HB 8 — Require health plan and Medicaid coverage of biomarker testing

76104 (3) Ongoing"Nationally monitoringrecognized clinical practice guidelines" 105 are evidence-based clinical practice guidelines establishing 106 standards of care informed by a diseasesystematic review and assessment 107 of benefits and risks of alternative care options and include 108 recommendations intended to optimize patient care, developed by 109 independent organizations or condition.medical professional societies 110 utilizing a transparent methodology and reporting structure and 111 with a conflict of interest policy.

77112 (C)(B) The medicaid program shall cover biomarker testingtesting, 78113 orderedsubject andto deemed medically necessary by the qualified treating 79 health care provider working within the provider's scope of 80 practice for the purposes included in division (B)(C) of this 81section, sectionfor whenany the test is supported by medical or scientific 82 evidence, as defined by section 3922.01 of the Revised114 Code,following 83purposes: including at least one of the following:

84115 (1) LabeledDiagnosis; indications for a United States food and drug 85 administration approved or cleared test;

86116 (2) IndicatedTreatment testsand forappropriate amanagement drugof approveda bydisease theor United117 87condition; States food and drug administration;

88118 (3) WarningsOngoing andmonitoring precautionsof fora Uniteddisease Statesor foodcondition. and 89 drug administration approved drug labels;

90119 (4)(C) NationalThe coveragemedicaid determinationsprogram madeshall cover biomarker testing 120 ordered and deemed medically necessary by a qualified treating 121 health care provider working within the Unitedprovider's 91scope Statesof centers122 practice for medicarethe andpurposes medicaidincluded services;in division (B) of this 123 section when the test is supported by medical or scientific 124 evidence, as defined by section 3922.01 of the Revised Code, 125 including at least one of the following:

92126 (5)(1) MedicareLabeled administrativeindications contractorfor locala coverageUnited 93States determinations;food and drug 127 administration approved or cleared test;

94128 (6)(2) NationallyIndicated recognizedtests clinicalfor practicea guidelines;drug approved by the United 129 Am.

95H. (7) Nationally recognized and peer reviewed studies 96 indicating that the test materially improves health outcomes.

97 (D) The Medicaid program shall ensure coverage as required 98 in division (B) of this section in a manner that limits 99 disruptions in care, including the need for multiple biopsies or 100 biospecimen samples.

101 H.

8 Page 56 As IntroducedReported (E)by Anythe appealHouse ofHealth aCommittee biomarkerStates testingfood coverageand policydrug 102administration; shall be handled in accordance with section 5160.31 of the 103 Revised Code.

The130 appeal(3) processWarnings shalland beprecautions madefor readilyUnited 104States accessiblefood to all participating providers and recipients131 indrug 105administration writingapproved anddrug online.labels;

106132 (F)(4) NothingNational incoverage thisdeterminations sectionmade shallby bethe construedUnited to133 requireStates 107centers coveragefor ofmedicare biomarkerand testingmedicaid forservices; screening purposes.

108134 Section(5) 2.Medicare administrative contractor local coverage 135 determinations;

It136 is(6) theNationally intentrecognized ofclinical thepractice Generalguidelines; Assembly to 109 ensure coverage for appropriate biomarker testing supported by 110 medical or scientific evidence, as defined by section 3922.01 of 111 the Revised Code, with the goal of producing long-term 112 healthcare cost savings and improving health outcomes for 113 Ohioans covered under this act.

The137 General(7) AssemblyNationally doesrecognized not 114 intend to create a landscape which allows manufacturers and 115peer administratorsreviewed ofstudies biomarker138 testsindicating tothat substantially increase 116 pricing for existing and new biomarker tests as a result of the 117test coveragematerially requirementsimproves for certain health insuranceoutcomes. markets under 118 this act.

119139 (D) If there are multiple available biomarker tests that 140 offer comparable information, include all needed biomarkers, and 141 are supported by medical or scientific evidence as required by 142 division (C) of this section, the medicaid program shall cover 143 at least one such test at the appropriate scope, duration, and 144 frequency for the purposes described in division (B) of this 145 section.

A provider ordering the test may request a coverage 146 exception for any reason, including time necessary to analyze a 147 sample.

148 (E) The Medicaid program shall ensure coverage as required 149 in division (B) of this section in a manner that limits 150 disruptions in care, including the need for multiple biopsies or 151 biospecimen samples.

152 (F) Any appeal of a biomarker testing coverage policy 153 shall be handled in accordance with section 5160.31 of the 154 Revised Code.

The appeal process shall be made readily 155 accessible to all participating providers and recipients in 156 writing and online.

157 Am.

H.

B.

No.

8 Page 7 As Reported by the House Health Committee (G) Nothing in this section shall be construed to require 158 coverage of biomarker testing for screening purposes.

159 (G)(1) Within ninety days of the effective date of this 160 section, again not later than February 1, 2027, and not later 161 than the first day of February of each year thereafter, the 162 medicaid director shall submit to the standing committees of 163 both the house of representatives and of the senate with primary 164 responsibility for insurance legislation a report on provider 165 reimbursement rates for biomarker testing provided under the 166 medicaid program in this state during the previous year.

167 (2) The report shall include the following statewide 168 aggregate information for both calendar year 2024 and the 169 calendar year immediately preceding the year the report is 170 submitted:

171 (a) The total number of patients who received biomarker 172 testing under the medicaid program;

173 (b) The number of prior authorization requests for 174 biomarker testing that were approved under the medicaid program;

175 (c) The number of prior authorization requests for 176 biomarker testing that were denied under the medicaid program;

177 (d) The average and median amounts billed by medicaid 178 providers per biomarker test and the average and median amounts 179 reimbursed by the medicaid program to medicaid providers for 180 biomarker testing, along with the average medicare provider 181 reimbursement for biomarker testing;

182 (e) The ten most common conditions for which or reasons 183 why biomarker testing was ordered;

184 (f) The number of patients who switched or avoided certain 185 Am.

H.

B.

No.

8 Page 8 As Reported by the House Health Committee treatments as a result of biomarker testing results;

186 (g) Cost savings as a result of covering biomarker testing 187 under the medicaid program during the applicable calendar year.

188 (3) If any of the above data is not available, the report 189 shall indicate why the data is unavailable.

190 (4) The report also shall provide recommendations on 191 future reporting and cost considerations for the committee.

192 Section 2.

It is the intent of the General Assembly to 193 ensure coverage for appropriate biomarker testing supported by 194 medical or scientific evidence, as defined by section 3922.01 of 195 the Revised Code, with the goal of producing long-term 196 healthcare cost savings and improving health outcomes for 197 Ohioans covered under this act.

The General Assembly does not 198 intend to create a landscape which allows manufacturers and 199 administrators of biomarker tests to substantially increase 200 pricing for existing and new biomarker tests as a result of the 201 coverage requirements for certain health insurance markets under 202 this act.

203