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Sen. Mike Gloor

Sen. Mike Gloor

District 35

(Reported in the May 18, 2010 edition of the National Cancer Institute’s bulletin, written by Carmen Phillips)

 A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care received by clinical trial participants. Click on the map above to view information by state. Note: The map does not reflect two recent updates, a new law in Iowa and a voluntary insurer agreement in Florida, both of which take effect on July 1.

The situation, repeated often, goes like this: A patient is diagnosed with cancer. She could choose to receive a standard treatment, but she is also a candidate for a clinical trial. Receiving the standard treatment would mean her insurance company would pay for her care. But were she to enroll in the clinical trial, any costs associated with her treatment would be denied because those costs are considered “experimental”—even though much of the care she might receive would be the same as the standard, with the potential exception of an investigational treatment.

Scenarios like this eventually generated a legislative wave of sorts, with many states adopting laws or other formal agreements requiring coverage for the cost of “routine care” received in clinical trials. The slow, methodical change began in the mid- to late-1990s in places such as Rhode Island, Maryland, and New Jersey. Not long after, Medicare and the U.S. Department of Defense, via its TRICARE health insurance plan, also began to cover such costs. The movement culminated in March with the enactment of the Patient Protection and Affordable Care Act, which requires health insurers to pay for routine costs of care delivered in phase I through phase IV clinical trials, including trials focused on prevention and early diagnosis. (See the sidebar.)

“Routine Costs” ExplainedThe Patient Protection and Affordable Care Act describes “routine patient costs” in clinical trials 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 items such as hospital visits, imaging or laboratory tests, and medications.

According to the act, it does not include:

  • “The investigational treatment, device, or service itself,” which is typically covered by the trial’s sponsor, such as NCI or a pharmaceutical company
  • “Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient”
  • “A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis”

Like many of the insurance reforms in the larger health care reform bill, the new requirement does not take effect until 2014, said Matt Brow, vice president of Government Relations and Public Policy for US Oncology. Once it does take effect, Brow explained, the new law will offer a baseline of coverage for clinical trial participants in all 50 states and the District of Columbia and help plug some gaps in existing state-level laws and agreements. It requires, for example, coverage of routine care costs for clinical trial participants in “self-insured” plans—that is, plans typically offered and run by employers who are paying the full cost of providing the benefits—governed by the federal ERISA law, Brow said. These self-insured plans cannot be regulated by the states.

Progress at the state level has been substantial, if uneven: 33 states and the District of Columbia have a law or agreement that addresses coverage of clinical trials, although the specifics of coverage vary from state to state. (See the sidebar for more information.)

In New Jersey, which has had a clinical trials coverage agreement in place with the state’s largest insurers for more than a decade, the experience has been very positive, said Dr. Susan Goodin, associate director of clinical trials and therapeutics at the Cancer Institute of New Jersey. “We haven’t had a problem with any of the insurers when it comes to covering the standard of care,” she said. “They don’t pay for the research—if we’re doing an extra CT scan or blood draw as part of the study, then that’s on us.”

Attempting to quantify the agreement’s impact on trial accrual has proven difficult, Dr. Goodin continued, but she’s convinced it’s had an effect. “The dialogue [with the insurance companies] was worthwhile and it’s delivered on the promise,” she said.

One of the states to tackle the issue most recently is Nebraska, which in November 2009 reached a voluntary agreement with the 27 health plan members of the Nebraska Insurance Federation to cover the costs of routine care of patients in clinical trials. The charge to get coverage came from Sen. Mike Gloor, who was president and executive officer of St. Francis Medical Center for 28 years prior to his election to the state legislature. During his first term, Sen. Gloor introduced legislation to mandate trial coverage and reached out to the state’s medical and cancer communities to gain their support for the bill.

What Are States Doing?A state-by-state overview of insurance coverage of clinical trials is available in both the Clinical Trials section of the NCI Web site and at the National Conference of State Legislatures’ Clinical Trials: What Are States Doing?

Regardless of whether a state has a law or agreement that addresses insurer coverage of clinical trials, in cases where resistance from an insurer does arise, Dr. Goodin recommended that a patient’s clinician speak directly with the health plan’s medical director. Those conversations should cover “what are the patient’s treatment options, and whether a clinical trial is the best or most appropriate option for that patient,” she said. “That’s where our success has been.”

“This was one of those nagging frustrations,” Sen. Gloor said of his time at St. Francis. Patients might not enroll in a trial at all because of coverage concerns, he said, or enroll but then drop out because their claims were denied. “Yet once they dropped out, then insurers started picking up the costs anyway,” Sen. Gloor continued. “And the patient lost the benefit of what the clinical trial could offer, and we lost the research data that went along with that.”

Although there are still some issues that need to be clarified, the federal law should address some of the gaps in coverage at the state level, agreed Patrick Taylor, associate general counsel at Children’s Hospital Boston. In a comprehensive analysis of state laws on clinical trials insurance coverage, published in March in the Journal of the National Cancer Institute, Taylor identified a number of potential trouble spots among the patchwork of state laws and agreements, including limitations on trial types that are covered and the adequacy of scientific review for covered trials.

Among the most pressing issues, he explained, was ambiguity about just what “routine care” encompasses, particularly “when you talk about research-related injuries,” Taylor said, which the federal law will cover. Ambiguities in legislation and laws can be unavoidable, he continued, “but it’s essential to cover research-related injuries. That’s a big one; that’s one thing that bankrupts people.”

The effort at the state, and now federal, level has been well worth it, stressed Dr. Kenneth Cowan, director of the University of Nebraska Medical Center’s Eppley Cancer Center. “Cancer patients have so many issues to deal with while they are undergoing treatment,” Dr. Cowan said. “The last thing you want [is for] patients who are enrolling in clinical trials—patients who are trying to help advance science and cancer research—to worry about is whether their care will be paid for.”

Sen. Mike Gloor

District 35
Room #1116
P.O. Box 94604
Lincoln, NE 68509
Phone: (402) 471-2617
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