C.R.S. Section 25.5-4-428
Prior authorization for a step-therapy exception

  • rules
  • definition

(1)

As used in this section, unless the context otherwise requires, “step therapy” means a protocol that requires a recipient to use a prescription drug or sequence of prescription drugs, other than the drug that the recipient’s health-care provider recommends for the recipient’s treatment, before the state department provides coverage for the recommended prescription drug.

(2)

Intentionally left blank —Ed.

(a)

The state department shall review and determine if an exception to step therapy is granted if the prescribing provider submits a prior authorization request with justification and supporting clinical documentation for treatment of a serious or complex medical condition, if required, that states:

(I)

The provider attests that the required prescription drug is contraindicated, or will likely cause intolerable side effects, a significant drug-drug interaction, or an allergic reaction to the recipient;

(II)

The required prescription drug lacks efficacy based on the known clinical characteristics of the recipient and the known characteristics of the prescription drug regimen;

(III)

The recipient has tried the required prescription drug, and the use of the prescription drug by the recipient was discontinued due to intolerable side effects, a significant drug-drug interaction, or an allergic reaction; or

(IV)

The recipient is stable on a prescription drug selected by the prescribing provider for the medical condition.

(b)

Intentionally left blank —Ed.

(I)

Except as provided in subsection (2)(b)(II) of this section, the state department shall provide a response to a prior authorization request for a step-therapy exception within twenty-four hours after receipt of the request.

(II)

If a prior authorization request for a step-therapy exception is incomplete or if additional clinically relevant information is required, the state department shall notify the prescribing provider within twenty-four hours after the submission of the request that the request is incomplete or that additional clinically relevant information is required. The state department shall specify the additional information that is required in order to consider the prior authorization request. If the state department does not receive a response within seventy-two hours after the state department’s request for additional information, the prior authorization request is denied. If the state department receives a timely response from the provider, the state department shall provide a response within twenty-four hours after receiving the response.

(c)

If the prior authorization request for a step-therapy exception is denied, the state department shall inform the recipient in writing that the recipient has the right to appeal the adverse determination pursuant to state department rules.

(3)

If the prior authorization request for a step-therapy exception request is granted, the state department shall authorize coverage for the prescription drug prescribed by the recipient’s prescribing provider.

(4)

The state department shall make the prior authorization requirements for coverage of prescription drugs and a description of the step-therapy exemption process available on the state department’s website.

(5)

This section does not prohibit:

(a)

The state department from requiring a recipient to try a generic equivalent of a brand name drug, a biosimilar drug as defined in 42 U.S.C. sec. 262 (i)(2), or an interchangeable biological product as defined in 42 U.S.C. sec. 262 (i)(3), unless such a requirement meets any of the criteria set forth in subsection (2)(a) of this section for an exception to step therapy and a prior authorization request is granted for the requested drug;

(b)

The state department from denying a prior authorization request for a step-therapy exception when the request does not meet one of the criteria set forth in subsection (2)(a) of this section based on the justification and supporting clinical documentation submitted by the provider, if applicable; or

(c)

A provider from prescribing a drug that, in the provider’s clinical judgment, is determined to be medically appropriate.

(6)

The state board may promulgate rules to implement this section.

Source: Section 25.5-4-428 — Prior authorization for a step-therapy exception - rules - definition, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-25.­5.­pdf (accessed Oct. 20, 2023).

25.5‑4‑101
Short title
25.5‑4‑102
Legislative declaration
25.5‑4‑103
Definitions
25.5‑4‑104
Program of medical assistance - single state agency
25.5‑4‑105
Federal requirements under Title XIX
25.5‑4‑106
Cooperation with federal government - grants-in-aid - cooperation with the state department of human services in delivery of services
25.5‑4‑107
Retaliation definition
25.5‑4‑201
Cash system of accounting - financial administration of medical services premiums - medical programs administered by department of human services - federal contributions - rules
25.5‑4‑203
Advisory council established
25.5‑4‑204
Automated medical assistance administration
25.5‑4‑205
Application - verification of eligibility - demonstration project - rules - repeal
25.5‑4‑205.5
Confined persons - suspension of benefits
25.5‑4‑206
Reimbursement to counties - costs of administration
25.5‑4‑207
Appeals - rules - applicability
25.5‑4‑208
County duties - transitional medicaid
25.5‑4‑209
Payments by third parties - copayments by recipients - review - appeal - children’s waiting list reduction fund - rules - repeal
25.5‑4‑210
Purchase of health insurance for recipients
25.5‑4‑211
Medicaid management information system - appropriation in annual general appropriation act - expenditure in next fiscal year
25.5‑4‑212
Medicaid client correspondence improvement process - legislative declaration - definition
25.5‑4‑213
Audit of medicaid client correspondence - definition
25.5‑4‑215
Study - benefits for persons on work release - repeal
25.5‑4‑216
Report on impact of hospital facility fees in Colorado - definitions - steering committee - repeal
25.5‑4‑300.4
Last resort for payment - legislative intent
25.5‑4‑300.7
Prevention of coding errors - prepayment review of claims
25.5‑4‑300.9
Explanation of benefits - medicaid recipients - legislative declaration
25.5‑4‑301
Recoveries - overpayments - penalties - interest - adjustments - liens - review or audit procedures - repeal
25.5‑4‑302
Recovery of assets
25.5‑4‑303
State income tax refund intercept - garnishment of earning - failure to provide medical support for child
25.5‑4‑303.3
Provider fraud - attorney general report
25.5‑4‑303.5
Short title
25.5‑4‑304
Definitions
25.5‑4‑305
False medicaid claims - liability for certain acts
25.5‑4‑306
Civil actions for false medicaid claims
25.5‑4‑307
False medicaid claims procedures - statute of limitations
25.5‑4‑308
False medicaid claims jurisdiction
25.5‑4‑309
False medicaid claims civil investigation demands
25.5‑4‑310
Medicaid false claims report
25.5‑4‑401
Providers - payments - rules
25.5‑4‑401.2
Performance-based payments - reporting - repeal
25.5‑4‑401.5
Review of provider rates - advisory committee - recommendations - repeal
25.5‑4‑402
Providers - hospital reimbursement - hospital review program - rules
25.5‑4‑402.4
Hospitals - healthcare affordability and sustainability fee - legislative declaration - Colorado healthcare affordability and sustainability enterprise - federal waiver - fund created - rules - reports - repeal
25.5‑4‑402.5
Providers - state university teaching hospitals
25.5‑4‑402.8
Hospital transparency report - definitions
25.5‑4‑403
Providers - behavioral health safety net providers - reimbursement
25.5‑4‑403.1
Providers - community mental health centers - cost reporting
25.5‑4‑404
Payments for clinic services - restrictions on use
25.5‑4‑405
Mental health managed care service providers - requirements
25.5‑4‑406
Rate setting - medicaid residential treatment service providers - monitoring and auditing - report
25.5‑4‑407
Services by licensed psychologists without a doctor’s referral
25.5‑4‑408
Services provided by licensed psychologists - cost containment program
25.5‑4‑409
Authorization of services - nurse anesthetists - advanced practice registered nurses
25.5‑4‑410
Services of audiologists and speech pathologists without supervision
25.5‑4‑411
Authorization of services provided by dental hygienists
25.5‑4‑412
Family planning services - family-planning-related services - rules - definitions
25.5‑4‑413
Certain providers to inform patients of rights concerning advance medical directives
25.5‑4‑414
Providers - physicians - prohibition of certain referrals - definitions
25.5‑4‑415
No public funds for abortion - exception - definitions - repeal
25.5‑4‑416
Providers - medical equipment and supplies - requirements
25.5‑4‑417
Provider fee - medicaid providers - state plan amendment - rules - definitions
25.5‑4‑420
Providers to obtain unique NPI - service site - provider type - definitions
25.5‑4‑422
Cost control - legislative intent - use of technology - stakeholder feedback - reporting - rules
25.5‑4‑423
Targets for investments in primary care
25.5‑4‑425
Providers - health-care services related to labor and delivery - reimbursement
25.5‑4‑427
Supplemental state payment to the Denver health and hospital authority - repeal
25.5‑4‑428
Prior authorization for a step-therapy exception - rules - definition
25.5‑4‑429
Hospital and provider billing requirements - description of service provided - rules
25.5‑4‑430
Increasing access to behavioral health care for children and youth - directed payment authority - fee schedule rates
25.5‑4‑503
Waiver applications - authorization
25.5‑4‑505
Federal authorization related to persons involved in the criminal justice system - assessment - report - repeal
25.5‑4‑506
Coverage for doula services - stakeholder process - federal authorization - scholarship program - training - report - definitions - repeal
Green check means up to date. Up to date

Current through Fall 2024

§ 25.5-4-428’s source at colorado​.gov