§ 514C.36 — Biomarker testing — coverage

Iowa § 514C.36

• Jurisdiction: Iowa
• Title XIII: COMMERCE
• Ch. 514C: SPECIAL HEALTH AND ACCIDENT INSURANCE COVERAGES

Text

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
toaspecifictherapeuticintervention, includingbutnotlimitedtogeneticmutationsorprotein
expression.
b. “Biomarker testing” means the analysis of an individual’s 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 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. “Nationalcoveragedeterminations”meansthesameasdefinedinsection1869(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
providecoverageforbiomarkertestingforthepurposesofdiagnosing,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
§514C.36, SPECIAL HEALTH AND ACCIDENT INSURANCE COVERAGES 34
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 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 person’s health care professional shall have access
to a clear and convenient process available on the health carrier’s internet site to request an
exception to coverage provided under this section.
5. a. Thissectionappliestothefollowingclassesofthird-partypaymentproviderpolicies,
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.