SB 280-MEDICAID/ INS FOR CANCER CLINICAL TRIALS  CHAIR DAVIS announced consideration of SB 280. 1:45:02 PM TOM OBERMEYER, Staff to Chair Davis, read the sponsor statement as follows: This is an Act requiring health care insurers to provide insurance coverage for medical care received by a patient during certain approved clinical trials designed to test and improve prevention, diagnosis, treatment, or palliation of cancer; directing the Department of Health and Social Services to provide Medicaid services to persons who participate in clinical trials; relating to experimental procedures; and providing for an effective date. Clinical trials are research studies that test how well new medical approaches work in patients. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat disease. Patients who take part in cancer clinical trials have an opportunity to contribute to the knowledge of, and progress against cancer. They also receive state-of-the art treatment from experts in the field. The National Cancer Institute, as part of the U.S. National Institutes of Health, reports 6,000 cancer trials in the United States at any one time. They include trials in prevention, screening, diagnosis, treatment, quality-of-life, and genetic studies. SB 280 removes important barriers to the participation of patients in cancer clinical trials in Alaska. It requires that all health care plans, including Medicaid, cover routine patient care costs for patients enrolled in all phases of clinical trials, including prevention, detection, treatment, and palliation (supportive care) of cancer. Currently Alaska health plans can exclude coverage for routine patient-care costs while a patient with cancer is enrolled in a clinical trial. Providers of health care plans often conclude that money is saved by excluding care while patients participate in clinical trials. But these patients, if not enrolled in clinical trials, will continue to receive conventional therapy at roughly the same or slightly increased costs in the short-run. Studies have shown that only 2-3 percent of eligible adult patients enroll in clinical trials with a 6.5 percent increase in costs for clinical trial participants compared to nonparticipants. (National Conference of State Legislatures ncsl.org/programs/health/clinicaltrials, accessed 2/27/08) Without in-state facilities and support of clinical trials participants in Alaska currently have to travel out of state, increasing the cost of non-emergency transportation which is about 3 percent of total Medicaid costs. In FY 2007 an estimated 4,600 patients received cancer treatments through Alaska's Medicaid program at a cost of $21.5 million. The average payment per beneficiary was about $4,675. The federal government reimburses the state at about 50 percent of the total costs. Based on an estimated 2.5 percent participation rate per above, about 115 patients are expected to participate in clinical trials each year. A 6.5 percent increase for 115 persons would add $35.00 per year to Medicaid for cancer treatments. Non- emergency transportation costs for the same group are estimated to add another $15.00 per year. The fiscal note adds an estimated $50,000 per year with the federal government paying half of this. Twenty-three states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care patients receive while participating in clinical trials. Passage of SB 280 will result in more successful outcomes in cancer treatments in Alaska, increase retention of patients in Alaska for their cancer care, and also, after full implementation, result in cost savings in the short and long term. 1:49:17 PM DR. JEANNE ANDERSON, Medical Oncologist, Anchorage, spoke on behalf of Alaska cancer physicians and patients. She thanked Chair Davis and the Health and Social Services Committee members for sponsoring and considering this bill. She disclosed that 2650 Alaskans were expected to be diagnosed with cancer in 2008, and many more would be diagnosed with a recurrence of cancer. In the 1970's only 50 percent of cancer patients lived 5 years after diagnosis. In 2008 it was predicted that 66 percent of patients would survive 5 years. Cancer physicians in Alaska were committed to providing the best care possible to their patients to relieve suffering and reduce deaths from cancer, and they often turned to clinical trials as providing the best treatment for their patients. As the sponsor statement indicated, clinical trials provided a formal and scientific way to test whether a new treatment was safe, effective and superior to existing treatments. The physicians and hospitals in Alaska supported clinical trials and there were currently at least 50 of them open in the state for cancer patients however, only a small number of their patients, about 40 patients per year, enrolled. The reasons included lack of knowledge or interest on the part of either the patient or the physician; lack of availability of an appropriate trial for the patient; and lack of insurance coverage, or fear by the patients that they would lose coverage if they did enroll. Passage of this bill would clearly remove that one important barrier to access to clinical trials for their patients. She believed it would result in improved care for patients, reducing the burden of cancer in the population, and facilitating patients to stay in Alaska for state-of-the-art care. SENATOR COWDERY asked Mr. Obermeyer why the fraternal benefit societies were excluded on page 2, line 5, Section C. CHAIR DAVIS said that they would discuss the bill after taking public testimony and asked Senator Cowdery to hold his question. 1:52:28 PM DR. ALAN LICHTER, CEO, American Society of Clinical Oncology (ASCO) said the Society had close to 26,000 members in 112 countries around the world. He reiterated that a clinical trial was a research study to find out if a new treatment was safe or effective, if treatment A was better than treatment B; it was governed by a rigorous review and oversight process; and it was the critical step in achieving progress in cancer treatment. In fact, the pace of progress against cancer was largely determined by the pace at which they could complete clinical studies. While they were making progress in clinical studies, the pace was not fast enough to satisfy them; less than 5 percent of adults went on to a cancer clinical trial. There were many reasons for that but, as stated, one of them was the uncertainty of whether their insurance would cover their routine clinical care costs if they were treated as part of a trial, or the certainty that it would not. He found it ironic when he realized that insurers increasingly asked physicians to practice evidence-based medicine, then turned around and told patients that if they participated in a clinical trial to gather such evidence, their care costs would be denied. For 15 years ASCO had fought to ensure coverage for those routine clinical costs and were successful in convincing Medicare to change their policy about 10 years ago. About 20 states had already passed legislation such as this and, when they asked their members in those states, over 2/3 said the passage of that law had been helpful in facilitating the entry of patients into clinical studies. Insurance companies were concerned over costs; and at least 4 major studies had been done that showed the routine care costs of treating a patient in a clinical trial were no greater than the costs an insurance company would pay anyway. He said he was extremely encouraged that Alaska was considering passage of this bill; these bills were critical if they were to continue the pace of discovery in cancer. 1:56:47 PM DR. STEPHEN COMPTON, Clinical Cardiologist, Alaska Heart Institute (AHI), said he specialized in clinical cardiac electrophysiology, the care of heart rhythm problems. He was one of about 23 cardiologists in the state, and they wanted to second the testimony of Dr. Lichter and others. Cardiologists faced the same problems; they clearly had not solved the problem of heart disease in the world and there were many unanswered clinical questions that needed to be addressed. In Alaska, they had had 2,000 patients involved in various clinical studies and trials during the previous 8 years. He thought it was naïve of insurance companies to think that medicine was a static issue; his own job didn't exist 20 years ago because it had been only in the past 20 years that they had learned enough about heart rhythm problems to routinely cure disabling or life-threatening arrhythmias. Treatments for these conditions were developed through progress in research based on clinical trials. He cited the development of implantable devices for heart failure monitoring and treatment as another example of devices that clearly improved quality of life, heart function and survival; the only way to learn about these strategies was through clinical trials. In closing, Dr. Compton said the need for clinical trials applied to every area of medicine and he fully supported this bill. 2:00:36 PM MR. OBERMEYER advised Chair Davis that Dennis Bailey with legislative legal would be available for only a short time to address Senator Cowdery's question about the inapplicability of fraternal benefit societies that now appeared on page 2, line 20 of Version \C. He restated the question for Mr. Bailey. DENNIS BAILEY, Legislative Legal and Research Services Division, Legislative Affairs Agency, Juneau, explained that a fraternal benefit society was an organization similar to the Elks or Moose Lodge, that provided specific benefits for their members. It was a category that was not exactly insurance and that was exempted from almost all mandatory insurance coverages already in the statutes. CHAIR DAVIS asked if such organizations could voluntarily be a part of this despite the exclusion. MR. BAILEY replied that, if a fraternal benefit society wished to include coverage or provide a benefit for clinical trials, they could do so. 2:03:07 PM DEBORAH APPERSON, representing herself, was a 3 time cancer patient. She said she would like to participate in a clinical trial but could not do so unless insurance would pay for the routine care. The treatments she had undergone were available due to the participation of others in clinical trials, and she wanted to "pay it forward" for those patients to come. With this bill, she could do so. 2:04:32 PM KRISTA RANGISCH, representing herself, said she was a cancer research nurse at Providence Alaska Medical Center in Anchorage. She said that when a clinical trial was recommended to a patient by his physician as the best treatment option, the patient was referred to her office. Part of her discussion with the patient about that study included informing them that insurance might not cover some or all of the costs associated with the cancer care while on the study; she strongly encouraged all patients to find out what their policy said about clinical trial coverage. It was at this stage that they encountered the majority of roadblocks. She stressed that patients went through a lot emotionally and financially when they were diagnosed with cancer and the last thing they needed to worry about was finding out whether their insurance would cover a clinical trial that the physician thought was in their best interest. One of the biggest reasons that patients did not go on in clinical trials was lack of, or fear of lack of, insurance coverage. In addition, there were many instances in which, due to the severity of the cancer, it was necessary to start treatment right away and there was not sufficient time to investigate coverage or to wait for the insurance company to determine coverage. In closing, she said that if insurance companies were mandated to cover clinical trial costs, she was confident many more people would be able to participate in clinical trials, which in turn would increase the likelihood of improved cancer care and someday finding a cure. 2:06:48 PM DR MARY STEWART, Oncologist, Anchorage, had been treating patients for over 20 years. During that time she had treated hundreds of patients with cancer; some went on to cure, but others traveled the path of a terminal disease, seeking more time to be with friends and loved ones. Every day radiation and medical oncologists struggled with difficult and life-altering questions. She related the cases of three patients whose lives were cut short by diagnoses of cancer and said she wanted to know how to do a better job for them. DR. STEWART said that the oncologists' collegial group in Alaska, the Denali Oncology Group (DOG), had a loose affiliation, putting together yearly conferences on the latest in cancer treatment for the past 24 years. Last year they became an official affiliate of The American Society of Clinical Oncology (ASCO). When they met in Homer in September, they asked what they should do to make their first priority to improve the treatment of all Alaskans. They wanted to enhance enrollment of patients on clinical trials, for that was where they learned what worked and what didn't. SB 280 would reduce barriers to patient enrollment. She pointed out that the costs of patient care changed very little and those patients would still need blood tests, X-rays, CT scans and MRIs no matter what. The physicians did not gain financially from this, but hoped to gain better clinical insight and treatment for the patients in their care. She urged the committee to move SB 280 forward. 2:09:42 PM EMILY NENON, Alaska Government Relations Director, American Cancer Society, Anchorage, emphasized that clinical trials were a critically important part of the fight against cancer. She also confirmed what Dennis Bailey had said, that the fraternal benefit society exclusion was common to all of this type of legislation but did not preclude participation. 2:11:20 PM CLAIRE WADDOUP, representing herself, Anchorage, said she was in a clinical trial that involved treatment to improve her chances of not having a recurrence of cancer. Ultimately, this treatment would save the insurance company money if she stayed clear. She wished Deb Apperson the very best and thanked the committee for hearing her testimony. 2:12:39 PM LINDA HALL, Director, Division of Insurance, Department of Commerce, Community & Economic Development, wanted first to comment on mandates in general. The division was concerned that mandates in Title 21 tended to apply only to approximately 40 percent of Alaskans because the other 60 percent were covered by some type of self-insurance plan that would not be subject to the mandate. That meant the mandate applied only to individual and small group policies; none of the self-insured large employer plans would be subject to it. She felt there was a misunderstanding that when they did a state mandated health benefit, it applied to everyone who had coverage and that was not accurate. MS. HALL said the division had reviewed other states that had coverage for clinical trials and felt that this bill was written with a fairly broad scope. She mentioned the medical oncologists' reference to coverage of "routine medical costs," and noted that 17 out of 20 states, according to their research, had language that only required coverage of routine medical costs. She said she would like to work with Senator Davis and her staff on the ability to have deductibles or co-pays more in line with other mandates in Title 21, and to make sure it did not expand into areas that were traditionally covered by the sponsors of the clinical trials. 2:17:08 PM DR. LARRY WICKERHAM, Associate Chairman, National Surgical Adjuvant Breast and Bowel Project (NSABP), one of the National Cancer Institute's cooperative trials groups, said the NSABP conducted large studies that compared standard treatments with newer, innovative therapies in patients with early stage breast and bowel cancers. The group's mission was to improve survival and quality of life for these patients. Over the years, they had entered over 130,000 individuals into their various trials; they had 200 centers and 300 satellite centers located through the US, Canada, Puerto Rico and Ireland, and had several centers participating in trials in Alaska. The results of their previous trials had a major impact on the care of both breast and bowel cancers; the results of their breast cancer trials were invaluable in eliminating radical mastectomies, demonstrating a lumpectomy was an effective alternative and that adjuvant therapy in addition to surgery, (chemo-therapy, hormonal therapy and the newer targeted agents) could improve survival. Figures from the American Cancer Society demonstrated that the mortality rates from breast cancer in the US had declined for over a decade. These improvements were thought to be the result of screening mammograms and improvements in treatment. These improvements in care came primarily from clinical trials like those conducted by the NSABP. The more patients who entered these trials, the more quickly they got the results and the faster they could improve care. Unfortunately, for a variety of reasons as Dr. Lichter mentioned, less than 5 percent of adult cancer patients actually entered clinical trials. Cost was indeed a major barrier to their participation. Requiring health care insurers to cover the standard-of-care costs for individuals participating in cancer clinical trials would substantially remove one of the significant barriers to increasing participation. Any research trial included 2 general categories: research costs, expenses the patient would not routinely incur if he/she were not part of that trial; and routine standard-of-care costs, expenses that would occur whether or not that patient entered a clinical study. NSABP studies routinely identified the non standard-of-care components; they provided the drug or drugs being studied free of charge and typically provided additional non-federal funding to help defray the costs of clinical trial participation, including the cost of non standard-of-care items. The goal was to minimize any additional cost to the patient, improve trial participation and improve cancer care in general. He urged them to enact this bill so that patients in Alaska would have access to state-of-the-art studies like those already available to patients in other states. 2:20:22 PM BEVERLY K. WOOLEY, Director, Alaska Division of Public Health, speaking for herself as a cancer survivor, said few things in life could rock you to the core like hearing that you have cancer. She had to go through that with her diagnosis in 2004; despite her family history of extensive cancer, her diligent and aggressive check-ups, it did hit her and she was not ready for the emotional turmoil. She admitted that her whole focus was on survival at that point; and it was soon after her diagnosis that she was told she was eligible for a clinical trial. She spent days researching it and came to the decision that it was the best news for her, not only because it gave her the best chance for survival, but because her young daughter, because of her diagnosis, was at a higher risk. "At a time when I didn't have much hope," she said, "thinking that, regardless of what happened to me, I could take part in something that might make her future and that of other young women better, gave me a silver lining. My enthusiasm was short lived however, when I found out my insurance might not pay." She started on an emotional roller-coaster, due in part to the fact that she had lost her father to cancer at 17 after a 3 year fight that took all of their family's savings and nearly cost them their home. Her 80 year old mother was still paying for the loss of those savings that could have made her life better, and Ms. Wooley feared that it was going to happen to her. It took time, but fortunately they worked with her and eventually her insurance did come through so she was able to go forward with the trials. She got the best care possible and was able to give hope to future generations through the research that was done at that time. MS. WOOLEY closed by saying that she did not know what would have happened if she had not been able to take advantage of that trial. To have the hope of the best possible care held out to you and to be afraid you could not take advantage of it was absolutely devastating. She pressed that they had the power to make a statement against cancer by moving this bill forward, and asked them to please move the bill out and get clinical trials for as many people in Alaska as possible. 2:23:54 PM CHAIR DAVIS announced she would hold SB 280 in order to complete some work on it with the division of insurance, and would bring it back in a short time.