S.F. 2159 Section 1. NEW SECTION . 514C.36 Biomarker testing —— 1 coverage. 2 1. As used in this section, unless the context otherwise 3 requires: 4 a. “Biomarker” means a characteristic that is objectively 5 measured and evaluated as an indicator of normal biological 6 processes, pathogenic processes, or pharmacologic responses to 7 a specific therapeutic intervention, including but not limited 8 to genetic mutations or protein expression. 9 b. “Biomarker testing” means the analysis of an individual’s 10 tissue, blood, or other biospecimen for the presence of a 11 biomarker, including but not limited to single-analyte tests, 12 multiplex panel tests, or whole genome sequencing. 13 c. “Clinical utility” means a biomarker test result 14 provides information used in the formulation of a treatment or 15 monitoring strategy that informs a covered person’s outcomes 16 and impacts clinical decisions. The most appropriate biomarker 17 test may include both information that is actionable and 18 information that cannot be immediately used in the formulation 19 of a clinical decision. 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- LSB 5095SV (2) 90 nls/ko 1/ 4

S.F. 2159 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 diagnosis, treatment, appropriate management, or ongoing 17 monitoring of a covered person’s disease or condition when the 18 test provides clinical utility as demonstrated by medical and 19 scientific evidence, including but not limited to any of the 20 following: 21 a. Labeled indications for a test approved or cleared by 22 the United States food and drug administration or indicated 23 tests for a drug approved by the United States food and drug 24 administration. 25 b. Centers for Medicare and Medicaid services of the 26 United States department of health and human services national 27 coverage determinations or Medicare administrative contractor 28 local coverage determinations. 29 c. Nationally recognized clinical practice guidelines and 30 consensus statements. 31 3. Coverage required under this section shall limit 32 disruptions in care, including mitigating the need for a 33 covered person to undergo multiple biopsies or to provide 34 multiple biospecimen samples. 35 -2- LSB 5095SV (2) 90 nls/ko 2/ 4

S.F. 2159 4. A covered person and the covered person’s health care 1 professional shall have access to a clear and convenient 2 process available on the health carrier’s internet site to 3 request an exception to coverage provided under this section. 4 5. a. This section applies to the following classes of 5 third-party payment provider policies, contracts, or plans 6 delivered, issued for delivery, continued, or renewed in this 7 state on or after January 1, 2025: 8 (1) Individual or group accident and sickness insurance 9 providing coverage on an expense-incurred basis. 10 (2) An individual or group hospital or medical service 11 contract issued pursuant to chapter 509, 514, or 514A. 12 (3) An individual or group health maintenance organization 13 contract regulated under chapter 514B. 14 (4) A plan established pursuant to chapter 509A for public 15 employees. 16 b. This section shall apply to all of the following: 17 (1) The medical assistance program under chapter 249A. 18 (2) The healthy and well kids in Iowa (Hawki) program under 19 chapter 514I. 20 (3) A managed care organization acting pursuant to a 21 contract with the department of health and human services under 22 chapter 249A, or with the healthy and well kids in Iowa (Hawki) 23 program under chapter 514I. 24 c. This section shall not apply to accident-only, 25 specified disease, short-term hospital or medical, hospital 26 confinement indemnity, credit, dental, vision, Medicare 27 supplement, long-term care, basic hospital and medical-surgical 28 expense coverage as defined by the commissioner, disability 29 income insurance coverage, coverage issued as a supplement 30 to liability insurance, workers’ compensation or similar 31 insurance, or automobile medical payment insurance. 32 6. The commissioner of insurance shall adopt rules pursuant 33 to chapter 17A to administer this section. 34 EXPLANATION 35 -3- LSB 5095SV (2) 90 nls/ko 3/ 4

S.F. 2159 The inclusion of this explanation does not constitute agreement with 1 the explanation’s substance by the members of the general assembly. 2 This bill relates to health insurance coverage for biomarker 3 testing. 4 The bill defines “biomarker testing” as an analysis of 5 an individual’s tissue, blood, or other biospecimen for the 6 presence of a biomarker. “Biomarker” is also defined in the 7 bill. 8 The bill requires a health carrier that offers individual, 9 group, or small group contracts, policies, or plans in this 10 state that provide for third-party payment or prepayment of 11 health or medical expenses to offer coverage for biomarker 12 testing for a covered person when the test provides clinical 13 utility as demonstrated by medical and scientific evidence 14 as detailed in the bill. “Clinical utility” is defined in 15 the bill.Coverage shall be provided in a manner which limits 16 disruptions in a person’s care. The bill requires a health 17 carrier to provide a process on its internet site for a person 18 and the person’s health care professional to seek an exception 19 to coverage required under the bill. 20 The bill applies to third-party payment provider contracts, 21 policies, or plans delivered, issued for delivery, continued, 22 or renewed in this state on or after January 1, 2025, by the 23 third-party payment providers enumerated in the bill. The bill 24 specifies the types of specialized health-related insurance 25 which are not subject to the bill’s coverage requirements. 26 The bill applies to the medical assistance program 27 under Code chapter 249A, the healthy and well kids in Iowa 28 (Hawki) program under Code chapter 514I, and a managed care 29 organization acting pursuant to a contract with the department 30 of health and human services to administer either the medical 31 assistance program or the Hawki program. 32 The commissioner of insurance is required to adopt rules to 33 administer the bill. 34 -4- LSB 5095SV (2) 90 nls/ko 4/ 4