Ohio Revised Code
Chapter 3923 | Sickness and Accident Insurance
Section 3923.80 | Denial of Coverage to Cancer Clinical Trial Participant.

Effective: April 7, 2009
Latest Legislation: Senate Bill 196 - 127th General Assembly
(A) Notwithstanding section 3901.71 of the Revised Code, no health benefit plan or public employee benefit plan shall deny coverage for the costs of any routine patient care administered to an insured participating in any stage of an eligible cancer clinical trial, if that care would be covered under the plan if the insured was not participating in a clinical trial.
(B) The coverage that may not be excluded under division (A) of this section is subject to all terms, conditions, restrictions, exclusions, and limitations that apply to any other coverage under the plan, policy, or arrangement for services performed by participating and nonparticipating providers. Nothing in this section shall be construed as requiring reimbursement to a provider or facility providing the routine care that does not have a health care contract with the entity issuing the health benefit plan or public employee benefit plan, or as prohibiting the entity issuing a health benefit plan or public employee benefit plan that does not have a health care contract with the provider or facility providing the routine care from negotiating a single case or other agreement for coverage.
(C) As used in this section:
(1) "Eligible cancer clinical trial" means a cancer clinical trial that meets all of the following criteria:
(a) A purpose of the trial is to test whether the intervention potentially improves the trial participant's health outcomes.
(b) The treatment provided as part of the trial is given with the intention of improving the trial participant's health outcomes.
(c) The trial has a therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology.
(d) The trial does one of the following:
(i) Tests how to administer a health care service, item, or drug for the treatment of cancer;
(ii) Tests responses to a health care service, item, or drug for the treatment of cancer;
(iii) Compares the effectiveness of a health care service, item, or drug for the treatment of cancer with that of other health care services, items, or drugs for the treatment of cancer;
(iv) Studies new uses of a health care service, item, or drug for the treatment of cancer.
(e) The trial is approved by one of the following entities:
(i) The national institutes of health or one of its cooperative groups or centers under the United States department of health and human services;
(ii) The United States food and drug administration;
(iii) The United States department of defense;
(iv) The United States department of veterans' affairs.
(2) "Subject of a cancer clinical trial" means the health care service, item, or drug that is being evaluated in the clinical trial and that is not routine patient care.
(3) "Health benefit plan" has the same meaning as in section 3924.01 of the Revised Code.
(4) "Routine patient care" means all health care services consistent with the coverage provided in the health benefit plan or public employee benefit plan for the treatment of cancer, including the type and frequency of any diagnostic modality, that is typically covered for a cancer patient who is not enrolled in a cancer clinical trial, and that was not necessitated solely because of the trial.
(5) For purposes of this section, a health benefit plan or public employee benefit plan may exclude coverage for any of the following:
(a) A health care service, item, or drug that is the subject of the cancer clinical trial;
(b) A health care service, item, or drug provided solely to satisfy data collection and analysis needs for the cancer clinical trial that is not used in the direct clinical management of the patient;
(c) An investigational or experimental drug or device that has not been approved for market by the United States food and drug administration;
(d) Transportation, lodging, food, or other expenses for the patient, or a family member or companion of the patient, that are associated with the travel to or from a facility providing the cancer clinical trial;
(e) An item or drug provided by the cancer clinical trial sponsors free of charge for any patient;
(f) A service, item, or drug that is eligible for reimbursement by a person other than the insurer, including the sponsor of the cancer clinical trial.

Structure Ohio Revised Code

Ohio Revised Code

Title 39 | Insurance

Chapter 3923 | Sickness and Accident Insurance

Section 3923.01 | Policy of Sickness and Accident Insurance Defined.

Section 3923.011 | Sickness and Accident Insurance Definitions.

Section 3923.02 | Form of Policy Filed With Superintendent.

Section 3923.021 | Approval or Disapproval of Premium Rates.

Section 3923.022 | Maximum Aggregate Administrative Expenses.

Section 3923.03 | Necessary Provisions.

Section 3923.04 | Policy Standard Provisions.

Section 3923.041 | Policies With Prior Authorization Requirement Provisions.

Section 3923.05 | Provisions to Conform to Prescribed Wording.

Section 3923.06 | Order of Presentation of Policy Provisions.

Section 3923.061 | Interest on Proceeds Payable Due to Death by Sickness or Accident.

Section 3923.07 | Omission or Substitution of Provisions.

Section 3923.071 | Policies, Applications, Riders or Indorsements Issued Prior to 10-1-53.

Section 3923.08 | Nonconflicting Provisions Permitted in Policy.

Section 3923.09 | Validity of Nonconforming Policy.

Section 3923.10 | Industrial Sickness and Accident Insurance.

Section 3923.11 | Sickness and Accident Insurance on a Franchise Plan.

Section 3923.12 | Group Sickness and Accident Insurance.

Section 3923.121 | Association of Insurers to Provide Basic Medical Coverage to Persons 65 or Older.

Section 3923.122 | [Suspended Eff. 1/1/2014 to 1/1/2026, per Section 3 of s.b. 9 of the 130th General Assembly, as Amended] Option for Conversion From Group Policy to Individual Policy.

Section 3923.123 | Association of Insurers to Provide Group Health Coverage to Qualified Unemployed Persons.

Section 3923.13 | Blanket Sickness and Accident Insurance.

Section 3923.14 | False Statement in Application - Alteration of Written Application.

Section 3923.141 | Agent of the Insurer.

Section 3923.15 | Unfair Discrimination Prohibited.

Section 3923.16 | Misleading or Deceptive Advertising Prohibited.

Section 3923.161 | Describing Cancellability and Renewability Provisions Clearly and With Prominence or Emphasis.

Section 3923.17 | Prohibition of Rebates Not to Prohibit Commissions or Dividends.

Section 3923.18 | Rights of Insurer in Defense of Claim Not Waived.

Section 3923.19 | Benefits Exempt From Legal Process - Exception.

Section 3923.20 | Exemptions for Certain Insurance Policies.

Section 3923.21 | Prohibition Against Delivery of Policy on Disapproved Insurance Form.

Section 3923.22 | Appeal - Applicability of Administrative Procedure Sections.

Section 3923.23 | Reimbursement for Services of Licensed Osteopath, Optometrist, Chiropractor or Podiatrist.

Section 3923.231 | Reimbursement for Services of Licensed Psychologist.

Section 3923.232 | Reimbursement for Services of Licensed Dentist.

Section 3923.233 | Reimbursement for Services of Certified Nurse-Midwife Performing Service in Collaboration With Licensed Physician.

Section 3923.234 | Reimbursement for Services of Certified Mechanotherapist.

Section 3923.24 | Continuing Coverage for Dependent Children.

Section 3923.241 | Public Employee Benefit Plans - Continuing Coverage for Dependent Children.

Section 3923.25 | Kidney Dialysis Benefits.

Section 3923.26 | Coverage for Newly Born Children From the Moment of Birth.

Section 3923.27 | Hospitalization Coverage for Mental Illness.

Section 3923.28 | Outpatient Coverage for Mental or Emotional Disorders.

Section 3923.281 | Sickness and Accident Policies - Biologically Based Mental Illness.

Section 3923.282 | Health Coverage Plans - Biologically Based Mental Illness.

Section 3923.29 | Outpatient, Inpatient, and Intermediate Primary Care Benefits for Alcoholism.

Section 3923.30 | Requiring Provision of Coverage of Treatment of Mental or Nervous Disorders and Alcoholism.

Section 3923.301 | Requiring Provision of Coverage for Services of Certified Nurse-Midwife Performing Service in Collaboration With Licensed Physician.

Section 3923.31 | Right to Rescind Individual Policy of Sickness and Accident Insurance.

Section 3923.32 | Right of Family Member to Continue Coverage After Subscriber's Death or Upon Change in Marital Relation to Subscriber.

Section 3923.33 | Medicare Supplement Policy Definitions.

Section 3923.331 | Statutes Applicable to Medicare Supplement Policies.

Section 3923.332 | Standards for Policy Provisions of Medicare Supplement Policies and Certificates.

Section 3923.333 | Benefits to Be Reasonable in Relation to Premium Charged.

Section 3923.334 | Outline of Coverage Delivered at Time Application Is Made.

Section 3923.335 | Right to Return Policy or Certificate and Have Premium Refunded.

Section 3923.336 | Review and Approval of Advertisement by Superintendent.

Section 3923.337 | Rules.

Section 3923.338 | Orders of Superintendent.

Section 3923.339 | Severability.

Section 3923.36 | Excluding Coverage of Illness or Injury Covered by Workers' Compensation.

Section 3923.37 | Prohibiting Exclusion or Reduction of Benefits Because of Benefits Payable Under Supplemental Policy.

Section 3923.38 | Continuing Policy Upon Termination of Employment.

Section 3923.381 | Continuing Coverage Under Group Policy When Reservist Is Called or Ordered to Active Duty.

Section 3923.382 | Continuing Coverage Under Group Plan When Reservist Is Called or Ordered to Active Duty.

Section 3923.39 | Consolidated Corporation Cancelling Individual Policy for Nonpayment.

Section 3923.40 | Coverage of Adopted Children.

Section 3923.41 | Long-Term Care Insurance Definitions.

Section 3923.42 | Citing Provisions - Applicability.

Section 3923.43 | Evidence to Be Filed by Long-Term Care Insurance Association.

Section 3923.44 | Standards for Full and Fair Disclosure for Sale of Long-Term Care Insurance Policies.

Section 3923.441 | Rescission of Long-Term Care Policy for Misrepresentation.

Section 3923.442 | Offer of Nonforfeiture Benefit Option With Long-Term Care Policy.

Section 3923.443 | Training Required for Agents Selling Long-Term Care Policies.

Section 3923.444 | Compensation of Agents Selling Long-Term Care Policies.

Section 3923.45 | Forms.

Section 3923.46 | Rates for Individual Policy.

Section 3923.47 | Rules.

Section 3923.48 | Violation Is Unfair and Deceptive Insurance Practice.

Section 3923.49 | Establishing Outreach Program to Educate Consumers.

Section 3923.50 | Notifying Department of Job and Family Services of Long-Term Care Insurance Policies That Comply With Insurance Department Requirements.

Section 3923.51 | Group Contracts of Sickness and Accident Insurance Persons Under Nineteen Who Are Members of Impoverished Families.

Section 3923.52 | Screening Mammography and Cytologic Screening Benefits.

Section 3923.53 | Public Employee Benefit Plan - Breast Cancer and Cervical Cancer Screening.

Section 3923.54 | Employee Health Care Benefit Plan.

Section 3923.55 | Policy to Include Benefits for Child Health Supervision Services From Moment of Birth Until Age Nine.

Section 3923.56 | Plan to Include Benefits for Child Health Supervision Services From Moment of Birth Until Age Nine.

Section 3923.57 | Pre-Existing Conditions Provisions.

Section 3923.571 | Conditions Applying to Group Policies of Sickness and Accident Insurance Sold in Connection With Employment-Related Group Health Plan.

Section 3923.58 | [Suspended Eff. 1/1/2014 to 1/1/2026, per Section 3 of s.b. 9 of the 130th General Assembly, as Amended] Open Enrollment Coverage - Insurers in the Business of Issuing Individual Policies of Sickness and Accident Insurance.

Section 3923.581 | [Suspended Eff. 1/1/2014 to 1/1/2026, per Section 3 of s.b. 9 of the 130th General Assembly, as Amended] Open Enrollment Coverage - Carriers in the Business of Issuing Health Benefit Plans to Individuals or Nonemployer Groups.

Section 3923.582 | [Suspended Eff. 1/1/2014 to 1/1/2026, per Section 3 of s.b. 9 of the 130th General Assembly, as Amended] Open Enrollment Coverage - Responsibilities of Superintendent of Insurance.

Section 3923.59 | [Suspended Eff. 1/1/2014 to 1/1/2026, per Section 3 of s.b. 9 of the 130th General Assembly, as Amended] Open Enrollment Reinsurance Program.

Section 3923.60 | Standard Medical Reference Compendia for Coverage of Prescription Drugs.

Section 3923.601 | Standardized Prescription Identification Information - Pharmacy Benefits to Be Included.

Section 3923.602 | Medication Synchronization for Insured.

Section 3923.61 | Public Employee Benefit Plans - Prescription Drugs.

Section 3923.62 | Disclosing Determination of Usual and Customary Fee for Dental Benefits.

Section 3923.63 | Coverage of Inpatient Care and Follow-Up Care for Mother and Her Newborn.

Section 3923.64 | Public Employee Benefit Plans - Maternity Benefits.

Section 3923.65 | Coverage for Emergency Services.

Section 3923.80 | Denial of Coverage to Cancer Clinical Trial Participant.

Section 3923.81 | Covered Person's Payments Not to Exceed Insurer Payments.

Section 3923.82 | Coverage for Alcohol or Drug Related Losses or Expenses.

Section 3923.83 | Standardized Prescription Identification Information - Pharmacy Benefits to Be Included - Public Employee Benefit Plan.

Section 3923.84 | Coverage for Autism Spectrum Disorder.

Section 3923.85 | Cancer Medication; Coverage for Orally and Intravenously Administered Treatments.

Section 3923.851 | Prior Authorization Requirements or Other Utilization Review Measures as Conditions of Providing Coverage of an Opioid Analgesic Prescribed for Treatment of Chronic Pain; Exceptions.

Section 3923.86 | Statement Provided to Insureds Under Vision Policy.

Section 3923.87 | Compliance With Section 3959.20.

Section 3923.89 | Payment or Reimbursement to Pharmacist.

Section 3923.90 | Teledentistry to Be Included in Coverage.

Section 3923.99 | Penalty.