BlueCross and BlueShield of Montana Medical Policy/Codes
Pneumatic Compression Devices
Chapter: Durable Medical Equipment
Current Effective Date: April 18, 2013
Original Effective Date: March 18, 2012
Publish Date: January 18, 2013
Revised Dates: December 12, 2012
Description

Pneumatic compression devices consist of an inflatable garment for the arm, leg, trunk or chest and an electrical pneumatic pump that fills the garment with compressed air.  The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices.

The following are descriptions of the different pneumatic compression devices:

  • A non-segmented pneumatic compressor is a device which has a single outflow port on the compressor. The air from the single tube may be transmitted to a sleeve/appliance with multiple compartments or segments.
  • A segmented pneumatic compressor is a device which has multiple outflow ports on the compressor which lead to distinct segments on the appliance which inflate sequentially.
  • A segmented device without calibrated gradient pressure is a device in which either (a) the same pressure is present in each segment or (b) there is a predetermined pressure gradient in successive segments but no ability to individually set or adjust pressures in each of several segments. In this device the pressure is usually set by a single control on the distal segment.
  • A segmented device with calibrated gradient pressure is characterized by a manual control on at least three outflow ports which can deliver an individually determined pressure to each segmental unit (e.g., Flexitouch®, Lympha Press®).
  • Segmental gradient pressure pneumatic appliances are appliances/sleeves which are used with a non-segmented pneumatic compressor but which achieve a pressure gradient through the design of the tubing and/or air chambers.

Deep Venous Thrombosis (DVT) Prophylaxis

Prophylactic therapy for prevention of DVT is routinely utilized in the in-patient setting with major abdominal, pelvic, extremity or neurologic surgery, or following major trauma.  DVT and PE are major complications associated with these surgeries resulting in significant morbidity and mortality.   Methods utilized in this prophylactic therapy are early ambulation, use of compression hose, and intermittent pneumatic compression pumps.  Generally, prophylactic therapy is discontinued when the patient is fully ambulatory and no longer requires extended periods of bed rest.  Patients who remain at high risk or who require extended periods of bed rest may require prophylaxis beyond an inpatient stay.

Treatment of Chronic Venous Stasis Ulcers

Compression therapy is an important part of treatment for chronic venous insufficiency (CVI) and venous leg ulcers.  Compliance with the bandage system (stockings, bandages, and Unna’s boot) may be a problem for some patients who may require higher levels of compression. 

The intermittent pneumatic compression (IPC) device is one means of intermittently increasing compression to relieve edema.  This device can be used as an adjunct or alternative to compression bandaging in patients who are relatively immobile and therefore, unable to activate the calf muscle pump.   In addition, pneumatic compression may be effective for patients who have previously failed treatment with other compression devices.

Treatment of Lymphedema

Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid.  The abnormal accumulation of lymph in the interstitial tissues is usually the result of impairment of the normal clearance by the lymphatic system caused by therapy or disease. The application of external pressure represents a reasonable and successful method for the mobilization of lymph from the affected limb in some patients. Pneumatic compression devices consisting of a single inflatable chamber or multiple chambers have been developed and used in the successful reduction of lymphedema.  Multichambered devices allow the application of pressure sequentially, starting from the distal chamber and progressing proximally, theoretically encouraging an effective, unidirectional flow of lymph out of the limb.

Regulatory Status

Several pneumatic compression pumps indicated for primary or adjunctive treatment of primary or secondary (e.g., postmastectomy) lymphedema have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of devices with these indications that are intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (Medmark Technologies, LLC, Perkasie, PA); the Sequential Circulator (Bio Compression Systems, Inc., Moonarchie, NJ); and the Lympha-Press and Lympha-Press Optimal (Mego Afek, Israel), the Flexitouch™ system (Tactile Systems Technology, Inc.) and the PowerPress Unit Sequential Circulator (Hanuri Distribution, Inc, Chatsworth, CA).

Treatment of Arterial and Diabetic Ulcers

Arterial ulcers affect 10% of all people with ulcers.  Generally ischemic (arterial) ulcers appear on distal feet and toes, sites of diminished vascular perfusion.  Ischemic symptoms include intermittent claudication and supine nocturnal pain, relieved by foot dangling.  Compression therapy is usually contraindicated in the treatment of arterial ulcers because it exacerbates ischemia.  However, one type of compression device (e.g., the Circulator Boot) is used to treat ischemic ulcers and incorporates a heart monitor so that pneumatic compression can be timed to the end-diastolic portion of the heart rhythm to improve arterial flow and heal the ischemic ulcers.    

Policy

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.

Medically Necessary

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:

Non-surgical:

  • Prior DVT/PE;
  • Age >60 years;
  • Sepsis or severe infection;
  • Hypercoagulable states;
    1. antithrombin III deficiency,
    2. protein C or S deficiency,
    3. activated Protein C resistance [Factor V Leiden],
    4. antiphospholipid syndrome,
    5. prothrombin 20210 defect,
    6. dysfibrinolysis
  • Active cancer or cancer treatment;
  • Kidney failure;
  • Recent myocardial infarction [MI);
  • Nonhemorrhagic stroke;
  • Congestive heart failure (CHF) (decompensated);
  • Low ejection fraction (EF);

Surgical:

  • Major pelvic surgery (e.g., radical hysterectomy, pelvic exenteration); 
  • Major orthopedic surgery (e.g., total hip replacement, total knee replacement);

Major Trauma:

  • 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.

NOTE: 

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.

Investigational

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

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.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. BCBSMT recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

Lymphedema

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.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration
 
ICD-9 Codes
Refer to ICD-9 manual.
ICD-10 Codes
I89.0, I97.2, Q82.0
Procedural Codes: A4600, E0650, E0651, E0652, E0655, E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673, E0675, E0676
References
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Special Report: Comparative Efficacy of Different Types of Pneumatic Compression Pumps for the Treatment of Lymphedema. TEC Assessments 1998; Volume 13, Tab 2.
  2. Oremus M, Walker K, Dayes I. Diagnosis and Treatment of Secondary Lymphedema: Technology assessment report by McMaster University Evidence-based practice center under contract with the Agency for Healthcare Research and Quality (AHRQ) (Project ID: LYMT0908). 2010. Available online at: https://www.cms.gov. Last accessed October, 2012.
  3. Oremus M, Dayes I, Walker K et al. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer 2012; 12:6.
  4. Pilch U, Wozniewski M, Szuba A. Influence of compression cycle time and number of sleeve chambers on upper extremity lymphedema volume reduction during intermittent pneumatic compression. Lymphology 2009; 42(1):26-35.
  5. Fife CE, Davey S, Maus EA et al. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Support Care Cancer 2012.
  6. Ridner SH, Murphy B, Deng J et al. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat 2012; 131(1):147-58.
  7. Lee BB, Andrade M, Bergan J et al. Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP) - 2009. Int Angiol 2010; 29(5):454-70.
  8. Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160): Available online at: www.clinicaltrials.gov. Last accessed July, 2012.
  9. Bates SM, Jaeschke R, Diagnosis of DVT: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians (ACCP) evidence-based clinical practice guidelines. Chest 2012 Feb; 141(2 Suppl):e351S-418S and Suppl: 195S-e226S.
  10. Montori VM, Kavros SJ, et al.  Intermittent compression pump for nonhealing wounds in patients with limb ischemia.  The Mayo Clinic experience (1998-2000).  International Journal of Angiology (2002) 21(4):360-6.
  11. Filp JR, Dillon RS. Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology 2008; 59(2):214-9.
  12. Pneumatic Compression Pumps for Treatment of Lymphedema Chicago Illinois:  Blue Cross and Blue Shield Association Medical Policy Reference Manual (August 2011) 1.01.18
  13. End-Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema Chicago Illinois:  Blue Cross and Blue Shield Association Medical Policy Reference Manual (January 2012) 2.02.17
History
January 2012 New Policy for BCBSMT
January 2013 Policy reviewed with literature search through August 2012. Title changed from "Pneumatic Compression Pumps for Treatment of Lymphedema" to "Pneumatic Compression Devices". Policy statement revised and more restrictive.  Additional criteria added to define conservative therapy and added criteria that must be submitted to make medically necessary determination.
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Pneumatic Compression Devices