Legislature(2021 - 2022)ADAMS 519
03/11/2022 09:00 AM House FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| HB246 | |
| HB306 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 246 | TELECONFERENCED | |
| + | HB 306 | TELECONFERENCED | |
| + | TELECONFERENCED |
HOUSE BILL NO. 306
"An Act extending the termination date of the Board of
Pharmacy; and providing for an effective date."
9:20:19 AM
REPRESENTATIVE ANDI STORY, SPONSOR, indicated that the bill
amended the statute to extend the termination date of the
Board of Pharmacy to June 30, 2028. The current sunset date
was June 30, 2022. The bill would have an immediate
effective date. She emphasized the importance of the board
to protect the public's safety and wellbeing and described
the responsibilities of pharmacists and of board members.
The Prescription Drug Monitoring Program (PDMP) was housed
within the Board of Pharmacy, and board members were
responsible for adopting regulations and monitoring the
program. The board was composed of seven members, five of
which must be licensed pharmacists actively engaged in the
state for a period of three years immediately preceding
appointment. The remaining two board members were
prohibited from having a direct financial interest in the
healthcare industry. She read from the sponsor statement
(copy on file):
House Bill 306 extends the termination date of the
Board of Pharmacy until June 30, 2028. The current
sunset date is June 30, 2022.
The first Alaska Board of Pharmacy was created in
1913. Those provisions were repealed in 1955 and a new
board was enacted with many of the same functions.
The Board of Pharmacy benefits Alaskans by regulating
pharmacies, pharmacists, pharmacy technicians, and
pharmacy interns, and ensuring the practice of
pharmacy is done safely and within the bounds of state
law. Allowing the board to terminate would not be in
the best interest of the state.
The Division of Legislative Audit (DLA) found in their
2021 audit of the Board of Pharmacy that the "board
served the public's interest by effectively conducting
its meetings and actively amending regulations;
however, improvements over the board's licensing
functions are needed." DLA recommended the extension
of the board for six years to reflect "the need for
more timely oversight of the board's evolving role in
combating the public health opioid crisis."
I respectfully ask for your support in the passage of
HB306.
Representative Story highlighted the importance of
pharmacists during the COVID-19 pandemic and appreciated
the committee's consideration of the extension of the
board.
Co-Chair Merrick invited the legislative auditor to the
table.
9:23:37 AM
KRIS CURTIS, LEGISLATIVE AUDITOR, ALASKA DIVISION OF
LEGISLATIVE AUDIT, reviewed the Division of Legislative
Audit's sunset review for the Board of Pharmacy. She read
directly from the audit report (copy on file):
Overall, the audit concluded that the board served the
public's interest by effectively conducting its
meetings and actively amending regulations; however,
improvements over the board's licensing function are
needed. Further, the audit concluded that Division of
Corporations, Business and Professional Licensing
(DCBPL) staff investigated complaints unrelated to the
controlled substance prescription database (CSPD) in a
timely manner and activity worked toward implementing
new CSPD requirements.
At the time of the audit, occupational boards were not
effectively monitoring or enforcing CSPD requirements.
Additionally, DCBPL licensing staff were not
consistently entering the existence of a Drug
Enforcement Administration (DEA) registration number
into DCBPL's licensing database, which prevented the
licensing database from being used to monitor
compliance with CSPD registration requirements.
In accordance with AS 08.03.010(c)(16), the board is
scheduled to terminate on June 30, 2022. We recommend
that the legislature extend the board's termination
date six years, to June 30, 2028, which is less than
the eight-year maximum allowed in statute. The reduced
extension reflects the need for more timely oversight
of the board's evolving role in combating the public
health opioid crisis.
Ms. Curtis asked members to turn to page 13 of the audit
report and directed attention to Exhibit 4, which detailed
the standard licensing information and financial
information in the audit. She relayed that as of January
31, 2021, there were 4,280 active licenses, which included
individual licenses and facility licenses. There was a 17
percent increase when compared to the prior 2017 sunset
audit due to three new license types.
Ms. Curtis directed members to turn to page 15 to view the
board's schedule of revenues and expenditures. The board
had a high surplus of almost $800 thousand as of January
31, 2021. She explained that the board discussed fee
reductions during the February 2021 board meeting and
decided against reducing fees. The board planned to add a
new licensing examiner position, which would result in
increased expenditures. Additionally, there was concern
that the disciplinary matrix established to cover the new
controlled substance prescription database (CSPD)
requirements would result in future investigative
expenditures. Fees were not reduced in recognition of the
potential future expenditures.
Ms. Curtis relayed that a large portion of the audit was
intended to evaluate the board's progress in administering
the CSPD. The last sunset audit in 2017 concluded that
changes to laws governing the database would give the board
a more active role in reducing the abuse and diversion of
controlled substances. The prior audit recommended a four-
year extension to monitor the board's progress in
implementing new laws that governed the database.
Ms. Curtis read from page 4 of the audit report in order to
provide background information:
Senate Bill 196, passed in 2008, required the Board of
Pharmacy (board) to establish and maintain a CSPD.3
The law was passed with the intent to improve patient
care and foster the goal of reducing misuse, abuse,
and diversion of controlled substances. The statute
requires each dispenser submit to the board, by
electronic means, information regarding each
prescription dispensed for a controlled substance. The
CSPD electronically collects information from in-state
pharmacies, as well as other dispensers of controlled
substance prescriptions.
Ms. Curtis shared that important authority was missing from
the original legislation that limited its effectiveness and
prevented the legislation from meeting its intent.
Significant changes were made to address the deficiencies
in 2017 and 2018, which significantly impacted the way in
which the board administered the database.
9:28:06 AM
Ms. Curtis directed members' attention to page 16 of the
audit, which outlined the significant changes to the CPSD.
She reported that during the audit period, administration
of the CSPD significantly changed in terms of legal
authority and organizational structure. The changes were
intended to make the CSPD more effective at preventing the
misuse, abuse, and diversion of controlled substances. She
read the three significant changes from the audit:
Register - licensees of the six occupational boards
that prescribe or dispense controlled substances were
required to register with the CSPD;
Report - data regarding prescriptions and dispensed
substances were required to be reported daily to the
CSPD; and
Review - practitioners were required to check the
database prior to dispensing, prescribing, or
administering medication, with specific exclusions.
Ms. Curtis noted that the audit concluded that changes to
statutes and regulations made the database more capable of
combating the opioid crisis.
Ms. Curtis continued to read from page 16 and 17 of the
audit:
Implementing the new CSPD laws required the
coordination of six occupational boards. The
Prescription Drug Monitoring Program (PDMP) is housed
within the Board of Pharmacy; however, each applicable
licensing board is responsible for monitoring and
enforcing the requirements for their respective
licensees. As of January 2021, each applicable board
was at a different stage in implementing new CSPD laws
and none of the boards were fully monitoring or
enforcing CSPD requirements.
Ms. Curtis directed members' attention to "Exhibit 7" on
page 17 of the audit report, which summarized the degree
each applicable occupational board monitored CSPD
registration and reporting requirements. She highlighted
that only the Board of Pharmacy monitored compliance with
both the registration and the reporting requirements.
However, none of the boards monitored whether licensees had
complied with the requirement to review the CSPD prior to
dispensing, prescribing, or administering controlled
substances.
Ms. Curtis turned to page 19 of the audit report, which
concluded that the new CPSD requirements were not actively
enforced by the respective boards. She read from page 19:
Enforcement was further limited by inadequate
disciplinary matrices. Board disciplinary matrices
needed to help guide the resolution of CSPD related
cases were not available for all boards during the
audit period. Exhibit 9 [on page 20] summarizes the
status of the disciplinary matrices as of January 31,
2021. Several board matrices covered a failure to
register, but not a failure to review CSPD information
or a failure to report controlled substances to the
CSPD. The Board of Examiners in Optometry disciplinary
matrix did not address the CSPD.
Ms. Curtis proceeded to page 20 and continued reading as
follows:
Enforcement was further limited by inadequate
disciplinary matrices. Board disciplinary matrices
needed to help guide the resolution of CSPD related
cases were not available for all boards during the
audit period. Exhibit 9 summarizes the status of the
disciplinary matrices as of January 31, 2021. Several
board matrices covered a failure to register, but not
a failure to review CSPD information or a failure to
report controlled substances to the CSPD. The Board of
Examiners in Optometry disciplinary matrix did not
address the CSPD.
Ms. Curtis noted that the audit contained more detail
regarding the CSPD, but she intended to advance to the
findings and recommendations made by the audit.
9:31:25 AM
Representative Carpenter wanted to hear more details.
Ms. Curtis obliged and continued to read from page 20 and
page 21:
Only two of the applicable boards set prescription
limitations in regulation. The State Medical Board set
a limitation of 50 morphine milligram equivalents
(MME) for initial opioid prescriptions only and the
Board of Dental Examiners set a limitation of 60 MME.
(See Recommendation 3)
The Board of Pharmacy may, but is not required to,
send patient specific utilization notifications to
pharmacists and practitioners. Instead of sending
patient-specific notifications, the PDMP coordinator
provided summary data to applicable occupational
boards as part of standard board reports and to
practitioners as part of prescriber report cards. The
following three metrics, referred to as "clinical
alerts," were provided:
1. Number of patients treated with over 90 and 120
MME;
2. Number of patients treated with dangerous
combinations; and
3. Number of patients who received controlled
substances from five prescribers, at five pharmacies,
over a three month period.
9:33:07 AM
Representative Wool did not know what the morphine amounts
meant as he had not gotten morphine prescriptions. He asked
whether 60 MME of morphine was a significant amount.
Ms. Curtis responded that she did not know what the amount
meant either and had researched it prior to the committee
meeting.
Representative Wool wanted to put the amount in terms of
equivalence to understand it better. He asked what the
equivalent amount of Percocet or Tylenol with Codeine would
be.
Ms. Curtis admitted that she did not have the knowledge to
properly answer the question and suggested that it would be
better suited for the chair of the board or a board member.
Co-Chair Merrick indicated the chair would testify later in
the meeting.
Representative LeBon speculated that in-state control of
substances via a database would be effective and manageable
with robust opportunity for oversight. He asked how
medications coming from other states were entered into the
database.
Ms. Curtis understood that pharmacies from other states
were required to enter prescriptions into the database.
There were exceptions to this requirement, and she offered
that it would be a good idea to confirm the details of the
exceptions. For example, she relayed that Native
corporations and army bases were not required to enter
prescriptions into the database.
9:35:52 AM
Ms. Curtis continued to read from the audit report on page
21 through page 22:
The process of sending board reports evolved during
the audit period. Not all boards were sent reports on
a routine basis and not all board reports included the
three metrics. Exhibit 10 identifies the number of
board reports issued during the audit period and the
number of reports that included one or more of the
three clinical alert metrics.
Beginning FY 18, CSPD information, referred to as
Prescriber Report Cards, was provided to prescribing
practitioners. The report cards were intended to give
practitioners the ability to review their prescribing
activity and compare the activity to other
practitioners within the same occupation and within a
specific specialty.
Quarterly report cards included:
• the three clinical alerts;
• the prescriber's current prescribing controlled
substance volume sand duration, including
comparison to peers;
• the top three prescribed controlled substances;
and
• the number of patients searched in the CSPD.
Exhibit 11 illustrates the number of practitioners who
received a prescriber report card by occupational
board.
9:37:04 AM
Ms. Curtis reviewed the recommendations beginning on page
25:
The board chair and DCBPL's director should improve
procedures and training to ensure applicants meet
requirements prior to licensure.
Three of 25 individual applications tested (12
percent) were missing affidavits of moral character.
Regulation 12 AAC 52.120(b)(8) requires an applicant
provide two affidavits from reputable citizens that
the applicant has known for at least one year
attesting to the applicant's good moral character.
Auditors noted that the DCBPL checklist used to ensure
applications were complete was missing the requirement
for affidavits of moral character, which contributed
to the deficiency.
Five of 25 facility license applications tested (20
percent) did not include all the required regulatory
documentation.
Ms. Curtis identified what the audit found to be the most
concerning lack of documentation on page 26 through page
27:
One out-of-state wholesale drug distributor, one out-
of-state pharmacy, and one in-state pharmacy were
issued licenses when the applicants answered yes to a
professional fitness question and the applicants'
licensing fi les lacked documentation of approval by a
supervisor prior to issuance. Alaska Statute
08.80.261(a) states that the 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. To help evaluate an
applicant's professional fitness, the application asks
a series of questions. Division policy (DOL-28)
requires the licensing supervisor review and approve
applications that contain "yes" answers to
professional fitness questions. Two of the three
licenses were issued without follow-up due to human
error. DCBPL management stated that the fitness
questions were reviewed by a supervisor for the third
license; however, no evidence was included in the fi
le to demonstrate the review and there was no evidence
that additional information was obtained upon which to
base the review.
According to DCBPL management, turnover in the
licensing examiner position, a lack of training, and
human error contributed to the facility license errors
noted above.
Ms. Curtis reported that recommendation 2 [on page 27]
advised the board to adopt regulations for renewing
outsourcing facilities and third-party logistics provider
licenses. The renewal regulations were not updated when two
new license types were originally added and would be a
simple fix.
Ms. Curtis added that recommendation 3 suggested applicable
occupational boards and DCBPL's director should continue to
coordinate efforts to improve the monitoring and
enforcement of CSPD requirements. An advisory group had
been formed in September 2020 consisting of all six
occupational boards to help improve compliance amongst
licensees. She recommended the utilization of the group to
improve compliance.
9:39:33 AM
Ms. Curtis continued to read recommendation 4 on page 29:
The Department of Commerce, Community, and Economic
Development's (DCCED) commissioner should allocate
sufficient resources to ensure licensees holding a
Drug Enforcement Administration (DEA) registration
number are consistently recorded in DCBPL's licensing
database.
Ms. Curtis reported that consistent record keeping had not
been happening, and that data matches with the CSPD and
registration monitoring were not possible without completed
licensing database records.
9:39:49 AM
Ms. Curtis read recommendation 5 on page 30 of the audit
report:
DCCED's commissioner should allocate sufficient
resources to ensure the CSPD requirements are
enforced.
Ms. Curtis explained that related cases were not being
investigated due to a lack of resources.
9:40:02 AM
Ms. Curtis continued to management's response to the
recommendations, which began on page 46 of the report. She
relayed that the DCCED commissioner [Julie Anderson]
generally agreed with the report conclusions. The
commissioner reported that corrective action had been taken
in response to the audit, such as providing training,
instituting additional procedures to address licensing
deficiencies, adding two additional grant funded positions
to the PDMP, and approving a new investigative position to
oversee enforcement of the CSPD requirements.
The response from the chair of the Board of Pharmacy
[Justin Ruffridge, PharmD] was found on page 51. He came to
the same conclusions as the commissioner.
9:40:58 AM
Representative Edgmon asked why the legislative auditor was
recommending a six-year extension. He referenced page 23 of
the audit report:
The board explained in the 2021 legislative report
that it was not possible to quantify the reduction of
inappropriate use or prescription of controlled
substances because the CSPD does not contain or relate
prosecutorial data regarding diversion cases and is
not informed when an individual, whether a patient or
provider, has avoided inappropriate use or
prescribing.
Representative Edgmon indicated the issue had been
discussed during deliberations of SB 76 [Legislation passed
in 2016 regarding real estate licensees for licensee
relationships]. He relayed that the discussion had been
controversial due to concerns about privacy and overreach.
He offered his perspective that the six-year extension
seemed incongruent with previous legislation.
9:42:26 AM
Ms. Curtis responded that in the 2021, the auditors "came
down fairly hard" on the board and recommended an extension
of only four years. At that point, new laws had been
introduced to fix issues associated with the database. She
opined that there were poor laws in place, such as monthly
reporting requirements, voluntary compliance, and an
ineffective database. As the opioid crisis progressed, the
legislature made attempts to correct the issues. She wanted
to recognize the great strides the board had made after
previous prescriber report cards and board reports were
released.
Ms. Curtis commented that page 23 of the audit listed
performance measures that could not have been realized
within the parameters of the law at the time. She did not
factor in the inability to meet the performance standards
because the standards were impossible to meet. She had
considered whether the board was placed in the right
department due to the focus of the licensing and the
regulation of the board. She researched what other states
had done in similar situations and had found it was common
to implement these requirements at the board level within
DCCED. The six-year extension recognized the strides that
had been made by the board. She noted that the board needed
additional recognition and support, particularly
considering the resource and hiring restraints of the last
few years.
9:45:28 AM
Representative Edgmon agreed and noted that the department
had been reduced by 78 percent since 2015. He added that
this issue was readdressed in 2016 and again in 2017 and
suggested shortening extension to around three years. He
thought there was a need for statutory change. He did not
want to overcomplicate the process and acknowledged that
the board had been tasked with a significant amount work
and responsibility. The database played a significant role
and he supposed that it had not been utilized enough. He
noted that was due to "political landmines" regarding
reporting requirements and data access.
9:46:56 AM
Representative LeBon asked Ms. Curtis about the audit
frequency. He wondered whether there would be a follow-up
audit.
Ms. Curtis indicated that the auditors would reevaluate the
need for an additional audit the year before the
termination date. The extension date given by the
legislature would determine the timeframe for the next
audit.
Representative LeBon asked whether it would be appropriate
to shorten the extension timeframe given the findings of
the audit.
Ms. Curtis indicated that none of the recommendations
factored into her reduced extension decision. The role of
the board was constantly evolving, and she did not want to
wait eight years to reassess the situation. She pointed out
that all five recommendations were administrative in nature
and were easily manageable. Some of the recommendations
were resource issues, which was the responsibly of the
legislature. She stated that the amount of time the
legislature wanted to wait to send her "back in" was a
policy call.
9:48:36 AM
Representative Carpenter noted that Ms. Curtis spoke of
potential statutory change. He wondered whether the board
had made any recommendations for statutory changes.
Ms. Curtis responded that the board had helped individual
legislators propose changes to the database. She thought
there were some existing bills regarding proposed
improvements to the database.
Representative Carpenter suggested that it would be wise
for the committee to request a summary of recommended
statutory changes.
Co-Chair Merrick thought the bill sponsor could work on the
issue.
9:50:03 AM
Representative Wool understood that pharmacists and doctors
were the users of the PDMP. He wondered if the medical
board had similar issues related to the PDMP.
Ms. Curtis responded that the auditors were in the process
of starting to work on the medical board. The auditors had
recently completed work on the Alaska Board of Examiners in
Optometry and had significant problems discovering whether
individuals had registered for the CSPD. It could not even
be tested due to problems with the DCBPL licensing
database. The auditors performed a deep investigation and
found many applicants that were in the licensing database
that were not in the CSPD, and many applicants who were in
the CSPD but not in the licensing database due to lapsed
licenses. The contractor who ran the CSPD was responsible
for discovering problems of this nature, but that oversight
had not been occurring. She reiterated that a similarly
thorough investigation would be performed for the medical
board. She highlighted that boards were not typically
enthusiastic to engage in investigations and that it was
typically a self-policing system. She explained it was not
coming from "the ground up, but more the top down." She was
certain that the boards would have input regarding
suggested changes.
Representative Carpenter appreciated Ms. Curtis' feedback.
He suggested that if the database was considered a tool to
assist against the opioid epidemic, but the board was not
appropriately managing that tool, perhaps it should not be
managed by the board. He speculated that the DCCED might
have been a more appropriate entity to entrust with
managing the database due to increased accountability,
budgets, and supervision. He asked whether the
administration might make a similar recommendation.
Ms. Curtis had come to the same conclusion in terms of the
most appropriate entity to house the database. The database
had not been effective as anticipated.
Representative Carpenter commented that if a tool that
intended to solve the opioid epidemic was not being
utilized, it was a failure and needed to be reassessed. He
suggested that extending the board another two years or six
years would not solve the problem.
Ms. Curtis explained it was the reason for the six-year
recommendation. The board was succeeding in registering
people and providing licenses, but success in managing the
CPSD was an entirely different situation. She opined that
each administration over the past 10 years had not
appropriately dealt with the issue.
Co-Chair Merrick noted Ms. Chambers with DCBPL was nodding
her head.
Representative Wool commented that there may be other
issues preventing the success of the boards that dealt with
the PDMP and CSPD. He thought there were also issues
regarding software integration with databases. He reminded
the committee of Representative LeBon's earlier question
about online sales and suggested that individuals who made
illegal online sales of drugs were likely not in the
database. He remarked that illegal sales contributed
significantly to the opioid overdose problem.
9:55:56 AM
SARA CHAMBERS, DIRECTOR, DIVISION OF CORPORATIONS, BUSINESS
AND PROFESSIONAL LICENSING, DEPARTMENT OF COMMERCE,
COMMUNITY AND ECONOMIC DEVELOPMENT, appreciated the
discussion from the auditor's team. She agreed that the
issue was difficult because there were so many independent
governors of the system. The board did not answer to the
departments or the administration, but to the legislature.
The board was a group of volunteers that spent personal and
free time dedicated to working on board issues. She
explained that DCBPL helped facilitate board conversations
and helped guide agenda items. There was also a meeting of
the chairs of all boards and a second meeting of just the
PDMP chairs to help facilitate conversation. The meetings
happened twice a month on a Tuesday at 4:30 p.m., which she
relayed was difficult timing because everyone was tired.
For several years, there had been discussions within DCCED
with the boards and with the Department of Health and
Social Services (DHSS) surrounding suggestions for
statutory change. She thanked Representative Josephson for
introducing legislation based on her recommendations. There
had been conversations in other committees that recognized
a need to revisit the PDMP because some of the laws were
setting the program up with expectations it could not meet.
9:59:12 AM
Ms. Chambers suggested there needed to be a reframing of
the PDMP from the legislature. She was involved in the
committee hearings mentioned earlier by Representative
Edgmon and recalled that the PDMP was not intended to be
used to crack down on doctors, nurses, optometrists,
dentists, and veterinarians. It was not intended to be a
heavy-handed enforcement tool, but to be an educational
tool. It was meant to provide accountability so that
prescribers could learn more about the opioid epidemic. She
explained that it enabled prescribers to compare their
prescribing habits with those of other prescribers and with
patient histories. If there was a significant difference,
it enabled prescribers to determine whether there was a
legitimate reason for the difference. The PDMP needed to be
utilized in the way the law was written in order to elicit
the results desired by the legislature.
Ms. Chambers provided an example. She opined that there
needed to be an increased ability to communicate with other
databases within the state. There were tools within DHSS
that would help link other data with PDMP data. She
emphasized that it was illegal under the current law for
DCCED to share with DHSS data that linked prescribing data
with overdose deaths. She suggested that that connection be
made legal in order to elicit the legislature's desired
outcomes.
Ms. Chambers explained that cases were often brought to the
medical board regarding medical and office assistants who
would access the PDMP to prepare the computer display for
the physician. This was illegal because medical assistants
cannot access the PDMP, even though it was legal for them
to view the same medical information through paper records.
Medical assistants were often asked by physicians to access
the PDMP without knowing it was illegal. She wondered
whether punishing the assistants and physicians was where
the state wanted to spend its limited resources. She wanted
to paint some of her frustrations with the PDMP, but
emphasized that she believed in the PDMP and in the boards.
The system had the potential to be a good tool.
10:03:14 AM
AT EASE
10:03:37 AM
RECONVENED
Representative Josephson asked about the last point
regarding medical assistants. He recalled working with
former Alaska State Senator Cathy Giessel on a bill that
created a new category for medical assistants in order to
delegate some database authority to the assistants.
Ms. Chambers reported there had been a bill that would have
created a license for medical assistants, but there was
concern within the medical community that prevented the
bill from going forward. There was legislation that allowed
physicians to delegate certain responsibilities to
unlicensed staff, but it did not include PDMP because it
was in statute that a person must be licensed on order to
view the database.
10:04:56 AM
Representative LeBon asked if the volunteers on the
pharmacy board risked any potential personal liability as
an outcome of their decisions.
Ms. Chambers responded that the state provided immunity for
board members acting in good faith. Board members were
protected unless they acted egregiously outside of the
norm. She noted that licensing boards had received
discipline all the way up to the United States Supreme
Court for failing to act in good faith, and there were many
models that provided examples of offensive actions. She
highlighted that this sort of disciplinary action had
thankfully not needed to take place in Alaska.
10:06:10 AM
Representative LeBon relayed that banks in Alaska were
examined by both the state and Federal Deposit Insurance
Corporation (FDIC) and were expected to hire an independent
auditor to perform an audit prior to an examination. The
audit provided information to the examiners on the ways in
which the bank was functioning and was paid for by the
financial institution. Ms. Curtis had mentioned that there
was about $800 thousand that had been designated for paying
various licensing dues and business operation expenses. He
wondered if it would be unusual for a board to use some of
those funds to hire an independent auditor or accounting
firm to help the board comply with the expectations of the
audit.
Ms. Chambers responded that DCCED looked to the legislature
and the legislative audit process to act as the audit. She
saw that there could be an opportunity for a board to hire
a consultant to help with audit recommendations.
10:08:01 AM
Representative LeBon thought the profession should be
collectively thinking about the potential liability of
members of the board. He suggested that there be an
independent auditor to confirm that expectations had been
met prior to the state audit.
10:08:38 AM
Representative Wool commented that there had been a bill to
license medical assistants to allow them to enter data into
the PDMP partially because if the assistants did something
wrong, the license could be revoked to punish them. He
shared that he opposed the licensure because it would be
another barrier to entry to a profession and there were
many licenses already. He had also heard from physicians
that they did not get into the profession to simply enter
data, and that data entry was a waste of a physician's
skills. He wondered if there were people leaving the
pharmacy profession due to the perceived waste of skills.
He didn't know whether the board was having issues at the
audit level prior to the PDMP implementation and asked if
most of the issues surrounded the database. He suggested
that everyone had concluded that the database needed work.
He asked about the source of the drugs people were
overdosing on, and whether the drugs had been prescribed or
were illicit drugs. He asked if the board had been
considered good operators prior to the implementation of
the PDMP.
Ms. Curtis answered that the last sunset audit received a
four-year extension, and she couldn't recall the extension
timeline prior to that. The changes made in 2017 and 2018
helped address the extent to which the licensee had to
enter data into the PDMP. She thought that there had been
some changes regarding delegating the task to medical
assistants, and that prior legislation had already
addressed this issue. She offered to follow-up on the
information and send a memo to committee members to
clarify. The PDMP was highly federally funded, and there
was consideration of whether the database belonged under
the jurisdiction of DCCED or DHSS. Another consideration
was to what degree did the state want to contribute monies
to the program.
10:12:23 AM
Ms. Chambers commented that PDMP data entry could be a
delegated task, but it could only be delegated to a
licensed individual. The original conversation centered
around registered nurses (RN) and licensed nurse
practitioners (LPN), but that model had been changed as
there were fewer LPNs and more unlicensed medical
assistants. The law needed to address where the resources
were practically occurring.
Representative Wool stated that pharmacy technicians and
veterinary technicians were licensed and were legally able
to enter information into the database. He thought that
might be addressed in another manner.
Representative Edgmon shared that it seemed there were two
different discussions occurring, one of which was to extend
the termination date of the Board of Pharmacy. He asked for
verification that the board's primary duty did not pertain
to overseeing the PDMP.
Ms. Chambers agreed.
Representative Edgmon asked what percentage of time the
board spent on the database versus its other duties.
Ms. Chambers asked for clarification on whether he was
referring to the volunteered time itself or the staff
support.
Representative Edgmon shared his understanding that the
database required a need for increased staff time. He noted
the board had many other responsibilities in addition to
the database and wondered whether the effort may be a
little displaced in some respects.
Ms. Chambers agreed that some of the findings regarding the
Board of Pharmacy and the other boards mentioned in the
audit related to policy decisions that the boards
themselves had to make. Some of the findings regarded staff
ability to perform daily licensing functions. She deferred
to the Board of Pharmacy's chair regarding the amount of
time that was spent on the database.
10:16:02 AM
Representative Edgmon requested to hear from the chair. He
stated that the conversation about the database could
continue for a long time. He remarked that the board needed
to continue.
JUSTIN RUFFRIDGE, CHAIR, BOARD OF PHARMACY (via
teleconference), indicated he had learned a significant
amount through the audit process. He agreed with
Representative Edgmon and stated that the board served a
vital role in a wide variety of capacities such as public
health, safety, and welfare. The last few years the board
had worked diligently on regulations regarding the COVID-19
pandemic response. The board regulated new processes such
as the continuation of therapy, which ensured that
individuals had uninterrupted access to medication and
released temporary and emergency licenses that expanded
access to care.
Dr. Ruffridge shared that the board had spent some time
considering the PDMP. The board usually had an update from
staff regarding use of the database as well as issues that
had arisen from other boards. He was happy to report that
pharmacies and pharmacists utilized the PDMP at the highest
level possible, and that the audit reflected that
information. He met with the chairs of other boards and
discussed PDMP issues for at least two hours twice a month.
There were also quarterly meetings which included an hour
of time dedicated to discussing the database. He stated
that a small percentage of board time was spent on PDMP
discussions. The board had many other responsibilities,
such as managing disciplinary action, licensing, and
regulations. The board was also working on an ongoing
regulation review project at the request of the
administration that promoted right-touch regulations. He
explained that the field of pharmacy had changed
dramatically over the last ten years, and options such as
robotics and tele-pharmacy were not yet reflected in
regulations. The board was close to finishing other
regulation projects and he expressed pride for the work
that had been done to make regulations understandable,
reasonable, and accessible.
Dr. Ruffridge recalled that Ms. Curtis mentioned that
another area the board had focused on was its finances.
There was a surplus in dollars put out by the audit that
was mostly due to additional licensing categories. Since
the audit, a more balanced budget had been put forward by
the board that included proposed fee reductions across
multiple license types. He highlighted that there was a
shortage of pharmacists and pharmacist technicians across
the state, and the new budget proposed reduced fees for
pharmacy technicians specifically to address the shortage.
He supported a six-year extension.
10:22:02 AM
Representative Edgmon appreciated the comment by Dr.
Ruffridge. He asked if there was a mechanism that could be
put in place to keep the legislature informed of the
staffing needs for the database, or any potential need to
pass new laws. Other states were also grappling with proper
regulation of the database. He wanted assurance that the
issues would be brought to the legislature.
Ms. Chambers responded that the board provided an annual
report which supplied additional information and was an
existing tool. She also suggested doing work in the interim
to come up with creative changes where needed.
10:24:22 AM
Representative Carpenter opined that the sunset issue was a
separate issue from the PDMP database. He was concerned
about there being a lack a conversation in the following
year about the same issue and wondered what would force the
legislature to have the conversation. The problem was that
no department seemed to have ownership over the database or
the opioid crisis at large. Volunteers were responsible for
managing the database. He wondered if the legislature was
willing to wait to bring forward new legislation to address
the problem. He supported requiring an independent audit in
addition to the financial audit and opposed the six-year
extension. The extension seemed to be a way to force the
legislature to have a conversation.
Ms. Curtis replied that the audit was a sunset audit and
the criteria for sunset audits was in statute. If the
legislative auditor performed a two-year extension, she
would likely come to the same conclusions because there
would not be enough time between audits to resolve issues
noted in her report. The criteria for the sunset audit
would not enable the action sought by Representative
Carpenter. She thought a private audit that looked at best
practices and possible statute changes might be a good
idea. She suggested it would be better to wait to do
another audit until some changes were made.
Representative Carpenter commented that he agreed and that
it did not seem like a good use of time to perform another
audit so soon. He suggested adding something to the bill
that would ask the administration to take action to
continue the conversation. There was diluted responsibility
for the problem and a single department could not be held
accountable. He thought the issue was not owned by anyone
and proposed that someone should be made responsible for it
to allow for more decision-making authority. He did not
believe it was the legislature's responsibility to enforce.
10:30:29 AM
Representative LeBon read from the audit on page 1:
The board was established for the Exhibit 1 purpose of
controlling and regulating the practice of pharmacy in
Alaska. According to AS 08.80.005, effective control
and regulation is necessary to promote, preserve, and
protect the public's health, safety, and welfare.
Representative LeBon asked the Dr. Ruffridge whether the
board had discussed utilizing an independent auditor or
consultant to carry out the duties described in the audit.
Dr. Ruffridge indicated that although an external audit
could be helpful, the board was already aware of the
issues. He reminded the committee that many stakeholders
were involved and met twice a month for at least an hour.
Stakeholders had many significant conversations about the
best ways to use the PDMP to benefit both the citizens of
Alaska as well as the board. Part of the problem uncovered
by the audit was that the board was expected to measure the
results of the PDMP, which was a nearly impossible standard
for one board to satisfy on its own. He did not know which
results in particular the board was intended to measure. He
suggested that there be a stakeholder group meeting with
interested legislators to discuss some of the larger PDMP
system issues. He relayed that the Board of Pharmacy and
other boards were ready to have that conversation. He
believed that the best place for the PDMP to be housed was
within the Board of Pharmacy because pharmacies and
pharmacists were the highest engaged users of the database.
Representative LeBon agreed that the board had a huge job.
He asked if DCCED was a good partner to the board.
Dr. Ruffridge responded that the department had done a
great job despite frequently inadequate resources. The
response from Ms. Chambers all the way down to PDMP staff
was excellent. The board was asking one person to perform
the duties of three or four people and employees often
needed to work beyond their required hours.
10:36:16 AM
Representative Johnson suggested that either some
additional resources should be considered or there should
be a change to the effective date. She wanted more clarity
before taking final action.
Co-Chair Merrick noted that the committee would be hearing
public testimony in the following week.
10:38:13 AM
Representative Josephson recalled being involved in a
meeting where several provider groups indicated that the
groups' own bylaws requested that they complied with the
PDMP, provided the necessary data, and ensured that
patients were not "doctor shopping." However, it was not
compulsory, and some groups did almost nothing. He wondered
if it was true that there had been some provider groups
that were vigilant while other groups were more relaxed.
10:39:13 AM
Ms. Curtis suggested there were some boards that had been
slow to implement the new changes. There had been a grace
period of a year to become accustomed to the new data
requirements, and some boards had been slow to embrace the
changes. She shared that the auditors did come down on
these boards during the audit. She didn't recall a specific
example.
10:40:06 AM
Representative Josephson asked whether there was a record
of a board that suspended a license because of the
database.
Ms. Curtis emphasized that enforcement had been relaxed. It
was reported that more than 700 licensees had potentially
not been compliant, and very little to no action was taken.
She explained that this was due to lack of a disciplinary
matrix, lack of resources, and lack of solid information.
It was a new area and standard investigative procedures
were not established. She emphasized that little had been
done in the area of enforcement.
Representative Josephson argued that this made criticism of
the role of the Board of Pharmacy difficult. It was not
possible for the board to be the enforcer.
Ms. Chambers thought there were "multiple cooks in the
kitchen" which had created confusion over authority and
resource allocation. She relayed that 750 licensees had
failed to comply with one of many requirements, which
required examination by several investigators. However,
many licensees had not violated a prescribing requirement
and therefore did not pose an immediate health and safety
risk. She exclaimed that a new investigator had been hired,
but the position had been unfilled for a significant amount
of time. This represented the legislature's past decision
to qualify the database as an educational tool and not an
enforcement tool; however, if every PDMP violation needed
to be investigated, there needed to be an increase in
resources and clarity from the legislature.
Co-Chair Merrick noted that Representative LeBon had an
earlier question regarding obtaining prescriptions via
mail.
10:44:20 AM
Representative LeBon asked Dr. Ruffridge to comment on
prescriptions coming into the state through national or
international sources.
Dr. Ruffridge responded that access to medication was a
federal issue and not within his purview. He explained that
the controlled substance statutory chapter required
external pharmacies to be registered with the state and for
pharmacy information to be entered into the PDMP. In
addition, there was shared services access within the PDMP
that allowed registered users to search other states'
databases to prevent issues like doctor shopping. He
explained that doctor shopping was not always a state issue
or local issue, and it was important to build an external
link into the database.
Representative LeBon asked whether individuals might
utilize Canadian prescriptions to get around the link.
Dr. Ruffridge responded that there would be no way to
access the Canadian database. An individual who traveled to
Canada and received a prescription from a Canadian provider
would only be able to fill the prescription in Canada. The
reverse was also true, meaning that an individual could not
get prescription written in Alaska and filled in Canada. He
agreed that if an individual received and filled a
prescription in Canada and requested the same medication in
Alaska, the board would not have a way of knowing.
Co-Chair Merrick asked Ms. Chambers to review the fiscal
note.
Ms. Chambers reviewed the fiscal note with the control code
oegIR. She reminded members that a fiscal note for a board
extension would look unusual because it anticipated that
the board would sunset if HB 306 did not pass. The fiscal
note added back the authority that the board would cease to
have if the board was to sunset. It included a standard
sunset board mechanism that expected the board to travel to
four board meetings every year. The board had become more
adept at teleconferencing, so that authority may or may not
be spent. If the bill failed to pass and the board was to
sunset, the sunset mechanism ensured that the licensing of
pharmacists would continue under the department's purview.
She emphasized that the fiscal note mainly referred to
required travel for board members to go to meetings.
Co-Chair Merrick thanked the testifiers for being in the
committee. She reviewed the agenda for the afternoon.
HB 306 was HEARD and HELD in committee for further
consideration.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB306 Legislative Audit Division Sunset Review BOP 07.15.21.pdf |
HFIN 3/11/2022 9:00:00 AM SFIN 5/17/2022 1:00:00 PM |
HB 306 |
| HB306 Letters of Support received by 02.22.22.pdf |
HFIN 3/11/2022 9:00:00 AM |
HB 306 |
| HB306 Sectional Analysis Ver A 02.09.22.pdf |
HFIN 3/11/2022 9:00:00 AM |
HB 306 |
| HB 246 Amendment Wool.pdf |
HFIN 3/11/2022 9:00:00 AM |
HB 246 |