Medicare Coverage Criteria

Tactile Systems Technology employs a dedicated team of reimbursement specialists to assist therapists and patients in complying with the Medicare policy for an E0652 pneumatic compression device. The policy states that the medical record for a lymphedema patient will contain documentation to meet the following criteria:

Documented diagnosis of lymphedema
Documentation must contain the treating diagnosis.

Symptoms and objective findings including measurements that establish the severity of the condition
Objective data may include actual measurement numbers, stage/grade of lymphedema, and description of fibrosis, pain, open wounds, history of cellulitis, or other data that demonstrates the severity of the patient’s lymphedema.

Evidence of a four-week trial of “conservative therapy” after which there has been no significant improvement in the patient’s condition or significant symptoms still remain
Medicare defines “conservative therapy” as a combination of compression garment/bandaging, exercise and elevation that is performed by the patient at home. All three components should be addressed in the record.

Symptoms that remain after the 4-week trial of self-care must be documented. These symptoms may include persistent edema, fibrosis, pain or impaired skin integrity.

Documented use and failure of a non-segmented, non-calibrated pressure pump
If your patient has previously used a lesser pump at home or in the clinic but discontinued use because it was ineffective, it was exacerbating the patient’s condition, or because it was not tolerated, the results of the trial including specific reasons for discontinuation of that pump must be documented in the medical record.

Or

Documentation of “unique characteristics” that prevent the patient from receiving satisfactory pneumatic compression treatment using a non-segmented, non-calibrated pressure device
• If your patient has not tried a non-calibrated pressure pump but it is your professional opinion as the treating clinician that the patient has other “unique characteristics” that you believe clinically prohibit use of a non-segmented, non-calibrated pressure pump, your documentation should indicate your evaluation of that pump and the basis for your decision to rule it out for this patient.

What are unique characteristics?
Medicare guidance has indicated that if the patient presents with “unique characteristics” requiring “the need to reduce pressure over sensitive areas such as wound sites, ulcers, and painful areas,” that patient may not be able to tolerate use of a non-calibrated nonprogrammable device and that the calibrated pressure and programmability of the Flexitouch (E0652) system is required to address those sensitive areas.

Why the features of the Flexitouch programmable calibrated pressure device (E0652) are medically necessary for your patient
You, as the treating clinician, know your patient best and should document your professional opinion about your patient’s case and should determine the “unique characteristics” that require the features of the Flexitouch system.

Clinical response to a trial treatment with the Flexitouch system
Medicare requires that the patient has had a treatment with the Flexitouch system with documentation of:

  • Pre and post measurements and
  • Ability to tolerate the treatment session and
  • Ability of the patient (or caregiver) to don/doff the device at home

Physician oversight of patient’s treatment plan
Medicare requires physician evaluation of the patient’s condition to determine medical necessity of the device. The Plan of Care, signed by the physician, will generally fulfill this requirement.


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