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President Clinton Signs Executive Memorandum On Medicare Payment For Patient Care Costs During Clinical Trials

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Home Publikationen President Clinton Signs Executive Memorandum On Medicare Payment For Patient Care Costs During Clinical Trials

INTRODUCTION

In a significant deveopment in Medicare coverage policy, on June 7, 2000 President Clinton signed an Executive Memorandum directing the Department of Health and Human Services ("HHS") to cover and pay for the routine patient care costs associated with clinical trials.(fn1) Among other things, this will encourage Medicare patients to participate in clinical trials. These actions follow a recent Institute of Medicine report recommending policy changes to encourage greater use of clinical trials by older Americans and the completion of a review of Administration policy.

PROVISIONS OF THE EXECUTIVE ORDER

The Memorandum directs HHS, acting through the Health Care Financing Administration ("HCFA") to, among other things:

  • Inform all claims processing contractors that Medicare immediately will begin to reimburse for the routine patient care costs as well as costs due to medical complications associated with participation in a clinical trial;
  • Launch activities to increase beneficiary and provider awareness of the new coverage option;
  • Establish a system to track spending in trials for which Medicare contributes financial support;
  • In cooperation with the National Institutes of Health ("NIH"), work with researchers prior to the beginning of a clinical trial to structure the trial to produce information necessary to inform subsequent Medicare coverage decisions when the therapies or devices under review have significant implications for the Medicare program;
  • Review, within 90 days, the feasibility and advisability of taking additional action to promote research on issues of importance to the Medicare population, including providing additional financial support for monitoring and evaluation, device implantation, and other non-covered costs for trials of importance to Medicare beneficiaries;
  • Take action to increase the participation of seniors in clinical trials; and
  • Develop a registry of ongoing clinical trials receiving Medicare reimbursement.

CONCLUSION

This announcement can be expected to have a dramatic impact on hospitals, physicians, manufacturers, researchers, and patients. It clarifies ambiguous Medicare reimbursement policies, and gives added recognition to earlier regulatory developments, that, for example, authorized coverage for certain Category B, non-experimental investigational devices and related costs. It does not appear, however, that this order will change HCFA’s longstanding policy not to cover most drugs and devices which have not yet received FDA approval. By assuring reimbursement for routine care rendered to Medicare patients during clinical trial, the new policy should encourage not only patients, but hospitals and physicians to utilize at an early phase new breakthrough medical technologies.

(fn1) A copy of the Executive Memorandum is on the internet at: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/2000/6/8/1.text.1

Please do not hesitate to contact Gordon B. Schatz (202/414-9259) or any other member of the Reed Smith health care group with whom you work if you would like additional information.

The contents of this Memorandum are for informational purposes only, and do not constitute legal advice.