State payer mandates to cover cancer trials offer heterogeneous protection for patients

March 2, 2010

A 2001 federal law mandates care for Medicare-eligible patients enrolled in clinical trials; however, only 25 state laws cover clinical-trial related medical costs for non-Medicare patients, and these offer less protection than the federal law. A lawyer explains these findings in a special article published online March 2 in the Journal of the National Cancer Institute.

In the United States, participants' costs for routine care and complications from are covered by Medicare because of a 2001 Determination. People not covered by Medicare, however, depend on state insurance mandates with respect to coverage. Few publications have examined state laws regarding insurance coverage for costs of cancer clinical trials, and none have addressed whether such provisions promote scientific and ethical quality.

To address these issues, Patrick L. Taylor, J.D., of the Children's Hospital Boston and Harvard Medical School, reviewed legal data from three nationwide cancer trial databases and from similar databases in each state. State mandates were reviewed for requirements to assure trials' scientific and ethical soundness, whom they covered and omitted, scope, and coverage for participants' research-related injuries in addition to routine care costs.

Taylor found that only 25 states had enacted legislation concerning coverage of cancer clinical trial costs. Among these, most did not expressly require unbiased scientific review or ethical review. About half of them required coverage of only certain kinds of trials, under certain conditions, and very few required publication of results.

"For science and ethics to matter in practice, there will need to be closer, more exact communication between legislators and diverse members of the oncology community, including clinical researchers, on essential policy elements…," the author writes.

There appears to be much room for legislative improvements both to help patients and to improve research, the author adds.

Explore further: House to introduce Medicare drug cost bill

More information:

Related Stories

House to introduce Medicare drug cost bill

January 10, 2007

Democrats in the U.S. House said they plan to introduce legislation that would require the government to negotiate prices for Medicare prescription drugs.

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

( -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.