99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
SB1465
 
Introduced 2/20/2015, by Sen. Donne E. Trotter
 
SYNOPSIS AS INTRODUCED:



305 ILCS 5/5-5.12b new

 Amends the Medical Assistance Article of the Illinois Public Aid Code. Provides that prior approval by the Department of Healthcare and Family Services to administer to a recipient of medical assistance any interferon-free therapy for the treatment of the hepatitis C virus shall be limited to certain criteria, including that: (i) the recipient must be 18 years of age; (ii) the recipient must have a diagnosis of chronic hepatitis C infection, genotype 1, 2, 3, or 4, confirmed by stage 2 fibrosis; (iii) the recipient must not have end stage renal disease requiring dialysis; and (iv) the recipient may not have abused a controlled substance within the past 6 months. Provides that the Department may not use certain criteria as a basis for requiring prior approval to administer to a recipient of medical assistance any interferon-free therapy for the treatment of the hepatitis C virus, including: (a) any evidence or known diagnosis of malignancy of any body organ; (b) the recipient's mental capacity or any determination related to the recipient's ability to make appropriate decisions about the interferon-free therapy treatment or to comply with related instructions; and (c) the fact that the recipient was previously administered an interferon-free therapy for the treatment of the hepatitis C virus. Contains provisions concerning persons authorized to prescribe an interferon-free therapy for the treatment of the hepatitis C virus to a recipient of medical assistance; the submission of lab results; an appeals process; and payments to managed care entities for any interferon-free therapy for the treatment of the hepatitis C virus that is prescribed to a recipient of medical assistance. Effective immediately.



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FISCAL NOTE ACT MAY APPLY
 
 
A BILL FOR
 


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1 AN ACT concerning public aid.


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

3represented in the General Assembly:



4 Section 5. The Illinois Public Aid Code is amended by 
5adding Section 5-5.12b as follows:

6 (305 ILCS 5/5-5.12b new)
7 Sec. 5-5.12b. Interferon-free therapy; prior approval.
8 (a)
Prior approval by the Department to administer to a 
9recipient of medical assistance any interferon-free therapy 
10for the treatment of the hepatitis C virus shall be limited to 
11the following criteria:
12  (1) The recipient must be 18 years of age.
13  (2) The recipient must have a diagnosis of chronic 
14 hepatitis C infection, genotype 1, 2, 3, or 4, confirmed by 
15 stage 2 fibrosis.
16  (3) The recipient may not have been previously denied a 
17 prescription for any interferon-free therapy for the 
18 treatment of the hepatitis C virus.
19  (4) The recipient may not have end-stage renal disease 
20 requiring dialysis.
21  (5) The recipient must have sufficient kidney function 
22 as defined by the Department by rule.
23  (6) The recipient may not have evidence of a known and 
 
 
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1 incurable disease, with a life expectancy of less than 12 
2 months.
3  (7) The recipient may not be receiving hospice care.
4  (8) The recipient may not be taking another treatment 
5 that is harmful to take in combination with any 
6 interferon-free therapy for the treatment of the hepatitis 
7 C virus.
8  (9) The recipient may not have abused a controlled 
9 substance within the past 6 months.
10  (10) The recipient must take a drug test no more than 
11 15 days prior to submission of the prior approval request.
12 (b) The Department may not use the following criteria as a 
13basis for requiring prior approval to administer to a recipient 
14of medical assistance any interferon-free therapy for the 
15treatment of the hepatitis C virus:
16  (1) The fact that the recipient or any female partner 
17 of the recipient is pregnant.
18  (2) The recipient's mental capacity or any 
19 determination related to the recipient's ability to make 
20 appropriate decisions about the interferon-free therapy 
21 treatment or to comply with related instructions.
22  (3) Any evidence or known diagnosis of malignancy of 
23 any body organ.
24  (4) The fact that the recipient is receiving or has 
25 received chemotherapy or radiation therapy.
26  (5) The fact that the recipient was previously 
 
 
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1 administered an interferon-free therapy for the treatment 
2 of the hepatitis C virus.
3 (c) A prescriber of any interferon-free therapy for the 
4treatment of the hepatitis C virus to a recipient of medical 
5assistance shall be one of the following:
6  (1) A gastroenterologist or physician practicing in a 
7 relevant sub-specialty.
8  (2) An infectious disease specialist.
9  (3) Any physician holding a current unrestricted 
10 license to practice medicine who, within 6 months prior to 
11 submitting a prior approval request as prescribed by the 
12 Department, has (i) completed a course in Illinois with a 
13 3-year certification period that is provided by a program 
14 which aims to build the healthcare system's capacity to 
15 diagnose and cure persons with the hepatitis C virus or 
16 (ii) received a written consultation report from a 
17 board-certified gastroenterologist or specialist in a 
18 relevant sub-specialty or from an infectious disease 
19 specialist. A formal request for prior approval to 
20 administer to a medical assistance recipient any 
21 interferon-free therapy for the treatment of the hepatitis 
22 C virus shall not be submitted before the Department 
23 receives either documentation that the physician has 
24 satisfied the 3-year certification period of an eligible 
25 program as provided in this paragraph or a written 
26 consultation report as provided in this paragraph.
 
 
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1 (d) The prescriber must submit lab results to the 
2Department before the treatment begins, at the end of therapy, 
3and 12 weeks after the treatment.
4 (e) The Department shall establish an appeals process for 
5recipients who either fail to meet the criteria established in 
6subsection (a) but who demonstrate a reasonable consideration 
7for continuing treatment, or who received a positive drug test 
8within 15 days of the submission of the prior approval request. 
9The Department shall review cases involving recipients who 
10received a positive drug test and who have documentation of a 
11drug interaction that would indicate a positive reading from a 
12urine test or other drug test.
13 (f) The Department shall pay managed care entities a 
14monthly non-capitated rate for any interferon-free therapy for 
15the treatment of the hepatitis C virus that is prescribed to a 
16recipient of medical assistance. The Department may consider 
17the fee-for-service cost of the prescription, the cost 
18differential of alternative treatments, and the utilization of 
19the drug being prescribed in the development of that rate. 


20 Section 99. Effective date. This Act takes effect upon 
21becoming law.