Legislature(2017 - 2018)GRUENBERG 120
03/29/2017 01:00 PM JUDICIARY
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HB 43-NEW DRUGS FOR THE TERMINALLY ILL 1:02:59 PM CHAIR CLAMAN announced that the first 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." 1:03:23 PM REPRESENTATIVE JASON GREEN, Alaska State Legislature, read his testimony as follows: So, the goal of HB 43, or "Right to Try" is to create a legal climate in which a terminally ill patient, who has exhausted all FDA approved treatment options, may work with their doctor and drug manufactures to access investigational treatments that have passed Phase 1 of the FDA approval process, but are not yet widely available. The Right to Try laws have now been passed in 33 states, 15 additional states, including Alaska, are considering the law. Each year it is estimated that over one million Americans die from terminally ill -- terminal illness. For those who have exhausted all FDA approved options, clinical trials become the next step. However, of those patients who attempt to gain entry into the clinical trial, it is found that fewer than 3 percent are accepted. In recognition of the 97 percent of patients denied access to clinical trials, the FDA does have a program in place for accessing investigational drugs outside of clinical trials known as the "Compassionate Use Program." Nevertheless, it is estimated that only about 1,200 people make it through this arduous federal process each year. Given this information, the goal of HB 43 is to provide the same access as the FDA's existing Compassionate Use Program, but on a shorter timeline. By ensuring -- by ensuring terminally ill patients have more timely access to safe, but experimental drugs in consultation with their doctor, HB 43 attempts to offer new hope when all FDA approved options have been exhausted. 1:05:31 PM BROOKE IVY, Staff, Representative Jason Grenn, Alaska State Legislature, paraphrased from the sectional analysis as follows [original punctuation provided]: Section 1: Prohibits disciplinary action of physicians by the State Medical Board for prescribing, dispensing or administering an investigational drug, biological product or device to terminally ill patients that are ineligible or unable to participate in a current clinical trial, have considered all other treatment options approved by the FDA and have provided written consent. Defines "investigational drugs, biological products and devices" as those that have successfully completed Phase 1 of the FDA drug review process and remain in ongoing Phase 2 or 3 clinical trials, but have not been approved for general use. Defines "terminal illness" as a disease that will result in death in the near future or permanent state of unconsciousness from which recovery is unlikely. Section 2: Establishes immunity for physicians, medical team members, manufacturers and distributors in the case of injury or death of a terminally ill patient from the use of an investigational drug, biological product or device, provided informed consent was obtained from the patient and notice of immunity was given in advance. Establishes immunity for physicians and manufacturers who choose not to participate in the distribution of an investigational drug, biological product or device. Section 3: Amends statute limiting the sale and distribution of new drugs (AS 17.20.110) so as not to apply to physicians prescribing or administering investigational drugs under the conditions established in Section 1. Section 4: Prohibits the Department of Health and Social Services from requiring a licensed health care facility to increase its services solely to accommodate physicians prescribing, dispensing or administering investigational drugs to a patient. 1:07:42 PM MS. IVY turned to the PowerPoint presentation titled "House Bill 43: The Right to Try," slide 3, "FDA Drug Review Process" and advised that it is helpful to be familiar with the different phases of the FDA drug review process. She explained that prior to Phase 1, sponsors of a drug are required to submit the form "Investigational New Drug Application" or IND application, and through this application process the FDA reviews the applicant's pre-clinical testing results and determines whether the drug is reasonably safe for human testing. She then moved to slide 4, "Phase 1 - Safety" wherein Phase 1 studies occur after approval of the IND application. These studies may be conducted on healthy volunteer when testing Ibuprofen or an anti- inflammatory, or individuals with specific diseases or terminal illnesses. The goal of Phase 1 testing is to determine possible side effects and toxicity levels, wherein Phase 1 focuses on safety. 1:08:43 PM MS. IVY turned to slide 5, "Phase 2- Efficacy" and advised that Phase 2 studies begin when a drug has passed Phase 1 and is considered relatively safe, with no unaccepted toxicity level, wherein Phase 2 focuses on the drug's effectiveness. She turned to slide 6, "Phase 3, and advised that if there was evidence the drug was effective, it would progress to Phase 3. During that phase, she explained, more information would be gained regarding safety and effectiveness, particularly, in varying populations or different dosages in combination with other medications. 1:09:18 PM MS. IVY turned to slide 7, "Review Meeting & New Drug Application (NDA" and advised that after Phase 3, sponsors of the drug participate in a review meeting with the FDA, and the sponsors go on to complete a form titled "New Drug Application" (NDA). In the event the drug was approved, the sponsors could then market their drug in the United States. From that point, the FDA has 60 days to decide whether to officially file the application for review and, she explained, filed applications are generally processed within 10 months of filing. She turned to slide 8, and said that within HB 43, the term "investigational drug" discusses those drugs that passed the safety testing in Phase 1, and remain in ongoing clinical trials under Phase 2 or 3 of the FDA approval process. 1:09:44 PM MS. IVY turned to slide 9, "Compassionate Use" and noted that the FDA has an existing Compassionate Use Program designed for terminally ill patients who do not have access to a clinical trial. Within this program, patients can still access those investigational treatments outside of the clinical trial. In order to start this process, a patient must work with their doctor and apply to the FDA. She commented that for years, by the FDA's own estimate, the application form alone would take an estimated 100 hours for the doctor to complete. Although recently, she pointed out, the FDA made great efforts to streamline the application process, but it is only the first step in the process. Manufacturers must submit lengthy documentation, and once application paperwork is complete, it must then make its way through the FDA internal approval process, and then to a separate institutional review board for approval, which is often a lengthy process. 1:10:59 PM MS. IVY turned to slide 10, "The Right to Try - A Nationwide Effort" and reiterated that 33 states signed The Right to Try into law, and most states have had overwhelming bipartisan and often unanimous support. 1:11:22 PM MS. IVY referred the members to a document titled "Clinical Trials" included in the packets, and said that HB 43 focuses on terminally ill patients who do not qualify for clinical trials. The sponsor included these Alaskan stories to illustrate local experiences with terminal illness, as well as the benefit of simply having access to new treatment options, whether in a clinical trial or not. CHAIR CLAMAN opened public testimony on HB 43. 1:12:40 PM JASON NORRIS, was unavailable and Representative Grenn read Mr. Norris's letter into the record, as follows: I write to you today in support of HB 43, with the short title "New Drugs for the Terminally Ill." I understand that your time is limited and; therefore, I'll make an effort to be as brief as possible. In June of 2011, my father was diagnosed with ALS, sometimes known as Lou Gehrig's disease. For those unfamiliar, this disease slowly saps a person's ability to move, rendering them bedridden. Eventually it takes away their ability to breathe, at which point they die. It should be noted that this disease does not affect a person's mind; therefore, they are acutely aware of their daily deterioration, and because of this the mind becomes a prisoner within the body. For my father, this began in June with a reduced range of motion in his left leg. At this point he had been working 12-hour days, 5-6 days a week, per week as a machinist. I feel this is important to point out because of the extended hours and physical nature of the job. He was, by all accounts, a very strong and healthy man at the time of diagnosis. But, by late fall he had completely lost his ability to walk, and at Thanksgiving he held our 5-month old son for the last time in his arms as he became too weak to trust him with such precious cargo. When he finally lost all movement in his limbs, he would hug our children by nuzzling his face against them. As we entered into the depths of winter, he and I carried on what conversations we could, trying to accelerate what should have been more years of passing knowledge and wisdom from father to son. These conversations became increasingly difficult as the disease made his breathing quite labored, even with the assistance of a BiPAP machine. While the painful and emotional moments are too many to list, the most painful came when I asked him a simple question: "Dad, are you angry?" He responded with uncommon grace and humility by uttering one word with every labored breath, "I'm not angry, I'm just sad that I won't see your kids grow up." And, in the early morning of February 1, 2012, he died at the all too young age of 58. My father was a good man and my hero, he was a tireless worker, and a great role model, and an unparalleled family man. He took a chance on Alaska in 1996, when he moved his family from the only home he had only known to a place that we had no connections, no network, no family, and no friends. The gamble paid off for all of us. He saw the potential in this state, he fought like we all do to make a life here, and in the end I wish the state had afforded him the right to fight this disease with the same ferocity. Recently, in the Washington Post there was an article detailing the experience of a man who had for all intents and purposes beaten ALS through advanced therapies pioneered by doctors at the ALS Center, in Atlanta, Georgia. In reading about this man I became aware of the Right to Try movement. Soon thereafter, I became aware of the bill of which I write to you in support of today. I implore you to pass this bill and encourage your colleagues in the Senate to do the same. I cannot say that these advanced therapies would have helped save my father's life, but they may yet save someone else's father, mother, daughter, or son. Thank you for your consideration on this important legislation. 1:15:56 PM ELIZABETH KROME said she supports HB 43, has been a licensed nurse since 1979, and practiced in a hospital setting for 30 years. Hope is one thing all humans require, she said, after being diagnosed with a terminal condition some patients hope for a peaceful death at home, for others their hope is to live to see the birth of a grandchild, or a child graduating from high school. Hope is so very important to individuals, she pointed out, and the Right to Try allows a treatment that may or may not prolong a life, and allows hope to continue. She said she would love to see Alaska give individuals the right to try, and to give them hope for the next stage of their life no matter what it might be. 1:18:03 PM MICHAEL MAHARREY, National Communications Director, Tenth Amendment Center, said his organization has supported this legislation across the United States since its beginning, and he called it "our no brainer issue." Law and regulations are supposed to protect people, but the regulatory scheme tends to create bureaucracy and red tape that can cause harm. Even with the FDA's expanded use program, it does not begin to address the black hole between the end of clinical trials and the final approval of treatment. This process can take up to 10 months, leaving patients in limbo and between the end of clinical trials and the final approval, patients do not have any alternatives. He offered a situation wherein more than 70 Texas cancer patients and a doctor began clinical trials when the doctor found a successful treatment for a specific type of cancer, and when the clinical trials were close to the end, the FDA still hadn't given final approval for the drug. He remarked that the FDA basically told the doctor he had to stop treating his patients, except he was able to begin treating them under the Right to Try new state law in Texas. Mr. Maharrey related that Right to Try has been so successful in the State of Texas that the Texas legislature is considering a bill to include chronically ill patients. This type of legislation illustrates the "beauty of our federated structure" wherein the American system was never to run based on a one-size fits all solutions imposed from Washington, D.C., he pointed out. In conclusion, he said, Right to Try is a specific example of states using their rightful authority to exercise control over local issues, and if Right to Try helps even one Alaskan patient, it is worth putting this legislation on the books. 1:20:43 PM KEN LANDFIELD said he was not aware of any downside to enacting this legislation, and the idea of creating false hope appears disingenuous as terminal is terminal. This is an easy call and, he pointed out, within the Constitution of the United States there is a guarantee for the right to the pursuit of happiness and it appears making potentially lifesaving medications available would fall under that category, he said. 1:22:18 PM STARLEE COLEMAN, Vice President of Communications, Goldwater Institute, advised that the Goldwater Institute crafted the model Right to Try law upon which this bill is based. She offered that it is important for Alaskans to understand that the organization reached out to doctors at major research facilities across the country as to why they don't use the FDA's existing Compassionate Use Program. She said that one of the best examples of why, was from a doctor who had previously run clinical trials for the Indy Anderson Cancer Center in Houston, Texas, and this doctor advised that she was possibly able to get one person each year through the FDA's expanded process. Ms. Colman said that if only one person a year, at the largest cancer trial center in the world, can get access to a drug through the FDA's process, imagine what it is like for a person in Alaska who has seen the community oncologist who has never run a clinical trial and doesn't know who to call at the FDA. The chances are not good that this patient would be helped through this program because the FDA program is actually for patients being treated at major research hospitals performing clinical trials all the time, they know who to call and how to navigate that system. She commented that it is not for regular people, although it is known that Right to Try is already working in Texas, Oregon, and Florida in accessing new treatment options. These are real people with real families who need help. She said she had received updated information and Right to Try has now been adopted in 34 states due to the State of Kentucky. She remarked that "no one who is dying expects that an investigational treatment will cure them," but they want the right to try and the choice to take the same medication used in clinical trials. The Goldwater Institute believes that dying people and their families are owed that opportunity, she said. 1:25:32 PM CHAIR CLAMAN, after ascertaining no one wished to testify, closed public testimony on HB 43. 1:25:42 PM REPRESENTATIVE LEDOUX apologized for coming in late and asked how a person is able to receive the experimental drugs. MS. IVY responded that the FDA has a Compassionate Use Program wherein a person can apply to for investigational drugs in conjunction with their doctor. Currently, she explained, it is an application process, and once the application has been turned in, the FDA has up to 30 days to review the application and, in the event a question comes up during the 30 day period, the 30 day clock can be reset. After that point, if the patient receives approval from the FDA, the patient and their doctor must seek out an external institutional review board (IRB), and "they have no requirements" when they have to get back to the person or approve the application. In the event the review board only meets every six months, the patient would have to wait for the review and approval of the request. She said that outside of a clinical trial, that is the only way a person could access those investigational drugs. 1:27:12 PM REPRESENTATIVE LEDOUX noted her understanding that HB 43 would not subject a doctor to disciplinary action, and asked how would a person obtain the drugs and from what manufacturer. MS. IVY explained that to be eligible, a patient must be diagnosed as terminally ill, their doctor has exhausted all other treatment options for whatever terminal illness they have, and they've attempted to access a clinical trial. After all of those steps have been taken, the person or doctor would contact the manufacturer and request its consent to providing that medication, outside of the clinical trial, with the Compassionate Use Program. The person, their doctor, and the manufacturer would all have to consent to that relationship, she said. 1:28:36 PM REPRESENTATIVE LEDOUX asked whether this type of legislation was law in other states, and inquired as to how cooperative the drug companies are to dispensing the drugs under the circumstances in which these types of laws have been enacted. MS. IVY responded that similar Right to Try laws have passed in 34 states, and are pending in 14 states, including Alaska. She acknowledged that no action could be taken to force a drug manufacturer to provide access to the medication. Interestingly, she offered, due to a new federal law, drug manufacturers are required to list drug on their websites to make the drug more accessible if the drug manufacturer participates in the Compassionate Use Program, and also lists who to contact. She said it is becoming more accessible for those seeking access to the Compassionate Use Program and those seeking access outside of that program, she said. 1:29:57 PM REPRESENTATIVE LEDOUX questioned whether any of these drugs are available in other countries, even when they haven't been approved by the FDA. MS. IVY described Representative LeDoux's question as powerful because when discussing this legislation people are thinking about experimental drugs the nation had never seen before, but some of the treatments going through the FDA approval process are currently in use. For example, in Europe cancer treatments have been in use for 15 years successfully, but those treatments still have to go through the FDA process, which could take anywhere from 10 - 15 years to reach approval. In the event a treatment passes Phase 1 of the FDA process, per this legislation, a person would be able to work with their doctor and the manufacturer to access that treatment. REPRESENTATIVE LEDOUX referred to drugs available in other countries which are unavailable from the United States manufacturers, and asked what it would take to import those drugs as she assumed this bill doesn't do it. MS. IVY replied that she was unsure that would be legal under federal law, and the patient would have to travel to that country to utilize the drug. 1:32:33 PM EBRAHIM DELPASSAND, M.D., Excel Diagnostics & Nuclear Oncology Center, said his specialty is Nuclear Oncology, and he is a professor at the University of Texas, Department of Radiation Oncology. He commented that Houston, Texas has been using Right to Try to offer high power targeted radiation nuclear therapy for a (indisc.) cancer, which are rare cancers in terms of other common cancers such as, breast, prostrate, or colon cancer. There is a special targeted therapy that was given to patients more than 10 years ago in Europe, and his patients had to travel to Europe to receive those treatments. In 2007, he found an investigation for new drug applications with the FDA to offer these treatments in Houston. He said it took him approximately 2.5 years to go through the FDA process and receive approval to start the investigation of trial to give patients access to these treatments. He explained that he received permission from the drug's owner to start these trials in the United States because, at that time, the drug was not ready to start a trial. He said they went through all of the hoops, and finally made the treatments available to their patients with the FDA's "sort of approval," and in 2015, their Investigational New Drug Application (IND) was active at his center for treatment of these patients. Initially, he advised, he requested the treatment for 60 patients, then increased it to 100 patients, and then 150 patients. In February 2015, as the center was moving closer to a 150 patient enrollment, he requested another 100 patients from the FDA because the drug was still not commercially available. The FDA responded that it did not want him to increase the number, not due to complaints because his patients had good responses, the drug had a very good safety profile, and there were many peer reviewed medical publications on this drug from other centers, but rather because it felt that would affect the commercialization of the drug and "This is why you have to stop." He said he advised the FDA that investigation of trial approval for this drug had already completed enrollment, and actually his center was one of the main contributors to that clinical trial so there was no way his continuation of treating these patients would have an effect on the commercialization of the drug. (Indisc.) to continue our treatment while the FDA had essentially stop them from providing these treatments to the patients. He pointed out that this is one of the scenarios in which the Right to Try laws can help patients receive their treatments while the FDA reviews all of the data to approve the drug and then later commercialize. He stressed that this is the gap in which patients will benefit from this law in receiving their medication if it is available to them. 1:38:25 PM REPRESENTATIVE KOPP referred to Dr. Delpassand's testimony regarding the FDA's decision affecting the commercialization of the drug, and asked whether he had ever witnessed the FDA colluding with pharmaceutical companies. Especially in the area of expediting or delaying approvals of investigational drugs through Phases 1-3 of clinical trials that Dr. Delpassand believed were harmful to a patient's interest. DR. DELPASSAND responded that the nature of the overall process in obtaining approval has been a lengthy process, and there are several reasons for that, such as, some clinical trials require follow up information and the long term effect on the patient, especially when discussing oncology and cancer. He related that that is the nature of clinical trials because the FDA wants to be sure the drug is safe and also effective. He explained there are several reasons for that length of time because after a review of considerable data, the final package is submitted to the FDA, and thereafter, he said, it sometimes takes between 12 and 18 months until the FDA is actually able to review the entire data and come back with its opinion as to whether it approves or does not approve the drug. It is this period of time wherein lies the problem, especially if the drug had already shown effectiveness, had many publications in the oncology community, or whatever physicians groups, and this drug becomes common knowledge because then patients come in and ask for the drug. The physician, knowing this drug could help their patient, has nothing to offer because the drug had not yet been approved and this is how Right to Try law comes into play in certain situations. He stressed that this law does not, by any means, provide a shortcut or cutting of corners for the FDA, or any kind of due diligence in terms of making sure the drug is safe and effective. 1:42:09 PM REPRESENTATIVE FANSLER asked whether the exact bill was passed in every state. MS. IVY answered that most of the other versions included the same FDA criteria, but there were different elements in each state. 1:43:05 PM REPRESENTATIVE FANSLER referred to a letter, in the committee packet recommending adding amendments, and also changing the definition of terminal illness, and he asked Ms. Ivy's response to the letter. MS. IVY pointed to the [3/7/17] letter from Premera, Blue Cross Blue Shield of Alaska, and offered that the first two suggestions were clarifying language in that a patient's health care insurance plan was not required to cover the investigational drugs or its possible adverse effects. She said that coverage is not required under federal or state statute at this time, it could be included for clarification purposes, but it is not something the sponsor is requiring in this legislation. Also, she noted, part of the written informed consent form required in the bill involves a conversation between a patient and their doctor regarding the lack of coverage for the investigational drug, which is FDA guidance on those informed consent forms. The third recommendation had to do with "what they may not deny coverage for," and the sponsor's reading was that it may add additional protections to the bill for the patient in that, "a health insurer may not deny coverage to a patient for pre-existing conditions, benefits that accrued before the day in which the patient was treated with the unapproved investigational drug or palliative care for a patient previously treated who is no longer currently using the investigational drug." She opined that a "majority of this" was already mandated in the Affordable Care Act; however, it could be something the committee could consider including if it wanted to look down the road whether there may be changes at the federal level. She advised that the sponsor's office spoke with Legislative Legal and Research Services regarding this language and it didn't indicate there were particular risks involved in including the language. Finally, she advised, the definition Premera, Blue Cross Blue Shield of Alaska suggested would streamline it with Medicare's definition of terminal illness and limit it to those who may die within the next six months. She explained that the sponsor believes the definition is narrow in that if a terminally ill patient was given seven months to live, they would not be eligible to participate under the Right to Try laws. The sponsor could not see this narrow definition, even though the Compassionate Use Program, and he does not necessarily support that amendment. 1:46:33 PM REPRESENTATIVE FANSLER thanked Ms. Ivy for the map because it depicted the almost universal acceptance of this program, and noticed that Hawaii vetoed the legislation. He asked whether she had any information as to the veto. MS. IVY answered that previously, California Governor Jerry Brown had vetoed the Right to Try law, and later the legislation was brought forward again and Governor Brown changed his mind based on its success stories. As far as Hawaii, Governor David Ige, in his veto statement listed four reasons, as follows: the Compassionate Use Program already existed and provided access; this could interfere with the overall FDA system which may have unintended consequences in delaying development of potentially lifesaving drugs, of which the bill sponsor would argue that this doesn't impact the Phases 1-3 clinical trial process; it violated the Supremacy Clause; and, he was unclear as to the actual benefits to the patient. MS. IVY, in response to Representative Fansler, agreed to provide the committee with Dr. Delpassand's written testimony. 1:49:50 PM MS. IVY, in responded to Representative Reinbold, answered that this bill is limited solely to the Right to Try in pharmaceuticals. REPRESENTATIVE REINBOLD commented that she was in pharmaceutical sales for almost 10 years in Alaska, and in response to Representative LeDoux's previous question, answered that within the company she worked for, it took approximately 17 years to move from inception to the FDA's final approval. In getting Alaskans on clinical trials, the company had to compete with big states because it is easier to have many patients in a concentrated effort. She encouraged continued vetting and related that the comment about giving "false hope" was valid. Recently, she said, a friend was put on a clinical trial in California, was given great hope that this would be a successful drug for her, and it ended up that there was no result at all. She said she appreciates the bill coming forward and that this is an opportunity for Alaska to participate. 1:52:54 PM REPRESENTATIVE EASTMAN commented that with the success of this legislation in 34 states, and states trying to expand the program to the chronically ill, asked the sponsor's perspective on an amendment that may expand it to the chronically ill based upon its success. MS. IVY responded that Texas is the one state looking at potentially expanding the definition of terminal illness to debilitating diseases due to the law's successes. The Goldwater Institute offered concerning regarding that concept and preferred the initial narrow definition move forward before looking to expand because it was a new process throughout the different states. Additionally, she said, there is the potential for a court challenge, and the bill sponsor is trying to target the existing access through the Compassionate Use Program and streamline that timing. Expanding the definition, she pointed out, could potentially get into questions as to whether the legislation was taking on the FDA's process on a larger scope, and how far to expand that definition. She offered that it is a policy call, and at this time the sponsor would prefer to stay within the more narrow definition of terminal illness. 1:54:56 PM REPRESENTATIVE EASTMAN acknowledged there are several parallels with this bill and a separate bill making its way through the legislature in dealing with assisted suicide. Due to the bills being similar, he asked the sponsor's thoughts as to inserting language into the bill to make clear that is definitely not the direction of this bill. MS. IVY advised that it is the sponsor's position that these bills are different as to intent because the issues are Right to Die and Right to Try; however, the sponsor is open to discussions regarding adding clarifying language. 1:55:52 PM REPRESENTATIVE LEDOUX noted that she was late attending this hearing, that some of her questions may have already been answered, and asked the committee's indulgence. She then asked whether there had been any organized opposition to this legislation, or organized opposition to similar bills in other states. MS. IVY answered, not to her knowledge in Alaska, but nationally there had been concern over creating false hope. Some individuals, in response to that concern have said, "It's better to have some hope than no hope at all." The Alaska Medical Board and the Commission on Aging offered letters of support, and as to the national support, she said she would defer to Starlee Coleman at the Goldwater Institute. 1:56:47 PM REPRESENTATIVE LEDOUX noted that either Aetna Insurance or Premera Blue Cross Blue Shield of Alaska had suggested an amendment, and asked the sponsor's view of that amendment. MS. IVY pointed to the 3/7/17 letter from Premera Blue Cross Blue Shield of Alaska that Representative Fansler had previously inquired about, and explained that the first two suggested amendments may be unnecessary as they are not currently requiring insurers to cover investigational drugs under federal or state statute. The third suggestion could add additional protections if that was the will of the committee, but currently, some of these are mandated by the Affordable Care Act. She advised that in terms of narrowing the scope of the definition of terminal illness, the sponsor does not support that suggestion. [HB 43 was held over.]