Recommended Revisions of HGSA Medical Policy

Introduction

The uncertainty of reimbursement has been the major stumbling block to the spread of Circulator Boot treatment over the last 25 years. In Pennsylvania the treating physician was lucky in 1982 as the Medical Policy Bulletin covering care (Bulletin E-7c, issued January 1982) said that Circulator Boot therapy was covered for the treatment of both arterial and venous diseases. It made no stipulations regarding treatment eligibility or duration of treatment. Essentially it allowed the physician to initiate treatment and other therapies as he/she saw fit. It was not blanket coverage as Medicare always reserved the right to review the patient’s case and see if the treatment was reasonable and justified. Appropriate history, physical examination and non-invasive vascular tests would satisfactorily justify initiation of therapy. Documentation of a clinical response was possible with serial photographs. It may be noted that each of these items were likely to be done in the absence of the question of Medicare coverage; they were proper and indicated. As noted elsewhere (Insurance history), this policy was reviewed and in time the various stipulations mentioned in the current Pennsylvania Policy were derived (Pennsylvania Policy).

Common Sense

It is a general rule in medicine that less invasive and safer methods of therapy be employed before surgical approaches. It is also a general rule of medicine that therapies be applied in a timely manner. It would make sense, hence, that Circulator Boot therapy be made a first line choice of therapy. It may obviate need for subsequent therapies. It does not prevent or decrease the chances for success of any needed subsequent therapies. Indeed, boot therapy before arteriography has been shown to enchance visualization of the arterial tree (D'Souza V et al. For abstract see www.circulatorboot.com/literature/vasctest.html.). The new Policy, however, placed boot therapy as an alternative treatment to be accomplished only after more invasive and expensive treatments have been considered or failed. Such requirements are not in the interest of Medicare or the public. In this spirit the various groups listed below sent HGSA (Pennsylvania Medicare) a recommended revision of the coverage policy in November 1992. The fears of the group are commonly realized: mandated referrals to physicians practicing invasive procedures may result in loss of the patient to the boot clinic and performance of a risky procedure with a poor outcome. It is to be appreciated that the rise in invasive procedures has not been associated with a decline in the incidence of amputations (http://www.circulatorboot.com/Newsletter/vol1numb1.html). It is emphasized the the following is not an official document in force but an unapproved revision of the Pennsylvania document and a revision that still compromises the potential full value of boot therapy for the patient:

Pennsylvania Podiatric Medical Association, Temple University School of Podiatric Medicine, Foot and Ankle Institute Advanced Wound Healing Center, and the Bryn Mawr Wound Care and Vascular Center Recommendations for Reconsideration and Revision of Medicare Medical Policy Bulletin Z-62 on End-Diastolic Pneumatic Compression Therapy

Contractor's Policy Number

Z-62

Contractor Name

HGSAdminstrators
00865

Contractor Type

Carrier

LMRP Title

End-Diastolic Pneumatic Compression Therapy

AMA CPT Copyright Statement

Italicized and/or quoted material is excerpted from the American Medical Association. Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 2001 American Medical Association. All Rights Reserved. Appliacable FARS/DFARS Clauses Apply.

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862(a) (7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1862 (a) (1) (A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
Medicare Carriers Manual, Section 2050.1
Coverage Issues Manual, CIM 60-9

Primary Geographic Jurisdiction

Pennyslvania

CMS Region

III

CMS Consortium

Northeast

Original Policy Effective Date

01/11/2003 (Z-62)

Original Policy Ending Date

N/A

Revision Effective Date

N/A

Revision Ending Date

N/A

LMRP Description

Pennsylvania Podiatric Medical Association, Temple University School of Podiatric Medicine, Foot and Ankle Institute Advanced Wound Healing Center, and the Bryn Mawr Wound Care and Vascular Center Recommendations:
End-diastolic pneumatic compression therapy is a non-surgical treatment designed to compress portions of the leg in the end phase of the cardiac cycle, enhancing blood flow to the extremity. Therapeutic effects from this treatment regimen is thought to decrease venous pressure, interstitial fluid pressure, vasoconstriction, and viscosity, and increase cardiac output, pulse pressure, and fibrinolosis in the treated extremity. This therapy is used for the treatment of non-healing ulcers, which result from, or are compounded by poor blood flow to and from the extermity. Additionally, this therapy may be useful in treating claudication pain and chronic lymphedema.(An important mechanism of action not emphasized in 1992 is the effect of rapid shear forces on the endothelium in releasing nitric oxide, prostacyclin, fibrinolysins and vascular endothelial growth factors (http://www.circulatorboot.com/literature/clotting.html). It has also subsequently been appreciated that the microvascular abnormalities in the diabetic foot associated with neuropathy may be benefited by boot therapy also and may make a critical difference especially in patients with cellulitis and/or osteomyelitis not responding to the standard forms of therapy.

Indications and Limitation of Coverage and/or Medical Necessity

End-diastolic pneumatic compression therapy may be covered for the following conditions:

Chronic venous insufficiency with venous stasis ulcers;
Diabetic ulcers of the lower extremity with or without osteomyelitis
Arterial ishemic ulcers or areas of focal gangrene of the lower extremity in situations where the ulcer(s) is not clinically amenable to revasculariztion and/or skin grafting or when skin grafting or surgical intervention is contraindicated.
Claudication pain and chronic lymphedema of the lower extremity for a specified time period.

Patients must be evaluated by a physician (MD, DO, DPM) prior to initiation of treatment in order to determine that they meet criteria for administration of End-Diastolic Compression therapy as a treatment modality. Patients should be reevaluated at regular intervals to demonstrate their response to therapy. This requirement applies to all treatment indications (i.e., venous insufficiency, diabetic ulcers, osteomyelitis, arterial ischemic ulcers or areas of focal gangrene, claudication pain and chronic lymphedema.

Treatment Criteria

Venous Stasis Ulcers Prior to the end-diastolic pneumatic compression therapy for the treatment of chronic venous insufficiency with venous stasis ulcers, the medical record must support that:
- For a minimum of 24 weeks, the ulcer(s) has been treated with conventional therapy. (e.g., moist wound dressings, compression bandage system or a compression garment, exercise and elevation of the limb) and;
- With conventional therapy the ulcer(s) has failed to decrease in size or show any indication (e.g., granulation or progression towards closure) that improvement is likely.
- The patient presented with circumstances making healing unlikely in spite of optimal conventional care over the next six months (a large ulcer over 10 square centimeters with a duration over a year with or without treatment. Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA: The accuracy of venous leg ulcer prognostic models in a wound care system.. Wound Repair Regen 12:163-8, 2004. ).
End-diastolic pneumatic compression therapy for the treatment of venous stasis ulcers of the lower extremity that meets the above criteria will be revaluated after 35 treatments and continued if improvement is demonstrated by documentation. Treatment beyond this frequency may be provided with a type of home program that uses a sequential intermittent pneumatic pump if the disease process is amenable to such a device and provided those services are covered by Medicare and are available to the patient in their locale. Services performed in the home setting should be billed to the Durable Medical Equipment Regional Carrier (DMERC) and are subject to the DMERC's coverage policy.
Diabetic Ulcers With or Without Osteomyelitis
Prior to end-diastolic pneumatic compression therapy for the treatment of a diabetic foot lesion, the medical record must support that:
- In the case of urgent care, that boot therapy was instituted because of danger of tissue loss and leg deterioration, and that previous care, if any, had failed to prevent the progression of the disease process.
- In the case of chronic lesions (e.g; those present for three or more weeks) which do not immediately threaten loss of tissue or advancing infection, that the lesions have been treated with appropriate conventional therapy for a minimum of 4 weeks and that previous care had failed to prevent the progression of the disease process, and that;
- With conventional therapy the ulcer(s) has failed to decrease in size or;
- With conventional therapy the ulcer(s) has not shown any indication(e.g., granulation or progression towards closure) that improvement is likely.
End-diastolic pneumatic compression therapy for the treatment of diabetic ulcers of the lower extremity that meets the above criteria will be revaluated after 35 treatments and continued if improvement is demonstrated by documentation. Treatment beyond this frequency may be provided with a type of home program that uses an impulse-type intermittent pneumatic pump if the disease process is amenable to such a device. Services performed in the home setting should be billed to the Durable Medical Equipment Regional Carrier (DMERC) and are subject to the DMERC's coverage policy.
Arterial Ischemic Ulcers, Ischemic Rest Pain, and Areas of Focal Gangrene
Prior to end-diastolic pneumatic compression therapy for the treatment of arterial disease on the legs, the medical record must support that:
- In the case of urgent care, that boot therapy was instituted because of tissue loss and leg deterioration, that previous care, if any had failed to prevent the progression of the disease process, that appropriate clinical findings have been documented, that appropriate vascular tests had been performed, and that invasive revascularization procedures and alternatives had been discussed with the patient, and when available and possible, referral to vascular surgery, radiology, cardiology or vascular medicine specialists who perform such procedures in their area were made available.
- In the case of chronic ischemia associated with rest pain and advanced claudication, defined as inability to ambulate without severe discomfort, that the condition had failed to improve after or was not amenable to invasive reconstruction procedures.
- In the case of chronic non-healing ischemic ulcers, that with conventional therapy the ulcers had failed to decrease in size or show an indication (e.g., granulation or progression towards closure) that improvement was likely. Treatment for arterial ischemic ulcers of the lower extremity that meets the above criteria will be reevaluated after 35 treatments and continued if improvement is demonstrated by documentation. Treatments beyond this frequency will be considered on an individual basis. All claims that exceed this frequency threshold must be accompanied by medical record documentation supporting the necessity for ongoing treatments. The medical record must include:
  - The patient's diagnosis and prognosis; and
  - Symptoms and objective findings, including measurements which establish the severity and progression of the condition; and
  - Confirmation that the patient has been evaluated (and re-evaluated) and it has been determined that the ulcers are not amenable to revascularization (surgical or endovascular intervention) and/or skin grafting or that the patient has co-morbidities (e.g., pulmonary and/or cardiovascular) of such severity that surgical intervention is contraindicated; and
  - The clinical response to the treatment had failed to show an indication (e.g., granulation or progression towards closure) that improvement was likely.
Claudication Pain and Chronic Lymphedema

End-diastolic pneumatic compression therapy may be beneficial for the treatment of claudication pain and chronic lymphedema. In the patient with claudication, this treatment is thought to promote lysis of thrombi and the development of new vessels (angiogenesis). In the patient with lymphedema, this treatment decreases venous pressure and interstitial fluid pressure; it thus reduces leg size and stiffness and, in some cases, may dilate efferent lymph channels effecting a cure. Chronic cases, in which fibrotic elements have infiltrated the fluid spaces in the leg, are less amenable to therapy and should be terminated after 6 treatments if no response to the therapy has been demonstrated. In patients with claudication therapy should be curtailed if no progress is documented after 12 treatments or before that time if walking capacity is increased sufficiently to meet the occupational and independence needs of the patient. The chart should document theses needs and the response to therapy.

CPT/HCPCS Section & Benefit Category

Medicine

CPT/HCPCS Codes

N/A

Not Otherwise Classified (NOC)

99199 Unlisted special service, procedure or report

ICD-9 Codes That Support Medical Necessity

The following codes are appropriate when reporting end-diastolic pneumatic compression therapy for the treatment of venous stasis ulcers.
454.0 Varicose vein of lower extremities, with ulcer (venous stasis ulcer)
454.2 Varicose veins of lower extremities, with ulcer and inflammation
The following codes are appropriate when reporting end-diastolic pneumatic compression therapy for the treatment of diabetic ulcers of the lower extremity.
250.70- Diabetes with peripheral circulatory disorders
250.73 250.80- Diabetes with other specified manifestations
250.83
785.4 Gangrene
730.07 Osteomyelitis, Acute/Chronic
730.17
The following codes are appropriate when reporting en-diastolic pneumatic compression therapy for the treatment of arterial ischemic ulcers of the lower extremity.
440.23 Atherosclerosis of the extremities with ulceration
440.24 Atherosclerosis of the extremities with gangrene
The following codes are appropriate when reporting en-diastolic pneumatic compression therapy for the treatment of claudication pain and chronic lymphedema of the lower extremity.
440.21 Atherosclerosis of the extremities with intermittent
440.22 Atherosclerosis of the extremities with rest pain
457.1 Other lymphedema

Reasons for Denial

Any service reported that does not meet the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy.
Any service reported for the treatment of venous stasis ulcers or diabetic ulcers of the lower extremity that exceeds 35 treatments per episode and is not accompanied by supporting documentation, as indicated in the " Indications and Limitations of Coverage and/or Medical Necessity" section of this policy, will be denied as not reasonable and necessary.
Any claim submitted for the treatment of arterial ischemic ulcers that exceed 35 treatments per episode and is not accompanied by supporting documentation, as indicated in the "Indications and Limitations of Coverage and/or Medical Necessity" section of the policy.
Any claim submitted for the treatment of claudication pain and chronic lymphedema of the lower extremity that exceeds the limitations listed above, will be denied as not reasonable and necessary.

Noncovered ICD-9 Codes

Any diagnosis not listed in the "ICD-9 Codes That Support Medical Necessity" section of this policy.

Coding Guidelines

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
End-diastolic pneumatic compression therapy should be reported using code 99199, Unlisted special service, procedure or report, with the verbiage/narrative "end-diastolic pneumatic compression therapy."
Code 99199 will represent all end-diastolic compression therapy provided to a patient per day. The code (99199) also encompasses the evaluation prior to, during and post service per day may be reported for this therapy, regardless of the time involved.

Documentation Requirements

When reporting end-diastolic pneumatic compression therapy, all elements outlined in the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy must be clearly reflected in the medical records.
The medical record must clearly reflect the vascular specialist's evaluation, recommendation for circulator boot treatment, and continued participation in the patient's care.
When reporting end-diastolic pneumatic compression therapy for the treatment of an ulcer(s), the medical record should clearly reflect the ulcer(s) location and size, diagnosis and the treatment number of the particular treatment session. This is in addition to the required documentation elements outlined in the "Indications Limitations of Coverage and/or Medical Necessity" section of the policy.

Utilization Guidelines

If a national or local policy identifies a frequency expectation, a claim for a test/service that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.
End-diastolic pneumatic compression therapy for the treatment of venous stasis ulcers and diabetic ulcers of the lower extremity that meets the above criteria will be limited to 35 treatments per episode. Treatments beyond this frequency may be covered with a type of home program that uses an impulse-type intermittent pneumatic pump, if the condition of the patient is amenable to the use of such devices.
End-diastolic pneumatic compression therapy for the treatment of arterial ischemic ulcers of the lower extremity that meets the above criteria will be limited to 35 treatments per episode. Treatments beyond this frequency will be considered on an individual consideration basis when submitted with medical record documentation.

Other Comments

Since this therapy is synchronized to end-diastolic function, can affect cardiac output, and can cause significant diuresis, it is to be performed only by or under the direct supervision of physicians. Physicians such as vascular surgeons, wound care specialists and podiatrists should consult the appropriate internal medicine or cardiology specialists in patients with leg edema, a history of congestive failure and usage of medications commonly utilized for the treatment of congestive failure. Direct supervision in the office setting does not mean that the physician must be present in the same room with his or her aide. However, the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the aid performing services.
Services performed in a nursing home for patients whose medical condition prevents their transport to the boot clinic in the hospital or physicians' offices, may be performed by the agent of the physician without his/her presence in the building. However, the record must show that the treatment was appropriately supervised with weekly written progress notes and orders by the physician and that the therapy resulted in improvement in the condition of the patient. The notes of the physician or social service workers should show that the costs of alternative therapies were considered (e.g., the cost of ambulance transportation etc.) and the cost to Medicare were kept at a reasonable minimum.
Services performed in the home setting should be billed to the DMERC regional carrier and are subject to DMERC's policy for coverage.
See Medical Policy Y-11 for information specific to Manual Lymphedema Drainage Therapy.
See Medical Policy Y-1 Physical Medicine and Rehabilitation Services for information specific to vasopneumatic device therapy.

Sources of Information and Basis for Decision

Dillon RS., Effect of therapy with the pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease; Angiology 1980 eo; 31(9) 614-38
Dillon RS., Treatment of resistant venous stasis ulcers and dermatitis with the end-diastolic pneumatic compression boot; Angiology 1986 Jan; 37(1): 47-56
Dillon RS: Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by local antibiotic injections and the end-diastolic pneumatic compression boot. Ann Surg 204(6): 643-9, 1986
Dillon RS: Management of soft-tissue infections in elderly persons with diabetes. Geriatric Medicine Today 6: 21-35, 1987
Dillon RS: Treatment of osteomyelitis in diabetic foot with systemic and locally-injected antibiotics and the end-diastolic pneumatic compression boot-Case studies. Vasc Surg (Westerminister Press) 24: 682-695, 1990
Dillon RS, Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the circulator boot. Results of treatments with the circulator boot; Angiology 1997 May; 48 (5 Pt 2): S17-34
Dillon RS., Patient assessment and examples of a method of treatment. Use of the circulator boot in peripheral vascular disease; Angiology 1997 ; May 48 (5Pt 2) S35-58
Dillon, RS., Improved hemodynamics shown by continuous monitoring of electrical impedance during external counterpulsation with the end-diastolic pneumatic boot and improved ambulatory EKG monitoring after 3 weeks of therapy; Angiology 1998 Jul; 49 (7) S23-35
Vella A, Carlson LA, Blier B, Felty C, Kuiper JD Rooke TW., Circulator boot therapy alters the natural history of ischemic limb ulceration; Vac Med 2000; 5; 21-28
Department of Health and Human Services correspondence dated June 10, 1985
HGS Administrators Medical Director

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups that include representatives from:

Start Date of Comment Period

08/21/2002 (Z-62)

End Date of Comment Period

10/05/2002 (Z-62)

Start Date of Notice Period

11/15/2002 (Z-62)

Revision History

N/A

Comments on Medicare Coverage and Circulator Boot Therapy as Breakthrough Technology
Some Helsinki Guidelines on Human Medical Research
Bailar et al and Medical Research without Controls
Evidence-Based Medicine and Invasive Procedures on the Diabetic Foot

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