Pennsylvania Statutes Title 40 P.S. Insurance § 764o. Coverage for biomarker testing

(a) An insurer that offers, issues or renews a health insurance policy in this Commonwealth shall include biomarker testing as a covered benefit. The following shall apply:

(b) Subject to Federal approval, as necessary, a medical assistance or Children's Health Insurance Program managed care plan shall provide coverage of biomarker testing. The following shall apply:

(c) The terms in this section shall be given the same definitions as the terms defined pursuant to section 2102  3 unless otherwise noted. As used in this section, the following words and phrases shall have the meanings given to them in this subsection unless the context clearly indicates otherwise:

“Agreement with the Department of Human Services.”An agreement between a medical assistance or Children's Health Insurance Program managed care plan and the Department of Human Services.

“Biomarker.” A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiologic or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how a covered person or enrollee feels, functions or survives.

“Biomarker testing.”The analysis of a covered person or enrollee's tissue, blood or other biospecimen for the presence of a biomarker. Biomarker testing includes, but is not limited to, single-analyte tests and multiplex panels performed at a participating in-network laboratory that is CLIA certified by the Federal Food and Drug Administration.

“Medical assistance” or “Children's Health Insurance Program managed care plan.”A health care plan that uses a gatekeeper to manage the utilization of health care services, including biomarker testing, by medical assistance or Children's Health Insurance Program enrollees, and integrates the financing and delivery of health care services, including biomarker testing.

“Screening.” A medical procedure or test for a covered person or enrollee who has yet to display symptoms of a particular disease or condition for the purpose of determining their likelihood of having the disease or condition.