
^: access to cov]age = addictive drugs  

"u a prescription drug plan has be5     
limit$ by a ,,pdp sponsor "u ?is        
p>agraph1 su* ,,pdp sponsor %all        
disclose data1 includ+ any necess>y     
individually id5tifiable heal?          
in=mation1 9 a =m & mann] specifi$ by ! 
,secret>y1 ab\t ! decision to impose su*
 limitations & ! limitations impos$ by !
 sponsor "u ?is "p4  7,i7 ,education ,! 
,secret>y %all provide education to     
enrollees 9 prescription drug plans (   
,,pdp sponsors & provid]s reg>d+ ! drug 
managem5t program = at-risk b5efici>ies 
describ$ 9 ?is p>agraph1 includ+        
education--  7i7 provid$ by ,m$ic>e     
adm9i/rative contractors ?r\gh ! improp]
 paym5t outrea* & education program     
describ$ 9 section #ahgd;,a7h72 &  7ii7 
?r\gh curr5t education ef=ts 7su* z     
,/ate heal? insurance assi/ance programs
 describ$ 9 subsection 7a77#a77;,a7 (   
section #aai ( ! ,m$ic>e ,improvem5ts = 
,pati5ts & ,provid]s ,act ( #bjjh 7#db  
,u4,s4,c4 #acie;b-#c note77 & mat]ials  
direct$ t[>d su* enrollees4  4  7#b7    

,in=mation = consum]s ,section          
#ahfj;,d-#d7;a77#a77;,b7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;a77#a77;,b77 is am5d$ by   
add+ at ! end ! foll[+3  7v7 ,! drug    
managem5t program = at-risk b5efici>ies 
"u subsection 7c77#d74  4  7b7          
,utilization managem5t programs ,section
 #ahfj;,d-#d7;c7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 z 
am5d$ by subsection 7a71 is am5d$--     
7#a7 9 p>agraph 7#a71 by ins]t+ aft]    
subp>agraph 7,d7 ! foll[+ new           
subp>agraph3  7,e7 ,a utilization       
managem5t tool to prev5t drug addiction 
7z describ$ 9 p>agraph 7#e77;,a774  2 & 
7#b7 by add+ at ! end ! foll[+ new      
p>agraph3  7#e7 ,utilization managem5t  
tool to prev5t drug addiction  7,a7 ,9  
g5]al ,a tool describ$ 9 ?is p>agraph is
 any ( ! foll[+3  7i7 ,a utilization    
tool design$ to prev5t addiction to     
addictive drugs by individuals & to     
prev5t ! div]sion ( su* drugs at        
ph>macies4  7ii7 ,retrospective         

utilization review to id5tify-- 7,i7    
individuals t receive addictive drugs at
 a frequ5cy or 9 am\nts t are n         
cl9ically appropriate2 &  7,,ii7        
provid]s ( s]vices or suppli]s t may    
facilitate ! addiction to or div]sion ( 
addictive drugs by b5efici>ies4  7iii7  
,consultation ) ! ,contractor describ$ 9
 subp>agraph 7,b7 to v]ify if an        
individual enroll+ 9 a prescription drug
 plan (f]$ by a ,,pdp sponsor has be5   
previ\sly id5tifi$ by ano!r ,,pdp       
sponsor z an individual describ$ 9      
clause 7ii77,i74  7,b7 ,report+ ,a ,,pdp
 sponsor (f]+ a prescription drug plan 9
 a ,/ate %all submit to ! ,secret>y & ! 
,m$ic>e drug integrity contractor ) :i* 
! ,secret>y has ent]$ into a contract "u
 section #ahic ) respect to su* ,/ate a 
report1 on a mon?ly basis1 conta9+      
in=mation on--  7i7 any provid] (       
s]vices or suppli] describ$ 9           
subp>agraph 7,a77ii77,,ii7 t is id5tifi$
 by su* plan sponsor dur+ ! #cj-;day    
p]iod be=e su* report is submitt$2 &    

7ii7 ! "n & prescription records (      
individuals describ$ 9 p>agraph         
7#d77;,c74  4  7c7 ,exp&+ ,activities ( 
,m$ic>e ,drug ,integrity ,contractors   
7,m,e,d,i,cs7 ,section #ahic ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acie;ddd7 is am5d$ by add+ at ! end !  
foll[+ new subsection3  7j7 ,exp&+      
,activities ( ,m$ic>e ,drug ,integrity  
,contractors 7,m,e,d,i,cs7  7#a7 ,access
 to in=mation ,"u contracts ent]$ into  
"u ?is section ) ,m$ic>e drug integrity 
contractors1 ! ,secret>y %all au?orize  
su* contractors to directly accept      
prescription & necess>y m$ical records f
 entities su* z ph>macies1 prescription 
drug plans1 & physicians ) respect to an
 individual 9 ord] = su* contractors to 
provide in=mation relevant to !         
det]m9ation ( :e!r su* individual is an 
at-risk b5efici>y = prescription drug   
addiction1 z def9$ 9 section            
#ahfj;,d-#d7;c77#d77;,c74  7#b7         
,requirem5t = ackn[l$gm5t ( ref]rals ,if
 a ,,pdp sponsor ref]s in=mation to a   

contractor describ$ 9 p>agraph 7#a7 9   
ord] = su* contractor to assi/ 9 !      
det]m9ation describ$ 9 su* p>agraph1 !  
contractor %all--  7,a7 ackn[l$ge to !  
,,pdp sponsor receipt ( ! ref]ral2 &    
7,b7 9 ! case t any ,,pdp sponsor       
contacts ! contractor reque/+ to "k !   
det]m9ation by ! contractor ( :e!r or n 
an individual has be5 det]m9$ to be an  
individual describ$ su* p>agraph1 %all  
in=m su* ,,pdp sponsor ( su* det]m9ation
 on a date t is n lat] ?an #ae days aft]
 ! date on :i* ! ,,pdp sponsor contacts 
! contractor4  7#c7 ,mak+ data available
 to o!r entities  7,a7 ,9 g5]al ,=      
purposes ( c>ry+ out ?is subsection1    
subject to subp>agraph 7,b71 ! ,secret>y
 %all au?orize ,m,e,d,i,cs to respond to
 reque/s = in=mation f ,,pdp sponsors1  
,/ate prescription drug monitor+        
programs1 & o!r entities delegat$ by    
,,pdp sponsors us+ available programs & 
sy/ems 9 ! ef=t to prev5t fraud1 wa/e1 &
 abuse4  7,b7 ,,hipaa compliant         
in=mation only ,in=mation may only be   

disclos$ by a ,,m$ic "u subp>agraph 7,a7
 if ! disclosure ( su* in=mation is     
p]mitt$ "u ! ,f$]al regulations 7conc]n+
 ! privacy ( individually id5tifiable   
heal? in=mation7 promulgat$ "u section  
#bfd7;c7 ( ! ,heal? ,insurance          
,portability & ,acc\ntability ,act (    
#aiif 7#db ,u4,s4,c4 #acbj;d-#b note74  
4  7d7 ,treatm5t ( c]ta9 compla9ts =    
purposes ( quality or p]=mance assessm5t
 ,section #ahfj;,d-#db ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7d7 ,treatm5t (
 c]ta9 compla9ts = purposes ( quality or
 p]=mance assessm5t ,9 conduct+ a       
quality or p]=mance assessm5t ( a ,,pdp 
sponsor1 ! ,secret>y %all develop or    
utilize exi/+ scre5+ me?ods = review+ & 
consid]+ compla9ts t are receiv$ f      
enrollees 9 a prescription drug plan    
(f]$ by su* ,,pdp sponsor & t are       
compla9ts reg>d+ ! lack ( access by !   
individual to prescription drugs due to 
a drug managem5t program = at-risk      

b5efici>ies4  4  7e7 ,,gao /udies &     
reports  7#a7 ,/udies ,! ,comptroll]    
,g5]al ( ! ,unit$ ,/ates %all conduct a 
/udy on ea* ( ! foll[+3 7,a7 ,!         
implem5tation ( ! am5dm5ts made by ?is  
section4  7,b7 ,! effectiv5ess ( !      
at-risk b5efici>ies = prescription drug 
addiction drug managem5t programs       
au?oriz$ by section #ahfj;,d-#d7;c77#d7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#aj7;c77#d771 z add$ by
 subsection 7a77#a71 includ+ an analysis
 (--  7i7 ! imp$im5ts1 if any1 t impair 
! ability ( individuals describ$ 9      
subp>agraph 7,c7 ( su* section          
#ahfj;,d-#d7;c77#d7 to access cl9ically 
appropriate levels ( prescription drugs2
 &  7ii7 ! types (-- 7,i7 individuals   
:o1 9 ! implem5tation ( su* section1 are
 det]m9$ to be individuals describ$ 9   
su* subp>agraph2 &  7,,ii7 prescrib]s & 
ph>macies t are select$ "u subp>agraph  
7,d7 ( su* section4  7#b7 ,reports ,n   
lat] ?an ,janu>y #a1 #bjag1 !           
,comptroll] ,g5]al ( ! ,unit$ ,/ates    

%all beg9 "w1 ) respect to ea* /udy     
describ$ 9 p>agraph 7#a71 on a report t 
describes ! result ( su* /udy4 ,^u !    
completion ( ea* su* report1 su*        
,comptroll] ,g5]al %all submit ! report 
to ea* ( ! committees describ$ 9        
p>agraph 7#c74  7#c7 ,committees        
describ$ ,! committees describ$ 9 ?is   
p>agraph are ! foll[+3 7,a7 ,!          
,committee on ,ways & ,means ( ! ,h\se (
 ,repres5tatives4  7,b7 ,! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives4  7,c7 ,! ,committee on 
,f9ance ( ! ,s5ate4  7,d7 ,! ,committee 
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate4  7,e7 ,! ,special  
,committee on ,ag+ ( ! ,s5ate4  7f7     
,effective date  7#a7 ,9 g5]al ,!       
am5dm5ts made by ?is section %all apply 
to prescription drug plans = plan ye>s  
beg9n+ on or aft] ,janu>y #a1 #bjah4    
7#b7 ,/akehold] meet+s prior to         
effective date  7,a7 ,9 g5]al ,n lat]   
?an ,janu>y #a1 #bjag1 ! ,secret>y %all 
conv5e /akehold]s1 includ+ individuals  

entitl$ to b5efits "u "p ,a ( title     
,,xviii ( ! ,social ,security ,act or   
enroll$ "u "p ,b ( su* title ( su* ,act1
 advocacy gr\ps repres5t+ su*           
individuals1 cl9icians1 plan sponsors1 &
 entities delegat$ by plan sponsors1 =  
input reg>d+ ! topics describ$ 9        
subp>agraph 7,b74  7,b7 ,topics describ$
 ,! topics describ$ 9 ?is subp>agraph   
are ! topics (-- 7i7 ensur+ af=dability 
& accessibility to prescription drugs = 
enrollees 9 prescription drug plans (   
,,pdp sponsors :o are at-risk           
b5efici>ies = prescription drug         
addiction 7z def9$ 9 p>agraph 7#d77;,c7 
( section #ahfj;,d-#d7;c7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#aj7;c771 z add$ by subsection   
7a77#a772  7ii7 ! use ( an exp$it$      
appeals process "u :i* su* an enrollee  
may appeal an id5tification ( su*       
enrollee z an at-risk b5efici>y =       
prescription drug addiction "u su*      
p>agraph 7simil> to ! processes e/abli%$
 "u ! ,m$ic>e ,advantage program "u "p  

,c ( title ,,xviii ( ! ,social ,security
 ,act t all[ an automatic escalation to 
ext]nal review ( claims submitt$ "u su* 
"p72  7iii7 ! types ( enrollees t %\ld  
be treat$ z exempt$ individuals1 z      
describ$ 9 clause 7ii7 ( su* p>agraph2  
7iv7 ! mann] 9 :i* t]ms & def9itions 9  
p>agraph 7#d7 ( su* section             
#ahfj;,d-#d7;c7 %\ld be appli$1 su* z ! 
use ( cl9ical appropriat5ess 9 det]m9+  
:e!r an enrollee is an at-risk b5efici>y
 = prescription drug addiction z def9$ 9
 subp>agraph 7,c7 ( su* p>agraph 7#d72  
7v7 ! in=mation to be includ$ 9 !       
notices describ$ 9 subp>agraph 7,b7 (   
su* section & ! /&>dization ( su*       
notices2 &  7vi7 ) respect to a ,,pdp   
sponsor t e/abli%es a drug managem5t    
program = at-risk b5efici>ies "u su*    
p>agraph 7#d71 ! responsibilities ( su* 
,,pdp sponsor ) respect to !            
implem5tation ( su* program4  7,c7      
,rulemak+ ,! ,secret>y %all promulgate  
regulations bas$ on ! input ga!r$       
pursuant to subp>agraph 7,a74