Dear Dr. Jacques:
The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers for Medicare and Medicaid Services’ (CMS) Draft Guidance for the Public, Industry, and CMS Staff on Coverage with Evidence Development (CED) in the Context of Coverage Decisions (Draft Guidance). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
As the representative of an industry that is devoted to improving health care through the discovery of new therapies, BIO shares CMS’s desire to use evidence to accelerate Medicare beneficiaries’ access to innovative items and services. Our members invest billions of dollars each year in clinical research to develop and disseminate evidence to help guide the effective use of their therapies. This investment continues long after the Food and Drug Administration’s (FDA’s) stringent approval requirements for each of our therapies are met. We also support Medicare policies, such as the Clinical Trial Policy (CTP), which encourage beneficiaries to participate in clinical research.
As CMS recognized when it first developed principles for applying CED,theneed to provide for a predictable coverage and reimbursement environment is still criticaltoday. The additional costs incurred as a result of a poorly designed and vague CED policy orinappropriate application of CED may culminate in a chilling effect on innovation, harmingpatient care both now and in the future.In addition, if manufacturers are unclear about the rationale for CMS’s application of CED, investment in newmedical technologies may be deterredand patient access to new and improved therapiesmay be delayed. Our comments are provided with these concerns in mind, to ensure that the CED policy achieves its goals without creating unpredictability or hampering future medical innovation.
Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the Context of Coverage Decisions, Nov. 29, 2012, http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=23 (hereinafter “CMS Draft Guidance”).
National Coverage Determination (NCD) Manual, § 310.1.