House File 2157 - Introduced HOUSE FILE 2157 BY LOHSE , YOUNG , and LUNDGREN A BILL FOR An Act relating to insurance coverage for biomarker testing. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 6095YH (2) 90 nls/ns
H.F. 2157 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 individuals 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 sufficient medical and 14 scientific evidence indicating the use of a specific biomarker 15 test will provide meaningful information that will affect 16 treatment decisions and improve a covered persons outcome. 17 d. Consensus statement means a statement developed by 18 an independent, multidisciplinary panel of experts, none of 19 whom have a conflict of interest, who utilize a transparent 20 methodology and reporting structure. A consensus statement 21 concerns specific clinical circumstances and is based on the 22 best available evidence for the purpose of optimizing the 23 outcomes of clinical care. 24 e. Covered person means a policyholder, subscriber, or 25 other person participating in a policy, contract, or plan that 26 provides for third-party payment or prepayment of health or 27 medical expenses. 28 f. Health care professional means the same as defined in 29 section 514J.102. 30 g. Local coverage determinations means the same as defined 31 in section 1869(f)(2)(B) of the federal Social Security Act. 32 h. National coverage determinations means the same as 33 defined in section 1869(f)(1)(B) of the federal Social Security 34 Act. 35 -1- LSB 6095YH (2) 90 nls/ns 1/ 4
H.F. 2157 i. Nationally recognized clinical practice guidelines 1 means evidence-based clinical practice guidelines developed by 2 independent organizations or medical professional societies, 3 none of which have a conflict of interest, that utilize a 4 transparent methodology and reporting structure. Clinical 5 practice guidelines establish standards of care informed 6 by a systematic review of evidence and assessment of the 7 costs and benefits of alternative care options and include 8 recommendations intended to optimize patient care. 9 2. Notwithstanding the uniformity of treatment requirements 10 of section 514C.6, a policy, contract, or plan providing for 11 third-party payment or prepayment of medical expenses shall 12 provide coverage for biomarker testing for the purposes of 13 diagnosing, treating, appropriately managing, or monitoring 14 cancer in a covered person when the biomarker testing has 15 demonstrated clinical utility, including but not limited to any 16 of the following: 17 a. Labeled indications for a test approved or cleared by 18 the United States food and drug administration or indicated 19 tests for a drug approved by the United States food and drug 20 administration. 21 b. Centers for Medicare and Medicaid services of the 22 United States department of health and human services national 23 coverage determinations or Medicare administrative contractor 24 local coverage determinations. 25 c. Nationally recognized clinical practice guidelines and 26 consensus statements. 27 3. Coverage required under this section shall limit 28 disruptions in care, including mitigating the need for a 29 covered person to undergo multiple biopsies or to provide 30 multiple biospecimen samples. 31 4. A covered person and the covered persons health care 32 professional shall have access to a clear and convenient 33 process available on the health carriers internet site to 34 request an exception to coverage provided under this section. 35 -2- LSB 6095YH (2) 90 nls/ns 2/ 4
H.F. 2157 5. a. This section applies to the following classes of 1 third-party payment provider policies, contracts, or plans 2 delivered, issued for delivery, continued, or renewed in this 3 state on or after January 1, 2025: 4 (1) Individual or group accident and sickness insurance 5 providing coverage on an expense-incurred basis. 6 (2) An individual or group hospital or medical service 7 contract issued pursuant to chapter 509, 514, or 514A. 8 (3) An individual or group health maintenance organization 9 contract regulated under chapter 514B. 10 (4) A plan established pursuant to chapter 509A for public 11 employees. 12 b. This section shall apply to all of the following: 13 (1) The medical assistance program under chapter 249A. 14 (2) The healthy and well kids in Iowa (Hawki) program under 15 chapter 514I. 16 (3) A managed care organization acting pursuant to a 17 contract with the department of health and human services under 18 chapter 249A, or with the healthy and well kids in Iowa (Hawki) 19 program under chapter 514I. 20 c. This section shall not apply to accident-only, 21 specified disease, short-term hospital or medical, hospital 22 confinement indemnity, credit, dental, vision, Medicare 23 supplement, long-term care, basic hospital and medical-surgical 24 expense coverage as defined by the commissioner, disability 25 income insurance coverage, coverage issued as a supplement 26 to liability insurance, workers compensation or similar 27 insurance, or automobile medical payment insurance. 28 6. The commissioner of insurance may adopt rules pursuant to 29 chapter 17A to administer this section. 30 EXPLANATION 31 The inclusion of this explanation does not constitute agreement with 32 the explanations substance by the members of the general assembly. 33 This bill relates to health insurance coverage for biomarker 34 testing. 35 -3- LSB 6095YH (2) 90 nls/ns 3/ 4
H.F. 2157 The bill defines biomarker testing as an analysis of 1 an individuals tissue, blood, or other biospecimen for the 2 presence of a biomarker. Biomarker is also defined in the 3 bill. 4 The bill requires a health carrier that offers individual, 5 group, or small group contracts, policies, or plans in this 6 state that provide for third-party payment or prepayment of 7 health or medical expenses to offer coverage for biomarker 8 testing for purposes of diagnosing, treating, appropriately 9 managing, or monitoring cancer in a covered person when the 10 test has demonstrated clinical utility as detailed in the bill. 11 Clinical utility is defined in the bill. Coverage shall be 12 provided in a manner which limits disruptions in a persons 13 care. The bill requires a health carrier to provide a process 14 on its internet site for a person and the persons health care 15 professional to seek an exception to coverage required under 16 the bill. 17 The bill applies to third-party payment provider contracts, 18 policies, or plans delivered, issued for delivery, continued, 19 or renewed in this state on or after January 1, 2025, by the 20 third-party payment providers enumerated in the bill. The bill 21 specifies the types of specialized health-related insurance 22 which are not subject to the bills coverage requirements. 23 The bill applies to the medical assistance program 24 under Code chapter 249A, the healthy and well kids in Iowa 25 (Hawki) program under Code chapter 514I, and a managed care 26 organization acting pursuant to a contract with the department 27 of health and human services to administer either the medical 28 assistance program or the Hawki program. 29 The commissioner of insurance may adopt rules to administer 30 the bill. 31 -4- LSB 6095YH (2) 90 nls/ns 4/ 4