Clinical Trials: State Laws About Insurance Coverage

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Clinical Trials: State Laws About Insurance Coverage

Research is important to cancer treatment. Clinical trials are research studies testing new drugs or treatments in people. These studies compare treatments being used today (standard treatments) with others that may be better. Before a new treatment is used on people, it’s studied in the lab. If lab studies suggest it might work, the next step is to test its value for patients. These human studies are called clinical trials.

In most cases, when a patient volunteers for and enrolls in a clinical trial, the cost of tests, procedures, drugs, extra doctor visits, and any research related to the study itself is covered by the group that sponsors the clinical trial. The sponsor of the clinical trial may be a government agency such as the National Cancer Institute, a drug company, or some other agency.

Some health insurance plans may define the care of a patient in a clinical trial as “experimental” or “investigational.” When this happens, the insurance may not even cover the costs of what’s really routine care. This routine care includes things like doctor visits, hospital stays, and tests or treatments that you would have needed even if you were not taking part in a clinical trial.

If you have Medicare, you may know that it pays for many of the routine medical costs for people with cancer who are in approved clinical trials. This is true no matter where in the United States you live (see below, “Medicare and Medicaid coverage”). Starting in 2014, the new health care law requires other insurers nationwide to cover these costs, too. You can read more about this in the section called “How to find out more about your health plan’s clinical trial coverage.”

It’s important for people with cancer to have insurance that covers clinical trials. Lack of insurance coverage can keep patients who might want to be in a clinical trial from taking part in one. This slows down new advances in cancer treatment and care.

Limitations in states’ requirements for clinical trial coverage

Many states have laws, state rulings, or legal agreements that require insurers to cover clinical trials. These states are listed in the section, “Clinical trials: Laws and agreements”.

But even states that require some sort of coverage don’t always require coverage of prevention trials or phase I trials. And some employers’ health plans are exempt from all state laws and requirements. For instance, state laws don’t affect self-funded insurance plans, which are often the type offered by large employers. Self-funded plans are those in which medical costs are paid by the employer, even though the employer often contracts with an insurance company to check claims and pay them.

Some of the barriers to clinical trials coverage are going away. State requirements are becoming less important because there’s now a federal law that requires new health plans to cover clinical trials – even those plans that are self-funded.

Clinical trial coverage goes national in 2014

As of January 1, 2014, the Affordable Care Act ensures that new health insurance plans cover the routine care costs of people taking part in clinical trials. Insurers are not allowed to drop or limit coverage because a person chooses to take part in a clinical trial. This applies to all clinical trials that treat cancer or other life-threatening diseases.

The new health law describes the clinical trial-related “routine patient costs” that health insurers must cover as “all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.” This includes things like hospital visits, imaging tests or laboratory tests, and medicines.

The law requires coverage for phase I, II, III, or IV clinical trials related to prevention, detection, or treatment of cancer or other life-threatening disease if the study is:

  • Federally funded or federally approved, or
  • Conducted under an FDA investigational new drug (IND) application, or
  • A drug trial that’s exempt from the FDA IND application

In addition, for approved clinical trials, under the law, health plans can’t:

  • Deny a person the right to take part in a clinical trial
  • Limit or deny routine patient costs for items or services connected with the clinical trial
  • Discriminate against a person on the basis of their participation in a study

According to the new health care law, insurers do not need to pay for:

  • The treatment, device, or service that’s being studied and is usually covered by the trial’s sponsor
  • Items and services only needed for data collection and analysis and are not used in direct patient care
  • Any service that’s clearly not in line with widely accepted and established standards of care for a certain diagnosis

States may require more of their health insurers than this, but these requirements are becoming the minimum. As of 2014, most state laws do require coverage of clinical trials beyond what’s required by the federal law.

The new federal law also requires self-funded plans to follow the rules about covering people in clinical trials. There are still exceptions that may apply to existing insurance plans, although these plans will go away over time.

Limitations in federal requirements for clinical trial coverage

It’s important to know that the new federal clinical trial coverage requirements do not apply to grandfathered health plans. Grandfathered plans are defined as any plan or coverage that an individual was enrolled in on or before March 23, 2010 (when the new health care was enacted.)

So, if you bought a private individual plan before that date, the new requirements don’t apply to it, although any state laws will.

If your employer has had the same health plan in place since before that date, it might also be grandfathered. But even if your plan is grandfathered, if your state has a clinical trials coverage requirement, those state laws should apply – as long as the plan isn’t self-funded.

How do I know if my plan covers clinical trials?

If you bought private, individual insurance on your state’s health care marketplace for 2014, your plan must follow all the laws and cover clinical trials. But if you’re getting your insurance through an employer, you’ll need to contact your health plan administrator or check your Summary of Plan Benefits to find out if your plan is grandfathered and if it’s self-funded.

In summary:

  • Self-funded plans are not required to follow state laws about clinical trials, but may have to follow the new federal laws.
  • Grandfathered plans are not required to follow the new federal law about clinical trials, but may have to follow state laws.
  • A self-funded plan can also be grandfathered, and if so, it’s not required to follow either the state or the federal law about clinical trials – at least until it stops being a grandfathered plan.

This is a very complex issue. Please call your American Cancer Society if you have questions. You can also get more information from your state’s insurance commissioner.


Last Medical Review: 01/22/2014
Last Revised: 02/05/2014