A newly published study in the Journal of Wound Care confirmed that cellular, acellular and matrix-like products (CAMPs) used to treat hard-to-heal lower-extremity diabetic ulcers (LEDUs) and venous leg ulcers (VLUs) “significantly outperformed” standard of care alone (SoC).
But the study also found no single U.S. Food & Drug Administration’s (FDA) regulatory category — section 361 products; 510(k) devices; or premarket-approval products — clinically outperformed the others.
The study — Rethinking regulatory tiers: Medicare real-world evidence shows CAMP outcomes are independent of FDA regulatory classification — was published earlier this year and is now available via the National Library of Medicine.
“Despite substantial differences in evidentiary requirements, the FDA’s regulatory categories largely distinguish CAMPs by their origin, degree of manipulation and intended purpose, rather than by demonstrated comparative effectiveness,” the study said. “In Medicare beneficiaries with hard-to-heal wounds, the regulatory pathway or category does not meaningfully predict real-world clinical effectiveness.”
The study did show that CAMP therapy plus SOC “regardless of regulatory classification” improved patient outcomes consistently when compared to SoC used alone. CAMP used in conjunction with SoC reduced “complications and hospital utilization across wound sizes and etiologies,” the research said. “The findings indicate that tiered reimbursement frameworks based on FDA regulatory categories lack empirical justification.
“Payment policy should instead prioritize demonstrated improvements in patient-centered outcomes, including reductions in amputations, infections, hospitalizations and total Medicare spending.”
The study said evidence supported a call for “outcome-based rather than regulatory category-based reimbursement for CAMPs and reinforces the importance of timely CAMP initiation,” described as within approximately 30 days.
Researchers performed a retrospective cohort study “using 2.65 million LEDU and 745,411 VLU episodes” taken from CMS’s limited data set from 2016 through 2024. Outcomes tracked included length of wound treatment, CAMP length of treatment, amputations, infections, hospitalizations and deaths.
Differences in outcomes between CAMP regulatory pathways, the study said, “were minimal.” Benefits seen in CAMP-treated patients included “substantially reduced inpatient, emergency department, intensive care unit and coronary care unit use compared with SoC-alone episodes.”
Those better outcomes were consistent across wounds of different sizes and across LEDU and VLU etiologies “with only two VLU exceptions: overall episode LoT and minor amputation rates, which did not differ significantly from SoC after adjustment for multiple comparisons.”
