| 1 | | - | House File 2668 - Enrolled House File 2668 AN ACT RELATING TO INSURANCE COVERAGE FOR BIOMARKER TESTING. BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: Section 1. NEW SECTION . 514C.36 Biomarker testing coverage. 1. As used in this section, unless the context otherwise requires: a. Biomarker means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including but not limited to genetic mutations or protein expression. b. Biomarker testing means the analysis of an individuals tissue, blood, or other biospecimen for the presence of a biomarker, including but not limited to single-analyte tests, multiplex panel tests, or whole genome sequencing. c. Clinical utility means sufficient medical and scientific evidence indicating that the use of a biomarker test will provide meaningful information that affects treatment decisions and guides improvement of net health outcomes, including an improved quality of life or longer survival. d. Consensus statement means a statement developed by an independent, multidisciplinary panel of experts, none of whom have a conflict of interest, who utilize a transparent methodology and reporting structure. A consensus statement concerns specific clinical circumstances and is based on the |
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| 1 | + | House File 2668 - Introduced HOUSE FILE 2668 BY COMMITTEE ON APPROPRIATIONS (SUCCESSOR TO HF 2492) (SUCCESSOR TO HF 2157) 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 6095HZ (4) 90 nls/ko |
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| 3 | | - | House File 2668, p. 2 best available evidence for the purpose of optimizing the outcomes of clinical care. e. Covered person means a policyholder, subscriber, or other person participating in a policy, contract, or plan that provides for third-party payment or prepayment of health or medical expenses. f. Health care professional means the same as defined in section 514J.102. g. Local coverage determinations means the same as defined in section 1869(f)(2)(B) of the federal Social Security Act. h. National coverage determinations means the same as defined in section 1869(f)(1)(B) of the federal Social Security Act. i. Nationally recognized clinical practice guidelines means evidence-based clinical practice guidelines developed by independent organizations or medical professional societies, none of which have a conflict of interest, that utilize a transparent methodology and reporting structure. Clinical practice guidelines establish standards of care informed by a systematic review of evidence and assessment of the costs and benefits of alternative care options and include recommendations intended to optimize patient care. 2. Notwithstanding the uniformity of treatment requirements of section 514C.6, a policy, contract, or plan providing for third-party payment or prepayment of medical expenses shall provide coverage for biomarker testing for the purposes of diagnosing, treating, appropriately managing, or monitoring a disease or condition in a covered person when the biomarker testing has demonstrated clinical utility, including but not limited to any of the following: a. Labeled indications for a test approved or cleared by the United States food and drug administration or indicated tests for a drug approved by the United States food and drug administration. b. Centers for Medicare and Medicaid services of the United States department of health and human services national coverage determinations or Medicare administrative contractor local coverage determinations. c. Nationally recognized clinical practice guidelines and |
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| 3 | + | H.F. 2668 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 6095HZ (4) 90 nls/ko 1/ 5 |
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| 5 | | - | House File 2668, p. 3 consensus statements. 3. Coverage required under this section shall limit disruptions in care, including mitigating the need for a covered person to undergo multiple biopsies or to provide multiple biospecimen samples. 4. A covered person and the covered persons health care professional shall have access to a clear and convenient process available on the health carriers internet site to request an exception to coverage provided under this section. 5. a. This section applies to the following classes of third-party payment provider policies, contracts, or plans delivered, issued for delivery, continued, or renewed in this state on or after January 1, 2025: (1) Individual or group accident and sickness insurance providing coverage on an expense-incurred basis. (2) An individual or group hospital or medical service contract issued pursuant to chapter 509, 514, or 514A. (3) An individual or group health maintenance organization contract regulated under chapter 514B. (4) A plan established pursuant to chapter 509A for public employees. b. This section shall apply to all of the following: (1) The medical assistance program under chapter 249A. (2) The healthy and well kids in Iowa (Hawki) program under chapter 514I. (3) A managed care organization acting pursuant to a contract with the department of health and human services under chapter 249A, or with the healthy and well kids in Iowa (Hawki) program under chapter 514I. c. This section shall not apply to accident-only, specified disease, short-term hospital or medical, hospital confinement indemnity, credit, dental, vision, Medicare supplement, long-term care, basic hospital and medical-surgical expense coverage as defined by the commissioner, disability income insurance coverage, coverage issued as a supplement to liability insurance, workers compensation or similar insurance, or automobile medical payment insurance. 6. The commissioner of insurance may adopt rules pursuant to chapter 17A to administer this section. |
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| 5 | + | H.F. 2668 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 a 14 disease or condition in a covered person when the biomarker 15 testing has demonstrated clinical utility, including but not 16 limited to any 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 6095HZ (4) 90 nls/ko 2/ 5 |
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| 7 | | - | House File 2668, p. 4 Sec. 2. DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIRED REPORT. Before November 1, 2025, the department of health and human services shall report the number of biomarker tests provided during fiscal year 2025, and the resulting cost of providing the biomarker tests during fiscal year 2025, to individuals pursuant to this Act that are covered by the medical assistance program under chapter 249A and the healthy and well kids in Iowa (Hawki) program under chapter 514I. ______________________________ PAT GRASSLEY Speaker of the House ______________________________ AMY SINCLAIR President of the Senate I hereby certify that this bill originated in the House and is known as House File 2668, Ninetieth General Assembly. ______________________________ MEGHAN NELSON Chief Clerk of the House Approved _______________, 2024 ______________________________ KIM REYNOLDS Governor |
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| 7 | + | H.F. 2668 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 Sec. 2. DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIRED 31 REPORT. Before November 1, 2025, the department of health 32 and human services shall report the number of biomarker tests 33 provided during fiscal year 2025, and the resulting cost of 34 providing the biomarker tests during fiscal year 2025, to 35 -3- LSB 6095HZ (4) 90 nls/ko 3/ 5 |
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| 9 | + | H.F. 2668 individuals pursuant to this Act that are covered by the 1 medical assistance program under chapter 249A and the healthy 2 and well kids in Iowa (Hawki) program under chapter 514I. 3 EXPLANATION 4 The inclusion of this explanation does not constitute agreement with 5 the explanations substance by the members of the general assembly. 6 This bill relates to health insurance coverage for biomarker 7 testing. 8 The bill defines biomarker testing as an analysis of 9 an individuals tissue, blood, or other biospecimen for the 10 presence of a biomarker. Biomarker is also defined in the 11 bill. 12 The bill requires a health carrier that offers individual, 13 group, or small group contracts, policies, or plans in this 14 state that provide for third-party payment or prepayment of 15 health or medical expenses to offer coverage for biomarker 16 testing for purposes of diagnosing, treating, appropriately 17 managing, or monitoring a disease or condition in a covered 18 person when the test has demonstrated clinical utility as 19 detailed in the bill. Clinical utility is defined in the 20 bill. Coverage shall be provided in a manner which limits 21 disruptions in a persons care. The bill requires a health 22 carrier to provide a process on its internet site for a person 23 and the persons health care professional to seek an exception 24 to coverage required under the bill. 25 The bill applies to third-party payment provider contracts, 26 policies, or plans delivered, issued for delivery, continued, 27 or renewed in this state on or after January 1, 2025, by the 28 third-party payment providers enumerated in the bill. The bill 29 specifies the types of specialized health-related insurance 30 which are not subject to the bills coverage requirements. 31 The bill applies to the medical assistance program 32 under Code chapter 249A, the healthy and well kids in Iowa 33 (Hawki) program under Code chapter 514I, and a managed care 34 organization acting pursuant to a contract with the department 35 -4- LSB 6095HZ (4) 90 nls/ko 4/ 5 |
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| 11 | + | H.F. 2668 of health and human services to administer either the medical 1 assistance program or the Hawki program. 2 The commissioner of insurance may adopt rules to administer 3 the bill. 4 Under the bill, before November 1, 2025, the department of 5 health and human services shall report the number of biomarker 6 tests provided during fiscal year 20242025, and the resulting 7 cost of providing the biomarker tests during fiscal year 8 20242025, to individuals pursuant to the bill that are covered 9 by the medical assistance program under Code chapter 249A and 10 the Hawki program under Code chapter 514I. 11 -5- LSB 6095HZ (4) 90 nls/ko 5/ 5 |
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