How SB 965 changes current law

AI-generated reading aid from the bill's amendatory text — verify against the official bill.

The bill mandates coverage for rapid whole genome sequencing under Pennsylvania's Medical Assistance programs for eligible beneficiaries.

• 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 fee-for-service program, if: (1) the beneficiary is under one year of age; (2) the beneficiary has a complex or acute illness of unknown etiology that is not confirmed to be caused by an environmental exposure, toxic ingestion, infection with normal response to therapy or trauma; and (3) the beneficiary is receiving hospital services in an intensive care unit or other high acuity care unit within a hospital.

  This clause establishes new coverage requirements for rapid whole genome sequencing.

• Section 449.3

  (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. (2) The beneficiary's treating health care provider has determined that timely identification of a molecular diagnosis is necessary to guide clinical decision making and testing results may guide the treatment or management of the beneficiary's condition. (3) The beneficiary has a complex or acute illness of unknown etiology, including at least one of the following conditions: ...

  This clause allows coverage to be subject to specific medical necessity criteria.

• Section 449.3

  (c) The department shall make payment for the testing required under this section as a fee-for-service reimbursement 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.

  This clause mandates payment structure for the genetic testing under specified programs.

• Section 449.3

  (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.

  This clause permits the addition of more conditions for coverage based on medical advancements.

• Section 449.3

  (e) Genetic data generated as a result of performing rapid whole genome sequencing covered under this section shall have a primary use of assisting the ordering health care professional and treating care team to diagnose and treat the beneficiary ...

  This clause clarifies the intended use of genetic data generated from the testing.

• Section 449.3

  (f) Genetic data generated from rapid whole genome sequencing covered under this section may be used in scientific research if consent for such use of the data is expressly given by the beneficiary or the beneficiary's legal guardian ...

  This clause outlines the conditions for using genetic data in research.

• Section 449.3

  (g) The secretary may take any actions necessary to implement the provisions of this section, which may include the following: ...

  This clause empowers the secretary to take necessary actions for implementation.

• Section 449.3

  (h) As used in this section, the following words and phrases shall have the following meanings: ...

  This clause provides definitions for terms used within the new section.

• Section 449.3

  "Rapid whole genome sequencing" means the investigation of the entire human genome, including coding and noncoding regions and mitochondrial deoxyribonucleic acid, ...

  This clause defines what is meant by rapid whole genome sequencing.