BIO Submits Comments Re: ESRD PPS Proposed Rule
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The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled <em>Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program</em>(the “Proposed Rule”).</p>
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Dear Acting Administrator Slavitt:
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program (the “Proposed Rule”).
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. The innovative therapies our members develop have the potential not only to improve patients’ health outcomes, but also to reduce overall healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions, but only if patients have timely access to them.
In the Proposed Rule, CMS proposes a transitional drug add-on payment adjustment, as part of the drug designation process, that we believe has the potential to facilitate the appropriate utilization of new-to-market therapies to drive greater efficiencies in care for the Medicare End-Stage Renal Disease (ESRD) population. Adequate reimbursement for technologies that improve patient health outcomes and/or drive other efficiencies in the provision of care can incentivize their uptake. Moreover, CMS’s proposal to utilize the payment adjustment for at least two years will provide a minimum period over which utilization and cost data can be gathered and analyzed to facilitate adding the new technology into the ESRD Prospective Payment System (PPS) bundled payment in future years. However, we are concerned that the proposed eligibility criteria for obtaining the payment adjustment are overly restrictive and will prevent this policy from motivating the provision of high-quality, efficient, and effective care.
