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Regardless of your answer, theres no question the 340B DrugPricing Program remains a critical resource for eligible healthcare providers, enabling them to stretch scarce federal resources to provide essential services to underserved communities. Perform self-audits to proactively identify and address your 340B program gaps.
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP).
10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation.
The alleged actions violated the Hatch-Waxman Act, formally known as the “DrugPrice Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. Gilenya is an oral medication for multiple sclerosis.
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