Press Releases

MEDICARE ANNOUNCES DRAFT GUIDANCE FOR NATIONAL COVERAGE DETERMINATIONS WITH EVIDENCE DEVELOPMENT

The Centers for Medicare & Medicaid Services (CMS) today announced its release of a draft guidance to improve the process for making Medicare coverage decisions involving additional evidence development, with the goal of providing better access and greater health benefits from certain medical technologies.

“To get the most benefits for seniors, we are committed to providing access for Medicare beneficiaries to the best care and effective medical technologies,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

“As health care becomes more personalized, better evidence can help doctors and patients use the treatments that Medicare covers more effectively,” McClellan said.  “That means faster coverage expansions, greater access to beneficial treatments, and better health outcomes.”

The purpose of the draft guidance document is to describe and get input from interested stakeholders on the factors that CMS may consider in deciding to extend national coverage for certain items and services in the context of protocol-specified prospective data collection, and how such coverage expansions can be undertaken as effectively as possible.  This policy approach is referred to as coverage with evidence development (CED).

In general, the National Coverage Determination (NCD) process involves a review of scientific and clinical evidence by internal and external experts.  Structured mechanisms for external review may include a commissioned health technology assessment and/or a meeting of the Medicare Coverage Advisory Committee.

The goal of the evidence-based review is to make an informed decision about whether the item or service is “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” the standard set by law for Medicare coverage.

In the specific circumstances in which coverage with evidence development is appropriate, it allows CMS to provide Medicare beneficiaries with faster and broader access to an item or service while also providing support for doctors and patients to use the technology effectively in individual cases.

The draft guidance describes and gives examples of two types of circumstances when the CED initiative may be considered: 1) when a particular medical intervention has been demonstrated to improve health outcomes in a broad population of patients, but the assurance that individual patients are receiving medically necessary care would be significantly more likely to occur when specific data is collected, and 2) when a particular medical intervention has yet to conclusively demonstrate an improvement in health outcomes, but existing information clearly suggests the intervention may provide an important benefit.  In both cases, collection of data for evidence development helps ensure that the care provided to individual patients will improve net health outcomes.

A recent decision involving CED under the first circumstance described above is the implantable cardioverter defibrillators (ICDs) final decision. That decision provided for broad access to a potentially life-saving new treatment, with data collection through systems now being widely used in hospitals.  The registry, which has been developed through a collaborative process involving medical experts, clinical specialists, and product developers, will help provide evidence on the use and course of disease in particular types of Medicare beneficiaries who receive ICDs. This includes many patient groups and settings of care that were not studied in substantial numbers in the clinical trials and some groups in which the clinical evidence of net benefits is less well established.

A recent decision involving CED under the second circumstance described above is the use of certain chemotherapy medications for colorectal cancer in off-label uses where the evidence of benefit is very limited, i.e., where the use is not listed in any major drug compendium.  That is, because few studies have been reported, the evidence base is not sufficient to conclude that the treatment is effective for the use in question, even though it has been shown to be effective in other uses.  The coverage of these drugs in the setting of clinical studies, with important patient protections, helps to develop more definitive evidence faster on whether the treatment is effective for seniors, and provides greater access than would be the case if CMS simply denied coverage. Both of these final decisions may be viewed at the coverage website www.cms.hhs.gov/coverage.

CMS poses numerous questions to the public addressing the following issues concerning CED: 

Factors to consider in applying CED;

• Process for deciding when and how to apply CED;
• Evidence development methods; and
• Process for study design and implementation.

This draft guidance document is available for review on the CMS website at www.cms.hhs.gov/coverage, and CMS is seeking public comment.  In order to ensure CMS considers all public comments, it requests that all comments be submitted by June 5, 2005.  Comments may be submitted on-line to caginquiries@cms.hhs.gov. 

CMS plans to hold an Open Door Form on May 9, 2005 to allow for public dialogue about the CED policy and is encouraging feedback on other potential venues for information sharing.