1 STATE OF OKLAHOMA
1
2 1st Session of the 59th Legislature (2023)
2
3 SENATE BILL 513 By: Rosino
3
4
4
5
5
6 AS INTRODUCED
6
7 An Act relating to biomarker testing; defining terms;
7 requiring coverage of biomarker testing under certain
8 conditions; requiring certain document be provided
8 with policy; directing plan to limit disruptions in
9 care with certain evidence; requiring plan to publish
9 accessible process on certain website for certain
10 requests; construing provision; amending 56 O.S.
10 2021, Section 4002.6, as amended by Section 10,
11 Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, Section
11 4002.6), which relates to the state Medicaid program;
12 clarifying certain prior authorization requirement;
12 updating statutory language; defining terms;
13 requiring certain coverage and provision of biomarker
13 testing; stipulating prior authorization requirements
14 for biomarker testing; directing creation of process
14 to request exceptions to certain coverage policies;
15 providing for codification; and providing an
15 effective date.
16
16
17
17
18 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
18
19 SECTION 1. NEW LAW A new section of law to be codified
19
20 in the Oklahoma Statutes as Section 6060.5a of Title 36, unless
20
21 there is created a duplication in numbering, reads as follows:
21
22 A. As used in this section:
22
23 1. “Biomarker” means a characteristic that is objectively
23
24 measured and evaluated as an indicator of normal biological
24
Req. No. 347 Page 1
 1 processes, pathogenic processes, or pharmacologic responses to a
1
2 specific therapeutic intervention, including known gene-drug
2
3 interactions for medications being considered for use or already
3
4 being administered. Biomarkers shall include but are not limited to
4
5 gene mutation or protein expression;
5
6 2. “Biomarker testing” means the analysis of a patient’s
6
7 tissue, blood, or other biospecimen for the presence of a biomarker.
7
8 Biomarker testing shall include but not be limited to single-analyte
8
9 tests, multiplex panel tests, protein expression, and whole exome,
9
10 whole genome, and whole transcriptome sequencing;
10
11 3. “Consensus statement” means a statement that:
11
12 a. is developed by an independent, multidisciplinary
12
13 panel of experts that use a transparent methodology
13
14 and reporting structure that includes a conflict of
14
15 interest policy,
15
16 b. is based on the best available evidence for the
16
17 purpose of optimizing clinical care outcomes, and
17
18 c. is aimed at specific clinical circumstances;
18
19 4. “Health benefit plan” means a plan as defined pursuant to
19
20 Section 6060.4 of Title 36 of the Oklahoma Statutes; provided,
20
21 health benefit plan shall also include individual, group, and
21
22 blanket disability insurance coverage; and
22
23 5. “Nationally recognized clinical practice guidelines” means
23
24 evidence-based clinical practice guidelines that:
24
Req. No. 347 Page 2
 1 a. are developed by independent organizations or medical
1
2 professional societies using a transparent methodology
2
3 and reporting structure and a conflict of interest
3
4 policy, and
4
5 b. establish standards of care that are informed by a
5
6 systemic review of evidence and an assessment of the
6
7 benefits and costs of alternative care options that
7
8 includes recommendations intended to optimize patient
8
9 care.
9
10 B. Any health benefit plan, including the Oklahoma Employees
10
11 Insurance Plan, that is offered, issued, or renewed in this state on
11
12 or after the effective date of this act shall provide coverage for
12
13 biomarker testing. An evidence of coverage document provided with a
13
14 health benefit plan under this section shall include biomarker
14
15 testing for the purpose of diagnosis, treatment, appropriate
15
16 management, or ongoing monitoring of an insured’s disease or
16
17 condition to guide treatment decisions when the biomarker test is
17
18 supported by medical and scientific evidence, including, but not
18
19 limited to:
19
20 1. Labeled indications for tests that are approved or cleared
20
21 by the United States Food and Drug Administration;
21
22 2. Indicated tests for a drug that is approved by the United
22
23 States Food and Drug Administration;
23
24
24
Req. No. 347 Page 3
 1 3. Warnings and precautions on United States Food and Drug
1
2 Administration approved drug labels;
2
3 4. Centers for Medicare and Medicaid Services national coverage
3
4 determinations or Medicare administrative contractor local coverage
4
5 determinations; or
5
6 5. Nationally recognized clinical practice guidelines and
6
7 consensus statements.
7
8 C. A health benefit plan shall ensure that coverage is provided
8
9 in a manner that limits disruptions in care, including the need for
9
10 multiple biopsies and biospecimen samples.
10
11 D. An insured and a prescribing practitioner shall have access
11
12 to a clear, readily available, and convenient process to request an
12
13 exception to a coverage policy of a health benefit plan under this
13
14 subsection. The process shall be readily accessible on the plan’s
14
15 website. This subsection shall not be construed to require a
15
16 separate process if the health benefit plan’s existing process
16
17 complies with this subsection.
17
18 SECTION 2. AMENDATORY 56 O.S. 2021, Section 4002.6, as
18
19 amended by Section 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022,
19
20 Section 4002.6), is amended to read as follows:
20
21 Section 4002.6. A. A contracted entity shall meet all
21
22 requirements established by the Oklahoma Health Care Authority
22
23 pertaining to prior authorizations. The Authority shall establish
23
24 requirements that ensure timely determinations by contracted
24
Req. No. 347 Page 4
 1 entities when prior authorizations are required including expedited
1
2 review in urgent and emergent cases that at a minimum meet the
2
3 criteria of this section.
3
4 B. A contracted entity shall make a determination on a request
4
5 for an authorization of the transfer of a hospital inpatient to a
5
6 post-acute care or long-term acute care facility within twenty-four
6
7 (24) hours of receipt of the request.
7
8 C. A contracted entity shall make a determination on a request
8
9 for any member who is not hospitalized at the time of the request
9
10 within seventy-two (72) hours of receipt of the request; provided,
10
11 that if the request does not include sufficient or adequate
11
12 documentation, the review and determination shall occur within a
12
13 time frame and in accordance with a process established by the
13
14 Authority. The process established by the Authority pursuant to
14
15 this subsection shall include a time frame of at least forty-eight
15
16 (48) hours within which a provider may submit the necessary
16
17 documentation.
17
18 D. A contracted entity shall make a determination on a request
18
19 for services for a hospitalized member including, but not limited
19
20 to, acute care inpatient services or equipment necessary to
20
21 discharge the member from an inpatient facility within one (1)
21
22 business day of receipt of the request.
22
23 E. Notwithstanding the provisions of subsection C of this
23
24 section, a contracted entity shall make a determination on a request
24
Req. No. 347 Page 5
 1 as expeditiously as necessary and, in any event, within twenty-four
1
2 (24) hours of receipt of the request for service if adhering to the
2
3 provisions of subsection C or D of this section could jeopardize the
3
4 member’s life, health or ability to attain, maintain or regain
4
5 maximum function. In the event of a medically emergent matter, the
5
6 contracted entity shall not impose limitations on providers in
6
7 coordination of post-emergent stabilization health care including
7
8 pre-certification or prior authorization.
8
9 F. Notwithstanding any other provision of this section, a
9
10 contracted entity shall make a determination on a request for
10
11 inpatient behavioral health services within twenty-four (24) hours
11
12 of receipt of the request.
12
13 G. A contracted entity shall make a determination on a request
13
14 for covered prescription drugs that are required to be prior
14
15 authorized by the Authority within twenty-four (24) hours of receipt
15
16 of the request. The contracted entity shall not require prior
16
17 authorization on any covered prescription drug for which the
17
18 Authority does not require prior authorization.
18
19 H. A contracted entity shall make a determination on a request
19
20 for coverage of biomarker testing in accordance with Section 3 of
20
21 this act.
21
22 I. Upon issuance of an adverse determination on a prior
22
23 authorization request under subsection B of this section, the
23
24 contracted entity shall provide the requesting provider, within
24
Req. No. 347 Page 6
 1 seventy-two (72) hours of receipt of such issuance, with reasonable
1
2 opportunity to participate in a peer-to-peer review process with a
2
3 provider who practices in the same specialty, but not necessarily
3
4 the same sub-specialty, and who has experience treating the same
4
5 population as the patient on whose behalf the request is submitted;
5
6 provided, however, if the requesting provider determines the
6
7 services to be clinically urgent, the contracted entity shall
7
8 provide such opportunity within twenty-four (24) hours of receipt of
8
9 such issuance. Services not covered under the state Medicaid
9
10 program for the particular patient shall not be subject to peer-to-
10
11 peer review.
11
12 I. J. The Authority shall ensure that a provider offers to
12
13 provide to an enrollee a member in a timely manner services
13
14 authorized by a contracted entity.
14
15 J. K. The Authority shall establish requirements for both
15
16 internal and external reviews and appeals of adverse determinations
16
17 on prior authorization requests or claims that, at a minimum:
17
18 1. Require contracted entities to provide a detailed
18
19 explanation of denials to Medicaid providers and members;
19
20 2. Require contracted entities to provide a prompt opportunity
20
21 for peer-to-peer conversations with licensed clinical staff of the
21
22 same or similar specialty which shall include, but not be limited
22
23 to, Oklahoma-licensed clinical staff upon adverse determination; and
23
24
24
Req. No. 347 Page 7
 1 3. Establish uniform rules for Medicaid provider or member
1
2 appeals across all contracted entities.
2
3 SECTION 3. NEW LAW A new section of law to be codified
3
4 in the Oklahoma Statutes as Section 4003 of Title 56, unless there
4
5 is created a duplication in numbering, reads as follows:
5
6 A. As used in this section:
6
7 1. “Biomarker”, “biomarker testing”, “consensus statement”, and
7
8 “nationally recognized clinical practice guidelines” shall have the
8
9 same meaning as provided by Section 1 of this act; and
9
10 2. “Contracted entity” shall have the same meaning as provided
10
11 by Section 4002.2 of Title 56 of the Oklahoma Statutes.
11
12 B. The state Medicaid program shall cover biomarker testing in
12
13 accordance with the requirements provided by this section.
13
14 C. Biomarker testing shall be covered for the purposes of
14
15 diagnosis, treatment, appropriate management, or ongoing monitoring
15
16 of a member’s disease or condition when the test is supported by
16
17 medical and scientific evidence, including, but not limited to:
17
18 1. Labeled indications for a Food and Drug Administration
18
19 (FDA)-approved or -cleared test;
19
20 2. Indicated tests for an FDA-approved drug;
20
21 3. Warnings and precautions on FDA-approved drug labels;
21
22 4. Centers for Medicare and Medicaid Services (CMS) national
22
23 coverage determinations or Medicare Administrative Contractor (MAC)
23
24 local coverage determinations; or
24
Req. No. 347 Page 8
 1 5. Nationally recognized clinical practice guidelines and
1
2 consensus statements.
2
3 D. Contracted entities under the state Medicaid program shall
3
4 provide biomarker testing at the same scope, duration, and frequency
4
5 as the Medicaid program otherwise provides to members.
5
6 E. If prior authorization is required for biomarker testing,
6
7 the contracted entity shall approve or deny a prior authorization
7
8 request and notify the member, the member’s provider, and any entity
8
9 requesting authorization of the service within seventy-two (72)
9
10 hours for non-urgent requests or within twenty-four (24) hours for
10
11 urgent requests.
11
12 F. The member and the member’s provider shall have access to
12
13 clear, readily accessible, and convenient processes to request an
13
14 exception to a coverage policy for biomarker testing of the state
14
15 Medicaid program. The process shall be made readily accessible to
15
16 all participating providers and members online.
16
17 SECTION 4. This act shall become effective January 1, 2024.
17
18
18
19 59-1-347 RD 1/17/2023 4:41:46 PM
19
20
20
21
21
22
22
23
23
24
24
Req. No. 347 Page 9


Statutes affected:
Introduced: 56-4002.6
Senate Committee Substitute: 56-4002.6
Floor (House): 56-4002.6
Floor (Senate): 56-4002.6
Engrossed: 56-4002.6
Amended And Engrossed: 56-4002.6
Enrolled (final version): 56-4002.6