A Michigan-based podiatry practice and its medical supplier are suing the Biden administration, alleging the arbitrary denial of coverage of human cell and tissue-based products for patients with osteoarthritis, tendonitis, and other orthopedic conditions.
In a complaint filed Tuesday in the US District Court for the District of Columbia, podiatry practice Macomb Foot, Ankle & Wound Care and StimLabs LLC, a manufacturer of placental-derived biologic products, alleged the Centers for Medicare & Medicaid Services misinterpreted FDA guidance by adopting a national non-coverage policy for “experimental exosome biologic products” to include products derived from placental and amniotic tissues.
The filing says ...
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