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Pneumatic compression pumps are proposed as a treatment option for patients with lymphedema who have failed conservative measures. They are also proposed to supplement standard care for patients with venous ulcers. A variety of pumps are available; they can be single chamber (nonsegmented) or multichamber (segmented) and have varying design and complexity.
Lymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities due to obstruction of lymphatic flow. Lymphedema can be subdivided into primary and secondary categories. Primary lymphedema has no recognizable etiology, while secondary lymphedema is related to a variety of causes including surgical removal of lymph nodes, post-radiation fibrosis, scarring of lymphatic channels, or congenital anomalies. Treatment includes compression garments, drugs, bandaging, manual lymphatic drainage, and pneumatic compression devices (i.e., lymphedema pumps). Comprehensive decongestive therapy combines manual drainage, bandaging, exercises and skin care, and may also include compression garments, dietary recommendations and/or breathing exercises. Rarely, surgery is used as a treatment option.
Venous ulcers, which occur most commonly on the medial distal leg, can develop in patients with chronic venous insufficiency when leg veins become blocked. Standard treatment for venous ulcers includes compression bandages or hosiery supplemented by conservative measures such as leg elevation. Pneumatic compression pumps are proposed as a treatment for venous ulcers, especially for patients who do not respond to these standard therapies.
Pneumatic compression pumps consist of pneumatic cuffs that are connected to a pump. They use compressed air to apply pressure to the affected limb. The intention is to force excess lymph fluid out of the limb and into central body compartments in which lymphatic drainage should be preserved. Many different pneumatic compression pumps for treating lymphedema are available, with varying materials, design, degree of pressure, and complexity. There are three primary types of pumps as follows:
Several pneumatic compression pumps indicated for primary or adjunctive treatment of primary or secondary (e.g., post-mastectomy) lymphedema have been cleared for marketing by the FDA through the 510(k) process. Examples of devices with these indications that are intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (Medmark Technologies, Perkasie, PA); the Sequential Circulator® (BioCompression Systems, Moonachie, NJ); the Lympha Press® and Lympha-Press Optimal (Mego Afek, Israel), the Flexitouch™ system (Tactile Medical, formerly Tactile Systems Technology); and the PowerPress Unit Sequential Circulator (Neomedic, Chatsworth, CA).
Several pneumatic compression devices are cleared by FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch®, and PowerPress Unit (listed above) as well as NanoTherm™ (ThermoTek), CTU676 devices (Compression Technologies), and Recovery+™ (Pulsar Scientific).
Related medical policies include Bioimpedence Devices for Detection of Lymphedema and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema.
Pneumatic compression pumps may be used in lymphedema clinics or purchased or rented for home use. This policy addresses the home use of these pumps.
POLICYSingle compartment or multi-chamber non-programmable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.
Single compartment or multi-chamber programmable lymphedema pumps applied to the limb are considered medically necessary for the treatment of lymphedema when:
Single compartment or multichamber lymphedema pumps applied to the limb are considered investigational in all situations other than those specified above in the first two policy statements.
The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational.
The use of lymphedema pumps to treat venous ulcers is considered investigational.
Pneumatic compression devices prescribed for patients undergoing surgery as a means of prophylaxis to prevent Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) should be included in the surgical facility's claim. This does not meet the criteria for Durable Medical Equipment and may not be billed separately. It is not appropriate for providers to bill the patient for this service.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
This policy is consistent with The Medicare Coverage Issues Manual which states the following : "In general, the nonsegmented (E0650) or segmented (E0651) compression device without manual control of pressure in each chamber is considered the least costly alternative that meets the clinical needs of the individual. Therefore, when a claim for a segmented pneumatic compression device that allows for manual control in each chamber is received, payment must be made for the least expensive medically appropriate device. If a patient medically needs a segmented device but does not need manual controls, payment must be made for E0651. The segmented device with manual control (E0652) is covered only when there are unique characteristics that prevent the individual from receiving satisfactory pneumatic treatment using a less costly device; e.g., significant sensitive skin scars or the presence of contracture or pain caused by a clinical condition that requires the more costly manual control device."
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY12/1992: Approved by Medical Policy Advisory Committee (MPAC) as "Segmental Lymphedema Pump"
8/1997: Revision approved by MPAC; policy renamed
2/19/2002: Managed Care Requirements deleted
5/1/2002: Type of Service and Place of Service deleted
8/19/2002: HCPCS code E0652 description added
9/20/2002: Policy reviewed, Sources updated
8/21/2003: HCPCS E0650-E0651, E0655-E0673 listed separately
10/17/2005: ICD-9 Diagnosis 990 deleted
7/13/2006: Policy updated
1/2/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.
11/20/2008: Policy reviewed by MPAC, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
08/12/2010: Policy title changed from "Lymphedema Pumps" to "Pneumatic Compression Pumps for Treatment of Lymphedema." Policy description revised to add information regarding available pumps. Links added to related medical policies. The first policy statement was revised to add "non-programmable" and the term "elastic" was changed to "compression." Policy statement regarding multi-chamber programmable lymphedema pumps was changed from not medically necessary to medically necessary under certain circumstances; single compartment programmable pumps are addressed in the same policy statement. Added policy statement to indicate that two-phase multi-chamber lymphedema pumps are investigational for treatment of lymphedema. FEP verbiage added to the Policy Exceptions section.
09/09/2010: Policy description updated to add information regarding compression pumps for treating truncal areas. Policy statement unchanged.
09/23/2011: Added the following to the Policy Statement: Single compartment or multichamber lymphedema pumps are considered investigational in all situations other than those specified above in the first two policy statements. Deleted outdated References from the Sources section.
02/17/2012: Add the following to the Policy Statement: Pneumatic compression devices prescribed for patients undergoing surgery as a means of prophylaxis to prevent Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) should be included in the surgical facility's claim. This does not meet the criteria for Durable Medical Equipment and may not be billed separately. It is not appropriate for providers to bill the patient for this service.
01/07/2013: Added "Venous Ulcers" to the policy title. Policy statement revised to add the following investigational statements: 1)The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational. 2) The use of lymphedema pumps to treat venous ulcers is considered investigational. Deleted the following policy statement: Two-phase multi-chamber lymphedema pumps are investigational for treatment of lymphedema. Added the following new 2013 CPT code to the Code Reference section: E0670.
03/19/2014: Added "applied to the limb" to the first 3 policy statements for clarification.
11/07/2014: Policy reviewed; description updated regarding comprehensive decongestive therapy, venous ulcers, and devices. Policy statements unchanged.
08/31/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 diagnosis codes 997.99 and 998.89 from the Code Reference section.
11/20/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.18
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.