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Legislative Support for Access to State-of-the-Art Cancer Treatment in Rhode Island

Arvin S. Glicksman, MD, John P. Fulton, PhD, and Paul Calabresi, MD

Published in: Medicine and Health/Rhode Island, 1998;81(02) 62-64

Arvin S. Glicksman, MD is Professor of Medical Science, Emeritus, Brown University, Providence, RI. John P. Fulton, PhD is Acting Associate Director, Division of Disease Prevention and Control, Rhode Island Department of Health, and Clinical Associate Professor of Community Health, Brown University, Providence, RI. Paul Calabresi, MD is Professor of Medicine, Brown University, Providence, RI.

Background

Historically, cancer mortality has been higher in Rhode Island than in the nation as a whole. In the 1970’s, Rhode Island had the highest cancer mortality rate for white males among all the states, and the fourth highest for white females. Although this differential has lessened considerably over time, cancer mortality in Rhode Island still exceeds the national rate. Increased access to state-of-the-art cancer treatment is generally believed to be one means of correcting this unfortunate situation. Accordingly, the Rhode Island Cancer Control Plan, published in 1989, recommended: "Promote participation in clinical trials by encouraging physicians to enroll eligible patients in phase three clinical trials, and by informing the public at large about current clinical trials, promoting the idea that all cancer patients should seek information about this form of care." Unfortunately, enrollment in clinical trials has been financially inaccessible to many Rhode Islanders, despite health insurance, because most health insurance policies did not cover the costs of investigational treatments.

Step 1: A Task Force to Increase Access to State-of-the-Art Cancer Treatment

In 1992, Senator John O’Leary sponsored legislation requesting the Department of Health to establish a Task Force to investigate problems of access to state-of-the-art cancer treatment in the State of Rhode Island. The Director of Health appointed 14 citizens, health care providers, and representatives of major health insurers to this Task Force.

The Task Force quickly concluded that the definition of state-of-the-art cancer care may not always be simple, since it must encompass multiple and dissimilar elements. Nonetheless, it identified two problems cancer patients have in gaining access to treatment: that usual physician practices may limit access to components of state-of-the-art care, and that usual reimbursement practices may deny payment for investigational treatment, including clinical trials. The Task Force recommended:

• A "Cancer Patient’s Bill of Rights" should be written to inform the public about state-of-the-art cancer care and the importance of their advocacy in obtaining it.

• Measures to improve the planning, provision, and coordination of state-of-the-art cancer care throughout Rhode Island should be developed.

• The Rhode Island General Assembly should consider passage of legislation to mandate health insurance coverage for investigative cancer therapies when specified stringent standards are met.

Representatives of the major health insurers on the Task Force issued a minority report opposing legislated mandates for health insurance coverage, contending that they raise the overall cost of health insurance.

Step 2: Health Insurance Coverage for Off-Label Use of Drugs (94-H-8144)

In 1993, while the Task Force was deliberating, and before it had issued its final report to the General Assembly, a bill was introduced independently which would require health insurers to provide insurance coverage for certain prescription drugs used for the treatment of cancer, even when the drugs are not approved by the FDA for that use, i.e., "off-label use." The bill did not survive committee review. It was reintroduced in 1994 by Representative Benoit with strong support from oncologists, cancer survivors, and the Rhode Island Division of the American Cancer Society. The bill followed legislative guidelines approved in twelve other states. It was passed by both Houses of the General Assembly and signed into law by the Governor.

Representative Benoit’s bill provided that insurers must cover the cost of prescription drugs even when prescribed for off-label use, that insurers may dispute such use, and that to settle such disputes the Director of Health may appoint an Advisory Panel of seven medical experts to determine if the disputed off-label use is medically appropriate. (The members of the Advisory Panel would include a physician appointed by a hospital and medical services corporation, a physician appointed by the Rhode Island Medical Society, three medical oncologists appointed by the State of Rhode Island Clinical Oncologists, a physician appointed by the Rhode Island Association of Health Maintenance Organizations, and a Rhode Island physician appointed by the Health Insurance Association of America.) Since the enactment of this bill three years ago, no such dispute has been brought to the Director of Health.

Step 3: Health Insurance Coverage for Phase III, IV Clinical Trials (94-S-2623 Sub B)

In 1994, based on Task Force recommendations, Senators O’Leary and Tavares introduced a bill mandating insurance coverage for investigational cancer treatments when provided as part of phase II, III, or IV clinical trials. The bill had strong support from oncologists and the Rhode Island Division of the American Cancer Society, and strong opposition from health insurers and the Small Business Association. A compromise was reached in which investigational treatments provided as part of phase II clinical trials were excluded from the mandate, and a "sunset clause" was added to terminate all provisions of the bill after two years, unless the clause was repealed before that time. The revised bill was passed by both Houses of the General Assembly and signed into law by the Governor. It took effect July 1, 1995 and became the first such legislation in the United States.

The bill requires that coverage be extended to investigative cancer therapies when they are provided under Phase III or IV clinical trials, with the following conditions:

• The clinical trials must be approved by the National Institutes of Health in cooperation with the National Cancer Institute, community Clinical Oncology programs, or the Food and Drug Administration in the form of an investigational new drug exemption, or the Department of Veteran Affairs, or a qualified non-governmental research entity as identified in the guidelines for National Cancer Institute Cancer Center Support Grants.

• Research protocols must be approved by a qualified Institutional Review Board.

• The facility and personnel providing treatment under research protocols must be qualified to to do so by virtue of experience, training, and volume of patients.

• The patients receiving treatment under research protocols must meet all protocol requirements.

• There must be no clearly superior non-investigational alternatives to protocol treatments, and available clinical and pre-clinical data must provide a reasonable expectation that the protocol treatment will be at least as efficacious as the non-investigational alternatives.

In January 1996 the sunset clause was repealed after a hearing of the Legislative Commission on Cancer Information Networking in which health insurers testified that the law had not raised health insurance costs demonstrably.

Step 4: Health Insurance Coverage for Phase II Clinical Trials (97-S-0001)

In January 1997 new legislation was introduced by Senator O’Leary and Representative Ginaitt to extend the law on insurance coverage for investigational cancer treatments to include phase II clinical trials. It is generally recognized among cancer researchers that phase II is the level of clinical investigation where advances in therapy actually occur. These advances may be tested against standard care in phase III trials, or the results of phase II trials may go directly into standard care without a randomized phase III trial. In a survey conducted in the fall of 1996, 88% of Rhode Island’s oncologists indicated that they considered insurance coverage for phase II trials very important. The Brown University Clinical Oncology Group strongly supported the O’Leary-Ginaitt bill. Senior medical, surgical, and radiation oncologists all personally testified before the Senate and House Committees considering this legislation. The Rhode Island Division of the American Cancer Society wrote in support of the bill, as did many others, including many cancer survivors. Even though health insurers had not observed increased costs for the coverage of phase III and phase IV clinical trials, they strongly opposed extension of the mandate to cover phase II clinical trials. Representatives of the Small Business Association also vigorously opposed the O’Leary-Ginaitt bill. Despite stiff opposition, the bill passed the House unanimously and with only one dissenting vote in the Senate. The law contains a sunset clause which terminates mandated coverage for phase II clinical trials in December 1998, unless the clause is repealed before that time. The Governor signed the legislation into law in July, 1997.

Conclusions

Rhode Island has developed a health insurance environment strongly supportive of clinical trials, making state-of-the-art cancer therapy more accessible. Physicians may offer their patients investigational treatments within clinical trials without imposing excessive financial burdens upon them or their families.

Acknowledgements

Strong community support was essential to accomplishing these legislative initiatives. The oncology community spoke at innumerable Senate and House Committee meetings, communicated with their individual representatives and senators, and encouraged their patients to do likewise. Drs. Michael Vezeridis, Sundaresan Sambandam, Louis Leone, Vishram Rege, Kirby Bland, and Harry Wanebo, as well as other members of BRUOG individually and collectively, were influential in this important endeavor. Laura Hilderly, as President of the Rhode Island Division of the American Cancer Society, and individually as a leader of oncology nurses in the State, made many visits to the General Assembly. Marlene McCarthy frequently recruited cancer survivors to give testimony on the importance of these measures to their own health, and Jerry Maldavir, Director of Public Education of the Rhode Island Division of the American Cancer Society, was especially influential in many aspects of the legislative process. The support of the Department of Health was particularly important for these legislative measures. Finally, without the perseverance and dedication of Mr. Paul Lupoli, who turned a personal tragedy into a force for the good of the community, these initiatives may not have come to fruition.