Legislature(2009 - 2010)CAPITOL 106
04/12/2010 08:30 AM House HEALTH & SOCIAL SERVICES
| Audio | Topic |
|---|---|
| Start | |
| SB10 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 10 | TELECONFERENCED | |
| + | 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
cancer;..."
... 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
costs.
Studies have shown that only 2% to 3% of adult cancer
patients and less than 0.5% Medicare patients enroll
in clinical trials of the approximately 20% who are
eligible -largely due to fear of denial of insurance.
A recent study found only slight increase in
treatment costs for adult clinical trial patients
compared to nonparticipants, $35,418 versus $33,248 or
about 6.5% increase in costs for clinical trial
participants compared to nonparticipants. Even if
enrollment was increased to the full 20%, it is
unlikely that these numbers will significantly impact
overall costs to health plans. See National
Conference of State Legislatures, "Clinical Trials:
What are States Doing? February, 2009 Update,"
www.ncsl.org/programs/health/clinicaltrials.htm.
Twenty-three or more states have passed legislation or
instituted special agreements requiring health plans
to pay the cost of routine medical care patients
receive while participating in clinical trials.
Passage of CSSB 10 will result in more successful
outcomes in cancer treatments in Alaska, increase
retention of patients in Alaska for their cancer care,
and also, after full implementation, result in cost
savings in the short and long term.
A description of "The Access to Cancer Clinical Trials
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
thought.
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
trial.
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
claims.
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
trial.
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
database.
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
pass.
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
regulate.
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
law.
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
trial.
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
populations.
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
1.
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
hearing.
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.
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