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External control arms and debunking real-world data myths

pharmaphorum

Still, in 2021, we have seen the industry evolve and develop strategies on how to establish a viable ECA. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. This can require new processes, technologies and an organisation mind shift.”.

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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

The NHC appreciates CMS’ efforts to gather patient-centered data as part of this ICR and its commitment to making the process more relevant for patients and patient organizations. While we acknowledge these improvements, it is important to note that some aspects of the data collection process may remain challenging.

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NHC’s comments in response to the 2025 Notice of Benefit and Payment Parameters (NBPP)

Putting Patients First Blog

Making available more specific information about total costs and coverage will ensure that all consumers have comprehensive information to help them make smart health care decisions. These resources should aim to clarify insurance terms and concepts, aiding consumers in navigating the complexities of selecting a health plan.

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State of Well-Being 2023-2024

The Happy PharmD

Since 2021, pharmacy-related organizations have been addressing stress and burnout in the profession. Or perhaps it’s the constant back-and-forth with insurance companies over coverage? The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

We believe that patient-centric engagement is essential to ensure that the negotiation process leads to outcomes that genuinely benefit patients. Patient Engagement The NHC recognizes and commends CMS’ willingness to improve the listening sessions and the data submission processes. Improving the Data Collection (ICR) Process.

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NHC Comments on the Federal Evidence Agenda on Disability Equity

Putting Patients First Blog

Too often the formal notice and comment process does not reach these marginalized communities and federal agencies must actively work to seek their input in non-traditional ways. This process respects their autonomy by involving them in decision-making to the extent that they are able.

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NHC Comments on Centers for Medicare & Medicaid Services (CMS) in response to the proposed rule Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies

Putting Patients First Blog

As these technologies become increasingly integral to patient care, it is essential for CMS to develop clear and consistent guidelines for the payment and coverage of AI-enabled services. Providing clear guidance, technical assistance, and streamlined processes can help facilitate the adoption of this innovative care model.