Indiana Code 12-15-5-21.5. Biomarker testing; federal approval; report
(1) normal biological processes;
Terms Used In Indiana Code 12-15-5-21.5
- Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
- United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
- Year: means a calendar year, unless otherwise expressed. See Indiana Code 1-1-4-5
(3) pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered.
The term includes gene mutations, characteristics of genes, and protein expression.
(b) As used in this section, “biomarker testing” means the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker. The term includes:
(1) single-analyte tests;
(2) multiplex panel tests;
(3) protein expression; and
(4) whole exome, whole genome, and whole transcriptome sequencing.
(c) As used in this section, “consensus statement” means a statement that is:
(1) issued by an independent, multidisciplinary panel of experts that:
(A) uses a transparent methodology and reporting structure; and
(B) has a conflict of interest policy;
(2) aimed at specific clinical circumstances;
(3) based on the best available evidence; and
(4) developed for the purpose of optimizing the outcomes of clinical care.
(d) As used in this section, “nationally recognized clinical practice guidelines” means evidence based clinical practice guidelines that:
(1) are developed by an independent organization or medical professional society that:
(A) uses a transparent methodology and reporting structure; and
(B) has a conflict of interest policy;
(2) establish standards of care informed by:
(A) a systematic review of evidence; and
(B) an assessment of the benefits and risks of alternative care options; and
(3) include recommendations intended to optimize patient care.
(e) The office shall provide, as a Medicaid program service, biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when biomarker testing is supported by medical and scientific evidence, including:
(1) labeled indications for a test approved or cleared by the United States Food and Drug Administration;
(2) indicated tests for a drug approved by the United States Food and Drug Administration;
(3) a warning or precaution on the label of a drug approved by the United States Food and Drug Administration;
(4) a national coverage determination of the Centers for Medicare and Medicaid Services (CMS);
(5) a local coverage determination of a Medicare administrative contractor; or
(6) nationally recognized clinical practice guidelines or consensus statements.
The service required by this section must be provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.
(f) Nothing in this section shall be construed to require coverage of biomarker testing for screening purposes.
(g) The office shall apply to the United States Department of Health and Human Services for approval of any waiver necessary under the federal Medicaid program for the purpose of providing biomarker testing. The office may not implement a waiver under this section until the office files an affidavit with the governor attesting that the federal waiver applied for under this section is in effect. The office shall file the affidavit under this subsection not later than five (5) days after the office is notified that the waiver is approved.
(h) If the office receives a waiver under this section from the United States Department of Health and Human Services and the governor receives the affidavit filed under subsection (g), the office shall implement the waiver not more than sixty (60) days after the governor receives the affidavit.
(i) Before November 1, 2025, and before November 1 of each year thereafter, the office of the secretary shall report to the budget committee on the Medicaid reimbursement rates provided for biomarker testing. The report shall include the following statewide aggregate information for the state fiscal year 2023 and the state fiscal year most recently ended:
(1) The total number of patients who received biomarker testing.
(2) The total number of patients who received biomarker testing for each biomarker test type.
(3) The total amount of state funding expended for biomarker testing.
(4) The ten (10) most common conditions or treatments for which biomarker testing was ordered.
(5) As a result of the biomarker testing, how many patients:
(A) were placed on particular therapies;
(B) avoided certain treatments; and
(C) were subject to any other treatment impacts.
(6) Any other information requested by the budget committee.
Each provider that receives state Medicaid funding under this section shall provide the information described in subdivisions (1) through (6) to the office of the secretary not later than August 1 of each year.
As added by P.L.37-2024, SEC.1.