510B.1 Definitions.
As used in this chapter, unless the context otherwise requires:
1. “Commissioner” means the commissioner of insurance.
2. “Covered entity” means a nonprofit hospital or medical services corporation, health insurer, health benefit plan, or health maintenance organization; a health program administered by a department or the state in the capacity of provider of health coverage; or an employer, labor union, or other group of persons organized in the state that provides health coverage. “Covered entity” does not include a self-funded health coverage plan that is exempt from state regulation pursuant to the federal Employee Retirement Income Security Act of 1974 (ERISA), as codified at 29 U.S.C. §1001 et seq.; a plan issued for health coverage for federal employees; or a health plan that provides coverage only for accidental injury, specified disease, hospital indemnity, Medicare supplemental, disability income, or long-term care, or other limited benefit health insurance policy or contract.
3. “Covered individual” means a member, participant, enrollee, contract holder, policyholder, or beneficiary of a covered entity who is provided health coverage by the covered entity, and includes a dependent or other person provided health coverage through a policy, contract, or plan for a covered individual.
4. “Generic drug” means a chemically equivalent copy of a brand-name drug with an expired patent.
5. “Labeler” means a person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal food and drug administration pursuant to
21 C.F.R. §207.20
.
6. “Maximum reimbursement amount” means the maximum reimbursement amount for a therapeutically and pharmaceutically equivalent multiple-source prescription drug that is listed in the most recent edition of the publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations”, published by the United States food and drug administration, otherwise known as the orange book.
7. “Pharmacy” means pharmacy as defined in section 155A.3.
8. “Pharmacy benefits management” means the administration or management of prescription drug benefits provided by a covered entity under the terms and conditions of the contract between the pharmacy benefits manager and the covered entity.
9. “Pharmacy benefits manager” means a person who performs pharmacy benefits management services. “Pharmacy benefits manager” includes a person acting on behalf of a pharmacy benefits manager in a contractual or employment relationship in the performance of pharmacy benefits management services for a covered entity. “Pharmacy benefits manager” does not include a health insurer licensed in the state if the health insurer or its subsidiary is providing pharmacy benefits management services exclusively to its own insureds, or a public self-funded pool or a private single employer self-funded plan that provides such benefits or services directly to its beneficiaries.
10. “Prescription drug” means prescription drug as defined in section 155A.3.
11. “Prescription drug order” means prescription drug order as defined in section 155A.3.
2007 Acts, ch 193, §1, 9; 2014 Acts, ch 1016, §1
Referred to in §505.26
Structure Iowa Code
Chapter 510B - REGULATION OF PHARMACY BENEFITS MANAGERS
Section 510B.2 - Certification as a third-party administrator required.
Section 510B.3 - Enforcement — rules.
Section 510B.4 - Performance of duties — good faith — conflict of interest.
Section 510B.5 - Contacting covered individual — requirements.
Section 510B.6 - Dispensing of substitute prescription drug for prescribed drug.
Section 510B.7 - Duties to pharmacy network providers.
Section 510B.8 - Pricing methodology for maximum reimbursement amount.
Section 510B.9 - Submission, approval, and use of prior authorization form.