Legislature(2007 - 2008)BUTROVICH 205
03/14/2008 01:30 PM Senate HEALTH, EDUCATION & SOCIAL SERVICES
| Audio | Topic |
|---|---|
| Start | |
| SB300 | |
| SB280 | |
| SJR18 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| *+ | SB 280 | TELECONFERENCED | |
| *+ | SB 288 | TELECONFERENCED | |
| *+ | SJR 18 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | SB 300 | TELECONFERENCED | |
SB 280-MEDICAID/ INS FOR CANCER CLINICAL TRIALS
CHAIR DAVIS announced consideration of SB 280.
1:45:02 PM
TOM OBERMEYER, Staff to Chair Davis, read the sponsor statement
as follows:
This is 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 clinical trials; relating to experimental
procedures; 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 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.
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. (National Conference of State
Legislatures ncsl.org/programs/health/clinicaltrials,
accessed 2/27/08) 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.
1:49:17 PM
DR. JEANNE ANDERSON, Medical Oncologist, Anchorage, spoke on
behalf of Alaska cancer physicians and patients. She thanked
Chair Davis and the Health and Social Services Committee members
for sponsoring and considering this bill. She disclosed that
2650 Alaskans were expected to be diagnosed with cancer in 2008,
and many more would be diagnosed with a recurrence of cancer. In
the 1970's only 50 percent of cancer patients lived 5 years
after diagnosis. In 2008 it was predicted that 66 percent of
patients would survive 5 years. Cancer physicians in Alaska were
committed to providing the best care possible to their patients
to relieve suffering and reduce deaths from cancer, and they
often turned to clinical trials as providing the best treatment
for their patients. As the sponsor statement indicated, clinical
trials provided a formal and scientific way to test whether a
new treatment was safe, effective and superior to existing
treatments. The physicians and hospitals in Alaska supported
clinical trials and there were currently at least 50 of them
open in the state for cancer patients however, only a small
number of their patients, about 40 patients per year, enrolled.
The reasons included lack of knowledge or interest on the part
of either the patient or the physician; lack of availability of
an appropriate trial for the patient; and lack of insurance
coverage, or fear by the patients that they would lose coverage
if they did enroll. Passage of this bill would clearly remove
that one important barrier to access to clinical trials for
their patients. She believed it would result in improved care
for patients, reducing the burden of cancer in the population,
and facilitating patients to stay in Alaska for state-of-the-art
care.
SENATOR COWDERY asked Mr. Obermeyer why the fraternal benefit
societies were excluded on page 2, line 5, Section C.
CHAIR DAVIS said that they would discuss the bill after taking
public testimony and asked Senator Cowdery to hold his question.
1:52:28 PM
DR. ALAN LICHTER, CEO, American Society of Clinical Oncology
(ASCO) said the Society had close to 26,000 members in 112
countries around the world. He reiterated that a clinical trial
was a research study to find out if a new treatment was safe or
effective, if treatment A was better than treatment B; it was
governed by a rigorous review and oversight process; and it was
the critical step in achieving progress in cancer treatment. In
fact, the pace of progress against cancer was largely determined
by the pace at which they could complete clinical studies. While
they were making progress in clinical studies, the pace was not
fast enough to satisfy them; less than 5 percent of adults went
on to a cancer clinical trial. There were many reasons for that
but, as stated, one of them was the uncertainty of whether their
insurance would cover their routine clinical care costs if they
were treated as part of a trial, or the certainty that it would
not. He found it ironic when he realized that insurers
increasingly asked physicians to practice evidence-based
medicine, then turned around and told patients that if they
participated in a clinical trial to gather such evidence, their
care costs would be denied. For 15 years ASCO had fought to
ensure coverage for those routine clinical costs and were
successful in convincing Medicare to change their policy about
10 years ago. About 20 states had already passed legislation
such as this and, when they asked their members in those states,
over 2/3 said the passage of that law had been helpful in
facilitating the entry of patients into clinical studies.
Insurance companies were concerned over costs; and at least 4
major studies had been done that showed the routine care costs
of treating a patient in a clinical trial were no greater than
the costs an insurance company would pay anyway. He said he was
extremely encouraged that Alaska was considering passage of this
bill; these bills were critical if they were to continue the
pace of discovery in cancer.
1:56:47 PM
DR. STEPHEN COMPTON, Clinical Cardiologist, Alaska Heart
Institute (AHI), said he specialized in clinical cardiac
electrophysiology, the care of heart rhythm problems. He was one
of about 23 cardiologists in the state, and they wanted to
second the testimony of Dr. Lichter and others. Cardiologists
faced the same problems; they clearly had not solved the problem
of heart disease in the world and there were many unanswered
clinical questions that needed to be addressed. In Alaska, they
had had 2,000 patients involved in various clinical studies and
trials during the previous 8 years. He thought it was naïve of
insurance companies to think that medicine was a static issue;
his own job didn't exist 20 years ago because it had been only
in the past 20 years that they had learned enough about heart
rhythm problems to routinely cure disabling or life-threatening
arrhythmias. Treatments for these conditions were developed
through progress in research based on clinical trials. He cited
the development of implantable devices for heart failure
monitoring and treatment as another example of devices that
clearly improved quality of life, heart function and survival;
the only way to learn about these strategies was through
clinical trials.
In closing, Dr. Compton said the need for clinical trials
applied to every area of medicine and he fully supported this
bill.
2:00:36 PM
MR. OBERMEYER advised Chair Davis that Dennis Bailey with
legislative legal would be available for only a short time to
address Senator Cowdery's question about the inapplicability of
fraternal benefit societies that now appeared on page 2, line 20
of Version \C. He restated the question for Mr. Bailey.
DENNIS BAILEY, Legislative Legal and Research Services Division,
Legislative Affairs Agency, Juneau, explained that a fraternal
benefit society was an organization similar to the Elks or Moose
Lodge, that provided specific benefits for their members. It was
a category that was not exactly insurance and that was exempted
from almost all mandatory insurance coverages already in the
statutes.
CHAIR DAVIS asked if such organizations could voluntarily be a
part of this despite the exclusion.
MR. BAILEY replied that, if a fraternal benefit society wished
to include coverage or provide a benefit for clinical trials,
they could do so.
2:03:07 PM
DEBORAH APPERSON, representing herself, was a 3 time cancer
patient. She said she would like to participate in a clinical
trial but could not do so unless insurance would pay for the
routine care. The treatments she had undergone were available
due to the participation of others in clinical trials, and she
wanted to "pay it forward" for those patients to come. With this
bill, she could do so.
2:04:32 PM
KRISTA RANGISCH, representing herself, said she was a cancer
research nurse at Providence Alaska Medical Center in Anchorage.
She said that when a clinical trial was recommended to a patient
by his physician as the best treatment option, the patient was
referred to her office. Part of her discussion with the patient
about that study included informing them that insurance might
not cover some or all of the costs associated with the cancer
care while on the study; she strongly encouraged all patients to
find out what their policy said about clinical trial coverage.
It was at this stage that they encountered the majority of
roadblocks. She stressed that patients went through a lot
emotionally and financially when they were diagnosed with cancer
and the last thing they needed to worry about was finding out
whether their insurance would cover a clinical trial that the
physician thought was in their best interest. One of the biggest
reasons that patients did not go on in clinical trials was lack
of, or fear of lack of, insurance coverage. In addition, there
were many instances in which, due to the severity of the cancer,
it was necessary to start treatment right away and there was not
sufficient time to investigate coverage or to wait for the
insurance company to determine coverage. In closing, she said
that if insurance companies were mandated to cover clinical
trial costs, she was confident many more people would be able to
participate in clinical trials, which in turn would increase the
likelihood of improved cancer care and someday finding a cure.
2:06:48 PM
DR MARY STEWART, Oncologist, Anchorage, had been treating
patients for over 20 years. During that time she had treated
hundreds of patients with cancer; some went on to cure, but
others traveled the path of a terminal disease, seeking more
time to be with friends and loved ones. Every day radiation and
medical oncologists struggled with difficult and life-altering
questions. She related the cases of three patients whose lives
were cut short by diagnoses of cancer and said she wanted to
know how to do a better job for them.
DR. STEWART said that the oncologists' collegial group in
Alaska, the Denali Oncology Group (DOG), had a loose
affiliation, putting together yearly conferences on the latest
in cancer treatment for the past 24 years. Last year they became
an official affiliate of The American Society of Clinical
Oncology (ASCO). When they met in Homer in September, they asked
what they should do to make their first priority to improve the
treatment of all Alaskans. They wanted to enhance enrollment of
patients on clinical trials, for that was where they learned
what worked and what didn't. SB 280 would reduce barriers to
patient enrollment. She pointed out that the costs of patient
care changed very little and those patients would still need
blood tests, X-rays, CT scans and MRIs no matter what. The
physicians did not gain financially from this, but hoped to gain
better clinical insight and treatment for the patients in their
care. She urged the committee to move SB 280 forward.
2:09:42 PM
EMILY NENON, Alaska Government Relations Director, American
Cancer Society, Anchorage, emphasized that clinical trials were
a critically important part of the fight against cancer. She
also confirmed what Dennis Bailey had said, that the fraternal
benefit society exclusion was common to all of this type of
legislation but did not preclude participation.
2:11:20 PM
CLAIRE WADDOUP, representing herself, Anchorage, said she was in
a clinical trial that involved treatment to improve her chances
of not having a recurrence of cancer. Ultimately, this treatment
would save the insurance company money if she stayed clear. She
wished Deb Apperson the very best and thanked the committee for
hearing her testimony.
2:12:39 PM
LINDA HALL, Director, Division of Insurance, Department of
Commerce, Community & Economic Development, wanted first to
comment on mandates in general. The division was concerned that
mandates in Title 21 tended to apply only to approximately 40
percent of Alaskans because the other 60 percent were covered by
some type of self-insurance plan that would not be subject to
the mandate. That meant the mandate applied only to individual
and small group policies; none of the self-insured large
employer plans would be subject to it. She felt there was a
misunderstanding that when they did a state mandated health
benefit, it applied to everyone who had coverage and that was
not accurate.
MS. HALL said the division had reviewed other states that had
coverage for clinical trials and felt that this bill was written
with a fairly broad scope. She mentioned the medical
oncologists' reference to coverage of "routine medical costs,"
and noted that 17 out of 20 states, according to their research,
had language that only required coverage of routine medical
costs. She said she would like to work with Senator Davis and
her staff on the ability to have deductibles or co-pays more in
line with other mandates in Title 21, and to make sure it did
not expand into areas that were traditionally covered by the
sponsors of the clinical trials.
2:17:08 PM
DR. LARRY WICKERHAM, Associate Chairman, National Surgical
Adjuvant Breast and Bowel Project (NSABP), one of the National
Cancer Institute's cooperative trials groups, said the NSABP
conducted large studies that compared standard treatments with
newer, innovative therapies in patients with early stage breast
and bowel cancers. The group's mission was to improve survival
and quality of life for these patients. Over the years, they had
entered over 130,000 individuals into their various trials; they
had 200 centers and 300 satellite centers located through the
US, Canada, Puerto Rico and Ireland, and had several centers
participating in trials in Alaska. The results of their previous
trials had a major impact on the care of both breast and bowel
cancers; the results of their breast cancer trials were
invaluable in eliminating radical mastectomies, demonstrating a
lumpectomy was an effective alternative and that adjuvant
therapy in addition to surgery, (chemo-therapy, hormonal therapy
and the newer targeted agents) could improve survival. Figures
from the American Cancer Society demonstrated that the mortality
rates from breast cancer in the US had declined for over a
decade. These improvements were thought to be the result of
screening mammograms and improvements in treatment. These
improvements in care came primarily from clinical trials like
those conducted by the NSABP. The more patients who entered
these trials, the more quickly they got the results and the
faster they could improve care. Unfortunately, for a variety of
reasons as Dr. Lichter mentioned, less than 5 percent of adult
cancer patients actually entered clinical trials. Cost was
indeed a major barrier to their participation. Requiring health
care insurers to cover the standard-of-care costs for
individuals participating in cancer clinical trials would
substantially remove one of the significant barriers to
increasing participation. Any research trial included 2 general
categories: research costs, expenses the patient would not
routinely incur if he/she were not part of that trial; and
routine standard-of-care costs, expenses that would occur
whether or not that patient entered a clinical study. NSABP
studies routinely identified the non standard-of-care
components; they provided the drug or drugs being studied free
of charge and typically provided additional non-federal funding
to help defray the costs of clinical trial participation,
including the cost of non standard-of-care items. The goal was
to minimize any additional cost to the patient, improve trial
participation and improve cancer care in general. He urged them
to enact this bill so that patients in Alaska would have access
to state-of-the-art studies like those already available to
patients in other states.
2:20:22 PM
BEVERLY K. WOOLEY, Director, Alaska Division of Public Health,
speaking for herself as a cancer survivor, said few things in
life could rock you to the core like hearing that you have
cancer. She had to go through that with her diagnosis in 2004;
despite her family history of extensive cancer, her diligent and
aggressive check-ups, it did hit her and she was not ready for
the emotional turmoil. She admitted that her whole focus was on
survival at that point; and it was soon after her diagnosis that
she was told she was eligible for a clinical trial. She spent
days researching it and came to the decision that it was the
best news for her, not only because it gave her the best chance
for survival, but because her young daughter, because of her
diagnosis, was at a higher risk. "At a time when I didn't have
much hope," she said, "thinking that, regardless of what
happened to me, I could take part in something that might make
her future and that of other young women better, gave me a
silver lining. My enthusiasm was short lived however, when I
found out my insurance might not pay." She started on an
emotional roller-coaster, due in part to the fact that she had
lost her father to cancer at 17 after a 3 year fight that took
all of their family's savings and nearly cost them their home.
Her 80 year old mother was still paying for the loss of those
savings that could have made her life better, and Ms. Wooley
feared that it was going to happen to her. It took time, but
fortunately they worked with her and eventually her insurance
did come through so she was able to go forward with the trials.
She got the best care possible and was able to give hope to
future generations through the research that was done at that
time.
MS. WOOLEY closed by saying that she did not know what would
have happened if she had not been able to take advantage of that
trial. To have the hope of the best possible care held out to
you and to be afraid you could not take advantage of it was
absolutely devastating. She pressed that they had the power to
make a statement against cancer by moving this bill forward, and
asked them to please move the bill out and get clinical trials
for as many people in Alaska as possible.
2:23:54 PM
CHAIR DAVIS announced she would hold SB 280 in order to complete
some work on it with the division of insurance, and would bring
it back in a short time.
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