Mis-Alignment of Clinical Goals and Financial Incentives in Coronary Stent Revascularizations Adversely Affects Patient Outcomes

Abstract

The misalignment of clinical and financial incentives for coronary stent revascularizations (percutaneous coronary interventions, PCI) by the Medicare payor, CMS (Centers for Medicare and Medicaid Services), has adversely affected patient-beneficiaries. Financial incentives, remunerations, encourage performance of inappropriate and unnecessary PCIs. While Fractional Flow Reserve (FFR) can prevent unnecessary PCIs, nevertheless, FFR adoption has not occurred despite documented unequivocal benefits by: (1) identifying a lesion’s ischemic potential, (2) determining need for stent revascularization, (3) replacing the inaccurate physician’s visual estimate of vessel narrowing severity with the nonaligned FFR metric, and (4) replacing the inaccurate angiographic silhouette as the measure of success with post-PCI FFR, which, in addition, supplies critical substantive outcome data. CMS’ payment schedules to physicians, hospitals, and, as a result, medical device vendors, unfortunately, incentivized maintenance of the status quo. If FFR were the requisite determinative that would disqualify ~1/3^rd of PCIs, procedures which would become coronary angiograms (CA), then, with present reimbursement schedules, the resulting devastating fiscal headwinds would be problematic for all parties. In contradistinction, CMS savings, considering that 231,000 among the 700,000 potential PCI SVA (Single Vessel Angioplasty) patients, that converted to CA, whose hospital reimbursement is $3,108/case, would range from $1.2- $2.9 billion. However, positively altering the reimbursement schedule for physicians is central. If a PCI became a CA, physician reimbursement would decrease to $228-$394, in contradistinction, a $1,000 increase for FFR guidewire manipulation and data interpretation, plus the $228-$394 for CA performance would increase their payment to $1,200-$1,400/procedure, which is separate from hospital payments. Hospital payments should increase by $1,000-2,000 (i.e., solely profit) above the CA payment of $3,108, plus an added vendor FFR wire payment of $2,500. This total, $6,608-$7,608, is significantly less than hospital PCI+DES (Drug Eluting Stent) of $12,767-$20,127 revascularization payments, which would have been paid for a PCI. For vendors, stent payment losses, selling prices of $600-$1,600/stent, is overcome by (1) the FFR wires manufacturing costs ($200-$300) that approximates 10% of the $2,500 payment (gross profit of 90%), and (2) the significant FFR market expansion of >1 million PCIs and a similar sized CA market with a considerable percentage of undiagnosed coronary artery obliterative disease. This proposal financially incentivizes physicians to perform FFR, and hospitals, without a procedural profit loss, should be financial indifferent to the procedure performed. The mis-alignment of financial incentives is not illusory but can be restored with appropriate alignment that benefits all parties financially, prevents unnecessary PCIs, improves patient outcomes, and reduces Medicare/CMS expenditures by billions.