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BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]

May 9, 2016
Andrew M. Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, SW
Washington, DC 20201
Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]
Dear Acting Administrator Slavitt:
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; Part B Drug Payment Model (the “Proposed Rule”).1
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.
BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals. To these ends, we are gravely concerned that CMS has issued a Proposed Rule that will diminish Medicare providers’ ability to obtain Part B therapies, and in turn, threaten patient access to needed medicines. Given these concerns, and the significant deviation of CMS’s proposed approach from the statutory requirements and congressional intent with respect to Center for Medicare & Medicaid Innovation (CMMI) demonstrations, BIO strongly urges the Agency to withdraw the Proposed Rule in its entirety. In its place, CMS should establish an inclusive dialogue with stakeholders to identify discrete opportunities for Part B changes in an evidence-based manner and work collaboratively to develop any future demonstration programs with a scope and approach that align with Congress’s intent in authorizing CMMI...
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BIO Comments Part B Proposed Rule May92016
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