ORS 743B.602
Step therapy


(1)

As used in this section:

(a)

“Beneficiary” means an individual receiving health care that is provided or reimbursed by an entity that provides health care coverage.

(b)

“Health care coverage” includes any of the following that reimburse the cost of prescription drugs:

(A)

A health benefit plan;

(B)

An insurance policy or certificate;

(C)

A medical services contract;

(D)

A multiple employer welfare arrangement, as defined in ORS 750.301 (Definitions for ORS 750.301 to 750.341);

(E)

A contract or agreement with a health care service contractor, as defined in ORS 750.005 (Definitions), or a preferred provider organization;

(F)

Claims payments by a pharmacy benefit manager, as defined in ORS 735.530 (Definitions for ORS 735.530 to 735.552), or other third party administrator; and

(G)

An accident insurance policy or any other insurance contract.

(2)

An entity that provides health care coverage that requires step therapy shall:

(a)

Post to the entity’s website clear explanations that are easily accessible to prescribing practitioners and beneficiaries of the coverage, written in plain language and understandable to practitioners and beneficiaries, of:

(A)

The clinical criteria for each step therapy protocol and the criteria for approving an exception to step therapy;

(B)

The procedure by which a practitioner may submit to the entity the practitioner’s medical rationale for determining that a particular step therapy is not appropriate for a particular beneficiary based on the beneficiary’s medical condition and history; and

(C)

The documentation, if any, that a practitioner must submit to the entity for the entity to determine the appropriateness of step therapy for a specific beneficiary.

(b)

Provide a clear, readily accessible and convenient process for a prescribing practitioner to request an exception to step therapy, which may be the same process used to request exceptions to other coverage restrictions or limitations.

(c)

Approve a request for an exception to step therapy if the entity determines that the evidence submitted by the prescribing practitioner is sufficient to establish that:

(A)

The prescription drug required by the step therapy is contraindicated or will cause the beneficiary to experience a clinically predictable adverse reaction;

(B)

The prescription drug required by the step therapy is expected to be ineffective based on the known clinical characteristics of the beneficiary and the known characteristics of the prescription drug regimen;

(C)

The beneficiary has tried the drug required by the step therapy, a drug in the same pharmacologic class as the drug required by the step therapy or a drug with the same mechanism of action as the drug required by the step therapy, and the beneficiary’s use of the drug required by the step therapy was discontinued due to the lack of efficacy or effectiveness, a diminished effect or an adverse reaction;

(D)

For a period of at least 90 days the beneficiary has experienced a positive therapeutic outcome from the drug for which the exception is requested while enrolled in the current or immediately preceding health care coverage and changing to the drug required by the step therapy may cause a clinically predictable adverse reaction or physical or mental harm to the beneficiary; or

(E)

The prescription drug required by the step therapy is not in the best interest of the beneficiary based on medical necessity.

(d)

Grant or deny a request for an exception to step therapy or an appeal of a denial of coverage no later than 72 hours or two business days, whichever is later, after receipt of the request unless exigent circumstances exist. If exigent circumstances exist the entity shall grant or deny the request for an exception no later than one business day after receipt of the request. A request for an exception to step therapy or an appeal of a denial of coverage shall be deemed granted if the entity fails to act within the time frames specified in this paragraph.

(3)

A prescribing practitioner may not use a pharmaceutical sample for the sole purpose of qualifying for an exception to step therapy under subsection (2)(c)(C) or (D) of this section.

(4)

This section does not prevent:

(a)

An entity that provides health care coverage from requiring a beneficiary to try an AB-rated generic equivalent or a biological product that is a biosimilar agent approved by the United States Food and Drug Administration prior to covering the equivalent brand name prescription drug;

(b)

An entity that provides health care coverage from denying a request for an exception to allow coverage of a drug that has been removed from the market due to the safety concerns of the United States Food and Drug Administration; or

(c)

A practitioner from prescribing a prescription drug that is medically appropriate regardless of coverage. [2014 c.55 §4; 2021 c.365 §§6,6a]
Note: Section 12 (2), chapter 154, Oregon Laws 2021, provides:
Sec. 12. (2) An entity described in ORS 743B.602 (Step therapy) must meet the website requirements in ORS 743B.602 (Step therapy), as amended by section 6a of this 2021 Act [section 6a, chapter 365, Oregon Laws 2021], no later than June 1, 2022. [2021 c.154 §12(2); 2021 c.365 §6c(2)]
Note: 743B.602 (Step therapy) was added to and made a part of the Insurance Code by legislative action but was not added to ORS chapter 743B or any series therein. See Preface to Oregon Revised Statutes for further explanation.

Source: Section 743B.602 — Step therapy, https://www.­oregonlegislature.­gov/bills_laws/ors/ors743B.­html.

743B.001
Definitions
743B.003
Purposes
743B.005
Definitions
743B.010
Issuance of group health benefit plan to affiliated group of employers
743B.011
Group health benefit plans subject to provisions of specified laws
743B.012
Requirement to offer all health benefit plans to small employers
743B.013
Requirements for small employer health benefit plans
743B.020
Eligible employees and small employers
743B.100
Department’s authority to regulate market
743B.102
Certifications and disclosure of coverage
743B.103
Use of health-related information
743B.104
Coverage in group health benefit plans
743B.105
Requirements for group health benefit plans other than small employer plans
743B.109
Short term health insurance policies
743B.110
Implementation of federal laws
743B.125
Individual health benefit plans
743B.126
Carrier marketing of individual health benefit plans
743B.127
Rules for ORS 743.022, 743B.125 and 743B.126
743B.128
Exceptions to requirement to actively market all plans
743B.129
Shortening period of exclusion following discontinued offering
743B.130
Requirement to offer bronze and silver plans
743B.195
Enforcement of Newborns’ and Mothers’ Health Protection Act of 1996
743B.197
Health Care Consumer Protection Advisory Committee
743B.200
Requirements for insurers offering managed health insurance
743B.202
Requirements for insurers offering managed health or preferred provider organization insurance
743B.204
Required managed health insurance contract provision
743B.220
Requirements for insurers that require designation of participating primary care physician
743B.222
Designation of women’s health care provider as primary care provider
743B.225
Continuity of care
743B.227
Referrals to specialists
743B.250
Required notices to applicants and enrollees
743B.252
External review
743B.253
Director to contract with independent review organizations to provide external review
743B.254
Required statements regarding external reviews
743B.255
Enrollee application for external review
743B.256
Duties of independent review organizations
743B.257
Civil penalty for failure to comply by insurer that agreed to be bound by decision
743B.258
Private right of action
743B.260
Claims and appeals of adverse benefit determinations under disability income insurance policies
743B.280
Definitions for ORS 743B.280 to 743B.285
743B.281
Estimate of costs for in-network procedure or service
743B.282
Estimate of costs for out-of-network procedure or service
743B.283
Submission of methodology used to determine insurer’s allowable charges
743B.284
Alternative mechanism for disclosure of costs and charges
743B.285
Rules
743B.287
Balance billing prohibited for health care facility services
743B.290
Hospital payment of copayment or deductible for insured patient
743B.300
Disclosure of differences in replacement health insurance policies
743B.310
Rescinding coverage
743B.320
Minimum grace period
743B.321
Applicability of ORS 743B.320
743B.323
Separate notice to policyholder required before cancellation of individual or group health insurance policy for nonpayment of premium
743B.324
Rules for certain notice requirements
743B.330
Notice to policyholder required for cancellation or nonrenewal of health benefit plan
743B.340
When group health insurance policies to continue in effect upon payment of premium by insured individual
743B.341
Continuation of benefits after termination of group health insurance policy
743B.342
Continuation of benefits after injury or illness covered by workers’ compensation
743B.343
Availability of continued coverage under group policy for surviving, divorced or separated spouse 55 or older
743B.344
Procedure for obtaining continuation of coverage under ORS 743B.343
743B.345
Premium for continuation of coverage under ORS 743B.344
743B.347
Continuation of coverage under group policy upon termination of membership in group health insurance policy
743B.400
Decisions regarding health care facility length of stay, level of care and follow-up care
743B.403
Insurer prohibited practices
743B.405
Medical services contract provisions
743B.406
Vision care providers
743B.407
Naturopathic physicians
743B.420
Prior authorization requirements
743B.422
Utilization review requirements for medical services contracts to which insurer not party
743B.423
Utilization review requirements for insurers offering health benefit plan
743B.424
Applicability
743B.425
Prior authorization prohibited for first 60 days of treatment for opioid or opiate withdrawal and for post-exposure prophylactic antiretroviral drugs
743B.427
Nonquantitative treatment limitations on coverage of behavioral health conditions
743B.450
Prompt payment of claims
743B.451
Refund of paid claims
743B.452
Interest on unpaid claims
743B.453
Underpayment of claims
743B.454
Claims submitted during credentialing period
743B.458
Performance-based incentive payments for primary care
743B.460
Conditions for restricting payments to only in-network providers
743B.462
Direct payments to providers
743B.470
Medicaid not considered in coverage eligibility determination
743B.475
Guidelines for coordination of benefits
743B.500
Selling and leasing of provider panels by contracting entity
743B.501
Registration of contracting entity
743B.502
Third party contracts for leasing of provider panels
743B.503
Additional requirements for third party contracts
743B.505
Provider networks
743B.550
Disclosure of information
743B.555
Confidential communications
743B.601
Synchronization of prescription drug refills
743B.602
Step therapy
743B.800
Risk adjustment procedures
743B.810
Enrollees covered by workers’ compensation
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