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Q. Why are four-week trials impossible to achieve? The condition just seems to be medical supervision of trial by a physician.

A. What is bad is that the trial conditions imposed in the LCD to justify obtaining a pneumatic compression device and appliances have been made impossible to achieve and medically questionable.

In order to obtain the simplest pneumatic compression device (E0850 or E0651) for treatment of lymphedema, all of the following must be completed:

  1. Diagnosis of "chronic and severe" lymphedema, and
  2. Documentation of at least 6 months of skin breakdown, and
  3. Non-responsiveness to a 4-week trial of "conservative" clinical treatment.
    1. Compression, MLD, medications as required, exercise and elevation.
    2. If improvement is evident after the 4-week trial, the pump is not justified, and the 4-week trial must be repeated until there is no further response.

So why do I say that meeting the pump criteria is "impossible"? First of all the patient cannot even enter the 4-week trial until there is severe lymphedema with 6 months of skin breakdown. This condition was written by persons confusing lymphatic with venous conditions -- a distinction I thought CMS learned 14 years ago when they separated these medical conditions and they rewrote the NCD on pumps. [see the FAQ on pump denial at faqs-pump_denial.php. Lymphedema in its treatable stages is not defined by skin breakdown. And by the time this state is reached, irreversible changes in the tissue have occurred which were preventable with earlier intervention.

The second problem is that the 4-week trial of conservative treatment is exactly the definition of complete decongestive therapy (CDT), which involves bandaging and compression garments which are not covered by Medicare, 4 weeks of manual lymph drainage which exceeds the Congressional cap on therapy, and bandaging by therapists who are not reimbursed for this service. So Medicare requires a trial which they do not cover!

The idea is, that all the while the CDT is effective, a pump is not justified. When the lymphedema is managed, and the CDT is shown to control the lymphedema--then Medicare will approve the pump. But then why do you need it, because having a pump does not eliminate the need to do the CDT and MLD, exercise and compression garments are still necessary to maintain the limb.

The DME MAC Medical Directors are wise in having withdrawn this LCD update. But when are they going to get some knowledgeable medical help from the lymphedema medical community to help them create medically sound practical criteria for pneumatic compression devices used in the treatment of lymphedema in the absence of (venous) ulcers?