CONGRESSIONAL AND REGULATORY OUTLOOK AND ACTIVITIES IMPACTING - - PowerPoint PPT Presentation

1/23/2018 1

CONGRESSIONAL AND REGULATORY OUTLOOK AND ACTIVITIES IMPACTING PHARMACY

JCPP member organization Government Affairs Staff

Ja nua ry 25, 2018

POL IT ICAL PE RSPE CT IVE AND OUT L OOK

K a rry L a Vio le tte , NCPA

PHARMACY PROVIDE R ST AT US L E GISL AT ION

Alic ia K e rry Mic a , APhA

115th 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

• Se na te – S. 109 – 50 c o spo nso rs
• Ho use – H.R. 592 – 242 c o spo nso rs

PROVIDE R ST AT US 4

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 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  Gra ssro o ts a nd Me dia Ac tivitie 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

PAPCC GOVE RNME NT AF F AIRS ACT IVIT IE S 5

 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

 Upc o ming PAPCC Org a niza tio n F

ly-I ns

 ASHP – Stude nt a nd Ne w Pra c titio ne r L

e g isla tive Da y – Ja nua ry 27

 NACDS – RxI

mpa c t Da y – Ma rc h 7-8

 APhA – Stude nt Summe r L

e a de rship Institute – July 13

 Co ntinue to b uild c o -spo nso r suppo rt/ utilize full c o a litio n g ra ssro o ts

PAPCC NE XT ST E PS 6 CONGRE SS AND HE AL T H CARE

• RE

L AT E D ACT IVIT IE S

Chris T

• po le ski, ASHP

 ACA re pe a l/ re pla c e  Me dic a id re fo rm  Me dic a re “e xte nde rs”  SCHI

P re a utho riza tio n

 UF

As (PDUF A, GDUF A, BsUF A)

 Drug pric ing b ills

POT E NT I AL HE AL T H-RE L AT E D L E GI SL AT I ON: JANUARY 2017

8

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 ACA re pe a l/ re pla c e  Me dic a id re fo rm  Me dic a re “e xte nde rs”  SCHI P re a utho riza tio n  UF As (PDUF A, GDUF A, BsUF A)  Drug pric ing b ills

L AWS PASSE D BY JANUARY 15, 2018

9

 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

 Co nse q ue ntly, 9 mo nths o f e ffo rts to pa ss so me thing , a nything , to

re pe a l the ACA

 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

a lo ng – c a n o nly a ffo rd to lo se 2 Se na to rs

WHAT HAPPE NE D? 10

 Surg e in drug pric e s “o ld” drug is re b ra nde d  Hig h la unc h pric e s  Off pa te nt drug s with no g e ne ric e q uiva le nt  Misuse o f RE

MS to ma nipula te the ma rke t

 L

a c k o f c o mpe titio n in g e ne ric ma rke t

 Que stio na b le pa te nt a rra ng e me nts

DRUG PRICING 11

 30 b ills intro duc e d in Ho use a nd Se na te to da te  Bills fa ll unde r o ne o r mo re o f the fo llo wing c a te g o rie s:

 Impo rta tio n  Dire c t F

e de ra l g o ve rnme nt ne g o tia tio n

 F

• ste ring c o mpe titio n

DRUG PRICING L E GISL AT ION 12

1/23/2018 4

 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 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

IMPORT AT ION AND PDUF A RE AUT HORIZAT ION 13

 ACA sta b iliza tio n  Me dic a id re fo rm  Me dic a re “e xte nde rs”  SCHI

P re a utho riza tio n

 Drug pric ing b ills  340B Pro g ra m

POT E NT IAL HE AL T H L E GISL AT ION 2018 14 E DUCAT ION ISSUE S

Je ffre y E ko ma , AACP

Pro mo ting Re a l Oppo rtunity, Suc c e ss a nd Pro spe rity thro ug h

E duc a tio n Re fo rm (PROSPE R Ac t)

 Re po rte d o ut o f c o mmitte e (a lo ng pa rty line s)  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

PROSPE R ACT (H.R. 4508) 16

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 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

 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  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

 10-ye a r sta nda rd re pa yme nt  IBR c a ppe d a t 15% o f inc o me  No lo a n fo rg ive ne ss

 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

IMPL ICAT IONS F OR PHARMACY E DUCAT ION 17

 Se na te ve rsio n sla te d fo r re le a se e a rly 2017  No c urre nt pla ns o n ne xt ste ps in the Ho use  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

WHAT S NE XT ? 18 AGE NCY ISSUE S AND UPDAT E CMS, F DA, DE A

So umi Sa ha , AMCP Jo a n Ba ird, ASCP Arnie Cla yma n, ASCP

BI OSI MI L ARS

 F

DA – Dra ft I nte rc ha ng e a b ility Guida nc e

 CMS – Me dic a re Pa rt B Co ding & Re imb urse me nt  Sta te Ac tivity

20

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ME DI CARE ADVANT AGE & ME DI CARE PART D PROPOSE D RUL E

21

Drug Ma na g e me nt Pro g ra ms Me dic a tio n T he ra py Ma na g e me nt Be ne fit De sig n & Utiliza tio n Ma na g e me nt HI T & Da ta I nte ro pe ra b ility F ra ud, Wa ste , & Ab use Any Willing Pro vide r

T HE “ME GARUL E ”

CMS – Re fo r m o f Re quir e me nts fo r L

• ng-T

e r m Car e F ac ilitie s

22

T HE “ME GARUL E ”

Me dic a re Co nditio ns o f Pa rtic ipa tio n

(SOM)

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 re c o rd

Antib io tic Ste wa rdship: syste ms to

mo nito r use ; a ntib io tic pro to c o ls

23 T HE “ME GARUL E ” – BACK GROUND I NF O

 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

 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

 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

24

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T HE “ME GARUL E ” – K E Y PHARMACY CHANGE S

 Phase 1 –  Do c ume nta tio n o f DRR re c o mme nda tio ns a nd

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 ” – NE

W

DE VE L OPME NT S

 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

 An 18-mo nth te mpo ra ry mo ra to rium o n impo sing

e nfo rc e me nt re me die s fo r c e rta in Pha se 2 re q uire me nts, inc luding Be ha vio ra l He a lth Se rvic e s (F 740), Psyc ho tro pic Me dic a tio ns (F 758), Antib io tic Ste wa rdship Pro g ra m (F 881), a s we ll a s 5 o the r a re a s o f c a re

 He a lth I

nspe c tio n Sta r Ra ting s F ro ze n fo r o ne ye a r

26

I MPACT ACT 2014

“IMPROVING ME DICARE POST

• ACUT

E CARE T RANSF ORMAT I ON ACT ”

I MPACT ACT 2014

 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 –

Qua lity Me a sure s De fine d b y CMS

 De fine s PAC pro vide rs to inc lude : Home He alth Age nc ie s, L

T ACHs, SNF s a nd IRF s

 Re q uire s PAC pro vide rs to re po rt sta nda rdize d pa tie nt a sse ssme nt

da ta b y Oc to b e r 2018

 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

 Co mmunic a tio n o f “Me d Re c ” to

 Pa tie nt  F

a mily

 Prima ry Ca re Do c  Co mmunity Pha rma c y

1/23/2018 8

IMPACT ACT ST ANDARDIZAT ION

I npa tie nt Re ha b ilita tio n F a c ilitie s - Pa tie nt Asse ssme nt I nstrume nt (I RF

• PAI

)

I RF

• PAI

Skille d Nursing F a c ilitie s - Minimum Da ta Se t (MDS)

MDS

Ho me He a lth Ag e nc ie s - Outc o me & Asse ssme nt I nfo rma tio n Se t (OASI S)

OASI S

L

• ng -T

e rm Ca re Ho spita ls - Co ntinuity Asse ssme nt Re c o rd & E va lua tio n (CARE ) Da ta Se t (L CDS)

L CDS

Me dic ation Re c onc ilia tion Me dic ation Re c onc ilia tion Me dic ation Re c onc ilia tion Me dic ation Re c onc ilia tion

Quality Domain SNF Due Date

F unc tio na l Sta tus Oc to b e r 2016 Skin I nte g rity Oc to b e r 2016 Me dic a tio n Re c o nc ilia tio n Oc to b e r 2018 Ma jo r F a lls Oc to b e r 2016 Pa tie nt Pre fe re nc e Oc to b e r 2018

ST ANDARD DAT A COL L E CT I ON T I ME L I NE ASCP DE A T ASK F ORCE

ASCP e sta b lishe d its DE

A T a sk F

• rc e in 1998 to a ddre ss

a mb ig uitie s within the CSA

 Ho spita l vs. Co mmunity vs. L

T C Pha rma c y

 CSA a nd the pra c tic e sta nda rds o f L

T CPs re pre se nte d a po te ntia l “re g ula to ry c o mplia nc e risk”

 DE

A T a sk F

• rc e - missio n o f wo rking with the DE

A to re so lve issue s a nd c ha lle ng e s - Ba la nc e pa tie nt c a re vs. re g ula to ry c o mplia nc e

 Ove r the ye a rs, c ha ng e s ma de to DE

A re g ula tio ns suc h a s time re q uire d fo r fo llo w-up writte n Rx fo r ve rb a l CI I

• rde rs a nd fa xing
• f CI

I Rx’ s

T a sk F

• rc e – wo rking dire c tly with DE

A sta ff sinc e 2015 o n list o f issue s, fo c use d o n Nurse Ag e nc y issue .

Issue s R e solve d: Obtaine d wr itte n c lar ific ation fr

• m DE

A:

 E

le c tro nic e -kits: use fo r 1st do se o nly do not re q uire se pa ra te DE A re g istra tio n (11/ 30/ 16).

Compr e he nsive Addic tion & Re c ove r y Ac t (CARA)

 DE

A Cla rific a tio n: CARA 30-da y fill limita tio n doe s not a pply to lo ng -te rm c a re a nd ho spic e pa tie nts (1/ 13/ 17)

 DE

A ve rifie d, pa rtia l-fills fo r CI I pre sc riptio n me dic a tio ns with up to 60-da ys to c o mple te .

ASCP- DE A T ASK F ORCE UPDAT E

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CURRE NT NURSE AGE NT OVE RVI E W

 Author

ity of Age nt (unde r c ur r e nt DE A guidanc e )

 Pre pa re CI

I

• CV pre sc riptio n fo r pra c titio ne r to sig n

 T

ra nsmit CI I

• CV pre sc riptio n tha t is sig ne d b y pra c titio ne r to pha rma c y via fa x

 T

a ke a ve rb a l CI I I

• CV pre sc riptio n fro m the physic ia n a nd c o mmunic a te tha t

pre sc riptio n via te le pho ne to the pha rma c y  Age nts ar

e e mploye d by the author ize d pr e sc r ibe r and may be :

 A nurse lo c a te d in the pre sc rib e rs o ffic e  A no n-lic e nse d re c e ptio nist  Ho spita l e mplo ye e s (b / c ho spita ls a re DE

A re g istra nts)

 NOTL

T CF Nurse s fo r CDS. Nurse s in a fa c ility to da y re ma in the

a g e nt o f the pre sc rib e r fo r no n-c o ntro lle d me dic a tio ns

CURRE NT NURSE AGE NT OVE RVI E W

 Oc to b e r 6, 2010 DE

A issue s Po lic y Sta te me nt tha t a ddre sse d the nurse a s a n a g e nt o f the pre sc rib e r

 L

T CF e mplo ye e s ma y b e c o me a g e nts b ut o nly thro ug h a ve ry pre sc riptive a nd de ta ile d pro c e ss tha t do c ume nts suc h de le g a tio n

 E

a c h Nurse must b e c o ntra c te d with e a c h pre sc rib e r a nd the pha rma c y a nd the fa c ility must ma inta in re c o rds o f a ll c o ntra c ts

 ASCP DE

A-T F Re c o mme nde d tha t DE A issue a re vise d Nurse Ag e nt Po lic y whic h spe c ific a lly a ddre sse s a n a lte rna tive po lic y a ppro a c h fo r the L T C se tting

 Co ntinue d me e ting s with DE

A in 2018 (Cha rt Orde rs, e tc )