Remove 2027 Remove Documentation Remove Drug Pricing
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NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

Putting Patients First Blog

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 drug price negotiations.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). Valuing life differently based on disability status, age, or other special populations is inappropriate.

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NHC Comments on IRA Guidance Response

Putting Patients First Blog

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. The NHC believes that CMS may need to reevaluate methodology for various pieces of the negotiation process, including aggregating drugs to determine MFP.

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March 2024 Newsletter

Safe Biologics

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.