PRINTER'S NO. 1215
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 965
Session of
2023
INTRODUCED BY CULVER, LAUGHLIN, COLLETT, DILLON, CAPPELLETTI,
J. WARD, PHILLIPS-HILL, COMITTA, SCHWANK AND HUTCHINSON,
NOVEMBER 9, 2023
REFERRED TO HEALTH AND HUMAN SERVICES, NOVEMBER 9, 2023
AN ACT
1 Amending the act of June 13, 1967 (P.L.31, No.21), entitled "An
2 act to consolidate, editorially revise, and codify the public
3 welfare laws of the Commonwealth," in public assistance,
4 providing for coverage of rapid whole genome sequencing.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. The act of June 13, 1967 (P.L.31, No.21), known
8 as the Human Services Code, is amended by adding a section to
9 read:
10 Section 449.3. Coverage of Rapid Whole Genome Sequencing.--
11 (a) Subject to any required approval of the Centers for
12 Medicare and Medicaid Services, the department shall include
13 coverage of rapid whole genome sequencing for medical assistance
14 beneficiaries enrolled in HealthChoices managed care program and
15 fee-for-service program, if:
16 (1) the beneficiary is under one year of age;
17 (2) the beneficiary has a complex or acute illness of
18 unknown etiology that is not confirmed to be caused by an
 1 environmental exposure, toxic ingestion, infection with normal
2 response to therapy or trauma; and
3 (3) the beneficiary is receiving hospital services in an
4 intensive care unit or other high acuity care unit within a
5 hospital.
6 (b) The coverage provided under this section may be subject
7 to applicable evidence-based medical necessity criteria that
8 shall be based on all of the following:
9 (1) The beneficiary has symptoms that suggest a broad
10 differential diagnosis that would require an evaluation by
11 multiple genetic tests if rapid whole genome sequencing is not
12 performed.
13 (2) The beneficiary's treating health care provider has
14 determined that timely identification of a molecular diagnosis
15 is necessary to guide clinical decision making and testing
16 results may guide the treatment or management of the
17 beneficiary's condition.
18 (3) The beneficiary has a complex or acute illness of
19 unknown etiology, including at least one of the following
20 conditions:
21 (i) Congenital anomalies involving at least two organ
22 systems or complex or multiple congenital anomalies in one organ
23 system.
24 (ii) Specific organ malformations highly suggestive of a
25 genetic etiology.
26 (iii) Abnormal laboratory tests or abnormal chemistry
27 profiles suggesting the presence of a genetic disease, complex
28 metabolic disorder or inborn error of metabolism.
29 (iv) Refractory or severe hypoglycemia or hyperglycemia.
30 (v) Abnormal response to therapy related to an underlying
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 1 medical condition affecting vital organs or bodily systems.
2 (vi) Severe muscle weakness, rigidity or spasticity.
3 (vii) A high-risk stratification on evaluation for a brief
4 resolved unexplained event with any of the following:
5 (A) A recurrent event without respiratory infection.
6 (B) A recurrent seizure-like event.
7 (C) A recurrent cardiopulmonary resuscitation.
8 (viii) Abnormal cardiac diagnostic testing results
9 suggestive of possible channelopathies, arrhythmias,
10 cardiomyopathies, myocarditis or structural heart disease.
11 (ix) Abnormal diagnostic imaging studies suggestive of
12 underlying genetic condition.
13 (x) Abnormal physiologic function studies suggestive on an
14 underlying genetic etiology.
15 (xi) Family genetic history related to the beneficiaries'
16 condition.
17 (c) The department shall make payment for the testing
18 required under this section as a fee-for-service reimbursement
19 for medical assistance beneficiaries enrolled in HealthChoices
20 managed care program and fee-for-service program, if the
21 beneficiaries meet the eligibility criteria of this section.
22 (d) Nothing in this section shall prohibit the secretary
23 from adding additional conditions to those contained in
24 subsection (b)(3) based upon new medical evidence or from
25 providing coverage for rapid whole genome sequencing or other
26 next generation sequencing and genetic testing for medical
27 assistance beneficiaries that is in addition to the coverage
28 required under this section.
29 (e) Genetic data generated as a result of performing rapid
30 whole genome sequencing covered under this section shall have a
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 1 primary use of assisting the ordering health care professional
2 and treating care team to diagnose and treat the beneficiary and
3 shall be subject to the requirements applicable to protected
4 health information as specified in the Health Insurance
5 Portability and Accountability Act of 1996 (Public Law 104-191,
6 110 Stat. 1936) and the Health Information Technology for
7 Economic and Clinical Health Act (Public Law 111-5, 123 Stat.
8 226-279 and 467-496) and the attendant regulations including,
9 but not limited to, the Health Information Portability Act
10 Privacy Rule as promulgated at 45 CFR Pt. 160 (relating to
11 general administrative requirements) and 45 CFR Pt. 164 Subpts.
12 A (relating to general provisions) and E (relating to privacy of
13 individually identifiable health information).
14 (f) Genetic data generated from rapid whole genome
15 sequencing covered under this section may be used in scientific
16 research if consent for such use of the data is expressly given
17 by the beneficiary or the beneficiary's legal guardian, in the
18 case of a minor. The beneficiary, or the beneficiary's health
19 care provider with the beneficiary's consent or consent of
20 beneficiary's legal guardian, may request access to the results
21 of the testing covered under this section for use in other
22 clinical settings. A health care provider may only charge a de
23 minimis fee to the beneficiary based on the direct costs of
24 producing the results in a format usable in other clinical
25 settings. A beneficiary or beneficiary's legal guardian, in the
26 case of a minor, shall have the right to rescind the original
27 consent to the use of the data in scientific research at any
28 time and upon receipt of a written revocation of the consent the
29 health care provider or other entity using the data shall cease
30 use and expunge the data from any data repository where it is
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 1 held.
2 (g) The secretary may take any actions necessary to
3 implement the provisions of this section, which may include the
4 following:
5 (1) submission to the Centers for Medicare and Medicaid
6 Services of a Medicaid State plan amendment necessary to ensure
7 Federal financial participation for medial assistance coverage
8 under this section; or
9 (2) any other administrative action determined by the
10 secretary as necessary to implement the requirement of this
11 section.
12 (h) As used in this section, the following words and phrases
13 shall have the following meanings:
14 "Rapid whole genome sequencing" means the investigation of
15 the entire human genome, including coding and noncoding regions
16 and mitochondrial deoxyribonucleic acid, to identify disease-
17 causing genetic changes that returns the preliminary positive
18 results within seven days and final results within fifteen days
19 from the date of receipt of the sample by the lab performing the
20 test. The term includes beneficiary-only whole genome sequencing
21 and duo and trio whole genome sequencing of the beneficiary and
22 biological parent or parents.
23 Section 2. This act shall take effect immediately.
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Statutes/Laws affected:
Printer's No. 1215: P.L.31, No.21