,,ii  #aae? ,,congress  #b;d ,session   
,s4 #bcab  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #af1 #bjah,mr4 
,cassidy introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to provide a moratorium on  
regi/ration ( new non-rural section     
#cdj;,b hospitals & associat$ sites1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ,help+ ,ensure       
,l[-income ,pati5ts h ,access to ,c>e & 
,treatm5t or ! ,,help ,act4  #b4        
,moratorium on regi/ration ( new        
non-rural section #cdj;,b hospitals &   
associat$ sites ,section #cdj;,b7a7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bef;b7a77 is am5d$--  7#a7 9 
p>agraph 7#d77,l71 by /rik+ ,a          
subsection 7d7 hospital & ins]t+        
,subject to p>agraph 7#aa71 a subsection
 7d7 hospital2 &  7#b7 by add+ at ! end 
! foll[+3  7#aa7 ,moratorium on         
regi/ration ( c]ta9 hospitals &         
associat$ sites ( su* hospitals ,dur+ ! 

#b-ye> p]iod beg9n+ on ! date ( enactm5t
 ( ! ,help+ ,ensure ,l[-income ,pati5ts 
h ,access to ,c>e & ,treatm5t ,act--    
7,a7 an entity describ$ 9 p>agraph      
7#d77,l7 %all n be consid]$ a cov]$     
entity "u ?is section unless su* entity 
0 a cov]$ entity on ,decemb] #ca1 #bjag 
7z evid5c$ by ! entity hav+ be5 id5tifi$
 z a cov]$ entity z ( ,decemb] #ca1     
#bjag1 "u ! cov]$ entity id5tification  
sy/em e/abli%$ "u subsection            
7d77#b77;,b77iv772 &  7,b7 no site %all 
be add$ to ! cov]$ entity id5tification 
sy/em e/abli%$ "u subsection            
7d77#b77;,b77iv7 or be p]mitt$ to beg9  
p>ticipat+ 9 ! drug disc\nt program "u  
?is section1 z a *ild site or o!rwise1  
on ! basis ( association ) a cov]$      
entity describ$ 9 p>agraph 7#d77,l7     
unless su* site 0 id5tifi$ z a *ild site
 z ( ,decemb] #ca1 #bjag1 "u ! sy/em    
e/abli%$ "u subsection 7d77#b77;,b77iv74
  7#ab7 ,regulations to be issu$ dur+ ! 
moratorium p]iod to implem5t /atutory   
requirem5ts cl>ify+ hospital eligibility

 crit]ia & hospital *ild site /&>ds &   
enhanc+ hospital transp>5cy  7,a7       
,issuance ( regulations  7i7 ,9 g5]al   
,dur+ ! moratorium p]iod "u p>agraph    
7#aa71 ! ,secret>y %all promulgate      
regulations ?r\gh notice & comm5t       
rulemak+ to implem5t ! /&>ds &          
requirem5ts describ$ 9 subp>agraph 7,b74
  7ii7 ,deadl9e ,su* f9al regulations   
%all be promulgat$ & take effect-- 7,i7 
be=e ! end date ( ! moratorium describ$ 
9 p>agraph 7#aa72 or  7,,ii7 9 ! ev5t t 
any ( su* regulations h n tak5 effect by
 su* end date1 ! moratorium "u          
subp>agraph 7#aa7 %all be ext5d$ until  
su* regulations are f9al & effective4   
7iii7 ,limitation ,! au?ority to        
promulgate regulations "u ?is p>agraph  
is limit$ to sett+ =? ! details necess>y
 & appropriate to c>ry out ! requirem5ts
 ( subp>agraph 7,b7 effici5tly1         
effectively1 & 9 con=mity ) su*         
subp>agraph4  7,b7 ,/&>ds & requirem5ts 
7i7 ,hospital ,*ild ,site ,/&>ds  7,i7  
,9 g5]al ,hospitals describ$ 9          

subp>agraphs 7,l7 & 7,m7 ( p>agraph 7#d7
 may regi/] (f-campus outpati5t         
facilities associat$ ) ! hospital 7also 
kn[n z *ild sites7 to p>ticipate 9 !    
drug disc\nt program "u ?is section     
7beg9n+ aft] ! moratorium "u p>agraph   
7#aa7 ends71 if--  7aa7 ! site is li/$  
on ! hospital's mo/ rec5tly fil$ ,m$ic>e
 co/ report on a l9e t is reimbursable  
"u ! ,m$ic>e program 7or1 if ! hospital 
is a *ildr5's hospital t does n file a  
,m$ic>e co/ report1 ! hospital submits  
to ! ,secret>y a sign$ /atem5t c]tify+ t
 ! facility w\ld be correctly includ$ on
 a reimbursable l9e ( a ,m$ic>e co/     
report if ! hospital fil$ a co/ report72
  7bb7 su* co/ report demon/rates t !   
s]vices provid$ at ! facility h         
associat$ co/s & *>ges = hospital       
outpati5t dep>tm5t s]vices "u title     
,,xviii ( ! ,social ,security ,act 7or1 
if ! hospital is a *ildr5's hospital t  
does n file a ,m$ic>e co/ report1 !     
hospital submits to ! ,secret>y a sign$ 
/atem5t c]tify+ t ! s]vices provid$ at !

 facility include or consi/ solely (    
outpati5t s]vices72  7cc7 ! facility is 
:olly own$ by ! cov]$ entity2  7dd7 !   
,secret>y has made a det]m9ation1 "u !  
process describ$ 9 section #dac4fe7;b7 (
 title #db1 ,code ( ,f$]al ,regulations 
7or any successor regulations71 t !     
facility meets ! ,m$ic>e provid]-bas$   
/&>ds "u section #dac4fe ( title #db1   
,code ( ,f$]al ,regulations 7or any     
successor regulations72  7ee7 ! facility
 provides a full range ( outpati5t      
s]vices1 9 addition to drugs2 &  7ff7 ! 
facility adh]es to ! *>ity c>e policy & 
any slid+ fee scale policy ( ! p>5t     
hospital4  7,,ii7 ,de-regi/ration ,if at
 any "t foll[+ regi/ration "o or m ( !  
/&>ds li/$ above are no long] satisfi$1 
a regi/]$ hospital %all imm$iately      
notify ! ,secret>y1 de-regi/] !         
facility1 & keep ! facility f mak+ any  
pur*ases "u ! drug disc\nt program "u   
?is section or repres5t+ to ?ird p>ties 
t x may pur*ase "u su* program4  7ii7   
,hospital eligibility /&>ds = hospitals 

n own$ or op]at$ by a unit ( ,/ate or   
local gov]nm5t ,= purposes (            
subp>agraphs 7,l77i7 & 7,m7 ( p>agraph  
7#d73 7,i7 ,a private hospital has be5  
=mally grant$ gov]nm5tal p[]s by a unit 
( ,/ate or local gov]nm5t if--  7aa7 !  
,secret>y receives a c]tification f a   
,/ate or local gov]nm5tal entity t su*  
gov]nm5tal entity has =mally delegat$1  
?r\gh ,/ate or local /atute or          
regulation or1 if p]mitt$ by applicable 
,/ate or local law1 ?r\gh a contract ) a
 ,/ate or local gov]nm5t1 to ! hospital 
a p[]1 describ$ 9 detail 9 !            
c]tification2  7bb7 ! p[] delegat$ z    
describ$ 9 item 7aa7-- 7,,aa7 is a bona 
fide p[] t is usually or exclusively    
ex]cis$ by sov]eign gov]nm5ts1 & is n   
m]ely ! p[] to provide heal? c>e s]vices
 on behalf ( ! gov]nm5t or to o!rwise   
act on behalf ( ! gov]nm5t2 & 7,,bb7 9 !
 case ( a hospital1 is limit$ to ! p[]  
to tax1 issue gov]nm5t bonds1 or        
qu>ant9e individuals ) communicable     
diseases2 &  7cc7 ! c]tification        

describ$ 9 item 7aa7 is accessible to ! 
public z "p ( ! in=mation describ+ !    
hospital 9 ! cov]$ entity id5tification 
sy/em e/abli%$ "u subsection            
7d77#b77;,b77iv7 7provid$ t su* sy/em   
specifies1 = ea* cov]$ entity hospital1 
:e!r x is publicly own$ or op]at$1 a    
private nonpr(it hospital =mally grant$ 
gov]nm5tal p[]s by a unit ( ,/ate or    
local gov]nm5t1 or a private nonpr(it   
hospital ) a contract ) a ,/ate or local
 gov]nm5t to provide heal? c>e s]vices  
to l[-income individuals :o are         
ineligible = ,m$ic>e & ,m$icaid74       
7,,ii7 ,a private hospital has a        
contract ) a ,/ate or local gov]nm5t to 
provide heal? c>e s]vices to l[-income  
individuals :o are n entitl$ to b5efits 
"u ,m$ic>e or ,m$icaid if--  7aa7 !     
hospital submits a copy ( ! contract to 
! ,secret>y = review2  7bb7 ! ,secret>y 
det]m9es t ! contract creates an        
en=ceable obligation = ! hospital to    
provide direct m$ical c>e to l[-income  
individuals ineligible = ,m$ic>e &      

,m$icaid 9 an am\nt t repres5ts at lea/ 
#aj p]c5t ( ! hospital's total co/s (   
c>e2 &  7cc7 ! contract is available to 
! public z "p ( ! in=mation describ+ !  
hospital 9 ! cov]$ entity id5tification 
sy/em e/abli%$ "u subsection            
7d77#b77;,b77iv74  7,,iii7 ,if at any "t
 a hospital n own$ or op]at$ by a unit (
 ,/ate or local gov]nm5t no long] meets 
"o or m requirem5ts "u subclause 7,i7 or
 7,,ii71 ! hospital %all imm$iately     
notify ! ,secret>y1 dis-enroll f ! drug 
disc\nt program "u ?is section1 & /op   
mak+ pur*ases "u su* program & repres5t+
 to ?ird p>ties t x may pur*ase "u su*  
program4  7iii7 ,hospital transp>5cy    
requirem5ts  7,i7 ,hospital requirem5ts 
to id5tify section #cdj;,b drugs ,9 !   
case ( cov]$ entity hospitals describ$ 9
 subsections 7,l7 & 7,m7 ( p>agraph     
7#d73 7aa7 ,claims = cov]$ outpati5t    
drugs pur*as$ "u ! drug disc\nt program 
"u ?is section %all be submitt$ to      
public & private payors us+ ! #cdj;,b   
modifi] e/abli%$ by ! ,secret>y "u !    

prospective paym5t sy/em = hospital     
outpati5t dep>tm5t s]vices1 9 con=mance 
) p>agraph 7#bb7 ( section #ahcc7t7 ( ! 
,social ,security ,act1 subsection 7h7 (
 #ahdg;,a1 subp>agraph 7,f7 ( section   
#aibg7;a77#e71 & p>agraph 7#e7 ( section
 #aheg7;g71 t is ,,jg 7or ,,tb 9 ! case 
( a claim = reimbursem5t "u su* sy/em   
submitt$ by a hospital describ$ 9       
subp>agraph 7,m7 ( p>agraph 7#d774  7bb7
 ,su* hospitals %all report to !        
,secret>y on an annual basis1 9 a =m &  
mann] specifi$ by ! ,secret>y-- 7,,aa7 !
 hospital's aggregate annual rev5ue f   
drugs pur*as$ "u ! program "u ?is       
section1 m9us its aggregate annual      
acquisition co/s = su* drugs brok5 out  
by hospital & by ea* *ild site2 7,,bb7 !
 pati5t mix1 brok5 d[n by expect$ paym5t
 s\rce 7includ+ at lea/ ! ,m$ic>e       
program "u title ,,xviii ( ! ,social    
,security ,act1 a ,/ate plan "u !       
,m$icaid program "u title ,,xix ( su*   
,act1 private insurance1 & un9sur$71 =  
ea* *ild site ( ! hospital li/$ 9 !     

cov]$ entity in=mation sy/em e/abli%$ "u
 subsection 7d77#b77;,b77iv71 ! co/s    
incurr$ at ea* site = *>ity c>e 7z      
describ$ 9 l9e #bc ( ,work%eet          
,s-#aj--;,hospital ,uncomp5sat$ &       
,indig5t ,c>e ,data to ! ,m$ic>e co/    
report or z report$ 9 any successor =m72
 7,,cc7 ! p]c5t ( total rev5ues at ea*  
site d]iv$ f infusion or injection (    
physician-adm9i/]$ drugs2 & 7,,dd7 )    
respect to su* hospital & ea* *ild site 
( ! hospital1 ! names ( all ?ird-p>ty   
v5dors or o!r simil> entities t ! cov]$ 
entity contracts ) to provide s]vices   
associat$ ) ! program "u ?is section    
7brok5 d[n by cov]$ entity & by ea* *ild
 site74  7,,ii7 ,public availability ,! 
,secret>y %all make ! in=mation report$ 
to ! ,secret>y "u subclause 7,i77bb7    
available to ! public 7) r$actions ( any
 in=mation ! ,secret>y det]m9es to be   
propriet>y or confid5tial1 & 9 no case  
%all ! report attribute specific disc\nt
 in=mation1 includ+ ! ceil+ price1 to   
any individual drug product7 9 an annual

 compilation ( ! report$ in=mation      
available on ! int]net website ( !      
,dep>tm5t ( ,heal? & ,human ,s]vices1 & 
z "p ( ! in=mation describ+ ! hospital &
 ! relevant *ild site 9 ! cov]$ entity  
id5tification sy/em e/abli%$ "u         
subsection 7d77#b77;,b77iv74  4  #c4    
#cdj;,b claims modifi]  7a7 ,m$icaid    
,section #aibg7;a77#e7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;a77#e77 is am5d$ by add+ at !
 end ! foll[+3  7,f7 #cdj;,b claims     
modifi]  7i7 ,9 g5]al ,all claims       
submitt$ to a ,m$icaid fee-=-s]vice     
program or a m$icaid manag$ c>e         
organization 7z def9$ 9 section         
#aijc7m77#a77;,a77 = reimbursem5t ( a   
unit ( a cov]$ outpati5t drug subject to
 an agreem5t "u section #cdj;,b ( !     
,public ,heal? ,s]vice ,act %all include
 ! #cdj;,b modifi] e/abli%$ by !        
,secret>y "u ! prospective paym5t sy/em 
= hospital outpati5t dep>tm5t s]vices "u
 section #ahcc7t7 t is ,,jg or !        
,submission ,cl>ification ,code ( #bj   

develop$ by ! ,national ,c\ncil =       
,prescription ,drug ,programs 7,,ncpdp74
  7ii7 ,data %>+ ,ea* s+le ,/ate ag5cy  
%all make available to a manufactur] ( a
 cov]$ outpati5t drug any fee-=-s]vice  
or manag$ c>e claim = reimbursem5t = a  
unit ( su* drug = ! purpose ( v]ify+ !  
propriety ( any claim = a rebate paym5t 
"u an agreem5t "u subsection 7b7 )      
respect to su* drug4 ,at ! manufactur]'s
 reque/1 9 lieu ( mak+ su* a claim      
available to ! manufactur]1 ! s+le ,/ate
 ag5cy may in/ead provide a li/ ( claims
 7& relevant data conc]n+ ea* claim7 =  
cov]$ outpati5t drugs t 7 pur*as$ "u an 
agreem5t "u section #cdj;,b ( ! ,public 
,heal? ,s]vice ,act or o!r summ>y data  
specifi$ by ! manufactur]4  7iii7       
,report ,ea* s+le ,/ate ag5cy %all      
publi% an annual report on utilization (
 cov]$ outpati5t drugs subject to an    
agreem5t "u section #cdj;,b ( ! ,public 
,heal? ,s]vice ,act by ! ,m$icaid       
fee-=-s]vice program or a m$icaid manag$
 c>e organization 7z def9$ 9 section    

#aijc7m77#a77;,a77 dur+ ! prec$+ cal5d> 
ye>4 ,! ,/ate ag5cy %all n include      
confid5tial pati5t-specific1            
drug-specific1 or manufactur]-specific  
in=mation 9 any su* annual report4  4   
7b7 ,m$ic>e  7#a7 ,m$ic>e "p ,b  7,a7   
,hospital outpati5t dep>tm5t s]vices    
,section #ahcc7t7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #aciel7 is am5d$ by 
add+ at ! end ! foll[+ p>agraph3  7#bb7 
#cdj;,b claims modifi] ,all claims      
submitt$ "u ! sy/em "u ?is subsection = 
reimbursem5t ( a unit ( a cov]$         
outpati5t drug subject to an agreem5t "u
 section #cdj;,b ( ! ,public ,heal?     
,s]vice ,act %all include ! #cdj;,b     
modifi] e/abli%$ by ! ,secret>y "u su*  
sy/em t is ,,jg 7or ,,tb 9 ! case ( a   
claim = reimbursem5t "u su* sy/em       
submitt$ by a hospital describ$ 9       
subp>agraph 7,m7 or 7,n7 ( section      
#cdj;,b7a77#d7 ( ! ,public ,heal?       
,s]vice ,act or a rural sole community  
hospital describ$ 9 subp>agraph 7,o7 (  
su* section74  4  7,b7 ,o!r "p ,b claims

 ,section #ahdg;,a ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is    
am5d$ by add+ ! foll[+ new subsection3  
7h7 #cdj;,b claims modifi] ,all claims  
submitt$ "u ?is "p 7o!r ?an "u !        
prospective paym5t sy/em = hospital     
outpati5t dep>tm5t s]vices "u section   
#ahcc7t77 = reimbursem5t ( a unit ( a   
cov]$ outpati5t drug subject to an      
agreem5t "u section #cdj;,b ( ! ,public 
,heal? ,s]vice ,act %all include !      
#cdj;,b modifi] e/abli%$ by ! ,secret>y 
"u su* paym5t sy/em t is ,,jg4  4  7#b7 
,m$ic>e ,advantage & ,m$ic>e "p ,d      
,section #aheg7;e7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is 
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#e7 #cdj;,b claims modifi]  
,all claims submitt$ to a ,m$ic>e       
,advantage organization or a ,,pdp      
sponsor "u ?is "p & "p ,d1 respectively1
 = reimbursem5t ( a unit ( a cov]$      
outpati5t drug subject to an agreem5t "u
 section #cdj;,b ( ! ,public ,heal?     
,s]vice ,act %all include ! #cdj;,b     

modifi] e/abli%$ by ! ,secret>y "u !    
prospective paym5t sy/em = hospital     
outpati5t dep>tm5t s]vices "u section   
#ahcc7t7 t is ,,jg or ! ,submission     
,cl>ification ,code ( #bj develop$ by ! 
,national ,c\ncil = ,prescription ,drug 
,programs 7,,ncpdp74  4  7#c7 ,report on
 utilization "u ,m$ic>e "p ,b ,!        
,secret>y ( ,heal? & ,human ,s]vices    
%all publi% an annual report on         
utilization "u "p ,b ( title ,,xviii ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#acie;j et seq47 ( cov]$ outpati5t drugs
 pur*as$ subject to an agreem5t "u      
section #cdj;,b ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 dur+
 ! prec$+ cal5d> ye>4 ,! ,secret>y %all 
n include confid5tial pati5t-specific1  
drug-specific1 or manufactur]-specific  
in=mation 9 any su* annual report4  7c7 
,effective date ,! am5dm5ts made by ?is 
section take effect on ! date t is #f   
mon?s aft] ! date ( enactm5t ( ?is ,act 
& apply to claims submitt$ on or aft] t 
date4  #d4 ,reports to ,congress        

,section #cdj;,b ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is  
am5d$ by add+ at ! end ! foll[+3  7f7   
,reports to ,congress  7#a7 ,,oig report
 ,n lat] ?an #b ye>s aft] ! date ( !    
enactm5t ( ?is subsection1 ! ,(fice ( ! 
,inspector ,g5]al %all submit to        
,congress a f9al report on ! level (    
*>ity c>e provid$ by cov]$ entities     
describ$ 9 subp>agraphs 7,l7 & 7,m7 (   
subsection 7a77#d7 & sep>ately by *ild  
sites ( su* cov]$ entities4  7#b7 ,,gao 
reports  7,a7 ,initial report ,n lat]   
?an #a ye> aft] ! date ( ! enactm5t (   
?is subsection1 ! ,comptroll] ,g5]al ( !
 ,unit$ ,/ates %all submit to ,congress 
a report--  7i7 analyz+ ! ,/ate & local 
gov]nm5t contracts int5d$ to satisfy !  
requirem5t "u subsection 7a77#d77,l77i7 
= a cov]$ entity to qualify z an entity 
describ$ 9 subp>agraph 7,l7 ( subsection
 7a77#d72  7ii7 assess+ ! am\nt ( c>e   
su* contracts obligate su* entity to    
provide to l[-income individuals        
ineligible = ,m$ic>e "u title ,,xviii ( 

! ,social ,security ,act & ,m$icaid "u  
title ,,xix ( su* ,act2 &  7iii7 analyz+
 h[ ^! contracts def9e l[-income        
individuals & :e!r ! ,secret>y reviews  
su* det]m9ations4  7,b7 ,subsequ5t      
report ,n lat] ?an #b ye>s aft] ! date (
 ! enactm5t ( ?is subsection1 !         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all submit to ,congress a f9al report  
on ! diff]5ce betwe5 ! aggregate gross  
reimbursem5t & aggregate acquisition    
co/s receiv$ by ea* su* cov]$ entity    
7includ+ *ild sites ( su* entity7 =     
drugs subject to an agreem5t "u ?is     
section4  4