Exploring the Latest LCD Updates for CAMPs: What You Need to Know

This morning (November 14, 2024), the MACs finalized the LCD impacting coverage for skin substitute products that were listed in the proposed updates. These changes will be effective February 12, 2025, for all MACs. Excerpts from the LCD are below, along with the link for each MAC's rule. The LCD has been postponed until January 1,2026.

Coverage requirements for skin substitute grafts/CTP

To qualify as a skin substitute graft/CTP, the product must be:

1. A non-autologous human cellular or tissue product (e.g., dermal or epidermal, cellular and acellular, homograft or allograft), OR non-human cellular and tissue product (i.e., xenograft), OR biological product (synthetic or xenogeneic) which is applied as a sheet, allowing the scaffolding for skin growth that is intended to remain on the recipient and grow in place or allow recipient’s cells to grow into the implanted graft material AND

2. Have quality supporting evidence to demonstrate the product’s safety, effectiveness, and positive clinical outcomes in the function as a graft for DFUs and/or VLUs. Predicate products are not sufficient evidence for an individual product.

Covered Indications

If the patient meets all criteria as outlined in this LCD, the application of a skin substitute graft/CTP in the treatment of DFUs and VLUs is considered medically reasonable and necessary for the following conditions:

1. The presence of a chronic, non-infected DFU having failed to respond to documented SOC treatment (outlined below) for a minimum of 4 weeks with documented compliance.

2. The presence of a chronic, non-infected VLU having failed to respond to documented SOC treatment (outlined below) for a minimum of 4 weeks with documented compliance. For purposes of this LCD, SOC treatment includes:

   • Comprehensive patient assessment (history, exam, Ankle-Brachial Index [ABI]) and diagnostic tests as indicated in an implemented treatment plan.

   • For patients with a DFU: assessment of Type 1 or Type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis), review of current blood glucose levels/hemoglobin A1c (HbA1c), diet and nutritional status, activity level, physical exam that includes assessment of skin, ulcer, ABI, and assessment of off-loading devices or use of appropriate footwear.

   • For patients with a VLU: assessment of clinical history (prior ulcers, phlebitis), physical exam (edema, skin changes), ABI, evaluation of superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis. The use of a firm strength compression garment (>20 mmHg) or multi-layered compressive dressings is an essential component of SOC for venous stasis ulcers.

3. An implemented treatment plan demonstrating all the following:

   • Debridement as appropriate to a clean granular base.

   • Documented evidence of offloading for DFUs and some form of sustained compression dressings for VLUs.

   • Infection control with removal of foreign body or nidus of infection.

   • Management of exudate with maintenance of a moist environment (moist saline gauze, other classic dressings, bioactive dressing, etc.).

   • Documentation of smoking history, and counseling on the effect of smoking on wound healing. Treatment for smoking cessation and outcome of counseling (if applicable).

4. The skin substitute graft/CTP is applied to an ulcer that has failed to heal or stalled in response to documented SOC treatment. Documentation of response to treatment requires measurements of the initial ulcer, pre- and post-completion of at least 4 weeks of SOC, with additional measurements at initial placement, and each subsequent placement of the skin substitute graft/CTP. Standard of care measures without measurable signs of healing must have preceded the application for a minimum of 4 weeks and must continue for the course of therapy. Continuous compression therapy for VLUs must be documented for the episode of care.

5. The medical record documentation must include the interventions that have failed during prior ulcer evaluation and management. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous ulcer evaluation, and explanation of the planned skin replacement with the choice of skin substitute graft/CTP. The procedure risks and complications must also be reviewed and documented.

6. The patient is under the care of a qualified physician/NPP for the treatment of the systemic disease process(es) etiologic for the condition (e.g., venous insufficiency, diabetes, neuropathy) and documented in the medical record.

LCDs: 

Noridian Healthcare Solutions, LLC - DL39764

Noridian Healthcare Solutions, LLC - DL39760

First Coast Service Options, Inc. - DL36377

Novitas Solutions, Inc. - DL35041

Palmetto GBA - DL39806

National Government Services, Inc. - DL39828

Wisconsin Physician's Service Insurance Corporation - DL39865

CGS Administrators, LLC - DL39756