Effective: April 5, 2019
Latest Legislation: Senate Bill 265 - 132nd General Assembly
(A)(1)(a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by a health plan issuer or utilization review organization through the use of a step therapy protocol, the health plan issuer or utilization review organization shall provide the prescribing health care provider access to a clear, easily accessible, and convenient process to request a step therapy exemption on behalf of a covered individual. A health plan issuer or utilization review organization may use its existing medical exceptions process to satisfy this requirement.
(b) A step therapy exemption request shall include supporting documentation and rationale.
(2)(a) A health plan issuer shall make available, to all health care providers, a list of all drugs covered by the issuer that are subject to a step therapy protocol. If the health plan issuer offers more than one health benefit plan, and the covered drugs subject to a step therapy protocol vary from one plan to another, then the health plan issuer shall issue a separate list for each plan.
(b) Along with the information required under division (A)(2)(a) of this section, a health plan issuer shall indicate what information or documentation must be provided to the issuer or organization for a step therapy exemption request to be considered complete. Such information shall be provided for each drug, if the requirements vary according to the drug, plan, or protocol in question.
(3)(a) The list required under division (A)(2)(a) of this section, along with the required information or documentation described in division (A)(2)(b) of this section, shall be made available on the issuer's web site or provider portal.
(b) A utilization review organization shall, for each health benefit plan it oversees that implements a step therapy protocol, similarly make the list and information required under divisions (A)(2)(a) and (b) of this section available on its web site or provider portal.
(4) From the time a step therapy exemption request is received by a health plan issuer or utilization review organization, the issuer or organization shall either grant or deny the request within the following time frames:
(a) Forty-eight hours for a request related to urgent care services;
(b) Ten calendar days for all other requests.
(5)(a) A provider may, on behalf of the covered individual, appeal any exemption request that is denied.
(b) From the time an appeal is received by a health plan issuer or utilization review organization, the issuer or organization shall either grant or deny the appeal within the following time frames:
(i) Forty-eight hours for appeals related to urgent care services;
(ii) Ten calendar days for all other appeals.
(c) The appeal shall be between the health care provider requesting the service in question and a clinical peer, as defined in section 3923.041 of the Revised Code.
(d)(i) The appeal shall be considered an internal appeal for purposes of section 3922.03 of the Revised Code.
(ii) A health plan issuer shall not impose a step therapy exemption appeal as an additional level of appeal beyond what is required under section 3922.03 of the Revised Code, unless otherwise permitted by law.
(e)(i) If the appeal does not resolve the disagreement, the covered individual, or the covered individual's authorized representative, may request an external review under Chapter 3922. of the Revised Code to the extent Chapter 3922. of the Revised Code is applicable.
(ii) As used in division (A)(5)(e) of this section, "authorized representative" has the same meaning as in section 3922.01 of the Revised Code.
(6) If a health plan issuer or utilization review organization does not either grant or deny an exemption request or an appeal within the time frames prescribed in division (A)(4) or (5) of this section, then such an exemption request or appeal shall be deemed to be granted.
(B) Pursuant to a step therapy exemption request initiated under division (A)(1) of this section or an appeal made under division (A)(5) of this section, a health plan issuer or utilization review organization shall grant a step therapy exemption if any of the following are met:
(1) The required prescription drug is contraindicated for that specific patient, pursuant to the drug's United States food and drug administration prescribing information.
(2) The patient has tried the required prescription drug while under their current, or a previous, health benefit plan, or another United States food and drug administration approved AB-rated prescription drug, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
(3) The patient is stable on a prescription drug selected by the patient's health care provider for the medical condition under consideration, regardless of whether or not the drug was prescribed when the patient was covered under the current or a previous health benefit plan, or has already gone through a step therapy protocol. However, a health benefit plan may require a stable patient to try a pharmaceutical alternative, per the federal food and drug administration's orange book, purple book, or their successors, prior to providing coverage for the prescribed drug.
(C) Upon the granting of a step therapy exemption, the health plan issuer or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.
(D) This section shall not be construed to prevent either of the following:
(1) A health plan issuer or utilization review organization from requiring a patient to try any new or existing pharmaceutical alternative, per the federal food and drug administration's orange book, purple book, or their successors, prior to providing or renewing coverage for the prescribed drug;
(2) A health care provider from prescribing a prescription drug, consistent with medical or scientific evidence.
(E) Committing a series of violations of this section that, taken together, constitute a practice or pattern shall be considered an unfair and deceptive practice under sections 3901.19 to 3901.26 of the Revised Code.
Structure Ohio Revised Code
Chapter 3901 | Superintendent of Insurance
Section 3901.01 | Department of Insurance.
Section 3901.011 | Superintendent of Insurance - Powers and Duties.
Section 3901.02 | Appointment or Hiring of Employees.
Section 3901.021 | Department of Insurance Operating Fund.
Section 3901.03 | Warden - Duties - Office of Warden.
Section 3901.04 | Superintendent - Specific Powers.
Section 3901.041 | Rule-Making and Adjudicating Powers of Superintendent.
Section 3901.042 | Service and Transaction Fees.
Section 3901.043 | Fees for Services or Transactions Performed by Department of Insurance.
Section 3901.044 | Rules for Implementing Health Insurance Portability and Accountability Act.
Section 3901.045 | Receiving Confidential or Privileged Documents and Information.
Section 3901.046 | Electronic Signatures.
Section 3901.05 | Deputy Superintendent - Duties.
Section 3901.051 | Assistant Superintendent - Duties.
Section 3901.052 | Application for Innovative Waiver.
Section 3901.06 | Instruments Under Seal of the Superintendent.
Section 3901.07 | Examination of Financial Affairs of Insurer.
Section 3901.071 | Superintendent's Examination Fund.
Section 3901.072 | Corporate Governance Annual Disclosure Act.
Section 3901.073 | Corporate Governance Annual Disclosure.
Section 3901.074 | Format of Disclosure.
Section 3901.075 | Documents Deemed Proprietary.
Section 3901.076 | Retention of Third-Party Consultant.
Section 3901.08 | Information From Banks.
Section 3901.09 | Duty of Bank Officers.
Section 3901.10 | Deficiency of Company Assets.
Section 3901.11 | Acquisition of Stock of Other Insurers.
Section 3901.12 | Interlocking Directorate.
Section 3901.13 | Hearing by Superintendent.
Section 3901.14 | Record and Report of Superintendent.
Section 3901.15 | Application of Law.
Section 3901.17 | Personal Jurisdiction Over Foreign or Alien Insurer.
Section 3901.18 | Requirements for Unauthorized Foreign or Alien Insurer to Enter an Appearance.
Section 3901.19 | Unfair and Deceptive Practices Definitions.
Section 3901.20 | Prohibition Against Unfair or Deceptive Acts.
Section 3901.21 | Unfair and Deceptive Acts or Practices in Business of Insurance Defined.
Section 3901.211 | Lending of Money, Extension of Credit - Prohibited Acts.
Section 3901.212 | Consumer Protection Rules.
Section 3901.213 | Unfair and Deceptive Practices - Exceptions.
Section 3901.214 | Applicability of Prohibition on Inducements.
Section 3901.215 | Intent to Promote Innovation and Maintain Strong Consumer Protection.
Section 3901.22 | Hearings on Violation - Orders - Administrative Remedies.
Section 3901.221 | Cease-and-Desist Orders.
Section 3901.23 | Self-Incrimination.
Section 3901.24 | Unlawful Advertising.
Section 3901.241 | List of Top Twenty per Cent of Services and Expected Contributions.
Section 3901.25 | Action by Superintendent Against Insurer.
Section 3901.27 | Adoption of Emergency Bylaws.
Section 3901.28 | Provisions Effective if No Emergency Bylaws.
Section 3901.29 | Succession List.
Section 3901.30 | Emergency Business Location.
Section 3901.31 | Filing Statements Indicating Ownership.
Section 3901.32 | Insurance Holding Company System Definitions.
Section 3901.321 | Mergers and Acquisitions of Domestic Insurers.
Section 3901.322 | Procedure for Violations.
Section 3901.323 | Jurisdiction.
Section 3901.341 | Prior Review of Proposed Transactions.
Section 3901.35 | Requiring Production of Records.
Section 3901.351 | Participation in Supervisory College.
Section 3901.352 | Group-Wide Supervisor for Internationally Active Insurance Group.
Section 3901.36 | Confidential and Privileged Treatment of Documents and Information - Exceptions.
Section 3901.37 | Suspension, Revocation or Refusal to Renew License - Civil Forfeiture.
Section 3901.371 | Purpose of Sections 3901.371 to 3901.378.
Section 3901.372 | Definitions.
Section 3901.373 | Risk Management Framework.
Section 3901.374 | Own Risk and Solvency Assessment.
Section 3901.375 | Summary Report.
Section 3901.376 | Exemptions.
Section 3901.377 | Form and Content of Report; Review.
Section 3901.378 | Confidentiality.
Section 3901.38 | Prompt Payments to Health Care Providers Definitions.
Section 3901.381 | Third-Party Payers Processing Claims for Payment for Health Care Services.
Section 3901.382 | Electronic Submission of Claims.
Section 3901.383 | Contractual Agreements for Payments by Third-Party Payers.
Section 3901.384 | Untimely Claim Process.
Section 3901.385 | Third-Party Payer - Prohibited Acts.
Section 3901.387 | Duplicative Claims - Claim Information System.
Section 3901.388 | Payments Considered Final - Overpayment.
Section 3901.389 | Computation of Interest.
Section 3901.3810 | Complaints by Provider or Beneficiary - Retaliation by Payer.
Section 3901.3811 | Failure to Comply by Third-Party Payer.
Section 3901.3812 | Administrative Remedies.
Section 3901.3814 | Exceptions to Provisions.
Section 3901.40 | Payment or Reimbursement to Unlicensed or Unaccredited Hospital Prohibited.
Section 3901.41 | Applicability of Uniform Electronics Transactions Act; Automated Transactions.
Section 3901.42 | Annual Filing With National Association of Insurance Commissioners.
Section 3901.44 | Records of Insurance Fraud Investigation.
Section 3901.45 | Effect of Sexual Orientation, Hiv, or AIDS or Related Condition.
Section 3901.46 | Requiring HIV Testing.
Section 3901.47 | Administration of Claims Unpaid Due to Insolvency of Insurer.
Section 3901.48 | Disclosing Work Papers Resulting From Conduct of Audit.
Section 3901.491 | Genetic Screening or Testing.
Section 3901.501 | Genetic Screening or Testing for Self-Insurance Plans.
Section 3901.51 | Uncertified Securities as Deposits Definitions.
Section 3901.53 | Placement of Securities Shall Satisfy Deposit Requirements.
Section 3901.54 | Securities May Not Be Used for Other Purposes.
Section 3901.56 | Rewards or Incentives for Insurer Wellness or Health Improvement Programs.
Section 3901.61 | Credit for Reinsurance Ceded Definitions.
Section 3901.621 | Suspension or Revocation of Reinsurer's Accreditation or Certification.
Section 3901.63 | Credit for Reinsurance Ceded as Reduction of Liability.
Section 3901.631 | Management of Reinsurance Recoverables by Domestic Ceding Insurer.
Section 3901.64 | Terms of Reinsurance or Security Agreement.
Section 3901.67 | Disclosure of Material Transactions Model Act Definitions.
Section 3901.68 | Provisions Application.
Section 3901.69 | Insurer to Report Material Transactions.
Section 3901.70 | Confidentiality of Reports - Exceptions.
Section 3901.71 | Application of Mandated Health Benefits.
Section 3901.72 | Money Advanced to Insurance Company or Health Insuring Corporation.
Section 3901.73 | Department to Forward Copy of Late Filing Notice to Board of Directors.
Section 3901.74 | Notice of Life Insurance Company Discontinuing Business.
Section 3901.75 | Notice of Insurance Companies Other Than Life Discontinuing Business.
Section 3901.76 | Security Valuation Expense Fund.
Section 3901.77 | Forms, Instructions, Manuals - Determination of Accounting Practices and Methods.
Section 3901.78 | Certificate of Compliance.
Section 3901.80 | Discriminating Against Living Organ Donors.
Section 3901.81 | Definitions.
Section 3901.811 | Pharmacy Audits.
Section 3901.812 | Rights of Pharmacy.
Section 3901.813 | Proceedings After Audit.
Section 3901.814 | Appeal Process.
Section 3901.815 | Applicability of Provisions.
Section 3901.82 | Restatement of the Law, Liability Insurance.
Section 3901.83 | Definitions for Sections 3901.83 to 3901.833.
Section 3901.831 | Implementation of Step Therapy Protocol.
Section 3901.832 | Step Therapy Exemption.
Section 3901.833 | Adoption of Rules.
Section 3901.86 | Retaliatory Provisions - Moneys Collected Paid to State Fire Marshal's Fund.
Section 3901.87 | No Coverage for Nontherapeutic Abortion.
Section 3901.88 | Actuarial Study Regarding Costs of Health Care Mandates.
Section 3901.89 | Health Plan Issuers Release Claim Information to Group Plan policyholders..
Section 3901.90 | Education on Mental Health and Addiction Services Insurance Parity.
Section 3901.91 | Adoption or Amendment of Rules Related to Insurance Rating Agencies.
Section 3901.95 | Direct Primary Care Agreement Not to Be Considered Insurance.