Legislature(2009 - 2010)BELTZ 211
03/12/2009 01:30 PM Senate LABOR & COMMERCE
| Audio | Topic |
|---|---|
| Start | |
| SB39 | |
| SB125 | |
| SB114 | |
| SB10 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 10 | TELECONFERENCED | |
| *+ | SB 114 | TELECONFERENCED | |
| *+ | SB 125 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| = | SB 39 | ||
SB 10-MEDICAID/INS FOR CANCER CLINICAL TRIALS
1:59:42 PM
CHAIR PASKVAN announced SB 10 to be up for consideration; CSSB
10(HSS), labeled 26-LS0073\S, was before the committee.
2:00:10 PM
TOM OBERMEYER, staff to Senator Davis, sponsor of SB 10,
explained the CS for SB 10. He said the CS regards cancer
clinical trials and requires health care insurers to provide
insurance for medical care received by a patient during certain
approved clinical trials designed to test and improve
prevention, diagnosis, treatment or palliation of cancer. It
directs the Department of Health and Social Services (DHSS) to
provide Medicaid services to persons who participate in those
clinical trials relating to the experimental procedures under a
state plan offered by a comprehensive health insurance
association and provides for an effective date.
He explained that clinical trials are research studies that test
how well new medical approaches work in patients. Each study
answers specific scientific questions and tries to find better
ways to prevent, screen for, diagnose or treat disease. Patients
who take part in cancer clinical trial 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 is part of the U.S.
National Institutes of Health reports 6,000 cancer trials in the
U.S. at any one time.
MR. OBERMEYER explained that SB 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. Currently, Alaska health plans
may exclude coverage for routine patient care costs while a
patient with cancer is enrolled in a clinical trial thinking it
saves them money. However, these patients who have not enrolled
in clinical trials, continue to receive conventional therapy at
roughly the same or slightly increased cost in the short-run.
Over 2,600 Alaskans are diagnosed with cancer each year. In FY
2007, an estimated 4,600 patients received cancer treatments
through Alaska's Medicare program at a cost of $21.5 million.
The average payment for beneficiaries is about $4,675. The
federal government reimburses the state at about 50 percent of
total costs. Without in-state facilities in support of clinical
trials, participants from Alaska must now travel out-of-state
increasing the cost of non-emergency transportation, which is
about 3 percent of total Medicaid costs.
Studies have shown that only about 2-3 percent of adult cancer
patients and less than 0.5 percent Medicare patients enroll in
clinical trials of the approximately 20 percent who are eligible
- largely due to fear of denial of insurance. A recent study
found only a slight increase in the costs for adult clinical
trials with patients compared to non-participants - 35,000
versus 33,000 or about a 6-percent increase in costs.
MR. OBERMEYER noted even if enrollment were increased to the
full eligible 20 percent, it is unlikely these numbers would
significantly impact the overall cost of health plans per the
National Conference of State Legislatures, "Clinical Trials:
What are the States Doing," February 2009 update.
He said that at least 23 states have passed legislation or
instituted special agreements requiring health care plans to pay
for the cost of routine medical care patients receive while
participating in clinical trials. Passage of SB 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 run.
MR. OBERMEYER said they 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 have experienced toward
finding a cure for cancer would not be possible.
2:06:21 PM
SENATOR BUNDE said anyone with common sense in this arena wants
progress made in the treatment of cancer. He asked if anyone
covered by the Employee Retirement and Income Security Act of
1974 (ERISA) would be covered by this legislation.
MR. OBERMEYER replied that was his understanding.
SENATOR BUNDE asked, in reference to the zero fiscal note. if
there would be an impact on Medicaid.
MR. OBERMEYER responded there was a zero fiscal note, dated
February 4, regarding Medicaid insurance.
2:08:48 PM
JON SHERWOOD, Medicaid Special Projects, Department of Health
and Social Services, said they did submit a zero fiscal note.
They don't cover experimental treatment, but they do cover the
routine costs of care. Making it a statutory requirement would
not impact their budget.
SENATOR BUNDE asked if someone under Medicaid would be impacted
by this legislation.
MR. SHERWOOD responded that this legislation would require them
to pay for what they are already paying for through regulations.
SENATOR THOMAS asked if anyone considered the idea that some
change in a Medicaid cancer patient's situation would cause
someone to say this experimental treatment is causing it and,
therefore, deny payment for it.
2:11:05 PM
MR. SHERWOOD answered they didn't factor that in because they
already pay for ancillary costs, and their program would
continue to operate the way it is today.
2:12:35 PM
SENATOR MEYER asked if SB 10 imposes the same mandate on self
insured groups.
MR. SHERWOOD replied that he understands that ERISA largely
applies to self-insured entities. But he is not an expert on
insurance.
SENATOR MEYER asked how many people this bill would impact.
MR. SHERWOOD didn't have that information.
SENATOR BUNDE said he thought this would affect only people with
private insurance, and most people in Alaska have state
insurance.
SENATOR THOMAS said ERISA plans could be either self funded bid
on by various insurance companies.
2:14:37 PM
JACK MCCRAY, Sr. Vice President, Primera Blue Cross, said they
cover phase 2 and 3 of cancer clinical trials. The main reason
phase 1 clinical trials aren't covered is because those get a
tremendous amount of funding from pharmaceutical companies and
others just because it is so experimental. They don't cover
phase 4 clinical trials, because there may be other treatments
or procedures that are be better for the patient than the
clinical trial. That needs to be evaluated by the doctor at the
time.
He said Premera Blue Cross is not required to cover phase 1 or 4
in Oregon or Washington. Since they don't pay for it in
Washington or Oregon, he doesn't have any idea of how much it
would be. If they start paying for phase 1, there would possibly
be more phase 1 treatments done not using some of the grants and
Institute of Health funding. Their costs would increase,
therefore, in Alaska.
2:17:53 PM
CHAIR PASKVAN asked him to clarify when he uses the term "better
for the patient" with respect to either phase 1 or 2 that he
wasn't offering that as a medical opinion.
MR. MCCRAY answered it is not a medical opinion, but they do
discuss different options with the patient's doctor.
SENATOR BUNDE asked from Blue Cross' point of view would this
bill impact the policies they write for private industry in
Alaska, but not the state policies that they administer.
MR. MCCRAY replied yes; it would not affect any ERISA self-
funded plans, but it would impact the individual market and the
small group marketplace.
SENATOR BUNDE said he thought it was ordinary business practice
to pass increased costs on to the consumer.
MR. MCCRAY answered yes.
2:19:37 PM
KRISTA RAYGITSCH, cancer research nurse, Providence Alaska
Medical Center, said she is testifying on her own behalf. She
supported SB 10 saying everyone should be have the equal
opportunity to participate in a clinical trial if they so
choose.
She explained when a clinical trial is recommended to patients
by their physician as the best treatment option, they are
referred to her office. Part of her discussion with the patient
includes informing them that the insurance company may not cover
some or all of the routines costs associated with treating their
cancer while on the study. This is the stage at which they
encounter the majority of barriers to patient enrollment to
clinical trials. Patients go through a lot emotionally and
financially when being diagnosed with cancer, and the last thing
they should have to worry about is finding out whether their
insurance will cover a clinical trial that their doctor feels is
in their best interest.
MS. RAYGITSCH said she has noticed the ever-increasing reason
for patients not enrolling in clinical trials is because of lack
of or fear of lack of insurance coverage. Sometimes because of
the severity of the cancer and the necessity to start treatment
immediately, there isn't enough time to find out if the
insurance company will cover the clinical trial expenses or the
company takes too long to determine coverage. "If insurance
companies were mandated to cover routine care costs associated
with clinical trials, I'm confident that many more people would
be able to participate in clinical trials which in turn would
hopefully increase the likelihood of improved cancer treatments
and maybe someday lead to a cure."
2:22:00 PM
CHAIR PASKVAN asked if she saw any distinction between phase 1
and phase 4 as compared to phases 2 or 3 for coverage.
MS. RAYGITSCH replied that phase 1 clinical trials are many
times covered by cooperative groups or the pharmaceutical
companies, so she didn't see that there would be any increased
cost. She couldn't speak to phase 4, because she doesn't get
many of those and doesn't have any of those open at the time.
2:23:04 PM
EMILY NENON, Director, Alaska Government Relations, Cancer
Action Network, American Cancer Society (ACS), said this
legislation is a key piece in a much broader effort to remove
barriers and increase participation in clinical trials. The
State and Alaska Native Comprehensive Cancer Control
Partnerships are working together on developing and
disseminating provider and patient education and increasing
understanding of clinical trials. They are also working with
non-state regulated plans and specifically with some of the
larger self insured plans to educate them on providing this
coverage. Providence has just decided to add this coverage for
its employees. It is important to include all the phases of the
trials. She recommended that they look at the collection of ACS
studies that look specifically at the costs.
2:26:05 PM
CLAIRE WADDOUP, representing herself, Anchorage, supported SB
10. She said she has benefited personally from her breast cancer
treatment gained through clinical trials, and she wouldn't be
able to participate in them if financial hardship was added.
DR. LATH SUBRAMANIAN, medical oncologist representing herself,
Anchorage supported SB 10. She said she takes care of cancer
patients and is a strong proponent of clinical trials. The
reason is because she has run into many situations where she
helps patients decide that the best treatment for them is a
clinical trial. She remembered two patients, in particular. One
had esophageal cancer, which is often a death sentence, and he
had the opportunity to receive a new drug, which was only
available for that cancer under a clinical trial. He opted to be
treated under that clinical trial, but he found out that his
insurance wouldn't pay for it. They even appealed it "to the
limit." When he had surgery, his esophageal cancer was found to
be in remission because of it.
She said another patient has sarcoma and couldn't enter the
clinical trials because of lack of insurance. This happens to
real people, and cancer is one of the commonest diseases. She
stated the only way to make advances in cancer treatment is
through clinical trials, and it is one of those diseases that
doesn't have a lot of time or a lot of effective standard
treatments. All the benefits they have seen have come through
patients who have been brave enough to enter clinical trials and
through the insurers who have paid for these patients.
DR. SUBRAMANIAN said they are not talking about covering the
cost of the whole clinical trial, but just one little piece -
the routine patient care costs. There are several other costs,
but a majority of those are borne by the sponsor and the study
groups. The routine care would be covered under insurance anyhow
if the patient was not participating in a clinical trial and not
covering it for clinical studies - "It just doesn't make any
sense."
DR. SUBRAMANIAN said one thing that has not been mentioned is
that phase 1 studies involve a very small number of patients -
sometimes as few as 20 or maybe as many as 80. Phase 2 and 3
trials involve 3-4,000 people; phase 2 trials involve a couple
hundred. The cost of a phase 1 trial for routine patient care
cannot be that enormous, and there is no reason that would drive
up the cost of insurance for everybody. The picture for phase 4
trials, especially for cancer, has changed; there are more new
drugs and more knowledge available. Since companies are "antsy"
to get the new drugs out into the market, they are conducted to
fully study the safety and other possible benefits of the drug.
It may have been approved for a certain condition, but a phase 4
trial could find it works for something else. A good example of
this is Temoxifin, which is an old drug for treating breast
cancer; a phase 4 study was conducted and it was shown to work
for prevention of breast cancer, as well.
2:32:29 PM
She also pointed out that when a patient has a successful
clinical trial, he gets better and saves money by not needing
further expensive treatment. Also, she said, Medicare patients
are covered, so why not cover younger patients, too?
She questioned where the data was that would back up claims that
paying for routine care during clinical trials would drive up
premium costs, because it is already being covered for
traditional treatments.
2:34:57 PM
SENATOR BUNDE said the actual drugs are incredibly expensive,
thousands of dollars per treatment, and asked what she means in
talking about routine care - is it the I.V. that administers the
drug, the infusion room and things like that?
DR. SUBRAMANIAN replied yes.
SENATOR BUNDE asked if someone was in for a cancer fighting
infusion drug that might cost $3-$4,000 per treatment, what the
routine care for that infusion would cost.
DR. SUBRAMANIAN replied the infusion charge is the same no
matter whether it is for a clinical trial drug or not. Clinical
trials collect data, as well, that might benefit future patients
or sometimes a patient gets a drug that might otherwise not be
available commercially to them. If that turns out to be the
better treatment, then those patients have benefited from it.
SENATOR BUNDE asked what routine care costs per visit.
DR. SUBRAMANIAN replied it depends on how long the infusion is.
Some are just 30 minutes; some are three hours. She didn't know
the costs.
2:37:57 PM
DR. JEANNIE ANDERSON, Oncologist, representing herself, aid she
is a member of the Katmai Oncology Group in Anchorage, and she
supported SB 10. From Linda Hall's testimony last year, she
knows that about 40 percent of Alaskans would benefit from this
bill. The other 60 percent are self-insured. The benefits of
participating in clinical trials are clear to patients and
physicians.
She said some health care insurers have refused to cover these
routine care costs because the perception has been that it will
make costs increase. However, one popular study indicated that
including patients on clinical trials would make costs only 6.5
percent higher; and as several people have already testified
(including her Oncology Group) costs may become even lower.
Since the year 2000, Medicare beneficiaries have been allowed to
participate in these trials, and there have been no reports of
increased cost for those patients.
She emphasized that participation in clinical trials can
actually reduce costs. In the 80s and 90s patients with breast
cancers thought they would live longer if they received high-
dose chemotherapy followed by bone marrow transplants, which is
a very costly treatment. Many patients sued their health care
insurers and that resulted in thousands of these procedures
being done outside the guidelines of clinical trials and without
the information that could be obtained from them on safety and
efficacy. Eventually patients did enroll in clinical trials and
this aggressive treatment was compared to standard treatment,
and transplantation was found to be neither effective nor safe
as treatment for breast cancer. In her opinion, if patients and
health care insurers had been more motivated to participate and
more able to participate in these carefully controlled clinical
trials, they would have obtained the results of the study
sooner, thus maximizing their safety and reducing health care
costs.
The second example she mentioned was an on-going national study
at Providence Alaska Medical Center, in which she enrolled four
patients. The study takes a simple blood test to predict whether
or not patients respond to chemotherapy after they have been on
treatment for only three weeks. Typically, a patient not on a
clinical trial like this will get treated for six or eight weeks
before making that prediction. If that prediction can be made in
three weeks, treatments could be stopped earlier reducing the
risks of chemotherapy and preventing additional treatments that
patients may not benefit from in a much sooner fashion.
2:42:01 PM
Finally, on the issue of safety in participating in studies,
multiple layers of safety are built into a clinical trial. She
emphasized that all phases of a trial have sound rationale
behind them. She recommended all phases to be opened to allow
unrestricted consideration of them that would result in positive
outcomes for all cancer patients.
2:43:32 PM
SENATOR BUNDE said he was still trying to understand what
routine costs would be for non-experimental people.
DR. ANDERSON said she didn't know, because she doesn't deal with
the billing. Furthermore, she very intentionally stays out of
that because she wants her decision making to be based on what
is best for the patient, not what the treatment would cost. The
cost of many drugs that are FDA approved and still on patent,
but not generic, are in the order of thousands of dollars, she
explained, but the office visit and infusion is in the order of
hundreds of dollars. She tries to remember what doses of drugs
to give rather than how much it costs.
She explained that for most clinical trials the drug is
supplied, especially when it is relatively new and they are
sorting out the indications. Generic drugs are used in just
comparing one schedule drug against another one, and those are
not extremely expensive or they would be given anyway even if
the patient were not on a clinical trial.
2:46:26 PM
DOUGLAS BLANEY, President-elect, American Society of Clinical
Oncology (ASCO), a 26,000-member professional association, said
ASCO has helped many states' legislatures understand and move
forward with clinical trial legislation such as this.
He wanted to submit three points in regards to previous
testimony. First, the issue of phase 1 clinical trials: new
drugs are given to patients with a known diagnosis of cancer
with the intent of determining the toxicity, the dose and
effectiveness in that type of tumor. Clearly phase 1 drugs in
cancer are different than phase 1 when used in normal
volunteers. Often, high blood pressure medicines, headache
remedies, et cetera will be used in normal volunteers. He
suggested it would be useful for them to distinguish phase 1
drugs for cancer, which are used with some therapeutic intent
and are covered by Medicare.
2:48:21 PM
Second, with regard to phase 4 studies, these are drugs that are
approved for marketing so they are paid for by insurance
companies already or third-party payers. The clinical study is
done to determine side effects and gain larger experience with
these drugs. So, the costs of collecting the data or making the
observations are paid for by the sponsors of the study. But the
drugs are typically given with therapeutic intent as they would
be routinely even if the patient was not participating in a
clinical study. He advocated that all phases be covered.
In response to routine care costs, he said, costs of infusion
are typically about $100/hr. The more important aspect is what
happens if a patient suffers a complication from the therapy.
For instance, people with lung cancer often get plural effusions
or collections of fluid around their lung that has to be drained
so that breathing can be restored and other symptoms of the
cancer can be managed. Often they have seen these routine care
costs denied coverage after a complication occurs, another
discouragement to enrollment.
Finally, he said, allowing your oncologist in Alaska to
participate in clinical trials will keep patients Alaska close
to home, and not have them go to cancer centers outside of
Alaska - and this is better for all concerned.
2:51:48 PM
MARIE DARLIN, AARP Capital City Task Force, supported SB 10.
Most of the significant advances in cancer have come about
because of clinical trials, she added.
2:53:34 PM
MR. OBERMEYER reminded them of the letter in their packets from
the American Association of Cancer Research dated December 1,
2008 indicating the tremendous need for phase 1 trials.
2:55:31 PM
DENNIS BAILEY, Legislative Counsel, Legislative Affairs Agency,
said he was available to answer questions on SB 10.
CHAIR PASKVAN observed there were no questions, and closed
public testimony.
SENATOR DAVIS said this bill had gone through the Health and
Social Services Committee already, and the issue was before them
last year when it passed the Labor and Commerce Committee, but
couldn't get out of the Finance Committee. Many people who have
gone through clinical trials have said their expensive drugs
were paid for through grants or pharmaceutical companies because
it was their product; it did not leave that much for the private
insurers to pay. Helping 40 percent of the people is better than
not helping any.
2:58:18 PM
SENATOR MEYER asked her why SB 10 has to go to Finance if it has
a zero fiscal note.
SENATOR DAVIS replied that she was going to ask to have the
Finance referral waived.
SENATOR BUNDE commented that it's important to note that the
major expense for cancer treatment is the drugs; routine costs
are a lot smaller. The state would follow for the other 60
percent if this passed. His concern is for the people this
affects.
3:00:36 PM
SENATOR BUNDE moved to report CSSB 10(HSS) from committee with
individual recommendations and zero fiscal note. There were no
objections and it was so ordered.
| Document Name | Date/Time | Subjects |
|---|---|---|
| CS for SB 10 Bill Packet.pdf |
SL&C 3/12/2009 1:30:00 PM |
SB 10 |
| SB 114 Bill Packet.pdf |
SL&C 3/12/2009 1:30:00 PM |
SB 114 |
| SB 125 Bill Packet.pdf |
SL&C 3/12/2009 1:30:00 PM |
SB 125 |
| SB 114 Proposed Amendment.pdf |
SL&C 3/12/2009 1:30:00 PM |
SB 114 |