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Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers

Policy Number: MP-123

Latest Review Date: January 2025

Category: Durable Medical Equipment (DME)                  

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)In accordance with the mandate listed above, lymphedema pumps/pneumatic compression devices or compression garments, are covered when used to treat lymphedema resulting from a mastectomy and ordered by the individual’s treating physician.

POLICY:

Lymphedema Pneumatic Compression Devices:

Lymphedema pumps/pneumatic compression devices or compression garments when applied to the limb may be considered medically necessary when used to treat lymphedema in the affected limbs resulting from a mastectomy and ordered by the individual’s treating physician.

Single-chamber lymphedema pumps/pneumatic compression devices when applied to the limb may be considered medically necessary when used to treat lymphedema not resulting from a mastectomy when all the following criteria are met:

  • The lymphedema is associated with functional impairment, e.g., impairment of activities of daily living; AND
  • The individual has tried and been compliant with four weeks of conservative therapy, i.e., elevation of the affected limb, exercise, massage, use of an appropriate compression garment; AND
  • The individual’s lymphedema is not improving with conservative measures; AND
  • Photographs or a diagnostic test must document the diagnosis of lymphedema (not required in cases of mastectomy related lymphedema).

Except when as a result of a mastectomy, a single-chamber/non-segmented device (E0650) or multi-chamber/segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs for individuals with lymphedema.

A multi-chamber programmable segmented device with manual control of the pressure in each chamber (E0652) when applied to the limb may be considered medically necessary only when there is documentation in the individual's medical record of a condition that will not allow treatment of the lymphedema with E0650 or E0651.

  • Such conditions include a significant sensitive skin scar or contracture, which make treatment with another device painful or unsafe for the individual.

The use of lymphedema pumps/pneumatic compression to treat venous ulcers is considered investigational.

Lymphedema pumps/pneumatic compression devices are considered investigational for the following indications:

  • Infection
  • Venous or arterial occlusive disease
  • Venous thrombosis
  • Massive edema secondary to conditions including, but not limited to, congestive heart failure, renal failure, or hepatic insufficiency or chronic venous insufficiency
  • Metastatic disease in the involved extremity

Lymphedema pumps/pneumatic compression devices for diabetic neuropathic ulcers and arterial ischemic ulcers are considered investigational.

External intermittent pneumatic compression devices for the feet are considered investigational.

The use of lymphedema pumps to treat the trunk, chest, head or neck in patients with lymphedema is considered investigational.

The use of non-pneumatic sequential compression garments (e.g. Dayspring™ Therapy) are considered investigational.

End-diastolic pneumatic compression boots are considered investigational as a treatment of peripheral vascular disease or lymphedema and its associated complications, including but not limited to ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, or thrombophlebitis.

Lymphedema Compression Garments:

The use of compression garments, including those for daytime and nighttime, which offer various levels of compression, are considered medically necessary. These include compression garments for the head, neck, trunk and limbs.

The ReidSleeve (A4465) is covered for individuals with post-mastectomy lymphedema.

A Compressure bra/Compression bra is covered for individuals with post-mastectomy lymphedema.

The Tribute™ garment is only covered for individuals with post-mastectomy lymphedema.

Non-elastic gradient compression wrap (A6545) and non-elastic leg binders (A4465), e.g., Circaid Juxta-lite, Circaid T-3 M and Circaid Cures, LegAssist, Caresia Bandage Liners, etc. are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pneumatic compression pumps are proposed as a treatment for individuals with lymphedema who have failed conservative measures. They are also proposed to supplement standard care for individuals with venous ulcers. A variety of pumps are available; they can be single chamber (nonsegmented) or multichamber (segmented) and have varying designs and complexity.

Lymphedema

Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. It is characterized by nonpitting swelling of an extremity or trunk, and is associated with wound healing impairment, recurrent skin infections, pain, and decreased quality of life. Lymphedema can be caused by congenital or inherited abnormalities in the lymphatic system (primary lymphedema) but is most often caused by acquired damage to the lymphatic system (secondary lymphedema). Breast cancer treatment (surgical removal of lymph nodes and radiotherapy) is one of the most common causes of secondary lymphedema. In a systematic review of 72studies (N=29,612 women), DiSipio et al. (2013) reported that nearly 20% of breast cancer survivors will develop arm lymphedema. The risk factors with robust evidence for the development of lymphedema included extensive surgical procedures(such as axillary lymph node dissection, a higher number of lymph nodes removed, and mastectomy) as well as being overweight or obese.

Diagnosis and Staging

A diagnosis of secondary lymphedema is based on history (e.g., cancer treatment, trauma) and physical examination (localized, progressive edema and asymmetric limb measurements) when other causes of edema can be excluded. Imaging, such as MRI, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases.

Table 1 lists International Society of Lymphology guidance for staging lymphedema (2023) based on "softness" or "firmness" of the limb and the changes with an elevation of the limb.

Table 1. Recommendations for Staging Lymphedema

Stage

Description

Stage 0 (latent or subclinical)

Swelling is not yet evident despite impaired lymph transport, subtle alterations in tissue fluid/composition, and changes in subjective symptoms. It can be transitory and may exist months or years before overt edema occurs(Stages 1-lll).

Stage I (mild)

Early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) which subsides with limb elevation. Pitting may occur. An increase in various types of proliferating cells may also be seen.

Stage II (moderate)

Involves the permanent accumulation of pathologic solids such as fat and proteins and limb elevation alone rarely reduces tissue swelling, and pitting is manifest. Later in this stage, the limb may not pit as excess subcutaneous fat and fibrosis develop.

Stage III (severe)

Encompasses lymphostatic elephantiasis where pitting can be absent and trophic skin changes such as acanthosis, alterations in skin character and thickness, further deposition of fat and fibrosis, and warty overgrowths have developed. It should be noted that a limb may exhibit more than one stage, which may reflect alterations in different lymphatic territories.

Management and Treatment

Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Patients are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by patients designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all the previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in patients who have difficulty performing self-manual lymphatic drainage. In patients with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.

Venous Ulcers

Venous ulcers, which occur most commonly on the medial distal leg, can develop in patients with chronic venous insufficiency when leg veins become blocked. Standard treatment for venous ulcers includes compression bandages or hosiery supplemented by conservative measures such as leg elevation.

Pneumatic Compression Pumps

Pneumatic compression pumps (PCPs) may be used in lymphedema or wound care clinics, purchased, or rented for home use; home use is addressed herein. PCPs consist of pneumatic cuffs connected to a pump. These pumps use compressed air to apply pressure to the affected limb. The intention is to force excess lymph fluid out of the limb and into central body compartments in which lymphatic drainage should be preserved. Many PCPs are available, with varying materials, designs, degrees of pressure, and complexity. There are 3 primary types of pumps. Single chamber nonprogrammable pumps are the simplest pumps, consisting of a single chamber that is inflated at 1 time to apply uniform pressure. Multichamber nonprogrammable pumps have multiple chambers ranging from 2 to 12 or more. The chambers are inflated sequentially and have a fixed pressure in each compartment. They can either have the same pressure in each compartment or a pressure gradient, but they do not include the ability to adjust the pressure manually in individual compartments. Single- or multi-chamber programmable pumps are similar to the pumps described above except that it is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including patients with scarring, contractures, or extremely sensitive skin, programmable pumps are generally considered the preferred option. PCPs are also proposed to supplement standard care for patients with venous ulcers.

KEY POINTS:

This evidence review was created with searches of the PubMed database. The most recent literature update was performed through November 25, 2024.

Summary of Evidence

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb only, the evidence includes randomized controlled trials (RCTs) and systematic reviews primarily focusing on upper-limb lymphedema secondary to breast cancer. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Most of these RCTs were deemed moderate-to-high quality by the Agency for Healthcare Research and Quality, and about half reported significant improvements with the use of pumps compared to conservative care. Recent meta-analyses indicate that incorporating intermittent pneumatic compression (IPC) with complete decongestive therapy can further enhance lymphedema management within four weeks post-treatment. Similar findings are observed when IPC is combined with decongestive lymphatic therapy compared to decongestive lymphatic therapy alone in managing upper limb lymphedema after breast cancer surgery, with the former combined regimen showing improved external rotation joint mobility. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb and chest and/or trunk, the evidence includes two RCTs of the Flexitouch system (Tactile Medical), published in 2012, comparing treatment with and without truncal involvement. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. In one RCT, two (of 4) key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (e.g., amount of fluid removed) rather than health outcomes (e.g., functional status, quality of life). The second RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to the head and neck, the evidence includes one RCT and a systematic review to assess the use of pneumatic compression treatment for head and neck lymphedema. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The RCT, comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone, examined the feasibility, adherence, and safety of the Flexitouch advanced pneumatic compression device (APCD) by Tactile Medical. The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily as prescribed. The systematic review also suggested benefits from using the APCD, and it was considered safe and feasible according to the observational studies that reported adverse events. Most studies included participants who had completed or were concurrently undergoing complete decongestive therapy. Out of the 5 observational studies included in the systematic review, four (80%) had potential conflicts of interest related to the funding source. The only study not sponsored by the industry highlighted difficulties in obtaining the APCD, with fewer than half of the patients receiving the device as prescribed. Further research with larger sample sizes and comparisons against the criterion standard of complete decongestive therapy is necessary to establish the efficacy of this treatment approach. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have venous ulcers who receive pneumatic compression pumps, the evidence includes RCTs and one systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at elevated risk of bias. A 2020 RCT compared lymphedema pumps with continuous compression did not find significant between-group differences in healing rates or durability of pain relief. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Family Physicians

In 2019, the American Academy of Family Physicians published recommendations for diagnosis and treatment of venous ulcers.

The following statements were issued regarding use of intermittent pneumatic compression.

"Intermittent pneumatic compression may be considered when there is generalized, refractory edema from venous insufficiency; lymphatic obstruction; and significant ulceration of the lower extremity. Although intermittent pneumatic compression is more effective than no compression, its effectiveness compared with other forms of compression is unclear. Intermittent pneumatic compression may improve ulcer healing when added to layered compression."

American Venous Forum et al.

In 2022, the American Venous Forum, American Vein and Lymphatic Society, and the Society for Vascular Medicine published an expert opinion consensus statement on lymphedema diagnosis and treatment. The following statements were issued regarding use of pneumatic compression:

  • "Sequential pneumatic compression should be recommended for lymphedema patients." (92% panel agreement; 32% strongly agree)
  • "Sequential pneumatic compression should be used for treatment of early stages of lymphedema." (62% panel agreement-consensus not reached; 38% panel disagreement; 2% strongly disagreed)

International Union of Phlebology

A 2013 consensus statement from the International Union of Phlebology indicated that primary lymphedema could be managed effectively by a sequenced and targeted management program based on a combination of decongestive lymphatic therapy and compression therapy. Treatment should include compression garments, self-massage, skin care, exercises, and, if desired, pneumatic compression therapy applied in the home.

Wound Healing Society

A 2015 guideline from the Wound Healing Society states that for patients with venous ulcers, intermittent pneumatic pressure can be used with or without compression dressings and can provide another option in patients who cannot or will not use an adequate compression dressing system.

Society for Vascular Surgery and American Venous Forum

The 2014 joint guidelines from the Society for Vascular Surgery and the American Venous Forum on the management of venous ulcers included the following statement on pneumatic compression:

“We suggest use of intermittent pneumatic compression when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy. [GRADE - 2; LEVEL OF EVIDENCE - C]”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Lymphedema pump, lymphedema compression device, pneumatic compression pump, pneumatic compression device, sequential gradient pneumatic compression device, pneumatic appliance, Reidsleeve, compression garment, compression sleeve, customized compression garment, compressure bra, Compressure Comfort® Bra, Bellise Compressure Bra, Morris Designs Compressure Bra, FP5000™ Pump System, external intermittent pneumatic compression of the foot, Flowtron® system, foot compression device, AV Impluse System Foot Pump, KCI Plexipuls, Tribute™ garment, Circaid Juxta-lite, Circaid T-3 M and Circaid Cures, LegAssist, non-elastic compression garment, Flexitouch™, 2-phase multi-chambered lymphedema pumps, Lympha Press Optimal™ Lympha Press® Plus, Lympha Pants II™, Lympha Jacket II™, Caresia Bandage Liners, End-Diastolic Pneumatic Compression Boot, The Circulator Boot™, The Miniboot, the Multicrus Circulator Boot™, Circulator Boot System, PowerPress Unit Sequential Circulator, Dayspring, WHCRA, Women's Health and Cancer Rights Act

APPROVED BY GOVERNING BODIES:

Several pneumatic compression pumps, indicated for the 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 intended for home or clinic/hospital use include the Compression Pump, ModelGS-128 (MedMark Technologies); the Sequential Circulator® (Bio Compression Systems); the Lympha-Press® and Lympha-Press Optimal (Mego Afek); the Flexitouch®™ and Flexitouch Plus systems (Tactile Medical, formerly Tactile Systems Technology); the Powerpress Unit Sequential Circulator (Neomedic); and the EzLymph and EzLymph M (EEZCare Medical).

Several pneumatic compression devices are cleared by the FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch®, and PowerPress Unit listed above as well as Nanotherm™ (ThermoTek, Inc.), CTU676® (Compression Technologies), and Recovery+™ (Pulsar Scientific).

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

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

CURRENT CODING:

CPT codes:

29581

APPLICATION OF MULTI-LAYER COMPRESSION SYSTEM; LEG (BELOW KNEE), INCLUDING ANKLE AND FOOT

29584

APPLICATION OF MULTI-LAYER COMPRESSION SYSTEM; UPPER ARM, FOREARM, HAND, AND FINGERS

97140

MANUAL THERAPY TECHNIQUES (EG, MOBILIZATION/ MANIPULATION, MANUAL LYMPHATIC DRAINAGE, MANUAL TRACTION), 1 OR MORE REGIONS, EACH 15 MINUTES

97535

SELF-CARE/HOME MANAGEMENT TRAINING (EG, ACTIVITIES OF DAILY LIVING (ADL) AND COMPENSATORY TRAINING, MEAL PREPARATION, SAFETY PROCEDURES, AND INSTRUCTIONS IN USE OF ASSISTIVE TECHNOLOGY DEVICES/ADAPTIVE EQUIPMENT) DIRECT ONE-ON-ONE CONTACT, EACH 15 MINUTES

HCPCS codes:

Claims for lymphedema pumps are coded for with a pair of HCPCS codes: one to describe the actual pump and one to describe the appliance (i.e., sleeve) that is put on the affected body part. The various types of pumps may be distinguished by HCPCS codes.

Single-Compartment Pumps

E0650

Pneumatic compressor, nonsegmental home model

The above code (E0650) is used in conjunction with any of the following appliances:

E0655

Nonsegmental pneumatic appliance for use with pneumatic compressor, half arm

E0660

Nonsegmental pneumatic appliance for use with pneumatic compressor, full leg

E0665

Nonsegmental pneumatic appliance for use with pneumatic compressor, full arm

E0666

Nonsegmental pneumatic appliance for use with pneumatic compressor, half leg

Multichamber Pumps

E0651

Pneumatic compressor, segmental home model without calibrated gradient pressure

The above code (E0651) may be used with any of the following appliance codes:

E0656

Segmental pneumatic appliance for use with pneumatic compressor, trunk

E0657

Segmental pneumatic appliance for use with pneumatic compressor, chest

E0667

Segmental pneumatic appliance for use with pneumatic compressor, full leg

E0668

Segmental pneumatic appliance for use with pneumatic compressor, full arm

E0669

Segmental pneumatic appliance for use with pneumatic compressor, half leg

E0670

Segmental pneumatic appliance for use with pneumatic compressor, integrated, 2 full legs and trunk

Multichamber Programmable Pumps

E0652

Pneumatic compressor, segmental home model with calibrated gradient pressure

The above code (E0652) may be used with any of the following appliance codes:

E0671

Segmental gradient pressure pneumatic appliance, full leg

E0672

Segmental gradient pressure pneumatic appliance, full arm

E0673

Segmental gradient pressure pneumatic appliance, half leg

Compression Garments:

A4465 Non-elastic binder for extremity

A6520

Gradient compression garment, glove, padded, for nighttime use, each (Effective 1/1/24)

A6521

Gradient compression garment, glove, padded, for nighttime use, custom, each(Effective 1/1/24)

A6522

Gradient compression garment, arm, padded, for nighttime use, each(Effective 1/1/24)

A6523

Gradient compression garment, arm, padded, for nighttime use, custom, each(Effective 1/1/24)

A6524

Gradient compression garment, lower leg and foot, padded, for nighttime use, each(Effective 1/1/24)

A6525

Gradient compression garment, lower leg and foot, padded, for nighttime use, custom, each(Effective 1/1/24)

A6526

Gradient compression garment, full leg and foot, padded, for nighttime use, each(Effective 1/1/24)

A6527

Gradient compression garment, full leg and foot, padded, for nighttime use, custom, each(Effective 1/1/24)

A6528

Gradient compression garment, bra, for nighttime use, each(Effective 1/1/24)

A6529

Gradient compression garment, bra, for nighttime use, custom, each(Effective 1/1/24)

A6530

Gradient compression stocking, below knee, 18-30 mmHg, each

A6531

Gradient compression stocking, below knee, 30-40 mmHg, each

A6532

Gradient compression stocking, below knee, 40-50 mmHg, each

A6533

Gradient compression stocking, thigh length, 18-30 mmHg, each

A6534

Gradient compression stocking, thigh length, 30-40 mmHg, each

A6535

Gradient compression stocking, thigh length, 40-50 mmHg, each

A6536

Gradient compression stocking, full length/chap style, 18-30 mmHg, each

A6537

Gradient compression stocking, full length/chap style, 30-40 mmHg, each

A6538

Gradient compression stocking, full length/chap style, 40-50 mmHg, each

A6539

Gradient compression stocking, waist length, 18-30 mmHg, each

A6540

Gradient compression stocking, waist length, 30-40 mmHg, each

A6541

Gradient compression stocking, waist length, 40-50 mmHg, each

A6545

Gradient compression wrap, non-elastic, below knee, 30-50 mmHg, each

A6549

Gradient compression stocking/sleeve, not otherwise specified

A6552

Gradient compression stocking, below knee, 30-40 mmHg, each(Effective 1/1/24)

A6553

Gradient compression stocking, below knee, 30-40 mmHg, custom, each(Effective 1/1/24)

A6554

Gradient compression stocking, below knee, 40 mmHg or greater, each(Effective 1/1/24)

A6555

Gradient compression stocking, below knee, 40 mmHg or greater, custom, each(Effective 1/1/24)

A6556

Gradient compression stocking, thigh length, 18-30 mmHg, custom, each(Effective 1/1/24)

A6557

Gradient compression stocking, thigh length, 30-40 mmhg, custom, each(Effective 1/1/24)

A6558

Gradient compression stocking, thigh length, 40 mmhg or greater, custom, each(Effective 1/1/24)

A6559

Gradient compression stocking, full length/chap style, 18-30 mmhg, custom, each(Effective 1/1/24)

A6560

Gradient compression stocking, full length/chap style, 30-40 mmhg, custom, each(Effective 1/1/24)

A6561

Gradient compression stocking, full length/chap style, 40 mmhg or greater, custom, each(Effective 1/1/24)

A6562

Gradient compression stocking, waist length, 18-30 mmhg, custom, each(Effective 1/1/24)

A6563

Gradient compression stocking, waist length, 30-40 mmhg, custom, each(Effective 1/1/24)

A6564

Gradient compression stocking, waist length, 40 mmhg or greater, custom, each(Effective 1/1/24)

A6565

Gradient compression gauntlet, custom, each(Effective 1/1/24)

A6566

Gradient compression garment, neck/head, each(Effective 1/1/24)

A6567

Gradient compression garment, neck/head, custom, each(Effective 1/1/24)

A6568

Gradient compression garment, torso and shoulder, each(Effective 1/1/24)

A6569

Gradient compression garment, torso/shoulder, custom, each(Effective 1/1/24)

A6570

Gradient compression garment, genital region, each(Effective 1/1/24)

A6571

Gradient compression garment, genital region, custom, each(Effective 1/1/24)

A6572

Gradient compression garment, toe caps, each(Effective 1/1/24)

A6573

Gradient compression garment, toe caps, custom, each(Effective 1/1/24)

A6574

Gradient compression arm sleeve and glove combination, custom, each(Effective 1/1/24)

A6575

Gradient compression arm sleeve and glove combination, each(Effective 1/1/24)

A6576

Gradient compression arm sleeve, custom, medium weight, each(Effective 1/1/24)

A6577

Gradient compression arm sleeve, custom, heavy weight, each(Effective 1/1/24)

A6578

Gradient compression arm sleeve, each(Effective 1/1/24)

A6579

Gradient compression glove, custom, medium weight, each(Effective 1/1/24)

A6580

Gradient compression glove, custom, heavy weight, each(Effective 1/1/24)

A6581

Gradient compression glove, each(Effective 1/1/24)

A6582

Gradient compression gauntlet, each(Effective 1/1/24)

A6583

Gradient compression wrap with adjustable straps, below knee, 30-50 mm Hg, each(Effective 1/1/24)

A6584

Gradient compression wrap with adjustable straps, not otherwise specified(Effective 1/1/24)

A6585

Gradient pressure wrap with adjustable straps, above knee, each(Effective 1/1/24)

A6586

Gradient pressure wrap with adjustable straps, full leg, each(Effective 1/1/24)

A6587

Gradient pressure wrap with adjustable straps, foot, each(Effective 1/1/24)

A6588

Gradient pressure wrap with adjustable straps, arm, each(Effective 1/1/24)

A6589

Gradient pressure wrap with adjustable straps, bra, each(Effective 1/1/24)

A6593

Accessory for gradient compression garment or wrap with adjustable straps, non-otherwise specified(Effective 1/1/24)

A6594

Gradient compression bandaging supply, bandage liner, lower extremity, any size or length, each

A6595

Gradient compression bandaging supply, bandage liner, upper extremity, any size or length, each

A6596

Gradient compression bandaging supply, conforming gauze, per linear yard, any width, each

A6597

Gradient compression bandage roll, elastic long stretch, linear yard, any width, each

A6598

Gradient compression bandage roll, elastic medium stretch, per linear yard, any width, each

A6599

Gradient compression bandage roll, inelastic short stretch, per linear yard, any width, each

A6600

Gradient compression bandaging supply, high density foam sheet, per 250 square centimeters, each

A6601

Gradient compression bandaging supply, high density foam pad, any size or shape, each

A6602

Gradient compression bandaging supply, high density foam roll for bandage, per linear yard, any width, each

A6603

Gradient compression bandaging supply, low density channel foam sheet, per 250 square centimeters, each

A6604

Gradient compression bandaging supply, low density flat foam sheet, per 250 square centimeters, each

A6605

Gradient compression bandaging supply, padded foam, per linear yard, any width, each

A6606

Gradient compression bandaging supply, padded textile, per linear yard, any width, each

A6607

Gradient compression bandaging supply, tubular protective absorption layer, per linear yard, any width, each

A6608

Gradient compression bandaging supply, tubular protective absorption padded layer, per linear yard, any width, each

A6609

Gradient compression bandaging supply, not otherwise specified

A6610

Gradient compression stocking, below knee, 18-30 mmhg, custom, each

E0677

Non-pneumatic sequential compression garment, trunk (Effective 4/1/23)

E0678

Non-pneumatic sequential compression garment, full leg (Effective 1/1/24)

E0679

Non-pneumatic sequential compression garment, half leg (Effective 1/1/24)

E0680

Non-pneumatic compression controller with sequential calibrated gradient pressure (Effective 1/1/24)

E0681

Non-pneumatic compression controller without calibrated gradient pressure (Effective 1/1/24)

E0682

Non-pneumatic sequential compression garment, full arm (Effective 1/1/24)

S8420

Gradient pressure aid (sleeve and glove combination), custom made

S8421

Gradient pressure aid (sleeve and glove combination), ready made

S8422

Gradient pressure aid (sleeve), custom made, medium weight

S8423

Gradient pressure aid (sleeve), custom made, heavy weight

S8424

Gradient pressure aid (sleeve), ready made

S8425

Gradient pressure aid (glove), custom made, medium weight

S8426

Gradient pressure aid (glove), custom made, heavy weight

S8427

Gradient pressure aid (glove), ready made

S8428

Gradient pressure aid (gauntlet), ready made

S8429

Gradient pressure exterior wrap

S8430

Padding for compression bandage, roll

S8431

Compression bandage, roll

REFERENCES:

  1. Alvarez OM, Markowitz L, Parker R, et al. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020; 20: e6.
  2. Bonkemeyer Millan S, Gan R, Townsend PE. Venous Ulcers: Diagnosis and Treatment. Am Fam Physician. Sep 01 2019; 100(5): 298-305.
  3. Cheng JT, Leite VF, Tennison JM, et al. Rehabilitation Interventions for Head and Neck Cancer-Associated Lymphedema: A Systematic Review. JAMA Otolaryngol Head Neck Surg. Aug 01 2023; 149(8): 743-753.
  4. Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in individuals with venous leg ulcers. Int J Med Sci. 2014; 11(1):34-43.
  5. Dolibog P, Franek A, Taradaj J et al. A randomized, controlled clinical pilot study comparing three types of compression therapy to treat venous leg ulcers in individuals with superficial and/or segmental deep venous reflux. Ostomy Wound Manage 2013; 59(8):22-30.
  6. 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; 20(12):3279-86.
  7. Gurdal SO, Kostanoglu A, Cavdar I et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol 2012; 10(3):129=35.
  8. Gutierrez C, Karni RJ, Naqvi S, et al. Head and Neck Lymphedema: Treatment Response to Single and Multiple Sessions of Advanced Pneumatic Compression Therapy. Otolaryngol Head Neck Surg. Apr 2019; 160(4): 622-626.
  9. Gutierrez C, Mayrovitz HN, Naqvi SHS, et al. Longitudinal effects of a novel advanced pneumatic compression device on individual-reported outcomes in the management of cancer-related head and neck lymphedema: A preliminary report. Head Neck.Aug 2020; 42(8): 1791-1799.
  10. Hammond TM, Mayrovitz HN. Programmable intermittent pneumatic compression as a component of therapy for breast cancer treatment-related truncal and arm lymphedema. Home Health Care Management Practice 2010; 22(6):397-402.
  11. Hou S, Li Y, Lu W, et al. Efficacy of intermittent pneumatic compression on breast cancer-related upper limb lymphedema: a systematic review and meta-analysis in clinical studies. Gland Surg. Aug 31 2024; 13(8): 1358-1369.
  12. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  13. Lee BB, Andrade M, Antignani PL, et al. Diagnosis and Treatment of Primary Lymphedema. Consensus Document of the International Union of Phlebology (IUP)-2013. Int Angiol. 2013 December; 32(6): 541-74. 2013.
  14. Lurie F, Malgor RD, Carman T, et al. The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment. Phlebology. May 2022; 37(4): 252-266.
  15. Marston W, Tang J, Kirsner RS, et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. Jan-Feb 2016; 24(1): 136-44.
  16. Mayrovitz HN, Ryan S, Hartman JM. Usability of advanced pneumatic compression to treat cancer-related head and neck lymphedema: A feasibility study. Head Neck. Jan 2018; 40(1): 137-143.
  17. Nelson EA, Mani R, Thomas K et al. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev 2011: (2); CD001899.
  18. Nelson EA, Hillman A, Thomas K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. 2014 May 12: 5; CD001899.
  19. O'Donnell TF, Jr., Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl):3s-59s.
  20. Oremus M, Dayes I, Walker K et al. Systematic review:  conservative treatments for secondary lymphedema. BMC Cancer 2012; 12:6.
  21. Oremus M, Walker K, Dayes I, et al. Technology Assessment: Diagnosis and Treatment of Secondary Lymphedema (Project ID: LYMT0908). Rockville, MD: Agency for Healthcare Research and Quality; 2010.
  22. 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.
  23. Rockson S, Karaca-Mandic P, et al. Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study. Lymphatic Research and Biology. July 2021.
  24. Shao Y, Qi K, Zhou QH, et al. Intermittent pneumatic compression pump for breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. Oncol Res Treat. 2014:37(4); 170-174.
  25. Shires CB, Harris P, Dewan K. Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. Laryngoscope Investig Otolaryngol. Jun 2022; 7(3): 774-778.
  26. Sponsored by the Centre for Research & Implementation of Clinical Practice (U.K.). Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160). Available online at www.clinicaltrials.gov.
  27. Su EP, Perna M, Boettner F et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br 2012; 94(11 Suppl A):153-6.
  28. Tastaban E, Soyder A, Aydin E, et al. Role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema: a randomized controlled trial. Clin Rehabil. Feb 2020; 34(2): 220-228.
  29. Uzkeser H, Karatay S, Erdemci B, et al. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. May 2015; 22(3):300-307.
  30. Xu Q, Li Z. Effects of pneumatic compression therapy on wound healing in patients with venous ulcers: A meta-analysis. Int Wound J.Nov 07 2023.
  31. Yao M, Peng P, Ding X, et al. Comparison of Intermittent Pneumatic Compression Pump as Adjunct to Decongestive Lymphatic Therapy against Decongestive Therapy Alone for Upper Limb Lymphedema after Breast Cancer Surgery: A Systematic Review and Meta- Analysis. Breast Care (Basel). Jun 2024; 19(3): 155-164.

POLICY HISTORY:

Medical Policy Group, January 1993

Medical Policy Group, September 1995

TEC Assessment, July 1998

Medical Policy Group, September 1999

Medical Policy Group, May 2000

BCBSA Medical Policy Panel Review, July 2002

Medical Policy Group, June 2003 (2)

Medical Policy Administration Committee, June 2003

Available for comment July 1-August 14, 2003

Medical Policy Group, June 2005 (1)

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, June 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 5-August 14, 2006

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 15-September 28, 2006

Medical Policy Group, October 2006 (2)

Medical Policy Administration Committee, October 2006

Available for comment November 3-December 17, 2006

Medical Policy Group, October 2007 (2)

Medical Policy Administration Committee, November 2007

Available for comment November 17-December 31, 2007

Medical Policy Group, December 2008 (2)

Medical Policy Administration Committee, January 2009

Available for comments, December 17, 2008-January 30, 2009

Medical Policy Group, May 2011(2): Updated Description, Key Points, and References

Medical Policy Group, June 2011(2): Updated Policy, Key Words

Medical Policy Administration, June 2011

Available for comment June 23 – August 28, 2011

Medical Policy Panel, August 2011

Medical Policy Group, September 2011 (2): Description, Policy, Key Points, Key Words, References updated

Medical Policy Administration Committee, October 2011

Available for comment November 11 through December 27, 2011

Medical Policy Panel, January 2012

Medical Policy Group, March 2012 (2): Updated related to non-coverage of end-diastolic pneumatic compression boot as treatment of peripheral vascular disease or lymphedema Description, Policy, Key Words, Approved Governing Bodies, Key Points, and References

Medical Policy Administration Committee, March 2012

Available for comment March 15 – April 30, 2012

Medical Policy Panel, August 2012

Medical Policy Group, September 2012 (2): Policy reviewed with literature search through June 2012.  Statement on 2-phase pumps deleted. Assessed that use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational. Description, Key Points, Key Words and References updated to support new Policy statement.

Medical Policy Administration Committee, September 2012

Available for comment September 18 through November 1, 2012

Medical Policy Group, November 2012: Added new Code- E0670, effective 1/1/13

Medical Policy Panel, January 2013 End-Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

Medical Policy Group, March 2013 (2): Added note for policy #515 Outpatient Use of Limb Pneumatic compression Devices for Venous Thromboembolism Prophylaxis.  No new information found to change policy statement re: End-diastolic pneumatic compression boots.

Medical Policy Group, April 2013(4): 2013 Update - Added Key Points and References related to cryopneumatic devices.

Medical Policy Panel, October 2013

Medical Policy Group. January 2014 (2): Policy reviewed with literature search through August 2013. “When applied to the limb” added to coverage statements. Policy statement to non-cover for venous ulcers added. Key Points and References updated to support policy statement changes.

Available for comment January 10 through February 25, 2014

Medical Policy Group, March 2014 (2): Corrected paragraph 3 to delete coverage statement for venous ulcers. 

Medical Policy Group, June 2014 (5): Removed (except venous stasis ulcers as described above) from paragraph 10 since coverage statement for venous ulcers was removed March 2014.

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (5): Policy update- Added Key Points, Approved Governing Bodies, and References updated regarding venous ulcers and breast cancer related lymphedema.  No change to policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (6): Updates to Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Group, October 2015 (6): Clarifications to policy statements – “primary”, “including, but not limited to” and “or chronic venous insufficiency”; no change in policy intent.

Medical Policy Group, July 2016 (6) Removed “Primary/True” from policy statement.

Medical Policy Group, January 2017 (6): Updates to the Key points to include literature for the Game Ready® device. Edited policy statement for “Game Ready” device, removed “for the treatment of acute or chronic musculoskeletal injuries or as part of postoperative care.”

Medical Policy Panel March 2017

Medical Policy Group, April 2017 (6) Updates to Description, Key Points, Practice Guidelines and References; Removed old policy statement from 2014.

Medical Policy Group, October 2017 (6): Transferred Game Ready device to MP #364 Cooling and Heating Devices Used in the Home Setting, removed from Key Words.

Medical Policy Group, January 2018 (6): Updated policy statement to include “The use of lymphedema pumps to treat the trunk, chest, head or neck in patients with lymphedema limited to the upper and/or lower limbs is considered not medically necessary and investigational.” Updated code definition for A6545.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6) Updates to Key Points.

Medical Policy Panel, March 2019

Medical Policy Group, March 2019 (6) Updates to Description, Key Points; no changes to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Description and References.  No change to policy statements.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Description, Key Points, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Group, September (6): Coding update 10/1/21: Updates to Policy statement, added for non-coverage statement of non-pneumatic compression garments, Key Words, Coding (K1024-K1025)and References.On Draft through November 11, 2021.

Medical Policy Group, March 2022 Quarterly Coding Update. Added HCPCS K1031/K1032/K1033 to Current Coding section.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (6): Updates to Key Points.

Medical Policy Group, November 2022 (6): Updates to Policy statement to include coverage may be subject to legislative mandates: Federal Women's Health and Cancer Rights Act (WHCRA).

Medical Policy Group, December 2022 (6): Added Key Words: WHCRA, Women's Health and Cancer Rights Act

Medical Policy Group, March 2023 Quarterly Coding Update. Added HCPCS E0677 to Current Coding section.

Medical Policy Panel, March 2023

Medical Policy Group, April 2023 (6): Updates to Key Points, Benefit Application, Practice Guidelines and References.

Medical Policy Group, December 2023: 2024 Annual HCPCS update. Added codes E0678-E0682, Revised A6545, Deleted K1024, K1025, K1031, K1032, K1033.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Key Points and References.

Medical Policy Group, August 2024 (6): Updates to Policy statement for compression garments, and Current Coding.

Medical Policy Panel, January 2025

Medical Policy Group, January 2025 (6): Updates to Description, Key Points, Practice Guidelines and References. Title updated: Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers.

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.