prevent or relieve pain, nausea, and other symptoms that arise from illnesses and injuries or their treatment. Trials may involve problems that are not life threatening, but many enroll patients with very serious conditions. Thus, although usually not intentionally, some end-of-life care is financed by research grants and other funds for clinical trials.

Insurance payments for those participating in clinical trials have long been controversial. Some private insurers have agreed to pay for certain trials or for routine care associated with trials, although many today and in the past have undoubtedly paid for such care without knowing it (IOM, 2000d; NCI, 2001b).23 In June of 2000, the President directed that Medicare explicitly authorize payment for routine patient care costs and costs to treat complications associated with participation in clinical trials.24 A recent study found that nearly 90 percent of Blue Cross Blue Shield plans already pay for routine care in clinical trials, and some encourage the creation of clinical trials to test certain therapies (IOM, 2000d). Coverage of investigational drugs is permitted by a few Medicaid plans, but the committee found no comprehensive information on such policies.



How insurers pay providers and how much they pay them can significantly affect child and family access to palliative and end-of-life care and


Routine costs have been defined to be those items or services that are “(1) typically provided absent a clinical trial (e.g., conventional care); (2) required solely for provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and (3) needed for reasonable and necessary care arising from the provision of an investigational item or service—in particular, for the diagnosis or treatment of complications” (HCFA/CMS, 2000d).


The Health Care Financing Administration (HCFA), now the Centers for Medicare and Medicaid Services announced in September 2000 that clinical trials with a therapeutic purpose that will qualify automatically include “1. Trials funded by NIH [National Institutes of Health], CDC [Centers for Disease Control and Prevention], AHRQ [Agency for Healthcare Research and Quality], HCFA, DOD [Department of Defense], and VA [Department of Veterans Affairs]; 2. Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, HCFA, DOD and VA; 3. Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration [FDA]; and 4. Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place” (announcement at Because Medicare covers few children, this program change will have little impact on children and their families unless Medicaid and private payers adopt similar policies.

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