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medicare_and_compression_pumps

Medicare and Compression Pumps

Except for the Flexitouch Device and the BioCompression compression pump used with a ReidSleeve Optiflow insert, I am still opposed to the treatment of leg lymphedema by compression pumps. It has been safely used for arm lymphedema in conjunction with lymphedema decongestive physiotherapy,The below informatino does not constitute an endorsement of compression pump therapy. It is provided as a service and for patient information.

Pat O'Connor

June 22, 2008

Medicare Coverage for Pneumatic Compression Devices (280.6)

Coverage Topic

  • Durable Medical Equipment
  • Lymphedema Pumps

Item/Service Description

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

Indications and Limitations of Coverage

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

A - Lymphedema

Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. 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. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as surgical removal of lymph nodes or post radiation fibrosis, 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. The trial of conservative therapy must include 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.

B - 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. 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 6 month trial of conservative therapy directed by the treating physician. 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.

C - General Coverage Criteria

Pneumatic compression devices are covered only when prescribed by a physician and when they are used with appropriate physician oversight, i.e., physician evaluation of the patient's condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.

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

  • The patient's diagnosis and prognosis;
  • Symptoms and objective findings, including measurements which establish the severity of the condition;
  • The reason the device is required, including the treatments which have been tried and failed; and
  • 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, and ability of the patient (or caregiver) to apply the device for continued use in the home.

The only time that a segmented, calibrated gradient pneumatic compression device (HCPCs code E0652) would be covered is when the individual has unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a nonsegmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber.

Cross Reference

See the NCD on Durable Medical Equipment Reference List, §280.1.

Transmittal Number

151

Transmittal Link

Revision History

09/1986 - Added section to place lymphedema pumps and accompanying information together. Non-segmental pumps are already covered. Segmental lymphedema pumps, previously noncovered, are now covered as DME if necessary criteria are met. Effective date 09/19/1986. (TN 9)

06/1995 - Clarified that nonsegmented and segmented pump without manual control of pressure in each chamber is considered the least costly alternative that meets the clinical needs of the individual for this type of DME, unless there is documentation that warrants payment of the more costly manual control pump. Effective date NA. (TN 77)

10/1995 - Changed effective date for TN 77 from NA to 06/01/1995. Effective date 06/01/1995. (TN 81)

12/2001 - Clarified policy by dividing it into 2 separate parts based on indications and establishes different coverage criteria for the 2 different indications. Effective and implementation dates 01/14/2001. (TN 148 ) (CR 1944)

01/2002 - Clarified language previously found in TN 148 so that it is clear when segmented, calibrated gradient pneumatic compression devices will be covered. Effective and implementaiton dates 01/14/2002. ([TN 151 ) (CR 1944)

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Original consideration for Lymphedema Pumps (CAG-00016N)

Original consideration for Pneumatic Compression Pumps for Venous Insufficiency (CAG-00075N)

Publication Number

100-3

Manual Section Number

280.6

Version Number

1

Medicare Expedites Access to Lymphedema Pumps

Article date: 2001/06/14

Officials say Medicare will now pay for compression pumps to treat the sometimes painful breast cancer-related arm swelling known as lymphedema, without the previous requirement that the pump only be used as a “last resort.”

“It’s important to make effective technologies available to Medicare beneficiaries when it helps them the most,” says Tommy G. Thompson, Secretary of Health and Human Services, the federal department that oversees Medicare administration.

Lymphedema Is Due to Lymph Node Removal or Damage

Our bodies have a network of lymph nodes and lymph vessels that carry and remove lymph fluid, similar to the way blood vessels circulate blood throughout the body. The lymph fluid contains white blood cells, which help fight infections.

Lymphedema can occur in men or women, in the arms, legs, breast, neck, or head, depending on the location of the cancer being treated, but it most commonly results from treatment of breast cancer.

During surgery for breast cancer, the doctor usually removes some of the lymph nodes from the underarm area to see if the cancer has spread. Some lymph vessels intertwined with the lymph nodes may be removed also.

The removal of lymph nodes and vessels changes the way the lymph fluid flows within that part of the upper body, making it more difficult for fluid in the arm to be removed. This sometimes results in swelling, or lymphedema.

Radiation treatment can affect the flow of lymph fluid in the arm and breast area in the same way, putting the patient at increased risk for lymphedema.

No Cure, But Pumps Help Manage Symptoms

Lymphedema usually develops slowly over time. The swelling can range from mild to severe, and it can develop soon after treatment or many months or even years later. Patients who have many lymph nodes removed and radiation therapy may have a higher risk of developing lymphedema but unfortunately, it is impossible to predict who will develop the condition and who will not.

Although there is currently no cure for the condition, effective treatment for lymphedema can be prescribed by a doctor. It should be given by an experienced therapist or other health-care professional with special training, and may include skin care, massage, special bandaging, exercise, and use of compression either by a compression sleeve or pneumatic compression pump.

Experts Welcome Quicker Access to Pumps

Pneumatic (air pressure-driven) compression pumps have been the mainstay of lymphedema treatment for many years. They are used to remove excess lymph fluid from the arm and to reduce the formation of lymphedema. The pumps have been covered by Medicare since 1986, but until recently Medicare wouldn’t pay for the pumps until all other treatments were tried first, a process that could often take months or longer.

With the recent change, which took effect this May, Medicare requires only that a patient first have undergone four weeks of other therapy before using the pump. Those familiar with the problems lymphedema can cause welcome the change in policy.

“Lymphedema is a major quality of life issue for women with breast cancer — it can affect a woman’s daily life and her ability to do things she has done in the past,” says Terri Ades, RN, MS, AOCN, director of health content, nursing staff at the American Cancer Society (ACS).

“Women respond differently to various treatments and for some, lymphedema compression pumps may be the best treatment. If women have found other therapies ineffective, and need this treatment, they should not be required to wait to gain access to it,” she emphasizes.

“This new policy — offering easier access to treatment options that may benefit more people with lymphedema — is welcomed by the ACS,” concludes Ades.

CPT/HCPCS Codes

  • E0650-0652 Pneumatic Compressor and Appliances
  • 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
  • E0655-0673 Arm and Leg Appliances used with Pneumatic Compressor
  • E0660 Nonsegmental pneumatic appliance for use with compressor, full leg
  • E0665 Nonsegmental pneumatic appliance for use with compressor, full arm
  • E0666 Nonsegmental pneumatic appliance for use with 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
  • L0100-L4398 Orthotics

ICD-9 Codes that Support Medical Necessity

Not specified.

Diagnoses that Support Medical Necessity

Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity

Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

Not specified.

Coding guidelines:

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

A non-segmented pneumatic compressor (E0650) is a device which has a single outflow port on the compressor. The fact that the air from the single tube may be transmitted to a sleeve/appliance with multiple compartments or segments (E0671-E0673) does not affect the coding of the compressor.

A segmented pneumatic compressor (E0651, E0652) is a device which has multiple outflow ports on the compressor which lead to distinct segments on the appliance which inflate sequentially. A segmented device without calibrated gradient pressure (E0651) is one in which either (a) the same pressure is present in each segment or (b) there is a predetermined pressure gradient in successive segments but no ability to individually set or adjust pressures in each of several segments. In an E0651 device the pressure is usually set by a single control on the distal segment. A segmented device with calibrated gradient pressure (E0652) is characterized by a manual control on at least three outflow ports which can deliver an individually determined pressure to each segmental unit. The fact that the tubing and/or appliance is capable of achieving a pressure gradient does not classify the compressor as E0652 because this is not a calibrated gradient pressure.

Segmental gradient pressure pneumatic appliances (E0671-E0673) are appliances/sleeves which are used with a non-segmented pneumatic compressor (E0650) but which achieve a pressure gradient through the design of the tubing and/or air chambers.

A non-segmented pneumatic compressor (E0650) is used with appliances/sleeves coded by E0655-E0666 or E0671-E0673. Segmented pneumatic compressors (E0651 or E0652) are used with appliances/sleeves coded by E0667-E0669.

When a foot or hand segment is used in conjunction with a leg or arm appliance respectively, there should be no separate bill for this segment. It is considered included in the code for the leg or arm appliance.

Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.

Utilization Guidelines

Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Documentation 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” (42 U.S.C. section 13951(e)). It is expected that the patient's medical records will reflect the need for the care provided. 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. This documentation must be available to the DMERC 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 to the DMERC upon request. Items billed to the DMERC 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 to the DMERC on request. 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 HCFA Form 846. The initial claim must include a copy of the CMN.

If question #3 on the CMN (“Does the patient have chronic venous insufficiency with venous stasis ulcers?”) is answered “Yes”, documentation supporting the medical necessity for the device should include a signed and dated statement from the treating physician indicating:

1) The location and size of venous stasis ulcer(s),

2) How long each ulcer has been continuously present,

3) Whether the patient has been treated with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for the past 6 months,

4) Whether the patient has been seen regularly by a physician for treatment of venous stasis ulcer(s)during the past 6 months.

If E0652 is billed, additional documentation supporting the medical necessity for this device must include a signed and dated statement from the ordering physician indicating:

1) The treatment plan including the pressure in each chamber, and the frequency and duration of each treatment episode,

2) 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,

3) Why the features of the system that was provided are needed for this patient,

4) 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. The information on the form must be supported by documentation in the patient's medical record which would be available to the DMERC upon request. If this additional information is present, the claim will generally have to be filed hard copy.

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

External Medicare Links

Lymphedema People Related Links

Lymphedema People Resources

medicare_and_compression_pumps.txt · Last modified: 2012/10/16 14:40 (external edit)