Public Act 099-0270

HB1335 Enrolled LRB099 08955 JLK 29128 b

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.

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

trial where an investigational drug, biological product, or

device 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

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 80. The Nursing Home Care Act is amended by

changing Section 2-104 as follows:

(210 ILCS 45/2-104) (from Ch. 111 1/2, par. 4152-104)

Sec. 2-104. (a) A resident shall be permitted to retain the

services of his own personal physician at his own expense or

under an individual or group plan of health insurance, or under

any public or private assistance program providing such

coverage. However, the facility is not liable for the

negligence of any such personal physician. Every resident shall

be permitted to obtain from his own physician or the physician

attached to the facility complete and current information

concerning his medical diagnosis, treatment and prognosis in

terms and language the resident can reasonably be expected to

understand. Every resident shall be permitted to participate in

the planning of his total care and medical treatment to the

extent that his condition permits. No resident shall be

subjected to experimental research or treatment without first

obtaining his informed, written consent. The conduct of any

experimental research or treatment shall be authorized and

monitored by an institutional review board appointed by the

Director. The membership, operating procedures and review

criteria for the institutional review board shall be prescribed

under rules and regulations of the Department and shall comply

with the requirements for institutional review boards

established by the federal Food and Drug Administration. No

person who has received compensation in the prior 3 years from

an entity that manufactures, distributes, or sells

pharmaceuticals, biologics, or medical devices may serve on the

institutional review board.

The institutional review board may approve only research or

treatment that meets the standards of the federal Food and Drug

Administration with respect to (i) the protection of human

subjects and (ii) financial disclosure by clinical

investigators. The Office of State Long Term Care Ombudsman and

the State Protection and Advocacy organization shall be given

an opportunity to comment on any request for approval before

the board makes a decision. Those entities shall not be

provided information that would allow a potential human subject

to be individually identified, unless the board asks the

Ombudsman for help in securing information from or about the

resident. The board shall require frequent reporting of the

progress of the approved research or treatment and its impact

on residents, including immediate reporting of any adverse

impact to the resident, the resident's representative, the

Office of the State Long Term Care Ombudsman, and the State

Protection and Advocacy organization. The board may not approve

any retrospective study of the records of any resident about

the safety or efficacy of any care or treatment if the resident

was under the care of the proposed researcher or a business

associate when the care or treatment was given, unless the

study is under the control of a researcher without any business

relationship to any person or entity who could benefit from the

findings of the study.

No facility shall permit experimental research or

treatment to be conducted on a resident, or give access to any

person or person's records for a retrospective study about the

safety or efficacy of any care or treatment, without the prior

written approval of the institutional review board. No nursing

home administrator, or person licensed by the State to provide

medical care or treatment to any person, may assist or

participate in any experimental research on or treatment of a

resident, including a retrospective study, that does not have

the prior written approval of the board. Such conduct shall be

grounds for professional discipline by the Department of

Financial and Professional Regulation.

The institutional review board may exempt from ongoing

review research or treatment initiated on a resident before the

individual's admission to a facility and for which the board

determines there is adequate ongoing oversight by another

institutional review board. Nothing in this Section shall

prevent a facility, any facility employee, or any other person

from assisting or participating in any experimental research on

or treatment of a resident, if the research or treatment began

before the person's admission to a facility, until the board

has reviewed the research or treatment and decided to grant or

deny approval or to exempt the research or treatment from

ongoing review.

The institutional review board requirements of this

subsection (a) do not apply to investigational drugs,

biological products, or devices used by a resident with a

terminal illness as set forth in the Right to Try Act.

(b) All medical treatment and procedures shall be

administered as ordered by a physician. All new physician

orders shall be reviewed by the facility's director of nursing

or charge nurse designee within 24 hours after such orders have

been issued to assure facility compliance with such orders.

All physician's orders and plans of treatment shall have

the authentication of the physician. For the purposes of this

subsection (b), "authentication" means an original written

signature or an electronic signature system that allows for the

verification of a signer's credentials. A stamp signature, with

or without initials, is not sufficient.

According to rules adopted by the Department, every woman

resident of child-bearing age shall receive routine

obstetrical and gynecological evaluations as well as necessary

prenatal care.

(c) Every resident shall be permitted to refuse medical

treatment and to know the consequences of such action, unless

such refusal would be harmful to the health and safety of

others and such harm is documented by a physician in the

resident's clinical record. The resident's refusal shall free

the facility from the obligation to provide the treatment.

(d) Every resident, resident's guardian, or parent if the

resident is a minor shall be permitted to inspect and copy all

his clinical and other records concerning his care and

maintenance kept by the facility or by his physician. The

facility may charge a reasonable fee for duplication of a

record.

(Source: P.A. 96-1372, eff. 7-29-10; 97-179, eff. 1-1-12.)

Section 90. 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;

(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.

(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

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,

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

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.

(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

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

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

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

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

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

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

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

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

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.)