Legislature(2007 - 2008)BELTZ 211

04/03/2008 01:30 PM Senate LABOR & COMMERCE


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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ HB 331 MOTOR VEHICLES:LICENSES/INSURANCE/NOTICES TELECONFERENCED
Heard & Held
+ SB 280 MEDICAID/ INS FOR CANCER CLINICAL TRIALS TELECONFERENCED
Heard & Held
Bills Previously Heard/Scheduled
= SB 113 NURSING MOTHERS IN WORKPLACE
Moved CSSB 113(L&C) Out of Committee
= HB 295 RECORDED OR FILED DOCUMENTS
Moved HB 295 Out of Committee
= HB 379 CPA EDUCATION REQUIREMENTS
Moved HB 379 Out of Committee
        SB 280-MEDICAID/ INS FOR CANCER CLINICAL TRIALS                                                                     
                                                                                                                                
CHAIR ELLIS  announced SB 280  to be up for  consideration. [CSSB
280(HES), 25-LS1464\M was before the committee.]                                                                                
                                                                                                                                
1:54:19 PM                                                                                                                    
TOM OBERMEYER,  staff to Senator  Davis, sponsor of SB  280, said                                                               
this measure  requires health care insurers  to provide insurance                                                               
coverage for  medical care received  by a patient  during certain                                                               
approved   clinical  trials   designed   to   test  and   approve                                                               
prevention,  diagnosis, treatment,  or palliation  of cancer.  It                                                               
directs the  Department of Health  and Social Services  (DHSS) to                                                               
provide Medicaid services to persons  who participate in clinical                                                               
trials relating  to experimental  procedures and provides  for an                                                               
effective date. He read the sponsor statement as follows:                                                                       
                                                                                                                                
     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 at  any  one time.  They                                                                    
     include  trials  in prevention,  screening,  diagnosis,                                                                    
     treatment, quality-of-life, and genetic studies.                                                                           
                                                                                                                                
     SB 280 removes important  barriers to the participation                                                                    
     of  patients in  cancer clinical  trials in  Alaska. It                                                                    
     requires   that  all   health  care   plans,  including                                                                    
     Medicaid,   cover  routine   patient  care   costs  for                                                                    
     patients  enrolled in  all phases  of clinical  trials,                                                                    
     including   prevention,   detection,   treatment,   and                                                                    
     palliation  (supportive  care)   of  cancer.  Currently                                                                    
     Alaska health  plans can  exclude coverage  for routine                                                                    
     patient-care  costs  while  a patient  with  cancer  is                                                                    
     enrolled in a clinical  trial. Providers of health care                                                                    
     plans often  conclude that money is  saved by excluding                                                                    
     care  while patients  participate  in clinical  trials.                                                                    
     But  these  patients,  if   not  enrolled  in  clinical                                                                    
     trials, will  continue to receive  conventional therapy                                                                    
     at roughly the same or  slightly increased costs in the                                                                    
     short-run.                                                                                                                 
                                                                                                                                
     National  Conference  of  State  Legislatures'  studies                                                                    
     have  shown that  only 2-3  percent  of eligible  adult                                                                    
     patients enroll  in clinical trials with  a 6.5 percent                                                                    
     increase  in  costs  for  clinical  trial  participants                                                                    
     compared    to   nonparticipants.    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  percent  of  total                                                                    
     Medicaid costs.                                                                                                            
                                                                                                                                
     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 percent  of  the total  costs.                                                                    
     Based on  an estimated  2.5 percent  participation rate                                                                    
     per  above,   about  115   patients  are   expected  to                                                                    
     participate  in  clinical  trials   each  year.  A  6.5                                                                    
     percent increase  for 115 persons would  add $35.00 per                                                                    
     year to  Medicaid for cancer  treatments. Non-emergency                                                                    
     transportation costs  for the same group  are estimated                                                                    
     to add  another $15.00 per  year. The fiscal  note adds                                                                    
     an  estimated   $50,000  per  year  with   the  federal                                                                    
     government paying half of this.                                                                                            
                                                                                                                                
     Twenty-three   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  SB  280  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.                                                                                        
                                                                                                                                
1:59:04 PM                                                                                                                    
MR. OBERMEYER  concluded that  this bill is  trying to  draw more                                                               
people into the trials because  Alaskans have a high incidence of                                                               
cancer; patients  who do  participate are always  at risk  of not                                                               
being  covered for  routine  care. This  will  encourage them  to                                                               
participate at  a greater rate  in order  to save lives  and find                                                               
answers to treating cancer.                                                                                                     
                                                                                                                                
SENATOR STEVENS asked what clinical trials are and if they are                                                                  
voluntary.                                                                                                                      
                                                                                                                                
MR. OBERMEYER  replied that clinical trials  are always voluntary                                                               
and  a patient  can  pull out  at any  time.  Their expenses  are                                                               
covered  by the  federal government,  drug companies  and private                                                               
organizations such  as the American Association  of Oncology. The                                                               
only  way   to  improve   the  present   state-of-the-art  cancer                                                               
treatment  is to  present trials  that can  document results.  He                                                               
said  that  all  of  the developments  are  followed  immediately                                                               
through journals that are sent all around the world.                                                                            
                                                                                                                                
2:01:26 PM                                                                                                                    
SENATOR STEVENS asked who pays for  this. Me? Why isn't all of it                                                               
covered by  the drug  companies? Why  ask insurance  companies to                                                               
pick up the cost?                                                                                                               
                                                                                                                                
MR.  OBERMEYER replied  all this  bill asks  is for  insurance to                                                               
cover routine patient care costs.  It seeks to encourage patients                                                               
who would normally hesitate to  participate in a trial because of                                                               
fear they will be dropped from routine coverage for doing it.                                                                   
                                                                                                                                
LINDA  HALL,  Director,  Division  of  Insurance,  Department  of                                                               
Commerce,   Community   &   Economic  Development,   echoed   Mr.                                                               
Obermeyer's  comments   saying  her  enforcement   concerns  were                                                               
addressed in  this CS and that  it brought the bill  in line with                                                               
other states' requirements.                                                                                                     
                                                                                                                                
MS.  HALL,  however,  cautioned   that  this  bill  is  mandating                                                               
coverage  for  only  a  small percentage  of  Alaskans  and  that                                                               
Alaskan plans  are about  60 percent  self-insured and  those are                                                               
regulated by  the feds under  the Employee Retirement  and Income                                                               
Security Act of  1974 (ERISA). She stated this  measure would not                                                               
apply  to  Alaska state  employees  through  the Select  Benefits                                                               
Plan. It may or may not apply  to some of the union health trusts                                                               
under Title  21, but she has  chosen not to use  her resources on                                                               
that litigation at  this point. She said  mandating this coverage                                                               
also  has the  potential of  increasing the  cost of  health care                                                               
even though  she agreed with  the sponsor  that it only  looks at                                                               
routine  health  care  that would  be  provided  otherwise.  Some                                                               
insurance contracts will exclude anything  to do with someone who                                                               
is involved  in an experimental  type of process. This  puts good                                                               
controls  on that.  This  is  not an  attempt  to have  insurance                                                               
companies pay for clinical trials.                                                                                              
                                                                                                                                
2:07:58 PM                                                                                                                    
SENATOR STEVENS  asked if this could  be applied to a  test where                                                               
someone is accidentally given the flu, for instance.                                                                            
                                                                                                                                
MS. HALL  replied no  and that  while she is  not an  expert, she                                                               
explained that it's  when someone has been  diagnosed with cancer                                                               
and various medications have already  been developed and approved                                                               
to  be  used on  human  beings.  There  are different  levels  of                                                               
testing like  tests with control  groups and with  therapies that                                                               
have  been  shown  to  have  some  reasonable  expectation  of  a                                                               
beneficial effect.                                                                                                              
                                                                                                                                
SENATOR STEVENS asked  if there would ever be more  demand on the                                                               
insurance  cost because  the treatment  made  the disease  worse.                                                               
Would it  force insurance  companies to  pay for  anything beyond                                                               
routine care?                                                                                                                   
                                                                                                                                
MS.   HALL  answered   that  the   patient   would  have   gotten                                                               
progressively  worse  anyway.   She  didn't  envision  additional                                                               
charges other than possible additional testing.                                                                                 
                                                                                                                                
2:11:36 PM                                                                                                                    
DR. MARY  STEWART, President,  Denali Oncology  Group, Anchorage,                                                               
said last year  their group found improving  access and enrolling                                                               
more patients  in clinical trials  was its biggest  priority. She                                                               
explained that there all different  kinds of clinical trials, but                                                               
a  typical   cancer  trial  would  take   a  standard  treatment,                                                               
Treatment  A,  and take  another  treatment,  Treatment B,  which                                                               
might  be better;  usually there  is a  good deal  of preliminary                                                               
evidence. So  patients enroll and  doctors find out which  one is                                                               
better.  Generally, using  placebos is  considered unethical  for                                                               
cancer treatment  because it's such  a serious  disease. Everyone                                                               
gets  the standard  of care  treatment, but  this is  how doctors                                                               
further  their knowledge  about  the diagnosis  and treatment  of                                                               
cancer.                                                                                                                         
                                                                                                                                
She  stated that  2,650 Alaskans  will be  diagnosed with  cancer                                                               
this  year and  having good  treatment options  is essential  for                                                               
them. Knowing what  doesn't work is just as  important as knowing                                                               
what does.  She said that  cancer is  a costly disease  no matter                                                               
how you cut it.                                                                                                                 
                                                                                                                                
DR.  STEWART related  that many  of the  tests and  medicines are                                                               
better  than  before.  For example,  when  clinical  trials  were                                                               
completed  for treating  breast cancer  with chemotherapy  in the                                                               
90s; it was  found that it didn't help. At  the time chemotherapy                                                               
was a  $100,000-procedure and it's  more now; money was  saved by                                                               
having accurate information.                                                                                                    
                                                                                                                                
2:16:37 PM                                                                                                                    
SENATOR  STEVENS  asked  what  routine   care  is  included  with                                                               
clinical trials.                                                                                                                
                                                                                                                                
DR. STEWART replied CAT scans,  blood tests and things that would                                                               
have  to be  done  any way.  Clinical trials  don't  add much  to                                                               
cancer care.                                                                                                                    
                                                                                                                                
SENATOR STEVENS asked  if she was saying there  are no additional                                                               
costs for a person who is in the clinical trial.                                                                                
                                                                                                                                
DR. STEWART answered not exactly.  The added cost would be small,                                                               
maybe less  than 1 percent,  for an extra  X-ray or a  blood test                                                               
monitoring tumor marker levels. But  these things have to be done                                                               
anyway.                                                                                                                         
                                                                                                                                
2:18:39 PM                                                                                                                    
DR.  JEANNE ANDERSON,  Katmai Oncology  Group,  agreed and  added                                                               
that in the 1970s, only 50  percent of cancer patients lived five                                                               
years  after diagnosis.  In  2008, 66  percent  are predicted  to                                                               
survive five years.                                                                                                             
                                                                                                                                
She said cancer  physicians in Alaska are  committed to providing                                                               
the best  care possible  to their  patients to  relieve suffering                                                               
and reduce death from cancer.  They often turn to clinical trials                                                               
for  providing the  best treatment.  She  explained, "A  clinical                                                               
trial is a formal scientific way  to test whether a new treatment                                                               
is safe, effective and superior to existing treatments."                                                                        
                                                                                                                                
DR.  ANDERSON said  Alaskan doctors  support the  clinical trials                                                               
and  have  more  than  50 open  currently  for  cancer  patients.                                                               
However,  she said,  only a  small number  of patients  enroll in                                                               
these trials, about 40 patients  per year. The reasons are varied                                                               
and include lack  of knowledge or interest by  either the patient                                                               
or the  doctor, lack of  availability of an appropriate  trial or                                                               
lack of  insurance or  just because of  fear of  losing insurance                                                               
coverage. Passing this  bill will remove an  important barrier to                                                               
access to  clinical trials and  will result in improved  care for                                                               
patients and  facilitate their stay  in Alaska  for state-of-the-                                                               
art care.                                                                                                                       
                                                                                                                                
2:20:44 PM                                                                                                                    
DENNY   DEWITT,   Alaska   Director,   National   Federation   of                                                               
Independent Business,  opposed SB  280. While he  appreciated the                                                               
intent of this  bill, he said to begin with,  state employees are                                                               
not covered  by it. And it  seems ironic that they  would mandate                                                               
this kind  of coverage on small  businesses in Alaska and  not on                                                               
employees of  the state.  ERISA plans  and union  welfare benefit                                                               
plans are not  covered; about 60 percent of  the state's coverage                                                               
is not  included in this  bill. So  those expenses that  do incur                                                               
will fall heavily on small businesses.                                                                                          
                                                                                                                                
MR.  DEWITT said  they know  the uninsured  group is  growing and                                                               
that small  employers are  more hesitant  now to  offer employee-                                                               
based health insurance than they  have been historically and many                                                               
that have  been providing health  care coverage are  finding ways                                                               
to get out of  it because of the cost. This is  one more straw on                                                               
the camel's back. Even though this  measure would add less than 1                                                               
percent to  the cost of coverage,  that number would be  borne by                                                               
the small  employers and would  encourage them  to not be  in the                                                               
employer-based market at all.                                                                                                   
                                                                                                                                
2:23:48 PM                                                                                                                    
KRISTA  RANGITSH,   Cancer  Research  Nurse,   Providence  Alaska                                                               
Medical Center,  said she  is speaking on  her own  behalf today.                                                               
She explained when  a clinical trial is recommended  to a patient                                                               
by a physician  as a best treatment option, they  are referred to                                                               
her  office. Part  of her  discussion  about the  study with  the                                                               
patient  includes informing  them  that  their insurance  company                                                               
many not  cover some or  all of  the costs associated  with their                                                               
cancer while on  the study. She strongly  encourages all patients                                                               
to  find  out  what  their   policy  says  about  clinical  trial                                                               
coverage. This is where the road blocks appear.                                                                                 
                                                                                                                                
She  related  that  being  diagnosed with  cancer  is  already  a                                                               
difficult time for  patients and the last thing  they should have                                                               
to  worry  about is  finding  out  if  their insurance  covers  a                                                               
clinical trial their physician thinks  is in their best interest.                                                               
One of  her ever-increasing reasons  for patients not going  on a                                                               
clinical  trial  is  because  of  lack of  or  fear  of  lack  of                                                               
insurance  coverage. In  many  instances,  treatments for  cancer                                                               
must be started right away  and insurance companies take too long                                                               
to determine  if they will  cover it  or not. She  concluded that                                                               
she  was  confident  more  people   would  enroll  in  trials  if                                                               
insurance coverage  was mandated  for them. This  would hopefully                                                               
lead to finding more cures for cancer.                                                                                          
                                                                                                                                
SENATOR STEVENS  asked if this  bill passed, would  her insurance                                                               
company offer her this coverage.                                                                                                
                                                                                                                                
MS. RANGITSH replied she wasn't sure, but she would find out.                                                                   
                                                                                                                                
CHAIR ELLIS thought she might be covered under ERISA.                                                                           
                                                                                                                                
2:26:33 PM                                                                                                                    
EMILY  NENON,  Alaska  Government  Relations  Director,  American                                                               
Cancer Society,  said just  because the  state regulates  only 40                                                               
percent  of insurance  coverage doesn't  mean that  the other  60                                                               
percent are not  providing this coverage; a lot of  them do. When                                                               
Medicare decided  to add this coverage  years ago, three-quarters                                                               
of the federal employee plans  were already making that coverage.                                                               
Having the  language in statute  would be important even  for the                                                               
plans that are not regulated by the state.                                                                                      
                                                                                                                                
2:28:13 PM                                                                                                                    
DONNA  CARROL,   representing  herself,  Juneau,  said   she  was                                                               
diagnosed with cancer  10 years ago. She was so  bad that she was                                                               
shipped immediately to  Seattle where she took part  in a phase-3                                                               
clinical trial and  was told the treatment was  no different than                                                               
what she  would get if  she weren't  in the clinical  trial. They                                                               
wanted  to  test two  drugs  to  find out  if  it  was better  to                                                               
administer them  together rather than  one after the  other. This                                                               
clinical trial found that it was good to give them together.                                                                    
                                                                                                                                
2:30:14 PM                                                                                                                    
BEVERLY WOOLEY,  Director, Division of Public  Health, Department                                                               
of Health and Social Services  (DHSS), said she was testifying as                                                               
a private  citizen and a  cancer survivor. She supported  SB 280.                                                               
She  expressed the  emotional turmoil  that comes  when diagnosed                                                               
with  cancer. She  was eligible  for a  clinical trial  and spent                                                               
days on  the Internet looking at  the options and decided  it was                                                               
the best  course of action  for her. She  also hoped that  at the                                                               
very least  she would be  contributing to research.  She panicked                                                               
when she  found her  insurance might  not cover  the cost  of the                                                               
trial. This brought her back to the  time when she was 17 and her                                                               
father died  of cancer  and depleted  all his  family's resources                                                               
because  he didn't  have  insurance.  Fortunately, her  insurance                                                               
company  eventually determined  it would  cover the  cost of  the                                                               
clinical  trial, which  was demonstrated  to not  be significant.                                                               
She received  the care  needed while  research and  new important                                                               
information vital to improving future cancer care was gained.                                                                   
                                                                                                                                
CHAIR ELLIS thanked everyone for  their testimony and said SB 280                                                               
would be held for consideration in the near future.                                                                             
                                                                                                                                

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