Legislature(2009 - 2010)
04/08/2009 04:35 PM Senate FIN
| Audio | Topic |
|---|---|
| Start | |
| HB172 | |
| SB10 | |
| SB75 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
SENATE BILL NO. 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 those
clinical trials; relating to experimental procedures
under a state plan offered by the Comprehensive Health
Insurance Association; and providing for an effective
date."
5:17:24 PM
TOM OBERMEYER, STAFF, SENATOR BETTYE DAVIS, SPONSOR
explained that the legislation requires health insurance
providers in Alaska cover the costs of routine care,
incurred to a patient participating in an approved clinical
trial relating to cancer. He expounded that the insurer is
required to provide coverage only if the patients physician
determines there are no superior existing treatments
available and the pre-clinical data shows a reasonable
expectation that the clinical (investigative) treatment is
as efficacious as conventional therapy. Mr. Obermeyer then
read from the Sponsor Statement (Copy on File):
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. 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 in the
short-run.
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
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Act of 2009" H.R. 716, 111 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 medial advancements we've experienced toward
finding a cure for cancer would not be possible.
5:23:29 PM
Mr. Obermeyer noted that there are two zero fiscal notes;
Department of Commerce, Community and Economic Development
and Department of Health and Social Services.
Senator Olson wondered who besides a university is carrying
out these clinical trials. Mr. Obermeyer stated he was not
able to answer. He offered that the trials must be approved
by agencies like the National Institute of Health or the
Department of Defense and are held to defined standards.
Senator Olson asked why an insurer would refuse to cover
costs if the clinical trials are funded by a university.
Mr. Obermeyer clarified that the clinical trial costs are
paid for by the research entity conducting the trial. He
stated that this legislation would ensure that associated
medical costs to the patient are covered. An example would
be a follow up visit with the patient's own oncologist.
Senator Thomas asked if the bill provides coverage for all
stages of the clinical trial. Mr. Obermeyer affirmed.
Senator Thomas noted that the bill does not require the
insurer to pay for charges that would not be covered if no
insurance existed or otherwise reimbursable charges.
5:25:55 PM
Co-Chair Hoffman stated that he provides health care
coverage for his employees in his personal business. He
addressed concern about the rising costs of premiums. He
cited a letter from Premera (copy on file) dated April 7th
that states concerns that the legislation would force a
premium increase for small group and individual
policyholders. He asked about keeping the premium costs
down for providers.
Mr. Obermeyer responded that overall cost may not be that
great. He related that presently cancer patients needing
treatment are getting their routine treatments covered by
their insurance provider. Insurers might realize a cost
savings by allowing patients participation in trials.
Routine follow up care is required regardless of whether a
patient participates in a trial or not. He summized that SB
10 requires that routine follow up care charges will be
covered if a patient chooses to participate in a clinical
trial and the trial will not be considered experimental by
the insurer. He felt passage of the legislation was in the
best interest of the patient and advancement of medicine.
5:29:38 PM
SENATOR BETTYE DAVIS, responded to Co-Chair Hoffman's
question. She affirmed that she had been contacted by
Premera stating their concerns that not all phases of a
clinical trial be covered [phases 1 and 4]. She emphasized
that based on doctor's testimony in the Senate Health
Social Services committee from around the state they
determined that all phases are important and that their
costs are being overstated by insurers. She qualified that
Premera did not enter into a constructive dialogue with her
office regarding the legislation except to recommend the
exclusion of those two phases.
Co-Chair Stedman asked if the legislation has an impact on
state employees. Senator Davis answered that it has no
impact on state employee plans. She explained that when
state employee plans come up for review in July they may
opt in to new programs.
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Co-Chair Hoffman cited the Premera letter of April 7,
2009. He reported that Premera's concerns are for treatment
efficacy and patient safety.
Mr. Obermeyer spoke to the concerns raised in the Premera
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letter dated April 7, for mandatory coverage for phases
one and four. He pointed out that in phase one trials are
offered to a very limited number of participants. The
medications administered are done typically to determine
safe dosage levels. Many of the drugs administered are
approved by the FDA. He stated that phase four trials
generally involve follow up paid for by the pharmaceutical
firms to determine the efficacy of the treatment. He
concluded that given the small number of participants any
added expense to insurers would be minimal. He reminded the
committee that oncologists advised extending insurance
coverage to all phases of the trial. They agreed it would
be in the best interest of the patient and based on their
experience additional cost is minimal.
5:33:31 PM
Co-Chair Stedman referred to page 2, line 29 and asked for
clarification. He wondered if this alluded to experimental
treatments received in phase one trials. Mr. Obermeyer
pointed out that the section, starting on line 27,
describes exclusions to the bill. Co-Chair Stedman stated
that he was under the impression that all phase one trials
are experimental.
Mr. Obermeyer reiterated that many drugs used in phase one
trials already have FDA approval. He exemplified that in
one trial an approved drug for colon cancer was
administered to a brain cancer patient with positive
results.
Senator Olson asked if stem cell research is included in
this bill.
5:35:57 PM
Mr. Obermeyer believed it was not.
Senator Huggins cited a letter from the NFIB dated January
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20, (copy on file) that the legislation excludes state
employee plans. He opined that if it excludes government
plans it does not provide a level playing field. Senator
Davis asserted that the bill will require Medicaid to
provide coverage but does not mandate the state to
participate. She reasoned that the state might opt in
because it is in the best interest of the employees.
5:38:25 PM
DR. JEANIE ANDERSON, KATMAI ONCOLOGY (via teleconference),
testified in support of the legislation. She clarified an
earlier discussion regarding clinical trial settings. She
said that most of the clinical trials in Alaska are also
open to participants throughout the country in university
and community institutions. All of these institutions
require that the routine medical costs are covered by the
patient's insurer. This is care the patient would receive
regardless of whether one is a participant in a study or
not.
Dr. Anderson noted that Medicare has included coverage for
clinical trial participation since 2000. She countered the
concerns raised by Blue Cross/Blue Shield by asserting that
patient safety and efficacy of treatment is maximized by
patient participation in clinical trials without any
significant cost increase. The medical community benefits
by maximizing cancer treatment knowledge without increasing
costs. She included details in previous written testimony.
[Testimony on SB 280, from 4/3/08 was provided to the
committee by Senator Davis (copy in file).]
5:41:48 PM
SHIELA TALLMAN, PREMERA BLUE CROSS/BLUE SHIELD OF ALASKA
(via teleconference), testified in opposition to the
legislation. She referenced the letter of April 7, 2009 to
the committee and reiterated Premera's concerns mandating
phases one and four of clinical trials. She considered
phase one trials experimental and questioned whether all
policy holders should be funding basic development of these
drugs, devices and procedures for the manufacturer. Patient
safety must also be considered. In phase four trials,
Premera would cover medically necessary treatment only if
existing medical treatments are not determined more
effective. She surmised that mandates can increase the cost
of health insurance. Specific costs will be difficult to
project in this instance.
5:45:29 PM
HANNA SMITH, CANCER RESEARCH REGISTERED NURSE, FAIRBANKS
(via teleconference) testified in support of the
legislation. She recounted an experience with her
hospital's participation in a clinical trial deemed
beneficial for a patient. She asserted that the
administrative costs incurred to appeal the patient's four
previous denials by the insurer was the only related cost
increase. It cost the insurer substantially less to cover
the patient as part of the trial.
5:49:05 PM
DR. MARY STEWART, MEDICAL ONCOLOGIST, PRESIDENT, DENALI
ONCOLOGY GROUP, ANCHORAGE (via teleconference), spoke in
support of SB 10. She echoed the importance and benefits of
phase one and four clinical trials, especially the
knowledge gained by the medical oncology community for new
and more effective beneficial cancer treatments. She
emphasized that trials do not cost more.
5:51:45 PM
EMILY NENON, ALASKA GOVERNMENT RELATIONS DIRECTOR, AMERICAN
CANCER SOCIETY CANCER ACTION NETWORK (via teleconference),
stated support for the legislation. Ms Nenon cited a paper,
submitted by The American Cancer Society (ACS) (copy on
file). The paper compiled results that determine costs
associated with routine cancer care provided in a clinical
study are comparable to the costs of standard care. She
emphasized the importance of covering all phases of the
trial treatment. She believed the legislation would protect
patients while maintaining access to insurance and quality
care.
5:57:01 PM AT EASE
5:57:11 PM RECONVENED
DR. LATHASUBARIAN, MEDICAL ONCOLOGIST, ANCHORAGE, SELF (via
teleconference), testified in support of SB 10. She
emphasized that insurers have been a barrier to patient's
participation in clinical trials. She asserted the
necessity of clinical trials in cancer research as the only
way to develop new lifesaving or life extending therapies.
She concluded that the medical and societal benefits of the
research and care advancements discovered in clinical
trials are immeasurable.
6:01:24 PM
PAT LUBY, ADVOCACY DIRECTOR, ALASKA ASSOCIATION OF RETIRED
PERSONS (AARP), ANCHORAGE (via teleconference), testified
in support of SB 10. Mr. Luby pointed out that if patients
pay health insurance premiums they should have the right to
the coverage paid for that includes routine cancer care.
6:02:53 PM
LINDA HALL, DIRECTOR, DIVISION OF INSURANCE, DEPARTMENT OF
COMMERCE, COMMUNITY AND ECONOMIC DEVELOPMENT, spoke
specifically to the issue of mandated programs and the
costs associated with mandates. Ms. Hall stated she did not
know what the cost of the program would be for health care
insurers. She noted with regards to the zero fiscal note
for the Division of Insurance (FN 2) that it is only a
reflection of their administrative costs. She suggested the
committee analyze the benefit of the mandate and segment of
the population being served in relation to any increase in
premium costs. Ms. Hall referred to a pie chart, "Health
Coverage of Alaska's Population" (copy on file) and noted
the 32% unregulated segment. She reiterated that this
legislation would only impact the individual and small
group rate payers reflected mostly in this group. The small
group segment consists of small private sector employers
who are likely to drop employee health coverage as premium
costs rise. She concluded by suggesting the committee
examine the broader picture of who the mandate benefits and
what segment of the population bears the cost.
6:07:57 PM
Senator Ellis queried about the logic of a cancer victim
requesting participation in a clinical trial but being
denied payment for routine treatments by the insurance
company even if it is cost effective to the insurer.
Ms. Hall conjectured that there may have been costs beyond
the routine care being offered. She contended that she can
not explain insurance company logic. Senator Ellis restated
his earlier point and alleged that the insurer was acting
unethically. Ms. Hall stated that different insurance
companies have different coverage forms particularly for
individuals and small groups that potentially contain
adverse selection. She pointed out that Alaska's statutes
provide for oversight and review. If a procedure or trial
is not covered, it has a specific exclusion and contractual
provision known in advance.
6:11:56 PM
Senator Ellis argued that he would have been reluctant to
support the legislation if it mandated coverage for
experimental procedures with extravagant associated costs.
He emphasized that the bill requires coverage for routine
care that the patient is entitled to and has paid for in
their premiums and that the insurer's payment denials are
indefensible.
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Senator Huggins referred to the January 20 letter stating
that the legislation is a mandate to small business and not
to programs provided by the state. He asked Ms. Hall if
this was accurate. Ms. Hall affirmed. Senator Huggins
wondered why the legislation is not a mandate to all state
plans. Ms. Hall responded that the state plan is not
considered insurance and is not regulated by the Division
of Insurance. She explained that the mandate in the
legislation is specific to Title 21 oversight, which has no
regulatory authority over the various state plans. She
pointed out that the legislature and or collective
bargaining units could choose to include coverage of the
mandate in the select benefits section of the state's
plans.
6:14:46 PM
Senator Olson referred to cancer treatment and the three
common treatments: chemotherapy, surgical, and radiation.
He asked if the plan covers all three.
Senator Davis replied that she did not know the answer.
She shared that the bill has circulated through the
legislature for three years. She felt that participation in
these programs is very important and lifesaving. She felt
that the bill has been thoroughly vetted from the health
and insurers' standpoint and determined cost is minimal to
the insurer. She asked for the Committee's consideration
of SB 10 in a timely manner.
SB 10 was HEARD and HELD in Committee for further
consideration.
6:19:37 PM AT EASE
6:27:43 PM RECONVENED
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