Regulatory monitoring and comment may not be one of the more glamorous parts of our advocacy efforts, but they're important and essential. Over the holidays, NCPA submitted comments on several proposals:
We submitted comments to the FDA on recent draft guidance regarding verification systems under the Drug Supply Chain Security Act (also known as the "track and trace" law). All dispensers, including community pharmacists, should have in place protocols to verify suspect and illegitimate product at their pharmacy under the DSCSA. Among many comments, NCPA asked for clarifications on the types of electronic systems that could be used for quarantining suspect product at a pharmacy.
NCPA also submitted comments to CMS on the Part D technical proposed rule, which was published in early November. NCPA supported the proposed expansion of telehealth benefits in Medicaid Advantage plans while highlighting the barriers to pharmacy participation in telehealth. NCPA also recommended that CMS ensure the Medicare preclusion list is updated frequently and consistently to minimize any gap between the time a provider is precluded and the time such information is available to plans.
Finally, NCPA submitted comments to the FDA on the future of the NDC. Comments were in response to a public hearing held on changes to the NDC length and/or format when FDA runs out of five-digit labeler codes. NCPA supported an option to harmonize the NDC assignment with other stakeholders by moving toward a uniform NDC in a 6-4-2 sequenced format at a future date. One standard configuration would offer many benefits to industry stakeholders, including the elimination of patient safety concerns from duplicate NDCs and streamline the reimbursement process.