Legislature(2017 - 2018)BUTROVICH 205

02/15/2017 01:30 PM HEALTH & SOCIAL SERVICES

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+= SB 36 OPTOMETRY & OPTOMETRISTS TELECONFERENCED
Moved SB 36 Out of Committee
-- Testimony <Invitation Only> --
+ Bills Previously Heard/Scheduled: TELECONFERENCED
+= SB 32 PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS TELECONFERENCED
Moved SB 32 Out of Committee
                    ALASKA STATE LEGISLATURE                                                                                  
      SENATE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE                                                                    
                       February 15, 2017                                                                                        
                           1:32 p.m.                                                                                            
                                                                                                                                
                                                                                                                                
MEMBERS PRESENT                                                                                                               
                                                                                                                                
Senator David Wilson, Chair                                                                                                     
Senator Natasha von Imhof, Vice Chair                                                                                           
Senator Cathy Giessel                                                                                                           
Senator Tom Begich                                                                                                              
                                                                                                                                
MEMBERS ABSENT                                                                                                                
                                                                                                                                
Senator Peter Micciche                                                                                                          
                                                                                                                                
COMMITTEE CALENDAR                                                                                                            
                                                                                                                                
SENATE BILL NO. 36                                                                                                              
"An Act relating to the practice of optometry."                                                                                 
                                                                                                                                
     - MOVED SB 36 OUT OF COMMITTEE                                                                                             
                                                                                                                                
SENATE BILL NO. 32                                                                                                              
"An Act relating to biological products; relating to the                                                                        
practice of pharmacy; relating to the Board of Pharmacy; and                                                                    
providing for an effective date."                                                                                               
                                                                                                                                
     - MOVED SB 32 OUT OF COMMITTEE                                                                                             
                                                                                                                                
PREVIOUS COMMITTEE ACTION                                                                                                     
                                                                                                                                
BILL: SB 36                                                                                                                   
SHORT TITLE: OPTOMETRY & OPTOMETRISTS                                                                                           
SPONSOR(s): SENATOR(s) GIESSEL                                                                                                  
                                                                                                                                
01/25/17       (S)       READ THE FIRST TIME - REFERRALS                                                                        
01/25/17       (S)       HSS, FIN                                                                                               
02/03/17       (S)       HSS AT 1:30 PM BUTROVICH 205                                                                           
02/03/17       (S)       Heard & Held                                                                                           
02/03/17       (S)       MINUTE(HSS)                                                                                            
02/15/17       (S)       HSS AT 1:30 PM BUTROVICH 205                                                                           
                                                                                                                                
BILL: SB 32                                                                                                                   
SHORT TITLE: PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS                                                                              
SPONSOR(s): SENATOR(s) HUGHES                                                                                                   
                                                                                                                                
01/23/17       (S)       READ THE FIRST TIME - REFERRALS                                                                        
01/23/17       (S)       HSS, L&C                                                                                               
02/10/17       (S)       HSS AT 1:30 PM BUTROVICH 205                                                                           
02/10/17       (S)       Heard & Held                                                                                           
02/10/17       (S)       MINUTE(HSS)                                                                                            
02/15/17       (S)       HSS AT 1:30 PM BUTROVICH 205                                                                           
                                                                                                                                
WITNESS REGISTER                                                                                                              
                                                                                                                                
DR. PAUL BARNEY, Chairman                                                                                                       
Board of Examiners in Optometry                                                                                                 
Corporations, Business & Professional Licensing                                                                                 
Department of Commerce, Community, and Economic Development                                                                     
Juneau, Alaska                                                                                                                  
POSITION STATEMENT: Testified in support of SB 36.                                                                            
                                                                                                                                
DR. JEFF GONNASON, Legislative Chair                                                                                            
Alaska Optometric Association                                                                                                   
Anchorage, Alaska                                                                                                               
POSITION STATEMENT: Testified in support of SB 36.                                                                            
                                                                                                                                
SENATOR SHELLEY HUGHES                                                                                                          
Alaska State Legislature                                                                                                        
Juneau, Alaska                                                                                                                  
POSITION STATEMENT: Sponsor of SB 32.                                                                                         
                                                                                                                                
JANE CONWAY, Staff                                                                                                              
Senator Giessel                                                                                                                 
Alaska State Legislature                                                                                                        
Juneau, Alaska                                                                                                                  
POSITION STATEMENT: Provided an overview of Amendment 1 for SB                                                                
32.                                                                                                                             
                                                                                                                                
                                                                                                                                
ACTION NARRATIVE                                                                                                              
                                                                                                                                
1:32:58 PM                                                                                                                    
CHAIR DAVID WILSON  called the Senate Health  and Social Services                                                             
Standing Committee meeting  to order at 1:32 p.m.  Present at the                                                               
call  to order  were  Senators von  Imhof,  Begich, Giessel,  and                                                               
Chair Wilson.                                                                                                                   
                                                                                                                                
                                                                                                                                
                 SB 36-OPTOMETRY & OPTOMETRISTS                                                                             
                                                                                                                                
1:33:22 PM                                                                                                                    
CHAIR WILSON  announced the consideration  of SB 36.  He welcomed                                                               
invited testimony to address SB 36.                                                                                             
                                                                                                                                
1:34:05 PM                                                                                                                    
DR.  PAUL  BARNEY, Chairman;  Board  of  Examiners in  Optometry,                                                               
Corporations,   Business   &   Professional   Licensing;   Alaska                                                               
Department  of  Commerce,  Community, and  Economic  Development;                                                               
Juneau, Alaska; testified  in support of SB 36. He  noted that he                                                               
has served on the board for  five years and was also the director                                                               
for Pacific  Cataract and Laser  Institute in  Anchorage, Alaska.                                                               
He  detailed  that his  practice  specializes  in cataract  care,                                                               
laser  vision correction,  and medical  eye-care. He  pointed out                                                               
that  he  works  with  an ophthalmic  surgeon  and  an  advanced-                                                               
practice  nurse; together  they  work  as a  team  and use  their                                                               
training to provide care more efficiently and affordably.                                                                       
                                                                                                                                
He  emphasized that  SB 36  would  not allow  optometrists to  do                                                               
anything more than what they have  already been trained to do. He                                                               
specified  that   there  is  a  limitation   that  would  prevent                                                               
optometrists from  writing regulations beyond the  scope of their                                                               
training.  He revealed  that  the Alaska  the  Department of  Law                                                               
oversees  all  health-care  boards; consequently,  the  Board  of                                                               
Examiners  in  Optometry  has  to  prove  that  optometrists  are                                                               
trained for  the regulations  that they  write. He  asserted that                                                               
the Alaska  Department of  Law oversight acts  as a  fail-safe to                                                               
prevent optometrists from doing  something outside of their scope                                                               
of  training. He  added that  as  a provider,  if he  were to  do                                                               
something  outside   of  his  scope  of   training,  his  medical                                                               
malpractice   insurance   would   be  immediately   negated.   He                                                               
summarized that there really is  no incentive for optometrists to                                                               
provide care that  they are not trained to do  because they would                                                               
not get paid  and more importantly, optometrists  could end their                                                               
careers by doing something outside of their scope of training.                                                                  
                                                                                                                                
1:37:11 PM                                                                                                                    
DR.  JEFF  GONNASON,   Legislative  Chairman,  Alaska  Optometric                                                               
Association, Anchorage,  Alaska, testified  in support of  SB 36.                                                               
He  disclosed that  he has  been  licensed as  an optometrist  in                                                               
Alaska for 40 years, the past  chairman of the Board of Examiners                                                               
in Optometry,  and served twice  on the  state board in  the past                                                               
under two different governors. He added that he was also a 22-                                                                  
year volunteer for the American Optometric Association.                                                                         
                                                                                                                                
He pointed out  that optometrists' education is  exactly the same                                                               
as  a dentistry-model  with  8 to  10  years of  university-level                                                               
education. He addressed testimony  from an ophthalmologist during                                                               
an  earlier committee  meeting and  noted  that he  had the  same                                                               
professor for pharmacology as the ophthalmologist.                                                                              
                                                                                                                                
DR.  GONNASON   disclosed  that   optometrists  are   defined  as                                                               
physicians under federal Medicare and  that has been the case for                                                               
approximately 18  years. He  divulged that  160-plus optometrists                                                               
serve  over  80 communities  in  the  state.  He set  forth  that                                                               
optometrists work together very  well with general-family doctors                                                               
and ophthalmologists.                                                                                                           
                                                                                                                                
He  opined  that  optometrist  training  cannot  be  compared  to                                                               
ophthalmologist  training because  it would  be like  comparing a                                                               
family physician with a neurosurgeon. He summarized as follows:                                                                 
                                                                                                                                
     We   need  ophthalmologists,   we  love   having  their                                                                    
     abilities to do  their surgeries, we only  overlap in a                                                                    
     small  area; but,  we do  very few  of the  things that                                                                    
     they do  and we are  not trying  to do things  that are                                                                    
     outside  of  our  scope  of   training.  Of  the  four-                                                                    
     prescribing professions,  only optometry has  to always                                                                    
     come  back to,  "Ask  daddy for  permission" to  change                                                                    
     something  as  technology  goes   along.  We  are  very                                                                    
     skilled  in using  our professional  judgement to  know                                                                    
     when to refer patients.                                                                                                    
                                                                                                                                
1:39:56 PM                                                                                                                    
SENATOR  BEGICH  revealed  that  Dr. Barney  did  his  Lasik  eye                                                               
surgery.                                                                                                                        
                                                                                                                                
DR.  BARNEY clarified  that  Dr. Ford  from  Seattle did  Senator                                                               
Begich's  surgery.  He specified  that  he  did the  preoperative                                                               
evaluation and the postoperative care.                                                                                          
                                                                                                                                
SENATOR  BEGICH disclosed  that he  had talked  earlier with  Dr.                                                               
Barney  and  Dr.  Gonnason  to express  his  concerns  about  the                                                               
Legislature's responsibility  to public safety. He  said he asked                                                               
both doctors about the importance  in clarifying surgery in a way                                                               
that  would  meet  the   American  Medical  Association's  health                                                               
concerns as well as meet some  of the needs and interests of what                                                               
optometrists in  Alaska are  doing. He said  he suggested  to Dr.                                                               
Barney that language  around surgery might be  required and noted                                                               
that  Dr. Barney  appeared to  respond that  his suggestion  made                                                               
sense. He  asked Dr. Barney to  comment on the idea  of a tighter                                                               
surgery definition to help committee  members understand what the                                                               
optometrists are seeking in statute.                                                                                            
                                                                                                                                
1:42:06 PM                                                                                                                    
DR.  BARNEY replied  that  if  necessary, he  is  not opposed  to                                                               
language that further defines surgery.                                                                                          
                                                                                                                                
SENATOR BEGICH set forth that his  hope is the committee can come                                                               
to a conclusion that further defines surgery.                                                                                   
                                                                                                                                
1:44:03 PM                                                                                                                    
DR.  GONNASON  remarked  that  part of  the  difficulty  is  that                                                               
"forces" have tried to suppress  the optometrist profession for a                                                               
long  time.  He  said  to answer  Senator  Begich's  question  on                                                               
surgery,  the problem  is  everyone knows  what  surgery is,  but                                                               
trying  to define  surgery can  get  murky. He  pointed out  that                                                               
clipping  a  finger nail  alters  tissue  and can  be  considered                                                               
surgery.  He noted  that  some states  have  defined surgery  for                                                               
physicians  and  dentists. He  remarked  that  putting a  surgery                                                               
definition  in SB  36 would  apply  to other  fields too,  unless                                                               
exempted. He opined  that details should be left  to the medical,                                                               
dental, and nursing boards. He  pointed out that there in nothing                                                               
in  the  nursing  statute  that  says, "You  will  not  do  brain                                                               
surgery" because nurses do not  do that. He asserted that there's                                                               
no  need for  defining surgery  in the  optometry law  that says,                                                               
"You will not do these 16  things." He noted that a proposal came                                                               
out to  put 110 procedures that  could not be done  in statute, a                                                               
proposal  that made  no sense.  He  emphasized that  optometrists                                                               
perform  procedures  that  do  not  "penetrate."  He  added  that                                                               
optometrists  do not  do the  things that  ophthalmologists claim                                                               
optometrists will be trying to do.                                                                                              
                                                                                                                                
1:46:26 PM                                                                                                                    
SENATOR  BEGICH   stated  that  Dr.  Gonnason's   reply  is  more                                                               
difficult for him to understand.  He said he thought Dr. Gonnason                                                               
provided a  clear answer  that surgery as  a definition  might be                                                               
something that he would entertain. He continued as follows:                                                                     
                                                                                                                                
     You  understood   that  concern   and  we  do   have  a                                                                    
     definition of  surgery in  statute and  admittedly part                                                                    
     of why  we have a legislative-affairs  agency here that                                                                    
     drafts bills is that they  look at other statutes where                                                                    
     those definitions  will conflict, and they  identify in                                                                    
     those statutes where they do  and they allow us to know                                                                    
     that in  the process  because all  of us  are generally                                                                    
     generalists   here.   With    that   understanding,   a                                                                    
     definition  of surgery  is a  norm in  many states  and                                                                    
     I've provided to some members  of the committee some of                                                                    
     those definitions  that I've researched some  myself. I                                                                    
     am now confused  whether you are or are  not willing to                                                                    
     look  at a  definition  of surgery  in statute  because                                                                    
     I've heard  you now  say "no," and  I heard  Dr. Barney                                                                    
     say "yes." So which is it, I'm confused.                                                                                   
                                                                                                                                
DR. GONNASON clarified that he did  not mean he would not look at                                                               
a  definition of  surgery. He  specified  that he  was trying  to                                                               
explain why  defining surgery is  difficult and pointed  out that                                                               
most  states address  through regulation.  He remarked  that laws                                                               
are  different in  all 50  states due  to legislative  compromise                                                               
that  results in  optometrists  having  to go  back  and ask  for                                                               
permission  when new  technology comes  along rather  than having                                                               
the board  be able to  say "yes"  when an optometrist  is trained                                                               
for a procedure.                                                                                                                
                                                                                                                                
1:48:29 PM                                                                                                                    
SENATOR VON IMHOF addressed Dr. Gonnason's remarks as follows:                                                                  
                                                                                                                                
     Trying to create  a bill, any bill, so  open ended that                                                                    
     it precludes  having to go  back and change  statute as                                                                    
     technology  changes,   as  circumstances   changes,  is                                                                    
     probably  too difficult  in any  industry. I'm  already                                                                    
     noticing  that  we  are tweaking  things  now  in  this                                                                    
     legislature for  all sorts of  different things  as new                                                                    
     chemicals come  about, as  new technology  comes about,                                                                    
     as new laws  come about, that's just the  nature of the                                                                    
     beast, I think.                                                                                                            
                                                                                                                                
     That being  said, what I'm  understanding is  that this                                                                    
     particular  conflict has  been  around  for quite  some                                                                    
     time  and I  understand the  challenge of  optometrists                                                                    
     having to  come legislatively  every single  time, it's                                                                    
     not cost effective  for any stakeholder. So  the key is                                                                    
     to stop  this nonsense and  to move forward  that while                                                                    
     we  may find  a  solution that  not  everyone is  happy                                                                    
     with, everyone can live with.                                                                                              
                                                                                                                                
     I think what's important is  Senator Begich and I and a                                                                    
     few others have looked at  what other states have done,                                                                    
     some are more onerous than  others, but some have tried                                                                    
     to  thread-the-needle to  make  it make  sense for  all                                                                    
     parties.  I think  what Senator  Begich was  asking you                                                                    
     today for a  deliverable is to perhaps,  could you take                                                                    
     a first crack at what  you think based on other states'                                                                    
     legislation, what might make sense.                                                                                        
                                                                                                                                
1:50:28 PM                                                                                                                    
At ease.                                                                                                                        
                                                                                                                                
1:50:38 PM                                                                                                                    
CHAIR WILSON called the committee back to order.                                                                                
                                                                                                                                
SENATOR GIESSEL  said she  was thrilled  that Senator  Begich has                                                               
done research  on the definition  of surgery, but noted  that she                                                               
was  one  of the  committee  members  that  did not  receive  his                                                               
information.                                                                                                                    
                                                                                                                                
She asked Dr. Barney to  address the number of patient complaints                                                               
that  the Board  of Examiners  in Optometry  has received  in the                                                               
last decade.                                                                                                                    
                                                                                                                                
DR. BARNEY answered that there  have been some complaints, but no                                                               
complaints that  required disciplinary  action over the  past ten                                                               
years.                                                                                                                          
                                                                                                                                
SENATOR GIESSEL  asked Dr.  Barney if the  Board of  Examiners in                                                               
Optometry  was  in  good standing  financially  with  regards  to                                                               
licensing fees covering their costs.                                                                                            
                                                                                                                                
DR. BARNEY replied that the  board is currently in good standing.                                                               
He noted  that the  last scope-of-practice  bill passed  10 years                                                               
ago and the board had  to address legal expenses implemented from                                                               
the scope-of-practice change.                                                                                                   
                                                                                                                                
SENATOR  GIESSEL asked  Dr. Barney  to clarify  the legal  issues                                                               
that he referenced.                                                                                                             
                                                                                                                                
1:52:57 PM                                                                                                                    
DR. BARNEY  specified that  the Alaska  Department of  Law billed                                                               
the board for  their investigative work involved  with the scope-                                                               
of-practice  change.  He  detailed  that license  fees  were  not                                                               
increased, and  the board fell  behind, but noted that  the board                                                               
will be caught up in the next cycle.                                                                                            
                                                                                                                                
SENATOR GIESSEL asked him to verify  that the board pays the cost                                                               
in  implementing regulatory  changes and  the funding  ultimately                                                               
comes from licensees.                                                                                                           
                                                                                                                                
DR. BARNEY answered correct.                                                                                                    
                                                                                                                                
CHAIR WILSON asked for final comments from the bill's sponsor.                                                                  
                                                                                                                                
1:54:15 PM                                                                                                                    
SENATOR  GIESSEL  summarized  intent  and  issues  of  SB  36  as                                                               
follows:                                                                                                                        
                                                                                                                                
     I think Senator von  Imhof really encapsulated it, this                                                                    
     has  been an  issue  that has  been discussed  multiple                                                                    
     times  over at  least a  decade, it  continues to  take                                                                    
     time  in this  legislature; in  that time  optometrists                                                                    
     have  been practicing  safely.  You've heard  testimony                                                                    
     that  professional  complaints against  their  practice                                                                    
     are zero.  I think it  is time  to allow this  board to                                                                    
     function as other boards do.                                                                                               
                                                                                                                                
     I  have the  definitions of  the scope-of-practice  for                                                                    
     the  four boards  that  currently  have authority  over                                                                    
     their regulation,  over their regulatory  authority and                                                                    
     that is: nursing,  physicians, dentistry, and pharmacy.                                                                    
     All are  extremely broad, I  will speak only of  my own                                                                    
     advanced   nurse  practitioner   scope-of-practice,  it                                                                    
     means that, "A registered  nurse authorized to practice                                                                    
     in the state, who  because of specialized education and                                                                    
     experience,  is certified  to perform  acts of  medical                                                                    
     diagnosis  and  the   prescription  and  dispensing  of                                                                    
     medical,  therapeutic  or   corrective  measures  under                                                                    
     regulations adopted by the board."                                                                                         
                                                                                                                                
     One of  the really interesting  ones is for  the scope-                                                                    
     of-practice  for  medicine and  osteopathy.  Osteopaths                                                                    
     are   not  medical   doctors,  they   are  doctors   of                                                                    
     osteopathy,  this is  a subspecialty  so to  speak that                                                                    
     believes  that  adjustment of  the  spine  is often  an                                                                    
     answer to medical problems, they  however fall into the                                                                    
     same  definition  and says,  "For  a  fee, donation  or                                                                    
     other consideration, to diagnose,  treat, operate on or                                                                    
     prescribe  for  or  administer to  any  human  ailment,                                                                    
     blemish,  deformity, disease,  disfigurement, disorder,                                                                    
     injury  or other  mental or  physical condition,  or to                                                                    
     attempt  to  perform  or represent  that  a  person  is                                                                    
     authorized to  perform any of  the acts set out  in the                                                                    
     subparagraph;" I  think listening to that  you can hear                                                                    
     that the  practice of medicine  is all  encompassing of                                                                    
     everything  possible  that  could  happen  to  a  human                                                                    
     being. We don't worry that  a family practice doctor is                                                                    
     going to  attempt heart surgery,  we don't  worry about                                                                    
     that. I suggest that  the same reasonable outlook could                                                                    
     be applied to optometry.                                                                                                   
                                                                                                                                
1:56:39 PM                                                                                                                    
CHAIR WILSON announced that hearing no call for amendments,                                                                     
asked for a motion to move SB 36 out of committee.                                                                              
                                                                                                                                
1:56:51 PM                                                                                                                    
SENATOR  VON IMHOF  moved to  report SB  36, [30-LS0328\A],  from                                                               
committee  with individual  recommendations  and attached  fiscal                                                               
note(s).                                                                                                                        
                                                                                                                                
1:57:02 PM                                                                                                                    
CHAIR WILSON announced that seeing  no objection SB 36 moved from                                                               
the Senate Health and Social Services Standing Committee.                                                                       
                                                                                                                                
1:57:15 PM                                                                                                                    
At ease.                                                                                                                        
                                                                                                                                
          SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS                                                                       
                                                                                                                                
1:58:35 PM                                                                                                                    
CHAIR WILSON  called the committee  back order. He  announced the                                                               
consideration of SB 32. He  summarized that the committee heard a                                                               
bill overview and  had taken public testimony on  February 10. He                                                               
asked  that  Senator  Hughes, the  bill  sponsor,  provide  final                                                               
comments on SB 32.                                                                                                              
                                                                                                                                
1:59:06 PM                                                                                                                    
SENATOR  SHELLEY   HUGHES,  Alaska  State   Legislature,  Juneau,                                                               
Alaska,  sponsor of  SB 32,  stated she  was available  to answer                                                               
questions.                                                                                                                      
                                                                                                                                
SENATOR BEGICH  noted that he  received a letter from  the Alaska                                                               
State Medical Association (ASMA)  that indicated opposition to SB                                                               
32.  He detailed  that  ASMA proclaimed  that SB  32  was not  as                                                               
permissive as it  needed to be because  biosimilars are perceived                                                               
by the FDA to be considerably safe.                                                                                             
                                                                                                                                
SENATOR HUGHES replied that she  was surprised by the ASMA letter                                                               
because  she received  an  earlier letter  from  a physician  who                                                               
requested  notification  and  prior authorization.  She  remarked                                                               
that ASMA  has indicated  their belief that  the FDA  process and                                                               
approval  of   biosimilars  for   substitution  at   the  "silver                                                               
standard"  level would  be  fine versus  the  "gold standard"  of                                                               
interchangeable. She opined that biosimilars  are new and because                                                               
the  FDA   does  plan  to   have  additional  criteria   for  the                                                               
interchangeable "gold  standard," SB 32  should be left as  is in                                                               
order to  provide another level of  safety. She set forth  that a                                                               
prescriber needs to stay in  the "driver's seat" with the ability                                                               
to  write,   "Dispense  as  written"   or  "Call   if  substitute                                                               
available".                                                                                                                     
                                                                                                                                
SENATOR   HUGHES    detailed   that   the   FDA    criteria   for                                                               
interchangeable is very strict:                                                                                                 
                                                                                                                                
   1. The interchangeable first has to be classified as a                                                                       
     biosimilar.                                                                                                                
   2. The biosimilar must be expected to produce the same                                                                       
     clinical results as the original-biologic product in any                                                                   
     given patient.                                                                                                             
   3. The risk in terms of safety and efficacy of alternating or                                                                
     switching between the use of an interchangeable and the                                                                    
     original biologic is not greater than the risk of continued                                                                
     use of just the original biologic product.                                                                                 
                                                                                                                                
2:02:45 PM                                                                                                                    
She  noted  health-care  provider  groups  that  announced  their                                                               
support as follows:                                                                                                             
                                                                                                                                
   · Every state medical society,                                                                                               
   · The American College of Rheumatology,                                                                                      
   · The National Medical Association,                                                                                          
   · The American Association of Clinical Endocrinologists,                                                                     
   · The American Association of Neurological Surgeons,                                                                         
   · The American College of Mohs Surgery,                                                                                      
   · Association of Black Cardiologists,                                                                                        
   · American Society of Plastic Surgeons,                                                                                      
   · The Congress of Neurological Surgeons,                                                                                     
   · The National Hispanic Medical Association.                                                                                 
                                                                                                                                
She emphasized that the list  consisted of health-care providers,                                                               
not  just patient-advocacy  groups.  She opined  that the  groups                                                               
looked hard  at the legislation  and the consensus  language that                                                               
was  reached  seems  to  be   appropriate.  She  reiterated  that                                                               
maintaining the  interchangeable "gold  standard" is  what's best                                                               
for Alaskans.                                                                                                                   
                                                                                                                                
2:04:02 PM                                                                                                                    
CHAIR WILSON asked Senator Hughes  to address a $4,500 Department                                                               
of Commerce,  Community and Economic Development  fiscal note for                                                               
the bill.                                                                                                                       
                                                                                                                                
SENATOR HUGHES  concurred that the  fiscal was a little  odd. She                                                               
remarked that she  is not accustomed to departments  that ask for                                                               
funding to write  a minor set of regulations. She  noted that the                                                               
fiscal note  can be addressed  in the Senator Labor  and Commerce                                                               
Committee, the next committee of referral.                                                                                      
                                                                                                                                
SENATOR GIESSEL  pointed out  that the  fiscal note  analysis was                                                               
referenced on page 2 of the fiscal note.                                                                                        
                                                                                                                                
CHAIR WILSON asked if there were any amendments for SB 32.                                                                      
                                                                                                                                
2:05:33 PM                                                                                                                    
SENATOR GIESSEL offered Amendment 1:                                                                                            
                                                                                                                                
                                                                                                                                
                                                      30-LS0188\J.1                                                             
                                                             Bruce                                                              
                                                           2/14/17                                                              
                                                                                                                                
                                                                                                                                
                          AMENDMENT 1                                                                                       
                                                                                                                                
                                                                                                                                
OFFERED IN THE SENATE                   BY SENATOR GIESSEL                                                                      
TO:  SB 32                                                                                                                      
                                                                                                                                
Page 2, line 17:                                                                                                                
Delete  "equivalent drug  product  or interchangeable  biological                                                           
product"                                                                                                                    
Insert "(1) equivalent drug product; or                                                                                 
(2)   interchangeable   biological    product   after   obtaining                                                           
authorization under (c) of this section"                                                                                  
                                                                                                                              
Page 2, line 25, following "shall":                                                                                             
Insert  ",  before   dispensing  the  interchangeable  biological                                                               
product,"                                                                                                                       
                                                                                                                                
Page 2, line 26:                                                                                                                
Delete "biological product"                                                                                                     
Insert "proposed biological product that may be"                                                                                
                                                                                                                                
Page 2, line 27, following "product":                                                                                           
Insert  ",   and  obtain   authorization  from   the  prescribing                                                               
practitioner"                                                                                                                   
                                                                                                                                
Page 2, lines 27 - 29:                                                                                                          
Delete "The communication must be  provided within three business                                                               
days after dispensing the biological product as follows:"                                                                       
Insert "The communication may be provided as follows:"                                                                          
                                                                                                                                
Page 3, line 10, following "information":                                                                                       
Insert "to or obtain authorization from the prescribing                                                                         
practitioner"                                                                                                                   
                                                                                                                                
Page 3, line 19, following "information":                                                                                       
Insert "and obtain the authorization"                                                                                           
                                                                                                                                
Page 3, lines 21 - 22:                                                                                                          
Delete ", without the prescriber's expressed authorization,"                                                                
                                                                                                                                
Page 3, line 23, following "(A)":                                                                                           
Insert "without the prescriber's expressed authorization,"                                                                      
                                                                                                                                
Page 3, line 25, following "(B)":                                                                                           
Insert "with the prescriber's authorization,"                                                                               
                                                                                                                                
2:05:40 PM                                                                                                                    
SENATOR VON IMHOF objected for discussion purposes.                                                                             
                                                                                                                                
2:06:14 PM                                                                                                                    
At ease.                                                                                                                        
                                                                                                                                
2:06:42 PM                                                                                                                    
CHAIR WILSON called the committee back to order.                                                                                
                                                                                                                                
2:06:48 PM                                                                                                                    
JANE CONWAY,  Staff, Senator  Giessel, Alaska  State Legislature,                                                               
Juneau,  Alaska,  summarized  that   Amendment  1  requires  that                                                               
communication must  be provided  and authorization  obtained from                                                               
the prescribing practitioner prior  to dispensing the medication,                                                               
the  interchangeable   biological  product.  She   explained  the                                                               
changes as follows:                                                                                                             
                                                                                                                                
     Page 2, line 17:                                                                                                       
     Page 2,  line 17:  adds "or  interchangeable biological                                                                    
     product."  It  also  adds  "interchangeable  biological                                                                    
     product  after obtaining  authorization"  under "C"  of                                                                    
     this section.                                                                                                              
                                                                                                                                
     Page 2, line 25:                                                                                                       
     Following  "shall",   insert  "before   dispensing  the                                                                    
     interchangeable   biological   product";  again,   just                                                                    
     emphasizing that  these things shall happen  before the                                                                    
     dispensing of the product.                                                                                                 
                                                                                                                                
     Page 2, line 26:                                                                                                       
     Deletes  the  words  "biological product"  and  inserts                                                                    
     "proposed biological product that may be" dispensed.                                                                       
                                                                                                                                
     Page 2, line 27:                                                                                                       
     Following  "product",  inserts  the words  "and  obtain                                                                    
     authorization from the prescribing practitioner".                                                                          
                                                                                                                                
     Page 2, lines 27-29:                                                                                                   
     Deletes the  line, "The communication must  be provided                                                                    
     within  three   business  days  after   dispensing  the                                                                    
     biological  product as  follows:", that  whole line  is                                                                    
     deleted  and inserted  instead  is, "The  communication                                                                    
     may be  provided as follows:",  and then it goes  on to                                                                    
     show how those different communications can be done.                                                                       
                                                                                                                                
     Page 3, line 10:                                                                                                       
     Following  "information",  inserts  the words,  "to  or                                                                    
     obtain     authorization    from     the    prescribing                                                                    
     practitioner".                                                                                                             
                                                                                                                                
     Page 3, line 19:                                                                                                       
     Following  "information",   inserts  the   words,  "and                                                                    
     obtain the authorization".                                                                                                 
                                                                                                                                
     Page 3, lines 21-22:                                                                                                   
     An error  to a comma  that was caught during  the draft                                                                    
     of the amendment, delete  "',' without the prescriber's                                                                    
     expressed authorization".                                                                                                  
                                                                                                                                
     Page 3, line 23:                                                                                                       
     Following  "(A)"  inserts,  "without  the  prescriber's                                                                    
     expressed authorization".                                                                                                  
                                                                                                                                
     Page 3, line 25:                                                                                                       
     Following   "(B)"  inserts,   "with  the   prescriber's                                                                    
     authorization".                                                                                                            
                                                                                                                                
     All  of these  changes have  to do  with the  intent of                                                                    
     that  amendment to  have all  of  the communication  be                                                                    
     provided and  authorized before  the dispensing  of the                                                                    
     drug.                                                                                                                      
                                                                                                                                
2:10:32 PM                                                                                                                    
SENATOR GIESSEL spoke to Amendment 1 as follows:                                                                                
                                                                                                                                
     We held  public testimony  on this  bill last  week. My                                                                    
     concern  is that  the testimony  was solely  from those                                                                    
     individuals who  advocates for  the bill.  Oral history                                                                    
     last week  had 7-national organizations  advocating for                                                                    
     this  bill  and  4-local organizations,  there  was  no                                                                    
     oppositional   testimony.  In   the  letters,   written                                                                    
     documents,    we    have   16-national    organizations                                                                    
     advocating and 1-local  organization, and 2-local folks                                                                    
     are opposing  this; those local folks  were never heard                                                                    
     from, so I'm  actually speaking on behalf  of them, I'm                                                                    
     actually told  that one of those  local individuals who                                                                    
     wrote a letter  was asked to withdraw  her letter, that                                                                    
     concerns me.                                                                                                               
                                                                                                                                
     The  argument  that's  put forth  in  the  most  recent                                                                    
     document I received today, in  fact an hour or so, came                                                                    
     from  the  Arthritis  Foundation and  I've  heard  this                                                                    
     argument  before  that  such   an  amendment  that  I'm                                                                    
     offering would  conflict with federal law,  because the                                                                    
     federal  law  allows  this  without  the  substitution,                                                                    
     without intervention  of the health-care  provider, and                                                                    
     this  is asserted  to be  a  reason that  the state  of                                                                    
     Alaska cannot be  more strict and I'm no  lawyer, but I                                                                    
     contested that  assertion. I believe  state law  can be                                                                    
     more restrictive  than federal law, so  I don't believe                                                                    
     that negates the amendment.                                                                                                
                                                                                                                                
     I'm a clinician,  it has been asserted that  if the FDA                                                                    
     approves this, it's  got to be okay. I  have heard from                                                                    
     specialists who  use these  medications that  these are                                                                    
     unique proteins that act uniquely  in each one of us in                                                                    
     a different way and that  switching from one protein to                                                                    
     the   other,    in   other   words    these   allegedly                                                                    
     interchangeable   products   actually  diminishes   the                                                                    
     effectiveness   of  these   unique   proteins  in   the                                                                    
     individual's body, that concerns me.                                                                                       
                                                                                                                                
     The  second  thing that  concerns  me  is FDA  approval                                                                    
     being  asserted as  a "gold  standard." About  15 years                                                                    
     ago, the Varivax vaccine was  approved by the FDA, this                                                                    
     is   a  vaccination   for  children   to  prevent   the                                                                    
     occurrence  of chicken  pox. I  worked  at a  pediatric                                                                    
     clinic  at that  time  and  we gave  one  of the  first                                                                    
     Varivax vaccines in this state;  a week later that two-                                                                    
     year old came  in and could no longer  walk, his verbal                                                                    
     skills were  significantly impaired, and he  was having                                                                    
     a reaction to  this Varivax vaccine. FDA  does not mean                                                                    
     that there will  not be adverse events;  that sticks in                                                                    
     my mind  as the  question I  always put  behind someone                                                                    
     who says, "FDA approves it, it must be okay."                                                                              
                                                                                                                                
     I also  question, and  I have  heard from  a pharmacist                                                                    
     that they are not sure  they have a concern about this,                                                                    
     but I have concerns  for the pharmacist's liability. So                                                                    
     the pharmacist is now making  a decision to change this                                                                    
     very unique protein  medication without discussion with                                                                    
     the clinician,  change it  to a  different formulation.                                                                    
     So  the  clinician  has  the  health  records  of  this                                                                    
     individual,  the  clinician  knows   a  lot  about  the                                                                    
     patient and he  has chosen, he or she,  has chosen this                                                                    
     unique protein  medication, wonderful  medications, and                                                                    
     now  the pharmacist  is  unilaterally  going to  change                                                                    
     that  without   consultation  with  the   clinician.  I                                                                    
     contend that there's  going to be a  liability for that                                                                    
     pharmacist  if  there's  an adverse  outcome;  that  of                                                                    
     course can only  be tested in a court of  law, that's a                                                                    
     very expensive process.                                                                                                    
                                                                                                                                
     So  that's my  reason  for offering  this amendment.  I                                                                    
     don't believe  this has to  be rushed, I  don't believe                                                                    
     this needs  to be done  without the team that  makes up                                                                    
     health  care: the  clinician, the  pharmacist, and  the                                                                    
     patient,   all  consulting   together   for  the   best                                                                    
     outcomes.                                                                                                                  
                                                                                                                                
2:15:27 PM                                                                                                                    
CHAIR WILSON asked if there was further objection to the                                                                        
amendment.                                                                                                                      
                                                                                                                                
SENATOR BEGICH announced that he objected to Amendment 1. He                                                                    
explained his objection as follows:                                                                                             
                                                                                                                                
     As Senator Giessel duly noted  in a duly noticed public                                                                    
     hearing  that all  of  the  proper, appropriate  notice                                                                    
     required by  law, a  number of  organizations testified                                                                    
     on this  bill and anyone  was able and  had opportunity                                                                    
     to  testify on  this  bill. We  had  testimony, as  she                                                                    
     points out,  that was overwhelmingly  in favor  of this                                                                    
     legislation.                                                                                                               
                                                                                                                                
     I  also take  note of  some  of the  comments from  the                                                                    
     Arthritis Foundation,  which I also received  today and                                                                    
     would  note  that  there's  a   question  here  of  the                                                                    
     amendment  proposed  potentially delaying  prescription                                                                    
     service,  but I  want to  go further  and since  we are                                                                    
     talking  about personal  stories,  a member  of my  own                                                                    
     staff is  a beneficiary  of these products.  My staffer                                                                    
     who  is in  the  audience,  Richard Benavides,  suffers                                                                    
     from cancer, uses  these and has identified  to me that                                                                    
     the ability to  have rapid access to what  are known to                                                                    
     be  safe  procedures  is something  that  he  finds  is                                                                    
     essential to his wellbeing.                                                                                                
                                                                                                                                
     I would argue  that our duty here is to  allow a public                                                                    
     process and  then through  that public  process, adjust                                                                    
     if necessary a bill. We  have done that public process,                                                                    
     the testimony overwhelmingly favored  the bill as is or                                                                    
     in  fact  moves  in  the  opposite  direction  of  what                                                                    
     Senator  Giessel is  proposing.  We  will have  further                                                                    
     committees and  there will be further  opportunity, but                                                                    
     at this  time I  just want to  express my  objection to                                                                    
     that  amendment  and  would urge  the  members  to  not                                                                    
     support this amendment.                                                                                                    
                                                                                                                                
2:17:56 PM                                                                                                                    
SENATOR  GIESSEL clarified  that public  testimony did  not allow                                                               
opposition. She  set forth that  the individuals who  opposed the                                                               
bill  were online  and were  not allowed  to testify  because the                                                               
meeting ran  out and public  testimony was  closed; consequently,                                                               
their voice  was not heard.  She explained that Amendment  1 does                                                               
not limit access to biologics in  any way. She specified that the                                                               
interchangeables, which  are addressed in  the bill, are  not yet                                                               
available and may  not be available for several  years. She asked                                                               
what the rush is.                                                                                                               
                                                                                                                                
CHAIR WILSON noted  for the record that some of  the comments for                                                               
and against  were publicized and  made available on  the internet                                                               
for folks to see.                                                                                                               
                                                                                                                                
SENATOR VON IMHOF commented on Amendment 1 as follows:                                                                          
                                                                                                                                
     I very  much appreciate  the robust dialogue  and thank                                                                    
     you  Senator  Giessel,  you brought  up  actually  some                                                                    
     interesting points  that gave  me pause today  and made                                                                    
     me  think,  it's  interesting   trying  to  digest  the                                                                    
     information that comes in associated  with all of these                                                                    
     bills,  both in  the  written form  and  in the  verbal                                                                    
     form. As  we sit here,  I feel that  it is best  to try                                                                    
     to,  again, to  use my  words  I said  in the  previous                                                                    
     bill, thread-the-needle and try  to find the best-foot-                                                                    
     forward based on the information  that we have in front                                                                    
     of us.                                                                                                                     
                                                                                                                                
     I understand  the concern with  the FDA, I  don't share                                                                    
     those  same  concerns; I  believe  that  it is  a  very                                                                    
     robust and  successful entity  and that  their analysis                                                                    
     gives me comfort. I also  see in the letter we received                                                                    
     today that  biosimilars have been  used in  Europe with                                                                    
     excellent safety  and efficacy profile since  2006, and                                                                    
     have resulted in  significant cost savings. Health-care                                                                    
     costs in  Alaska is a  significant issue as we  can all                                                                    
     attest   and  if   there's   no  clinical,   meaningful                                                                    
     differences   between   biologic  and   the   reference                                                                    
     biological in terms of safety,  purity and potency, yet                                                                    
     it provides  a cost difference,  then I think  it makes                                                                    
     sense to go forward with this.                                                                                             
                                                                                                                                
     I  understand  that there  are  no  biosimilars on  the                                                                    
     market now, but  yes it could be years from  now, or it                                                                    
     could be months  from now, we don't know. So  as a good                                                                    
     boy scout it's  best to be prepared. I'm  going to vote                                                                    
     for  the pure  form of  this bill  and not  support the                                                                    
     amendment.                                                                                                                 
                                                                                                                                
2:21:40 PM                                                                                                                    
A roll call vote was taken. Senator Giessel and Chair Wilson                                                                    
voted in favor of Amendment 1; Senators Begich and von Imhof                                                                    
voted against it. Therefore, Amendment 1 failed by a 2:2 vote.                                                                  
                                                                                                                                
CHAIR WILSON announced that hearing no further amendments, he                                                                   
would entertain a motion to move SB 32 out of committee.                                                                        
                                                                                                                                
2:21:53 PM                                                                                                                    
SENATOR VON IMHOF moved to report SB 32, [30-LD0188\J], from                                                                    
committee with individual recommendations and attached fiscal                                                                   
note(s)                                                                                                                         
                                                                                                                                
2:22:03 PM                                                                                                                    
CHAIR WILSON announced that without objection, SB 32 moved from                                                                 
Senate Health and Social Services Standing Committee.                                                                           
                                                                                                                                
2:22:12 PM                                                                                                                    
SENATOR GIESSEL commented as follows:                                                                                           
                                                                                                                                
     Before  we  leave  this subject,  you  know  there's  a                                                                    
     reason  that  Senator  von  Imhof  is  on  the  finance                                                                    
     committee. She  has expertise in  that area.  There's a                                                                    
     reason  that  I  am  on the  health  committee.  I'm  a                                                                    
      clinician. I appreciate the discussion today, thank                                                                       
     you.                                                                                                                       
                                                                                                                                
2:22:32 PM                                                                                                                    
At ease.                                                                                                                        
                                                                                                                                
2:23:58 PM                                                                                                                    
CHAIR WILSON called the committee back to order.                                                                                
                                                                                                                                
2:24:17 PM                                                                                                                    
There being no further business to come before the committee,                                                                   
Chair Wilson adjourned the Senate Health and Social Services                                                                    
Committee at 2:24 p.m.                                                                                                          
                                                                                                                                

Document Name Date/Time Subjects
ASPS Comments - Scope Optometric - AK SB36 - 02-13-2017.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Carmen Moore - oppose.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Drug schedules - Giessel.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
New Mexico House Business & Industry Committee Letter 2007.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
SB 32 Legislation - Version J.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB 36 ASMA oppose.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Alaska Biosimilars Arth Fdn oppose amendment sb 32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB32 - Clarification on Questions Asked in the Committee (Sen Hughes).doc HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB32_ASMA.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB 32 Am No. 1.PDF SHSS 2/15/2017 1:30:00 PM
SB 32