Medicare Audits of Lymphedema Compression Treatment Items
Dear Supplier,
Medicare has initiated audits of Lymphedema Compression Treatment Items, resulting in further clarification regarding acceptable documentation standards. In the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD), suppliers must adhere to documentation principles outlined in Medicare manuals and publications.
The information below reflects a compilation of published guidance, established documentation principles, clarifications received from the DME Medicare Administrative Contractors (MACs), and insights gained through navigating Medicare audits. This article is not intended to replace official Medicare guidance or serve as an exhaustive resource. For the most current and comprehensive information, please refer to the DME MAC website. Lymphedema Compression Treatment Items.
Coverage Overview
Section 4133 of the Consolidated Appropriations Act (CAA), 2023, established a new Medicare DMEPOS benefit category for standard and custom-fitted compression garments and additional lymphedema compression treatment items to serve a medical purpose.
The new benefit started January 1, 2024, and includes standard and custom-fitted lymphedema compression treatment items for each affected body part:
- Standard and custom daytime and nighttime compression garments
- Gradient Compression wraps with adjustable straps
- Compression bandaging systems and supplies provided during Phase 1 (intensive) and Phase 2 (maintenance)
- Accessories needed for effective use of lymphedema compression treatment (not all-inclusive):
- Donning and Doffing aids (Aids for putting on and taking off compression stockings)
- Fillers
- Lining
- Padding
- Zippers
For Medicare to consider coverage, the beneficiary must have one of these ICD-10-CM codes:
- I89.0 Lymphedema, not elsewise classified
- 197.2 Postmastectomy lymphedema syndrome
- I97.89 Other postprocedural complications and disorders of the circulatory system, not elsewhere classified
- Q82.0: Hereditary lymphedema
If the beneficiary does not have one of the above diagnosis codes, Medicare will deny the claim as not covered:
Documentation Requirements
To simplify, I have broken down the medical documentation requirement into three categories; confirmation of the qualifying diagnosis, justification of medical necessity and justification for custom garments.
In the event of audit, there must be medical records from the prescribing practitioner (MD, DO, NP etc.) confirming the diagnosis of lymphedema. This documentation cannot come from a license clinical medical practitioner (LCMP) such as physical therapist, occupational therapist, or lymphedema therapist even if the medical records are countersigned by the prescribing practitioner. Diagnosis documentation may be older than 12 months from the prescription date; however, justification for medical necessity must be contemporaneous with the order.
In the event of audit, medical records from the prescribing practitioner or LCMP can justify the medical necessity for compression garments and accessories. The medical records should reflect the medical/clinical need for garments and accessories. As a general rule, the prescribing practitioner and the LCMP should not have any financial relationship with the supplier. Any exceptions to those rules must comply with federal and state laws. The medical records justifying medical necessity must be timely and contemporaneous to the prescription date.
The beneficiary’s medical record must clearly substantiate the medical necessity for a custom-fitted gradient compression garment as opposed to a standard, off-the-shelf garment (ready to wear). The prescribing practitioner, LCMP or the fitter can justify the need for custom garments over ready to wear off the shelf garments. It is important to note; a trained fitter is generally an employee of the supplier with financial interests in the claim therefore they cannot justify medical necessity. However, upon receipt of medical records affirmed the medical need, with their knowledge of the products, the fitter can document the need for custom garment. Once the determination is made, this information must be communicated to the prescribing practitioner so he or she can write a SWO to affirm the medical need of the custom garment. This position is supported by the DME MAC’s published Q&A that reads “Can the fitters rather than the practitioner justify lymphedema compression custom fitted vs off-the shelf garments?"
- The fitter may justify the need for custom-fitted; however, the treating practitioner must acknowledge the medical necessity for custom-fitted by completion of a new SWO.”
Custom-fitted gradient compression garments are specifically designed and tailored to match the precise dimensions of an individual’s affected extremity. This ensures accurate gradient compression for the effective management of lymphedema.
Examples of scenarios where a custom-fitted gradient compression garment may be required include (but are not limited to):
- A significant disparity between the proximal and distal limb circumference;
- Presence of skin folds or tissue contours necessitating a specialized knitting pattern;
- Intolerance to the fabric composition of standard, off-the-shelf (ready to wear) garments.
In addition to the medical records, suppliers should also have in their possession and make available the following to Medicare and/or its contractors:
- Standard Written Order (SWO)
- Proof of delivery documentation
- Request for refill/replacement (if applicable)
- Any other documentation specifically requested by Medicare or its contractors
For more information on the SWO, proof of delivery documentation, and refill request, please see the Medicare’s Standard Documentation Requirements for All Claims Submitted to DME MACs Article (A55426).
A friendly reminder: supplier should always respond to all audits timely and monitor the results. If suppliers disagree with the audit determination, you are encouraged to challenge the determination via the administrative appeal process.
If you have additional questions or concerns, please reach out at [email protected]
Sincerely,
Noel Neil JM CDME
Chief Compliance Officer