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  Pha rma c ist a nd la wye r  Pha rma c e utic a l po lic y e xpe rt with mo re tha n 20 ye a rs e xpe rie nc e  Co nsulting  Co rpo ra te  Asso c ia tio n ma na g e me nt

Pr e se ntation Ove r vie w  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 o we r Drug Pric e s a nd Sub se q ue nt Ac tio ns  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 o o d a nd Drug 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  I 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

Pr e se ntation Ove r vie w  F e de r a l a nd Sta te Dr ug Pr ic ing Initia tive s  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  T 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 o we r 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.

Pr e se ntation Ove r vie w  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  L e g a l a c tio ns  T 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

Pr e se ntation Ove r vie w  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

Pr e se ntation Ove r vie w  Compe titive Mar ke tplac e : Biosimilar s and Ge ne r ic s  F o o d a nd Drug Administra tio n (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  L 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  T 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

F e de ra l a nd Sta te Drug Pric ing I nitia tive s

2018 Blue print to L o we r Drug Pric e s a nd Re duc e Out-o f-Po c ke t Co sts  Re le a se d b y Administra tio n o n Ma y 11, 2018  I 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  Co nta ine d do ze ns o f sug g e stio ns a nd po lic y pro po sa ls o n ho w sta ke ho lde rs thro ug ho ut the he a lth c a re syste m c a n a ddre ss the issue o f hig h drug c o sts  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

Pillars of the Blueprint I nc re a se d ma rke t Be tte r I nc e ntive s fo r L o we r Out-o f- c o mpe titio n Ne g o tia tio n L o we r L ist Pric e s Po c ke t Co sts

T rump Administra tio n E ffo rts to L o we r Drug Pric e s: Pro po se d Re b a te Rule --Re sc inde d  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  I nc re a se d pre mium c o st fo r Me dic a re b e ne fic ia rie s  I 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

T rump Administra tio n Pathway 1: State s, pharmac ists, and whole sale rs E ffo rts to L o we r  Must sub mit pla n to F DA Drug Pric e s  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 HHS/ F DA Safe q ua lity, re c o rd ke e ping a nd pro duc t te sting with furthe r de ta il o utline d in future no tic e o f pro po se d rule ma king (NPRM) Importation Ac tion  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 Plan Pathway 2: Manufac ture r importation of forfe it produc ts with F DA e quivale nts in the Unite d State s Re le a se d o n  F o re ig n a nd Unite d Sta te s pro duc ts c o uld ha ve diffe re nt na tio na l drug c o de s (NDCs) Aug ust 1, 2019 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

T rump Administra tio n E ffo rts to L o we r Drug Pric e s: I nte rna tio na l Pric ing I nde x (I PI ) fo r Me dic a re Pa rt B c o ve re d pro duc ts  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 o the r c o untrie s plus a n a dd o n fo r ho spita l a nd do c to r fe e s  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 o re ig n F re e lo a ding . Oc to b e r 25, 2018.

 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 T rump Administra tio n $35 o r mo re E ffo rts to L o we r Drug  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 Pric e s 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 T r a nspa r e nc y in disc lo se pric e s Dir e c t- to- Consume r  Did no t rule o n F irst Ame ndme nt pro visio ns Adve r tising  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 HHS Rule F ina lize d in  So me c o mpa nie s c o ntinue to re le a se pric ing in Ma y 2019; F e de ra l a dve rtise me nts judg e inva lida te d in  Critic s fo und tha t pric e disc lo sure s no t a lwa ys re lia b le July 2019 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.