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
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…
March 20, 2019
BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To…
March 20, 2019
On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy…
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