Proposed LCD - Pneumatic Compression Devices (DL33829)

CMS National Coverage PolicyCMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1, Section 280.6Coverage Indications, Limitations, and/or Medical NecessityFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act  1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act  1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.PRESCRIPTIONSPrescriptions for Pneumatic Compression Devices (PCDs) (E0650, E0651, E0652, E0675, E0676) are limited to Physicians (MD, DO, DPM) and physician extenders (NP, PA, CNS) to the extent allowed by their applicable state scope-of-practice and other license requirements. Providers must use care because the treatment of lymphedema, chronic venous insufficiency with ulceration and complications related to the treatment of these conditions by use of PCDs, commonly require consideration of diagnoses and management of systemic conditions. In no event should a provider order PCDs or PCD appliances that are to be used for or are to be applied to areas of the body that fall outside of their state scope of practice and other license limitations.DEFINITIONSFor Medicare DMEPOS reimbursement purposes the following definitions are used in this policy.Edema:Edema is a non-specific term for the accumulation of fluid in tissue, most often in the extremities. There are numerous causes for edema, ranging from systemic disorders (e.g. congestive heart failure) to local conditions (e.g. post-surgery, congenital abnormalities). (Examples are not all-inclusive.)Lymphedema, as discussed below, is just one group of conditions that can be a cause of accumulation of fluid in the tissue. Lymphedema arises from disorders of the lymphatic system. It is essential to rule out other causes of edema in order to diagnose lymphedema. Edema from other causes is not classified as lymphedema for purposes of Medicare reimbursement for PCDs (E0650, E0651, E0652).Primary lymphedema:Primary lymphedema is a disorder of the lymphatic system that occurs on its own. It is inherited and uncommon. Examples (not all-inclusive) are:Congenital lymphedema due to lymphatic aplasia or hypoplasiaMilroy's disease, an autosomal dominant familial form of congenital lymphedemaLymphedema praecoxLymphedema tardaSecondary lymphedema:Secondary lymphedema is a disorder of lymphatic flow that is caused by some other disease or condition. It is more common than primary lymphedema. It is most commonly caused by surgery (especially lymph node dissection, such as for breast cancer), radiation therapy (especially axillary or inguinal), trauma, lymphatic obstruction by tumor, and, in developing countries, lymphatic filariasis. Secondary lymphedema may also result from compression of the lymphatic and venous channels resulting from leakage of fluid into interstitial tissues in patients with chronic venous insufficiency (CVI). (See below)Chronic Venous Insufficiency (CVI)Lymphedema may also be caused by CVI when fluid leaks into the tissues from the venous system. 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 stasis ulcers. The incidence of lymphedema from CVI is not well established.Peripheral Arterial Disease (PAD)PAD is a circulatory problem in which narrowed arteries reduce blood flow to limbs, resulting in compromised blood flow to the distal tissue and failure to keep up with oxygen demands.GENERALPCDs coded as E0650, E0651, E0652 are used only in the treatment of lymphedema or CVI with venous stasis ulcers. Reimbursement for these items is based upon the criteria in the following sections. PCD coded as E0675 is used in the treatment of PAD. Claims for E0675 will be denied as not reasonable and necessary as outlined below.I - LYMPHEDEMAA 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 following three requirements are met:The beneficiary has a diagnosis of lymphedema as defined above, andThe beneficiary has persistence of chronic and severe lymphedema as identified by the documented presence of at least one of the following clinical findings:Marked hyperkeratosis with hyperplasia and hyperpigmentation,Papillomatosis cutis lymphostatica,Deformity of elephantiasis,Skin breakdown with persisting lymphorrhea,Detailed measurements over time confirming the persistence of the lymphedema with a history evidencing a likely etiology, andIn addition to this documented persistence, the lymphedema is then documented to be unresponsive to other clinical treatment over the course of a required four-week trial. (See below for trial guidelines.)A PCD coded as E0650 or E0651 used to treat lymphedema that does not meet all of the requirements above is not eligible for reimbursement. Claims will be denied as not reasonable and necessary.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.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 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.Four-Week Trial for LymphedemaA four-week trial of conservative therapy demonstrating failed response to treatment is required. The four-week trial of conservative therapy must include all of the following:Regular and compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compressionAdequate 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.Regular exerciseElevation of the limbWhen available, manual lymphatic drainage is a key component of conservative treatment as is appropriate medication treatment when there is concurrent congestive heart failure.At the end of the four-week trial, if there has been improvement, then reimbursement for a PCD is not justified. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessment at intervals at least a week apart. Only when no significant improvement has occurred in the most recent four weeks and the coverage criteria above are still met, may the lymphedema be considered unresponsive to conservative therapy, and coverage for a PCD considered.The medical necessity determination for a PCD by the treating practitioner must include symptoms and objective findings, including measurements, to establish the severity of the condition.The documentation by thetreatingpractitionerof the medical necessity of a PCD must include:The patients 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; andThe clinical response to an initial treatment with the deviceAt a minimum, re-assessments conducted for a trial must include detailed measurements, obtained in the same manner and with reference to the same anatomic landmarks, prior to and at the conclusion of the various trials and therapy, with bilateral comparisons where appropriate.The trial of conservative therapy must be documented in the beneficiarys medical record before prescribing any type of PCD (E0650, E0651, E0652). This assessment may be performed by thetreatingpractitioneror any other licensed/certified medical professional (LCMP) directly involved in the beneficiarys lymphedema treatment. The LCMP may not have any financial relationship with the DMEPOS supplier providing the device. If the assessment is performed by an LCMP, thetreatingpractitionermust receive and review the report of the evaluation. In addition, thetreatingpractitionermust sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.II - CHRONIC VENOUS INSUFFICIENCY (CVI) WITH VENOUS STASIS ULCERSA PCD coded as E0650 or E0651 is covered for the treatment of CVI of the lower extremities only if the patient has all of the following:Edema in the affected lower extremityOne or more venous stasis ulcer(s)The ulcer(s) have failed to heal after a six-month trial of conservative therapy directed by thetreatingpractitioner. (See below for trial guidelines.)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.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.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.Six-Month Trial for CVIA 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:Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compressionAdequate 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.Medications as appropriate (e.g. diuretics and/or other treatment of congestive heart failure)Regular exerciseElevation of the limbAppropriate wound care for the ulcer (including sharp debridement where appropriate)At the end of the six-month trial, if there has been improvement, then reimbursement for a PCD is not reasonable and necessary. Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessments. When no significant improvement has occurred for a continuous period of six months and the coverage criteria above are still met, then the use of a PCD to treat CVI is eligible for reimbursement.The trial of conservative therapy must be documented in the beneficiarys medical record before prescribing any type of PCD (E0650, E0651, E0652). This assessment may be performed by thetreatingpractitioneror any other licensed/certified medical professional (LCMP) directly involved in the beneficiarys CVI treatment. The LCMP may not have any financial relationship with the DMEPOS supplier providing the device. If the assessment is performed by an LCMP, thetreatingpractitionermust receive and review the report of the evaluation. In addition, thetreatingpractitionermust sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMENA segmented, calibrated gradient PCD (E0652) is only covered when the individual has unique characteristics which prevent them from receiving adequate satisfactory pneumatic compression treatment using a nonsegmented device along with a segmented appliance or compression device without manual control of the pressure in each chamber.A PCD coded as E0652, is covered for the treatment of lymphedema extending onto the chest, trunk and/or abdomen when all of the following are met: