PDAC Coding Guidelines for Gradient Compression Garments for Lymphedema Treatment

The information presented in this article comes from the current coding guidelines and assessment of products that have been submitted to the PDAC for Code Verification Review.

As of January 1, 2024, section 4133 of the Consolidated Appropriations Act (CAA), 2023 establishes a new Medicare DMEPOS benefit category for standard and custom fitted compression garments as well as additional lymphedema compression treatment items for the treatment of lymphedema that are prescribed by an authorized practitioner.

Per the Medicare Benefit Policy Manual, Chapter 15, §145 Lymphedema Compression Treatment Items, the following gradient compression garments are covered when determined to be reasonable and necessary for the treatment of lymphedema:

1. Standard daytime gradient compression garments; 
2. Custom daytime gradient compression garments; 
3. Nighttime gradient compression garments; 
4. Gradient compression wraps with adjustable straps 

With respect to gradient compression garments/wraps: 

• Gradient compression means the ability to apply a higher level of compression or pressure to the distal (farther) end of the limb or body part affected by lymphedema with lower, decreasing compression or pressure at the proximal (closer) end of the limb or body part affected by lymphedema.
• Custom fitted gradient compression garment means a garment that is uniquely sized and shaped to fit the exact dimensions of the affected extremity or part of the body, of an individual to provide accurate gradient compression to treat lymphedema. 

This article’s objective is to guide manufacturers and distributors in providing the necessary information to the Pricing, Data Analysis, and Coding (PDAC) contractor for the correct coding of gradient compression garments. The following requirements should be included with the Code Verification Review (CVR) application and specified on the Section C form for Gradient Compression Garments.

Requirement 1:  Garment/Wrap Location

Review Criteria: The CVR application must clearly identify the body region where the garment or wrap is intended to be worn. Examples include glove, gauntlet, arm, shoulder, head/neck, bra, torso, genital, thigh, foot, toe, etc.

Requirement 2: Verification of Gradient Compression

Review Criteria: Manufacturers must demonstrate that their product(s) provide gradient compression.  The CVR application must include a numerical pressure range that conveys the garment’s gradient compression. To qualify, the garment or wrap should exert varying pressure levels on at least two distinct points when worn on the body. The applicant should specify all available gradient compression ranges for the product line by providing minimum and maximum values for each item (e.g., 18-30 mmHg). Qualitative and/or quantitative testing documentation must accompany the application to support the accuracy of the stated compression ranges. This requirement applies to both standard and custom garments, and the method of evidence is up to the submitter.

Requirement 3: Measurements for custom gradient compression garments

Review Criteria: When requesting a HCPCS code for a custom gradient compression garment, manufacturers must indicate the number of measurements required for fabrication. It is recommended to provide an example order form as supporting documentation depicting the anatomical landmarks for the corresponding measurements. Based on PDAC’s assessment and review of custom gradient compression garments, a suggested minimum number of measurements per custom gradient compression garment HCPCS code has been specified in the following table. Applicants should aim to meet or exceed these respective measurement requirements in their CVR application. 

Table 1:  Minimum Number of Measurements Suggested for Custom Lymphedema Garments

Source: PDAC

Additionally, to facilitate the code review process, applicants submitting for a lymphedema compression treatment item HCPCS code should provide either a sample of the item or detailed marketing information, including a picture of the item. This additional information must accompany the CVR application at the time of submission.

Finally, the PDAC would like to remind submitters that in addition to the completed application and required documentation, please provide any relevant information that further validates the requested code in your submission (e.g., nighttime use). The PDAC’s review and code decision rely on the information provided by the applicant.

If you have questions, please contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit our website to chat with a representative or select the Contact Us button at the top of the page for email inquiry, FAX or postal mail information.