Consolidated Amendment #A to S.3141

Consolidated Amendment "A" to S3141

Consolidated Amendment A

Fiscal Note: $0

Amendments: 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 103, 104, 105, 106, 107, 108, 109, 111, 112, 113, 114, 116, 117, 118, 119, 120, 121, 123, 124

Mr. Michlewitz of Boston and others move to amend H.5618, in section 20, by striking out, in line 248, the figure “50” and inserting in place thereof the figure “80”.

And further amend the bill, in section 22, by striking out, in line 530, the figure “2” and inserting in place thereof the figure “3”.

And further amend the bill, in said section 22, by adding the following section:-

Section 17DD. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker”, a molecular, genetic, or biochemical characteristic, including gene mutations, characteristics of genes or protein expression, 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.

“Biomarker testing”, the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal food and drug administration; provided, however, that biomarker testing does not include testing for the purpose of screening in asymptomatic individuals

“CLIA certified”, holding a certificate issued by the federal Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988 authorizing a laboratory to perform testing on human specimens.

“CLIA waived”, holding a certificate of waiver issued under the Clinical Laboratory Improvement Amendments of 1988 authorizing a laboratory to perform only those tests categorized as waived by the federal Food and Drug Administration under 42 C.F.R. section 493.15.

(i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic;

(iii) warnings and precautions in the FDA-approved labeling of a drug;

(iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or

(v) a nationally recognized clinical practice guideline.

“Nationally recognized clinical practice guidelines”, 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, including, but not limited to those of the National Comprehensive Cancer Network or the American Society of Clinical Oncology.  

(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, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(c) Biomarker testing shall be covered when the test: (i) is conducted at either a CLIA-certified or CLIA-waived laboratory and (ii) provides clinical utility to the enrollee, as demonstrated by medical and scientific evidence establishing that the result will be used to select, initiate, exclude, or discontinue a specific therapy, or to determine appropriate dosing of a specific therapy.

(d) In the case of coverage that requires prior authorization, a carrier or a utilization review organization subject to this section shall 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 5 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 48 hours. If a response by a carrier or utilization review organization is not received within the time required under this subsection, said request or appeal shall be deemed granted.

(e) The patient and prescribing practitioner shall have access to 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.

And further amend the bill by inserting after section 23 the following section:-

SECTION 23A. Section 24N of chapter 111 of the General Laws, as most recently amended by section 28 of chapter 73 of the acts of 2025, is hereby further amended by striking out subsections (c) and (d) and inserting in place thereof the following subsections:-

(c) There shall be a vaccine program advisory council consisting of the commissioner of public health or a designee, who shall serve as chair; the medical director of the universal immunization program of the department of public health established under section 24I; the executive director for the center for health information and analysis or a designee; the executive director of the commonwealth health insurance connector authority or a designee; 1 person to be appointed by the director of Medicaid, who shall be a representative of managed care organizations contracting with MassHealth; 3 persons to be appointed by the commissioner of insurance, each of whom shall be a representative of 1 of the 3 health insurance companies having the most insured lives in the commonwealth; and 7 persons to be appointed by the commissioner of public health, 1 of whom shall be a representative of an employer that self-insures for health coverage who shall be appointed from lists of nominees submitted by statewide associations of employers, 1 of whom shall be a member of the Massachusetts Medical Society, 1 of whom shall be a member of the Massachusetts chapter of the American Academy of Pediatrics, 1 of whom shall be a member of the Massachusetts Academy of Family Physicians, and 3 of whom shall be physicians licensed to practice in the commonwealth and who shall have expertise in the area of childhood vaccines. The council shall recommend the amount of funding needed each fiscal year by calculating the total non-federal program cost.

(d) Under regulations adopted by the commissioner of public health, each surcharge payor in the commonwealth shall pay to the commissioner of public health, for deposit in the Vaccine Purchase Trust Fund, a routine childhood immunizations surcharge assessed by the commissioner. By January 1 of each year, the commissioner of public health shall determine the total amount of the surcharge for the current fiscal year by determining the final amount required to be included in the Vaccine Purchase Trust Fund for the current fiscal year to cover the estimated costs to purchase, store and distribute immunizations for routine childhood immunizations and to administer the fund and the immunization registry, established pursuant to section 24M. The amount shall take into consideration the limitations on expenditures described in subsection (b) any anticipated surplus or deficit in the trust fund, and shall exclude any costs anticipated to be covered by federal contribution. Any increase in the surcharge amount for the prior fiscal year shall not be more than the percentage set as the health care cost growth benchmark, established under section 9 of chapter 6D, unless the commissioner of public health submits a detailed report to the clerks of the house of representatives and senate who shall forward the report to the house and senate committees on ways and means, the house and senate chairs of the joint committee on public health and the house and senate chairs of the joint committee on health care financing explaining the need for the increase.

And further amend the bill in section 25, by striking out, in lines 598 to 600, inclusive, the words “an acute care hospital classified as a community-high public payer hospital by the center for health information and analysis in its most recently published Massachusetts Acute Hospital Profiles, or successor publication”, and inserting in place thereof the following words:- (i) an acute care hospital established under chapter 147 of the acts of 1995 and its corporate affiliates; (ii) a non-state, government public hospital system established pursuant to chapter 147 of the acts of 1996; or (iii) an acute care hospital classified as a community-high public payer hospital by the center for health information and analysis in its most recently published Massachusetts Acute Hospital Profiles, or successor publication.

And further amend the bill by inserting after section 25 the following section:-

SECTION 25A. Said chapter 111 is hereby further amended adding the following section:-

Section 251. (a) The department shall implement a provider immunization brand choice requirement as part of the commonwealth’s universal immunization program pursuant to sections 24I and 24N and in any other existing or future immunization program for children or adults administered through the state using local, state or federal funds.

(b)(1) Pursuant to the provider immunization brand choice requirement, for all categories of immunizations included in the programs described in subsection (a), all healthcare providers participating in these programs shall be able to select any brand or type of any immunization, including any combination immunization and dosage form, as long as the immunization is licensed or authorized for emergency use by the federal Food and Drug Administration, recommended by the national Centers for Disease Control and Prevention Advisory Committee on Immunization Practices or is recommended by national professional medical societies.

(2) The universal immunization program shall reflect adequate patient and provider immunization brand choice to preserve clinical judgement for healthcare providers, enhance vaccine confidence, stabilize the vaccine supply and encourage access to future vaccines. The department may exclude certain brand vaccines based on concerns for the health and safety of patients or excessive purchase cost in comparison to comparable agents. This section shall not apply in the event of a shortage or delay in vaccine availability, disaster or public health emergency, terrorist attack, hostile military or paramilitary action or extraordinary law enforcement emergency.

And further amend the bill in section 27 by striking out, in line 653, the words “the following section” and inserting in place thereof the following words:- “the following 2 sections”.

And further amend the bill in said section 27 by adding the following:-

Section 10CC. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker”, a molecular, genetic or biochemical characteristic, including gene mutations, characteristics of genes or protein expression, 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.

“Biomarker testing”, the analysis of a patient’s tissue, blood or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal Food and Drug Administration; provided, however, that biomarker testing shall not include testing for the purpose of screening in asymptomatic individuals

(i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic;

(iii) warnings and precautions in the FDA-approved labeling of a drug;

(iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or

(v) a nationally recognized clinical practice guideline.

(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, accountable care organization or primary care clinician plan shall provide to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(c) Biomarker testing shall be covered when the test: (i) is conducted at either a CLIA-certified or CLIA-waived laboratory; and (ii) provides clinical utility to the enrollee, as demonstrated by medical and scientific evidence establishing that the result will be used to select, initiate, exclude or discontinue a specific therapy, or to determine appropriate dosing of a specific therapy.

(d) In the case of coverage that requires prior authorization, a carrier or a utilization review organization subject to this section shall 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 5 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 48 hours. If a response by the division or utilization review organization is not received within the time required under this subsection, said request or appeal shall be deemed granted.

(e) 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.

And further amend the bill in section 29 by striking out the figure “2”, in line 681, and inserting in place thereof the following figure:- “3”.

And further amend the bill in said section 29 by adding the following section:-

Section 47GGG. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker testing”, the analysis of a patient’s tissue, blood or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal food and drug administration; provided, however, that biomarker testing does not include testing for the purpose of screening in asymptomatic individuals

“CLIA certified”, holding a certificate issued by the federal Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. section 263 authorizing a laboratory to perform testing on human specimens.

“Clinical utility”, the test result that 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. Clinical utility shall be established by any of the following:

(i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic;

(iii) warnings and precautions in the FDA-approved labeling of a drug;

(iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or

(v) a nationally recognized clinical practice guideline.

(b) Any carrier offering a policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the commonwealth shall provide to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(c) Biomarker testing shall be covered when the test: (i) is conducted at either a CLIA-certified or CLIA-waived laboratory and (ii) provides clinical utility to the enrollee, as demonstrated by medical and scientific evidence establishing that the result will be used to select, initiate, exclude or discontinue a specific therapy, or to determine appropriate dosing of a specific therapy.

And further amend the bill by inserting after section 29 the following section:-

SECTION 29A. Section 11 of chapter 175M of the General Laws, as appearing in the 2024 Official Edition, is hereby amended by adding the following subsection:-

(f) An employer with not more than 25 employees shall be permitted to submit a private plan subject to the requirements of paragraph (1) of subsection (a) to the department directly; provided, that such employer shall be exempt from the requirements set forth in clause (i) and (iii) of paragraph (2) of subsection (a).

And further amend the bill in section 30 by striking out, in line 721, the figure “2” and inserting in place thereof the figure “3”.

And further amend the bill in said section 30 by adding the following section:-

Section 8HHH. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker testing”, the analysis of a patient’s tissue, blood or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal food and drug administration; provided, however, that biomarker testing does not include testing for the purpose of screening in asymptomatic individuals

(i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic;

(iii) warnings and precautions in the FDA-approved labeling of a drug;

(iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or

(v) a nationally recognized clinical practice guideline.

(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 to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(d) In the case of coverage which requires prior authorization, a carrier or a utilization review organization subject to this section shall 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 5 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 48 hours. If a response by a carrier or utilization review organization is not received within the time required under this subsection, said request or appeal shall be deemed granted.

(e) 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.

And further amend the bill in section 31 by striking out, in line 760, the figure “2” and inserting in place thereof the following figure “3”.

And further amend the bill in said section 31 by adding the following section:-

Section 4HHH. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker testing”, the analysis of a patient’s tissue, blood or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal food and drug administration; provided, however, that biomarker testing does not include testing for the purpose of screening in asymptomatic individuals

(i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic;

(iii) warnings and precautions in the FDA-approved labeling of a drug;

(iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or

(v) a nationally recognized clinical practice guideline.

(b) A subscription certificate under an individual or group medical service agreement delivered, issued or renewed within the commonwealth shall provide to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

And further amend the bill in section 33 by striking out, in line 820, the figure “2” and inserting in place thereof the following figure “3”.

And further amend the bill in said section 33 by adding the following section:-

Section 4ZZ. (a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

“Biomarker”, a molecular, genetic or biochemical characteristic, including gene mutations, characteristics of genes or protein expression, 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.

“Biomarker testing”, the analysis of a patient’s tissue, blood or other biospecimen for the presence of a biomarker, including, but 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 CLIA-certified or CLIA-waived by the federal food and drug administration; provided, however, that biomarker testing does not include testing for the purpose of screening in asymptomatic individuals

“Clinical utility”, 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. Clinical utility shall be established by any of the following: (i) the labeled indications for a test approved or cleared by the federal Food and Drug Administration; (ii) a test indicated in the FDA-approved labeling of a drug, including as a companion diagnostic; (iii) warnings and precautions in the FDA-approved labeling of a drug; (iv) a national coverage determination of the federal Centers for Medicare and Medicaid Services, or a local coverage determination issued by the Medicare Administrative Contractor; or (v) a nationally recognized clinical practice guideline.

(b) A health maintenance organization organized pursuant to this chapter shall provide to any active or retired employee of the commonwealth who is insured under the group insurance commission coverage for biomarker testing, pursuant to criteria established under subsection (c); provided, that coverage shall be applied in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples.

(d) In the case of coverage that requires prior authorization, a carrier or a utilization review organization subject to this section shall 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 5 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 48 hours. If a response by a carrier or utilization review organization is not received within the time required under this subsection, said request or appeal shall be deemed granted.

And further amend the bill by inserting after section 33 the following 6 sections:-

SECTION 33A. Section 1 of chapter 176J of the General Laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after the definition of “Health benefit plan” the following definition:-

“Health screening benefits”, a fixed dollar amount payable to an insured, without regard to the amount of any expenses incurred and without regard to benefits payable under any other coverage, upon proof that a test or diagnostic procedure, including a laboratory or radiological service, was performed in connection with a routine physical examination or preventive care visit.

SECTION 33B. Said section 1 of said chapter 176J, as so appearing, is hereby further amended by inserting after the word “plans”, in line 206, the second time it appears, the following words:- ; provided, however, that accident only, hospital indemnity insurance policies, disability income insurance and specified disease insurance may also offer health screening benefits.

SECTION 33C. Section 1 of chapter 176M of the General Laws, as so appearing, is hereby amended by inserting after the definition of “Health plan” the following definition:-

SECTION 33D. Said section 1 of said chapter 176M, as so appearing, is hereby further amended by inserting after the figure “176K”, in line 218, the following words:- ; provided, however, that accident only, hospital indemnity insurance policies, disability income insurance and specified disease may also offer health screening benefits.

SECTION 33E. Section 1 of chapter 176N of the General Laws, as so appearing, is hereby amended by inserting after the definition of “Health plan” the following definition:-

SECTION 33F. Said section 1 of said chapter 176N, as so appearing, is hereby further amended by inserting after the figure “176K”, in line 42, the following words:- ; provided, however, that accident only, hospital indemnity insurance policies, disability income insurance and specified disease insurance may also offer health screening benefits.

And further amend the bill in section 35 by inserting after the words “consumer organizations”, in line 940, the following words:- , health equity organizations.

And further amend the bill by inserting after section 39 the following section:-

SECTION 39A. Section 75 of chapter 260 of the acts of 2020 is hereby amended by striking out the figure “2027”, inserted by section 31 of chapter 248 of the acts of 2024, and inserting in place thereof the following figure:- 2029.

And further amend the bill in section 48, in line 1164, by striking out the figure “2028” and inserting in place thereof the figure “2029”.