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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-31

Original Effective Date: 11/15/02

Reviewed: 04/28/16

Revised: 05/15/16

Subject: Pneumatic Compression Devices

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Lymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities resulting from an obstruction of lymphatic flow. Lymphedema can be subdivided into primary and secondary lymphedema. 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, spread of malignant tumors to regional lymph nodes with lymphatic obstruction, scarring of lymphatic channels, or congenital anomalies. Treatment may include mechanical measures such as compression garments, bandaging, manual massage, pneumatic compression devices (i.e., lymphedema pumps), drugs, or rarely surgery.

Pneumatic compression devices use compressed air to apply pressure to the affected limb, in order to force excess lymph fluid out of the limb and into central body compartments, where lymphatic drainage should be preserved. There are several types of compression devices. There are single compartment devices, multi-chamber devices with fixed pressure in each cell and there are multi-chamber devices with manually calibrated pressure in each cell. The system consists of a pneumatic sleeve or boot that is attached by hoses to a compression device. The appliance is intermittently inflated with air which provides a squeezing or "milking action" to facilitate the flow of lymph from the affected limb. The appliance then deflates allowing for circulation within the limb. Repeated cycles reduce the lymphedema.

Contraindications to the use of pneumatic compression devices include, but are not limited to, the following:

This guideline addresses the use of pneumatic compression devices in the home setting.

POSITION STATEMENT:

Segmental or non-segmental pneumatic compression devices meet the definition of medical necessity when used to treat any of the following conditions, when conservative treatment (e.g., compression garments, bandaging, limb elevation, manual massage) has failed:

The use of pneumatic compression devices for all other indications is considered experimental or investigational. Data in published medical literature are inadequate to permit scientific conclusions on long-term and net health outcomes for all other indications.Other indications include but are not limited to:

Treatment of the trunk or chest the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs

Treatment of venous ulcers

Treatment of peripheral arterial occlusive disease and arterial insufficiency

NOTE: The use of a pneumatic compression device for prevention of deep vein prophylaxis (DVT) following surgery does not meet the definition of medical necessity. Exception: When there is physician documentation of contraindication to pharmacological DVT prophylaxis following surgery, the use of a pneumatic compression device may meet the definition of medical necessity, by individual case consideration.

The use of advanced pneumatic compression devices, or devices with additional features such as specific programming to treat problem areas, or a pre-therapy phase, do not meet the definition of medical necessity. There is insufficient clinical evidence published in the peer-reviewed literature demonstrating that these devices are superior to or add benefit over standard calibrated gradient pressure pneumatic compression devices. These include but are not limited to the following devices:

Flexitouch® System

Lympha Press Optimal™

ACTitouch Adaptive Compression Therapy System

Gradient compression garments (A6530-A6541, A6545, A6549, S8420-S8429) used instead of a pneumatic compression device, such as the Reid Sleeve (A4465 or S8429), meet the definition of medical necessity when used for treatment of the conditions listed above.

BILLING/CODING INFORMATION:

The following codes may be used to describe pneumatic compression devices:

HCPCS Coding:

A4600

Sleeve for intermittent limb compression device, replacement only, each

E0650

Pneumatic compressor, non-segmental home model (single-compartment pump)

E0651

Pneumatic compressor, segmental home model without calibrated gradient pressure (multichamber pump)

E0652

Pneumatic compressor, segmental home model with calibrated gradient pressure (multichamber pump)

E0655

Non-segmental pneumatic appliance for use with pneumatic compressor, half arm (single-compartment pump)

E0656

Segmental pneumatic appliance for use with pneumatic compressor, trunk (multichamber pump) (investigational)

E0657

Segmental pneumatic appliance for use with pneumatic compressor, chest (multichamber pump) (investigational)

E0660

Non-segmental pneumatic appliance for use with pneumatic compressor, full leg (single-compartment pump)

E0665

Non-segmental pneumatic appliance for use with pneumatic compressor, full arm (single-compartment pump)

E0666

Non-segmental pneumatic appliance for use with pneumatic compressor, half leg (single-compartment pump)

E0667

Segmental pneumatic appliance for use with pneumatic compressor, full leg (multichamber pump)

E0668

Segmental pneumatic appliance for use with pneumatic compressor, full arm (multichamber pump)

E0669

Segmental pneumatic appliance for use with pneumatic compressor, half leg (multichamber pump)

E0670

Segmental pneumatic appliance for use with pneumatic compressor, integrated, 2 full legs and trunk (investigational)

E0671

Segmental gradient pressure pneumatic appliance, full leg

E0672

Segmental gradient pressure pneumatic appliance, full arm

E0673

Segmental gradient pressure pneumatic appliance, half leg

E0675

Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system) (investigational)

E0676

Intermittent limb compression device (includes all accessories) not otherwise specified

Coding Notes:

A non-segmented pneumatic compressor (E0650) is a device that has a single outflow port on the compressor. The air from the single tube may be transmitted to a sleeve/appliance with multiple compartments or segments. These are the simplest pumps, consisting of a single chamber that is inflated at one time to apply uniform pressure.

A segmented pneumatic compressor without calibrated pressure gradient (E0651) is a device that has multiple outflow ports on the compressor that lead to distinct segments on the appliance. This device inflates sequentially. They can have either the same pressure in each compartment, or a predetermined pressure gradient in successive segments, but there is no ability to individually set or manually adjust pressures in each of the individual compartments. The pressure is usually set by a single control on the distal segment.

A segmented pneumatic compressor with calibrated pressure gradient (E0652), can be single-chamber or multi-chamber programmable pump. These are similar to the devices described above, except the device has a manual control on at least three outflow ports which can deliver an individually determined pressure to each segmental unit. It is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles.

An advanced pneumatic compression device with segmented (multiple chambers), calibrated pressure gradient (E0652) allow for pre-set treatment options, digital programming to mimic manual lymphatic drainage techniques, and promote fluid clearance from the proximal trunk and extremity.

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

I89.0

Lymphedema, not elsewhere classified [secondary]

I97.2

Postmastectomy lymphedema syndrome

Q82.0

Hereditary lymphedema [congenital]

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, physician treatment notes, treatment plan, operative reports, physical therapy notes (if applicable).

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0,

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician treatment/ visit notes including documentation of failure of conservative medical management

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician operative note

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physical therapy notes

28579-1

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Pneumatic Compression Devices (280.6) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Pneumatic Compression Devices (L33829), and Surgical Dressings (L33831) located at cgsmedicare.com.

DEFINITIONS:

Deep vein thrombosis (DVT): when a blood clot (thrombus) forms in one or more of the deep veins in the body, most often in the lower extremities.

Lymphedema: The accumulation of fluid in soft tissue, often the result of surgery, radiation or the presence of a tumor in an area near the lymph nodes.

Milroy’s Disease: chronic hereditary edema of the legs.

Peripheral arterial occlusive disease and arterial insufficiency: narrowing of the arteries in the extremities (most often the lower extremities), usually the result plaque deposits.

Venous stasis ulcers: lesions that develop as a result of poor blood flow, usually on the legs.

RELATED GUIDELINES:

None applicable.

OTHER:

Index terms:

Lymphedema pump
Non-segmental pneumatic compressor
Pneumatic compressor
Segmental pneumatic compressor

REFERENCES:

  1. American College of Cardiology. Management of patients with peripheral arterial disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations). A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. November 2013. Accessed at: http://www.acc.org.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual – 1.01.18 Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers (September 2015).
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual. 1.01.28, Postsurgical Outpatient Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis (December 2014).
  4. Blue Cross Blue Shield Association TEC Assessments – “Comparative Efficacy of Different Types of Pneumatic Compression Pumps for the Treatment of Lymphedema” (1998, Tab 2).
  5. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Pneumatic Compression Devices, Publication 100-3, Section 280.6 (effective date 01/14/02).
  6. ClinicalTRials.gov. NCT00577317: Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer. Gynecologic Oncology Group. 2014.
  7. Eberhardt Robert T, Raffetto Joseph D. Chronic Venous Insufficiency. Circulation. 2005;111:2398-2409.
  8. Fife CE, Davey S, Maus EA, Guilliod R, Mayrovitz HN. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Support Care Cancer. 2012 Dec;20(12):3279-86.
  9. Hayes Directory of Medical Technology: “Compression Pump Treatment of Postmastectomy Lymphedema” (07/01).
  10. Hayes, Inc., Flexitouch® Lymphedema System for Lymphedema, 10/23/06.
  11. Hayes, Inc., Pneumatic Compression Devices for Treatment of Peripheral Lymphedema, 12/13/06.
  12. Koo KH, Choi JS2 Ahn JH1 Kwon JH3 Cho KT4 Comparison of clinical and physiological efficacies of different intermittent sequential pneumatic compression devices in preventing deep vein thrombosis: a prospective randomized study. Clin Orthop Surg. 2014 Dec;6(4):468-75.
  13. McKesson Corporation – InterQual, 2009 Durable Medical Equipment Criteria: Lymphedema Compression Devices.
  14. Medicare Region C DMERC Local Coverage Determination for Pneumatic Compression Devices (L5017), (effective 08/05/11) (Retired 09/30/15)
  15. Medicare Region C DMERC Local Coverage Determination for Pneumatic Compression Devices (L33829). Effective 10/01/15.
  16. Medicare Region C DMERC Local Coverage Determination for Pneumatic Compression Devices Coding Guidelines Article (A24141) (revised 08/05/11).
  17. Medicare Region C DMERC Local Coverage Determination for Surgical Dressings (L11449) (effective 08/05/2011).
  18. Medicare Region C DMERC Local Coverage Determination for Surgical Dressings Coding Guidelines Article (L11449) (effective 08/05/2011).
  19. National Cancer Institute. Lymphedema (PDQ) Health Professional Version (09/09/08).
  20. National Institute for Health and Clinical Excellence (NICE). Clinical Guidance 92: Venous thromboembolism: reducing the risk for patients in hospital. January 2010. Accessed at https://www.nice.org.uk.
  21. National Lymphedema Network, Position Statement, Topic: Treatment of Lymphedema. (Board approved 08/10/06; reviewed 08/10/09).
  22. Rasmussen JC, et al. Lymphatic transport in patients with chronic venous insufficiency and venous leg ulcers following sequential pneumatic compression. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):9-17.
  23. Ridner SH, Murphy B, Deng J, Kidd N, Galford E, Dietrich MS. Advanced pneumatic therapy in self-care of chronic lymphedema of the trunk. Lymphat Res Biol. 2010 Dec;8(4):209-15.
  24. Zaleska M, Olszewski WL, Durlik M. The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. Lymphat Res Biol. 2014 Jun;12(2):103-9.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/28/16.

GUIDELINE UPDATE INFORMATION:

11/15/02

Medical Coverage Guideline Reformatted; added limitation for replacement sleeves; added Program Exception for Medicare & More.

10/15/04

Scheduled review; no change in coverage statement.

01/01/06

Annual HCPCS coding update: replace L8210 and L8220 with A6542 and A6543.

10/15/06

Scheduled review (consensus review); no change in coverage statement.

01/01/07

Annual HCPCS coding update: added A4600 and E0676.

08/15/07

Reviewed; coverage statement maintained, Medicare Advantage products section updated, guideline reformatted, references updated.

01/01/09

Annual HCPCS coding update: added A6545, E0656, and E0657.

07/15/09

Scheduled review; no change to position statement; references updated.

01/01/10

Annual HCPCS coding update: removed A6542 and A6543.

01/01/11

Revisions; related ICD-10 codes added.

03/15/11

Revisions; added position statement regarding two-phase lymphedema systems/devices; updated references.

05/15/11

Revision; formatting changes.

06/15/11

Revision to Billing/Coding section to include information regarding CPT code 97016.

08/15/11

Revision to Position Statement to include note regarding coverage of pneumatic compression devices.

09/15/11

Revision; formatting changes.

01/01/13

Annual HCPCS coding update: added E0670.

02/15/13

Review; Title changed; Position Statement added for venous ulcers; the phrase “lymphedema pump” changed to “pneumatic compression pump”; formatting changes; references updated.

02/15/14

Revision to clarify coverage of gradient compression garments; Coding section updated; Program Exceptions section updated.

10/01/15

Revision; updated ICD9 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

05/15/16

Scheduled review. Revised MCG title, position statement, HCPCS coding section, program exceptions, and definitions section. Updated references. Reformatted guideline.

Date Printed: October 20, 2017: 08:41 AM