A Unique All-Payer Rate-Setting System Controls the Cost but Not the Racial Disparity in Lower Extremity Revascularization Procedures.

BACKGROUND: Patients with peripheral arterial disease often have high comorbidity burden that may complicate post-interventional course and drive increased health-care expenditures. Racial disparity had been observed in lower extremity revascularization (LER) patterns and outcomes. In 2014, Maryland adopted an all-payer rate-setting system to limit the rising hospitalization costs. This resulted in an aggregate payment system in which hospital compensation takes place as an overall per capita expenditure for hospital services. We sought to examine racial differences and other patient-level factors that might lead to discrepancies in LER hospital costs in the State of Maryland. METHODS: We used International Classification of Diseases, Ninth Revision codes to identify patients who underwent infrainguinal open bypass (open) and endovascular repair (endo) in the Maryland Health Services Cost Review Commission database (2009-2015). Multivariable generalized linear model regression analysis was conducted to report cost differences adjusting for patient-specific demographics, comorbidities, and insurance status. Logistic regression analysis was used to assess quality metrics: intensive care unit (ICU) admission, 30-day readmission, protracted length of stay (pLOS) (endo: pLOS >9, open: pLOS > 10 days) and in-hospital mortality. RESULTS: Among patients undergoing open, costs were higher for nonwhite patients (African-American [AA]: $6,092 [4,682-7,501], other: $3,324 [437-6,212]; both P ≤ 0.024), diabetics ($2,058 [837-3,279]; P < 0.001), and patients with Medicaid had an increased cost over Medicare patients by $4,325 (1,441-7,209). Critical limb ischemia (CLI) was associated with $5,254 (4,014-6,495) risk-adjusted cost increment. In addition, AA patients demonstrated higher risk-adjusted odds of ICU admission (adjusted odds ratio [aOR] [95% confidence interval {CI}]:1.65 [1.46-1.86]; P < 0.001) and pLOS (aOR [95% CI]: 1.56 [1.37-1.79]; P < 0.001) than their white counterparts. For patients undergoing endo, costs were higher for nonwhite patients (AA: $2,642 [1,574-3,711], other: $4,124 [2,091-6,157]; both P < 0.001). Patients with CLI and heart failure had increased costs after endo. AA patients were more likely to be readmitted or stayed longer after endo (1.16 [1.03-1.29], 1.34 [1.21-1.49]; both P < 0.010, respectively). The overall cost trend was rapidly increasing before all-payer rate policy implementation but it dramatically plateaued after 2014. CONCLUSIONS: This study showed that the all-payer rate-setting system has curbed the LER rising costs, but these costs remained disproportionally higher for disadvantaged populations such as AA and Medicaid communities. This underpins the existing racial disparity in LER. AA patients had higher LER costs, most likely driven by extended hospitalization and ICU admission. Efforts could be directed to evaluate the contributing socioeconomic factors, invest in primary prevention of comorbid conditions that had shown to be associated with prohibitive costs, and identify mechanisms to overcome the existing racial disparity in LER within the promising cost-saving payment system at the State of Maryland.

Malpractice litigation in the endovascular era.

OBJECTIVE: The standard of care in the treatment of vascular disease continues to evolve as endovascular therapies develop. Currently, it is unclear how medical malpractice litigation has adapted to the "endovascular era." This retrospective case review is the most comprehensive analysis to date of malpractice actions involving endovascular procedures performed by vascular surgeons (VSs), interventional radiologists (IRs), interventional cardiologists (ICs), and cardiothoracic surgeons (CTSs). METHODS: The legal databases LexisNexis and Westlaw were searched for all published legal cases in the United States involving endovascular procedures. The search was limited to state and federal cases up to and including the year 2016. Keywords included "malpractice," "vascular," "endovascular," "catheter," "catheterization," "stent," "angiogram," "angiography," and "surgery." Cases involving tax revenue, insurance disputes, Social Security Disability, and hospital employment contract disputes were excluded. Data were analyzed using χ2 test. RESULTS: There were 2115 initial search results identified, and 369 cases were included in final analysis. The rate of endovascular procedure-related lawsuits (per 1000 active physicians in the specialty) was highest for ICs (105.56), whereas rates for VSs and IRs were comparable (18.47 and 16.85, respectively); 93% of the IC cases were related to coronary interventions. Overall, 55% (148/271 classifiable cases) of actions were related to elective procedures. For VSs specifically, 46% (25/54) of cases arose from diagnostic angiography and inferior vena cava filter placement, two relatively minor procedure types. Overall, 83% (176/211 finalized cases) of verdicts favored defendants, with no significant differences across the specialties; 43% (157/368) of total cases involved death of the patient. Among the four specialties, there was a significant (P = .0004) difference in the primary allegation (informed consent, preprocedure negligence, intraprocedure complications, or postprocedure complications) underlying the litigation. For CTSs and VSs, there was a predominance of informed consent and preprocedure negligence allegations (70% [7/10] and 52% [28/54], respectively). Intraprocedure negligence was the most common allegation for IRs (59% [23/39]), whereas allegations were more evenly distributed among ICs. CONCLUSIONS: Key issues were identified regarding malpractice litigation involving the specialties that commonly perform endovascular procedures. Despite the increasing number of ICs doing peripheral interventions, a large majority of IC cases were related to coronary treatments. A surprisingly large percentage of VS cases were related to seemingly minor cases. There were significant interspecialty differences in the primary underlying allegations. As the scope of endovascular procedures broadens and deepens, it is important for clinicians to be aware of legal considerations relevant to their practice.

El aneurisma de aorta abdominal / The abdominal aortic aneurysm

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A surgeon's perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices.

Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification.

Legal implications of pushing the endovascular envelope.

Endovascular technology continues to improve for the treatment of vascular disease. However, application of these technologies without first obtaining proper informed consent may result in medical malpractice litigation. Similarly, use of these technologies without proper government and/or hospital approval may result in both criminal and/or civil liability. Care must be taken when pushing the envelope of endovascular interventions.