Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Pneumatic Compression Therapy Devices
Policy #:MA05.004c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

PRIMARY AND SECONDARY LYMPHEDEMA
A pneumatic compression device (E0650 or E0651) for the treatment of lymphedema, is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a diagnosis of lymphedema
  • The individual has persistence of chronic and severe lymphedema as documented in the medical record with at least one of the following clinical findings:
    • Marked hyperkeratosis with hyperplasia and hyperpigmentation
    • Papillomatosis cutis lymphostatica
    • Deformity of elephantiasis
    • Skin Breakdown with persisting lymphorrhea
    • Detailed measurements over time confirming the persistence of the lymphedema with a history evidencing a likely etiology
  • Documentation that the lymphedema has been unresponsive or failed to show improvement to conservative treatment over the course of a required four-week trial, which must include all of the following:
    • Regular and compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated 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 of the limb
    • When available, manual lymphatic drainage and appropriate medication when there is concurrent congestive failure

CHRONIC VENOUS INSUFFIENCY (CVI) WITH VENOUS STATSIS ULCERS
A pneumatic compression device (PCD) (E0650 or E0651) for the treatment of CVI of the lower extremities is considered medically necessary and, therefore, covered when All of the following criteria are met:
  • The individual has edema in the affected lower extremity
  • The individual has one or more venous stasis ulcer(s)
  • Documentation that the ulcer(s) have failed to heal after a six-month trial of conservative treatment, which must include all of the following:
    • Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated 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.
    • Medications as appropriate
    • Regular exercise
    • Elevation of the limb
    • Appropriate wound care for the ulcer (including sharp debridement when appropriate).

LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN
A pneumatic compression device (PCD) (E0652) 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 PCD (E0650 or E0651)
  • The individual has lymphedema extending onto the chest, trunk and/or abdomen that extends past the limitations of a standard compression sleeve used with (E0650 or E0651) 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 E0650 or E0651
    • 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

NOT MEDICALLY NECESSARY

All other uses for pneumatic compression devices are considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL

PERIPHERAL ARTERY DISEASE (PAD)
A pneumatic compression device (E0675) for the treatment of PAD is considered experimental/investigational and, therefore, not covered because there is insufficient evidence supporting the use of PCD for PAD.

NOT COVERED

PREVENTION OF VENOUS THROMBOEMBOLISM
A pneumatic compression device (E0676) for the prevention of venous thromboembolism is not covered by the Company because it is an item not covered by Medicare. This item is used as a preventive service. Therefore, it is not eligible for reimbursement consideration.

BILLING OF APPLIANCES/ACCESSORIES

PCD appliances are only covered and eligible for reimbursement consideration when medical necessity criteria for the PCD (i.e., compressor) are met.

In accordance with Medicare, pneumatic appliances are not covered when billed with pneumatic compression devices (E0675, E0676) that are not covered. Therefore, these items are not eligible for reimbursement consideration.

PLACE OF SERVICE

Pneumatic compression therapy devices are only eligible for coverage when reported by a DME company for services rendered in the home setting. It is not eligible for separate reimbursement in any place of service other than the home.

FACE-TO-FACE REQUIREMENTS

As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person examination with the individual within the six (6) months prior to the date of the written order prior to delivery.
  • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
  • For all claims for purchases or initial rentals
  • When there is a change in the prescription for the accessory, supply, drug, etc.
  • If periodic prescription renewal required per medical policy
  • When an item is replaced
  • When there is a change in the supplier
  • When required by state law

In this policy the specified items are:

Code
Narrative
E0650
Pneumatic compressor, nonsegmental home modelatic 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
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

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:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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 durable medical equipment (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.

Documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

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

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, pneumatic compression therapy devices are covered as durable medical equipment (DME) under the medical benefits of most of the Company's Medicare Advantage products when the medical necessity criteria listed in the medical policy are met. However, services that are identified in this policy as not covered or experimental/investigational are not eligible for coverage or reimbursement by the Company.

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

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.

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 nonsegmented or segmented, with or without calibrated gradient pressure.

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

A segmented pneumatic compression 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 should be 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 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.

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, deep vein thrombosis, 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

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 280.6: Pneumatic compression devices. [CMS Web site]. 01/14/02. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=225&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=pneumatic&KeyWordLookUp=Title&KeyWordSearchType=And&article_id=37216&article_version=6&show=all&bc=gAAAABAAAAAAAA%3d%3d&. Accessed: February 5, 2019.

Noridian Healthcare Solutions LLC. Local Coverage Article for Pneumatic Compression Devices A52488. Effective Date 10/01/2015. Revision Effective Date 01/01/2017. Available at:https://med.noridianmedicare.com/documents/2230703/7218263/Pneumatic+Compression+Devices+LCD/95830c2a-352e-4a8a-9a8f-cebc4d88b77b. Accessed February 5, 2019.

Noridian Healthcare Solutions LLC. Local Coverage Determination (LCD).L33829: Pneumatic compression devices. Effective Date 10/01/2015. Revision Effective Date 01/01/2017. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Pneumatic+Compression+Devices+LCD/95830c2a-352e-4a8a-9a8f-cebc4d88b77b. Accessed February 05, 2019.



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

THE FOLLOWING CODES ARE USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES FOR THE TREATMENT OF PRIMARY AND SECONDARY LYMPHEDEMA:

E0650 Pneumatic compressor, nonsegmental home model

E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure

THE FOLLOWING CODES ARE USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES APPLIANCES USED WITH PCDS FOR THE TREATMENT OF PRIMARY AND SECONDARY LYMPHEDEMA AND FOR THE TREATMENT OF CHRONIC VENOUS INSUFFICIENCY (CVI) WITH VENOUS STASIS ULCERS:

E0655 Nonsegmental 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 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

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

E0671 Segmental gradient pressure pneumatic appliance, full leg

E0672 Segmental gradient pressure pneumatic appliance, full arm

E0673 Segmental gradient pressure pneumatic appliance, half leg


THE FOLLOWING CODES ARE USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES FOR THE TREATMENT OF CHRONIC VENOUS INSUFFICIENCY (CVI) WITH VENOUS STASIS ULCERS AND FOR THE TREATMENT OF CHRONIC VENOUS INSUFFICIENCY (CVI) WITH VENOUS STASIS ULCERS:

E0650 Pneumatic compressor, nonsegmental home model

E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure


THE FOLLOWING CODES ARE USED TO A REPRESENT PNEUMATIC COMPRESSION DEVICE FOR THE TREATMENT OF LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN:

E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure


THE FOLLOWING CODES ARE USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES APPLIANCES USED WITH PCDS FOR THE TREATMENT OF LYMPHEDEMA EXTENDING ONTO 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

THE FOLLOWING CODE IS USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES FOR THE TREATMENT OF PERIPHERAL ARTERY DISEASE:

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


NOT COVERED

THE FOLLOWING CODE IS USED TO REPRESENT PNEUMATIC COMPRESSION DEVICES FOR THE PREVENTION OF VENOUS THROMBOEMBOLISIM

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



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

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







Policy History

MA05.004c
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.
10/01/2017This version of the policy will become effective 10/01/2017.

The following ICD-10 codes have been added to Attachment A in this policy:

L97.105, L97.106, L97.108, L97.115, L97.116, L97.118, L97.125, L97.126, L97.128, L97.205, L97.206, L97.208, L97.215, L97.216, L97.218, L97.225, L97.226, L97.228, L97.305, L97.306, L97.308, L97.315, L97.316, L97.318, L97.325, L97.326, L97.328, L97.405, L97.406, L97.408, L97.415, L97.416, L97.418, L97.425, L97.426, L97.428, L97.505, L97.506, L97.508, L97.515, L97.516, L97.518, L97.525, L97.526, L97.528, L97.805, L97.806, L97.808, L97.815, L97.816, L97.818, L97.825, L97.826, L97.828, L97.905, L97.906, L97.908, L97.915, L97.916, L97.918, L97.925, L97.926, L97.928

MA05.004b
07/28/2017Policy updated in accordance with Medicare:
  • The policy section was revised to reflect the local Medicare's Local coverage determination.
  • The Company’s coverage position has changed from Not Medically Necessary, to Medically Necessary on the following codes:
    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

MA05.004a
05/06/2016This policy will become effective 05/06/2016

The policy section was updated to include non-coverage of limb compression devices for venous thromboembolism (VTE) prophylaxis.

MA05.004
08/19/2015This policy has been reviewed and reissued to communicate the Company's position on pneumatic compression therapy devices for lymphedema and chronic venous insufficiency.
01/01/2015This is a new policy.





Version Effective Date: 10/01/2017
Version Issued Date: 09/29/2017
Version Reissued Date: 03/13/2019