||Pneumatic Compression Devices
||Durable Medical Equipment
||July 2, 2018
||July 2, 2018
A pneumatic compression therapy device functions as a pump to improve circulation. The device consists of an inflatable garment, usually for the arm, leg, and/or ankle, and an electric pump. The inflatable garment is intermittently inflated and deflated in a cycle of time and pressure. Pneumatic compression therapy devices are classified as non-segmented or segmented, with or without calibrated gradient pressure.
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.|
Pneumatic compression devices/lymphedema pumps and appliances for in-home use may be covered as durable medical equipment (DME) when ALL of the following are met:
- When prescribed by a physician; and
- Has appropriate physician oversight (i.e., physician evaluation of the individual’s condition to determine medical necessity of the device, suitable instruction in the operation of the machine as to the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment).
Segmented or non-segmented pneumatic compression devices without calibrated gradient pressure for in-home use may be considered medically necessary for the treatment of ANY ONE of the following:
- Lymphedema treatment (pumps and appliances) of the arm or leg that has failed a four (4) week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include ALL of the following:
- A compression bandage system or compression garment; and
- Exercise; and
- Elevation of the limb.
- Chronic venous insufficiency (CVI) of the lower extremities with non-healing venous stasis ulcer(s) after a six (6) month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include ALL of the following:
- A compression bandage system or compression garment; and
- Appropriate dressings for the wound; and
- Exercise; and
- Elevation of the limb.
In-home use of limb compression devices for the following indications may be considered medically necessary for ANY ONE of the following:
- Prevention of post-thrombotic syndrome; or
- Venous thromboembolism (VTE) prophylaxis after major orthopedic surgery (e.g. total hip arthroplasty, total knee arthroplasty, hip fracture surgery) in individuals with a contraindication to pharmacological agents, i.e., at high risk for bleeding; or
- VTE prophylaxis after major non-orthopedic surgery or non-major orthopedic surgery in patients who are at moderate or high risk of VTE (see Professional Statements and Societal Positions) with a contraindication to pharmacological agents, i.e., at high risk for bleeding.
The in-home use of limb compression devices for VTE prophylaxis for the following conditions, are considered experimental/investigational and, therefore, non-covered:
- After major orthopedic surgery for individuals without a contraindication to pharmacological prophylaxis; or
- After major non-orthopedic surgery or non-major orthopedic surgery, for individuals who are at moderate or high risk of VTE without a contraindication to pharmacological prophylaxis and in patients who are at low risk of VTE; or
- After all other surgeries.
The efficacy of these devices for the above conditions is unproven.
A portable, intermittent, limb compression device (i.e. Vena Pro) is considered experimental/ investigational and, therefore, non-covered. There is a lack of evidence based literature to confirm the efficacy and safety of these devices.
In-home use of limb compression devices for VTE prophylaxis for periods longer than 30 days post-surgery is not medically necessary.
|E0650, E0651, E0652, E0655, E0660, E0665, E0666, E0667, E0668, E0669, E0671, E0672, E0673, E0676, E1399|
Segmented pneumatic compression therapy devices with calibrated gradient pressure may be considered medically necessary for in-home use when the following medical necessity criteria are met:
- The individual's medical condition has failed to respond to therapy using a segmented pneumatic compressor without calibrated gradient pressure with clear documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device with a segmented appliance/sleeve or a segmented device without manual control of the pressure in each chamber.
|E0652, E0671, E0672, E0673|
The use of pneumatic compression devices for the treatment of lymphedema of the head, neck, chest or trunk, and/or the treatment of arterial insufficiency, is considered experimental/investigational and, therefore, non-covered. The evidence is insufficient to determine the effects of the technology on health outcomes.
|E0656, E0657, E0670, E0675, E1399|
|Professional Statements and Societal Positions|
Guidance on Determining High Risk for Bleeding
American College of Chest Physicians (ACCP) 2012 guidelines on prevention of VTE in orthopedic surgery patients list the following general risk factors for bleeding:
- Previous major bleeding (and previous bleeding risk similar to current risk)
- Severe renal failure
- Concomitant antiplatelet agent
- Surgical factors: history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery
The guidelines note, however, that “specific thresholds for using mechanical compression devices or no prophylaxis instead of anticoagulant thromboprophylaxis have not been established.”
Guidance on Risk Level for Patients Undergoing Non-orthopedic Surgery
The 2012 ACCP guidelines on prevention of VTE in non-orthopedic surgery patients included the following discussion of risk levels: “In patients undergoing general and abdominal-pelvic surgery, the risk of VTE varies depending on both patient-specific and procedure-specific factors. Examples of relatively low-risk procedures include laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, inguinal herniorrhaphy, and unilateral or bilateral mastectomy. Open-abdominal and open-pelvic procedures are associated with a higher risk of VTE. VTE risk appears to be highest for patients undergoing abdominal or pelvic surgery for cancer…”
“Independent risk factors include age at least 60 years, prior VTE, and cancer; age greater than or equal to 60 years, prior VTE, anesthesia greater than or equal to 2 hours, and bed rest greater than or equal to 4 days; older age, male sex, longer length of hospital stay, and higher Charlson comorbidity score; and sepsis, pregnancy or postpartum state, central venous access, malignancy, prior VTE, and inpatient hospital stay more than 2 days. In another study, most of the moderate to strong independent risk factors for VTE were surgical complications, including urinary tract infection, acute renal insufficiency, postoperative transfusion, perioperative myocardial infarction, and pneumonia”.
The American College of Obstetricians and Gynecologists (ACOG, 2007, reaffirmed 2012) proposed the following risk classification for VTE in patients undergoing major gynecological surgery:
- Low: Surgery lasting less than 30 minutes in patients younger than 40 years with no additional risk factors.
- Moderate: Surgery lasting less than 30 minutes in patients with additional risk factors; surgery lasting less than 30 minutes in patients age 40 to 60 years with no additional risk factors; major surgery in patients younger than 40 years with no additional risk factors.
- High: Surgery lasting less than 30 minutes in patients older than 60 years or with additional risk factors; major surgery in patients older than 40 years or with additional risk factors.
- Highest: Major surgery in patients older than 60 years plus prior venous thromboembolism, cancer, or molecular hypercoagulable state.
|Place of Service: Outpatient|
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Pneumatic Compression Devices are typically an outpatient service which is only eligible for coverage as an inpatient service in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
|The policy position applies to all commercial lines of business|
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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