SPECIAL ALERT: CMS Announces Revisions to Clinical Trial Policy

On Monday, July 9, 2007, the Centers for Medicare & Medicaid Services ("CMS") published a final Decision Memorandum that amends its Clinical Trials Policy ("CTP") on Medicare coverage for items and services provided to Medicare beneficiaries when they participate in clinical research studies. Although there are only two modest changes in the Decision Memorandum, CMS has signaled that it will revisit this issue in the future. The final Decision Memorandum, which concludes CMS's first reconsideration of the CTP, is available at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=186.

CMS began the reconsideration of the CTP in July 2006, and it published a proposed Decision Memorandum and draft revisions to the CTP on April 10, 2007. Although CMS had proposed several significant revisions to the scope of the CTP, they are all absent from the final Decision Memorandum. CMS noted that due to numerous comments on key issues, it decided to "preserve the status quo" for now and made only two changes to the original CTP that was published in 2000.

  • First, the final Decision Memorandum revises the original CTP to clarify that items or services used in a clinical research study will be covered if they would otherwise be covered outside of the clinical research trial. As revised, the CTP provides that: "Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries ... that are provided in either the experimental or the control arms of a clinical trial except the investigational item or service, itself, unless otherwise covered outside of the clinical trial.?..." (Emphasis added to reflect the language added by the final Decision Memorandum).
  • Second, CMS added a paragraph to the CTP that ties together CMS' Coverage with Evidence Development ("CED") policy with the CTP. Specifically, this new language provides that CMS, through the National Coverage Determination ("NCD") process, may determine that an item or service is reasonable and necessary only in the context of a clinical trial.

Nevertheless, CMS stated that it intends to propose some additional changes soon in order to address stakeholder comments that suggested that Medicare contractors have paid for claims CMS considered to be outside of the original CTP's terms, and to address Medicare policies and statements that the agency acknowledges "may have been confusing or ambiguous." CMS indicated that it intends to open another reconsideration of the CTP and publish a new proposed NCD with a 30-day comment period. This new proposed decision memorandum will build on the numerous public comments CMS has already received. CMS also intends to amend its policies to ensure that they are clear and consistent, and to propose changes to regulations that pertain to clinical trials. It has not yet specified which regulations and policies may be affected.

CMS indicated that it intends to make these revisions soon, so interested parties should watch for additional developments in this area.

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