What is an approved cancer clinical trial as defined under this agreement?
An approved cancer clinical trial is a trial authorized or approved by one of the following:
- The National Institutes of Health (NIH)
- The US Food and Drug Administration (FDA) (IND applications only)
- The US Department of Defense (DOD)
- The US Department of Veterans Affairs (VA)
What costs are covered by this agreement?
Routine medical costs will be borne by the health plans. All other costs (administrative, monitoring, and additional tests required by the protocol) will be paid for either by the investigating sponsor, the institution at which the trial is being conducted, or some other party. Patients should be aware that the Working Group does not guarantee that all costs of clinical trials will be covered under this agreement. However, many costs such as doctor visits and common tests will be covered.
How will the cost of routine patient costs be determined?
Routine patient care cost will be determined by the health plan in accordance with the definition of these costs contained in the consensus agreement.
What types of insurance policies are included under the agreement?
Because the agreement is voluntary, each individual health plan will make the determination as to the lines of business the agreement will cover. Health plans may find it advantageous to make an across-the-board decision with respect to all fully insured or self-funded business in order to simplify benefit administration and network issues for the company. Additionally, the coverage provided by the consensus agreement could be offered to those qualified entities purchasing administrative services for self-funded business. The Medicaid contract now also includes this service for CMS, formally HCFA. In 2000, former President Clinton announced an executive memorandum that authorizes payment for the routine costs of clinical trials under Medicare. While the federal regulations may differ from the New Jersey agreement, this additional step means that New Jersey cancer patients have the broadest coverage for the routine costs of clinical trials in the country.
Medicare Coverage of Clinical Trials
What if I do not have any insurance?
Medicaid beneficiaries may be covered by participating NJAHP HMOs under the agreement. Some hospitals in New Jersey will provide access to clinical trials for uninsured patients on a case-by-case basis. In addition, the Working Group is committed to work to increase access to cancer clinical trials through education, advocacy, and innovative interventions.
Are all cancers included in this agreement? Are prevention and supportive care trials also covered?
All types of cancers are included within the agreement. Prevention, treatment, and supportive care studies may also be included within the agreement as long as they fulfill the approved requirements.
How have other states handled this issue? What mandates have been adopted and how are they working?
Some states have relied upon legislation and regulation to deal with insurance coverage for the routine care of clinical trials. According to the National Conference of State Legislatures, Rhode Island has mandated coverage for phase II and III trials. In 1998, Maryland mandated insurance coverage for phases II and III of clinical research involving a life-threatening disease and phase I coverage for cancer. In April 1999, Virginia mandated insurance coverage for phase II and III clinical trials. Michigan recently announced a voluntary consensus agreement similar to New Jersey’s, but does not yet include phase I trials. Other states, including New York, Pennsylvania, and Vermont have bills pending that would mandate coverage. Studies indicate that mandates increase costs and result in adversarial relationships between health insurers and providers.
How many clinical trials will be included?
Currently, there are over 400 trials available to patients in New Jersey. These include cooperative group trials, those at the Cancer Institute of New Jersey, and investigational drug studies.
What if I am insured in New Jersey, but want to participate in a trial outside the state? Will coverage be provided?
Insurers have agreed to cover the routine costs of approved clinical trials in New Jersey. Participation by any individual is still subject to contractual terms and benefit limitations of the member’s plan, including physicians and facility providers. Decisions about trials conducted at nonparticipating institutions or outside the state of New Jersey are determined by individual companies. Patients should contact their insurer prior to starting any clinical trial to obtain specific information about their benefits.
What if my insurer is not part of the agreement?
All New Jersey health insurance underwriters are invited to participate in the consensus agreement. Most insurance contracts have an exclusion clause for experimental investigations. If your insurer is not participating in the agreement, then you will have to negotiate any coverage for your involvement in a investigational study.