The Centers for Medicare & Medicaid Services (CMS), the federal agency overseeing major healthcare programs including Medicare, has introduced a significant policy change affecting Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) used in wound care. Medicare, a government health insurance program for individuals 65 and older, now mandates proof of efficacy for HCT/Ps to qualify for reimbursement. This policy shift means that companies must conduct clinical trials to demonstrate the effectiveness of their products.

The CMS has proposed a Local Coverage Determination (LCD) for the use of skin substitute grafts and cellular and tissue-based products (CTPs) in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The LCD aims to create a policy that aligns with current evidence, covering products with peer-reviewed, published evidence supporting their use when standard care has failed. The proposed LCD emphasizes the importance of demonstrating the medical necessity and proper application of these products, ensuring they are used as intended and regulated by the FDA. This proposed LCD was posted on April 25, 2024. The public comment period ended on June 8, 2024, with the final LCD effective date to be determined soon.

Understanding the New CMS Policy

The upcoming Medicare policy for HCT/Ps is a substantial change aimed at ensuring that products used in wound care are both safe and effective. This policy demands that manufacturers of HCT/Ps provide evidence from clinical trials to receive reimbursement coverage. The objective is to safeguard patient health by confirming that the products deliver the claimed benefits.

Regulatory Landscape: FDA vs. CMS

From the FDA's perspective, most HCT/Ps that meet specific criteria under 21 CFR 1271.10 are regulated solely under Section 361 of the Public Health Service Act. This means they do not require premarket authorization or clinical trials. These criteria include minimal manipulation of cells or tissues and homologous use. However, with CMS's new reimbursement requirements, companies producing HCT/Ps for wound care will need to navigate both the regulatory landscape and the new demands for clinical trial evidence.

Amarex Clinical Research: Pioneering Clinical Trials in Wound Care

Amarex Clinical Research, LLC, with over 20 years of extensive experience in managing clinical trials for wound care indications, is well-positioned to help companies navigate this new landscape. The firm's expertise in clinical trial management makes it an ideal partner for companies needing to conduct trials to meet the new Medicare requirements.

Amarex's deep understanding of the regulatory environment, coupled with its robust experience in clinical trials, ensures that it can provide comprehensive support to its clients. This support includes designing and managing trials, ensuring compliance with both FDA and CMS requirements, and ultimately helping companies achieve reimbursement coverage for their HCT/P products.

Seizing the Opportunity

The CMS policy change represents a significant opportunity for growth. By partnering with Amarex, companies can not only meet the new requirements but also gain a competitive edge in the market. Successfully demonstrating the efficacy of HCT/Ps through clinical trials will not only secure Medicare reimbursement but also enhance the credibility and marketability of these products.

This support includes designing and managing trials, ensuring compliance with both FDA and CMS requirements, and ultimately helping companies achieve reimbursement coverage for their HCT/P products.

In conclusion, the new Medicare policy for HCT/Ps used in wound care is a pivotal development in the healthcare landscape. For companies in this field, it presents both a challenge and an opportunity. With Amarex Clinical Research's expertise, companies can confidently navigate this new requirement, ensuring compliance and positioning themselves for success in the evolving market.

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