ENROLLED
ACT No. 181
2020 Regular Session
HOUSE BILL NO. 263
BY REPRESENTATIVE HUVAL
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 application; to provide for
9 effectiveness; to provide for technical changes; and to 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.(1) Any health coverage plan specified in Subsection H L 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, shall
17 comply with the provisions of this Section.
18 (2) The provisions of this Section shall not be construed to prohibit the
19 substitution of an AB-rated generic equivalent or interchangeable biological product
20 as designated by the federal Food and Drug Administration.
21 B.(1) Any step therapy or fail first protocol established by a health coverage
22 plan shall consider clinical review criteria and clinical practice guidelines that are
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1 developed and endorsed by a multidisciplinary panel of experts who manage
2 conflicts of interest among the members of writing and review groups by doing all
3 of the following:
4 (a) Requiring members to disclose any potential conflicts of interest with
5 health coverage plans or pharmaceutical manufacturers and to recuse themselves
6 from voting if they have a conflict of interest.
7 (b) Using a methodologist to work with writing groups to provide objectivity
8 in data analysis and ranking of evidence through the preparation of evidence tables
9 and facilitating consensus.
10 (c) Offering opportunities for public review and comments.
11 (d) Creating an explicit and transparent decisionmaking process.
12 (e) Basing decisions on high quality studies, research, peer-reviewed
13 publications, and medical practice.
14 (f) Minimizing biases and conflicts of interest.
15 (g) Explaining the relationship between treatment options and outcomes.
16 (h) Rating the quality of the evidence supporting recommendations.
17 (i) Considering relevant patient subgroups and preferences.
18 (j) Considering the needs of atypical patient populations and diagnoses when
19 establishing clinical review criteria.
20 (k) Recommending that the prescription drugs be taken in the specific
21 sequence required by the step therapy protocol.
22 (l)(i) Continuously reviewing new evidence, research, and newly developed
23 treatments to update the clinical review criteria and clinical practice guidelines.
24 (ii) If clinical practice guidelines are not reasonably available, any step
25 therapy or fail first protocol established by a health coverage plan shall consider
26 peer-reviewed publications or expert guidance from independent experts, which may
27 include practioners with expertise applicable to the relevant health condition.
28 (2) This Subsection shall not be construed to require health coverage plans
29 to establish a new entity to develop clinical review criteria used for step therapy or
30 fail first protocols.
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1 C. When medications for the treatment of any medical condition are
2 restricted for use by an insurer by any health coverage plan through a step therapy
3 or fail first protocol, the prescribing physician practitioner shall have access to a
4 clear and convenient process to expeditiously request an override of such the
5 restriction from the insurer. The override process shall be made easily accessible on
6 the health coverage plan's website. An override of such the restriction shall be
7 expeditiously granted by the insurer under health coverage plan if the prescribing
8 practitioner, using sound clinical evidence, can demonstrate any of the following
9 circumstances:
10 (1) The prescribing physician can demonstrate to the health coverage plan,
11 based on sound clinical evidence, that the The preferred treatment required under the
12 step therapy or fail first protocol has been ineffective in the treatment of the insured's
13 patient's disease or medical condition. The prescribing practitioner shall demonstrate
14 to the health coverage plan that the patient has tried the required prescription drug
15 while under his current or a previous health insurance or health coverage plan, or
16 another prescription drug in the same pharmacologic class or with the same
17 mechanism of action, and the prescription drug was discontinued due to lack of
18 efficacy or effectiveness, diminished effect, or an 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 an
27 adverse reaction or other physical or mental harm to the insured patient.
28 (4) The patient is currently receiving a positive therapeutic outcome on a
29 prescription drug for the medical condition under consideration if, while on his
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1 current health coverage plan or the immediately preceding health coverage plan, the
2 patient received coverage for the prescription drug.
3 (5) The required prescription drug is not in the best interest of the patient
4 based on medical necessity as evidenced by valid documentation submitted by the
5 prescriber.
6 D. Approval of a step therapy or fail first protocol override request, when
7 issued by a health coverage plan, shall include clear authorization of coverage for the
8 prescription drug prescribed by the patient's prescribing practitioner, provided the
9 drug is covered under the health coverage plan.
10 E. Denial of a step therapy or fail first protocol override request shall not be
11 considered a final adverse determination and shall be eligible for an appeal of
12 coverage determination pursuant to R.S. 22:2401.
13 F. A health coverage plan shall approve or deny a step therapy or fail first
14 protocol override request within seventy-two hours of receipt. In cases where
15 exigent circumstances exist, a health coverage plan shall approve or deny a step
16 therapy or fail first protocol override request within twenty-four hours of receipt. If
17 a health coverage plan fails to comply with the timelines provided for in this
18 Subsection, the override request shall be considered approved.
19 G. In the case of a denial, the health coverage plan shall provide the patient
20 and the prescribing practitioner with the reason for the denial, an alternative covered
21 medication, if applicable, and information regarding the procedure for submitting an
22 appeal to the denial.
23 H. In the case of an appeal, the practitioner or, if appropriate, other
24 healthcare provider deciding the appeal shall consider atypical diagnoses and the
25 needs of atypical patient populations.
26 C. I. The duration of any step therapy or fail first protocol shall not be longer
27 than the customary period for the medication when such the treatment is
28 demonstrated by the prescribing physician practitioner to be clinically ineffective.
29 When the health coverage plan can demonstrate, through sound clinical evidence,
30 that the originally prescribed medication is likely to require more than the customary
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1 period for such the medication to provide any relief or an amelioration to the insured
2 patient, the step therapy or fail first protocol may be extended for an additional
3 period of time no longer than the original customary period for the medication.
4 D. J.(1) No health coverage plan shall use step therapy or fail first protocols
5 as the basis to restrict any prescription benefit for the treatment of stage-four
6 advanced, metastatic cancer or associated conditions if at least one of the following
7 criteria is met:
8 (1)(a) The prescribed drug or drug regimen has the United States Food and
9 Drug Administration approved indication.
10 (2)(b) The prescribed drug or drug regimen has the National Comprehensive
11 Cancer Network Drugs and Biologics Compendium indication.
12 (3)(c) The prescribed drug or drug regimen is supported by peer-reviewed,
13 evidenced-based medical literature.
14 E.(2) The provisions of this Subsection D of this Section shall not apply if
15 the preferred drug or drug regimen is considered clinically equivalent for therapy,
16 contains the identical active ingredient or ingredients, and is proven to have the same
17 efficacy. For purposes of this Subsection, different salts proven to have the same
18 efficacy shall not be considered as different active ingredients.
19 F.(3) For drugs prescribed for associated conditions as defined in this
20 Section, the treating healthcare provider shall inform the health coverage plan that
21 the condition is a condition associated with stage-four advanced, metastatic cancer
22 when requesting authorization.
23 G. K.(1) If a prescribed drug is denied by a health coverage plan based upon
24 step therapy or fail first protocols, the health coverage plan shall provide the
25 prescriber with a list of the alternative comparable formulary medications in writing
26 and attached to the letter of denial of prescription drug coverage.
27 (2) It shall be deemed sufficient to meet the requirements of this Subsection
28 if a health coverage plan includes the information required by this Subsection in the
29 denial letter sent by the health coverage plan or its agent. For any request made by
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1 providers utilizing electronic health records with capabilities, the notice may be sent
2 electronically.
3 (3) Simple notification of the availability and location of the formulary shall
4 not be deemed sufficient to meet the requirements of this Subsection.
5 L. As used in this Section, the following definitions shall apply:
6 (1) "Health coverage plan" means:
7 (a) An individual or group plan or program which is established by contract,
8 certificate, law, plan, policy, subscriber agreement, or by any other method and
9 which is entered into, issued, or offered for the purpose of arranging for, delivering,
10 paying for, providing, or reimbursing any of the costs of health or medical care,
11 including pharmacy services, drugs, or devices.
12 H.(1)(a) As used in this Section, a "health coverage plan" shall mean any
13 (b) Any hospital, health, or medical expense insurance policy, hospital or
14 medical service contract, employee welfare benefit plan, contract or agreement with
15 a health maintenance organization or a preferred provider organization, health and
16 accident insurance policy, or any other insurance contract of this type, including a
17 group insurance plan and the Office of Group Benefits programs.
18 (b)(c) "Health coverage plan" shall include any Any plan that is subject to
19 the provisions of this Section which is administered by a pharmacy benefit manager.
20 (2) As used in this Section, "stage-four "Stage-four advanced, metastatic
21 cancer" means cancer that has spread from the lymph nodes or other areas or parts
22 of the body.
23 (3) As used in this Section, and "associated conditions" means the symptoms
24 or side effects associated with stage-four advanced, metastatic cancer or its
25 treatment.
26 Section 2.(A) This Act shall become effective upon signature by the governor or, if
27 not signed by the governor, upon expiration of the time for bills to become law without
28 signature by the governor, as provided by Article III, Section 18 of the Constitution of
29 Louisiana. If vetoed by the governor and subsequently approved by the legislature, this Act
30 shall become effective on the day following such approval.
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1 (B) This Act shall apply to any new health coverage plan specified in R.S.
2 22:1053(A) and issued in this state on and after January 1, 2021.
SPEAKER OF THE HOUSE OF REPRESENTATIVES
PRESIDENT OF THE SENATE
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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