Joshua Beckman, MD
Despite the broad evidence base describing the burden of peripheral arterial disease (PAD) and supporting the identification and management of PAD patients for the reduction of cardiovascular events and death, Medicare reimbursement guidelines severely limit individuals with PAD from achieving a timely diagnosis. The P.A.D. Coalition continues to work to improve access to evidence-based diagnostic and treatment strategies and, in particular, securing Medicare coverage for PAD screening in patients at the highest risk for having the disease.
Approximately 20% of the Medicare population has PAD, and many of these patients are undiagnosed. Under current Medicare reimbursement guidelines, the anklebrachial index (ABI) is reimbursable only in the presence of very late PAD symptoms, such as leg pain, leg ulcers, atheroemboli, or follow-up of a vascular surgery or catheter-based revascularization procedure. Unfortunately, most patients with undiagnosed PAD are asymptomatic or have atypical symptoms. There currently is no reimbursement provided for the ABI to identify PAD among highrisk asymptomatic patients, such as those with diabetes and/or the elderly. Yet, it is well established that all patients with PAD, regardless of the presence of symptoms, are at the highest risk of cardiovascular events, and this risk is comparable to or greater than that documented for individuals with coronary heart disease (CHD).
We know that cardiovascular events can be reduced and quality of life improved through the use of evidencebased PAD diagnostic and treatment guidelines. In 2005, the American College of Cardiology and the American Heart Association (ACC/AHA) released the ACC/AHA Practice Guidelines for the Management of Patients With Peripheral Arterial Disease.1 The Guidelines were developed in partnership with the Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, and Society of Interventional Radiology. These Guidelines were also endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Society for Vascular Nursing, TransAtlantic Inter-Society Consensus, Vascular Disease Foundation, and the National Heart, Lung, and Blood Institute.
These guidelines provide a series of class I recommendations that support the use of the ABI as an accurate, simple, and cost-effective diagnostic test that should be performed in individuals at highest risk for having the disease, including adults over age 50 with a history of diabetes or smoking and all adults over 70 years of age. Once diagnosed, evidence-based therapies known to reduce cardiovascular risk may be offered.
We believe that these intersocietal, evidence-based guidelines can help elevate the standard of care for patients with noncoronary atherosclerosis in this country. Yet, we must ensure that Medicare reimbursement guidelines facilitate the use of these national guidelines.
Here is a summary of what we have been doing.
PAD SCREENING AND THE
UNITED STATES PREVENTIVE
SERVICES TASK FORCE
Currently, in order for any screening test to be reimbursed by Medicare, it must receive an “A” or “B” rating from the United States Preventive Services Task Force (USPSTF). The USPSTF has issued two ratings regarding PAD screening. In 2005, the Task Force gave a “D” (not recommended) rating to routine screening for PAD in the general population. It stated that the prevalence of PAD in the general population was low, and there was insufficient evidence that treatment of PAD at this asymptomatic stage, beyond standard cardiovascular risk factor management, improves health outcomes.
In a 2009 statement on the use of nontraditional risk factors to identify patients at risk for CHD, the Task Force concluded that the evidence is insufficient (an “I” rating) to recommend using the ABI to screen asymptomatic men and women with no history of CHD to prevent CHD events.
Over the past few years, the P.A.D. Coalition has met and corresponded with the USPSTF to state our case and provide our interpretation of the current evidence base. We have emphasized the need for greater accountability and congressional oversight of the Task Force.
We were successful in securing the inclusion of a provision in health care reform that we believe will one day lead to improved Medicare coverage for ABI screening. Sponsored by Senators Kay Hagan (D-NC) and Richard Burr (R-NC), the provision required the USPSTF to consider the views of medical specialty organizations when assessing the benefits of preventive health services, particularly when a test receives an “I” rating.
The amendment calls for greater transparency and involvement in the USPSTF's work and decision-making process.
In an effort to be more transparent and encourage public involvement, the Agency for Healthcare Research and Quality recently released a call for nominations for clinical preventive health topics to be considered for USPSTF review. The P.A.D. Coalition responded by submitting a request that ABI screening for lower extremity atherosclerosis be considered as a primary prevention topic for review. The response included our rationale as well as a review of relevant studies.
The Coalition is now working with Members of Congress to generate support for the review of ABI screening. A delegation of P.A.D. Coalition members will meet with key Congressional leaders this month to garner more support.
PAD RESOLUTION INTRODUCED IN US
HOUSE OF REPRESENTATIVES
In June, Minnesota Congressman Erik Paulsen (MN-03) introduced historic legislation to help elevate PAD on the nation's public health agenda. The resolution serves as a “Call to Action” that encourages government agencies, health care organizations, professional societies, health systems, and clinicians to take actions to improve the diagnosis and treatment of PAD.
Increasing the number of Medicare beneficiaries tested for PAD is one of the issues highlighted in the resolution. The PAD Resolution offers specific recommendations to the Centers for Medicare and Medicaid Services, the United States Centers for Disease Control and Prevention, National Institutes of Health, Agency for Healthcare Research and Quality, and the Food and Drug Administration.
To be enacted, a majority of representatives must cosponsor the PAD Resolution. We urge you to ask your Representative to support this critical resolution today.
PETITION AIMS TO IMPROVE THE CARE
OF PATIENTS WITH PAD
Last fall, the P.A.D. Coalition launched a petition drive at padcoalition.org to urge President Obama and Congress to increase access to evidence-based health care for individuals with PAD. The P.A.D. Coalition aims to collect at least 10,000 signatures and will deliver the petition to Congressional leadership. To sign the petition, go to www.padcoalition.org/petition.
Please help us advocate for better care for patients with vascular disease. To stay informed on advocacy developments and receive future “action alerts,” sign up for the P.A.D. Coalition's e-news at www.padcoalition.org.