02/28/2017 03:00 PM House HEALTH & SOCIAL SERVICES
| Audio | Topic |
|---|---|
| Start | |
| HB25 | |
| HB43 | |
| Presentation: Reducing Use of Emergency Department Services | |
| Adjourn |
+ teleconferenced
= bill was previously heard/scheduled
| *+ | HB 25 | TELECONFERENCED | |
| *+ | HB 43 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| + | TELECONFERENCED |
ALASKA STATE LEGISLATURE
HOUSE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE
February 28, 2017
3:04 p.m.
MEMBERS PRESENT
Representative Ivy Spohnholz, Chair
Representative Bryce Edgmon, Vice Chair
Representative Sam Kito
Representative Geran Tarr
Representative David Eastman
Representative Jennifer Johnston
Representative Colleen Sullivan-Leonard
MEMBERS ABSENT
Representative Matt Claman (alternate)
Representative Dan Saddler (alternate)
COMMITTEE CALENDAR
HOUSE BILL NO. 25
"An Act relating to insurance coverage for contraceptives and
related services; relating to medical assistance coverage for
contraceptives and related services; and providing for an
effective date."
- HEARD & HELD
HOUSE BILL NO. 43
"An Act relating to prescribing, dispensing, and administering
an investigational drug, biological product, or device by
physicians for patients who are terminally ill; providing
immunity related to manufacturing, distributing, or providing
investigational drugs, biological products, or devices; and
relating to licensed health care facility requirements."
- HEARD & HELD
PRESENTATION: REDUCING USE OF EMERGENCY DEPARTMENT SERVICES
- HEARD
PREVIOUS COMMITTEE ACTION
BILL: HB 25
SHORT TITLE: INSURANCE COVERAGE FOR CONTRACEPTIVES
SPONSOR(s): REPRESENTATIVE(s) CLAMAN
01/18/17 (H) PREFILE RELEASED 1/9/17
01/18/17 (H) READ THE FIRST TIME - REFERRALS
01/18/17 (H) HSS, FIN
02/28/17 (H) HSS AT 3:00 PM CAPITOL 106
BILL: HB 43
SHORT TITLE: NEW DRUGS FOR THE TERMINALLY ILL
SPONSOR(s): REPRESENTATIVE(s) GRENN
01/18/17 (H) PREFILE RELEASED 1/13/17
01/18/17 (H) READ THE FIRST TIME - REFERRALS
01/18/17 (H) HSS, JUD
02/28/17 (H) HSS AT 3:00 PM CAPITOL 106
WITNESS REGISTER
REPRESENTATIVE MATT CLAMAN
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented HB 25 as the sponsor of the bill.
LIZZIE KUBITZ, Staff
Representative Matt Claman
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented HB 25 on behalf of the bill
sponsor, Representative Claman.
MARGARET BRODIE, Director
Director's Office
Division of Health Care Services
Department of Health and Social Services
Juneau, Alaska
POSITION STATEMENT: Answered questions during discussion of HB
25.
REPRESENTATIVE JASON GRENN
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented HB 43 as the sponsor of the bill.
BROOKE IVY, Staff
Representative Jason Grenn
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented HB 43 on behalf of the sponsor of
the bill, Representative Grenn.
LINDA BRUCE, Attorney
Legislative Legal Counsel
Legislative Legal Services
Juneau, Alaska
POSITION STATEMENT: Answered questions during discussion of HB
43.
STARLEE COLEMAN, Vice President
Communications
Goldwater Institute
Phoenix, AZ
POSITION STATEMENT: Testified in support of HB 43.
CONNIE BEEMER, Director
Member Services and Operations
Alaska State Hospital and Nursing Home Association (ASHNHA)
Anchorage, Alaska
POSITION STATEMENT: Presented a PowerPoint presentation of the
Alaska ED Coordination Project.
ANN ZINK, MD
President
Alaska (ACEP) American College of Emergency Physicians
Palmer, Alaska
POSITION STATEMENT: Testified during the presentation of the
Alaska ED Coordination Project.
BEN ZANIELLO, MD
Vice President
Chief Medical Officer
Collective Medical Technologies (CMT)
Sandy, Utah
POSITION STATEMENT: Testified during the presentation of the
Alaska ED Coordination Project.
ACTION NARRATIVE
3:04:05 PM
CHAIR IVY SPOHNHOLZ called the House Health and Social Services
Standing Committee meeting to order at 3:04 p.m.
Representatives Spohnholz, Kito, Johnston, and Eastman were
present at the call to order. Representatives Edgmon, Tarr, and
Sullivan-Leonard arrived as the meeting was in progress.
HB 25-INSURANCE COVERAGE FOR CONTRACEPTIVES
3:05:35
CHAIR SPOHNHOLZ announced that the first order of business would
be HOUSE BILL NO. 25, "An Act relating to insurance coverage for
contraceptives and related services; relating to medical
assistance coverage for contraceptives and related services; and
providing for an effective date."
3:05:44 PM
REPRESENTATIVE MATT CLAMAN, Alaska State Legislature, explained
that Alaskan women living and working in rural areas, in the
tourism industry, in the military, and on the North Slope did
not always have ready access to women's health services, and
faced additional barriers for obtaining access to family
planning options. He stated that women who currently used
hormonal contraceptives had to return to a pharmacy everyone to
three months to refill their prescriptions. He reported that
proposed HB 25 required health insurers to offer consumers the
option to receive a 12-month supply of hormonal contraception.
He declared that the women in his family supported the proposed
bill as improved access to contraceptives meant huge reductions
in unintended pregnancies. He added that unintended pregnancies
had a profound effect on the overall well-being of Alaskan
families, as it was associated with adverse maternal and child
health outcomes. Along with health concerns, unintended
pregnancy was a dramatic cost driver to public health programs.
He pointed out that it was often time consuming and inconvenient
to obtain a prescription for contraceptives every one to three
months. He offered his belief that, with the financial
challenges in the state, there should be discussion for ways to
reduce costs in both the short and long term. He declared that
proposed HB 25 offered these cost reductions, and that it made
sense for Alaska women and families.
3:07:34 PM
LIZZIE KUBITZ, Staff, Representative Matt Claman, Alaska State
Legislature, stated that proposed HB 25 mandated that health
care insurers provide coverage for a 12-month supply of
contraceptives. She pointed out that prescriptive
contraceptives included self-administered hormonal
contraceptives which did not require insertion or other
administration by a medical professional, namely oral
contraceptives, noting that this was discussed in Section 1 of
the proposed bill. She moved on to discuss the Sectional
Analysis of the bill [included in members' packets]. She said
that Section 1 also included a religious exemption and defined a
health care insurer as including a self-insured employer, such
as the State of Alaska. She moved on to discuss Section 2 of
the proposed bill, which directed the Department of Health and
Social Services to pay for the 12-month supply of prescription
contraceptives for eligible recipients of medical assistance.
She relayed that Section 3 of the proposed bill required the
Department of Health and Social Services to amend and submit for
federal approval a state plan for medical assistance coverage
consistent with Section 2. She explained that Section 4
provided a conditional effect of Section 2 and Sections 5 and 6
pertained to the effective dates.
MS. KUBITZ stated that one major premise behind the proposed
bill was that when women had greater access and availability to
contraceptives, there was a reduction of unintended pregnancies.
This resulted in a direct cost savings to the state, which was
reflected in the fiscal notes from Department of Health and
Social Services [included in members' packets]. She relayed
that one 2010 study in Alaska [included in members' packets]
found that 48 percent of all pregnancies in Alaska were
unintended. She added that an estimated 94.3 percent of these
unintended pregnancies were publicly funded. She reported that
Alaska spent $113.7 million on unintended pregnancies, of which
$70.8 million was paid for by the federal government and $42.9
million was paid for by the state. She pointed to an additional
study [included in members' packets] which studied 84,000 women
in California given 1 month, 3 month, or 12 month supplies of
oral contraceptives. The researchers of this study observed a
30 percent reduction in the odds of conceiving an unintended
pregnancy for those women given the 12 month supply of oral
contraceptives. This study also reported that the California
family planning program paid $99 more annually for women who
received three cycles and $44 more for women who received one
cycle than for women who received a year-long supply all at
once. She stated that this cost "was mostly due to the costs of
associated visits and the higher use of pregnancy tests among
women who received fewer cycles." She relayed that women who
received three cycles were almost twice as likely as women who
received the 12 month supply to visit a clinic to get a
pregnancy test. She noted that the proposed bill did not change
who was eligible for coverage, or the types of prescriptions
covered. The bill merely allowed women already receiving
coverage for prescription contraceptives to receive, if they so
choose, a 12 month prescription. She addressed concerns brought
forward by the Alaska National Federation of Independent
Business (NFIB) and by America's Health Insurance Plan (AHIP)
[included in members' packets]. As NFIB had concerns for
whether the proposed bill would include the state employee
health care plan, a definition of health care insurer which
included self-insured employers, such as the State of Alaska,
had been included in the proposed bill. She relayed that an
additional concern voiced by NFIB was for the cost burden of
supplying a 12 month supply of contraception at one time. She
pointed to multiple studies which had found that contraceptive
coverage did not raise insurance premiums, and that the
employers providing coverage could save money by avoiding the
costs associated with unintended pregnancy. She relayed that
the average commercial insurer payment for all maternal and
newborn care ranged from $18,000 to $28,000, whereas the average
hormonal birth control cost ranged from $100 to $600 per year.
She stated that prevention of one unintended pregnancy could
save an insurer at least $17,000, enough savings to pay for 29
additional years of contraception. She moved on to discuss the
concerns from AHIP [included in members' packets] which
concluded that the 12-month supply of contraceptives could
compromise patient safety as a result of decreased patient
visits to the prescribing physician. She pointed to research
which showed that birth control pills were safe and could be
safely prescribed based on a careful review of the patient's
medical history and blood pressure measurement. For most women,
no further examinations were necessary after the initial
prescription, unless the patient asked for a follow up during
the recommended yearly examination. She stated that the Centers
for Disease Control and Prevention (CDC) and the World Health
Organization (WHO) had presented a study in 2013 which
recommended dispensing a yearly supply of contraception with an
advisement to return at any time for discussion of side effects
or other problems, or to change the method. The study had
declared that no routine follow-up was required. She added
that, although AHIP had concerns for the efficacy of oral
contraceptives due to improper storage for a 12 month supply,
CDC had declared that oral contraceptives had a shelf life of
three to five years, dependent on the manufacturer, although
temperature and moisture could diminish this time frame. CDC
stated that most women who opted for a 12-month supply, and were
regular users of hormonal contraception, would know how to
properly store the medication. She addressed concerns for
waste, fraud, and abuse, and pointed out that research had found
that the average waste of a 12-month supply was for one cycle of
prescription contraceptives, and this was insignificant in
comparison to the other cost savings for fewer clinician and
pharmacy visits, and the associated costs for pregnancy.
Regarding fraud and abuse, although there were existing criminal
statutes for sale of hormonal contraceptives, this was not
anticipated as women would have greater access to the
contraceptives. She concluded by stating that proposed HB 25
would offer "huge advantages for Alaskan women, from eliminating
the inconvenience of refilling the prescription every one to
three months at a time, to the real inability of some Alaskan
women to make it to the clinic, hospital, or pharmacy to refill
that prescription at all." She pointed out that fisherwomen
sometimes spend three to four months out on a boat, women
attending college often have busy schedules balancing school and
a job, and women in Rural Alaska often had trouble making it to
a clinic or hospital due to a lack of transportation and limited
operating hours. She declared the HB 25 ensured that all
Alaskan women had the freedom to make decisions about their
futures.
3:16:28 PM
REPRESENTATIVE JOHNSTON shared that a three month supply of
birth control pills for her daughter was $800. She asked if
there was a discount for a 12 month supply.
MS. KUBITZ replied that her research had shown a cost savings
for buying in bulk.
REPRESENTATIVE JOHNSTON suggested more research for this.
3:17:40 PM
REPRESENTATIVE EDGMON pointed to the zero fiscal note.
MS. KUBITZ replied that there were two zero fiscal notes
[included in members' packets] provided by the Department of
Health and Social Services [OMB Component 242 and OMB Component
2007]. She relayed that one fiscal note projected anticipated
costs due to implementation of the proposed bill and the second
fiscal note detailed the cost savings.
3:18:35 PM
MARGARET BRODIE, Director, Director's Office, Division of Health
Care Services, Department of Health and Social Services,
addressed the Department of Health and Social Services (DHSS)
fiscal note labeled OMB Component 2007, and explained that this
fiscal note analyzed 7,940 female Medicaid recipients using oral
contraceptives. She estimated that 10 percent, 794 women, would
require duplication of services because the medication was not
effective, it was lost or stolen, or was not stored properly and
could lose its efficacy. She based the replacement value at $45
per month which was the national average drug acquisition cost
and the cost that the state used for its determination. She
shared that DHSS assumed that 75 percent of the women planned to
use oral contraceptives longer than 12 months, and that, as the
CDC cited a standard failure rate of 9 percent, this would
result in 540 unintended pregnancies. She reported that the
failure rate would decrease about 30 percent with a 12-month
supply of contraceptives, thereby lowering the failure rate to 7
percent. She pointed out that about 120 unintended pregnancies
could be avoided by using the 12-month contraception. She
stated that the estimated savings was based on the Medicaid
data, which reported that 5.28 births of the 120 avoided
pregnancies would have been complicated births, with the
remainder of births being non-complicated. She reported that
the cost factor for a complicated birth was $110,000, whereas
the cost factor for a non-complicated birth was $8,000. This
would result in a benefit cost savings to the Medicaid program
estimated to be $1,498,000, of which $562,000 would be
attributed to the Medicaid expansion population. She reported
an annual projected savings of $1,355,600. She added that this
was a conservative estimate, as some complicated births could
cost hundreds of thousands of dollars.
MS. BRODIE addressed the second fiscal note, OMB Component 242.
She offered her belief that this fiscal note could be removed,
as there was no state or federal statute that declared a need
for the department to go back and collect from the recipients.
3:24:41 PM
CHAIR SPOHNHOLZ expressed her agreement with saving the "money
in this particular area." She suggested that the savings would
be $1.2 - $1.3 million annually in overall Medicaid costs
related to contraception and unintended pregnancies.
MS. BRODIE expressed her agreement.
3:25:03 PM
REPRESENTATIVE SULLIVAN-LEONARD asked whether the proposed bill
would allow the state workers' health insurance program to offer
this benefit.
REPRESENTATIVE CLAMAN, in response, relayed that the intent of
the proposed bill was for this benefit to be included in the
state workers' health insurance plan.
REPRESENTATIVE SULLIVAN-LEONARD asked if there were other
medications that could be prescribed on a yearly basis, or was
this the first proposal for a year-long prescription.
MS. KUBITZ asked if Representative Sullivan-Leonard was asking
specifically about contraceptives. She stated that she was not
aware of any other medications that could have a year-long
prescription, as often many of these medications were controlled
substances.
REPRESENTATIVE SULLIVAN-LEONARD asked if any other prescription
drugs could be included in this format, pointing out that a 90-
day prescription was because a physician wanted to oversee the
interaction of the drug for the patient.
REPRESENTATIVE CLAMAN said that his office had not researched
this specific question. He recollected that certain mail-in
drug programs allowed for longer prescriptions, although it
depended on the medication.
CHAIR SPOHNHOLZ offered her belief that some other medications,
including some hormonal medications, were available on a yearly
prescription.
REPRESENTATIVE CLAMAN replied that he would look into this.
3:28:53 PM
CHAIR SPOHNHOLZ said that HB 25 would be held over.
3:29:18 PM
The committee took an at-ease from 3:29 p.m. to 3:32 p.m.
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
3:32:40 PM
CHAIR SPOHNHOLZ announced that the next order of business would
be HOUSE BILL NO. 43, "An Act relating to prescribing,
dispensing, and administering an investigational drug,
biological product, or device by physicians for patients who are
terminally ill; providing immunity related to manufacturing,
distributing, or providing investigational drugs, biological
products, or devices; and relating to licensed health care
facility requirements."
3:32:49 PM
REPRESENTATIVE JASON GRENN, Alaska State Legislature, shared
that the proposed bill was often referenced nationally as "Right
to Try" legislation. He stated that the goal of the proposed
bill was:
to create a legal climate in which terminally ill
patients who have exhausted all FDA (U.S. Food and
Drug Administration) approved treatment options may
work with their doctors and drug manufacturers to
access investigational and safe treatments that have
passed Phase I of the FDA approval process but are not
yet widely available.
REPRESENTATIVE GRENN reported that "Right to Try" laws had been
passed in 33 states, with this legislation being considered in
another 15 states, now including Alaska. Paraphrasing from the
Sponsor Statement [included in members' packets], he stated
that, each year, it was estimated that more than 1 million
Americans died from terminal illness. "For those who have
exhausted all FDA approved options, clinical trials become the
next step. However, of those patients who attempt to gain entry
into a clinical trial, it is found that fewer than 3 percent are
accepted." He declared that, although the FDA did have a
program in place for accessing investigational drugs outside of
clinical trials, which was known as the "Compassionate Use
Program," it was estimated that only about 1200 people made it
through the long, arduous federal process annually. He declared
that the goal of the proposed bill was to provide the same
access as the existing program but on a shorter timeline. He
said that by assuring that terminally ill patients had more
timely access to safe, though experimental drugs, in
consultation with their doctor, the proposed bill would offer
new hope after all FDA approved options had been exhausted.
3:35:02 PM
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State
Legislature, presented a PowerPoint titled "House Bill 43: The
Right to Try." She directed attention to the sectional analysis
[included in members' packets] and to slide 2, "House Bill 43."
She addressed Section 1 of the proposed bill, and stated that
this section prohibited disciplinary action by the State Medical
Board against physicians for prescribing or administering an
investigational drug to a terminally ill patient who met certain
criteria. She reported that patients had to be ineligible or
unable to participate in an ongoing clinical trial, had
considered all available treatment options in consultation with
their doctor, and had provided written consent. She moved on to
Section 2 of the proposed bill, which established that
physicians, medical team members, manufacturers, importers, and
distributors acting in good faith and with reasonable care would
not be held liable in the case of injury or death of a
terminally ill patient from the use of an investigational drug,
provided that the informed consent was obtained from the patient
and notice of immunity was also given to the patient in advance.
She added that the section also established immunity for
physicians and manufacturers who chose not to participate in the
distribution of investigational drugs. She addressed Section 3
which amended AS 17.20.110, and would allow physicians to
prescribe or administer investigational drugs under the
conditions established in Section 1 of the proposed bill. She
spoke about Section 4, which prevented the Department of Health
and Social Services from requiring a licensed health care
facility to increase its services, solely to accommodate
physicians who were prescribing or administering investigational
drugs to a patient.
3:37:37 PM
MS. IVY directed attention to slide 3, "FDA Drug Review
Process," and explained this process. She reported that, prior
to Phase 1, the sponsors of a drug were required to submit an
"Investigation New Drug" (IND) application, and through this
application, the FDA reviewed the applicant's pre-clinical
testing results, and then determined whether the drug was
reasonably safe for testing in humans.
MS. IVY spoke about slide 4, "FDA Drug Review Process (cont'd),"
and explained that in Phase 1, the studies occurring after
approval of the IND application, the studies could be conducted
on healthy volunteers dependent on the purpose of the
medication, or on individuals with specific diseases or terminal
illness. She stated that safety to determine possible side
effects and toxicity levels was the goal of Phase 1. She
addressed slide 5, "FDA Drug Review Process (cont'd)," and spoke
about the Phase 2 studies, which began when a drug was
determined to be safe, and was focused on the effectiveness of
the drug. She stated that, if there was evidence that a drug
was effective, it moved on to Phase 3, slide 6, "FDA Drug Review
Process (cont'd)." In Phase 3, more information was gained on
safety and effectiveness, particularly in varying populations
and in different dosages. After Phase 3, sponsors of the drug
have a review meeting with the FDA, and submit a new drug
application requesting approval to market the drug in the United
States, slide 7, "FDA Drug Review Process (cont'd)." After this
application, the FDA had 60 days to decide whether to file an
application for review and then applications were generally
processed within 10 months.
3:39:26 PM
MS. IVY reviewed slide 8, and explained that investigational
drugs had passed the safety testing in Phase 1, and were
currently in ongoing clinical trials in Phase 2 and Phase 3 of
the FDA process.
3:39:43 PM
MS. IVY directed attention to slide 9, "FDA's Expanded Access
Program," and spoke about the "Compassionate Use" program, which
was designed for terminally ill patients without access to
clinical trials so they could apply for these investigational
treatments. She explained that the patient had to work with
their doctor to apply directly to the FDA. She noted that,
until recently, this application took more than 100 hours for a
doctor to complete, but it had now been shortened. She
acknowledged that this was still just the first step in the
approval process. She added that manufacturers also had to
submit lengthy documentation before the application went through
the internal FDA approval process and on to a separate
institutional review board, often a lengthy multi-month process.
She reported that approximately 1200 applicants made it through
the process annually. She addressed slide 10, "The Right to Try
- A Nationwide Effort," and pointed out that this legislation
had been passed or was under consideration in all but one state.
3:41:20 PM
REPRESENTATIVE SULLIVAN-LEONARD, referencing slide 9, asked how
many applicants did not make it through the process.
MS. IVY said that she did not have that number.
REPRESENTATIVE SULLIVAN-LEONARD offered her belief that it was
an important component to the proposed bill.
3:42:05 PM
MS. IVY pointed to the Clinical Trials document [included in
members' packets] which included stories of Alaskans facing
terminal illness and the benefit of having access to the drugs.
She stated that, additionally, there was a Goldwater Institute
policy report [included in members' packets] which delved into
greater detail for the challenges of the Compassionate Use
program.
REPRESENTATIVE TARR asked for an update to the policy signed by
President Obama prior to leaving office, which had included some
provisions to expand drug trials for non-approved drugs, and for
its interaction to the proposed bill.
MS. IVY said that she would research the specifics.
3:44:18 PM
REPRESENTATIVE KITO asked why the legislation was vetoed in
Hawaii.
MS. IVY replied that, although the legislation had passed
unanimously from the legislature in Hawaii, the governor had
vetoed it. She shared that Governor Brown in California had
also vetoed the legislation, but had since changed his mind,
purportedly because of instances of benefits to patients in
Texas.
3:46:00 PM
REPRESENTATIVE KITO referenced the statement from the bill
sponsor that this was an opportunity for individuals who have
terminal illnesses to try something that was not a standard
procedure. He offered his belief that there might be
opportunities for treatment benefits prior to waiting until a
diagnosis of terminal illness. He asked why it was necessary to
wait to prescribe a potential remedy until a terminal diagnosis.
MS. IVY replied that the national advisors on this legislation
had suggested to keep a narrow focus, as this was something
already available through the FDA. She pointed out that taking
on preventative care with all medications that go through the
FDA approval process was a much larger federal policy discussion
regarding the approval of drugs in the U.S.
3:47:59 PM
CHAIR SPOHNHOLZ added that, as medications had side effects, an
important part of the FDA approval process was to ensure that
the medication was safe, did what it claimed, and its benefits
outweighed the costs. The FDA approval process was set up to
protect consumers. She offered an example of aspirin being
taken to prevent heart problems, whereas it actually increased
gastric problems as a side effect. She pointed out that
experimental drugs needed to be proven safe. She asked for the
definition of terminally ill in the proposed bill.
MS. IVY directed attention to page 2, line 12 of the proposed
bill, and she read:
"terminal illness" means a disease that, without life-
sustaining procedures, will result in death in the
near future or a state of permanent unconsciousness
from which recovery is unlikely.
3:50:43 PM
LINDA BRUCE, Attorney, Legislative Legal Counsel, Legislative
Legal Services, stated that this was a new definition which had
been drafted for this bill.
MS. IVY offered her belief that the definition came from model
legislation in other states.
3:51:32 PM
REPRESENTATIVE SULLIVAN-LEONARD asked whether the information
collected from terminally ill patients could be used for other
patients.
MS. IVY replied that the data from investigational drugs, used
outside a clinical trial, was being collected and that federal
law dictated that manufacturers needed to provide this
information to the FDA. She offered her belief that it was
required that the data be collected.
3:53:16 PM
REPRESENTATIVE TARR commented that this was Rare Diseases
Awareness Day. She shared that, as there was not a large enough
population to have statistically relevant information for
appropriate interventions, it was often a fight to get access to
medication.
3:54:50 PM
STARLEE COLEMAN, Vice President, Communications, Goldwater
Institute, reported that her organization had crafted the
language on which proposed HB 43 was based, although, she
acknowledged, there had been some Alaska specific adjustments.
She relayed that diagnosis for a terminal illness currently
offered three paths of approved options for the access to
promising investigational treatments: the first path was for
the clinical trials; the second path was for those who could
afford to travel overseas to access drugs that were already
available in countries other than the U.S; the third path was
for the connected, the aforementioned FDA "Expanded Access"
program. For the remainder of the public, there was no path to
access investigational treatments, hence the "Right to Try"
program. She stated that it was important to understand that
this program was the opposite of the right to die movement,
which was for people ready to end their own lives. The "Right
to Try" program allows patients with terminal illnesses who had
tried existing treatments with no success, and could not enroll
with a clinical trial, to access promising treatments being
safely used in government approved clinical trials. She pointed
out that it was not a question for whether or not trying an
investigational treatment was too risky, as the risk from these
treatments was exactly the same as for those entered into
government clinical trials. She emphasized that it was hard to
be selected for a clinical trial. She offered an example of
clinical trials for children diagnosed with spinal muscular
atrophy (SMA). She reported that 97 percent of cancer patients
had to rely on drugs already on the market, even if a drug in a
clinical trial was being developed specifically for their type
of cancer, and had already been approved in other countries.
She reiterated that, although about 1200 people annually made it
through the application process, it was not known how many
people were declined as FDA did not keep records. She reported
that, although the FDA declared that its approval rate was about
99 percent, she had questioned this rate. She offered an
example of a cancer trial center in Houston, the largest in the
world, which claimed that it had only been able to get one
person through the FDA "Expanded Access" process annually. She
surmised that many doctors spoke to the FDA in advance and would
not apply if the FDA stated they would not accept the
application. She pointed out the difficulty for doctors in
Alaska who were not familiar with the FDA process or hierarchy.
She compared the FDA program with a similar program in France
which treated 25,000 people annually, and declared that there
was a problem with the FDA program.
4:04:00 PM
MS. COLEMAN stated that, although no one expected a guarantee
that an investigational drug would offer a cure, they just
wanted an opportunity to try the medications already being used
in clinical trials. She declared that dying people and their
families were owed that opportunity. She stated that "Right to
Try" was already working and saving lives. She offered an
example of terminal pancreatic cancer patients. She emphasized
that states were able to do this to complement the federal drug
approval process, and not compete with it. She declared that
the right to save your own life was a human right, and that it
should not be necessary to also fight government red tape.
4:05:49 PM
REPRESENTATIVE JOHNSTON asked for clarification that the
proposed bill was for the right to try drugs that had gone
through the first, second, and third steps toward FDA approval.
MS. IVY replied that all of these drugs had passed Phase 1 for
safety testing and were currently in Phase 2 or Phase 3.
REPRESENTATIVE JOHNSTON asked if drugs allowed in Europe had
already passed Phase 1 by the FDA, and were also in Phase 2 or
Phase 3.
MS. IVY replied that was correct. She stated that in some
countries medications or treatments were in general use, and
considered safe and effective, but had not yet gone through
Phase 1 of the FDA process in order to be eligible under the
"Right to Try" program. She pointed out that a person could
travel to that country and utilize the medication, but that was
outside this process.
MS. COLEMAN offered an example for five FDA investigational
treatment drugs for breast cancer which had been approved in
other countries. She stated that "Right to Try" would allow
those treatments already in use to become available to American
women.
4:07:59 PM
CHAIR SPOHNHOLZ asked how many people had taken advantage of the
access to "Right to Try."
MS. COLEMAN replied that there was not a complete record for
that information, as there was not a state specific reporting
requirement for the use of drugs in a state with a "Right to
Try" law. She noted that this would be duplicative of drug
company reports to the FDA, adding that the FDA did not make
this information available under public records laws.
4:09:27 PM
REPRESENTATIVE JOHNSTON asked if a drug would qualify if it was
used for one treatment, even though its purpose was for
something else. She pointed out that it had already gone
through the Phase 1 safety test, but not through the next
phases.
MS. COLEMAN said that she would need more specifics about the
drug's placement in the trial process. She reiterated that the
goal of "Right to Try" was to provide access for terminal
patients to any drug which had passed the initial safety trial,
and was in on-going trials and under active investigation. She
said that it was legal for drugs to be used for another purpose,
which she termed "off label use."
4:11:28 PM
REPRESENTATIVE TARR expressed concern for the provision of
immunity, noting that medical malpractice provisions were still
in place, and asked if this had been an issue in any other
states. She asked if there was protection for an individual who
felt pressured or coerced into taking a drug.
MS. COLEMAN shared this concern that patients were protected
from any undue pressure to try something they were not fully
comfortable with and to protect them from medical malpractice.
She shared that the proposed bill had two patient protections:
(1) that a patient must voluntarily sign a comprehensive,
informed consent document, and (2) that this was totally
voluntary with no incentive for the pharmaceutical company to
participate. She said that medical malpractice laws were not
impacted by the proposed bill, and these laws would remain in
place. She declared that a point of the liability shield was to
ensure that doctors, hospitals, and pharmaceutical companies
understand that should a patient in a terminal situation die
while taking an investigational treatment, that, in and of
itself, was not a reason to be sued.
4:15:05 PM
MS. IVY added that there were other protections in the proposed
bill, as it included investigational drugs in on-going trials.
She offered her belief that, under federal law, manufacturers
cannot engage in the marketing and sale of unapproved drugs, and
were not legally permitted to sell investigational drugs for
more than the production cost. She stated that this removed the
cost benefit for manufacturers to participate.
CHAIR SPOHNHOLZ asked whether the informed consent described in
the proposed bill included a verbal discussion for the risks and
benefits.
MS. IVY, in response to Chair Spohnholz, expressed her agreement
and added that discussion would include all available treatment
options currently approved by the FDA.
CHAIR SPOHNHOLZ directed attention to page 2, lines 26 - 27, as
the guarantee of a verbal conversation with the doctor regarding
the risks and benefits of a potential treatment, and that
writing was a codification of that consent.
MS. IVY expressed her agreement that this was the intent of the
proposed bill, and expressed her support of any necessary
amendment to clarify the requirement for a verbal conversation.
4:18:24 PM
CHAIR SPOHNHOLZ said that HB 43 would be held over and public
testimony would be opened at that time.
4:18:51 PM
The committee took a brief at ease.
^Presentation: Reducing Use of Emergency Department Services
Presentation: Reducing Use of Emergency Department Services
4:20:00 PM
CHAIR SPOHNHOLZ announced that the final order of business would
be a presentation titled "Reducing Use of Emergency Department
Services."
4:20:20 PM
CONNIE BEEMER, Director, Member Services and Operations, Alaska
State Hospital and Nursing Home Association (ASHNHA), directed
attention to the PowerPoint titled "Alaska ED Coordination
Project," and stated that the project was a result of the
Medicaid Redesign efforts initially proposed in 2015. She noted
that rising health care costs and the decline in the state
budget had been a reason for this project in collaboration with
the Alaska Chapter of the American College of Emergency
Physicians. She stated that the project was not solely focused
on Medicaid patients, but for all patients, as they wanted to do
the right things for their patients. She acknowledged that
emergency rooms were a great place if there was an emergency,
but that it was not the best place to provide for re-occurring
primary care and behavioral health issues. She reported that
this project was based on the State of Washington seven best
practices model, slide 3. She shared that Alaska saw these
successes and "we wanted to steal them so that's what we're
working on." She reported that Washington was also under
financial pressures, similar to Alaska, and was faced with
threats from the governor to limit emergency department (ED)
visits for Medicaid patients. She addressed slide 4, "Learning
from Others," which listed the reductions for ED use in the
first year, and included a 10.7 percent reduction among frequent
utilizers and a 24 percent reduction for narcotic prescriptions
from the ED.
4:23:16 PM
ANN ZINK, MD, President, Alaska (ACEP) American College of
Emergency Physicians, offered her belief that "what you do
really matters." She said that a lot of great things can build
off this project. She directed attention to slide 5, "Alaska's
ED Coordination Project," and reported that this was actual
language from Senate Bill 74, emphasizing that this was Alaska
specific. She shared that ideas had been taken from the States
of Washington and Oregon, as well as others, for what had been
done well, what could have been done differently, what would be
recommended, and what made sense for Alaska. She read from the
list on slide 5, which included creating an interdisciplinary
process for defining, identifying, and minimizing the number of
frequent visitors of emergency department services, creating a
real-time electronic information exchange mechanism which
crossed all IT platforms for electronic medical records,
educating patients, and providing primary care and behavioral
health follow-up within 96 hours. They also reviewed ways to
create statewide narcotics guidelines for the emergency
departments, and ways to review the successes and challenges of
this program when moving forward. She relayed that they had
been receiving input from other hospitals, as well as working on
the statewide opiate guidelines; however, the big project was
research for an IT system that would cross the platforms, be
easy to use, be interface friendly, and have the potential for
future expansion. She lauded Collective Medical Technologies as
an ideal partner.
4:25:31 PM
BEN ZANIELLO, MD, Vice President, Chief Medical Officer,
Collective Medical Technologies (CMT), shared that he was also a
practicing physician at Providence Hospital in the State of
Washington. He shared some background about Collective Medical
Technologies (CMT), slide 7, stating that it was a small,
mission driven company started by an Emergency Room (ER) social
worker in Idaho, and that CMT was focused on ER care
coordination and the sharing of information between hospitals.
He said that the focus of CMT was to create a national care
coordination network around the concept of medical uncertainty
versus medical necessity. He pointed out that there was a lot
of information asymmetry in the emergency department (ED), as
decisions had to be made quickly. He stated that the CMT
software would provide the information to reduce the medical
uncertainty, and they were now working with more than 1,000
hospitals. He directed attention to slide 8, "PreManage
Platform," and said that the program was called EDIE, Emergency
Department Information Exchange. He explained that, in order to
focus on the emergency department, it was necessary to get
information from outside the ER, from all aspects of the "care
ecosystem." He pointed to slide 9, as an example of the type of
data shared.
4:30:01 PM
DR. ZINK moved on to slide 10, "ED Narcotic Guidelines." She
reported that there was a coordinated effort with the ED
departments to implement statewide guidelines to reduce drug
seeking and drug dispensing to frequent emergency room users.
She shared that the State of Washington had reported "a huge
difference in their overall narcotic dispensing out of the
emergency department." She directed attention to slide 12,
"Ultimate Goal," and stated that, since the IT platform had been
determined, there was work to get the platform in place in
hospitals. She shared that support was widespread. She pointed
to slide 13, "Participating Organizations," which listed many of
the collaborating organizations. She declared that this was an
opportunity to put patients first, and reduce restrictions and
decrease silos between different providers. She stated the need
for tools to reduce costs and improve care.
4:33:09 PM
REPRESENTATIVE JOHNSTON asked if she would encourage her
facility to use this platform for all patients.
DR. ZINK explained that this was emergency department specific,
as it was different than for someone with chronic pain, and that
it had 100 percent support from the emergency department
physicians, as well as support from the urgent cares.
REPRESENTATIVE JOHNSTON asked it the IT platform could be used
for all emergencies, and not just Medicaid.
DR. ZINK replied that this was correct. She said that it
crossed all platforms and patients, and it could access data
from the other states that had the CMT platform.
REPRESENTATIVE JOHNSTON asked whether any hospital or
organization which used this IT platform could interchange
throughout the system.
DR. ZINK said, "Correct."
4:34:31 PM
REPRESENTATIVE SULLIVAN-LEONARD asked if there were forms which
were clearly highlighted for sharing this information with
another facility for an emergency room patient. She questioned
the Health Insurance Portability and Accountability Act (HIPAA)
information.
DR. ZINK replied that different hospitals could set up
individual criteria and this was on a tracking board. She
reported that when a patient checked into an emergency room,
they agreed to be treated via the Health Insurance Portability
and Accountability Act, hence there was access to the
information, and then their information could be accessed. She
offered some examples for the information, including any recent
violent actions by the patient, an important care plan, or a
notice of frequent visitations to emergency departments.
4:35:53 PM
REPRESENTATIVE SULLIVAN-LEONARD reiterated her question that the
patient would need to sign an agreement for the medical
facilities to share their personal information.
DR. ZINK said that, when checking in to the emergency
department, the patient basically agrees to allow access for
anything to do with their medical emergency at that moment,
which is in compliance with HIPAA. She added that any follow-up
in an outpatient clinic does not automatically allow access to
that patient information. She explained that all the patients
in the mental health court signed a full information release for
willingness to share their information.
4:37:14 PM
REPRESENTATIVE TARR asked if this was a tool which fed into each
EMR system, and, as a result, there was not any unnecessary
information, although this was governed by HIPAA.
DR. ZANIELLO explained that, when a patient registered in the
ER, the IT system was fed a narrow slice of patient data which
was matched against their larger data base. He reported that
the CMT system would report on recent patient activities and
actions. He stated that each emergency room maintained its
"deep clinical repository on each patient."
4:39:05 PM
REPRESENTATIVE TARR asked about any issues of privacy, as each
use of electronic records allowed an opportunity for a data
breach.
DR. ZANIELLO replied that a lot of his work was with data
privacy concerns. He reminded that committee that HIPAA
referenced portability, not privacy. He reported that CMT had
not had any data breach or HIPAA violation.
CHAIR SPOHNHOLZ asked about the projected time line for
implementation of the CMT platform.
MS. BEEMER said that the bulk of the CMT implementation was for
the legal review, projected to be a 3 - 4 month process. She
allowed that the actual IT implementation was "a fairly light
lift." She pointed out that the program had been implemented at
Providence Hospital in Anchorage, as it had already been
implemented in other Providence Hospitals in Oregon and
Washington. She reported that her team was currently
demonstrating the CMT program to the mid and large hospitals in
Alaska.
4:41:52 PM
CHAIR SPOHNHOLZ offered her belief that it was important to have
as many hospitals involved as possible. She mentioned an
earlier reference to prescription drug monitoring programs, and
asked about the timing for integrating that information.
MS. BEEMER offered her belief that the language in Senate Bill
74 regarding the prescription drug monitoring program allowed
for some regulations which were due to go into effect in July.
She expressed the desire to soon have discussions with that
program.
CHAIR SPOHNHOLZ asked whether regulations were necessary to take
effect prior to integration with the prescription drug database.
MS. BEEMER offered her understanding that this was already
underway.
CHAIR SPOHNHOLZ asked for the end date goal to have a complete
rollout of integration with EDIE.
MS. BEEMER opined that the hospitals needed six months to have a
legal review before signing the contract. She reported that
phase 2 would be access by the communities and primary care
through the portal. She added that discussion was still
necessary with the rural critical access hospitals. She allowed
that there was still a lot of work, although there was hope to
have this in all the large and mid-size emergency departments
within six months.
4:44:30 PM
DR. ZINK pointed out that the IT was only one component, and the
prescription drug database regulation component was now being
finished. She stated that there was a lot of opportunity to
build on care coordination, end of life care, and other cost
savings issues for improvement for patient health.
REPRESENTATIVE TARR asked about participation with Indian Health
Services or Tri Care.
DR. ZINK replied that there was extensive work with Indian
Health Services. She reported that there was ongoing work with
the leaders within the VA (Veterans Administration) system for
changes to regulations, with a desire to bring this program to
the federal level. She surmised that this was just a temporary
barrier in the work toward integrating these systems.
4:47:03 PM
ADJOURNMENT
There being no further business before the committee, the House
Health and Social Services Standing Committee meeting was
adjourned at 4:47 p.m.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB025 ver A 2.16.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Sponsor Statement 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Sectional Analysis ver A 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Cost Savings Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-ADN Commentary 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Guttmacher Alaska Statistics 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Guttmacher Public Costs from Unintended Pregnancies 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Kachemak Bay Family Planning Clinic 2.23.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter League of Women Voters Alaska 2.24.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Unintended Pregnancies Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Planned Parenthood Votes Northwest & Hawaii 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-UCSF Study Newspaper Article 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Letter Dr. Tina Tomsen 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Supporting Document-Support Emails 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Opposing Document-America's Health Insurance Plans 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Opposing Document-Letter NFIB 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DHSS-Medicaid Services 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DHSS-DHCS 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB025 Fiscal Note DCCED-DIO 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
| HB043 ver D 2.22.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Sponsor Statement 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Sectional Analysis ver D 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Legislative Map 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - FDA Drug Review Process 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Clinical Trials in Alaska.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Fact Sheet 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Patient Stories 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Supporting Document - Goldwater Institute Policy Report Summary 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB43 Supporting Document - Letters of Support 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB043 Fiscal Note DCCED--DCBPL 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| HB 43 Powerpoint Presentation.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
| AK ED Coordination Project from SB 74 to H HSS.pdf |
HHSS 2/28/2017 3:00:00 PM |