Bill Text: IA SSB1115 | 2017-2018 | 87th General Assembly | Introduced

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Bill Title: A bill for an act relating to the use of experimental treatments for patients with a terminal illness.

Spectrum: Committee Bill

Status: (N/A - Dead) 2017-02-22 - Subcommittee recommends passage. [SSB1115 Detail]

Download: Iowa-2017-SSB1115-Introduced.html

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Senate Study Bill 1115 - Introduced
SENATE FILE _____
BY (PROPOSED COMMITTEE
ON COMMERCE BILL BY
CHAIRPERSON ANDERSON)
A BILL FOR
An Act relating to the use of experimental treatments for
patients with a terminal illness.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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Section 1. NEW SECTION . 144E.1 Title.
This chapter shall be known and may be cited as the “Right
to Try Act” .
Sec. 2. NEW SECTION . 144E.2 Definitions.
As used in this chapter:
1. “Eligible patient” means an individual who meets all of
the following conditions:
a. Has a terminal illness, attested to by the patient’s
treating physician.
b. Has considered and rejected or has tried and failed to
respond to all other treatment options approved by the United
States food and drug administration.
c. Has received a recommendation from the individual’s
physician for an investigational drug, biological product, or
device.
d. Has given written informed consent for the use of the
investigational drug, biological product, or device.
e. Has documentation from the individual’s physician that
the individual meets the requirements of this subsection.
2. “Investigational drug, biological product, or device”
means a drug, biological product, or device that has
successfully completed phase 1 of a United States food and drug
administration-approved clinical trial but has not yet been
approved for general use by the United States food and drug
administration and remains under investigation in a United
States food and drug administration-approved clinical trial.
3. “Terminal illness” means a progressive disease or medical
or surgical condition that entails significant functional
impairment, that is not considered by a treating physician to
be reversible even with administration of treatments approved
by the United States food and drug administration, and that,
without life-sustaining procedures, will result in death.
4. “Written informed consent” means a written document that
is signed by the patient, a parent of a minor patient, or a
legal guardian or other legal representative of the patient and
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attested to by the patient’s treating physician and a witness
and that includes all of the following:
a. An explanation of the products and treatments approved by
the United States food and drug administration for the disease
or condition from which the patient suffers.
b. An attestation that the patient concurs with the
patient’s treating physician in believing that all products
and treatments approved by the United States food and drug
administration are unlikely to prolong the patient’s life.
c. Clear identification of the specific proposed
investigational drug, biological product, or device that the
patient is seeking to use.
d. A description of the best and worst potential outcomes
of using the investigational drug, biological product, or
device and a realistic description of the most likely outcome.
The description shall include the possibility that new,
unanticipated, different, or worse symptoms might result
and that death could be hastened by use of the proposed
investigational drug, biological product, or device. The
description shall be based on the treating physician’s
knowledge of the proposed investigational drug, biological
product, or device in conjunction with an awareness of the
patient’s condition.
e. A statement that the patient’s health plan or third-party
administrator and provider are not obligated to pay for any
care or treatments consequent to the use of the investigational
drug, biological product, or device, unless they are
specifically required to do so by law or contract.
f. A statement that the patient’s eligibility for hospice
care may be withdrawn if the patient begins curative treatment
with the investigational drug, biological product, or device
and that care may be reinstated if this treatment ends and the
patient meets hospice eligibility requirements.
g. A statement that the patient understands that the
patient is liable for all expenses consequent to the use of
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the investigational drug, biological product, or device and
that this liability extends to the patient’s estate unless
a contract between the patient and the manufacturer of the
investigational drug, biological product, or device states
otherwise.
Sec. 3. NEW SECTION . 144E.3 Manufacturer rights.
1. A manufacturer of an investigational drug, biological
product, or device may make available and an eligible patient
may request the manufacturer’s investigational drug, biological
product, or device under this chapter. This chapter does not
require a manufacturer of an investigational drug, biological
product, or device to provide or otherwise make available the
investigational drug, biological product, or device to an
eligible patient.
2. A manufacturer described in subsection 1 may do any of
the following:
a. Provide an investigational drug, biological product, or
device to an eligible patient without receiving compensation.
b. Require an eligible patient to pay the costs of, or the
costs associated with, the manufacture of the investigational
drug, biological product, or device.
Sec. 4. NEW SECTION . 144E.4 Treatment coverage.
1. This chapter does not expand the coverage required of an
insurer under Title XIII, subtitle 1.
2. A health plan, third-party administrator, or
governmental agency may provide coverage for the cost of an
investigational drug, biological product, or device, or the
cost of services related to the use of an investigational drug,
biological product, or device under this chapter.
3. This chapter does not require any governmental agency
to pay costs associated with the use, care, or treatment of a
patient with an investigational drug, biological product, or
device.
4. This chapter does not require a hospital licensed under
chapter 135B or other health care facility to provide new or
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additional services.
Sec. 5. NEW SECTION . 144E.5 Heirs not liable for treatment
debts.
If a patient dies while being treated by an investigational
drug, biological product, or device, the patient’s heirs are
not liable for any outstanding debt related to the treatment
or lack of insurance due to the treatment, unless otherwise
required by law.
Sec. 6. NEW SECTION . 144E.6 Provider recourse.
1. To the extent consistent with state law, the board of
medicine created under chapter 147 shall not revoke, fail
to renew, suspend, or take any action against a physician’s
license based solely on the physician’s recommendations to
an eligible patient regarding access to or treatment with an
investigational drug, biological product, or device.
2. To the extent consistent with federal law, an entity
responsible for Medicare certification shall not take action
against a physician’s Medicare certification based solely on
the physician’s recommendation that a patient have access to an
investigational drug, biological product, or device.
Sec. 7. NEW SECTION . 144E.7 State interference.
An official, employee, or agent of this state shall not
block or attempt to block an eligible patient’s access to
an investigational drug, biological product, or device.
Counseling, advice, or a recommendation consistent with medical
standards of care from a licensed physician is not a violation
of this section.
Sec. 8. NEW SECTION . 144E.8 Private cause of action.
1. This chapter shall not create a private cause of
action against a manufacturer of an investigational drug,
biological product, or device or against any other person
or entity involved in the care of an eligible patient using
the investigational drug, biological product, or device
for any harm done to the eligible patient resulting from
the investigational drug, biological product, or device, if
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the manufacturer or other person or entity is complying in
good faith with the terms of this chapter and has exercised
reasonable care.
2. This chapter shall not affect any mandatory health care
coverage for participation in clinical trials under Title XIII,
subtitle 1.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
This bill, titled the “Right to Try Act”, permits
manufacturers of investigational drugs, biological products, or
devices to make available, and eligible patients with terminal
illnesses to attempt treatment with, an investigational
drug, biological product, or device as long as they provided
written informed consent. The bill defines the terms “eligible
patient”, “terminal illness”, “investigational drug, biological
product, or device”, and “written informed consent”.
Under the bill, an eligible patient’s physician must
acknowledge that the patient’s illness is terminal and
recommend the patient try an investigational drug, biological
product, or device. The patient’s written informed consent
must acknowledge that treatments currently approved by the
United Stated food and drug administration are unlikely to
prolong the patient’s life. It must identify the specific
treatment sought and the potential best, worst, and expected
results from the treatment. It must acknowledge that the
patient’s insurance is not required to pay for the treatment
and that any hospice service may refuse to accept the patient
after receiving the treatment. It must also acknowledge
that expenses will be credited to the patient, including the
patient’s estate, unless an agreement with the manufacturer of
an investigational drug, biological product, or device states
otherwise. If the patient dies during treatment, the patient’s
heirs are not liable for any remaining debts unless otherwise
required by law.
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The manufacturer of an investigational drug, biological
product, or device may charge an eligible patient or provide
the treatment free of charge. Governmental entities are
not required to pay costs associated with the use, care,
or treatment of a patient with an investigational drug,
biological product, or device. The bill does not require
hospitals licensed under Code chapter 135B or other health care
facilities to provide new or additional services.
Consistent with existing law, the board of medicine shall
not take an adverse action against a physician’s license solely
for recommending an investigational drug, biological product,
or device for the physician’s eligible patient. The bill does
not create a new private cause of action against any person or
entity involved in the care of an eligible patient using the
investigational drug, biological product, or device for any
harm done to the patient resulting from the treatment if the
person or entity is complying in good faith with the terms of
the bill and has exercised reasonable care.
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