Latest Review Date: July 2024

Category: Medical                                                    

POLICY:

Note: Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:

• Federal Women's Health and Cancer Rights Act (WHCRA)

For dates of service October 7, 2024 and after:

I. Lymphedema

The use of segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps) may be considered medically necessary for the treatment of lymphedema of the upper or lower limbs in the outpatient or home setting when ALL of the following criteria are met:

• The patient has undergone a four-week trial of conservative therapy which includes:
  • Use of an appropriate compression bandage system or compression garment; AND
  • Exercise; AND
  • Elevation of the limb; 

AND

• The treating physician determines that no significant improvement has occurred or significant symptoms remain following the four-week trial.

The use of segmented pneumatic compression therapy devices with calibrated gradient pressure (programmable pumps) may be considered medically necessary for the treatment of lymphedema of the upper or lower limbs in the outpatient or home setting when the patient meets criteria for a device without calibrated gradient pressure (non-programmable pumps) and either of the following criteria are met:

• The patient's medical condition has failed to respond to therapy using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps); OR
• The individual has unique characteristics (e.g., significant scarring) that prevent satisfactory pneumatic compression treatment using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps).

II. Chronic Venous Insufficiency

The use of segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities in the outpatient or home setting when ALL of the following criteria are met:

• The patient has one or more venous stasis ulcers; AND
• The patient has undergone a trial of conservative therapy for a minimum of six months which includes ALL of the following:
  • The use of an appropriate compression bandage system or compression garment, AND
  • Appropriate dressings for the wound, AND
  • Exercise, AND
  • Elevation of the limb; 

AND

• The treating physician determines that the venous stasis ulcer has failed to heal.

The use of segmented pneumatic compression therapy devices with calibrated gradient pressure (programmable pumps) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities in the outpatient or home setting when the patient meets criteria for a device without calibrated gradient pressure (non-programmable pumps) and either of the following criteria are met:

• The patient's medical condition has failed to respond to therapy using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps), OR
• The individual has unique characteristics (e.g., significant scarring) that prevent satisfactory pneumatic compression treatment using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps).

III. Post-Surgical Venous Thromboembolism (VTE) Prophylaxis

The use of pneumatic compression devices in the outpatient or home setting may be considered medically necessary in patients who have undergone a surgical procedure when BOTH 1 and 2 are met:

1. Patient meets ONE OR MORE of the following:
   • Major surgery (e.g., total hip arthroplasty, total knee arthroplasty, hip fracture repair, open abdominal or open pelvic procedure); OR
   • Patient is at moderate to severe risk of VTE. Examples include:
     • Patient is not able to walk unassisted or is bedridden
     • Age greater than 60 years, anesthesia at least 2 hours and bed rest at least 4 days during current episode of care
     • Inpatient stay of more than 2 days during current episode of care
     • Central venous access during current  episode of care
     • Sepsis during current episode of care
     • Active cancer or cancer treatment
     • Significant comorbidity such as recent myocardial infarction, congestive heart failure, cerebrovascular disease, moderate to severe chronic obstructive pulmonary disease, moderate to severe liver disease, moderate to severe chronic kidney disease
     • Pregnancy or post-partum state (<1 month)
     • Hypercoagulable state (e.g., Factor V Leiden, antithrombin III deficiency, protein C or S deficiency, antiphospholipid syndrome, dysfibrinolysis, prothrombin 20210 defect)
     • Prior VTE; 

AND

2. The patient has a contraindication to pharmacologic anticoagulants, such as being at high-risk for bleeding. Risk factors for bleeding include:
   • Bleeding disorder such as hemophilia
   • Active liver disease
   • Severe renal failure
   • Previous major bleed (and previous bleeding risk similar to current risk)
   • Concomitant antiplatelet agent
   • History of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery.

Outpatient or home use of pneumatic compression devices for post-surgical VTE prophylaxis is considered investigational for patients who have undergone a surgical procedure with a low risk of VTE and who have no additional risk factors for VTE. Examples of lower risk surgical procedures include, but are not limited to, laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, and inguinal herniorrhaphy.

IV. Investigational Uses

The use of pneumatic compression devices in the outpatient or home setting is considered investigational for all other indications, including but not limited to the following, due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

• treatment of arterial insufficiency (e.g., peripheral arterial disease) and restless legs syndrome;
• treatment of the head, neck, trunk, or chest for lymphedema.

The use of non-pneumatic compression devices in the outpatient or home setting is considered investigational for all indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

For dates of service prior to October 7, 2024:

I. Lymphedema

The use of segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps) may be considered medically necessary for the treatment of lymphedema of the upper or lower limbs in the outpatient or home setting when ALL of the following criteria are met:

• The patient has undergone a four-week trial of conservative therapy which includes:
  • Use of an appropriate compression bandage system or compression garment; AND
  • Exercise; AND
  • Elevation of the limb; AND
• The treating physician determines that no significant improvement has occurred or significant symptoms remain following the four-week trial.

The use of segmented pneumatic compression therapy devices with calibrated gradient pressure (programmable pumps) may be considered medically necessary for the treatment of lymphedema of the upper or lower limbs in the outpatient or home setting when the patient meets criteria for a device without calibrated gradient pressure (non-programmable pumps) and either of the following criteria are met:

• The patient's medical condition has failed to respond to therapy using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps); OR
• The individual has unique characteristics (e.g., significant scarring) that prevent satisfactory pneumatic compression treatment using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps).

II. Chronic Venous Insufficiency

The use of segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities in the outpatient or home setting when ALL of the following criteria are met:

• The patient has one or more venous stasis ulcers; AND
• The patient has undergone a trial of conservative therapy for a minimum of six months which includes ALL of the following:
  • The use of an appropriate compression bandage system or compression garment, AND
  • Appropriate dressings for the wound, AND
  • Exercise, AND
  • Elevation of the limb; AND
• The treating physician determines that the venous stasis ulcer has failed to heal.

The use of segmented pneumatic compression therapy devices with calibrated gradient pressure (programmable pumps) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities in the outpatient or home setting when the patient meets criteria for a device without calibrated gradient pressure (non-programmable pumps) and either of the following criteria are met:

• The patient's medical condition has failed to respond to therapy using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps), OR
• The individual has unique characteristics (e.g., significant scarring) that prevent satisfactory pneumatic compression treatment using segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps).

III. Post-Surgical Venous Thromboembolism (VTE) Prophylaxis

The use of pneumatic compression devices in the outpatient or home setting may be considered medically necessary  in patients who have undergone a surgical procedure when BOTH 1 and 2 are met:

1. Patient meets one or more of the following:
   • Major surgery (e.g., total hip arthroplasty, total knee arthroplasty, hip fracture repair, open abdominal or open pelvic procedure) OR
   • Patient is at moderate to severe risk of VTE. Examples include:
     • Patient is not able to walk unassisted or is bedridden
     • Age greater than 60 years, anesthesia at least 2 hours and bed rest at least 4 days during current episode of care
     • Inpatient stay of more than 2 days during current episode of care
     • Central venous access during current  episode of care
     • Sepsis during current episode of care
     • Active cancer or cancer treatment
     • Significant comorbidity such as recent myocardial infarction, congestive heart failure, cerebrovascular disease, moderate to severe chronic obstructive pulmonary disease, moderate to severe liver disease, moderate to severe chronic kidney disease
     • Pregnancy or post-partum state (<1 month)
     • Hypercoagulable state (e.g., Factor V Leiden, antithrombin III deficiency, protein C or S deficiency, antiphospholipid syndrome, dysfibrinolysis, prothrombin 20210 defect)
     • Prior VTE; AND
2. The patient has a contraindication to pharmacologic anticoagulants, such as being at high-risk for bleeding. Risk factors for bleeding include:
   • Bleeding disorder such as hemophilia
   • Active liver disease
   • Severe renal failure
   • Previous major bleed (and previous bleeding risk similar to current risk)
   • Concomitant antiplatelet agent
   • History of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery.

Outpatient or home use of pneumatic compression devices for post-surgical VTE prophylaxis is considered not medically necessary for patients who have undergone a surgical procedure with a low risk of VTE and who have no additional risk factors for VTE. Examples of lower risk surgical procedures include, but are not limited to, laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, and inguinal herniorrhaphy.

IV. Investigational Uses

The use of pneumatic compression devices in the outpatient or home setting is considered investigational due to the lack of clinical evidence demonstrating its impact on improved health outcomes for all other indications, including but not limited to:

• treatment of arterial insufficiency (e.g., peripheral arterial disease) and restless legs syndrome
• treatment of the head, neck, trunk, or chest for lymphedema

DESCRIPTION OF PROCEDURE OR SERVICE:

Pneumatic compression devices consist of an inflatable garment and an electrical pneumatic controller or pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures to improve venous circulation and lymphatic drainage. This treatment is also referred to as intermittent pneumatic compression (IPC).

Pneumatic compression devices are used in the treatment of lymphedema, chronic venous insufficiency and for prevention of venous thromboembolism after major surgery. 

Many different pneumatic compression devices are available, with varying materials, design, and complexity. These devices are classified into three types:

• Non-segmented (single compartment) device;
• Segmented (multi-chamber) device with sequential inflation of each chamber and with fixed pressure (no manual control of pressure) in each chamber; and
• Segmented (multi-chamber) programmable device with sequential inflation and with manually calibrated pressure in each chamber.

Non-programmable devices cleared by the Food and Drug Administration (FDA) for primary or adjunctive (e.g., post mastectomy) treatment of lymphedema include but are not limited to:

• LymphaPress
• NanoThermTM
• Sequential Circulator®

Programmable devices include but are not limited to:

• Aria™ System
• Compression Pump, Model GS-128
• Flexitouch® system
• Lympha-Press Optimal

Non-programmable devices listed above are also indicated for treatment of venous stasis ulcers. Programmable devices for treatment of venous stasis ulcers include but are not limited to:

• AIROS 8
• Compression pump Model GS-12
• ACTitouch™
• CTU676 device
• PowerPress Unit Sequential Circulator

FDA-cleared devices with indications that include prevention of deep vein thrombosis (DVT) include, but are not limited to, the following:

• Ezvena IPC
• Hemo-Force DVT Compression Sleeve
• ActiveCare+SFT® System
• Flowtron Pump and Pulse Garments
• Restep® DVT System
• Kendall SCD™ 700 Sequential Compression System
• Venowave™ VW5

A non-pneumatic compression system or garment is a wearable compression device that uses sequential gradient compression for the treatment and management of individuals with conditions such as lymphedema and other similar conditions that impact lymphatic flow in the upper and lower extremities. These devices provide patients with mobility during treatment.

The Koya Dayspring™ system obtained FDA approval in 2021 via the 510(k) process as a wearable compression system. The Dayspring™ system is the first non-pneumatic compression device approved by the FDA. This device is approved for several conditions including, but not limited to lymphedema, post mastectomy edema, venous insufficiency, and other similar conditions that impact lymphatic flow in the upper and lower extremities. Dayspring™ is also indicated for reduction of wound healing time and treatments that assist with healing stasis dermatitis.

Definitions

Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as surgical removal of lymph nodes or post radiation fibrosis, among other causes.

Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.

Venous thromboembolism (VTE) refers to deep vein thrombosis (DVT) or pulmonary embolism (PE). Risk of DVT increases due to venous stasis of the lower limbs as a consequence of immobility during or after surgery. Patients who have major orthopedic surgery (such a total hip arthroplasty, total knee arthroplasty and hip fracture surgery) are at particularly high risk. While most DVTs are asymptomatic and generally resolve when mobility is restored, some acute DVTs can be associated with substantial morbidity. The most serious adverse consequence of an acute DVT is a PE, which occurs when a DVT detaches and migrates to the lungs. Antithrombotic prophylaxis is recommended for patients undergoing major orthopedic surgery and for other surgical patients at increased risk of VTE. Specialty society guidelines recommend pharmacotherapy unless it is contraindicated.

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

POLICY HISTORY:

Reviewed and posted July 1, 2021.

June 2022 : Annual update completed. No change to policy intent.

June 2023: Annual update completed. No change to policy intent.

July 2024: Annual update completed. Updates to Policy Statement to include non-coverage for non-pneumatic compression devices, Description and Current Coding (+ E0677-E0682). On DRAFT through October 6, 2024.

October 2024: Updates to Current Coding (+E0683).

​​​This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.