MARCH I 2012 I VOL 2

NE

WS

LE

TT

ER

d e p u y . c o m / i n t o u c h

2

3

5

6

HEALIX KNOTLESS™ANCHOR: My ExperienceRichard L. Angelo, MD

MANAGINGTHROUGH CHANGES: Payment and Policy ImpactsWilliam R. Beach, MD& Louis F. McIntyre, MD

A NEW ERA FORHEALTHCARE POLICY Samir K. Bhattacharyya, PhD

AN INNOVATIONIN PARTIAL THICKNESS REPAIRS Ron Farkash, BSME

Welcome

1

Dear Customer,

Welcome to the second edition of INTOUCH - our new digital newsletter aimed at reaching out to you, our valued surgeon

customer. I want to start by thanking those amongst you that took the time to visit our website - www.depuy.com/intouch

- to checkout our digital content from the first edition of INTOUCH. We were overwhelmed by the number of people that

signed up for future news and editions of INTOUCH and encourage you to invite your colleagues to take a couple of

minutes to do the same at www.depuy.com/intouch.

Coming from an engineering background, I am always incredibly excited when we have the opportunity to launch a new

meaningful technological innovation. In this edition, we are delighted to have an article on the very latest addition to DePuy

Mitek’s Rotator Cuff Portfolio– the Healix Knotless™ anchor! We are proud to have Dr. Richard Angelo share some of

his early impressions and experiences with the DePuy Mitek Healix Knotless™ anchor.

While we continue to strive to bring you the best innovations in minimally invasive mobility therapies, we must also be

mindful about the rapidly changing healthcare environment around the globe. These changes can pose some real chal-

lenges and opportunities for key stakeholders in the healthcare system - payors, providers and patients. We have chosen to

focus a significant portion of this INTOUCH edition on topics related to the changes in healthcare:

•Samir K. Bhattacharyya, PhD – Our Director of Market Access - looks at some of the ways in which DePuy

Mitek is working to help physicians and their Hospitals understand the meaningful clinical value of our new

technologies and innovations.

•Dr. William Beach and Dr. Louis McIntyre look at the impact of our changing healthcare environment on

physicians and more specifically, surgeons.

Finally, we have a short article from our Shoulder R&D Manager, Ron Farkash, highlighting another procedural innovation

from DePuy Mitek - our HEALIX TRANSTEND™ Implant System. Ron takes us through all the reasons he is excited

about this meaningful advancement in the treatment of partial thickness rotator cuff tears.

We hope you will enjoy this second edition and the associated digital content we have made available for you at

www.depuy.com/intouch

As always, we welcome your input and contributions at depuymitekmarketing@its.jnj.com

Kind regards,

Meghan Scanlon

WW Director of Marketing

Click Here to experience the digitalversion of this edition of INTOUCH

The Second Edition of the INTOUCH Newsletter

Meghan Scanlon WW Director of Marketing,DePuy Mitek

Attractive features of the Healix Knotless™ BR & PEEK Lateral Row Anchor:

• Accepts4#2braidedsuturesthroughtheanchoreyelet

• Suturesloadsmoothlythroughtheanchor/driverviathedeliveryloopmechanism

• Anchoriseasytodelivertothepreparedholeinthelateralaspectofthegreatertuberositywithout

theentanglementofsutures

• Accurate,selectivetensioningofsuturesispermittedpriortofinaldeploymentoftheanchor

• Theconvolutedpathwhichthesuturestakethroughtheimplantresultsinaddedsecurityforfixation

ofthelateralrow

2

Richard L. Angelo, MDPresident of the Arthroscopy Association of North AmericaEvergreen Orthopedic Clinic;Kirkland, WA

DePuy Mitek Healix Knotless™ Anchor MyExperience

Dual Row Rotator Cuff Fixation:

Biomechanicalstudiesofdualrowcuffrepair,whencontrastedtosinglerowrepair,havedemonstratedimprovedfootprintcoverage,greatercontactpressureofthecuff

withthegreatertuberosity,decreasedgapformationandgreaterloadtofailure.Concerns,however,havebeenraisedregardingthepossibilityofover-constrainingthe

repairedcuffandthepotentialcompromiseofcuffvascularity.Whilethereisacleartendencytowardimprovedbiomechanicalstabilityandstructuralhealingwithdual

rowrepairs,todate,datasupportingimprovedclinicaloutcomesfordualrowrepairsissparse.

5 Keys to Successful Dual Row Rotator Cuff Repair:

1. AdequateTissue–rotatorcufftissueofadequatelengthandintegritymustbeavailabletospanthegreatertuberosityandavoidover-constraint;

sufficienttendonthicknessisnecessary,especiallymedially,toavoidtendoncut-throughandmedialrowfailure

2. SafeMedialRowAnchorPlacement–whenpreparing/introducingmedialrowanchorsthroughalateralacromialapproach,theshoulder

mustbesubstantiallyadductedtopermitpositioningtheanchorsadjacenttothearticularcartilageandyetavoida“shallow”approachtothe

tuberositywhichrisksanchorpenetrationofthehumeralheadarticularcartilage

3. AccurateMedialRowSutures-themedialrowsuturesshouldbeplacedattheanatomicmedial

marginofthecuff;excessivemedialplacementrisksover-tensioningofthecuffandcreating

anteriorandposterior“dogears”intherepair

4. Broad,SecureMedialFixation–multiplepassesofsuturematerialthroughthecuffina

broadly-spacedpattern,aswellastheuseofacombinedsimpleandhorizontalmattresslocking

configurationwillimprovethestrengthandsecurityofthemedialrow

5. SecureLateralRowConstruct–thelateralrowofanchor/smustoptimizefixationinthelateral

aspectofthegreatertuberosity,whichisoftenosteopenic,andprovideforsecureanchorfixation

ofspanningsuturesfromthemedialrow

Click Here to experience ourHealix Knotless™ digital animation!!

Inthecurrentenvironmentofdebtandregulation,physicians,especiallysurgeons,arechallengedwithvariousattempts

atcostreductionbytheCenterforMedicareandMedicaidServices(CMS)andprivateinsurers.Despitethefactthat

physicianservicesareasmall(13%)portionofthetotalcostofMedicareexpenditures,thisfocusonusiscuriousand

instructive.Acaseinpointistherecent“confrontation”betweenCMS,MEDPACandtheRelativeValueUpdateCommit-

tee(RUC).MEDPAC,anindependentcongressionalagency,criticizedCMSandtheRUCfornotaggressivelydecreasing

therelativevalueunits(RVUs)forsurgicalproceduresandnotcuttingcostsorslowingthegrowthofMedicarespending.

AthoroughdiscussionoftheRUC,therelativevalueofprocedures,andthepolicyofdecreasingthevalueofanRVUis

outsidethescopeforthisarticle.TherearemanypoliticalandprocessrelatedissuesregardingtheMEDPAC/CMS/RUCre-

lationship,butitistheonlymechanismthatcurrentlyallowsphysicianinputtoCMSpaymentpolicydiscussions.Despite

thisprovisionforinputs,thevalueofsurgicalservicesappearstobeselectivelydiscountedinthisforum.

Whatdoesthismeantothepracticingarthroscopicsurgeon?Lessreimbursementfromcodingchangesforthreecom-

monarthroscopicprocedures:arthroscopicsubacromialdecompression/acromioplasty(29826),arthroscopicmeniscec-

tomy–medialandlateral(29880),andarthroscopicmeniscectomy–medialorlateral(29881).

Letusreviewtherationaleandchangesfor29826(acromioplasty).CMShasdecidedtoreviewallproceduresthat

areperformedandbilledwithanotherproceduregreaterthan50%oftimes.Thisistheirattempttodecreasecostsby

denyingpaymenttoprovidersforallegedly“redundant”services;servicesperformedatthesametimearenowdeemed

inclusiveofeachotherwhenreimbursementisconsideredAcromioplastyisperformedwitharthroscopicdistalclavicle

resection(29824),rotatorcuffrepair(29827)andbicepstenodesis(29828)inover90%ofMedicarebillings.Because

ofthisrelationship,thedecisionwasmadethatarthroscopicacromioplasty(29826)shouldnolongerbeabletobelisted

alone,i.e.itmustbean“add-on”procedureandmustalwaysbelistedwithanothershoulderprocedure(forCMS).

Asforthedecreaseinthereimbursement,thatdiscussionismorecomplicatedandillustratesthelackofuniformityinthe

currentsystem.Mostphysiciansareawareofhowprivateinsurersreimbursesurgeonsformultipleprocedures.Reim-

bursementforthefirstprocedureis100%ofthecarrierallowanceandtheotherprocedures(sometimeswithalimiton

howmanycanbeadded,oftenuptofive)arereimbursedat50%ofthecarrierallowance.

Example–29826’sworkRVUfor2011is9.16andsoifitislistedwithaprocedurethathasahigherRVUvalue(29824,

29827,29828)itwouldbereimbursedatarateof4.58(9.16x50%).CMS,however,createdthe“endoscopy”rules

Managing Through Changes:PaymentandPolicyImpacts

3

William R. Beach, MD Secretary of the Arthroscopy Association of North AmericaTuckahoe Orthopaedic Associates, Richmond, VA

4

todecreasetheirreimbursementformultipleproceduresatahigherrate.CMS,forthesecondaryprocedures/

codes,subtractsthereimbursementforadiagnosticarthroscopyfromeachofthesecondarycodes.Thus

forCMS,thereimbursementfordiagnosticashoulderarthroscopy(29805)wouldbesubtractedfromthe

reimbursementforarthroscopicacromioplasty(29826).For2011,29826=9.16RVU’sandifyousubtract

theRVU’sfor29805(6.03)thenthereimbursementfor29826inconjunctionwithotherprocedureswouldbe

3.13.AtthelastRUCmeeting,29826wasvaluedat3.00RVUandthiswasacceptedbyCMS.

Whatisunknowniswhattheprivateinsurerswilldo.Wouldtheyfollowsuitandtakeadvantageoftheir

serviceproviders(US!)astheyusuallyadoptMedicarerulesthataretotheireconomicadvantage?

Changesinthereimbursementof29880and29881areevenmoresevere.Thetotal(work+practice

expense+malpracticeexpense)RVUreimbursementhasbeendecreasedfor29880from20.14to16.85

andfor29881from18.82to16.16.Inaddition,forCMS,arthroscopicchondroplasty(29877orG0289)

cannolongerbelisted/reimbursedwitheither29880or29881!Youmaystillperform29877(arthroscopic

chondroplasty/debridement)butwillnotbereimbursedbyCMS.Whataboutforpatientswithaprivateinsur-

ance?Youcanperformandcanbereimbursedforanisolatedchondroplasty(29877).Arthroscopicabra-

sionchondroplasty/microfracture(29879)isnotbundledwitheither29880or29881soitcanbebilledand

reimbursedwithbothcodes.

Inthisarticle,wecitedsomeexamplesonhowrecentpaymentstrategiesimplementedbyCMSaffectreim-

bursementforarthroscopicsurgeries.Costcontainmentpressureisrealandweallneedtoworkthroughit.

Thereimbursementinformationcontainedinthisarticleisprovidedforinformationalpurposesonlyandrepresentsnostatement,promise,orguaranteebyDePuyMitek,Inc.concerninglevelsofreimbursement,payment,orcharge.Similarly,allCPTandHCPCScodesaresuppliedforinformationalpurposesonlyandrepresentnostatement,promise,orguaranteebyDePuyMitek,Inc.thatthesecodeswillbeappropriateorreimbursementwillbemade.Theinformationpresentedisnotintendedtoincreaseormaximizereimbursementbyanypayor.Westronglyrecommendthatyouconsultyourpayororganizationwithregardtoitsreimbursementpolicies.

JCodeSource:FederalRegister/Vol.72,No.227,pp66774/Tuesday,November27,2007.AllCurrentProceduralTerminology(CPT)five-digitnumericcodes,descriptions,numericmodifiers,instructions,guidelines,andothermaterialareCopyright2007AmericanMedicalAssociation.AllRightsReserved.

Louis F. McIntyre, MDBoard of Directors or the Arthroscopy Association of North AmericaChief of Orthopaedics, Westchester Orthopaedic Associates, White Plains, NY

5

Wehaveenteredintoanunprecedentederaofcostcontainmentpressure,qualityscrutiny,andglobalizationinhealth

care,whichcollectivelybrewaperfectstorm.Risinghealthcarecostsasapercentofgrossdomesticproducts(GDP)

intheUnitedStates(approaching16%)havepromptedseveralmeasuresbypayersandpolicymakers–compara-

tiveeffectiveness,valuebasedpurchasing,healthtechnologyassessment,accountablecareorganization,payfor

performance,sharedsavings,bundledpayments–tonameafew.

Sportsmedicinemaynotbeimmunefromthesemeasures.ThestateofWashington’sHealthTechnologyAssessment

process(HTA)recentlycompletedareviewonFemoroacetabularImpingementSyndrome(FAI)andrecommendeda

non-coveragedecision(http://www.hta.hca.wa.gov).AsimilarreviewwascompletedforOsteochondralAllograft/

AutograftTransplantation(OATS/Mosaicplasty)thatresultedinacoveragedecisionwithconditions(November18,

2011).Thesedecisionswerepredominantlybasedonanassessmentofthepublishedliteratureandagradingofthe

evidenceforthestrengthoftheconclusionsthatcouldbederivedfromtheevidence.Thequestionthatremainsto

beaddressediswhetherthecriteriaemployedforsuchreviewsareappropriateforsurgicalproceduresastheywere

developedlargelywiththepharmaceuticalmodelofevidenceinmind.Thetimehascometoappreciatethefactthat

medicaldevicesposeuniquechallengesinconductingblinded,randomizedclinicalstudiesanddifferentlevelsof

evidenceneedtobeappropriatelyconsideredforpayerdecisionmaking.

Thecurrentenvironment,asexemplifiedabove,caninducecostsensitivitytonewinnovationsorproductslacking

relevantattributes,quality,orservices.DePuyMitekrecentlyembarkedonanendeavortodevelopandcommunicate

valuepropositionsforsomeofitsdifferentiatedtechnologies.TheseproductValueAnalysisBriefscanhelpsurgeons

communicatethevalueofDePuyMitek’sofferingstoValueAssessmentCommitteesinhospitalswithafocusonthe

clinical,economicandproceduralbenefitsthatmaybemeaningfulforpatients,surgeons,andhospitals.Wehopeyou

willfindtheseProductValueBriefsusefulandinformativeasyourseektosupportthevalueofclinicalinnovationsin

yourpractice.PleaseaskyourDePuyMiteksurgicalsalesrepresentativeforadditionalinformation.

Weareexcitedtohavetheopportunitytoworkwithyoutomakesurepatientshaveaccesstoinnovativetechnology.

Verybest,

Samir

A New Era for Healthcare

Samir K. Bhattacharyya, PhD WWDirectorofMarketAccessDePuy Mitek

Click Here to see Value Analysis Briefs

A New Innovation in Partial Thickness Rotator Cuff Repairs

Ron Farkash, BSMER&D Manager for ShoulderDePuy Mitek

6

AstheR&DmanagerforDePuyMitek’sshoulderplatformIamalwaysproudwhenwebringaninnovative

producttothemarket.TheHEALIXTRANSTEND™ImplantSystemrepresentsarevolutionaryadvancement

inthetreatmentofpartialthicknessrotatorcufftears.Thiscomprehensivepercutaneoussolution,featuring

HEALIXTRANSTEND™AnchorsandtheinnovativePERCANNULA™System,enablesthereattachmentofa

partiallytornrotatorcuffwhileminimizingtendontraumaandmaximizingproceduralvisualization.

Weengineeredthisanchorfortherepairofbothsmallandlargepartialthicknessrotatorcufftears.This

novelsolutionnotonlyaidsinthepreventionoftearpropagation,butitalsoallowsfortheretentionofthe

connectedtendon,ultimatelytopreservethepatient’snaturalanatomy.

TheHEALIXTRANSTENDAnchorfeatures:

• ReductionintendontraumabypercutaneouslyaccessingthePASTAlesionwiththe1.1mm

guidewireand4.0mmPERCANNULA®System.

• Enhancementofvisualizationbyretractingthecuffutilizingthedistalribonthe4.0mmcannula.

• OptimalcorticalandcancellousfixationstrengthwiththeHealixthreaddesignonour2.9mmTi

anchorand3.4mmBRandPEEKanchors.

• TissuetobonefixationsupportedbyORTHOCORD®highstrengthsuture

-55lbsoftensilestrength*

-45%lessstiffthanFiberwire†

*DataonfileatDePuyMitek.†FiberwireisaregisteredtrademarkofArthrex,Inc.

908070605040302010

0

Anchor Pull-Out Strength

Ave

rage

Loa

d (lb

s)

HEALIX TRANSTEND™ BR

HEALIX TRANSTEND™ Ti

HEALIX TRANSTEND™ PEEK

Click Here to experience a digital animation of THE HEALIX TRANSTEND™ Implant System

7

The new HEALIX KNOTLESS™ BR lateral anchor. The reliability you know – now for the lateral row.

• The first and only dual-thread, double-row, 100% biocomposite solution

• Unique dual-thread HEALIX KnoTLEss anchor design provides optimal fixation1

• Knotless design:

Eliminates arthroscopic knot-tying at the lateral anchor site

Easily accommodates up to four suture limbs

Maximizes surgeon control of suture tensioning

• The only knotless anchor made of BIoCRYL® RAPIDE™ biocomposite material,

which allows absorption and bony ingrowth1

FOR TRANSOSSEUS-EQUIVALENT REPAIR

Stronger Together

Healix Knotless BR lateral anchor 1Data on file at DePuy Mitek, Inc.

©DePuy Mitek, Inc. 2012. All rights reserved.

Introducing

Click Here to experience ourHealix Knotless™ digital animation!!