Potentially Far-Reaching Ramifications in LCD Draft Policy for Lower-limb Prostheses

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have released a local coverage determination (LCD) draft policy for lower-limb prostheses; LCDs are the basis for decisions made by a Medicare contractor’s medical review staff in the absence of statute, regulations, or national coverage policy. This particular draft LCD/Policy Article “contains significant revisions from existing Lower Limb Prosthesis medical policy…” and some aspects “appear to be incompatible with quality patient care,” reports the American Orthotic & Prosthetic Association (AOPA).

Industry Concerns

AOPA has released an executive summary of the proposed LCD/Policy Article and has outlined major issues therein, as follows, along with their potential impacts and pathways to improvement:

1. Creates clear definitions and distinctions between immediate, preparatory, and definitive prostheses
2. Language regarding “All Inclusive” nature of prosthetic base codes
3. All additions, adjustments, modifications, replacements, etc. for the first 90 days after delivery of the prosthesis are included in the Medicare payment for the prosthesis
4. Requirements for provision of a preparatory prosthesis
5. Requirements for provision of a definitive prosthesis
6. Acrylic lamination and total contact are considered inherent in the design of the prosthetic socket
7. Serious misinterpretation of socket insert codes
8. Distinction between mechanical suspension and suction suspension
9. Consolidation of foot and ankle codes
10. Prosthetic knee coverage
11. Inconsistency between coverage for ultralight material codes in the LCD and Policy Article
12. Coverage of prosthetic outer surface coverings (skins)
13. Requirement for rehabilitation program
14. Functional level status
15. Requirement for an independent medical examination
16. Adjustments, repairs, and component replacement within 90 days of delivery are no longer separately reimbursable when required due to a change in patient condition
17. Non-coverage of L-5990, adjustable heel height
18. Definition of a custom fabricated socket insert (L-5673, L-5679, L-5681, and L-5683)
19. (Re)programming of microprocessor based components is considered a non-covered service
20. Non-coverage of L-5969
21. Proof of delivery and failure to recognize the validity of prosthetist’s notes

An Össur reimbursement and regulatory blog post addressed this draft LCD as well, and said that the “ramifications are potentially far reaching.” While the blog post said there were “too many changes to easily address in a single post,” it outlined preliminary “top ten” concerns, including new definitions for many terms, such as for different types of prostheses and “Licensed or Certified Medical Professional”; socket code restrictions; two L-Codes for elevated vacuum systems are declared “not reasonable and necessary” due to lack of sufficient clinical evidence; major foot code changes; K1 and K2 patients are restricted to fixed-ankle feet only; and prosthetic cover restrictions.

Comment Period Open Through August 31

This draft LCD is open for public comments from physicians, manufacturers, suppliers, and other professionals involved in the ordering or provision of the items. It requires a 45-day public comment period, which began July 16 and closes at the end of business on August 31. Comments can be e-mailed to the DME MAC medical director at [email protected], or mailed to:

Stacey V. Brennan, MD, FAAFP
Medical Director, DME MAC, Jurisdiction B National Government Services
8115 Knue Road
Indianapolis, IN 46250-1936

The DME MACs request that disagreement with any aspect of a policy be addressed very specifically in the comments and, if possible, an alternative should be offered. Clinical rationale should also be included, with references from the published clinical literature (e.g., standard textbooks, peer-reviewed journals, etc.).
The comment process also requires a public meeting, which will be held as a joint DME MAC meeting on August 26 in Linthicum, Maryland; interested parties from any DME MAC jurisdiction may attend. Registration for the public meeting must be completed by close of business on August 21. The meeting will provide opportunities for brief oral presentations only; there will be no question-and-answer or discussion period. In order for oral presentation comments to be considered, they must be presented through the formal comment process.

To read the full instructions for comments, click here.