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The Council on Technology and Innovation (CTI) at the Centers for Medicare & Medicaid Services (CMS) now oversees the agency's cross-cutting priority on coordinating coverage, coding and payment processes for Medicare with respect to new technologies and procedures, including new drug therapies, as well as promoting the exchange of information on new technologies between CMS and other entities. The Council, composed of senior CMS staff and clinicians, was established under Section 942 (a) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. It is co-chaired by the Director of the Center for Medicare Management (CMM), who is also designated as the Council's Executive Coordinator, and the director of the Office of Clinical Standards and Quality (OCSQ). The specific processes for coverage, coding, and payment are implemented by the Center for Medicare Management, the Office of Clinical Standards and Quality, and the local claims-payment contractors (in the case of local coverage and payment decisions). The CTI supplements rather than replaces these processes by working to assure that all of these activities reflect the agency-wide priority on promoting high-quality, innovative care, and to streamline, accelerate, and improve coordination of these processes and ensure that they remain up to date as new issues arise. To achieve its goals, the Council works to streamline and create a more transparent coding and payment process, improve the quality of medical decisions and speed patient access to effective new treatments. It is also dedicated to supporting better decisions by patients and doctors in using Medicare-covered services through the promotion of better evidence development, which is critical for improving the quality of care for Medicare beneficiaries. CTI is one of six forums that report to the CMS Quality Council, which is chaired by the CMS Administrator. CTI is currently leading a range of important agency initiatives to carry out its mission. Guidance and Predictability for Product Developers The agency plans to continue its Open Door forums with stakeholders who are interested in CTI's initiatives. In addition, to improve understanding of CMS processes for coverage, coding, and payment and how to access them, CTI has developed the "Innovators' Guide to Navigating CMS". This guide outlines decision points, regulation cycles, application deadlines, and points of contact. The intent is to consolidate this information, which is already available in a variety of CMS documents and in various places on CMS' web site, in a single user-friendly resource document. Version 1.0 of the guide was posted on August 26, 2008 and is now available in the Download Section below. CTI welcomes comments from the public and will review them for incorporation in future versions. We continue to invite any product developers with specific issues involving the agency, to contact us early in the process of product development if they have questions or concerns about the evidence that would be needed later in the development process for the agency's coverage decisions for Medicare. For those companies interested in parallel processes with FDA, we will facilitate coordinated regulatory actions by both agencies. (Please see further comments below.) Preparing for New Technologies To enable CMS to more efficiently identify high value technologies and services that will improve healthcare quality and the lives of Medicare beneficiaries, CTI is developing the capacity to better prepare for new kinds of medical innovations. Sharing knowledge with industry and other agencies already engaged in identifying and tracking innovative healthcare solutions will enable CMS to better anticipate and accommodate new technology to assure a more orderly, timely, and appropriate coverage process. In turn, these steps can help promote better support and faster development for valuable innovative technologies. In that vein, CMS components meet regularly with other HHS agencies to explore how processes and decision making might be better aligned. In support of Secretary Leavett's priority on personalized medicine, the CTI also will be examining issues arising in connection with emerging genomic tests and other diagnostic tests that support more personalized use of medical therapies, and how they may be appropriately linked to payment for associated therapies. The goal is to promote the adoption of more targeted approaches to care that can increase quality and avoid unnecessary health care costs. Developing Better Evidence for Better Treatment Decisions The agency recently issued a revised guidance on Coverage with Evidence Development (CED). CED makes innovative treatments available for Medicare beneficiaries more rapidly in a context where we can develop more evidence about how the treatments are being used and their impact. In turn, better evidence on the natural history, risks, benefits, and costs of treatments can help patients and doctors get more out of Medicare's coverage of these treatments. CED coverage may take one of two forms. Under one type, we cover items or services when they are tied to a requirement for collecting more clinical data. This clinical data allows us to ensure the patients who are covered are the ones receiving the treatment. Under the other approach to CED, Medicare coverage may be provided for beneficiaries in approved clinical studies. CMS has reopened its national coverage determination on clinical research, so that we can better clarify how we pay for routine costs of clinical studies, in what kinds of trials, and when and why we can pay for the cost of investigational items in clinical studies. Related to the use of evidence by the agency, we are in the process of rechartering and renaming MCAC to permit this body to more effectively advise the agency on the use of evidence in Medicare's coverage decision making process, and on identifying areas where CMS can promote the development of evidence that can help Medicare beneficiaries get better care. Coding Reforms The agency has implemented a number of initiatives to reform one of its major coding systems, the Healthcare Common Procedure Coding System (HCPCS). These codes are used for durable medical equipment, drugs, devices, supplies, and other items and services paid for under Part B of Medicare. Included are expansions of certain public meetings, public notice of decisions, revisions of forms, elimination of the requirement of six months of marketing data for drugs, and reduction in the requirement for marketing data for non-drug items. The agency is also moving towards replacing the increasingly outmoded International Classification of Diseases, Ninth Edition (ICD-9) coding system, used for coding diagnoses and for services in inpatient settings, with the more flexible and clinically relevant ICD-10 system. ICD-10 will accommodate improved coding for new technology used in inpatient settings. CMS expects to issue a proposed regulation on ICD-10 adoption in the coming months. In addition, electronic reporting of results of clinical laboratory tests, if properly implemented, could dramatically improve the availability of valid, low-cost quality measures for physician and other services. CTI will consider the potential usefulness of Logical Observation Identifiers Names and Codes (LOINC) codes for this purpose and help coordinate consideration of feasibility of implementation of these codes in the Medicare program. Conclusion Through this web page and other outreach initiatives, the CTI aims to provide information on CTI activities to stakeholders including Medicare beneficiaries, advocates, medical product manufacturers, providers, and health policy experts, and other stakeholders with useful information on CTI initiatives. Stakeholders with further questions about Medicare's coverage, coding, and payment processes, or who want further guidance about how they can navigate these processes, can contact the Council or from the "Contact Us" section of the CTI home page. The links below provide useful information on both CTI and Medicare's processes for coverage, coding, and payment.
Page Last Modified: 08/26/2008 11:09:02 AM
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