2nd Quarter 2007

Medicare Updates Clinical Research Policy

By John McDermott and Qasim Zaidi

On April 10, 2007, the Centers for Medicare and Medicaid Services (CMS) released its proposed decision for the Medicare National Clinical Trial Policy. This is the first update of the clinical trial policy since its inception in 2000, when the Health Care Financing Administration (now known as CMS) created it in response to an executive memorandum requiring Medicare to pay for routine care costs in clinical trials. Prior to the publication of this memorandum, CMS published a tracking sheet and sought public comment, as well as input from the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) and the Agency for Healthcare Research and Quality (AHRQ).

Below, we summarize the key revisions to the clinical trial policy:

1. The name of the policy has been changed to the Clinical Research Policy (CRP), and contains a definition of clinical research.
2. CMS established general and Medicare-specific standards for a scientifically and technically sound clinical research study. The Medicare-specific standards specify that research studies
   • should not be designed exclusively to test toxicity or disease pathophysiology unless the disease being studied is chronic, life-threatening, or debilitating; and
   • must be registered on the clinicaltrials.gov Web site for Medicare to provide reimbursement of routine costs.
3. CMS established a requirement that all research studies have a written protocol. The study protocol must
   • specify the timing of public release of all pre-specified outcomes, even if outcomes are negative or the study is terminated early;
   • explicitly disclose inclusion criteria and consider relevant subpopulations (as defined by age, gender, race/ethnicity, socioeconomic, or other factors); and
   • explain how the results will generalize to the Medicare population.
   • explicitly disclose inclusion criteria and consider relevant subpopulations (as defined by age, gender, race/ethnicity, socioeconomic, or other factors); and
   • explain how the results will generalize to the Medicare population.
4. Studies will be "deemed" to have met CMS's standards if they meet several criteria. Although we will not discuss the details of these criteria here, studies reviewed and funded by the Department of Health and Human Services (DHHS), the Department of Veterans' Affairs (VA), and the Department of Defense (DOD) will be considered to have met CMS's standards.
5. Study coordinators will no longer be able to "self-certify" their studies. If a study coordinator enrolls Medicare beneficiaries and expects Medicare reimbursement for routine clinical services, the investigators must request certification (if the study does not meet any of the "deeming" criteria).
6. Medicare will only cover routine clinical items and services that are
   • available to Medicare beneficiaries outside of a clinical study (unless they are defined as investigational);
   • used for patient management within the study;
   • required solely for the provision of the investigational item or service;
   • appropriately clinically monitored; and
   • required for the prevention, diagnosis, or treatment of complications.

CMS received several comments in response to its proposed decisions, many concerned about the requirement to publicly disclose sensitive information, such as clinical trial results. CMS responded that full public disclosure is necessary for a clinical trial to get funding through Medicare premiums and U.S. taxpayer dollars; this will be a mandatory requirement.

Some sponsors may not want to relinquish the competitive advantage of keeping their clinical trials outside the public domain and may therefore opt to pay the costs of routine medical services instead of seeking Medicare reimbursement. Performing a preliminary cost-benefit analysis can help weigh the costs for routine medical services against the potential risk of publicly disclosing the trial design and results.

Certain types of studies that Covance and its clients conduct will be excluded from the CRP, including

• simple, non-comparative case reports and case series;
• retrospective analyses that rely exclusively on previously collected administrative records;
• quality assessment, quality improvement, or performance improvement studies; and
• prospective studies in which natural human behavior is observed in a way that does not affect behavior of patients, physicians, and other clinical staff.

Although we do not expect that this policy will have a large impact on the work that is currently conducted by Covance, it is important to keep these changes in mind as we design future studies involving the Medicare patient population. Routine clinical services can constitute a major cost in any clinical research study, and CMS's willingness to pay for these costs should not be overlooked. If you have any questions regarding this policy, please feel free to contact John McDermott at 240/632-3328 or Qasim Zaidi at 240/632-3438.