OEISAdvocacyUpdateWhatisOEISandtheCVCdoingforyou?

JeffreyG.Carr,MD,FACC,FSCAIPastPresident-OEIS,BoardMember-CardiovascularCoaliKon

DISCLOSURES

I have the following potential conflicts of interest to report:

None pertaining to this presentation

Faculty/Consulting/Speaking: Medtronic, Cardiovascular Systems Inc, Spectranetics, Avinger, Astra Zeneca, National Cardiovascular Partners/Fresenius, Philips/Volcano, Abbott

Research: Medtronic, Boston Scientific, Cardiovascular Systems Inc, Spectranetics, Astra Zeneca, Veryan Medical, Novartis, Advanced Cardiovascular Therapies, St Jude, Rex Medical

BACKGROUNDOFOEISADVOCACY:

2013—NOREPRESENTATION—NOUNDERSTANDINGOFPADORPVI

LOOMINGCUTSUPTO51%INOFFICELABS--MPFS2014CVCANDGRASSROOTSEFFORTSFORMED-

STAVEDOFFCUTS

CardiovascularCoaliKon

WhoistheCardioVascularCoaliKon?

USSitesforOfficeIntervenKonalSuitesCardiovascular Coalition Members (as of Feb 2018)

OutpaKentatherectomyoutcomesmaybe“worsethanthenaturalhistoryofdisease”

7thAugust2017Atherectomyforocclusivediseaseinthefemoral-poplitealand6bial-peronealsegmentsforclaudica6oninoutpa6entse9ngsmayresultinoutcomesworsethanthenaturalhistoryofthedisease,accordingtodatapresentedatthe2017VascularAnnualMee6ng(VAM;30May–3June,SanDiego,USA).DipankarMukherjee(FallsChurch,USA),whopresentedthedata,alsotoldVAMdelegates,“OurstudysupportsthepreviouslymadeobservaKonthatrepeatintervenKonsresultinworseoutcomes.”ThestudywasinspiredbythecombinaKonof“massiveincrease”inoutpaKentatherectomy,especiallyinofficesedngswithpoorlyunderstoodoutcomes.Thestudyincludedreal-worldresultsofclaudicaKonforinfrainguinalocclusivediseaseasdeterminedfromMedicareclaims-baseduKlizaKondata—thefirststudytodoso.PaKentsincludedintheanalysisunderwenteitherafemoropopliteal(n=924)orKbial-peroneal(n=423)atherectomybetweenJanuary2012andJune2013.AllwereanalyzedforrepeatintervenKonwithin12monthsofthefirstprocedure.Ofthe924femoropoplitealatherectomypaKents,28.4%(n=262)weretreatedinanofficesedng,ofwhich40.1%underwentarepeatintervenKons.Theremaining71.6%(n=662)werehospitaloutpaKents,ofwhich31.6%underwentrepeatintervenKon.TheproporKonoftheoffice-basedfemoropoplitealatherectomypaKentsneedinganylowerextremityamputaKonwas2.7%,comparedwith4.8%inthehospitaloutpaKentgroup.TherateofanymajorloweramputaKonwas1.9%foroffice-basedpaKentsand2.9%forhospitaloutpaKents.MukherjeealsonotedthatrepeatintervenKonswereassociatedwithworseoutcomes—amputaKonrateforallpaKentsaleronerepeatintervenKonwas7%,risingto8.9%alertwoormore.TheKbial-peronealatherectomygroupwascomprisedof423paKents.Ofthese,47.8%(n=202)underwentoffice-basedtreatments,ofwhich44.6%requiredrepeatintervenKon.Theother52.2%(n=221)weretreatedashospitaloutpaKents,and34.8%underwentrepeatintervenKon.Oftheoffice-basedpaKents,therateofneedforanylowerextremityamputaKonwas4.4%,comparedwith10.4inthehospitaloutpaKentgroup.TherateofrequiredmajorlowerextremityamputaKonwas3%foroffice-basedpaKentsand7.2%forhospitaloutpaKents.

MukherjeecomparedtheseoutcomestothenaturalhistoryofclaudicaKon,explainingthatpre-1980studiesdocumentedacumulaKveamputaKonrateof11%over10yearsatapproximately1%peryear.Morerecentstudieshaveshownsimilarrates,withapproximately30%ofpaKentsexperiencingsymptomaKcdeterioraKonoverKme.“LowanklebrachialindexanddiabeteshavebeenassociatedwiththedevelopmentofischemicrestpainandischemiculceraKon,”Mukherjeesaid,“andallpriorstudiesconfirmlowamputaKonratesbuthighmortalityrates.”

Mukherjeepointedtoa2013study(Jonesetal)onthegrowingimpactofrestenosisonthesurgicaltreatmentofperipheralarterydisease,inwhichsecondaryrevascularizaKonalerfailedpreviousintervenKonforclaudicaKonincreasedfrom13%to22%overeightyears.Thisrepresentsa“treatmentgap”,Mukherjeesaid,bywhicheachsubsequentintervenKon—foraniniKallybenigndisease—producesworseoutcomes.Furthermore,theBASIL-1trialshowedthatbypassfollowingthefailureofendovasculartreatmentwassignifcantlylesssuccessfulthanprimarybypass,showingthat“endovascularisnotafreeshot,”Mukherjeesaid.“Theresultssuggestthatatherectomyforocclusivediseaseinthefemoral-poplitealandKbial-peronealsegmentswhendoneforclaudicaKonintheofficeandhospitaloutpaKentsedngsresultsinoutcomesworsethanthenaturalhistoryofthedisease,”Mukherjeetoldtheaudience.“WerecommendaprospecKvestudytoconfirmtheabovemenKonedfindingsandcauKonoperatorsthatourfirstresponsibilitytothepaKentsisto‘donoharm

StatewideandRegionalConcerns

2017Florida—FirstCoast--MAC

Severelylimitreimbursement:Arterialandvenous--TibialintervenKonsforIC--Off-labelintervenKons--IVUSinPAD

Advocacy:--StrongleoersfromOEIS,CVCand

specialtysocieKes--ConferencecallwithOEISandState MedicalDirector

InvesKgaKonsandCMSPenalKes

Severaloffice-basedintervenKonists****PVIClaimsdenied****

27-40claimseachfor2015-2016 $400-600,000inclaims Texas,Nevada,Illinois,Florida

Incommon:•  NodocumentaKonofwalkingdistances•  NodocumentaKonofmaxmedicaltherapy•  NodocumentaKonofsupervisedexercise

program•  NoparKcipaKoninaRegistry

PennsylvaniaDept.OfHealthLePertoOfficeandOutpa6entPrac66oners

JAN12,2018

“GuidancetoPerformPeripheralVascularAccessProceduresinAmbulatorySurgicalFacili6esWhereCertainSurgeriesMayViolate§551.21(d).”

(Excerpted)•Surgicalproceduremaynotbeofatypethat:1)Areassociatedwiththeriskofextensivebloodloss;and3)Directlyinvolvemajorbloodvessels.

March 19, 2018

Nancy Lescavage Deputy Secretary for Quality Assurance PA Department of Health 625 Forster Street Room 532 H & W Bldg. Harrisburg, PA 17120-0701 Dear Deputy Secretary Lescavage: On behalf of members of the Dialysis Vascular Access Coalition and the CardioVascular Coalition, we are writing to express our concerns regarding a January 12, 2018 document released by the Pennsylvania Department of Health (PA DOH) entitled, “Guidance to Perform Peripheral Vascular Access Procedures in Ambulatory Surgical Facilities Where Certain Surgeries May Violate §551.21(d).” The PA DOH document sets forth guidance relating to exception requests to 28 Pa. Code § 551.21(d)(1) & (3). Regulations at 28 Pa. Code § 551.21(d)(1) & (3) read (in relevant part):

• Surgical procedures may not be of a type that: o 1) Are associated with the risk of extensive blood loss; and o 3) Directly involve major blood vessels.

We believe these regulations are outdated in the case of vascular access and lower extremity revascularization procedures, given overwhelming evidence that these services may be safely performed in Ambulatory Surgical Facilities (ASFs). It is only through “exception requests” to these regulations that Pennsylvania patients have been able to benefit from the aforementioned services in the ASF setting for a number of years. The recent guidance relating to these exception requests provided in the January 12, 2018 PA DOH document provides significant restrictions on performance of these procedures in the ambulatory setting. In reviewing the letter, we are deeply concerned that these restrictions will (1) likely result in increased patient mortality, (2) limit access to healthcare in underserved areas, (3) result in markedly increased patient copays for the same services, (4) unnecessarily cause greater expenditures (given the significantly higher cost of providing these services in the hospital setting), (5) shift thousands of procedures to the hospital setting (thereby overwhelming their capacity), and (6) harm local economies (please see Addendum I for additional information). Each year in the United States, hundreds of thousands of dialysis vascular access and peripheral vascular procedures are performed in the office setting, and more than 60% of dialysis vascular access procedures are performed outside of hospitals. Supported with current and robust clinical peer reviewed literature, these procedures are performed in an ambulatory setting safely with superior outcomes and increased patient satisfaction at a fraction of the cost of hospital-based

LeoertoPenn.Dept.ofHealth-Mar19,2018

“Inreviewingtheleoer,wearedeeplyconcernedthattheserestricKonswill:

(1) likelyresultinincreasedpaKentmortality,

(2) limitaccesstohealthcareinunderservedareas,

(3) resultinmarkedlyincreasedpaKentcopaysforthesameservices,

(4) unnecessarilycausegreaterexpenditures(giventhesignificantlyhighercostofprovidingtheseservicesinthehospitalsedng),

(5) shilthousandsofprocedurestothehospitalsedng(therebyoverwhelmingtheircapacity),

(6) harmlocaleconomies“ excerptedfromLeoertoPenn.DOH,Mar19,2018

AdvocacyontheHill

CVCCongressionalLeoertoSecretariesofCMSandVA

FourKeyStrategiestoRacetoZero(amputaKons):

1. IncreasePADawareness2. IncreasePADscreeningforatriskpaKents3. NoamputaKonwithoutarterialtesKng4. MulKdisciplinarycare

PressreleaseCardiovascularCareCommunityApplaudsLawmakersfor

UrgingAdministra6ontoMakeUnnecessaryAmputa6onsaThingofthePast

Bipar&sangroupoflawmakerscallforana&onalstrategytoreducenon-trauma&camputa&onstozero

• Washington–TheCardioVascularCoali6on(CVC)todayapplauded32membersoftheU.S.HouseofRepresenta6vesforurgingtheDepartmentofHealthandHumanServicesandtheVeteransHealthAdministra6ontoadoptana6onalstrategytoreducenon-trauma6camputa6onsthroughincreasedawarenessofperipheralarterydisease(PAD),increasedscreeningsforatriskpopula6ons,andimprovedaccesstomul6disciplinarycare.

Who Is Listening

CONGRESSWOMAN ROBIN KELLYLiked a thank you post by the CVC and followed CVC on Twitter

AMERICAN JOURNAL OF MANAGED CARELiked a post by the CVC on Twitter

NEW BRUNSWICK NAACPLiked a post by the CVC on Twitter

SOCIETY FOR VASCULAR ULTRASOUND Liked a post by the CVC on Twitter

UNIVERSITY OF KENTUCKY VASCULARShared a post by CVC on Twitter

COMMONWEALTH CARE ALLIANCEShared a post by CVC on Twitter

DR. KUMAR MADASSERYInterventional Radiologist at Rush University Medical Center Liked a post by CVC on Twitter

PUBLIC HEALTH LAW WATCHLiked a post by CVC on Twitter

Pulse Check: February 2018

This pulse check is brought to you by Schmidt Public Affairs.

Vital Signs

Under the MicroscopeThis month’s digital media highlights

Social media advertisements were launched to thank Rep. Paulsen and Rep. Payne for their leadership on the amputation letter to the HHS and the Veterans Health Administration. The promoted posts reached over 30,000 impressions in their Congressional districts.

56,544Online views of

CVC content

275Online interactions

with CVC

3,860Online community members, up 65

from January

Digital Scan

LET’S MAKE UNNECESSARY AMPUTATIONS A THING OF THE PASTMorning ConsultFebruary 13, 2018

What Influencers Are Saying

“I applaud the bipartisan lawmakers in Congress who are calling for a robust, comprehensive, nationwide strategy to “sprint to zero” for non-traumatic amputations and encourage others to lend their voice to this effort.”

DR. JEFFREY CARR, MORNING CONSULT

THE CARDIOVASCULAR COALITION THANKSCongressman Donald Payne Jr.

Twitter Post

Twitter Advertisement

Start Date: February 8, 2018Number of Views by Indvidiuals in NJ-10: 16,497Number of Engagements from Indvidiuals in NJ-10: 198

2017LawmakerTourOutreach

2017FacilityTourTargetsCongressionalBlackCaucus

MedicalTechnologyCaucus

MaxineWaters AnnaEshoo*

JohnLewis* RaulRuiz*

SanfordD.BishopJr. DebbieDingell*

BrendaL.Lawrence EliotL.Engel*

GregoryW.Meeks RobertA.Brady

SheilaJacksonLee

Energy&CommerceCommiPee

Ways&MeansCommiPee

AnnaEshoo* JudyChu

RaulRuiz* JohnLewis*

DebbieDingell* PeterJ.Roskam

EliotL.Engel* JosephCrowley

PeteOlson KevinBrady

BillFlores KennyMarchant

SamJohnson

LloydDoggeo

SenateFinanceCommiPee

JohnMcCain DebbieStabenow

DianneFeinstein ChuckSchumer

BillNelson RichardBurr

JohnIsakson BobCasey,Jr.

DickDurbin LamarAlexander

PatRoberts JohnCornyn

DavidCassidy MarkWarner

AdvocacywithCMS

QualityMeasuredevelopment-CMSQualityandStandardsCommioee

PADMeasuresetislackingOpportuniKesforOEISNaKonalRegistryQualifiedClinicalDataRegistry

PeripheralVascularDiseaseManagementSubcommiPee-

AssistthedevelopmentofcareepisodeandpaKentcondiKon groupsforCostMeasures(MACRA)-Dr.RichardGrayCVC

representaKve

NewcodesforCADinASC

Ini6a6veswithCMS

CVC Social Engagement

5K+TwiPerFollowers!

StandingTALLCampaignObjecKves

•  RaiseawarenessonamputaKondispariKesamongAfricanAmericanandotherminoritycommuniKes.

•  Getpeopleenergized!

ItisuptoustoENDracialdispariKesamongamputeesinAmerica.

•  Leverageresponsetoadvancepro-paKentpoliciestoreduceamputaKons.

StandingTALLPartnerOutreach

PromotedPADAwarenessMonthSeptember

CurbLimbLossinAmerica

ByJackRichmond,AmputeeCoaliHon

It�s6meforAmericanstounderstandPeripheralArtery

Disease

ByDr.JeffCarr,CardioVascularCoaliHon

OPINION Let�s Make Unnecessary Amputations a

Thing of the Past BY JEFFREY CARR FEBRUARY 13, 2018

MEDCACMeeKng2015onPADPhysicianFeeSchedule-CommentLeoersMACRAProposedRule-CommentLeoerLERevascularizaKonEpisode-CMSMeeKngandCommentLeoerCongressionalLeoersenttoCMSre.PADIniKaKvesCVCRepresentaKononPADEpisodeCostUSPSTF-LeoerrePADscreeningFirstCoastLCDrePVIPADeptofHealthLeoerrePVICareDozensofOp-eds,arKclesandmediapublishedHillBriefingsonPADPADAwarenessMonthCBCAnnualHealthBrainTrustMeeKngSocialMedia/TwioerMonthlyNewsleoers/WebsiteIntersocietalandStakeholderNetworking

CVCACCOMPLISHMENTS:

CVCACTIVITIESIN2017-2018Campaigns:

PADMonth—SeptemberStandingTallPADCongressionalLeoer–SponsorsWaysandMeansMeeKngsAmpPrevenKon-QualityMeasures/SafetyMeasures

PromoKonandEducaKon:

CongressionalfacilitytoursPublicaKonsTwioerStakeholderNetworking

CURRENTPOLICYTHREATSANDCONCERNS

SiteNeutralityTrendsMACRA-MIPSandNewAPMsLERevascCodes-rereviewedACARepealandReplaceMACLCDsStateDeptofHealthDCBCoverageinPOS11PaucityofdataforLEPVIintervenKons

VisitcardiovascularcoaliKon.org

VisitCVCboothtoday

NowistheKmetobeengaged

NowistheKmetobeheard

WeneedacKon—Doyourpart

THANKYOU