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Centers for Medicare & Medicaid Services (CMS)’s upcoming review of Coverage with Evidence Development Policy

March 19, 2012

The Centers for Medicare & Medicaid Services (CMS) is convening a public meeting to review Medicare’s Coverage with Evidence Development (CED) Process. The goal of this meeting is to solicit feedback to improve the CED process, so that this policy tool can help CMS make better, informed decisions about promising medical technologies that eventually improve the health outcomes of its beneficiaries. This meeting will be held on May 16th, 2012 in Baltimore, MD. More information on this meeting is available here:


CMTP Response to CMS CED Public Solicitation

January 27, 2012

The Center for Medical Technology Policy submitted a response to the Centers for Medicare and Medicaid Services public solicitation on CED (please see previous post for a link to the public solicitation announcement). CMTP’s response letter can be found at the link below. Comments on the response are welcome from blog readers.
CED comment letter to CMS from CMTP 1-23-12 Final

CMS Solicitation for Public Comment on CED in Medicare

December 30, 2011

The Centers for Medicare and Medicaid Services (CMS) has issued a solicitation for public comment on CED in Medicare. The goal of the solicitation is to improve the implementation, impact, and approach of CED to maximize its benefit to Medicare beneficiaries. The deadline for providing input is January 20, 2012. CMS will weigh public input it receives to issue new guidance for the use of CED in the Medicare program. Please follow the link below for more information on the public comment solicitation and for instructions on submitting your own comments:

Proposals for the Evolution of CED Policy

December 21, 2011

Before the role of CED can be fully determined and embraced there are a number of significant policy issues that will need to be resolved. The first step in resolving these issues is for decision makers to move beyond regarding CED as a set of discrete ad-hoc decisions and to commit themselves to seeing this as a policy worth developing in a systematic way. To a certain extent the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom and the Centers for Medicare and Medicaid Services (CMS) in the United States have already done this but these organizations are largely restricted to making recommendations that a drug should undergo CED without having the power to act on those recommendations. Specifically, they do not have the resources or the authority to dictate the terms of the studies that drugs should be subject to and they do not have the funds to commission CED projects.

Separating the ability to make recommendations without the means to implement them is a recipe for policy failure. Either organizations need to be given the necessary power or there needs to be formal collaboration established between them and those who do have the power, for example between NICE and the National Health Service in the UK. Once this step has been taken then there are other measures that can be considered.

As an example, one possibility is to build in a policy analysis component into new CED projects. Not only would the studies generate new information about the drug being examined but at the same time policy issues could be studied. For instance, if different CED projects adopted different data collection and management strategies these could be compared; interviews could be undertaken with pharmaceutical companies to see if CED altered their research and development priorities; part of process of recruiting patients could involve exploring the ethical issues with them; decision makers could also be queried about their rationale for undertaking particular CED projects. CED for pharmaceuticals offers a way to help ensure appropriate use of medications while at the same time helping to control costs, however at present it is only a policy in the early stages of development and whether it will mature is uncertain.
Special thanks to Dr. Joel Lexchin, Professor in the School of Health Policy and Management, York University, Toronto, Canada for writing this post.

Only in Research (OIR) versus Approval with Research (AWR): An Assessment

November 9, 2011
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Whether widespread approval of a technology should be withheld until research findings are available (an only in research policy), or granted while the research is being conducted, (an approval with research policy), requires a comparison of the value of early access to a technology and the value of additional evidence which will accrue to future patients. Establishing the key principles of what assessments might lead to approval ‘only in research’ (OIR) or ‘approval with research’ (AWR) will enable them to be addressed in an explicit and transparent manner, with wider relevance beyond the National Institute for Health and Clinical Excellence (NICE) and the UK health service. The key findings of research funded by the Medical Research Council and NIHR in the UK to inform when NICE should recommend technologies only in the context of research, has recently been published, with the full report due to be published in early 2012 in the NIHR Health Technology Assessment Journal. Please find the summary of the key research findings here: Uncertainty, evidence and irrecoverable costs: Informing approval, pricing and research decisions for health technologies

This research aimed to establish the key principles of what assessments are needed to inform OIR recommendations and evaluate how these assessments might be informed by additional information and analysis through a series of case studies.

The key principles and assessments needed fall into four broad areas: i) expected cost-effectiveness and population net health effects; ii) the need for evidence and whether the type of research required can be conducted once a technology is approved for widespread use; iii) whether there are sources of uncertainty which will resolve over time; and iv) whether there are significant (opportunity) costs which will be committed and cannot be recovered once the technology is approved.

The sequence of assessment and judgment required is represented as an algorithm, which can also be summarised as a simple set of explicit criteria or a seven point checklist of assessments. This sequence of assessment identifies how different policies might be arrived at; the order in which they might be made; and how similar policies might be arrived at through different combinations of considerations. These principles demonstrate that cost-effectiveness is only a necessary but not sufficient condition for approval since OIR may be appropriate when a technology is expected to be cost-effective. Indeed, if there are significant irrecoverable costs OIR may be appropriate even when research is possible with approval. A more explicit assessment of OIR and AWR, founded on this sequence of assessment and judgement has implications for drug pricing and incentives for evaluative research, as well as the process and the methods of appraisal of health technologies.

The application of the check list of assessment to the series of case studies also show how analysis can be used to consider the value of: i) being able to conduct research while a technology is approved; ii) making evidence that is needed available at launch; and iii) acquiring evidence more quickly. This can inform investments in better data collection, early advice to manufacturers from payers, public investment in transitional and evaluative research earlier in the development process or other incentives for research and development.

The relevance of this work to NICE was evaluated through a series of two workshops involving key stakeholders. The briefing documents, which formed the basis of the workshop presentations and related group discussions, as well as a summary of feedback from participants which informed the recommendations is available here: Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an appropriately designed programme of evidence development

Special thanks to Karl Claxton, Professor in the Department of Economics and Related Studies at the University of York, for writing this post. 

Coverage with Evidence Development in Medicare

February 26, 2011

There is continuing interest among policy makers in the United States about the use of Coverage with Evidence Development (CED) in the Medicare program,   In 2010, the Medicare Payment Advisory Commission (MedPAC), an influential panel of experts that advise the US Congress on Medicare payment policy, commissioned the Center for Medical Technology Policy (CMTP) to complete a detailed review of Medicare’s experience with CED.   The CMTP report was discussed at a March 2010 meeting of the MedPAC, and this discussion provided the basis for several recommendations in the June 2010 MedPAC report to Congress.   With this posting, we have included the CMTP report, the transcript of the MedPAC discussion, and the final MedPAC report to Congress. These documents can be found at the end of this post.

The general conclusions of this program review were that the limited impact of CED as implemented by Medicare is not the result of inherent flaws in concept of CED, but can be at least partially explained by a combination of statutory, methodological, financial and timing issues. The absence of a clear statutory foundation for CED has served as a major impediment to the development of a well-articulated, coherent and consistent policy approach by Medicare. The lack of a designated source of funding to pay for the research costs of CED studies has also led to reliance on other sources of funding, which have inevitably led to compromises in study design and flaws in implementation. Overcoming these limitations and creating a well-crafted, consistent policy framework is possible, but will likely require senior level policy support for CED in the Department of Health and Human Services, or new statutory authority from the Congress to support the policy.

CER and CED in Medicare


MedPAC_Report to Congress_June2010

Linking Payment to Health Outcomes

November 29, 2010

Over the past decade, there has been growing enthusiasm in many countries for linking access to new medical products with a requirement for collection of additional evidence on “real world” and comparative benefits and risk.

In the United States, the approach has been called “coverage with evidence development”, in the UK it is “only in research” and “risk-sharing”, and more recently the terms “access with evidence development” and “managed entry” have been more widely used. It is our hope that this new website will provide a forum for information sharing, dialogue and conceptual development for all of these initiatives that share the common objective of balanced access to new technology with the desire to have better information on how well they work. Read more…

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