PNEUMATIC COMPRESSION DEVICE (PCD): MEDICAL NECESSITY AND DOCUMENTATION REQUIREMENTS

Pneumatic compression devices consist of an inflatable garment for the arm or leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices. Medicare covers pneumatic devices for the treatment of lymphedema or for the treatment of Chronic Venous Insufficiency (CVI) with venous stasis ulcers. (See the National Coverage Determination Manual (NCD) 280.6)

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. (NCD 280.6)

Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as surgical removal of lymph nodes or post radiation fibrosis, among other causes. (NCD 280.6) 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. (LCD L33829)

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. (NCD 280.6)

Medicare Policy:

Medicare covers PCDs in the home setting for the treatment of lymphedema if the patient has undergone a 4-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. (See the (NCD) 280.6)

Medicare covers PCDs 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 6-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. (NCD 280.6)

The only time Medicare covers a segmented, calibrated gradient PCD (HCPCS code E0652) is when the individual has unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a non-segmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber. (NCD 280.6)

General Coverage Criteria (NCD 280.6)

Medicare covers PCDs only when prescribed by a physician when the physician uses appropriate oversight to:

● evaluate the patient’s condition to determine medical necessity of the device

● assure suitable instruction in the operation of the machine

● provide a treatment plan defining the pressure to be used and the frequency and duration of use

● monitor use and response to treatment on an ongoing basis

The determination by the physician of the medical necessity of a PCD device must include:

● The patient’s 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

● The clinical response to an initial treatment with the device

Note: The clinical response includes the change in pretreatment 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.

Documentation Requirements

The medical record must meet the documentation requirements as outlined in the Local Coverage Articles, A55426 and A52488

Medical Necessity Requirements

E0650, E0651 for Lymphedema (LCD L33829)

• Used to treat lymphedema, when meeting the following requirements:
  • Has a diagnosis of lymphedema as defined above
  • The 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, and
  • In 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.
    • 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 compression
        • Adequate 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 exercise
      • Elevation of the limb

Note: When available, manual lymphatic drainage is a key component of conservative treatment as is appropriate medication treatment when there is concurrent congestive failure.

Note: 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. At 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.

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.

Note: The trial of conservative therapy must be documented in the beneficiary’s medical record before prescribing any type of pneumatic compression device (E0650, E0651). This assessment may be performed by the treating practitioner or any other Licensed/Certified Medical Professional (LCMP) directly involved in the beneficiary’s 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, the treating practitioner must receive and review the report of the evaluation. In addition, the treating practitioner must sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.

Note: 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.

E0650, E0651 for Chronic Venous Insufficiency with Venous Stasis Ulcers (CVI) (LCD L33829)

• 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 extremity
  • One or more venous stasis ulcer(s)
    • Note: 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.
  • The ulcer(s) have failed to heal after a six-month trial of conservative therapy directed by the treating practitioner.
    • 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 compression
  • Adequate 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 failure, etc.)  Regular exercise
• Elevation of the limb
• Appropriate wound care for the ulcer (including sharp debridement where appropriate)

Note: 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.

Note: The trial of conservative therapy must be documented in the beneficiary’s medical record before prescribing any type of pneumatic compression device (E0650, E0651). This assessment may be performed by the treating practitioner or any other licensed/certified medical professional (LCMP) directly involved in the beneficiary’s 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, the treating practitioner must receive and review the report of the evaluation. In addition, the treating practitioner must sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.

E0652 for Lymphedema extending onto the Chest, Trunk, and/or Abdomen (LCD L33829)

• is covered for the treatment of lymphedema extending onto the chest, trunk and/or abdomen when ALL of the following are met:
  • The beneficiary has lymphedema of an extremity as defined above
  • The coverage criteria for an E0650 or E0651 are met
  • The beneficiary has lymphedema extending onto the chest, trunk and/or abdomen that extends past the limits of a standard compression sleeve, and the chest, trunk and/or abdominal lymphedema has failed to improve with a four-week trial.
    • A four-week trial of conservative therapy demonstrating failed response to treatment with an E0650 or E0651 is required. The four-week trial of conservative therapy must include all of the following:
      • At least four weeks of regular, daily, multiple-hour home usage of the E0650 or E0651 after careful, in-person fitting, training and supervision by a technician who is skilled in and who regularly and successfully uses the appliance provided
      • Compliant use of an appropriate compression bandage system or compression garment to provide adequate graduated compression
        • Adequate 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 exercise
    • Elevation where appropriate
    • Manual lymphatic drainage (where available) and self-manual lymphatic drainage (MLD) for at least 30 minutes per day
    • Evaluation of diet and implementation of any necessary change
    • Medications as appropriate (e.g. diuretics and/or other treatment of congestive failure, etc.)

Correction (where possible) of anemia and/or hypoproteinemia

Note: Where improvement has occurred, the trial of conservative therapy must be continued with subsequent reassessment at intervals at least a week apart. When and only when no significant improvement has occurred in the most recent four weeks and the coverage criteria above are still met, an E0652 is eligible for reimbursement.

Note: The trial of conservative therapy must be documented in the beneficiary’s medical record before prescribing any type of pneumatic compression device (E0652). This assessment may be performed by the treating practitioner or any other licensed/certified medical professional (LCMP) directly involved in the beneficiary’s 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, the treating practitioner must receive and review the report of the evaluation. In addition, the treating practitioner must sign and date the report, and state concurrence or disagreement with the assessment. The signature date must be on or before the prescription date.

Note: 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.

PCD related accessories (E0655, E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673) are eligible for reimbursement only when the appropriate, related base PCDs (E0650, E0651, E0652, E0675) meets the applicable coverage criteria for that type of PCD. If the base PCD is not covered, related accessories are not eligible for reimbursement and Medicare will deny such claims as not reasonable and necessary. (LCD L33829)

Resources:

You may want to review the following information to help avoid documentation and medical necessity errors when prescribing PCDs:

● Medicare National Coverage Determination Manual, Chapter 1, Part 4, Section 280.6, Pneumatic Compression Devices https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/ downloads/ncd103c1_part4.pdf

● CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, LCD L33829 – Pneumatic Compression Devices; Effective 10/01/2015; Revised 01/01/2020 https://www.cms.gov/medicarecoverage-database/details/lcd-details.aspx?LCDId=33829

● CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A52488- Pneumatic Compression Devices- Policy Article; Effective 10/01/2015; Revised 01/01/2020 https:// www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52488

● CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A55426- Standard Documentation Requirements for All Claims Submitted to DME MACs; Effective 01/01/2017; Revised 04/06/2020 https://calmedmedical.com/wp-content/uploads/2018/11/A55426.pdf

● Medicare Fee for Service Recovery Audit Program, https://www.cms.gov/Research-Statistics-Dataand-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program