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Lymphedema Pumps/Pneumatic Compression Devices

Policy Number: MP-123

Latest Review Date: August 2021

Category: DME                                                                     

Policy Grade:  B

POLICY:

Lymphedema pumps/pneumatic compression devices or compression garments when applied to the limb may be considered medically necessary when used to treat lymphedema in the affected limbs resulting from a mastectomy and ordered by the patient’s treating physician.

Single-chamber lymphedema pumps/pneumatic compression devices when applied to the limb may be considered medically necessary when used to treat lymphedema not resulting from a mastectomy when all the following criteria are met:

  • The lymphedema is associated with functional impairment, e.g., impairment of activities of daily living; AND
  • The patient has tried and been compliant with four weeks of conservative therapy, i.e. elevation of the affected limb, exercise, massage, use of an appropriate compression bandage system or compression garment; AND
  • The patient’s lymphedema is not improving with conservative measures; AND
  • Photographs or a diagnostic test must document the diagnosis of lymphedema (not required in cases of mastectomy related lymphedema).

Except when as a result of a mastectomy, a single-chamber/non-segmented device (E0650) or multi-chamber/segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs for patients with lymphedema.

A multi-chamber programmable segmented device with manual control of the pressure in each chamber (E0652) when applied to the limb may be considered medically necessary only when there is documentation in the patient’s medical record of a condition that will not allow treatment of the lymphedema with E0650 or E0651. Such conditions include a significant sensitive skin scar or contracture, which make treatment with another device painful or unsafe for the patient.

The ReidSleeve when applied to the limb may be considered medically necessary for patients with intractable lymphedema from either axillary radiation therapy or surgery for breast cancer who have not improved with conservative measures of four weeks of elevation, exercise, and massage.

A Compressure bra may be considered medically necessary when used to treat lymphedema of the breast or trunk resulting from treatment of breast cancer.

The Tribute™ garment when applied to the limb may be considered medically necessary for patients with intractable lymphedema from either axillary radiation therapy or surgery for breast cancer who have not improved with conservative measures of four weeks of elevation, exercise, and massage.

The use of lymphedema pumps to treat venous ulcers is considered investigational.

Lymphedema pumps/pneumatic compression devices are considered investigational for:

  • Infection
  • Venous or arterial occlusive disease
  • Venous thrombosis
  • Massive edema secondary to conditions including, but not limited to, congestive heart failure, renal failure, or hepatic insufficiency or chronic venous insufficiency.
  • Metastatic disease in the involved extremity.

Lymphedema pumps/pneumatic compression devices for diabetic neuropathic ulcers and arterial ischemic ulcers are considered investigational.

Non-elastic gradient compression wrap (A6545) and non-elastic leg binders (A4465), e.g., Circaid Juxta-lite, Circaid T-3 M and Circaid Cures, LegAssist, Caresia Bandage Liners, etc. are considered not medically necessary.

External intermittent pneumatic compression devices for the feet are considered investigational.

The use of lymphedema pumps to treat the trunk, chest, head or neck in patients with lymphedema limited to the upper and/or lower limbs is considered investigational.

End-diastolic pneumatic compression boots are considered investigational as a treatment of peripheral vascular disease or lymphedema and its associated complications, including but not limited to ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, or thrombophlebitis.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pneumatic compression pumps are proposed as a treatment 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 designs and complexity.

Lymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities resulting from 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. Conservative therapy is the initial treatment for lymphedema and includes general measures such as limb elevation and exercise as well as the use of compression garments and compression bandaging. Another conservative treatment is manual lymphatic drainage, a massage-like technique used to move edema fluid from distal to proximal areas. Manual lymphatic drainage is performed by physical therapists with special training. Complete decongestive therapy is a comprehensive program that includes manual lymphatic drainage in conjunction with a range of other conservative treatments. Rarely, surgery is used as a treatment option. Pneumatic compression pumps are proposed as a treatment for patients with lymphedema who have failed conservative measures.

Pneumatic compression pumps are also proposed to supplement standard care for patients with venous ulcers. 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 may be used in lymphedema or wound care clinics, purchased, or rented for home use; home use is addressed herein. Pneumatic compression pumps consist of pneumatic cuffs connected to a pump. These pumps 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 pneumatic compression pumps are available, with varying materials, designs,degrees of pressure, and complexity. There are 3 primary types of pumps. Single chamber nonprogrammable pumps are the simplest pumps, consisting of a single chamber that is inflated at 1 time to apply uniform pressure. Multichamber nonprogrammable pumps have multiple chambers ranging from 2 to 12 or more. The chambers are inflated sequentially and have a fixed pressure in each compartment. They can either have the same pressure in each compartment or a pressure gradient but they do not include the ability to adjust the pressure manually in individual compartments. Single- or multi-chamber programmable pumps are similar to the pumps described above except that it is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered the preferred option.

KEY POINTS:

The most recent literature search was through June 17, 2021.

Table 1. Summary of Key RCT Characteristics Head and Neck Lymphedema

Author, year, country

Study Design

Dates

Population Characteristics

Interventions

Comparators

 

Clinical Outcomes, Length of Follow up

Ridner (2021), US

RCT

NR

N=49 patients who had completed treatment for head and neck cancer with no active disease, had a clinical diagnosis of head and neck lymphedema, and had either already received lymphedema therapy or were unable to access therapy due to barriers (e.g., lack of insurance)

Lymphedema self-management(n=25)

Lymphedema self-management plus the use of the Flexitouch system twice daily for 8 weeks (n=24)

The following practices are currently being used to treat lymphedema: conservative therapy (e.g., range of motion exercises,compression therapy), manual lymphatic drainage, and complete decongestive therapy.

The general outcomes of interest are symptoms, change in disease status, functional outcomes (e.g., range of motion), and quality of life (eg, ability to conduct activities of daily living). The Lymphedema Symptom Intensity and Distress Survey-Head and Neck is a patient-reported tool that captures symptom intensity and distress.

Lymphedema is a chronic condition and follow-up of at least 6 weeks to 6 months would be desirable to assess outcomes.

NR: not reported; RCT: randomized controlled trial

a Provided with a self-care kit that included a diary, self-care checklist, and calendar of future study appointments

Table 2. Summary of Key RCT Results

Study

LSIDS-HN, change from baseline(median [IQR])

Swelling, median change from baseline in percentage grids with observable swelling

Adverse events

Ridner (2021)

Soft tissue

Neurological

Activity

Function

Front view

Right view

Left view

 

Lymphedema self-management plus Flexitouch system (n=19)

-2.0 [-2,0]

0.0 [-2, 0]

0.0 [-3,0]

0.0 [-1,+1]

-24%

-22%

-17%

4 serious adverse events reported( consided unrelated to device use)

Lymphedema self-management only (n=24)

 

0.0 [0,+2]

0.0 [0, +2]

0.0 [-3,+1]

0.0 [-1,+2]

+5%

-7%

-4%

-

p-value

.004

.047

.08

.479

<.001

.004

.005

 

IQR: interquartile range; LSIDS-HN: Lymphedema Symptom Intensity and Distress Survey-Head and Neck; RCT: randomized controlled trial.

Section Summary: Lymphedema–Pneumatic Compression Pumps Applied to Head and Neck

One RCT has evaluated pneumatic compression treatment for head and neck lymphedema. The trial evaluated the feasibility,adherence, and safety of the intervention. Results demonstrated some improvements in patient-reported outcomes and swelling, but adherence was low, with only 1 patient using the pneumatic compression treatment device twice daily as prescribed. Further investigation in larger studies and those that compare against the gold standard comparator of complete decongestive therapy areneeded to determine efficacy of this treatment approach.

Summary of Evidence

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb only, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Most RCTs were rated as moderate-to-high quality by an Agency for Healthcare Research and Quality review, and about half reported significant improvements with pumps compared with conservative care. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to trunk and/or chest as well as a limb, the evidence includes 2 RCTs comparing treatment with and without truncal involvement. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. In 1 RCT, 2 of 4 key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (e.g., amount of fluid removed) rather than health outcomes (e.g., functional status, quality of life). The other RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to the head and neck, the evidence includes 1 RCT comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone. Relevant outcomes are symptoms, change in disease status,functional outcomes, and quality of life. The trial evaluated the feasibility, adherence, and safety of the intervention. Results demonstrated some improvements in patient-reported outcomes and swelling, but adherence was low, with only 1 patient using the pneumatic compression treatment device twice daily as prescribed. Further investigation in larger studies and those that compare against the gold standard comparator of complete decongestive therapy are needed to determine efficacy of this treatment approach.The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have venous ulcers who receive pneumatic compression pumps, the evidence includes several RCTs and a systematic review of RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at high risk of bias. Moreover, the 2 trials comparing lymphedema pumps with continuous compression did not find significant between-group differences in healing rates. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

Wound Healing Society

A 2015 guideline from the Wound Healing Society states that for patients with venous ulcers, intermittent pneumatic pressure can beused with or without compression dressings and can provide another option in patients who cannot or will not use an adequatecompression dressing system.

Society for Vascular Surgery and American Venous Forum

The 2014 joint guidelines from the Society for Vascular Surgery and the American Venous Forum on the management of venous ulcers included the following statement on pneumatic compression:

“We suggest use of intermittent pneumatic compression when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy. [GRADE - 2; LEVEL OF EVIDENCE - C]”

International Union of Phlebology

A 2013 consensus statement from the International Union of Phlebology stated that primary lymphedema can be managed effectively by a sequenced and targeted management program based on a combination of decongestive lymphatic therapy and compression therapy. Treatment should include: compression garments, self-massage, skin care, exercises and, if desired, pneumatic compression therapy applied in the home.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Lymphedema pump, lymphedema compression device, pneumatic compression pump, pneumatic compression device, sequential gradient pneumatic compression device, pneumatic appliance, Reidsleeve, compression garment, compression sleeve, customized compression garment, compressure bra, Compressure Comfort® Bra, Bellise Compressure Bra, Morris Designs Compressure Bra, FP5000™ Pump System, external intermittent pneumatic compression of the foot, Flowtron® system, foot compression device, AV Impluse System Foot Pump, KCI Plexipuls, Tribute™ garment, Circaid Juxta-lite, Circaid T-3 M and Circaid Cures, LegAssist, non-elastic compression garment, Flexitouch™, 2-phase multi-chambered lymphedema pumps, Lympha Press Optimal™ Lympha Press® Plus, Lympha Pants II™, Lympha Jacket II™, Caresia Bandage Liners, End-Diastolic Pneumatic Compression Boot, The Circulator Boot™, The Miniboot, the Multicrus Circulator Boot™, Circulator Boot System, PowerPress Unit Sequential Circulator

APPROVED BY GOVERNING BODIES:

Several pneumatic compression pumps, indicated for the primary or adjunctive treatment of primary or secondary (e.g.,postmastectomy) lymphedema, have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k)process. Examples of devices with these indications intended for home or clinic/hospital use include the Compression Pump, ModelGS-128 (MedMark Technologies); the Sequential Circulator® (Bio Compression Systems); the Lympha-Press® and Lympha-Press Optimal (Mego Afek); the Flexitouch®™ and Flexitouch Plus systems (Tactile Medical, formerly Tactile Systems Technology); the Powerpress Unit Sequential Circulator (Neomedic); and the EzLymph and EzLymph M (EEZCare Medical).

Several pneumatic compression devices are cleared by the 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, Inc.), CTU676(R) (Compression Technologies), and Recovery+™ (Pulsar Scientific).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.   Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HPCPS codes:

Claims for lymphedema pumps are coded for with a pair of HCPCS codes: one to describe the actual pump and one to describe the appliance (i.e., sleeve) that is put on the affected body part. The various types of pumps may be distinguished by HCPCS codes.

Single-Compartment Pumps

E0650

Pneumatic compressor, nonsegmental home model

The above code (E0650) is used in conjunction with any of the following appliances:

E0655

Nonsegmental pneumatic appliance for use with pneumatic compressor, half arm

E0660

Nonsegmental pneumatic appliance for use with pneumatic compressor, full leg

E0665

Nonsegmental pneumatic appliance for use with pneumatic compressor, full arm

E0666

Nonsegmental pneumatic appliance for use with pneumatic compressor, half leg

Multichamber Pumps

E0651

Pneumatic compressor, segmental home model without calibrated gradient pressure

The above code (E0651) may be used with any of the following appliance codes:

E0656

Segmental pneumatic appliance for use with pneumatic compressor, trunk

E0657

Segmental pneumatic appliance for use with pneumatic compressor, chest

E0667

Segmental pneumatic appliance for use with pneumatic compressor, full leg

E0668

Segmental pneumatic appliance for use with pneumatic compressor, full arm

E0669

Segmental pneumatic appliance for use with pneumatic compressor, half leg

E0670

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

Multichamber Programmable Pumps

E0652

Pneumatic compressor, segmental home model with calibrated gradient pressure

The above code (E0652) may be used with any of the following appliance codes:

E0671

Segmental gradient pressure pneumatic appliance, full leg

E0672

Segmental gradient pressure pneumatic appliance, full arm

E0673

Segmental gradient pressure pneumatic appliance, half leg

Compression Appliances:

A4465

Non-elastic binder for extremity

A6545

Gradient compression wrap, non-elastic, below knee, 30-50 mm hg, each

REFERENCES:

  1. Alvarez OM, Markowitz L, Parker R, et al. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated WithIntermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020; 20: e6.
  2. Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int J Med Sci. 2014; 11(1):34-43.
  3. Dolibog P, Franek A, Taradaj J et al.  A randomized, controlled clinical pilot study comparing three types of compression therapy to treat venous leg ulcers in patients with superficial and/or segmental deep venous reflux.  Ostomy Wound Manage 2013; 59(8):22-30.
  4. Fife CE, Davey S, Maus EA et al. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Support Care Cancer 2012; 20(12):3279-86.
  5. Gurdal SO, Kostanoglu A, Cavdar I et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol 2012; 10(3):129=35.
  6. Gutierrez C, Karni RJ, Naqvi S, et al. Head and Neck Lymphedema: Treatment Response to Single and Multiple Sessions ofAdvanced Pneumatic Compression Therapy. Otolaryngol Head Neck Surg. Apr 2019; 160(4): 622-626.
  7. Gutierrez C, Mayrovitz HN, Naqvi SHS, et al. Longitudinal effects of a novel advanced pneumatic compression device onpatient-reported outcomes in the management of cancer-related head and neck lymphedema: A preliminary report. Head Neck.Aug 2020; 42(8): 1791-1799.
  8. Hammond TM, Mayrovitz HN. Programmable intermittent pneumatic compression as a component of therapy for breast cancer treatment-related truncal and arm lymphedema.  Home Health Care Management Practice 2010; 22(6):397-402.
  9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  10. Lee BB, Andrade M, Antignani PL, et al. Daignosis and Treatment of Primary Lymphedema. Consensus Document of the International Union of Phlebology (IUP)-2013. Int Angiol. 2013 December; 32(6): 541-74. 2013.
  11. Marston W, Tang J, Kirsner RS, et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound RepairRegen. Jan-Feb 2016; 24(1): 136-44.
  12. Mayrovitz HN, Ryan S, Hartman JM. Usability of advanced pneumatic compression to treat cancer-related head and necklymphedema: A feasibility study. Head Neck. Jan 2018; 40(1): 137-143.
  13. Nelson EA, Mani R, Thomas K et al. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev 2011: (2); CD001899.
  14. Nelson EA, Hillman A, Thomas K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. 2014 May 12: 5; CD001899.
  15. O'Donnell TF, Jr., Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl):3s-59s.
  16. Oremus M, Dayes I, Walker K et al. Systematic review:  conservative treatments fro secondary lymphedema. BMC Cancer 2012; 12:6.
  17. Oremus M, Walker K, Dayes I, et al. Technology Assessment: Diagnosis and Treatment of Secondary Lymphedema (Project ID: LYMT0908). Rockville, MD: Agency for Healthcare Research and Quality; 2010.
  18. Ridner SH, Murphy B, Deng J et al. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat 2012; 131(1):147-58.
  19. Shao Y, Qi K, Zhou QH, et al. Intermittent pneumatic compression pump for breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. Oncol Res Treat. 2014:37(4); 170-174.
  20. Sponsored by the Centre for Research & Implementation of Clinical Practice (U.K.). Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160). Available online at www.clinicaltrials.gov.
  21. Su EP, Perna M, Boettner F et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br 2012; 94(11 Suppl A):153-6.
  22. Tastaban E, Soyder A, Aydin E, et al. Role of intermittent pneumatic compression in the treatment of breast cancer-relatedlymphoedema: a randomized controlled trial. Clin Rehabil. Feb 2020; 34(2): 220-228.
  23. Uzkeser H, Karatay S, Erdemci B, et al. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. May 2015; 22(3):300-307.

POLICY HISTORY:

Medical Policy Group, January 1993

Medical Policy Group, September 1995

TEC Assessment, July 1998

Medical Policy Group, September 1999

Medical Policy Group, May 2000

BCBSA Medical Policy Panel Review, July 2002

Medical Policy Group, June 2003 (2)

Medical Policy Administration Committee, June 2003

Available for comment July 1-August 14, 2003

Medical Policy Group, June 2005 (1)

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, June 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 5-August 14, 2006

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 15-September 28, 2006

Medical Policy Group, October 2006 (2)

Medical Policy Administration Committee, October 2006

Available for comment November 3-December 17, 2006

Medical Policy Group, October 2007 (2)

Medical Policy Administration Committee, November 2007

Available for comment November 17-December 31, 2007

Medical Policy Group, December 2008 (2)

Medical Policy Administration Committee, January 2009

Available for comments, December 17, 2008-January 30, 2009

Medical Policy Group, May 2011(2): Updated Description, Key Points, and References

Medical Policy Group, June 2011(2): Updated Policy, Key Words

Medical Policy Administration, June 2011

Available for comment June 23 – August 28, 2011

Medical Policy Panel, August 2011

Medical Policy Group, September 2011 (2): Description, Policy, Key Points, Key Words, References updated

Medical Policy Administration Committee, October 2011

Available for comment November 11 through December 27, 2011

Medical Policy Panel, January 2012

Medical Policy Group, March 2012 (2): Updated related to non-coverage of end-diastolic pneumatic compression boot as treatment of peripheral vascular disease or lymphedema Description, Policy, Key Words, Approved Governing Bodies, Key Points, and References

Medical Policy Administration Committee, March 2012

Available for comment March 15 – April 30, 2012

Medical Policy Panel, August 2012

Medical Policy Group, September 2012 (2): Policy reviewed with literature search through June 2012.  Statement on 2-phase pumps deleted. Assessed that 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. Description, Key Points, Key Words and References updated to support new Policy statement.

Medical Policy Administration Committee, September 2012

Available for comment September 18 through November 1, 2012

Medical Policy Group, November 2012: Added new Code- E0670, effective 1/1/13

Medical Policy Panel, January 2013 End-Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

Medical Policy Group, March 2013 (2): Added note for policy #515 Outpatient Use of Limb Pneumatic compression Devices for Venous Thromboembolism Prophylaxis.  No new info found to change policy statement re: End-diastolic pneumatic compression boots.

Medical Policy Group, April 2013(4): 2013 Update - Added Key Points and References related to cryopneumatic devices.

Medical Policy Panel, October 2013

Medical Policy Group. January 2014 (2): Policy reviewed with literature search through August 2013. “When applied to the limb” added to coverage statements. Policy statement to non-cover for venous ulcers added. Key Points and References updated to support policy statement changes.

Available for comment January 10 through February 25, 2014

Medical Policy Group, March 2014 (2): Corrected paragraph 3 to delete coverage statement for venous ulcers. 

Medical Policy Group, June 2014 (5): Removed (except venous stasis ulcers as described above) from paragraph 10 since coverage statement for venous ulcers was removed March 2014.

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (5): Policy update- Added Key Points, Approved Governing Bodies, and References updated regarding venous ulcers and breast cancer related lymphedema.  No change to policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (6): Updates to Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Group, October 2015 (6): Clarifications to policy statements – “primary”, “including, but not limited to” and “or chronic venous insufficiency”; no change in policy intent.

Medical Policy Group, July 2016 (6) Removed “Primary/True” from policy statement.

Medical Policy Group, January 2017 (6): Updates to the Key points to include literature for the Game Ready® device. Edited policy statement for “Game Ready” device, removed “for the treatment of acute or chronic musculoskeletal injuries or as part of postoperative care.”

Medical Policy Panel March 2017

Medical Policy Group, April 2017 (6) Updates to Description, Key Points, Practice Guidelines and References; Removed old policy statement from 2014.

Medical Policy Group, October 2017 (6): Transferred Game Ready device to MP #364 Cooling and Heating Devices Used in the Home Setting, removed from Key Words.

Medical Policy Group, January 2018 (6): Updated policy statement to include “The use of lymphedema pumps to treat the trunk, chest, head or neck in patients with lymphedema limited to the upper and/or lower limbs is considered not medically necessary and investigational.” Updated code definition for A6545.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6) Updates to Key Points.

Medical Policy Panel, March 2019

Medical Policy Group, March 2019 (6) Updates to Description, Key Points; no changes to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Description and References.  No change to policy statements.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Description, Key Points, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (6): Updates to Key Points, Governing Bodies and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.