SB 280-MEDICAID/ INS FOR CANCER CLINICAL TRIALS  CHAIR ELLIS announced SB 280 to be up for consideration. [CSSB 280(HES), 25-LS1464\M was before the committee.] 1:54:19 PM TOM OBERMEYER, staff to Senator Davis, sponsor of SB 280, said this measure requires health care insurers to provide insurance coverage for medical care received by a patient during certain approved clinical trials designed to test and approve prevention, diagnosis, treatment, or palliation of cancer. It directs the Department of Health and Social Services (DHSS) to provide Medicaid services to persons who participate in clinical trials relating to experimental procedures and provides for an effective date. He read the sponsor statement as follows: 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. National Conference of State Legislatures' 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. 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. 1:59:04 PM MR. OBERMEYER concluded that this bill is trying to draw more people into the trials because Alaskans have a high incidence of cancer; patients who do participate are always at risk of not being covered for routine care. This will encourage them to participate at a greater rate in order to save lives and find answers to treating cancer. SENATOR STEVENS asked what clinical trials are and if they are voluntary. MR. OBERMEYER replied that clinical trials are always voluntary and a patient can pull out at any time. Their expenses are covered by the federal government, drug companies and private organizations such as the American Association of Oncology. The only way to improve the present state-of-the-art cancer treatment is to present trials that can document results. He said that all of the developments are followed immediately through journals that are sent all around the world. 2:01:26 PM SENATOR STEVENS asked who pays for this. Me? Why isn't all of it covered by the drug companies? Why ask insurance companies to pick up the cost? MR. OBERMEYER replied all this bill asks is for insurance to cover routine patient care costs. It seeks to encourage patients who would normally hesitate to participate in a trial because of fear they will be dropped from routine coverage for doing it. LINDA HALL, Director, Division of Insurance, Department of Commerce, Community & Economic Development, echoed Mr. Obermeyer's comments saying her enforcement concerns were addressed in this CS and that it brought the bill in line with other states' requirements. MS. HALL, however, cautioned that this bill is mandating coverage for only a small percentage of Alaskans and that Alaskan plans are about 60 percent self-insured and those are regulated by the feds under the Employee Retirement and Income Security Act of 1974 (ERISA). She stated this measure would not apply to Alaska state employees through the Select Benefits Plan. It may or may not apply to some of the union health trusts under Title 21, but she has chosen not to use her resources on that litigation at this point. She said mandating this coverage also has the potential of increasing the cost of health care even though she agreed with the sponsor that it only looks at routine health care that would be provided otherwise. Some insurance contracts will exclude anything to do with someone who is involved in an experimental type of process. This puts good controls on that. This is not an attempt to have insurance companies pay for clinical trials. 2:07:58 PM SENATOR STEVENS asked if this could be applied to a test where someone is accidentally given the flu, for instance. MS. HALL replied no and that while she is not an expert, she explained that it's when someone has been diagnosed with cancer and various medications have already been developed and approved to be used on human beings. There are different levels of testing like tests with control groups and with therapies that have been shown to have some reasonable expectation of a beneficial effect. SENATOR STEVENS asked if there would ever be more demand on the insurance cost because the treatment made the disease worse. Would it force insurance companies to pay for anything beyond routine care? MS. HALL answered that the patient would have gotten progressively worse anyway. She didn't envision additional charges other than possible additional testing. 2:11:36 PM DR. MARY STEWART, President, Denali Oncology Group, Anchorage, said last year their group found improving access and enrolling more patients in clinical trials was its biggest priority. She explained that there all different kinds of clinical trials, but a typical cancer trial would take a standard treatment, Treatment A, and take another treatment, Treatment B, which might be better; usually there is a good deal of preliminary evidence. So patients enroll and doctors find out which one is better. Generally, using placebos is considered unethical for cancer treatment because it's such a serious disease. Everyone gets the standard of care treatment, but this is how doctors further their knowledge about the diagnosis and treatment of cancer. She stated that 2,650 Alaskans will be diagnosed with cancer this year and having good treatment options is essential for them. Knowing what doesn't work is just as important as knowing what does. She said that cancer is a costly disease no matter how you cut it. DR. STEWART related that many of the tests and medicines are better than before. For example, when clinical trials were completed for treating breast cancer with chemotherapy in the 90s; it was found that it didn't help. At the time chemotherapy was a $100,000-procedure and it's more now; money was saved by having accurate information. 2:16:37 PM SENATOR STEVENS asked what routine care is included with clinical trials. DR. STEWART replied CAT scans, blood tests and things that would have to be done any way. Clinical trials don't add much to cancer care. SENATOR STEVENS asked if she was saying there are no additional costs for a person who is in the clinical trial. DR. STEWART answered not exactly. The added cost would be small, maybe less than 1 percent, for an extra X-ray or a blood test monitoring tumor marker levels. But these things have to be done anyway. 2:18:39 PM DR. JEANNE ANDERSON, Katmai Oncology Group, agreed and added that in the 1970s, only 50 percent of cancer patients lived five years after diagnosis. In 2008, 66 percent are predicted to survive five years. She said cancer physicians in Alaska are committed to providing the best care possible to their patients to relieve suffering and reduce death from cancer. They often turn to clinical trials for providing the best treatment. She explained, "A clinical trial is a formal scientific way to test whether a new treatment is safe, effective and superior to existing treatments." DR. ANDERSON said Alaskan doctors support the clinical trials and have more than 50 open currently for cancer patients. However, she said, only a small number of patients enroll in these trials, about 40 patients per year. The reasons are varied and include lack of knowledge or interest by either the patient or the doctor, lack of availability of an appropriate trial or lack of insurance or just because of fear of losing insurance coverage. Passing this bill will remove an important barrier to access to clinical trials and will result in improved care for patients and facilitate their stay in Alaska for state-of-the- art care. 2:20:44 PM DENNY DEWITT, Alaska Director, National Federation of Independent Business, opposed SB 280. While he appreciated the intent of this bill, he said to begin with, state employees are not covered by it. And it seems ironic that they would mandate this kind of coverage on small businesses in Alaska and not on employees of the state. ERISA plans and union welfare benefit plans are not covered; about 60 percent of the state's coverage is not included in this bill. So those expenses that do incur will fall heavily on small businesses. MR. DEWITT said they know the uninsured group is growing and that small employers are more hesitant now to offer employee- based health insurance than they have been historically and many that have been providing health care coverage are finding ways to get out of it because of the cost. This is one more straw on the camel's back. Even though this measure would add less than 1 percent to the cost of coverage, that number would be borne by the small employers and would encourage them to not be in the employer-based market at all. 2:23:48 PM KRISTA RANGITSH, Cancer Research Nurse, Providence Alaska Medical Center, said she is speaking on her own behalf today. She explained when a clinical trial is recommended to a patient by a physician as a best treatment option, they are referred to her office. Part of her discussion about the study with the patient includes informing them that their insurance company many not cover some or all of the costs associated with their cancer while on the study. She strongly encourages all patients to find out what their policy says about clinical trial coverage. This is where the road blocks appear. She related that being diagnosed with cancer is already a difficult time for patients and the last thing they should have to worry about is finding out if their insurance covers a clinical trial their physician thinks is in their best interest. One of her ever-increasing reasons for patients not going on a clinical trial is because of lack of or fear of lack of insurance coverage. In many instances, treatments for cancer must be started right away and insurance companies take too long to determine if they will cover it or not. She concluded that she was confident more people would enroll in trials if insurance coverage was mandated for them. This would hopefully lead to finding more cures for cancer. SENATOR STEVENS asked if this bill passed, would her insurance company offer her this coverage. MS. RANGITSH replied she wasn't sure, but she would find out. CHAIR ELLIS thought she might be covered under ERISA. 2:26:33 PM EMILY NENON, Alaska Government Relations Director, American Cancer Society, said just because the state regulates only 40 percent of insurance coverage doesn't mean that the other 60 percent are not providing this coverage; a lot of them do. When Medicare decided to add this coverage years ago, three-quarters of the federal employee plans were already making that coverage. Having the language in statute would be important even for the plans that are not regulated by the state. 2:28:13 PM DONNA CARROL, representing herself, Juneau, said she was diagnosed with cancer 10 years ago. She was so bad that she was shipped immediately to Seattle where she took part in a phase-3 clinical trial and was told the treatment was no different than what she would get if she weren't in the clinical trial. They wanted to test two drugs to find out if it was better to administer them together rather than one after the other. This clinical trial found that it was good to give them together. 2:30:14 PM BEVERLY WOOLEY, Director, Division of Public Health, Department of Health and Social Services (DHSS), said she was testifying as a private citizen and a cancer survivor. She supported SB 280. She expressed the emotional turmoil that comes when diagnosed with cancer. She was eligible for a clinical trial and spent days on the Internet looking at the options and decided it was the best course of action for her. She also hoped that at the very least she would be contributing to research. She panicked when she found her insurance might not cover the cost of the trial. This brought her back to the time when she was 17 and her father died of cancer and depleted all his family's resources because he didn't have insurance. Fortunately, her insurance company eventually determined it would cover the cost of the clinical trial, which was demonstrated to not be significant. She received the care needed while research and new important information vital to improving future cancer care was gained. CHAIR ELLIS thanked everyone for their testimony and said SB 280 would be held for consideration in the near future.