Relating to access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.

Contracts

• Patient Financial Agreements: You must amend financial responsibility forms for these specific patients. Since the law prohibits collecting from heirs/estates, agreements must require upfront payment, escrow, or third-party guarantees *prior* to treatment administration.
• Manufacturer MSAs: Hospitals allowing manufacturers to operate within their facility must update Master Service Agreements to clearly assign responsibility for maintaining the required Federal Assurance (45 C.F.R. Part 46) compliance.

Hiring/Training

• Clinical Staff: Oncology and genetic department staff must be trained to distinguish SB984 "individualized treatments" from standard "Right to Try" pathways.
• Discharge Planners: Staff must be trained on the hospice eligibility conflict; patients must be warned that starting this treatment may trigger a withdrawal of hospice benefits.

Reporting & Record-Keeping

• New Informed Consent Form: Legal must draft a standalone SB984 Consent Form. It must contain the seven mandatory statutory disclosures, including the explicit warning that the treatment may hasten death and that insurers are not liable.
• Physician Attestation: Create a standardized template for the treating physician to document the exhaustion of FDA-approved options and the specific genomic rationale for the investigational treatment.

Fees & Costs

• Revenue Cycle Management: Update billing software to flag these specific encounters as "Non-Recourse/Estate Exempt." Accidental billing of an estate after the patient's death constitutes a compliance violation.
• Insurance Denials: Expect 100% denial rates from commercial payers unless a specific rider is negotiated.