SB1465 99TH GENERAL ASSEMBLY

LRB099 07911 KTG 28051 b

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.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning public aid.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

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

(305 ILCS 5/5-5.12b new)

Sec. 5-5.12b. Interferon-free therapy; prior approval.

(a) Prior approval by the Department to administer to a recipient of medical assistance any interferon-free therapy for the treatment of the hepatitis C virus shall be limited to the following criteria:

(1) The recipient must be 18 years of age.

(2) The recipient must have a diagnosis of chronic hepatitis C infection, genotype 1, 2, 3, or 4, confirmed by stage 2 fibrosis.

(3) The recipient may not have been previously denied a prescription for any interferon-free therapy for the treatment of the hepatitis C virus.

(4) The recipient may not have end-stage renal disease requiring dialysis.

(5) The recipient must have sufficient kidney function as defined by the Department by rule.

(6) The recipient may not have evidence of a known and incurable disease, with a life expectancy of less than 12 months.

(7) The recipient may not be receiving hospice care.

(8) The recipient may not be taking another treatment that is harmful to take in combination with any interferon-free therapy for the treatment of the hepatitis C virus.

(9) The recipient may not have abused a controlled substance within the past 6 months.

(10) The recipient must take a drug test no more than 15 days prior to submission of the prior approval request.

(b) The Department may not use the following 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:

(1) The fact that the recipient or any female partner of the recipient is pregnant.

(2) 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.

(3) Any evidence or known diagnosis of malignancy of any body organ.

(4) The fact that the recipient is receiving or has received chemotherapy or radiation therapy.

(5) The fact that the recipient was previously administered an interferon-free therapy for the treatment of the hepatitis C virus.

(c) A prescriber of any interferon-free therapy for the treatment of the hepatitis C virus to a recipient of medical assistance shall be one of the following:

(1) A gastroenterologist or physician practicing in a relevant sub-specialty.

(2) An infectious disease specialist.

(3) Any physician holding a current unrestricted license to practice medicine who, within 6 months prior to submitting a prior approval request as prescribed by the Department, has (i) completed a course in Illinois with a 3-year certification period that is provided by a program which aims to build the healthcare system's capacity to diagnose and cure persons with the hepatitis C virus or (ii) received a written consultation report from a board-certified gastroenterologist or specialist in a relevant sub-specialty or from an infectious disease specialist. A formal request for prior approval to administer to a medical assistance recipient any interferon-free therapy for the treatment of the hepatitis C virus shall not be submitted before the Department receives either documentation that the physician has satisfied the 3-year certification period of an eligible program as provided in this paragraph or a written consultation report as provided in this paragraph.

(d) The prescriber must submit lab results to the Department before the treatment begins, at the end of therapy, and 12 weeks after the treatment.

(e) The Department shall establish an appeals process for recipients who either fail to meet the criteria established in subsection (a) but who demonstrate a reasonable consideration for continuing treatment, or who received a positive drug test within 15 days of the submission of the prior approval request. The Department shall review cases involving recipients who received a positive drug test and who have documentation of a drug interaction that would indicate a positive reading from a urine test or other drug test.

(f) The Department shall pay managed care entities a monthly non-capitated rate for any interferon-free therapy for the treatment of the hepatitis C virus that is prescribed to a recipient of medical assistance. The Department may consider the fee-for-service cost of the prescription, the cost differential of alternative treatments, and the utilization of the drug being prescribed in the development of that rate.

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