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Clinical Policy Bulletin:
Lymphedema Treatments
Number: 0069


Policy

Complex Decongestive Physiotherapy:

Aetna considers a course of complex decongestive physiotherapy (CDP), also called manual lymphoid drainage, medically necessary when both of the following criteria are met:

  1. The member has any of the following conditions:

    1. Intractable lymphedema of the extremities, unrelieved by elevation; or
    2. One or more previous admissions to treat complications of intractable lymphedema (i.e., cellulitis, ulceration); or
    3. Evidence of ulceration due to lymphedema; and

  2. The member has shown a past record of compliance and the member or his/her caregiver is capable of following the instructions associated with CDP.

Lymphedema Pumps:

Aetna considers lymphedema pumps (pneumatic compression devices) medically necessary durable medical equipment (DME) for home use for the treatment of lymphedema if the member has undergone a four-week trial of conservative therapy and the treating doctor 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.

Note: For members without DME benefits, lymphedema pumps are only covered for members with arm lymphedema due to mastectomy for breast cancer who meet the criteria for a lymphedema pump stated above.*

When medical necessity criteria for a pneumatic compression device are met, a non-segmented device or segmented device without manual control of the pressure in each chamber is generally considered medically necessary to meet the clinical needs of the member.  A segmented device with manual control of the pressure in each chamber is considered medically necessary only if there is clear documentation of medical necessity in the individual case.  A segmented device with manual control of the pressure in each chamber is considered medically necessary only when there is 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.

A 2-phase lymph preparation and drainage therapy device (Flexitouch Device, Tactile Systems Technology, Minneapolis, MN) is considered equally effective to standard segmented pneumatic compression devices.  

For Aetna’s clinical policy on pneumatic compression devices for chronic venous insufficiency, see CPB 500 - Intermittent Pneumatic Compression Devices for the Legs.

Note: Although the literature suggests that the use of lymphedema pumps is commonly initiated in the hospital, there is no medical necessity for this practice unless the member has other complications of lymphedema (i.e., cellulitis) that would require hospitalization. The use of lymphedema pumps can be initiated in the clinic or in the home setting.

Static Compression Sleeves:

Aetna considers static compression sleeves (e.g., the ReidSleeve, ArmAssist) to be medically necessary supplies for members with intractable lymphedema of the arms. Note: For members whose plans exclude coverage of supplies, static compression sleeves are only covered for intractable lymphedema of the arms due to mastectomy for breast cancer.*  See also CPB 482 - Compression Garments for the Legs.

Static Compression Garments for the Trunk:

Aetna considers static compression garments for the trunk experimental and investigational. There is a lack of peer-reviewed published literature evaluating the clinical utility of static compression garments for truncal lymphedema

Microsurgical Lymphaticovenous Anastomosis:

Aetna considers microsurgical lymphaticovenous anastomosis experimental and investigational for the treatment of members with chronic obstructive lymphedema because the long-term effectiveness of this procedure has not been established by the peer-reviewed medical literature.

*Note: HR 4328 (Public Law 105-277) requires individual and employer group health plans (including indemnity, PPO, POS and HMOs), that provide medical and surgical benefits with respect to a mastectomy, to provide coverage for lymphedema treatment in a manner determined in consultation with the attending physician and the member for a participant or beneficiary who is receiving benefits for a mastectomy and who elects breast reconstruction after the mastectomy. Therapy is subject to annual deductibles and co-insurance provisions for physical therapy. Therapy is not subject to visit limitation provisions for physical therapy.



Background

Lymphedema refers to edema (i.e. swelling) due to inadequate lymphatic circulation related to either: (i) defective development of the lymphatics (primary lymphedema); or  (ii) destruction or obliteration of the lymphatic system (secondary lymphedema) due to either trauma, wounds, surgery, radiation therapy, or infection with a tropical filarial parasite.  Primary lymphedema typically involves the lower extremities and typically afflicts females.  When it arises at birth it is called lymphedema congenita, before the age of 35 it is called lymphedema praecox, and when arising later in life it is called lymphedema tarda.  Secondary lymphedema occurs most commonly after lymph node dissections.  For example, 10 to 20% of women with breast cancer who have undergone axillary dissection will experience lymphedema.  Leg edema can result after groin dissection, most typically for melanoma.  Lymphedema results in a feeling of heaviness, aching or tightness.  In severe cases, mobility can be impaired.  Development of angiosarcoma, know as the Stewart-Trewes syndrome, is a very rare complication of  long standing severe lymphedema.

The severity of lymphedema can be graded as follows:

Grade I: Mild and intermittent lymphedema which pits easily

Grade II: Moderate and persistent lymphedema, no pitting, unrelieved by elevation

Grade III: Fibrosclerotic lymphedema (elephantiasis)

Conservative treatment of lymphedema focuses on a combination of physical therapies: elevation of the arm or leg, manual physical therapy, wearing of various types of compression stockings/bandages, or pneumatic pumps.  

The use of elastic stockings is considered a valuable component of lymphedema therapy, and appears to be critical to the long term success of treatment.  Compliance with elastic stocking may be problematic since they are frequently hot, uncomfortable, and considered unsightly by some.  Lack of compliance may result in requests for further treatment, such as pneumatic pumps or complex decongestive physiotherapy.  However, elastic garments are a component of all treatments of lymphedema and compliance has a major impact on the success of any treatment of lymphedema.

Pneumatic pumps can consist either of static unicompartmental pumps where an equal amount of pressure is applied throughout the edematous limb, or a sequential pump which essentially attempts to “wring out” the edema by graded compression from distal to proximal.  Due to the short cycles of pressure, higher pressures can be applied compared to the static pumps.  Pressures higher than the systolic blood pressure are avoided; pressures up to 80 to 90 mm Hg are typical.  At this point sequential pumps (such as the Lymphapress or the Wright linear sequential pump) appear to be more commonly used than static pumps. The Lymphapress device is composed of a series of overlapping cells that apply a sequential pattern of compression moving distally to proximally along the affected limb.  Using this strategy, higher levels of pressure can be applied compared to other unicompartmental devices which apply the same degree of pressure along the entire limb. The Lymphapress device seems to be effective in acutely decreasing lymphedema, and many patients have purchased this device for home use.

The Flexitouch Device (Tactile Systems Technology, Minneapolis, MN) is a 2-phase lymph preparation and drainage therapy device. The device consists of an electronic controller unit and garments which are worn on the trunk and upper and lower affected extremities and connected to the controller unit by tubing harnesses. The garment consists of 32 inflatable chambers that sequentially inflate and deflate at 1 to 3 second intervals, according to one of the 13 pre-programmed treatment patterns selected.  Chamber pressure and treatment times can be adjusted.  The manufacturer states that device’s sequential action evacuates lymph from the trunk and extremities and drains it into the venous system.  The garments are made from stretch material and are fitted with Velcro enclosures, so custom fitting of garments is not required.  There are no published studies comparing the effectiveness of this 2-phase lymph preparation and drainage therapy device to standard segmented pneumatic compression devices.

Drug therapy with benzopyrone can also result in slow reduction of lymphedema. This drug is a protoeolytic agent which acts by activating macrophages, which then break down the protein-rich lymphedema fluid, thus decreasing its viscosity and thereby facilitating its flow.

A technique developed in Germany, complex decongestive physiotherapy (CDP), has been introduced in the United States.  CDP is most frequently offered in specialized clinics. Patients attend the clinics for about 4 hours a day for one to 4 weeks.  CDP consists of four basic components as follows:

  1. Meticulous skin and nail care. The protein rich lymphedema fluid is highly susceptible to infection which can then further damage the lymphatics resulting in a vicious cycle.  Thus meticulous skin and nail care is required.  Emollients are often used to prevent drying and cracking of the skin and all fungal infections must be treated promptly.
  2. Manual lymphatic drainage (MLD). This massage technique seems to be the unique component of this multidisciplinary approach and is based on the concept that the lymphatic system is subdivided into individual lymphotomes which communicate through collateral channels.  The idea behind MLD is to increase the collateral circulation between these lymphotomes, such that the lymphedema fluid can be shunted from an inadequately draining lymphotome into a normal one.  Thus, unlike other massage techniques, MLD begins with massage of the contralateral truncal lymphotome and then progresses toward the edematous extremity.  Theoretically, in this way the collateral circulation is opened and dilated and the lymphatic drainage is “decongested.”  There is no specific description of the technique of MLD, or theories as to how this technique can open and dilate collateral channels.Patients enrolled in the CDP clinic may undergo 1-2 such MLD sessions (about 45 minutes each) each day.
  3. Bandaging. After the MLD session, the lymphedematous limb is wrapped with a pure cotton, minimally elastic bandages in order to provide adequate tissue pressure which in turn prevents reaccumulation of lymphedema.
  4. Remedial Exercises. These exercises are performed while wearing the bandages, and thus the muscles contract against a firm external force, further stimulating lymph flow.

During the clinical sessions the patients receive additional counseling in various aspects of self management, such as skin care, nutrition, weight control, etc.  Prior to discharge from the clinic, the patient is fitted with an elastic support garment.  It is recommended that this garment be worn as much as possible, and even at night.  Some clinics may recommend wearing the bandages at night, and the compressive garment during the day.  The use of these garments can be gradually reduced as the patient improves, however, typically, the patient will need to continue wearing the compressive garment at least part time. An initial course of CDP may require 30 days, or in the case of lower extremity care, 45 days.

No conservative treatment is entirely curative and all require a committed physical therapy team and a committed and compliant patient.

Surgery has been used in patients with severe lymphedema.  Excisional surgical procedures involve resection of the redundant tissue that may develop in long-standing severe lymphedema and elephantiasis.

Physiologic surgical procedures attempt to provide or enhance lymphatic drainage with either anastomoses between lymphatic systems (i.e. linking subcutaneous tissues with the deep lymphatics), creating lymphovenous anastomoses or creation of artificial lymph channels.  These surgical techniques are controversial and rarely used.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
97016
97140
CPT codes not covered for indications listed in the CPB:
38308
HCPCS codes covered if selection criteria are met:
E0650 Pneumatic compressor; non-segmental home model
E0651     segmental home model without calibrated gradient pressure
E0652     segmental home model with calibrated gradient pressure
E0655 Non-segmental pneumatic appliance for use with pneumatic compressor; half arm
E0660     full leg
E0665     full arm
E0666     half leg
E0667 Segmental pneumatic appliance for use with pneumatic compressor; full leg
E0668     full arm
E0669     half leg
E0671 Segmental gradient pressure pneumatic appliance, full leg
E0672     full arm
E0673     half leg
E0676 Intermittent limb compression device (includes all accessories), not otherwise specified
S8950 Complex lymphedema therapy, each 15 minutes
Other HCPCS codes related to the CPB:
A6530 - A6549 Gradient compression stockings
S8420 - S8428 Gradient pressure aids (sleeves, gloves, gauntlets)
ICD-9 codes covered if selection criteria are met:
174.0 - 175.9 Malignant neoplasm of breast [with intractable lymphedema]
451.0 - 451.2 Phlebitis and thrombophlebitis of superficial or deep vessels of lower extremities [with intractable lymphedema]
451.81 Phlebitis and thrombophlebitis of iliac vein [with intractable lymphedema]
453.8 Other venous embolism and thrombosis of other specified veins [with intractable lymphedema]
454.0 Varicose veins of lower extremities, with ulcer [with intractable lymphedema]
454.2 Varicose veins of lower extremities, with ulcer and inflammation [with intractable lymphedema]
457.0 Postmastectomy lymphedema syndrome
457.1, 457.2, 457.8 Other lymphedema, lymphangitis, and other noninfectious disorders of lymphatic channels [intractable lymphedema]
459.10 - 459.19 Postphlebitic syndrome [with intractable lymphedema]
459.30 - 459.31 Chronic venous hypertension without complication or with ulcer [with intractable lymphedema]
459.33 Chronic venous hypertension with ulcer and inflammation [with intractable lymphedema]
459.81 Venous (peripheral) insufficiency, unspecified [with intractable lymphedema]
707.0 - 707.19 Chronic ulcer of skin [due to or complication of intractable lymphedema]
757.0 Hereditary edema of legs
782.3 Edema [intractable lymphedema of extremities, unrelieved by elevation]
V10.3 Personal history of malignant neoplasm of breast [with intractable lymphedema]
V45.71 Acquired absence of breast [with intractable lymphedema]
Other ICD-9 codes related to the CPB:
681.00 - 682.9 Cellulitis and abscess
997.99 Other complications affecting other specified body systems, not elsewhere classified


The above policy is based on the following references:
  1. Lerner R. Complete decongestive physiotherapy and the Lerner Lymphedema Services Academy of Lymphatic Studies (the Lerner School). Cancer. 1998;83(12 Suppl American):2861-2863.
  2. Casley-Smith JR, Boris M, Weindorf S, Lasinski B. Treatment for lymphedema of the arm--the Casley-Smith method: A noninvasive method produces continued reduction. Cancer. 1998;83(12 Suppl American):2843-2860.
  3. Brennan MJ, Miller LT. Overview of treatment options and review of the current role and use of compression garments, intermittent pumps, and exercise in the management of lymphedema. Cancer. 1998;83(12 Suppl American):2821-2827.
  4. Szuba A, Rockson SG. Lymphedema: Classification, diagnosis and therapy. Vasc Med. 1998;3(2):145-156.
  5. Rinehart-Ayres, ME. Conservative approaches to lymphedema treatment. Cancer. 1998;83(12 Suppl American):2828-2832.
  6. Megens A, Harris SR. Physical therapist management of lymphedema following treatment for breast cancer: A critical review of its effectiveness. Phys Ther. 1998;78(12):1302-1311.
  7. Meek AG. Breast radiotherapy and lymphedema. Cancer. 1998;83(12 Suppl American):2788-2797.
  8. Tunkel RS, Lachmann E. Lymphedema of the limb. An overview of treatment options. Postgrad Med. 1998;104(4):131-134, 137-138, 141 passim.
  9. Daane S, Poltoratszy P, Rockwell WB. Postmastectomy lymphedema management: Evolution of the complex decongestive therapy technique. Ann Plast Surg. 1998;40(2):128-134.
  10. Rockson SG, Miller LT, Senie R, et al. American Cancer Society Lymphedema Workshop. Workgroup III: Diagnosis and management of lymphedema. Cancer. 1998;83(12 Suppl American):2882-2885.
  11. Ko DS, Lerner R, Klose G, Cosimi AB. Effective treatment of lymphedema of the extremities. Arch Surg. 1998;133(4):452-458.
  12. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology Executive Committee. Lymphology. 1995;28(3):113-117.
  13. Boris M, Weindrof S, Lasinski B. Lymphedema reduction by noninvasive complex lymphedema therapy. Oncology. 1994;8(9):95-106, discussion 109-110.
  14. Casley-Smith JR, Casley-Smith JR. Modern treatment of lymphoedema. I. Complete physical therapy: The first 200 Australian limbs. Australas J Dermatol. 1992;33(2):61-68.
  15. Pappas CJ, O'Donnell TF. Long-term results of compression treatment for lymphedema. J Vasc Surg. 1992;16(4):555-562, discussion 562-564.
  16. Gloviczki P. Principles of surgical treatment of chronic lymphedema. Int Angiol. 1999;18(1):42-46.
  17. Petrek JA, Pressman PI, Smith RA. Lymphedema: Current issues in research and management. CA Cancer J Clin. 2000;50(5):292-311.
  18. Szuba A, Cooke JP, Yousuf S, Rockson SG. Decongestive lymphatic therapy for patients with cancer-related or primary lymphedema. Am J Med. 2000;109(4):296-300.
  19. Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405.
  20. Women's Health and Cancer Rights Act of 1998. Pub. L. No. 105-277. October 21, 1998.  Available at: http://www.hcfa.gov/medicaid/hipaa/content/whcra.pdf. Accessed August 6, 2001.
  21. Trinity Lymphedema Centers. ArmAssist Non-Elastic Adjustable Limb Containment System [website]. Tampa, FL: Trinity Lymphedema Centers; 2002. Available at: http://www.trinitylc.com/cmpgarm1.html. Accessed April 26, 2002.
  22. TriCenturion, LLC. Pneumatic compression devices (used for lymphedema). Policy No. LYPH20021201. Medicare Local Medical Review Policy. DMERC Region A. Columbia, SC: TriCenturion; April 1, 2002.
  23. Tiwari A, Cheng KS, Button M, et al. Differential diagnosis, investigation, and current treatment of lower limb lymphedema. Arch Surg. 2003;138(2):152-161.
  24. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003;36(2):84-91.
  25. Kligman L, Wong RK, Johnston M, Laetsch NS. The treatment of lymphedema related to breast cancer: A systematic review and evidence summary. Support Care Cancer. 2004;12(6):421-431.
  26. Swedish Council on Technology Assessment in Health Care (SBU). Manual lymph drainage combined with compression therapy for arm lymphedema following breast cancer treatment (Alert). SBU Alert Report No: 2005-04. Stockholm, Sweden: SBU; 2005.
  27. Tactile Systems Technology. Flexitouch Device. Physician Information [website].  Minneapolis, MN: Tactile Systems; 2005. Available at: http://www.tactilesystems.com/html/professionals.html. Accessed November 4, 2005.
  28. Medical Services Advisory Committee (MSAC). Review of current practices and future directions in the diagnosis, prevention and treatment of lymphoedema in Australia. Report to the Australian Health Ministers' Advisory Council. Canberra, ACT: MSAC; February 2004. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/completed-assessments-lp-1. Accessed January 26, 2007.
  29. Badger C, Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev. 2004;(4):CD003141.
  30. BC Kansas. Complex decongestive physiotherapy (CDP) for lymphedema. Medicare Part B Local Medical Review Policy. 200402PP. Topeka, KS: BC Kansas; effective February 1 2005. Available at: http://www.kansasmedicare.com/part_B/LMRP/policies/ComplexDecongestive
    PhysiotherapyCDPforLymphedema.htm
    . Accessed January 10, 2008.
  31. Anttila H, Kärki A, Rautakorpi U, et al. Lymphoedema therapy in breast cancer patients. Effectiveness, current practice and costs [abstract]. FinOHTA Report 30/2007. Helsinki, Finland: Finnish Office for Health Care Technology Assessment (FinOHTA) / National Research and Develompment Centre for Welfare and Health STAKES; September 2007.
  32. Moseley AL, Carati CJ, Piller NB.  A systematic review of common conservative therapies for arm lymphoedema secondary to breast cancer treatment. Ann Oncol. 2007;18(4):639-646.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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