State Clinical Trials Law
The ACA requires that most, non-grandfathered, group health plans provide coverage for the routine costs when participating in clinical trials. Some states have more consumer protections. Click here for more information about clinical trials.
Ga. Code Ann. §33-24- 59.1 – The statute provides that any health plan offering medical coverage to children must cover routine patient care costs associated with the child’s participation in a Phase II or III clinical trial. The child must be under the age of 19 when diagnosed with cancer.
The trial must test prescription drugs. Moreover, the trial must be approved by the U.S. F.D.A. or the NCI, and certified by the Pediatric Oncology Group, Children’s Cancer Group, or commissioner. (Current as of 7/2011)
Georgia Clinical Trial Agreement –The Georgia Cancer Coalition, a nonprofit corporation, has a voluntary agreement among insurers including: Aetna, Blue Cross/Blue Shield, CIGNA, Coventry, Humana, Kaiser, OneHealth and United Healthcare to provide coverage of routine patient care costs for patients enrolled in Phase I, II, III or IV cancer clinical trials. In addition, the insurers must also pay for enrollees’ nationally recommended cancer detection screenings.
The treating physician must recommend the patient after it has been determined that the potential for a meaningful benefit exists. Second, the trial must either: (1) involve a drug that is currently exempt under federal regulations from a new drug application or (2) be approved by one of the following: (a) NIH, (b) NIH cooperative group or center, (c) U.S. Dept. of Defense, (d) U.S. Dept. of Veterans Affairs, (e) U.S. F.D.A or (f) any state IRB belonging to an accredited medicine, nursing, or pharmacy school. www.georgiacancer.org/treat-trials.php) (Current as of 7/11)