Senate File 2159 S-5123 Amend Senate File 2159 as follows: 1 1. By striking everything after the enacting clause and 2 inserting: 3 < Section 1. NEW SECTION . 514C.36 Biomarker testing —— 4 coverage. 5 1. As used in this section, unless the context otherwise 6 requires: 7 a. “Biomarker” means a characteristic that is objectively 8 measured and evaluated as an indicator of normal biological 9 processes, pathogenic processes, or pharmacologic responses to 10 a specific therapeutic intervention, including but not limited 11 to genetic mutations or protein expression. 12 b. “Biomarker testing” means the analysis of an individual’s 13 tissue, blood, or other biospecimen for the presence of a 14 biomarker, including but not limited to single-analyte tests, 15 multiplex panel tests, or whole genome sequencing. 16 c. “Clinical utility” means sufficient medical and 17 scientific evidence indicating the use of a specific biomarker 18 test will provide meaningful information that will affect 19 treatment decisions and improve a covered person’s outcome. 20 d. “Consensus statement” means a statement developed by 21 an independent, multidisciplinary panel of experts, none of 22 whom have a conflict of interest, who utilize a transparent 23 methodology and reporting structure. A consensus statement 24 concerns specific clinical circumstances and is based on the 25 best available evidence for the purpose of optimizing the 26 outcomes of clinical care. 27 e. “Covered person” means a policyholder, subscriber, or 28 other person participating in a policy, contract, or plan that 29 provides for third-party payment or prepayment of health or 30 medical expenses. 31 f. “Health care professional” means the same as defined in 32 section 514J.102. 33 g. “Local coverage determinations” means the same as defined 34 in section 1869(f)(2)(B) of the federal Social Security Act. 35 -1- SF 2159.4032 (1) 90 (amending this SF 2159 to CONFORM to HF 2668) nls/ko 1/ 4 #1.

h. “National coverage determinations” means the same as 1 defined in section 1869(f)(1)(B) of the federal Social Security 2 Act. 3 i. “Nationally recognized clinical practice guidelines” 4 means evidence-based clinical practice guidelines developed by 5 independent organizations or medical professional societies, 6 none of which have a conflict of interest, that utilize a 7 transparent methodology and reporting structure. Clinical 8 practice guidelines establish standards of care informed 9 by a systematic review of evidence and assessment of the 10 costs and benefits of alternative care options and include 11 recommendations intended to optimize patient care. 12 2. Notwithstanding the uniformity of treatment requirements 13 of section 514C.6, a policy, contract, or plan providing for 14 third-party payment or prepayment of medical expenses shall 15 provide coverage for biomarker testing for the purposes of 16 diagnosing, treating, appropriately managing, or monitoring a 17 disease or condition in a covered person when the biomarker 18 testing has demonstrated clinical utility, including but not 19 limited to any of the following: 20 a. Labeled indications for a test approved or cleared by 21 the United States food and drug administration or indicated 22 tests for a drug approved by the United States food and drug 23 administration. 24 b. Centers for Medicare and Medicaid services of the 25 United States department of health and human services national 26 coverage determinations or Medicare administrative contractor 27 local coverage determinations. 28 c. Nationally recognized clinical practice guidelines and 29 consensus statements. 30 3. Coverage required under this section shall limit 31 disruptions in care, including mitigating the need for a 32 covered person to undergo multiple biopsies or to provide 33 multiple biospecimen samples. 34 4. A covered person and the covered person’s health care 35 -2- SF 2159.4032 (1) 90 (amending this SF 2159 to CONFORM to HF 2668) nls/ko 2/ 4

professional shall have access to a clear and convenient 1 process available on the health carrier’s internet site to 2 request an exception to coverage provided under this section. 3 5. a. This section applies to the following classes of 4 third-party payment provider policies, contracts, or plans 5 delivered, issued for delivery, continued, or renewed in this 6 state on or after January 1, 2025: 7 (1) Individual or group accident and sickness insurance 8 providing coverage on an expense-incurred basis. 9 (2) An individual or group hospital or medical service 10 contract issued pursuant to chapter 509, 514, or 514A. 11 (3) An individual or group health maintenance organization 12 contract regulated under chapter 514B. 13 (4) A plan established pursuant to chapter 509A for public 14 employees. 15 b. This section shall apply to all of the following: 16 (1) The medical assistance program under chapter 249A. 17 (2) The healthy and well kids in Iowa (Hawki) program under 18 chapter 514I. 19 (3) A managed care organization acting pursuant to a 20 contract with the department of health and human services under 21 chapter 249A, or with the healthy and well kids in Iowa (Hawki) 22 program under chapter 514I. 23 c. This section shall not apply to accident-only, 24 specified disease, short-term hospital or medical, hospital 25 confinement indemnity, credit, dental, vision, Medicare 26 supplement, long-term care, basic hospital and medical-surgical 27 expense coverage as defined by the commissioner, disability 28 income insurance coverage, coverage issued as a supplement 29 to liability insurance, workers’ compensation or similar 30 insurance, or automobile medical payment insurance. 31 6. The commissioner of insurance may adopt rules pursuant to 32 chapter 17A to administer this section. 33 Sec. 2. DEPARTMENT OF HEALTH AND HUMAN SERVICES —— REQUIRED 34 REPORT. Before November 1, 2025, the department of health 35 -3- SF 2159.4032 (1) 90 (amending this SF 2159 to CONFORM to HF 2668) nls/ko 3/ 4

and human services shall report the number of biomarker tests 1 provided during fiscal year 2025, and the resulting cost of 2 providing the biomarker tests during fiscal year 2025, to 3 individuals pursuant to this Act that are covered by the 4 medical assistance program under chapter 249A and the healthy 5 and well kids in Iowa (Hawki) program under chapter 514I. > 6 ______________________________ WAYLON BROWN -4- SF 2159.4032 (1) 90 (amending this SF 2159 to CONFORM to HF 2668) nls/ko 4/ 4