The Durable Medical Equipment Medicare Administrative Contractors (DME MAC) Open Meeting
Pneumatic Compression Devices (#DL27028) Draft Local Coverage Determinations (LCD)
Tuesday, August 30, 2011 from 9:00 – 11:00 AM EDT
Sheraton Baltimore North Hotel, 903 Dulaney Valley Road, Baltimore, MD 21204
The American College of Foot and Ankle Surgeons (ACFAS) respectfully offers the Durable Medical Equipment Medicare
Administrative Contractors (DME MAC) its members’ expertise in the areas related to Pneumatic Compression Devices (PCDs).
ACFAS is a medical specialty society of more than 6,400 foot and ankle surgeons. Founded in 1942, ACFAS promotes the art and
science of foot, ankle, and related lower extremity surgery; address the concerns of foot and ankle surgeons; and advances and
improves standards of education and surgical skill.
Foot and ankle surgery is a subspecialty practiced mainly by podiatric foot and ankle surgeons (DPMs). Only podiatric foot and
ankle surgeons (DPMs) are eligible for unique board-certification in foot and ankle surgery.
Podiatric foot and ankle surgeons conduct medical history and physical examinations, diagnose, and perform medical and surgical
management of all diseases, deformities, injuries and defects of the foot, ankle and related lower extremities, as governed by
appropriate state statute(s).
Additionally, the Council on Podiatric Medical Education (CPME) sets rigorous criteria for residencies in
podiatric medicine and surgery, and during the standardized three year surgical residencies performed by DPMs, they are
functioning under the full scope of practice that their licenses allow. A major portion of the DPM training includes managing
patients on services such as general and vascular surgery, medicine, emergency medicine, etc. All DPMs finish their residency
training with thorough knowledge on how to medically manage patients, including systematic fluid management. ACFAS
members have had extensive training in foot, ankle and related lower extremity surgery and are examined and board certified (or
board qualified) in foot and ankle surgery by the American Board of Podiatric Surgery (ABPS). Additionally, medical staff
privileges in acute and ambulatory settings are held by most ACFAS podiatric surgeons.
REQUESTED CHANGES TO THE DRAFT LCD POLICY ON PNEUMATIC COMPRESSION DEVICES:
The current draft states: “Prescriptions for PCDs used to treat lymphedema or chronic venous insufficiency with ulceration
(E0650-E0652) are limited to MDs, DOs, NPs, CNS and PAs enrolled in Medicare and authorized by Medicare to prescribe as
"physicians". Podiatrists and other providers are excluded because management of the systemic intravascular changes and fluid
shifts that may be caused by the use of a PCD is beyond their scope of practice.”
ACFAS notes that it is within the podiatric foot and ankle surgeons’ scope of practice to treat lymphedema or chronic venous
insufficiency with ulceration (E0650-E0652). DPMs are recognized as physicians by Medicare for many coverages. A properly
conducted review comparing the training, education and experience of DPMs to NPs, CNSs and PAs would clearly
confirm that prescribing these PCDs for lymphedema or chronic venous insufficiency with ulceration by DPMs is
appropriate and permissible."
Many ACFAS members, foot and ankle surgeons, prescribe lymphedema pumps regularly, and consider it to be the standard of
care for treating these patients. For example, many states allow the podiatric surgeon to treat the soft tissue to the tibial
tuberosity, reminding everyone that it is the states that regulate the scopes of practice for licensed individuals. We strive to also
point out that lymphedema and chronic edemas are not only vascular issues, but they can affect the lower extremity following
surgery, trauma, and Charcot deformity to name a few other pathologies.
Additionally, using PCDs for chronic venous disease of the lower extremities when associated with recalcitrant venous ulcers is
the accepted standard of care. PCDs are also sometimes used to treat PAD especially when a patient is not a candidate for
open or endovascular procedures. Many foot and ankle surgeons treat venous and ischemic wounds as part of their practice, and
also work at wound care centers.
DPMs must be allowed to prescribe PCDs. An examination of published podiatric literature, staffing at key medical institutions,
Wound Care Centers, the Association for the Advancement in Wound Care (AAWC), and the Alliance of Wound Care
Stakeholders all support this conclusion. Allowing DPMs to give Medicare patients wound care and surgical debridement of distal
ulcers while specifically precluding the use of a non-invasive modality is inconsistent and potentially forces Medicare beneficiaries
to seek alternate care and added expense. LCD guidelines for the use of PCD’s are sufficient; specific exclusion of a recognized
medical scope of practice does not improve quality of care or appropriate device use.
At a time of many reforms in the nation’s healthcare system, recognizing all healthcare providers who can provide safe, effective
and efficient care to the citizens of the United States (U.S.) it is crucial that we not leave podiatric foot and ankle surgeons out of
this ability to prescribe for Medicare patients. Collaboration among the healthcare team can only occur if the playing field is
leveled to allow all those providers who can demonstrate appropriate training, education and experience to care for patients safely,
while allowing for optimal access. We urge the DME MAC to allow DPMs to prescribe PCDs.
ADDITIONAL POINTS ACFAS SUPPORTS IN CHANGING THE DRAFT LCD:
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ACFAS agrees with the need to control the use of devices coded as E0675 to the appropriate patient population suffering from
morbidity related to peripheral arterial disease (PAD). The code was initially created to identify a new class of Pneumatic
Compression devices (PCD) that had emerged with peer reviewed published evidence in the treatment of PAD and Chronic
Limb Ischemia (CLI) related wounds, limb salvage and scleroderma.
ACFAS supports the devices and evidence reviewed by the Alpha-numeric Committee and later identified as E0675 was intended
to recognize a unique category of PCD’s that are targeted at specifically treating “arterial insufficiency”, which is why that
language was inserted into the HCPCS product descriptor. These devices are characterized by their unusually rapid and frequent
inflation/deflation compression cycles, using relatively high pressures as compared to most PCD’s. It is not the high pressure
alone that identifies devices in this category. The brevity and frequency of compression are critical to create the clinical result of
increased arterial perfusion. Clinical results, laboratory tests and published basic science studies support these unique cycle
requirements.
ACFAS acknowledges that existing peer reviewed published evidence on the use of these devices includes authors who are
generally recognized opinion leaders in wound management. These authors have specialties in vascular surgery, vascular
medicine, podiatry, endocrinology and internal medicine. These medical specialties are very representative of the medical
community that currently routinely treats these PAD and CLI patients with chronic wounds and related morbidity.
Limiting the scripting of E0675 to Vascular Surgeons does not represent an existing or effective healthcare model for the use of a
non-invasive treatment modality which typically requires wound care, related general medical care, patient monitoring and
repeated follow-up. Referral patterns seen at the Mayo Clinic, Cleveland Clinic and other Institutionally related wound care
centers are much more representative of PAD or CLI patient care where surgery is not indicated, failed or otherwise medically
inappropriate.
Requiring and documenting a vascular surgical consult, and deeming the patient inappropriate for surgery at this time is a
reasonable standard of care prerequisite for scripting an E0675 device. Objective testing as part of a vascular consult is a
reasonable requirement. Specifically requiring an angiogram when other non-invasive objective tests may, in the opinion of the
treating physician suffice, would seem to create a guideline that unnecessarily raises the cost of care and patient risk.
Determination of appropriate PAD and CLI surgical candidates is a complicated risk reward determination best left in the hands
of the Surgeon and the Patient. Current practice for this process seems sufficient and does not require specific LCD language.
While we completely support the idea of a vascular surgical consult prior to the use of E0675, the current Draft Policy language is
awkward in that it fundamentally forces a Medicare beneficiary, who does not have a contraindication, to elect a surgical
intervention. The concept that an LCD has limited a patient’s choice of whether or not to have surgery is concerning. In the
absence of a contraindication, draft policy would deny coverage of a non-invasive option to a beneficiary who simply says they do
not want to have surgery at this time or for that matter one who says they do not want to have more surgery. The Medicare
beneficiary population diagnosed with PAD or CLI typically has a significant number of co-morbidities that make them generally
poor surgical candidates. The Draft Policy language needs to allow for the use of an E0675 device in patients who voluntarily
elect not to undergo the risk, discomfort and cost of surgery.
In closing, ACFAS offers the DME MAC its assistance as requested related to this policy or others related to podiatric foot and
ankle surgeons. Please contact Kristin Hellquist Cunningham, Director of Health Policy, Practice Advocacy & Research at
Kristin.Hellquist@acfas.org or 773.444.1322.
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