SLS 20RS-96 ORIGINAL
2020 Regular Session
SENATE BILL NO. 59
BY SENATOR FRED MILLS
PHARMACEUTICALS. Provides relative to coverage of step therapy or fail first protocols.
(8/1/20)
1 AN ACT
2 To amend and reenact R.S. 22:1053, relative to coverage of step therapy or fail first
3 protocols; to provide for clinical review criteria and use of clinical practice
4 guidelines to be used as minimum standards in developing a step therapy or fail first
5 protocol; to provide for clarification on providers lawfully allowed to prescribe; to
6 provide for an override request process for restricted prescription drugs; to provide
7 for override clinical evidence; to provide for decision-making timelines; to provide
8 for appeal rights; to provide for definitions; to provide for technical changes; and to
9 provide for related matters.
10 Be it enacted by the Legislature of Louisiana:
11 Section 1. R.S. 22:1053 is hereby amended and reenacted to read as follows:
12 ยง1053. Requirement for coverage of step therapy or fail first protocols
13 A. Any health coverage plan specified in Subsection H K of this Section
14 which includes prescription benefits as part of its policy or contract, which utilizes
15 step therapy or fail first protocols, and which is issued for delivery, delivered,
16 renewed, or otherwise contracted for in this state on or after January 1, 2011 2020,
17 shall comply with the provisions of this Section.
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1 B.(1) Any step therapy or fail first protocol established by a health
2 coverage plan shall be based on clinical review criteria and clinical practice
3 guidelines that are developed and endorsed by a multidisciplinary panel of
4 experts who manage conflicts of interest among the members of writing and
5 review groups by:
6 (a) Requiring members to disclose any potential conflicts of interest with
7 health coverage plans or pharmaceutical manufacturers and to recuse
8 themselves from voting if they have a conflict of interest.
9 (b) Using a methodologist to work with writing groups to provide
10 objectivity in data analysis and ranking of evidence through the preparation of
11 evidence tables and facilitating consensus.
12 (c) Offering opportunities for public review and comments.
13 (d) Creating an explicit and transparent decision making process.
14 (e) Basing decisions on high quality studies, research, peer reviewed
15 publications, and medical practice.
16 (f) Minimizing biases and conflicts of interest.
17 (g) Explaining the relationship between treatment options and outcomes.
18 (h) Rating the quality of the evidence supporting recommendations.
19 (i) Considering relevant patient subgroups and preferences.
20 (j) Considering the needs of atypical patient populations and diagnoses
21 when establishing clinical review criteria.
22 (k) Recommending that the prescription drugs be taken in the specific
23 sequence required by the step therapy protocol.
24 (l) Continuously updating, through a review of new evidence, research,
25 and newly developed treatments.
26 (2) This Subsection shall not be construed to require health coverage
27 plans to establish a new entity to develop clinical review criteria used for step
28 therapy or fail first protocols.
29 C. When medications for the treatment of any medical condition are
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1 restricted for use by an insurer by any health coverage plan through a step therapy
2 or fail first protocol, the prescribing physician practitioner shall have access to a
3 clear and convenient process to expeditiously request an override of such restriction
4 from the insurer. The override process shall be made easily accessible on the
5 health coverage plan's website. An override of such restriction shall be
6 expeditiously granted by the insurer under health coverage plan if the prescribing
7 practitioner, using sound clinical evidence, can demonstrate any of the following
8 circumstances:
9 (1) The prescribing physician can demonstrate to the health coverage plan,
10 based on sound clinical evidence, that the The preferred treatment required under the
11 step therapy or fail first protocol has been ineffective in the treatment of the insured's
12 patient's disease or medical condition. The prescribing practitioner shall
13 demonstrate to the health coverage plan that the patient has tried the required
14 prescription drug while under their current or a previous health insurance or
15 health coverage plan, or another prescription drug in the same pharmacologic
16 class or with the same mechanism of action, and such prescription drug was
17 discontinued due to lack of efficacy or effectiveness, diminished effect, or an
18 adverse event.
19 (2) The prescribing physician can demonstrate to the health coverage plan,
20 based on sound clinical evidence, that the The preferred treatment required under the
21 step therapy or fail first protocol is reasonably expected to be ineffective based on
22 the known relevant physical or mental characteristics and medical history of the
23 insured patient and known characteristics of the drug regimen.
24 (3) The prescribing physician can demonstrate to the health coverage plan,
25 based on sound clinical evidence, that the The preferred treatment required under the
26 step therapy or fail first protocol will cause is contraindicated or will likely cause
27 an adverse reaction or other physical or mental harm to the insured patient.
28 (4) The patient is stable on a prescription drug selected by their
29 healthcare provider for the medical condition under consideration while on a
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1 current or previous health insurance or health coverage plan.
2 (5) The required prescription drug is not in the best interest of the
3 patient based on medical necessity.
4 D. Approval of a step therapy or fail first protocol override request,
5 when issued by a health coverage plan, shall include clear authorization of
6 coverage for the prescription drug prescribed by the patient's prescribing
7 practitioner.
8 E. Denial of a step therapy or fail first protocol override request shall not
9 be considered a final adverse determination and shall be eligible for an appeal
10 of coverage determination pursuant to R.S. 22:2401.
11 F. A health coverage plan shall approve or deny a step therapy or fail
12 first protocol override request, or an appeal of a step therapy or fail first
13 protocol override request determination made pursuant to R.S. 22:2401, within
14 seventy-two hours of receipt. In cases where exigent circumstances exist, a
15 health coverage plan shall approve or deny a step therapy or fail first protocol
16 override request, or an appeal of a step therapy or fail first protocol override
17 request determination made pursuant to R.S. 22:2401, within twenty-four hours
18 of receipt. If a health coverage plan fails to comply with the timelines provided
19 for in this Subsection, the override request shall be considered approved.
20 G. In the case of a denial, the health coverage plan shall provide the
21 patient and the prescribing practitioner with the reason for the denial, an
22 alternative covered medication, if applicable, and information regarding the
23 procedure for submitting an appeal to the denial.
24 C.H. The duration of any step therapy or fail first protocol shall not be longer
25 than the customary period for the medication when such treatment is demonstrated
26 by the prescribing physician practitioner to be clinically ineffective. When the
27 health coverage plan can demonstrate, through sound clinical evidence, that the
28 originally prescribed medication is likely to require more than the customary period
29 for such medication to provide any relief or an amelioration to the insured patient,
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1 the step therapy or fail first protocol may be extended for an additional period of
2 time no longer than the original customary period for the medication.
3 D. I.(1) No health coverage plan shall use step therapy or fail first protocols
4 as the basis to restrict any prescription benefit for the treatment of stage-four
5 advanced, metastatic cancer or associated conditions if at least one of the following
6 criteria is met:
7 (1)(a) The prescribed drug or drug regimen has the United States Food and
8 Drug Administration approved indication.
9 (2)(b) The prescribed drug or drug regimen has the National Comprehensive
10 Cancer Network Drugs and Biologics Compendium indication.
11 (3)(c) The prescribed drug or drug regimen is supported by peer-reviewed,
12 evidenced-based medical literature.
13 E.(2) The provisions of this Subsection D of this Section shall not apply if
14 the preferred drug or drug regimen is considered clinically equivalent for therapy,
15 contains the identical active ingredient or ingredients, and is proven to have the same
16 efficacy. For purposes of this Subsection, different salts proven to have the same
17 efficacy shall not be considered as different active ingredients.
18 F.(3) For drugs prescribed for associated conditions as defined in this
19 Section, the treating healthcare provider shall inform the health coverage plan that
20 the condition is a condition associated with stage-four advanced, metastatic cancer
21 when requesting authorization.
22 G.J.(1) If a prescribed drug is denied by a health coverage plan based upon
23 step therapy or fail first protocols, the health coverage plan shall provide the
24 prescriber with a list of the alternative comparable formulary medications in writing
25 and attached to the letter of denial of prescription drug coverage.
26 (2) It shall be deemed sufficient to meet the requirements of this Subsection
27 if a health coverage plan includes the information required by this Subsection in the
28 denial letter sent by the health coverage plan or its agent. For any request made by
29 providers utilizing electronic health records with capabilities, the notice may be sent
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1 electronically.
2 (3) Simple notification of the availability and location of the formulary shall
3 not be deemed sufficient to meet the requirements of this Subsection.
4 K. As used in this Section, the following definitions shall apply:
5 (1) "Health coverage plan" means:
6 (a) An individual or group plan or program which is established by
7 contract, certificate, law, plan, policy, subscriber agreement, or by any other
8 method and which is entered into, issued, or offered for the purpose of
9 arranging for, delivering, paying for, providing, or reimbursing any of the costs
10 of health or medical care, including pharmacy services, drugs, or devices.
11 (b) Any hospital, health, or medical expense insurance policy, hospital
12 or medical service contract, employee welfare benefit plan, contract or
13 agreement with a health maintenance organization or a preferred provider
14 organization, health and accident insurance policy, or any other insurance
15 contract of this type, including a group insurance plan and the Office of Group
16 Benefits programs.
17 (c) Any plan that is subject to the provisions of this Section which is
18 administered by a pharmacy benefit manager.
19 H.(1)(a) As used in this Section, a "health coverage plan" shall mean any
20 hospital, health, or medical expense insurance policy, hospital or medical service
21 contract, employee welfare benefit plan, contract or agreement with a health
22 maintenance organization or a preferred provider organization, health and accident
23 insurance policy, or any other insurance contract of this type, including a group
24 insurance plan and the Office of Group Benefits programs.
25 (b) "Health coverage plan" shall include any plan that is subject to the
26 provisions of this Section which is administered by a pharmacy benefit manager.
27 (2) As used in this Section, "stage-four "Stage-four advanced, metastatic
28 cancer" means cancer that has spread from the lymph nodes or other areas or parts
29 of the body.
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1 (3) As used in this Section, and "associated conditions" means the symptoms
2 or side effects associated with stage-four advanced, metastatic cancer or its
3 treatment.
The original instrument and the following digest, which constitutes no part
of the legislative instrument, were prepared by Christine Arbo Peck.
DIGEST
SB 59 Original 2020 Regular Session Fred Mills
Present law provides certain requirements for implementation of step therapy or fail first
protocols utilized by any health coverage plan.
Proposed law retains present law and adds further requirements for the development of the
step therapy or fail first protocol to be based on clinical review criteria and clinical practice
guidelines that are developed and endorsed by a multidisciplinary panel of experts based on
certain identified criteria.
Proposed law does not require the health coverage plan to establish a new entity to develop
clinical review criteria.
Present law provides for a step therapy or fail first protocol override process to be utilized
by prescribing physicians.
Proposed law retains present law relative to the override process, expands the accessibility
of the process to the health coverage plan's website, and changes the designation of the
prescriber from a prescribing physician to a prescribing practitioner and changes the
designation of the effected individual from insured to patient.
Present law provides opportunity for the prescriber to demonstrate to the health coverage
plan that the preferred treatment has been ineffective in treating the disease or mental
condition of the insured.
Proposed law retains present law and provides additional criteria in which a prescriber can
demonstrate that the patient tried the required prescription drug under a current or prior
health coverage plan, or another drug in the same drug class, and it was discontinued due to
lack of efficacy or effectiveness, diminished effect, or an adverse event.
Present law provides the prescriber with an opportunity to demonstrate to the health
coverage plan that the preferred treatment will cause or will likely cause an adverse reaction
or other physical harm to the patient.
Proposed law retains present law and further allows the prescriber to demonstrate that the
preferred treatment is contraindicated or will cause mental harm to the patient, that the
patient is stable on a certain prescription drug, or that the preferred drug is not in the best
interest of the patient based on medical necessity.
Proposed law provides that a health coverage plan shall approve or deny a step therapy of
fail first protocol override request within 72 hours of receipt. Proposed law provides that in
exigent circumstances, the health coverage plan shall approve or deny a step therapy or fail
first protocol override request within 24 hours of receipt. Proposed law provides that failure
by a health coverage plan to comply with the timelines in proposed law shall cause the
override request to be considered approved.
Proposed law provides that if a health coverage plan denies an override request, the health
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coverage plan shall provide the prescribing practitioner and the patient with a reason for the
denial, an alternative covered medication, and information regarding the procedure for
submitting an appeal to the denial.
Proposed law provides definitions for health coverage plan and stage-four advanced,
metastatic cancer.
Effective August 1, 2020.
(Amends R.S. 22:1053)
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