Smoking during pregnancy and afterwards can increase the chance of sudden infant death syndrome
Second-line agents that have not received an FDA indication for smoking cessation include the prescription medications clonidine and nortriptyline
Key manufacturers operating from states like Rajasthan, Maharashtra, and Delhi also contribute meaningfully to national supply
In cases when NDCs that are marketed under different NDA/BLAs are assigned to the same HCPCS code, using the example in the table in this section, NDC3 (marketed under NDA 111111) was first sold on November 1, 2024, and first billed under HCPCS Y0000, and the first marketed date for HCPCS Y0000 would remain January 15, 2022, as noted, given that HCPCS Y0000 includes NDC2, associated with NDA 000000
More details regarding the PRMR process may be found in the PQM Guidebook of Policies and Procedures for Pre-Rulemaking Measure Review and Measure Set Review
We provided a detailed discussion of these concerns in the CY 2015 PFS final rule (79 FR 67582 through 67591)