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

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. The act of June 13, 1967 (P.L.31, No.21), known

as the Human Services Code, is amended by adding a section to

read:

Section 449.3. Coverage of Rapid Whole Genome Sequencing.--

(a) Subject to any required approval of the Centers for

Medicare and Medicaid Services, the department shall include

coverage of rapid whole genome sequencing for medical assistance

beneficiaries enrolled in HealthChoices managed care program and

(3) the beneficiary is receiving hospital services in an

intensive care unit or other high acuity care unit within a

hospital.

(b) The coverage provided under this section may be subject

to applicable evidence-based medical necessity criteria that

shall be based on all of the following:

(1) The beneficiary has symptoms that suggest a broad

differential diagnosis that would require an evaluation by

multiple genetic tests if rapid whole genome sequencing is not

performed.

unknown etiology, including at least one of the following

conditions:

(i) Congenital anomalies involving at least two organ

systems or complex or multiple congenital anomalies in one organ

system.

(ii) Specific organ malformations highly suggestive of a

genetic etiology.

(iii) Abnormal laboratory tests or abnormal chemistry

profiles suggesting the presence of a genetic disease, complex

metabolic disorder or inborn error of metabolism.

(vii) A high-risk stratification on evaluation for a brief

resolved unexplained event with any of the following:

(A) A recurrent event without respiratory infection.

(B) A recurrent seizure-like event.

(C) A recurrent cardiopulmonary resuscitation.

(viii) Abnormal cardiac diagnostic testing results

suggestive of possible channelopathies, arrhythmias,

cardiomyopathies, myocarditis or structural heart disease.

(ix) Abnormal diagnostic imaging studies suggestive of

underlying genetic condition.

for medical assistance beneficiaries enrolled in HealthChoices

managed care program and fee-for-service program, if the

beneficiaries meet the eligibility criteria of this section.

(d) Nothing in this section shall prohibit the secretary

from adding additional conditions to those contained in

subsection (b)(3) based upon new medical evidence or from

providing coverage for rapid whole genome sequencing or other

next generation sequencing and genetic testing for medical

assistance beneficiaries that is in addition to the coverage

required under this section.

shall be subject to the requirements applicable to protected

health information as specified in the Health Insurance

Portability and Accountability Act of 1996 (Public Law 104-191,

110 Stat. 1936) and the Health Information Technology for

Economic and Clinical Health Act (Public Law 111-5, 123 Stat.

226-279 and 467-496) and the attendant regulations including,

but not limited to, the Health Information Portability Act

Privacy Rule as promulgated at 45 CFR Pt. 160 (relating to

general administrative requirements) and 45 CFR Pt. 164 Subpts.

A (relating to general provisions) and E (relating to privacy of

care provider with the beneficiary's consent or consent of

beneficiary's legal guardian, may request access to the results

of the testing covered under this section for use in other

clinical settings. A health care provider may only charge a de

minimis fee to the beneficiary based on the direct costs of

producing the results in a format usable in other clinical

settings. A beneficiary or beneficiary's legal guardian, in the

case of a minor, shall have the right to rescind the original

consent to the use of the data in scientific research at any

time and upon receipt of a written revocation of the consent the

implement the provisions of this section, which may include the

following:

(1) submission to the Centers for Medicare and Medicaid

Services of a Medicaid State plan amendment necessary to ensure

Federal financial participation for medial assistance coverage

under this section; or

(2) any other administrative action determined by the

secretary as necessary to implement the requirement of this

section.

(h) As used in this section, the following words and phrases

from the date of receipt of the sample by the lab performing the

test. The term includes beneficiary-only whole genome sequencing

and duo and trio whole genome sequencing of the beneficiary and

biological parent or parents.