A. Yes, all seven Part A/B MACs were unified in their release of the future policies, adopting nearly identical policy language. Furthermore, the MACs incorporated many of the recommendations made by MIMEDX, the Alliance of Wound Care Stakeholders, the clinical community, and other important stakeholders. For example, evidence requirements are now applied consistently across all products, regardless of the FDA regulatory pathway, and wording throughout for improved clarity.

A. The future effective date is 02/12/2025.

A. Yes. EPIFIX (Q4186) will remain covered for DFUs and VLUs and EPICORD (Q4187) will remain covered for DFUs.

A. No. The MACs provided a path forward for DFUs and VLUs with a longer treatment window based on submitted literature, comments received, and recommendations from SMEs. The application limit has been expanded from 4 to 8, and the duration has increased from 12 to 16 weeks.

A. There is not any type of prior authorization process. However, providers must document attestation of medical necessity using the -KX modifier when more than 4 applications are needed. Providers should be aware that the -KX modifier flags the MACs in case they would like to review the record. This mechanism gives MACs the ability to monitor trends and to review documentation as needed. If a patient requires more than 12 weeks of treatment, providers must document progression of wound closure under the current treatment plan.

A. Yes. A maximum of 8 skin substitute grafts/CTP applications per ulcer will be allowed for the episode of skin replacement surgery (defined as 12-to-16 weeks from the first application of a skin substitute grafts/CTP). Product change within the episode of skin replacement surgery may be appropriate. When more than 1 specific product is used during the 12-to-16-week period, it is expected that the total number of applications or treatments will still not exceed 8.

A. The LCD intent is to cover the products with evidence for the specific condition. The products that have demonstrated evidence for DFUs are covered under DFU ICD-10-CM codes. Similarly, products with evidence supporting their use in treating VLUs are covered under VLU ICD-10-CM codes. To enhance clarity, the LCD has separated the evidence into 2 distinct tables listing products covered for DFUs and VLUs separately. Additionally, these products are now categorized separately in the billing and coding guidelines to further elucidate which products are eligible for coverage based on the indications.

A. Yes the list is final. If additional substantive evidence is published in peer-reviewed journals, a product can be submitted to the MACs for reconsideration or inclusion. A product code cannot be added to the Billing and Coding Article without going through the reconsideration process since Medicare requirements mandate that a coverage change must go through the entire process, including open meetings and comment. It is the intention of the MACs to review literature at least once every 12 months.

A. These LCDs cover skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of DFUs and VLUs in the Medicare population. Other wound types are not addressed.

As always, MACs can place claim edits (independent of the LCD process) that allow or limit coverage. We will need to monitor claim trends, but there is no LCD language that limits coverage outside of DFUs or VLUs.

In absence of National or Local Coverage Determinations, coverage defers to the definition of reasonable and necessary as codified in the Medicare Program Integrity Manual.

A. When fully implemented, Medicare Advantage plans cannot restrict the coverage as outlined in the LCDs. Traditional Medicaid is never required to follow LCDs but do often look to them for guidance when setting their own lists of covered products.

A. Reimbursement methodology is managed by CMS via rulemaking. LCD development addresses coverage at a regional level. Therefore, all Q-coded skin substitute products will continue to report ASP, and (if published on the national file) be reimbursed with an ASP+6% methodology in the private office. There is much discussion about this methodology changing in the future as well.

A. MUEs are managed via a different process, and a different unit of CMS.

A. There are no wound size requirements.

A. The future LCD bestows coverage on products with Level 1 clinical evidence (Randomized Controlled Trials). MIMEDX will continue to clarify evidence requirements. While this is occurring, we believe EPIEFFECT is well-positioned going forward after the RCT is complete.

A. Yes. It is essential that providers document wastage using either the:

• -JZ to attesting there was no discarded amount
• -JW to designate waste (unused)

A. To determine the surface area for application of skin substitute graft codes for multiple wounds, all wound areas within the same anatomic site, as described by the skin application code descriptors, should be added. If the skin substitute graft is applied to wounds on a different anatomic site, they should bill the corresponding application code for the anatomical site for each date of service (DOS).

A. The reason(s) for any repeat application should be specifically addressed in the medical record, including whether the current treatment plan has resulted in wound healing and expectation that the wound will continue to heal with this plan. Documentation should include estimated time for extended treatment, number of additional applications anticipated and plan of care if healing is not achieved as planned.

Documentation must include an assessment outlining the plan for skin replacement therapy and the choice of skin substitute grafts/CTP for the 12-to-16-week period as well as any anticipated repeat applications within the 12-to-16-week period.