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BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information

BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.

Dear Acting Director Bassano,

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS/the Agency) Innovation Center New Direction Request for Information (new direction/RFI) released on September 20, 2017. 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. Our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, 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 have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.

As a threshold matter, we would like to reiterate the tenants of CMMI model design, which we believe are essential to incorporate within the context of the guiding principles and central to the development of models outlined in the focus areas of this new direction. The authorizing statute for CMMI, Section 1115A of the Social Security Act, requires that: (1) innovation models "address a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures"; (2) models reducing cost must do so while also "preserving or enhancing the quality of care received by the individuals served in the model;" (3) evaluation of each model is to be conducted, including an analysis of "the quality of care furnished under the model and measurement of patient-level outcomes and patient-centeredness criteria," and such information should be made publicly available in a timely fashion; and (4) in carrying out development of models, CMMI shall "consult relevant clinical and analytic experts" and "use open door forums to seek input from interested parties."

BIO finds that there are key themes within the context of the authorizing statute that should be clearly defined as a part of the guiding principles and the new direction of the Innovation Center. We strongly urge CMS, in moving forward with this new direction to include and adhere to the following in development, implementation, and assessment of all models (discussed further in this letter):

1. Utilize robust and transparent data assessments in the development and evaluation of CMMI demonstration models;
2. Delineate a clear stakeholder engagement strategy and process for collection and incorporation of feedback when CMMI models are being considered, implemented, and evaluated, and for CMMI generally;
3. Assure that CMMI demonstration models represent "true tests" in their size and scope; and
4. Develop patient protection guardrails to ensure quality, patient-centric care is being delivered through each CMMI demonstration model.

Furthermore, within the context of these considerations, CMMI models should prioritize and preserve patient access to innovative therapies, as they serve a critical role in improving patient health outcomes and reducing overall healthcare costs. Models that ensure timely initiation of the most appropriate course of treatment for a patient are aligned with the patient-centric approach of this RFI.