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The
importance of program service volumes in health service development and
operations, and their connection to certificate of need (CON) regulation, has
been demonstrated recently with the publication of a nationwide study of
Medicare patients that documents statistically significant lower mortality
rates for coronary artery bypass graft (CABG) surgery patients receiving
treatment in programs in states that regulate open-heart surgery under CON.
The
authors note most CON studies have focused on whether CON has affected capital
investment and health care costs, and that few have examined directly the
relationship between CON regulation and quality. The study was designed to
“compare risk-adjusted mortality and hospital volumes for CABG surgery in
states with and without certificate of need regulation.”
The
study analyzed the experience of more than 900,000 Medicare patients 65 years
of age or older, who underwent CABG surgery in the six-year period between 1994
and 1999. They received care in a total of more than 1,000 US hospitals. States
were divided into those with continuous CON regulation (27 states), those that
had no CON regulation during the study period (18 states), and those that
terminated or reinstated CON during the period (6 states). The analysis found
that risk-adjusted mortality rates were 22% higher in states without CON
regulation than in states with regulation. A statistically significant
difference was observed in each of the six years of the study period. The study
also determined that:     
•States with CON regulation had average program volumes 84% higher than those
without regulation,
•
States that recently terminated CON regulation had large decreases in average
CABG surgery volumes, and
•In states without CON regulation, the percentage of patients that had surgery
in low volume programs was three times higher than in states with CON
regulation.
In
addition, the data showed that the repeal of CON regulation resulted in a tripling
of the percentage of patients having CABG surgery in low-volume hospitals. This
study documents the positive role of planning and CON regulation in assuring
higher average CABG surgery program volumes and the resulting lower
risk-adjusted mortality rates.
It
is noteworthy that this study also found that a higher percentage of those
having CABG surgery in states without CON regulation underwent diagnostic
cardiac catheterization or percutaneous transluminal coronary angioplasty
(PTCA) on the same day as surgery. This suggests that the treatment outcomes
for these procedures may be worse, for the same reason that CABG surgery
mortality rates are worse, in states without CON regulation. The researchers
observe “the higher incidence of cardiac catheterization and PTCA on the same
day as CABG surgery may reflect higher complication rates for those procedures,
rather than greater patient pre-surgical risk.”
State specific data for the six years covered by the study
can be seen by clicking on the state of interest.
 
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