Bill Text: IL HB2508 | 2015-2016 | 99th General Assembly | Introduced

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Bill Title: Creates the Right to Try Act. Provides that an eligible patient with a terminal illness who has considered all other treatment options approved by the United States Food and Drug Administration may acquire from a manufacturer an investigational drug, biological product, or device that has successfully completed Phase I of a clinical trial, but has not been approved for general use by the United States Food and Drug Administration. Provides that a manufacturer may, but is not required to, provide an investigational drug, biological product, or device to an eligible patient, either with or without receiving compensation. Provides that an accident and health insurer may, but is not required to, provide coverage for an eligible patient seeking such a drug, product, or device. Contains a penalty provision. Defines required terms. Contains legislative findings. Amends the Medical Practice Act of 1987. Provides that the Department of Financial and Professional Regulation may not revoke, suspend, place on probation, reprimand, refuse to issue or renew, or take any other disciplinary or non-disciplinary action against the license or permit of a physician to practice medicine based solely on the physician's recommendation to an eligible patient regarding, or prescription for, or treatment with an investigational drug, biological product, or device.

Spectrum: Slight Partisan Bill (Democrat 2-1)

Status: (Introduced - Dead) 2015-03-27 - Rule 19(a) / Re-referred to Rules Committee [HB2508 Detail]

Download: Illinois-2015-HB2508-Introduced.html

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99TH GENERAL ASSEMBLY State of Illinois 2015 and 2016 HB2508 Introduced , by Rep. David Harris SYNOPSIS AS INTRODUCED:
New Act
225 ILCS 60/22 from Ch. 111, par. 4400-22
Creates the Right to Try Act. Provides that an eligible patient with a terminal illness who has considered all other treatment options approved by the United States Food and Drug Administration may acquire from a manufacturer an investigational drug, biological product, or device that has successfully completed Phase I of a clinical trial, but has not been approved for general use by the United States Food and Drug Administration. Provides that a manufacturer may, but is not required to, provide an investigational drug, biological product, or device to an eligible patient, either with or without receiving compensation. Provides that an accident and health insurer may, but is not required to, provide coverage for an eligible patient seeking such a drug, product, or device. Contains a penalty provision. Defines required terms. Contains legislative findings. Amends the Medical Practice Act of 1987. Provides that the Department of Financial and Professional Regulation may not revoke, suspend, place on probation, reprimand, refuse to issue or renew, or take any other disciplinary or non-disciplinary action against the license or permit of a physician to practice medicine based solely on the physician's recommendation to an eligible patient regarding, or prescription for, or treatment with an investigational drug, biological product, or device.
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CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY FISCAL NOTE ACT MAY APPLY
A BILL FOR
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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the Right
to Try Act.
Section 5. Findings. The General Assembly finds that the
process of approval for investigational drugs, biological
products, and devices in the United States often takes many
years, and a patient with a terminal illness does not have the
luxury of waiting until such drug, product, or device receives
final approval from the United States Food and Drug
Administration. As a result, the standards of the United States
Food and Drug Administration for the use of investigational
drugs, biological products, and devices may deny the benefits
of potentially life-saving treatments to terminally ill
patients. A patient with a terminal illness has a fundamental
right to attempt to preserve his or her own life by accessing
investigational drugs, biological products, and devices.
Whether to use available investigational drugs, biological
products, and devices is a decision that rightfully should be
made by the patient with a terminal illness in consultation
with his or her physician and is not a decision to be made by
the government.

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Section 10. Definitions. For the purposes of this Act:
"Accident and health insurer" has the meaning given to that
term in Section 126.2 of the Illinois Insurance Code.
"Eligible patient" means a person who:
(1) has a terminal illness;
(2) has considered all other treatment options
approved by the United States Food and Drug Administration;
(3) has received a prescription or recommendation from
his or her physician for an investigational drug,
biological product, or device;
(4) has given his or her informed consent in writing
for the use of the investigational drug, biological
product, or device or, if he or she is a minor or lacks the
mental capacity to provide informed consent, a parent or
legal guardian has given informed consent on his or her
behalf; and
(5) has documentation from his or her physician
indicating that he or she has met the requirements of this
Act.
"Investigational drug, biological product, or device"
means a drug, biological product, or device that has
successfully completed Phase I of a clinical trial, but has not
been approved for general use by the United States Food and
Drug Administration.
"Phase I of a clinical trial" means the stage of a clinical

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trial where an investigational drug, biological product, or
device that has been tested in a small group for the first time
to evaluate its safety, determine a safe dosage range, and
identify side effects.
"Terminal illness" means a disease that, without
life-sustaining measures, can reasonably be expected to result
in death in 24 months or less.
Section 15. Availability of drugs, biological products,
and devices.
(a) A manufacturer of an investigational drug, biological
product, or device may make available such drug, product, or
device to eligible patients. Nothing in this Act shall be
construed to require a manufacturer to make available any drug,
product, or device.
(b) A manufacturer may:
(1) provide an investigational drug, biological
product, or device to an eligible patient without receiving
compensation; or
(2) require an eligible patient to pay the costs of or
associated with the manufacture of the investigational
drug, biological product, or device.
Section 20. Insurance coverage. An accident and health
insurer may choose to provide coverage for the cost of an
investigational drug, biological product, or device. Nothing

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in this Act shall be construed to require an accident and
health insurer to provide coverage for the cost of any
investigational drug, biological product, or device.
Section 25. Penalty. Any official, employee, or agent of
the State who blocks or attempts to block access by an eligible
patient to an investigational drug, biological product, or
device shall be guilty of a misdemeanor, punishable by a fine
not to exceed $1,500.
Section 30. The Medical Practice Act of 1987 is amended by
changing Section 22 as follows:
(225 ILCS 60/22) (from Ch. 111, par. 4400-22)
(Section scheduled to be repealed on December 31, 2015)
Sec. 22. Disciplinary action.
(A) The Department may revoke, suspend, place on probation,
reprimand, refuse to issue or renew, or take any other
disciplinary or non-disciplinary action as the Department may
deem proper with regard to the license or permit of any person
issued under this Act, including imposing fines not to exceed
$10,000 for each violation, upon any of the following grounds:
(1) Performance of an elective abortion in any place,
locale, facility, or institution other than:
(a) a facility licensed pursuant to the Ambulatory
Surgical Treatment Center Act;

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(b) an institution licensed under the Hospital
Licensing Act;
(c) an ambulatory surgical treatment center or
hospitalization or care facility maintained by the
State or any agency thereof, where such department or
agency has authority under law to establish and enforce
standards for the ambulatory surgical treatment
centers, hospitalization, or care facilities under its
management and control;
(d) ambulatory surgical treatment centers,
hospitalization or care facilities maintained by the
Federal Government; or
(e) ambulatory surgical treatment centers,
hospitalization or care facilities maintained by any
university or college established under the laws of
this State and supported principally by public funds
raised by taxation.
(2) Performance of an abortion procedure in a wilful
and wanton manner on a woman who was not pregnant at the
time the abortion procedure was performed.
(3) A plea of guilty or nolo contendere, finding of
guilt, jury verdict, or entry of judgment or sentencing,
including, but not limited to, convictions, preceding
sentences of supervision, conditional discharge, or first
offender probation, under the laws of any jurisdiction of
the United States of any crime that is a felony.

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(4) Gross negligence in practice under this Act.
(5) Engaging in dishonorable, unethical or
unprofessional conduct of a character likely to deceive,
defraud or harm the public.
(6) Obtaining any fee by fraud, deceit, or
misrepresentation.
(7) Habitual or excessive use or abuse of drugs defined
in law as controlled substances, of alcohol, or of any
other substances which results in the inability to practice
with reasonable judgment, skill or safety.
(8) Practicing under a false or, except as provided by
law, an assumed name.
(9) Fraud or misrepresentation in applying for, or
procuring, a license under this Act or in connection with
applying for renewal of a license under this Act.
(10) Making a false or misleading statement regarding
their skill or the efficacy or value of the medicine,
treatment, or remedy prescribed by them at their direction
in the treatment of any disease or other condition of the
body or mind.
(11) Allowing another person or organization to use
their license, procured under this Act, to practice.
(12) Adverse action taken by another state or
jurisdiction against a license or other authorization to
practice as a medical doctor, doctor of osteopathy, doctor
of osteopathic medicine or doctor of chiropractic, a

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certified copy of the record of the action taken by the
other state or jurisdiction being prima facie evidence
thereof. This includes any adverse action taken by a State
or federal agency that prohibits a medical doctor, doctor
of osteopathy, doctor of osteopathic medicine, or doctor of
chiropractic from providing services to the agency's
participants.
(13) Violation of any provision of this Act or of the
Medical Practice Act prior to the repeal of that Act, or
violation of the rules, or a final administrative action of
the Secretary, after consideration of the recommendation
of the Disciplinary Board.
(14) Violation of the prohibition against fee
splitting in Section 22.2 of this Act.
(15) A finding by the Disciplinary Board that the
registrant after having his or her license placed on
probationary status or subjected to conditions or
restrictions violated the terms of the probation or failed
to comply with such terms or conditions.
(16) Abandonment of a patient.
(17) Prescribing, selling, administering,
distributing, giving or self-administering any drug
classified as a controlled substance (designated product)
or narcotic for other than medically accepted therapeutic
purposes.
(18) Promotion of the sale of drugs, devices,

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appliances or goods provided for a patient in such manner
as to exploit the patient for financial gain of the
physician.
(19) Offering, undertaking or agreeing to cure or treat
disease by a secret method, procedure, treatment or
medicine, or the treating, operating or prescribing for any
human condition by a method, means or procedure which the
licensee refuses to divulge upon demand of the Department.
(20) Immoral conduct in the commission of any act
including, but not limited to, commission of an act of
sexual misconduct related to the licensee's practice.
(21) Wilfully making or filing false records or reports
in his or her practice as a physician, including, but not
limited to, false records to support claims against the
medical assistance program of the Department of Healthcare
and Family Services (formerly Department of Public Aid)
under the Illinois Public Aid Code.
(22) Wilful omission to file or record, or wilfully
impeding the filing or recording, or inducing another
person to omit to file or record, medical reports as
required by law, or wilfully failing to report an instance
of suspected abuse or neglect as required by law.
(23) Being named as a perpetrator in an indicated
report by the Department of Children and Family Services
under the Abused and Neglected Child Reporting Act, and
upon proof by clear and convincing evidence that the

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licensee has caused a child to be an abused child or
neglected child as defined in the Abused and Neglected
Child Reporting Act.
(24) Solicitation of professional patronage by any
corporation, agents or persons, or profiting from those
representing themselves to be agents of the licensee.
(25) Gross and wilful and continued overcharging for
professional services, including filing false statements
for collection of fees for which services are not rendered,
including, but not limited to, filing such false statements
for collection of monies for services not rendered from the
medical assistance program of the Department of Healthcare
and Family Services (formerly Department of Public Aid)
under the Illinois Public Aid Code.
(26) A pattern of practice or other behavior which
demonstrates incapacity or incompetence to practice under
this Act.
(27) Mental illness or disability which results in the
inability to practice under this Act with reasonable
judgment, skill or safety.
(28) Physical illness, including, but not limited to,
deterioration through the aging process, or loss of motor
skill which results in a physician's inability to practice
under this Act with reasonable judgment, skill or safety.
(29) Cheating on or attempt to subvert the licensing
examinations administered under this Act.

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(30) Wilfully or negligently violating the
confidentiality between physician and patient except as
required by law.
(31) The use of any false, fraudulent, or deceptive
statement in any document connected with practice under
this Act.
(32) Aiding and abetting an individual not licensed
under this Act in the practice of a profession licensed
under this Act.
(33) Violating state or federal laws or regulations
relating to controlled substances, legend drugs, or
ephedra as defined in the Ephedra Prohibition Act.
(34) Failure to report to the Department any adverse
final action taken against them by another licensing
jurisdiction (any other state or any territory of the
United States or any foreign state or country), by any peer
review body, by any health care institution, by any
professional society or association related to practice
under this Act, by any governmental agency, by any law
enforcement agency, or by any court for acts or conduct
similar to acts or conduct which would constitute grounds
for action as defined in this Section.
(35) Failure to report to the Department surrender of a
license or authorization to practice as a medical doctor, a
doctor of osteopathy, a doctor of osteopathic medicine, or
doctor of chiropractic in another state or jurisdiction, or

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surrender of membership on any medical staff or in any
medical or professional association or society, while
under disciplinary investigation by any of those
authorities or bodies, for acts or conduct similar to acts
or conduct which would constitute grounds for action as
defined in this Section.
(36) Failure to report to the Department any adverse
judgment, settlement, or award arising from a liability
claim related to acts or conduct similar to acts or conduct
which would constitute grounds for action as defined in
this Section.
(37) Failure to provide copies of medical records as
required by law.
(38) Failure to furnish the Department, its
investigators or representatives, relevant information,
legally requested by the Department after consultation
with the Chief Medical Coordinator or the Deputy Medical
Coordinator.
(39) Violating the Health Care Worker Self-Referral
Act.
(40) Willful failure to provide notice when notice is
required under the Parental Notice of Abortion Act of 1995.
(41) Failure to establish and maintain records of
patient care and treatment as required by this law.
(42) Entering into an excessive number of written
collaborative agreements with licensed advanced practice

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nurses resulting in an inability to adequately
collaborate.
(43) Repeated failure to adequately collaborate with a
licensed advanced practice nurse.
(44) Violating the Compassionate Use of Medical
Cannabis Pilot Program Act.
(45) Entering into an excessive number of written
collaborative agreements with licensed prescribing
psychologists resulting in an inability to adequately
collaborate.
(46) Repeated failure to adequately collaborate with a
licensed prescribing psychologist.
Except for actions involving the ground numbered (26), all
proceedings to suspend, revoke, place on probationary status,
or take any other disciplinary action as the Department may
deem proper, with regard to a license on any of the foregoing
grounds, must be commenced within 5 years next after receipt by
the Department of a complaint alleging the commission of or
notice of the conviction order for any of the acts described
herein. Except for the grounds numbered (8), (9), (26), and
(29), no action shall be commenced more than 10 years after the
date of the incident or act alleged to have violated this
Section. For actions involving the ground numbered (26), a
pattern of practice or other behavior includes all incidents
alleged to be part of the pattern of practice or other behavior
that occurred, or a report pursuant to Section 23 of this Act

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received, within the 10-year period preceding the filing of the
complaint. In the event of the settlement of any claim or cause
of action in favor of the claimant or the reduction to final
judgment of any civil action in favor of the plaintiff, such
claim, cause of action or civil action being grounded on the
allegation that a person licensed under this Act was negligent
in providing care, the Department shall have an additional
period of 2 years from the date of notification to the
Department under Section 23 of this Act of such settlement or
final judgment in which to investigate and commence formal
disciplinary proceedings under Section 36 of this Act, except
as otherwise provided by law. The time during which the holder
of the license was outside the State of Illinois shall not be
included within any period of time limiting the commencement of
disciplinary action by the Department.
The entry of an order or judgment by any circuit court
establishing that any person holding a license under this Act
is a person in need of mental treatment operates as a
suspension of that license. That person may resume their
practice only upon the entry of a Departmental order based upon
a finding by the Disciplinary Board that they have been
determined to be recovered from mental illness by the court and
upon the Disciplinary Board's recommendation that they be
permitted to resume their practice.
The Department may refuse to issue or take disciplinary
action concerning the license of any person who fails to file a

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return, or to pay the tax, penalty or interest shown in a filed
return, or to pay any final assessment of tax, penalty or
interest, as required by any tax Act administered by the
Illinois Department of Revenue, until such time as the
requirements of any such tax Act are satisfied as determined by
the Illinois Department of Revenue.
The Department, upon the recommendation of the
Disciplinary Board, shall adopt rules which set forth standards
to be used in determining:
(a) when a person will be deemed sufficiently
rehabilitated to warrant the public trust;
(b) what constitutes dishonorable, unethical or
unprofessional conduct of a character likely to deceive,
defraud, or harm the public;
(c) what constitutes immoral conduct in the commission
of any act, including, but not limited to, commission of an
act of sexual misconduct related to the licensee's
practice; and
(d) what constitutes gross negligence in the practice
of medicine.
However, no such rule shall be admissible into evidence in
any civil action except for review of a licensing or other
disciplinary action under this Act.
In enforcing this Section, the Disciplinary Board or the
Licensing Board, upon a showing of a possible violation, may
compel, in the case of the Disciplinary Board, any individual

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who is licensed to practice under this Act or holds a permit to
practice under this Act, or, in the case of the Licensing
Board, any individual who has applied for licensure or a permit
pursuant to this Act, to submit to a mental or physical
examination and evaluation, or both, which may include a
substance abuse or sexual offender evaluation, as required by
the Licensing Board or Disciplinary Board and at the expense of
the Department. The Disciplinary Board or Licensing Board shall
specifically designate the examining physician licensed to
practice medicine in all of its branches or, if applicable, the
multidisciplinary team involved in providing the mental or
physical examination and evaluation, or both. The
multidisciplinary team shall be led by a physician licensed to
practice medicine in all of its branches and may consist of one
or more or a combination of physicians licensed to practice
medicine in all of its branches, licensed chiropractic
physicians, licensed clinical psychologists, licensed clinical
social workers, licensed clinical professional counselors, and
other professional and administrative staff. Any examining
physician or member of the multidisciplinary team may require
any person ordered to submit to an examination and evaluation
pursuant to this Section to submit to any additional
supplemental testing deemed necessary to complete any
examination or evaluation process, including, but not limited
to, blood testing, urinalysis, psychological testing, or
neuropsychological testing. The Disciplinary Board, the

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Licensing Board, or the Department may order the examining
physician or any member of the multidisciplinary team to
provide to the Department, the Disciplinary Board, or the
Licensing Board any and all records, including business
records, that relate to the examination and evaluation,
including any supplemental testing performed. The Disciplinary
Board, the Licensing Board, or the Department may order the
examining physician or any member of the multidisciplinary team
to present testimony concerning this examination and
evaluation of the licensee, permit holder, or applicant,
including testimony concerning any supplemental testing or
documents relating to the examination and evaluation. No
information, report, record, or other documents in any way
related to the examination and evaluation shall be excluded by
reason of any common law or statutory privilege relating to
communication between the licensee, permit holder, or
applicant and the examining physician or any member of the
multidisciplinary team. No authorization is necessary from the
licensee, permit holder, or applicant ordered to undergo an
evaluation and examination for the examining physician or any
member of the multidisciplinary team to provide information,
reports, records, or other documents or to provide any
testimony regarding the examination and evaluation. The
individual to be examined may have, at his or her own expense,
another physician of his or her choice present during all
aspects of the examination. Failure of any individual to submit

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to mental or physical examination and evaluation, or both, when
directed, shall result in an automatic suspension, without
hearing, until such time as the individual submits to the
examination. If the Disciplinary Board or Licensing Board finds
a physician unable to practice following an examination and
evaluation because of the reasons set forth in this Section,
the Disciplinary Board or Licensing Board shall require such
physician to submit to care, counseling, or treatment by
physicians, or other health care professionals, approved or
designated by the Disciplinary Board, as a condition for
issued, continued, reinstated, or renewed licensure to
practice. Any physician, whose license was granted pursuant to
Sections 9, 17, or 19 of this Act, or, continued, reinstated,
renewed, disciplined or supervised, subject to such terms,
conditions or restrictions who shall fail to comply with such
terms, conditions or restrictions, or to complete a required
program of care, counseling, or treatment, as determined by the
Chief Medical Coordinator or Deputy Medical Coordinators,
shall be referred to the Secretary for a determination as to
whether the licensee shall have their license suspended
immediately, pending a hearing by the Disciplinary Board. In
instances in which the Secretary immediately suspends a license
under this Section, a hearing upon such person's license must
be convened by the Disciplinary Board within 15 days after such
suspension and completed without appreciable delay. The
Disciplinary Board shall have the authority to review the

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subject physician's record of treatment and counseling
regarding the impairment, to the extent permitted by applicable
federal statutes and regulations safeguarding the
confidentiality of medical records.
An individual licensed under this Act, affected under this
Section, shall be afforded an opportunity to demonstrate to the
Disciplinary Board that they can resume practice in compliance
with acceptable and prevailing standards under the provisions
of their license.
The Department may promulgate rules for the imposition of
fines in disciplinary cases, not to exceed $10,000 for each
violation of this Act. Fines may be imposed in conjunction with
other forms of disciplinary action, but shall not be the
exclusive disposition of any disciplinary action arising out of
conduct resulting in death or injury to a patient. Any funds
collected from such fines shall be deposited in the Medical
Disciplinary Fund.
All fines imposed under this Section shall be paid within
60 days after the effective date of the order imposing the fine
or in accordance with the terms set forth in the order imposing
the fine.
(B) The Department shall revoke the license or permit
issued under this Act to practice medicine or a chiropractic
physician who has been convicted a second time of committing
any felony under the Illinois Controlled Substances Act or the
Methamphetamine Control and Community Protection Act, or who

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has been convicted a second time of committing a Class 1 felony
under Sections 8A-3 and 8A-6 of the Illinois Public Aid Code. A
person whose license or permit is revoked under this subsection
B shall be prohibited from practicing medicine or treating
human ailments without the use of drugs and without operative
surgery.
(C) The Department shall not revoke, suspend, place on
probation, reprimand, refuse to issue or renew, or take any
other disciplinary or non-disciplinary action against the
license or permit issued under this Act to practice medicine to
a physician based solely upon the recommendation of the
physician to an eligible patient regarding, or prescription
for, or treatment with, an investigational drug, biological
product, or device.
(D) (C) The Disciplinary Board shall recommend to the
Department civil penalties and any other appropriate
discipline in disciplinary cases when the Board finds that a
physician willfully performed an abortion with actual
knowledge that the person upon whom the abortion has been
performed is a minor or an incompetent person without notice as
required under the Parental Notice of Abortion Act of 1995.
Upon the Board's recommendation, the Department shall impose,
for the first violation, a civil penalty of $1,000 and for a
second or subsequent violation, a civil penalty of $5,000.
(Source: P.A. 97-622, eff. 11-23-11; 98-601, eff. 12-30-13;
98-668, eff. 6-25-14; 98-1140, eff. 12-30-14.)