Senate File 436 S-3301 Amend Senate File 436 as follows: 1 1. By striking everything after the enacting clause and 2 inserting: 3 < Section 1. NEW SECTION . 514F.7 Use of step therapy 4 protocols. 5 1. Definitions. For the purposes of this section: 6 a. “Authorized representative” means the same as defined in 7 section 514J.102. 8 b. “Clinical practice guidelines” means a systematically 9 developed statement to assist health care professionals and 10 covered persons in making decisions about appropriate health 11 care for specific clinical circumstances and conditions. 12 c. “Clinical review criteria” means the same as defined in 13 section 514J.102. 14 d. “Covered person” means the same as defined in section 15 514J.102. 16 e. “Health benefit plan” means the same as defined in 17 section 514J.102. 18 f. “Health care professional” means the same as defined in 19 section 514J.102. 20 g. “Health care services” means the same as defined in 21 section 514J.102. 22 h. “Health carrier” means an entity subject to the 23 insurance laws and regulations of this state, or subject 24 to the jurisdiction of the commissioner, including an 25 insurance company offering sickness and accident plans, a 26 health maintenance organization, a nonprofit health service 27 corporation, a plan established pursuant to chapter 509A 28 for public employees, or any other entity providing a plan 29 of health insurance, health care benefits, or health care 30 services. “Health carrier” includes an organized delivery 31 system. “Health carrier” does not include a managed care 32 organization as defined in 441 IAC 73.1 when the managed care 33 organization is acting pursuant to a contract with the Iowa 34 department of human services to provide services to Medicaid 35 -1- SF436.2090 (1) 87 (amending this SF 436 to CONFORM to HF 233) av/nh 1/ 6 #1.

recipients. 1 i. “Pharmaceutical sample” means a unit of a prescription 2 drug that is not intended to be sold and is intended to promote 3 the sale of the drug. 4 j. “Step therapy override exception” means a step therapy 5 protocol should be overridden in favor of coverage of the 6 prescription drug selected by a health care professional 7 within the applicable time frames and in compliance with the 8 requirements specified in section 505.26, subsection 7, for a 9 request for prior authorization of prescription drug benefits. 10 This determination is based on a review of the covered person’s 11 or health care professional’s request for an override, along 12 with supporting rationale and documentation. 13 k. “Step therapy protocol” means a protocol or program that 14 establishes a specific sequence in which prescription drugs for 15 a specified medical condition and medically appropriate for 16 a particular covered person are covered under a pharmacy or 17 medical benefit by a health carrier, a health benefit plan, or 18 a utilization review organization, including self-administered 19 drugs and drugs administered by a health care professional. 20 l. “Utilization review” means a program or process by which 21 an evaluation is made of the necessity, appropriateness, and 22 efficiency of the use of health care services, procedures, or 23 facilities given or proposed to be given to an individual. 24 Such evaluation does not apply to requests by an individual or 25 provider for a clarification, guarantee, or statement of an 26 individual’s health insurance coverage or benefits provided 27 under a health benefit plan, nor to claims adjudication. 28 Unless it is specifically stated, verification of benefits, 29 preauthorization, or a prospective or concurrent utilization 30 review program or process shall not be construed as a guarantee 31 or statement of insurance coverage or benefits for any 32 individual under a health benefit plan. 33 m. “Utilization review organization” means an entity that 34 performs utilization review, other than a health carrier 35 -2- SF436.2090 (1) 87 (amending this SF 436 to CONFORM to HF 233) av/nh 2/ 6

performing utilization review for its own health benefit plans. 1 2. Establishment of step therapy protocols. A health 2 carrier, health benefit plan, or utilization review 3 organization shall consider available recognized evidence-based 4 and peer-reviewed clinical practice guidelines when 5 establishing a step therapy protocol. Upon written request 6 of a covered person, a health carrier, health benefit plan, 7 or utilization review organization shall provide any clinical 8 review criteria applicable to a specific prescription drug 9 covered by the health carrier, health benefit plan, or 10 utilization review organization. 11 3. Step therapy override exceptions process transparency. 12 a. When coverage of a prescription drug for the 13 treatment of any medical condition is restricted for use 14 by a health carrier, health benefit plan, or utilization 15 review organization through the use of a step therapy 16 protocol, the covered person and the prescribing health 17 care professional shall have access to a clear, readily 18 accessible, and convenient process to request a step therapy 19 override exception. A health carrier, health benefit plan, or 20 utilization review organization may use its existing medical 21 exceptions process to satisfy this requirement. The process 22 used shall be easily accessible on the internet site of the 23 health carrier, health benefit plan, or utilization review 24 organization. 25 b. A step therapy override exception shall be approved by 26 a health carrier, health benefit plan, or utilization review 27 organization if any of the following circumstances apply: 28 (1) The prescription drug required under the step therapy 29 protocol is contraindicated pursuant to the drug manufacturer’s 30 prescribing information for the drug or, due to a documented 31 adverse event with a previous use or a documented medical 32 condition, including a comorbid condition, is likely to do any 33 of the following: 34 (a) Cause an adverse reaction to a covered person. 35 -3- SF436.2090 (1) 87 (amending this SF 436 to CONFORM to HF 233) av/nh 3/ 6

(b) Decrease the ability of a covered person to achieve 1 or maintain reasonable functional ability in performing daily 2 activities. 3 (c) Cause physical or mental harm to a covered person. 4 (2) The prescription drug required under the step therapy 5 protocol is expected to be ineffective based on the known 6 clinical characteristics of the covered person, such as the 7 covered person’s adherence to or compliance with the covered 8 person’s individual plan of care, and any of the following: 9 (a) The known characteristics of the prescription drug 10 regimen as described in peer-reviewed literature or in the 11 manufacturer’s prescribing information for the drug. 12 (b) The health care professional’s medical judgment based 13 on clinical practice guidelines or peer-reviewed journals. 14 (c) The covered person’s documented experience with the 15 prescription drug regimen. 16 (3) The covered person has had a trial of a therapeutically 17 equivalent dose of the prescription drug under the step 18 therapy protocol while under the covered person’s current or 19 previous health benefit plan for a period of time to allow for 20 a positive treatment outcome or of another prescription drug 21 in the same pharmacologic class or with the same mechanism 22 of action, and such prescription drug was discontinued by 23 the covered person’s health care professional due to lack of 24 effectiveness. 25 (4) The covered person is currently receiving a positive 26 therapeutic outcome on a prescription drug selected by the 27 covered person’s health care professional for the medical 28 condition under consideration while under the covered person’s 29 current or previous health benefit plan. This subparagraph 30 shall not be construed to encourage the use of a pharmaceutical 31 sample for the sole purpose of meeting the requirements for a 32 step therapy override exception. 33 c. Upon approval of a step therapy override exception, the 34 health carrier, health benefit plan, or utilization review 35 -4- SF436.2090 (1) 87 (amending this SF 436 to CONFORM to HF 233) av/nh 4/ 6

organization shall authorize coverage for the prescription 1 drug selected by the covered person’s prescribing health care 2 professional if the prescription drug is a covered prescription 3 drug under the covered person’s health benefit plan. 4 d. A health carrier, health benefit plan, or utilization 5 review organization shall make a determination to approve or 6 deny a request for a step therapy override exception within the 7 applicable time frames and in compliance with the requirements 8 specified in section 505.26, subsection 7, for a request for 9 prior authorization of prescription drug benefits. 10 e. If a request for a step therapy override exception is 11 denied, the health carrier, health benefit plan, or utilization 12 review organization shall provide the covered person or the 13 covered person’s authorized representative and the patient’s 14 prescribing health care professional with the reason for the 15 denial and information regarding the procedure to request 16 external review of the denial pursuant to chapter 514J. Any 17 denial of a request for a step therapy override exception 18 that is upheld on appeal shall be considered a final adverse 19 determination for purposes of chapter 514J and is eligible 20 for a request for external review by a covered person or the 21 covered person’s authorized representative pursuant to chapter 22 514J. 23 4. Limitations. This section shall not be construed to do 24 either of the following: 25 a. Prevent a health carrier, health benefit plan, or 26 utilization review organization from requiring a covered 27 person to try a prescription drug with the same generic name 28 and demonstrated bioavailability or a biological product that 29 is an interchangeable biological product pursuant to section 30 155A.32 prior to providing coverage for the equivalent branded 31 prescription drug. 32 b. Prevent a health care professional from prescribing 33 a prescription drug that is determined to be medically 34 appropriate. 35 -5- SF436.2090 (1) 87 (amending this SF 436 to CONFORM to HF 233) av/nh 5/ 6