Some of the Insurance History for Circulator Boot Treatments

Stimulating interest by physicians in Circulator Boot treatments has always been difficult. In the past, most physicians in the vascular field were paid well for invasive procedures and have not had the interest or patience necessary to initiate a boot service. Without widespread interest and knowledge of the treatment, gaining insurance coverage might be expected to be difficult. The fact that insurance coverage was gained in the past reflects the need for the treatment, the determination of a few doctors and patients and the insight of some insurance carriers. More recently, there has been the growth of wound-healing centers who have had an interest and have had adequate personnel to deliver treatments appropriately. In the following documents, we find in the pre-managed care era, the treatments were covered in Southeast Pennsylvania where consulting physicians, patients and treating physicians appealed for coverage. We do not have the correspondence of other physicians in other states with their insurance carriers.

As long ago as 1979, Blue Cross responded positively as did other local insurance carriers.

This Medicare bulletin was the result of submissions to Medicare of patient histories and claims, of notice of FDA approval and of our early literature. Such approval does not signify blanket coverage of Circulator Boot treatments. Medicare reserves the right to review charts and documentation as to the need for care. Without such documentation, Medicare, of course, had the right to ask for the return of any funds paid to the provider. These circumstances allowed for optimal therapy. The physician at the scene could make immediate decisions regarding appropriate care. Thus, the physician could care for the patient and had only to document the care and need.

Here, Blue Shield was not questioning if Circulator Boot was covered, but was directing how to code for the treatment. However, the appropriateness of Circulator Boot treatment was questioned a few years later. Again, medical literature, letters from expert vascular physicians at Philadelphia academic centers and case histories were submitted to our regional HCFA office.

This Bulletin was sent to the various Medicare carriers in our area. Circulator Boot therapy was specifically to be covered for the case material submitted, the indications for therapy approved by the FDA. Unfortunately, the bulletin did not specify usage of the Circulator Boot for arterial diseases. US Health Care and Medicare now were approving care with few obstacles. Medicare patients served by Keystone, however, were refused care unless they sought legal help. The Keystone physicians reserved the right to consider the appropriateness of treatments... and rarely considered the treatments necessary. All of the adverse outcomes of such determinations in our patient history section involved Keystone patients. The next Medicare Bulletin added ammunition to the position of the Keystone doctors. In spite of the HCFA bulletin, the Circulator Boot was to be considered a lymphedema pump?


The differences between the Circulator Boot and lymphedema boots are spelled out elsewhere on this website. How could such a bulletin be distributed in the face of the HCFA notice? We put the question to HCFA.

There was no new HCFA determination to allow the discontinuation of coverage for Circulator Boot treatments for arterial diseases. The best guess was that the Bulletin was the result of the need for a new bulletin to cover new lymphedema boots, the failure of the HCFA bulletin above to specify arterial diseases and the ignorance of the insurance carriers and their consultants regarding the differences between the various pneumatic devices on the market. The confusion caused by this bulletin was brought to the attention of the Pennsylvnia Medicare carrier in Camp Hill. Familiar with the sequence of events, they did not feel there was need for a new bulletin and continued to pay for Medicare patients during this period. The bulletin, however, deterred other physicians from opening boot centers and, as noted above, became reason for Keystone to refuse care for patients with limb-threatening arterial diseases.

While the administration of Medicare saw no need for clarification, the continued existence of a bulletin disallowing coverage became more of a problem. The bulletin was always available while those administrators who could appropriately settle claims were not.


With a formal appeal to the Pennsylvania Medicare carrier at Camp Hill, the issues were clarified and it was shown that the 1985 HCFA declaration was to be applied to arterial diseases. A visit to our Circulator Boot Center proved very instructive for the Medicare officials. They were astonished to see the differences among the various pneumatic boots displayed for their education. The appropriate bulletin was back-dated to 1991. The confusion resulting from the need to cover a new lymphedema boot was settled. However, new problems were on the horizon. Most patients with peripheral arterial diseases also have coronary heart disease. An article showing that Circulator Boot therapy benefited angina and cardiac output was published. The article detailed the differences between the Circulator Boot systems and the ECP boots that were designed specifically for patients with angina. The ECP boots sacrifice the legs in pumping earlier in the heart cycle than the Circulator Boots and by pumping at pressures higher than systolic pressure to push the arterial blood backwards out of the legs to increase diastolic pressure in hopes of benefiting the heart. As Medicare does not presumably write regulations to benefit a single company, it was appropriate for their regulation to specify that the ACP device and similar devices were indicated only for patients with stable angina and not for those with arterial leg diseases. The new regulation follows.




The description of the ECP devices clearly separates them from the Circulator Boot systems. The latter do not have three bags compressing the legs in sequence from the calves to the buttocks, thus creating a pressure gradient from the legs to the abdomen and chest; the Circulator Boot has one bag covering the area to be treated. The Circulator Boot does not pump with a force greater than systolic pressure as the ECP devices do, thus forcing arterial blood backwards and sacrificing the legs; the Circulator Boot pumps with a force equal to diastolic blood pressure thus providing a driving force to disseminate blood around the leg to low pressure areas. In keeping the compression force below systolic pressure, the Circulator Boots have not been found to collapse the arteries at the ends of the compression bags, a phenomenon described for the Cardiac-assist device, for example. One of the Circulator Boot patents allows that the boot may be programmed to compress the legs after each pulse wave, after every other pulse wave, or after every third pulse wave as needed to produce a mass of arterial inflow sufficient to allow the pumping action of the boot to indeed increase the delivery of blood to the distal leg; no such concern or allowance is designed into the ECP devices. The forces applied to the leg by the ECP devices produce pain and are sufficient to cause the patient to bounce upward with each compression; The Circulator Boot systems are comfortable and allow many patients to sleep through the treatment without sedation. The ECP devices are applied to the patient in the supine position on a special table that houses the pressure tubes and garments; the Circulator Boot is applied in the sitting position with the legs extended forward (Long-Boot) or bent at the knee in the sitting position (Mini-Boot). The erect position allows gravity to help prime the legs with blood before boot compressions and makes a suction phase in the boot cycle unnecessary. The ECP devices apply pressure to the legs immediately after the aortic valve closes and then apply a square wave of pressure that may end at various intervals before the next heartbeat; the Circulator Boot delays leg compression as long as possible to allow the pulse waves to enter the legs and releases the legs in anticipation of the next heartbeat. The Circulator Boot heart monitor actually has a patented computer process that allows it to predict the duration of the interval between heartbeats and to place boot compressions at the end of the interval between beats (end-diastolic timing). The ECP device attempts to improve the coronary circulation by raising the diastolic blood pressure to what are commonly considered pathological levels in hopes of forcing the development of new vessels (angiogenesis or rechannelization). While the heart would have to work hard to achieve the blood pressure levels produced by the ECP device, it does not have to work hard with either the ECP device or the Circulator Boot systems as release of the legs allows a sudden drop in blood pressure just before the heartbeats. In both devices, this reduction in afterload allows for an increase in cardiac output and a decrease in heart work. Both devices in pressing on the legs stimulate the release of vascular hormones and factors that breakup clot (see our Vascular Hormone library). Indeed, blocking the action of these vascular factors has been shown to block the benefits of one pumping device in increasing coronary blood flow (the aortic balloon). Neither the ECP devices or the Circulator Boot systems have had widespread usage. At the time Medicare issued their positive coverage policy for ECP, the number of patients reported in the literature treated by the Circulator Boot systems far exceeded that reported by the ECP devices. The Circulator Boot systems have a 20 year record of safety. Both the ECP devices and the Circulator Boot systems are contraindicated in patients with aortic valvular insufficiency and in those suspected of having risks for pulmonary emboli, but unlike the ECP devices, the Circulator Boot systems have no other contraindications.

Comments: It would appear that had the ECP devices not been approved for the treatment of stable angina, coverage for the Circulator Boot systems would not have been interrupted. The failure of the HCFA reviewers to understand the multiple differences between the ECP devices and the Circulator Boot systems had led them to lump both together and limit them to the treatment of stable angina. Our response to these issues and its outcome is found in another file, Medcomments (Go to Medcomments). For more on the differences between the ECP and Circulator Boot apparatuses go to (CBC versus ECP treatments)

HGSAdministrators (Pennsylvania Medicare)have determined that as a result of the July 19, 2001 CMS decision Circulator Boot treatments are again covered. Prior to coming to this decision, they asked for input from interested parties and received objections from local vascular surgical societies and Blue Cross/Blue Shield. The latter input resulted in significant shortcomings in their policy which, unfortunately, exists as a model for other insurance groups. Thus, in their June 2003 policy statement, Highmark Blue Shield (previously Pennsylvania Blue Shield) announced their coverage of end-diastolic boot therapy. Their policy has the same shortcomings as the Pennsylvania Medicare policy. These shortcomings have been outlined for HGSAdministrators Medical Affairs (Letter to Pennsylvania Medicare).

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