SB 280-MEDICAID/ INS FOR CANCER CLINICAL TRIALS  2:03:36 PM CHAIR DAVIS announced consideration of SB 280 and noted the proposed committee substitute (CS). TOM OBERMEYER, Staff to Senator Davis, read an overview of version \E CS to SB 280, labeled 25-LS1464\E. The E version reflects and defines language routinely found in other state statutes concerning clinical trials. These changes make clear the objective of this bill to require insurers to cover no more than routine patient care costs and specifically exclude other extraordinary non-clinical costs of housing, companion costs, etc related to clinical trials. In detail, the "E" version: 1. Replaces "coverage of the costs of medical care" with "routine patient care costs" as defined on page 2, lines 30-31, ending page 3, line 17. Specifically, a. Routine patient care costs are medical care costs which are related to cancer that would otherwise be covered under a health care insurance plan if the medical care was not in connection with an approved clinical trial related to cancer, including cost of transportation essential to the medical care. b. This section excludes: 1) A drug or device associated with the clinical trial not approved by US Food & Drug Administration; 2) Housing, companion expenses, or other nonclinical expenses associated with the trial; 3) An item or service provided solely to satisfy data collection and analysis and not used in the clinical management of the patient; 4) An item or service excluded from coverage under the patient's health care insurance plan; and 5) An item or service paid for or customarily paid for through grants or other funding. 2. Requires insurer to provide coverage under this section only if: a. There were clearly no superior non- investigational treatment alternative; and b. Available clinical or preclinical data provide a reasonable expectation that the treatment provided in the clinical trial will be at least as "efficacious" (i.e., capable of producing the desired effect) as any non-investigational alternative. (ref: page 1, line 13, beginning with "The health care..., and ending on page 2, line 7). 3. Coverage is subject to the standard policy provisions applicable to other benefits, including deductible or copayment provisions (page 2, lines 10-11). CHAIR DAVIS added that these changes had been provided to the people who asked that the bill be introduced and they had no problem with them. She said they had also met with the Division of Insurance and the changes were in line with their recommendations. Although this was a Labor & Commerce Issue, since the bill was in their presence she decided to go ahead with the modifications. SENATOR DYSON asked if this had to go to Labor & Commerce and whether there were any other referrals. CHAIR DAVIS answered yes, it had to go to Labor & Commerce, then Finance. SENATOR THOMAS said, as he understood it, unless he was misunderstanding the routine patient care costs, it specifically addressed only care that directly related to the clinical procedures and would rule out other diagnoses or any other issues that might arise during the trial. He asked if that was correct. MR. OBERMEYER responded that it was directed only to the clinical trial and if routine patient care were to include a contemporaneous discovery of other diseases or ailments, that might be included but he did not know; he suggested that might be a question for the medical doctors or even the insurers. SENATOR THOMAS assumed that if it was considered something that might be due to the treatment itself, it would be taken are of by this bill. MR. OBERMEYER answered yes, and said the language of the bill itself defined the types of diseases and cancers that might be discovered. SENATOR COWDERY asked what other states had instituted this type of language. MR. OBERMEYER replied that with 5,000 to 6,000 cancer trials going on at any one time, virtually every state in the United States had trials going on; and he carefully examined the statutes of a number of states before coming up with this language. SENATOR DYSON questioned what would happen if the treatment in a clinical trial turned out to be 10 times as expensive as the usual treatment and whether this bill would require the insurance company to pay the unexpected cost. CHAIR DAVIS responded that she would need to get more information in order to answer Senator Dyson's question; but she expected that the oncologists involved in the trial would bring in other doctors to handle any other diseases discovered during treatment. SENATOR DYSON clarified that he was talking about [treatment] for the cancer. 2:13:52 PM TOM OBERMEYER answered that the [cost of the] clinical trial would be completely separate. Routine costs meant the same costs the patients would incur for treatment if they were not involved in a clinical trial. This bill sought simply to ensure that patients did not have to fear losing coverage for their routine care through participation in a clinical trial. SENATOR DYSON said Mr. Obermeyer had answered part of his question. He persisted that if the cost of treatment for a patient involved in a clinical trial was 10 times as much as the alternative [treatment] would have been, he wanted to know if the insurance company would be on the hook to pay 10 times as much for the treatment because they had passed this bill. MR. OBERMEYER said that was already remedied in the "E" version. It required the insurer to provide coverage only if there was: a) clearly no superior "non-investigational" treatment alternative; and b) available clinical or preclinical data provide a reasonable expectation that the treatment provided in the clinical trial will be at least as "efficacious" as any non-investigational alternative He continued that they did not want to drive up costs unreasonably. CHAIR DAVIS interjected that testimony from patients who had been involved in clinical trials indicated that they were concerned about whether their insurance companies would continue to cover them. One individual said her insurance company had approved coverage for the trial. SENATOR DYSON stated that it was not a doctor question; it was a legal question. CHAIR DAVIS said they could get a legal opinion. 2:17:43 PM SENATOR THOMAS asked for clarification on paragraph (d) on page 2, line 12: "This section does not apply to a fraternal benefit society." MR. OBERMEYER said the drafter explained during the last hearing that this needed to be in here because there was language in other statutes that required it. SENATOR THOMAS moved to adopt the proposed committee substitute, CSSB 280, Version E, as the working document of the committee. There being no objection, the motion carried. CHAIR DAVIS expressed her desire to move this out of committee. 2:19:37 PM EMILY NEENAN, Alaska Government Relations Director, American Cancer Society, responded to Senator Dyson that, in general, the impetus behind this kind of legislation was not to increase any cost to the insurance company, simply to make sure people had access to clinical trials. That was what the whole piece around routine care costs was referring to. She added that 20 other states had this provision in statute and 4 that had worked out voluntary agreements with all of the insurance companies in their states. CHAIR DAVIS asked if there was further testimony. There being none, she asked for a motion. 2:21:43 PM SENATOR THOMAS moved to report CSSB 280, Version \E, from committee with individual recommendations and the attached fiscal note(s). There being no objection, CSSB 280(HES).