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Illinois General Assembly· HB 4834Governor Approved

CONTROLLED SUB-TESTOSTERONE, the official text

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HB4834 Enrolled                     LRB104 19323 RLC 32769 b

1   AN ACT concerning criminal law.

2   Be it enacted by the People of the State of Illinois,

3 represented in the General Assembly:

4   Section 5. The Illinois Controlled Substances Act is

5 amended by changing Section 316 and by adding Section 316.2 as

6 follows:

7   (720 ILCS 570/316)

8   Sec. 316. Prescription Monitoring Program.

9   (a) The Department must provide for a Prescription

10 Monitoring Program for Schedule II, III, IV, and V controlled

11 substances, except testosterone, that includes the following

12 components and requirements:

13  (1) The dispenser must transmit to the central

14  repository, in a form and manner specified by the

15  Department, the following information:

16          (A) The recipient's name and address.

17          (B) The recipient's date of birth and gender.

18          (C) The national drug code number of the

19  controlled substance dispensed.

20          (D) (Blank).

21          (E) The quantity of the controlled substance

22  dispensed and days supply.

23          (F) The dispenser's United States Drug Enforcement
    HB4834 Enrolled  -2-                LRB104 19323 RLC 32769 b

1   Administration registration number.

2   (G) The prescriber's United States Drug

3   Enforcement Administration registration number.

4   (H) The dates the controlled substance

5   prescription is filled.

6   (I) The payment type used to purchase the

7   controlled substance (i.e. Medicaid, cash, third party

8   insurance).

9   (J) The patient location code (i.e. home, nursing

10  home, outpatient, etc.) for the controlled substances

11  other than those filled at a retail pharmacy.

12  (K) Any additional information that may be

13  required by the department by administrative rule,

14  including but not limited to information required for

15  compliance with the criteria for electronic reporting

16  of the American Society for Automation and Pharmacy or

17  its successor.

18  (2) The information required to be transmitted under

19  this Section must be transmitted not later than the end of

20  the business day on which a controlled substance is

21  dispensed, or at such other time as may be required by the

22  Department by administrative rule.

23  (3) A dispenser must transmit electronically, as

24  provided by Department rule, the information required to

25  be transmitted under this Section.

26  (3.5) The requirements of paragraphs (1), (2), and (3)
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1   of this subsection also apply to opioid treatment programs

2   that are licensed or certified by the Department of Human

3   Services' Division of Substance Use Prevention and

4   Recovery and are authorized by the federal Drug

5   Enforcement Administration to prescribe Schedule II, III,

6   IV, or V controlled substances for the treatment of opioid

7   use disorders. Opioid treatment programs shall attempt to

8   obtain written patient consent, shall document attempts to

9   obtain the written consent, and shall not transmit

10  information without patient consent. Documentation

11  obtained under this paragraph shall not be utilized for

12  law enforcement purposes, as proscribed under 42 CFR 2, as

13  amended by 42 U.S.C. 290dd-2. Treatment of a patient shall

14  not be conditioned upon his or her written consent.

15  (4) The Department may impose a civil fine of up to

16  $100 per day for willful failure to report controlled

17  substance dispensing to the Prescription Monitoring

18  Program. The fine shall be calculated on no more than the

19  number of days from the time the report was required to be

20  made until the time the problem was resolved, and shall be

21  payable to the Prescription Monitoring Program.

22  (a-5) Notwithstanding subsection (a), a licensed

23 veterinarian is exempt from the reporting requirements of this

24 Section. If a person who is presenting an animal for treatment

25 is suspected of fraudulently obtaining any controlled

26 substance or prescription for a controlled substance, the
    HB4834 Enrolled   -4-        LRB104 19323 RLC 32769 b

1 licensed veterinarian shall report that information to the

2 local law enforcement agency.

3   (b) The Department, by rule, may include in the

4 Prescription Monitoring Program certain other select drugs

5 that are not included in Schedule II, III, IV, or V. The

6 Prescription Monitoring Program does not apply to

7 testosterone, mifepristone, misoprostol, GnRH analogues,

8 estrogen, or controlled substance prescriptions as exempted

9 under Section 313.

10  (c) The collection of data on select drugs and scheduled

11 substances by the Prescription Monitoring Program may be used

12 as a tool for addressing oversight requirements of long-term

13 care institutions as set forth by Public Act 96-1372.

14 Long-term care pharmacies shall transmit patient medication

15 profiles to the Prescription Monitoring Program monthly or

16 more frequently as established by administrative rule.

17  (d) The Department of Human Services shall appoint a

18 full-time Clinical Director of the Prescription Monitoring

19 Program.

20  (e) (Blank).

21  (f) It is the responsibility of any new, ceased, or

22 unconnected healthcare facility and its selected Electronic

23 Health Records System or Pharmacy Management System to make

24 contact with and ensure integration with the Prescription

25 Monitoring Program. As soon as practicable after the effective

26 date of this amendatory Act of the 103rd General Assembly, the
    HB4834 Enrolled  -5-  LRB104 19323 RLC 32769 b

1 Department shall adopt rules requiring Electronic Health

2 Records Systems and Pharmacy Management Systems to interface,

3 by January 1, 2024, with the Prescription Monitoring Program

4 to ensure that providers have access to specific patient

5 records during the treatment of their patients. The Department

6 shall identify actions to be taken if a prescriber's

7 Electronic Health Records System and Pharmacy Management

8 Systems does not effectively interface with the Prescription

9 Monitoring Program once the Prescription Monitoring Program is

10 aware of the non-integrated connection.

11  (g) The Department, in consultation with the Prescription

12 Monitoring Program Advisory Committee, shall adopt rules

13 allowing licensed prescribers or pharmacists who have

14 registered to access the Prescription Monitoring Program to

15 authorize a licensed or non-licensed designee employed in that

16 licensed prescriber's office or a licensed designee in a

17 licensed pharmacist's pharmacy who has received training in

18 the federal Health Insurance Portability and Accountability

19 Act and 42 CFR 2 to consult the Prescription Monitoring

20 Program on their behalf. The rules shall include reasonable

21 parameters concerning a practitioner's authority to authorize

22 a designee, and the eligibility of a person to be selected as a

23 designee. In this subsection (g), "pharmacist" shall include a

24 clinical pharmacist employed by and designated by a Medicaid

25 Managed Care Organization providing services under Article V

26 of the Illinois Public Aid Code under a contract with the
    HB4834 Enrolled           -6-          LRB104 19323 RLC 32769 b

1 Department of Healthcare and Family Services for the sole
2 purpose of clinical review of services provided to persons
3 covered by the entity under the contract to determine
4 compliance with subsections (a) and (b) of Section 314.5 of
5 this Act. A managed care entity pharmacist shall notify
6 prescribers of review activities.
7 (Source: P.A. 102-527, eff. 8-20-21; 102-813, eff. 5-13-22;
8 103-477, eff. 8-4-23.)

9   (720 ILCS 570/316.2 new)

10  Sec. 316.2. Information concerning testosterone. The

11 Department shall purge from the records of the Prescription

12 Monitoring Program, as established by Section 316 of this Act,

13 all existing information concerning the prescribing or

14 dispensing of testosterone, including any such information

15 contained in the central repository or database created under

16 Section 317 of this Act, on or before January 1, 2027, and

17 shall ensure that no further records concerning the

18 prescribing and dispensing of testosterone are created or

19 maintained by the Prescription Monitoring Program. The

20 Department shall update and adopt rules consistent with this

21 Section no later than January 1, 2027.

22  Section 99. Effective date. This Act takes effect upon

23 becoming law.
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