By: Dr. J.D. Meler, VP, Clinical and Medical Affairs, Peripheral Intervention, BD

Last month, Congress introduced legislation to help address amputation and Peripheral Artery Disease (PAD). PAD is a serious condition that restricts blood flow to the limbs, and impacts about 20 million patients in the United States.1 When left untreated, PAD can develop into Critical Limb Ischemia (CLI), the most advanced form of PAD, which is a major cause of amputations. Of patients with CLI, 40% will have an amputation.2

There are about 100,000 amputations in the United States every year due to vascular disease, including PAD and CLI. Amputation not only impacts quality of life, but it is linked to future amputations and increased mortality: Patients with CLI have been reported to have a major amputation rate as high as 40% at six months, and a mortality rate of 20-25% in the first year after presentation.2 Over a five-year period, mortality rates for patients with an amputation have been estimated to be between 50 and 74%.3 Unfortunately, while some amputations are preventable with proper screening and treatment, between 60-71% of CLI patients will receive an amputation without prior vascular intervention.1

PAD disproportionately impacts people of color: Black and Hispanic Americans are at the highest risk for PAD.4 They are also at higher risk for health conditions that can contribute to PAD, particularly type 2 diabetes.5 It is extremely important that all patients, regardless of race, have access to screenings and quality treatment to address PAD and CLI and reduce preventable amputations.

BD is working to improve diagnosis and treatment for patients with PAD, and is committed to developing innovative technologies to address this serious disease. We are also educating patients and providers about risks and treatment options, and more information is available at LoveYourLimbs.com. Fortunately, Congress is also working to address this challenge. In April, two important bills were introduced to improve the lives and treatment options of patients at risk for amputation:

The Triple A Study Act is a bipartisan, bicameral bill led by Senators Marsha Blackburn (R-TN) and Tammy Duckworth (D-IL) and Congressmen G.K. Butterfield (D-NC) and Brett Guthrie (R-KY).  The legislation would study the coverage of services related to amputation, including barriers to care, gaps in assessments and treatment options, performance measures, and post-amputation care including policies to reduce vascular disease. These are steps that will provide lawmakers with valuable information to improve care and treatment for patients.

The ARC Act is legislation led by Congressman Donald Payne, Jr. (D-NJ), who also co-chairs the Congressional PAD Caucus. The ARC Act would ensure that Medicare, Medicaid, and federal healthcare exchange plans would fully cover screenings for patients at risk for PAD. This is an important step to help reduce unnecessary amputations. It could also help patients receive diagnoses and appropriate care earlier, which could allow for better management of PAD.  

BD supports this legislation, and is very encouraged by Congress’ focus on these important issues. These bills will help to prevent amputation and improve diagnosis and treatment for the millions of Americans who are at risk of PAD and CLI. We look forward to working with the 117^th Congress on addressing this health care challenge.

Visit the Love Your Limbs website to learn more about PAD, risk factors, and treatment options.

Sources
1.  Yost, ML. The Sage Group (2017). Critical Limb Ischemia by Rutherford Category: Prevalence and Markets in Patients and Limbs
2. Norgren, L., Hiatt, W. R., Dormandy, J. A., Nehler, M. R., Harris, K. A., & Fowkes, F. G. R. (2007). Inter-society consensus for the management of peripheral arterial disease (TASC II). Journal of vascular surgery, 45(1), S5-S67.
3. Robbins, J. M. et al (2005). Mortality rates and diabetic foot ulcers: is it time to communicate mortality risk to patients with diabetic foot ulceration?. J Am Podiat Med Assn, 98(6), 489-493.
4. Allison, M. A., Ho, E., Denenberg, J. O., Langer, R. D., Newman, A. B., Fabsitz, R. R., & Criqui, M. H. (2007). Ethnic-specific prevalence of peripheral arterial disease in the United States. American journal of preventive medicine, 32(4), 328-333
5. U.S. Centers for Disease Control and Prevention, Diabetes Risk Factors, available online: https://www.cdc.gov/diabetes/basics/risk-factors.html.