To: From: Sent: Subject: Steven Stranne[SStranne@Polsinelli.com] Shah, Anand (CMS/CMMI) Tue 3/27/2018 2:43:15 PM RE: Innovation Demo for ESRD Hi Steve – Thank you for your note on Rockwell’s proposal. We have carefully reviewed your concept and submitted materials. Unfortunately, given the other initiatives CMS has underway, we will not be able to pursue this model. I appreciate you and Rob Chioini coming to CMMI to present Rockwell’s idea, as well as the continued follow up with us. Anand Anand Shah, MD, MPH Chief Medical Officer Center for Medicare & Medicaid Innovation Centers for Medicare & Medicaid Services From: Steven Stranne [mailto:SStranne@Polsinelli.com] Sent: Saturday, March 24, 2018 4:51 PM To: Shah, Anand (CMS/CMMI) <Anand.Shah1@cms.hhs.gov> Subject: Innovation Demo for ESRD Dr. Shah, I am writing to follow up on the proposal we submitted in October of 2017 for a potential CMMI project for new, transformative therapies that are likely to significantly control overall costs and improve care for Medicare beneficiaries with end stage renal disease (ESRD). Thanks again for meeting with us, along with your colleagues in the Innovation Center, in November, 2017. As time continues to pass, I urge you and the CMS leadership team to adopt and expedite this proposal. The demonstration would enable the Agency to select, evaluate, and support transformative innovations like Triferic that have reasonable pricing and that show promise to improve care, reduce complications, and save the Medicare program money. The Agency would retain significant control over decisions involving the innovations to be selected for the demonstration and the ongoing payment policies. We need to break down barriers to innovations that can deliver value, save federal resources, and improve care in this vulnerable and expensive patient population. Our proposal would result in good policy that would disrupt and refine the counterproductive aspects of the status quo. As you may recall, there is significant support for our proposal in the ESRD community and in Congress. Although this list is not inclusive, recall that well-respected patient advocacy groups such as the American Association of Kidney Patients (AAKP) and Dialysis Patient Citizens (DPC) support this proposal. In addition to a number of other stakeholders in the provider and ESRD communities, many Members of Congress in the House and Senate have communicated their support through letters and other means, including but not limited to Chairman Brady and his staff. Please let us know what we can do to be helpful. This proposal provides a straightforward way to ensure that the Medicare program can identify and harness reasonably-priced innovation in a way that improves lives and holds down overall health costs. That seems to fall squarely within the Administration’s objectives and the Innovation Center’s mission. We encourage you to adopt this proposal and to do so quickly. Thanks again for your help, Steve Steven Stranne, MD, JD Shareholder, Polsinelli PC 202-626-8313 sstranne@polsinelli.com http://www.polsinelli.com/sstranne/ 1401 Eye Street, NW Suite 800 Washington, DC 20005