514F.7 Use of step therapy protocols. 1. Definitions. For the purposes of this section:a. 'Authorized representative' means the same as defined in section 514J.102.b. 'Clinical practice guidelines' means a systematically developed statement to assist health care professionals and covered persons in making decisions about appropriate healthcare for specific clinical circumstances and conditions. c. 'Clinical review criteria' means the same as defined in section 514J.102.d. 'Covered person' means the same as defined in section 514J.102.e. 'Health benefit plan' means the same as defined in section 514J.102.f. 'Health care professional' means the same as defined in section 514J.102. g. 'Health care services' means the same as defined in section 514J.102.h. 'Health carrier' means an entity subject to the insurance laws and regulations of this state, or subject to the jurisdiction of the commissioner, including an insurance companyoffering sickness and accident plans, a health maintenance organization, a nonprofit healthservice corporation, a plan established pursuant to chapter 509A for public employees, or anyother entity providing a plan of health insurance, health care benefits, or rganization, a nonprofit healthservice corporation, a plan established pursuant to chapter 509A for public employees, or anyother entity providing a plan of health insurance, health care benefits, or health care services.'Health carrier' does not include a managed care organization as defined in 441 IAC 73.1when the managed care organization is acting pursuant to a contract with the department ofhealth and human services to provide services to Medicaid recipients. i. 'Pharmaceutical sample' means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug. j. 'Step therapy override exception' means a step therapy protocol should be overridden in favor of coverage of the prescription drug selected by a health care professional withinthe applicable time frames and in compliance with the requirements specified in section505.26, subsection 7, for a request for prior authorization of prescription drug benefits. Thisdetermination is based on a review of the covered person’s or health care professional’srequest for an override, along with supporting rationale and documentation. k. prescription drug benefits. Thisdetermination is based on a review of the covered person’s or health care professional’srequest for an override, along with supporting rationale and documentation. k. 'Step therapy protocol' means a protocol or program that establishes a specific sequence in which prescription drugs for a specified medical condition and medicallyappropriate for a particular covered person are covered under a pharmacy or medical benefitby a health carrier, a health benefit plan, or a utilization review organization, includingself-administered drugs and drugs administered by a health care professional. l. 'Utilization review' means a program or process by which an evaluation is made of the necessity, appropriateness, and efficiency of the use of health care services, procedures,or facilities given or proposed to be given to an individual. Such evaluation does not applyto requests by an individual or provider for a clarification, guarantee, or statement of anindividual’s health insurance coverage or benefits provided under a health benefit plan, nor toclaims adjudication. ests by an individual or provider for a clarification, guarantee, or statement of anindividual’s health insurance coverage or benefits provided under a health benefit plan, nor toclaims adjudication. Unless it is specifically stated, verification of benefits, preauthorization,or a prospective or concurrent utilization review program or process shall not be construed asa guarantee or statement of insurance coverage or benefits for any individual under a healthbenefit plan. m. 'Utilization review organization' means an entity that performs utilization review, other than a health carrier performing utilization review for its own health benefit plans. 2. Establishment of step therapy protocols. A health carrier, health benefit plan, or utilization review organization shall consider available recognized evidence-based andpeer-reviewed clinical practice guidelines when establishing a step therapy protocol. Uponwritten request of a covered person, a health carrier, health benefit plan, or utilization revieworganization shall provide any clinical review criteria applicable to a specific prescriptiondrug covered by the health carrier, health benefit plan, or utilization review plan, or utilization revieworganization shall provide any clinical review criteria applicable to a specific prescriptiondrug covered by the health carrier, health benefit plan, or utilization review organization. 3. Step therapy override exceptions process transparency.a. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by a health carrier, health benefit plan, or utilization review organizationthrough the use of a step therapy protocol, the covered person and the prescribing health careprofessional shall have access to a clear, readily accessible, and convenient process to requesta step therapy override exception. A health carrier, health benefit plan, or utilization review Sat Dec 23 00:45:35 2023 Iowa Code 2024, Section 514F.7 (12, 2) §514F.7, UTILIZATION AND COST CONTROL 2 organization may use its existing medical exceptions process to satisfy this requirement. Theprocess used shall be easily accessible on the internet site of the health carrier, health benefitplan, or utilization review organization. b. A step therapy override exception shall be approved by a health carrier, health benefit plan, or utilization review e of the health carrier, health benefitplan, or utilization review organization. b. A step therapy override exception shall be approved by a health carrier, health benefit plan, or utilization review organization if any of the following circumstances apply: (1) The prescription drug required under the step therapy protocol is contraindicated pursuant to the drug manufacturer’s prescribing information for the drug or, due to adocumented adverse event with a previous use or a documented medical condition, includinga comorbid condition, is likely to do any of the following: (a) Cause an adverse reaction to a covered person.(b) Decrease the ability of a covered person to achieve or maintain reasonable functional ability in performing daily activities. (c) Cause physical or mental harm to a covered person.(2) The prescription drug required under the step therapy protocol is expected to be ineffective based on the known clinical characteristics of the covered person, such as thecovered person’s adherence to or compliance with the covered person’s individual plan ofcare, and any of the following: (a) The known characteristics of the prescription drug regimen as described in peer-reviewed n’s adherence to or compliance with the covered person’s individual plan ofcare, and any of the following: (a) The known characteristics of the prescription drug regimen as described in peer-reviewed literature or in the manufacturer’s prescribing information for the drug. (b) The health care professional’s medical judgment based on clinical practice guidelines or peer-reviewed journals. (c) The covered person’s documented experience with the prescription drug regimen.(3) The covered person has had a trial of a therapeutically equivalent dose of the prescription drug under the step therapy protocol while under the covered person’s currentor previous health benefit plan for a period of time to allow for a positive treatmentoutcome, and such prescription drug was discontinued by the covered person’s health careprofessional due to lack of effectiveness. (4) The covered person is currently receiving a positive therapeutic outcome on a prescription drug selected by the covered person’s health care professional for the medicalcondition under consideration while under the covered person’s current or previoushealth benefit plan. on a prescription drug selected by the covered person’s health care professional for the medicalcondition under consideration while under the covered person’s current or previoushealth benefit plan. This subparagraph shall not be construed to encourage the use of apharmaceutical sample for the sole purpose of meeting the requirements for a step therapyoverride exception. c. Upon approval of a step therapy override exception, the health carrier, health benefit plan, or utilization review organization shall authorize coverage for the prescription drugselected by the covered person’s prescribing health care professional if the prescription drugis a covered prescription drug under the covered person’s health benefit plan. d. A health carrier, health benefit plan, or utilization review organization shall make a determination to approve or deny a request for a step therapy override exception within theapplicable time frames and in compliance with the requirements specified in section 505.26,subsection 7, for a request for prior authorization of prescription drug benefits. e. If a request for a step therapy override exception is denied, the health carrier, health benefit plan, or 505.26,subsection 7, for a request for prior authorization of prescription drug benefits. e. If a request for a step therapy override exception is denied, the health carrier, health benefit plan, or utilization review organization shall provide the covered person orthe covered person’s authorized representative and the patient’s prescribing health careprofessional with the reason for the denial and information regarding the procedure torequest external review of the denial pursuant to chapter 514J. Any denial of a request for astep therapy override exception that is upheld on appeal shall be considered a final adversedetermination for purposes of chapter 514J and is eligible for a request for external review bya covered person or the covered person’s authorized representative pursuant to chapter 514J. 4. Limitations. This section shall not be construed to do either of the following:a. Prevent a health carrier, health benefit plan, or utilization review organization from requiring a covered person to try a prescription drug with the same generic name anddemonstrated bioavailability or a biological product that is an interchangeable biologicalproduct pursuant to section 155A.32 a covered person to try a prescription drug with the same generic name anddemonstrated bioavailability or a biological product that is an interchangeable biologicalproduct pursuant to section 155A.32 prior to providing coverage for the equivalent brandedprescription drug. Sat Dec 23 00:45:35 2023 Iowa Code 2024, Section 514F.7 (12, 2) b. Prevent a health care professional from prescribing a prescription drug that is determined to be medically appropriate. 2017 Acts, ch 124, §1, 2; 2017 Acts, ch 148, §103; 2023 Acts, ch 19, §1203Subsection 1, paragraph h amended Sat Dec 23 00:45:35 2023 Iowa Code 2024, Section 514F.7 (12, 2)
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