Legislature(2009 - 2010)CAPITOL 106

04/12/2010 08:30 AM HEALTH & SOCIAL SERVICES

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08:32:36 AM Start
08:33:12 AM SB10
10:39:39 AM Adjourn
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
-- Please Note Time Change --
Moved Out of Committee
+ Bills Previously Heard/Scheduled TELECONFERENCED
         SB  10-MEDICAID/INS FOR CANCER CLINICAL TRIALS                                                                     
8:33:12 AM                                                                                                                    
CO-CHAIR HERRON announced  that the only order  of business would                                                               
be CS  FOR SENATE  BILL NO. 10(HSS)(efd  del), "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;  and relating                                                               
to  experimental procedures  under a  state plan  offered by  the                                                               
Comprehensive Health Insurance Association."                                                                                    
8:33:46 AM                                                                                                                    
SENATOR  BETTYE DAVIS  introduced  SB 10,  paraphrasing from  the                                                               
sponsor  statement in  members' packets.   The  sponsor statement                                                               
read as follows [original punctuation provided]:                                                                                
     CS  Senate  Bill  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                                                                    
     ...  directing  the  Department of  Health  and  Social                                                                    
     Services to  provide Medicaid  services to  persons who                                                                    
     participate   in    clinical   trials;    relating   to                                                                    
     experimental procedures  under a state plan  offered by                                                                    
     the  Comprehensive  Health Insurance  Association;  and                                                                    
     providing for an effective date."                                                                                          
     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.  Medicare,                                                                    
     the  VA  and  military   insurance  already  cover  the                                                                    
     benefits that SB 10  provides.  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.                                                                                      
     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                                                                    
     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,"                                                                             
     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                                                                    
     Act of 2009" H.R.  716, 111th 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  medical  advancements                                                                    
     we've  experienced toward  finding  a  cure for  cancer                                                                    
     would not be possible."                                                                                                    
SENATOR DAVIS  stated she was  anxious to  move this bill  to the                                                               
next committee  of referral.   She expressed concern  that adding                                                               
any amendments  at this  stage of  the legislative  process would                                                               
slow the  down the  bill and it  may not pass.   She  related her                                                               
understanding  that an  amendment  "being  floated around"  would                                                               
"gut"  the bill  by removing  the fundamental  principles of  the                                                               
bill.  She characterized SB 10  as very worthwhile to patients in                                                               
Alaska.  She highlighted the  value of having insurance companies                                                               
cover  clinical trials  by  sharing a  personal  story about  her                                                               
husband's bout with cancer.  She  related that five years ago her                                                               
husband  was  diagnosed with  stage  4  cancer.   His  oncologist                                                               
determined  the  tumor  could   not  be  surgically  removed  but                                                               
outlined  treatment options,  which  were necessary  or he  would                                                               
likely  die  in  six  months.   His  oncologist  had  trained  at                                                               
University of  Texas M.D. Anderson  Cancer Center in  Houston and                                                               
recommended  it   as  a  treatment  center,   but  also  outlined                                                               
chemotherapy treatment.   Her  husband chose  to stay  in Alaska.                                                               
As the  tumor spread to  his liver,  he then became  eligible for                                                               
clinical trials.  He was still  healthy so he traveled to Houston                                                               
to apply for clinical trials.   After six weeks her husband found                                                               
out  "did not  make the  cut" and  at that  point he  returned to                                                               
Alaska.   Later when he  was selected to participate  in clinical                                                               
trials his  health had  deteriorated to  a point  that he  was no                                                               
longer eligible.   She  said that as  predicted her  husband died                                                               
within  six months  after diagnosis.   She  said that  she has  a                                                               
vested interest in helping ensure  that other people could obtain                                                               
coverage for treatment in Alaska.                                                                                               
8:40:36 AM                                                                                                                    
REPRESENTATIVE T.  WILSON asked whether  the cost of  any medical                                                               
complications  from clinical  trial are  covered by  insurance or                                                               
are absorbed by the clinical trial.                                                                                             
SENATOR  DAVIS said  she  did  not know.    She  deferred to  the                                                               
professionals to answer that question.                                                                                          
8:41:16 AM                                                                                                                    
REPRESENTATIVE CARL  GATTO, Alaska  State Legislature,  said that                                                               
patients sign "about a 30-page  document" and "if everything goes                                                               
south"  the  clinical trials  will  cover  the patient's  medical                                                               
costs.   He offered his belief  that it is likely  less expensive                                                               
to hold  clinical trials  and discover a  good medicine  than for                                                               
insurance  companies  to  cover  medical costs  for  an  extended                                                               
period, such as for ten years.                                                                                                  
REPRESENTATIVE GATTO  related an  incident, in  which researchers                                                               
tested  MDX-010,  Ipilimumab,  which  is  a  type  of  monoclonal                                                               
antibody, to  see if it  will stimulate a strong  immune response                                                               
to attack  the prostate  cancer or other  cancer cells.   Several                                                               
hundred  people  participated  and  after  a  year,  five  people                                                               
decided they no  longer wanted to continue.  Prior  to the trial,                                                               
patients  were  required  to  have   a  visible  lesion  or  some                                                               
measurable evidence  of cancer so  any progress  or deterioration                                                               
could be measured.  During surgery  surgeons found that in two of                                                               
the  five instances,  the clinical  trial  patients' cancers  had                                                               
disappeared  or  were  so  small,   the  person  would  not  have                                                               
initially been  qualified to participate  in the  clinical trial.                                                               
He suggested the  other three patients outcome  was not reported,                                                               
but he surmised they likely were  in the placebo group.  Clinical                                                               
trials  can  produce  an  effective medicine,  he  stated.    The                                                               
alternative is to  undergo chemotherapy or take  drugs, which are                                                               
generally very expensive  and often do not cure  the disease, but                                                               
will delay the patient's death.   He offered his view that people                                                               
who are really  sick are the ones selected to  participate in the                                                               
clinical trial.                                                                                                                 
REPRESENTATIVE    GATTO   related    his   personal    experience                                                               
participating  in  a  clinical  trial  for  CTLA4,  Cytotoxic  T-                                                               
lymphocyte antigen,  which is a  protein that plays  an important                                                               
regulatory role  in the  immune system.   The clinical  trial was                                                               
aborted when one  patient's blood platelet levels  dropped so low                                                               
that the  patient had to be  hospitalized.  He remarked  that the                                                               
drug was modified and is currently  being used again.  He offered                                                               
his  view that  clinical  trials  can save  money  and can  offer                                                               
patients a  better life.   The one  exception is that  people who                                                               
are not "clearly"  sick are excluded from the  clinical trial, he                                                               
8:47:32 AM                                                                                                                    
REPRESENTATIVE  T. WILSON  asked  for  clarification of  "routine                                                               
care" and  at what point the  care is identified as  routine, and                                                               
whether it  includes care given  prior to or during  the clinical                                                               
REPRESENTATIVE GATTO responded  that participants frequently must                                                               
undergo screening tests  such as bone scans or CT  scans prior to                                                               
participating  in  a clinical  trial.    He explained  that  drug                                                               
companies  like  Bristol-Myers  Squibb  will  provide  the  drug,                                                               
administration,   and  monitoring   at   no   cost,  but   prefer                                                               
participants  in  clinical trials  have  insurance  to cover  the                                                               
remaining costs.   He surmised it may cost $1  billion to develop                                                               
a specific drug.   He pointed out routine care  for a patient may                                                               
be an instance in which the  patient has a recurring headache and                                                               
sees his/her  physician who  subsequently diagnoses  the headache                                                               
as not  related to  the clinical  trial drug.   The  doctor would                                                               
treat the headache under routine patient care.                                                                                  
8:49:08 AM                                                                                                                    
REPRESENTATIVE  T.  WILSON asked  how  a  primary care  physician                                                               
could differentiate routine care from cancer care.                                                                              
REPRESENTATIVE  GATTO  answered   the  doctor  administering  the                                                               
program replaces the patient's  normal physician, administers the                                                               
drug,  and performs  checkups to  monitor blood  counts or  other                                                               
tests to determine effectiveness.                                                                                               
8:50:20 AM                                                                                                                    
CO-CHAIR  KELLER asked  whether he  could report  on the  medical                                                               
costs  the pharmaceutical  company or  insurance company  covered                                                               
during the clinical trial.                                                                                                      
REPRESENTATIVE  GATTO remarked  that  patients  are not  declined                                                               
treatment simply because they do not have insurance.                                                                            
CO-CHAIR  KELLER referred  to  pages  62 and  63  of the  state's                                                               
insurance plan for further information.                                                                                         
8:51:51 AM                                                                                                                    
SENATOR DAVIS asked  to have members listen  to the professionals                                                               
who will testify  today rather than ask questions  at this point.                                                               
She  suggested  that  Representative  Gatto should  not  have  to                                                               
answer all the questions.                                                                                                       
CO-CHAIR   HERRON   agreed   that  the   committee   would   have                                                               
opportunities to hear answers from other testifiers.                                                                            
8:53:31 AM                                                                                                                    
LATHA   SUBRAMANIAN,   President;  Medical   Oncologist;   Denali                                                               
Oncology Group - Alaska (ASHO), offered  her support for SB 10 on                                                               
behalf  of  the  Alaska  affiliate of  the  American  Society  of                                                               
Clinical  Oncology and  her patients.   She  stated her  patients                                                               
could  not  participate in  cancer  clinical  trials since  their                                                               
insurance refused  to pay  for routine patient  care costs.   She                                                               
expressed gratitude for  the hearing.  She stated  that cancer is                                                               
a deadly disease.  Our  guidelines through National Comprehensive                                                               
Cancer  Network   (NCCN),  which  are  based   on  evidence-based                                                               
medicine, strongly  recommend treatment under clinical  trial for                                                               
patients  diagnosed with  cancer.   She  explained that  patients                                                               
decline  participation in  clinical trials  when their  insurance                                                               
will not  cover their costs, yet  the same insurers will  pay for                                                               
routine patient  care cost when  patients are treated  outside of                                                               
clinical trials.   She stated that as long as  patient has cancer                                                               
and is  under the care  of an  oncologist, they still  need care.                                                               
It  does not  matter if  the  course of  action is  chemotherapy,                                                               
clinical  trials, or  not, the  patient  still needs  care.   The                                                               
patient  needs routine  care, which  is covered  by an  insurance                                                               
company if  the patient is  not on a  clinical trial.   She said,                                                               
"That's what this whole bill is  about."  She understood the main                                                               
concern has  surrounded the  cost to the  insurers and  effect on                                                               
premiums.   However, all the scientifically  published data shows                                                               
the impact on the  cost of premiums is less than  1 percent.  The                                                               
Memorial  Sloan-Kettering Cancer  Center compared  clinical trial                                                               
cost with  routine care.   The center  found the mean  total cost                                                               
for  six months  for clinical  trials was  $30,775 as  opposed to                                                               
$37,000 for standard  care.  The quality of  adjusted life years,                                                               
which was  averaged at $50,000  cost effectiveness.   She related                                                               
that spoke to  the successes from clinical trials.   It turns out                                                               
the drug, MDX-010,  Ipilimumab, is being used for  Phase 3 trials                                                               
for melanoma  since the mortality  rate decreased and  is thought                                                               
to  double  the  life  span  for patients  with  melanoma.    She                                                               
remarked this drug came out of  clinical trials.  She pointed out                                                               
that it is because of  cancer clinical trials that survival rates                                                               
in childhood  cancer has significantly improved,  and death rates                                                               
have decreased  by 62  percent.  The  survival rate  for children                                                               
with  acute  lymphocytic  leukemia,  which  is  the  most  common                                                               
leukemia in  children, survival has  increased from 4  percent to                                                               
80 percent  due to  advances in  treatment made  possible through                                                               
clinical  trials.   She concluded  by emphasizing  that the  only                                                               
reason to initiate SB 10 is  to ensure that insurers will pay for                                                               
services of  usual and  customary care  for patients  on clinical                                                               
trials that would  be covered it the patient  did not participate                                                               
on clinical trials.                                                                                                             
8:57:48 AM                                                                                                                    
CO-CHAIR KELLER said  cost was not a concern if  it is "the right                                                               
thing to  do."  He asked  if she had documentation  for denial of                                                               
routine care.                                                                                                                   
8:58:25 AM                                                                                                                    
DR.  SUBRAMANIAN  answered yes.    She  referred  to two  of  her                                                               
patients who would  have participated in clinical  trials if they                                                               
had been eligible:  one was  diagnosed with breast cancer and the                                                               
other  was  diagnosed  with  lymphoma.   She  stated  that  their                                                               
insurance companies  opted out  of providing  routine care.   She                                                               
reported   that   both    patients   currently   are   undergoing                                                               
chemotherapy  and the  insurance companies  are paying  the costs                                                               
outside of the clinical trials.   In further response to Co-Chair                                                               
Keller, she  clarified that the  insurance company would  not pay                                                               
for routine care.                                                                                                               
8:59:20 AM                                                                                                                    
CO-CHAIR KELLER said a section  of the bill requires coverage for                                                               
Medicaid.  He  referred to the zero  fiscal note.  He  said he is                                                               
trying to understand the insurance companies' concerns.                                                                         
DR. SUBRAMANIAN said she asked the same question.                                                                               
9:00:23 AM                                                                                                                    
REPRESENTATIVE  T.  WILSON  asked   which  companies  denied  the                                                               
DR.  SUBRAMANIAN  did  not  recall   the  specific  name  of  the                                                               
insurance companies for her patients.                                                                                           
REPRESENTATIVE  T.  WILSON  asked  who decides  which  costs  are                                                               
considered  routine  care and  which  costs  are covered  by  the                                                               
clinical trials.                                                                                                                
DR.  SUBRAMANIAN defined  routine  care as  the  care that  would                                                               
normally be given  to the patient if they were  not on a clinical                                                               
REPRESENTATIVE T. WILSON asked for a definition of routine care.                                                                
DR. SUBRAMANIAN  answered yes.   She thought most  trials defined                                                               
routine care and standard care.                                                                                                 
9:02:01 AM                                                                                                                    
CO-CHAIR KELLER  related his  understanding that  clinical trials                                                               
are  experimental and  cancer is  diagnosed in  four phases.   He                                                               
commented that some  states have passed the  bill excluding Phase                                                               
1  cancer   patients.    He  recalled   the  sponsor's  testimony                                                               
suggested  an amendment  would gut  the  bill, which  is not  the                                                               
intent.    He suggested  only  providing  insurance coverage  for                                                               
cancer clinical trials for Phases 2-4.                                                                                          
9:03:21 AM                                                                                                                    
DR.  SUBRAMANIAN  answered that  Phase  1  trials relate  to  the                                                               
initial step of  studying a treatment or a drug  on patients with                                                               
cancer.   The drug  is designated as  promising after  lab tests.                                                               
Since advancement  in molecular advancement has  occurred, it has                                                               
become  more important  since that  is how  many drugs  come into                                                               
use.   She explained that Phase  2 and 3 clinical  trials are for                                                               
drugs  known  to work  in  certain  cancers  that are  tested  to                                                               
determine  if  they  work  better   than  the  standard  of  care                                                               
treatment  or  if  their  use  can be  expanded  to  treat  other                                                               
cancers, such  as Perceptin in  breast cancer, which is  now used                                                               
in ovarian  cancer or stomach  cancer.   Phase 4 studies  cover a                                                               
larger group  of patients  to test for  toxicity not  detected in                                                               
preliminary studies.   She pointed out that the  studies all have                                                               
their value in cancer care.                                                                                                     
9:04:37 AM                                                                                                                    
CO-CHAIR KELLER asked whether more  people participate in Phase 1                                                               
clinical trials.                                                                                                                
DR.  SUBRAMANIAN  answered  that   actually  a  fewer  number  of                                                               
patients  participate   in  Phase  1  clinical   trials,  usually                                                               
numbering 10 to 20 patients.                                                                                                    
CO-CHAIR KELLER surmised that all  Phase 1 clinical trials do not                                                               
proceed to Phases 2, 3, or 4  so it seems fewer patients would be                                                               
involved in Phase one clinical trials.                                                                                          
DR. SUBRAMANIAN  agreed, but noted that  more Phases 2, 3,  and 4                                                               
trials are currently open.                                                                                                      
9:05:44 AM                                                                                                                    
DR. SUBRAMANIAN,  in response to  Representative T.  Wilson, said                                                               
patients  without  insurance can  obtain  care,  but usually  the                                                               
hospitals or  physicians write  off the  cost unless  the patient                                                               
pays something.   She  emphasized that  physicians always  try to                                                               
provide the best care available to their patients.                                                                              
9:06:33 AM                                                                                                                    
JEANNE   ANDERSON,   M.D.;   Oncologist,  Medical   Director   of                                                               
Providence Cancer  Center, stated  that she  has been  in private                                                               
practice in  Anchorage for nine years.   She stated that  she has                                                               
been involved  in clinical trials  and cancer treatments  for the                                                               
past twenty  years.   She worked initially  at the  University of                                                               
Washington in  Seattle, at the Hutchison  Cancer Research Center,                                                               
and  at the  University of  Texas Health  Science Center,  in San                                                               
Antonio, Texas.   She  is currently the  Medical Director  of the                                                               
Cancer Research Department of the  Providence Cancer Center.  She                                                               
reiterated the importance of this  bill.  She clarified that each                                                               
patient's plan  is examined to  determine the  Medicare coverage.                                                               
This  analysis  uses  the  National  Comprehensive  Care  Network                                                               
(NCCN) guidelines  to identify routine  care.   Additionally, she                                                               
clarified that the  bill requires insurance companies  to pay for                                                               
complications.   When a  patient is enrolled  in a  study, he/she                                                               
may  obtain a  standard  chemotherapy drug  and  a "blind"  drug.                                                               
Thus,  when  someone  has  a complication,  it  is  difficult  to                                                               
identify the reason.  Cancer  patients have so many complications                                                               
that the medical staff grades  and attributes the likelihood that                                                               
investigation  blinded  drug  "x,"  the placebo,  or  other  drug                                                               
caused the complication.   It may be due  to underlying diabetes,                                                               
lung cancer, or hypertension.                                                                                                   
DR. ANDERSON stated that more studies  are in Phase 2 and 3 since                                                               
many studies  are not looking  for a  development of a  new drug.                                                               
Many studies  use standard drugs,  such as Adriamycin,  which are                                                               
then combined  with other drugs  and that the frequency  of doses                                                               
is  studied for  effectiveness.    She offered  her  view that  a                                                               
myriad of  types of  clinical trials  exist.   One reason  why an                                                               
increase  in  cost  for  clinical   trials  is  not  observed  is                                                               
treatment  consists of  variations of  routine treatments.   Last                                                               
year,  Providence  Alaska  Medical Center  (Providence)  excluded                                                               
enrollment of clinical trials to  employees.  However, Providence                                                               
will  now allow  employees to  enroll  in clinical  trials.   She                                                               
currently has  two such patients  in her  care and there  has not                                                               
been  additional  patient cost  to  participate  in the  clinical                                                               
trials.  She  surmised that other self insured  plans will likely                                                               
follow suit.   Medicare recipients and the  Department of Defense                                                               
recipients have this coverage.                                                                                                  
9:12:14 AM                                                                                                                    
MARY STEWART,  M.D., Hematologist; Oncologist; Past  President of                                                               
the Denali Oncology Group, stated  she has practiced in Anchorage                                                               
for 25  years providing care  to cancer patients.   She explained                                                               
that clinical trials provide one  avenue to find better treatment                                                               
for cancer patients.  She  said, "Any barriers to clinical trials                                                               
should be brought  down.  Insurance coverage for  routine care is                                                               
one of them.  Please pass this bill."                                                                                           
9:13:20 AM                                                                                                                    
CO-CHAIR KELLER  remarked that there were  different perspectives                                                               
in viewing the bill.  One  is from the patient's perspective.  He                                                               
commented  that he  is a  patient of  the Denali  Oncology Group.                                                               
Patients facing  death is one  perspective.   Another perspective                                                               
considers     pharmaceutical     and     insurance     companies.                                                               
Pharmaceutical  companies invest  sometimes billions  of dollars,                                                               
assuming risk, in  order to develop drugs for  profit.  Insurance                                                               
companies  make their  profits  on policies,  but  are a  heavily                                                               
regulated  industry.   He expressed  concern  that the  insurance                                                               
companies may  pick up  some of  the cost  and that  could affect                                                               
clinical trials.   He  said, "We're messing  with the  market, if                                                               
we're not real  careful."  He reiterated that it  is difficult to                                                               
know the effect the bill would have on two huge industries.                                                                     
DR.  STEWART said  that  the interplay  between  the entities  is                                                               
complicated,  but not  the  bill.   This  bill  is for  insurance                                                               
covering routine  care for  patients since  those costs  would be                                                               
covered normally.  She provides  a certain number of blood tests,                                                               
imaging,  x-rays routinely  since that  is normal  patient cancer                                                               
care.  Those tests do not  disappear just because a patient is on                                                               
a clinical  trial.  This bill  does not involve any  interplay of                                                               
pharmaceuticals or insurance entities.                                                                                          
9:17:38 AM                                                                                                                    
CO-CHAIR  KELLER  asked whether  Dr.  Stewart  is confident  that                                                               
insurance companies were denying routine care.                                                                                  
DR. STEWART  said that  insurance denials do  happen.   She said,                                                               
"It's  very  sad.     Not  only  does  it  deny   help  to  those                                                               
individuals,  but  it  denies  help  to  people  with  cancer  in                                                               
general.   The more clinical trials  we have the more  answers we                                                               
will get,  the more people we  can help, the more  cancers can be                                                               
cured.  This is just routine care."                                                                                             
9:18:29 AM                                                                                                                    
DR.  STEWART,  in  response  to  T.  Wilson,  related  that  some                                                               
clinical  trials are  "blinded"  and some  "are  not" so  doctors                                                               
sometimes know which  patients are in each  clinical trial group.                                                               
In further  response to Representative  T. Wilson,  she explained                                                               
that some clinical trial patients  receive placebos, but if those                                                               
patients were  not involved  in the  clinical trials,  they still                                                               
would have  checkups.  The  NCCN Guidelines  previously mentioned                                                               
identify the standard version of care to determine routine care.                                                                
REPRESENTATIVE  T. WILSON  expressed  concern  that the  patients                                                               
involved in the  placebo group add costs to  insurance groups but                                                               
are not receiving care.                                                                                                         
DR. STEWART explained  it is rare to have a  "placebo only" group                                                               
so typically  the patients  receive a standard  of care  and need                                                               
regular visits.   Placebo trials  are only prevention  trials, or                                                               
trials to  prevent cancer and some  Phase 1 or Phase  2 trials to                                                               
determine effectiveness in a certain type of cancer.                                                                            
9:21:29 AM                                                                                                                    
HANNAH  BRICE   SMITH,  Clinical  Research  Nurse,   referred  to                                                               
previous  questions asked  by committee  members.   She clarified                                                               
that  not every  drug  during the  clinical  trials process  goes                                                               
through  Phases  1-4.   The  Federal  Drug  Administration  (FDA)                                                               
conducts  clinical  trials on  Phases  1-4  and subsequently  the                                                               
oncologist and  research staff experiment with  dosage, combining                                                               
drugs,  and   time  intervals  of  administering   the  drug  for                                                               
effectiveness and work to decrease  the side effect.  She related                                                               
that  routine  care  is based  on  diagnosis  and  evidence-based                                                               
practice.    Thus, if  a  person  is  diagnosed with  "cancer  A"                                                               
evidence shows  the person requires blood  work on day 1,  5, and                                                               
10,  an  x-ray on  day  1  and  10.   Currently,  some  insurance                                                               
companies will  agree to pay  for these  services so long  as the                                                               
person does  not participate  on any clinical  trials.   The same                                                               
insurance companies will  deny all coverage for  any treatment of                                                               
patients  who   participate  in  clinical  trials.     Therefore,                                                               
patients  participating  in  clinical  trials  are  discriminated                                                               
against by some insurance companies.   She explained the national                                                               
guidelines identify routine  care for all types of  cancer.  This                                                               
bill  would require  insurance coverage  for routine  care.   She                                                               
pointed out that  the routine care is based on  the diagnosis and                                                               
not on  the cancer phase.   She said, "We've gotten  so caught up                                                               
on  the phases  of the  trials that  we are  forgetting, in  some                                                               
ways, how many  different types of clinical trials  are out there                                                               
for  cancer."   She  listed them  as  prevention trials,  symptom                                                               
management  trials,  treatment  trials, and  end-of-life  trials.                                                               
There are  trials that look  at all  aspects of cancer,  not just                                                               
someone  who is  on the  end of  the spectrum,  she stated.   She                                                               
described an  instance in which  a patient offered to  provide an                                                               
insurance  denial  letter,  but  the  patient  has  since  had  a                                                               
recurrence  of  cancer and  feared  reprisal  from the  insurance                                                               
company.  She concluded, "That  breaks my heart for my patients."                                                               
She said  she has  been an  oncology nurse for  23 years  and has                                                               
been in cancer research for the past two years.                                                                                 
9:26:34 AM                                                                                                                    
EMILY  NENON,  Alaska  Government  Relations  Director,  American                                                               
Cancer  Society, related  that initially  she did  not know  much                                                               
about  clinical trials.   She  learned that  clear standards  for                                                               
routine care exist,  whether or not the patient is  involved in a                                                               
clinical trial.  She advised  that placebos are never used solely                                                               
in a treatment  trial.  When testing a drug,  the efficacy of the                                                               
drug is  tested in  conjunction with  other drugs.   The  code of                                                               
ethics would not allow an  oncologist to only administer placebos                                                               
to  their patients  during  clinical trials.    She has  examined                                                               
market  segments.   The trial  sponsors  pay for  investigational                                                               
drugs and treatments and any  research-related costs such as data                                                               
collection and analysis  but do not pay for routine  care.  Thus,                                                               
any uninsured  patient involved in  a clinical trial  and routine                                                               
care would  be absorbed  by the  doctors.   She reported  that in                                                               
Alaska all  insurance plans are  not regulated, but the  group it                                                               
does  cover is  usually the  last  to add  coverage.   Currently,                                                               
Medicare,  Medicaid,  the   Veterans  Administration,  and  self-                                                               
insured  plans  such  as  Providence,  Banner  Health,  and  many                                                               
federal employee health benefit plans  provide coverage.  Thus, a                                                               
significant portion  of the companies  all have this  as standard                                                               
coverage.  "This  is really one of the last  pieces we're getting                                                               
at," she  said.  Finally,  costs are a  significant consideration                                                               
and  the costs  for routine  care are  comparable whether  or not                                                               
patients are  participating in  a study.   In some  instances the                                                               
costs are less, she stated.                                                                                                     
9:32:01 AM                                                                                                                    
REPRESENTATIVE  T.  WILSON  asked  how this  would  affect  self-                                                               
insured small businesses.                                                                                                       
MS. NENON answered that the  bill would not apply to self-insured                                                               
small plans as they are not technically insurance plans.                                                                        
9:32:50 AM                                                                                                                    
REPRESENTATIVE T.  WILSON asked how  many companies do  not cover                                                               
routine care for cancer treatment.                                                                                              
MS.  NENON  said she  did  not  know and  was  not  aware of  any                                                               
9:33:59 AM                                                                                                                    
REPRESENTATIVE  CISSNA  explained that  she  is  a breast  cancer                                                               
survivor  who  underwent a  mastectomy.    Five other  women  had                                                               
similar operations  at the same  time.  She learned  from support                                                               
groups that  after one year  lapsed that  only three of  the five                                                               
cancer patients were  still alive.  She related that  she was the                                                               
first  person  in her  family  to  have  cancer so  her  daughter                                                               
inherits the  risk of cancer.   She offered that  clinical trials                                                               
are  reducing the  risk for  women now  and for  next generation.                                                               
She  recalled from  her  work  in villages  that  elders did  not                                                               
remember cancer  as a prevalent  disease nor was it  discussed in                                                               
oral  histories.   She surmised  that Alaskans  face risk  and to                                                               
address  the  risk  requires  lifestyle  changes  and  to  ensure                                                               
everything possible  is done  to eliminate  cancer.   She offered                                                               
her belief that  clinical trials are the "pathway  forward."  She                                                               
said she supported SB 10.                                                                                                       
9:39:57 AM                                                                                                                    
REPRESENTATIVE T. WILSON asked who  should be responsible for the                                                               
costs of clinical  trials.  She surmised  that the pharmaceutical                                                               
companies will  potentially "make  a lot of  money" from  the new                                                               
drug.  She  asked if smaller companies would have  to pay for the                                                               
routine care.                                                                                                                   
REPRESENTATIVE CISSNA  replied in  Alaska the companies  who earn                                                               
large profits tend  to be those involved in  chronic health care.                                                               
She pointed out  that there are not  any pharmaceutical companies                                                               
in the  state.  She  offered her  view that policy  makers should                                                               
seek to safeguard  Alaskans and not discourage  profit since that                                                               
translates to  jobs.   However, policy makers  must also  keep in                                                               
mind  whether  the policy  benefits  people.    The profit  is  a                                                               
separate  issue.   She  is  more  concerned with  keeping  people                                                               
healthy.   Hospitals  "make a  lot of  money" but  that does  not                                                               
interfere with her desire to provide hospital care to Alaskans.                                                                 
9:43:17 AM                                                                                                                    
REPRESENTATIVE T.  WILSON surmised  that all  insurance companies                                                               
are not  required to provide  routine care since only  23 percent                                                               
of  the private  industry  covers  this care.    The majority  of                                                               
Alaskans are  covered under  self-insured plans.   She  asked how                                                               
that percentage is offset.                                                                                                      
JON SHERWOOD, Medical Special Projects,  Medicaid and Health Care                                                               
Policy,  Department   of  Health  and  Social   Services  (DHSS),                                                               
explained  that the  state's Medicaid  program  already pays  for                                                               
routine care for  clinical trials.  He reported that  a number of                                                               
elderly  patients  are on  Medicare.    Thus, a  disproportionate                                                               
number of patients fall into the  Medicare group.  He stated that                                                               
the state reviewed its policy  and costs and made a determination                                                               
to add coverage of routine costs.                                                                                               
9:45:42 AM                                                                                                                    
REPRESENTATIVE T.  WILSON referred  to the  title of  bill, which                                                               
read:     "...to  provide  Medicaid   services  to   persons  who                                                               
participate   in  those   clinical   trials;   and  relating   to                                                               
experimental  procedures..."   However,  Medicaid already  covers                                                               
clinical trials, she said.                                                                                                      
MR.  SHERWOOD said,  "That is  correct."   This  bill would  give                                                               
statutory authority  instead of  by policy  and regulation.   The                                                               
department is  not required to do  so by statute and  SB 10 would                                                               
put it in statute to disallow policy reversal.                                                                                  
REPRESENTATIVE  T.  WILSON  related   this  would  apply  to  all                                                               
insurance companies not  just Medicaid.  She  emphasized that the                                                               
state cannot mandate groups currently covered under federal law.                                                                
9:46:58 AM                                                                                                                    
LINDA HALL,  Director, Division  of Insurance,  Anchorage Office,                                                               
Department   of  Community   &   Economic  Development   (DCCED),                                                               
introduced herself.                                                                                                             
REPRESENTATIVE  T.  WILSON  related her  understanding  that  the                                                               
self-insured companies  currently are  covered under  federal law                                                               
and would not be affected by SB 10.                                                                                             
MS. HALL agreed that most  large companies have self-funded plans                                                               
but the state's plan does not  fall under federal law.  The state                                                               
self-funded  plan   is  not  considered   to  be   insurance  and                                                               
governmental  plans are  exempted  from  the Employee  Retirement                                                               
Income Security Act (ERISA).  The  state plan is not regulated by                                                               
anyone, she  advised.  She  reported that most  self-funded plans                                                               
are regulated by ERISA under the federal Department of Labor.                                                                   
9:48:22 AM                                                                                                                    
REPRESENTATIVE  T.  WILSON asked  for  the  financial impact  for                                                               
those affected by  the requirement in SB 10  that insurance plans                                                               
cover routine care.                                                                                                             
MS. HALL responded no.  She said  she did not think there was any                                                               
way  to know  the financial  impact ahead  of time.   Alaska  has                                                               
fewer  mandates than  most states.   It  is not  tracked to  that                                                               
degree of specificity to obtain a cost for a mandate.                                                                           
REPRESENTATIVE T. WILSON said what  she viewed as happening would                                                               
result in battles in discerning  routine care from clinical trial                                                               
costs.   She asked if  doctors could identify routine  care costs                                                               
for patients in clinical trials.                                                                                                
MS. HALL  said that she  was not sure.   She said she  just heard                                                               
testimony that  "routine care"  was defined.   She did  not think                                                               
that a situation existed in  which all insurance companies denied                                                               
coverage  for  all  treatments.     She  offered  to  review  the                                                               
individual  health  policies,  if  necessary,  to  examine  which                                                               
companies deny  routine care in  clinical trials.  She  was aware                                                               
that some  large companies did  provide routine care  for certain                                                               
phases.  The  exclusion usually falls under policy  of not paying                                                               
for  experimental drugs,  but does  not  generally cover  routine                                                               
care.   She said she met  with her staff on  consumer complaints.                                                               
She reported that  about 50 percent were  complaints about health                                                               
insurance.  She  said she asked whether complaints  were made for                                                               
lack of routine care during  clinical trials and was advised that                                                               
they were not the cause for  complaint.  Thus, she finds that the                                                               
division  does  not  currently receive  complaints  on  insurance                                                               
coverage for  clinical trials.   She said, "I'm  very interested.                                                               
And I've  heard some testimony  today that I would  be interested                                                               
in follow-up with people  that are seeing that.  And  it may be a                                                               
contractual exclusion  in the policy."   She stated that  she was                                                               
aware of complaints about experimental  drugs not being approved.                                                               
Alaska  currently has  an internal  and  external review  process                                                               
that   "brings   in"  outside   doctors   to   review  and   make                                                               
determinations.  She  offered that there are  procedures in place                                                               
that review  things like routine  care for clinical trials.   She                                                               
anticipated that even  if SB 10 became law, that  a wide range of                                                               
matters would not be clarified  about experimental exclusion in a                                                               
policy.    She  offered  that  insurance  policy  is  subject  to                                                               
interpretation.    She  said  that  the  division  provides  that                                                               
technical  level  of expertise,  but  a  lot of  questions  still                                                               
remain.  She said  she did not see this as "cut  and dried."  She                                                               
suggested  she  is  available  to  provide  a  broader  range  of                                                               
information to the legislature as it makes the policy decisions.                                                                
9:54:17 AM                                                                                                                    
CO-CHAIR  HERRON recapped  her  testimony  revealed that  routine                                                               
care  is  not defined  in  statute,  but the  federal  guidelines                                                               
define "routine care."                                                                                                          
REPRESENTATIVE T. WILSON  stated that if the  clinical trials are                                                               
successful,  someone will  obtain great  profits.   She saw  this                                                               
bill  as one  in  which "if  I  can make  more  profit over  here                                                               
because I can  make this group pay for part  of this trial, which                                                               
is exactly  what they would have  to do if the  insurance company                                                               
didn't do it  to make their case  go forward."  She  viewed SB 10                                                               
as  requiring the  company to  cover routine  costs for  clinical                                                               
trials if  the funds  are not  coming from  another source.   She                                                               
asked  whether clinical  trials would  end if  this bill  did not                                                               
MS.  HALL said  that she  could not  answer that  question.   She                                                               
surmised that  drug companies cover  a large portion of  the cost                                                               
of clinical trials.  She said she  did not know if they would end                                                               
the clinical trials if other funding sources were not available.                                                                
9:56:10 AM                                                                                                                    
REPRESENTATIVE CISSNA asked  whether self-insured companies could                                                               
be required to  cover some of the costs even  though the DOI does                                                               
not have oversight.                                                                                                             
MS. HALL said  the requirement to mandate coverage  would have to                                                               
be in federal  law.  The state is pre-empted  in federal law from                                                               
having any oversight of the  self- insured groups.  Sometimes the                                                               
state passes law  that mirrors federal law so  the department can                                                               
9:58:02 AM                                                                                                                    
REPRESENTATIVE  CISSNA said,  "If I  understand it  correctly, we                                                               
can't make the law  to do that but we can adopt  a federal law to                                                               
enforce the duties."                                                                                                            
MS. HALL agreed.  She  reiterated that the legislature adopts the                                                               
federal law  by reference  so the DOI  would enforce  the federal                                                               
CO-CHAIR KELLER  asked whether the  DOI would take any  action if                                                               
the  DOI determined  that insurance  companies were  not covering                                                               
routine care for patients involved in a clinical trial.                                                                         
MS. HALL  said it would  depend on the  contract.  The  DOI would                                                               
review the contract to see  whether the terms were ambiguous, and                                                               
make  a  determination  whether   a  specific  exclusion  in  the                                                               
insurance  contract existed.   If  a specific  exclusion did  not                                                               
exist,  the  DOI would  likely  debate  with  the insurer  as  to                                                               
whether it should provide coverage.   Additionally, if it was not                                                               
clearly  excluded,  the  DOI  would suggest  to  consumer  to  go                                                               
through formal appeals process.                                                                                                 
9:59:52 AM                                                                                                                    
CO-CHAIR HERRON closed public testimony on SB 10.                                                                               
CO-CHAIR  HERRON  advised  that  Rep  Keller  has  withdrawn  his                                                               
written amendment, but will offer a conceptual amendment.                                                                       
SENATOR DAVIS said she was glad  to have a thorough discussion of                                                               
the issues on SB  10.  She said "it boils down"  to the debate of                                                               
covering a  portion of  the insurance plans,  with 23  percent of                                                               
the plans  not covered due to  federal law.  However,  people can                                                               
choose to  have this as  part of plan,  she stated.   She offered                                                               
her  belief that  a large  percent of  patients would  be covered                                                               
under  the  bill.    She offered  that  currently,  the  standard                                                               
routine  care is  covered regardless  of the  disease.   Thus, it                                                               
does not  matter whether  the patient is  involved in  a clinical                                                               
trial since the insurance covers the routine care in any case.                                                                  
10:02:41 AM                                                                                                                   
REPRESENTATIVE  T.  WILSON  said that  routine  "follow-up"  care                                                               
depends  on treatment.    She  described a  scenario  in which  a                                                               
person is diagnosed  with cancer and their routine  care is based                                                               
on the number of prescribed  chemotherapy sessions.  She said the                                                               
routine care would depend on the  treatment.  Thus, if the person                                                               
was involved in  a clinical trial, he/she would  follow a routine                                                               
treatment based  on the patients  receiving the trial  drug, even                                                               
if the patient  received a placebo.  Therefore,  the routine care                                                               
for  the  patient receiving  the  placebo  or  a portion  of  the                                                               
treatment  would be  different  than the  patients receiving  the                                                               
full drug regime being tested.                                                                                                  
SENATOR DAVIS disagreed.   She said routine care is  based on the                                                               
diagnosis  and not  on the  treatment.   The insurance  companies                                                               
cover  the routine  care  whether  or not  the  patient  is in  a                                                               
clinical trial.                                                                                                                 
REPRESENTATIVE T. WILSON  said, "I'm sorry but  that's not true."                                                               
She  illustrated her  point  with a  personal  experience when  a                                                               
family  member  underwent  chemotherapy.    Her  family  member's                                                               
routine  care   changed  when  the   patient  had  a   stem  cell                                                               
transplant.  The standard of  care changed once the diagnosis was                                                               
at the  point where nothing more  could be done for  the patient.                                                               
She  related  her understanding  that  "we're  not talking  about                                                               
allowing  routine  care  for  everybody  who's  insured.    We're                                                               
picking out  one designated group of  private insurance companies                                                               
and demanding,  as a state, that  they have to take  care of it."                                                               
She  expressed concern  with SB  10,  since this  bill would  not                                                               
apply to every insurance company in the state.                                                                                  
SENATOR  DAVIS agreed  that "in  a  perfect world  we would  want                                                               
everybody to do it."  She  explained that this must be handled in                                                               
phases  and anyone  can opt  out  of the  routine care  coverage,                                                               
including the  state or any  independent insurance company.   She                                                               
related that  she did not  want to  debate the matter,  but would                                                               
base  her information  on  the  medical professionals'  comments.                                                               
She  offered  her  belief  that  the  costs  are  comparable  for                                                               
coverage for  a patient on clinical  trials or not.   She did not                                                               
view  SB  10  as  placing  a burden  on  the  individual  or  the                                                               
insurance  company for  patients  to be  involved  in a  clinical                                                               
10:07:08 AM                                                                                                                   
SENATOR DAVIS  emphasized that she  would prefer not to  have any                                                               
amendments to  the bill  to improve the  chances of  passage this                                                               
legislative session.                                                                                                            
10:07:31 AM                                                                                                                   
CO-CHAIR KELLER offered Conceptual Amendment  1.  On page 1, line                                                               
12, following "approved" insert "Phases II, III, IV."                                                                           
CO-CHAIR  HERRON  restated  Conceptual  Amendment  1  would  also                                                               
require, after "trial" add "(s)" since it would be plural.                                                                      
CO-CHAIR KELLER  remarked that he did  not thing it needed  to be                                                               
plural but  since it is  a conceptual amendment the  bill drafter                                                               
would decide.                                                                                                                   
REPRESENTATIVE CISSNA objected.                                                                                                 
SENATOR DAVIS asked for the reason for Conceptual Amendment 1.                                                                  
REPRESENTATIVE  SEATON said  that  he was  not  cognizant of  the                                                               
intricacies  of the  phases of  the cancer  clinical trials.   He                                                               
asked for  the definition of  the phases, recalling that  Phase 1                                                               
referred to  testing the safety  and effectiveness of  drug, with                                                               
Phases  2-4, testing  items  such as  dosages  and tolerance  and                                                               
interactions of the drug being tested.                                                                                          
10:09:49 AM                                                                                                                   
CO-CHAIR KELLER stated that definitions  of phases are defined in                                                               
previously  mentioned   NCCN  Clinical  Practice   Guidelines  in                                                               
Oncology  (NCCN  Guidelines).   He  provided  a  brief  synopsis,                                                               
describing that Phase  1 is the first time a  drug has been tried                                                               
on human  beings.   He pointed  out that  clinical trials  are by                                                               
definition "experimental"  whose purpose  is to determine  if the                                                               
drug should be used for standard  of treatment for a disease.  He                                                               
acknowledged  the  process   is  not  as  simplistic   as  he  is                                                               
suggesting,  but  he believed  he  has  accurately described  the                                                               
Phase 1 cancer clinical trials.                                                                                                 
10:11:35 AM                                                                                                                   
TOM  OBERMEYER,  Staff  to Senator  Bettye  Davis,  Alaska  State                                                               
Legislature,  stated   that  Representative  Keller   is  largely                                                               
correct on  clinical trials.   He referred to  members' committee                                                               
packets and to the two  definitions.  Definitions are provided on                                                               
page two  of the printout  from the National Conference  of State                                                               
Legislatures (NCSL)  titled "Clinical  Trials:  What  are State's                                                               
Doing?   February  2009 Update."    It defines  Phase I  clinical                                                               
trials as research  conducted on a small group  of people ranging                                                               
from 20  to 80 people  to initially evaluate safety,  determine a                                                               
safe  dosage range  and identity  side effects.   He  offered his                                                               
belief  that the  more  persuasive document  was  a letter  dated                                                               
December 1,  2008, signed by  three medical doctors (MD)  who are                                                               
presidents   of  the   American  Association   for  Cancer,   the                                                               
Association  of  American  Cancer Institutes,  and  the  American                                                               
Society  of Clinical  Oncology,  respectively.   This letter  was                                                               
written during discussion of whether  Medicare should cover Phase                                                               
1 cancer clinical  trials.  He remarked that  Medicare does cover                                                               
Phase 1  trials.  He  read: "As the world's  leading professional                                                               
and  scientific organizations  representing oncology  cancer care                                                               
professionals,  we write  to  affirm our  position  that Phase  1                                                               
cancer clinical trials are the  essential gateway for advancement                                                               
of new  cancer treatments - and  a vital component of  our cancer                                                               
treatment  armamentarium."    He  referred to  page  two  of  the                                                               
letter, under  the heading "Phase  1 Cancer Clinical  Trials Have                                                               
Therapeutic Intent"  and read,  "The National  Cancer Institute's                                                               
(NCI)   Investigator  Handbook"   is   instructive   as  to   the                                                               
therapeutic intent  of a Phase  1 trial.  That  handbook includes                                                               
the following  information about  Phase 1 cancer  clinical trials                                                               
(emphasis added):                                                                                                               
     Phase  1  trials determine  a  safe  dose for  Phase  2                                                                    
     trials and define acute effects  on normal tissues.  In                                                                    
     addition,    these   trials    examine   the    agent's                                                                    
     pharmacology  and  may  reveal  evidence  of  antitumor                                                                    
     activity.   Therapeutic  intent  is  always present  in                                                                  
     Phase  1  trials;  indeed, anticancer  agents  are  not                                                                  
     tested in patients  unless preclinical activity studies                                                                    
     have  already  demonstrated   evidence  of  significant                                                                    
     activity in laboratory models.                                                                                             
TOM OBERMEYER referred to page three, which read as follows:                                                                    
     Additionally, many  of the NCI  Phase 1  trials involve                                                                    
     agents that  are already approved for  the treatment of                                                                    
     one  type  of  cancer  and   are  being  studied  in  a                                                                    
     different type of cancer, or  in combination with other                                                                    
     treatments.   As  a result,  we have  some evidence  of                                                                    
     therapeutic    effectiveness   that    provides   solid                                                                    
     grounding   on  which   to  base   therapeutic  intent.                                                                    
     Indeed,   an  analysis   of   12,000  individuals   who                                                                    
     participated in  460 NCI-funded Phase 1  trials done in                                                                    
     2005  found  that  10.6%  of  patients  experienced  an                                                                    
     objective response.  This number  increased to 17.8% of                                                                    
     patients when  one drug included  in the  trial regimen                                                                    
     was already FDA-approved."                                                                                                 
     Furthermore,  our growing  knowledge  of the  molecular                                                                    
     basis of cancer is  allowing us to increasingly develop                                                                    
     treatments  that are  targeted to  particular molecular                                                                    
     pathways   and   personalized   to   specific   patient                                                                    
MR. OBERMEYER  summarized that these are  very important clinical                                                               
trials and are not random.   He explained that the percentages he                                                               
cited earlier  provide enough proof  for the FDA approval  or are                                                               
close to  FDA approval.   He  related that  the increase  from 11                                                               
percent to 17.8  percent for FDA approved  drugs demonstrates the                                                               
value of the  Phase 1 clinical trials.  He  pointed out that this                                                               
letter  from the  top three  organizations  regarding cancer  and                                                               
substantiates   the  importance   of   cancer  clinical   trials.                                                               
Medicare  approved  Phase  I  immediately  after  receiving  this                                                               
letter.   He stated that  exclusion of  one phase will  create an                                                               
atmosphere  of fear  for patients  who  would not  be willing  to                                                               
participate in  later trials.   He  referred to  statistics cited                                                               
earlier,  that  nationally  3  of the  20  percent  eligible  for                                                               
clinical trials  do not participate  in trials.  He  offered that                                                               
Alaska  falls well  below  the national  norms,  with hardly  any                                                               
Phase 1  clinical trials.   He offered  his belief  that adopting                                                               
Conceptual   Amendment  1   would  discourage   participation  in                                                               
clinical trials and encouraging  participation in cancer clinical                                                               
trials is the intent of the  bill and not to target the insurance                                                               
industry.   The insurance  companies "will  be dragged  back into                                                               
this"  under the  federal  bill in  2014 anyway.    This bill  is                                                               
intended  to  save lives  today  and  help  the 2600  new  cancer                                                               
patients each year.                                                                                                             
10:16:57 AM                                                                                                                   
CO-CHAIR HERRON opened public testimony on SB 10.                                                                               
REPRESENTATIVE  SEATON said  that  Conceptual  Amendment 1  would                                                               
remove Phase  1 trials from SB  10.  He asked  for the definition                                                               
of Phase 1 clinical trials.                                                                                                     
DR. STEWART explained that Phase  1 clinical trials are primarily                                                               
to "work out" the dose  or schedule for effectiveness, often used                                                               
for new  medications that had  been through some  clinical trials                                                               
and animal studies.   The Phase 1 clinical trials  allow the drug                                                               
to be checked for specific cancers.   As a practical matter, very                                                               
few  patients will  choose  to participate  in  Phase 1  clinical                                                               
trials.   The point of studies  is therapeutic intent is  to help                                                               
patients  and  work out  the  dosage.    In response  to  earlier                                                               
comments  by  Representative  T. Wilson,  she  reviewed  clinical                                                               
trials  in  Anchorage,  and  very  few  involve  new  drugs  that                                                               
potentially  would  result  in large  profits  to  pharmaceutical                                                               
companies.   Most clinical trials  in Alaska are not  testing new                                                               
drugs  but examine  new  scheduling.   She  thought  it would  be                                                               
uncommon to involve new drugs.                                                                                                  
10:21:08 AM                                                                                                                   
CO-CHAIR HERRON asked Dr.  Stewart supported Conceptual Amendment                                                               
DR. STEWART  answered absolutely  not.  She  stated that  Phase 1                                                               
studies should  be available to  Alaskans.  She explained  that 8                                                               
of the  31 states that have  coverage for clinical trials  do not                                                               
include Phase  1 clinical  trials.   She said,  "I don't  see any                                                               
reason  why should  Alaskans have  less  availability of  studies                                                               
than people in other states -  Nebraska, Iowa; I think we deserve                                                               
the best."                                                                                                                      
CO-CHAIR HERRON closed public testimony on SB 10.                                                                               
10:22:05 AM                                                                                                                   
REPRESENTATIVE CISSNA  commented on  her objection.   She related                                                               
that that  number of cancers  in Alaska is increasing  and Alaska                                                               
leads the  nation in cancer  deaths.  She raised  questions about                                                               
the causes  of cancer and  why Alaska  has a higher  incidence of                                                               
unusual cancers.   She offered  her belief that Alaska  should be                                                               
aggressive to acquire tools to  protect its citizens and "I think                                                               
the trials get us there."                                                                                                       
10:23:25 AM                                                                                                                   
REPRESENTATIVE T.  WILSON asked  for clarification on  the reason                                                               
to remove Phase 1 clinical trials from the bill.                                                                                
CO-CHAIR KELLER  explained that he  did not  wish to hold  up the                                                               
bill.   He  said,  "The last  thing we  need  is more  government                                                               
regulations,  especially when  we  are  talking about  government                                                               
regulations like  this that  are messing with  the market."   The                                                               
pharmaceutical  industry  has  a  lot  to gain  if  they  have  a                                                               
successful four phase  process.  Insurance companies  pass on the                                                               
cost on  to the customer.   In effect, the additional  cost helps                                                               
pay for the  experimental process of approving drugs.   He stated                                                               
that the  federal government  already provides  a 50  percent tax                                                               
credit  to  pharmaceutical   companies  for  conducting  clinical                                                               
trials.    He viewed  Phase  1  trials as  experimental,  whereas                                                               
clinical  trials for  Phases 2-4  consider toxicity  and dosages.                                                               
He related  some other  states exclude  Phase 1  clinical trials,                                                               
although he  was not certain  which states currently  exclude the                                                               
Phase 1 clinical  trials.  He cautioned he did  not wish to "mess                                                               
with the  market" when  the effect  is unknown.   He  offered his                                                               
belief that this reduces that risk.                                                                                             
10:26:12 AM                                                                                                                   
REPRESENTATIVE  T. WILSON  asked  whether removing  Phase 1  from                                                               
clinical  trials would  cause concern  that  insurance would  not                                                               
cover clinical trials.                                                                                                          
CO-CHAIR KELLER  said he had  not heard convincing  evidence that                                                               
insurance  companies  refuse  routine  care.    If  evidence  was                                                               
produced, he  would have  a different  opinion on  the bill.   He                                                               
said  he  thought  to  refuse   routine  care  on  the  basis  of                                                               
participation  in clinical  trials  would be  inappropriate.   He                                                               
said  he   thought  it   was  telling  that   no  one   from  the                                                               
pharmaceutical  or  insurance  industries  was  present  at  this                                                               
10:27:30 AM                                                                                                                   
REPRESENTATIVE SEATON  recalled most of  the drugs being  used in                                                               
the  cancer clinical  trials are  approved by  the Food  and Drug                                                               
Administration (FDA)  and are being  "cross utilized"  by testing                                                               
the drugs in other cancers.   He stated that currently any doctor                                                               
can  prescribe  FDA  approved drugs  approved  medicine  and  the                                                               
routine  care  would be  covered.    However,  if the  drugs  are                                                               
prescribed in  an organized  study that can  be published,  it is                                                               
called a  clinical trial and  insurance coverage would  not cover                                                               
the  routine  care  even  though   it  would  be  covered  if  an                                                               
individual doctor  prescribed it.   He stated based  on testimony                                                               
that he would vote against Conceptual Amendment 1.                                                                              
10:28:51 AM                                                                                                                   
REPRESENTATIVE  CISSNA  maintained  her objection  on  Conceptual                                                               
Amendment 1.                                                                                                                    
A  roll call  vote  was  taken.   Representatives  T. Wilson  and                                                               
Keller   voted    in   favor    of   Conceptual    Amendment   1.                                                               
Representatives Cissna,  Holmes, Lynn,  Seaton, and  Herron voted                                                               
against it.   Therefore, Conceptual Amendment 1  failed the House                                                               
Health and Social Services Standing Committee by a vote of 2-5.                                                                 
10:29:29 AM                                                                                                                   
REPRESENTATIVE  T. WILSON  referred to  the NCCN's  definition of                                                               
routine care,  which she did  not think  was clear.   She offered                                                               
her belief  that a better  definition of routine care  is needed.                                                               
She stated that  people were being caught  between drug companies                                                               
and insurance carriers.                                                                                                         
CO-CHAIR HERRON encouraged the research  should be performed done                                                               
for the House Finance Committee.                                                                                                
REPRESENTATIVE  T.  WILSON said  that  defining  routine care  is                                                               
information that  should be examined.   She  felt it was  part of                                                               
duty  of  this committee  to  review  the  health aspects.    She                                                               
surmised that  50 percent of the  people will not be  affected by                                                               
this bill.   She  suggested taking  a few  more hours  to explore                                                               
this issue.                                                                                                                     
CO-CHAIR HERRON said  he appreciated the comments.   He expressed                                                               
concern that placing a definition  in statute may not provide the                                                               
result she seeks.   The routine care process  or procedure should                                                               
be  determined   by  professionals  for  specific   diseases  for                                                               
cancers.    He did  not  want  to place  a  "one  size fits  all"                                                               
definition in statute.                                                                                                          
REPRESENTATIVE  T.  WILSON  expressed concern  that  the  patient                                                               
would be  caught between  the insurance  and the  clinical trial.                                                               
The bill would "put them in  a bad position" and could bring more                                                               
stress,  not   less  stress.     She  said  she   personally  has                                                               
experienced cancer in her family.                                                                                               
CO-CHAIR HERRON offered his opinion  that this is important and a                                                               
finite issue that should be debated by the body.                                                                                
10:34:28 AM                                                                                                                   
REPRESENTATIVE SEATON  moved to report CSSB10  (HSS)(efd del) out                                                               
of   committee   with    individual   recommendations   and   the                                                               
accompanying fiscal notes.                                                                                                      
CO-CHAIR KELLER objected.  He stated  that he would like the bill                                                               
to move  forward but was  not sure of  the effects of  this bill.                                                               
He said,  "The market  has a  lot to  do with  health care."   He                                                               
related that  it could be  covered in  2014, but a  really "rocky                                                               
road" is ahead  as the regulations on health  care are developed.                                                               
He  offered his  belief that  the legislature  will revisit  this                                                               
matter in the future.                                                                                                           
CO-CHAIR KELLER removed his objection.                                                                                          
10:36:19 AM                                                                                                                   
REPRESENTATIVE T. WILSON  objected.  She stated that  the bill is                                                               
using small  insurance businesses to  "make a point",  instead of                                                               
the self-insured  big businesses  that can  afford to  make these                                                               
changes.   She said, "That's  the wrong way  to do things."   The                                                               
committee  is  taking  something  that   is  not  a  problem  and                                                               
expanding it.  She did not  want to receive calls from people who                                                               
have problems as a result of the bill.                                                                                          
A  roll  call vote  was  taken.   Representatives  Holmes,  Lynn,                                                               
Seaton,  Cissna, Keller,  and  Herron voted  in  favor of  CSSB10                                                               
(HSS)(efd del).  Representative T. Wilson voted against it.                                                                     
Therefore, CSSB10 (HSS)(efd del) was reported out of the House                                                                  
Health and Social Services Standing Committee by a vote of 6-1.                                                                 

Document Name Date/Time Subjects