Indiana Code
Chapter 5. Accident and Sickness Insurance─policy Provisions
27-8-5-31.5. Insurer Removing Prescription Drug From Formulary or Changing Cost Sharing; Written Notice and Appeal Process

Sec. 31.5. (a) This section applies to a policy of accident and sickness insurance that is issued, entered into, amended, or renewed after June 30, 2020.
(b) The definitions in section 30 of this chapter apply throughout this section.
(c) This section applies to an insurer that uses a formulary or cost sharing review for prescription drug coverage.
(d) An insurer shall not remove a prescription drug from the insurer's formulary or change the cost sharing requirements that apply to a prescription drug unless the insurer does the following:
(1) At least sixty (60) days before the removal or change is effective, sends written notice of the removal or change to each insured for whom the prescription drug has been prescribed during the plan year.
(2) Provides a timely appeal process through which an insured may request an extension of coverage for the prescription drug through the end of the plan year. The appeal process must consider the following:
(A) Clinical appropriateness that is evidence based.
(B) Whether the insured has been adherent to the prescription drug regimen long enough that discontinuation of the prescription drug would cause a significant barrier to the insured's adherence to or compliance with the insured's plan of care.
(C) Whether discontinuation of the prescription drug would worsen a comorbid condition of the insured.
(D) Whether discontinuation of the prescription drug would decrease the insured's ability to achieve or maintain reasonable functional ability to perform daily activities.
(e) If the request for an extension made by an insured under subsection (d) is supported by documentation from the prescribing health care provider, the insurer shall make a determination concerning the insured's request:
(1) in an urgent care situation, not more than one (1) business day after receiving the request; or
(2) in a non-urgent situation, not more than three (3) business days after receiving the request.
(f) If an appeal under subsection (d)(2) is granted, the insurer shall notify the insured and the insured's health care provider of the authorization for coverage of the prescription drug that was the subject of the appeal.
(g) An extension of coverage of a prescription drug through the end of the plan year under this section is permitted only once and may not be repeated unless otherwise provided by the insurer.
(h) Nothing under this section prohibits an insurer from removing a prescription drug from its formulary or denying an insured coverage if:
(1) the federal Food and Drug Administration has issued a statement about the prescription drug that calls into question the clinical safety of the prescription drug;
(2) the manufacturer of the prescription drug has notified the federal Food and Drug Administration of a manufacturing discontinuance or potential discontinuance of the prescription drug as required by 21 U.S.C. 356c of the federal Food, Drug, and Cosmetic Act; or
(3) the manufacturer of the prescription drug has removed the prescription drug from the market.
(i) This chapter does not prohibit a pharmacist from substituting:
(1) a generically equivalent drug product for a brand name drug under IC 16-42-22; or
(2) a biosimilar biological product for a prescribed biological product under 16-42-25.
As added by P.L.114-2020, SEC.19.

Structure Indiana Code

Indiana Code

Title 27. Insurance

Article 8. Life, Accident, and Health

Chapter 5. Accident and Sickness Insurance─policy Provisions

27-8-5-0.1. Application of Certain Amendments to Chapter

27-8-5-1. Policy of Accident and Sickness Insurance; Filing; Review; Conformity With Federal Act

27-8-5-1.5. Filing, Review, Approval, and Disapproval Process

27-8-5-2. Requirements for Issuance and Delivery of Policy

27-8-5-2.5. Coverage Under Individual, and Certain Association Group, Policies of Accident and Sickness Insurance; Waivers

27-8-5-2.6. Repealed

27-8-5-2.7. Individual Policy of Accident and Sickness Insurance; Waiver of Coverage

27-8-5-3. Required Provisions; Statutory Option Provisions; Inapplicable or Inconsistent Provisions; Order of Provisions; Third Party Ownership; Requirements of Other Jurisdictions; Filing Procedure

27-8-5-4. Effect of Other Policy Provisions or Policy Conflicting With Chapter

27-8-5-5. Application; Attaching Copy to Policy; Furnishing Copy to Insured; Alterations; Effect of False Statements

27-8-5-6. Defenses of Insurer; Acts Not Constituting Waiver

27-8-5-7. Acceptance of Premium for Period Beyond Termination Date; Effect; Misstatement of Age

27-8-5-8. Exemption of Accident and Sickness Coverage Incidental to Designated Other Forms of Insurance

27-8-5-9. Exemption of Certain Individual Policies

27-8-5-10. Repealed

27-8-5-11. Franchise Plan; Accident and Sickness Insurance; Definitions, Limitations, Requirements, and Standards

27-8-5-12. Supplementary Character of Chapter

27-8-5-13. Repeal of 1935 Act

27-8-5-14. Exception of Fraternal Benefit Associations

27-8-5-15. Blanket Accident and Sickness Insurance; Qualification of Groups; Policy Provisions; Payment of Benefits

27-8-5-15.5. Inpatient Services for Treatment of Mental Illness or Substance Abuse

27-8-5-15.6. Treatment Limitations or Financial Requirements on Coverage of Services for Mental Illness

27-8-5-15.7. Exemption of Policies or Contracts From Laws Resulting in Certain Annual Premium Increases

27-8-5-15.8. "Treatment of a Mental Illness or Substance Abuse"; "Act"; "Nonqualitative Treatment Limitations"; Insurer Reporting and Analysis Requirements

27-8-5-16. Policy of Group Accident and Sickness Insurance; Requirements

27-8-5-16.3. "Small Employer"; Implementation of Program for Joint Purchase of Health Insurance; Rules

27-8-5-16.5. Conditions for Issuance of Certificate to Resident of Indiana Under Group Policy Delivered or Issued in Another State

27-8-5-17. Exceptions; Discretionary Groups; Group Accident and Sickness Insurance

27-8-5-18. Extension to Family Members or Dependents; Premiums; Exclusions; Group Accident and Sickness Insurance

27-8-5-19. Contents; Group Accident and Sickness Insurance

27-8-5-19.2. Repealed

27-8-5-19.3. Association and Discretionary Group Policies of Accident and Sickness Insurance; Waiver of Coverage

27-8-5-20. Notice of Right to Return Policy

27-8-5-21. Adopted Children

27-8-5-22. Refund of Unused Premiums

27-8-5-23. Statute or Rule Mandating Particular Types of Health Care Coverage; Applications to Insurer

27-8-5-24. Insured Issued New Policy Within Year After Cancellation or Nonrenewal; Mandatory Coverage

27-8-5-25. Maternity Benefits; Replacement of Discontinued Policy; Prohibition on Preexisting Condition Limitation or Exclusion of Coverage

27-8-5-26. Post-Mastectomy Coverage

27-8-5-27. Dental Care Provisions Required

27-8-5-28. Coverage of Child to 26 Years of Age

27-8-5-29. Health Plans Offered Through Health Benefit Exchange

27-8-5-30. Step Therapy Protocol

27-8-5-31. Repealed

27-8-5-31.5. Insurer Removing Prescription Drug From Formulary or Changing Cost Sharing; Written Notice and Appeal Process