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CMS Releases Non-Coverage Policy for Amniotic Injectables
LCD Highlights Plantar Fasciitis Studies Three industry-sponsored studies investigating the effects of amniotic and placental-derived products on plantar fasciitis were detailed in the LCD.
The Centers for Medicare and Medicaid Services (CMS) released a Local Coverage Determination (LCD) outlining noncoverage of amniotic and placental-derived product injections and applications for musculoskeletal indications.
One study found a modest clinically significant benefit for pain reduction and functional improvement in the intervention group compared to placebo at the primary endpoint (three months follow-up). The certainty of these results was rated as moderate, with further concern about generalizability to the Medicare population.
The detailed LCD notes “there is insufficient evidence-based literature to support coverage of amniotic and placental-derived products injected or applied, both non-operatively and intra-operatively in the treatment of musculoskeletal conditions or pain related to such.” This guidance does not include discussion on burns, wounds, or ophthalmic conditions. What are Amniotic and Placental-derived Products? Amniotic and placental-derived products are obtained from the placenta of donors, usually, immediately post caesarean-section at full term, and screened for transmittable diseases. These products are made up of varying combinations of amniotic membrane, amniotic fluid, chorionic membrane, umbilical cord, umbilical cord blood, and what is known as Wharton’s jelly. These biological products are being investigated for a multitude of indications, including but not limited to musculoskeletal conditions involving joint pain and back pain, chronic pain in general, dental conditions, alopecia, wounds, and burns. These products are aimed at decreasing pain and increasing function by treating musculoskeletal conditions to heal injury and trauma, slow down degenerative conditions, and effectuate regeneration of tissues.
None of the other studies reported significant differences between groups for measures of pain-related outcomes, nor did they assess function. The alleged shortcomings of the studies led CMS to conclude there is insufficient evidence to support the use of amniotic and placental-derived injections for plantar fasciitis. The LCD noted similar issues with other studies focusing on the spine, upper extremities, and lower extremity osteoarthritis: Due to the lack of randomized controlled trials, poor study designs, small sample sizes, lack of comparators, lack of long-term efficacy and safety data, and high risk of bias in the current body of literature, CMS found there is insufficient evidence to demonstrate efficacy of any amniotic and placentalderived product in the treatment of specific musculoskeletal conditions, whether injected or applied intra-operatively. There is lack of knowledge of intermediate or long-term safety data derived from human clinical trials. Therefore, the CMS issued its non-coverage policy noting that the Medicare Reasonable and Necessary requirements have not been met.
THE OHFAMA JOURNAL | SPRING 2024 | 11