CS FOR SENATE BILL NO. 172(L&C) "An Act extending the termination date of the State Medical Board; requiring a report on the State Medical Board's audit compliance; and providing for an effective date." 2:56:47 PM ELIZABETH REXFORD, STAFF, SENATOR DONNY OLSON, introduced herself and read the sponsor statement: SB 172 will extend the termination date of the State Medical Board (board). The State Medical Board has served the public's interest by effectively licensing physicians, osteopaths, podiatrists, physician assistants, and paramedics. The board monitored licensees and worked to ensure that only qualified individuals practiced in Alaska. Furthermore, the board has developed and adopted certain regulatory changes to protect the public, improve the licensing process, and improve the delivery of services. The most recent audit completed by the Division of Legislative Audit has proposed a termination date that is three years less than the eight-year maximum allowed per statute. The Senate Labor and Commerce committee recently amended the bill to reduce the termination date by an additional two years for a sunset date of June 30, 2023. Additionally, the committee also required that the legislative audit division submit a report concerning compliance of the recommendations from the audit to the medical board within one year after the effective date. The reduced extensions and one-year report requirement are due to the audit's finding that board had failed to follow through on a few set priorities. First, the board failed to consistently report license actions to the Federation of State Medical Boards. Secondly, the board has failed to adopt regulations governing registration in the controlled substance prescription database. These regulations require licensees to register in a controlled substances prescription database. Thirdly, the board did not monitor compliance with the database registration requirement. The board is tasked with adequately monitoring licensees to ensure that those with a DEA number register with the controlled substance prescription database. We respectfully request that the termination date of the board be extended to align with the Senate Labor & Commerce committee's recommendation of June 30, 2023, as well as requiring the one-year report from legislative audit. These changes are incorporated into the current version. Co-Chair Johnston thanked the sponsor and his staff for the bill and invited Kris Curtis to the table. 2:59:52 PM KRIS CURTIS, LEGISLATIVE AUDITOR, ALASKA DIVISION OF LEGISLATIVE AUDIT, conducted an audit of the State Medical Board. She indicated a copy of the report was in members packets. She reviewed the state audit: The audit concluded the board served the public's interest by effectively licensing physicians, osteopaths, podiatrists, physician assistants, and paramedics. The board monitored licensees and worked to ensure only qualified individuals practiced in Alaska. Furthermore, the board developed and adopted certain regulatory changes to protect the public, improve the licensing process, and improve the delivery of services. The audit also concluded the board did not serve the public interest by inconsistently reporting board license actions to the Federation of State Medical Boards (FSMB). In addition, the board did not adopt regulations to require licensees register in the controlled substance prescription database and did not adequately monitor licensees to ensure those with a DEA number registered with the controlled substance prescription database. Ms. Curtis indicated the audit recommended the Legislature extend the board for 5 years. Ms. Curtis referred to the background section of the audit on page 5. She read from the report: Senate Bill 74, effective July 2017, required occupational board licensees that prescribe controlled substances to register with the controlled substance prescription database maintained by the Board of Pharmacy. The database is intended to reduce misuse, abuse, and diversion of controlled substances. Practitioners are required to check the database prior to dispensing, prescribing, or administering medications, with certain exclusions. Ms. Curtis turned to page 11 which showed a schedule of licensing activity. The board issued just over 1600 new licenses from FY 16 through January 2019. As of the end of January 2019 there were 5073 active licensees which represented a 9 percent increase compared to the 2012 sunset audit. Ms. Curtis pointed to page 14 which displayed a schedule of revenues and expenditures. She indicated there was a deficit in 2018 of over $800,000. In response to the deficit they increased fees. The schedule of fees was shown on page 15. Ms. Curtis reported that the auditors made 3 recommendations for improvement beginning on page 18 of the audit. She read from the report: Recommendation No. 1: The board should adopt regulations to guide the process for registering with the controlled substance prescription database. The board did not adopt regulations to require licensees with a Drug Enforcement Administration (DEA) number register with the controlled substance prescription database. Senate Bill 74, Section 60 included uncodified law that directed all boards that licensed occupations with prescription authority to adopt regulations to implement the law. Rather than adopt regulatory guidance for registering, the board expanded the regulatory definition of unprofessional conduct to include licensees that do not register. The board also implemented regulations that require review of the controlled substance prescription database prior to prescribing or dispensing and added an opioid maximum daily dosage. Board members did not consider the importance of establishing regulations to guide in the process and believed the regulatory changes that were made were sufficient to satisfy the requirements of Senate Bill 74. The database was intended to reduce misuse, abuse, and diversion of controlled substances. The lack of regulations regarding registration requirements increases the risk that licensees will not register which, in turn, limits the database's effectiveness. As described in Recommendation No. 2, the audit found a high degree of noncompliance with the registration requirements. We recommend the board adopt regulations to guide the process for registering with the controlled substance prescription database. Recommendation 2: The board should develop procedures to ensure licensees with a DEA number register in the controlled substance prescription database. Per AS 08.64.101(a)(7), effective July 2017, the board must require a licensee who has a DEA registration number to register with the controlled substance prescription database. The audit reviewed 25 new licenses (of which 19 had a DEA number) and 15 renewal licenses (of which 13 had a DEA number). Auditors noted that the application form for new licenses did not require an applicant provide evidence of registration with the controlled substance prescription database. Division staff processed the applications and the board approved the applications without regard for whether or not the applicant registered with the database. Auditors checked the database and found that five of the 19 new license applicants with a DEA number (26 percent) had not registered four applicants were not listed in the database and one was listed in the database with a status of "pending." Auditors noted that the renewal application was revised in November 2018 to request applicants for renewal licenses list their controlled substance prescription database registration number. However, applicants were permitted to list a status of "pending," and division staff did not verify that a licensee obtained a registration number at a later date. Four of the 13 renewal applicants with a DEA number (31 percent) had a status of "pending." The board and DCBPL failed to comply with AS 08.64.101(a)(7) due to a lack of procedures and the board's decision to allow licensees a grace period before enforcing the new requirements. The law did not provide for a grace period and had an effective date of July 2017. The controlled substance prescription database was intended to reduce misuse, abuse, and diversion of controlled substances. Incomplete information within the database limits its effectiveness, which increases the risk that controlled substances may be abused or diverted. We recommend the board develop procedures to ensure licensees with a DEA number register with the controlled substance prescription database. Recommendation 3: The board chair should work with DCBPL's director to establish and implement procedures to ensure board disciplinary actions are reported in accordance with state law. Of the 140 board disciplinary actions issued by the State Medical Board between FY 16 and January 2019, 44 (31 percent) were not reported to the FSMB as required by AS 08.64.335. Alaska Statute 08.64.335 states: The board shall promptly report to the Federation of State Medical Boards for inclusion in the nationwide disciplinary data bank license and permit refusals under AS 08.64.240, actions taken by the board under AS 08.64.331, and license and permit suspensions or surrenders under AS 08.64.332 or 08.64.334. The 44 disciplinary actions not reported to FSMB were actions taken by the board under AS 08.64.331. According to DCBPL management, staff misunderstood the types of actions to be reported. Additionally, the board and DCBPL lacked written procedures to ensure the actions were correctly reported in a timely manner. The national data bank maintained by FSMB is designed to restrict the ability of incompetent physicians to move from state to state without disclosure or discovery of a physician's damaging or incompetent performance. DCBPL's failure to report disciplinary actions increases the risk to public safety. We recommend the board chair work with DCBPL's director to establish and implement procedures to ensure board disciplinary actions are reported in accordance with state law. Ms. Curtis directed attention to the responses to the audit beginning on page 31. The commissioner of DCCED stated that corrective action had already been taken to make sure that disciplinary actions were reported in compliance with state law. Ms. Curtis continued to page 33 of the audit containing the response from the board chair. In response to recommendation 1 to adopt regulations the board chair reiterated her belief that the statutes clearly required licensees to register with the controlled substance prescription database. In her opinion, regulation did not seem necessary. She also stated that the regulations that were created were reviewed by the Department of Law and were found to be sufficient. However, the chair stated that the board would consult the Department of Law and take any corrective actions that they deemed necessary. Ms. Curtis continued that in response to recommendation 2 to develop procedures, the chair stated that a procedure had been created to ensure that their licensees would be registering with the database. Ms. Curtis reported that in response to recommendation 3 the chair agreed to implement procedures to ensure disciplinary actions were reported in accordance with state law. 3:05:45 PM Representative LeBon asked Ms. Curtis if she had a sense that the State Medical Board was investigating as appropriate. He queried about issues that might be falling through the cracks and not actually reaching the decision level. Ms. Curtis commented. "Theres always things that we dont know." The audit always focused on efficiency to which investigations were happening. The auditors did not look at actual investigations and evaluate whether they made a right decision. She could not properly address Representative LeBons question. Representative Knopp asked if the board was fully staffed. Ms. Curtis relayed that the entire board had changed over within the previous few months. Representative Knopp asked Ms. Curtis to tell the committee about the make-up of the board. He asked if the board consisted of members of the public or whether they were medical professionals. He asked the question because Ms. Curtis had mentioned regulations. Ms. Curtis referenced page 1 of the audit which went into detail about the organization and function of the board. The board was comprised of 8 members 5 physicians, 1 physicians assistant, and 2 public members with no direct financial interest. The Division of Corporations, Business, and professional Licensing provided support for the board in terms of drafting regulations. The Department of Law reviewed the regulations. Representative Knopp asked where the board fell short. He wondered if it was turnover in membership. Ms. Curtis thought they had a valid argument in that they felt like the statutes were clear. The statute stated that licensees had to register. In the boards opinion, additional regulations were not needed. The auditors felt that the non-compliance was so high, that it warranted putting regulations into place. 3:08:39 PM SENATOR DONNY OLSON, SPONSOR, wanted to respond to Representative Knopps question. He indicated that the board had changed out completely over the previous couple of months. The issue he had with the new board members was that they were either from Anchorage or Fairbanks with only one person from Sitka. He thought there was a maldistribution of board members. He agreed with the auditors recommendation of having tighter constraints. Co-Chair Johnston relayed that Dr. Richard Wein was online and available for questions. Senator Olson indicated he had been on the board previously. He expressed concerns that a chairman had not been named. He thought the circumstance was similar to a ship without a captain at the helm. Representative Knopp noted Senator Olsons comments about proper geographic representation. He wondered if the board would be better served with members that were more evenly distributed throughout the state. He asked if there was something the legislature could do to help. Senator Olson responded that there was a statute which stated that members should be from as many geographical areas of the state as possible. However, the statute could be interpreted loosely, giving the governor the ability to choose whomever he wanted. He mentioned equipment and lab tests. He deferred to Ms. Curtis to answer the remainder of Representative Knopps question. Ms. Curtis asked Representative Knopp to restate his question. Representative Knopp thought an executive director was needed for the board, as it did not appear that certain things were being done. Ms. Curtis responded that the board had an executive director. She reported that the position had been occupied by someone for a long time but had left. A new person had recently taken the position. She also noted that the auditors were conducting an audit on the Direct Entry Midwives whose board had turned over 100 percent. In the prior year, the Board of Nursing had turned over 100 percent as well. She commented that there appeared to be a pattern. 3:12:55 PM Representative Josephson indicated his office had a bill to improve the PDMP [Prescription Drug Monitoring Program]. He thought Ms. Curtis had testified that the board did not think regulations were needed, as the statutes were clear enough in terms DEA prescribers having to register. He asked if he had heard her correctly. Ms. Curtis responded affirmatively. Representative Josephson asked about the 26 percent that did not register. He noted there were several providers that did not prescribe opiates and would not need to register. There were other providers that did prescribe opiates but had not registered. He asked if he was correct. Ms. Curtis responded that the percentage applied to the number of providers that should have registered. He was correct that not all providers had to register. However, 26 percent of providers who had a DEA number and were required to register, did not do so. Representative Josephson suggested it meant that providers who had not registered could not get into the system to look someone up, even if they wanted to. He asked if he was correct. Ms. Curtis responded, "Yes." 3:14:27 PM Representative Wool asked that if someone registered with the PDMP, they would not necessarily check the database before writing a prescription. Essentially, they could write 10 prescriptions to 10 different people, never look them up, and no one would know. Ms. Curtis was unsure whether there was an audit trail function within the database to monitor inquiries. There certainly could be. There was no one responsible for monitoring the system. Representative Wool thought there was a requirement that physicians also enter prescription information that would be accessible to pharmacies. However, it was not part of the law. Only pharmacists had to check the database. Ms. Curtis indicated it applied to all individuals who had prescribing authority. They were supposed to check the database before they administered or prescribed medications. It was both. Representative Wool explained that as he understood it, providers only had to check the database to see the patients history at the pharmacy. The provider did not have to enter the prescription they were prescribing. Ms. Curtis reported that there was a requirement that prescriptions were uploaded into the database at some time in the process. The audit took a deeper look at the issue when it conducted a pharmacy audit. The Board of Pharmacy extension date was limited to 3 years. In the next Board of Pharmacy audit, the auditors would be looking at compliance across all occupations. Representative Josephson mentioned HB 242. He was astonished that the board did not notify prescribers that they were not in compliance with the law. It could put pressure on the board to revoke a providers license. Co-Chair Johnston noted Ms. Chambers was online and available for questions. Ms. Curtis mentioned that the auditors found it slightly egregious that the board granted a grace period, as the law did not provide for a grace period. The Board Chairs response was that it was not the boards intention to grant a grace period for complying with the law. The board only intended to grant a grace period for enforcing the law. From the auditors perspective there was not a difference. Representative Carpenter wondered if the board members were the same members through the previous 2 audits. Ms. Curtis did not know what percentage of the board was in place previously. The prior audit was in 2012. The auditors had consistently found problems with reporting. In the chairs response she did not think the auditors characterized the finding correctly. She stated that the prior finding was not exactly the same as the current funding. Ms. Curtis agreed that the findings were slightly different, however, the recommendation was the same. The auditors recommended that they start reporting correctly in compliance with the law which they had not been doing consistently. She highlighted that they were not reporting the portion related to civil fines. 3:19:18 PM Co-Chair Johnston OPENED Public Testimony. 3:19:47 PM CHARLES MCKEE, SELF, ANCHORAGE (via teleconference), was a beneficiary of the McKee Trust and had had access to medical facilities as recently as October. He spoke in support of the extension of the medical board. He recalled the governors veto of Medicaid funds. He referred to a lawsuit in which a medical establishment of doctors and nurses sued the current administration. The case was settled out of court due to an artificial emergency that was created by the current administration related to the veto of Medicaid which he needed to access. He reminded members the state was currently in emergency status but, the artificial emergency was manifested by the current administration which mandated that everyone sign a loyalty pledge. Co-Chair Johnston interjected that the testifier needed to stay on the topic of the bill. Mr. McKee indicated the State Medical Board should have refused compliance like the staff at the Alaska Psychiatric Institute (API) who resigned in protest. He reiterated his approval of the extension. 3:21:46 PM Co-Chair Johnston CLOSED public testimony. CSSB 172(L&C) was HEARD and HELD in committee for further consideration. 3:21:59 PM AT EASE 3:22:53 PM RECONVENED