Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

Practice Patterns of Vascular Surgery's "1%".

BACKGROUND: Public focus on health care spending has increased attention on variation in practice patterns and overutilization of high-cost services. Mainstream news reports have revealed that a small number of providers account for a disproportionate amount of total Medicare payments. Here, we explore variation in Medicare payments among vascular surgeons and compare practice patterns of the most highly reimbursed surgeons to the rest of the workforce. METHODS: 2016 Medicare Provider Utilization Data were queried to identify procedure, charge, and payment data to vascular surgeons, identified by National Provider Identification taxonomy. Commonly performed services (>10/year) were stratified into categories (endovascular, open surgery, varicose vein, evaluation and management, etc.). Practice patterns of vascular surgeons comprising the top 1% Medicare payments (n = 31) were compared with the remainder of the workforce (n = 3,104). RESULTS: In 2016, Medicare payments to vascular surgeons totaled $589 M. 31 vascular surgeons-1% of the workforce-received $91 million (15% of total payments). Practice patterns of the 1% differed significantly from the remainder of vascular surgeons (P < 0.05), with endovascular procedures accounting for 85% of their reimbursement. Specifically, the 1% received 49% of total Medicare payments for atherectomy ($121 M), 98% of which were performed in the office setting. CONCLUSIONS: One percentage of vascular surgeons receive an inordinate amount of total Medicare payments to the specialty. This discrepancy is due to variations in volume, utilization, and site of service. Disproportionate use of outpatient atherectomy in a small number of providers, for example, raises concerns regarding appropriateness and overutilization. Given current scrutiny over health care spending, these findings should prompt serious discussion regarding the utility of personal and societal self-regulation.

Provider Trends in Atherectomy Volume between Office-Based Laboratories and Traditional Facilities.

BACKGROUND: As patient care is being increasingly transitioned out of the hospital and into the outpatient setting, there is a growing interest in developing office-based angiography suites, that is, office-based laboratories. Office-based care has been associated with increased efficiency and greater patient satisfaction, with substantially higher reimbursement directly to the physicians providing care. Prior studies have demonstrated a shift of revascularization procedures to office-based laboratories with a concomitant increase in atherectomy use, a procedure with disproportionately high reimbursement in comparison to other peripheral revascularization techniques. We sought to determine provider trends in endovascular procedure volume, settings, and shifts in practice over time, specific to atherectomy. METHODS: Using Centers for Medicare & Medicaid Services Provider Utilization and Payment Data Public Use Files from 2013 to 2015, we identified providers who performed diagnostic angiography (DA), percutaneous transluminal angioplasty (PTA), stent placement (stent), and atherectomy, and procedures were aggregated at the provider level. Trends in procedures performed in office-based laboratory and facility-based settings were analyzed. Atherectomy was specifically analyzed using the total number and proportion of office-based laboratory procedures, and providers were stratified into quintiles by case volume. RESULTS: Between 2013 and 2015, 5,298 providers were identified. Over this time period, the number of providers performing atherectomy increased 25.7%, with the highest quintile of atherectomy providers performing an average of 263 cases (range 109-1,455). The proportion of physicians who performed atherectomy only in the office increased from 39.8% to 50.7% from 2013 to 2015, whereas only 20.8% of physicians who performed DA, PTA, or stent in 2015 did so only in an office-based laboratory. Of the physicians with the highest atherectomy volume, 77.8% operated only in the office in 2015, and these physicians increased their atherectomy volume to 114.1% during the study period. Of those physicians who transitioned to a solely office-based laboratory practice over the study period, atherectomy volume increased 63.4%, which was disproportionate compared with the growth of their DA, PTA, and stent volume. CONCLUSIONS: Over this short study period, a rapid shift into the office setting for peripheral intervention occurred, with a concomitant increase in atherectomy volume that was disproportionate to the increase in other peripheral interventions. This increase in office-based laboratory atherectomy occurred in the setting of increased reimbursement for the procedure and despite a lack of data supporting superiority over PTA/stent.

Effect of hospital volume on outcomes of percutaneous peripheral atherectomy - An observational analysis from National Inpatient Sample.

BACKGROUND: Although the published literature has reported an inverse association between hospital volume and outcomes of coronary interventions, sparse data are available for percutaneous peripheral atherectomy (PPA). The aim of our study was to examine the effect of hospital volume on outcomes of PPA. METHODS: Using the Nationwide Inpatient Sample (NIS) database of the year 2012, PPA with ICD-9 code of 17.56 was identified. The primary outcomes were mortality and amputation rates; secondary outcomes were peri-procedural complications, cost, and length of hospitalization and discharge disposition of the patient. Multivariate models were generated for predictors of the outcomes. RESULTS: We identified a total of 21,015 patients with mean age of 69.53 years, with 56% males. Higher hospital volume centers were associated with a significantly lower mortality (OR 0.42, 95% CI 0.30-0.57, p < 0.0001), amputation rates (5.34% vs. 9.32%, p < 0.0001), combined endpoint of mortality and complications (OR 0.53, 95% CI 0.49-0.58, p < 0.0001), shorter length of hospital stay (LOS) (4.86 vs. 6.79 days, p < 0.0001) and lower hospitalization cost ($23,062 vs. $30,794, p < 0.0001). Subgroup analysis for acute and chronic limb ischemia showed similar results. CONCLUSION: Hospital procedure volume is an independent predictor of mortality, amputation rates, complications, LOS, and costs in patients undergoing PPA with an inverse relationship.

Directional Atherectomy Is Associated with Better Long-Term Efficiency Compared with Angioplasty for Common Femoral Artery Occlusive Disease in Rutherford 2-4 Patients.

BACKGROUND: Despite increased interest in treating common femoral artery (CFA) with endovascular technology, there are little data regarding the long-term outcomes of different endovascular treatment modalities. We report the results after endovascular therapy of symptomatic obstructions of the CFA in a single center. METHODS: We retrospectively reviewed the records of consecutive patients with eligible CFA lesions who were treated with endovascular methods between 2011 and 2013. The preoperative demographic operative details and postoperative outcomes were compared and statistically analyzed. RESULTS: Ninety patients with CFA lesions were treated, and 76 (84.4%) completed a follow-up. Claudication was present in 62 of 76 (81.6%) patients, and stenosis was present in 60 of 76 (78.9%) patients. Angioplasty was performed in 45 patients, and atherectomy was performed in 31 patients. There was no significant difference in the preoperative demographic data, procedure time, contrast administration, or length of hospital stay between the 2 groups. In-hospital treatment costs were significantly higher in the atherectomy group (69,822 RenMinBi Yuan vs. 49,078 RenMinBi Yuan; P = 0.043). During the 4-year primary patency, for whole group or bifurcated/claudicant subgroup, all patients within the atherectomy group were significantly better than those in the angioplasty group. CONCLUSIONS: Atherectomy may be a better alternative to angioplasty for CFA atherosclerotic obstructions lesions. Compared with angioplasty, atherectomy seems to have better results in bifurcated lesions or claudicant patients. In diabetic patients, no superiority was found on either patency or improvement in walking distance.

Utilization and in-hospital outcomes associated with atherectomy in the treatment of peripheral vascular disease: An observational analysis from the National Inpatient Sample.

Objective Percutaneous revascularization for patients with peripheral arterial disease has become a treatment of choice for many symptomatic patients. The presence of severe arterial calcification presents many challenges for successful revascularization. Atherectomy is an adjunctive treatment option for patients with severe calcification undergoing percutaneous intervention. We sought to analyze the impact of atherectomy on in-hospital outcomes, length of stay, and cost in the percutaneous treatment of peripheral arterial disease. Methods Patients with lower extremity peripheral arterial disease undergoing percutaneous revascularization were assessed, utilizing the National Inpatient Sample (2012-2014) and appropriate International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes. Patients who were not treated with atherectomy ( n = 51,037) were compared to those treated with atherectomy ( n = 11,408). Propensity score-matched analysis was performed to address baseline differences. Results After performing propensity score-matched analysis, 11,037 patients were included in each group. Utilization of atherectomy was associated with lower in-hospital mortality (2% vs. 1.4% p = 0.0006). All secondary outcomes were lower when using atherectomy except acute renal failure. Length of stay was slightly lower when using atherectomy (7.2 vs. 7.0 days, p = 0.0494). However, median cost was higher in patients treated with atherectomy ($21,589 vs. $24,060, p = <0.0001). Conclusion The use of atherectomy was associated with significantly decreased in-hospital mortality, adverse events, and length of stay. Though, cost associated with atherectomy use is increased, this is offset by decreased in-hospital adverse outcomes. Appropriate use of atherectomy devices is an important tool in revascularization of peripheral arterial disease in select patients.

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach.

AIM: The incremental cost of peripheral orbital atherectomy system (OAS) plus balloon angioplasty (BA) versus BA-only for critical limb ischemia was estimated. MATERIALS & METHODS: A deterministic simulation model used clinical and healthcare utilization data from the CALCIUM 360° trial and current cost data. Incremental cost of OAS + BA versus BA-only included differential utilization during the procedure and adverse-event costs at 3, 6 and 12-months. RESULTS: For every 100 procedures, incremental annual costs to the hospital were US$350,930 lower with OAS + BA compared with BA-only. Despite higher upfront costs, savings were realized due to reduced need for revascularization, amputation and end-of-life care over 6-12-month postoperative period. CONCLUSION: Atherectomy with OAS prior to BA was associated with cost savings to the hospital.

The disproportionate growth of office-based atherectomy.

OBJECTIVE: The purpose of this study was to evaluate the trends in procedure volume, clinical sites of care, and Medicare expenditure for peripheral vascular interventions (PVIs) for lower extremity occlusive disease since the Centers for Medicare and Medicaid Services instituted reimbursement policy changes that broadened payment for procedures performed in physician-owned office-based laboratories (OBLs). METHODS: We analyzed fee-for-service Medicare claims data from 2011 to 2014 to obtain the frequency of use of PVI by type, care setting, and physician specialty. We also assessed changes in the total Medicare cost for PVI by setting. RESULTS: There was a 60% increase in atherectomy cases among Medicare beneficiaries between 2011 and 2014. During the same period, OBLs experienced a 298% increase in atherectomy volume vs a 27% increase in hospital outpatient settings and an 11% decrease for inpatient hospital settings. In 2014, OBLs were the most common setting for atherectomy. Nonatherectomy PVIs grew more modestly at just 3% but also experienced site of care shifts. Vascular surgeons and cardiologists accounted for the majority of office-based PVIs in 2014. Total Medicare costs for PVIs increased 18% from 2011 to 2014. Hospital inpatient costs declined 1%, whereas costs for hospital outpatient PVIs increased by 41% and physician office costs increased by 258%. CONCLUSIONS: The migration of revascularization procedures for lower extremity peripheral arterial occlusive disease continues from the inpatient to the outpatient setting and especially to OBLs. Increased use of atherectomy in all segments of the lower extremity arterial system has been observed, particularly in OBLs, without substantial evidence in the literature of increased efficacy compared with standard angioplasty with or without stenting. Generous Medicare reimbursement for in-office atherectomy procedures is likely contributing to the volume shifts observed.

Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system.

BACKGROUND: Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to encourage more efficient outpatient use of PVI in the United States. OBJECTIVES: The purpose of this study was to evaluate trends in the use and clinical settings of PVI and the effect of changes in reimbursement. METHODS: Using a 5% national sample of Medicare fee-for-service beneficiaries from 2006 to 2011, we examined age- and sex-adjusted rates of PVI by year, type of procedure, clinical setting, and physician specialty. RESULTS: A total of 39,339 Medicare beneficiaries underwent revascularization for PAD between 2006 and 2011. The annual rate of PVI increased slightly from 401.4 to 419.6 per 100,000 Medicare beneficiaries (p = 0.17), but the clinical setting shifted. The rate of PVI declined in inpatient settings from 209.7 to 151.6 (p < 0.001), whereas the rate expanded in outpatient hospitals (184.7 to 228.5; p = 0.01) and office-based clinics (6.0 to 37.8; p = 0.008). The use of atherectomy increased 2-fold in outpatient hospital settings and 50-fold in office-based clinics during the study period. Mean costs of inpatient procedures were similar across all types of PVI, whereas mean costs of atherectomy procedures in outpatient and office-based clinics exceeded those of stenting and angioplasty procedures. CONCLUSIONS: From 2006 to 2011, overall rates of PVI increased minimally. However, after changes in reimbursement, PVI and atherectomy in outpatient facilities and office-based clinics increased dramatically, neutralizing cost savings to Medicare and highlighting the possible unintended consequences of coverage decisions.

In-hospital outcomes and cost comparison of femoropopliteal reopening strategies.

PURPOSE: Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies. METHODS: We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006. The choice of reopening strategy was left to the treating physician, and no patients with relative contraindications to stent placement (specifically common femoral artery lesions) were included. Device and supply costs were calculated using the hospital resource-based accounting system, and other costs were calculated using the hospital micro-cost accounting system. Professional fees were calculated from the Medicare Fee Schedule. RESULTS: Baseline characteristics were generally well matched. There were no significant differences in complications (vascular complications, urgent repeat reopening, death, myocardial infarction, or stroke) between groups (PTA 8.7% vs. atherectomy 5.4%, P=.53). PTA required more balloons (2.0±0.8 vs. 0.7±1.0, P<.001) and stents (1.5±0.8 vs. 0.2±0.5, P<.001), but fewer atherectomy catheters (0.0±0.0 vs. 1.2±0.4, P<.001). Neither procedural supply costs (PTA $3137±1459 vs. atherectomy $3338±1505, P=.20) nor total costs differed between PTA and atherectomy patients ($10,945±4521 vs. $10,783±3857, P=.42). CONCLUSIONS: Initial outcomes and costs are comparable for femoropopliteal PTA and atherectomy. The choice of reopening strategy should therefore be based on operator experience and anatomic suitability. Further studies are required to determine whether there are differences in long-term outcomes or costs between these approaches.

Saving lives, money and resources: drug and CABG/PCI use after myocardial infarction in a Swedish record-linkage study.

BACKGROUND: Drug costs are increasing despite the introduction of cheaper generic drugs. The aim of the present study was to analyse the entire costs of hospital care, out-patient care, and the cost of drugs for 16 months following a myocardial infarction (MI) to see to what extent drug costs contribute to the overall costs of care. METHODS: Diagnoses and costs for care as well as mortality data obtained from the Västra Götaland Region, Sweden, and drug costs from the Swedish Board of Health and Welfare, were merged in a computer file. Patients registered from 1 July 2005 to 30 June 2006 were followed from 28 days after an MI, with follow-up until 31 October 2006. RESULTS: Of 4,725 patients, 711 died before the start of the study and 721 during follow-up. Higher age [hazard ratio (HR, 95%CI) = 1.06 (1.05-1.07)], previous MI [HR = 1.31 (1.13-1.53)] and diabetes mellitus [HR = 1.34 (1.13-1.58)] were associated with increased mortality, which decreased with coronary interventions: CABG/PCI [HR = 0.19 (0.14-0.27)]. In a multivariable analysis, mortality was lower for patients taking simvastatin [HR = 0.62 (0.50-0.76)] and clopidogrel [HR = 0.58 (0.46-0.74)]. CONCLUSION: Costs for out-patient care accounted for 25% and drugs for 5% of total costs. If patients not treated with simvastatin or clopidogrel had received these drugs, an additional 154-306 lives might have been saved. Drug costs would be higher, but total costs lower. Thus, even expensive drugs may reduce overall costs.

Lower extremity endovascular interventions: can we improve cost-efficiency?

OBJECTIVE: Management of lower extremity arterial disease with endovascular intervention is on the rise. Current practice patterns vary widely across and within specialty practices that perform endovascular intervention. This study evaluated reimbursement and costs of different approaches for offering endovascular intervention and identified strategies to improve cost-efficiency. METHODS: The medical records of all patients admitted to a university health system during 2005 for an endovascular intervention were retrospectively reviewed. Procedure type, setting, admission status, and financial data were recorded. Groups were compared using analysis of variance, Student t test for independent samples, and chi2. RESULTS: A total of 296 endovascular interventions were completed, and 184 (62%) met inclusion criteria. Atherectomy and stenting were significantly more costly when performed in the operating room than in the radiology suite: atherectomy, dollars 6596 vs dollars 4867 (P = .002); stent, dollars 5884 vs dollars 3292, (P < .001); angioplasty, dollars 2251 vs dollars 1881 (P = .46). Reimbursement was significantly higher for inpatient vs ambulatory admissions (P < .001). Costs were lowest when the endovascular intervention was done in the radiology suite on an ambulatory basis and highest when done as an inpatient in the operating room (dollars 5714 vs dollars 12,278; P < .001). Contribution margins were significantly higher for inpatients. Net profit was appreciated only for interventions done as an inpatient in the radiology suite. Reimbursement, contribution margins, and net profit were significantly lower among private pay patients in both the ambulatory and inpatient setting. The 30-day hospital readmission after ambulatory procedures was seven patients (6%). CONCLUSIONS: Practice patterns for endovascular interventions differ considerably. Costs vary by procedure and setting, and reimbursement depends on admission status and accurate documentation; these dynamics affect affordability. Organizing vascular services within a hub will ensure that care is delivered in the most cost-efficient manner. Guidelines may include designating the radiology suite as the primary venue for endovascular interventions because it is less costly than the operating room. Selective stenting policies should be considered. Contracts with private insurers must include carve-outs for stent costs and commensurate reimbursement for ambulatory procedures, and Current Procedural Terminology (CPT; American Medical Association, Chicago, Ill) coding must be proficient to make ambulatory endovascular interventions fiscally acceptable.

Examining the economic impact of restenosis: implications for the cost-effectiveness of an antiproliferative stent.

Over the past decade, coronary stenting has been shown to reduce the rates of angiographic and clinical restenosis compared with conventional balloon angioplasty. Despite these improved outcomes, however, coronary stenting is still hampered by a high incidence of restenosis, with important clinical and economic consequences. Recently, the development of antiproliferative, drug-eluting stents has emerged as a promising solution for the primary prevention of restenosis. This paper summarizes the current evidence on the economic impact of coronary restenosis and explores the potential impact of introducing an antiproliferative stent on the cost-effectiveness of percutaneous coronary revascularization. A decision-analytic model based on current clinical and cost data is used to examine the potential cost-effectiveness of such stents. Although prospectively designed studies will be critical to define the true impact of drug-eluting stents on long-term survival, quality of life, and costs in a broad patient population our decision analytic model suggests that as long as these stents are reasonably priced, they may be cost saving for certain patients and cost-effective for virtually all patients undergoing PCI--at least within the U.S. healthcare system.

Endovascular-assisted versus conventional in situ saphenous vein bypass grafting: cumulative patency, limb salvage, and cost results in a 39-month multicenter study.

OBJECTIVE: In this retrospective multicenter study, the results of a minimally invasive method of endovascular-assisted in situ bypass grafting (EISB) versus "open" conventional in situ bypass grafting (CISB) were evaluated with a comparison of primary and secondary patency, limb salvage, and cost. METHODS: Enrolled in this study were 273 patients: 117 underwent CISB (42 femoropopliteal, 75 femorocrural) and 156 underwent EISB (41 femoropopliteal, 115 femorocrural). EISB was performed with an angioscopic Side Branch Occlusion system and an angioscopically guided valvulotome. All the patients underwent follow-up examination with serial color-flow ultrasound scanning. RESULTS: Both groups had similar comorbid risk factors for diabetes mellitus, coronary artery heart disease, hypertension, and cigarette smoking. The primary patency rates (CISB, 78.2% +/- 5% [SE]; EISB, 70.5% +/- 5%; P =.156), the secondary patency rates (CISB, 84.1% +/- 4%; EISB, 82.9% +/- 5%; P =.26), and the limb salvage rates (CISB, 85.8%; EISB, 88.4%; P =.127) were statistically similar, with a follow-up period that extended to 39 months (mean, 16.6 months; range, 1 to 40 months). In veins that were less than 2.5 to 3.0 mm in diameter, the EISB grafts fared poorly, with an increased incidence of early (12-month) graft thromboses (CISB, 10 grafts, 8.5%; EISB, 24 grafts, 15.3%). However, wound complications (CISB, 23%; EISB, 4%; P =.003), mean hospital length of stay (CISB, 6.5 days +/- 4.83; EISB, 3.2 days +/- 3.19; P =.001), and mean hospital charges (CISB, $25,349 +/- $19,476; EISB, $18,096 +/- $14,573; P =.001) were all significantly reduced in the EISB group. CONCLUSION: The CISB and EISB midterm primary and secondary patency and limb salvage rates were statistically similar. In smaller veins (< 2.5 to 3.0 mm in diameter), however, EISB is not appropriate because overly aggressive instrumentation may cause intimal trauma, with resultant early graft failure. With the avoidance of a long leg incision in the EISB group, wound complications and hospital length of stay were significantly reduced, which lowered hospital charges and justified the additional cost of the endovascular instruments. When in situ bypass grafting is contemplated, EISB in appropriate patients is a safe, minimally invasive, and cost-effective alternative to CISB.