Highmark Medicare Services

12102, 12202, 12302

MAC Part A & B

L27491

End-Diastolic Pneumatic Compression Therapy

L27491

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

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 1862(a)(7).  This section excludes routine physical examinations.

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.

CMS On-Line Manual Pub. 100-2, Chapter 15, Section 60.4.1.

CMS On-Line Manual Pub. 100.3, Chapter 1, Section 280.1.

CMS On-Line Manual Pub. 100.3, Chapter 1, Section 280.6

Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after N/A

N/A

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

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 are thought to decrease venous pressure, interstitial fluid pressure, vasoconstriction, and viscosity; and to increase cardiac output, pulse pressure, and fibrinolysis 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 extremity. Additionally, this therapy may be useful in treating claudication and chronic lymphedema.

Indications

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
• Arterial ischemic ulcers of the lower extremity in limited situations where the ulcer(s) is not clinically amenable to revascularization and/or skin grafting or when skin grafting or surgical intervention is contraindicated
• Claudication and chronic lymphedema of the lower extremity for a specified time period.

Prior to the initiation of end-diastolic pneumatic compression therapy for the treatment of chronic venous insufficiency with venous stasis ulcers, diabetic ulcers or arterial ischemic ulcers, the medical record must support all of the following:

• 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) for a minimum of 24 weeks,
• The ulcer(s) has failed to decrease in size with conventional therapy,
• The ulcer(s) has not shown any indication (e.g., granulation or progression towards closure) that improvement is likely with conventional therapy, and
• The affected limb is free of osteomyelitis.

Limitations

In order to ensure that alternative accepted treatment modalities have been exhausted prior to the performance of end-diastolic compression therapy, the patient must have been evaluated by a vascular specialist and subsequently re-evaluated at such intervals as to demonstrate his/her participation in the patient's care. This requirement applies to all treatment indications (i.e., venous insufficiency with ulcers, diabetic ulcers, arterial ischemic ulcers, claudication, and chronic lymphedema). In addition, requirements and limitations of services are dependent upon the type of medical condition treated.

Venous Stasis Ulcers

End-diastolic pneumatic compression therapy for the treatment of venous stasis ulcers of the lower extremity that meets the above criteria will be limited to 35 treatments per episode. Treatment beyond this frequency may be covered with a type of home program that uses an impulse-type intermittent pneumatic pump. 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

End-diastolic pneumatic compression therapy for the treatment of diabetic ulcers of the lower extremity that meets the above criteria will be limited to 35 treatments per episode. Treatment beyond this frequency may be covered with a type of home program that uses an impulse-type intermittent pneumatic pump. 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

Treatment for 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 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) by a vascular specialist who has concluded 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.

Claudication and Chronic Lymphedema

End-diastolic pneumatic compression therapy may be beneficial for the treatment of claudication and chronic lymphedema. This treatment is thought to provide decreases in venous pressure, interstitial fluid pressure, vasoconstriction and viscosity. End-diastolic pneumatic compression therapy will be limited to six (6) treatments for these conditions.

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.

Claims will be denied if any of the following are noted:

• 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 will be denied as not reasonable and necessary.
• Any claim submitted for the treatment of arterial ischemic ulcers 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.
• Any claim submitted for the treatment of claudication and chronic lymphedema of the lower extremity that exceeds 6 treatments will be denied as not reasonable and necessary.

Outpatient Hospital Services, Doctor Office Visits

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)).  The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
3. The submitted medical record should support the use of the selected ICD-9-CM code(s).  The submitted CPT/HCPCS code should describe the service performed.  
4. The medical record must clearly reflect the vascular specialist's evaluation, recommendation for end-diastolic pneumatic compression therapy (sometimes referred to as “circulator boot treatment”), and continued participation in the patient's care.
5. 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 and Limitations of Coverage and/or Medical Necessity" section of the policy.

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.

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.

End-diastolic pneumatic compression therapy for the treatment of claudication and chronic lymphedema of the lower extremity that meets the above criteria will be limited to 6 treatments.

Other Contractor’s Policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27491

05/22/2008

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