HB 306-EXTEND BOARD OF PHARMACY  3:28:35 PM CO-CHAIR FIELDS announced that the next order of business would be HOUSE BILL NO. 306, "An Act extending the termination date of the Board of Pharmacy; and providing for an effective date." 3:28:46 PM GREG SMITH, Staff, Representative Andi Story, Alaska State Legislature, introduced HB 306 on behalf of Representative Story, sponsor. He explained that HB 306 would extend the Board of Pharmacy's termination date from 6/30/22 until 6/30/28, a six-year extension recommended by the Division of Legislative Audit. He explained that the Board of Pharmacy was established for purposes of controlling and regulating the practice of pharmacy in Alaska, which is necessary to protect the public's health, safety, and welfare. The board is comprised of seven members, of which five must be licensed pharmacists and two must be members of the public with a direct financial interest in the health care industry. The Board of Pharmacy was first created in 1913, those provisions were repealed, and a new board was enacted in 1955. An audit was completed by the Division of Legislative Audit in 2021 and that report is in the committee's packets. 3:30:10 PM CO-CHAIR FIELDS [opened invited testimony]. 3:30:22 PM KRIS CURTIS, CPA, CISA, Legislative Auditor, Division of Legislative Audit, provided invited testimony regarding the division's sunset audit of the Board of Pharmacy. She stated that the July 2021 audit report concluded that, overall, the board is serving the public's need by effectively conducting its meetings and actively amending regulations, but that the division found improvements are needed with the board's licensing function. She said the audit further concluded that the Division of Corporations, Business and Professional Licensing staff actively worked at implementing the new requirements for the controlled substance prescription database, but at the time of the audit, occupational boards were not effectively monitoring or enforcing those requirements. She said the division recommends the legislature extend this board six years, two years less than the allowed maximum in statute of eight years to reflect the need for more timely oversight of the board's evolving role in combatting the opioid crisis. MS. CURTIS referred to Exhibit 4, Licensing and Registration activity, on page 13 of the audit report. As of January 2021, she related, there were 4,280 active individual and facility licenses, a 14 percent increase compared to the 2017 audit due to the addition of three new license types. [Speaking to Exhibit 6, Schedule of Revenues and Expenditures] on page 15, she stated that as of January 2021 the board had a surplus of nearly $800,000, but that at its February 2021 meeting the board decided not to reduce the fees because it planned to hire a new licensing examiner position which would increase expenditures in the future. [The board] was also concerned that establishing a disciplinary matrix that covered noncompliance with the controlled substance prescription database requirements would likely increase future investigative expenditures. She then drew attention to [Exhibit 5, License, Registration, and Permit Fees] on page 14. 3:32:56 PM MS. CURTIS recounted that the 2017 sunset audit concluded that changes to laws governing the database would significantly change the board's role in helping combat the misuse and abuse of controlled substances. She noted that the [2017] audit recommended only a four-year extension to allow the legislature to evaluate the board's progress in administering these new laws. Therefore, she advised, a large portion of the [2021] audit report is dedicated to evaluating the board's progress in administering the controlled substance prescription database (CSPD). She referenced the background information section of the report and recalled that Senate Bill 196, passed in 2008, required the board to establish and maintain a CSPD. The law intent was to improve patient care and foster the goal of reducing the misuse, abuse, and diversion of controlled substances. The law requires that each dispenser electronically submit information to the board regarding each prescription dispensed of controlled substances. The CSPD electronically collects this information from in-state pharmacies as well as other dispensers. MS. CURTIS explained that after the law's passage it became apparent that important authority was omitted, thereby limiting the ability of the database to meet its intent. Subsequent changes to the law in 2017 and 2018 dramatically impacted how the Board of Pharmacy administers the database. She called attention to the audit report conclusions regarding the database starting on page 16. The first of the three significant changes, she continued, requires licensees of the six occupational boards which prescribe or dispense controlled substances to now register with the CSPD. The second significant change requires that data regarding prescriptions and dispensed substances be reported daily to the CSPD. The third requires practitioners to check the database prior to dispensing, prescribing, or administering medications, with certain exclusions. She said the audit concluded that in general these changes made the database more capable of combating the opioid crisis. 3:35:15 PM MS. CURTIS stated that implementing the new CSPD laws requires the coordination of six occupational boards. The Board of Pharmacy administers the database and provides information to the other occupational boards, while all the occupational boards are responsible for monitoring compliance of their respective licensees. As of January 2021, she continued, each board was at a different stage in implementing the laws and none of the boards were fully monitoring or enforcing the new requirements. She explained that Exhibit 7 on page 17 summarizes the degree each of the six boards has monitored the requirements to register with the database and report to the database. Only the Board of Pharmacy, she continued, was monitoring both the registration and reporting requirements; none of the boards were monitoring whether their individual licensees were complying with reviewing the database prior to dispensing, prescribing, or administering medications. Starting second quarter 2020, the prescription drug monitoring program coordinator began providing summary information on a quarterly basis to the boards regarding the percent of their licensees that are reviewing the database, but detailed information about individual licensee's compliance is not included. MS. CURTIS spoke to Exhibit 8 on page 18 of the audit report. She related that according to [the 2021 Prescription Drug Monitoring Program (PDMP) Legislative Report] from the Alaska Drug Monitoring Program, most prescribers are not reviewing the CSPD. She said the division also found that enforcement was limited by inadequate disciplinary matrices. In general, she explained, a disciplinary matrix guides the resolution of a board's cases. Board disciplinary matrices did not cover the CSPD requirements during the audit period. She drew attention to Exhibit 9 on page 20 of the audit report summarizing the status of disciplinary matrices as of January 2021. She related that several board matrices covered a failure to register with the database but not a failure to review the database or report to the database. 3:37:24 PM MS. CURTIS discussed the provision of unsolicited notifications on page 20. She said statutes authorize the Board of Pharmacy to provide unsolicited notifications to a pharmacist or a practitioner if a patient has received one or more prescriptions [for controlled substances] inconsistent with the generally recognized standards of safe practice. Generally recognized standards of safe practice must be defined by the respective boards, she stated, and at the time of the audit those standards had not been fully defined. Only two applicable boards had set prescription limitations in regulations. The State Medical Board set a limitation for just their initial prescriptions of 50 morphine milligram equivalents (MME); the Board of Dental Examiners set a limitation of 60 MME. She noted that page 20 of the report explains that the Board of Pharmacy may, but is not required to, send patient-specific utilization notifications to pharmacists and practitioners. The division found that these patient-specific notifications were not issued during the audit period and instead the prescription drug monitoring coordinator sent summary data to the applicable occupational boards in the form of standard board reports and to practitioners in the form of prescriber report cards. 3:38:48 PM The House Labor and Commerce Standing Committee was recessed at 3:38 p.m. to a call of the co-chair. 5:09:50 PM CO-CHAIR FIELDS called the House Labor and Commerce Standing Committee meeting back to order at 5:09 p.m. Representatives Nelson, Kaufman, Schrage, Spohnholz, and Fields were present at the call back to order. Representatives Snyder and McCarty arrived as the meeting was in progress. CO-CHAIR FIELDS continued the committee's hearing on HB 306. 5:10:23 PM MS. CURTIS resumed her invited testimony regarding the Division of Legislative Audit's sunset audit of the Board of Pharmacy. She brought attention to the five recommendations in the audit report found under the Findings and Recommendations section beginning on page 25. She said the first recommendation is that the board chair and the DCBPL director should improve procedures and training to ensure applicants meet requirements prior to licensure. The division's licensing testing found several errors, the most concerning finding being that 20 percent of facility licenses tested did not include all the required regulatory documentation. This included the finding that three of the facility licenses tested answered yes to a professional fitness question, but their application was not further reviewed by a supervisor. Statutes state that a board may deny a license if the board finds the applicant has been convicted of a crime or acted in a way that does not conform to minimum professional standards. Policy states that if the person answers yes to one of the series of questions to determine the person's professional fitness, it should be reviewed by a supervisor and possibly forwarded to investigations for follow-up. Three cases were found where that did not occur, but the license was issued. MS. CURTIS continued her review of the audit's recommendations. She said the second recommendation is that the board should adopt regulations for renewing outsourcing facilities and third- party logistics provider licenses. When these new license types were brought on, the renewal section of the regulations was not updated. She related that the third recommendation is that the applicable occupational boards and DCBPL's director should continue to coordinate efforts to improve the monitoring and enforcement of CSPD requirements. Ms. Curtis specified that the fourth recommendation is that the DCCED commissioner should allocate sufficient resources to ensure licensees holding a Drug Enforcement Administration (DEA) registration number are accurately and consistently recorded in DCBPL's licensing database. This helps ensure there could be electronic crossmatch with the controlled substance prescription database. She said the fifth recommendation is that DCCED's commissioner should allocate sufficient resources to ensure the CSPD requirements are enforced. MS. CURTIS noted that the commissioner's and board chair's responses begin on page 47. She said that both the commissioner and the chair discuss some of the corrective action that has already been taken. She further noted that generally the commissioner and board chair agree with the recommendations and the conclusion. 5:12:49 PM REPRESENTATIVE NELSON asked Ms. Curtis whether the Board of Pharmacy is meeting online. MS. CURTIS replied that through the pandemic the boards shifted to meeting online, and whether the boards continue doing online meetings is dependent upon their business need. 5:13:23 PM CO-CHAIR SPOHNHOLZ asked whether any statutory changes are needed to ensure maximum participation in the prescription drug monitoring program. 5:14:02 PM SARA CHAMBERS, Director, Division of Corporations, Business and Professional Licensing (DCBPL), Department of Commerce, Community, and Economic Development (DCCED), responded that when the Prescription Drug Monitoring Program (PDMP) became mandatory as part of the Medicaid reform bill that the legislature grappled with in about 2016, there was a clear desire on the part of the legislature to move in a particular direction. But, she continued, legislation, regulations, and policy sometimes don't work as intended and tweaks are needed. She said the administration has identified some areas where that could be improved, and the Department of Health and Social Services (DHSS) has also identified some areas for improvement. It has been heard from the Board of Veterinary Examiners in both House and Senate bills that there are some problems in statute that the Board of Veterinary Examiners and Board of Pharmacy cannot overcome in regulation, which makes it very difficult to use and a hot topic among the boards and staff. The other remaining boards have identified some areas where the focus of the PDMP needs to be narrowed or further focus needs to be clarified and then be prepared to resource up if those clarifications are indicating a greater intent than maybe what was expressed at that time. 5:15:55 PM CO-CHAIR SPOHNHOLZ opined that excluding people from participating in the PDMP because the PDMP isn't working well isn't what is wanted. Instead, she said, the statute should be modernized to make it serve those who are trying to utilize it. She noted that veterinarians are required to log in daily, yet veterinarians don't prescribe many opioids. She said small details like that could be refined, through working with Ms. Chambers, to make the PDMP serve the licensees better while ensuring that the opioid epidemic health crisis is addressed. MS. CHAMBERS replied that the board chairs meet every other week, are interested, want to be engaged in those conversations, and DCBPL would be happy to facilitate that conversation. 5:17:02 PM CO-CHAIR FIELDS continued with the invited testimony. 5:17:19 PM JUSTIN RUFFRIDGE, Chair, Board of Pharmacy, provided invited testimony. He said the board has taken much effort to respond to the COVID-19 pandemic, while ensuring that licenses continue to be renewed and available specifically in an emergency capacity. Some of the recommendations brought forth in the audit, he stated, are recommendations that the board has already addressed in regulations that are awaiting processing. The PDMP continues to be an issue that he and the PDMP board chairs work on bi-weekly at the PDMP meeting. He said he agrees with Ms. Chambers' statements and the questions from Co-Chair Spohnholz about opportunities to potentially address some of the issues within the PDMP and move forward on some of those changes that could be efficient and help serve the ultimate purpose. Overall, he continued, the board is functioning at high capacity and would welcome any questions. He agreed with renewing the board for the maximum time that Auditor Curtis put forward. 5:18:57 PM CO-CHAIR FIELDS asked whether the members of the board are mostly owners of independent pharmacies or with national chains. MR. RUFFRIDGE answered that during his time on the board there has been a decent number of representatives from different practice types. He said the previous chair was with the Walmart national chain, but currently none of the board members are from national chain pharmacies. He referenced a regulatory or statutory requirement that individuals serving on the board represent Alaska's judicial districts and that potentially there is over-representation from the Southcentral [Third] Judicial District in the current board representatives. 5:20:36 PM CO-CHAIR SPOHNHOLZ asked whether it is a recommendation or a statutory requirement that members of the Board of Pharmacy reflect Alaska's judicial districts. MR. RUFFRIDGE replied that as far as he is aware, it is part of the current statutory definition that the Board of Pharmacy represent the judicial districts whenever possible. However, he noted, language is included that gives an out if that isn't possible or if there are no individuals willing to serve from the other districts. 5:21:32 PM CO-CHAIR FIELDS announced that HB 306 was held over.