The Lynx Group

33 States Not Prepared to Cover Patients in Clinical Trials by 2014

February 2012, Vol 3, No 1

In an attempt to eliminate insurance coverage status as a barrier to clinical trial enrollment, the Affordable Care Act of 2010 (ACA) requires that by January 2014, all payers in all states must cover routine medical costs associated with patient participation in approved clinical trials.

A new study reveals, however, that most states either have laws that do not properly comply with these regulations or have no laws or agreements regarding clinical trial (phases 1-4) insurance coverage (Kircher SM, et al. J Clin Oncol. Epub December 27, 2011).

In April 2011, investigators from cancer treatment centers in Chicago, IL, and Rockville, MD, reviewed databases from the National Cancer In­stitute, the American Cancer Society, and the National Conference of State Legislatures to identify the state mandates and current agreements for clinical trials involving patients with cancer. This study shows that:

  • 18 states currently meet the ACA requirements for clinical trial coverage, either through state law or through voluntary agreements with payers
  • 3 states have laws that are not compliant with the 2014 ACA mandate
  • Of those, 15 states have no laws addressing trial participation coverage: Alabama, Arkansas, Hawaii, Idaho, Kansas, Minnesota, Missis­­ippi, Montana, New York, North Dakota, Oklahoma, Pennsylvania, South Dakota, Utah, and Washington.

The most common problem was the lack of coverage for phase 1 trials, followed by coverage for therapeutic studies only.

The difficulty in determining the true benefit of the 2014 ACA mandate is compounded by the “grandfather” provision in the ACA, which exempts health plans and other payers from covering patients enrolled in trials on or before March 23, 2010.

Rather than wait years for the effects of the grandfather regula­tion to pass, the governments of 6 states—Florida, Georgia, Michigan, Nebras­ka, New Jersey, and South Carolina—have already initiated their own voluntary agreements directly with insurers for covering routine medical care for patients enrolled in clinical trials.

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