L5017

LCD/NCD Portal

Automated World Health

L5017

PNEUMATIC COMPRESSION DEVICES

08/05/2011

DME Region IV

Jurisdiction C

• For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted.

o If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

• Pneumatic compression devices are only covered for the treatment of lymphedema or for the treatment of chronic venous insufficiency with venous stasis ulcers.

o If the coverage criteria below are not met the devices will be denied as not reasonable and necessary.

LYMPHEDEMA:

• Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid.

o The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph.

o Lymphedema is divided into two broad classes according to etiology.

o Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies.

o Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as:

 Radical surgical procedures with removal of regional groups of lymph nodes.

• (For example, after radical mastectomy.).

 Post-radiation fibrosis.

 Spread of malignant tumors to regional lymph nodes with lymphatic obstruction.

 Among other causes.

• Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial.

o The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb.

o The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS:

• Chronic venous insufficiency (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.

o Signs of CVI include:

 Hyperpigmentation.

 Stasis dermatitis.

 Chronic edema.

 Venous ulcers.

• Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if:

o The patient has one or more venous stasis ulcer(s).

o Which have failed to heal after a six month trial of conservative therapy directed by the treating physician.

o The trial of conservative therapy must include:

 A compression bandage system or compression garment.

 Appropriate dressings for the wound.

 Exercise.

 Elevation of the limb.

GENERAL COVERAGE CRITERIA:

• For any item to be covered by Medicare, it must:

o Be eligible for a defined Medicare benefit category.

o Be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

o Meet all other applicable Medicare statutory and regulatory requirements.

 For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

• For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted.

o If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

• Pneumatic compression devices are only covered for the treatment of lymphedema or for the treatment of chronic venous insufficiency with venous stasis ulcers.

o If the coverage criteria below are not met the devices will be denied as not reasonable and necessary.

LYMPHEDEMA:

• Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid.

o The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph.

o Lymphedema is divided into two broad classes according to etiology.

o Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies.

o Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as:

 Radical surgical procedures with removal of regional groups of lymph nodes. (For example, after radical mastectomy.).

 Post-radiation fibrosis.

 Spread of malignant tumors to regional lymph nodes with lymphatic obstruction.

 Among other causes.

o The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb.

o The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS:

• Chronic venous insufficiency (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.

o Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.

• Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a six month trial of conservative therapy directed by the treating physician.

o The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

GENERAL COVERAGE CRITERIA:

• For either lymphedema or CVI with venous stasis ulcers, pneumatic compression devices are covered only when:

o prescribed by a physician,

o When they are used with appropriate physician oversight.

 Physician evaluation of the patient's condition to determine medical necessity of the device.

 Assuring suitable instruction in the operation of the machine.

 a treatment plan defining the pressure to be used and the frequency and duration of use

 Ongoing monitoring of use and response to treatment.

• The determination by the physician of the medical necessity of a pneumatic compression device must include:

o The patient's diagnosis and prognosis.

o Symptoms and objective findings, including measurements which establish the severity of the condition.

o the reason the device is required, including the treatments which have been tried and failed

o The clinical response to an initial treatment with the device.

 The clinical response includes:

• The change in pre-treatment measurements.

• Ability to tolerate the treatment session and parameters.

• Ability of the patient (or caregiver) to apply the device for continued use in the home.

• When a pneumatic compression device is covered, a non-segmented device (E0650) or segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs of the patient.

o A non-segmented compressor (E0650) with a segmented appliance/sleeve (E0671- E0673) is considered functionally equivalent to an E0651 compressor with a segmented appliance/sleeve (E0667-E0669).

o When a segmented device with manual control of the pressure in each chamber (E0652) is ordered and provided, the claim will be denied as not reasonable and necessary unless there is clear documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device (E0650) with a segmented appliance/sleeve (E0671- E0673) or a segmented device without manual control of the pressure in each chamber (E0651).

• Appliances used for pneumatic compression of the chest or trunk (E0656 and E0657) will be denied as NOT reasonable and necessary.

Coding Information

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

• The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIER:

• EY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

E0650 PNEUMATIC COMPRESSOR, NON-SEGMENTAL 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

Documentations Requirements

• Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider".

o It is expected that the patient's medical records will reflect the need for the care provided.

o The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.

o This documentation must be available upon request.

• An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.

o Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

• A Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available upon request.

o The CMN may act as a substitute for a written order if it contains all of the required elements of an order. The CMN for pneumatic compression pumps is CMS Form 846 (DME Form 04.04B).

o The initial claim must include an electronic copy of the CMN.

• If question #1 on the CMN ("Does the patient have chronic venous insufficiency with venous stasis ulcers?") is answered "Yes", documentation reflecting all of the following must be in the patient's medical record and made available upon request:

o The location of venous stasis ulcer(s).

o How long each ulcer has been continuously present.

o Previous treatment with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for at least the past 6 months.

o Evidence of regular physician visits for treatment of venous stasis ulcer(s) during the past 6 months.

• If E0652 is billed, the following additional documentation supporting the medical necessity for this device must be substantiated by information in the patient's medical records and available upon request:

o The treatment plan including the pressure in each chamber, and the frequency and duration of each treatment episode.

o Whether a segmented compressor without calibrated gradient pressure (E0651) or a non-segmented compressor (E0650) with a segmented appliance (E0671-E0673) had been tried and the results.

o Why the features of the device that was provided are needed for this patient.

o The name, model number, and manufacturer of the device.

• Questions pertaining to medical necessity on any form used to gather the above information may not be completed by the supplier or anyone in a financial relationship with the supplier.

o The information on the form must be supported by documentation in the patient's medical record and made available upon request.

• Refer to the Supplier Manual for more information on documentation requirements.