Legislature(2017 - 2018)GRUENBERG 120
04/03/2017 01:00 PM JUDICIARY
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HB 43-NEW DRUGS FOR THE TERMINALLY ILL 2:36:50 PM CHAIR CLAMAN announced that the final order of business would be HOUSE BILL NO. 43, "An Act relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill; providing immunity related to manufacturing, distributing, or providing investigational drugs, biological products, or devices; and relating to licensed health care facility requirements." 2:37:38 PM REPRESENTATIVE EASTMAN moved to adopt Amendment 1, Version 30- LS0207\D.2, which read as follows: Page 1, line 2, following "ill": Insert "for the purpose of sustaining the patient's life" Page 1, line 10, following the first occurrence of "patient": Insert "for the purpose of sustaining the patient's life" Page 2, line 19, following "device": Insert "for the purpose of sustaining the patient's life" REPRESENTATIVE FANSLER objected for purposes of discussion. 2:37:48 PM REPRESENTATIVE EASTMAN offered that the bill sponsor was supportive of Amendment 1, as it was introduced for the sake of clarity, to be certain there was no confusion about how this bill would be used in the future. 2:38:22 PM BROOKE IVY, Staff, Representative Jason Grenn, Alaska State Legislature, advised that the bill sponsor is supportive of Amendment 1, and thanked the sponsor of the amendment for bringing it forward. REPRESENTATIVE REINBOLD said she supports Amendment 1. 2:39:04 PM REPRESENTATIVE FANSLER removed his objection. There being no objection, Amendment 1 was adopted. 2:39:14 PM REPRESENTATIVE FANSLER moved to adopt Amendment 2, Version 30- LS0207\D.3, which read as follows: Page 2, line 10, following "Phase 3": Insert "or is in the new drug application process following Phase 3 of clinical trials" CHAIR CLAMAN objected for purposes of discussion. 2:39:20 PM REPRESENTATIVE FANSLER offered that the bill sponsor supports Amendment 2, as it allows folks to use experimental drugs that have followed Phase 3, but have not yet been approved, and it extends the ability to use these drugs. 2:39:57 PM MS. IVY said that the bill sponsor supports Amendment 2. REPRESENTATIVE EASTMAN commented to the maker of the amendment, "good job." 2:40:20 PM CHAIR CLAMAN removed his objection. There being no objection, Amendment 2 was adopted. 2:40:49 PM REPRESENTATIVE EASTMAN commented that he supports this bill as it can only do good things for Alaskans. REPRESENTATIVE REINBOLD asked the sponsor of the bill to respond to Premera Blue Cross's request to add Section 5 due to the fear that a new product may cost $100,000, and Blue Cross had to pay the bill. 2:41:47 PM MS. IVY responded that Section 5, as suggested by Premera Blue Cross would essentially codify that an insurer or a patient's health care insurance plan would not be responsible for covering the costs of an investigational drugs or the effects that may occur from these drugs. Currently, she said, that is not a requirement under state or federal statute, and at this time it is not something the sponsor necessarily opposes but it may be somewhat redundant. 2:42:36 PM REPRESENTATIVE REINBOLD asked whether she believes this could create conflict between the patient and the insurance company if the insurance company denied [coverage], whether it was setting unrealistic expectations or whether she believes this is not part of state law so the company can, but is not required to, provide this product for insurance coverage. MS. IVY related that the sponsor spoke with Premera and its intention was to create clarifying language in the statute. She opined that, per FDA guidelines, regarding the written informed consent form, that conversation would take place between the doctor and the patient regarding coverage, or lack of coverage, as part of the process. 2:43:53 PM REPRESENTATIVE REINBOLD advised she was speaking to the insurance company and the patient [relationship], and asked whether it was the intention of the bill sponsor to mandate that insurance companies pick up the costs for these experimental drugs, or to leave it as an option. MS. IVY explained that she couldn't speak to conversations between an individual and their insurance company, but the sponsor's intent and understanding was to not require an insurance company to cover the investigational drugs at this time. Thus, it was not referenced in the bill and the sponsor did not broaden that scope into the insurance section of statute for that reason. The sponsor realizes, she said, this doesn't solve everyone's problem in attempting to access this medication, but the sponsor was not ready to ask an insurance company to cover an unapproved drug, and it is not currently required under statute. 2:45:00 PM REPRESENTATIVE REINBOLD surmised that the intention of the bill was to allow [patients] the opportunity and [insurance companies] the option. MS. IVY answered in the affirmative, and pointed out that it would be under the purview of the insurance company and that individual's health care plan as to what was covered. 2:45:30 PM REPRESENTATIVE FANSLER moved to report HB 40, Version 30- LS0207\D, as amended, from the committee with individual recommendations and the accompanying zero fiscal notes. There being no objection, HB 43(JUD) was moved from the House Judiciary Standing Committee.