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House File 156 - IntroducedA Bill ForAn Act 1relating to the use of experimental treatments for
2patients with a terminal illness.
3BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. NEW SECTION. 144E.1 Title.
2This chapter shall be known and may be cited as the “Right
3to Try Act”.
4 Sec. 2. NEW SECTION. 144E.2 Definitions.
5As used in this chapter:
61. “Eligible patient” means an individual who meets all of
7the following conditions:
8a. Has a terminal illness, attested to by the patient’s
9treating physician.
10b. Has considered and rejected or has tried and failed to
11respond to all other treatment options approved by the United
12States food and drug administration.
13c. Has received a recommendation from the individual’s
14physician for an investigational drug, biological product, or
15device.
16d. Has given written informed consent for the use of the
17investigational drug, biological product, or device.
18e. Has documentation from the individual’s physician that
19the individual meets the requirements of this subsection.
202. “Investigational drug, biological product, or device”
21means a drug, biological product, or device that has
22successfully completed phase 1 of a United States food and drug
23administration-approved clinical trial but has not yet been
24approved for general use by the United States food and drug
25administration and remains under investigation in a United
26States food and drug administration-approved clinical trial.
273. “Terminal illness” means a progressive disease or medical
28or surgical condition that entails significant functional
29impairment, that is not considered by a treating physician to
30be reversible even with administration of treatments approved
31by the United States food and drug administration, and that,
32without life-sustaining procedures, will result in death.
334. “Written informed consent” means a written document that
34is signed by the patient, a parent of a minor patient, or a
35legal guardian or other legal representative of the patient and
-1-1attested to by the patient’s treating physician and a witness
2and that includes all of the following:
3a. An explanation of the products and treatments approved by
4the United States food and drug administration for the disease
5or condition from which the patient suffers.
6b. An attestation that the patient concurs with the
7patient’s treating physician in believing that all products
8and treatments approved by the United States food and drug
9administration are unlikely to prolong the patient’s life.
10c. Clear identification of the specific proposed
11investigational drug, biological product, or device that the
12patient is seeking to use.
13d. A description of the best and worst potential outcomes
14of using the investigational drug, biological product, or
15device and a realistic description of the most likely outcome.
16The description shall include the possibility that new,
17unanticipated, different, or worse symptoms might result
18and that death could be hastened by use of the proposed
19investigational drug, biological product, or device. The
20description shall be based on the treating physician’s
21knowledge of the proposed investigational drug, biological
22product, or device in conjunction with an awareness of the
23patient’s condition.
24e. A statement that the patient’s health plan or third-party
25administrator and provider are not obligated to pay for any
26care or treatments consequent to the use of the investigational
27drug, biological product, or device, unless they are
28specifically required to do so by law or contract.
29f. A statement that the patient’s eligibility for hospice
30care may be withdrawn if the patient begins curative treatment
31with the investigational drug, biological product, or device
32and that care may be reinstated if this treatment ends and the
33patient meets hospice eligibility requirements.
34g. A statement that the patient understands that the
35patient is liable for all expenses consequent to the use of
-2-1the investigational drug, biological product, or device and
2that this liability extends to the patient’s estate unless
3a contract between the patient and the manufacturer of the
4investigational drug, biological product, or device states
5otherwise.
6 Sec. 3. NEW SECTION. 144E.3 Manufacturer rights.
71. A manufacturer of an investigational drug, biological
8product, or device may make available and an eligible patient
9may request the manufacturer’s investigational drug, biological
10product, or device under this chapter. This chapter does not
11require a manufacturer of an investigational drug, biological
12product, or device to provide or otherwise make available the
13investigational drug, biological product, or device to an
14eligible patient.
152. A manufacturer described in subsection 1 may do any of
16the following:
17a. Provide an investigational drug, biological product, or
18device to an eligible patient without receiving compensation.
19b. Require an eligible patient to pay the costs of, or the
20costs associated with, the manufacture of the investigational
21drug, biological product, or device.
22 Sec. 4. NEW SECTION. 144E.4 Treatment coverage.
231. This chapter does not expand the coverage required of an
24insurer under Title XIII, subtitle 1.
252. A health plan, third-party administrator, or
26governmental agency may provide coverage for the cost of an
27investigational drug, biological product, or device, or the
28cost of services related to the use of an investigational drug,
29biological product, or device under this chapter.
303. This chapter does not require any governmental agency
31to pay costs associated with the use, care, or treatment of a
32patient with an investigational drug, biological product, or
33device.
344. This chapter does not require a hospital licensed under
35chapter 135B or other health care facility to provide new or
-3-1additional services.
2 Sec. 5. NEW SECTION. 144E.5 Heirs not liable for treatment
3debts.
4If a patient dies while being treated by an investigational
5drug, biological product, or device, the patient’s heirs are
6not liable for any outstanding debt related to the treatment
7or lack of insurance due to the treatment, unless otherwise
8required by law.
9 Sec. 6. NEW SECTION. 144E.6 Provider recourse.
101. To the extent consistent with state law, the board of
11medicine created under chapter 147 shall not revoke, fail
12to renew, suspend, or take any action against a physician’s
13license based solely on the physician’s recommendations to
14an eligible patient regarding access to or treatment with an
15investigational drug, biological product, or device.
162. To the extent consistent with federal law, an entity
17responsible for Medicare certification shall not take action
18against a physician’s Medicare certification based solely on
19the physician’s recommendation that a patient have access to an
20investigational drug, biological product, or device.
21 Sec. 7. NEW SECTION. 144E.7 State interference.
22An official, employee, or agent of this state shall not
23block or attempt to block an eligible patient’s access to
24an investigational drug, biological product, or device.
25Counseling, advice, or a recommendation consistent with medical
26standards of care from a licensed physician is not a violation
27of this section.
28 Sec. 8. NEW SECTION. 144E.8 Private cause of action.
291. This chapter shall not create a private cause of
30action against a manufacturer of an investigational drug,
31biological product, or device or against any other person
32or entity involved in the care of an eligible patient using
33the investigational drug, biological product, or device
34for any harm done to the eligible patient resulting from
35the investigational drug, biological product, or device, if
-4-1the manufacturer or other person or entity is complying in
2good faith with the terms of this chapter and has exercised
3reasonable care.
42. This chapter shall not affect any mandatory health care
5coverage for participation in clinical trials under Title XIII,
6subtitle 1.
7EXPLANATION
8The inclusion of this explanation does not constitute agreement with
9the explanation’s substance by the members of the general assembly.
10This bill, titled the “Right to Try Act”, permits
11manufacturers of investigational drugs, biological products, or
12devices to make available, and eligible patients with terminal
13illnesses to attempt treatment with, an investigational
14drug, biological product, or device as long as they provided
15written informed consent. The bill defines the terms “eligible
16patient”, “terminal illness”, “investigational drug, biological
17product, or device”, and “written informed consent”.
18Under the bill, an eligible patient’s physician must
19acknowledge that the patient’s illness is terminal and
20recommend the patient try an investigational drug, biological
21product, or device. The patient’s written informed consent
22must acknowledge that treatments currently approved by the
23United Stated food and drug administration are unlikely to
24prolong the patient’s life. It must identify the specific
25treatment sought and the potential best, worst, and expected
26results from the treatment. It must acknowledge that the
27patient’s insurance is not required to pay for the treatment
28and that any hospice service may refuse to accept the patient
29after receiving the treatment. It must also acknowledge
30that expenses will be credited to the patient, including the
31patient’s estate, unless an agreement with the manufacturer of
32an investigational drug, biological product, or device states
33otherwise. If the patient dies during treatment, the patient’s
34heirs are not liable for any remaining debts unless otherwise
35required by law.
-5- 1The manufacturer of an investigational drug, biological
2product, or device may charge an eligible patient or provide
3the treatment free of charge. Governmental entities are
4not required to pay costs associated with the use, care, or
5treatment of a patient with an investigational drug, biological
6product, or device. The bill does not require hospitals
7licensed under chapter 135B or other health care facilities to
8provide new or additional services.
9Consistent with existing law, the board of medicine shall
10not take an adverse action against a physician’s license solely
11for recommending an investigational drug, biological product,
12or device for the physician’s eligible patient. The bill does
13not create a new private cause of action against any person or
14entity involved in the care of an eligible patient using the
15investigational drug, biological product, or device for any
16harm done to the patient resulting from the treatment if the
17person or entity is complying in good faith with the terms of
18the bill and has exercised reasonable care.
-6-tr/nh
2patients with a terminal illness.
3BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. NEW SECTION. 144E.1 Title.
2This chapter shall be known and may be cited as the “Right
3to Try Act”.
4 Sec. 2. NEW SECTION. 144E.2 Definitions.
5As used in this chapter:
61. “Eligible patient” means an individual who meets all of
7the following conditions:
8a. Has a terminal illness, attested to by the patient’s
9treating physician.
10b. Has considered and rejected or has tried and failed to
11respond to all other treatment options approved by the United
12States food and drug administration.
13c. Has received a recommendation from the individual’s
14physician for an investigational drug, biological product, or
15device.
16d. Has given written informed consent for the use of the
17investigational drug, biological product, or device.
18e. Has documentation from the individual’s physician that
19the individual meets the requirements of this subsection.
202. “Investigational drug, biological product, or device”
21means a drug, biological product, or device that has
22successfully completed phase 1 of a United States food and drug
23administration-approved clinical trial but has not yet been
24approved for general use by the United States food and drug
25administration and remains under investigation in a United
26States food and drug administration-approved clinical trial.
273. “Terminal illness” means a progressive disease or medical
28or surgical condition that entails significant functional
29impairment, that is not considered by a treating physician to
30be reversible even with administration of treatments approved
31by the United States food and drug administration, and that,
32without life-sustaining procedures, will result in death.
334. “Written informed consent” means a written document that
34is signed by the patient, a parent of a minor patient, or a
35legal guardian or other legal representative of the patient and
-1-1attested to by the patient’s treating physician and a witness
2and that includes all of the following:
3a. An explanation of the products and treatments approved by
4the United States food and drug administration for the disease
5or condition from which the patient suffers.
6b. An attestation that the patient concurs with the
7patient’s treating physician in believing that all products
8and treatments approved by the United States food and drug
9administration are unlikely to prolong the patient’s life.
10c. Clear identification of the specific proposed
11investigational drug, biological product, or device that the
12patient is seeking to use.
13d. A description of the best and worst potential outcomes
14of using the investigational drug, biological product, or
15device and a realistic description of the most likely outcome.
16The description shall include the possibility that new,
17unanticipated, different, or worse symptoms might result
18and that death could be hastened by use of the proposed
19investigational drug, biological product, or device. The
20description shall be based on the treating physician’s
21knowledge of the proposed investigational drug, biological
22product, or device in conjunction with an awareness of the
23patient’s condition.
24e. A statement that the patient’s health plan or third-party
25administrator and provider are not obligated to pay for any
26care or treatments consequent to the use of the investigational
27drug, biological product, or device, unless they are
28specifically required to do so by law or contract.
29f. A statement that the patient’s eligibility for hospice
30care may be withdrawn if the patient begins curative treatment
31with the investigational drug, biological product, or device
32and that care may be reinstated if this treatment ends and the
33patient meets hospice eligibility requirements.
34g. A statement that the patient understands that the
35patient is liable for all expenses consequent to the use of
-2-1the investigational drug, biological product, or device and
2that this liability extends to the patient’s estate unless
3a contract between the patient and the manufacturer of the
4investigational drug, biological product, or device states
5otherwise.
6 Sec. 3. NEW SECTION. 144E.3 Manufacturer rights.
71. A manufacturer of an investigational drug, biological
8product, or device may make available and an eligible patient
9may request the manufacturer’s investigational drug, biological
10product, or device under this chapter. This chapter does not
11require a manufacturer of an investigational drug, biological
12product, or device to provide or otherwise make available the
13investigational drug, biological product, or device to an
14eligible patient.
152. A manufacturer described in subsection 1 may do any of
16the following:
17a. Provide an investigational drug, biological product, or
18device to an eligible patient without receiving compensation.
19b. Require an eligible patient to pay the costs of, or the
20costs associated with, the manufacture of the investigational
21drug, biological product, or device.
22 Sec. 4. NEW SECTION. 144E.4 Treatment coverage.
231. This chapter does not expand the coverage required of an
24insurer under Title XIII, subtitle 1.
252. A health plan, third-party administrator, or
26governmental agency may provide coverage for the cost of an
27investigational drug, biological product, or device, or the
28cost of services related to the use of an investigational drug,
29biological product, or device under this chapter.
303. This chapter does not require any governmental agency
31to pay costs associated with the use, care, or treatment of a
32patient with an investigational drug, biological product, or
33device.
344. This chapter does not require a hospital licensed under
35chapter 135B or other health care facility to provide new or
-3-1additional services.
2 Sec. 5. NEW SECTION. 144E.5 Heirs not liable for treatment
3debts.
4If a patient dies while being treated by an investigational
5drug, biological product, or device, the patient’s heirs are
6not liable for any outstanding debt related to the treatment
7or lack of insurance due to the treatment, unless otherwise
8required by law.
9 Sec. 6. NEW SECTION. 144E.6 Provider recourse.
101. To the extent consistent with state law, the board of
11medicine created under chapter 147 shall not revoke, fail
12to renew, suspend, or take any action against a physician’s
13license based solely on the physician’s recommendations to
14an eligible patient regarding access to or treatment with an
15investigational drug, biological product, or device.
162. To the extent consistent with federal law, an entity
17responsible for Medicare certification shall not take action
18against a physician’s Medicare certification based solely on
19the physician’s recommendation that a patient have access to an
20investigational drug, biological product, or device.
21 Sec. 7. NEW SECTION. 144E.7 State interference.
22An official, employee, or agent of this state shall not
23block or attempt to block an eligible patient’s access to
24an investigational drug, biological product, or device.
25Counseling, advice, or a recommendation consistent with medical
26standards of care from a licensed physician is not a violation
27of this section.
28 Sec. 8. NEW SECTION. 144E.8 Private cause of action.
291. This chapter shall not create a private cause of
30action against a manufacturer of an investigational drug,
31biological product, or device or against any other person
32or entity involved in the care of an eligible patient using
33the investigational drug, biological product, or device
34for any harm done to the eligible patient resulting from
35the investigational drug, biological product, or device, if
-4-1the manufacturer or other person or entity is complying in
2good faith with the terms of this chapter and has exercised
3reasonable care.
42. This chapter shall not affect any mandatory health care
5coverage for participation in clinical trials under Title XIII,
6subtitle 1.
7EXPLANATION
8The inclusion of this explanation does not constitute agreement with
9the explanation’s substance by the members of the general assembly.
10This bill, titled the “Right to Try Act”, permits
11manufacturers of investigational drugs, biological products, or
12devices to make available, and eligible patients with terminal
13illnesses to attempt treatment with, an investigational
14drug, biological product, or device as long as they provided
15written informed consent. The bill defines the terms “eligible
16patient”, “terminal illness”, “investigational drug, biological
17product, or device”, and “written informed consent”.
18Under the bill, an eligible patient’s physician must
19acknowledge that the patient’s illness is terminal and
20recommend the patient try an investigational drug, biological
21product, or device. The patient’s written informed consent
22must acknowledge that treatments currently approved by the
23United Stated food and drug administration are unlikely to
24prolong the patient’s life. It must identify the specific
25treatment sought and the potential best, worst, and expected
26results from the treatment. It must acknowledge that the
27patient’s insurance is not required to pay for the treatment
28and that any hospice service may refuse to accept the patient
29after receiving the treatment. It must also acknowledge
30that expenses will be credited to the patient, including the
31patient’s estate, unless an agreement with the manufacturer of
32an investigational drug, biological product, or device states
33otherwise. If the patient dies during treatment, the patient’s
34heirs are not liable for any remaining debts unless otherwise
35required by law.
-5- 1The manufacturer of an investigational drug, biological
2product, or device may charge an eligible patient or provide
3the treatment free of charge. Governmental entities are
4not required to pay costs associated with the use, care, or
5treatment of a patient with an investigational drug, biological
6product, or device. The bill does not require hospitals
7licensed under chapter 135B or other health care facilities to
8provide new or additional services.
9Consistent with existing law, the board of medicine shall
10not take an adverse action against a physician’s license solely
11for recommending an investigational drug, biological product,
12or device for the physician’s eligible patient. The bill does
13not create a new private cause of action against any person or
14entity involved in the care of an eligible patient using the
15investigational drug, biological product, or device for any
16harm done to the patient resulting from the treatment if the
17person or entity is complying in good faith with the terms of
18the bill and has exercised reasonable care.
-6-tr/nh