The current state of skin substitute use in wound care is not sustainable largely due to lack of proper pricing policy and abuse. The Centers for Medicare and Medicaid Services (CMS) is right to seek appropriate controls regarding skin substitute pricing, but attempting to achieve this measure through product exclusion and draconian reimbursement cuts is the wrong approach and will have detrimental impacts. 

1. The rationale for the covered/non-covered list segmentation is not in alignment with FDA’s regulation of tissue products. If CMS is not going to cover products which are permitted to be marketed by FDA, CMS should set out clear requirements for evidence such that products can be covered fairly.

2. The limit on applications is not consistent with the evidence cited or with the clinical needs of real world patients.  This limit will almost certainly result in poorer outcomes, including morbidity.  In many cases, these poorer short-term wound outcomes will translate to higher overall costs of care due to amputation.

3. Manufacturers should support pricing policies that establish a long-term, sustainable environment which maximizes the number of patients treated.

4. Flat rate pricing may be appropriate but the current proposed rate is far too low. The providers most affected by the proposed rate work in the office and mobile environment, but CMS based the proposed rate entirely on data from the hospital outpatient departments, which face very different circumstances and represent a minority of skin substitute usage.

5. CMS and the MACs should abandon the current LCD and draft a more thoughtful and workable policy which will not limit the number of wounds treated or negatively impact outcomes. 

You can help ensure that CMS and the MACs do not move forward with the current proposal. Act now and let your voice be heard!