Sorting T hroug h Curre nt T re nds in F e de ra l & Sta te - - PowerPoint PPT Presentation
Sorting T hroug h Curre nt T re nds in F e de ra l & Sta te L e g isla tive a nd Re g ula tory Issue s: Wha t Me dic a id Administra tors Ne e d to Know E MPAA Me e ting Aug ust 19, 2019 ABOUT ME M a ry Jo C a rd e n, RPh, JD
E MPAA Me e ting Aug ust 19, 2019
F
e de r al and State Dr ug Pr ic ing Initiative s
T
rump Administra tio n E ffo rts
Brie f Ove rvie w o f 2018 Blue print to L
Wha t ha ppe ne d to the pro po se d re b a te rule ? De pa rtme nt o f He a lth a nd Huma n Se rvic e s a nd F
Administra tio n (HHS/ F DA) Sa fe I mpo rta tio n Ac tio n Pla n re le a se d o n Aug ust 1
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nte rna tio na l Pric ing I nde x—Antic ipa te d Pro po se d Rule
Pric e tra nspa re nc y in dire c t-to -c o nsume r (DT
C) a dve rtise me nt
E
xe c utive Orde rs a nd Ac tio ns to I nc re a se T ra nspa re nc y in He a lth Ca re Pric ing a nd Pre sc riptio n Drug s
Co ng re ssio na l Ac tio n
Pre sc riptio n Drug Pric ing Re d uc tio n Ac t o f 2019
Re le a se d b y Se na te F
ina nc e Co mmitte e in July 2019
Ge ne ra l sta te tre nds
As o f July 25, 2019: 49 b ills e na c te d
Ac tio n b y 47 sta te s o n 271 b ills
Pha rma c y b e ne fit ma na g e me nt o ve rsig ht a nd g a g
c la use pro hib itio ns
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ra nspa re nc y a nd a ffo rda b ility le g isla tio n
PBM spre a d pric ing
Na tio na l Ac a de my fo r Sta te He a lth Po lic y. L e g isla tive Ac tio ns to L
Pha rma c e utic a l Co sts. Upda te d July 25, 2019. https:/ / na shp.o rg / rx-le g isla tive - tra c ke r-2019/ . Ac c e sse d Aug ust 2, 2019.
Me dic a id, Affor
da ble Ca r e Ac t (ACA) a nd Othe r He a lth Ca r e Re for m Initia tive s
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e g a l a c tio ns
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e xas v Azar a nd the future o f the ACA
Supre me Co urt will he a r c a se o n risk c o rrido rs in Oc to b e r Upda te o n Me dic a id wa ive r a c tivity a nd e xisting c ha lle ng e s Alte rna tive pa yme nt mo de ls Okla ho ma Mic hig a n Co lo ra do Me dic a id b lo c k g ra nts a nd o the r po te ntia l a c tio ns Po lic y o n he a lth re imb urse me nt a c c o unts (HRAs) in June 2019
Me dic ar
e Par t D and Me dic ar e Advantage
K
e y 2020 initia tive s
CMS a nno unc e d lo we r pre miums fo r Me dic a re Pa rt D E
nha nc ing to o ls fo r c o mb a ting o pio id e pide mic
Supple me nta l b e ne fits fo r c hro nic a lly ill in Me dic a re
Adva nta g e
I
ndic a tio ns-b a se d pric ing
Ste p the ra py fo r Pa rt B/ D in Me dic a re Adva nta g e Re stric tio ns o n g a g c la use s
Compe titive Mar
ke tplac e : Biosimilar s and Ge ne r ic s F
DA)
Bio simila r na ming : upda te d dra ft g uida nc e Upda te o n a c tio ns fo r tra nsitio na l b io lo g ic s, inc luding insulin, tha t will e nte r b io lo g ic
pa thwa y in 2020
Othe r ke y a c tivitie s
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e g isla tio n to e nsure a c c e ss to pro duc t sa mple s a nd o f g e ne ric s a nd b io simila rs to pro mo te c o mpe titio n
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he b a ttle o ve r b io lo g ic mo no g ra ph de ve lo pme nt: F DA v Unite d Sta te s Pha rma c o pe ia
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nc lude d a re q ue st fo r info rma tio n o n wa ys to lo we r pre sc riptio n drug c o sts fo r Ame ric a ns
Me dic a re Pa rt D fo rmula ry fle xib ility Va lue -b a se d c o ntra c ting Pro mo ting b io simila rs a nd g e ne ric a do ptio n in the ma rke t Re b a te re fo rm a nd o the r sa fe ha rb o r c ha ng e s
I nc re a se d ma rke t c o mpe titio n Be tte r Ne g o tia tio n I nc e ntive s fo r L
ist Pric e s L
Po c ke t Co sts
Pro po se d rule issue d b y the De pa rtme nt o f He a lth a nd Huma n Se rvic e s
Offic e o f I nspe c to r Ge ne ra l in April 2019
So ug ht sa fe ha rb o r pro je c tio ns fo r re b a te s in fe de ra l g o ve rnme nt pro g ra ms a nd
re pla c e with a lte rna tive po int o f sa le disc o unts a nd ne w sa fe ha rb o r fo r pha rma c y b e ne fit ma na g e me nt c o mpa ny se rvic e s
Critic ism inc lude d
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nc re a se d pre mium c o st fo r Me dic a re b e ne fic ia rie s
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nc lusio n o f Me dic a id ma na g e me nt c a re re b a te s
Did no t spe c ific a lly inc lude re b a te s in c o mme rc ia l c o ntra c ts
Re sc inde d in July 2019
HHS/ F DA Safe Importation Ac tion Plan
Pathway 1: State s, pharmac ists, and whole sale rs
Must sub mit pla n to F DA
E xc lude s c o ntro lle d sub sta nc e s, b io lo g ic s (inc luding insulin), infuse d a nd IV pro duc ts, inha la nts use d during surg e ry, pa re nte ra lly a dministra te d pro duc ts a nd tho se sub je c t to RE MS
Pla ns must de ta il a ssura nc e s re la te d to c o mplia nc e with drug
q ua lity, re c o rd ke e ping a nd pro duc t te sting with furthe r de ta il
Must a lso c e rtify no ha rm to c o nsume rs will re sult a nd will re sult in
lo we r c o sts
Pathway 2: Manufac ture r importation of forfe it produc ts with F DA e quivale nts in the Unite d State s
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na tio na l drug c o de s (NDCs) Sta te s with impo rta tio n la ws, inc luding F lo rida , Ve rmo nt, a nd Ma ine ha ve ta ke n a c tio n in impo rta tio n
Adva nc e d no tic e o f pro po se d rule ma king re le a se d in Oc to b e r 2018 a nd
NPRM a ntic ipa te d so o n
Se e ks to b e nc hma rk Unite d Sta te s drug pric e s a g a inst tho se in o the r
de ve lo pe d ma rke ts, inc luding c e rta in E uro pe a n c o untrie s, Ca na da , Ja pa n, a nd the Unite d K ing do m
Pro po se d a s a 5-ye a r de mo nstra tio n mo de l (2019-2023) tha t will inc lude
a ppro xima te ly 50% o f the Unite d Sta te s
Pric e s in the Unite d Sta te s wo uld b e b a se d o n 126% o f the a ve ra g e pric e in
Pro je c te d to de c re a se c o sts b y 30% whe n fully imple me nte d
HHS Pre ss re le a se : Wha t Yo u Ne e d to Kno w a b o ut Cutting Do wn o n F
re e lo a ding . Oc to b e r 25, 2018.
T rump Administra tio n E ffo rts to L
Pric e s
T r a nspa r e nc y in Dir e c t- to- Consume r Adve r tising
HHS Rule F ina lize d in Ma y 2019; F e de ra l judg e inva lida te d in July 2019
Wo uld re q uire ma nufa c ture rs to disc lo se who le sa le
a c q uisitio n c o st o r list pric e o f a pro duc t with a c o st o f $35 o r mo re
Cha lle ng e d b y pha rma c e utic a l c o mpa nie s in c o urt o n
F irst Ame ndme nt F re e spe e c h g ro unds
F
e de ra l distric t c o urt judg e fo und tha t HHS do e s no t ha ve re g ula to ry a utho rity to c o mpe l c o mpa nie s to disc lo se pric e s
Did no t rule o n F
irst Ame ndme nt pro visio ns
Whe n pro po se d rule wa s re le a se d, PhRMA re le a se d
vo lunta ry g uide line s fo r DT C pric e re le a se s
So me c o mpa nie s c o ntinue to re le a se pric ing in
a dve rtise me nts
Critic s fo und tha t pric e disc lo sure s no t a lwa ys re lia b le
b e c a use c o nsume rs c o ve re d b y pub lic a nd priva te insura nc e do no t pa y list pric e
He a th, S. Judg e rule s a g a inst HHS Drug Adve rtising Pric e T ra nspa re nc y Rule . July 10, 2019. https:/ / pa tie nte ng a g e me nthit.c o m/ ne ws/ judg e -rule s-a g a inst-hhs- drug -a dve rtising -pric e -tra nspa re nc y-rule . Ac c e sse d Aug ust 1, 2019.
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n July, Pre side nt sig na le d tha t he ma y re le a se a n e xe c utive o rde r to lo we r pric e s o n a ll b ra nde d pro duc ts use d b y Me dic a re a nd o the r g o ve rnme nt pro g ra ms unle ss Co ng re ss a c ts
Co uld b e mo de le d a fte r De pa rtme nt o f De fe nse c o ntra c t pric ing
On June 24, Pre side nt re le a se d a n e xe c utive o rde r tha t wo uld re q uire
pub lic disc lo sure s o f pric e s b y insura nc e c o mpa nie s, pha rma c e utic a l industry, a nd ho spita ls
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nc lude d in NPRM fo r o utpa tie nt ho spita l syste ms with pub lic c o mme nt pe rio d until Se pte mb e r 29, 2019
E rma n, M; O’ Do nne ll C. E xc lusive : White Ho use pre pa ring o rde r tha t wo uld c ut drug pric e s fo r Me dic a re : so urc e s. Re ute rs: July 25, 2019. https:/ / www.re ute rs.c o m/ a rtic le / us- usa -drug pric ing -e xc lusive / e xc lusive -white -ho use -pre pa ring -o rde r-tha t-wo uld-c ut-drug - pric e s-fo r-me dic a re -so urc e s-idUSK
He a th S. CMS Pro po se s Upda te s, Pitc he s Pric e T ra nspa re nc y Rule s. July 29, 2019. https:/ / re vc yc le inte llig e nc e .c o m/ ne ws/ c ms-pro po se s-upda te s-fo r-o pps-pitc he s-pric e - tra nspa re nc y-rule s. Ac c e sse d Aug ust 1, 2019.
c o st sha ring in the initia l c o ve ra g e limit a nd c o ve ra g e g a p
T
c a ta stro phic c o ve ra g e
Pro vide s inc e ntive s to use lo we r c o st me dic a tio ns fo r b o th
the pa tie nt a nd pla ns
$0 c o st sha ring fo r b io simila rs Shifts prima ry re spo nsib ility fo r c a ta stro phic c o ve ra g e fro m
fe de ra l g o ve rnme nt to pla ns a nd b ra nd na me ma nufa c ture rs E
limina te s c urre nt ma nufa c ture r disc o unt in c o ve ra g e g a p
Gove r nme nt (Cur r e nt law 80% )
20% Bra nd drug s 40% Ge ne ric Drug s
Par t D plans (Cur r e nt law 15% ) and Br and Name Manufac tur e r s (Cur r e nt law 0% )
60% Pla n re spo nsib ility fo r b ra nd a nd g e ne ric drug s 20% Bra nd ma nufa c ture r Be ne fic ia ry 5% c a ta stro phic pha se c o st sha ring e limina te d b y 2022
Wo uld re q uire HHS to pub lic ly disc lo se a g g re g a te pric e c o nc e ssio ns inc luding
re b a te s a nd disc o unts b a se d o n the a g g re g a te disc o unt tha t the PBM pa ys re ta il a nd ma il o rde r pha rma c ie s
Do e s no t re q uire disc lo sure o f spe c ific c o ntra c t te rms Re q uire s Pa rt D pla ns to re po rt to pha rma c ie s a ny sa le a djustme nts fo r pric e
c o nc e ssio ns a t the po int o f sa le
Pa rt D pla ns must inc lude d a c tua l a nd pro je c te d DI
R fe e s in Pa rt D b ids
Be g inning in 2020, re q uire s Pa rt D pla ns to re po rt DI
R fe e s, disc o unts, c ha rg e b a c ks, a nd re b a te s to CMS within 6 mo nths a fte r the c lo se o f the pla n ye a r
HHS must pro vid e a n ind e pe nd e nt third -pa rty a ud it o f DIR fe e s a nd pub lic ly re po rt
d isc re pa nc ie s
Wo uld e sta b lish a ma nda to ry Pa rt D re b a te if a ma nufa c ture r
inc re a se s list pric e fo r a Pa rt D b ra nd o r b io lo g ic pro duc t a b o ve infla tio n
Re b a te s pro vide d to Me dic a re e ve ry 6 mo nths Re b a te is e q ua l to the q ua ntity o f e a c h drug c o ve re d during he
re b a te d pe rio d a nd the a mo unt b y whic h the a c tua lly a ve ra g e da ily list pric e e xc e e d the infla tio n-a djuste d list pric e
Be g inning in 2022, wo uld re q uire pla ns to justify pric e inc re a se s
fo r drug s a nd b io lo g ic s a s me a sure d b y who le sa le a c q uisitio n c o st
HHS Se c re ta ry ide ntifie s ne e d fo r pric e justific a tio n a nd no tifie s ma nufa c ture r
within 60 da ys a nd the n ma nufa c ture r ha s 180 da ys to re spo nd
Wo uld re q uire Pa rt D to pro vide a re a l-time b e ne fit to o l a s a do pte d b y
CMS to e na b le tra nsmissio n o f fo rmula ry info rma tio n
Wo uld e na b le physic ia ns to re c e ive c re dit fo r using the to o l unde r the Me rit-
b a se d I nc e ntive Pa yme nt Syste m
Wo uld a llo w Pa rt D pla ns to use fe e -fo r-se rvic e c la ims da ta fo r Pa rt D
c o ve ra g e de te rmina tio ns b e g inning in 2021
Wo uld re q uire e nha nc e me nts to Me dic a id Pha rma c y & T
he ra pe utic s Co mmitte e s in sta te s using a fo rmula ry syste m
Must inc lude physic ia ns a nd pha rma c ists a nd o the r individua ls a ppo inte d b y the
g o ve rno r
At le a st o ne pra c tic ing pha rma c ist a nd o ne physic ia n must b e fre e o f ma nufa c ture r,
Me dic a id pla n, a nd PBM c o nflic ts a nd must ha ve e xpe rtise in a t le a st o ne Me dic a id- spe c ific b e ne fic ia ry po pula tio n
Must inc lude a pub lic ly a c c e ssib le c o nflic t o f inte re st po lic y tha t re q uire s
c o mmitte e me mb e r disc lo sure a nd re c usa l pro c e sse s
Ave ra g e ma nufa c ture r pric e (AMP) initia tive s
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xc lude a utho rize d g e ne ric s fro m AMP c a lc ula tio n fo r Me dic a id re b a te pro g ra m
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nc re a se s the ma ximum re b a te a mo unt to 125% o f c o nve rg e drug s AMP fo r the pe rio ds b e g inning Oc to b e r 1, 2022
Ma nufa c ture r AMP inc re a se s b e yo nd infla tio n wo uld b e sub je c t to a ll re b a te o b lig a tio ns
if the re wa s no c a p
Re q uire PBMs to pro vide pa ss-thro ug h pric ing L
imits pha rma c y ma na g e me nt se rvic e s to b e limite d to ing re die nt c o st a nd pro c e ssio na l dispe nding fe e no t le ss tha n pro fe ssio na l dispe nsing fe e tha t sta te pla n o r wa ive r wo uld pa y a nd must b e pa ss thro ug h to the pha rma c y in its e ntire ty
PBM a dministra tive fe e ds wo uld b e limite d to “re a so na b le a dministra tive
fe e ”
Pro hib its spre a d pric ing fo r purpo se s o f fe de ra l ma tc hing Ma nda te s a re po rt to Co ng re ss e xa mining spe c ia lty drug c o ve ra g e a nd
Me dic a id re imb urse me nt
xpa nds a ve ra g e sa le s pric e (ASP) re po rting pro visio ns to ma nufa c ture rs tha t do no t ha ve a Me dic a id drug re b a te a g re e me nt
inde x fo r urb a n c o nsume rs
c a lc ula tio n o f ASP b e c a use if the va lue o f c o upo ns is hig h, ASP fo r purpo se s o f Me dic a re Pa rt B pa yme nts c o uld b e hig he r
ffe c tive Ja nua ry 2019, e sta b lishe s a who le sa le a c q uisitio n c o st (WAC) plus 3% fo r Me dic a re Pa rt B drug s a nd b io lo g ic s tha t do no t ha ve a n ASP in the first 2 q ua rte rs o f a va ila b ility
b e g inning in July 2020
Ga g Cla use Prohibitions
AL ME MN NE NM (plus a de q ua te pha rma c y re imb urse me nt) NV (plus o ve rsig ht o f re b a te s) SC
PBM Spre a d Pric ing a nd Othe r Re imburse me nt Issue s
AR (plus a ppe a ls fo r pha rma c ie s) L A (pha rma c ist ma y de c line pre sc riptio n if re imb urse me nt le ss tha n a c q uisitio n pric e MT —ve to e d b y g o ve rno r NE SD T N
PBM Re g istra tion a nd Ove rsig ht
AL DE (plus MAC pric ing pro visio ns) L A MN (plus re b a te pric e info rma tio n disc lo sure a nd MAC pric ing ) SC UT (PBM fiduc ia ry a nd re po rting )
Na tio na l Ac a de my fo r Sta te He a lth Po lic y. L e g isla tive Ac tio ns to L
Co sts. Upda te d July 25, 2019. https:/ / na shp.o rg / rx-le g isla tive -tra c ke r-2019/ . Ac c e sse d Aug ust 2, 2019.
Pa sse d c o mpre he nsive le g isla tio n to re g ula te a nd e va lua te PBMs a nd sta te
purc ha sing o f pre sc riptio n drug s
Me dic a id dire c to r will se le c t a third pa rty a dministra to r a nd will ide ntify a sing le
ra te to PBMs
Must e nsure a ppro pria te c o st sha ring Cre a te s a Pre sc riptio n Drug T
ra nspa re nc y a nd Affo rda b ility Adviso ry Co unc il within the De pa rtme nt o f Administra tive Se rvic e s tha t will pro vide re po rt to the Ge ne ra l Asse mb ly a nd Go ve rno r within 6 mo nths tha t e va lua te s the fo llo wing
Drug pric e tra nspa re nc y Ne w pa yme nt mo de ls I
mpro ving e ffic ie nc y a c ro ss he a lth syste ms
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e ve ra g e sta te purc ha sing po we r a nd me a sure s to impro ve o utc o me s to impro ve purc ha sing
Ma ximizing fe de ra l, sta te , a nd lo c a l re so urc e s to lo we r drug pric e s
Na tio na l Ac a de my fo r Sta te He a lth Po lic y. L e g isla tive Ac tio ns to L
Co sts. Upda te d July 25, 2019. https:/ / na shp.o rg / rx-le g isla tive -tra c ke r-2019/ . Ac c e sse d Aug ust 2, 2019.
On Aug ust 1, 2019, fe de ra l judg e a llo ws pha rma c e utic a l industry to mo ve
fo rwa rd with la wsuit a g a inst CA sta tute tha t re q uire s a dva nc e no tic e to the sta te o n drug pric e inc re a se s
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a wsuit c a n pro c e e d o n F irst Ame ndme nt I ssue s a nd vio la tio ns o f inte rsta te c o mme rc e c la use
So urc e : K a ise r He a lth Ne ws. Aug ust 2, 2019. https:/ / khn.o rg / . Ac c e sse d Aug ust 2, 2019.
State Medicaid Managed Care: Proposals include those which look at
eligibility for state Medicaid and/or work requirements; carving in or carving out pharmacy benefits in the state Medicaid managed care program; implementing a standard process for prior authorizations; and proposals which look at Medicaid formularies
Formulary Management: Several states are looking at proposals
which prohibit formulary changes during a plan year or require notice to prescribers in advance of changes Prior Auth/Step Therapy: A majority of states in session have at least
standard formats for PA, and setting timeframes for responses; another proposal looks to make step therapy and PA protocols readily accessible online for prescribers
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nitia lly file d b y 20 Re pub lic a n sta te a tte nds g e ne ra l a nd g o ve rno rs a nd 2 individua ls c la iming tha t whe n Co ng re ss inva lida te d the individua l ma nda te in a 2017 la w, the ACA is no lo ng e r e nfo rc e a b le
Supre me Co urt pre vio usly he ld tha t the individua l ma nda te is ke y to
c o nstitutio na lity o f the ACA
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n Ma y 2019, 17 De mo c ra tic a tto rne ys g e ne ra l inte rve ne d to de fe nd the ACA in its e ntire ty
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n June 2018, De pa rtme nt o f Justic e de c line d to de fine the c o nstitutio na lity o f the ma nda te a nd re q ue ste d tha t ma jo r po rtio ns o f ACA b e stric ke n, inc luding pre e xisting c o nditio n c o ve ra g e
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n De c e mb e r 2018, a fe de ra l judg e in the No rthe rn Distric t o f T e xa s fo und tha t the e ntire ACA is inva lid
DOJ a nd De mo c ra tic a tto rne ys g e ne ra l a ppe a le d in Ja nua ry 2019 Ora l a rg ume nts he a rd in July 2019 a nd Supre me Co urt c o uld he a r c a se
So urc e : Zho u, L . T he la te st le g a l c ha lle ng e to the Affo rda b le Ca re Ac t, e xpla ine d. Vo x.c o m: July 10, 2019. https:/ / www.vo x.c o m/ po lic y-a nd- po litic s/ 2019/ 7/ 9/ 20686224/ a ffo rda b le -c a re -a c t-c o nstitutio na l-la wsuit-fifth-c irc uit-c o urt- te xa s-distric t-c o urt. Ac c e sse d Aug ust 2, 2019.
So urc e : Me dic a id Wa ive r T ra c ke r: Appro ve d a nd Pe nding Me dic a id Wa ive rs b y Sta te . K F F : July 30,2019. https:/ / www.kff.o rg / me dic a id/ issue -b rie f/ me dic a id-wa ive r-tra c ke r-a ppro ve d- a nd-pe nding -se c tio n-1115-wa ive rs-b y-sta te / . Ac c e sse d Aug ust 2, 2019.
Co lo ra do , Mic hig a n, a nd Okla ho ma ’ s sta te pla n a me ndme nts a llo w fo r
Me dic a id a lte rna tive pa yme nt mo de ls (APMs) using o utc o me s-b a se d c o ntra c ts fo r pha rma c e utic a ls
Pe rfo rma nc e c o ntra c ts a llo w fo r pa yme nt b a se d o n pre -e sta b lishe d
Pa yme nts fo r suc c e ssful inte rve ntio ns pa id a s a supple me nta l re b a te b y
ma nufa c ture r
Sa mple c o ntra c t is a va ila b le a t the Sta te Me dic a id Alte rna tive Re imb urse me nt
a nd Purc ha sing T e st fo r Hig h-c o st Drug s (SMART
https:/ / c e nte rfo re vide nc e b a se dpo lic y.o rg / o ur-a ppro a c h/ sma rt-d/
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nfo rma tio n fro m the Na tio na l Ac a de my fo r Sta te He a lth Po lic y sug g e sts tha t APMs mig ht pro vide so me b e ne fit b ut pre sc riptio n drug pric e s re ma in a b a rrie r a nd c o ntra c ts a re time -c o nsuming a nd diffic ult to imple me nt
Co lo ra do e xpe c te d to pro duc e o ne -ye a r da ta re sults so o n
So urc e : Re c k J. A Ne w Sta te T
xpe rts Sha re I nsig hts into Outc o me -Ba se d Co ntra c ts fo r Me dic a id Pha rma c y Cla ims. NASHP: Ma y 27, 2019. https:/ / na shp.o rg / a -ne w-sta te -to o l-to -ma na g e -drug -c o sts-e xpe rts-sha re -insig hts-into -
Pro po sa l inc lude d in the Pre side nt’ s 2020 b udg e t pla n No t a ppro ve d b y Co ng re ss a nd unlike ly to b e a ppro ve d g ive n
De mo c ra tic -c o ntro lle d Ho use
Ce nte rs fo r Me dic a re a nd Me dic a id Se rvic e s ha s so ug ht wa ys to use
wa ive r pro g ra m fo r sta te s to use b lo c k g ra nts
Pro po sa l se nt to Offic e o f Ma na g e me nt a nd Budg e t in June T
rump Administra tio n in disc ussio ns with sta te s, suc h a s Ala ska to use the b lo c k g ra nt pro c e ss
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e nne sse e , Uta h, a nd T e xa s ha ve a ll c o nside re d b lo c k g ra nts in le g isla tio n o r study
Use o f wa ive r a utho rity fo r b lo c k g ra nts ma y pro ve c ha lle ng ing
b e c a use o f le g a l inte rpre ta tio ns re la te d to whe the r the y me e t the de finitio n o f “furnishing me dic a l a ssista nc e ” a nd re c e nt HHS de fe a ts o n whe the r wo rk re q uire me nts c o nstitute he a lth c a re ma y a lso b e a b a rrie r
So urc e : Sa c hs R. Hub e rfe ld N. T he Pro b le ma tic L a w a nd Po lic y o f Blo c k Gra nts. He a lth Affa irs Blo g : July 24, 2019. https:/ / www.he a ltha ffa irs.o rg / do / 10.1377/ hb lo g 20190722.62519/ full/ . Ac c e sse d Aug ust 2, 2019.
Jo int po lic y b y HHS, L
a b o r De pa rtme nt, a nd T re a sury De pa rtme nt to a llo w e mplo ye rs to o ffe r he a lth re imb urse me nt a c c o unts fo r individua ls to purc ha se in the ma rke t b e g inning in Ja nua ry 2020
De sig ne d to he lp mo re tha n 2 millio n uninsure d individua ls re c e ive a c c e ss
to he a lth insura nc e in the sho rt te rm
So urc e : U.S. De pa rtme nts o f He a lth a nd Huma n Se rvic e s, L a b o r, a nd T he T re a sury E xpa nd Ac c e ss to Qua lity, Affo rda b le He a lth Co ve ra g e T hro ug h He a lth Re imb urse me nt Arra ng e me nts. HHS Pre ss Offic e : https:/ / www.hhs.g o v/ a b o ut/ ne ws/ 2019/ 06/ 13/ hhs-la b o r- tre a sury-e xpa nd-a c c e ss-q ua lity-a ffo rda b le -he a lth-c o ve ra g e .html. Ac c e sse d Aug ust 2, 2019.
Pre miums will a ve ra g e $30 pe r mo nth in 2020, pa rt o f a 3-ye a r re duc tio n in
pre miums a nd sub sidie s will a lso de c re a se b y $6 b illio n
CMS a lso ha s no te d wa ys to tha t ha s ta ke n o the r e ffo rt to inc re a se
tra nspa re nc y to b e ne fic ia rie s, inc luding pro hib iting g a g c la use s a nd re q uiring e xpla na tio n o f b e ne fits to inc lude info rma tio n o n the ra pe utic a lte rna tive s tha t ma y lo we r c o sts
So urc e : T rump Administra tio n Drive s Do wn Co sts fo r Se nio rs. CMS.g o v Ne wsro o m: July 3e 0,
drug -c o sts-se nio rs. Ac c e sse d Aug ust 2, 2019.
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nc o ura g ing a c c e ss to me dic a tio n a ssiste d tre a tme nt fo r a ddic tio n a t lo we r c o st sha ring le ve ls a nd re minding pla ns tha t sub sta nc e a b use tre a tme nt ma y b e a disa b ility a nd must c o ve r the se a g e nts
I
mple me nting a dditio na l b e ne fits unde r Me dic a re Adva nta g e tha t a llo w b e ne fic ia rie s to re c e ive c o st re duc tio ns fo r pa in ma na g e me nt tha t do e s no t inc lude use o f o pio ids o r o pio id po te ntia to r a g e nts a nd o the r inte g ra te d the ra pie s a t lo we r c o st
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e sting sta r ra ting s tha t me a sure pla n ma na g e me nt a sso c ia te d with use o f hig h do se o pio ids a nd c o nc urre nt use o f o pio ids a nd o pio id po te ntia to r a g e nts, suc h a s b e nzo dia ze pine s
So urc e : 2020 Me dic a re Adva nta g e a nd Me dic a re Pa rt D ra te Anno unc e me nt a nd F ina l Ca ll L e tte r F a c t She e t. CMS Me dia Re la tio ns: April 1, 2019. https:/ / www.c ms.g o v/ ne wsro o m/ fa c t-she e ts/ 2020-me dic a re -a dva nta g e -a nd-pa rt-d-ra te - a nno unc e me nt-a nd-fina l-c a ll-le tte r-fa c t-she e t Ac c e sse d Aug ust 2, 2019.
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mple me nts a pro visio n o f a la w e na c te d in 2018 tha t mo difie s tha t re q uire me nt tha t Me dic a re Adva nta g e Pla ns o ffe r “prima rily he a lth re la te d” supple me nta l b e ne fits to a llo w pro visio n o f me a ls, tra nspo rta tio n se rvic e s a nd o the r ho me -b a se d se rvic e s o n a limite d b a sis to po te ntia lly he lp impro ve the he a lth o f c hro nic a lly ill Me dic a re b e ne fic ia rie s
Ma y he lp re duc e the b urde n o n so me Me dic a id de pa rtme nts tha t o fte n c o ve r
b e ne fits fo r so me indig e nt Me dic a re b e ne fic ia rie s
So urc e : 2020 Me dic a re Adva nta g e a nd Me dic a re Pa rt D ra te Anno unc e me nt a nd F ina l Ca ll L e tte r F a c t She e t. CMS Me dia Re la tio ns: April 1, 2019. https:/ / www.c ms.g o v/ ne wsro o m/ fa c t-she e ts/ 2020-me dic a re -a dva nta g e -a nd-pa rt-d-ra te - a nno unc e me nt-a nd-fina l-c a ll-le tte r-fa c t-she e t Ac c e sse d Aug ust 2, 2019.
Allo ws Me dic a re Adva nta g e to ha ve limite d a utho rity to use ste p the ra py
a nd prio r a utho riza tio n to ha ve fle xib ility to c o ve r c e rta in me dic a tio ns unde r Pa rt B o r Pa rt D
Me dic a re Adva nta g e pla ns g e ne ra lly must fo llo w Me dic a re Pa rt B re q uire me nts,
this pro visio n wa ive s this a utho rity to c o ve r so me pro duc ts, suc h a s b io simila rs, unde r Me dic a re Pa rt D
Allo ws fo r fo rmula ry indic a tio ns-b a se d pric ing a nd ne g o tia tio n Did no t imple me nt a pro po se d pro visio n to pro hib it pla ns fro m pla c ing
g e ne ric s o n a b ra nd tie r a nd re q uiring pla ns to pla c e g e ne ric s o n g e ne ric tie rs
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mple me nts a sta tuto ry re q uire me nt tha t Pa rt D pla ns do no t pro hib it pha rma c ists a nd pha rma c ie s fro m disc ussing lo we r c o st a lte rna tive s with pa tie nts a t the po int o f sa le
So urc e : 2020 Me dic a re Adva nta g e a nd Me dic a re Pa rt D ra te Anno unc e me nt a nd F ina l Ca ll L e tte r F a c t She e t. CMS Me dia Re la tio ns: April 1, 2019. https:/ / www.c ms.g o v/ ne wsro o m/ fa c t-she e ts/ 2020-me dic a re -a dva nta g e -a nd-pa rt-d-ra te - a nno unc e me nt-a nd-fina l-c a ll-le tte r-fa c t-she e t Ac c e sse d Aug ust 2, 2019.
DA will no t re tro a c tive ly na me le g a c y b io lo g ic pro duc ts with a ra ndo m fo ur le tte r hyphe na te d suffix a s de sc rib e d in a Ja nua ry 2017 fina l g uida nc e o n na ming
DA indic a te d tha t it will inc lude a hyphe na te d suffix with a ll ne w inno va to r b io lo g ic pro duc ts a nd b io simila rs mo ving fo rwa rd
pro duc t na me s in q ue stio n
So urc e : F
Upda te ; Dra ft Guida nc e fo r I
e de ra l Re g iste r: Ma rc h 8, 2019. https:/ / www.g o vinfo .g o v/ c o nte nt/ pkg / F R-2019-03-08/ pdf/ 2019-04242.pdf. Ac c e sse d Aug ust 2, 2019.
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ra nsitio na l pro duc ts inc lude g ro wth ho rmo ne s a nd insulins
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he se a re b io lo g ic pro duc ts a ppro ve d unde r the Pub lic He alth Se rvic e Ac t a nd inte g ra tio n into the b io lo g ic s pa thwa y wa s de la ye d until Ma rc h 2020 b y the Bio lo g ic s Pric e Co mpe titio n and I nno vatio n Ac t o f 2009
Be g inning in Ma rc h 2020, the se a g e nts will b e de e me d to b e inc lude d in the
b io lo g ic s pa thwa y a nd thus liste d in the F DA “Purple Bo o k” ra the r tha n the ”Ora ng e Bo o k”
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DA a nno unc e d tha t a ll a g e nts will b e inc o rpo ra te d a s o rig ina to r b io lo g ic s a nd ma y la te r b e sub je c t to b io simila r c o mpe titio n
Que stio ns pe rsist o n ho w this c ha ng e will impa c t pric ing a nd c o mpe titio n,
pa rtic ula rly fo r insulins
So urc e : Sta te me nt fro m F DA Co mmissio n Sc o tt Go ttlie b , MD, o n ne w a c tio ns a dva nc ing the a g e nc y’ s b io simila rs po lic y fra me wo rk. F DA Sta te me nt: De c e mb e r 11, 2018. https:/ / www.fda .g o v/ ne ws-e ve nts/ pre ss-a nno unc e me nts/ sta te me nt-fda -c o mmissio ne r- sc o tt-g o ttlie b -md-ne w-a c tio ns-a dva nc ing -a g e nc ys-b io simila rs-po lic y. Ac c e sse d Aug ust 2, 2019.
Cre a ting a nd Re sto ring E q ua l Ac c e ss to E q uiva le nt Sa mple s Ac t (CRE AT E S Ac t)
e b rua ry b y Se n. L e a hy (D-VT ) a nd H.R. 965 intro duc e d b y Re p. Ce c illine (D-RI)
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g e ne ric a nd b io simila r ve rsio ns
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re fe re nc e drug o r b io lo g ic a l pro duc t to suppo rt the ir a pplic a tio n
Cre a te s a c ivil c a use o f a c tio n fo r fa ilure to pro vide suffic ie nt q ua ntitie s o f a c o ve re d pro duc t
Dire c to r o f the F DA Ce nte r fo r Drug E va lua tio n a nd Re se a rc h te stifie d tha t so me ma nufa c ture rs ha ve use d RE MS a nd inte rna l distrib utio n re stric tio ns a s a re a so n no t to se ll pro duc t sa mple s to de ve lo pe rs
Re c e nt d ra ft le g isla tio n fro m Se na te He a lth, E d uc a tio n, L a b o r a nd Pe nsio ns inc lud e d a pro visio n to re mo ve the Unite d Sta te s Pha rma c o pe ia a s the sta nd a rd -se tting o rg a niza tio n fo r b io lo g ic mo no g ra phs
Inno va to r c o mpa nie s a nd F DA ha ve e xpre sse d suppo rt while pha rma c y g ro ups a nd o the rs e xpre sse d c o nc e rn
T he re is a q ue stio n o n whe the r sta nda rdiza tio n in mo no g ra phs he lp o r hurt a c c e ss to b io lo g ic s a nd the impa c t mo ving fo rwa rd
So urc e : We lc h AR. T he De b a te o n Bio lo g ic Sta nda rds He a ts Up. Bio simila r De ve lo pme nt: July 11, 2019. https:/ / www.b io simila rde ve lo pme nt.c o m/ do c / the -de b a te -o n-sta nda rds-in-b io lo g ic s-de ve lo pme nt-he a ts-up-0001. Ac c e sse d Aug ust 2 2019.