HOUSE BILL NO. 268 "An Act relating to the prescription of opioids; relating to the Department of Health and Social Services; relating to the practice of dentistry; relating to the practice of medicine; relating to the practice of podiatry; relating to the practice of osteopathy; relating to the practice of nursing; and relating to the practice of optometry." 3:01:13 PM REPRESENTATIVE LES GARA, SPONSOR, introduced himself. CLAIRE GROSS, STAFF, REPRESENTATIVE GARA, introduced herself. Representative Gara explained that the difference between the proposed Committee substitute (CS) and the original bill was the transfer of requirements that were consistent with the Center for Disease Control (CDC) guidelines for informing patients about the dangers of opioid addiction and reasonable drug alternatives. The change moved from the legislature prescribing rules to allowing the board to adopt their own regulations that were consistent with CDC guidelines. The bill proposed to provide nine months for the boards to adopt regulations. Co-Chair Seaton MOVED to ADOPT proposed committee substitute for SSHB 268, Work Draft 30-LS1081\E (Radford, 3/30/18). There being NO OBJECTION, it was so ordered. Representative Gara began the PowerPoint presentation: "HB 268 - Opioid Prescription Warnings." He referenced HB 159 [legislation pertaining to the prescription of opioids passed in 2017], a bill sponsored by the governor. The legislature since had learned about the addictive nature of opioids, that 80 percent of those using heroin started on a pain-killing drug, and that the longer a person used an opioid the more likely one was to become addicted. He relayed that the death rate from prescribed opioid overdose in Alaska was about twice the national level. There was still a gap between prescribers either being informed or informing their patients of the dangers of opioids. He shared that a number of states were adopting similar bills. 3:05:00 PM Representative Gara moved to slide 2: "The Nationwide Opioid Epidemic." Representative Gara continued discussing the bill. He detailed that roughly 91 people died per day from opioid overdoses. Representative Gara scrolled to slide 3: "The Alaskan Opioid Epidemic." He reported that heroin-associated deaths in Alaska were 50 percent higher than the national average, and there was a link between opioid addiction and heroin use. Representative Gara moved to slide 4: "Extended Opioid Use Raises Risk of Addiction." The chart on the slide showed that the longer a person was on an opioid prescription, the more likely they would become addicted. Representative Gara advanced to slide 5: "Link Between Opioid Abuse and Heroin Addiction." He specified that roughly 80 percent of those using heroine started out misusing prescription opioids such as hydrocodone. Representative Gara turned to slide 6: "HB 268": Is a patient information bill which seeks to provide new regulations for prescribing: Dentists Doctors Podiatrists Osteopaths Nurses Optometrists Representative Gara reported that the bill was a patient information bill. He considered that if patients were informed about the dangers and addictive qualities of opioids, it would be possible to find less dangerous alternative treatments. Representative Gara discussed the language from the bill on slide 7: "HB 268 con't": Requires the state Board of Dental examiners, the State Medical Board, the Board of Nursing, and the Board of Examiners in Optometry to adopt regulations.... Representative Gara advanced to slide 8: "HB 268 Regulations": Requiring prescribers to: "Advise patients, using oral and written information, before prescribing an opioid, of the potential dangers of opioid addiction, and alternatives to the opioid prescription the provider considers reasonable" Representative Gara qualified that the bill would not interfere with the provider-patient relationship. The intent was to make the bill as simple as possible so that it was useful for providers. The bill aimed to give boards leeway to make exceptions to the requirement. The requirement would generally apply to outpatients, and providers could exempt classes of patients. He discussed prescriptions of opioids for cancer patients and suggested some thought that cancer patients did not need the same information on the dangers of opioids. He thought a board might determine that it was not sensible to have to provide information in certain circumstances such as for Hospice care patients. He discussed extenuating circumstances and asserted that boards should have leeway. Representative Gara discussed slide 9: "HB 268 Regulations": The boards may: "Determine which classes of patients may be reasonably exempted from the information requirement and may allow an exemption from the requirement for violations the board considers to be unintentional, periodic accidental violations, and for good cause, including when a licensee needs to attend to the perceived immediate health care of another patient." Representative Gara scrolled to slide 10: "HB 268 DHSS": HB 268 also requires that the Department of Health and Social Services "Post on the department's Internet website, and provide access to a printable version of, a written statement, which may include graphics, that provides easily understandable information on opioids, including the potentially addictive and harmful qualities of opioids." This written statement will assist prescribers in complying with the patient information regulations adopted by the state boards under this bill 3:09:30 PM Representative Gara reviewed slide 11: "Making HB 268 Effective Without Hurting Doctor-Patient Relationship": No civil liability for violating bill requirements Prescribers given broad leeway to make honest mistakes Representative Gara expressed that he did not want there to be interference in the doctor-patient relationship by the threat of lawsuits. He reiterated that the intent was to give boards the ability to allow practitioners the leeway to make honest mistakes. Representative Gara explained how the idea for the legislation was brought to his attention on slide 12: "CDC Checklist for Prescribing Opioids: Bill Implements CDC Opioid Crisis Voluntary Recommendations": Bill Implements CDC Opioid Crisis Voluntary Recommendations The CDC recommends that prescribers discuss the risks, benefits, and alternatives to opioid medication with their patients when they prescribe ... and much more. Representative Gara thought that many providers were providing the opioid information, but many were not. Representative Gara showed slide 13: "CDC Checklist for Prescribing Opioids: Checklist for prescribing opioids for chronic pain." He noted that the CDC guidelines were much more comprehensive than what was proposed in the bill; and boards could adopt more if desired. Representative Gara reported on slide 14: "Why Inform Patients?" He read the bubbles from the slide: We know of no other medication routinely used for a nonfatal condition that kills patients so frequently?" Only about 5 percent of patients being prescribed opioid painkillers are receiving them for chronic pain. But that small group accounts for nearly three- quarters of opioid prescriptions. 1 More than 70 percent of patients who die of opioid- related overdoses became addicted while being treated for chronic pain. 1 The CDC found that "many patients lack information about opioids and identified concerns that some clinicians miss opportunities to effectively communicate about safety." 1.The Washington Post, CDC Warns Doctors About the Dangers of Prescribing Opioid Painkillers, (March 15 2016) 2.Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016. MMWR RecommRep 2016;65(No. RR-1):1 49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 Representative Gara lamented that expanded opioid information was not being communicated to patients in a uniform way. The bill proposed to require providers to get training to understand the dangers of opioids and addiction. Representative Gara looked at slide 15: "CDC Guidelines": This first national guidance on the subject is nonbinding, and doctors cannot be punished for failing to comply. ...the head of the Centers for Disease Control and Prevention, which issued the guidelines, said the effort was critical to bringing about "a culture shift for patients and doctors." "Starting a patient on opiates is a momentous decision, and it should only be done if the patient and doctor have a full understanding of the substantial risks involved." --CDC Director Tom Frieden Source: The Washington Post, CDC Warns Doctors About the Dangers of Prescribing Opioid Painkillers, (March 15 2016) Representative Gara stated that while there was not conclusive proof, it was known that not all doctors were providing the opioid information, and therefore the CDC had issued the guidelines. 3:13:13 PM Representative Gara advanced to slide 16: "Recognition that Prescribers Don't Always Inform Patients about the Dangers of Opioids." He read a portion of the slide: This problem of overprescribing opioidsand, according to other research, failing to warn patients about the risks of dependence and overdoseisn't unique to emergency doctors. Physicians in other specialties, like internal medicine and primary care, prescribe even more opioids, Barnett says. "The whole medical community has a responsibility for this." --TIME Health, How Doctors Are Fueling the Opioid Epidemic (Feb 17, 2017) Representative Gara relayed that other states had followed the same approach as proposed in the bill. It was found that emergency room doctors understood the need for greater information as they witnessed the ill effects of opioids. He referenced similar legislation in the states of Michigan and Maine. He felt that the medical community was still catching up to the body of information about opioids. Representative Gara wanted to go through the presentation quickly, and to provide additional information. There had been progress with the bill. The Dental Society (a prescribing authority) had testified as to the necessity of the bill. Optometrists had a board and had not communicated a position on the bill. Nurse practitioners had a board. A board covering doctors and osteopaths had initially objected to the bill and had referenced informed consent from patients for any treatment from a physician. Most recently the board for physicians had advised it was considering regulations to comply with CDC guidelines. The regulations of doctors would not govern dentists, optometrists, and advanced nurse practitioners; who would be governed by the bill. He considered that when the physicians and osteopaths came onboard it would solve over 90 percent of the problem. Representative Gara thought the bill was a matter of life and death. He stated that the bill had addressed the opioid issue in as non-intrusive a way as possible for medical practitioners by giving them help and leeway to formulate exceptions to the rules. He made himself available for questions. Co-Chair Foster relayed the available testifiers on the bill. 3:17:34 PM Co-Chair Seaton referred to slide 4 and asked about the probability of using opioids for one year versus three years. He wondered if it meant that only half as many were continuing to use. Representative Gara responded that the 1-year probability was maintaining and overusing opioids for one year. The number of people that used for 3 years was smaller. A number of people that used for one year did not continue for three years. The information was provided by the CDC and was in the governor's packet from 2016. Representative Wilson asked whether each board had a chance to look at the bill and determine the outcomes. Representative Gara responded that the Medical Board had originally opposed the bill but was now coming onboard with the legislation. He had no other information from the Department of Commerce, Community and Economic Development (DCCED) that other boards had adopted the regulations. Representative Wilson asked if the boards had the chance to discuss the legislation. She wondered if the bill had been on any of their agendas, so it could be a full discussion. Representative Gara responded that he had communicated with boards through DCCED and had only heard a response from the Medical Board. He stated there were some practitioners that were supportive, and some that were not. For those who were already providing the information would not be impacted. He thought boards should be aware of the bill, which was pre- filed. The current version of the bill was more relaxed in terms of adoption of regulations. 3:21:30 PM Representative Wilson asked how the bill would be policed. She looked at page 3 of the "E" draft of the bill and wondered how classes of patients would be reasonably exempted. She asked about the term "good cause." Representative Gara responded that "good cause" was a commonly understood term, and a board could come up with additional exemptions that it determined reasonable. He used hospice patients and certain cancer patients as reasonable examples of exemptions that would be under the purview of boards. He reiterated the desire to leave boards with leeway to make exceptions and interfere with the patient-provider relationship as little as possible. He stated that the term "reasonable" was also well defined in law. Representative Wilson asked about quantifying the percentage of providers that did not provide expanded opioid information. Representative Gara argued that any providers not sharing the information were too many. The CDC had decided that enough providers were not providing information that it necessitated the adoption of national guidelines, and a number of states had addressed the issue as well. He relayed that the head of the CDC had been very clear that the evidence showed providers were not routinely giving out the information. Representative Wilson asked if the invited testifiers were available. Co-Chair Foster indicated that none of the invited testifiers were not online. Representative Gara argued that the bill was a policy call. He continued that a number of practitioners had contacted his office with support as well as opposition. He was willing to listen to other medical board input and stated that the Medical Board had already impacted the bill. He was not interested in a response that included not wanting to be regulated. He emphasized the need to mitigate the deaths from opioid abuse and addiction. 3:26:41 PM Representative Wilson agreed that the bill was a policy call. However, she thought an invitation to testify should be extended for boards. She questioned how to make a policy call without input from medical boards. Co-Chair Foster conveyed the names of others available to testify on the bill. Representative Gara responded that he had sat down with the deputy director at DCCED that worked with boards. He had authored letters requesting boards to comment and hoped for a response by the time the bill moved to the other body. He hoped the bill would not get held in committee. He believed that having proactive legislation such as HB 268, would result in boards examining the CDC guidelines and deciding to make them mandatory. Representative Wilson did not want to hold the bill in committee. She wanted to understand what boards currently required. She did not want to duplicate efforts that were already in place. 3:29:17 PM Co-Chair Seaton referred to slide 11 of the presentation. He asked about the provision of no civil liability for violation of bill requirements and wondered if it applied to providers or boards. Representative Gara informed that the former bill was a requirement enforced in statute. The current bill simply asked boards to adopt regulations, and the boards would decide on punishment and the adoption of rules. There was no civil liability attached to the bill. Co-Chair Seaton wanted to make sure that the terms would not prevent the boards from having sanctions on providers. He discussed statistics associated with Medicare Part B prescriptions. There were large areas of the state where 9.5 percent of all prescriptions for seniors were for opioids; which was more than twice the national average. He was very concerned that the problem was much greater than was known. He agreed with the bill. He thought it was much better for boards to be more involved in the process. 3:33:19 PM Representative Guttenberg had no doubt that therapeutic and behavioral health providers recognized that there was a huge opioid epidemic. He did not believe that the medical community thought it was their problem. He asked where the doctors considered the problem came from, when a significant part of the problem came from prescribing and over-prescribing. He asked if doctors understood their role in the matter. Representative Gara thought many doctors and prescribers had a good idea of the problem. However, he thought it was true for every profession that some people did stronger work than others. He was impressed with an emergency room physician from Mat-Su that understood the problem and had recommended passing a bill with a sunset. He chose to leave the regulation to the boards instead. He referenced the opioid addiction training required by HB 159, which had a deadline in the following two months. 3:37:02 PM Representative Guttenberg was concerned with the fact that the boards had not come up with a policy to address the problem. Co-Chair Foster OPENED Public Testimony. Co-Chair Foster CLOSED Public Testimony. Co-Chair Seaton was confused regarding the effective dates of the bill. He referred to page 7 of the bill. He read from Section 7 and Section 8. He asked if there was some contradiction in the language. He wondered if the dates for implementing regulation was a long enough time period. He thought it was important to raise the question earlier rather than later. Representative Gara stated he would provide greater detail at the next hearing of the bill. He offered that the department could put the information up on a website for doctors to access. He wanted the bill to provide boards the time to give public notice and perhaps retract and redo regulations. The regulations would not have to be in place until February 1, 2019. Co-Chair Foster indicated that amendments were due on Wednesday, April 4th at 5:00pm. HB 268 was HEARD and HELD in committee for further consideration.