The Council for Technology and Innovation (CTI) at the Centers for Medicare & Medicaid Services (CMS) 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. The CTI also promotes the exchange of information on new technologies between CMS and other entities that make similar decisions. The Council, composed of senior CMS staff and clinicians, was established under Section 942 (a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). It is co-chaired by the Director of the Center for Medicare (CM), who is also designated as the Council's Executive Coordinator, and the Director of the Center for Clinical Standards and Quality (CCSQ).
The specific processes for coverage, coding, and payment are implemented by CM, CCSQ, 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 of promoting high-quality, innovative care. The CTI works 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 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.
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 Medicare". This guide outlines decision points, regulation cycles, application deadlines, and points of contact. The intent is to consolidate this information, which is available in a variety of CMS documents and on the CMS web site, in a single user-friendly resource document. Version 1.0 of the guide was posted on August 26, 2008 and version 2.0 is now available in the Download Section below. CTI welcomes comments from the public and will review them for incorporation in future versions.
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 facilitating open lines of communication to better prepare for 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. We continue to invite product developers with specific issues involving the agency to contact us early in the process of product development if there are questions or concerns about the evidence needed for Medicare coverage decisions. For those companies interested in parallel review processes with the Food and Drug Administration, we will facilitate coordinated regulatory actions by both agencies.
Developing Better Evidence for Better Treatment Decisions
The agency issued guidance on Coverage with Evidence Development (CED). CED makes innovative treatments available for Medicare beneficiaries more rapidly in a context where evidence is developed 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.
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 under Part B of Medicare. Initiatives include expansion of certain public meetings, public notices of decisions, revision 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.
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, health policy experts, and other stakeholders with useful information on CTI initiatives. The links below provide useful information on both CTI and Medicare's processes for coverage, coding, and payment.