Rep. Norm Thurston — Voting Record

Bill

Number

H.B. 94 Fifth Substitute (2015GS)

Sponsor

Rep. Froerer, G.

Final action

Governor Signed 3/24/2015

Outcome

Became law — signed by Gov. Gary R. Herbert

Summary

What it does

• This bill:
• provides that a terminally ill patient may obtain an investigational drug or device from the drug's or device's manufacturer under certain circumstances;
• exempts certain conduct from the definition of unlawful and unprofessional conduct for a physician who administers an investigational drug or uses an investigational device to treat a terminally ill patient;
• allows an insurance company to deny, under certain circumstances, coverage to an individual who is treated with an investigational drug or device; and
• provides that certain health care providers are not subject to civil or criminal liability or licensure sanctions for treating a patient with an investigational drug or device.

Every vote on this bill

Bill text

INVESTIGATIONAL DRUG AND DEVICE ACCESS FOR
TERMINALLY ILL PATIENTS
GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Gage Froerer
Senate Sponsor: 
Evan J. Vickers
LONG TITLE
General Description:
This bill amends provisions related to investigational drugs and devices.
Highlighted Provisions:
This bill:
▸ provides that a terminally ill patient may obtain an investigational drug or device
from the drug's or device's manufacturer under certain circumstances;
▸ exempts certain conduct from the definition of unlawful and unprofessional conduct
for a physician who administers an investigational drug or uses an investigational
device to treat a terminally ill patient;
▸ allows an insurance company to deny, under certain circumstances, coverage to an
individual who is treated with an investigational drug or device; and
▸ provides that certain health care providers are not subject to civil or criminal
liability or licensure sanctions for treating a patient with an investigational drug or
device.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
58-67-501
, as last amended by Laws of Utah 2001, Chapter 116
58-67-502
, as last amended by Laws of Utah 2014, Chapter 72
58-68-501
, as last amended by Laws of Utah 2001, Chapter 116
58-68-502
, as last amended by Laws of Utah 2014, Chapter 72
ENACTS:
58-85-101
, Utah Code Annotated 1953
58-85-102
, Utah Code Annotated 1953
58-85-103
, Utah Code Annotated 1953
58-85-104
, Utah Code Annotated 1953
58-85-105
, Utah Code Annotated 1953
Be it enacted by the Legislature of the state of Utah:
Section 1. Section 
58-67-501
 is amended to read:
58-67-501.
Unlawful conduct.
(1) "Unlawful conduct" includes, in addition to the definition in Section 
58-1-501
:
(a) buying, selling, or fraudulently obtaining, any medical diploma, license, certificate,
or registration;
(b) aiding or abetting the buying, selling, or fraudulently obtaining of any medical
diploma, license, certificate, or registration;
(c) substantially interfering with a licensee's lawful and competent practice of medicine
in accordance with this chapter by:
(i) any person or entity that manages, owns, operates, or conducts a business having a
direct or indirect financial interest in the licensee's professional practice; or
(ii) anyone other than another physician licensed under this title, who is engaged in
direct clinical care or consultation with the licensee in accordance with the standards and ethics
of the profession of medicine; or
(d) entering into a contract that limits a licensee's ability to advise the licensee's
patients fully about treatment options or other issues that affect the health care of the licensee's
patients.
(2) "Unlawful conduct" does not include:
(a) establishing, administering, or enforcing the provisions of a policy of accident and
health insurance by an insurer doing business in this state in accordance with Title 31A,
Insurance Code;
(b) adopting, implementing, or enforcing utilization management standards related to
payment for a licensee's services, provided that:
(i) utilization management standards adopted, implemented, and enforced by the payer
have been approved by a physician or by a committee that contains one or more physicians; and
(ii) the utilization management standards does not preclude a licensee from exercising
independent professional judgment on behalf of the licensee's patients in a manner that is
independent of payment considerations;
(c) developing and implementing clinical practice standards that are intended to reduce
morbidity and mortality or developing and implementing other medical or surgical practice
standards related to the standardization of effective health care practices, provided that:
(i) the practice standards and recommendations have been approved by a physician or
by a committee that contains one or more physicians; and
(ii) the practice standards do not preclude a licensee from exercising independent
professional judgment on behalf of the licensee's patients in a manner that is independent of
payment considerations;
(d) requesting or recommending that a patient obtain a second opinion from a licensee;
(e) conducting peer review, quality evaluation, quality improvement, risk management,
or similar activities designed to identify and address practice deficiencies with health care
providers, health care facilities, or the delivery of health care;
(f) providing employment supervision or adopting employment requirements that do
not interfere with the licensee's ability to exercise independent professional judgment on behalf
of the licensee's patients, provided that employment requirements that may not be considered to
interfere with an employed licensee's exercise of independent professional judgment include:
(i) an employment requirement that restricts the licensee's access to patients with
whom the licensee's employer does not have a contractual relationship, either directly or
through contracts with one or more third-party payers; or
(ii) providing compensation incentives that are not related to the treatment of any
particular patient;
(g) providing benefit coverage information, giving advice, or expressing opinions to a
patient or to a family member of a patient to assist the patient or family member in making a
decision about health care that has been recommended by a licensee; [
or
]
(h) in compliance with Section 
58-85-103
:
(i) obtaining an investigational drug or investigational device;
(ii) administering the investigational drug to an eligible patient; or
(iii) treating an eligible patient with the investigational drug or investigational device;
or
[
(h)
] 
(i)
 any otherwise lawful conduct that does not substantially interfere with the
licensee's ability to exercise independent professional judgment on behalf of the licensee's
patients and that does not constitute the practice of medicine as defined in this chapter.
Section 2. Section 
58-67-502
 is amended to read:
58-67-502.
Unprofessional conduct.
(1)
 "Unprofessional conduct" includes, in addition to the definition in Section
58-1-501
:
[
(1)
] 
(a)
 using or employing the services of any individual to assist a licensee in any
manner not in accordance with the generally recognized practices, standards, or ethics of the
profession, state law, or division rule;
[
(2)
] 
(b)
 making a material misrepresentation regarding the qualifications for licensure
under Section 
58-67-302.7
; or
[
(3)
] 
(c)
 violating the dispensing requirements of Section 
58-17b-309
 or Chapter 17b,
Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy,
if applicable.
(2) "Unprofessional conduct" does not include, in compliance with Section 
58-85-103
:
(a) obtaining an investigational drug or investigational device;
(b) administering the investigational drug to an eligible patient; or
(c) treating an eligible patient with the investigational drug or investigational device.
Section 3. Section 
58-68-501
 is amended to read:
58-68-501.
Unlawful conduct.
(1) "Unlawful conduct" includes, in addition to the definition in Section 
58-1-501
:
(a) buying, selling, or fraudulently obtaining any osteopathic medical diploma, license,
certificate, or registration; and
(b) aiding or abetting the buying, selling, or fraudulently obtaining of any osteopathic
medical diploma, license, certificate, or registration;
(c) substantially interfering with a licensee's lawful and competent practice of medicine
in accordance with this chapter by:
(i) any person or entity that manages, owns, operates, or conducts a business having a
direct or indirect financial interest in the licensee's professional practice; or
(ii) anyone other than another physician licensed under this title, who is engaged in
direct clinical care or consultation with the licensee in accordance with the standards and ethics
of the profession of medicine; or
(d) entering into a contract that limits a licensee's ability to advise the licensee's
patients fully about treatment options or other issues that affect the health care of the licensee's
patients.
(2) "Unlawful conduct" does not include:
(a) establishing, administering, or enforcing the provisions of a policy of accident and
health insurance by an insurer doing business in this state in accordance with Title 31A,
Insurance Code;
(b) adopting, implementing, or enforcing utilization management standards related to
payment for a licensee's services, provided that:
(i) utilization management standards adopted, implemented, and enforced by the payer
have been approved by a physician or by a committee that contains one or more physicians; and
(ii) the utilization management standards does not preclude a licensee from exercising
independent professional judgment on behalf of the licensee's patients in a manner that is
independent of payment considerations;
(c) developing and implementing clinical practice standards that are intended to reduce
morbidity and mortality or developing and implementing other medical or surgical practice
standards related to the standardization of effective health care practices, provided that:
(i) the practice standards and recommendations have been approved by a physician or
by a committee that contains one or more physicians; and
(ii) the practice standards do not preclude a licensee from exercising independent
professional judgment on behalf of the licensee's patients in a manner that is independent of
payment considerations;
(d) requesting or recommending that a patient obtain a second opinion from a licensee;
(e) conducting peer review, quality evaluation, quality improvement, risk management,
or similar activities designed to identify and address practice deficiencies with health care
providers, health care facilities, or the delivery of health care;
(f) providing employment supervision or adopting employment requirements that do
not interfere with the licensee's ability to exercise independent professional judgment on behalf
of the licensee's patients, provided that employment requirements that may not be considered to
interfere with an employed licensee's exercise of independent professional judgment include:
(i) an employment requirement that restricts the licensee's access to patients with
whom the licensee's employer does not have a contractual relationship, either directly or
through contracts with one or more third-party payers; or
(ii) providing compensation incentives that are not related to the treatment of any
particular patient;
(g) providing benefit coverage information, giving advice, or expressing opinions to a
patient or to a family member of a patient to assist the patient or family member in making a
decision about health care that has been recommended by a licensee; [
or
]
(h) in compliance with Section 
58-85-103
:
(i) obtaining an investigational drug or investigational device;
(ii) administering the investigational drug to an eligible patient; or
(iii) treating an eligible patient with the investigational drug or investigational device;
or
[
(h)
] 
(i)
 any otherwise lawful conduct that does not substantially interfere with the
licensee's ability to exercise independent professional judgment on behalf of the licensee's
patients and that does not constitute the practice of medicine as defined in this chapter.
Section 4. Section 
58-68-502
 is amended to read:
58-68-502.
Unprofessional conduct.
(1)
 "Unprofessional conduct" includes, in addition to the definition in Section
58-1-501
:
[
(1)
] 
(a)
 using or employing the services of any individual to assist a licensee in any
manner not in accordance with the generally recognized practices, standards, or ethics of the
profession, state law, or division rule; or
[
(2)
] 
(b)
 violating the dispensing requirements of Section 
58-17b-309
 or Chapter 17b,
Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy,
if applicable.
(2) "Unprofessional conduct" does not include, in compliance with Section 
58-85-103
:
(a) obtaining an investigational drug or investigational device;
(b) administering the investigational drug to an eligible patient; or
(c) treating an eligible patient with the investigational drug or investigational device.
Section 5. Section 
58-85-101
 is enacted to read:
CHAPTER 85. UTAH RIGHT TO TRY ACT
 58-85-101.
Title.
This chapter is known as the "Utah Right to Try Act."
Section 6. Section 
58-85-102
 is enacted to read:
 58-85-102.
Definitions.
As used in this chapter:
(1) "Eligible patient" means an individual who has been diagnosed with a terminal
illness by a physician.
(2) "Insurer" means the same as that term is defined in Section 
31A-1-301
.
(3) "Investigational device" means a device that:
(a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and
(b) has successfully completed the United States Food and Drug Administration Phase
testing for an investigational device described in 21 C.F.R. Part 812.
(4) "Investigational drug" means a drug that:
(a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and
(b) has successfully completed the United States Food and Drug Administration Phase
testing for an investigational new drug described in 21 C.F.R. Part 312.
(5) "Physician" means an individual who is licensed under:
(a) Title 58, Chapter 67, Utah Medical Practice Act; or
(b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.
(6) "Terminal illness" means a condition of a patient that:
(a) as determined by a physician:
(i) is likely to pose a greater risk to the patient than the risk posed to the patient by
treatment with an investigational drug or investigational device; and
(ii) will inevitably lead to the patient's death; and
(b) presents the patient, after the patient has explored conventional therapy options,
with no treatment option that is satisfactory or comparable to treatment with an investigational
drug or device.
Section 7. Section 
58-85-103
 is enacted to read:
 58-85-103.
Right to request investigational drug or device.
(1) An eligible patient may obtain an investigational drug through an agreement with
the investigational drug's manufacturer and the eligible patient's physician that provides:
(a) for the transfer of the investigational drug from the manufacturer to the physician;
and
(b) that the physician will administer the investigational drug to the patient.
(2) An eligible patient may obtain an investigational device through an agreement with
the investigational device's manufacturer and the eligible patient's physician that provides:
(a) for the transfer of the investigational device from the manufacturer to the physician;
and
(b) that the physician will use the investigational device to treat the patient.
(3) An agreement described in Subsection (1) or (2), between an eligible patient, a
physician, and a manufacturer, shall include an informed consent document that, based on the
physician's knowledge of the relevant investigational drug or investigational device:
(a) describes the possible positive and negative outcomes the eligible patient could
experience if the physician treats the eligible patient with the investigational drug or
investigational device, including that the investigational drug or investigational device could
increase the possibility of death;
(b) states that an insurer is not required to cover the cost of providing the
investigational drug or investigational device to the patient;
(c) states that, subject to Section 58-85-105, an insurer may deny coverage for the
eligible patient; and
(d) states that the patient may be liable for all expenses caused by the physician treating
the patient with the investigational drug or investigational device, unless the agreement
provides otherwise.
(4) A physician or an eligible patient shall notify the eligible patient's insurer of the day
on which the physician treated an eligible patient with an investigational drug or investigational
device, and the investigational drug or device used, under an agreement described in
Subsection (1) or (2).
Section 8. Section 
58-85-104
 is enacted to read:
 58-85-104.
Standard of care -- Medical practitioners not liable -- No private right
of action.
(1) It is not a breach of the applicable standard of care for a physician, other licensed
health care provider, or hospital to treat an eligible patient with an investigational drug or
investigational device under this chapter.
(2) A physician, other licensed health care provider, or hospital that treats an eligible
patient with an investigational drug or investigational device under this chapter may not, for
any harm done to the eligible patient by the investigational drug or device, be subject to:
(a) civil liability;
(b) criminal liability;
(c) licensure sanctions under:
(i) for a physician:
(A) Title 58, Chapter 67, Utah Medical Practice Act; or
(B) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;
(ii) for the other licensed health care provider, the act governing the other licensed
health care provider's license; or
(iii) for the hospital, Title 26, Chapter 21, Health Care Facility Licensing and
Inspection Act.
(3) This chapter does not:
(a) require a manufacturer of an investigational drug or investigational device to agree
to make an investigational drug or investigational device available to an eligible patient or an
eligible patient's physician;
(b) require a physician to agree to:
(i) administer an investigational drug to an eligible patient under this chapter; or
(ii) treat an eligible patient with an investigational device under this chapter; or
(c) create a private right of action for an eligible patient:
(i) against a physician or hospital, for the physician's or hospital's refusal to:
(A) administer an investigational drug to an eligible patient under this chapter; or
(B) treat an eligible patient with an investigational device under this chapter; or
(ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient
with an investigational drug or an investigational device under this chapter.
Section 9. Section 
58-85-105
 is enacted to read:
 58-85-105.
Insurance coverage.
(1) This chapter does not:
(a) require an insurer to cover the cost of:
(i) administering an investigational drug under this chapter; or
(ii) treating a patient with an investigational device under this chapter; or
(b) prohibit an insurer from covering the cost of:
(i) administering an investigational drug under this chapter; or
(ii) treating a patient with an investigational device under this chapter.
(2) Except as described in Subsection (3), an insurer may deny coverage to an eligible
patient who is treated with an investigational drug or investigational device, for harm to the
eligible patient caused by the investigational drug or investigational device.
(3) An insurer may not deny coverage to an eligible patient under Subsection (2) for:
(a) the eligible patient's preexisting condition;
(b) benefits that commenced before the day on which the eligible patient is treated with
the investigational drug or investigational device; or
(c) palliative or hospice care for an eligible patient that has been treated with an
investigational drug or device, but is no longer receiving curative treatment with the
investigational drug or device.