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Smokers arent all the same, says Daniel nor is their quitting process
Accordingly, in the CY 2023 PFS final rule (87 FR 69775 through 69777), we revised the regulation in paragraph (vi) of the definition of Opioid treatment services at 410.67(b) to allow the OTP intake add-on code to be furnished via two-way audio-video communications technology when billed for the initiation of treatment with buprenorphine, to the extent that the use of audio-video telecommunications technology to initiate treatment with buprenorphine is authorized by DEA and SAMHSA at the time the service is furnished
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3.3 Example reiterating the importance of involving the regulatory agency early in the experimental development process and to clearly describe the NAMs In the decision summary of a PMTA where five separate in vitro organotypic studies were submitted, it was noted The experimental approach taken in these studies included using methods that are exploratory, have not been independently validated, and have unknown utility for regulatory use
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