99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
SB3037

 

Introduced 2/18/2016, by Sen. Julie A. Morrison

 

SYNOPSIS AS INTRODUCED:
 
215 ILCS 134/45.1
215 ILCS 134/45.3 new
215 ILCS 134/45.4 new

    Amends the Managed Care Reform and Patient Rights Act. Applies the medical exemptions process to all entities licensed in the State to sell a policy of group or individual accident and health insurance or health benefits plan. Provides certain exceptions upon which a step therapy override will always be provided. Sets clinical review criteria that must be used to establish step therapy protocols. Effective immediately.


LRB099 18442 EGJ 42818 b

 

 

A BILL FOR

 

SB3037LRB099 18442 EGJ 42818 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Managed Care Reform and Patient Rights Act
5is amended by changing Section 45.1 and by adding Sections 45.3
6and 45.4 as follows:
 
7    (215 ILCS 134/45.1)
8    Sec. 45.1. Medical exceptions procedures required.
9    (a) Notwithstanding any other provision of law, on or after
10the effective date of this amendatory Act of the 99th General
11Assembly, every insurer licensed in this State to sell a policy
12of group or individual accident and health insurance or a
13health benefits plan shall Every health carrier that offers a
14qualified health plan, as defined in the federal Patient
15Protection and Affordable Care Act of 2010 (Public Law
16111-148), as amended by the federal Health Care and Education
17Reconciliation Act of 2010 (Public Law 111-152), and any
18amendments thereto, or regulations or guidance issued under
19those Acts (collectively, "the Federal Act"), directly to
20consumers in this State shall establish and maintain a medical
21exceptions process that allows covered persons or their
22authorized representatives to request any clinically
23appropriate prescription drug when (1) the drug is not covered

 

 

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1based on the health benefit plan's formulary; (2) the health
2benefit plan is discontinuing coverage of the drug on the
3plan's formulary for reasons other than safety or other than
4because the prescription drug has been withdrawn from the
5market by the drug's manufacturer; (3) the prescription drug
6alternatives required to be used in accordance with a step
7therapy requirement (A) has been ineffective in the treatment
8of the enrollee's disease or medical condition or, based on
9both sound clinical evidence and medical and scientific
10evidence, the known relevant physical or mental
11characteristics of the enrollee, and the known characteristics
12of the drug regimen, is likely to be ineffective or adversely
13affect the drug's effectiveness or patient compliance or (B)
14has caused or, based on sound medical evidence, is likely to
15cause an adverse reaction or harm to the enrollee; or (4) the
16number of doses available under a dose restriction for the
17prescription drug (A) has been ineffective in the treatment of
18the enrollee's disease or medical condition or (B) based on
19both sound clinical evidence and medical and scientific
20evidence, the known relevant physical and mental
21characteristics of the enrollee, and known characteristics of
22the drug regimen, is likely to be ineffective or adversely
23affect the drug's effective or patient compliance.
24    (b) The health carrier's established medical exceptions
25procedures must require, at a minimum, the following:
26        (1) Any request for approval of coverage made verbally

 

 

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1    or in writing (regardless of whether made using a paper or
2    electronic form or some other writing) at any time shall be
3    reviewed by appropriate health care professionals.
4        (2) The health carrier must, within 72 hours after
5    receipt of a request made under subsection (a) of this
6    Section, either approve or deny the request. In the case of
7    a denial, the health carrier shall provide the covered
8    person or the covered person's authorized representative
9    and the covered person's prescribing provider with the
10    reason for the denial, an alternative covered medication,
11    if applicable, and information regarding the procedure for
12    submitting an appeal to the denial.
13        (3) In the case of an expedited coverage determination,
14    the health carrier must either approve or deny the request
15    within 24 hours after receipt of the request. In the case
16    of a denial, the health carrier shall provide the covered
17    person or the covered person's authorized representative
18    and the covered person's prescribing provider with the
19    reason for the denial, an alternative covered medication,
20    if applicable, and information regarding the procedure for
21    submitting an appeal to the denial.
22    (c) A step therapy override determination request shall be
23expeditiously granted if:
24        (1) the required prescription drug is contraindicated
25    or will likely cause an adverse reaction by or physical or
26    mental harm to the patient;

 

 

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1        (2) the required prescription drug is expected to be
2    ineffective based on the known relevant physical or mental
3    characteristics of the patient and the known
4    characteristics of the prescription drug regimen;
5        (3) the patient has tried the required prescription
6    drug while under their current or a previous health
7    insurance or health benefit plan, or another prescription
8    drug in the same pharmacologic class or with the same
9    mechanism of action and such prescription drug was
10    discontinued due to lack of efficacy or effectiveness,
11    diminished effect, or an adverse event;
12        (4) the required prescription drug is not in the best
13    interest of the patient, based on medical appropriateness;
14    or
15        (5) the patient is stable on a prescription drug
16    selected by their health care provider for the medical
17    condition under consideration.
18    (d) Upon the granting of an exception request, the insurer,
19health plan, utilization review organization, or other entity
20shall authorize the dispensing of and coverage for the drug
21prescribed by the enrollee's treating health care provider,
22provided the drug is a covered drug under the policy or
23contract.
24    (c) Notwithstanding any other provision of this Section,
25nothing in this Section shall be interpreted or implemented in
26a manner not consistent with the Federal Act.

 

 

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1(Source: P.A. 98-1035, eff. 8-25-14.)
 
2    (215 ILCS 134/45.3 new)
3    Sec. 45.3. Clinical review criteria used in step therapy
4protocols. Notwithstanding any other provision of law, on or
5after the effective date of this amendatory Act of the 99th
6General Assembly, every insurer licensed in this State to sell
7a policy of group or individual accident and health insurance
8or a health benefits plan shall base their clinical review
9criteria for step therapy protocols on clinical practice
10guidelines that:
11        (1) recommend that the prescription drugs be taken in
12    the specific sequence required by the step therapy
13    protocol;
14        (2) are developed and endorsed by an independent,
15    multidisciplinary panel of experts not affiliated with an
16    insurer, health plan or utilization review organization;
17        (3) are based on high quality studies, research, and
18    medical practice;
19        (4) are created by an explicit and transparent process
20    that:
21            (A) minimizes biases and conflicts of interest;
22            (B) explains the relationship between treatment
23        options and outcomes;
24            (C) rates the quality of the evidence supporting
25        recommendations; and

 

 

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1            (D) considers relevant patient subgroups and
2        preferences; and
3        (5) are continually updated through a review of new
4    evidence and research.
5    The Department shall adopt any rules necessary to enforce
6this Section.
 
7    (215 ILCS 134/45.4 new)
8    Sec. 45.4. Cost sharing.
9    (a) Notwithstanding any other provision of law, on or after
10the effective date of this amendatory Act of the 99th General
11Assembly, every insurer licensed in this State to sell a policy
12of group or individual accident and health insurance or a
13health benefits plan shall ensure that where step therapy
14protocols are used to impose clinical prerequisites for
15coverage of prescription drugs, such drugs shall be available
16to the consumer at the preferred cost-sharing level for the
17item once the clinical prerequisites have been satisfied.
18    (b) This Section shall not be construed to prevent insurers
19from using tiered copayment structures.
 
20    Section 99. Effective date. This Act takes effect upon
21becoming law.