02/23/2022 03:15 PM House LABOR & COMMERCE

                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.