When selecting a plan, look closely at the marketing materials supplied by your plan and your employer to see how the plan defines experimental care, and under what conditions the plan might cover such care. This is very important for cancer patients who are joining a new insurance plan, or consumers who believe they are at high risk for the disease. For example, because of a strong family history of cancer. If the plan's materials don't clearly define the term and how the plan uses it, consumers can ask their employers to let them see the contract with the plan. Consumers also can call the plan and ask plan administrators to give them information on the plan's coverage of experimental care, such as use of off-label medicines and care in clinical trials, which are discussed in greater detail below, and guidelines on how the plan decides what care is experimental.
Some consumers in managed care plans have reported problems getting access to care because their plan considers a particular product or service experimental. When plans deny coverage for a service on this basis, the plan will not pay for the care. Most managed care plans routinely exclude experimental care from coverage in their contracts.
While there is no widely accepted and utilized definition of experimental care, plans typically regard it to mean that the medical benefit of a particular service has not been proven to the plan's satisfaction. Thus, each plan defines the term as it wishes and may apply it differently from contract to contract. Some of the things that plans commonly exclude from coverage as experimental are the following:
Off-label use of some medicines. In some cancers, healthcare providers and patients want to use a medicine for a diagnosis other than what the medicine is approved for by the FDA. Plans make case-by-case decisions on whether to cover off-label use of the medicine and may deem some off-label uses experimental, if the plan believes there is insufficient scientific basis to justify it.
New tests or treatments. As medical technology produces new services for cancer patients, managed care plans evaluate these new services to make policy decisions about what they will cover and pay for. They review published medical studies of the new test or procedure and government approvals (where applicable), and consult with leading oncologists. After this review, if the plan's administration believes that a new test or procedure has not been sufficiently evaluated, or its effectiveness is uncertain, the plan may designate the service as experimental and refuse to provide coverage and payment.
Clinical trials. The Affordable Care Act (ACA) requires that insurance pay for all of the healthcare services related to the clinical trial. But this is true for insurance starting after Jan. 1, 2014. Insurance started before Jan. 1, 2014, can limit or even stop paying for your health care.
The issue of whether something is or is not experimental is not black and white. Plans, patients, and healthcare providers often disagree about whether a service, such as a bone marrow transplant, is an experimental treatment for a particular diagnosis. There have also been many state and federal court cases in which patients and healthcare providers have challenged plans' decisions not to cover and pay for care of a plan labeled experimental, but which the patient and healthcare provider believed appropriate. The courts have ruled that whether a service is or is not experimental may depend not only on published medical studies, but also on whether the healthcare providers in a community believe it is appropriate for a particular diagnosis, as well as expert opinion. Thus, standards of care vary around the country. If a managed care plan refuses to cover and pay for a treatment or test on the grounds that the service is experimental, consumers and their healthcare providers need to work closely together to challenge the decision.
When consumers and their managed care plan disagree over whether a test or treatment is experimental, consumers can appeal the plan's decision. This process starts with notifying the managed care plan. All managed care plans have an appeal process for reviewing denials of care. Consumers should file an appeal by writing a letter to the plan, and get a letter supporting their position from their healthcare provider. The healthcare provider also should submit to the plan copies of medical studies and expert opinion that support the appeal.
If a consumer and a plan cannot resolve their differences, the consumer may want to consider filing a complaint with a state regulatory agency, such as the state health department, insurance department, or attorney general's office. A complaint to these agencies should include copies of all correspondence with the plan and copies of relevant medical studies. The state agency may be able to help mediate a resolution to the complaint, or it may intervene directly on the consumer's behalf if it discovers that the plan is not adhering to the terms of its contract with you or is violating a provision of state law. State laws vary in how much authority these agencies have over managed care plans.
In some cases, consumers need legal help, and might consider filing a lawsuit against the plan to get the care they need. Consumers in a self-insured plan (employers or plans can identify if they are self-insured) cannot turn to state regulatory agencies for help. They need to speak with a lawyer who has experience helping consumers pursue complaints against self-insured plans. Self-insured plans are regulated by the federal Department of Labor, which generally does not help consumers with complaints over a denial of care on the grounds that it is experimental.
An ethics committee is now part of the formal review system in many managed care organizations. These committees may have medical and legal representatives, ethicists and other healthcare providers as members. One of the functions of an ethics committee is to review cases in order to develop coverage policies and criteria for benefit application.