Legislature(2009 - 2010)BUTROVICH 205
02/18/2009 01:30 PM Senate 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
CHAIR DAVIS announced consideration of SB 10.
1:36:44 PM
SENATOR PASKVAN moved to adopt the proposed committee substitute
to SB 10, labeled 26-LS0073\E, as the working document. There
being no objection, version E was before the committee.
TOM OBERMEYER, aid to Senator Davis said the committee
substitute provides substantive definitional changes in the body
of the bill to clarify sections of the original bill; so the
title of the bill was changed slightly to read:
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.
1:38:41 PM
He mentioned that Dennis Bailey, the drafter, should be online
to answer any legal questions about the bill and then continued
with the sponsor statement.
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.
CSSB 10 removes important barriers to the participation of
patients in cancer clinical trials in Alaska. It requires
that applicable health care plans, including Medicaid,
cover routine patient care costs for patients enrolled in
all phases of clinical trials, including prevention,
detection, treatment, and palliation (supportive care) of
cancer. Currently Alaska health care 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 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.
MR. OBERMEYER mentioned that the member packets include zero
fiscal notes for both the Division Of Insurance and Medicaid
Services.
Studies have shown that only 2 to 3 percent enroll in
clinical trials with a 6.5 percent increase in costs for
clinical trial participants compared to non-participants.
He said the sponsor statement in the member packets was just
updated with new National Conference Of State Legislatures
Information on 2009, which also indicates that a growing number
of states have instituted special agreements requiring health
plans to pay the cost of routine medical care a patient
receives. [See National Conference of State Legislatures,
"Clinical Trials: What are States Doing? February, 2009 Update."
Of the approximately 20 percent of cancer patients who are
eligible to participate in clinical trials only 3 percent
participate and less than 0.5 percent are Medicare
patients; so even if the enrollment increased considerably,
it is unlikely that the numbers will significantly impact
overall costs to health plans. 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. Dr, Anderson noted last year that in the 1970s
only 50 percent of cancer patients lived five years after
diagnosis. That figure is now over 2/3 in 2008.
1:42:10 PM
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 long run.
MR. OBERMEYER noted that there are a number of attachments that
might be of help to members if they have questions, including
documentation from the American Society of Clinical Oncology. A
letter from Dr. Mary Stewart of the Denali Oncology Group in
Anchorage indicates that for many people with cancer,
participation in a clinical trial is their best treatment
option, yet many third-party payers take the position that
routine patient care costs should be denied to anyone who
enrolls in such trials. The sponsors believe such a policy
deprives beneficiaries of the value of their health insurance,
wrongly restricts their treatment options and inhibits medical
progress against serious and life-threatening diseases.
CHAIR DAVIS said that Jonathan Sherwood with the Department of
Health and Social Services (DHSS) is online to answer any
questions that may come up. She then opened the meeting for
public testimony.
1:44:20 PM
SENATOR ELLIS joined the meeting.
MARIE DARLIN, AARP Capital City Task Force, Juneau, AK, said
AARP is very much in favor of this bill. Most of the significant
advances in cancer treatment that have become standard
procedures began as clinical trials; so it would seem that if
persons covered by insurance, even Medicaid, have the
opportunity to participate in clinical trials, they should not
be denied the opportunity.
SENATOR ELLIS mentioned that when his dad was battling lung
cancer, he learned about clinical trials through the AARP
newsletter; even though he was not a good candidate at that
time, he appreciated AARP for providing the information.
1:46:23 PM
DR. MARY STEWART, Medical Oncologist, President, Denali Oncology
Group, Anchorage, AK, has been practicing in Alaska since 1985
and has seen a lot of improvement in cancer care as the result
of dedicated laboratory researchers and patients, who are very
motivated to help them find better treatments. One way to do
that is enrolling in a clinical trial to test one strategy of
care against another. It is important, she said, to recognize
that these are real individuals whose lives have been touched by
cancer. A nurse educator she saw last week has had her treatment
altered because of an Austrian clinical trial that found a way
to reduce the risk of breast cancer recurrence; a local baseball
coach has just come back from Seattle after his second stem cell
transplant for myeloma; a young man she met today who was newly
diagnosed with a curable cancer has benefited from all the
people who enrolled in trials over the last 25 years.
DR. STEWART stressed that each trial asks a specific question;
the study tests the new treatment to find out if it is better
than the standard treatment, as well as whether it is safe and
effective. Research and animal models can never duplicate what
happens in the complex human body. When insurance rules prevent
individuals from enrolling in these trials, it means it will
take longer to find the answers the medical community needs
today. She said she is quite sure that everyone in this room has
been touched by cancer in some way and knows what the urgency
is. She asked the committee to please pass SB 10 today.
1:48:57 PM
SENATOR DYSON said he has an acquaintance who is indigent and
who felt coerced to participate, believing that participation in
one of these experimental regimens was the only way he could get
care. He asked if she could comment on that.
DR. STEWART said it is possible to get medicines for free if the
medicines are being tested before being FDA approved; so one
could get free care, depending on the situation. But for
individuals who are medically indigent in general, the medical
community always finds a way to provide treatment for their
cancers.
SENATOR PASKVAN said he understands that the medical drug costs
are paid for by the pharmaceutical company; he asked for
examples of the routine patient care costs that are being denied
to patients who participate in a clinical program.
DR. STEWART answered that patients with cancer have routine
blood tests to check liver and kidney functions to ascertain
whether they have become anemic. In order to monitor the state
of the cancer and whether it is responding to treatment,
physicians routinely do x-rays, CT scans, bone scans and other
things. This is normal care; these are things that have to be
done whether or not patients are enrolled in a clinical trial.
1:51:38 PM
SHEILA TALLMAN, Premera Blue Cross/Blue Shield of Alaska,
Anchorage, AK, said they do not oppose the bill but would like
to work with the committee on some amendments. Premera
recognizes the importance of cancer clinical trials in
identifying effective and safe treatments that are based on
evidence and research and does currently cover routine medical
care for members who are participating in phase 2 and 3 cancer
clinical trials. There are concerns however, about expanding
coverage to phase 1 and 4 trials because of patient safety and
treatment effectiveness issues. For example, in a phase 1 trial,
the drug or treatment is still being evaluated and there is no
reasonable expectation of a theraputive or curative benefit to
the member at that time. The basic dose mechanisms, drug
toxicities and safety aspects have not yet been validated; so
including phase 1 trials may raise significant patient safety
concerns if Premera is required to cover them in an insurance
plan. In a phase 4 clinical trial, the treatment will be covered
if it is medically necessary; but there may be other known, more
effective medical treatments available and Premera would like
the flexibility to look at and pay for those other types of
medical treatments, which may be more beneficial to their
members.
In conclusion, Ms. Tallman said, they believe clinical trial
participation is important in identifying and testing evidence-
based care and they encourage this participation while at the
same time balancing safety, treatment-effectiveness and the
rising cost of health insurance. Premera will be able to support
this bill if their amendments are included.
1:53:35 PM
CHAIR DAVIS asked Dr. Stewart to speak to Ms. Tallman's concerns
about phase 1 and phase 4 clinical trials.
DR. STEWART suggested that Dr. Anderson may be better able to
speak to this.
DR. JEANNE ANDERSON, representing herself, Katmai Oncology
Group, Anchorage, AK, explained that phase 4 clinical trials are
generally conducted to get more experience with a drug, to learn
about very rare side effects that can only be picked up after
many thousands of patients have been treated. Cancer physicians
would only recommend that a patient enroll in a phase 4 study if
it is a drug that has been SEA approved, if they believe it is
the most effective treatment and if it is in the best interests
of the patient. She disagreed with Premera's position that the
insurer should have the ability to choose which drug is the most
effective; the oncologist is the person most informed and the
one who should make that decision. She stressed that if a
patient goes into a phase 4 study, there is no increased cost
[to the patient or the insurance company]; additional tracking
and monitoring costs are born by the pharmaceutical company.
DR. ANDERSON admitted that phase 1 studies are somewhat
contentious. Medicare, which has provided coverage since 2000
for all Medicare beneficiaries who are on qualified clinical
trials, requires that studies have "therapeutic intent" and
there are differences of opinion across the country regarding
whether or not phase 1 studies have therapeutic intent. Phase 1
studies are testing what is the best dose to give to a patient
who has cancer, but they are using background information that
was obtained from pre-clinical data, studies done in animals
and/or laboratory testing; these may be drugs that were used on
patients with other types of cancers. A phase 1 study is only
conducted if there is an expectation that the drugs will have
some therapeutic benefit. Doctors do not want to give a drug in
phase 1 that they believe has no potential to help the patient.
She agreed that a critical part of phase 1 trials is looking at
safety, but physicians only recommend these trials if they have
a plausible reason to believe there will be a therapeutic
benefit to the patient. Patients are monitored very closely and
safety is always of the utmost concern; so she does not think
the insurance companies need to worry about patients' safety.
1:57:00 PM
DR. ANDERSON thanked the committee for hearing this bill. She
said that approximately 2600 Alaskans were diagnosed with cancer
last year. Decades ago only about 50 percent of patients lived
five years from diagnosis, but as of last year, 2/3 of patients
were predicted to survive five years. She hopes that continuing
to advance physicians' knowledge in cancer care through clinical
trials will increase that 66 percent to even higher cure rates.
Even so, she knows that many Alaskans die every day from cancer
and that there need to be improvements. Physicians in Alaska are
committed to providing the best care possible for their patients
to relieve suffering and reduce death from cancer. In caring for
their patients, they often turn to a clinical trial as, in their
opinion, providing the best treatment for an individual patient.
Dr. Anderson stressed that clinical trials are a formal and
scientific way to test whether a new treatment is safe and
effective and better than existing treatments.
DR. ANDERSON said the physicians and hospitals in Alaska do
support clinical trials; they have over 50 trials open in the
state for patients but, as has been mentioned, only about 40
patients per year enroll. There are many reasons why enrollment
is low; some include lack of knowledge or interest on the part
of either the patient or the physician, or lack of availability
of an appropriate trial for the patient. However, a critical
barrier also is lack of insurance coverage or fear by patients
that they will lose coverage if they enroll in a study. Passage
of this bill will clearly remove an important barrier to access
to clinical trials; it will result in physicians providing
improved care to their patients, reduce the burden of cancer in
the population and help patients to stay in Alaska for state-of-
the-art care.
She referred members to a position paper published by the Denali
Oncology Group for additional information.
1:59:25 PM
KRISTA RANGITSCH, representing herself, is a cancer research
nurse at Providence Alaska Medical Center, Anchorage, AK, and
supports SB 10. Patients are referred to her office when a
clinical trial is recommended by a physician as the best
treatment option; part of her discussion with the patient about
the study includes informing them that their insurance company
may not cover some or all of the routine costs associated with
treating their cancer while on the study. Her office strongly
encourages all patients to find out what their [insurance]
policy says about clinical trial coverage, but this is the stage
at which she finds they encounter the majority of barriers to
enrollment. She added that people go through a lot emotionally
and financially when they are diagnosed with cancer; the last
thing they should have to worry about is whether their insurance
will cover a clinical trial that the physician feels is in their
best interests. One of the ever-increasing reasons that patients
are not enrolling in clinical trials is the lack of coverage or
the fear that they will not be covered. In many instances, due
to the severity of the cancer and the need to begin treatment
immediately, there just isn't enough time to investigate whether
an insurance company will cover the costs or to get through the
carrier's determination process.
In closing, she said, if insurance companies were mandated to
cover routine care costs associated with a clinical trial, she
is pretty confident that many more people would be able to
participate in the clinical trials, which would increase the
likelihood of improved cancer treatments, maybe someday leading
to a cure.
2:01:45 PM
DOUGLAS BLAYNEY, Medical Oncologist, President Elect, American
Society of Clinical Oncology (ASCO), Professor of Medicine,
University of Michigan, Ann Arbor, MI, thanked the committee for
allowing him to testify. He said he knows both Dr. Stewart and
Dr. Anderson and believes Alaska is fortunate to have such
articulate and caring physicians. He wanted to address two
questions that came up today, the first by Senator Dyson about
denied routine care costs. At ASCO they see a variety of
questions that come in from members throughout the states.
Sometimes when a patient is known to be on a clinical trial, the
insurance company or third-party carrier will deny coverage for
things such as pain medicines, radiation therapy, which might be
used to reduce pain or fluid collection that may be necessary
for lung cancer patients. These routine things physicians do for
cancer patients whether they are involved in a clinical trial or
not, are sometimes denied. He thinks it is important to include
the provision in the bill that requires carriers to continue to
pay for the routine patient care costs for patients on clinical
trials.
He also mentioned that phase 4 clinical studies are often used
for drugs that are approved and widely used like Tamoxifen,
which has been approved for use in breast cancer for over 20
years. ASCO was recently involved in a clinical study that found
certain antidepressants negate the effects of Tamoxifen.
Tamoxifen needs to be converted in the body to an active
substance and some antidepressants, but not others, prohibit or
impede this conversion, which renders Tamoxifen ineffective.
Without the use of a phase 4 study, they would not have
discovered that; so he strongly encouraged the committee to
consider coverage of phase 4 studies.
Finally, regarding phase 1 clinical trials, he reminded the
members that they are talking about patients with cancer; phase
1 drugs being tested in cancer patients are, almost by
definition, being given with therapeutic intent. He encouraged
them to retain the provision for coverage of phase 1 trials in
SB 10.
2:06:02 PM
HANNAH BRYCE SMITH, a Cancer Research Nurse working at Fairbanks
Memorial Hospital, Fairbanks, AK, was authorized to speak on
behalf of one of her patients about a situation they bumped into
with her insurance company. The patient was diagnosed with and
treated for breast cancer and was looking for alternatives to
prevent the recurrence of her breast cancer. Researching online,
she found quite a few clinical trials that were open; she spoke
with her physician about it and her physician recommended that
she enroll for one in particular. The physician's office called
her insurance company and was told that any tests and any care
given to her while on the clinical trial would not be covered.
The physician's office sent the insurance company the protocol
and called again to explain that they were not asking the
insurer to pay for any drugs or anything experimental, but were
again told that her insurance would not pay for anything if she
elected to participate in a clinical trial. After a third
unsuccessful attempt, the physician called Ms. Smith's office
and told her that the patient would not be able to participate
because she needed her insurance coverage to pay for the routine
tests.
When Ms. Smith called and tried to explain the situation more
thoroughly, they refused yet again, saying that their policies
do not pay for any experimental procedures. She repeated that
they were not being asked to pay for anything experimental, that
this was a phase 3 trial testing the efficacy of three different
types of drugs; she was referred to their case management
service, which also refused to authorize payment. At that point,
she asked the company to submit that denial to her in a written
statement that she could use as part of the evidence she was
putting together for the legislature about barriers to patients'
participation in clinical trials. Two days later they contacted
her to ask for more information about the clinical trial and
then came back with an authorization to pay for all of the
patient's routine standard-of-care tests. The patient then
enrolled in the clinical trial and moved forward; but when she
considers the amount of time that went into getting approval for
her to do this, it is clear that insurance issues present a huge
barrier.
MS. SMITH said she was born in Fairbanks and is trying to
convince patients that they can stay in Fairbanks and still get
state-of-the-art cancer care, but lack of access to clinical
trials is a huge barrier to keeping people in the interior.
2:10:17 PM
PAULA CALL, representing herself, is a breast cancer patient
involved in a phase 3 trial. Her insurance company has covered
most of her routine treatment; she could not have considered
participating without their agreement to do so. She is comforted
to know she has been receiving the best drug treatment possible
to prevent a recurrence of her cancer and feels strongly that
this bill must be passed. Her situation would have taken a
different course if her insurance company had not agreed to
cover this.
ANGELA VER PLOEG, representing herself, is a cancer patient
involved in a clinical trial. She was first diagnosed with
breast cancer 25 yrs ago; since that time, her brothers'
daughters have had breast cancer. Ms. Ver Ploeg's cancer has
returned and she is afraid that her nieces will have to go
through it too, that their cancers will return. She hopes that
by that time, through clinical trials and research, medicine
will have better answers for them than it has for her. She very
much wants to encourage the continuation of clinical trials to
promote research so they can find a cure for cancer.
2:14:39 PM
DR. MICHAEL J. O'CONNELL, Associate Chairman, National Surgical
Adjuvant Breast and Bowel Project, Pittsburg, PA, Professor of
Oncology Emeritus at the Mayo Clinic College of Medicine,
Rochester, MN , has practiced medical oncology for 33 years. He
said the previous testimony by all of the medical personnel was
extremely articulate and very accurate and he agreed with all of
the points that had been made; he wanted to briefly expand on
three of those points for the committee's consideration.
First, a statement was made that clinical trials provide the
best treatment for cancer patients and that is something he
definitely believes. The clinical trials involve a protocol that
outlines the specific eligibility criteria, in other words, what
types of patients would be best suited for treatment with that
particular regimen; in addition, they outline the dosing of
chemo-therapy or radiation therapy and dose modifications based
upon the side-effects that might occur. So it is not a single
physician who is making these judgments; because of the peer
review process that goes on in the development of clinical
trials, there is actually an improvement in the selection of
patients, the methods of treatment and the evaluation of the
outcomes. Scientific peer review is an important component of
why clinical trials do provide the best treatment. In addition,
patient safety is paramount and is also subjected to review by
institutional review boards consisting not only of physicians,
but of lay personnel and others to ensure that the risk/benefit
ratio of any particular clinical trial is in the patients'
favor. As has been commented previously, clinical trials may
represent the only treatment option available once standard
therapy has failed to be effective for a given patient with
cancer.
DR. O'CONNELL continued; the second point regards the statement
that the standard care for most cancers has actually been
established by the results of clinical trials and this is
definitely true. They provide scientific evidence with regard to
the side-effects associated with those treatments. Another
important point is that clinical trials have indicated that some
treatments are very toxic or ineffective and some of these
treatments are very expensive and have contributed to the rise
in health care costs. He said one example he would point to is
the use of high-dose chemo-therapy and bone marrow transplant in
the treatment of patients with metastatic breast cancer, which
was practiced in the United States for a number of years.
Through randomized clinical trials comparing this toxic and
expensive treatment to more standard therapies, it was clearly
shown that there was no benefit with the bone marrow transplant
and high-dose chemo-therapy; as a result the treatment is no
longer used, thus saving patients the toxicity and expense.
Finally, he believes that from the insurance companies'
standpoint, it is very important that they only be required to
pay expenses that would normally be incurred in routine clinical
practice. Tests and procedures that are considered experimental
and non standard-of-care must be funded by research dollars and
the studies' sponsors and not passed along to the insurance
companies. This is accomplished by incorporating designation of
any experimental aspects of the protocol in the peer review
process and he fully supports not passing along research
expenses to the insurance industry.
In conclusion, he said, he also agrees that lack of insurance
coverage for routine costs of cancer clinical trials is a major
barrier that prevents patients from receiving the best care and
contributing to knowledge that will improve future outcomes and
he strongly supports the legislation before the committee to
require insurance coverage under the conditions he has just
discussed.
2:20:15 PM
EMILY NENON, Alaska Government Relations Director, American
Cancer Society, Cancer Action Network, Anchorage, AK, spoke in
support of SB 10. As an organization, their mission is to
eliminate cancer as a major health problem and clinical trials
are a key part of realizing that mission. She thanked the
committee for taking the time to get so much information about
this issue on the public record; the bill that is before them is
a comprehensive education effort to increase participation in
clinical trials in Alaska and removing this one barrier is an
important step. This bill will apply to a significant percentage
of the insured population in the state; Medicare and some self-
insured plans already provide this coverage. In closing, she
mentioned that the cost of routine care provided in clinical
trials is comparable to the cost in traditional therapy and said
she would be happy to share a fact sheet put together by the
American Cancer Society, which looks at a number of cross-
studies that have been done on this issue.
2:22:54 PM
CLAIRE WADDOUP, representing herself, is a cancer patient in the
care of Dr. Jeanne Anderson. She feels that she has benefited
from the results of previous clinical trials and wants to pay it
back by participating in clinical trials. She strongly
encouraged the legislature to pass SB 10 including coverage for
all phases of clinical trials.
2:24:03 PM
CHAIR DAVIS closed public testimony. She said she does not
intend to pass the bill out at this time but is ready to
entertain discussion.
CHAIR DAVIS thanked all of the people who testified on the bill
and expressed her hope that the legislature will be successful
in passing it this year.
2:25:05 PM
SENATOR DYSON said this issue seems like a "no brainer" and
wants to understand why the insurance companies have taken the
position that they seem to have taken. He said he is glad to
support this bill, but feels as if he is missing something and
would like to hear from representatives of the insurance
industry.
CHAIR DAVIS said the bill has referrals to the Labor and
Commerce and the Finance committees; so maybe the insurance
industry will choose to testify for one of those committees. She
noted that there is no fiscal note with the bill.
SENATOR THOMAS responded to Senator Dyson's query about the
insurance companies. He said when he was sitting as a trustee on
the board of a health plan, the only reason he ever heard for
the insurance industry's reluctance to pay for this type of
thing was their belief that the medical community wanted as much
covered by insurance as possible because insurance pays more,
which brings in money to build more hospitals and centers.
2:27:49 PM
SENATOR DYSON suspects there are a lot of financial incentives
for things; but he is interested that the insurance companies
would deny payment for routine things they have to pay for even
if a person is not on a clinical trial. He suspects that they
don't want to take fiscal responsibility for any potential
adverse effects; which would indicate that the industry must
think there is a record of people participating in clinical
trials who have had some bad results that had a negative
financial impact on the carrier. He said he would like to know
if there is some track record.
2:29:32 PM
CHAIR DAVIS closed testimony on the bill and said she will bring
SB 10 back on Friday with bills previously heard.
| Document Name | Date/Time | Subjects |
|---|---|---|
| Letters for or against.PDF |
SHSS 2/18/2009 1:30:00 PM |
SB 10 |
| Backup doc for sb 10.PDF |
SHSS 2/18/2009 1:30:00 PM |
SB 10 |