Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Pneumatic Compression Therapy Devices

Policy #:05.00.01m



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies


MEDICALLY NECESSARY

NON-SEGMENTED AND SEGMENTED PNEUMATIC COMPRESSION THERAPY DEVICES FOR CHRONIC VENOUS INSUFFICIENCY (CVI) / LYMPHEDEMA
Non-segmented or segmented pneumatic compression therapy devices without calibrated gradient pressure (i.e., non-programmable) are considered medically necessary and, therefore, covered in the home setting when one of the following medical necessity criteria is met:
  • The individual has chronic venous insufficiency (CVI) with a non-healing lower extremity ulcer of six months duration that has failed a trial of conservative treatment directed by the treating professional provider, including a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.
  • The individual has lymphedema that is congenital, hereditary, or has resulted from the removal of regional lymph nodes (e.g., post-mastectomy), radiation fibrosis, or lymph node obstruction due to malignancy, and has failed a four-week trial of conservative therapy directed by the treating professional provider that must include the use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom fabricated but must provide adequate graduated compression.

Segmented pneumatic compression therapy devices with calibrated gradient pressure (i.e., programmable) are considered medically necessary and, therefore, covered in the home setting 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 (i.e., non-programmable) pressure.
    • Approval for the continued use of a pneumatic compression therapy device requires 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.

The ongoing application and approval of a pneumatic compression therapy device with calibrated gradient pressure is considered medically necessary and, therefore, covered in the home setting when documentation in the individual's medical record reflects the individual's compliance with the device and the device's effectiveness in treating the individual's condition.

LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK, AND/OR ABDOMEN
A pneumatic compression therapy device, segmental home model with calibrated gradient pressure (i.e., programmable) for the treatment of lymphedema of the chest, trunk, and/or abdomen is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has lymphedema of an extremity.
  • The individual meets the coverage criteria for pneumatic compression therapy device, non-segmented or segmented without calibrated gradient pressure.
  • The individual has lymphedema extending onto the chest, trunk, and/or abdomen that extends past the limitations of a standard compression sleeve used with pneumatic compression therapy device, non-segmented or segmented without calibrated gradient pressure and/or the abdominal lymphedema has failed to improve following a four-week trial of conservative treatment, which must be documented and include all of the following:
    • At least four weeks of regular, daily, multiple-hour home use of pneumatic compression therapy device, non-segmented or segmented without calibrated gradient pressure
    • Compliant use of an appropriate compression bandage system or compression garment to provide adequate compression (i.e., sufficient pressure at the lowest point to cause fluid movement and sufficient pressure across the gradient to move fluid from distal to proximal), with a prefabricated or custom-fabricated compression garment, with a minimum of 30 mmHg distally.
    • Regular exercise
    • Elevation where appropriate
    • Manual lymphatic drainage (where available) and self-manual lymphatic drainage (MLD) for at least 30 minutes per day
    • Evaluation of diet and implementation of any necessary change
    • Medications as appropriate (e.g., diuretics and/or other treatment of congestive failure, etc.)
    • Correction of anemia and or hypoproteinemia, where possible

PNEUMATIC COMPRESSION THERAPY DEVICES FOR VENOUS THROMBOEMBOLISM (VTE) PROPHYLAXIS POST-SURGERY
Post-surgical use of intermittent pneumatic compression therapy devices used for VTE prophylaxis is considered medically necessary and, therefore, covered in the home setting for individuals with a contraindication to anticoagulant agents, i.e., high risk for bleeding, when any of the following criteria are met:
  • Following major orthopedic surgery
  • Following non-major orthopedic surgery in individuals at moderate or high risk (see guidelines for risk factors)
  • Following other major surgery (non-orthopedic)

EXPERIMENTAL/INVESTIGATIONAL

Although the US Food and Drug Administration (FDA) has approved pneumatic compression therapy devices for arterial insufficiency (e.g., peripheral arterial occlusive disease, unreconstructable peripheral vascular disease), the Company has determined that the safety and/or effectiveness of these devices cannot be established by review of the available published peer-reviewed literature. Therefore, pneumatic compression therapy devices for arterial insufficiency is considered experimental/investigational by the Company and not covered.

NOT MEDICALLY NECESSARY

Pneumatic compression therapy devices for the trunk and the chest alone or for the trunk or chest in individuals with lymphedema limited to the upper and/or lower limbs are considered not medically necessary and, therefore, not covered because the available published literature does not support their use in the diagnosis or treatment of illness or injury.

The use of intermittent pneumatic compression therapy devices for VTE prophylaxis, when used in the home setting for periods longer than 30 days post-surgery, is considered not medically necessary and, therefore, not covered.

All other uses of pneumatic compression therapy devices not listed in this medical policy are considered not medically necessary and, therefore, not covered because the available published literature does not support their use in the diagnosis or treatment of illness or injury.

PLACE OF SERVICE

Pneumatic compression therapy devices are only eligible for coverage when reported by a durable medical equipment (DME) company for services rendered in the home setting. It is not eligible for separate reimbursement in places of service other than the home.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.
Guidelines

AMERICAN COLLEGE OF CHEST PHYSICIANS

Guidance on determining high risk for bleeding:

The American College of Chest Physicians (ACCP) guidelines (Falck-Ytter et al, 2012) on prevention of venous thromboembolism (VTE) in orthopedic surgery individuals 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

For individuals undergoing non-orthopedic surgery the risk of venous thromboembolism (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. The VTE risk appears to be highest for patients undergoing abdominal or pelvic surgery for cancer.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, pneumatic compression therapy devices are covered as durable medical equipment (DME) under the medical benefits of most of the Company products when the medical necessity criteria listed in the medical policy are met. Individual benefits must be verified because some contracts exclude DME.

Subject to the terms and conditions of the applicable benefit contract, pneumatic compression therapy devices for use in arterial insufficiency are not eligible for payment under the medical benefits of the Company's products because they are considered experimental/investigational and, therefore, not covered.

However, services that are identified in this policy as not medically necessary and experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Devices used for lymphedema therapy are cleared for marketing under the US Food and Drug Administration (FDA) 510(k) process. No clinical or safety data was needed to clear most of the devices currently on the market, because they existed prior to the Medical Device Amendment of 1976.

MANDATES

This policy is consistent with applicable mandates and coverage requirements. The Women's Health and Cancer Rights Act of 1998 and individual state mastectomy coverage laws require coverage for all treatment of the physical complications resulting from mastectomy (including lymphedema).

Description

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.

A non-segmented pneumatic compression therapy device has a single outflow port connected to a sleeve or an appliance with multiple compartments or segments. Typically, non-segmented pneumatic compression therapy devices do not have calibrated gradient pressure and provide the same pressure throughout the entire sleeve or appliance.

A segmented pneumatic compression therapy device has multiple outflow ports that lead to distinct segments on the appliance that inflate sequentially. Segmented devices without calibrated gradient pressure have either the same pressure in each segment or a predetermined pressure gradient in successive segments. However, the pressure in each segment of this type of device cannot be set or adjusted individually. Segmented devices with calibrated gradient pressure have a manual control on at least three outflow ports and segments that can each be set to deliver an individually determined pressure.

Pneumatic compression therapy devices are used for conditions such as chronic venous insufficiency (CVI) resulting in stasis ulcers, including chronic leg ulcers unresponsive to other therapy. CVI of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.

Pneumatic compression therapy devices are also used for the treatment of both primary and secondary lymphedema. Primary lymphedema, which is less common than secondary lymphedema, may be caused by conditions such as Milroy's disease or congenital deformities. Secondary, or acquired, lymphedema occurs from damage to the lymphatic network. Damage to formerly functioning lymphatic channels may be caused by infection; physical trauma; surgical removal of regional lymph nodes, post-radiation; or as a result of lymph node obstruction due to malignancy. Obstruction of the lymphatic vessels in primary and secondary lymphedema is usually characterized by swelling of the surrounding subcutaneous tissues caused by an accumulation of lymphatic fluid.

Pneumatic compression therapy devices are prescribed following initial conservative treatments for stasis ulcers, chronic leg ulcers, and both primary and secondary lymphedema. Conservative treatments for these conditions include, but are not limited to, leg or arm elevation, moist wound dressings, compression bandage systems, compression garments, and exercise. For individuals with lymphedema, a pneumatic compression therapy device may be prescribed if an initial decongestive lymphatic therapy (DLT) program has resulted in significant improvement or if the individual is unable to adhere to the maintenance phase of the program.

Intermittent pneumatic compression therapy devices are used in the home setting to prevent venous thromboembolism (VTE) and complications of venous stasis in individuals after trauma, orthopedic surgery, neurosurgery, or who for other reasons are unable to walk.

Individuals who undergo major surgeries such as orthopedic surgery experience a high risk for venous thromboembolism (VTE). For these high-risk individuals, VTE prophylaxis may be indicated beyond just the hospitalization period. Standard treatment is pharmacologic prophylaxis; however, some individuals are at high bleeding risk, which is a contraindication to anticoagulation. Based on clinical practice guidelines, evidence from randomized controlled studies on different populations, and the lack of good alternatives, when prophylaxis is indicated in the outpatient setting, limb compression devices are a reasonable alternative for individuals requiring major orthopedic, or other high-risk, surgery.

Limb compression devices have been used as an adjunct or alternative to anticoagulation in the home setting for individuals during the post-operative period as a method to reduce VTEs.

There are few relative contraindications for the use of pneumatic compression therapy devices; these include, but are not limited to, edema due to congestive heart failure, active phlebitis, venous thromboembolism, or the presence of localized wound infection or cellulitis.

Present published literature does not support the application of pneumatic compression therapy devices for individuals with arterial insufficiency (e.g., peripheral arterial occlusive disease, unreconstructable peripheral vascular disease). Furthermore, well-designed, large-scale, randomized, controlled studies with long-term follow-up are necessary to determine optimal treatment protocols for the use of pneumatic compression therapy devices for individuals with this condition. Until such studies are published, the use of intermittent pneumatic compression in the treatment of peripheral arterial occlusive disease should not be considered as a medical treatment.
References


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Zareba P, Wu C, Agzarian J, et al. Meta-analysis of randomized trials comparing combined compression and anticoagulation with either modality alone for prevention of venous thromboembolism after surgery. Br J Surg. 2014;101(9):1053-1062.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

NON-SEGMENTED AND SEGMENTED PNEUMATIC COMPRESSION DEVICES FOR CHRONIC VENOUS INSUFFICIENCY (CVI) / LYMPHEDEMA

E0650 Pneumatic compressor, nonsegmental home model

E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure

E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure

NONSEGMENTED AND SEGMENTED PNEUMATIC COMPRESSION APPLIANCES FOR CHRONIC VENOUS INSUFFICIENCY (CVI) / LYMPHEDEMA

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

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

E0671 Segmental gradient pressure pneumatic appliance, full leg

E0672 Segmental gradient pressure pneumatic appliance, full arm

E0673 Segmental gradient pressure pneumatic appliance, half leg

PNEUMATIC COMPRESSION DEVICES FOR LYMPHEDEMA EXTENDING INTO THE CHEST, TRUNK, AND/OR ABDOMEN

E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure

PNEUMATIC COMPRESSION DEVICES FOR VENOUS THROMBOEMBOLISM PROPHYLAXIS POST-SURGERY

E0676 Intermittent limb compression device (includes all accessories), not otherwise specified

PNEUMATIC COMPRESSION APPLIANCES FOR LYMPHEDEMA EXTENDING INTO THE CHEST, TRUNK, AND/OR ABDOMEN

E0656 Segmental pneumatic appliance for use with pneumatic compressor, trunk

E0657 Segmental pneumatic appliance for use with pneumatic compressor, chest

E0670 Segmental pneumatic appliance for use with pneumatic compressor, integrated, 2 full legs and trunk

EXPERIMENTAL/INVESTIGATIONAL

PNEUMATIC COMPRESSION DEVICES FOR ARTERIAL INSUFFICIENCY

E0675 Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system)


Revenue Code Number(s)

N/A



Coding and Billing Requirements


Cross References

Attachment A: Pneumatic Compression Therapy Devices
Description: ICD-10 Codes




Policy History

REVISIONS FROM 05.00.01m:
07/06/2020This version of the policy will become effective 07/06/2020.

In accordance with the Centers for Medicare & Medicaid Services' (CMS) Final Rule 1713 (84 Fed. Reg Vol 217), face-to-face encounter has been removed for the specified HCPCS codes:

E0650 PNEUMATIC COMPRESSOR, NONSEGMENTAL HOME MODEL

E0651 PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITHOUT CALIBRATED GRADIENT PRESSURE

E0652 PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITH CALIBRATED GRADIENT PRESSURE

E0655 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF ARM

E0656 SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, TRUNK

E0657 SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, CHEST

E0660 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL LEG

E0665 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL ARM

E0666 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF LEG

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

E0671 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL LEG

E0672 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL ARM

E0673 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, HALF LEG


REVISIONS FROM 05.00.01l:
03/13/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Pneumatic Compression Therapy Devices.
08/15/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 07/06/2020
Version Issued Date: 07/07/2020
Version Reissued Date: N/A



2017 AmeriHealth.