S.F. _____ 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. “Consensus statement” means a statement developed by 14 an independent, multidisciplinary panel of experts, none of 15 whom have a conflict of interest, who utilize a transparent 16 methodology and reporting structure. A consensus statement 17 concerns specific clinical circumstances and is based on the 18 best available evidence for the purpose of optimizing the 19 outcomes of clinical care. 20 d. “Covered person” means a policyholder, subscriber, or 21 other person participating in a policy, contract, or plan that 22 provides for third-party payment or prepayment of health or 23 medical expenses. 24 e. “Health care professional” means the same as defined in 25 section 514J.102. 26 f. “Local coverage determinations” means the same as defined 27 in section 1869(f)(2)(B) of the federal Social Security Act. 28 g. “National coverage determinations” means the same as 29 defined in section 1869(f)(1)(B) of the federal Social Security 30 Act. 31 h. “Nationally recognized clinical practice guidelines” 32 means evidence-based clinical practice guidelines developed by 33 independent organizations or medical professional societies, 34 none of which have a conflict of interest, that utilize a 35 -1- LSB 5095XC (2) 90 nls/ko 1/ 4

S.F. _____ transparent methodology and reporting structure. Clinical 1 practice guidelines establish standards of care informed 2 by a systematic review of evidence and assessment of the 3 costs and benefits of alternative care options and include 4 recommendations intended to optimize patient care. 5 2. Notwithstanding the uniformity of treatment requirements 6 of section 514C.6, a policy, contract, or plan providing for 7 third-party payment or prepayment of medical expenses shall 8 provide coverage for biomarker testing for the purposes of 9 diagnosis, treatment, appropriate management, or ongoing 10 monitoring of a covered person’s disease or condition when the 11 test is supported by medical and scientific evidence, including 12 but not limited to any of the following: 13 a. Labeled indications for a test approved or cleared by 14 the United States food and drug administration or indicated 15 tests for a drug approved by the United States food and drug 16 administration. 17 b. Centers for Medicare and Medicaid services of the 18 United States department of health and human services national 19 coverage determinations or Medicare administrative contractor 20 local coverage determinations. 21 c. Nationally recognized clinical practice guidelines and 22 consensus statements. 23 3. Coverage required under this section shall limit 24 disruptions in care, including mitigating the need for a 25 covered person to undergo multiple biopsies or to provide 26 multiple biospecimen samples. 27 4. A covered person and the covered person’s health care 28 professional shall have access to a clear and convenient 29 process available on the health carrier’s internet site to 30 request an exception to coverage provided under this section. 31 5. a. This section applies to the following classes of 32 third-party payment provider policies, contracts, or plans 33 delivered, issued for delivery, continued, or renewed in this 34 state on or after January 1, 2025: 35 -2- LSB 5095XC (2) 90 nls/ko 2/ 4

S.F. _____ (1) Individual or group accident and sickness insurance 1 providing coverage on an expense-incurred basis. 2 (2) An individual or group hospital or medical service 3 contract issued pursuant to chapter 509, 514, or 514A. 4 (3) An individual or group health maintenance organization 5 contract regulated under chapter 514B. 6 (4) A plan established pursuant to chapter 509A for public 7 employees. 8 b. This section shall apply to all of the following: 9 (1) The medical assistance program under chapter 249A. 10 (2) The healthy and well kids in Iowa (Hawki) program under 11 chapter 514I. 12 (3) A managed care organization acting pursuant to a 13 contract with the department of health and human services under 14 chapter 249A, or with the healthy and well kids in Iowa (Hawki) 15 program under chapter 514I. 16 c. This section shall not apply to accident-only, 17 specified disease, short-term hospital or medical, hospital 18 confinement indemnity, credit, dental, vision, Medicare 19 supplement, long-term care, basic hospital and medical-surgical 20 expense coverage as defined by the commissioner, disability 21 income insurance coverage, coverage issued as a supplement 22 to liability insurance, workers’ compensation or similar 23 insurance, or automobile medical payment insurance. 24 6. The commissioner of insurance shall adopt rules pursuant 25 to chapter 17A to administer this section. 26 EXPLANATION 27 The inclusion of this explanation does not constitute agreement with 28 the explanation’s substance by the members of the general assembly. 29 This bill relates to health insurance coverage for biomarker 30 testing. 31 The bill defines “biomarker testing” as an analysis of 32 an individual’s tissue, blood, or other biospecimen for the 33 presence of a biomarker. “Biomarker” is also defined in the 34 bill. 35 -3- LSB 5095XC (2) 90 nls/ko 3/ 4

S.F. _____ The bill requires a health carrier that offers individual, 1 group, or small group contracts, policies, or plans in this 2 state that provide for third-party payment or prepayment of 3 health or medical expenses to offer coverage for biomarker 4 testing for a covered person when the test is supported by 5 medical and scientific evidence as detailed in the bill. 6 Coverage shall be provided in a manner which limits disruptions 7 in a person’s care. The bill requires a health carrier to 8 provide a process on its internet site for a person and the 9 person’s health care professional to seek an exception to 10 coverage required under the bill. 11 The bill applies to third-party payment provider contracts, 12 policies, or plans delivered, issued for delivery, continued, 13 or renewed in this state on or after January 1, 2025, by the 14 third-party payment providers enumerated in the bill. The bill 15 specifies the types of specialized health-related insurance 16 which are not subject to the bill’s coverage requirements. 17 The bill applies to the medical assistance program 18 under Code chapter 249A, the healthy and well kids in Iowa 19 (Hawki) program under Code chapter 514I, and a managed care 20 organization acting pursuant to a contract with the department 21 of health and human services to administer either the medical 22 assistance program or the Hawki program. 23 The commissioner of insurance is required to adopt rules to 24 administer the bill. 25 -4- LSB 5095XC (2) 90 nls/ko 4/ 4