OIG HHS ASP Report 1-11

8/7/2019 OIG HHS ASP Report 1-11

1/43

!"#$%&'(#)'!*+!,#%-'.!%)/!,0(%)!1#&234#5OFFICE OF

INSPECTOR GENERAL!!!!

!!!!!!!7"89:;7!?1!!@A;!>7BC=!:D:8C:EC7!F7>7;89!";GF1!!!!!!!

!"%)3#-!;H!C#23)5*)!!8)5$#4'*&!F#)#&%-!

I%)0%&J!KLMM!A78NLONLPNLLQML!


2/43

E X E C U T I V E S U M M A R Y

OBJECTIVES!

"# $%!&'()*+(&!(,&!-).+./)+0!)*1+/(!%-!(,&!(2%345+6(&6!6&)*756'&*&.(!0+8!%.!9&:)/+6&!1+;*&.('!-%6!&6&:!:658'!2)(,!.&20;!

+>+)0+70&!8&.&6)/!>&6')%.'#!

?# $%!&'()*+(&!2,&.!,)8,3&@1&.:)(56&!76+.:3%.0;!&6&:!:658'!2)00!0)A&0;!,+>&!-)6'(38&.&6)/!>&6')%.'!6&+/,!(,&!*+6A&(#!

BACKGROUND

B0(,%58,!9&:)/+6&!&6'!*%'(!16&'/6)1()%.!:658'D!

Q%6!(,)'!'(5:;D!2&!&@+*).&:!(,&!9&:)/+6&!1+;*&.(!+*%5.('!-%6!"F!&6&:!:658'!(,+(!2&!):&.()-)&:!+'!,+>).8!-)6'(38&.&6)/!>&6')%.'!

6&+/,!(,&!*+6A&(!).!?EERD!?EESD!%6!(,&!-)6'(!(2%!45+6(&6'!%-!?EET#!!Q%6!

&+/,!%-!(,&!:658'D!2&!:&(&6*).&:!,%2!*5/,!+)0+7)0)(;!G)#D!(,&!-)6'(!(,6&&!45+6(&6'!).!2,)/,!

8&.&6)/'!2&6&!+>+)0+70&I#!!U&!(,&.!(%(+0&:!(,&'&!-)856&'!(%!:&(&6*).&!(,&!

.&(!-).+./)+0!)*1+/(!%-!(,&!(2%345+6(&6!0+8!%.!):&!/%.(&@(!-%6!(,&!-5(56&!)*1+/(!%-!(,&!!!!!!!!!!!!!

!O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S )


3/43


!"#$%&'(!)(*+',-*")*'+.#*()%&).!)/*0(#1*!2)*3##/*'4/*5(&,*

6/1747.!('!7#4*83569*!2)*).!71'!)/*/'!)*#0*,)4)(7:*';;(#


4/43

E X E C U T I V E S U M M A R Y!"#$%&'($)*+,&-%-)$.'#-)*$/%*'01+'"22-")'+/'!"#-'%-#-)')-".!-3'+!-'

4")5-+6''7/)'"%/+!-)'&)/12'/('3)1&*8'&-%-)$.'4"%1(".+1)-)*'("$9-3'+/'

)-2/)+':;/,D1")+-)'9"&'$%'2"=4-%+*'(/)'%->9='

"#"$9"09-'&-%-)$.'3)1&*6''E-'(/1%3'+!"+'F-3$.")-'2"=4-%+'"4/1%+*'

>-)-'*$&%$($."%+9='!$&!-)'+!"%'4")5-+'2)$.-*'(/)'"%'-G+-%3-3'2-)$/3'(/)'

+!-'%->9='"#"$9"09-'&-%-)$.'3)1&*'1%3-)')-#$->6''A%'/+!-)'>/)3*8'&-%-)$.'

#-)*$/%*'/('+!-*-'3)1&*'>-)-'0-$%&'"34$%$*+-)-3'/)'3$*2-%*-3'+/'0-%-($.$")$-*8'01+'F-3$.")-'>"*'*+$99'2"=$%&'0)"%3'2)$.-*6'':9+!/1&!'

/+!-)'&/#-)%4-%+'"%3'2)$#"+-9='*2/%*/)-3'2)-*.)$2+$/%'3)1&'2)/&)"4*'

")-'3-*$&%-3'+/'+"5-'"3#"%+"&-'/('9/>-),2)$.-3'&-%-)$.'3)1&*8'/1)'

($%3$%&*'3-4/%*+)"+-'+!"+'+!-'/,D1")+-)'9"&'"%3'4"5-'F-3$.")-'2"=4-%+'

"4/1%+*'4/)-')-(9-.+$#-'/('".+1"9'4")5-+'2)$.-*6 A('IF;'($%3*'+!$*'+/'0-'

"%'-((-.+$#-'4-"%*'(/)'"99-#$"+$%&'+!-'($%"%.$"9'$42".+'/('+!-''''''''''''''

+>/,D1")+-)'9"&8'+!-'"&-%.='4"='>$*!'+/'./%*$3-)')-D1$)$%&'4/%+!9='

:;


5/43

O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S !"#


$%&'!&($()*!(+$(!"(!,)%")#)&!(+)!(-'./0$1()1!%$2!31'()4(&!5)*"4$1)!$6*!"(&!

,)6)7"4"$1")&!71'8!064+)49)*!31"4)!"641)$&)&!$6*!"&!$6!"64)6("#)!7'1!

7$&()1!2)6)1"4!0("%":$("'6;!!!

$1(!

1)"8,01&)8)6(!%$2!8$@!'0(-)"2+!$6@!*"77"40%(")&!-"(+!"83%)8)6("62!$!

8'6(+%@!AB>!1)3'1("62!&@&()8;!!C01(+)18'1)=!-)!6'()!(+$(!(+)!!!!!!!!

AB>.,$&)*!1)"8,01&)8)6(!&@&()8!D"6!-+"4+!$%%!#)1&"'6&!'7!$!*102!

$&&"26)*!('!'6)!3$@8)6(!4'*)!$1)!3$"*!$(!(+)!&$8)!$8'06(E!"&!$!6$(01$%!

"64)6("#)!7'1!8$607$4(01)1&!('!%"8"(!1$3"*!31"4)!"641)$&)&=!$&!-)%%!$&!7'1!

31'#"*)1&!('!0("%":)!2)6)1"4!#)1&"'6&;!


6/43

T A B L E O F C O N T E N T S

E X E C U T I V E S U M M A R Y ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! "

I N T R O D U C T I O N ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! #$

F I N D I N G S ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! #%$

$ &'(")*+'$),-.($/*0'$1*0'($*2$'13"4*3'($5###$4"..",2$/*($$$$$$$$$$6*74'23$*4,-231$"44'("*3'.7$+'8.')3'($9'2'+")$1*.'1$6+")'1$8,+$$$$$$$$#:$(+-91! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! #%$

$ ;)),+("29$3,$$2-4'+,-1$/"9/?'@6'2("3-+'$(+-91$),-.($/*0'$$$$

8"+13?9'2'+")$0'+1",21$*66+,0'($"2$3/'$2'@3$1'0'+*.$7'*+1 ! ! ! ! ! ! ! #A$

$ B"92"8")*23$,C13*).'1$+'4*"2$"2$6+,*)3"0'.7$"('23"87"29$2'D.7$$*0*".*C.'$9'2'+")$(+-91 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! #:$

R E C O M M E N D A T I O N ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! #E$

;9'2)7$F,44'231$*2($G88")'$,8$H216')3,+$I'2'+*.$J'16,21' ! ! ! KL$

A P P E N D I X E S ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! K%$

$ ;M$$='3*".'($&'3/,(,.,97$8,+$H('23"87"29$$;)),+("29$3,$


7/43

I N T R O D U C T I O NOBJECTIVES

!" #$%&'()*+(&%(,&%-).+./)+0%)*1+/(%$-%(,&%(2$345+6(&6%6&)*756'&*&.(%0+8%$.%9&:)/+6&%1+;*&.('%-$6%&6&:%:658'%2)(,%.&20;%+>+)0+70&%8&.&6)/%>&6')$.'"%

?" #$%&'()*+(&%2,&.%,)8,3&@1&.:)(56&%76+.:3$.0;%&6&:%:658'%2)00%0)A&0;%,+>&%-)6'(38&.&6)/%>&6')$.'%6&+/,%(,&%*+6A&("%

BACKGROUND

B.%?CCDE%9&:)/+6&%'1&.(%+116$@)*+(&0;%F!!%7)00)$.%$.%&6&:%

:658'"!%%9&:)/+6&%1+;'%-$6%*$'(%16&'/6)1()$.%:658'%/$>&6&:%5.:&6%)$5'%L--)/&%$-%B.'1&/($6%M&.&6+0%GLBMJ%6&1$6(?%-$5.:%(,+(%(,)'%%%%%

(2$345+6(&6%6&)*756'&*&.(%0+8%,+:%.&8+()>&%-).+./)+0%/$.'&45&./&'%-$6%

(,&%9&:)/+6&%16$86+*%+.:%)('%7&.&-)/)+6)&'%G(,6$58,%,)8,&6%

/$).'56+./&J%2,&.%0$2&6316)/&:%8&.&6)/%>&6')$.'%$-%(,&%/+./&6%:658%

)6).$(&/+.%-)6'(%6&+/,&:%(,&%*+6A&("%%B.%)('%/$**&.('%($%(,+(%6&1$6(E%(,&%

N&.(&6'%-$6%9&:)/+6&%O%9&:)/+):%I&6>)/&'%GN9IJ%/$./566&:%2)(,%$56%

6&/$**&.:+()$.%(,+(%(,&%+8&./;%&@10$6&%$1()$.'%(,+(%2$50:%+00$2%

1+;*&.(%+*$5.('%($%*$6&%+//56+(&0;%6&-0&/(%.&2%8&.&6)/%16)/&'"%%N9I%'(+(&:%(,+(%)(%)'%).(&6&'(&:%).%+.;%'588&'()$.'%LBM%*+;%,+>&%($%)*16$>&%

(,&%*&(,$:'%5'&:%($%/$00&/(%+.:%+66+;%:+(+%5.:&6%(,&%HI&6%+%0)*)(&:%.5*7&6%$-%$5(1+()&.(%16&'/6)1()$.%

:658'%+.:%7)$0$8)/+0'%G,&6&).+-(&6%6&-&66&:%($%+'%:658'J%5.:&6%)('%


8/43

I N T R O D U C T I O N

!"#$%&'($)*++,'-%)+.-'/()0$,+(/!(,$/#+#&+"+102)(!("/3)+)$'4(!$+++++++++++++

5$6%67+(/8$!#"9:$+,'-%)+-)$,+(/+!&//$!#(&/+;(#0+#0$+#'$"#


9/43


!"#$%&''($#)!*+$',$-$.)!)*+)$%'*+$'+$%/"-%),0$'."+'12'/$+!$-3'".'34)%'

*5"6-3')-'34$'."+5'".'!")-%6+*-!$&'

Manufacturer Reporting Requirements

ASP data.''(*-6.*!36+$+%'7)34'($#)!*)#'#+68'+$,*3$'*8+$$5$-3%')-'

$..$!3'56%39'*5"-8'"34$+'34)-8%9'/+":)#$';(*+3'?@!":$+$#'#+68%',D'

-*3)"-*0'#+68'!"#$%'AEF;B9'74)!4'*+$'CC@#)8)3'-65$+)!'!"#$%'#):)#$#'

)-3"'34+$$'%$85$-3%')#$-3).D)-8'ACB'34$'.)+5'34*3'5*-6.*!36+$%9'

#)%3+),63$%9'"+'+$/*!G*8$%C1'34$'#+68'/+"#6!3'A)&$&9'34$'0*,$0$+'!"#$BH'''''

A1B'34$'%/$!).)!'%3+$-8349'#"%*8$'."+59'*-#'."+560*3)"-'".'34$'/+"#6!3H'

*-#'AIB'34$'/+"#6!3J%'/*!G*8$'%)K$&''(*-6.*!36+$+%'*+$'+$L6)+$#'3"'/+":)#$';(*+3'?@!":$+$#'#+68%')%',*%$#'"-'M;>;


10/43


!"#"$%&'$(")*$+,-$./#*/0$12$!"34$"%#('$#*($)5&4($&%$(")*$67"'#('8$$-9:$

#*(0$)"5)75"#(4$"$;&57*#(!$?:@$%&'$(")*$A-@-:$)&!(8$$B*/4$

?:@$C()&N4$?:@$!()5/0(4G$"4$#*($D"3$(0#('4$

#*($N4$C'"0!$(67/;"5(0#8$$?!!/#/&0"553G$>(0('/)$;('4/&04$&%#(0$67/)Q53$

"))&70#$%&'$#*($G$&;('#"Q/0>$#*($$/0$#*($

?:@$)"5)75"#/&0G$#*($5&.('$D'/)(4$"0!$/0)'("4(!$7#/5/S"#/&0$&%$>(0('/)$

;('4/&04$"'($0$/(0('/)$";"/5"C/5/#3G$"5#*&7>*$

9(!/)"'($D"3(8$

MP$A('(/0"%#('G$#*($#('$?DD'&;"548$$?))(44(!$"#$*##DWXX...8%!"8>&;$&0$?D'/5$HYG$H2M28$

$O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S Z


11/43


FDAs Generic Approval Process

!"#$%&%"'()"*&(+,*$&-#.*$.&-"/.*0.+/$&12&.3*&4565&7#.*$.$%&

8"#%*9#":&;)/&("#$.*%&

9#":*.&*H0>')+,+.2&>2G&(*$*"+0&%"'(&9').&1*&.3*&)#9*)&

#&1"#$%&%"'(&I+.3&"*)-*0.&./&0/$%+.+/$)&/&/&3+)./"2G&

+$0>'%+$(&I3*.3*"&+.&I#)--"/,*%&'$%*"$&FNEFG&.3*"*12&+$%+0#.+$(&

#&(*$*"+0&%"'(5&&E"'()WDEF&+)&)*#"03#1>*&12-->+0#.+/$&$'91*"G&

-"/-"+*.#"2&%"'(&$#9*G$%.+,*&+$("*%+*$.5?Y&&

Previous OIG WorkF&?@@J&;PO&"*-/".&+%*$.+&D//%G&E"'(G$%&\/)9*.+0&F0.Ac&&&&&&&&&&&&

?B&\D]&aa&UBY5M?$%&UBY5B@Z=0A5&?U&DEFG&FNEF&=O*$*"+0A&E"'(&F--"/,#>)5&&F00*))*%.&3..-T^^III5


12/43


!"#$%&'()**)*(%)*%+',-#.%/0012%)*%34'%!)#53%6,-#3'#%"!%/0017%%84'%

9':);-#'%'%

34-3%-$",*3%?@A/B7CA27%%D'%!",*:%34-3%9':);-#'%'E';3':%-;3,->%$-#G'3%'()5>-3)F'%;4-*('2%34-3%=",>:%->>"=%';3%*'=%('*'#);%>';3%:-3-7%%Q"='F'#M%-5%"!%9-.%/0A0M%I9J%4-5%*"3%3-G'*%-*.%-;3)"*5%3"%-::#'55%

>"=)*(%:-3-%5",#;'5%='#'%,5':%)*%",#%-*->.5)5%3"%):'*3)!.%*'=>.%

-F-)>-&>'%('*'#);%:#,(5M%;->;,>-3'%34'%!)*-*;)->%)$.%4-F'%!)#53R('*'#);%F'#5)"*5%#'-;4%34'%

$-#G'37

FDAs monthly list of first-generic drug approvals. T-;4%$"*34M%+UK%

)54'5%"*%)35%D'&%5)3'%-%>)53%"!%!)#53R3)$'%('*'#);%:#,(%-5%-*:%=4'34'#%-%:#,(%=-5%-


13/43


FDA staff. !"#$"%&"'(")#*+,-$./(*-+#,$-.#'(/,,#/(#012#$"3/(*+4#(-#(5"#

4"+"$*6#/77$-8/3#'(/(&'#-,#6"$(/*+#5*459":7"+)*(&$"#;$/+)9-+3


14/43


!"!#$%&'(!)%#'*%!"!#$%#+"&'!%,-(+.&,)-*%/",%-#01%23435%0"*-%*&,('6%#%

6(7-'%8,!-,%",%9-#,:%%

Micromedexs quarterly Red Book file. ;1-%%/($-%()%#'%%%%%%%%%

('*&)!,9?@,"*&0-*%0"+@-'*(&+%0"'!#('('6%*,&6%@,"*&0!%('/",+#!("'%

#'*%@,(0('6%*#!#%#!%!1-%AB3%$-7-$:%%CDE%,-0-(7-)%&@*#!-*%%*#!#%

-#01%8,!-,:

Manufacturer online press releases. ;1,"&61%+#'&/#0!&,-,%F-.%)(!-)%#'*%

"'$('-%!,#*-%@&.$(0#!("')G%+#'&/#0!&,-,)%@-,("*(0#$$9%#''"&'0-%!1-%

$#&'01%"/%,-0-'!$9%#@@,"7-*%6-'-,(0%*,&6):%

Identification of Newly Available Generic Drugs

F-%0"')&$!-*%HBIJ)%+"'!1$9%$()!%"/%/(,)!?6-'-,(0%*,&6%#@@,"7#$)%!"%

(*-'!(/9%#$$%*,&6)%!1#!%1#*%/(,)!?6-'-,(0%7-,)("')%@"!-'!(#$$9%.-0"+-%#7#($#.$-%('%KLLMG%KLLNG%",%!1-%/(,)!%!O"%8,!-,)%"/%KLLP:QK%%F-%

0"+@#,-*%!1()%$()!%"/%*,&6)%!"%3R5J)%4#,!%=%0,"))O#$>%/($-)%!"%*-!-,+('-%

O1(01%"/%!1-)-%/(,)!?6-'-,(0%*,&6)%O-,-%0"7-,-*%&'*-,%4#,!%=%#'*%

,-(+.&,)-*%.#)-*%"'%!1-%I54%@#9+-'!%+-!1"*"$"69:%

=-0#&)-%())&-)%)&01%#)%@#!-'!%('/,('6-+-'!%$(!(6#!("'%@,-7-'!%)"+-%

HBI?#@@,"7-*%/(,)!%6-'-,(0)%/,"+%.-0"+('6%#7#($#.$-%",%#7#($#.$-%

(++-*(#!-$9%#/!-,%#@@,"7#$G%O-%@-,/",+-*%!1-%/"$$"O('6%#**(!("'#$%

01-0>)%!"%*-!-,+('-%O1-!1-,%4#,!%=%*,&6)%"'%HBIJ)%$()!%#0!$$9%

,-#01-*%!1-%+#,>-!%('%KLLMG%KLLNG%",%!1-%/(,)!%!O"%8,!-,)%"/%KLLPS%

T:

F-%/(,)!%&)-*%3R5J)%8,!-,$9%I54%.#0>6,"&'*%/($-)%!"%*-!-,+('-%!1-%'&+.-,%"/%+#'&/#0!&,-,)%!1#!%,-@",!-*%)#$-)%"/%@"!-'!(#$%%%%%%%%%%%%%

/(,)!?6-'-,(0%*,&6)%0"7-,-*%&'*-,%4#,!%=%#'*%!1-%*,&6)J%

0",,-)@"'*('6%AB3):%%=-0#&)-%+#'&/#0!&,-,)%#,-%,-8&(,-*%!"%)&.+(!%

8,!-,$9%I54%*#!#%!"%3R5G%!1-%.#0>6,"&'*%/($-)%-'#.$-*%&)%!"%

(*-'!(/9%!1-%'&+.-,%"/%+#'&/#0!&,-,)%!1#!%)"$*%-#01%*,&6%('%-#01%

8,!-,G%!1-,-.9%0"'/(,+('6%O1-!1-,%HBIJ)%/(,)!?6-'-,(0%#@@,"7#$%

*#!-%0"('0(*-*%O(!1%!1-%+#,>-!%-'!,9%"/%'-O%+#'&/#0!&,-,)%/",%-#01%

*,&6:%%2"O-7-,G%.-0#&)-%@,-7("&)%CDE%O",>QQ%/"&'*%!1#!%

+#'&/#0!&,-,)%*"%'"!%#$O#9)%,-@",!%I54)%('%#%!(+-$9%+#''-,G%O-%

QK%=-0#&)-%!1-,-%()%"/!-'%#%6#@%.-!O--'%!1-%!(+-%O1-'%#%*,&6%,-0-(7-)%HBI%#@@,"7#$%#'*%

O1-'%(!%.-0"+-)%#7#($#.$-%"'%!1-%+#,>-!@$#0-G%O-%#$)"%('0$&*-*%*,&6)%/,"+%HBIJ)%$()!%"/%

6-'-,(0%*,&6)%#@@,"7-*%('%A"7-+.-,%#'*%B-0-+.-,%KLLU%(/%*#!#%)"&,0-)%('*(0#!-*%!1-9%*(*%

'"!%.-0"+-%#7#($#.$-%&'!($%KLLM:%

QQ%CDEG%I7-,#6-%5#$-)%4,(0-)S%%R#'&/#0!&,-,%


15/43


!"#$%&$$'%!(()&)$*!"%#&+,#%&$%)(+*&)-.%/0+&0+1%!*(%/0+*%!%,1$(23&%

1+!30+(%&0+%4!1'+&5%

657+%,+1-$14+(%#)4)"!1%30+3'#%2#)*8%9:;%-)"+#E%/+%/+1+%!D"+%&$%(+&+14)*+%&0+%-)1#&%

4$*&0%&0!&%8+*+1)3%#!"+#%/+1+%1+,$1&+(%&$%9:;5%%F0+%#!4+%BC9#%

/+1+%!"#$%2#+(%&$%(+&+14)*+%&0+%-)1#&%G2!1&+1%&0!&%8+*+1)3%

4!*2-!3&21+1#%1+,$1&+(%,1$(23&%)*-$14!&)$*%&$%@+(%A$$'E%/0)30%

#+1H+(%!#%!*%!(()&)$*!"%3$*-)14!&)$*%$-%&0+%(!&+%$-%8+*+1)3%4!1'+&%

+*&1.5%%%

I5=#%!%-)*!"%30+3'E%/+%1+H)+/+(%8+*+1)3%4!*2-!3&21+1%$*")*+%,1+##%1+"+!#+#%!**$2*3)*8%&0+%!H!)"!D)")&.%$-%8+*+1)3%(128#%&$%3$*-)14%&0+%

(!&+%$-%4!1'+&%+*&1!*3+5%

F0)#%,1$3+##%,1$(23+(%!%-)*!"%")#&%$-%JK%>!1&%A%(128#%&0!&%0!(%%%%%%%%%%%

-)1#&L8+*+1)3%H+1#)$*#%!,,+!1%$*%&0+%4!1'+&%)*%6MMNE%6MMOE%$1%&0+%-)1#&%

&/$%G2!1&+1#%$-%6MMP5IQE%IR%

S$1%#$4+%(128#E%*$&%!""%$-%&0+#+%(!&!%#$213+#%4+*&)$*+(%!D$H+%,1$H)(+(%

&0+%#!4+%(!&+%$-%8+*+1)3%+*&1.5%%7)&0%4$#&%()#31+,!*3)+#E%/+%30$#+%&0+%

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!"#$%&'()*+(,-&./(.#01&.2(3/($"(2.$.4!-#.(5%.$%.4(6.#.4-7(

!0#3,07$34.4/(5.4.(&0$.($"(4.8"4$()9+/:((;#(/37%(70/./0#2($%3/(5.4.(4.?3-4.2($"(/31!-$(

)9+/@:((9..()88.#2-A()(,"4(0(2.$0-&.2(2./74-8$-"#(",("34(!.$%"2"&"6'(,"4(

-2.#$-,'-#6(,-4/$(6.#.4-7/:(

Financial Impact of the Two-Quarter Lag During Initial Generic Availability

B"(2.$.4!-#.($%.(,-#0#7-0&(-!807$(",($%.(4.-!134/.!.#$(&06(,"4($%.((((((

CD(#.5&'(0E0-&01&.(6.#.4-7(2436/


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I N T R O D U C T I O NI N T R O D U C T I O N

!"#$%&!"'()*+()*!,&(-%.,)+,(/0('+"+,!#(.1.!$.2!$!)3(!"(/%,(0!"."#!.$(

!45.#)(.".$36!67(8+(8+,+(.2$+()/(.##/%")(0/,()*+6+(+9)+"&+&(+00+#)6:(

;"(!"6)."#+6(!"(8*!#*(.(0!,6)('+"+,!#(8.6(.55,/1+&(.0)+,()*+(0!,6)(4/")*(

/0(.(-%.,)+,(.)!/"(&.).()/(,+0$+#)()*+(.4/%")(/0(

)!4+()*+('+"+,!#6(8+,+(.1.!$.2$+(!"()*.)(-%.,)+,:?@(((

A"#+(8+(+6)!4.)+&()*+(0!"."#!.$(!45.#)(0/,(+.#*(&,%'7(8+()/).$+&()*+6+(

0!'%,+6()/(&+)+,4!"+()*+("+)(0!"."#!.$(!45.#)(/0()*+()8/B-%.,)+,(

,+!42%,6+4+")($.'(/"(C.,)(D(."&(!)6(2+"+0!#!.,!+6(0/,()*+(EF(&,%'6(/1+,(

)*+!,(!"!)!.$(5+,!/&6(/0('+"+,!#(.1.!$.2!$!)3:((G+(#/45.,+&()*+()/).$(

5/)+")!.$(6.1!"'6()/()*+()/).$(.4/%")(,+!42%,6+&(0/,(.$$(&,%'6(/1+,()*+(

6.4+(5+,!/&(."&(&+)+,4!"+&()*+(5,/5/,)!/"(/0(5/)+")!.$$3(+9#+66!1+(

+95+"&!)%,+6(,+6%$)!"'(0,/4()*+()8/B-%.,)+,($.':(

Comparison of generic and brand ASPs.((H*+(1/$%4+B8+!'*)+&(IJC(0/,(.(

KLCLJ(#/&+(!6(#.$#%$.)+&(%6!"'()*+(!"&!1!&%.$(IJC6(0/,(.$$(

#/,,+65/"&!"'(MNL6:((G!)*!"(+.#*(KLCLJ(#/&+7()*+(IJC6(0/,()*+(2,."&(

."&(."3('+"+,!#(MNL6(/0)+"(1.,3(#/"6!&+,.2$3(

?@(LOJP6(IOC(0!$+6(.$$/8+&(%6()/(&+)+,4!"+()*+(0!,6)(4/")*(/0('+"+,!#(.1.!$.2!$!)3:(?R(N.).(8+,+(%".1.!$.2$+(0/,()8/(&,%'6:(UV(D+#.%6+()*,++(&,%'6(&!&("/)(,+.#*()*+(4.,Q+)(%")!$(0!,6)B(/,(6+#/"&B-%.,)+,(TVVR7(

5.34+")(.4/%")6(0/,()*+6+(&,%'6(8+,+("/)(.1.!$.2$+(0/,()*+(0%$$(T(3+.,6:(

(O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S EE


18/43


!"#$%&'()(*+!,'(-!&+,./0((1*(2#"3!,4%5(&6+(7+842!,+(3!*"+%&(!"#$%&'(

9+:#,+(!%8(!:&+,(5+%+,42('!-+'(;+,+(,+:-+2&+8(4%(&6+(Identification of Future First-Generic Drugs

C+(3,#(;4&6(!(-4'&(#:(&6+((/F(9,!%8=#%-*(8,$5'(G9*(

7+842!,+(+H3+%84&$,+I(2#884&4#%!--*A(DE>Q'(

5+%+,42(!33,#NE>(!33,#

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"!,J+&(+%&,*.(

Standards

K64'('&$8*(;!'(2#%8$2&+8(4%(!22#,8!%2+(;4&6(&6+(R$!-4&*(?&!%8!,8'(:#,(

S%'3+2&4#%'(!33,#


19/43

F I N D I N G S!"#$%&'('$)''*$*+$%,+-./"(%'($

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20/43

F I N D I N G S

!"#$%#&'($"()*++(,-"..%/+0(/'!*&.'(")(%#!1'*.%#2(&$%+%3*$%"#(")(2'#'1%!(

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/0(JF(-'1!'#$C((K6'(-*05'#$(*5"$(!"#$%#&'>($"(>'!1'*.'('*!6(

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+'..($6*#($6'("1%2%#*+(/1*#>;"#+0(-*05'#$(*5"$.CPM((Q'!*&.'("&1(

PM(K:"()&++(0'*1.(")(>*$*(:'1'(*4*%+*/+'()"1(EJ(>1&2.("#+0R(F(")($6'.'(EJ(>1&2.(:'1'(

1'5"4'>()1"5($6'(.*4%#2.(*#*+0.%.(/'!*&.'(2'#'1%!(5*#&)*!$&1'1.(>%>(#"$(1'-"1$(*#0(@AB.C(

(O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S EP


21/43

F I N D I N G S

!"#$%&!'"%"()!$!'$%*(+,-,'.%()'/0-'1$2!/'/02--'3+"2/-2!'.1'-"*0',2+&4!'

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+7'/.'9')-"2!6'/0-'7./-%/$"('!"#$%&!'.1':;;;'8$(($.%'+%,-2-!/$8"/-'/0-'/./"('7./-%/$"('!"#$%&!'/0"/''

On average, brand drugs were initially 3 times more expensive than their

generic versions

C+2$%&'/0-'1$2!/'3+"2/-2'.1'&-%-2$*'"#"$("5$($/)'1.2'-"*0',2+&6'/0-'52"%,'

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FG'C"/"''

O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S ;F


22/43

F I N D I N G S

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*-,.)',*=%'-%*A,*"+'


23/43

F I N D I N G S

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&+)4-@3)&"!$%5&"12-4"%"+5#-6"+!5$%!-A"+"-*77+$6"&-3B-CDE-*%&-+"*#8"&-,8"-9*+:",-;$+-*-;"A-&*B!2-3),-*!-*-+"!)F,-$;-7*,"%,-F5,54*,5$%2-4"%"+5#-

6"+!5$%!-#"*!"&-3"5%4-9*+:","&-&)+5%4-,8"-7"+5$&-)%&"+-+"65"A


24/43

F I N D I N G S

Table 2: First Generics With ASP Reporting Issues

HCPCS DrugFDA Generic

Approval DateEstimated Actual

Generic Entry Date

Period Coveredby First Reported

Generic ASP1

J7620Albuterol sulfate/

ipratropium bromide inh. soln. Dec. 21, 2006 JulySept. 2007 4Q 2007

J1451 Fomepizole inj. Dec. 14, 2007 Jan. 2008 2Q 2008

Q01672

Dronabinol oral, 2.5 mg June 27, 2008 July 2008 (none listed)3

Q01682

Dronabinol oral, 5 mg June 27, 2008 July 2008 (none listed)3

! Source: FDA's ANDA (Generic) Drug Approvals and OIG analysis.!1

Based on the first appearance of generic manufacturer NDC(s) in the ASP background file. See Appendix A for adescription of this analysis.

2These drugs were not included in our potential savings analysis.

3No generic ASPs were reported as of fourth-quarter 2009.

!O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S "#


25/43

R E C O M M E N D A T I O N S R E C O M M E N D A T I O N!

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67;!$*!/'$385/%'3'*&?!!@'!1)5*+!&!0723'*&!73)5*&%!


26/43

R E C O M M E N D A T I O N

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8"9(%:)

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL

RESPONSE

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27/43


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28/43


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29/43

A P P E N D I X ~ ADetailed Methodology for Identifying First-Generic Drugs andTheir Dates of Market Entry

!"The Food and Drug Administrations (FDA) monthly list of first-generic drug

approvals. #$%#&'()*#+,-.'/%0#1#/')*#,//#0(23)#/')*%0#240%(#5678)#

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30/43

A P P E N D I X ~ A

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3&+&/*&*#/"-#


31/43

A P P E N D I X ~ B!

Table B-1: First-Generic Drugs Included in Our Analysis

HCPCSCode

Drug NameBrandName

First GenericEntry Date

1

Part B Expenditures Duringthe Three Quarters of Initial

Generic Availability2

Potential Savings Duringthe Three Quarters of

Initial Generic Availability

J0207Amifostine, inj.,

500milligrams (mg) Ethyol May 2008 $8,479,381 $1,364,634J0692

Cefepime inj.,500 mg Maxipime Jan.Mar. 2008 $567,286 $48,719

J1325Epoprostenol inj.,

0.5 mg Flolan May 2008 $19,576,492 $66,109

J1451Fomepizole inj.,

15 mg Antizol Jan. 2008 $23 -$2

J1626Granisetron inj.,

0.1 mg Kytril Jan. 2008 $13,040,208 $1,816,964

J3030Sumatriptan

Succinate inj., 6 mg Imitrex Feb. 2009 $957 $75

J7517

MycophenolateMofetil oral,

250 mg Cellcept May 2009 $132,035,240 $28,958,160

J7620

Albuterol Sulfate/Ipratropium

Bromide inh. soln.,2.5 mg/0.5 mg Duoneb JulySept. 2007 $165,624,799 $32,073,194

J9206Irinotecan inj.,

20 mg Camptosar Mar. 2008 $90,705,689 $44,131,109

J9245

Melphalan inj.,

50 mg Alkeran June 2009 $277,347 $9,909

J9268Pentostatin inj.,

10 mg Nipent Aug. 2007 $3,915,369 $273,111

Q0166Granisetron oral,

1 mg Kytril Jan. 2008 $649,379 $375,497

Q0179Ondansetron oral,

8 mg Zofran Jan.Mar. 2007 $4,296,612 $1,859,387

Q2009Fosphenytoin inj.,

50 mg Cerebyx Aug. 2007 $61 $48

Q01673

Dronabinol oral,2.5 mg Marinol July 2008 (n/a) (n/a)

Q01683

Dronabinol oral,5 mg Marinol July 2008 (n/a) (n/a)

Total $439,168,842 $110,976,913Source: Office of Inspector General analysis of newly available generic drugs, 2009.1 For some drugs, we could not determine from the available data the specific month in which generics first became available. For these drugs, we

provided the first quarter of generic availability (e.g., JanuaryMarch 2008).2 Part B Analytics Reporting (98 percent of claims reported). Accessed on March 25, 2010.3

Generic manufacturers for these two drugs did not report any average sales prices and were therefore not included in our savings analysis.



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A P P E N D I X ~ C

Table C-1: Medicare Payment Amounts for 16 Newly Available Generic Drugs

QuarterJ0207

(2Q 2008)1

J0692(1Q 2008)

J1325(2Q 2008)

J1451(1Q 2008)

J1626(1Q 2008)

J3030(1Q 2009)

J7517(2Q 2009)

J7620(3Q 2007)

Q0(Brand Only)PaymentAmount $496.281 $8.026 $14.526 $12.924 $5.792 $72.575 $3.190 $1.148Q1(First GenericReaches Market)PaymentAmount $511.217 $5.718 $14.362 $13.731 $4.721 $74.704 $3.436 $1.105Q2 PaymentAmount $511.316 $6.749 $14.368 $14.115 $6.046 $84.495 $3.441 $1.079Q3 PaymentAmount

2 $424.029 $5.711 $14.332 $14.804 $5.341 $82.659 $2.494 $0.805

Q4 PaymentAmount

3 $386.293 $5.721 $14.355 $11.850 $4.329 $56.559 $2.600 $0.830

Q5 PaymentAmount $373.298 $5.249 $14.218 $11.412 $4.053 $43.545 $1.884 $0.581

Q6 PaymentAmount $367.756 $4.589 $14.101 $10.100 $3.292 $46.678 (dataunavailable) $0.307Q7 PaymentAmount $356.806 $4.417 $14.023 $8.753 $2.344 (dataunavailable) (dataunavailable) $0.273Q8 PaymentAmount $340.108 $3.781 $14.032 $8.146 $2.004 (dataunavailable) (dataunavailable) $0.243

1

Quarter and year in parenthesis denote the first quarter in which generics were available. (continued on next page)2

Q3 refers to the quarter in which the Medicare payment amount begins to reflect sales of the first generic(s).3Q4 refers to the quarter in which the Medicare payment amount fully reflects sales of the first generic(s).

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A P P E N D I X ~ C

Table C-1: Medicare Payment Amounts for 16 Newly Available Generic Drugs (Continued)Quarter

J9206(1Q 2008)

1

J9245(2Q 2009)

J9268(3Q 2007)

Q0166(1Q 2008)

Q0179(1Q 2007)

Q2009(3Q 2007)

Q01672

(3Q 2008)Q0168

2

(3Q 2008)

Q0(Brand Only)PaymentAmount $125.800 $1,624.598 $1,934.913 $50.436 $36.064 $5.555 $5.415 $10.835

Q1(First GenericReaches Market)PaymentAmount $126.309 $1,624.598 $1,977.801 $50.224 $36.829 $5.795 $5.387 $11.711

Q2 PaymentAmount $126.235 $1,624.598 $2,071.219 $46.955 $36.550 $5.813 $5.876 $11.838

Q3 PaymentAmount3 $74.753 $1,654.023 $1,858.684 $17.173 $25.029 $3.595 $5.822 $11.508

Q4 PaymentAmount

4 $36.997 $1,549.472 $1,828.915 $17.877 $18.543 $0.817 $5.824 $11.676

Q5 PaymentAmount $21.715 $1,500.321 $1,741.579 $16.583 $9.169 $1.217 $6.799 $13.515

Q6 PaymentAmount $18.296

(dataunavailable) $1,622.651 $9.244 $4.604 $0.728 $6.795 $13.567





Source: Centers for Medicare & Medicaid Services posted Part B payment limits.1

Quarter and year in parenthesis denote the first quarter in which generics were available.2 Not included in our savings analysis.3

Q3 refers to the quarter in which the Medicare payment amount begins to reflect sales of the first generic(s).4 Q4 refers to the quarter in which the Medicare payment amount fully reflects sales of the first generic(s).

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A P P E N D I X ~ DTable D-1: Estimated Generic Approval Timeline for the Top 26 Dollar-Volume Brand-Only Part B

Drugs (Biologics Excluded), According to FDA

Drug Name Brand NameFDA-Estimated Generic

Approval Timeline1

2009 Part BExpenditures

2

2009 Part BRank

3

Oxaliplatin Eloxatin Approved in generic form4

$307,305,870 8

Docetaxel Taxotere After February 10, 2012 $273,059,887 9

Zoledronic acid Zometa After April 30, 2012 $228,200,463 12

Pemetrexed Alimta Currently eligible for approval $224,725,011 13

Gemcitabine hydrochloride Gemzar Approved in generic form $214,841,468 14

Bortezomib Velcade After August 31, 2011 $157,915,565 19

Leuprolide acetate Lupron Approved in generic form $148,807,207 20

Palonosetron hydrochloride Aloxi After April 30, 2012 $141,432,119 22

Treprostinil sodium Remodulin After April 30, 2012 $112,277,602 26

Octreotide acetate Sandostatin Lar Depot After April 30, 2012 $107,672,719 28

Azacitidine Vidaza After May 19, 2011 $101,648,346 29

Zoledronic acid Reclast After May 18, 2011 $100,768,293 30

Arformoterol tartrate Brovana After March 30, 2012 $77,081,333 32

Paclitaxel protein-bound Abraxane After April 30, 2012 $72,033,094 36

Adenosine AdenoscanCurrently eligible for approval

(legal disputes remain) $69,316,718 39

Triptorelin pamoate Trelstar After April 30, 2012 $67,684,223 40

Decitabine Dacogen After May 2, 2013 $62,196,704 42

Doxorubicin hydrochloride liposome Doxil After May 17, 2014 $49,619,144 47

Iloprost Ventavis Currently eligible for approval $48,970,602 48

Mycophenolate acid Myfortic After January 17, 2012 $46,469,720 51

Sirolimus Rapamune After April 30, 2012 $45,449,381 52

Topotecan hydrochloride Hycamtin Approved in generic form $43,430,255 54

Fulvestrant Faslodex After March 30, 2012 $40,709,396 57

Ibandronate sodium Boniva Currently eligible for approval $25,710,811 66

Imiglucerase Cerezyme After April 30, 2012 $24,355,150 70

Verteporfin Visudyne After April 30, 2012 $17,308,914 80

Total $2,808,989,996Source: Food and Drug Administration (FDA) analysis of Part B drugs, 2009.1

Approximate date of April 30, 2012, is used by FDA to estimate how long it would take to approve an abbreviated new drug application if it issubmitted before November 10, 2009, with a Paragraph IV Patent Certification.

2Part B Analytics Reporting (98 percent of claims reported). Accessed on March 29, 2010. Figures do not add to total because of rounding.

3Rankings include single-source drugs, multiple-source drugs, and biologics.

4Generic versions of this drug were initially approved and marketed, but litigation brought by the brand manufacturer against the genericmanufacturers resulted in the discontinuation of generic sales.



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A P P E N D I X ~ E

Table E-1: Top 22 Dollar-Volume Biologics Under Part B

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Source: Food and Drug Administration analysis of Part B drugs, 2009.1Part B Analytics Reporting (98 percent of claims reported). Accessed on March 29, 2010.

2Rankings include single-source drugs, multiple-source drugs, and biologics.

Drug Name Brand Name2009 Part B

Expenditures1

2009 Part BRank

2

Ranibizumab Lucentis $814,869,580 1

Rituximab Rituxan $807,136,671 2

Bevacizumab Avastin $723,336,581 3

Infliximab Remicade $605,603,464 4

Pegfilgrastim Neulasta $493,788,366 5

Darbepoetin alfa Aranesp $426,599,502 6

Epoetin alfa Epogen/Procrit $332,792,303 7

Trastuzumab Herceptin $211,603,637 15

Cetuximab Erbitux $165,132,074 18

Abatacept Orencia $145,050,591 21

Antihemophilic factor VIII(Recombinant) (All brands) $125,289,250 24

Botulinum toxin type A Botox $88,997,730 31

Coagulation factor VIIa Novoseven $74,330,848 33

Filgrastim Neupogen $69,897,511 38

Natalizumab Tysabri $54,497,650 46

Omalizumab Xolair $43,285,268 55

Immune globulin Vivaglobin $42,709,895 56

Immune globulin Gammagard Liquid $30,226,662 61

Panitumumab Vectibix $27,170,683 63

Coagulation factor IXRecombinant Benefix $25,176,467 67

Antihemophilic factor VIII:CHuman (All brands) $24,453,801 69

Immune globulin, powder (All brands) $21,200,286 74

Total $5,353,148,820

O E I - 0 3 - 0 9 - 0 0 5 1 0 M E D I C A R E PA Y M E N T S F O R N E W L Y AV A I L A B L E G E N E R I C D R U G S "#


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A P P E N D I X ~ F

Table F-1: Comparison of FDAs ANDA Approval Dates and Actual GenericEntry Dates

HCPCSCode

Drug NameFDA Generic

Approval DateEstimated Actual

Generic Entry Date

First Generics With Comparable Entry Dates

J0207 Amifostine, inj. Mar. 14, 2008 May 2008

J1325 Epoprostenol inj. Apr. 23, 2008 May 2008

J1451 Fomepizole inj. Dec. 14, 2007 Jan. 2008

J1626 Granisetron inj. Dec. 31, 2007 Jan. 2008

J3030 Sumatriptan succinate inj. Feb. 6, 2009 Feb. 2009

J9206 Irinotecan inj. Feb. 20, 2008 Mar. 2008

J9245 Melphalan inj. June 9, 2009 June 2009

J9268 Pentostatin inj. Aug. 7, 2007 Aug. 2007

Q0166 Granisetron oral Dec. 31, 2007 Jan. 2008

Q0179 Ondansetron oral Dec. 26, 2006 Jan.Mar. 2007

Q2009 Fosphenytoin inj. Aug. 6, 2007 Aug. 2007

Q01671

Dronabinol oral, 2.5 mg June 27, 2008 July 2008

Q01681

Dronabinol oral, 5 mg June 27, 2008 July 2008

First Generics With Conflicting Entry DatesJ0692 Cefepime inj. June 18, 2007 Jan.Mar. 2008

J7517 Mycophenolate mofetil oral July 29, 2008 May 2009

J7620Albuterol sulfate/

ipratropium bromide inh. soln. Dec. 21, 2006 JulySept. 2007

FDA-Identified First Generics Which Did Not Come to Market2

J92011

Gemcitabine inj. Dec. 18, 2008(Generics did notcome to market)

J32651

Torsemide inj. June 10, 2008(Generics did notcome to market)

FDA-Identified First Generics Which Temporarily Came to Market

J76261

Budesonide inh. soln. Nov. 18, 2008

(Products were launched inNov. 2008 and ceased being

distributed for sale by the genericmanufacturer later that month)

Source: Food and Drug Administration's (FDA) Abbreviated New Drug Application (ANDA) Generic Drug Approvals andOffice of Inspector General analysis.1

These drugs were not included in our savings analysis.

2No generics available as of fourth-quarter 2009.



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A P PEN 0 x GAgency Comments

/- ...( DEPARTMENT OF HEALTH & HUMAN SERVICES Cenlers for MedIcare & Medicaid Services

AdministrAtorWashington, DC 20201

OCT 0 7 2010DATE:TO: Daniel R. LevinsonInspector GeneralFROM: Donald Berwick, M.D.AdministratorSUBJECT: Office of Inspector General (OIG) Draft Report: Medicare Payments for NewlyAvailable Generic Drugs (OEI"03-09-0051 0)

The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review andrespond to the OIG Draft Report entitled, "Medicare Payments for Newly Available GenericDrugs" (OEI-03-09-0051 0). We appreciate the OIG's continuing efforts to examine paymentmade under the average sales price (ASP) methodology.The OIG report presents findings from a comparison ofMedicare payment amounts to marketprices for certain newly available generic drugs. The report finds differences between theMedicare payment limits and the market prices for the generic drugs and attributes thesedifferences primarily to the "two-quarter lag" inherent in the Medicare payment limit calculationprocess. The OIG claims that Medicare could have saved $111 million ifMedicare paymentlimits had reflected sales prices during the period of initial generic availability of 16 differentdrugs, and, therefore, urges that the two quarter lag be eliminated.However, this estimate is based on the premise that no time lag would exist between theintroduction and inclusion of generics in the ASP. Such potential savings could not be achievedbecause any calculation of payment that relies on manufacturer reporting would require a lagtime to allow manufacturers to calculate and submit their pricing data. Moreover, the 01G'sestimate also assumes that providers would immediately switch from branded to generic productswithout factoring the lag time associated with the introduction of any new product in the market.In addition, it is not clear from the report that the $111 million is not an annualized savingsamount, but instead a sum of potential savings over the course of several years.CMS notes that almost 95 percent of the OIG's reported savings are attributed to three drugs and,therefore, the 0I0's savings projections may not be accurate. Nearly $105 million of the $111million in projected savings is attributed to three products, mycophenolate mofetil (genericCeIlCept), albuterol sulfateiipratropium Bromide (generic DuoNeb) and irinotecan (genericCamptostar). We do not believe that extrapolating savings projections that are based on such asmall subset of drugs to all generic drugs correctly represents Part B drug price changes due tothe introduction ofgeneric drugs.

OEI030900510 MEDICARE PAYMENTS FOR NEWLY AVAILABLE GENERIC DRUGS 31

/S/


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Documents

OIG HHS ASP Report 1-11