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ENGROSSED HOUSE AMENDME NT
TO
ENGROSSED SENATE BILL NO . 513 By: Rosino and Garvin of the
Senate
and
Miller, Fugate, and Stinson
of the House
An Act relating to biomarker testing; defining terms;
requiring coverage of biomarker testing under certain
conditions; requiring certain contract to be provided
with policy; directing plan to limit disruptions in
care with certain evidence; requiring plan to publish
accessible process on certain website for certain
requests; construing provision; amending 56 O.S.
2021, Section 4002.6, as amended by Section 10,
Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, Section
4002.6), which relates to the state Medicaid program;
clarifying certain prio r authorization requirement;
updating statutory language; defining terms;
requiring certain coverage and provision of biomarker
testing; stipulating prior au thorization requirements
for biomarker testing; directing creation of process
to request exceptions to certain coverage policies;
providing for codification; and providing an
effective date.
AUTHOR: Add the following House Coauthor s: Sneed, Burns, Davis,
Newton, McEntire, Williams, Cantrell, McCall, Bennett,
Hilbert, Stark, Randleman, Marti, Roe, Tedford, Lowe
(Dick), Munson, Boles, Manger, Roberts, and Baker
AMENDMENT NO. 1. Strike the title, enacting clause, and entire bill
and insert:
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"An Act relating to biomarker testing; defining
terms; requiring coverage of biomarker testing under
certain conditions; requiring certain contract to be
provided with policy; directing plan to limit
disruptions in care with certa in evidence; requiring
plan to publish accessible process on certain website
for certain requests; construing provision; amending
56 O.S. 2021, Section 4002.6, as amended by Section
10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022,
Section 4002.6), which relates to the state Medicaid
program; clarifying certain prio r authorization
requirement; updating statutory language; defining
terms; requiring certain coverage and provision of
biomarker testing; stipulating prior authorization
requirements for biomarke r testing; directing
creation of process to request exceptions to certain
coverage policies; providing for codification; and
providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6060.5a of Title 36, unless
there is created a duplication in numbering, reads as follows:
A. As used in this section:
1. "Biomarker" means a biological molecule found in blood,
other body fluids, or tissues that is a sign of a normal or abnormal
process, or of a condition or disease. A biomarker may be u sed to
see how well the body responds to a treatment for a disease or
condition or for other purposes . Biomarkers shall include but are
not limited to gene m utation or protein expression;
2. "Biomarker testing" means the analysis of a patient’s
tissue, blood, or other biospecimen for the presence of a biomarker.
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Biomarker testing shall include but not be limited to single-analyte
tests, multiplex panel tests, gene or protein expression, and whole
exome, whole genome, and whole transcriptome sequencing;
3. "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. Th e most appropriate test may include both
information that is actionable and some information that cannot be
immediately used in the formulation of a clinical decision ;
4. "Consensus statement" means a statement that:
a. is developed by an independent, multidisciplinary
panel of experts that use a transparent methodolo gy
and reporting structure that includes a conflict of
interest policy,
b. is based on the best available evidence for the
purpose of optimizing clinical care outcomes , and
c. is aimed at specific clinical circumstances;
5. "Health benefit plan" means a plan as defined pursuant to
Section 6060.4 of Title 36 of the Oklahoma Statutes; and
6. "Nationally recognized clinical practice guidelines" means
evidence-based clinical practice guidelines that:
a. are developed by independent organizations or medical
professional societies using a transparent methodology
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and reporting structure and a conflict of interest
policy, and
b. establish standards of care that are informed by a
systemic review of evi dence and an assessment of the
benefits and costs of alternative care options that
includes recommendations intended to optimize patient
care.
B. Any health benefit pla n, including the Oklahoma Employees
Insurance Plan, that is offered, issued, or renewed in this state on
or after the effective date of this act shall provide coverage for
biomarker testing. A contract provided with a health benefit plan
under this section shall include biomarker testing for the purpose
of diagnosis, treatment, appropriate management, or ongoing
monitoring of an insured’s disease or condition to guide treatment
decisions when the biomarker test provides clinical utility as
demonstrated by medical and scientific evidence including, but not
limited to:
1. Labeled indications for tests that are approved or cleared
by the United States Food and D rug Administration;
2. Indicated tests for a drug that is approved by the United
States Food and Drug Administration;
3. Warnings and precautions o n United States Food and Drug
Administration-approved drug labels;
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4. Centers for Medicare and Medicaid S ervices national coverage
determinations or Medicare administrative contractor local coverage
determinations; or
5. Nationally recognized clinical pr actice guidelines and
consensus statements.
C. A health benefit plan shall ensure that coverage is provid ed
in a manner that limits disruptions in care, including the need for
multiple biopsies and biospeci men samples.
D. An insured and a prescribing practitioner shall have access
to a clear, readily available, and convenient proc ess to request an
exception to a coverage policy of a health benefit plan under this
subsection. The process shall be readily accessible on the plan’s
website. This subsection shall not be construed to require a
separate process if the health benefit pla n’s existing process
complies with this subsection.
SECTION 2. AMENDATORY 56 O.S. 2021, Section 4002.6, a s
amended by Section 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022,
Section 4002.6), is amended to read as follows:
Section 4002.6 A. A contracted entity shall meet all
requirements established by the Oklahoma Health Care Authority
pertaining to prior authorizations. The Authority shall establish
requirements that ensure timely determinations by contracted
entities when prior authorizations are required including expedited
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review in urgent and emergent cases that at a minimum meet the
criteria of this section.
B. A contracted entity shall make a determination on a request
for an authorization of the transfer of a hospital inpatient to a
post-acute care or long-term acute care facility within twenty-four
(24) hours of receipt of the request.
C. A contracted entity shall make a determination on a request
for any member who is not hospitalized at the time of the request
within seventy-two (72) hours of receipt of the request; provided,
that if the request does not include sufficient or adequate
documentation, the review and determination shall occur within a
time frame and in accordance with a process established by the
Authority. The process established by the Authority pursuant to
this subsection shall include a time frame of at least forty-eight
(48) hours within which a provider may submit the necessary
documentation.
D. A contracted entity shall make a determination on a request
for services for a hospitalized member including, but not limited
to, acute care inpatient services or equipment necessary to
discharge the member from an inpatient facility within one (1)
business day of receipt of the request.
E. Notwithstanding the provisions of subsection C of this
section, a contracted entity shall make a determination on a request
as expeditiously as necessary and, in any event, within twenty-four
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(24) hours of receipt of the request for service if adhering to the
provisions of subsection C or D of this section could jeopardize the
member’s life, health or ability to attain, maintain or regain
maximum function. In the event of a medically emergent matter, the
contracted entity shall not impose limitations on providers in
coordination of post-emergent stabilization health care including
pre-certification or prior authorization.
F. Notwithstanding any other provision of this section, a
contracted entity shall make a determination on a request for
inpatient behavioral health s ervices within twenty-four (24) hours
of receipt of the request.
G. A contracted entity shall make a determination on a request
for covered prescription drugs that are required to be prior
authorized by the Authority within twenty-four (24) hours of receipt
of the request. The contracted entity shall not require prior
authorization on any covered prescription drug for which the
Authority does not require prior authorization.
H. A contracted entity shall make a dete rmination on a request
for coverage of biomarker testing in accordan ce with Section 3 of
this act.
I. Upon issuance of an adverse determination on a prior
authorization request under subsection B of this section, the
contracted entity shall provide the requesting provider, within
seventy-two (72) hours of receipt of suc h issuance, with reasonable
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opportunity to participate in a peer-to-peer review process with a
provider who practices in the same specialty, but not necessarily
the same sub-specialty, and who has experience treating the same
population as the patient on w hose behalf the request is submitted;
provided, however, if the requesting provider determin es the
services to be clinically urgent, the contracted entity shall
provide such opportunity within twenty-four (24) hours of receipt of
such issuance. Services not covered under the state Medicaid
program for the particular patient shall not be subject to peer-to-
peer review.
I. J. The Authority shall ensure that a provider offers to
provide to an enrollee a member in a timely manner services
authorized by a contracted entity.
J. K. The Authority shall establish requirements for both
internal and external reviews and appeals of adverse determinations
on prior authorization requests or claims that, at a minimum:
1. Require contracted entities to provide a detailed
explanation of denials to Medicaid providers and members;
2. Require contracted entities to provide a prompt opportunity
for peer-to-peer conversations with licensed clinical staff of the
same or similar specialty which shall include, but not be limited
to, Oklahoma-licensed clinical staff upon adverse determination; and
3. Establish uniform rules for Medicaid provider or member
appeals across all contracted entities.
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SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 4003 of Title 56, unless there
is created a duplication in numb ering, reads as follows:
A. As used in this section:
1. "Biomarker", "biomarker testing", "consensus statement", and
"nationally recognized clinical practice guidelines" shall have the
same meaning as provided by Section 1 of this act; and
2. "Contracted entity" shall have the same meaning as provided
by Section 4002.2 of Title 56 of the Oklahoma Statutes.
B. The state Medicaid program s hall cover biomarker testing in
accordance with the requirements provided by this section.
C. Biomarker testing shall be cove red for the purposes of
diagnosis, treatment, approp riate management, or ongoing monitoring
of a member’s disease or condition whe n the test is supported by
medical and scientific evidence, including, but not limited to:
1. Labeled indications for a United States Food and Drug
Administration (FDA)-approved or -cleared test;
2. Indicated tests for an FDA-approved drug;
3. Warnings and precautions on FDA-approved drug labels;
4. Centers for Medicare and Medicaid Services (CMS) national
coverage determinations or Medicare Administrative Contrac tor (MAC)
local coverage determinations; or
5. Nationally recognized clinical pra ctice guidelines and
consensus statements.
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D. Contracted entities under the state Medicaid program shall
provide biomarker testing at the same sc ope, duration, and frequency
as the Medicaid program otherwise provides to members.
E. If prior authorization is required for biomar ker testing,
the contracted entity shall approve or deny a prior authorization
request and notify the member, the member’s provider, and any entity
requesting authorization of th e service within seventy-two (72)
hours for non-urgent requests or within twenty-four (24) hours for
urgent requests.
F. The member and t he member’s provider shall have access to
clear, readily access ible, and convenient process es to request an
exception to a coverage policy for biomarker testing of the state
Medicaid program. The process shall be made readily accessible to
all participating providers and members online.
SECTION 4. This act shall become effective January 1, 2024."
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Passed the House of Representat ives the 20th day of April, 2023.
Presiding Officer of the House of
Representatives
Passed the Senate the ____ day of __________, 2023.
Presiding Officer of the Senate
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ENGROSSED SENATE
BILL NO. 513 By: Rosino and Garvin of the
Senate
and
Miller, Fugate, and Stinson
of the House
An Act relating to biomarker testing; defining terms;
requiring coverage of biomarker testing under certain
conditions; requiring certain contract to be provided
with policy; directing plan to limit disruptions in
care with certain evidence; requiring plan to publish
accessible process on certain website for certain
requests; construing provision; amending 56 O.S.
2021, Section 4002.6, as amended by Section 10,
Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, Section
4002.6), which relates to the state Medicaid program;
clarifying certain prio r authorization requirement;
updating statutory language; defining terms;
requiring certain coverage and provision of biomarker
testing; stipulating prior au thorization requirements
for biomarker testing; directing creation of process
to request exceptions to certain coverage policies;
providing for codification; and providing an
effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 5. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6060.5a of Title 36, unless
there is created a duplication in numbering, reads as follows:
A. As used in this section:
1. “Biomarker” means a biological molecule found in blood,
other body fluids, or tissues that is a sign of a normal or abnormal
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process, or of a condition or disease. A biomarker may be u sed to
see how well the body responds to a treatment for a disease or
condition or for other purposes . Biomarkers shall include but are
not limited to gene m utation or protein expression;
2. “Biomarker testing” means the analysis of a patient’s
tissue, blood, or other biospecimen for the presence of a biomarker.
Biomarker testing shall include but not be limited to single-analyte
tests, multiplex panel tests, gene or protein expression, and whole
exome, whole genome, and whole transcriptome sequencing;
3. “Consensus statement” means a statement that:
a. is developed by an independent, multidisciplinary
panel of experts that use a transparent methodolo gy
and reporting structure that includes a conflict of
interest policy,
b. is based on the best available evidence for the
purpose of optimizing clinical care outcomes , and
c. is aimed at specific clinical circumstances;
4. “Health benefit plan” means a plan as defined pursuant to
Section 6060.4 of Title 36 of the Oklahoma Statutes; and
5. “Nationally recognized clinical practice guidelines” means
evidence-based clinical practice guidelines that:
a. are developed by independent organizations or medical
professional societies using a transparent methodology
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and reporting structure an d a conflict of interest
policy, and
b. establish standards of care that are informed by a
systemic review of evidence and an assessment of the
benefits and costs of alternative care options that
includes recommendations intended to optimize patient
care.
B. Any health benefit pla n, including the Okla homa Employees
Insurance Plan, that is offered, issued, or renewed in this stat e on
or after the effective date of this act shall provide coverage for
biomarker testing. A contract provided with a health benefit plan
under this section shall include bioma rker testing for the purpose
of diagnosis, treatment, appropriate management, or ongoing
monitoring of an insured’s disease or condition to guide treatment
decisions when the biomarker test is supported by medical and
scientific evidence including, but not limited to:
1. Labeled indications for tests that are approved or cleared
by the United States Food and D rug Administration;
2. Indicated tests for a drug that is approved by the United
States Food and Drug Administration;
3. Warnings and precautions o n United States Food and Drug
Administration approved d rug labels;
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4. Centers for Medicare and Medicaid S ervices national coverage
determinations or Medicare admini strative contractor local coverage
determinations; or
5. Nationally recognized clinical pr actice guidelines and
consensus statements.
C. A health benefit plan shall ensure that coverage is provid ed
in a manner that limits disruptions in care, including the need for
multiple biopsies and biospeci men samples.
D. An insured and a prescribing practitioner shall have access
to a clear, readily available, and convenient proc ess to request an
exception to a coverage policy of a health benefit plan under this
subsection. The process shall be readily accessible on the plan’s
website. This subsection shall not be construed to require a
separate process if the health benefit pla n’s existing process
complies with this subsection.
SECTION 6. AMENDATORY 56 O.S. 2021, Section 4002.6, a s
amended by Section 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022,
Section 4002.6), is amended to read as follows:
Section 4002.6. A. A contracted entity shall meet all
requirements established by the Oklah oma Health Care Authority
pertaining to prior authorizations. The Authority shall establish
requirements that ensure timely determinations by contracted
entities when prior authorizations are required including expedited
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review in urgent and emergent case s that at a minimum meet the
criteria of this section.
B. A contracted entity shall make a determination on a request
for an authorization of the transfer of a hospital inpatient to a
post-acute care or long-term acute care facility within twenty-four
(24) hours of receipt of the request.
C. A contracted entity shall make a determination on a request
for any member who is not hospitalized at the time of the request
within seventy-two (72) hours of receipt of the request; provided,
that if the request does not include sufficient or adequate
documentation, the review and determination shall occur within a
time frame and in accordance with a process established by the
Authority. The process established by the Authority pursuant to
this subsection shall include a time frame of at least forty-eight
(48) hours within which a provider may submit the necessary
documentation.
D. A contracted entity shall make a determination on a request
for services for a hospitalized member including, but not limited
to, acute care inpatient services or equipment necessary to
discharge the member from an inpatient facility within one (1)
business day of receipt of the request.
E. Notwithstanding the provisions of subsection C of this
section, a contracted entity shall make a determination on a request
as expeditiously as necessary and, in any eve nt, within twenty-four
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(24) hours of receipt of the request for service if adhering to the
provisions of subsection C or D of this section could jeopardize the
member’s life, health or ability to attain, maintain or regain
maximum function. In the event of a medically emergent matter, the
contracted entity shall not impose limitations on providers in
coordination of post-emergent stabilization health care including
pre-certification or prior authorization.
F. Notwithstanding any other provision of this section, a
contracted entity shall make a determination on a request for
inpatient behavioral health s ervices within twenty-four (24) hours
of receipt of the request.
G. A contracted entity shall make a determination on a request
for covered prescription dr ugs that are required to be prior
authorized by the Authority within twenty-four (24) hours of receipt
of the request. The contracted entity shall not require prior
authorization on any covered prescription drug for which the
Authority does not require prior authorization.
H. A contracted entity shall make a determination on a re quest
for coverage of biomarker testing in accordan ce with Section 3 of
this act.
I. Upon issuance of an adverse determination on a prior
authorization request under subsection B of this section, the
contracted entity shall provide the requesting provider, within
seventy-two (72) hours of receipt of suc h issuance, with reasonable
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opportunity to participate in a peer-to-peer review process with a
provider who practices in the same specialty, but not necessarily
the same sub-specialty, and who has experience treating the same
population as the patient on w hose behalf the request is submitted;
provided, however, if the requesting provider determin es the
services to be clinically urgent, the contracted entity shall
provide such opportunity within twenty-four (24) hours of receipt of
such issuance. Services not covered under the state Medicaid
program for the particular patient shall not be subject to peer-to-
peer review.
I. J. The Authority shall ensure that a provider offers to
provide to an enrollee a member in a timely manner services
authorized by a contracted entity.
J. K. The Authority shall establish requirements for both
internal and external reviews and appeals of adverse determinations
on prior authorization requests or claims that, at a minimum:
1. Require contracted entities to provide a detailed
explanation of denials to Medicaid providers and members;
2. Require contracted entities to provide a prompt opportunity
for peer-to-peer conversations with licensed clinical staff of the
same or similar specialty which shall include, but not be limited
to, Oklahoma-licensed clinical staff upon adverse determination; and
3. Establish uniform rules for Medicaid provider or member
appeals across all contracted entities.
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SECTION 7. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Se ction 4003 of Title 56, unless there
is created a duplication in numb ering, reads as follows:
A. As used in this section:
1. “Biomarker”, “biomarker testing”, “consensus statement”, and
“nationally recognized clinical practice guidelines” shall have the
same meaning as provided by Section 1 of this act; and
2. “Contracted entity” shall have the same meaning as provided
by Section 4002.2 of Title 56 of the Oklahoma Statutes.
B. The state Medicaid program s hall cover biomarker testing in
accordance with the requirements p rovided by this secti on.
C. Biomarker testing shall be cove red for the purposes of
diagnosis, treatment, approp riate management, or ongoing monitoring
of a member’s disease or condition whe n the test is supported by
medical and scientific evidence, includ ing, but not limited to:
1. Labeled indications for a Food and Drug Administration
(FDA)-approved or -cleared test;
2. Indicated tests for an FDA-approved drug;
3. Warnings and precautions on FDA-approved drug labels;
4. Centers for Medicare and Medicaid Services (CMS) national
coverage determinations or Medicare Administrative Contractor (MAC)
local coverage determinations; or
5. Nationally recognized clinical pra ctice guidelines and
consensus statements.
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D. Contracted entities under the sta te Medicaid program shall
provide biomarker testing at the same scope, dur ation, and frequency
as the Medicaid program otherwise provides to members.
E. If prior authorization is required for biomar ker testing,
the contracted entity shall approve or deny a prior authorization
request and notify the member, the member’s provider, and any entity
requesting authorization of th e service within seventy-two (72)
hours for non-urgent requests or within twenty-four (24) hours for
urgent requests.
F. The member and the mem ber’s provider shall have access to
clear, readily accessible, an d convenient processes to request an
exception to a coverage policy for biomarker testing of the state
Medicaid program. The process shall be made readily accessible to
all participating providers and members on line.
SECTION 8. This act shall become effective January 1, 2024.
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Passed the Senate the 6th day of March, 2023.
Presiding Officer of the Senate
Passed the House of Representatives the ____ day of __________,
2023.
Presiding Officer of the House
of Representatives