HB 242-PRESCRIPTION OF OPIOIDS; DATABASE  3:33:18 PM CHAIR ZULKOSKY announced that the next order of business would be HOUSE BILL NO. 242, "An Act relating to the prescription of opioids; 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; relating to the practice of optometry; relating to the practice of pharmacy; relating to the practice of veterinary medicine; relating to the state medical examiner; relating to the controlled substance prescription database; relating to the duties of the Board of Pharmacy; and providing for an effective date." 3:33:30 PM The committee took a brief at-ease. 3:34:36 PM REPRESENTATIVE ANDY JOSEPHSON, Alaska State Legislature, stated that there was a problem which needed to be addressed, and, although the proposed bill presented some ideas, he was open to solutions. He paraphrased from a prepared statement [Included in members' packets], which read: The purpose of this bill is to reduce addiction and overdose death from opioids prescribed by health care professionals, by improving the effectiveness of the State's controlled substance prescription database by requiring healthcare licensing boards to set prescription standards for their professions. Alaska's controlled substance prescription database was created and placed under the responsibility of the Board of Pharmacy in 2008. The database was designed as a tool to help healthcare providers identify patients who were "doctor shopping" or deliberately obtaining prescriptions from multiple unknowing providers to feed addictions. As opioid addition has increased in Alaska and the nation so has our understanding of links between legal prescription, addiction and illegal use of controlled substances. Healthcare providers and policy makers are looking for ways to turn the tide of addiction and death. Strengthening the prescription database system is one positive step we can take. HB 242 will improve the prescription practice of Alaska's many great healthcare providers and help identify and remove the small minority of prescribers who deliberately or negligently over prescribe controlled substances. I encourage you to support this legislation and to reach out to my office with any questions and suggestions. REPRESENTATIVE JOSEPHSON paraphrased a KTUU news story [Included in members' packets], which addressed a doctor from Soldotna and a nurse practitioner from Eagle River who were accused of illegally overprescribing opiates for years, raising questions about how the state tracked prescription drug abuse. He reported that the news story ended by noting the state had no prescription limit flags that automatically alerted licensing boards when someone appeared to be overprescribing. He reported that his office had done exhaustive research, acknowledging there was a problem, and that he wanted to discuss a solution. He said that making changes to prescriptions of controlled substances and the use of the database required reviewing the statutes of each of the five professions that were able to prescribe controlled substances: physicians, advanced practice nurses, dentists, optometrists, and veterinarians. He added that it was also necessary to review the pharmacy statutes. REPRESENTATIVE JOSEPHSON stated that the basis of the proposed bill: (1) gave each of the five licensing boards explicit responsibility to adopt regulations establishing opiate prescription standards for their respective professions, referred to as MMEs; standards would enable the Department of Commerce, Community & Economic Development employees who staff the licensing boards to proactively identify prescribers who deviated from standards, share that information with the practitioners and the boards, and investigate when appropriate; (2) addressed the problem of prescribers who failed to register with the database or failed to review the patient information before prescribing. He opined that the boards did not enforce registration by the prescribing physicians. The proposed bill (3) upgraded the database software to record when a prescriber enters the database and reviews the patient records, and (4) required licensing boards to take disciplinary action against licensee who fail to register a review; To require pharmacists to check the data base before filling a prescription to confirm that the prescriber reviewed the patient's record in the database as was required by law. REPRESENTATIVE JOSEPHSON suggested that, as two pharmacy organizations had submitted concerns regarding this, there may be a database solution. He went on to state that the proposed bill required the state medical examiner to inform the Board of Pharmacy when a death was caused by an overdose, as that board was responsible for managing the database. The Board, in turn, would inform healthcare providers and their licensing boards if a provider prescribed a controlled substance during the three months preceding death; this provision was intended to educate prescribers who may not be aware that a patient had addictions and to bring investigators' attention to events. He reiterated that he was receptive to suggestions on this proposed legislation. He acknowledged that there were important medical practices such as pain clinics which prescribed more controlled substances, and that he wanted to develop a system as seamless as possible. He pointed out that not only was there patient addiction, but that there also existed "pill mills." 3:42:12 PM CATHERINE REARDON, Staff, Representative Andy Josephson, Alaska State Legislature, presented the Sectional Analysis [Included in members' packets], which read: Section 1: Amends the powers and responsibilities of the Dental Board to require the board to adopt regulations establishing opioid prescription dosage standards for practitioners licensed by the board. Section 2: Amends the powers and responsibilities of the State Medical Board to require the board to adopt regulations establishing opioid prescription dosage standards for practitioners licensed by the board. Section 3: Amends the powers and responsibilities of the Board of Nursing to require the board to adopt regulations establishing opioid prescription dosage standards for practitioners licensed by the board. Section 4: Amends the powers and responsibilities of the Board of Optometry to require the board to adopt regulations establishing opioid prescription dosage standards for practitioners licensed by the board. Section 5: Adds a new subsection to the Board of Pharmacy statutes requiring pharmacists to confirm, before filling a prescription for a Schedule II-IV controlled substance, that the prescriber reviewed the patient's prescription records in the controlled substance prescription database before prescribing. Section 6: Amends the powers and responsibilities of the Board of Veterinary Examiners to require the board to adopt regulations establishing opioid prescription dosage standards for practitioners licensed by the board. Section 7: Adds a new subsection to the statutes governing investigation of death by the State Medical Examiner, directing the Medical Examiner to report to the Board of Pharmacy when a person's death was caused by an overdose of a schedule II-IV controlled substance. The Medical Examiner shall report the deceased person's name, address and date of birth to the Board of Pharmacy which shall act as directed in Section 15 of the bill. Section 8: Amends the statutes governing the Controlled Substance Prescription Database to specify that the database will identify healthcare practitioners who fail to review patient information in the database as required by law and that the database will identify each occurrence of failure to review. Section 9: Clarifies that security and confidentiality of the database is a requirement rather than an aspiration by deleting the words "undertake to" on page 8 line 11. Section 10: Requires licensing boards to take disciplinary action against practitioners who fail to register with the database or review patient information as required by law. Section 11: Removes protection from civil liability for healthcare practitioners who fail to access information in the database. Section 12: Deletes the requirement that prescription information in the database be purged after two years and removes the requirement that the Board of Pharmacy establish a "time frame" for healthcare practitioners to register with the database. Section 13: Makes mandatory rather than optional, the notification by the Board of Pharmacy, to the relevant practitioner, licensing board and pharmacist when a patient receives a prescription for controlled substances in quantities or frequency inconsistent with generally recognized standards of safe practice. Section 14: Makes mandatory rather than optional, the issuance of annual reports that compare individual healthcare practitioner's opioid prescribing practice with other practitioners of the same occupation and similar specialty. Section 14 also requires copies of the reports to be sent to the practitioner's licensing board and to the medical director of a group practice. Those copies will exclude information that identifies patients. Recipients of reports may only disclose information to other individuals who have access to the database. Section 15: Directs the actions of the Board of Pharmacy when the board receives notice from the Medical Examiner as required by Section 7 of the bill, that a person's death was caused by an overdose of a schedule II-IV controlled substance. The board shall review the database to identify healthcare practitioner who prescribed a schedule II-IV controlled substance to the person during the three months preceding death and notify the practitioner and relevant licensing board. Section 16: Requires the six licensing covered by this bill boards and the Department of Commerce, Community and Economic Development to adopt necessary regulations within one year of the January 1, 2021 effective date of Sections 1-15. Section 17: Establishes an immediate effective date for the regulation adoption authority required to implement Section 16. Section 18: States the bill takes effect on January 1, 2021 with the exception of the authority to adopt regulations contained in Sections 16 and 17 of the bill. 3:55:56 PM REPRESENTATIVE TARR directed attention to the fiscal note for business and professional licensing and asked about the request for two investigators and a paralegal for enforcement. MS. REARDON replied that she had not heard anything about the fiscal note, but that she was not surprised that it could take those resources for effective enforcement. 3:58:15 PM SARA CHAMBERS, Director, Division of Corporations, Business, and Professional Licensing, Department of Commerce, Community & Economic Development, reported that the proposed fiscal note was extremely conservative, and it leaned toward a best-case scenario. She stated that the worst-case scenario would necessitate a doubling of the investigative team in order to close the gap and fulfill the proposed bill. REPRESENTATIVE TARR asked about the increase to the participant fee in order to pay for the proposed cost. MS. CHAMBERS replied that the current fee was $25, although the intent language for the database had declared that it is not funded by user fees. She stated, "we're in a pickle right now. There isn't grant funding for enforcement." She stated that there was a policy call for the Legislature on whether to change the fee or use another model for payment, as there was less than 100 percent compliance with registration. REPRESENTATIVE SPOHNHOLZ asked about the delta for the number of registrants and the number of licensees. MS. CHAMBERS said that she would supply that specific data but pointed out that there were many medical professionals who did not have the authority to prescribe controlled substances. REPRESENTATIVE PRUITT reflected on the passage of the bill, and relayed that the intent of the bill had been to make the database mandatory. He asked what had been done to ensure compliance, and would the proposed bill be fulfilling any gaps. He then asked about the security and confidentiality. 4:05:18 PM LAURA CARRILLO, Executive Administrator, Board of Pharmacy, explained that the rationale for removing the two years was in consideration of Senate Bill 74 to allow the assessment of prescription data over time. She reported that removal of the requirement to purge the data would not allow Department of Health and Social Services to analyze the data. MS. CHAMBERS stated that this database was complex and only two people were authorized to view it. She declared that it was used as a research tool to attack the opioid crisis, and that the spirit of Senate Bill 74 was for this to be an educational tool to allow prescribers to make better decisions, and not to be used as an enforcement tool. She stated that there was another delta between expectations and reality for the database. She pointed out that to maintain security and confidentiality, it had to be determined how many state employees would have access to certain levels of data. She declared that the biggest expense was for the technology behind this. CHAIR ZULKOSKY asked how many states had this Prescription Drug Monitoring Program (PDMP) database. MS. CARRILLO said there were 43 states using this same platform connected through [indisc.] health. CHAIR ZULKOSKY asked for more context to how a more mature PDMP was using that information. MS. CARRILLO said that she would research the evolution of the PDMP in other states. CHAIR ZULKOSKY expressed her agreement that there was a policy call for how to use this collected data and added that more data would allow for better understanding for risks in the community. She asked for more information as to how other states utilized this data within their systems. 4:09:54 PM REPRESENTATIVE PRUITT offered his belief that there had been a positional shift from, in 2008, "if you want to," and no one did, to "you're going to." He opined that there was an insistence on wanting this to be mandatory, but there was not any enforcement. He asked why this position had changed and what was an appropriate balance of pressure. MS. CHAMBERS replied that boards, as was put into Title 17 and into Title 8 as a requirement for each separate board, could determine within the scope of their existing authority what the penalty might be. She shared some examples for the allowable civil authority. She reported that the Alaska State Legislature was interested in "taking the temperature" of the position to the opioid crisis. She pointed out that data had not been mandatory, and that during a presentation by then-Chief Medical Officer, Dr. Butler, it had been noted that it wasn't even known what was being prescribed. She reported that current review of the data indicated there was inadvertent misuse of the PDMP, as well as over-prescription. She pointed out that, as there was not even a definition for over-prescription, it was difficult to set a threshold for any red flags. She noted that only the State Medical Board had set in regulation a threshold, which could be "squishy" depending on the type of practice. She declared the need for determining what Alaska wanted from the PDMP, and that each board had existing authority to determine discipline. She added that the Alaska State Legislature could set penalties in statute. REPRESENTATIVE PRUITT asked if there was a need for the legislature to make a larger statement to the boards for a certain level of enforcement. 4:17:03 PM MS. CHAMBERS explained that the MME requirement in the proposed bill had not been asked of the boards, although it made sense if a definition for over prescription was a concern. She pointed out that the State Medical Board had taken a leadership role, even though the other boards had not been asked to determine a definition. She reported that some of the boards had set extremely long time periods for allowance of non-registration as they did not want to be "heavy-handed." She pointed to some of the problems for registration. She reiterated that, if this was the expectation of the Legislature, this proposed bill was a good vehicle to offer more tools. REPRESENTATIVE DRUMMOND referenced a report [Included in members' packets] which stated that 49 states, as well as Guam and the District of Columbia, had fully operational PDMPs. She asked if the DEA (Drug Enforcement Administration) authorized the prescribers of Schedule II to IV controlled substances and questioned whether this information could be included in the PDMP. She asked whether the pharmacies were aware of prescribers who were DEA-authorized for controlled substances. MS. CHAMBERS expressed her agreement that there was this list and that they did work with the DEA. She pointed out that one state, Missouri, had the PDMP as the municipal, not the state, level. In response to Representative Drummond, she said that Missouri used a different software. REPRESENTATIVE SPOHNHOLZ offered her belief that the PDMP history was good for context but did not matter for her current decisions. She shared a list of topics she would like to hear addressed in a future hearing. 4:22:41 PM REPRESENTATIVE SPOHNHOLZ referenced a section of the bill which asked pharmacists to review whether the original prescriber had checked the database and asked whether this policy would turn pharmacists into monitors of other providers. REPRESENTATIVE JOSEPHSON reported that this concern was shared by the sponsor, as he wanted that both the providers and the pharmacists treat the patients, prescribe medication, and focus on the job. He shared an anecdote for a pharmacist being rebuked for refusing to fill a prescription. He pointed out that, although the Board of Pharmacy was the ultimate decider, it did not want to be involved in calling other boards regarding other providers. He suggested that a system should contact the boards when a provider had not registered or had not checked that a patient had recently received a prescription from another provider. He reiterated that he was "wedded to solving the problem not to any particular solution." He pointed out that these burdens were placed on the pharmacist because they were "in the catbird seat, they're the ones who are entering the data." He questioned the timing for when the data was entered into the data base. 4:27:07 PM HB 242 was held over.