Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the

Akash Kataruka1, Charles C Maynard2, Ravi S Hira3

  • 1Division of Cardiology University of Washington Seattle WA.

Insights

Washington State

Area of Science:

  • Cardiovascular Medicine
  • Health Policy
  • Health Services Research

Background:

  • Geographic distribution of percutaneous coronary intervention (PCI) programs is not optimized for patient outcomes.
  • Washington State's Certificate of Need (CON) program regulates elective PCI to balance hospital volume and patient access.
  • Current CON policies may lead to suboptimal outcomes and access.

Purpose of the Study:

  • To evaluate the impact of Washington State's Certificate of Need (CON) program on the geographic distribution and outcomes of percutaneous coronary intervention (PCI) programs.
  • To assess whether current regulations effectively balance hospital volume and patient access for PCI services.

Main Methods:

  • Retrospective cohort study of non-Veterans Affairs hospitals with PCI programs in Washington State (2009-2018).
  • Hospitals categorized into three groups: legacy (full services with surgical backup), new certificate of need (CON) (full services without surgical backup), and myocardial infarction (MI) access (nonelective PCI only).
  • Analysis of hospital volumes, patient access times, and risk-adjusted mortality rates.

Main Results:

  • Legacy hospitals had the highest annual median volumes, followed by new CON and MI access hospitals.
  • Risk-adjusted mortality for nonelective PCI was lower in legacy and new CON hospitals compared to MI access hospitals.
  • Adding new CON and MI access hospitals provided only a marginal increase (1.5%) in population access within 60 minutes.

Conclusions:

  • Many PCI programs in Washington State operate below minimum volume standards despite CON regulations.
  • The CON strategy has created a tiered system with low-volume centers treating high-risk patients, leading to poorer outcomes without substantial gains in geographic access.
  • Certificate of Need policies require re-evaluation regarding the number and distribution of PCI programs to improve patient outcomes and access.

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