This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

 

DESCRIPTION

The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the EKG and to appropriately time boot compressions in the end portion of the heart cycle; a rapid action valve assembly capable of both pressurizing and exhausting the boots; rigid, adjustable long boots to enclose the leg from groin to toes; and double-walled plastic bags to enclose the treated portion of the leg and to contain the compressed air.

Poor lower extremity circulation can be associated with compromised arterial flow, impaired venous return or both. When oxygen demand exceeds the supply to the lower extremity, such as during physical activity, claudication pain can result. Small amounts of oxygen deprivation over a chronic period will lead to skin breakdown and poor healing capacity. Peripheral artery disease, typically caused be arteriosclerosis, worsens with age, smoking, high lipids and diabetes. Venous stasis and lymphedema compress small arterioles and shunt blood from these areas.

Therapeutic approaches to peripheral artery disease include risk factor modification, control of diabetes, hypertension and hyperlipidemia, aspirin and other antiplatelet therapies, and progressive exercise. Percutaneous or open surgical procedures can reestablish arterial flow. Approaches to venous stasis include compression and elevation.

End diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis and lymphedema. Timed, sequential inflation during the end diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic fluid.

In January 1980, device “The Circulator Boot™” (Circulator Boot Corporation, Malvern, PA) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for treatment of leg vascular diseases and congestive heart failure.  In May 1984, the FDA approved a modification to limit the treatment area to the lower leg: The Miniboot.  In August 1997, the FDA approved a computerized delay timing based on electrocardiogram.

In May 2009, “The Circulator Boot™” was cleared for marketing by the FDA through the 510(k) process as follows: “The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat:

Poor arterial flow in extremities associated with:

  • Ischemic ulcers
  • Rest pain or claudication (pain with walking)
  • Threatened gangrene
  • Insufficient blood supply at amputation site
  • Persisting ischemia after embolectomy or bypass surgery
  • Pre- and post-arterial reconstruction to improve runoff

Diabetes complicated by the above or other conditions possible related to arterial insufficiency including:

  • Nocturnal leg cramps
  • Necrobiosis diabeticorum

Venous disease (once risk of emboli minimized)

  • Prophylaxis of deep vein thrombophlebitis
  • Edema and induration associated with chronic venous stasis
  • Venous stasis ulcers

Athletic injuries: “Charlie horses”, pulled muscles, and edematous muscles

 

POLICY

End diastolic pneumatic compression boots are considered investigational as a treatment of peripheral vascular disease or lymphedema and its associated complications, including but not limited to ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, or thrombophlebitis. 

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

There are no specific CPT codes for this technology, but a series of CPT codes may be used to describe the individual components of the overall therapy, similar to those used for external counterpulsation therapy for chronic refractory angina or congestive heart failure.

 

POLICY HISTORY

 7/27/2006:  Approved by Medical Policy Advisory Committee (MPAC)

08/03/2011: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exception section.

02/24/2012:  Policy reviewed; no changes.

04/04/2013:  Policy reviewed; no changes.

 

SOURCE(S)

 Blue Cross Blue Shield Association policy # 2.02.17

 

CODE REFERENCE

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes

Code Number

Description

CPT-4

92971Cardioassist-method of circulatory assist; external

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

 

HCPCS

G0166

External counterpulsation, per treatment session

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