|
| | 99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016 HB5928 Introduced , by Rep. Laura Fine 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.
|
| |
| | A BILL FOR |
|
|
| | HB5928 | | LRB099 18441 EGJ 42817 b |
|
|
1 | | AN ACT concerning regulation.
|
2 | | Be it enacted by the People of the State of Illinois,
|
3 | | represented in the General Assembly:
|
4 | | Section 5. The Managed Care Reform and Patient Rights Act |
5 | | is amended by changing Section 45.1 and by adding Sections 45.3 |
6 | | and 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 |
10 | | the effective date of this amendatory Act of the 99th General |
11 | | Assembly, every insurer licensed in this State to sell a policy |
12 | | of group or individual accident and health insurance or a |
13 | | health benefits plan shall Every health carrier that offers a |
14 | | qualified health plan, as defined in the federal Patient |
15 | | Protection and Affordable Care Act of 2010 (Public Law |
16 | | 111-148), as amended by the federal Health Care and Education |
17 | | Reconciliation Act of 2010 (Public Law 111-152), and any |
18 | | amendments thereto, or regulations or guidance issued under |
19 | | those Acts (collectively, "the Federal Act"), directly to |
20 | | consumers in this State shall establish and maintain a medical |
21 | | exceptions process that allows covered persons or their |
22 | | authorized representatives to request any clinically |
23 | | appropriate prescription drug when (1) the drug is not covered |
|
| | HB5928 | - 2 - | LRB099 18441 EGJ 42817 b |
|
|
1 | | based on the health benefit plan's formulary; (2) the health |
2 | | benefit plan is discontinuing coverage of the drug on the |
3 | | plan's formulary for reasons other than safety or other than |
4 | | because the prescription drug has been withdrawn from the |
5 | | market by the drug's manufacturer; (3) the prescription drug |
6 | | alternatives required to be used in accordance with a step |
7 | | therapy requirement (A) has been ineffective in the treatment |
8 | | of the enrollee's disease or medical condition or, based on |
9 | | both sound clinical evidence and medical and scientific |
10 | | evidence, the known relevant physical or mental |
11 | | characteristics of the enrollee, and the known characteristics |
12 | | of the drug regimen, is likely to be ineffective or adversely |
13 | | affect the drug's effectiveness or patient compliance or (B) |
14 | | has caused or, based on sound medical evidence, is likely to |
15 | | cause an adverse reaction or harm to the enrollee; or (4) the |
16 | | number of doses available under a dose restriction for the |
17 | | prescription drug (A) has been ineffective in the treatment of |
18 | | the enrollee's disease or medical condition or (B) based on |
19 | | both sound clinical evidence and medical and scientific |
20 | | evidence, the known relevant physical and mental |
21 | | characteristics of the enrollee, and known characteristics of |
22 | | the drug regimen, is likely to be ineffective or adversely |
23 | | affect the drug's effective or patient compliance. |
24 | | (b) The health carrier's established medical exceptions |
25 | | procedures must require, at a minimum, the following: |
26 | | (1) Any request for approval of coverage made verbally |
|
| | HB5928 | - 3 - | LRB099 18441 EGJ 42817 b |
|
|
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 |
23 | | expeditiously 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; |
|
| | HB5928 | - 4 - | LRB099 18441 EGJ 42817 b |
|
|
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, |
19 | | health plan, utilization review organization, or other entity |
20 | | shall authorize the dispensing of and coverage for the drug |
21 | | prescribed by the enrollee's treating health care provider, |
22 | | provided the drug is a covered drug under the policy or |
23 | | contract. |
24 | | (c) Notwithstanding any other provision of this Section, |
25 | | nothing in this Section shall be interpreted or implemented in |
26 | | a manner not consistent with the Federal Act.
|
|
| | HB5928 | - 5 - | LRB099 18441 EGJ 42817 b |
|
|
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 |
4 | | protocols. Notwithstanding any other provision of law, on or |
5 | | after the effective date of this amendatory Act of the 99th |
6 | | General Assembly, every insurer licensed in this State to sell |
7 | | a policy of group or individual accident and health insurance |
8 | | or a health benefits plan shall base their clinical review |
9 | | criteria for step therapy protocols on clinical practice |
10 | | guidelines 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 |
|
| | HB5928 | - 6 - | LRB099 18441 EGJ 42817 b |
|
|
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 |
6 | | this 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 |
10 | | the effective date of this amendatory Act of the 99th General |
11 | | Assembly, every insurer licensed in this State to sell a policy |
12 | | of group or individual accident and health insurance or a |
13 | | health benefits plan shall ensure that where step therapy |
14 | | protocols are used to impose clinical prerequisites for |
15 | | coverage of prescription drugs, such drugs shall be available |
16 | | to the consumer at the preferred cost-sharing level for the |
17 | | item once the clinical prerequisites have been satisfied. |
18 | | (b) This Section shall not be construed to prevent insurers |
19 | | from using tiered copayment structures.
|
20 | | Section 99. Effective date. This Act takes effect upon |
21 | | becoming law.
|