1. History and Current Status of
PCI Services in New Jersey
Charles Dennis, MD
Chairman, Cardiovascular Health Advisory Panel
Interventional Cardiologist, Virtua Health

2. Regulation of Medical Services
• Certificate of Need
– Designed to
• Restrain health care costs
• Coordinate services and construction
– Underlying assumption is that excess capacity
leads to health care cost inflation
– Exists in some form in 36 states
– Originated from the federally mandated “Health
Planning Resources Development Act” of 1974
– Repealed in 1987
– New Jersey remains a CON state
– Mechanism for approving new facilities/services
Charles Dennis, MD – November 2012

3. Certificate Of Need
Pros and Cons
 Advocates  Opponents
 Healthcare is not a typical  CON has not clearly lowered
economic product healthcare costs
 Market forces do not follow  By restricting services, CON
the same rules in healthcare reduces price competition
 Patients do not “shop” for  Prospective payment (DRG)
healthcare, making it price makes hospitals more
insensitive responsive to market pressures
 CON limits healthcare costs  CON programs may be subject
 CON promotes appropriate to political influence or
competition institutional prestige rather
 CON distributes healthcare to than community need
the economically
disadvantaged
Charles Dennis, MD – November 2012

4. Regulation of Existing Services
 Hospital Licensing Standards
 259 pages available at
http://www.state.nj.us/health/healthfacilities/rules.shtml
 Subchapter 7 - Cardiac
 Specific regulations for
 Cardiac surgery
 Cardiac catheterization and PCI
 Electrophysiology
Charles Dennis, MD – November 2012

5. Hospital Licensing Standards
• Address
– Facilities and environment of care
– Staffing, equipment and supplies
– Quality assessment and improvement
– Scope of services
– Hospital and practitioner volume standards
– Mechanisms for review of performance
• Focus
• Volume (Facility and Provider)
• Quality (Difficult to measure)
• Do Not Address (Directly)
– Physician professional performance
Charles Dennis, MD – November 2012

6. Fundamental Concepts
 DOH sets licensing standards for facilities
 Facilities credential medical staff and are expected to
conform to regulatory requirements (both facility and
physician)
 DOH collects performance data that assist in the
evaluation of conformance to regulations
 The CHAP advises the Commissioner on licensing
standards and other issues
Charles Dennis, MD – November 2012

7. Cardiac Catheterization Services
Drivers of Expansion
 There were insufficient cardiac catheterization
labs in the mid 1990’s
 Demand accelerated after initial expansion of
laboratories
 Primary PCI became the standard of care in the
early 2000’s
 Success with Primary PCI led to demands for
expansion of Elective PCI
Charles Dennis, MD – November 2012

8. Cardiac Catheterization Program Growth Responds to Demand
12 Full Service laboratories in the mid 1990’s
Introduction of the Low Risk Catheterization Pilot Project
“Graduation” of Low Risk labs to Full Service status
Failure of a few low volume labs
Charles Dennis, MD – November 2012

9. Growth of Demand and Services
Catheterization demand grew 32% over seven years
Catheterization demand then declined, but remains 12% over base year
Market forces have rewarded successful labs and punished marginal facilities
8 labs are not meeting the 200 annual case minimum requirement
Charles Dennis, MD – November 2012

10. Primary PCI Program Growth Leads to Elective PCI Investigation
Primary PCI investigation begins in a single hospital in 1999
Efficacy of Primary PCI leads to program expansion
Question of safety and efficacy of Elective PCI without cardiac surgery on
site leads to CPORT-E
Charles Dennis, MD – November 2012

11. Growth of PCI Facilities Follows Demand
Following introduction of stents in 1995, PCI demand grew 52% to 2006
Demand for PCI fell in 2006 after introduction of drug eluting stents
Demand has been relatively stable for the past five years
Facility growth has been primarily in the Primary PCI arena, with a small
contribution of CPORT-E
Charles Dennis, MD – November 2012

12. Demand for Primary PCI Increases Slowly
Limited data for all Primary PCI
Demand has grown 10% over five years
Charles Dennis, MD – November 2012

13. Diagnostic Catheterization and PCI
Facility Requirements
 Low Risk Catheterization Lab
 Perform a minimum of 350 diagnostic cases by end
of second year of operation
 Perform a minimum of 200 diagnostic cases
annually after the second year
 Have a “normal rate” not to exceed 25%
 Clinical Restrictions (recent MI, LV dysfunction)
 No PCI
Charles Dennis, MD – November 2012

14. Diagnostic Catheterization and PCI
Facility Requirements
 Full Service Catheterization Lab
 Perform a minimum of 400 diagnostic cases
annually
 No “normal rate” criteria
 No clinical restrictions
 Full Service Primary PCI Catheterization Lab
 Meet Full Service Requirements for minimum of 6
months
 Perform at least 36 Primary PCI procedures annually
Charles Dennis, MD – November 2012

15. Diagnostic Catheterization and PCI
Facility Requirements
 CPORT-E Catheterization Laboratory
 Meet Full Service and Primary PCI Requirements
 Receive designation under competitive CON
 Meet study training requirements
 Perform a minimum of 200 PCI (Primary plus
Elective) annually
Charles Dennis, MD – November 2012

16. Diagnostic Catheterization
Physician Requirements
 Low Risk Catheterization Lab
 Director
 150 procedures annually
 100 procedures in the Low Risk Lab
 All Catheterization Laboratories
 Physicians
 Minimum of 200 procedures as independent operator
 Minimum of 50 procedures annually
Charles Dennis, MD – November 2012

17. PCI
Physician Requirements
 Primary and Elective PCI
 75 cases annually
 Volume minimums are not enforced at cardiac
surgery facilities
Charles Dennis, MD – November 2012

18. Diagnostic Catheterization 2011
Operator 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

19. PCI 2011
Operator 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

20. Meeting Facility Requirements
2011 Volumes
Total Diagnostic Primary Elective
Surgery
Facilities Cath PCI PCI
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
Charles Dennis, MD – November 2012

21. Cardiac Surgery As Metaphor
 In 1994 there were 13 cardiac surgery programs
in New Jersey
 In the face of rising demand, five additional
programs were approved between 1997 and
2001
Charles Dennis, MD – November 2012

22. Cardiac Surgery Program Growth Responds to Demand
Rising surgical volume in 1990’s
Additional programs approved
Declining surgical volumes since 2001
Charles Dennis, MD – November 2012

23. Program Growth and Case Decline
Average facility case volume 700 – 800 annually per program in 1990’s
Growth from 12 to 18 programs with concomitant case decline
Average facility case volume of 400 – 450 currently Charles Dennis, MD – November 2012

24. The Pain Is Not Shared Equally
2 programs have grown 5-32%
4 programs have shrunk 1-49%
4 programs have shrunk 52-62%
3 programs have shrunk 66-72%
Average decline is 50% Charles Dennis, MD – November 2012

25. BMS
Observations
•Predicting surgical case volume
decline should have been easy (stents)
•Predicting sub-prime mortgage crisis
should have been easy (Japan)
•8 of 18 cardiac surgery centers failed
to meet 350 case minimum in 2011
•Once open, clinical programs usually
do not close
Charles Dennis, MD – November 2012

26.  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?
Charles Dennis, MD – November 2012

27. The Three Legged Stool of Health Policy
Quality Access Cost
Mortality Geographic Patient
Morbidity Disadvantaged Payor
QOL Queuing Provider
Charles Dennis, MD – November 2012