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Both compounds would benefit significantly from independent replication, chronic safety studies, and -- if warranted by safety data -- carefully designed early human studies

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A few commenters indicated that the allowed amounts encoded in hospitals' MRFs may be much lower than the payer-specific negotiated charge for those items and services if CMS finalizes the requirement to use only EDI 835 ERA transaction data, as hospitals may have ongoing payment disputes with payers at the time the MRF is updated