{"AmendmentNumber":"8","ParentBillNumber":"S3141","Bill":null,"Sponsor":{"Id":"M_K1","Name":"Meghan K. Kilcoyne","Type":1,"Details":"https://malegislature.gov/api/GeneralCourts/194/LegislativeMembers/M_K1","ResponseDate":"2026-07-29T12:16:45.59"},"Category":null,"Action":null,"RollCall":[],"Title":"Patient Access to Biomarker Testing to Provide Appropriate Therapy","Branch":"House","RedraftNumber":null,"IsFurther":false,"GeneralCourtNumber":194,"Text":"Ms. Kilcoyne of Clinton moves to amend the bill by adding the following section:\r\n\r\n\"SECTION XXXX. Chapter 32A of the General Laws is hereby amended by inserting after section 17Z, the following section:-\r\n\r\nSection 17AA. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals.\r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.  \r\n\r\n(b) The commission shall provide to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test;\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n\r\nSECTION XXXX. Chapter 118E of the General Laws is hereby amended by inserting after section 10Z, the following section:-\r\n\r\nSection 10AA. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals. \r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.  \r\n\r\n(b) The division and its contracted health insurers, health plans, health maintenance organizations, behavioral health management firms and third-party administrators under contract to a Medicaid managed care organization or primary care clinician plan shall provide coverage for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n\r\nSECTION XXXX. Chapter 175 of the General Laws is hereby amended by inserting before section 47CCC, the following section:-\r\n\r\nSection 47AAA. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals.\r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.  \r\n\r\n(b) Any blanket or general policy of insurance described in subdivision (A), (C), or (D) of section one hundred and ten which is issued or subsequently renewed by agreement between the insurer and the policyholder, within or without the commonwealth, during the period within which this premium is effective, or any policy of accident or sickness insurance as described in section one hundred and eight which provides hospital expense and surgical expense insurance and which is delivered or issued for delivery or subsequently renewed by agreement between the insurer and the policyholder in the commonwealth, during the period within which this provision is effective, or any employers' health and welfare fund which provides hospital expense and surgical expense benefits and which is issued or renewed to any person or group of persons in the commonwealth, during the period within which this provision is effective, shall provide benefits for residents of the commonwealth and all group members having a principal place of employment in the commonwealth for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n\r\nSECTION XXXX. Chapter 176A of the General Laws is hereby amended by inserting after section 8DDD, the following section:-\r\n\r\nSection 8EEE. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome, sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals.\r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.  \r\n\r\n(b) Any contract between a subscriber and the corporation under an individual or group hospital service plan that is delivered, issued or renewed within the commonwealth shall provide coverage for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n\r\nSECTION XXXX. Chapter 176B of the General Laws is hereby amended by inserting after section 4DDD, the following section:-\r\n\r\nSection 4EEE. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals.\r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy\r\n\r\n(b) Any subscription certificate under an individual or group medical service agreement delivered, issued or renewed within the commonwealth shall provide coverage for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n\r\nSECTION XXXX. Chapter 176G of the General Laws is hereby amended by inserting after section 4VV, as so appearing, the following section:-\r\n\r\nSection 4WW. (a) As used in this section, the following words shall have the following meanings:\r\n\r\n“Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include but are not limited to gene mutations, characteristics of genes or protein expression.\r\n\r\n“Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.  Biomarker testing includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a laboratory facility that is either Clinical Laboratory Improvement Amendments (CLIA) certified or CLIA waived by the federal food and drug administration (FDA). It does not include testing for the purpose of screening in asymptomatic individuals.\r\n\r\n“Clinical Utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.\r\n\r\n“Nationally recognized clinical practice guidelines” as used here are evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.  \r\n\r\n(b) Any individual or group health maintenance contract that is issued or renewed within or without the commonwealth shall provide coverage for biomarker testing as defined in this section, pursuant to criteria established under subsection (c).\r\n\r\n(c) Biomarker testing must be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the test performed at a laboratory facility that is either CLIA certified or CLIA waived by the federal food and drug administration (FDA) that provides clinical utility to the patients as demonstrated by medical and scientific evidence, including, but not limited to:\r\n\r\n1. Labeled indications for an FDA-approved or -cleared test\r\n2. Indicated tests for an FDA-approved drug;\r\n3. Warnings and precautions on FDA-approved drug labels;\r\n4. Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations or any Medicare Administrative Contractor (MAC) Local Coverage Determinations; or\r\n5. Nationally recognized clinical practice guidelines.\r\n\r\n(d) coverage as defined in subsection (c) of this section shall be provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.\r\n\r\n(e) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section must approve or deny a prior authorization request and notify the enrollee, the enrollee’s health care provider and any entity requesting authorization of the service within three business days.  If additional delay would result in significant risk to the insured’s health or well-being, a carrier or a utilization review organization shall approve or deny the request within 24 hours. If a response by a carrier or utilization review organization is not received within the time required under this paragraph, said request or appeal shall be deemed granted.\r\n\r\n(f) The patient and prescribing practitioner shall have access to a clear, readily accessible, and convenient processes to request an exception to a coverage policy or an adverse utilization review determination.  The process shall be made readily accessible on the carrier’s website.\r\n"}