With this large body of scientific literature, it is no surprise that the leading interventional cardiology professional organizations have endorsed this method as a standard of care:
ACC/AHA guidelines recognize the usefulness of fractional flow measurements in determining whether intervention is needed:
Coronary pressure or Doppler velocimetry may also be useful as an alternative to performing noninvasive functional testing (e.g., when the functional study is absent or ambiguous) to determine whether an intervention is warranted.5
The Society for Cardiovascular Angiography and Interventions has also recognized the importance of this physiological measurement in deciding whether percutaneous treatment is necessary:
Intervention should be employed only after documentation of the clinical and/or physiological significance of the individual lesions.6
While the scientific data is powerful, the cost effectiveness data for FFRmyo is equally compelling. Studies published in peer-reviewed journals document the savings to the healthcare system provided by effective utilization of FFRmyo.
Compared to next-day thallium ischemia testing, cath lab physiologic measurement saves at least one hospital day and nearly $800 per patient without any significant increase in procedure time, radiation exposure, or contrast media usage.7 A separate study concluded, In patients with an intermediate coronary lesion and no prior functional study, measuring [FFRmyo] to guide the decision to perform PCI may lead to significant cost savings ($1,795) compared with performing nuclear stress imaging or with simply stenting lesions in all patients ($3,830).8
Physiologic lesion assessment, such as with FFRmy, can reduce the number of coronary artery bypass graft (CABG) operations, thereby generating additional cost savings. Deferral of just one unnecessary CABG procedure results in savings of $16,999 per patient.9 A recently published study found that the benefits of this tailored use of physiological assessment, when allocated across the population of patients with multivessel coronary artery disease, results in a cost savings in excess of $4,200 per patient.10
Based on this well-documented clinical and cost effectiveness data, CMS has proposed new reimbursement rules for FFRmyo scheduled for January 1, 2005. According to the proposed 2005 outpatient classification and rate tables, published in the in the Federal Register on August 16, 2004, CPT 93571 and 93572 would be assigned to Ambulatory Payment Classification (APC) groups for the first time.
CPT 93571 would be assigned to APC group 0670, which would be renamed Level II Intravenous and Intracardiac Ultrasound and Flow Reserve, with a national average payment rate of $1,698.64. CPT 93572 would be assigned to APC group 0416, which would be renamed Level I Intravenous and Intracardiac Ultrasound and Flow Reserve, with a national average payment rate of $255.05.
In addition, the status indicators for CPT 93571 and 93572 would be changed from N (signifying that payment is packaged into payment for other services), to S (signifying separate APC payment for the service, without multiple service reduction).
The proposal, when implemented January 1, 2005, will provide the necessary reimbursement for interventional cardiac catheterization laboratories to cost effectively utilize this beneficial method for assessing coronary artery disease.
1. Pijls et al., Measurement of Fractional Flow Reserve to Assess the Functional Severity of Coronary Artery Stenoses, <i>N Eng J Med</i> 1996; 334:1703-1708. <p>2. Pijls, Fractional Flow Reserve After Stenting to Predict Need for Repeated Target Vessel Revascularization During Follow-Up, Supp. to <i>J Amer Coll Cardiol</i>, March 6, 2002;39(5). </p><p>3. Pijls, et al., Measurement of Fractional Flow Reserve to assess the functional severity of coronary-artery stenoses, <i>N Eng J Med</i> 1996;334:1703-08. </p><p>4. Fischer, et al. Comparison between visual assessment and quantitative angiography versus fractional flow reserve for native coronary narrowings of moderate severity. <i>Am J Cardiol </i>2002 Aug 1;90(3):210-215. </p><p>5. Brueren et al. How good are experienced cardiologists at predicting the hemodynamic significance of coronary stenoses when taking fractional flow reserve as the gold standards, <i>Int’l J Cardiovasc Imaging</i> 2002;18:73-76. </p><p>6. Pijls, et al., Measurement of Fractional Flow Reserve to assess the functional severity of coronary-artery stenoses, <i>N Eng J Med</i> 1996;334:1703-1708. </p><p>7. Smith et al., ACC/AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines, <i>J Amer Coll Cardiol</i> 2001;37:8,2239i, 2239xxxvii. </p><p>8. Hodgson, et al., SCAI Statement on Drug-Eluting Stents: Practice and Health Care Delivery Implications, <i>Catheterization and Cardiovascular Interventions</i> 2003;58:399. </p><p>9. Leesar et al., Use of fractional flow reserve versus stress perfusion scintigraphy after unstable angina: Effect on duration of hospitalization, cost, procedural characteristics, and clinical outcome. <i>J Am Coll Cardiol</i> 2003;41:1115-21. </p><p>10. Fearon et al. Cost-effectiveness of measuring fractional flow reserve to guide coronary interventions. <i>Am Heart J</i> 2003; 145:882-87. </p><p>11. 2003 CMS data. </p><p>12. Botman, et al. Percutaneous coronary intervention or bypass surgery in multivessel disease? A tailored approach based on coronary pressure measurements. <i>Cardiac Catheterization and Intervention</i> 2004. </p><p> 13. Federal Register, August 16, 2004</p>
