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House File 225 - IntroducedA Bill ForAn Act 1relating to the right to try Act.
2BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. Section 144E.2, Code 2023, is amended to read as
2follows:
3144E.2 Definitions.
4As used in this chapter:
51. “Eligible facility” means an institution operating under
6a federalwide assurance for the protection of human subjects
7pursuant to 42 U.S.C.§289(a) and 28 C.F.R.pt.46.
81. 2. “Eligible patient” means an individual who meets all
9of the following conditions:
10a. Has a terminal life-threatening or severely debilitating
11 illness, attested to by the patient’s treating physician.
12b. Has considered and rejected or has tried and failed to
13respond to all other treatment options currently approved by
14the United States food and drug administration.
15c. Has received a recommendation from the individual’s
16physician for an individualized investigational drug,
17biological product, or device treatment based on an analysis
18of the patient’s genomic sequence, human chromosomes,
19deoxyribonucleic acid, ribonucleic acid, genes, gene products
20such as enzymes and other types of proteins, or metabolites.
21d. Has given written informed consent for the use of the
22individualized investigational drug, biological product, or
23device treatment.
24e. Has documentation from the individual’s physician that
25the individual meets the requirements of this subsection.
262. “Investigational drug, biological product, or device”
27 means a drug, biological product, or device that has
28successfully completed phase 1 of a United States food and drug
29administration-approved clinical trial but has not yet been
30approved for general use by the United States food and drug
31administration and remains under investigation in a United
32States food and drug administration-approved clinical trial.
333. “Terminal illness” means a progressive disease or medical
34or surgical condition that entails significant functional
35impairment, that is not considered by a treating physician to
-1-1be reversible even with administration of treatments approved
2by the United States food and drug administration, and that,
3without life-sustaining procedures, will result in death.
43. “Individualized investigational treatment” means a drug,
5biological product, or device that is unique to and produced
6exclusively for use by an individual patient based on the
7individual patient’s own genetic profile. “Individualized
8investigational treatment” includes but is not limited to
9individualized gene therapy, antisense oligonucleotides, and
10individualized neoantigen vaccines.
114. “Written informed consent” means a written document that
12is signed by the patient, a parent of a minor patient, or a
13legal guardian or other legal representative of the patient and
14attested to by the patient’s treating physician and a witness
15and that, at a minimum, includes all of the following:
16a. An explanation of the products and treatments currently
17 approved by the United States food and drug administration
18for the disease or condition life-threatening or severely
19debilitating illness from which the patient suffers.
20b. An attestation that the patient concurs with the
21patient’s treating physician in believing that all products and
22 treatments currently approved by the United States food and
23drug administration or conventionally recognized are unlikely
24to prolong the patient’s life.
25c. Clear identification of the specific proposed
26individualized investigational drug, biological product, or
27device treatment that the patient is seeking to use.
28d. A description of the best and worst potential outcomes
29of using the individualized investigational drug, biological
30product, or device treatment and a realistic description of
31the most likely outcome. The description shall include the
32possibility that new, unanticipated, different, or worse
33symptoms might result and that death could be hastened by
34use of the proposed individualized investigational drug,
35biological product, or device treatment. The description shall
-2-1be based on the treating physician’s knowledge of the proposed
2individualized investigational drug, biological product,
3or device treatment in conjunction with an awareness of the
4patient’s condition.
5e. A statement that the patient’s health plan or third-party
6administrator and provider are not obligated to pay for any
7care or treatments consequent to the use of the individualized
8 investigational drug, biological product, or device treatment,
9unless they are specifically required to do so by law or
10contract.
11f. A statement that the patient’s eligibility for hospice
12care may be withdrawn if the patient begins curative treatment
13with the individualized investigational drug, biological
14product, or device treatment and that care may be reinstated if
15this treatment ends and the patient meets hospice eligibility
16requirements.
17g. A statement that the patient understands that the
18patient is liable for all expenses consequent to the use of
19the individualized investigational drug, biological product,
20or device treatment and that this liability extends to the
21patient’s estate unless a contract between the patient and
22the manufacturer of the individualized investigational drug,
23biological product, or device treatment states otherwise.
24 Sec. 2. Section 144E.3, Code 2023, is amended to read as
25follows:
26144E.3 Manufacturer and eligible facility rights.
271. A manufacturer of an individualized investigational
28drug, biological product, or device treatment operating
29within an eligible facility and in compliance with all laws
30applicable to an eligible facility may make available and an
31eligible patient may request the manufacturer’s individualized
32 investigational drug, biological product, or device treatment
33 under this chapter. This chapter does not require a
34manufacturer of an individualized investigational drug,
35biological product, or device treatment to provide or otherwise
-3-1make available the individualized investigational drug,
2biological product, or device treatment to an eligible patient.
32. A An eligible facility or a manufacturer described in
4subsection 1 may do any of the following:
5a. Provide an individualized investigational drug,
6biological product, or device treatment to an eligible patient
7without receiving compensation.
8b. Require an eligible patient to pay the costs of, or the
9costs associated with, the manufacture of the individualized
10 investigational drug, biological product, or device treatment.
11 Sec. 3. Section 144E.4, Code 2023, is amended to read as
12follows:
13144E.4 Treatment coverage.
141. This chapter does not expand the coverage required of an
15insurer under Title XIII, subtitle 1.
162. A health plan, third-party administrator, or
17governmental agency may provide coverage for the cost of an
18individualized investigational drug, biological product, or
19device treatment, or the cost of services related to the use of
20an individualized investigational drug, biological product, or
21device treatment under this chapter.
223. This chapter does not require any governmental agency
23to pay costs associated with the use, care, or treatment of a
24patient with an individualized investigational drug, biological
25product, or device treatment.
264. This chapter does not require a hospital licensed under
27chapter 135B or other health care facility to provide new or
28additional services, unless approved by the hospital or health
29care facility.
30 Sec. 4. Section 144E.5, Code 2023, is amended to read as
31follows:
32144E.5 Heirs not liable for treatment debts.
33If a patient dies while being treated by an individualized
34 investigational drug, biological product, or device treatment,
35the patient’s heirs are not liable for any outstanding debt
-4-1related to the treatment or lack of insurance due to the
2treatment, unless otherwise required by law.
3 Sec. 5. Section 144E.6, Code 2023, is amended to read as
4follows:
5144E.6 Provider recourse.
61. To the extent consistent with state law, the board of
7medicine created under chapter 147 shall not revoke, fail
8to renew, suspend, or take any action against a physician’s
9license based solely on the physician’s recommendations to
10an eligible patient regarding access to or treatment with an
11individualized investigational drug, biological product, or
12device treatment.
132. To the extent consistent with federal law, an entity
14responsible for Medicare certification shall not take action
15against a physician’s Medicare certification based solely on
16the physician’s recommendation that a patient have access to
17an individualized investigational drug, biological product, or
18device treatment.
19 Sec. 6. Section 144E.7, Code 2023, is amended to read as
20follows:
21144E.7 State interference.
22An official, employee, or agent of this state shall not
23block or attempt to block an eligible patient’s access to an
24individualized investigational drug, biological product, or
25device treatment. Counseling, advice, or a recommendation
26consistent with medical standards of care from a licensed
27physician is not a violation of this section.
28 Sec. 7. Section 144E.8, Code 2023, is amended to read as
29follows:
30144E.8 Private cause of action.
311. This chapter shall not create a private cause of action
32against a manufacturer of an individualized investigational
33drug, biological product, or device treatment or against any
34other person or entity involved in the care of an eligible
35patient using the individualized investigational drug,
-5-1biological product, or device treatment for any harm done
2to the eligible patient resulting from the individualized
3 investigational drug, biological product, or device treatment,
4if the manufacturer or other person or entity is complying in
5good faith with the terms of this chapter and has exercised
6reasonable care.
72. This chapter shall not affect any mandatory health care
8coverage for participation in clinical trials under Title XIII,
9subtitle 1.
10 Sec. 8. REPEAL. Section 144E.9, Code 2023, is repealed.
11EXPLANATION
12The inclusion of this explanation does not constitute agreement with
13the explanation’s substance by the members of the general assembly.
14This bill relates to Code chapter 144E, the right to try Act.
15Under current law, an “eligible patient” under the Code
16chapter is, in part, a person who has a terminal illness.
17Under the bill, an “eligible patient” is instead, in part, a
18person who has a life-threatening or severely debilitating
19illness.
20Under current law, the Code chapter applies to an
21“investigational drug, biological product, or device”
22meaning a drug, biological product, or device that has
23successfully completed phase I of a United States food and drug
24administration (FDA)-approved clinical trial but has not yet
25been approved for general use by the FDA and that remains under
26investigation in an FDA-approved clinical trial. Under the
27bill, the Code chapter instead applies to an “individualized
28investigational treatment”, meaning a drug, biological product,
29or device that is unique to and produced exclusively for use
30by an individual patient based on the individual patient’s
31own genetic profile and includes individualized gene therapy,
32antisense oligonucleotides, and individualized neoantigen
33vaccines.
34The bill amends the definition under the Code chapter for
35“written informed consent” to reflect the changes made to
-6-1“eligible patient” and the application of the Code chapter to
2individualized investigational treatments.
3The bill provides a definition of “eligible facility” to
4mean an institution that is operating under a federalwide
5assurance for the protection of human subjects pursuant
6to federal law. The bill amends provisions relating to
7a manufacturer’s rights under the Code chapter to provide
8that a manufacturer of an individualized investigational
9treatment operating within an eligible facility and in
10compliance with all laws applicable to an eligible facility
11may make available, and an eligible patient may request, the
12manufacturer’s individualized investigational treatment under
13the Code chapter. However, the Code chapter does not require
14a manufacturer of an individualized investigational treatment
15to provide or otherwise make available the individualized
16investigational treatment to an eligible patient. The bill
17provides that an eligible facility or a manufacturer may
18provide an individualized investigational treatment to an
19eligible patient without receiving compensation, or require an
20eligible patient to pay the costs of, or the costs associated
21with, the manufacture of the individualized investigational
22treatment.
23The bill makes other conforming changes in the Code chapter
24to reflect the bill provisions.
25The bill repeals Code section 144E.9, which provides that
26the Code chapter shall not be construed to allow a patient’s
27treating physician to assist the patient in committing or
28attempting to commit suicide.
-7-pf/rh
2BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. Section 144E.2, Code 2023, is amended to read as
2follows:
3144E.2 Definitions.
4As used in this chapter:
51. “Eligible facility” means an institution operating under
6a federalwide assurance for the protection of human subjects
7pursuant to 42 U.S.C.§289(a) and 28 C.F.R.pt.46.
81. 2. “Eligible patient” means an individual who meets all
9of the following conditions:
10a. Has a terminal life-threatening or severely debilitating
11 illness, attested to by the patient’s treating physician.
12b. Has considered and rejected or has tried and failed to
13respond to all other treatment options currently approved by
14the United States food and drug administration.
15c. Has received a recommendation from the individual’s
16physician for an individualized investigational drug,
17biological product, or device treatment based on an analysis
18of the patient’s genomic sequence, human chromosomes,
19deoxyribonucleic acid, ribonucleic acid, genes, gene products
20such as enzymes and other types of proteins, or metabolites.
21d. Has given written informed consent for the use of the
22individualized investigational drug, biological product, or
23device treatment.
24e. Has documentation from the individual’s physician that
25the individual meets the requirements of this subsection.
262. “Investigational drug, biological product, or device”
27 means a drug, biological product, or device that has
28successfully completed phase 1 of a United States food and drug
29administration-approved clinical trial but has not yet been
30approved for general use by the United States food and drug
31administration and remains under investigation in a United
32States food and drug administration-approved clinical trial.
333. “Terminal illness” means a progressive disease or medical
34or surgical condition that entails significant functional
35impairment, that is not considered by a treating physician to
-1-1be reversible even with administration of treatments approved
2by the United States food and drug administration, and that,
3without life-sustaining procedures, will result in death.
43. “Individualized investigational treatment” means a drug,
5biological product, or device that is unique to and produced
6exclusively for use by an individual patient based on the
7individual patient’s own genetic profile. “Individualized
8investigational treatment” includes but is not limited to
9individualized gene therapy, antisense oligonucleotides, and
10individualized neoantigen vaccines.
114. “Written informed consent” means a written document that
12is signed by the patient, a parent of a minor patient, or a
13legal guardian or other legal representative of the patient and
14attested to by the patient’s treating physician and a witness
15and that, at a minimum, includes all of the following:
16a. An explanation of the products and treatments currently
17 approved by the United States food and drug administration
18for the disease or condition life-threatening or severely
19debilitating illness from which the patient suffers.
20b. An attestation that the patient concurs with the
21patient’s treating physician in believing that all products and
22 treatments currently approved by the United States food and
23drug administration or conventionally recognized are unlikely
24to prolong the patient’s life.
25c. Clear identification of the specific proposed
26individualized investigational drug, biological product, or
27device treatment that the patient is seeking to use.
28d. A description of the best and worst potential outcomes
29of using the individualized investigational drug, biological
30product, or device treatment and a realistic description of
31the most likely outcome. The description shall include the
32possibility that new, unanticipated, different, or worse
33symptoms might result and that death could be hastened by
34use of the proposed individualized investigational drug,
35biological product, or device treatment. The description shall
-2-1be based on the treating physician’s knowledge of the proposed
2individualized investigational drug, biological product,
3or device treatment in conjunction with an awareness of the
4patient’s condition.
5e. A statement that the patient’s health plan or third-party
6administrator and provider are not obligated to pay for any
7care or treatments consequent to the use of the individualized
8 investigational drug, biological product, or device treatment,
9unless they are specifically required to do so by law or
10contract.
11f. A statement that the patient’s eligibility for hospice
12care may be withdrawn if the patient begins curative treatment
13with the individualized investigational drug, biological
14product, or device treatment and that care may be reinstated if
15this treatment ends and the patient meets hospice eligibility
16requirements.
17g. A statement that the patient understands that the
18patient is liable for all expenses consequent to the use of
19the individualized investigational drug, biological product,
20or device treatment and that this liability extends to the
21patient’s estate unless a contract between the patient and
22the manufacturer of the individualized investigational drug,
23biological product, or device treatment states otherwise.
24 Sec. 2. Section 144E.3, Code 2023, is amended to read as
25follows:
26144E.3 Manufacturer and eligible facility rights.
271. A manufacturer of an individualized investigational
28drug, biological product, or device treatment operating
29within an eligible facility and in compliance with all laws
30applicable to an eligible facility may make available and an
31eligible patient may request the manufacturer’s individualized
32 investigational drug, biological product, or device treatment
33 under this chapter. This chapter does not require a
34manufacturer of an individualized investigational drug,
35biological product, or device treatment to provide or otherwise
-3-1make available the individualized investigational drug,
2biological product, or device treatment to an eligible patient.
32. A An eligible facility or a manufacturer described in
4subsection 1 may do any of the following:
5a. Provide an individualized investigational drug,
6biological product, or device treatment to an eligible patient
7without receiving compensation.
8b. Require an eligible patient to pay the costs of, or the
9costs associated with, the manufacture of the individualized
10 investigational drug, biological product, or device treatment.
11 Sec. 3. Section 144E.4, Code 2023, is amended to read as
12follows:
13144E.4 Treatment coverage.
141. This chapter does not expand the coverage required of an
15insurer under Title XIII, subtitle 1.
162. A health plan, third-party administrator, or
17governmental agency may provide coverage for the cost of an
18individualized investigational drug, biological product, or
19device treatment, or the cost of services related to the use of
20an individualized investigational drug, biological product, or
21device treatment under this chapter.
223. This chapter does not require any governmental agency
23to pay costs associated with the use, care, or treatment of a
24patient with an individualized investigational drug, biological
25product, or device treatment.
264. This chapter does not require a hospital licensed under
27chapter 135B or other health care facility to provide new or
28additional services, unless approved by the hospital or health
29care facility.
30 Sec. 4. Section 144E.5, Code 2023, is amended to read as
31follows:
32144E.5 Heirs not liable for treatment debts.
33If a patient dies while being treated by an individualized
34 investigational drug, biological product, or device treatment,
35the patient’s heirs are not liable for any outstanding debt
-4-1related to the treatment or lack of insurance due to the
2treatment, unless otherwise required by law.
3 Sec. 5. Section 144E.6, Code 2023, is amended to read as
4follows:
5144E.6 Provider recourse.
61. To the extent consistent with state law, the board of
7medicine created under chapter 147 shall not revoke, fail
8to renew, suspend, or take any action against a physician’s
9license based solely on the physician’s recommendations to
10an eligible patient regarding access to or treatment with an
11individualized investigational drug, biological product, or
12device treatment.
132. To the extent consistent with federal law, an entity
14responsible for Medicare certification shall not take action
15against a physician’s Medicare certification based solely on
16the physician’s recommendation that a patient have access to
17an individualized investigational drug, biological product, or
18device treatment.
19 Sec. 6. Section 144E.7, Code 2023, is amended to read as
20follows:
21144E.7 State interference.
22An official, employee, or agent of this state shall not
23block or attempt to block an eligible patient’s access to an
24individualized investigational drug, biological product, or
25device treatment. Counseling, advice, or a recommendation
26consistent with medical standards of care from a licensed
27physician is not a violation of this section.
28 Sec. 7. Section 144E.8, Code 2023, is amended to read as
29follows:
30144E.8 Private cause of action.
311. This chapter shall not create a private cause of action
32against a manufacturer of an individualized investigational
33drug, biological product, or device treatment or against any
34other person or entity involved in the care of an eligible
35patient using the individualized investigational drug,
-5-1biological product, or device treatment for any harm done
2to the eligible patient resulting from the individualized
3 investigational drug, biological product, or device treatment,
4if the manufacturer or other person or entity is complying in
5good faith with the terms of this chapter and has exercised
6reasonable care.
72. This chapter shall not affect any mandatory health care
8coverage for participation in clinical trials under Title XIII,
9subtitle 1.
10 Sec. 8. REPEAL. Section 144E.9, Code 2023, is repealed.
11EXPLANATION
12The inclusion of this explanation does not constitute agreement with
13the explanation’s substance by the members of the general assembly.
14This bill relates to Code chapter 144E, the right to try Act.
15Under current law, an “eligible patient” under the Code
16chapter is, in part, a person who has a terminal illness.
17Under the bill, an “eligible patient” is instead, in part, a
18person who has a life-threatening or severely debilitating
19illness.
20Under current law, the Code chapter applies to an
21“investigational drug, biological product, or device”
22meaning a drug, biological product, or device that has
23successfully completed phase I of a United States food and drug
24administration (FDA)-approved clinical trial but has not yet
25been approved for general use by the FDA and that remains under
26investigation in an FDA-approved clinical trial. Under the
27bill, the Code chapter instead applies to an “individualized
28investigational treatment”, meaning a drug, biological product,
29or device that is unique to and produced exclusively for use
30by an individual patient based on the individual patient’s
31own genetic profile and includes individualized gene therapy,
32antisense oligonucleotides, and individualized neoantigen
33vaccines.
34The bill amends the definition under the Code chapter for
35“written informed consent” to reflect the changes made to
-6-1“eligible patient” and the application of the Code chapter to
2individualized investigational treatments.
3The bill provides a definition of “eligible facility” to
4mean an institution that is operating under a federalwide
5assurance for the protection of human subjects pursuant
6to federal law. The bill amends provisions relating to
7a manufacturer’s rights under the Code chapter to provide
8that a manufacturer of an individualized investigational
9treatment operating within an eligible facility and in
10compliance with all laws applicable to an eligible facility
11may make available, and an eligible patient may request, the
12manufacturer’s individualized investigational treatment under
13the Code chapter. However, the Code chapter does not require
14a manufacturer of an individualized investigational treatment
15to provide or otherwise make available the individualized
16investigational treatment to an eligible patient. The bill
17provides that an eligible facility or a manufacturer may
18provide an individualized investigational treatment to an
19eligible patient without receiving compensation, or require an
20eligible patient to pay the costs of, or the costs associated
21with, the manufacture of the individualized investigational
22treatment.
23The bill makes other conforming changes in the Code chapter
24to reflect the bill provisions.
25The bill repeals Code section 144E.9, which provides that
26the Code chapter shall not be construed to allow a patient’s
27treating physician to assist the patient in committing or
28attempting to commit suicide.
-7-pf/rh