Comments on Medicare Coverage

1. Circulator Boot therapy has been legitimately covered in the past by local coverage decisions (LCD) which apparently have been more common than national coverage decisions (NCD) for the many therapies that Medicare covers. In Pennsylvania, the following Policy was in force:

   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 did not signify blanket coverage of Circulator Boot treatments. Medicare reserved 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.

   This coverage was curtailed in the summer of 2000 because of confusion about the relevance of the new ECP coverage policy to the Circulator Boot systems. Circulator Boot brought this confusion to the attention of HCFA and made available literature detailing the differences between Circulator Boot and the ECP devices (CBCvsECP).

2. In their website, HCFA disclosed the criteria they consider for Medicare coverage (this website since removed). In their April 1999 disclosure, they described criteria for covering new technologies:
   1. A breakthrough technology without consideration of cost. (Boot therapy can be considered in this category as many of our patients have no other alternative.)
   2. A medically beneficial item or service if no other medically beneficial alternative is available. (Again, the lack of an alternative is a common cause for referral for boot therapy.)
   3. A medically beneficial item or service if it is a different clinical modality compared to an existing covered beneficial alternative, without consideration of cost or magnitude of benefit. (Alternatives to boot therapy may include none, amputation, balloon angioplasty, bypass surgery of leg or heart, or dialysis. Clearly boot therapy is a different modality and a much more economical one in each instance. It is to be further noted that the magnitude of benefit need not be known, suggesting that further studies to determine the magnitude are not necessary.)
3. Congress has been interested in financial responsibility and has declared that expenses should be reasonable and necessary. If HCFA chose to make a NCD covering Circulator Boot therapy (CB), all components of the Medicare system are obliged to do likewise. On the other hand, if HCFA decided against such coverage, all likewise are obliged not to cover CB. (Circulator Boot Corporation appreciated, hence, the opportunity to proceed in the request for clarification versus ECP and did not ask for national coverage. But while negotiating about ECP, Circulator Boot hoped to put its best foot forward for national coverage.)
4. In the absence of an NCD, a decision concerning Medicare coverage for an individual could be resolved on a case-by-case basis after a claim is submitted. This review only applies to claims that have been denied and is not a mechanism for attaining prior authorization for a specific item or service for an individual. (This route has been suggested by some regional Medicare Medical Directors. The problems for the provider are that there is great uncertainty; the bills accumulate for the patient and expenses and operating funds diminish without guarantee that coverage will eventually be coming. As a result, during our non-coverage period patients dropped out of treatment, choosing uncertain but covered invasive procedures, and generally did poorly [Remember that these patients are generally referred because standard therapies either had not worked or appeared to offer little.] The LCD previously in place solved this problem . The confusion with the ECP directive precipitated our problems.)
5. The Proposed Criteria for Medicare Coverage requires first FDA approval if appropriate (Circulator Boot is so covered). They then list:
   1. Step 1--Medical Benefit: Is there sufficient evidence that demonstrates that the item or service is medically beneficial for a defined population? (The Circulator Boot population has historically been those patients who were not getting better on their current standard care or who had no alternative care except amputation. We have clearly helped this population.)
   2. Step 2 (If the answer to Step 1 is "yes")--Added Value: For the defined patient population, is there a medically beneficial alternative item or service(s) that is the same clinical modality and is currently covered by Medicare? If "no", the item or service is covered under Medicare for the defined population. (Historically, the answer here is "no". We are not the same modality as bypass or angioplasty. We have served a population that had either failed bypass and angioplasty or were not candidates for such therapy. The question, of course, can be asked that if we can treat patients that are too difficult for bypass or angioplasty, can we treat the easier cases that can be bypassed or ballooned? Common sense in medicine has for years dictated that the simplest, safest and most economical effective form of therapy should first be tried. Booting is simple. It is safe. It is noninvasive. It has few complications. It can be done as an outpatient. It can be used to treat patients with disease too advanced to respond to other modalities of therapy. It can be used to treat patients with disease so mild that the practitioners of invasive therapies might feel obliged to dismiss the complaints of the patient. Boot threrapy has been used by some to improve visualization of vessels with arteriography. Finally, it can be used either before or after invasive procedures to improve their likelihood of success.)
   3. Step 3--Added Value: Is the item or service substantially more or substantially less beneficial than the Medicare-covered alternative? If the item or service is substantially more beneficial (that is, a breakthrough), it is covered under Medicare for the defined population. (In that booting has been prescribed for years when no other form of therapy has been available, it is a "breakthrough" and one that has been greatly under utilized. It is to be appreciated that the clinician does not have to choose only one form of therapy. We have booted patients who have had some partial benefit from their angioplasty or bypass and have done well with the addition of the booting. Booting may add benefit to other forms of therapy.)
   4. Step 4--Added Value: Will the item or service result in equivalent or lower total costs for the Medicare population than the Medicare-covered alternative? (In most cases, booting is cheaper. It can be done as an outpatient. It may avoid amputations that involve many ancillary costs. It may be done by fewer professionals. While a single doctor in a boot clinic may care for a patient, the same patient hospitalized for a diabetic foot ulcer may be seen by or require the services of a podiatrist, a radiologist, perhaps a radiologist who does angioplasties, a vascular surgeon, perhaps an orthopedic surgeon, an anesthetist, an infectious disease specialist, and a cardiologist. Any tissue removed will be examined by a pathologist. Booting is attended by few-to-no complications. So far, in spite of the advanced disease of the patients treated by boot therapy, there are no known legal suits against doctors giving boot therapy. The usage of local antibiotics in conjunction with boot therapy has avoided need for intravenous therapies that may require visiting nurses, hospitalization, indwelling catheters etc. Further, the technique has been associated with cures that otherwise have not been thought possible: e.g. advanced cases of cellulitis and osteomyelitis as illustrated both in the Circulator Boot literature on this website.)
6. Definition and discussion of medical benefit: The HCFA writer reported "We believe an item or service is medically beneficial if it produces a health outcome better than the natural course of illness or disease with customary medical management of symptoms. We would require the requestor to demonstrate that an item or service is medically beneficial by objective clinical scientific evidence. (The proof of medical benefit is open for discussion, HCFA allowed. Prospective controlled large studies are obviously desirable if possible, but as the HCFA writer intimated they have limitations also. Indeed, in a recent coverage guideline, clinical trials were noted to be unnecessary when the benefits of treatment were large in observational studies: "In an observational, non-randomized study, it is usually very difficult to determine whether bias could account for the results. However, there may be important exceptions, especially if the intervention dramatically improves the outcome of a disease. For example, if a disease is uniformly fatal within six weeks, and an observational study demonstrates that half of all patients receiving a new treatment survive for at least a year, it is not necessary to conduct a randomized controlled trial to obtain adequate evidence that the treatment is effective." (MCAC Recommendations for Evaluating Effectiveness)(CAC Executive Committee Recommendations for Evaluating Effectiveness, revised February 23, 2001). In the case of boot therapy, the issue is frequently amputation versus no amputation.) Some of these issues are discussed at the end of the Case History menu on the Circulator Boot website (case menu). The literature section provides other material of interest. The material on the website may be summarized as follows:
   1. The Epidemiology section (Epidemiology) describes the cost and extent of the problems that the Circulator Boot is capable of treating.
   2. The Neuropathy section (Neuropathy literature) provides articles describing the pathogenesis, diagnosis and effects of diabetic neuropathy. One learns that there are both small vessel abnormalities causing neuropathy and vascular consequences of neuropathy which is a leading cause of amputations in the diabetic. In the patient history section are found pictures of diabetics whose sensation has obviously improved with boot therapy.
   3. The Vascular test section (Vascular literature) provides information of the various noninvasive tests available to evaluate and follow the effects of treatments on the vascular status of a patient's leg. The effect of booting on these vascular tests is reported in the Pneumatic Boot library.
   4. In the Claudication section (Claudication), literature describing prognosis and the benefits and lack of benefits of angioplasty, bypass, drugs, chelation and exercise programs are quoted. Boot therapy is commonly effective in place of these techniques or when they are either are not possible or have proved ineffective.
   5. The section on Cellulitis, Osteomyelitis and Sepsis (Cellulitis) provides recent articles on standard therapies that might be compared with the results obtained by local antibiotic administration and boot therapy . In our Case History section, we give examples of cases in which these standard therapies failed and boot therapy succeeded.
   6. In the section titled "Angioplasty, Bypass and Invasive Procedures" (Angioplasty and Bypass), the technical successes of these procedures are seen. The reports generally enumerate the percentage of procedures resulting in patent vessels and patent bypasses. The reader is asked to assume that the technical success of the procedures resulted in an increased limb salvage rate. The studies are generally not controlled. The one controlled study by Morris et al. points out that bypass is associated with an increased rate of occlusive disease. The risks for amputation are not spelled out. The need for maintenance procedures is clear. Recent studies suggest that the rate of major amputation is reduced. The role of medical measures (therapy of lipids, homocysteine, and blood pressure along with antiplatelet drugs and new antibiotics etc) is uncertain. Older studies (Eickhoff et al, Humphrey et al, Sayers et al and others) have suggested that bypass has not influenced the rate of major amputation. Further, the facts that (1) over the last 22 years the rate of lower extremity has increased yearly except for 4 of those years; (2) this increase remains even after the data is corrected for age; (3) mortality rates after leg amputation have changed little over 50 years; and (4) the fate of the contralateral leg after leg amputation has changed little over the last 50 years, all suggest that current therapies are inadequate (Slide Presentations).
   7. The section titled "Clotting Factors, Vascular hormones and Ischemic Disease" (Vascular Factors) provides information on fibrinolysins, growth factors, and vasodilator substances that are important in angiogenesis and healing and that may be elicited by boot therapy. These vasoactive substances are likely contributing factors to the beneficial effects of boot therapy.
   8. In the Pneumatic Boot section (Pneumatic Boot literature), we provide the literature describing the cardiac and the peripheral vascular effects of boot therapy. In considering the beneficial effects of therapy with the Circulator Boot on the circulation in the leg, one learns that the Circulator Boot does not stand alone. There have been multiple studies documenting that various boots increase peripheral arterial flow. The literature on ECP devices is also given and these devices are compared with the Circulator Boot in the commentary. The Report by Dillon on 2177 episodes of foot problems shows that the therapy is beneficial in the real world.
   9. In the Angiology section (Angiology articles), the full text of Dillon's 2177 cases are provided along with his paper describing the method of treatment.
   10. Finally, we are building a section of Boot Clinics and their doctors (Boot Centers). We hope to list here their case reports and provide a means for the physicians to show and discuss their cases.

HCFA determined that the Circulator Boot systems and ECP were different and that their determination limiting the use of ECP to patients with angina did not apply to Circulator Boot (HCFA Decision). Likewise, the notation in the ECP coverage description that boots that were not cardiac synchronous should use a venous boot code would not seem to apply to Circulator Boot, which is cardiac synchronous. A lack of uniformity in Coding remains a problem around the country. As the HCFA decision noted, FDA considered the Circulator Boot in a cardiovascular category and not a physical therapy category. A designation of a specific cardiovascular code would be helpful in avoiding confusion in the future.

In Pennsylvania, HGSAdministrators determined that as a result of the July 19, 2001 CMS decision Circulator Boot treatments were again covered. In the absence of a specific national or local coverage policy, Medicare coverage of services entails individual consideration to determine "reasonable and necessary" criteria per the Social Security Act, Section 1862(a)(I)(A). Until such time that either a national coverage decision or local medical review policy is implemented, HGSAdministrators determined to continue Circulator Boot treatments utilizing this process.

Code 99199 (unlisted special service, procedure, or report) was to be used to report circulator boot treatments. The claim must indicate "Circulator Boot treatments", and documentation supporting the procedure performed and its necessity must accompany the claim. Also, procedure code, 99199, was to represent all Circulator Boot treatments provided to a patient per day. Therefore, one (1) unit of service per day regardless of the time involved was to be used.

Lastly, those services and supplies that are eligible under "incident to" or are "significant, separately identifiable evaluation and management services performed by the same physician on the same day of the procedure"(modifier 25), were to be documented and billed accordingly.

Return to Circulator Boot Home Page
Return to Medicare and Insurance Issues