Vaughan-Sarrazin Mary S, Hannan Edward L, Gormley Carol J, Rosenthal Gary E
Division of General Internal Medicine, Department of Medicine, VA Medical Center and University of Iowa College of Medicine, Iowa City , USA.
JAMA. 2002 Oct 16;288(15):1859-66. doi: 10.1001/jama.288.15.1859.
Certificate of need regulation was designed to control health care costs by preventing health care facilities from expanding unnecessarily. While there have been several studies investigating whether these regulations have affected health care investment, few have evaluated the relationship between certificate of need regulation and quality of care.
To compare risk-adjusted mortality and hospital volumes for coronary artery bypass graft (CABG) surgery in states with and without certificate of need regulation.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of 911 407 Medicare beneficiaries aged 65 years or older, who underwent CABG surgery between 1994 and 1999 in 1063 US hospitals.
States (and the District of Columbia) with continuous (n = 27), none (n = 18), or intermittent (n = 6) certificate of need regulation; mortality (in-hospital or within 30 days of CABG surgery) rates; and mean annual hospital volumes for CABG surgery.
Unadjusted mortality was 5.1% in states without certificate of need regulation compared with 4.4% in states with continuous regulation, and 4.3% in states with intermittent certificate of need regulation (P<.001 for each comparison). Adjusting for demographic and clinical factors, mortality remained higher in states without certificate of need regulation compared with states with continuous certificate of need regulation (odds ratio [OR], 1.22; 95% confidence interval [CI], 1.15-1.28; P<.001). Using the same groups for comparison, the mean annual hospital volume for CABG surgery was 84% lower in states without certificate of need regulation (104 vs 191; P<.001) and more patients underwent CABG surgery in low-volume hospitals (<100 procedures annually) (30% vs 10% for states with continuous certificate of need programs; P<.001). Following the repeal of certificate of need regulation in states categorized as intermittent, the percentage of patients undergoing CABG surgery in low-volume hospitals tripled.
Mortality rates for Medicare patients undergoing CABG surgery were higher in states without certificate of need regulation. Repeal of certificate of need regulations during the study period was associated with declines in hospital volume for CABG surgery.
需求证明法规旨在通过防止医疗保健机构不必要地扩张来控制医疗保健成本。虽然已有多项研究调查这些法规是否影响了医疗保健投资，但很少有研究评估需求证明法规与医疗质量之间的关系。
比较有需求证明法规和没有需求证明法规的州中冠状动脉搭桥术（CABG）的风险调整死亡率和医院手术量。
设计、设置和参与者：对911407名年龄在65岁及以上的医疗保险受益人的回顾性队列研究，这些人于1994年至1999年在美国1063家医院接受了冠状动脉搭桥术。
有持续需求证明法规的州（及哥伦比亚特区）（n = 27）、无需求证明法规的州（n = 18）和有间歇性需求证明法规的州（n = 6）；死亡率（冠状动脉搭桥术住院期间或术后30天内）；以及冠状动脉搭桥术的年平均医院手术量。
在没有需求证明法规的州，未调整的死亡率为5.1%，而在有持续法规的州为4.4%，在有间歇性需求证明法规 的州为4.3%（每次比较P<0.001）。在对人口统计学和临床因素进行调整后，没有需求证明法规的州的死亡率仍然高于有持续需求证明法规的州（优势比[OR]，1.22；95%置信区间[CI]，1.15 - 1.28；P<0.001）。使用相同的组进行比较，没有需求证明法规的州冠状动脉搭桥术的年平均医院手术量低84%（104对191；P<0.001），并且更多患者在手术量低的医院（每年<100例手术）接受冠状动脉搭桥术（有持续需求证明计划的州为30%对10%；P<0.001）。在归类为间歇性的州废除需求证明法规后，手术量低的医院中接受冠状动脉搭桥术的患者百分比增加了两倍。
在没有需求证明法规的州，接受冠状动脉搭桥术的医疗保险患者的死亡率更高。在研究期间废除需求证明法规与冠状动脉搭桥术的医院手术量下降有关。
