Clinical Medical Policy Department Clinical Affairs Division DESCRIPTION

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1 Pneumatic Compression Devices for Lymphedema Treatment [For the list of services and procedures that need preauthorization, please refer to go to Comunicados a Proveedores, and click Cartas Circulares.] Medical Policy: MP-DME Original Effective Date: February 5, 2009 Revised: December 13, 2016 Next Revision: August, 2017 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. 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. 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 excessive production of lymph. It is divided into two broad classes according to etiology: 1) Defective development of the lymphatic system (primary lymphedema) a relatively uncommon, chronic condition which may be due to Milroy s Disease i or congenital anomalies; and 2) Secondary lymphedema, which is much more common. It results from the destruction or damage to formerly functioning lymphatic channels, such as radical surgical procedures with removal or regional groups of lymph nodes (for example, after radical mastectomy), postradiation fibrosis, and spreading of malignant tumors to regional lymph nodes with lymphatic obstruction, among other causes. 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. Lymphedema Sleeves - Compression garments or sleeves have been widely used in the treatment of lymphedema. They are used alone or in conjunction with other treatments, including lymphedema pumps and complex decongestive treatment (CDT). They are used for the purpose of preventing an increase in lymphedema and maintaining the reduction of lymphedema after treatment. 1

2 They are custom fitted or prefabricated and have varying degrees of elasticity. The type of sleeve used is dependent on the size needed and whether the patient correctly fits the parameters of the prefabricated garment. The sleeve will usually need replacement when elasticity is lost, approximately every 4-6 months. Lymphedema Pumps - Pneumatic compression pumps have been used as a treatment for lymphedema. Pumps may be classified as single chambered, multi chambered with fixed sequential inflation, or multi chambered with sequential inflation and manually calibrated gradient chamber pressure. Established conservative medical treatments include the use of bandaging and compression garments, limb elevation, and home exercise programs. Segmental pumps that have a calibrated pressure feature are typically used only in patients who require limited pressure to be applied to a specific area (e.g., significant scars or the presence of contracture or pain caused by the clinical condition). Types of Lymphedema Pumps Lymphedema pumps include, but are not limited to the following: Non-segmented pneumatic compressor. Segmented pneumatic compressor; this device has multiple outflow ports on the compressor that lead to distinct segments on the appliance, which inflates in a sequential manner. A segmented device without calibrated pressure 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 not the ability to individually set or c. Adjust pressures in each of the several segments. The pressure is usually set by a single control on the distal segment. d. A segmented device with calibrated gradient pressure is characterized by a manual control on at least three outflow ports than can deliver individually determined pressure to each segmental unit. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits, and coverage. CONDITIONS FOR COVERAGE Pneumatic compression devices will be covered ONLY when: 1. They are ordered, and supervised by a physician (a medical doctor (MD), an osteopathic physician (DO), or a doctor of podiatric (DPM)) or a physician extenders (Nurse Practitioner (NP), A physician assistant (PA), or A clinical nurse specialist (CNS)) when are used with appropriate physician oversight, i.e., physician evaluation of the beneficiary's condition to 2

3 determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used, the frequency and duration of use, and ongoing monitoring of use and response to treatment. 2. Pneumatic compression devices are ONLY covered for the treatment of lymphedema or for the treatment of chronic venous insufficiency with venous stasis ulcers. If the coverage criteria below are not met the devices will be denied as not medically necessary. 3. For Pneumatic compression devices in this policy to be covered, a written order prior to delivery (WOPD) is required. INDICATIONS, (MCS) will consider medically necessary the use of Pneumatic Compression Devices when ONE of the following conditions is met: I. Pneumatic Compression devices are covered in the home setting for the treatment of Lymphedema when: 1. The member has a diagnosis of lymphedema, AND 2. The member has persistence of chronic and severe lymphedema as identified by the documented presence of at least one of the following clinical findings: a. Marked hyperkeratosis with hyperplasia and hyperpigmentation b. Papillomatosis cutis lymphostatica, c. Deformity of elephantiasis, d. Skin breakdown with persisting lymphorrhea, e. Detailed measurements over time confirming the persistence of the lymphedema with a history evidencing a likely etiology. 3. The member 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 four-week trial of conservative therapy must include use of an appropriate: a. Compression bandage system or compression garment (The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with the Minimum of 30 mm Hg distally). b. Regular exercise c. Elevation of the limb 3

4 II. Pneumatic Compression Devices are covered in the home setting for the treatment of Chronic Venous Insufficiency with Venous Stasis Ulcers (CVI) of the lower extremities only if the patient has all of the following: 1. Edema in the affected lower extremity 2. One or more venous stasis ulcer(s) 3. The ulcer(s) have failed to heal after a six-month trial of conservative therapy directed by the treating physician. A six-month trial of conservative therapy demonstrating failed response to treatment is required. The six-month trial of conservative therapy must include all of the following: a. Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compression. Adequate compression is defined as (1) sufficient pressure at the lowest pressure point to cause fluid movement and (2) sufficient pressure across the gradient (from highest to lowest pressure point) to move fluid from distal to proximal. The compression used must not create a tourniquet effect at any point. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with a minimum of 30 mmhg distally b. Medications as appropriate (e.g. diuretics and/or other treatment of congestive failure, etc.) c. Regular exercise d. Elevation of the limb e. Appropriate wound care for the ulcer (including sharp debridement where appropriate) III. Pneumatic Compression Devices are covered in the home setting for the treatment of lymphedema extending onto the chest, trunk and/or abdomen when: 1. 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. a. The beneficiary has Lymphedema of an extremity as defined above. 4

5 b. The Coverage criteria in Section I or Section II are met. c. The member 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. Four-Week Trial for Lymphedema Extending onto the Chest, Trunk and/or Abdomen must include all the following: a. At least four weeks of regular, daily, multiple-hour home usage of the Pneumatic Compression Devices (the E0650 or E0651) after careful, in person fitting, training and supervision by a technician who is skilled in and who regularly and successfully uses the appliance provided. b. Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compression (The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression starting with a minimum of 30 mmhg distally). c. Regular exercise and Elevation where appropriate. d. Manual lymphatic drainage (where available) and self-manual lymphatic drainage (MLD) for at least 30 minutes per day. e. Evaluation of diet and implementation of any necessary change. f. Medications as appropriate (e.g. diuretics and/or other treatment of congestive failure, etc.) g. Correction (where possible) of anemia and/or hypoprotenemia. CONTRAINDICATIONS 1. Relative contraindications to pneumatic compression are significant arterial insufficiency, edema from congestive heart failure, active phlebitis, deep vein thrombosis, and the presence of localized wound infection or cellulitis. LIMITATIONS/EXCLUSION 1. Peripheral artery disease - A Pneumatic Compression Device coded as E0675 to treat peripheral artery disease is not eligible for reimbursement. There is insufficient evidence to demonstrate that reimbursement is justified. Claims for E0675 will be denied as not reasonable and necessary. 5

6 2. Deep venous thrombosis prevention - A Pneumatic Compression Device coded as E0676 will be only used for prevention of venous thrombosis. CODING INFORMATION CPT Codes (List may not be all inclusive) CPT Codes DESCRIPTION Application of A Modality To 1 Tor More Areas; Vasopneumatic Devices Current Procedural Terminology (CPT ) 2016 American Medical Association: Chicago, IL. HCPCS CODES (List may not be all inclusive) HCPCS CODES E0650 E0651 E0652 E0655 E0656 E0657 E0660 E0665 E0666 E0667 E0668 E0669 E0670 E0671 E0672 E0673 E0675 E0676 DESCRIPTION Pneumatic Compressor, Non-Segmental Home Model Pneumatic Compressor, Segmental Home Model Without Calibrated Gradient Pressure Pneumatic Compressor, Segmental Home Model With Calibrated Gradient Pressure Non-Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Half Arm Segmental Pneumatic appliance for use with pneumatic compressor, trunk Segmental Pneumatic appliance for use with Pneumatic compressor, chest Non-Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Full Leg Non-Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Full Arm Non-Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Half Leg Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Full Leg Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Full Arm Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Half Leg Segmental pneumatic appliance for use with pneumatic compressor, integrated, 2 full legs and trunk Segmental Gradient Pressure Pneumatic Appliance, Full Leg Segmental Gradient Pressure Pneumatic Appliance, Full Arm Segmental Gradient Pressure Pneumatic Appliance, Half Leg Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system) Intermittent limb compression device (includes all accessories), not otherwise specified 2016 HCPCS LEVEL II Professional Edition (American Medical Association). HCPCS MODIFIER: EY - No physician or other licensed health care provider order for this item or service. NOTES FOR COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY: 6

7 NOTE 1 : LYMPHEDEMA: 1. PCD coded as E0650 or E0651 is covered for both primary and secondary lymphedema in beneficiaries with chronic and severe lymphedema when all of the requirements described in Section I are met. 2. A PCD coded as E0650 or E0651 used to treat lymphedema that does not meet all of the requirements above in Section I is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. 3. A PCD coded as E0650 or E0651 used to treat edema from causes other than lymphedema is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. 4. A PCD coded as E0652 is not covered for the treatment of lymphedema of the extremities alone even if the criteria in this section are met. Claims will be denied as not reasonable and necessary. Refer to the section III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN and PCD Code Selection for additional information about the limited coverage for PCD coded as E0652. NOTE 2 : CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS (CVI): 1. A PCD coded as E0650 or E0651 is covered for the treatment of CVI of the lower extremities only if the patient has all the conditions Specified in the Section II of this policy. 2. A PCD coded as E0650 or E0651 used to treat CVI that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. 3. A PCD coded as E0650 or E0651 used to treat ulcers in locations other than the lower extremity or ulcers and wounds from other causes is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. 4. A PCD coded as E0652 is not covered for the treatment of CVI even if the criteria in this section are met. Claims will be denied as not reasonable and necessary. Refer below to the sections III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN and PCD Code Selection for additional information about the limited coverage for PCD coded as E0652. NOTE 3 : LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN: 1. A PCD coded as E0652 used to treat lymphedema extending onto the chest, trunk and/or abdomen that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. 7

8 2. A PCD coded as E0652 used to treat lymphedema not extending onto the chest, trunk and/or abdomen or CVI is not eligible for reimbursement. Claims will be denied as not reasonable and necessary. NOTE 4 : Accessories 1. PCD related accessories (E0655-E0673) are eligible for reimbursement only when the appropriate, related base PCDs (E E0651, E0675) meets the applicable coverage criteria for that type of PCD. If the base PCD is not covered, related accessories are not eligible for reimbursement. Claims for related items will be denied as not reasonable and necessary. NOTE 5 : Pneumatic compression device PCD code selection (E E0652, E0675, and E0676): 1. A pneumatic Compression Device coded as E0650 or E0651 is used for lymphedema or CVI. An E0650 compressor with a segmented appliance/sleeve (E E0673) is considered functionally equivalent to an E0651 compressor with a segmented appliance/sleeve (E E0669). 2. A PCD coded as E0652 has limited coverage. The NCD for Pneumatic Compression Devices (IOM , 280.6) provides: "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 no segmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber." The only unique characteristics identified in the clinical literature that requires the use of an E0652 device is lymphedema extending onto the chest, trunk and/or abdomen which has remained unresponsive to all other therapies. 3. A PCD coded as E0675 is used only for peripheral artery disease. Other PCD codes are not used for this condition. 4. A PCD coded as E0676 is used only for prevention of venous thrombosis. Item that are used for a preventive service or function are excluded from coverage under the Medicare DME benefit. ICD-10 Codes (List may not be all inclusive) ICD -10 Codes DESCRIPTION I Atherosclerosis of native arteries of right leg with ulceration of thigh I Atherosclerosis of native arteries of right leg with ulceration of calf I Atherosclerosis of native arteries of right leg with ulceration of ankle I Atherosclerosis of native arteries of right leg with ulceration of heel and midfoot I Atherosclerosis of native arteries of right leg with ulceration of other part of foot 8

9 I Atherosclerosis of native arteries of right leg with ulceration of other part of lower right leg I Atherosclerosis of native arteries of right leg with ulceration of unspecified site I Atherosclerosis of native arteries of left leg with ulceration of thigh I Atherosclerosis of native arteries of left leg with ulceration of calf I Atherosclerosis of native arteries of left leg with ulceration of ankle I Atherosclerosis of native arteries of left leg with ulceration of heel and midfoot I Atherosclerosis of native arteries of left leg with ulceration of other part of foot I Atherosclerosis of native arteries of left leg with ulceration of other part of lower left leg I Atherosclerosis of native arteries of left leg with ulceration of unspecified site I Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of thigh I Atherosclerosis of unspecified type of bypass graft (s) of the right leg with ulceration of calf I Atherosclerosis of unspecified type of bypass graft (s) of the right leg with ulceration of ankle I Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of heel and midfoot I Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of other part of foot I Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of other part of lower leg I Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of unspecified site I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of thigh I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of calf I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of ankle I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of heel and midfoot I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of other part of foot I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of other part of lower leg I Atherosclerosis of unspecified type of bypass graft(s) of the left leg with ulceration of unspecified site I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of thigh I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of calf 9

10 I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of ankle I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of heel and midfoot I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of other part of foot I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of other part of lower leg I Atherosclerosis of autologous vein bypass graft(s) of the right leg with ulceration of unspecified site I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of thigh I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of calf I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of ankle I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of heel and midfoot I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of other part of foot I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of other part of lower leg I Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration of unspecified site I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of thigh I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of calf I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of ankle I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of heel and midfoot I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of other part of foot I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of other part of lower leg I Atherosclerosis of non-autologous biological bypass graft(s) of the right leg with ulceration of unspecified site I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of thigh I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of calf I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of ankle 10

11 I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of heel and midfoot I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of other part of foot I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of other part of lower leg I Atherosclerosis of non-autologous biological bypass graft(s) of the left leg with ulceration of unspecified site I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of thigh I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of calf I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of ankle I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of heel and midfoot I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of other part of foot I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of other part of lower leg I Atherosclerosis of non-biological bypass graft(s) of the right leg with ulceration of unspecified sit e I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of thigh I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of calf I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of ankle I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of heel and midfoot I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of other part of foot I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of other part of lower leg I Atherosclerosis of non-biological bypass graft(s) of the left leg with ulceration of unspecified site I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of thigh I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of calf I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of ankle I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of heel and midfoot I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of 11

12 other part of foot I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of other part of lower leg I Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of unspecified site I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of thigh I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of calf I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of ankle I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of heel and midfoot I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of other part of foot I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of other part of lower leg I Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of unspecified site I Acute embolism and thrombosis of superior vena cava I Acute embolism and thrombosis of other thoracic veins I Acute embolism and thrombosis of unspecified veins of right upper extremity I Acute embolism and thrombosis of unspecified veins of left upper extremity I Acute embolism and thrombosis of unspecified veins of upper extremity, bilateral I Acute embolism and thrombosis of unspecified veins of unspecified upper extremity I Acute embolism and thrombosis of superficial veins of right upper extremity I Acute embolism and thrombosis of superficial veins of left upper extremity I Acute embolism and thrombosis of superficial veins of upper extremity, bilateral I Acute embolism and thrombosis of superficial veins of unspecified upper extremity I Acute embolism and thrombosis of deep veins of right upper extremity I Acute embolism and thrombosis of deep veins of left upper extremity I Acute embolism and thrombosis of deep veins of upper extremity, bilateral I Acute embolism and thrombosis of deep veins of unspecified upper extremity I Acute embolism and thrombosis of other specified veins I82.90 Acute embolism and thrombosis of unspecified vein I82.91 Chronic embolism and thrombosis of unspecified vein I82.A11 I82.A12 I82.A13 I82.A19 Acute embolism and thrombosis of right axillary vein Acute embolism and thrombosis of left axillary vein Acute embolism and thrombosis of axillary vein, bi lateral Acute embolism and thrombosis of unspecified axillary vein 12

13 I82.B11 I82.B12 I82.B13 I82.B19 I82.C11 I82.C12 I82.C13 I82.C19 Acute embolism and thrombosis of right subclavian vein Acute embolism and thrombosis of left subclavian vein Acute embolism and thrombosis of subclavian vein, bilateral Acute embolism and thrombosis of unspecified subclavian vein Acute embolism and thrombosis of right internal jugular vein Acute embolism and thrombosis of left internal jugular vein Acute embolism and thrombosis of internal jugular vein, bilateral Acute embolism and thrombosis of unspecified internal jugular vein I Varicose veins of unspecified lower extremity with ulcer of thigh I Varicose veins of unspecified lower extremity with ulcer of calf I Varicose veins of unspecified lower extremity with ulcer of ankle I Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I Varicose veins of unspecified lower extremity with ulcer other part of foot I Varicose veins of unspecified lower extremity with ulcer other part of lower leg I Varicose veins of unspecified lower extremity with ulcer of unspecified site I Varicose veins of right lower extremity with ulcer of thigh I Varicose veins of right lower extremity with ulcer of calf I Varicose veins of right lower extremity with ulcer of ankle I Varicose veins of right lower extremity with ulcer of heel and midfoot I Varicose veins of right lower extremity with ulcer other part of foot I Varicose veins of right lower extremity with ulcer other part of lower leg I Varicose veins of right lower extremity with ulcer of unspecified site I Varicose veins of left lower extremity with ulcer of thigh I Varicose veins of left lower extremity with ulcer of calf I Varicose veins of left lower extremity with ulcer of ankle I Varicose veins of left lower extremity with ulcer of heel and midfoot I Varicose veins of left lower extremity with ulcer other part of foot I Varicose veins of left lower extremity with ulcer other part of lower leg I Varicose veins of left lower extremity with ulcer of unspecified site I83.10 Varicose veins of unspecified lower extremity with inflammation I83.11 Varicose veins of right lower extremity with inflammation I83.12 Varicose veins of left lower extremity with inflammation I Varicose veins of unspecified lower extremity with both ulcer of thigh and inflammation I Varicose veins of unspecified lower extremity with both ulcer of calf and inflammation I Varicose veins of unspecified lower extremity with both ulcer of ankle and inflammation 13

14 I Varicose veins of unspecified lower extremity with both ulcer of heel and midfoot and inflammation I Varicose veins of unspecified lower extremity with both ulcer other part of foot and inflammation I Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and inflammation I Varicose veins of unspecified lower extremity with both ulcer of unspecified site and inflammation I Varicose veins of right lower extremity with both ulcer of thigh and inflammation I Varicose veins of right lower extremity with both ulcer of calf and inflammation I Varicose veins of right lower extremity with both ulcer of ankle and inflammation I Varicose veins of right lower extremity with both ulcer of heel and midfoot and inflammation I Varicose veins of right lower extremity with both ulcer other part of foot and inflammation I Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation I Varicose veins of right lower extremity with both ulcer of unspecified site and inflammation I Varicose veins of left lower extremity with both ulcer of thigh and inflammation I Varicose veins of left lower extremity with both ulcer of calf and inflammation I Varicose veins of left lower extremity with both ulcer of ankle and inflammation I Varicose veins of left lower extremity with both ulcer of heel and midfoot and inflammation I Varicose veins of left lower extremity with both ulcer other part of foot and inflammation I Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation I Varicose veins of left lower extremity with both ulcer of unspecified site and inflammation I Post thrombotic syndrome with ulcer of right lower extremity I Post thrombotic syndrome with ulcer of left lower extremity I Post thrombotic syndrome with ulcer of bilateral lower extremity I Post thrombotic syndrome with ulcer of unspecified lower extremity I Post thrombotic syndrome with ulcer and inflammation of right lower extremity I Post thrombotic syndrome with ulcer and inflammation of left lower extremity I Post thrombotic syndrome with ulcer and inflammation of bilateral lower extremity I Post thrombotic syndrome with ulcer and inflammation of unspecified lower extremity I Post thrombotic syndrome with other complications of right lower extremity I Post thrombotic syndrome with other complications of left lower extremity I Post thrombotic syndrome with other complications of bilateral lower extremity 14

15 I Post thrombotic syndrome with other complications of unspecified lower extremity I Chronic venous hypertension (idiopathic) with ulcer of right lower extremity I Chronic venous hypertension (idiopathic) with ulcer of left lower extremity I Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity I Chronic venous hypertension (idiopathic) with ulcer of unspecified lower extremity I Chronic venous hypertension (idiopathic) with inflammation of right lower extremity I Chronic venous hypertension (idiopathic) with inflammation of left lower extremity I Chronic venous hypertension (idiopathic) with inflammation of bilateral lower extremity I Chronic venous hypertension (idiopathic) with inflammation of unspecified lower extremity I Chronic venous hypertension (idiopathic) with ulcer and inflammation of right lower extremity I Chronic venous hypertension (idiopathic) with ulcer and inflammation of left lower extremity I Chronic venous hypertension (idiopathic) with ulcer and inflammation of bilateral lower extremity I Chronic venous hypertension (idiopathic) with ulcer and inflammation of unspecified lower extremity L Non-pressure chronic ulcer of unspecified thigh limited to breakdown of skin L Non-pressure chronic ulcer of unspecified thigh with fat layer exposed L Non-pressure chronic ulcer of unspecified thigh with necrosis of muscle L Non-pressure chronic ulcer of unspecified thigh with necrosis of bone L Non-pressure chronic ulcer of unspecified thigh with unspecified severity L Non-pressure chronic ulcer of right thigh limited to breakdown of skin L Non-pressure chronic ulcer of right thigh with fat layer exposed L Non-pressure chronic ulcer of right thigh with necrosis of muscle L Non-pressure chronic ulcer of right thigh with necrosis of bone L Non-pressure chronic ulcer of right thigh with unspecified severity L Non-pressure chronic ulcer of left thigh limited to breakdown of skin L Non-pressure chronic ulcer of left thigh with fat layer exposed L Non-pressure chronic ulcer of left thigh with necrosis of muscle L Non-pressure chronic ulcer of left thigh with necrosis of bone L Non-pressure chronic ulcer of left thigh with unspecified severity L Non-pressure chronic ulcer of unspecified calf limited to breakdown of skin L Non-pressure chronic ulcer of unspecified calf with fat layer exposed L Non-pressure chronic ulcer of unspecified calf with necrosis of muscle L Non-pressure chronic ulcer of unspecified calf with necrosis of bone L Non-pressure chronic ulcer of unspecified calf with unspecified severity 15

16 L Non-pressure chronic ulcer of right calf limited to breakdown of skin L Non-pressure chronic ulcer of right calf with fat layer exposed L Non-pressure chronic ulcer of right calf with necrosis of muscle L Non-pressure chronic ulcer of right calf with necrosis of bone L Non-pressure chronic ulcer of right calf with unspecified severity L Non-pressure chronic ulcer of left calf limited to breakdown of skin L Non-pressure chronic ulcer of left calf with fat layer exposed L Non-pressure chronic ulcer of left calf with necrosis of muscle L Non-pressure chronic ulcer of left calf with necrosis of bone L Non-pressure chronic ulcer of left calf with unspecified severity L Non-pressure chronic ulcer of unspecified ankle limited to breakdown of skin L Non-pressure chronic ulcer of unspecified ankle with fat layer exposed L Non-pressure chronic ulcer of unspecified ankle with necrosis of muscle L Non-pressure chronic ulcer of unspecified ankle with necrosis of bone L Non-pressure chronic ulcer of unspecified ankle with unspecified severity L Non-pressure chronic ulcer of right ankle limited to breakdown of skin L Non-pressure chronic ulcer of right ankle with fat layer exposed L Non-pressure chronic ulcer of right ankle with necrosis of muscle L Non-pressure chronic ulcer of right ankle with necrosis of bone L Non-pressure chronic ulcer of right ankle with unspecified severity L Non-pressure chronic ulcer of left ankle limited to breakdown of skin L Non-pressure chronic ulcer of left ankle with fat layer exposed L Non-pressure chronic ulcer of left ankle with necrosis of muscle L Non-pressure chronic ulcer of left ankle with necrosis of bone L Non-pressure chronic ulcer of left ankle with unspecified severity L Non-pressure chronic ulcer of unspecified heel and midcourt limited to breakdown of skin L Non-pressure chronic ulcer of unspecified heel and midfoot with fat layer exposed L Non-pressure chronic ulcer of unspecified heel and midfoot with necrosis of muscle L Non-pressure chronic ulcer of unspecified heel and midfoot with necrosis of bone L Non-pressure chronic ulcer of unspecified heel and midfoot with unspecified severity L Non-pressure chronic ulcer of right heel and midfoot limited to breakdown of skin L Non-pressure chronic ulcer of right heel and midfoot with fat layer exposed L Non-pressure chronic ulcer of right heel and midfoot with necrosis of muscle L Non-pressure chronic ulcer of right heel and midfoot with necrosis of bone L Non-pressure chronic ulcer of right heel and midfoot with unspecified severity L Non-pressure chronic ulcer of left heel and midfoot limited to breakdown of skin 16

17 L Non-pressure chronic ulcer of left heel and midfoot with fat layer exposed L Non-pressure chronic ulcer of left heel and midfoot with necrosis of muscle L Non-pressure chronic ulcer of left heel and midfoot with necrosis of bone L Non-pressure chronic ulcer of left heel and midfoot with unspecified severity L Non-pressure chronic ulcer of other part of unspecified foot limited to breakdown of skin L Non-pressure chronic ulcer of other part of unspecified foot with fat layer exposed L Non-pressure chronic ulcer of other part of unspecified foot with necrosis of muscle L Non-pressure chronic ulcer of other part of unspecified foot with necrosis of bone L Non-pressure chronic ulcer of other part of unspecified foot with unspecified severity L Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin L Non-pressure chronic ulcer of other part of right foot with fat layer exposed L Non-pressure chronic ulcer of other part of right foot with necrosis of muscle L Non-pressure chronic ulcer of other part of right foot with necrosis of bone L Non-pressure chronic ulcer of other part of right foot with unspecified severity L Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin L Non-pressure chronic ulcer of other part of left foot with fat layer exposed L Non-pressure chronic ulcer of other part of left foot with necrosis of muscle L Non-pressure chronic ulcer of other part of left foot with necrosis of bone L Non-pressure chronic ulcer of other part of left foot with unspecified severity L Non-pressure chronic ulcer of other part of unspecified lower leg limited to breakdown of skin L Non-pressure chronic ulcer of other part of unspecified lower leg with fat layer exposed L Non-pressure chronic ulcer of other part of unspecified lower leg with necrosis of muscle L Non-pressure chronic ulcer of other part of unspecified lower leg with necrosis of bone L Non-pressure chronic ulcer of other part of unspecified lower leg with unspecified severity L Non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin L Non-pressure chronic ulcer of other part of right lower leg with fat layer exposed L Non-pressure chronic ulcer of other part of right lower leg with necrosis of muscle L Non-pressure chronic ulcer of other part of right lower leg with necrosis of bone L Non-pressure chronic ulcer of other part of right lower leg with unspecified severity L Non-pressure chronic ulcer of other part of left lower leg limited to breakdown of skin L Non-pressure chronic ulcer of other part of left lower leg with fat layer exposed 17

18 L Non-pressure chronic ulcer of other part of left lower leg with necrosis of muscle L Non-pressure chronic ulcer of other part of left lower leg with necrosis of bone L Non-pressure chronic ulcer of other part of left lower leg with unspecified severity Q82.0 Hereditary lymphedema REFERENCES 1. Badger CM, Peacock JL, Mortimer PS. A randomized, controlled, parallel-group clinical trial comparing multilayer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphedema of the limb. Source: Institute of Cancer Research, Royal Marsden Hospital, London, United Kingdom Jun 15; 88 (12): Accessed August 03, Available at URL address: 2. Centers for Medicare & Medicaid Services (CMS). CGS Administrators, LLC. Pneumatic Compression Devices. LCD L Effective Date: 10/01/2015. Revision effective date. 07/01/2016. Accessed August 3, Available at URL address: 140&s=46&DocType=Active&bc=AggAAAIAAAAAAA%3d%3d& 3. Centers of Medicare & Medicaid Services (CMS). Decision Memo for Pneumatic Compression Pumps for Venous Insufficiency (CAG-00075N). Date: October 17, Accessed August 04, Available at URL Address: +Pumps+for+Venous+Insufficiency&bc=AAAAAAAACAAAAA%3D%3D& 4. Centers of Medicare & Medicaid Services (CMS). Local Coverage Article: Pneumatic Compression Devices. (A52488). Original Article Effective Date: 10/01/2015. Revision Effective Date: 07/01/2016. Accessed: August 4, Available at URL: =140*2&Cntrctr=140&s=46&DocType=Active&bc=AggAAAQAIAAAAA%3d%3d& 5. Centers of Medicare & Medicaid Services (CMS). Medicare Coverage Issue Manual, Transmittal 150, December 26, Section Pneumatic Compression Devices. Accessed August 4, Available at URL address: Guidance/Guidance/Transmittals/downloads/R150CIM.pdf 18

19 6. Centers of Medicare & Medicaid Services (CMS). NCD Manual, Chapter 1, Part 4 (Section 280.6) Pneumatic Compression Devices. (REV 189/190, / ) Accessed August 4, Available at URL address: Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf 7. Mohler E. MD; and Mehrara B. Clinical Staging and Conservative management of Peripheral Lymphedema. Literature review current through: Jul This topic last updated: Jan 22, Accessed August 4, Available at URL address: 8. HIPPA Space. HCPCS 2016 Code: E0675. Pneumatic Compression Device, High Pressure, Rapid Inflation/Deflation Cycle, For Arterial Insufficiency (Unilateral or Bilateral System). Dated in the Website Accessed August 4, Available at URL: ystem/e Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al.; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC; AHA Task Force on Practice Guidelines; Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter- Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol Mar 21; 47 (6): Accessed August 4, Available at URL Address: cdn.com/s /1-s2.0-s main.pdf?_tid=1a c8cf- 11e4-a08d-00000aacb361&acdnat= _9ceb6f28dc7631fd703098fe7f68cc Lymphedema Framework. Best Practice for the Management of Lymphedema International Consensus. (2006). Accessed August 10, Available at URL Address: 19

20 11. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, et al. (2011) ACCF/AHA Focused Update of the Guideline for the Management of Patients with Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol Nov 1; 58(19): Doi: /j.jacc Accessed August 10, Available at URL Address: J.L. Feldman, N.L. Stout, A. Wanchai, B.R. Stewart, J.N. Cormier, J.M. Armer. Intermittent pneumatic compression therapy: a systematic review. Lymphology 45 (2012) Accessed August 4, Available At URL Address: Kristen E. Adams; John C. Rasmussen; Chinmay Darne; Chih Tan; Melissa B. Aldrich; Milton V. Marshall; Caroline E. Fife; Erik A. Maus; Latisha A. Smith; Renie Guilloid; Sunday Hoy; and Eva M. Sevick-Muraca. Direct evidence of lymphatic function improvement after advanced pneumatic compression device treatment of lymphedema. Biomedical Optics Express. August Vol.1, No. 1, Page Accessed August 04, Available at URL address: Kurtis I. Auguste, MD. Et al. Efficacy of Mechanical Prophylaxis for Venous Thromboembolism in Patients with Brain Tumors. Medscape Today. Pneumatic Compression Devices. Neurosurgery Focus 17 (4), Accessed August 4, Available at URL address: NLM Medical Advisory Committee. Position Statement of the National Lymphedema Network Updated February Accessed August 5, Available at URL Address: Pam Stepham. What is a Compression Sleeve? Updated: February 20, Accessed August 5, Available at URL Address: Sheila H. Ridner, Ph.D., R.N., Barbara Murphy, M.D., Jie Deng, Ph.D., R.N., Nancy Kidd, B.S., Emily Galford, R.N., and Mary S. Dietrich, Ph.D. Advanced Pneumatic Therapy in Self-Care of Chronic Lymphedema of the Trunk. Lymphat Res Biol Dec; 8 (4): Accessed August 5, Available at URL Address: or SunMed Medical Solutions. Compression Pumps Accessed August 5, Available at URL Address: 20

21 POLICY HISTORY DATE ACTION COMMENT February 5, 2009 Origination of Policy February 18, 2010 Revised I. Policy revised to add under indication #2, bullet 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. II. Under Contraindications/Limitations, the following was added: Relative contraindications to pneumatic compression are significant arterial insufficiency, edema from congestive heart failure, active phlebitis, deep vein thrombosis, and the presence of localized wound infection or cellulitis. III. HCPCS and ICD-9 code list updated IV. References updated February 18, 2011 Yearly Review 1. Reference updated Centers for Medicare and Medicaid Services. Cigna Government Services. Pneumatic Compression Devices. LCD L5017. Revision Effective Date: February 4, Accessed February 18, March 16, 2012 Yearly Review References updated Center for Medicare & Medicaid Services (CMS). CGS Administrators, LLC. Pneumatic Compression Devices. LCD L5017. Effective Date: 10/01/1993. Revision effective date. 08/05/2011. Deleted ICD-9 code and March 6, 2013 Revised References updated. To Coding Information added ICD-9 Codes: February 26, 2014 Yearly Review References updated. To the HCPCS Section: code E0670 was added to the policy. March 13, 2015 Yearly Review References updated. New ICD#10 section was added to the policy. To the references section: New references (3, 10, 11 and 12) were added to the policy. To the Description Section: The Information described was reviewed and corroborated in the following documents: 1. Centers of Medicare & Medicaid Services (CMS). Medicare Coverage Issue Manual, Transmittal 150, December 26, Section Pneumatic Compression Devices. Accessed February 19, Pam Stepham. What is a Compression Sleeve? Updated: December 04, Accessed February 19, NLM Medical Advisory Committee. Position Statement of the National Lymphedema Network. Updated February Accessed February 19, To the Coverage Section: Limitations section was incorporated in the coverage description of this section. 21

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