PNEUMATIC COMPRESSION DEVICES COVERAGE REVISIONS FOR LYMPHEDEMA
The National Coverage Determination (NCD) 280.61 for pneumatic compression devices (PCDs) was implemented more than 20 years ago on January 14, 2002. Shortly thereafter, the durable medical equipment Medicare Administrative Contractors (DME MACs) released PCDs local coverage determinations (LCDs) and local coverage articles (LCAs). Since then, manufacturers, professionals, and patients have repeatedly collaborated with the DME MACs to refine the coverage documents. In recent years, these stakeholders have been trying to eliminate the requirement of serial 4-week conservative trials for Medicare beneficiaries with lymphedema to continue use of covered PCDs. These serial trials presented an unnecessary barrier to access for these beneficiaries.
In 2023, the LCAs and the LCDs pertaining to PCDs were refined, providing great coverage news for Medicare beneficiaries with primary or secondary chronic or severe lymphedema and the physicians and other qualified healthcare professionals (QHPs) who prescribe PCDs. These coverage refinements were created and implemented because of the successful US District Court, District of Columbia decision in Greenwald v. Becerra (decided June 7, 2022). Let us look at the portions of the LCD and LCA coverage refinements that positively impact all lymphedema stakeholders.
Revision to PCD Article A62488
On January 1, 2023, both DME MACs released a revision to their PCD Article (A62488),2 retroactive to the June 7, 2022 court decision. Because this LCA contains valuable coverage guidance, physicians; QHPs; and DME, prosthetics, orthotics, and supplies (DMEPOS) suppliers should read the entire LCA, not just the revision.
The lymphedema-pertinent revision is in the section entitled "Policy Specific Documentation Guides" under the "GENERAL" heading. Previous versions of the LCA listed three guidelines. The third guideline that referred to serial trials was removed from the revised LCA (Table 1).
1. For PCDs coded E0650 or E0651 the medical record must contain sufficient detailed and specific information to show that the applicable coverage criteria for I - LYMPHEDEMA or II - CHRONIC VENOUS INSUFFICIENCY WITH VENOUS STASIS ULCERS (CVI) are met.
2. For PCDs coded as E0652 the medical record must contain sufficient detailed and specific information to show that the applicable coverage criteria in III - LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN are met.
Revision to PCD LCD L33829
On July 13, 2023, both DME MACs released a revision to PCD LCD L33829,3 also retroactive to June 7, 2022. This LCD contains valuable coverage and documentation guidelines that make it a "must-read document" for all physicians/QHPs who order PCDs for their Medicare patients to use at home and all DMEPOS suppliers who provide PCDs to Medicare beneficiaries.
The important revisions are in the section entitled "Coverage Indications, Limitations, and/or Medical Necessity" under the heading "4-Week Trial for Lymphedema." The serial trial requirement (Table 2) was removed from the 4-week trial guidelines. The LCD now reads as follows:
A four-week trial of conservative therapy demonstrating failed response to treatment is required. The four-week trial of conservative therapy must include all 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
When available, manual lymphatic drainage is a key component of conservative treatment as is appropriate medication treatment when there is concurrent congestive heart failure.
The medical necessity determination for a PCD by the treating practitioner must include symptoms and objective findings, including measurements, to establish the severity of the condition.
The documentation by the treating practitioner of the medical necessity of a PCD 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; and
* The clinical response to an initial treatment with the device.
The trial of conservative therapy must be documented in the beneficiary's medical record before prescribing any type of PCD (E0650, E0651, 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.
New Documentation Checklist for PCDs
On July 31, 2023, CGS released a documentation checklist that provides clear directions for professionals who order PCDs. Download and use the Pneumatic Compression Device Documentation Checklist4 to create your documentation template for PCDs. Please share this great news about the removal of serial 4-week trials with your lymphedema patients and with physicians/QHPs who prescribe PCDs.
ADDITIONAL SURGICAL DRESSING COVERAGE AND DOCUMENTATION GUIDELINES
This author has written multiple articles about the surgical dressings LCD (most recently in the June 2023 column5) and recently co-presented a relevant Words on Wounds podcast with Dr Windy Cole.9 Because all MACs want Medicare beneficiaries to receive medically necessary surgical dressings for use at home, they provide a variety of educational programs and tools for physicians/QHPs and DMEPOS suppliers. To further assist physicians/QHPs, the MACs recently updated a variety of surgical dressing documentation checklists. For example:
* Several MACs published articles entitled "Physicians: Are you ordering surgical dressings for your patients?" Each article includes a clear list of surgical dressing coverage criteria documentation requirements.7-11
* CGS Administrators and Noridian Healthcare Solutions both published the article "Documentation Checklist for Surgical Dressings," which itemizes the information 1) that the DMEPOS supplier must provide to the DME MAC and 2) that must be documented in each patient's medical record.12,13
* Noridian Healthcare Solutions also published two other very useful surgical dressing tools:
The "Clinician Checklist for Surgical Dressings" assists clinicians with coverage and documentation requirements.14 It contains references to the surgical dressing LCD and LCA, the documentation LCA, wounds that qualify for surgical dressing coverage, and the documentation required to support the use of surgical dressings.
The "Surgical Dressings Reference Chart" describes which surgical dressings are covered for various wound depths and amounts of exudate, along with Medicare's recommended frequency of change coverage information.15
All physicians/QHPs who prescribe surgical dressings for patients to use at home should download, read, and implement the learnings from these useful tools.
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