July 3, 2024

On behalf of the physicians who care for patients with peripheral artery disease (PAD) and other forms of vascular disease, we want to address the deeply flawed characterizations of vascular disease treatment portrayed in a series of media articles published over the last year.  Our mission as clinicians must always be to act in the best interest of our patients, which demands that we provide patients with the highest standard of care based on scientific evidence. Yet we also feel a responsibility to speak out against misleading information that has the potential to dissuade patients from seeking necessary care or to introduce external pressures into the clinical decision-making process. Our response aims to separate fact from narrative.

Atherectomy is a proven treatment for vascular disease patients

PAD and other forms of vascular disease are among the leading causes of the approximately 150,000 amputations performed in the United States annually, and atherectomy has been used to save life and limb in countless patients who have suffered from vascular disease.  Data from the Sage Group has found between 25-33 percent of CLI patients are treated with primary amputation, which is more expensive than revascularization.[1]  These data are compounded by health equity access concerns as noted in a ProPublica article, “The Black American Amputation Epidemic.”[2]

Contrary to claims made in certain media articles, atherectomy is not a “particularly controversial” procedure.  Atherectomy, a minimally invasive procedure in which a physician uses a catheter with a blade, laser, or rotating device to remove plaque in blocked arteries, has repeatedly proven to be safe and effective.  The Vascular Quality Initiative (VQI) analyzed data with outcomes from over 25,000 patients that revealed that the combination of atherectomy and balloon angioplasty (BA) significantly lowers the rates of major adverse limb events (MALE) and amputation compared to BA alone at the cost of a higher propensity for reintervention.[3]  The National Cardiovascular Data Registry PVI Registry, encompassing 30,847 patients, further affirms atherectomy’s safety profile, showing no associated increase in in-hospital bleeding or thrombosis.[4]  These findings align with another study highlighting low complication rates and favorable short to intermediate outcomes in a PAD safety-net population undergoing directional atherectomy and drug-coated balloon therapy.[5]  The OEIS National Registry is currently submitting a paper for publication review encompassing over 19,000 patients (all patients who underwent either office or outpatient atherectomy procedures) with similar favorable findings.  Finally, a meta-analysis conducted by Wu et al. involving more than 10,000 patients across ten studies, supports the superiority of atherectomy plus BA over BA alone for treating infrapopliteal arterial disease. The study found notable improvements in Target Lesion Revascularization (TLR) and amputation rates, again supporting atherectomy’s role in enhancing treatment efficacy.[6]

While atherectomy is a procedure with proven benefit in patients with severe forms of vascular disease, there is a further need for evidence concerning its use in patients with milder symptoms.  For patients who have only experienced milder symptoms of vascular disease, physicians must exercise cautious judgment about whether an atherectomy is appropriate by weighing the benefits and risks. That decision is best determined by a physician and their patient, based on specific clinical factors.

We remain committed to promoting the highest standard of care for our patients. That is why we have been involved in developing, and repeatedly updating, the guidelines and appropriate use criteria that represent the consensus on what the scientific literature tells us about when atherectomy or other vascular intervention is likely to be more beneficial to patients, or when the risks outweigh the harms. See, for instance, the “ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention,” [7]the “Society for Vascular Surgery appropriate use criteria for management of intermittent claudication,” [8]the “2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease,” [9]the “SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions,” [10]which are just a few examples of the work done to ensure physicians are equipped with the knowledge to provide their patients the highest level of care possible. Clinicians must ultimately make decisions about the optimal treatment approach, based on the needs of their patients.

Assertions by media articles of financial incentives to overuse atherectomy are based on flawed data

A 2019 JVS study highlighted by multiple media articles states, “For example, the 2018 Medicare reimbursement for a femoropopliteal atherectomy and stent placement (CPT 37225) is $10,864 for procedures performed in an ASC compared with only $765 for procedures performed in a hospital setting.”11]  In fact, the global payment to hospitals for 37225 under the 2018 Hospital Outpatient PPS and PFS Final Rules was $11,147 ($10,510 + $637) compared to global payments for the office of $11,130.  In other words, in studies highlighted by multiple media articles, reimbursement for 37225 was close to parity during the study periods in question and, in the case of other studies cited, was based on significantly outmoded data.[12] [13]  Medicare payments for interventional services, particularly in the office-based setting have undergone substantial revisions in recent years.  In 2024, according to CMS’ own data, there are at least 195 CPT codes – all in the office-based setting – for which total reimbursement is less than their direct costs.[14]  Specific to femoropopliteal atherectomy and stent placement (CPT 37225), global payments in the office-based setting are $8,545 compared to direct costs of $10,396.  Said another way, in 2024, Medicare actually under-reimburses atherectomy by at least 22% in the office-based setting.  In contrast, the global payment to hospitals for 37225 under the 2024 Hospital Outpatient and PFS Final Rules is $17,287 ($16,707 + $580).

In fact, physicians now are shifting cases back to higher cost sites-of-service, or in some cases closing their office-based facilities because of the lack of adequate reimbursements.  A 2023 survey by OEIS, AVLS, SIR, SVS, SCAI, and AVF of mostly non-hospital providers found, among other things, 26% of doctors said that they are “likely” or “very likely” to close their practice in the next two years.[15]

Patients deserve access to the best available care

 We believe it is important to speak out, not just against the mischaracterizations included in these articles, but on behalf of patients who need this critical care. Far too often, we have seen patients suffer from the symptoms of vascular disease without appropriate treatment. Patients suffering from serious, untreated vascular disease face the risk of amputation or death. PAD and other forms of vascular disease can often be managed with exercise or medicine, provided treatment is provided to a patient early in the disease progression. There is much more to be done on behalf of patients suffering from vascular disease. We will continue to follow our mission to act in our patients’ best interests.

___________

[1] Diagnostic and Interventional Cardiology, Annual U.S. Economic Burden of Critical Limb Ischemia Exceeds $200 Billion, July 17, 2019

[2] ProPublica, The Black American Amputation Epidemic, 19 May 2020

[3] Jamil Y, Nanna MG, Chaar CIO, Mena-Hurtado C, Attaran RR. Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI. J Endovasc Ther. 2023 Nov 3:15266028231208895. doi: 10.1177/15266028231208895. Epub ahead of print. PMID: 37919968.

[4] Albaghdadi M, Young MN, Al-Bawardy R, Monteleone P, Hawkins B, Armstrong E, Kassab M, Khraishah H, Chowdhury M, Tripathi A, Kennedy KK, Secemsky EA. Outcomes of atherectomy in patients undergoing lower extremity revascularisation. EuroIntervention. 2023 Sep 25:EIJ-D-23-00432. doi: 10.4244/EIJ-D-23-00432. Epub ahead of print. PMID: 37750241.

[5] Hogan SE, Holland M, Burke J, Johnson P, McNeal D, Cicutto L, Nehler M, Peterson PN. Retrospective Review of Directional Atherectomy and Drug-Coated Balloon Use in a PAD Safety-Net Population. J Invasive Cardiol. 2023 Apr;35(4):E205-E216. PMID: 37029994.

[6] Wu H, Zheng D, Zhou L, Wang Q, Wang T, Liang S. A Systematic Review and Meta-analysis of Atherectomy Plus Balloon Angioplasty Versus Balloon Angioplasty Alone for Infrapopliteal Arterial Disease. J Endovasc Ther. 2023 Nov 7:15266028231209236. doi: 10.1177/15266028231209236. Epub ahead of print. PMID: 37933456.

[7] Bailey SR, Beckman JA, Dao TD, et al. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention. Journal of the American College of Cardiology. 2019;73(2):214-237.

[8] Woo K, Siracuse JJ, Klingbeil KD, et al. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication. 2022;76(1):3-22.e1. doi:https://doi.org/10.1016/j.jvs.2022.04.012

[9] Gornik HL, Aronow HD, Goodney PP, et al. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Journal of the American College of Cardiology. Published online May 1, 2024. doi:https://doi.org/10.1016/j.jacc.2024.02.013

[10] Riley RF, Patel MP, J. Dawn Abbott, et al. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. Journal of the Society for Cardiovascular Angiography & Interventions. Published online January 1, 2024:101259-101259. doi:https://doi.org/10.1016/j.jscai.2023.101259

[11] Hicks, Caitlin et. al. “Overuse of early peripheral vascular interventions for claudication”. Society for Vascular Surgery. June 14, 2019.

[12] For example, a 2021 JACC study cited by multiple media articles states, “In 2019, the national average Medicare physician payment rate for atherectomy was $635 for in-hospital cases compared to $12,444 for office-based cases.”  This study also omits the vast majority of payments going to the hospital for 37225 through technical payments under the Hospital Outpatient PPS. Hicks CW, Holscher CM, Wang P, Dun C, Abularrage CJ, Black JH 3rd, Hodgson KJ, Makary MA. Use of Atherectomy During Index Peripheral Vascular Interventions. JACC Cardiovasc Interv. 2021 Mar 22;14(6):678-688. doi: 10.1016/j.jcin.2021.01.004. PMID: 33736774; PMCID: PMC9069395.

[13] For example, a 2021 Annals of Vascular Surgery cited by multiple media articles was conducted using 2016 data on payments and utilization.  Sheaffer WW, Davila VJ, Money SR, Soh IY, Breite MD, Stone WM, Meltzer AJ. Practice Patterns of Vascular Surgery’s “1%”. Ann Vasc Surg. 2021 Jan;70:20-26. doi: 10.1016/j.avsg.2020.07.010. Epub 2020 Jul 29. PMID: 32736025.

[14] Medicare Physician Fee Schedule Reimbursement is Less Than Costs for At Least 195 Office-Based Physician Fee Schedule Services: https://oeiswebprd.wpenginepowered.com/wp-content/uploads/2024/03/MedicareReimbursementvsDirectCosts.pdf

[15] New Survey Data Illustrates Bleak Outlook For Office-Based Specialists Due to MPFS Cuts: https://4d8e3af8-89c2-49cb-ba78-e20e7bd02215.usrfiles.com/ugd/4d8e3a_215c6f7e87d4400fa872a02a8666256c.pdf