Perspective               

HCFA Releases Decision on Coverage of Clinical Trials

Following the executive memorandum that President Clinton issued this past June, the Health Care Financing Administration recently released a final national decision approving Medicare coverage of clinical trials. This national coverage decision is intended to promote the use of clinical trials by older and disabled Americans. Medicare now covers the routine patient costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.

Clinical trials are the first step towards providing new clinical innovations to the forefront of medical practice. Their purpose is to test the value of new drugs and medical treatments. All new pharmaceuticals must pass through three phases of clinical trials before the Food and Drug Administration approves them for public use. Despite the fact that older and disabled Americans have a high occurrence of diseases that could be treated by experimental therapy, a recent report showed that only about one percent of seniors participate in clinical trials.

People with Medicare can now receive coverage for participating in clinical trials that evaluate a Medicare benefit, have a therapeutic intent, enroll diagnosed patients with Medicare, and have desirable characteristics expected of clinical trials. Scientists believe that increased participation of older and disabled adults in clinical trials should expedite the development of therapies, diagnostics, and cures.

In announcing the decision to assure Medicare coverage to those in clinical trials a few months ago, President Clinton noted that many seniors and disabled individuals were reluctant to participate in trials for fear they would lose their Medicare coverage. You can now be sure that Medicare will cover your costs for clinical trials. If you have a disease that is difficult to treat, ask your doctor about participating in an experimental therapy. You can also read about the new decision at www.hcfa.gov/quality/8d.htm.

_________________________________