House File 233 H-1239 Amend the amendment, H-1235, to House File 233, as follows: 1 1. Page 1, by striking lines 2 through 26 and inserting: 2 < ___. By striking everything after the enacting clause and 3 inserting: 4 Section 1. NEW SECTION . 514F.7 Use of step therapy 5 protocols. 6 1. Definitions. For the purposes of this section: 7 a. “Authorized representative” means the same as defined in 8 section 514J.102. 9 b. “Clinical practice guidelines” means a systematically 10 developed statement to assist health care professionals and 11 covered persons in making decisions about appropriate health 12 care for specific clinical circumstances and conditions. 13 c. “Clinical review criteria” means the same as defined in 14 section 514J.102. 15 d. “Covered person” means the same as defined in section 16 514J.102. 17 e. “Health benefit plan” means the same as defined in 18 section 514J.102. 19 f. “Health care professional” means the same as defined in 20 section 514J.102. 21 g. “Health care services” means the same as defined in 22 section 514J.102. 23 h. “Health carrier” means an entity subject to the 24 insurance laws and regulations of this state, or subject 25 to the jurisdiction of the commissioner, including an 26 insurance company offering sickness and accident plans, a 27 health maintenance organization, a nonprofit health service 28 corporation, a plan established pursuant to chapter 509A 29 for public employees, or any other entity providing a plan 30 of health insurance, health care benefits, or health care 31 services. “Health carrier” includes an organized delivery 32 system. “Health carrier” does not include a managed care 33 organization as defined in 441 IAC 73.1 when the managed care 34 organization is acting pursuant to a contract with the Iowa 35 -1- H1235.1736 (4) 87 av/nh 1/ 6 #1.

department of human services to provide services to Medicaid 1 recipients. 2 i. “Pharmaceutical sample” means a unit of a prescription 3 drug that is not intended to be sold and is intended to promote 4 the sale of the drug. 5 j. “Step therapy override exception” means a step therapy 6 protocol should be overridden in favor of coverage of the 7 prescription drug selected by a health care professional 8 within the applicable time frames and in compliance with the 9 requirements specified in section 505.26, subsection 7, for a 10 request for prior authorization of prescription drug benefits. 11 This determination is based on a review of the covered person’s 12 or health care professional’s request for an override, along 13 with supporting rationale and documentation. 14 k. “Step therapy protocol” means a protocol or program that 15 establishes a specific sequence in which prescription drugs for 16 a specified medical condition and medically appropriate for 17 a particular covered person are covered under a pharmacy or 18 medical benefit by a health carrier, a health benefit plan, or 19 a utilization review organization, including self-administered 20 drugs and drugs administered by a health care professional. 21 l. “Utilization review” means a program or process by which 22 an evaluation is made of the necessity, appropriateness, and 23 efficiency of the use of health care services, procedures, or 24 facilities given or proposed to be given to an individual. 25 Such evaluation does not apply to requests by an individual or 26 provider for a clarification, guarantee, or statement of an 27 individual’s health insurance coverage or benefits provided 28 under a health benefit plan, nor to claims adjudication. 29 Unless it is specifically stated, verification of benefits, 30 preauthorization, or a prospective or concurrent utilization 31 review program or process shall not be construed as a guarantee 32 or statement of insurance coverage or benefits for any 33 individual under a health benefit plan. 34 m. “Utilization review organization” means an entity that 35 -2- H1235.1736 (4) 87 av/nh 2/ 6

performs utilization review, other than a health carrier 1 performing utilization review for its own health benefit plans. 2 2. Establishment of step therapy protocols. A health 3 carrier, health benefit plan, or utilization review 4 organization shall consider available recognized evidence-based 5 and peer-reviewed clinical practice guidelines when 6 establishing a step therapy protocol. Upon written request 7 of a covered person, a health carrier, health benefit plan, 8 or utilization review organization shall provide any clinical 9 review criteria applicable to a specific prescription drug 10 covered by the health carrier, health benefit plan, or 11 utilization review organization. 12 3. Step therapy override exceptions process transparency. 13 a. When coverage of a prescription drug for the 14 treatment of any medical condition is restricted for use 15 by a health carrier, health benefit plan, or utilization 16 review organization through the use of a step therapy 17 protocol, the covered person and the prescribing health 18 care professional shall have access to a clear, readily 19 accessible, and convenient process to request a step therapy 20 override exception. A health carrier, health benefit plan, or 21 utilization review organization may use its existing medical 22 exceptions process to satisfy this requirement. The process 23 used shall be easily accessible on the internet site of the 24 health carrier, health benefit plan, or utilization review 25 organization. 26 b. A step therapy override exception shall be approved by 27 a health carrier, health benefit plan, or utilization review 28 organization if any of the following circumstances apply: 29 (1) The prescription drug required under the step therapy 30 protocol is contraindicated pursuant to the drug manufacturer’s 31 prescribing information for the drug or, due to a documented 32 adverse event with a previous use or a documented medical 33 condition, including a comorbid condition, is likely to do any 34 of the following: 35 -3- H1235.1736 (4) 87 av/nh 3/ 6

(a) Cause an adverse reaction to a covered person. 1 (b) Decrease the ability of a covered person to achieve 2 or maintain reasonable functional ability in performing daily 3 activities. 4 (c) Cause physical or mental harm to a covered person. 5 (2) The prescription drug required under the step therapy 6 protocol is expected to be ineffective based on the known 7 clinical characteristics of the covered person, such as the 8 covered person’s adherence to or compliance with the covered 9 person’s individual plan of care, and any of the following: 10 (a) The known characteristics of the prescription drug 11 regimen as described in peer-reviewed literature or in the 12 manufacturer’s prescribing information for the drug. 13 (b) The health care professional’s medical judgment based 14 on clinical practice guidelines or peer-reviewed journals. 15 (c) The covered person’s documented experience with the 16 prescription drug regimen. 17 (3) The covered person has had a trial of a therapeutically 18 equivalent dose of the prescription drug under the step 19 therapy protocol while under the covered person’s current or 20 previous health benefit plan for a period of time to allow for 21 a positive treatment outcome or of another prescription drug 22 in the same pharmacologic class or with the same mechanism 23 of action, and such prescription drug was discontinued by 24 the covered person’s health care professional due to lack of 25 effectiveness. 26 (4) The covered person is currently receiving a positive 27 therapeutic outcome on a prescription drug selected by the 28 covered person’s health care professional for the medical 29 condition under consideration while under the covered person’s 30 current or previous health benefit plan. This subparagraph 31 shall not be construed to encourage the use of a pharmaceutical 32 sample for the sole purpose of meeting the requirements for a 33 step therapy override exception. 34 c. Upon approval of a step therapy override exception, the 35 -4- H1235.1736 (4) 87 av/nh 4/ 6

health carrier, health benefit plan, or utilization review 1 organization shall authorize coverage for the prescription 2 drug selected by the covered person’s prescribing health care 3 professional if the prescription drug is a covered prescription 4 drug under the covered person’s health benefit plan. 5 d. A health carrier, health benefit plan, or utilization 6 review organization shall make a determination to approve or 7 deny a request for a step therapy override exception within the 8 applicable time frames and in compliance with the requirements 9 specified in section 505.26, subsection 7, for a request for 10 prior authorization of prescription drug benefits. 11 e. If a request for a step therapy override exception is 12 denied, the health carrier, health benefit plan, or utilization 13 review organization shall provide the covered person or the 14 covered person’s authorized representative and the patient’s 15 prescribing health care professional with the reason for the 16 denial and information regarding the procedure to request 17 external review of the denial pursuant to chapter 514J. Any 18 denial of a request for a step therapy override exception 19 that is upheld on appeal shall be considered a final adverse 20 determination for purposes of chapter 514J and is eligible 21 for a request for external review by a covered person or the 22 covered person’s authorized representative pursuant to chapter 23 514J. 24 4. Limitations. This section shall not be construed to do 25 either of the following: 26 a. Prevent a health carrier, health benefit plan, or 27 utilization review organization from requiring a covered 28 person to try a prescription drug with the same generic name 29 and demonstrated bioavailability or a biological product that 30 is an interchangeable biological product pursuant to section 31 155A.32 prior to providing coverage for the equivalent branded 32 prescription drug. 33 b. Prevent a health care professional from prescribing 34 a prescription drug that is determined to be medically 35 -5- H1235.1736 (4) 87 av/nh 5/ 6