Expanding the Coverage with Evidence Development Program to Drive Innovation: Reimbursement for medical treatments is a powerful driver of industry investment. Under the Coverage with Evidence Development (CED) program, Medicare reimburses for promising new technologies that do not currently meet the standard for full coverage. The CED program requires more evidence to be collected to determine full potential benefit of new technologies. The CED authority has existed for more than a decade but has been applied sparingly. The Centers for Medicare & Medicaid Services (CMS) is poised to implement the next phase of CED by better defining the parameters and guidance for CED so it can be used more widely and effectively as a driver of innovation. CMS believes that the lessons learned during the initial implementation of CED can inform its more frequent use and create predictable incentives for innovation while providing greater assurance that new technologies in fact fulfill their initial claims of benefit.
Reducing the Time to Market by Implementing Parallel Regulatory Reviews for Medical Products: FDA approval and CMS coverage significantly influence the development and commercial success of new medical products. The time required for FDA and CMS to sequentially review new medical products—often multiple years—is frequently cited as a disincentive for innovators and investors in the medical technology industry. A significant portion of this delay is due to the fact that most sponsors of new products approach each reviewing agency separately, first working to meet the evidentiary requirements of the FDA and only later focusing on the requirements of CMS. To address this problem, the FDA and CMS initiated a pilot program for the parallel review of medical devices, creating a pathway for new medical products to be simultaneously reviewed by both agencies. By engaging CMS earlier in the process, the parallel review program is expected to limit the duplication of effort on the part of product sponsors and agency reviewers and reduce the time it takes new products to enter the market and receive payments from Medicare and other providers.
Improve Clarity and Transparency of the Medicare Coverage Process
Many stakeholders find the process and standards for the Medicare coverage determination process lack clarity. This proposal requires CMS to issue additional guidance around the Medicare coverage process, including sub-regulatory guidance on the evidence standards that CMS utilizes in assessing coverage and the process to appeal coverage determinations, in an effort to improve clarity around Medicare coverage. [Budget Neutral]
Strengthen the Parallel Review Process to Streamline Medicare Coverage
The Parallel Review program is a collaborative effort between the Food and Drug Administration (FDA) and CMS that reduces the time between FDA approval of a device and Medicare coverage of that item. This proposal strengthens the existing parallel review process to improve device manufacturer participation and increase transparency. [Budget Neutral]
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