Prior authorization is recommended. Call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.
BCBSMT may consider pneumatic compression devices medically necessary for:
- Venous thromboembolism (VTE) prophylaxis for patients at high risk* for VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), AND who cannot fully ambulate due to major trauma, major surgery or other circumstances preventing ambulation. OR
- Treatment of chronic venous stasis ulcers caused by chronic venous insufficiency (CVI) which have failed to heal after a six month trial of conservative** physician-directed medical therapy, OR
- Treatment of lymphedema in the home setting for patients that have failed a four week trial of conservative therapy. NOTE: The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.
*NOTE: High risk factors for VTE include:
- Prior DVT/PE;
- Age >60 years;
- Sepsis or severe infection;
- Hypercoagulable states;
- antithrombin III deficiency,
- protein C or S deficiency,
- activated Protein C resistance [Factor V Leiden],
- antiphospholipid syndrome,
- prothrombin 20210 defect,
- Active cancer or cancer treatment;
- Kidney failure;
- Recent myocardial infarction [MI);
- Nonhemorrhagic stroke;
- Congestive heart failure (CHF) (decompensated);
- Low ejection fraction (EF);
- Major pelvic surgery (e.g., radical hysterectomy, pelvic exenteration);
- Major orthopedic surgery (e.g., total hip replacement, total knee replacement);
- Spinal cord paralysis injury;
- Multiple limb fractures;
- Lower extremity or pelvic fracture;
- Use of clotting medications or transfusions.
**NOTE: Conservative therapy must include use of a compression bandage system or garment (garment must provide adequate graduated compression), exercise, and elevation of the limb.
The following coverage criteria must be submitted to establish medical necessity of pneumatic compression devices.
- Documentation of appropriate physician oversight (i.e., physician evaluation of the patient’s condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine), and
- A treatment plan defining the pressure to be used, frequency and duration of use, and ongoing monitoring of use and response to treatment.
NOTE: Physician evaluation documentation must include:
- diagnosis and prognosis;
- symptoms and objective findings, including measurements which establish the severity of the condition;
- reason the device is required, including the treatments which have been tried and failed; and
- clinical response to an initial treatment with the device. The clinical response should include the change in pre-treatment measurements, ability to tolerate the treatment session and parameters, and ability of the patient (or caregiver) to apply the device for continued use in the home.
A segmented, calibrated gradient pneumatic compression device is allowed only when the patient has *unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a non-segmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber.
*Unique characteristics may be defined as:
- A need to reduce pressure over sensitive areas such as wound sites, ulcers, and painful areas, and
- That the patient is unable to tolerate use of a non-calibrated nonprogrammable device, and
- That the calibrated pressure and programmability of the segmental pneumatic compressor with calibrated gradient pressure is required to address these sensitive areas.
BCBSMT considers all other indications for pneumatic compression devices are experimental, investigational and unproven including but not limited to diabetic neuropathic ulcers and arterial ischemic ulcers.
Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.
A 1998 Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Assessment focused on the comparison among types of lymphedema pumps. (1) A comparison of the efficacy of lymphedema pumps to other lymphedema treatments was not addressed by the TEC Assessment. The assessment concluded that the minimal amount of available data was inadequate to validate the superiority of one type of lymphedema pump over another. Only 2 small trials including direct comparisons of pump types were identified. Among additional uncontrolled studies, heterogeneity among studies made it difficult to compare efficacy across the different trials. Despite these limitations, however, results across all of the studies were consistent in showing a substantial improvement in lymphedema following treatment with any of the pumps tested. The TEC Assessment concluded that pneumatic compression devices are efficacious to some degree but that it was not possible to estimate precisely the magnitude of this effect.
In 2010, the McMaster University Evidence-based Practice Center, under contract with the Agency for Healthcare Research and Quality (AHRQ), (2) published a technology assessment on diagnosis and treatment of secondary lymphedema that included discussion of pneumatic compression pumps. The authors, Oremus and colleagues, identified a total of 10 studies; 6 moderate-to-high-quality randomized controlled trials (RCTs), 2 low-quality RCTs, and 2 observational studies. There was a high degree of heterogeneity between studies: 7 types of lymphedema pumps were used, pumps were compared to 6 different alternative interventions (including compression bandages, laser, and massage), and 5 studies used pumps in combination with other interventions. Six trials compared the addition of massage, including manual lymphatic drainage (a specialized type of massage performed by a trained therapist), to more conservative treatments such as bandaging or physical therapy. Five of the 6 studies included women with arm lymphedema after breast cancer treatment. Only 1 of these 5 studies found that massage led to greater reduction in arm volume than more conservative therapy. The sixth trial, which addressed lymphedema after ankle surgery, found significantly greater reduction in volume when manual lymph drainage massage was added to standard physical therapy versus physical therapy alone. Due to the relatively small number of studies and high degree of variability in study design, the authors concluded that there was insufficient evidence to determine whether any type of intermittent pneumatic compression (IPC) device and sleeve was more effective than another type.
In 2012, Oremus and colleagues (3) published an updated systematic review on conservative treatments for secondary lymphedema. The authors identified a total of 36 English-language studies, 30 of which were RCTs and 6 were observational studies. Six RCTs evaluated intermittent pneumatic compression. Study findings were not pooled. The authors reported that 2 RCTs showed that IPC was superior to decongestive therapy or self-massage but 3 other RCTs failed to show that IPC was superior to a different type of conservative treatment of lymphedema. In addition, the authors identified 1 RCT comparing types of IPC devices. This study, Pilch et al:. 2009 (4) found that a 3-chamber IPC sleeve was superior to a 1-chamber sleeve for reducing edema.
Two industry-sponsored RCTs were published in 2012 that included women with breast cancer who had documented post-surgical upper-extremity lymphedema. Fife and colleagues (5) compared treatment with the Flexitouch™ system to the Biocompression Systems Sequential Circulator. Participants needed to have at least 5% edema volume in the upper extremity at the time of study enrollment. A total of 36 women from 3 centers were included, 18 in each group. Participants used the devices for home treatment for 1 hour per day for 12 weeks in addition to standard care e.g. wearing compression garments. The Biocompression Systems device utilized an arm garment only whereas the Flexitouch device utilized three garments and treated the full upper extremity (arm, chest and truncal quadrant). Outcome assessment was conducted by experienced lymphedema therapists; blinding was not reported. Edema outcomes were available for all participants and local tissue water analysis for 28 of 36 (78%) of participants.
Ridner and colleagues (6) conducted an RCT comparing treatment with the Flexitouch™ system of the arm-only versus the arm, chest and trunk in women with breast cancer who had arm lymphedema. To be eligible for participation, there needed to have a 2 cm difference in girth on the affected arm compared to the unaffected arm. A total of 47 patients were enrolled; 5 patients were withdrawn in the course of the study, leaving n=21 in each treatment group. Participants completed training in using the device and were observed in the laboratory to insure they used proper technique; the remainder of the sessions was conducted at home. Patients in the experimental group (arm, chest and trunk treatment) were told to perform 30 daily sessions of 1-hour each; patients in the control group (arm-only) were told to perform 30 daily treatments of 36 minutes each. Final outcome assessment took place at the end of the 30-day treatment period. The authors did not report whether the staff members that assessed objective outcomes were blinded to the patient’s treatment group. There were no statistically significant differences between groups in efficacy outcomes. For example, change in the volume of the affected arm was -2.66 ml in the experimental group and -0.38 ml in the control group, p=0.609. In addition, the mean number of symptoms reported at the end of the study was 10.0 in the experimental group and 6.0 in the control group (p=0.145).
Practice Guidelines and Position Statements
A 2009 consensus statement from the International Union of Phlebology (7) stated that sequential pneumatic compression is an effective treatment for primary lymphedema and is particularly useful in situations in which lymphedema is best treated by physical passive therapy e.g., elderly and disabled patients.
Ongoing Clinical Trials
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160): This multicenter single-blind randomized trial will compare the efficacy of two types of lymphedema pumps in 262 patients with lower limb lymphedema. (8) Patients are randomized to use a pump without calibrated compression (Hydroven PFR) or a pump with calibrated compression (Flexitouch System). The primary endpoint is limb volume reduction after 12 weeks of treatment, with the outcome at 24 weeks included as a secondary endpoint. The trial is sponsored by the Centre for Research and Implementation of Clinical Practice in the U.K. and Tactile Technologies. The expected date of completion is December 2013.
Venous Thromboembolism (VTE)
Approximately 70% of patients with fatal pulmonary embolism are diagnosed at autopsy because the diagnosis of pulmonary embolism is not suspected clinically. The majority of patients with pulmonary embolism die within 30 minutes after the onset of symptoms, preventing timely administration of thrombolytic therapy or surgical intervention. Improved methods of DVT prevention are therefore needed to lower the mortality associated with pulmonary embolism.
Coverage criterion specific to VTE prophylaxis was enhanced to address the risk of VTE in high risk; surgical, trauma, and non-surgical patients. Literature confirms that mechanical and/or chemical preventive strategy should be individualized based on patient risk factors.
Bates et al 2012 noted in “Approach to Outcome Measurement in the Prevention of Thrombosis in Surgical and Medical Patients” (9) notes that evidence is stronger for anticoagulants and aspirin than for mechanical prophylaxis. The authors also noteed that “the compelling evidence of a decrease in fatal PE that exists for anticoagulants and for aspirin does not exist for mechanical methods.”
Review of scientific literature and existing guidelines (through October 2012) support the current coverage position as written regarding VTE (DVT and PE) prophylaxis.
Venous Stasis Ulcers
In a 2005 retrospective study the authors examined the value of intermittent external pneumatic compression therapy in venous stasis ulcers. Out of 1,250 patients with posthrombolphlebetic syndromes, 235 patients with leg ulcers revealed this therapy modality shortens therapy duration and cost, and hastens the return to active life in comparison to the classical therapy with compression stockings and anti-aggregant or low-dose oral anticoagulant therapy. Based on these findings the authors of this study recommend the wider use of this adjuvant therapy.
Arterial Ulcers and Circulator Boot Therapy
Montori and colleagues conducted a retrospective analysis of intermittent compression pump therapy for critical limb ischemia at the Mayo wound clinic. (10) Of the 107 patients, 101 had lower extremity ulcers. Of all the wounds, 64% were multifactorial in etiology, and 60% had associated transcutaneous oxygen tension (TcPO (2)) levels below 20 mmHg. Median follow-up after initiation of treatment was six months. Complete wound healing with limb preservation was achieved by 40% of patients with TcPO(2) levels below 20mmHg; by 48% with osteomyelitis or active wound infection; by 46% with diabetes treated with insulin; and by 28% with a previous amputation. Conclusions from this analysis found that patients with critical limb ischemia and nonhealing wounds at high risk of amputation can achieve complete wound healing and limb preservation by using an intermittent pneumatic compression device.
Filp and Dillon authored a report of a series of 27 patients (41 legs) with cholesterol-embolization syndrome (CES) treated between 1997 and 2005. (11) The alternate therapy offered to most patients at the time of referral was limb amputation. After a median interval of 11 months (range, 3-32 months) after initiation of therapy, 33 legs were totally healed, 6 improved, and 2 amputated. One patient died of causes unrelated to CES or use of the circulator boot. Another improved and discontinued treatment before he was totally healed. The authors concluded that the circulator boot seems to be the only effective therapy for CES. No comparison to alternative interventions at the time of treatment is possible, and treatment, particularly for cutaneous ulcers associated with vascular insufficiency, has continued to evolve since the patients in this study were treated. Large studies are lacking in the case of the Circulator Boot and unfortunately, due to the lack of patient protection are likely never to be done.