By John P. Leonard, MD, and Tracy Roades

2008-01-01

Dr. Leonard is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Director of Hematology/Oncology Clinical Research Program, and Professor of Medicine at Weill Cornell Medical College.

Ms. Roades is the Research Advocacy Manager at ASH.

Last spring, CMS initiated several rounds of proposed revisions to the rules governing Medicare coverage of services provided to beneficiaries enrolled in clinical research studies.

Under the Medicare Clinical Trial Policy, first developed in September 2000, Medicare will pay for certain items and services for Medicare beneficiaries involved in clinical trials. In April, CMS issued proposed revisions to this policy. Some of these had the potential to impact the ability of patients to participate in clinical trials, and therefore could have affected clinical trial accrual and operations in significant ways. ASH submitted comments expressing concern with a number of the proposed revisions.

In commenting on CMS's proposed revisions to its coverage policy, ASH sought to ensure that Medicare beneficiaries are not, in any way, discouraged from participating in clinical trials. ASH's comments to CMS took into account comments and input from the Reimbursement Subcommittee, the Committee on Government Affairs, and the general ASH membership. These comments detailed concerns about proposed new requirements for publication of research study information, the generalization of studies to the Medicare population, and self-certification and deeming (to verify that studies meet certain qualifying criteria). In some of these areas, individual investigators and institutions potentially would have been held responsible for ensuring that new and higher standards were met to ensure that Medicare beneficiaries could participate in trials. Some of these were not fully defined or were beyond the scope of expected conduct of clinical research practice, and therefore had the potential to hinder activities in a significant way.

As a result of the comments submitted by ASH and other organizations during the agency's first reconsideration of the policy, CMS announced in a July 9 Decision Memorandum that it was backing away from the proposed changes and indicated that the agency was "issuing this national coverage determination in order to preserve the status quo with the exception of two changes" — clarifying that items or services under investigation in a clinical trial will be covered by Medicare if they would be otherwise covered outside of a clinical trial and adding language indicating that Medicare could cover routine costs in connection with clinical trials required as a result of a National Coverage Decision (NCD) based on a Coverage with Evidence Development (CED) determination.

However, after issuing the Decision Memorandum, CMS reopened the Clinical Trial Policy for a second reconsideration. ASH once again submitted comments on the proposed revisions and again focused on concerns about proposed new requirements for public release of research study information and self-certification requirements. In mid-October, CMS announced that the final policy would maintain the revisions contained in the July 9 final Decision Memorandum on the policy but negate all of the other proposed changes to the Clinical Trial Policy.

The fact that CMS has, in the end, not made major modifications to how it handles participation for Medicare beneficiaries seems to be good news for ASH members, in that clinical research in hematology and hematologic malignancies should be able to continue without new hurdles to overcome. However, CMS has indicated that it may again reopen the Clinical Trial Policy for another reconsideration in the future and that the agency may still issue one or more proposed rules to modify Medicare regulations pertaining to coverage and payment in connection with clinical trials. ASH members should be alert to updates from the ASH leadership in this area. It is clearly important to both the clinical and research missions of hematologists that clinical research efforts are facilitated rather than hindered and that Medicare beneficiaries have the opportunity to participate in clinical trials both now and in the future.

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