03/29/2017 01:00 PM House JUDICIARY
| Audio | Topic |
|---|---|
| Start | |
| HB43 | |
| HB108 | |
| HB42 | |
| HB123 | |
| Adjourn |
+ teleconferenced
= bill was previously heard/scheduled
| + | HB 43 | TELECONFERENCED | |
| += | HB 108 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | HB 123 | TELECONFERENCED | |
| += | HB 42 | TELECONFERENCED | |
FALASKA STATE LEGISLATURE
HOUSE JUDICIARY STANDING COMMITTEE
March 29, 2017
1:02 p.m.
MEMBERS PRESENT
Representative Matt Claman, Chair
Representative Zach Fansler, Vice Chair
Representative Jonathan Kreiss-Tomkins
Representative Gabrielle LeDoux
Representative David Eastman
Representative Chuck Kopp
Representative Lora Reinbold
MEMBERS ABSENT
Representative Charisse Millett
Representative Louise Stutes
COMMITTEE CALENDAR
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
HOUSE BILL NO. 108
"An Act adopting and relating to the Revised Uniform Fiduciary
Access to Digital Assets Act."
- MOVED CSHB 108(JUD) OUT OF COMMITTEE
HOUSE BILL NO. 42
"An Act relating to seizure of property; relating to forfeiture
to the state; relating to criminal law; amending Rules 3, 4, 11,
12, 16, 32, 32.2, 32.3, 39, 39.1, and 42, Alaska Rules of
Criminal Procedure, Rules 501, 801, and 803, Alaska Rules of
Evidence, and Rules 202, 209, and 217, Alaska Rules of Appellate
Procedure; and providing for an effective date."
- MOVED CSHB 42(JUD) OUT OF COMMITTEE
HOUSE BILL NO. 123
"An Act relating to disclosure of health care services and price
information; and providing for an effective date."
- MOVED CSHB 123(HSS) OUT OF COMMITTE
PREVIOUS COMMITTEE ACTION
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
02/28/17 (H) Heard & Held
02/28/17 (H) MINUTE (HSS)
03/02/17 (H) HSS AT 3:00 PM CAPITOL 106
03/02/17 (H) Heard & Held
03/02/17 (H) MINUTE (HSS)
03/07/17 (H) HSS AT 3:00 PM CAPITOL 106
03/07/17 (H) Moved HB 43 Out of Committee
03/07/17 (H) MINUTE (HSS)
03/08/17 (H) HSS RPT 5DP 1NR 1AM
03/08/17 (H) DP: JOHNSTON, TARR, EDGMON, SULLIVAN-
LEONARD, SPOHNHOLZ
03/08/17 (H) NR: KITO
03/08/17 (H) AM: EASTMAN
03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120
BILL: HB 108
SHORT TITLE: FIDUCIARY ACCESS TO DIGITAL ASSETS
SPONSOR(s): REPRESENTATIVE(s) CLAMAN
02/08/17 (H) READ THE FIRST TIME - REFERRALS
02/08/17 (H) L&C, JUD
03/08/17 (H) L&C AT 3:15 PM BARNES 124
03/08/17 (H) Heard & Held
03/08/17 (H) MINUTE (L&C)
03/10/17 (H) L&C AT 3:15 PM BARNES 124
03/10/17 (H) Moved HB 108 Out of Committee
03/10/17 (H) MINUTE (L&C)
03/13/17 (H) L&C RPT 7DP
03/13/17 (H) DP: SULLIVAN-LEONARD, STUTES, WOOL,
JOSEPHSON, BIRCH, KNOPP, KITO
03/24/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/24/17 (H) Heard & Held
03/24/17 (H) MINUTE (JUD)
03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120
BILL: HB 42
SHORT TITLE: FORFEITURE & SEIZURE: PROCEDURE; LIMITS
SPONSOR(s): REPRESENTATIVE(s) WILSON
01/18/17 (H) PREFILE RELEASED 1/13/17
01/18/17 (H) READ THE FIRST TIME - REFERRALS
01/18/17 (H) JUD, FIN
01/23/17 (H) JUD AT 1:00 PM GRUENBERG 120
01/23/17 (H) Heard & Held
01/23/17 (H) MINUTE (JUD)
03/01/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/01/17 (H) Heard & Held
03/01/17 (H) MINUTE (JUD)
03/13/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/13/17 (H) Scheduled but Not Heard
03/22/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/22/17 (H) Heard & Held
03/22/17 (H) MINUTE (JUD)
03/27/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/27/17 (H) Heard & Held
03/27/17 (H) MINUTE (JUD)
03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120
BILL: HB 123
SHORT TITLE: DISCLOSURE OF HEALTH CARE COSTS
SPONSOR(s): REPRESENTATIVE(s) SPOHNHOLZ
02/13/17 (H) READ THE FIRST TIME - REFERRALS
02/13/17 (H) HSS, JUD
03/02/17 (H) HSS AT 3:00 PM CAPITOL 106
03/02/17 (H) Heard & Held
03/02/17 (H) MINUTE (HSS)
03/09/17 (H) HSS AT 3:00 PM CAPITOL 106
03/09/17 (H) Moved CSHB 123(HSS) Out of Committee
03/09/17 (H) MINUTE (HSS)
03/10/17 (H) HSS RPT CS (HSS) 5DP 2NR
03/10/17 (H) DP: JOHNSTON, TARR, EDGMON, SULLIVAN-
LEONARD, SPOHNHOLZ
03/10/17 (H) NR: KITO, EASTMAN
03/24/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/24/17 (H) Heard & Held
03/24/17 (H) MINUTE (JUD)
03/27/17 (H) JUD AT 1:00 PM GRUENBERG 120
03/27/17 (H) Heard & Held
03/27/17 (H) MINUTE (JUD)
03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120
WITNESS REGISTER
REPRESENTATIVE JASON GRENN
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: Presented HB 43 as prime sponsor, and read
a letter written by Jason Norris into the record.
BROOKE IVY, Staff
Representative Jason Grenn
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: During the hearing of HB 43, offered a
PowerPoint presentation.
JASON NORRIS
Unknown location
POSITION STATEMENT: During the hearing of HB 43, Representative
Grenn read a letter from Mr. Norris.
ELIZABETH KROME
Wasilla, Alaska
POSITION STATEMENT: During the hearing of HB 43, offered
support for the legislation.
MICHAEL MAHARREY
National Communications Director
Tenth Amendment Center
Lexington, Kentucky
POSITION STATEMENT: During the hearing of HB 43, offered
support for the legislation.
KEN LANDFIELD
Homer, Alaska
POSITION STATEMENT: During the hearing of HB 43, offered
support for the legislation.
STARLEE COLEMAN, Vice President of Communications
Goldwater Institute
Phoenix, Arizona
POSITION STATEMENT: During the hearing of HB 43, offered
support for the legislation.
EBRAHIM DELPASSAND, M.D.
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas
POSITION STATEMENT: During the hearing of HB 43, testified,
answered questions, and offered support for the legislation.
DEBORAH BEHR, Member
Alaska Uniform Law Delegation
Juneau, Alaska
POSITION STATEMENT: During the hearing of HB 108, answered
questions.
REPRESENTATIVE IVY SPONHOLTZ
Alaska State Legislature
Juneau, Alaska
POSITION STATEMENT: During the hearing of HB 123, spoke to
certain amendments, and answered questions.
ACTION NARRATIVE
1:02:23 PM
CHAIR MATT CLAMAN called the House Judiciary Standing Committee
meeting to order at 1:02 p.m. Representatives Claman, Reinbold,
Kopp, Fansler, and Eastman were present at the call to order.
Representatives Kreiss-Tomkins and LeDoux arrived as the meeting
was in progress.
HB 43-NEW DRUGS FOR THE TERMINALLY ILL
1:02:59 PM
CHAIR CLAMAN announced that the first 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."
1:03:23 PM
REPRESENTATIVE JASON GREEN, Alaska State Legislature, read his
testimony as follows:
So, the goal of HB 43, or "Right to Try" is to create
a legal climate in which a terminally ill patient, who
has exhausted all FDA approved treatment options, may
work with their doctor and drug manufactures to access
investigational treatments that have passed Phase 1 of
the FDA approval process, but are not yet widely
available. The Right to Try laws have now been passed
in 33 states, 15 additional states, including Alaska,
are considering the law.
Each year it is estimated that over one million
Americans die from terminally ill -- 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 the
clinical trial, it is found that fewer than 3 percent
are accepted.
In recognition of the 97 percent of patients denied
access to clinical trials, the FDA does have a program
in place for accessing investigational drugs outside
of clinical trials known as the "Compassionate Use
Program." Nevertheless, it is estimated that only
about 1,200 people make it through this arduous
federal process each year.
Given this information, the goal of HB 43 is to
provide the same access as the FDA's existing
Compassionate Use Program, but on a shorter timeline.
By ensuring -- by ensuring terminally ill patients
have more timely access to safe, but experimental
drugs in consultation with their doctor, HB 43
attempts to offer new hope when all FDA approved
options have been exhausted.
1:05:31 PM
BROOKE IVY, Staff, Representative Jason Grenn, Alaska State
Legislature, paraphrased from the sectional analysis as follows
[original punctuation provided]:
Section 1: Prohibits disciplinary action of physicians
by the State Medical Board for prescribing, dispensing
or administering an investigational drug, biological
product or device to terminally ill patients that are
ineligible or unable to participate in a current
clinical trial, have considered all other treatment
options approved by the FDA and have provided written
consent.
Defines "investigational drugs, biological products
and devices" as those that have successfully completed
Phase 1 of the FDA drug review process and remain in
ongoing Phase 2 or 3 clinical trials, but have not
been approved for general use.
Defines "terminal illness" as a disease that will
result in death in the near future or permanent state
of unconsciousness from which recovery is unlikely.
Section 2: Establishes immunity for physicians,
medical team members, manufacturers and distributors
in the case of injury or death of a terminally ill
patient from the use of an investigational drug,
biological product or device, provided informed
consent was obtained from the patient and notice of
immunity was given in advance.
Establishes immunity for physicians and manufacturers
who choose not to participate in the distribution of
an investigational drug, biological product or device.
Section 3: Amends statute limiting the sale and
distribution of new drugs (AS 17.20.110) so as not to
apply to physicians prescribing or administering
investigational drugs under the conditions established
in Section 1.
Section 4: Prohibits the Department of Health and
Social Services from requiring a licensed health care
facility to increase its services solely to
accommodate physicians prescribing, dispensing or
administering investigational drugs to a patient.
1:07:42 PM
MS. IVY turned to the PowerPoint presentation titled "House Bill
43: The Right to Try," slide 3, "FDA Drug Review Process" and
advised that it is helpful to be familiar with the different
phases of the FDA drug review process. She explained that prior
to Phase 1, sponsors of a drug are required to submit the form
"Investigational New Drug Application" or IND application, and
through this application process the FDA reviews the applicant's
pre-clinical testing results and determines whether the drug is
reasonably safe for human testing. She then moved to slide 4,
"Phase 1 - Safety" wherein Phase 1 studies occur after approval
of the IND application. These studies may be conducted on
healthy volunteer when testing Ibuprofen or an anti-
inflammatory, or individuals with specific diseases or terminal
illnesses. The goal of Phase 1 testing is to determine possible
side effects and toxicity levels, wherein Phase 1 focuses on
safety.
1:08:43 PM
MS. IVY turned to slide 5, "Phase 2- Efficacy" and advised that
Phase 2 studies begin when a drug has passed Phase 1 and is
considered relatively safe, with no unaccepted toxicity level,
wherein Phase 2 focuses on the drug's effectiveness. She turned
to slide 6, "Phase 3, and advised that if there was evidence the
drug was effective, it would progress to Phase 3. During that
phase, she explained, more information would be gained regarding
safety and effectiveness, particularly, in varying populations
or different dosages in combination with other medications.
1:09:18 PM
MS. IVY turned to slide 7, "Review Meeting & New Drug
Application (NDA" and advised that after Phase 3, sponsors of
the drug participate in a review meeting with the FDA, and the
sponsors go on to complete a form titled "New Drug Application"
(NDA). In the event the drug was approved, the sponsors could
then market their drug in the United States. From that point,
the FDA has 60 days to decide whether to officially file the
application for review and, she explained, filed applications
are generally processed within 10 months of filing. She turned
to slide 8, and said that within HB 43, the term
"investigational drug" discusses those drugs that passed the
safety testing in Phase 1, and remain in ongoing clinical trials
under Phase 2 or 3 of the FDA approval process.
1:09:44 PM
MS. IVY turned to slide 9, "Compassionate Use" and noted that
the FDA has an existing Compassionate Use Program designed for
terminally ill patients who do not have access to a clinical
trial. Within this program, patients can still access those
investigational treatments outside of the clinical trial. In
order to start this process, a patient must work with their
doctor and apply to the FDA. She commented that for years, by
the FDA's own estimate, the application form alone would take an
estimated 100 hours for the doctor to complete. Although
recently, she pointed out, the FDA made great efforts to
streamline the application process, but it is only the first
step in the process. Manufacturers must submit lengthy
documentation, and once application paperwork is complete, it
must then make its way through the FDA internal approval
process, and then to a separate institutional review board for
approval, which is often a lengthy process.
1:10:59 PM
MS. IVY turned to slide 10, "The Right to Try - A Nationwide
Effort" and reiterated that 33 states signed The Right to Try
into law, and most states have had overwhelming bipartisan and
often unanimous support.
1:11:22 PM
MS. IVY referred the members to a document titled "Clinical
Trials" included in the packets, and said that HB 43 focuses on
terminally ill patients who do not qualify for clinical trials.
The sponsor included these Alaskan stories to illustrate local
experiences with terminal illness, as well as the benefit of
simply having access to new treatment options, whether in a
clinical trial or not.
CHAIR CLAMAN opened public testimony on HB 43.
1:12:40 PM
JASON NORRIS, was unavailable and Representative Grenn read Mr.
Norris's letter into the record, as follows:
I write to you today in support of HB 43, with the
short title "New Drugs for the Terminally Ill." I
understand that your time is limited and; therefore,
I'll make an effort to be as brief as possible.
In June of 2011, my father was diagnosed with ALS,
sometimes known as Lou Gehrig's disease. For those
unfamiliar, this disease slowly saps a person's
ability to move, rendering them bedridden. Eventually
it takes away their ability to breathe, at which point
they die. It should be noted that this disease does
not affect a person's mind; therefore, they are
acutely aware of their daily deterioration, and
because of this the mind becomes a prisoner within the
body. For my father, this began in June with a
reduced range of motion in his left leg. At this
point he had been working 12-hour days, 5-6 days a
week, per week as a machinist. I feel this is
important to point out because of the extended hours
and physical nature of the job. He was, by all
accounts, a very strong and healthy man at the time of
diagnosis. But, by late fall he had completely lost
his ability to walk, and at Thanksgiving he held our
5-month old son for the last time in his arms as he
became too weak to trust him with such precious cargo.
When he finally lost all movement in his limbs, he
would hug our children by nuzzling his face against
them. As we entered into the depths of winter, he and
I carried on what conversations we could, trying to
accelerate what should have been more years of passing
knowledge and wisdom from father to son. These
conversations became increasingly difficult as the
disease made his breathing quite labored, even with
the assistance of a BiPAP machine. While the painful
and emotional moments are too many to list, the most
painful came when I asked him a simple question: "Dad,
are you angry?" He responded with uncommon grace and
humility by uttering one word with every labored
breath, "I'm not angry, I'm just sad that I won't see
your kids grow up." And, in the early morning of
February 1, 2012, he died at the all too young age of
58.
My father was a good man and my hero, he was a
tireless worker, and a great role model, and an
unparalleled family man. He took a chance on Alaska
in 1996, when he moved his family from the only home
he had only known to a place that we had no
connections, no network, no family, and no friends.
The gamble paid off for all of us. He saw the
potential in this state, he fought like we all do to
make a life here, and in the end I wish the state had
afforded him the right to fight this disease with the
same ferocity.
Recently, in the Washington Post there was an article
detailing the experience of a man who had for all
intents and purposes beaten ALS through advanced
therapies pioneered by doctors at the ALS Center, in
Atlanta, Georgia. In reading about this man I became
aware of the Right to Try movement. Soon thereafter,
I became aware of the bill of which I write to you in
support of today. I implore you to pass this bill and
encourage your colleagues in the Senate to do the
same. I cannot say that these advanced therapies
would have helped save my father's life, but they may
yet save someone else's father, mother, daughter, or
son. Thank you for your consideration on this
important legislation.
1:15:56 PM
ELIZABETH KROME said she supports HB 43, has been a licensed
nurse since 1979, and practiced in a hospital setting for 30
years. Hope is one thing all humans require, she said, after
being diagnosed with a terminal condition some patients hope for
a peaceful death at home, for others their hope is to live to
see the birth of a grandchild, or a child graduating from high
school. Hope is so very important to individuals, she pointed
out, and the Right to Try allows a treatment that may or may not
prolong a life, and allows hope to continue. She said she would
love to see Alaska give individuals the right to try, and to
give them hope for the next stage of their life no matter what
it might be.
1:18:03 PM
MICHAEL MAHARREY, National Communications Director, Tenth
Amendment Center, said his organization has supported this
legislation across the United States since its beginning, and he
called it "our no brainer issue." Law and regulations are
supposed to protect people, but the regulatory scheme tends to
create bureaucracy and red tape that can cause harm. Even with
the FDA's expanded use program, it does not begin to address the
black hole between the end of clinical trials and the final
approval of treatment. This process can take up to 10 months,
leaving patients in limbo and between the end of clinical trials
and the final approval, patients do not have any alternatives.
He offered a situation wherein more than 70 Texas cancer
patients and a doctor began clinical trials when the doctor
found a successful treatment for a specific type of cancer, and
when the clinical trials were close to the end, the FDA still
hadn't given final approval for the drug. He remarked that the
FDA basically told the doctor he had to stop treating his
patients, except he was able to begin treating them under the
Right to Try new state law in Texas. Mr. Maharrey related that
Right to Try has been so successful in the State of Texas that
the Texas legislature is considering a bill to include
chronically ill patients. This type of legislation illustrates
the "beauty of our federated structure" wherein the American
system was never to run based on a one-size fits all solutions
imposed from Washington, D.C., he pointed out. In conclusion,
he said, Right to Try is a specific example of states using
their rightful authority to exercise control over local issues,
and if Right to Try helps even one Alaskan patient, it is worth
putting this legislation on the books.
1:20:43 PM
KEN LANDFIELD said he was not aware of any downside to enacting
this legislation, and the idea of creating false hope appears
disingenuous as terminal is terminal. This is an easy call and,
he pointed out, within the Constitution of the United States
there is a guarantee for the right to the pursuit of happiness
and it appears making potentially lifesaving medications
available would fall under that category, he said.
1:22:18 PM
STARLEE COLEMAN, Vice President of Communications, Goldwater
Institute, advised that the Goldwater Institute crafted the
model Right to Try law upon which this bill is based. She
offered that it is important for Alaskans to understand that the
organization reached out to doctors at major research facilities
across the country as to why they don't use the FDA's existing
Compassionate Use Program. She said that one of the best
examples of why, was from a doctor who had previously run
clinical trials for the Indy Anderson Cancer Center in Houston,
Texas, and this doctor advised that she was possibly able to get
one person each year through the FDA's expanded process. Ms.
Colman said that if only one person a year, at the largest
cancer trial center in the world, can get access to a drug
through the FDA's process, imagine what it is like for a person
in Alaska who has seen the community oncologist who has never
run a clinical trial and doesn't know who to call at the FDA.
The chances are not good that this patient would be helped
through this program because the FDA program is actually for
patients being treated at major research hospitals performing
clinical trials all the time, they know who to call and how to
navigate that system. She commented that it is not for regular
people, although it is known that Right to Try is already
working in Texas, Oregon, and Florida in accessing new treatment
options. These are real people with real families who need
help. She said she had received updated information and Right
to Try has now been adopted in 34 states due to the State of
Kentucky. She remarked that "no one who is dying expects that
an investigational treatment will cure them," but they want the
right to try and the choice to take the same medication used in
clinical trials. The Goldwater Institute believes that dying
people and their families are owed that opportunity, she said.
1:25:32 PM
CHAIR CLAMAN, after ascertaining no one wished to testify,
closed public testimony on HB 43.
1:25:42 PM
REPRESENTATIVE LEDOUX apologized for coming in late and asked
how a person is able to receive the experimental drugs.
MS. IVY responded that the FDA has a Compassionate Use Program
wherein a person can apply to for investigational drugs in
conjunction with their doctor. Currently, she explained, it is
an application process, and once the application has been turned
in, the FDA has up to 30 days to review the application and, in
the event a question comes up during the 30 day period, the 30
day clock can be reset. After that point, if the patient
receives approval from the FDA, the patient and their doctor
must seek out an external institutional review board (IRB), and
"they have no requirements" when they have to get back to the
person or approve the application. In the event the review
board only meets every six months, the patient would have to
wait for the review and approval of the request. She said that
outside of a clinical trial, that is the only way a person could
access those investigational drugs.
1:27:12 PM
REPRESENTATIVE LEDOUX noted her understanding that HB 43 would
not subject a doctor to disciplinary action, and asked how would
a person obtain the drugs and from what manufacturer.
MS. IVY explained that to be eligible, a patient must be
diagnosed as terminally ill, their doctor has exhausted all
other treatment options for whatever terminal illness they have,
and they've attempted to access a clinical trial. After all of
those steps have been taken, the person or doctor would contact
the manufacturer and request its consent to providing that
medication, outside of the clinical trial, with the
Compassionate Use Program. The person, their doctor, and the
manufacturer would all have to consent to that relationship, she
said.
1:28:36 PM
REPRESENTATIVE LEDOUX asked whether this type of legislation was
law in other states, and inquired as to how cooperative the drug
companies are to dispensing the drugs under the circumstances in
which these types of laws have been enacted.
MS. IVY responded that similar Right to Try laws have passed in
34 states, and are pending in 14 states, including Alaska. She
acknowledged that no action could be taken to force a drug
manufacturer to provide access to the medication.
Interestingly, she offered, due to a new federal law, drug
manufacturers are required to list drug on their websites to
make the drug more accessible if the drug manufacturer
participates in the Compassionate Use Program, and also lists
who to contact. She said it is becoming more accessible for
those seeking access to the Compassionate Use Program and those
seeking access outside of that program, she said.
1:29:57 PM
REPRESENTATIVE LEDOUX questioned whether any of these drugs are
available in other countries, even when they haven't been
approved by the FDA.
MS. IVY described Representative LeDoux's question as powerful
because when discussing this legislation people are thinking
about experimental drugs the nation had never seen before, but
some of the treatments going through the FDA approval process
are currently in use. For example, in Europe cancer treatments
have been in use for 15 years successfully, but those treatments
still have to go through the FDA process, which could take
anywhere from 10 - 15 years to reach approval. In the event a
treatment passes Phase 1 of the FDA process, per this
legislation, a person would be able to work with their doctor
and the manufacturer to access that treatment.
REPRESENTATIVE LEDOUX referred to drugs available in other
countries which are unavailable from the United States
manufacturers, and asked what it would take to import those
drugs as she assumed this bill doesn't do it.
MS. IVY replied that she was unsure that would be legal under
federal law, and the patient would have to travel to that
country to utilize the drug.
1:32:33 PM
EBRAHIM DELPASSAND, M.D., Excel Diagnostics & Nuclear Oncology
Center, said his specialty is Nuclear Oncology, and he is a
professor at the University of Texas, Department of Radiation
Oncology. He commented that Houston, Texas has been using Right
to Try to offer high power targeted radiation nuclear therapy
for a (indisc.) cancer, which are rare cancers in terms of other
common cancers such as, breast, prostrate, or colon cancer.
There is a special targeted therapy that was given to patients
more than 10 years ago in Europe, and his patients had to travel
to Europe to receive those treatments. In 2007, he found an
investigation for new drug applications with the FDA to offer
these treatments in Houston. He said it took him approximately
2.5 years to go through the FDA process and receive approval to
start the investigation of trial to give patients access to
these treatments. He explained that he received permission from
the drug's owner to start these trials in the United States
because, at that time, the drug was not ready to start a trial.
He said they went through all of the hoops, and finally made the
treatments available to their patients with the FDA's "sort of
approval," and in 2015, their Investigational New Drug
Application (IND) was active at his center for treatment of
these patients. Initially, he advised, he requested the
treatment for 60 patients, then increased it to 100 patients,
and then 150 patients. In February 2015, as the center was
moving closer to a 150 patient enrollment, he requested another
100 patients from the FDA because the drug was still not
commercially available. The FDA responded that it did not want
him to increase the number, not due to complaints because his
patients had good responses, the drug had a very good safety
profile, and there were many peer reviewed medical publications
on this drug from other centers, but rather because it felt that
would affect the commercialization of the drug and "This is why
you have to stop." He said he advised the FDA that
investigation of trial approval for this drug had already
completed enrollment, and actually his center was one of the
main contributors to that clinical trial so there was no way his
continuation of treating these patients would have an effect on
the commercialization of the drug. (Indisc.) to continue our
treatment while the FDA had essentially stop them from providing
these treatments to the patients. He pointed out that this is
one of the scenarios in which the Right to Try laws can help
patients receive their treatments while the FDA reviews all of
the data to approve the drug and then later commercialize. He
stressed that this is the gap in which patients will benefit
from this law in receiving their medication if it is available
to them.
1:38:25 PM
REPRESENTATIVE KOPP referred to Dr. Delpassand's testimony
regarding the FDA's decision affecting the commercialization of
the drug, and asked whether he had ever witnessed the FDA
colluding with pharmaceutical companies. Especially in the area
of expediting or delaying approvals of investigational drugs
through Phases 1-3 of clinical trials that Dr. Delpassand
believed were harmful to a patient's interest.
DR. DELPASSAND responded that the nature of the overall process
in obtaining approval has been a lengthy process, and there are
several reasons for that, such as, some clinical trials require
follow up information and the long term effect on the patient,
especially when discussing oncology and cancer. He related that
that is the nature of clinical trials because the FDA wants to
be sure the drug is safe and also effective. He explained there
are several reasons for that length of time because after a
review of considerable data, the final package is submitted to
the FDA, and thereafter, he said, it sometimes takes between 12
and 18 months until the FDA is actually able to review the
entire data and come back with its opinion as to whether it
approves or does not approve the drug. It is this period of
time wherein lies the problem, especially if the drug had
already shown effectiveness, had many publications in the
oncology community, or whatever physicians groups, and this drug
becomes common knowledge because then patients come in and ask
for the drug. The physician, knowing this drug could help their
patient, has nothing to offer because the drug had not yet been
approved and this is how Right to Try law comes into play in
certain situations. He stressed that this law does not, by any
means, provide a shortcut or cutting of corners for the FDA, or
any kind of due diligence in terms of making sure the drug is
safe and effective.
1:42:09 PM
REPRESENTATIVE FANSLER asked whether the exact bill was passed
in every state.
MS. IVY answered that most of the other versions included the
same FDA criteria, but there were different elements in each
state.
1:43:05 PM
REPRESENTATIVE FANSLER referred to a letter, in the committee
packet recommending adding amendments, and also changing the
definition of terminal illness, and he asked Ms. Ivy's response
to the letter.
MS. IVY pointed to the [3/7/17] letter from Premera, Blue Cross
Blue Shield of Alaska, and offered that the first two
suggestions were clarifying language in that a patient's health
care insurance plan was not required to cover the
investigational drugs or its possible adverse effects. She said
that coverage is not required under federal or state statute at
this time, it could be included for clarification purposes, but
it is not something the sponsor is requiring in this
legislation. Also, she noted, part of the written informed
consent form required in the bill involves a conversation
between a patient and their doctor regarding the lack of
coverage for the investigational drug, which is FDA guidance on
those informed consent forms. The third recommendation had to
do with "what they may not deny coverage for," and the sponsor's
reading was that it may add additional protections to the bill
for the patient in that, "a health insurer may not deny coverage
to a patient for pre-existing conditions, benefits that accrued
before the day in which the patient was treated with the
unapproved investigational drug or palliative care for a patient
previously treated who is no longer currently using the
investigational drug." She opined that a "majority of this" was
already mandated in the Affordable Care Act; however, it could
be something the committee could consider including if it wanted
to look down the road whether there may be changes at the
federal level. She advised that the sponsor's office spoke with
Legislative Legal and Research Services regarding this language
and it didn't indicate there were particular risks involved in
including the language. Finally, she advised, the definition
Premera, Blue Cross Blue Shield of Alaska suggested would
streamline it with Medicare's definition of terminal illness and
limit it to those who may die within the next six months. She
explained that the sponsor believes the definition is narrow in
that if a terminally ill patient was given seven months to live,
they would not be eligible to participate under the Right to Try
laws. The sponsor could not see this narrow definition, even
though the Compassionate Use Program, and he does not
necessarily support that amendment.
1:46:33 PM
REPRESENTATIVE FANSLER thanked Ms. Ivy for the map because it
depicted the almost universal acceptance of this program, and
noticed that Hawaii vetoed the legislation. He asked whether
she had any information as to the veto.
MS. IVY answered that previously, California Governor Jerry
Brown had vetoed the Right to Try law, and later the legislation
was brought forward again and Governor Brown changed his mind
based on its success stories. As far as Hawaii, Governor David
Ige, in his veto statement listed four reasons, as follows: the
Compassionate Use Program already existed and provided access;
this could interfere with the overall FDA system which may have
unintended consequences in delaying development of potentially
lifesaving drugs, of which the bill sponsor would argue that
this doesn't impact the Phases 1-3 clinical trial process; it
violated the Supremacy Clause; and, he was unclear as to the
actual benefits to the patient.
MS. IVY, in response to Representative Fansler, agreed to
provide the committee with Dr. Delpassand's written testimony.
1:49:50 PM
MS. IVY, in responded to Representative Reinbold, answered that
this bill is limited solely to the Right to Try in
pharmaceuticals.
REPRESENTATIVE REINBOLD commented that she was in pharmaceutical
sales for almost 10 years in Alaska, and in response to
Representative LeDoux's previous question, answered that within
the company she worked for, it took approximately 17 years to
move from inception to the FDA's final approval. In getting
Alaskans on clinical trials, the company had to compete with big
states because it is easier to have many patients in a
concentrated effort. She encouraged continued vetting and
related that the comment about giving "false hope" was valid.
Recently, she said, a friend was put on a clinical trial in
California, was given great hope that this would be a successful
drug for her, and it ended up that there was no result at all.
She said she appreciates the bill coming forward and that this
is an opportunity for Alaska to participate.
1:52:54 PM
REPRESENTATIVE EASTMAN commented that with the success of this
legislation in 34 states, and states trying to expand the
program to the chronically ill, asked the sponsor's perspective
on an amendment that may expand it to the chronically ill based
upon its success.
MS. IVY responded that Texas is the one state looking at
potentially expanding the definition of terminal illness to
debilitating diseases due to the law's successes. The Goldwater
Institute offered concerning regarding that concept and
preferred the initial narrow definition move forward before
looking to expand because it was a new process throughout the
different states. Additionally, she said, there is the
potential for a court challenge, and the bill sponsor is trying
to target the existing access through the Compassionate Use
Program and streamline that timing. Expanding the definition,
she pointed out, could potentially get into questions as to
whether the legislation was taking on the FDA's process on a
larger scope, and how far to expand that definition. She
offered that it is a policy call, and at this time the sponsor
would prefer to stay within the more narrow definition of
terminal illness.
1:54:56 PM
REPRESENTATIVE EASTMAN acknowledged there are several parallels
with this bill and a separate bill making its way through the
legislature in dealing with assisted suicide. Due to the bills
being similar, he asked the sponsor's thoughts as to inserting
language into the bill to make clear that is definitely not the
direction of this bill.
MS. IVY advised that it is the sponsor's position that these
bills are different as to intent because the issues are Right to
Die and Right to Try; however, the sponsor is open to
discussions regarding adding clarifying language.
1:55:52 PM
REPRESENTATIVE LEDOUX noted that she was late attending this
hearing, that some of her questions may have already been
answered, and asked the committee's indulgence. She then asked
whether there had been any organized opposition to this
legislation, or organized opposition to similar bills in other
states.
MS. IVY answered, not to her knowledge in Alaska, but nationally
there had been concern over creating false hope. Some
individuals, in response to that concern have said, "It's better
to have some hope than no hope at all." The Alaska Medical
Board and the Commission on Aging offered letters of support,
and as to the national support, she said she would defer to
Starlee Coleman at the Goldwater Institute.
1:56:47 PM
REPRESENTATIVE LEDOUX noted that either Aetna Insurance or
Premera Blue Cross Blue Shield of Alaska had suggested an
amendment, and asked the sponsor's view of that amendment.
MS. IVY pointed to the 3/7/17 letter from Premera Blue Cross
Blue Shield of Alaska that Representative Fansler had previously
inquired about, and explained that the first two suggested
amendments may be unnecessary as they are not currently
requiring insurers to cover investigational drugs under federal
or state statute. The third suggestion could add additional
protections if that was the will of the committee, but
currently, some of these are mandated by the Affordable Care
Act. She advised that in terms of narrowing the scope of the
definition of terminal illness, the sponsor does not support
that suggestion.
[HB 43 was held over.]
HB 108-FIDUCIARY ACCESS TO DIGITAL ASSETS
1:58:34 PM
CHAIR CLAMAN announced that the next order of business would be
HOUSE BILL NO. 108, "An Act adopting and relating to the Revised
Uniform Fiduciary Access to Digital Assets Act." [Before the
committee was CSHB 108, Version U.]
CHAIR CLAMAN advised that this is the second hearing on the bill
and being the sponsor of the bill, passed the gavel to Vice
Chair Fansler for the duration of the hearing on HB 108.
[Chair Claman passed the gavel to Vice Chair Fansler.]
1:58:58 PM
VICE CHAIR FANSLER advised that committee members did not submit
amendments for HB 108, Version U, and asked whether there was
further discussion.
REPRESENTATIVE KOPP asked whether there had been any organized
opposition to HB 108.
2:00:09 PM
DEBORAH BEHR, Member, Alaska Uniform Law Delegation, answered
that this legislation has passed in 24 states, pending in 18
states, and of those 18 states, 2 are on the governors' desks.
She offered that there had been no organized opposition on
Google or Facebook, the industry, senior groups, or AARP Alaska,
and that a major trust company in Alaska supports it. She
continued that she was unaware of anyone raising any objection
to HB 108.
VICE CHAIR FANSLER asked for final comments from the members,
and seeing none, he asked for a motion.
2:01:09 PM
REPRESENTATIVE KREISS-TOMKINS moved to report CSHB 108, Version
30-LS0210/U, out of committee with individual recommendations
and the accompanying fiscal notes. There being no objection,
CSHB 108(JUD) passed from the House Judiciary Standing
Committee.
[Vice Chair Fansler passed the gavel back to Chair Claman.]
HB 42-FORFEITURE & SEIZURE: PROCEDURE; LIMITS
2:01:46 PM
CHAIR CLAMAN announced that the next order of business would be
HOUSE BILL NO. 42, "An Act relating to seizure of property;
relating to forfeiture to the state; relating to criminal law;
amending Rules 3, 4, 11, 12, 16, 32, 32.2, 32.3, 39, 39.1, and
42, Alaska Rules of Criminal Procedure, Rules 501, 801, and 803,
Alaska Rules of Evidence, and Rules 202, 209, and 217, Alaska
Rules of Appellate Procedure; and providing for an effective
date." [Before the committee was CSHB 42, Version U.]
CHAIR CLAMAN advised as follows: this is the fifth hearing on
this bill; Amendments 1, 2, and 3, were adopted; Amendment 4
failed; and Amendments 5 - 7 were withdrawn. Since the last
hearing he worked with committee members, the Department of Law,
and the bill sponsor to re-draft Amendment 4, which was before
the committee as Amendment 8.
2:02:24 PM
REPRESENTATIVE LEDOUX moved to adopt Amendment 8, Version 30-
LS0193\U.12, Martin, 3/28/17, which read as follows:
Page 7, line 5:
Delete all material and insert:
"(4) obtained the property
(A) as a bona fide purchaser for fair market
value;
(B) by inheritance before the date of the
offense resulting in forfeiture;
(C) as a gift from a person other than the
defendant; or
(D) lawfully in a manner the court considers
just."
CHAIR CLAMAN there being no objection, Amendment 8 was adopted.
2:02:45 PM
REPRESENTATIVE EASTMAN commented that with all of the changes to
this bill he was unsure it accomplished everything within the
original bill; however, he was hopeful that with passage of this
bill "we can take a small step closer to where we want to be."
REPRESENTATIVE KOPP said he appreciated the team effort in
moving this bill forward. Although, it may not have
accomplished everything in the bill, he pointed out that not
everything intended in the bill was beneficial overall to good
public policy. Certainly, he said, the bill sponsor's intent
was to make sure there was due process any time there was a
seizure of property and forfeiture, and great strides were taken
in that direction.
2:04:16 PM
REPRESENTATIVE FANSLER moved to report CSHB 42, Version 30-
LS0193\U, Martin, 3/20/17, out of committee with individual
recommendations and the accompanying fiscal notes. There being
no objection, amended CSHB 42(JUD) passed from the House
Judiciary Standing Committee.
HB 123-DISCLOSURE OF HEALTH CARE COSTS
2:04:48 PM
CHAIR CLAMAN announced that the final order of business would be
HOUSE BILL NO. 123, "An Act relating to disclosure of health
care services and price information; and providing for an
effective date." [Before the committee was CSHB 123, Version D.]
2:05:27 PM
REPRESENTATIVE KREISS-TOMKINS requested that Amendment 1 be
moved to the bottom of the amendments stack because he recently
received "fresh data" he would like to circulate amongst the
committee members and the bill sponsor.
2:05:48 PM
REPRESENTATIVE REINBOLD moved to adopt Amendment 2, Version 30-
LS0380\I.3, which read as follows:
Page 3, line 18, following "municipal,":
Insert "federal,"
Page 3, line 24:
Delete ""health care facility" does not include"
Page 3, line 25, through page 4, line 3:
Delete all material.
REPRESENTATIVE FANSLER objected.
2:06:16 PM
REPRESENTATIVE REINBOLD noted that during her discussion with
the sponsor she mentioned this amendment and the sponsor did not
offer opposition. This amendment, she explained, removes the
federal exemption and keeps everyone on the same page.
2:06:41 PM
The committee took a brief at-ease.
2:09:13 PM
CHAIR CLAMAN noted that the initial question of Representative
Reinbold was whether the bill sponsor supported or did not
support Amendment 2.
2:09:51 PM
REPRESENTATIVE IVY SPONHOLTZ, Alaska State Legislature, said she
does not support Amendment 2 because it is in conflict with the
Supremacy Clause of the United States Constitution [Article VI,
Clause 2], which read as follows:
This Constitution, and the laws of the United States
which shall be made in pursuance thereof; and all
treaties made, or which shall be made, under the
authority of the United States, shall be the supreme
law of the land; and the judges in every state shall
be bound thereby, anything in the Constitution or laws
of any State to the contrary notwithstanding.
REPRESENTATIVE SPOHNHOLZ continued that there is not a bright
line separating government institutions from private
institutions in this bill, but rather it separates out federally
funded organizations. She opined it would put the state in the
position of defending costly lawsuits which is not in the best
interests of the state.
2:10:48 PM
REPRESENTATIVE REINBOLD said that her impression, during their
discussion on this bill, was that Representative Spohnholz did
not have any strong feelings one way or another. She stressed
that federal dollars are private tax dollars; therefore, the
private sector dollars would fund public facilities, and this
amendment eliminates exemptions for public facilities funded by
private dollars. Also, she commented, sometimes with state
facilities there are matches, such as Medicaid dollars, which is
also the peoples' money. She opined that, at a minimum, it is
only fair that public facilities be on the same playing field as
the private sector.
2:12:12 PM
REPRESENTATIVE LEDOUX related that she understands page 3, line
18, and inserting federal, but she doesn't follow when it comes
to [Section 1, AS 18.15.360(h)], page 3, lines 24-25, and page
4, lines 1-3, which read as follows:
(A) the Alaska Pioneers' Home and the
Alaska Veterans' Home administered by the department
under AS 47.55;
(B) an assisted living home as defined
in AS 47.33.l990;
(C) a nursing facility licensed by the
department to provide long-term care;
(D) a facility operated by an Alaska
tribal health organization; and
(E) a hospital operated by the United
States Department of Veterans Affairs or the United
States Department of Defense, or any other federally
operated hospital or institution;
REPRESENTATIVE LEDOUX asked how a nursing facility licensed by
the department to provide long-term care would be federal.
2:12:59 PM
REPRESENTATIVE SPOHNHOLZ answered "that it is not," and
clarified that she was speaking to the first section of which
inserts "federal." The second section would delete out the
Pioneers' Homes, Veterans' Homes, assisted living homes, and
nursing facilities, in particular. She said she chose not to
include those facilities because everyone living in those
facilities knew exactly what their stay would cost, no one goes
into a long term care facility or the Pioneers' Home without
knowing the exact daily cost. Therefore, having it posted on
the wall was not additional information. In the case of the
tribal health organizations and subparagraph (E), it was her
understanding that the tribal health organizations were largely
federally funded, and she actually received verbal feedback that
a lawsuit would probably ensue because it viewed itself as part
of a federal entity. She said she chose not to take that on
because her primary focus was on the individual marketplace and
having the most opportunity to make a big difference.
2:15:04 PM
REPRESENTATIVE LEDOUX referred to a nursing facility licensed by
the department to provide long term care, and opined that with
some of these facilities possibly basic "stuff" was provided,
but there's the "other stuff" that's provided upon request for
necessity. She said she was thinking of her folks in
California, when her father broke his hip he went into a long
term care facility and was billed for specific services. It
wasn't just that he had to pay "X" amount of dollars in order to
enter the place, and she asked how the facilities are run in
Alaska.
REPRESENTATIVE SPOHNHOLZ opined that the facilities tend to be
that the patient pays for the level of care they need, there may
be some individual distinctions, but the pricing tends to be
based on the level of care for the patient. She explained there
are different pricings for different levels of care, and
generally speaking, the patient knows the cost, and their bill
doesn't change dramatically from one month to another, unless
there was a major medical event. She explained that she was not
discussing that level of care, but rather care such as, routine
and/or elective care when going to the traditional health care
provider. It was her intent, she said, to focus in on that
routine and/or elective care, of which makes up the bulk of the
particular kind of marketplace this bill could influence.
2:18:06 PM
REPRESENTATIVE KOPP referred to Amendment 2 and inserting the
word "federal," and noted that any person or provider eligible
under the federally funded Indian Health Service program does
not compete in the marketplace with respect to price
transparency. Also, with respect to the word "federal," how
would this impact military hospitals, such as the hospital on
Joint Base Elmendorf-Richardson (JBER). He said he was not
familiar with how TRICARE works currently, and opined that with
the intent being marketplace transparency he was unsure how it
aligned with a military hospital posting a price disclosure.
2:19:26 PM
REPRESENTATIVE SPOHNHOLZ remarked that they were discussing two
distinct elements when talking about this one specific
population served through TRICARE, the Veterans Affairs, or the
United States Department of Defense (DoD) delivered health care
services. In the case of the federal facilities operated on
bases, or just outside of the military bases in the case of the
Department of Veterans Affairs, those are excluded on page 4,
lines 1-3, [subparagraph (E)], which read as follows:
(E) a hospital operated by the United States
Department of Veterans Affairs or the United States
Department of Defense, or any other federally operated
hospital or institution;
REPRESENTATIVE SPOHNHOLZ pointed out that those were treated as
separate because they are federal institutions. Although, in
the event a veteran with TRICARE received approval for some sort
of care outside of the military system and visited a private
provider in the marketplace, the veteran should be able to see
that information. TRICARE can be used within the private
market, with some restrictions outside of military
installations, but she said she did not know all of the details.
2:20:51 PM
REPRESENTATIVE KOPP referred to Amendment 2, page 1, lines 4-5,
deleting subparagraphs (D) and (E), and asked whether there
would be a problem leaving subparagraphs (A), (B), and (C).
REPRESENTATIVE SPOHNHOLZ advised that the way the bill was
drafted was actually the inverse because ...
REPRESENTATIVE KOPP clarified that he asked the question
backwards.
REPRESENTATIVE SPOHNHOLZ responded that she did not object to
his suggestion, although she did not believe anyone moves into
an assisted living home without first receiving the exact cost,
how they are charged for services, and how the services will be
paid. Therefore, she remarked, the need for transparency was
not the same when compared to the needs at the Pioneers' Home or
an assisted living home, and walking into an emergency room at
the hospital and considering an MRI, or to the local doctor for
additional bloodwork.
2:23:01 PM
CHAIR CLAMAN explained that when his family had to determine
which assisted living community center would be best for his
parents, his siblings talked to approximately four and six
different assisted living centers, and they knew the exact price
for each center.
2:23:54 PM
REPRESENTATIVE EASTMAN referred to federal jurisdiction and
opined that it made sense for the Department of Veterans Affairs
to determine what goes on in its facilities, and to keep those
standards consistent state-to-state. Which, he commented, is
different from the federal medical facilities not competing with
the private sector in the marketplace because they absolutely do
compete in this state. For example, he said, the Alaska Native
Medical Center (ANMC) provides treatment for federally eligible
beneficiaries and also any number of different people. It is
the only hospital in Anchorage with the ability to serve
multiple trauma cases simultaneously, and it can compete with
other aspects of the private sector. He offered concern with
the idea that transparency was needed for all of the various
facilities covered under this bill because transparency was
already working well, such as with a senior center. He said he
hoped for consistency and equity in applying these requirements
to everyone in Alaska, and if the legislature made the
requirement to post prices, that requirement should be made for
everyone regardless of the facility. In the event the word
"federal" was not inserted at line 18, he said, there would be
no need for any of the federal references in subparagraphs (D)
or (E.
2:31:21 PM
REPRESENTATIVE FANSLER related that he could see a difference
between subparagraphs (A), (B), and (C), and what this bill was
attempting to provide in that he could not walk into an assisted
living facility and have his broken arm examined unless he lived
there. The bill encourages transparency in the situation of an
elective surgery and the patient would know where they would
want to go based on that transparency. As for subparagraphs (D)
and (C), he could see their complete difference, obviously, with
the Supremacy Clause. Perhaps, he suggested, when facilities
are required to post fees, if the federal facilities suddenly
were no longer taking in the patients they once did because it
didn't have that transparency, he pointed out, that chances are
that the free market would pull them into the transparency on
its own.
2:33:10 PM
REPRESENTATIVE REINBOLD offered that she was open to a friendly
amendment, but in reviewing the Supremacy Clause she would like
the Department of Law to weigh in. She opined that the
Supremacy Clause had nothing to do with this and that it was an
overuse of that clause. However, she said she would go to the
United States Constitution, Amendment IX and X, which read as
follows:
Amendment IX
The enumeration in the Constitution, of certain
rights, shall not be construed to deny or disparage
others retained by the people.
Amendment X
The powers not delegated to the United States by the
Constitution, nor prohibited by it to the states, are
reserved to the states respectively, or to the people.
REPRESENTATIVE REINBOLD asked whether it was the sponsor's
intention that the private sector be required to publically post
their CPT codes and fees, while the public sector, using private
sector dollars, would not be required to post those codes and
fees.
2:34:23 PM
REPRESENTATIVE SPOHNHOLZ pointed out that page 3, lines 18-24,
read as follows:
(2) "health care facility" means
private, municipal, or state hospital, psychiatric
hospital, independent diagnostic testing facility,
residential psychiatric treatment center ...
REPRESENTATIVE SPOHNHOLZ continued that it is a long list,
several of which include public entities. She pointed out that
she had said several times that the distinction was not between
public and private institutions. She reiterated that the only
entities carved out, specifically due to the Supremacy Clause,
are federal in nature, and she stressed that was the only
distinction.
REPRESENTATIVE REINBOLD asked that the Department of Law weigh
in on the Supremacy Clause because she believed it was a misuse
of the Supremacy Clause.
2:35:09 PM
REPRESENTATIVE LEDOUX pointed out that she did not pretend to be
an expert in the Supremacy Clause, but there is a long line of
judicial precedent stating that the state can't make the federal
government do things. For example, she said, the state cannot
tax the federal government, and while the states do not always
have to adhere to what the federal government tells them what to
do, the state cannot make the federal government do things.
2:35:53 PM
CHAIR CLAMAN commented that he completely agrees with
Representative LeDoux about the Supremacy Clause, and as he
offered during the last hearing, he intends to move this bill
out of committee today. He pointed out that the question of the
Supremacy Clause came up during the last hearing on this bill
and Representative Reinbold could have followed up with the
Department of Law or Legislative Legal and Research Services
before today. He stated that there was no reason to call
Legislative Legal and Research Services during this hearing
because the courts have consistently ruled, again and again,
exactly as Representative LeDoux described.
REPRESENTATIVE REINBOLD argued that it is important for the
Department of Law or Legislative Legal and Research Services to
weigh in on the Supremacy Clause, and the committee needs to
discuss the Constitution of the United States, Amendments IX and
X. She then described herself as a federalist "and I do believe
that the -- the rights that are not absolutely specifically ...
and I see nothing in the constitution that says that -- that
they can't, you know, post, or they shouldn't be transparent
with -- with public dollars. It just -- it just seems to me
outlandish to be using that Supremacy Clause in this case." She
said the committee needs [this bill] to be on a fair playing
field.
2:38:27 PM
A roll call vote was taken. Representatives Eastman and
Reinbold voted in favor of adopting Amendment 2.
Representatives Fansler, Kopp, Kreiss-Tomkins, LeDoux, and
Claman voted against it. Therefore, Amendment 2 failed to be
adopted by a vote of 2-5.
2:39:07 PM
REPRESENTATIVE REINBOLD moved to adopt Amendment 3, Version 30-
LS0380\I.4, which read as follows:
Page 1, line 1, following "information;":
Insert "relating to health care insurers;"
Page 2, line 1, following "AS 18.23.400":
Insert "and AS 21.96.125"
Page 4, following line 21:
Insert a new bill section to read:
"* Sec. 3. AS 21.96 is amended by adding a new
section to read:
Sec. 21.96.125. Disclosure of health care
services and price information by health care
insurers. (a) A health care insurer shall annually
(1) compile a list describing, by procedure
code, including a brief description in plain language
that an individual with no medical training can
understand, the 50 most common health care services
covered by the insurer in this state in the previous
calendar year and the total cost to the insurer for
each of those health care services during that period;
(2) publish and update the list on the
insurer's Internet website by January 31 each year;
and
(3) submit the list by January 31 each year
to the Department of Health and Social Services for
entry in the database under AS 18.15.360(a).
(b) The Department of Commerce, Community, and
Economic Development may adopt regulations under
AS 44.62 (Administrative Procedure Act) to implement
this section.
(c) A health care insurer that fails to comply
with the requirements of this section is liable for a
civil penalty. The Department of Health and Social
Services may impose a civil penalty of not more than
$150 for each day after March 31 that a health care
insurer fails to provide and post information as
required under (a) of this section. The total penalty
may not exceed $2,500. A person penalized under this
subsection is entitled to a hearing conducted by the
office of administrative hearings under AS 44.64.
(d) In this section,
(1) "health care insurer" has the meaning
given in AS 21.54.500;
(2) "health care service" has the meaning
given in AS 18.23.400;
(3) "insured" means an individual covered
by a health care insurance policy."
Renumber the following bill section accordingly.
REPRESENTATIVE FANSLER objected
2:39:25 PM
REPRESENTATIVE REINBOLD explained that Amendment 3, requires a
posting of the prices paid by the insurance companies.
2:39:52 PM
REPRESENTATIVE SPOHNHOLZ offered that while she appreciates the
intent of expanding price transparency, unfortunately, in
looking at Amendment 3, she could not support it at this time.
She noted that lines 15-16 ask for the total cost to the insurer
for each of those health care services during that period, and
she was unsure what that meant because there are a variety of
definitions of health care costs are out there. She asked
whether Amendment 3 referenced the total amount they've paid
out, in which case that would be getting into a totally
different issue than under HB 123, because it is about informing
consumer price transparency. She noted that it could also mean
what the insurers are paying to different providers, and that
would vary depending upon whether or not that providers was
within a preferred provider network or out of the provider
network. She related that a lot of time was spent in
determining how to have a clean, clear bill that was
understandable by the end user, and Amendment 3 muddies the
water.
2:41:20 PM
REPRESENTATIVE LEDOUX asked Representative Reinbold to explain
Amendment 3 because she was unsure whether the amendment was so
doctors could see what the insurance companies were going to
pay, or whether the consumer would see what the insurance
company pays.
REPRESENTATIVE REINBOLD explained that doctors will post their
rack rate fee, the CPT codes, except doctors receive different
reimbursements from insurers for their different types of
insurance patients. Unfortunately, she said, patient's will
"freak out" over the posted charge, not understanding that is
not the amount the doctor is actually reimbursed, and it becomes
more complicated under managed care. For example, while working
in a doctor's business office in Texas, the office was only
allowed to charge $400 and the rack rate fee may have been
$10,000 because it had negotiated a low price. The amendment
allows that the reimbursable price the insurance companies pay
be transparent, she said.
2:43:50 PM
REPRESENTATIVE LEDOUX offered that while she was sympathetic to
what this amendment was trying to do, but was complicated in its
manner because around here things are sometimes accomplished
through baby steps. She remarked that she will not support this
amendment because, in the context of this bill, it would not
work.
2:44:51 PM
REPRESENTATIVE EASTMAN referred to page 2, line 3, wherein the
fine appears to have tripled and asked why it went from $50 per
day to $150 per day.
REPRESENTATIVE REINBOLD noted that she had not requested that
language and asked that the drafter explain the difference.
2:45:28 PM
REPRESENTATIVE SPOHNHOLZ pointed out that this amendment
requires the health care insurer to post information allowing
patients to see what the insurer would charge for the service.
In that manner, a person would have to review the doctor's rack
rates and then review their insurer's website to determine what
the insurer would pay. Essentially, she related, her source at
the Department of Health and Social Services advised that an all
payor claims database would be required to mesh this amendment
with the bill.
2:46:49 PM
REPRESENTATIVE REINBOLD advised that her intention is to include
insurers because the third party insurance company pays the
bills. She commented that the amendment is fair if the goal is
to get true transparency and make this a consumer friendly bill.
2:48:26 PM
REPRESENTATIVE EASTMAN commented that Amendments 1 and 3 appear
to be going in the same direction, yet applying different
language to get there.
CHAIR CLAMAN interjected that Amendment 1 has nothing to do with
information from insurance carriers, and Amendment 3 is all
about information from insurance carriers. He pointed out that
Representative Eastman cannot claim they address the same issue
as they are completely different.
REPRESENTATIVE EASTMAN opined that they do, and that obtaining
information from insurers appears to be a fairly important part
of this whole equation. He related that when he visits a
doctor's office, that office queries his insurance company for
information and relays that information to him. He said, "I
work with them on whether or not I'm gonna actually contract
with them for the services." His concern with the bill,
unamended, is that it runs into the "bridge too far problem."
He explained that there was an idea to go straight from Britain
to Berlin, during World War II, by way of several bridges.
Unfortunately, the forces were unable to reach the last bridge,
and; therefore, the whole idea and effort crumbled because they
never got there. He related that if the legislature doesn't
actually get to the point of an Alaska resident receiving
helpful information, then it appears like a lot of effort and it
doesn't get the legislature where it needs to be.
2:50:50 PM
REPRESENTATIVE KOPP suggested that this amendment raises
questions in that the health care insurance market negotiates
rates for procedures individually with health care facilities
and employers. Certainly, he commented, those rates are
different depending upon volume, how well the health care
program is managed, history with the insurer, and a host of
issues. He suggested getting an insurance expert online and ask
whether the legislature can do this because it will get into
market proprietary information between insurance companies.
Also, he said, possibly the committee would be interfering with
insurers as to the market by requiring them to disclose their
negotiated rates for a whole host of entities, such as health
care facilities or employers.
2:52:24 PM
CHAIR CLAMAN commented that the House Health and Social Services
Standing Committee heard this bill and the insurance companies
said little, but they did say there were significant privacy
issues between commercial relationships, the insurance
companies, and their insured.
He commented that he recognizes the sponsor's intent for more
transparency as to health care costs and insurance costs, and
rather than try to globally fix everything, the sponsor prefers
to take baby steps toward improved transparency. He related
that the [amendment] requires Premera, Blue Cross Blue Shield of
Alaska to voice how much it paid in the state last year for all
of the completed blood counts, and to give a total number. He
suggested this amendment asks that, instead of letting the
consumer know the average price for a complete blood count paid
by insurance company "X," it would provide the total number of
the many hundreds of thousands of people they provide insurance
for, and the consumer would not be helped.
CHAIR CLAMAN advised that Ms. Glover was online regarding the
$150 penalty. He said he believes the committee could agree to
change the figure to $50 consistent with the bill, and treat it
as an informal amendment.
2:55:50 PM
CHAIR CLAMAN asked the committee to agree that on page 2, line
3, delete "$150" and insert "$50." There being no objection,
the informal amendment was adopted.
2:56:28 PM
REPRESENTATIVE REINBOLD opined that Chair Claman said something
about insurance companies not wanting to disclose their
information due to it being proprietary information, even though
a lot of doctors don't want to do that either due to sticker
shock. She commented that people believe the rate posted is the
amount the doctor receives and it turns the patient against the
doctor. Unfortunately, she said, the patient doesn't know their
doctor has far more specialties, went through 10-20 more years
of schooling with loans, or that the doctor may take a Medicare
patient and only receive 10 percent of the rack rate posted.
She argued that if the legislature doesn't require government
facilities to meet the same standards as the private sector,
they don't have to comply. The fact that these doctors may post
a $500 fee, they may only receive $50 for their service because
the insurance company negotiated a deal where it racks in
hundreds of millions of dollars and takes no risk. Yet, she
pointed out, it is the doctors seeing the patients, the doctors
have the insurance, the doctors have to deal with the follow up,
and now the insurance companies "get scot-free clean." She
stressed that it would be completely misguided if the insurance
companies were not included in this bill.
2:58:59 PM
A roll call vote was taken. Representatives Eastman, Reinbold,
Kopp voted in favor of adopting Amendment 3. Representatives
LeDoux, Fansler, Kreiss-Tomkins, and Claman voted against it.
Therefore, Amendment 3 failed to be adopted by a vote of 3-4.
2:59:31 PM
REPRESENTATIVE REINBOLD moved to adopt Amendment 4, Version 30-
LS0380\I.5, which read as follows:
Page 2, line 11, following "charged":
Insert "and the amount the provider actually
received"
Page 2, line 16, following "charged":
Insert "and the amount the provider actually
received"
REPRESENTATIVE FANSLER objected.
2:59:35 PM
REPRESENTATIVE REINBOLD referred to her comments regarding a
posted fee of $500, and explained that the doctor may only
receive $50 or write off the entire fee, and Amendment 4
requires "the amount the provider actually received" because
that information is important for the patients. Some patients
may believe their doctors are millionaires, not knowing they may
have extensive education loans, and insurance costs to pay. She
related that the insurance companies treat doctors
"horrendously," the sticker shock can be high, and the amendment
requires the amount the providers actually received for their
services to be posted.
3:00:52 PM
REPRESENTATIVE EASTMAN commented that Amendment 4 moves the
committee closer to actual transparency by requiring all doctors
to post the actual amount they receive from the insurer, thereby
allowing an even playing field.
3:02:34 PM
REPRESENTATIVE LEDOUX said she was sympathetic to what this
amendment was trying to do, but if the committee was really
concerned about the impact on the private sector, she was
hesitant to ask doctors to post the amount they actually receive
from insurers, Medicaid, Medicare, or workers' compensation
insurance. In response to Representative Eastman's argument
that doctors certainly have the opportunity to explain their
rack rates during the patient's visit, she pointed out that
there is nothing in the bill prohibiting physicians from posting
all of those rates.
3:03:59 PM
REPRESENTATIVE KREISS-TOMKINS noted that Amendments 3 and 4,
appear to approach health care price transparency from the
insurance side of the equation, as opposed to the provider side,
and agreed that it was important to approach it in both
directions. Amendment 4 is elegant in its simplicity, he
described, but the element he struggles with was what
Represented LeDoux pointed out, that different insurers have
different rates and no one has any idea how much anything costs.
He commented that he was unsure this bill was the correct
vehicle because it was more of a provider based bill. He then
read the language in the amendment "and the amount the provider
actually received," and asked how Representative Reinbold saw
that being implemented and practiced.
REPRESENTATIVE REINBOLD responded that if this was a provider
based bill, because most providers hate this bill, and it will
make patients "freak out" at the sticker shock. In response to
Representative LeDoux comment that nothing prohibits the doctor
from discussing their rates, she answered that some doctors may
not want to tell their patients they receive $50 for a Medicare
patient, $55 for a veteran, and $200 for a lawyer. She opined
that doctors want to discuss the patient's medical and emotional
issues, and not get into this "price fixing, this anti-trust,
this movement toward -- I think this is a much bigger issue,
like with stark laws and anti-trust laws, and all sorts of other
things." She said she believes that even with this amendment,
"it's none of our business."
3:07:52 PM
REPRESENTATIVE EASTMAN surmised that, currently the bill states
the discounted price charged, and this amendment would then add
the amount the provider received, and commented that he hoped
the committee was not worried about having too much
transparency. There is a medical facility in his district with
a history of "being on the high side," but with that information
available it would give patients the opportunity to ask why the
prices are high. He described the bill as helpful in starting
conversations so that 10 years from now the population would not
be looking at the same problem.
3:09:41 PM
REPRESENTATIVE KOPP commented that a couple of years ago he
threw his lower back out, and the chiropractor advised it would
be $80 if he self-paid, or $260 would be billed to the insurance
company. He commented that Amendment 4 gets right at this issue
because if the committee was really looking at transparency in
the marketplace, at some point it must be recognized there is a
business relationship, which is not inherently evil or
nefarious, with third party payor insurance companies.
Currently, patients are not directly paying physicians, and if
the goal is transparency without including the insurer in any
manner, it does make it harder to get there, he commented.
While realizing Amendment 4 was problematic, he said he would
support the amendment.
REPRESENTATIVE REINBOLD commented that she would stick with
Representative Kopp's good comments.
3:11:40 PM
REPRESENTATIVE FANSLER maintained his objection.
3:11:47 PM
A roll call vote was taken. Representatives Eastman, Reinbold,
and Kopp voted in favor of adopting Amendment 4.
Representatives Kreiss-Tomkins, LeDoux, Fansler, and Claman
voted against it. Therefore, Amendment 4 failed to be adopted
by a vote of 3-4.
3:12:46 PM
REPRESENTATIVE KREISS-TOMKINS withdrew Amendment 1, labeled 30-
LS0380\I.2 [prior to offering a motion to adopt the amendment].
REPRESENTATIVE KREISS-TOMKINS commented that after reviewing
actual CPT codes in a facility realized that many of the CPT
codes are diagnostic and testing in nature and that none of the
"meat and potatoes" procedures the committee was interested in
actually made the top 50 CPT codes. After reviewing a workers'
compensation medical fee schedule which included all of the meat
and potatoes procedures, such as MRIs, X-rays, stitches for a
laceration, he drafted an amendment to maintain the simplicity
of the bill and integrates all of that information The Alaska
State Hospital and Nursing Association (ASHNA) worked closely
with his office to provide a list of the top 10 grossing
procedures at a sample facility, and from a different facility,
and there was 100 percent overlap between the top 10 grossing
procedures and the top 50 most common procedures. Therefore,
Amendment 1 is redundant; however, he opined, the way to get
there is using NTCI data which comes from workers' compensation.
It listed the 10 top grossing procedures within different AMA
service categories, and the four largest AMA service categories
in health care include: surgery at 31 percent of all health care
costs; physical medicine at 29 percent; evaluation and
management at 16 percent; and radiology at 13 percent. Those
four AMA service areas account for the preponderance of medical
costs. He summarized that today is not the day, but he felt it
was important to put on the record that possibly there is a way
to get at the meat and potatoes procedures while still working
within the parameters of the simplicity in this legislation.
3:15:59 PM
CHAIR CLAMAN advised that the bill was back before the committee
with no amendments attached, and asked for further comments or
discussion.
3:16:12 PM
REPRESENTATIVE EASTMAN said that Representative Kreiss-Tomkins
solution was not before the committee, and he could not support
the bill. In determining how to get from "where we are" to a
more transparent system and possibly more economical pricing in
dealing with the cost of delivering health care, he said this
bill "gets us somewhere" but was unsure whether it moves the
state closer to where it wants to be and was possibly pulling
the committee farther away. The bill imposes more government
regulations, institutes the threat of fines on health care
facilities, and the problem of the disparity between what is
expected of the state's facilities and state departments and
what is being asked of the private sector hasn't been solved.
For example, the sponsor made an effective date of HB 123 at
January 1, and on that date the requirements would be instituted
for health care facilities with total penalties not to exceed
$2,500, but the fiscal note has a department that will not have
the regulations in place for it to uphold its end of the bargain
until July 1, 2019. He said he will vote against the bill.
3:19:44 PM
REPRESENTATIVE REINBOLD offered that the bill is coming from a
"fabulous place," but her philosophy is that this will have some
negative unintended consequences in patients against their
doctors due to fees. She described it as a double standard when
asking the private sector to post fees without requiring public
facilities to also post fees, and that the is being missed if
the bill doesn't include insurance companies, which are the key
third party payor, as part of this government solution. She
referred to the Constitution of the State of Alaska, Article 1,
Section 22, and commented, "It is the legislature's job to not
infringe on privacy of our citizens" and this may be on the
verge of that infringement.
3:23:22 PM
REPRESENTATIVE FANSLER moved to report CSHB 123(HSSS), Version
30-LS0380\I, out of committee with individual recommendations
and the accompanying fiscal notes.
REPRESENTATIVE EASTMAN objected.
3:23:35 PM
A roll call vote was taken. Representatives Kopp, Kreiss-
Tomkins, LeDoux, Fansler, and Claman voted in favor of CSHB 123.
Representatives Eastman and Reinbold voted against it.
Therefore, CSHB 123(HSS) was reported out of the House Judiciary
Standing Committee by a vote of 5-2.
3:25:02 PM
ADJOURNMENT
There being no further business before the committee, the House
Judiciary Standing Committee meeting was adjourned at 3:25 p.m.