[MOL] Manage Care Plans want to be more involved in clinical trials.... [01014]

Managed Care Plans Asked to be More Involved in Clinical Trials

March 25, 1999 - Speaking for its members, the largest trade group for health maintenance organizations and other forms of managed care plans says managed care companies will now help pay for the cost of clinical trials.

After a year of negotiations with the National Institutes of Health (NIH), the American Association of Health Plans (AAHP), which has more than 1,000 health plan members including many HMOs, agreed to encourage its members to participate in clinical trials and to pay the routine cost of care associated with experimental treatment. Routine costs usually include physician care and hospital stays, but not the cost of experimental drugs.

While the two sides settled on the terms of the agreement in December, it has yet to be cemented by signatures from both sides, said Don Young, MD, senior vice president for policy and clinical services for AAHP.

The Agreement
According to the agreement:

AAHP member plans will work with the NIH to develop a process that will increase health plan participation in NIH-sponsored clinical trials.
AAHP will encourage plans to reimburse the routine patient-care costs associated with clinical trials, as long as the costs are not substantially higher than the costs a plan would incur from standard treatment by an in-network provider.
For clinical trials that are likely to be costly, NIH and clinical trial investigators will distinguish regular care costs from additional costs related to participating in clinical research, and will identify reasonable methods to fund additional costs.
Both NIH and AAHP will support research that provides better insight into the effect of clinical trials on health care costs.
NIH will encourage researchers to include health plan physicians and institutions in their research networks during all phases of a clinical trial.

The next step in the AAHP-NIH agreement is for both sides to agree on an advisory panel – which would include NIH officials, AAHP representatives, and outside parties – to evaluate clinical trials. In addition, AAHP will produce educational material for both physicians and consumers to help involve more patients in clinical trials.

Cost vs. Treatment
As an industry, HMOs and preferred provider organizations have been stigmatized for not providing their enrollees access and coverage for experimental treatments. AAHP officials hope the agreement will help remove the impression that managed care companies are unwilling to cover clinical trials because of the costs associated with experimental treatment.

“The money issue has hung up the discussion in the past,” said the AAHP’s Dr.Young. “The fact is the cost of routine care for experimental treatments is not very different from routine care for standard treatments.”

Still, Young acknowledged cost was an issue in the negotiations of the agreement. While plans recognize that clinical trial routine costs vary slightly from most non-experimental routine costs, AAHP members were concerned the agreement would mandate them to pay for expensive care such as stem-cell replacement and high-dose chemotherapy.

Expanding Participation
With nearly 150 million Americans belonging to some type of managed care plan, the agreement has the potential to open clinical trials to patients who otherwise never would have known they were candidates for promising new therapies.

Consumer health advocates are cautiously optimistic, however. While the AAHP has considerable influence in the managed care industry, some question whether health plans will follow by adopting experimental treatment policies put forward in the NIH-AAHP agreement.

“You’re talking about a trade group that has agreed to encourage its members to participate more in clinical trials,” said Vikram Khanna, a consultant with State Health Policy Solutions Inc., health care consulting firm. “They [AAHP’s members] really don’t have any control. It’s a step in the right direction to provide greater access and reimbursement for clinical trials. But it’s not enough.”

Expanding Trials
Joseph Bailes, MD, president-elect of the American Society of Clinical Oncology and a medical oncologist with Texas Oncology in Dallas, said the cancer community would like to see managed care companies agree to cover trials sponsored by others, such as the US Food and Drug Administration, the National Cancer Institute, and the Coalition of National Cancer Cooperative Groups, a network of six nationwide networks and 12,000 cancer researchers supported by the NIH.

“FDA trials are where the promising drugs are being tested,” Dr. Bailes said. He is encouraged by AAHP’s acknowledgement that routine costs in clinical trials are not significantly higher than costs associated with standard treatment, but was skeptical the managed care companies would disregard the cost issues.

“I think this shows we are beginning to move past the issue of cost,” Dr. Bailes said. “Certainly, though, no one has put cost in a closet and closed the door.”

Pursuing Legislation
How health plans react to the AAHP’s agreement with the NIH remains to be seen. The agreement could lead to various ways managed care companies might cover clinical trials.

For that reason, Khanna is an advocate of national or state legislation that would require HMOs to pay for routine costs associated with clinical trials as long as the patient fits the profile for participation.

Maryland is the only state that currently requires plans to cover experimental treatment for life-threatening illnesses, and the prevention, early detection, and treatment of cancer.

“Having a state law levels the playing field and protects consumers,” Khanna said.

Relaxing Policies
UnitedHealth Group a large managed care company based in Minnetonka, Minn., already has begun using more relaxed clinical trial policies. While the organization’s policies still exclude coverage for experimental or investigative treatment, it has agreed to waive the exclusion for large, multicenter clinical trials. It will now pay the costs incurred by any of its 13 million members in 32 states who enroll in clinical trials. The trials, however, must be sponsored by the Coalition of National Cancer Cooperative Groups.