CONGRESSIONAL AND REGULATORY OUTLOOK AND ACTIVITIES IMPACTING - PowerPoint PPT Presentation

1/23/2018 CONGRESSIONAL AND REGULATORY OUTLOOK AND ACTIVITIES IMPACTING PHARMACY PHARMACY PROVIDE R ST AT US L E GISL AT ION JCPP member organization Alic ia K e rry Mic a , APhA Government Affairs Staff Ja nua ry 25, 2018 PROVIDE R ST AT US 115 th Co ng re ss – Re intro duc tio n o f the Pharmac y and Me dic ally U nde rse rve d Are as E nhanc e me nt Ac t POL IT ICAL PE RSPE CT IVE • Se na te – S. 109 – 50 c o spo nso rs AND OUT L OOK • Ho use – H.R. 592 – 242 c o spo nso rs K a rry L a Vio le tte , NCPA 4 1

1/23/2018 PAPCC GOVE RNME NT AF F AIRS ACT IVIT IE S  Co ntinua l disc ussio ns with c o mmitte e sta ff/ le a de rship  Me e ting s with the ne w a dministra tio n CONGRE SS AND HE AL T H CARE -  Gra ssro o ts a nd Me dia Ac tivitie s RE L AT E D ACT IVIT IE S  T a rg e te d Se na to rs  Vulne ra b le Ho use Me mb e rs  Que stio n fo r the Re c o rd fo r HHS Se c re ta ry No mine e Ale x Aza r Chris T o po le ski, ASHP 5 POT E NT I AL HE AL T H-RE L AT E D PAPCC NE XT ST E PS L E GI SL AT I ON: JANUARY 2017  Wo rk with le a d spo nso rs a nd c o mmitte e le a de rship o n ne xt ste ps a nd time line  ACA re pe a l/ re pla c e  Me dic a id re fo rm  Upc o ming PAPCC Org a niza tio n F ly-I ns  Me dic a re “e xte nde rs”  ASHP – Stude nt a nd Ne w Pra c titio ne r L e g isla tive Da y – Ja nua ry 27  SCHI  NACDS – RxI P re a utho riza tio n mpa c t Da y – Ma rc h 7-8  APhA – Stude nt Summe r L e a de rship Institute – July 13  UF As (PDUF A, GDUF A, BsUF A)  Drug pric ing b ills  Co ntinue to b uild c o -spo nso r suppo rt/ utilize full c o a litio n g ra ssro o ts 6 8 2

1/23/2018 L AWS PASSE D BY JANUARY 15, 2018 DRUG PRICING  ACA re pe a l/ re pla c e  Surg e in drug pric e s “o ld” drug is re b ra nde d  Me dic a id re fo rm  Hig h la unc h pric e s  Me dic a re “e xte nde rs”  Off pa te nt drug s with no g e ne ric e q uiva le nt  SCHI P re a utho riza tio n  Misuse o f RE MS to ma nipula te the ma rke t  UF As (PDUF A, GDUF A, BsUF A)  L a c k o f c o mpe titio n in g e ne ric ma rke t  Drug pric ing b ills  Que stio na b le pa te nt a rra ng e me nts 9 11 WHAT HAPPE NE D? DRUG PRICING L E GISL AT ION  30 b ills intro duc e d in Ho use a nd Se na te to da te  Afte r 7 ye a rs o f pushing fo r re pe a l, Re pub lic a ns didn’ t c o me to the ta b le with a c o mple te a nd a g re e d upo n re pla c e me nt to the ACA  Bills fa ll unde r o ne o r mo re o f the fo llo wing c a te g o rie s:  Co nse q ue ntly, 9 mo nths o f e ffo rts to pa ss so me thing , a nything , to  Impo rta tio n re pe a l the ACA  Dire c t F e de ra l g o ve rnme nt ne g o tia tio n  One -side d b ill, stra te g y wa s to re ly o nly o n Re pub lic a n Se na te vo te s a ll  F o ste ring c o mpe titio n a lo ng – c a n o nly a ffo rd to lo se 2 Se na to rs 10 12 3

1/23/2018 IMPORT AT ION AND PDUF A RE AUT HORIZAT ION  Se na to r Be rnie Sa nde rs (I -VT ) ha d a po te ntia l a me ndme nt tha t wo uld ha ve a llo we d pha rma c ie s, who le sa le rs a nd pa tie nts to impo rt pre sc riptio n drug s into the U.S. fro m Ca na da a nd o the r se le c te d E DUCAT ION ISSUE S c o untrie s  Ultima te ly o nly 3 a me ndme nts we re a tta c he d to PDUF A a nd the impo rta tio n a me ndme nt wa s no t o ffe re d o r disc usse d Je ffre y E ko ma , AACP 13 POT E NT IAL HE AL T H L E GISL AT ION 2018 PROSPE R ACT (H.R. 4508)  ACA sta b iliza tio n  Pro mo ting Re a l Oppo rtunity, Suc c e ss a nd Pro spe rity thro ug h  Me dic a id re fo rm E duc a tio n Re fo rm (PROSPE R Ac t)  Me dic a re “e xte nde rs”  Re po rte d o ut o f c o mmitte e (a lo ng pa rty line s)  SCHI P re a utho riza tio n  L e g isla tia ve ve hic le to re a utho rize the Hig he r E duc a tio n Ac t o f 1965  Drug pric ing b ills  340B Pro g ra m 14 16 4

1/23/2018 IMPL ICAT IONS F OR PHARMACY E DUCAT ION  E imina tio n o f a ll dire c t lo a n pro g ra ms; tra nsitio n to ONE lo a n pro g ra m  E limina tio n o f g ra dua te stude nt e lig ib ility fo r fe de ra l wo rk study  E limina tio n o f Gra dPL US AGE NCY ISSUE S AND UPDAT E  Gra dua te a g g re g a te lo a n limits (pe r 9-mo nth a c a de mic ye a r) - $41,000 CMS, F DA, DE A  Gra dua te a g g re g a te lo a n limits (pe r 12-mo nth a c a de mic ye a r) - $45,167  Co nso lilda tio n o f lo a n re pa yme nt pla ns into two (2) inc o me b a se d re pa yme nt (IBR) pla ns So umi Sa ha , AMCP  10-ye a r sta nda rd re pa yme nt Jo a n Ba ird, ASCP  IBR c a ppe d a t 15% o f inc o me  No lo a n fo rg ive ne ss Arnie Cla yma n, ASCP  Re pe a l o f De pt. o f E d. re g ula tio ns o n sta te a utho riza tio ns 17 WHAT S NE XT ? BI OSI MI L ARS  F DA – Dra ft I nte rc ha ng e a b ility Guida nc e  Se na te ve rsio n sla te d fo r re le a se e a rly 2017  CMS – Me dic a re Pa rt B Co ding & Re imb urse me nt  No c urre nt pla ns o n ne xt ste ps in the Ho use  Sta te Ac tivity  Jo int le tte r fro m F ASHP o rg a niza tio ns to Ho use E dua tio n a nd Wo rkfo rc e Co mmitte e  AACP c o o rdina ting re spo nse to the Co mmitte e 18 20 5

1/23/2018 ME DI CARE ADVANT AGE &  Me dic a re Co nditio ns o f Pa rtic ipa tio n (SOM) ME DI CARE PART D PROPOSE D RUL E  DRR/ MRR re c o mme nda tio n & a c tio n do c ume nta tio n in pa tie nt me dic a l Me dic a tio n Be ne fit De sig n & Drug Ma na g e me nt re c o rd T he ra py Utiliza tio n Pro g ra ms  Antib io tic Ste wa rdship: syste ms to Ma na g e me nt Ma na g e me nt mo nito r use ; a ntib io tic pro to c o ls HI T & Da ta F ra ud, Wa ste , & T HE “ME GARUL E ” Any Willing Pro vide r I nte ro pe ra b ility Ab use 21 23  Me dic a re Co nditio ns first pub lishe d in 1989  Se t sta nda rds fo r he a lth c a re a nd sa fe ty  F ir st c ompr e he nsive update sinc e 1991 CMS – Re fo r m o f Re quir e me nts fo r  Pro po se d rule pub lishe d July, 2015  CMS r e c e ive d ne ar ly 10,000 c omme nts L o ng-T e r m Car e F ac ilitie s  F ina l rule pub lishe d Oc to b e r 4, 2016  Phase d Imple me ntation  Pha se 1 – 11/ 28/ 2016  Phase 2 – 11/ 28/ 2017  Pha se 3 – 11/ 28/ 2019 T HE “ME GARUL E ” 22 T HE “ME GARUL E ” – BACK GROUND I NF O 24 6

1/23/2018  Phase 1 – I MPACT ACT 2014  Do c ume nta tio n o f DRR re c o mme nda tio ns a nd “IMPROVING ME DICARE POST -ACUT E CARE T RANSF ORMAT I ON ACT ” pre sc rib e r re spo nse  Upda te s de finitio n o f me dic a tio n “irre g ula rity”  Phase 2 -  Antib io tic Ste wa rdship Pro g ra m  Re -de fine s “psyc ho tro pic drug s”  PRN a ntipsyc ho tic & psyc ho tro pic drug rule s (14 da ys)  “F -T AGS” RE -NUMBE RE D 25 T HE “ME GARUL E ” – K E Y PHARMACY CHANGE S I MPACT ACT 2014  On 11/ 24/ 17, just prior to Phase 2 imple me ntation, CMS r e le ase d a me mo to sur ve yor s  Sta nda rdize d pa tie nt a sse ssme nt da ta a c ro ss a ll fo ur PAC se tting s –  An 18-mo nth te mpo ra ry mo ra to rium o n impo sing Qua lity Me a sure s De fine d b y CMS e nfo rc e me nt re me die s fo r c e rta in Pha se 2  De fine s PAC pro vide rs to inc lude : Home He alth Age nc ie s, L T ACHs, re q uire me nts, inc luding Be ha vio ra l He a lth Se rvic e s SNF s a nd IRF s (F 740), Psyc ho tro pic Me dic a tio ns (F 758), Antib io tic  Re q uire s PAC pro vide rs to re po rt sta nda rdize d pa tie nt a sse ssme nt Ste wa rdship Pro g ra m (F 881), a s we ll a s 5 o the r da ta b y Oc to b e r 2018 a re a s o f c a re  Do c ume nta tio n o f Me dic a tio n Re c o nc ilia tio n a t Admissio n & Disc ha rg e  He a lth I nspe c tio n Sta r Ra ting s F ro ze n fo r o ne ye a r  Co mmunic a tio n o f “Me d Re c ” to  Pa tie nt T HE “ME GARUL E ” – NE W  F a mily  Prima ry Ca re Do c DE VE L OPME NT S  Co mmunity Pha rma c y 26 7