04/11/2023 03:00 PM House HEALTH & SOCIAL SERVICES

        HB 96-LICENSING:DRUGS/DEVICES FOR HOME DIALYSIS                                                                     
                                                                                                                                
5:05:23 PM                                                                                                                    
                                                                                                                                
CHAIR PRAX passed the gavel to Vice Chair Ruffridge.                                                                            
                                                                                                                                
VICE CHAIR RUFFRIDGE  announced that the final  order of business                                                               
would be  HOUSE BILL NO.  96, "An  Act relating to  licensing and                                                               
registration    requirements   for    certain   wholesale    drug                                                               
distributors; and providing for an effective date."                                                                             
                                                                                                                                
CHAIR  PRAX moved  to adopt  Amendment 1  to HB  96, labeled  33-                                                               
LS0426\A.1, Bergerud, 4/05/23, which read:                                                                                      
                                                                                                                                
     Page 2, line 8:                                                                                                            
          Delete ", drug,"                                                                                                  
          Insert   "drug   composed    solely   of   fluids,                                                                
     electrolytes, and sugars"                                                                                              
                                                                                                                                
     Page 2, line 13:                                                                                                           
          Delete the second occurrence of "and"                                                                             
                                                                                                                                
     Page 2, lines 14 - 16:                                                                                                     
          Delete all material and insert:                                                                                       
              "(B)  the wholesale drug distributor                                                                          
               (i)  delivers the dialysate drug or device                                                                   
     directly to a patient  with end-stage renal disease, or                                                                
     to  the patient's  designee,  for  the patient's  self-                                                                
     administration of dialysis therapy;                                                                                    
               (ii)  uses a bar code scanning and                                                                           
     verification system confirming  that the dialysate drug                                                                
     or device  selected to fill the  patient-specific order                                                                
     matches the information  on the patient-specific label;                                                                
     and                                                                                                                    
               (iii)  has additional secondary accuracy and                                                                 
     delivery checks in place; and                                                                                          
               (C)  a licensed pharmacist serves as a                                                                       
     consultant to the wholesale drug distributor to                                                                        
               (i)  conduct a retrospective audit of 10                                                                     
     percent  of  the  dialysate   drug  and  device  orders                                                                
     provided   directly  to   patients  processed   by  the                                                                
     wholesale drug distributor every month; and                                                                            
               (ii)  perform assessments at least twice                                                                     
     monthly   to  ensure   quality   of  product   storage,                                                                
     handling,  and  distribution   by  the  wholesale  drug                                                                
     distributor;"                                                                                                          
                                                                                                                                
5:05:56 PM                                                                                                                    
                                                                                                                                
The committee took an at-ease from 5:05 p.m. to 5:06 p.m.                                                                       
                                                                                                                                
5:06:25 PM                                                                                                                    
                                                                                                                                
VICE CHAIR RUFFRIDGE announced there being no objection,                                                                        
Amendment 1 was adopted.                                                                                                        
                                                                                                                                
5:06:49 PM                                                                                                                    
                                                                                                                                
CHAIR PRAX spoke to the [adopted] Amendment 1.                                                                                  
                                                                                                                                
5:08:13 PM                                                                                                                    
                                                                                                                                
The committee took an at-ease from 5:08 p.m. to 5:09 p.m.                                                                       
                                                                                                                                
5:09:04 PM                                                                                                                    
                                                                                                                                
CHAIR PRAX  moved to report HB  96, as amended, out  of committee                                                               
with  individual  recommendations  and  the  accompanying  fiscal                                                               
notes.                                                                                                                          
                                                                                                                                
REPRESENTATIVE SADDLER  objected.  He requested  clarification on                                                               
the  language  "delivered  in its  original  sealed  and  labeled                                                               
packaging".     He  questioned  whether  the   package  would  be                                                               
delivered  to  the  patient  from the  wholesaler  as  a  pallet,                                                               
without being broken down into individual units.                                                                                
                                                                                                                                
CHAIR PRAX deferred to a representative from Baxter Health Care.                                                                
                                                                                                                                
5:10:49 PM                                                                                                                    
                                                                                                                                
ELIZABETH  STOLL,  Director,  State  Government  Affairs,  Baxter                                                               
Health  Care, stated  that the  word  "pallet" would  not be  the                                                               
correct terminology.   She stated  that the bags of  solution are                                                               
packed  into  boxes  at   the  manufacturing  facility,  labeled,                                                               
sealed,  and sent  to Anchorage.   She  continued that  the boxes                                                               
would  remain   unopened  since   packed  initially.     Once  in                                                               
Anchorage, they would be stored  at the wholesale warehouse where                                                               
they would  be labeled, and then  they would be delivered  to the                                                               
patient.   She stated  that there  would never  be any  mixing of                                                               
sizes or  solutions.   She maintained that  once the  solution is                                                               
packed, the box  would remain unopened until  the patient unpacks                                                               
it.                                                                                                                             
                                                                                                                                
5:12:21 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE   SADDLER   questioned    whether   the   language                                                               
"patient's designee"  refers to  a third-party  distributor which                                                               
would deliver to the patient.                                                                                                   
                                                                                                                                
MS. STOLL responded  that this is the  standard language accepted                                                               
across  the  country.   She  stated  that  when the  solution  is                                                               
shipped,  the   patient  or  their  designee   will  receive  the                                                               
shipment.   She stated that the  designee would be the  person at                                                               
the home of the  patient, such as a spouse.   She stated that the                                                               
wholesale distributor  would deliver the package  directly to the                                                               
patient or patient's designee.                                                                                                  
                                                                                                                                
REPRESENTATIVE SADDLER  clarified that the package  would go from                                                               
the  manufacturer  directly  to  the patient  or  designee.    He                                                               
questioned whether there would be any other intermediary.                                                                       
                                                                                                                                
MS. STOLL  responded that there  is no  intermediary distributor.                                                               
She  stated that  sometimes contractors  are  used for  delivery,                                                               
especially  in Alaska,  but  Baxter Health  Care  is in  complete                                                               
ownership and control of the  drug until it reaches the patient's                                                               
home.                                                                                                                           
                                                                                                                                
5:14:37 PM                                                                                                                    
                                                                                                                                
REPRESENTATIVE  SADDLER removed  his objection.   There  being no                                                               
further objection,  CSHB 96(HSS)  was reported  out of  the House                                                               
Health and Social Services Standing Committee.