Cardiac Care 5-Year
Horizon Project Report
  Appendix I:
Regulatory Policy in Other States
Background Cardiac
Introduction Cardiology Issues and

On several issues there was interest in how other states use regulatory tools, and the resultant effect on cardiac care in those markets. Below are examples from four states, plus a brief summary of New Jersey regulations for comparison. The bordering states of New York and Pennsylvania are relevant examples by virtue of their proximity and overlapping markets. California is a high-profile example of a state where certificate of need was abandoned in the 1980s and where high managed care penetration, a very competitive market for cardiac services and the lack of regulation have shaped the delivery of care; Washington State is an example of a Western state with high managed care penetration plus CofN laws.

  1. New Jersey has CofN requirements for both catheterization labs and cardiac surgery programs. Minimum volume standards (500 cases for a full service catheterization lab, 350 cases for a low risk catheterization lab, and 350 cases for a cardiac surgery program) are enforced. Angioplasty requires surgical back up; angiography labs do not. All catheter-based procedures are carried out in a hospital setting. New Jersey produces a yearly report at the hospital level on risk adjusted cardiac surgery outcomes in the state.
  2. New York State has CofN requirements for both catheterization labs and cardiac surgery programs. Minimum volume standards of 400 cardiac catheterizations per year for a catheterization lab and 500 cases per three years for a cardiac surgery program are in effect. Coronary angiography procedures, but not angioplasty, are performed in facilities without cardiac surgery on stand-by. As of 1998 there were 33 cardiac surgery programs in New York State (15 of these in the New York City area) with patient volumes for that year that ranged from 126 (in a small, rural hospital upstate) to over 2400. New York State has public reporting at the hospital and physician levels on outcomes from both CABG surgery and coronary angioplasty, and the reporting system is directed by a Cardiac Advisory Committee which is authorized to require plans of correction for under-performing programs, which can be closed if they continue to under-perform.
  3. Pennsylvania no longer has CofN regulations for either catheterization laboratories or cardiac surgery programs. All cardiac catheterization procedures must be performed in an acute care hospital. Only "low-risk" patients are eligible for coronary angiography or angioplasty at hospitals without surgical back up and all high risk angiography and angioplasty is done at facilities with cardiac surgery programs. Pennsylvania also has public reporting of CABG outcomes at the hospital and physician levels.
  4. California has not had CofN regulations since the mid-1980s. As long as cardiac surgery volumes continued to grow (due to the state's rapid population growth) programs continued to multiply - the only check on this being the ability of the largest managed care plans (such as Kaiser Permanente in both Northern and Southern California) and integrated delivery systems (such as Sutter Health in Northern California) to selectively contract and channel their large volumes to a few providers. Coronary angiography is performed in hospital-based facilities with only three exceptions: three pilot programs that established free-standing labs as part of a program that was never expanded (there were four pilot labs established originally under the program and one has since closed). Angioplasty is performed in facilities with surgical back-up, but stand-by is not required.
  5. Washington State has CofN for cardiac surgery programs and there is a minimum volume standard of 250 CABG procedures per program (with an initial three-year period for new programs to attain that level), but it is not tightly enforced. Even though catheterization labs do not require a CofN in Washington State, almost all are hospital-based. Diagnostic catheterizations and some primary angioplasties are performed in facilities without surgical backup, but elective angioplasty is done in hospitals with surgical stand-by, in accordance with ACC guidelines.

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