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Since our policy has been to accept the physician or NPP's signature on the plan of treatment to be their certification of the treatment plan's conditions in the content requirements of 424.24(c)(1)that the patient needs or needed physical therapy, occupational therapy or speech-language pathology services, the services were furnished while the individual was under the care of a physician, NP, PA, or CNS, and the services were furnished under a plan of treatment that meets the requirements of 410.61we proposed that a signed and dated order/referral from a physician/NPP combined with documentation of such order/referral in the patient's medical record along with further evidence in the medical record that the therapy plan of treatment was transmitted/submitted to the ordering/referring physician or NPP is sufficient to demonstrate the physician or NPP's certification of these required conditions

A batch-specific Certificate of Analysis from an independent third-party laboratory is essential

How will benefits and side effects be monitored