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NCD/CED: Successfully defended significant oncology asset from a National Coverage Decision/Coverage with Evidence Development at CMS, which would have markedly reduced sales. To deliver this result, we worked extensively with CMS leadership, HHS, the White House, and a coalition of providers and patients and NIH trial sites.
The Advent of OPPS: Successfully worked with CMS to retool large portions of the agency’s proposals to create a prospective payment system in the outpatient setting. Our aim was to successfully build a coalition to prevent the commoditization of Class III medical devices.
AWP to ASP: Successfully defended AWP-based reimbursement for outpatient cancer hospitals in MMA 2003, directly impacting the financial stability of community cancer centers.
Coding: Successfully reversed CMS policy on shared codes for a product, significantly impacting revenues and pricing strategy. To be successful, we worked closely with CMS leadership and staff, HHS/GC, and trade associations.
Coding: Successfully negotiated legislation requiring timely issuance of C codes at CMS in the MMA, ensuring new technologies could be prescribed at cancer centers without financial burden.
Inpatient Change: Successfully developed and executed New Technology Add-On Payment Reform strategy for a company. This work created a pathway for collection of billing data in Phase III trial, and amended protocols, informed consent forms and manuals to ensure appropriate data collection for CMS. Proven success in working across Congress, CMS, FDA, CDC, and HHS.