L5017-LCD

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Local Coverage Determination (LCD) for Pneumatic Compression Devices (L5017)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L5017

LCD Title Pneumatic Compression Devices

Contractor's Determination Number PCD

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2012 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Primary Geographic Jurisdiction

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993

Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/05/2011

Revision Ending Date

CMS National Coverage Policy

CMS Pub. 100-3, (Medicare National Coverage Determinations Manual), Chapter 1, Section 280.6 Indications and Limitations of Coverage and/or Medical Necessity

For 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. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

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 reasonable and necessary.

LYMPHEDEMA:

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 an excessive production of lymph. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy), post-radiation fibrosis, and spread of malignant tumors to regional lymph nodes with lymphatic obstruction, among other causes.

Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient 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 trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS:

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.

Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a six month trial of conservative therapy directed by the treating physician. 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.

GENERAL COVERAGE CRITERIA:

LYMPHEDEMA:

CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS:

GENERAL COVERAGE CRITERIA:

For either lymphedema or CVI with venous stasis ulcers, pneumatic compression devices are covered only when prescribed by a physician and when they are used with appropriate physician oversight, i.e., physician evaluation of the patient's condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.

The determination by the physician of the medical necessity of a pneumatic compression device must include (1) the patient's diagnosis and prognosis; (2) symptoms and objective findings, including measurements which establish the severity of the condition; (3) the reason the device is required, including the treatments which have been tried and failed; and (4) the clinical response to an initial treatment with the device. The clinical response includes the change in pre-treatment measurements, ability to tolerate the treatment session and parameters, and ability of the patient (or caregiver) to apply the device for continued use in the home.

When a pneumatic compression device is covered, a non-segmented device (E0650) or segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs of the patient. A non-segmented compressor (E0650) with a segmented appliance/sleeve (E0671- E0673) is considered functionally equivalent to an E0651 compressor with a segmented appliance/sleeve (E0667-E0669). When a segmented device with manual control of the pressure in each chamber (E0652) is ordered and provided, the claim will be denied as not reasonable and necessary unless there is clear documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device (E0650) with a segmented appliance/sleeve (E0671- E0673) or a segmented device without manual control of the pressure in each chamber (E0651).

Appliances used for pneumatic compression of the chest or trunk (E0656 and E0657) will be denied as not reasonable and necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIER:

EY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

E0650 PNEUMATIC COMPRESSOR, NON-SEGMENTAL HOME MODEL

E0651 PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITHOUT CALIBRATED GRADIENT PRESSURE E0652 PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITH CALIBRATED GRADIENT PRESSURE E0655 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF ARM E0656 SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, TRUNK

E0657 SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, CHEST

E0660 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL LEG E0665 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL ARM E0666 NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF LEG 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 E0671 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL LEG

E0672 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL ARM E0673 SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, HALF LEG

ICD-9 Codes that Support Medical Necessity AsteriskNoteText

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

A Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it contains all of the required elements of an order. The CMN for pneumatic compression pumps is CMS Form 846 (DME Form 04.04B). The initial claim must include an electronic copy of the CMN.

If question #1 on the CMN ("Does the patient have chronic venous insufficiency with venous stasis ulcers?") is answered "Yes", documentation reflecting all of the following must be in the patient's medical record and made available upon request:

1. The location of venous stasis ulcer(s),

2. How long each ulcer has been continuously present,

3. Previous treatment with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for at least the past 6 months,

4. Evidence of regular physician visits for treatment of venous stasis ulcer(s) during the past 6 months.

If E0652 is billed, the following additional documentation supporting the medical necessity for this device must be substantiated by information in the patient's medical records and available upon request:

1. The treatment plan including the pressure in each chamber, and the frequency and duration of each treatment episode,

2. Whether a segmented compressor without calibrated gradient pressure (E0651) or a non-segmented compressor (E0650) with a segmented appliance (E0671-E0673) had been tried and the results,

3. Why the features of the device that was provided are needed for this patient,

4. The name, model number, and manufacturer of the device.

Questions pertaining to medical necessity on any form used to gather the above information may not be completed by the supplier or anyone in a financial relationship with the supplier. The information on the form must be supported by documentation in the patient's medical record and made available upon request.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision

Reserved for future use. Advisory Committee Meeting Notes

Start Date of Comment Period 04/16/1993

End Date of Comment Period 05/31/1993

Start Date of Notice Period 08/01/1993

Revision History Number 008

Revision History Explanation Revision Effective Date: 02/04/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Deleted: Least Costly Alternative for HCPCPS code E0652

Revision Effective Date: 01/01/2009 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Statement regarding appliances for the chest and trunk HCPCS CODES AND MODIFIERS:

Added: E0656 and E0657

03/01/2008 - In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

06/01/2007 -In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 01/01/2007 DOCUMENTATION REQUIREMENTS:

Revised: CMN form number and instructions. LCD ATTACHMENTS:

Deleted: Previous CMN Added: New CMN

03/01/2006 -In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006

LMRP converted to LCD and Policy Article. DOCUMENTATIONS REQUIREMENTS:

Removed: Requirement of extra documentation to be sent in with claim if E0652 and/or question #3 or #4 of the CMN is answered yes.

Revision Effective Date: 04/01/2003 HCPCS CODES AND MODIFIERS:

Added: EY modifier to HCPCS Modifier array INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Standard language concerning coverage of items without an order DOCUMENTATION:

Added: EY verbiage OTHER COMMENTS:

Moved definitions of lymphedema and CVI here

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

04/01/2002 - Based on a CMS National Coverage Decision, the distinction between lymphedema and chronic venous insufficiency and the respective coverage and payment rules for use of these devices for either condition is further clarified.

03/01/1998 – Removed HCPCS code E0670 and removed language for that code in Coding Guidelines section 10/01/1995 – Revised descriptions for HCPCS codes and added codes E0669-E0673. Revised to clarify (1) that

nonsegmented and segmented pump with manual control of pressure in each chamber is considered the least

costly alternative that meets the clinical needs of the individual for this type of durable medical equipment (HCPCS codes E0650 and E0651), unless there is documentation that warrants payment of the more costly manual control pump (HCPCS code E0652); (2) the documentation needed for determination of the type of pump to be used for the treatment of lymphedema; and (3) which pneumatic compression pump is appropriate for chronic venous insufficiency.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Reason for Change Maintenance (annual review with new changes, formatting, etc.)