C.R.S. Section 25.5-5-326
Access to clinical trials

  • definitions

(1)

As used in this section, unless the context otherwise requires:

(a)

“Approved clinical trial” means a phase I, II, III, or IV clinical trial involving the prevention, detection, diagnosis, or treatment of a life-threatening or debilitating disease or condition if any one of the following conditions apply:

(I)

The clinical trial is conducted under an investigational new drug application or an investigational device exemption reviewed by the federal food and drug administration, or is exempted from review by the federal food and drug administration; or

(II)

The clinical trial is approved or funded by:

(A)

The national institutes of health;

(B)

The centers for disease control and prevention;

(C)

The agency for health care research and quality;

(D)

The federal centers for medicare and medicaid services;

(E)

A cooperative group or center of any of the entities described in subsections (1)(a)(II)(A) to (1)(a)(II)(D) of this section, the federal department of defense, or the federal department of veterans affairs;

(F)

A qualified nongovernmental research entity identified in guidelines issued by the national institutes of health for center support grants; or

(G)

The federal department of veterans affairs, the federal department of defense, or the federal department of energy, provided that review and approval of the clinical trial occurs through a system of peer review that is comparable to the peer review of clinical trials performed by the national institutes of health, including an unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

(b)

“Life-threatening or debilitating disease or condition” means a disease or condition from which the likelihood of death is probable, or the disease or condition is progressive or significantly debilitating, unless the course of the disease or condition is interrupted.

(c)

“Qualified individual” means an individual who is eligible for and enrolled in the state medical assistance program and who a treating physician determines has a life-threatening or debilitating disease or condition and meets the selection criteria for the approved clinical trial.

(d)

Intentionally left blank —Ed.

(I)

“Routine costs” means medically necessary items and services that are included under the medical assistance program for a medical assistance recipient, to the extent that the provision of such items or services to the individual outside the course of such participation would otherwise be covered under the medical assistance program, without regard to whether the recipient is enrolled in a clinical trial. For medical assistance recipients participating in an approved clinical trial, “routine costs” include medically necessary items and services that are not otherwise excluded pursuant to subsection (1)(d)(II)(D) of this section, relating to the detection and treatment of complications arising from the medical assistance recipient’s medical care, including complications relating to participation in the clinical trial, to the extent that the provision of such items or services to the individual outside the course of such participation would otherwise be included under the medical assistance program.

(II)

“Routine costs” do not include:

(A)

The investigational item, device, or service itself;

(B)

Items and services provided solely to satisfy the data collection and analysis needs of the clinical trial;

(C)

Items, drugs, or services customarily provided free of charge to any qualified individual enrolled in the clinical trial; or

(D)

Items, drugs, or services that the clinical trial is required to provide.

(2)

The medical assistance program established pursuant to this article 5 and articles 4 and 6 of this title 25.5 must include coverage and payment for the routine costs associated with participation in an approved clinical trial for a qualified individual.

Source: Section 25.5-5-326 — Access to clinical trials - definitions, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-25.­5.­pdf (accessed Oct. 20, 2023).

25.5‑5‑101
Mandatory provisions - eligible groups - rules - repeal
25.5‑5‑102
Basic services for the categorically needy - mandated services
25.5‑5‑103
Mandated programs with special state provisions - rules
25.5‑5‑104
Qualified medicare beneficiaries
25.5‑5‑105
Qualified disabled and working individuals
25.5‑5‑201
Optional provisions - optional groups - rules - repeal
25.5‑5‑202
Basic services for the categorically needy - optional services
25.5‑5‑203
Optional programs with special state provisions - repeal
25.5‑5‑204
Presumptive eligibility - pregnant person - children - long-term care - state plan
25.5‑5‑204.5
Continuous eligibility - children
25.5‑5‑206
Medicaid buy-in program - disabled children - disabled adults - federal authorization - rules
25.5‑5‑207
Adult dental benefit - adult dental fund - creation - legislative declaration
25.5‑5‑208
Additional services - training - grants - screening, brief intervention, and referral
25.5‑5‑301
Clinic services
25.5‑5‑302
Clinic services - children and pregnant women - utilization of certain providers
25.5‑5‑303
Private-duty nursing
25.5‑5‑304
Hospice care
25.5‑5‑305
Pediatric hospice care - legislative declaration - federal authorization - rules - fund
25.5‑5‑307
Child mental health treatment and family support program
25.5‑5‑308
Breast and cervical cancer prevention and treatment program - creation - legislative declaration - definitions - funds - repeal
25.5‑5‑309
Pregnant women - needs assessment - referral to treatment program - definition
25.5‑5‑310
Treatment program for high-risk pregnant and parenting women - cooperation with private entities - definition
25.5‑5‑311
Treatment program for high-risk pregnant and parenting women - data collection
25.5‑5‑312
Treatment program for high-risk pregnant and parenting women - extended coverage - federal approval
25.5‑5‑314
Substance use disorder treatment for Native Americans - federal approval
25.5‑5‑315
Acceptance of gifts, grants, and donations - Native American substance abuse treatment cash fund
25.5‑5‑316
Legislative declaration - state department - disease management programs authorization - report
25.5‑5‑318
Health services - provision by school districts - repeal
25.5‑5‑319
Family planning pilot program - rules - federal waiver - repeal
25.5‑5‑320
Telemedicine - reimbursement - disclosure statement - rules - definition
25.5‑5‑321
Telemedicine - home health care - home health telemedicine cash fund - rules - repeal
25.5‑5‑321.5
Telehealth - interim therapeutic restorations - reimbursement - definitions
25.5‑5‑322
Over-the-counter medications - rules
25.5‑5‑323
Complex rehabilitation technology - no prior authorization - metrics - report - rules - legislative declaration - definitions
25.5‑5‑324
Nonemergency medical transportation - urgent and secure transportation need - report - repeal
25.5‑5‑325
Residential and inpatient substance use disorder treatment - medical detoxification services - federal approval - performance review report
25.5‑5‑326
Access to clinical trials - definitions
25.5‑5‑327
Eligible peer support services - reimbursement - definitions
25.5‑5‑328
Secure transportation for behavioral health crises - benefit - funding
25.5‑5‑329
Family planning services - federal authorization - rules - definitions
25.5‑5‑330
Screening for perinatal mood and anxiety disorder
25.5‑5‑331
Federally qualified health center - clinical pharmacy services - reimbursement - rules
25.5‑5‑332
Therapy using equine movement - federal authorization - definition
25.5‑5‑333
Primary care and behavioral health statewide integration grant program - creation - report - definition - repeal
25.5‑5‑334
Community health worker services - federal authorization - reporting - rules - definition
25.5‑5‑335
Continuous medical coverage for children and adults feasibility study - federal authorization - rules - report - definition
25.5‑5‑336
Prohibition on using the body mass index or ideal body weight - medical necessity criteria
25.5‑5‑401
Short title
25.5‑5‑402
Statewide managed care system - rules - definitions - repeal
25.5‑5‑403
Definitions
25.5‑5‑406.1
Required features of statewide managed care system
25.5‑5‑408
Capitation payments - availability of base data - adjustments - rate calculation - capitation payment proposal - preference - assignment of medicaid recipients - definition
25.5‑5‑410
Data collection for managed care programs
25.5‑5‑412
Program of all-inclusive care for the elderly - services - eligibility - legislative declaration - rules - definitions
25.5‑5‑414
Telemedicine - legislative intent
25.5‑5‑415
Medicaid payment reform and innovation pilot program - legislative declaration - creation - selection of payment projects - report - rules
25.5‑5‑418
Primary care provider sustainability fund - creation - use of fund
25.5‑5‑419
Accountable care collaborative - reporting - rules
25.5‑5‑420
Advancing care for exceptional kids
25.5‑5‑421
Parity reporting - state department - public input
25.5‑5‑422
Medication-assisted treatment - limitations on MCEs - definition
25.5‑5‑423
Independent review organization - review denial of residential and inpatient substance use disorder treatment claims - contract
25.5‑5‑424
Residential and inpatient substance use disorder treatment - MCE standardized utilization management process - medical necessity - report
25.5‑5‑425
Audit of MCE denials for residential and inpatient substance use disorder treatment authorization - report
25.5‑5‑500.3
Authorization to bill third party
25.5‑5‑501
Providers - drug reimbursement
25.5‑5‑502
Unused medications - reuse - rules - definition
25.5‑5‑503
Prescription drug benefits - authorization - dual-eligible participation
25.5‑5‑504
Providers of pharmaceutical services
25.5‑5‑505
Prescribed drugs - mail order - rules
25.5‑5‑506
Prescribed drugs - utilization review
25.5‑5‑507
Prescription drug information and technical assistance program - rules
25.5‑5‑509
Substance use disorder - prescription drugs - opiate antagonist
25.5‑5‑510
Pharmacy reimbursement - substance use disorder - injections
25.5‑5‑511
Reimbursement for pharmacists’ services - legislative declaration
25.5‑5‑512
Pharmacy benefit - mental health and substance use disorders - legislative declaration
25.5‑5‑513
Pharmacy benefits - prescription drugs - rebates - analysis
25.5‑5‑514
Prescription drugs used for treatment or prevention of HIV - prohibition on utilization management - definition
25.5‑5‑515
Pharmacy reimbursement - vaccine administration to children - legislative declaration
25.5‑5‑516
Serious mental illness - prescribed drugs
25.5‑5‑801
Legislative declaration
25.5‑5‑802
Definitions
25.5‑5‑803
High-fidelity wraparound services for children and youth - federal approval - reporting
25.5‑5‑804
Integrated funding pilot
Green check means up to date. Up to date

Current through Fall 2024

§ 25.5-5-326’s source at colorado​.gov