§ 12-15-5-21.5 — Biomarker testing; federal approval; report

Indiana § 12-15-5-21.5

• Jurisdiction: Indiana
• Art. 15: MEDICAID
• Ch. 5: Services Provided

Text

5. (a) As used in this section, "biomarker"
means a characteristic that is objectively measured and evaluated as an
indicator of:
(1) normal biological processes;
(2) pathogenic processes; or
(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.

Legislative History

As added by P.L.37-2024, SEC.1.