Legislature(2009 - 2010)

04/08/2009 04:35 PM FIN


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* first hearing in first committee of referral
+ teleconferenced
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SENATE BILL NO. 10                                                                                                            
                                                                                                                                
     "An  Act  requiring  health care  insurers  to  provide                                                                    
     insurance  coverage  for  medical care  received  by  a                                                                    
     patient   during  certain   approved  clinical   trials                                                                    
     designed  to test  and  improve prevention,  diagnosis,                                                                    
     treatment,  or  palliation  of  cancer;  directing  the                                                                    
     Department  of Health  and Social  Services to  provide                                                                    
     Medicaid services  to persons who participate  in those                                                                    
     clinical  trials; relating  to experimental  procedures                                                                    
     under a state plan  offered by the Comprehensive Health                                                                    
     Insurance Association;  and providing for  an effective                                                                    
     date."                                                                                                                     
                                                                                                                                
5:17:24 PM                                                                                                                    
                                                                                                                                
TOM   OBERMEYER,  STAFF,   SENATOR  BETTYE   DAVIS,  SPONSOR                                                                    
explained  that the  legislation  requires health  insurance                                                                    
providers  in  Alaska  cover  the  costs  of  routine  care,                                                                    
incurred to a patient  participating in an approved clinical                                                                    
trial relating to  cancer. He expounded that  the insurer is                                                                    
required to provide coverage only  if the patients physician                                                                    
determines  there   are  no  superior   existing  treatments                                                                    
available  and  the  pre-clinical data  shows  a  reasonable                                                                    
expectation that  the clinical (investigative)  treatment is                                                                    
as efficacious  as conventional therapy. Mr.  Obermeyer then                                                                    
read from the Sponsor Statement (Copy on File):                                                                                 
                                                                                                                                
     Clinical  trials are  research  studies  that test  how                                                                    
     well  new medical  approaches work  in patients.   Each                                                                    
     study answers  scientific questions  and tries  to find                                                                    
     better ways to prevent,  screen for, diagnose, or treat                                                                    
     disease.   Patients  who take  part in  cancer clinical                                                                    
     trials  have  an  opportunity   to  contribute  to  the                                                                    
     knowledge of,  and progress against cancer.   They also                                                                    
     receive state-of-the art treatment  from experts in the                                                                    
     field. The  National Cancer Institute,  as part  of the                                                                    
     U.S.  National  Institutes  of  Health,  reports  6,000                                                                    
     cancer trials in  the United States any  one time. They                                                                    
     include  trials  in prevention,  screening,  diagnosis,                                                                    
     treatment, quality-of-life, and genetic studies.                                                                           
                                                                                                                              
     CSSB   10    removes   important   barriers    to   the                                                                    
     participation of patients in  cancer clinical trials in                                                                    
     Alaska.    It  requires  that  applicable  health  care                                                                    
     plans, including  Medicaid, cover routine  patient care                                                                    
     costs for  patients enrolled in all  phases of clinical                                                                    
     trials,  including  prevention,  detection,  treatment,                                                                    
     and palliation  (supportive care) of  cancer. Currently                                                                    
     Alaska health  plans may  exclude coverage  for routine                                                                    
     patient-care  costs  while  a patient  with  cancer  is                                                                    
     enrolled in a clinical  trial. Providers of health care                                                                    
     plans often  conclude that money is  saved by excluding                                                                    
     care  while patients  participate  in clinical  trials.                                                                    
     But  these  patients,  if   not  enrolled  in  clinical                                                                    
     trials, will  continue to receive  conventional therapy                                                                    
     at roughly the same or  slightly increased costs in the                                                                    
     short-run.                                                                                                                 
                                                                                                                              
     Over  2600  Alaskans  are diagnosed  with  cancer  each                                                                    
     year.  In FY 2007  an estimated 4,600 patients received                                                                    
     cancer treatments through  Alaska's Medicaid program at                                                                    
     a  cost of  $21.5  million.   The  average payment  per                                                                    
     beneficiary was  about $4,675.  The  federal government                                                                    
     reimburses the state  at about 50% of  the total costs.                                                                    
     Without  in-state facilities  and  support of  clinical                                                                    
     trials participants in Alaska  currently have to travel                                                                    
     out  of state,  increasing  the  cost of  non-emergency                                                                    
     transportation  which is  about  3%  of total  Medicaid                                                                    
     costs.                                                                                                                     
                                                                                                                              
     Studies have shown that only 2%  to 3%  of adult cancer                                                                    
     patients and  less than  0.5% Medicare  patients enroll                                                                    
     in  clinical trials  of the  approximately 20%  who are                                                                    
     eligible -largely  due to fear of  denial of insurance.                                                                  
     A recent study found  only slight increase in treatment                                                                    
     costs  for adult  clinical trial  patients compared  to                                                                    
     nonparticipants, $35,418  versus $33,248 or  about 6.5%                                                                    
     increase  in  costs  for  clinical  trial  participants                                                                    
     compared to  nonparticipants.   Even if  enrollment was                                                                    
     increased to  the full 20%,  it is unlikely  that these                                                                    
     numbers  will  significantly  impact overall  costs  to                                                                    
     health  plans.    See   National  Conference  of  State                                                                    
     Legislatures, "Clinical Trials:  What are States Doing?                                                                    
     February, 2009 Update:"                                                                                                    
     www.ncsl.org/programs/health/clinicaltrials.htm.                                                                           
                                                                                                                                
     Twenty-three or more states  have passed legislation or                                                                    
     instituted  special agreements  requiring health  plans                                                                    
     to  pay  the  cost  of routine  medical  care  patients                                                                    
     receive   while  participating   in  clinical   trials.                                                                  
     Passage  of  CSSB 10  will  result  in more  successful                                                                    
     outcomes  in  cancer  treatments  in  Alaska,  increase                                                                    
     retention of patients in Alaska  for their cancer care,                                                                    
     and also, after full implementation, result in cost                                                                        
     savings in the short and long term.                                                                                        
                                                                                                                                
     A description of "The Access to Cancer Clinical Trials                                                                     
                                th                                                                                              
     Act of 2009"  H.R. 716, 111   Congress 2009-2010, (Rep.                                                                    
     Sue Myrick) per "The  Hill's Congress Blog" January 30,                                                                    
     2009  sums  up  to  a  large extent  what  CSSB  10  is                                                                    
     attempting to do:                                                                                                          
                                                                                                                                
                                                                                                                                
          Clinical trials  are so critical for  patients and                                                                    
          or medical  research, yet many patients  find that                                                                    
          their  health insurance  won't cover  the rest  of                                                                    
          their routine  cancer treatment if they  decide to                                                                    
          enroll  in  clinical  trials.   We're  not  asking                                                                    
          insurance companies to pay for clinical trials.                                                                       
          This  bill   simply  states  that   insurers  must                                                                    
          continue  to pay  for  routine  treatments -  that                                                                    
          they would be paying  for regardless - if patients                                                                    
          enroll in a clinical trial.                                                                                           
                                                                                                                                
          No patient should ever have  to fear exploring all                                                                    
          treatment   options   at   the  cost   of   losing                                                                    
          coverage.  We should  be encouraging participation                                                                    
          in  clinical   trials,  not  discouraging   it  by                                                                    
          removing coverage  for routine care.  Were  it not                                                                    
          for  patients who  have enrolled  in past  trials,                                                                    
          the medial  advancements we've  experienced toward                                                                    
          finding a cure for cancer would not be possible.                                                                      
                                                                                                                                
5:23:29 PM                                                                                                                    
                                                                                                                                
Mr. Obermeyer  noted that there  are two zero  fiscal notes;                                                                    
Department of  Commerce, Community and  Economic Development                                                                    
and Department of Health and Social Services.                                                                                   
                                                                                                                                
Senator Olson wondered who besides  a university is carrying                                                                    
out these clinical  trials. Mr. Obermeyer stated  he was not                                                                    
able to answer. He offered  that the trials must be approved                                                                    
by agencies  like the  National Institute  of Health  or the                                                                    
Department of Defense and are held to defined standards.                                                                        
                                                                                                                                
Senator Olson  asked why  an insurer  would refuse  to cover                                                                    
costs if  the clinical  trials are  funded by  a university.                                                                    
Mr. Obermeyer  clarified that the  clinical trial  costs are                                                                    
paid for  by the  research entity  conducting the  trial. He                                                                    
stated that  this legislation  would ensure  that associated                                                                    
medical costs to  the patient are covered.  An example would                                                                    
be a follow up visit with the patient's own oncologist.                                                                         
                                                                                                                                
Senator Thomas asked  if the bill provides  coverage for all                                                                    
stages  of  the  clinical  trial.  Mr.  Obermeyer  affirmed.                                                                    
Senator  Thomas noted  that the  bill does  not require  the                                                                    
insurer to pay  for charges that would not be  covered if no                                                                    
insurance existed or otherwise reimbursable charges.                                                                            
                                                                                                                                
5:25:55 PM                                                                                                                    
                                                                                                                                
Co-Chair  Hoffman  stated  that   he  provides  health  care                                                                    
coverage  for his  employees in  his  personal business.  He                                                                    
addressed  concern about  the rising  costs of  premiums. He                                                                    
cited a letter  from Premera (copy on file)  dated April 7th                                                                    
that  states concerns  that the  legislation  would force  a                                                                    
premium   increase   for    small   group   and   individual                                                                    
policyholders.  He asked  about  keeping  the premium  costs                                                                    
down for providers.                                                                                                             
                                                                                                                                
Mr. Obermeyer  responded that overall  cost may not  be that                                                                    
great.  He related  that presently  cancer patients  needing                                                                    
treatment are  getting their  routine treatments  covered by                                                                    
their  insurance provider.  Insurers  might  realize a  cost                                                                    
savings  by  allowing   patients  participation  in  trials.                                                                    
Routine follow up  care is required regardless  of whether a                                                                    
patient participates in a trial  or not. He summized that SB
10  requires that  routine follow  up care  charges will  be                                                                    
covered if  a patient chooses  to participate in  a clinical                                                                    
trial and the trial will   not be considered experimental by                                                                    
the insurer. He  felt passage of the legislation  was in the                                                                    
best interest of the patient and advancement of medicine.                                                                       
                                                                                                                                
5:29:38 PM                                                                                                                    
                                                                                                                                
SENATOR  BETTYE  DAVIS,   responded  to  Co-Chair  Hoffman's                                                                    
question.  She  affirmed  that she  had  been  contacted  by                                                                    
Premera  stating their  concerns that  not all  phases of  a                                                                    
clinical trial be  covered [phases 1 and  4]. She emphasized                                                                    
that  based  on  doctor's  testimony in  the  Senate  Health                                                                    
Social  Services  committee  from   around  the  state  they                                                                    
determined  that all  phases are  important  and that  their                                                                    
costs are  being overstated by insurers.  She qualified that                                                                    
Premera did not enter into  a constructive dialogue with her                                                                    
office  regarding the  legislation except  to recommend  the                                                                    
exclusion of those two phases.                                                                                                  
                                                                                                                                
Co-Chair Stedman asked  if the legislation has  an impact on                                                                    
state  employees.  Senator Davis  answered  that  it has  no                                                                    
impact  on state  employee plans.  She  explained that  when                                                                    
state employee  plans come  up for review  in July  they may                                                                    
opt in to new programs.                                                                                                         
                                                                                                                                
                                                          th                                                                    
Co-Chair  Hoffman cited  the  Premera  letter of  April  7,                                                                     
2009. He reported that Premera's  concerns are for treatment                                                                    
efficacy and patient safety.                                                                                                    
                                                                                                                                
Mr. Obermeyer  spoke to the  concerns raised in  the Premera                                                                    
                     th                                                                                                         
letter dated  April 7,   for  mandatory coverage  for phases                                                                    
one and  four. He pointed out  that in phase one  trials are                                                                    
offered  to  a  very  limited number  of  participants.  The                                                                    
medications  administered are  done  typically to  determine                                                                    
safe  dosage  levels. Many  of  the  drugs administered  are                                                                    
approved  by  the FDA.  He  stated  that phase  four  trials                                                                    
generally involve  follow up paid for  by the pharmaceutical                                                                    
firms  to  determine  the  efficacy  of  the  treatment.  He                                                                    
concluded that  given the small  number of  participants any                                                                    
added expense to insurers would  be minimal. He reminded the                                                                    
committee  that  oncologists   advised  extending  insurance                                                                    
coverage to  all phases of  the trial. They agreed  it would                                                                    
be in  the best interest of  the patient and based  on their                                                                    
experience additional cost is minimal.                                                                                          
                                                                                                                                
5:33:31 PM                                                                                                                    
                                                                                                                                
Co-Chair Stedman referred  to page 2, line 29  and asked for                                                                    
clarification. He  wondered if this alluded  to experimental                                                                    
treatments  received  in  phase one  trials.  Mr.  Obermeyer                                                                    
pointed  out   that  the  section,  starting   on  line  27,                                                                    
describes exclusions  to the  bill. Co-Chair  Stedman stated                                                                    
that he was  under the impression that all  phase one trials                                                                    
are experimental.                                                                                                               
                                                                                                                                
Mr. Obermeyer reiterated  that many drugs used  in phase one                                                                    
trials  already have  FDA approval.  He exemplified  that in                                                                    
one   trial  an   approved  drug   for   colon  cancer   was                                                                    
administered  to  a  brain   cancer  patient  with  positive                                                                    
results.                                                                                                                        
                                                                                                                                
Senator Olson  asked if  stem cell  research is  included in                                                                    
this bill.                                                                                                                      
                                                                                                                                
5:35:57 PM                                                                                                                    
                                                                                                                                
Mr. Obermeyer believed it was not.                                                                                              
                                                                                                                                
Senator Huggins cited  a letter from the  NFIB dated January                                                                    
  th                                                                                                                            
20,   (copy  on file)  that the  legislation excludes  state                                                                    
employee  plans. He  opined that  if it  excludes government                                                                    
plans it  does not  provide a  level playing  field. Senator                                                                    
Davis  asserted  that  the bill  will  require  Medicaid  to                                                                    
provide  coverage   but  does  not  mandate   the  state  to                                                                    
participate.  She  reasoned  that  the state  might  opt  in                                                                    
because it is in the best interest of the employees.                                                                            
                                                                                                                                
5:38:25 PM                                                                                                                    
                                                                                                                                
DR. JEANIE  ANDERSON, KATMAI ONCOLOGY  (via teleconference),                                                                    
testified in  support of the  legislation. She  clarified an                                                                    
earlier  discussion regarding  clinical trial  settings. She                                                                    
said that  most of  the clinical trials  in Alaska  are also                                                                    
open to  participants throughout  the country  in university                                                                    
and  community  institutions.   All  of  these  institutions                                                                    
require that  the routine medical  costs are covered  by the                                                                    
patient's insurer.  This is care  the patient  would receive                                                                    
regardless of  whether one  is a participant  in a  study or                                                                    
not.                                                                                                                            
                                                                                                                                
Dr. Anderson  noted that Medicare has  included coverage for                                                                    
clinical trial  participation since 2000. She  countered the                                                                    
concerns raised by Blue Cross/Blue  Shield by asserting that                                                                    
patient  safety and  efficacy of  treatment is  maximized by                                                                    
patient  participation   in  clinical  trials   without  any                                                                    
significant  cost increase.  The medical  community benefits                                                                    
by maximizing cancer  treatment knowledge without increasing                                                                    
costs. She  included details in previous  written testimony.                                                                    
[Testimony  on  SB 280,  from  4/3/08  was provided  to  the                                                                    
committee by Senator Davis (copy in file).]                                                                                     
                                                                                                                                
5:41:48 PM                                                                                                                    
                                                                                                                                
SHIELA  TALLMAN, PREMERA  BLUE CROSS/BLUE  SHIELD OF  ALASKA                                                                    
(via  teleconference),   testified  in  opposition   to  the                                                                    
legislation. She referenced  the letter of April  7, 2009 to                                                                    
the  committee and  reiterated Premera's  concerns mandating                                                                    
phases  one  and four  of  clinical  trials. She  considered                                                                    
phase  one trials  experimental and  questioned whether  all                                                                    
policy holders should be funding  basic development of these                                                                    
drugs, devices and procedures  for the manufacturer. Patient                                                                    
safety  must  also  be considered.  In  phase  four  trials,                                                                    
Premera would  cover medically  necessary treatment  only if                                                                    
existing   medical  treatments   are  not   determined  more                                                                    
effective. She surmised that mandates  can increase the cost                                                                    
of  health insurance.  Specific costs  will be  difficult to                                                                    
project in this instance.                                                                                                       
                                                                                                                                
5:45:29 PM                                                                                                                    
                                                                                                                                
HANNA  SMITH, CANCER  RESEARCH  REGISTERED NURSE,  FAIRBANKS                                                                    
(via   teleconference)   testified   in   support   of   the                                                                    
legislation.     She  recounted   an  experience   with  her                                                                    
hospital's   participation  in   a  clinical   trial  deemed                                                                    
beneficial   for   a   patient.  She   asserted   that   the                                                                    
administrative costs  incurred to appeal the  patient's four                                                                    
previous denials  by the insurer  was the only  related cost                                                                    
increase. It  cost the insurer  substantially less  to cover                                                                    
the patient as part of the trial.                                                                                               
                                                                                                                                
5:49:05 PM                                                                                                                    
                                                                                                                                
DR.  MARY  STEWART,  MEDICAL ONCOLOGIST,  PRESIDENT,  DENALI                                                                    
ONCOLOGY  GROUP, ANCHORAGE  (via  teleconference), spoke  in                                                                    
support of SB 10. She  echoed the importance and benefits of                                                                    
phase  one   and  four   clinical  trials,   especially  the                                                                    
knowledge gained  by the medical oncology  community for new                                                                    
and  more   effective  beneficial  cancer   treatments.  She                                                                    
emphasized that trials do not cost more.                                                                                        
                                                                                                                                
5:51:45 PM                                                                                                                    
                                                                                                                                
EMILY NENON, ALASKA  GOVERNMENT RELATIONS DIRECTOR, AMERICAN                                                                    
CANCER SOCIETY  CANCER ACTION NETWORK  (via teleconference),                                                                    
stated support for the legislation.  Ms Nenon cited a paper,                                                                    
submitted  by The  American Cancer  Society  (ACS) (copy  on                                                                    
file).  The  paper  compiled results  that  determine  costs                                                                    
associated with  routine cancer care provided  in a clinical                                                                    
study  are comparable  to the  costs of  standard care.  She                                                                    
emphasized  the importance  of covering  all  phases of  the                                                                    
trial treatment. She believed  the legislation would protect                                                                    
patients while  maintaining access to insurance  and quality                                                                    
care.                                                                                                                           
                                                                                                                                
5:57:01 PM          AT EASE                                                                                                   
5:57:11 PM          RECONVENED                                                                                                
                                                                                                                                
DR. LATHASUBARIAN, MEDICAL  ONCOLOGIST, ANCHORAGE, SELF (via                                                                    
teleconference),  testified   in  support  of  SB   10.  She                                                                    
emphasized that  insurers have been  a barrier  to patient's                                                                    
participation   in  clinical   trials.   She  asserted   the                                                                    
necessity of clinical trials in  cancer research as the only                                                                    
way to  develop new lifesaving or  life extending therapies.                                                                    
She concluded that the medical  and societal benefits of the                                                                    
research  and  care   advancements  discovered  in  clinical                                                                    
trials are immeasurable.                                                                                                        
                                                                                                                                
6:01:24 PM                                                                                                                    
                                                                                                                                
PAT LUBY,  ADVOCACY DIRECTOR, ALASKA ASSOCIATION  OF RETIRED                                                                    
PERSONS  (AARP), ANCHORAGE  (via teleconference),  testified                                                                    
in support of  SB 10. Mr. Luby pointed out  that if patients                                                                    
pay health insurance premiums they  should have the right to                                                                    
the coverage paid for that includes routine cancer care.                                                                        
                                                                                                                                
6:02:53 PM                                                                                                                    
                                                                                                                                
LINDA HALL,  DIRECTOR, DIVISION OF INSURANCE,  DEPARTMENT OF                                                                    
COMMERCE,   COMMUNITY   AND  ECONOMIC   DEVELOPMENT,   spoke                                                                    
specifically  to  the issue  of  mandated  programs and  the                                                                    
costs associated with mandates. Ms.  Hall stated she did not                                                                    
know what the  cost of the program would be  for health care                                                                    
insurers. She  noted with  regards to  the zero  fiscal note                                                                    
for  the Division  of Insurance  (FN 2)  that it  is only  a                                                                    
reflection of their administrative  costs. She suggested the                                                                    
committee analyze the benefit of  the mandate and segment of                                                                    
the population being  served in relation to  any increase in                                                                    
premium costs.  Ms. Hall  referred to  a pie  chart, "Health                                                                    
Coverage of  Alaska's Population"  (copy on file)  and noted                                                                    
the  32%  unregulated  segment.  She  reiterated  that  this                                                                    
legislation  would  only  impact the  individual  and  small                                                                    
group rate payers reflected mostly  in this group. The small                                                                    
group  segment consists  of small  private sector  employers                                                                    
who are likely  to drop employee health  coverage as premium                                                                    
costs  rise.  She  concluded  by  suggesting  the  committee                                                                    
examine the broader picture of  who the mandate benefits and                                                                    
what segment of the population bears the cost.                                                                                  
                                                                                                                                
6:07:57 PM                                                                                                                    
                                                                                                                                
Senator Ellis  queried about  the logic  of a  cancer victim                                                                    
requesting  participation  in  a clinical  trial  but  being                                                                    
denied  payment  for  routine treatments  by  the  insurance                                                                    
company even if it is cost effective to the insurer.                                                                            
                                                                                                                                
Ms. Hall conjectured  that there may have  been costs beyond                                                                    
the routine care  being offered. She contended  that she can                                                                    
not explain insurance company  logic. Senator Ellis restated                                                                    
his earlier  point and alleged  that the insurer  was acting                                                                    
unethically.  Ms.  Hall   stated  that  different  insurance                                                                    
companies  have different  coverage  forms particularly  for                                                                    
individuals  and  small   groups  that  potentially  contain                                                                    
adverse selection.  She pointed  out that  Alaska's statutes                                                                    
provide for  oversight and review.  If a procedure  or trial                                                                    
is not covered, it has  a specific exclusion and contractual                                                                    
provision known in advance.                                                                                                     
                                                                                                                                
6:11:56 PM                                                                                                                    
                                                                                                                                
Senator Ellis  argued that he  would have been  reluctant to                                                                    
support  the   legislation  if  it  mandated   coverage  for                                                                    
experimental procedures  with extravagant  associated costs.                                                                    
He emphasized  that the bill  requires coverage  for routine                                                                    
care that  the patient is  entitled to  and has paid  for in                                                                    
their premiums  and that the  insurer's payment  denials are                                                                    
indefensible.                                                                                                                   
                                                                                                                                
                                           th                                                                                   
Senator Huggins referred  to the January 20   letter stating                                                                    
that the legislation is a  mandate to small business and not                                                                    
to  programs provided  by the  state. He  asked Ms.  Hall if                                                                    
this  was  accurate. Ms.  Hall  affirmed.   Senator  Huggins                                                                    
wondered why the  legislation is not a mandate  to all state                                                                    
plans.  Ms.  Hall  responded  that the  state  plan  is  not                                                                    
considered insurance  and is not  regulated by  the Division                                                                    
of  Insurance.  She  explained   that  the  mandate  in  the                                                                    
legislation is specific to Title  21 oversight, which has no                                                                    
regulatory  authority  over  the various  state  plans.  She                                                                    
pointed  out   that  the   legislature  and   or  collective                                                                    
bargaining  units could  choose to  include coverage  of the                                                                    
mandate  in  the  select benefits  section  of  the  state's                                                                    
plans.                                                                                                                          
                                                                                                                                
6:14:46 PM                                                                                                                    
                                                                                                                                
Senator  Olson referred  to cancer  treatment and  the three                                                                    
common  treatments: chemotherapy,  surgical, and  radiation.                                                                    
He asked if the plan covers all three.                                                                                          
                                                                                                                                
Senator  Davis replied  that she  did not  know the  answer.                                                                    
She  shared  that  the  bill   has  circulated  through  the                                                                    
legislature for three years. She  felt that participation in                                                                    
these programs  is very important  and lifesaving.  She felt                                                                    
that the  bill has  been thoroughly  vetted from  the health                                                                    
and insurers'  standpoint and determined cost  is minimal to                                                                    
the insurer.   She  asked for the  Committee's consideration                                                                    
of SB 10 in a timely manner.                                                                                                    
                                                                                                                                
SB  10  was   HEARD  and  HELD  in   Committee  for  further                                                                    
consideration.                                                                                                                  
                                                                                                                                
6:19:37 PM          AT EASE                                                                                                   
6:27:43 PM          RECONVENED                                                                                                
                                                                                                                                

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