As discussed in more detail later in this section, we are finalizing the proposed attestation requirement, but with modification to retain the current phrase, to the best of its knowledge and belief. We appreciate the comment that patients will use the MRF to be able to understand the dollar amount for an item or service, but caution that the standard charge information encoded within the MRF reflects the standard charge, or the regular rate established by the hospital for an item or service provided to a specific group of paying patients, which is not necessarily reflective of an individualized charge for an episode of care
The standard multivitamin b12 content may not suffice
Response: We continue to believe that the procedures described by CPT codes 38225, 38226, and 38227 describe the various steps required to collect and prepare the genetically modified T-cells, and Medicare does not generally pay separately for each step used to manufacture a drug or biological product
No human clinical trials have been completed
There is no evidence that doses above 500mcg produce proportionally better results, and clinical trials using 1mg daily did not dramatically outperform lower doses
This absence of hyperglycemic effects makes the peptide safer for individuals concerned about glucose metabolism, and the lack of IGF-1 elevation reduces theoretical concerns about cell proliferation
