美国西北大学Karl Y. Bilimoria团队研究了各州需求证明监管与医保受益人的手术量、市场份额和临床预后的相关性。2020年11月24日，该研究发表在《美国医学会杂志》上。

需求证明法规定了各州对卫生系统支出的监管。这些法律旨在限制支出并控制医院的扩张，以防止医疗资源过剩，并改善护理质量。在美国政府2017年10月发布的第13813号行政命令的鼓励下，一些州最近推出了修改或废除这些法规的立法。

为了通过各州需求证明状况，来评估医院活动和质量指标（包括医院手术量、医院市场份额、每万人县级层面的手术量以及患者层面的术后结局）的差异，研究组进行了一项横断面研究，招募65岁以上的医保受益人，2016年1月1日至2018年11月30日，他们接受了以下10项手术中的1项：全膝或髋关节置换术、冠状动脉搭桥术、结肠切除术、腹侧疝修补术、下肢血管搭桥、肺切除、胰腺切除、膀胱切除术或食管切除术。主要结局包括医院手术量、医院市场份额、每万人县级手术量，以及患者层面的术后30天死亡、手术部位感染和再次入院率。

共有1545952例患者在3631所医院中接受了10项手术中的1项，其中女性占58.0％，中位年龄为72岁。468236例（30.3％）患者来自15个无需求证明法的州，1077716例（69.7％）来自35个有需求证明法的州。手术总数从全膝关节置换术的729855例（47.21％）到食管切开术的4558例（0.29％）不等。在有或没有需求证明法的各州之间，医院手术量，医院间市场份额，每万名符合医保资格人群的手术率、30天死亡率、手术部位感染率或再入院率均无统计学差异。

研究结果表明，对于2016-2018年间接受过一系列外科手术治疗的医保受益人，有或没有需求证明法的各州之间，医院数量或质量指标之间没有显著差异。

附：英文原文

Title: Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries

Author: Tarik K. Yuce, Jeanette W. Chung, Cynthia Barnard, Karl Y. Bilimoria

Issue&Volume: 2020/11/24

Abstract:

Importance  Certificate of need laws provide state-level regulation of health system expenditure. These laws are intended to limit spending and control hospital expansion in order to prevent excess capacity and improve quality of care. Several states have recently introduced legislation to modify or repeal these regulations, as encouraged by executive order 13813, issued in October 2017 by the Trump administration.

Objective  To evaluate the difference in markers of hospital activity and quality by state certificate of need status. These markers include hospital procedural volume, hospital market share, county-level procedures per 10000 persons, and patient-level postoperative outcomes.

Design, Setting, and Participants  A cross-sectional study involving Medicare beneficiaries aged 65 years or older who underwent 1 of the following 10 procedures from January 1, 2016, through November 30, 2018: total knee or hip arthroplasty, coronary artery bypass grafting, colectomy, ventral hernia repair, lower extremity vascular bypass, lung resection, pancreatic resection, cystectomy, or esophagectomy.

Exposures  State certificate of need regulation status as determined by data from the National Conference of State Legislatures.

Main Outcomes and Measures  Outcomes of interest included hospital procedural volume; hospital market share (range, 0-1; reflecting 0%-100% of market share); county-level procedures per 10000 persons; and patient-level postoperative 30-day mortality, surgical site infection, and readmission.

Results  A total of 1545952 patients (58.0% women; median age 72 years; interquartile range, 68-77 years) at 3631 hospitals underwent 1 of the 10 operations. Of these patients, 468236 (30.3%) underwent procedures in the 15 states without certificate of need regulations and 1077716 (69.7%) in the 35 states with certificate of need regulations. The total number of procedures ranged between 729855 total knee arthroplasties (47.21%) and 4558 esophagectomies (0.29%). When comparing states without vs with certificate of need regulations, there were no significant differences in overall hospital procedural volume (median hospital procedure volume, 241 vs 272 operations per hospital for 3 years; absolute difference, 31; 95% CI, 27.64 to 89.64; P=.30). There were no statistically significant differences between states without vs with certificate of need regulations for median hospital market share (median, 28% vs 52%; absolute difference, 24%; 95% CI, 5% to 55%; P=.11); procedure rates per 10000 Medicare-eligible population (median, 239.23 vs 205.41 operations per Medicare-eligible population in 3 years; absolute difference, 33.82; 95% CI, 84.08 to 16.43; P=.19); or 30-day mortality (1.17% vs 1.33%, odds ratio [OR], 1.04; 95% CI, 0.93 to 1.16; P=.52), surgical site infection (1.24% vs 1.25%; OR, 0.93; 95% CI, 0.83 to 1.04; P=.21), or readmission rate (9.69% vs 8.40%; OR, 0.80; 95% CI, 0.57 to 1.12; P=.19).

Conclusions and Relevance  Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.

DOI: 10.1001/jama.2020.21115

Source: https://jamanetwork.com/journals/jama/article-abstract/2773272