Peripheral artery disease (PAD) is a condition that affects approximately 236 million adults, with an estimated 8.5 million Americans being affected nationally; however, there is a need for more contemporary data.¹ Although data linking race to incident PAD is limited, the lifetime estimated risk of PAD is highest among African American and non-Hispanic White patients.¹ Despite the global and national prevalence of PAD, it remains underappreciated in comparison to coronary artery disease (CAD) and cerebrovascular disease.¹ Data from the REACH Registry highlights that PAD is not simply narrowed arterial vasculature but a clue of possible polyvascular disease.² Despite the national prevalence of the disease and objective data from the REACH Registry, the U.S. Preventative Services Task Force (USPSTF) concluded there is insufficient data to screen asymptomatic individuals for PAD with an ankle-brachial index. However, supporting recommendations are found in the 2016 AHA/ACC Guidelines on the Management of Patients with Lower Extremity Peripheral Artery Disease.^3,4 This leaves millions of at-risk Americans vulnerable to the potential long-term morbidity and mortality not only associated with PAD but also potential polyvascular disease, as the Centers for Medicare and Medicaid Services only provides full benefit coverage for USPSTF grade A and B screening recommendations. This vulnerability in the health care of all Americans has caused multiple cardiovascular disease organizations across the U.S. to spearhead awareness campaigns and work with federal lawmakers in supporting the introduction of legislation to address this health care gap.

Initially founded in 2019, the Congressional PAD Caucus was formed to educate Congress and communities about PAD and support federal initiatives in preventing PAD-related morbidity and mortality. The bipartisan caucus co-chairs include Reps. Donald M. Payne, Jr. (D-NJ) and Gus Bilirakis (R-FL). The caucus' initiatives for the 118th Congress included the reintroduction of the Amputation Reduction and Compassion (ARC) Act.⁵ As of today, the ARC Act of 2023 (H.R. 4261), introduced on June 21, 2023, has been jointly referred to the U.S. House Committees on Energy and Commerce and Ways and Means for further deliberation. This legislation seeks to amend titles XVIII and XIX of the Social Security Act to provide coverage for PAD screening tests to at-risk beneficiaries under the Medicare and Medicaid programs without imposing cost-sharing requirements. "At-risk beneficiaries" include those listed in the 2016 AHA/ACC PAD guidelines.^4,6 Furthermore, this legislation amends Part P of Title III of the Public Health Service Act (42 USC 280g et seq.) and tasks the Secretary of the U.S. Department of Health and Human Services to work with other federal agencies and stakeholders to implement a PAD education program. The bill appropriates 6 million dollars annually from fiscal years 2024-2028 to carry out these tasks. Although the appropriations will initially cost American taxpayers $24 million, the return on investment is arguably undeniable.

The realized return on investment can be appreciated by understanding the fiscal strain PAD and its most severe form, chronic limb-threatening ischemia (CLTI), place on the current U.S. health care system. CLTI can lead to ulcerations, gangrene and ultimately amputation, with one-year rates of amputation reaching as high as 22% and increasing mortality rates to approximately 35-48% within one year.⁷ In a review of health care-related expenditure data from 2011 to 2014, the Agency for Healthcare Research and Quality Medical Expenditure Panel estimated a greater than $7,000 increase in health care-related costs per year in each patient diagnosed with PAD in comparison to U.S. adults 40 years of age and older without PAD when adjusted for age, gender and race.⁸ Vascular-related hospitalization in patients with PAD based on 2004 U.S. census data was estimated to cost more than $21 billion annually, which is now greater than $33 billion annually, adjusting for inflation based on consumer price index estimates.^9,10

Despite PAD being responsible for the highest health care-related cost in cardiovascular disease and worse quality of life, it continues to be underrecognized and undertreated.⁷ The REACH Registry provides a clear insight into the relationship of PAD with other polyvascular diseases, and current USPSTF recommendations are incongruent with the 2016 AHA/ACC PAD guidelines.^2,3,4 This leaves millions of at-risk Americans vulnerable to the long-term outcomes of underrecognized and untreated atherosclerotic disease; thus, it is imperative that federal legislation be enacted to improve PAD-related outcomes.

This article was Authored by Omar Leonards, MD, a Cardiovascular Disease Fellow at LSUHSC-New Orleans.

References

1. Aday, Aaron W., Kunihiro Matsushita. "Epidemiology of Peripheral Artery Disease and Polyvascular Disease." Circulation Research, vol. 128, no. 12, 11 June 2021, pp. 1818–1832, https://doi.org/10.1161/circresaha.121.318535.
2. Ohman, E. Magnus, et al. "The REduction of Atherothrombosis for Continued Health (REACH) Registry: An International, Prospective, Observational Investigation in Subjects at Risk for Atherothrombotic Events-Study Design." American Heart Journal, vol. 151, no. 4, Apr. 2006, pp. 786.e1–786.e10, https://doi.org/10.1016/j.ahj.2005.11.004. Accessed 22 Oct. 2020.
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4. Gerhard-Herman, Marie D., et al. "2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines." Circulation, vol. 135, no. 12, 21 Mar. 2017, www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000470, https://doi.org/10.1161/cir.0000000000000470.
5. "Congressional PAD Caucus." Congressman Donald Payne, 18 Feb. 2020, payne.house.gov/pad-caucus.
6. In, et al. 18TH CONGRESS 1ST SESSION to Amend Titles XVIII and XIX of the Social Security Act to Provide for Coverage of Peripheral Artery Disease Screening Tests Furnished to At- Risk Beneficiaries under the Medicare and Medicaid Programs without the Imposition of Cost-Sharing Requirements, and for Other Purposes. 2023.
7. "Peripheral Matters | Peripheral Artery Disease: Moving from Awareness to Action." American College of Cardiology, www.acc.org/Latest-in-Cardiology/Articles/2023/09/01/01/42/peripheral-matters-peripheral-artery-disease-moving-from-awareness-to-action. Accessed 25 Nov. 2023.
8. Scully, Rebecca E., et al. "Estimated Annual Health Care Expenditures in Individuals with Peripheral Arterial Disease." Journal of Vascular Surgery, vol. 67, no. 2, 1 Feb. 2018, pp. 558–567, www.ncbi.nlm.nih.gov/pubmed/28847660, https://doi.org/10.1016/j.jvs.2017.06.102.
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