Blue Cross Blue Shield of Minnesota Medical Policy

 
 

Medical Policy:
II-60-008
Topic:
Pneumatic Compression Devices in the Outpatient or Home Setting
Section:
Medicine
Effective Date:
August 2, 2021
Issued Date:
August 2, 2021
Last Revision Date:
July 2021
Annual Review:
July 2021
 
 

This policy version was replaced June 27, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

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. This policy addresses use of pneumatic compression devices in the home and outpatient settings.

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 statis ulcers. Programmable devices for treatment of venous statis 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

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.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I.    Lymphedema

The use of segmented or non-segmented pneumatic compression devices without calibrated gradient pressure (non-programmable pumps) may be considered MEDICALLY NECESSARY AND APPROPRIATE 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 AND APPROPRIATE 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 AND APPROPRIATE 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 AND APPROPRIATE 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 AND APPROPRIATE 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 AND APPROPRIATE 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.     Experimental/Investigative Uses

The use of pneumatic compression devices in the outpatient or home setting is considered EXPERIMENTAL/INVESTIGATIVE 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
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Denial Statements

No additional statements.



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Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Acknowledgements:

CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.