Access & Reimbursement

Breakthrough medicines and biologics have the potential to transform the way we treat some of the most serious and rare diseases, but patient access will be at risk until existing reimbursement policies are updated to reflect the current state of innovation. Novel payment mechanisms that reflect the full value of these transformative therapies, and the promise they bring to seriously ill patients, are needed to sustain this important biomedical progress.

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Robust reimbursement across sites of care:

Ensuring that physicians and other providers can provide access to the most appropriate course of treatment in the preferred setting for each patient is critical. This can be achieved through reimbursement that fully recognizes the value of these therapies and the associated care and services required for their delivery.

Avoiding a one-size-fits-all approach to the coverage of transformative therapies:

Each therapy in the transformative medicines space will have individualized applications and require unique clinical circumstances, even though they may have similarities in mechanism of action or route of administration. Patients will be treated across varying healthcare settings with differing associated care needs by specialized providers with significant experiences and expertise in providing transformative therapies. The reimbursement system should ensure appropriate reimbursement for these therapies and that providers have the ability to provide these groundbreaking therapies through adequate reimbursement for the associated care they deliver. Novel payment approaches should be considered to help facilitate patient access to continued innovations in care and treatment.

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Incorporating transformative therapies into the reimbursement structure upon their approval, and…

The current coverage and reimbursement system is not structured in the most efficient and effective way to ensure timely patient access of these transformative therapies. As more of these therapies come to market, it will be critical for existing coding and reimbursement pathways and timelines to be adequately flexible to provide timely coverage and access of these therapies for patients that need them.

Letters, Comments & Testimony
July 20, 2020
The following letter provides BIO’s feedback on a number of regulatory proposals by the Centers for Medicare & Medicaid Services that would ease barriers to use of value-based purchasing arrangements within Medicaid and commercial plans, broaden definitions of line extension, and place limits…
February 14, 2020
Dear Sir/Madam:  The Biotechnology Innovation Organization (BIO) thanks to the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Qualification Process for Drug Development Tools. BIO is the world's largest trade association…
November 4, 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk. “For many small, innovative…
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