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Oklahoma Legislature· HB 1576To Senate

An act relating to Medicaid, the official text

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1                            STATE OF OKLAHOMA

2   1st Session of the 60th Legislature (2025)

3 HOUSE BILL 1576            By: Lawson

4

5

6                            AS INTRODUCED

7   An Act relating to Medicaid; defining terms;

    requiring the Oklahoma Health Care Authority to

8   provide coverage through Medicaid for certain

    services; providing certain criteria; providing for

9   certain medical necessity criteria; authorizing

    discretion to the Chief Operating Officer of the

10  Oklahoma Health Care Authority; providing for Health

    Information Portability and Accountability Act

11  requirements; providing for scientific research;

    providing for consent to provide data for research;

12  providing for opting-out; providing for minors;

    providing for the promulgation of rules and

13  regulations; providing for waiver application;

    providing for codification; providing for an

14  effective date; and declaring an emergency.

15

16

17 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

18  SECTION 1.      NEW LAW  A new section of law to be codified

19 in the Oklahoma Statutes as Section 4005 of Title 56, unless there

20 is created a duplication in numbering, reads as follows:

21  A. For purposes of this section, "rapid whole genome sequencing

22 (RWGS)" is defined as an investigation of the entire human genome,

23 including coding and non-coding regions and mitochondrial

24 deoxyribonucleic acid, to identify disease-causing genetic changes

    Req. No. 10968                                            Page 1
1 that returns the preliminary positive results within seven (7) days

2 and final results within fifteen (15) to twenty-one (21) days from

3 the date of receipt of the sample by the lab performing the test,

4 and includes patient-only whole genome sequencing (WGS) and duo and

5 trio whole genome sequencing of the patient and biological parent or

6 parents.

7   B. Subject to any required approval of the Centers for Medicare

8 and Medicaid Services, the Oklahoma Health Care Authority shall

9 include coverage of rapid whole genome sequencing as a separately

10 payable service for Medicaid beneficiaries when all of the following

11 criteria are met:

12  1. Beneficiary is under twenty-one (21) years of age;

13  2. Beneficiary has a complex or acute illness of unknown

14 etiology, that is not confirmed to be caused by an environmental

15 exposure, toxic ingestion, infection with normal response to

16 therapy, or trauma; and

17  3. Beneficiary is receiving hospital services in an intensive

18 care unit or other high acuity care unit within a hospital.

19  C. The coverage provided pursuant to this section may be

20 subject to applicable evidence-based medical necessity criteria that

21 shall be based on all of the following:

22  1. The patient has symptoms that suggest a broad differential

23 diagnosis that would require an evaluation by multiple genetic tests

24 if rapid whole genome sequencing is not performed;

    Req. No. 10968                                                 Page 2
1   2. The patient's treating healthcare provider has determined

2 that timely identification of a molecular diagnosis is necessary to

3 guide clinical decision-making and testing results may guide the

4 treatment or management of the patient's condition; and

5   3. The patient has a complex or acute illness of unknown

6 etiology, including at least one of the following conditions:

7   a. congenital anomalies involving at least two organ

8   systems or complex and multiple congenital anomalies

9   in one organ system,

10  b. specific organ malformations highly suggestive of a

11  genetic etiology,

12  c. abnormal laboratory tests or abnormal chemistry

13  profiles suggesting the presence of a genetic disease,

14  complex metabolic disorder, or inborn error of

15  metabolism,

16  d. refractory or severe hypoglycemia or hyperglycemia,

17  e. abnormal response to therapy related to an underlying

18  medical condition affecting vital organs or bodily

19  systems,

20  f. severe muscle weakness, rigidity, or spasticity,

21  g. refractory seizures,

22  h. a high-risk stratification on evaluation for a brief

23  resolved unexplained event with any of the following:

24  (1) a recurrent event without respiratory infection,

    Req. No. 10968                                               Page 3
1   (2) a recurrent event witnessed seizure-like event,

2                   or

3   (3) a recurrent cardiopulmonary resuscitation.

4   i. abnormal cardiac diagnostic testing results suggestive

5   of possible channelopathies, arrhythmias,

6   cardiomyopathies, myocarditis, or structural heart

7   disease,

8   j. abnormal diagnostic imaging studies suggestive of

9   underlying genetic condition,

10  k. abnormal physiologic function studies suggestive of an

11  underlying genetic etiology, or

12  l. family genetic history related to the patient's

13  condition.

14  D. Nothing in this section prohibits the Chief Operating

15 Officer of the Oklahoma Health Care Authority from adding additional

16 conditions to those contained in paragraph 3 of subsection C based

17 upon new medical evidence or from providing coverage for rapid whole

18 genome sequencing or other next generation sequencing (NGS) and

19 genetic testing for Medicaid beneficiaries that is in addition to

20 the coverage required under this section.

21  E. Genetic data generated as a result of performing rapid whole

22 genome sequencing, covered pursuant to this section, shall have a

23 primary use of assisting the ordering health care professional and

24 treating care team to diagnose and treat the patient, and as

    Req. No. 10968                                               Page 4
1 protected health information it shall be subject to the requirements

2 applicable to protected health information as set forth in the

3 Health Information Portability and Accountability Act (HIPAA), the

4 Health Information Technology for Economic and Clinical Health Act,

5 and their attendant regulations, including but not limited to, the

6 HIPAA privacy rule as promulgated at 45 CFR Part 160 and Subparts A

7 and E of 45 CFR Part 164.

8   F. Genetic data generated from rapid whole genome sequencing,

9 covered pursuant to this section, can be used in scientific research

10 if consent for such use of the data has been expressly given by the

11 patient, or the patient's legal guardian in the case of a minor.

12 The patient, the patient's legal guardian in the case of a minor, or

13 the patient's health care provider with the patient's consent, may

14 request access to the results of the testing covered by this section

15 for use in other clinical settings. A health care provider may only

16 charge a small fee to the patient based on the direct costs of

17 producing the results in a format usable in other clinical settings.

18 A patient, or patient's legal guardian in the case of a minor, shall

19 have the right to rescind the original consent to the use of the

20 data in scientific research at any time, and upon receipt of a

21 written revocation of the consent the health care provider or other

22 entity using the data shall cease use and expunge the data from any

23 data repository where it is held.

24

    Req. No. 10968                                                 Page 5
1   G. The Chief Operating Officer of the Oklahoma Health Care

2 Authority will take any actions necessary to implement the

3 provisions of this section, which can include, if deemed necessary,

4 the following:

5   1. Promulgation of rules and regulations to provide for

6 Medicaid coverage pursuant to this section;

7   2. Submission to the Centers for Medicare and Medicaid Services

8 of any new waiver application, amendment to an existing waiver, or

9 Medicaid state plan amendment necessary to ensure federal financial

10 participation for Medicaid coverage pursuant to this section; or

11  3. Any other administrative action determined by the Chief

12 Operating Officer as necessary to implement the requirements of this

13 section.

14  SECTION 2. This act shall become effective July 1, 2025.

15  SECTION 3. It being immediately necessary for the preservation

16 of the public peace, health or safety, an emergency is hereby

17 declared to exist, by reason whereof this act shall take effect and

18 be in full force from and after its passage and approval.

19

20  60-1-10968      TJ  12/17/24

21

22

23

24

    Req. No. 10968                                                Page 6
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