Dennis presentation

History and Current Status of History and Current Status of PCI Services in New JerseyPCI Services in New Jersey

Charles Dennis, MDCharles Dennis, MDChairman, Cardiovascular Health Advisory PanelChairman, Cardiovascular Health Advisory Panel

Interventional Cardiologist, Virtua HealthInterventional Cardiologist, Virtua Health

Regulation of Medical ServicesRegulation of Medical Services• Certificate of NeedCertificate of Need

– Designed to Designed to • Restrain health care costsRestrain health care costs• Coordinate services and constructionCoordinate services and construction

– Underlying assumption is that excess capacity Underlying assumption is that excess capacity leads to health care cost inflationleads to health care cost inflation

– Exists in some form in 36 statesExists in some form in 36 states– Originated from the federally mandated “Health Originated from the federally mandated “Health

Planning Resources Development Act” of 1974Planning Resources Development Act” of 1974– Repealed in 1987Repealed in 1987– New Jersey remains a CON stateNew Jersey remains a CON state– Mechanism for approving new facilities/servicesMechanism for approving new facilities/services

Charles Dennis, MD – November 2012

Certificate Of Need Certificate Of Need Pros and ConsPros and Cons

AdvocatesAdvocates Healthcare is not a typical Healthcare is not a typical

economic producteconomic product Market forces do not follow Market forces do not follow

the same rules in healthcarethe same rules in healthcare Patients do not “shop” for Patients do not “shop” for

healthcare, making it price healthcare, making it price insensitiveinsensitive

CON limits healthcare costsCON limits healthcare costs CON promotes appropriate CON promotes appropriate

competitioncompetition CON distributes healthcare to CON distributes healthcare to

the economically the economically disadvantageddisadvantaged

OpponentsOpponents CON has not clearly lowered CON has not clearly lowered

healthcare costshealthcare costs By restricting services, CON By restricting services, CON

reduces price competitionreduces price competition Prospective payment (DRG) Prospective payment (DRG)

makes hospitals more makes hospitals more responsive to market pressuresresponsive to market pressures

CON programs may be subject CON programs may be subject to political influence or to political influence or institutional prestige rather institutional prestige rather than community needthan community need


Regulation of Existing ServicesRegulation of Existing Services

Hospital Licensing StandardsHospital Licensing Standards 259 pages available at 259 pages available at

http://www.state.nj.us/health/healthfacilities/rules.shtml

Subchapter 7 - CardiacSubchapter 7 - Cardiac Specific regulations forSpecific regulations for

Cardiac surgeryCardiac surgery Cardiac catheterization and PCICardiac catheterization and PCI ElectrophysiologyElectrophysiology


Hospital Licensing StandardsHospital Licensing Standards• AddressAddress

– Facilities and environment of careFacilities and environment of care– Staffing, equipment and suppliesStaffing, equipment and supplies– Quality assessment and improvementQuality assessment and improvement– Scope of servicesScope of services– Hospital and practitioner volume standardsHospital and practitioner volume standards– Mechanisms for review of performanceMechanisms for review of performance

• FocusFocus• Volume (Facility and Provider)Volume (Facility and Provider)• Quality (Difficult to measure)Quality (Difficult to measure)

• Do Not Address (Directly)Do Not Address (Directly)– Physician professional performancePhysician professional performance


Fundamental ConceptsFundamental Concepts

DOH sets licensing standards for facilitiesDOH sets licensing standards for facilities Facilities credential medical staff and are expected to Facilities credential medical staff and are expected to

conform to regulatory requirements (both facility and conform to regulatory requirements (both facility and physician)physician)

DOH collects performance data that assist in the DOH collects performance data that assist in the evaluation of conformance to regulationsevaluation of conformance to regulations

The CHAP advises the Commissioner on licensing The CHAP advises the Commissioner on licensing standards and other issuesstandards and other issues


Cardiac Catheterization ServicesCardiac Catheterization ServicesDrivers of ExpansionDrivers of Expansion

There were insufficient cardiac catheterization There were insufficient cardiac catheterization labs in the mid 1990’slabs in the mid 1990’s

Demand accelerated after initial expansion of Demand accelerated after initial expansion of laboratorieslaboratories

Primary PCI became the standard of care in the Primary PCI became the standard of care in the early 2000’searly 2000’s

Success with Primary PCI led to demands for Success with Primary PCI led to demands for expansion of Elective PCIexpansion of Elective PCI


Cardiac Catheterization Program Growth Responds to DemandCardiac Catheterization Program Growth Responds to Demand

12 Full Service laboratories in the mid 1990’s12 Full Service laboratories in the mid 1990’s

Introduction of the Low Risk Catheterization Pilot ProjectIntroduction of the Low Risk Catheterization Pilot Project

““Graduation” of Low Risk labs to Full Service statusGraduation” of Low Risk labs to Full Service status

Failure of a few low volume labsFailure of a few low volume labsCharles Dennis, MD – November 2012

Growth of Demand and ServicesGrowth of Demand and Services

Catheterization demand grew 32% over seven yearsCatheterization demand grew 32% over seven years

Catheterization demand then declined, but remains 12% over base yearCatheterization demand then declined, but remains 12% over base year

Market forces have rewarded successful labs and punished marginal facilitiesMarket forces have rewarded successful labs and punished marginal facilities

8 labs are not meeting the 200 annual case minimum requirement8 labs are not meeting the 200 annual case minimum requirement


Primary PCI Program Growth Leads to Elective PCI InvestigationPrimary PCI Program Growth Leads to Elective PCI Investigation

Primary PCI investigation begins in a single hospital in 1999Primary PCI investigation begins in a single hospital in 1999

Efficacy of Primary PCI leads to program expansionEfficacy of Primary PCI leads to program expansion

Question of safety and efficacy of Elective PCI without cardiac surgery on Question of safety and efficacy of Elective PCI without cardiac surgery on site leads to CPORT-Esite leads to CPORT-E


Growth of PCI Facilities Follows DemandGrowth of PCI Facilities Follows DemandFollowing introduction of stents in 1995, PCI demand grew 52% to 2006Following introduction of stents in 1995, PCI demand grew 52% to 2006

Demand for PCI fell in 2006 after introduction of drug eluting stents Demand for PCI fell in 2006 after introduction of drug eluting stents

Demand has been relatively stable for the past five yearsDemand has been relatively stable for the past five years

Facility growth has been primarily in the Primary PCI arena, with a small Facility growth has been primarily in the Primary PCI arena, with a small contribution of CPORT-Econtribution of CPORT-E


Demand for Primary PCI Increases SlowlyDemand for Primary PCI Increases Slowly

Limited data for all Primary PCILimited data for all Primary PCI

Demand has grown 10% over five yearsDemand has grown 10% over five years


Diagnostic Catheterization and PCIDiagnostic Catheterization and PCIFacility RequirementsFacility Requirements

Low Risk Catheterization LabLow Risk Catheterization Lab Perform a minimum of 350 diagnostic cases by end Perform a minimum of 350 diagnostic cases by end

of second year of operationof second year of operation Perform a minimum of 200 diagnostic cases Perform a minimum of 200 diagnostic cases

annually after the second yearannually after the second year Have a “normal rate” not to exceed 25%Have a “normal rate” not to exceed 25% Clinical Restrictions (recent MI, LV dysfunction)Clinical Restrictions (recent MI, LV dysfunction) No PCINo PCI



Full Service Catheterization LabFull Service Catheterization Lab Perform a minimum of 400 diagnostic cases annuallyPerform a minimum of 400 diagnostic cases annually No “normal rate” criteriaNo “normal rate” criteria No clinical restrictionsNo clinical restrictions

Full Service Primary PCI Catheterization LabFull Service Primary PCI Catheterization Lab Meet Full Service Requirements for minimum of 6 Meet Full Service Requirements for minimum of 6

monthsmonths Perform at least 36 Primary PCI procedures annuallyPerform at least 36 Primary PCI procedures annually



CPORT-E Catheterization LaboratoryCPORT-E Catheterization Laboratory Meet Full Service and Primary PCI Requirements Meet Full Service and Primary PCI Requirements Receive designation under competitive CONReceive designation under competitive CON Meet study training requirementsMeet study training requirements Perform a minimum of 200 PCI (Primary plus Perform a minimum of 200 PCI (Primary plus

Elective) annuallyElective) annually


Diagnostic CatheterizationDiagnostic CatheterizationPhysician RequirementsPhysician Requirements

Low Risk Catheterization LabLow Risk Catheterization Lab DirectorDirector

150 procedures annually150 procedures annually 100 procedures in the Low Risk Lab100 procedures in the Low Risk Lab

All Catheterization LaboratoriesAll Catheterization Laboratories PhysiciansPhysicians

Minimum of 200 procedures as independent operatorMinimum of 200 procedures as independent operator Minimum of 50 procedures annuallyMinimum of 50 procedures annually


PCIPCIPhysician RequirementsPhysician Requirements

Primary and Elective PCIPrimary and Elective PCI 75 cases annually75 cases annually Volume minimums are not enforced at cardiac Volume minimums are not enforced at cardiac

surgery facilitiessurgery facilities


Diagnostic Catheterization 2011Diagnostic Catheterization 2011Operator VolumeOperator Volume

Annual Cases

Operators Percentage

< 50 106 24%

50 - 75 57 13%

76 - 100 40 9%

101 - 150 57 13%

151 - 200 54 12%

200+ 122 28%

Total 436 100%Charles Dennis, MD – November 2012

PCI 2011PCI 2011Operator VolumeOperator Volume

Annual Cases

Operators Percentage

< 50 86 31%

50 - 75 38 14%

76 - 100 46 17%

101 - 150 57 21%

151 - 200 25 9%

200+ 22 8%

Total 274 100%Charles Dennis, MD – November 2012

Meeting Facility RequirementsMeeting Facility Requirements2011 Volumes2011 Volumes

Total Facilities

Diagnostic Cath

Primary PCI

Elective PCI

Surgery

Surgery 18 18 16 18 10

CPORT-E 11 11 10 11

Full Service PCI 13 13 10

Full Service 4 2

Low Risk 8 2


Cardiac Surgery As MetaphorCardiac Surgery As Metaphor

In 1994 there were 13 cardiac surgery programs In 1994 there were 13 cardiac surgery programs in New Jerseyin New Jersey

In the face of rising demand, five additional In the face of rising demand, five additional programs were approved between 1997 and programs were approved between 1997 and 20012001


Cardiac Surgery Program Growth Responds to DemandCardiac Surgery Program Growth Responds to Demand

Rising surgical volume in 1990’sRising surgical volume in 1990’s

Additional programs approvedAdditional programs approved

Declining surgical volumes since 2001Declining surgical volumes since 2001Charles Dennis, MD – November 2012

Program Growth and Case DeclineProgram Growth and Case Decline

Average facility case volume 700 – 800 annually per program in 1990’sAverage facility case volume 700 – 800 annually per program in 1990’s

Growth from 12 to 18 programs with concomitant case declineGrowth from 12 to 18 programs with concomitant case decline

Average facility case volume of 400 – 450 currentlyAverage facility case volume of 400 – 450 currentlyCharles Dennis, MD – November 2012

The Pain Is Not Shared EquallyThe Pain Is Not Shared Equally2 programs have grown 5-32%2 programs have grown 5-32%

4 programs have shrunk 1-49%4 programs have shrunk 1-49%



Average decline is 50%Average decline is 50%Charles Dennis, MD – November 2012

ObservationsObservations•Predicting surgical case volume Predicting surgical case volume decline should have been easy (stents)decline should have been easy (stents)•Predicting sub-prime mortgage crisis Predicting sub-prime mortgage crisis should have been easy (Japan)should have been easy (Japan)•8 of 18 cardiac surgery centers failed 8 of 18 cardiac surgery centers failed to meet 350 case minimum in 2011to meet 350 case minimum in 2011•Once open, clinical programs usually Once open, clinical programs usually do not closedo not close

BMS


Progressive decline in cardiac surgery volumes Decline in PCI after DES introduction with stable volumes since What is the expected effect of percutaneous valves? What is the expected effect of new studies comparing CABG to

PCI with multi-vessel coronary disease?


The Three Legged Stool of Health PolicyThe Three Legged Stool of Health PolicyQualityQuality AccessAccess CostCost

MortalityMortality GeographicGeographic PatientPatient

MorbidityMorbidity DisadvantagedDisadvantaged PayorPayor

QOLQOL QueuingQueuing ProviderProviderCharles Dennis, MD – November 2012

Dennis presentation

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