All Roll Calls
Yes: 122 • No: 0
South DakotaHB 1139100th South Dakota Legislature (2025)HouseWALLET
allow individualized investigative treatments for patients with life-threatening or debilitating diseases or conditions.
Sponsored By: Andera, Bobbi L. (Republican)
Signed by Governor
Health CareHealth Maintenance OrganizationsInsurancePublic Health and Safety
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Bill Overview
Analyzed Economic Effects
6 provisions identified: 2 benefits, 2 costs, 2 mixed.
Limits on patients' treatment harm claims
The law does not create a private right to sue covered parties for harm from general or custom investigative treatment. Covered parties include manufacturers and others involved in an eligible patient's care. This limit requires both good-faith compliance with the law and reasonable care.
Custom treatment access for seriously ill patients
Patients with life-threatening or severely debilitating conditions can seek treatments made only for them using their genetic profiles. Doctors must confirm eligibility, document consideration of FDA-approved options, and recommend treatment based on genetic or related biological analysis. Disease definitions and facilities' federal human-subject protection standards follow federal rules as of January 1, 2025. Manufacturers need not supply treatment, and licensed facilities need not add services without their approval. South Dakota officials cannot block eligible patients' access to general or custom investigative treatments; providers can still give advice following medical standards.
Treatment debt protection for patient estates
This protection applies when a patient dies while receiving a general or custom investigative treatment. Manufacturers and eligible facilities cannot seek repayment from the patient's or caretaker's estate for outstanding treatment-related debt. It also covers reimbursement claims tied to lack of insurance due to treatment. The law sets no dollar limit on this protection.
Doctors protected for investigative treatment advice
Licensing boards cannot revoke, suspend, refuse renewal, or otherwise act against a doctor's license solely for recommending investigative treatment access. Medicare certification entities likewise cannot act against the doctor's certification for that recommendation alone. The protection covers recommendations to eligible patients about general or custom investigative treatments.
Patients face custom treatment costs
Eligible facilities and manufacturers working within them can charge patients for making custom investigative treatments and related manufacturing costs. The law sets no price and does not require a charge. Government agencies are not required by this law to pay for the treatment or associated care. Health plans, insurers, and claims administrators are not required to cover the treatment or related services. These payment exceptions do not themselves require patients to pay or prohibit coverage.
Patients must sign treatment risk disclosures
Before general or custom investigative treatment, patients or authorized representatives must sign written consent attested to by their doctor. General treatments have completed FDA phase I, remain in an FDA-approved trial, and lack approval for general use. Consent identifies the treatment, explains approved options, and states agreement that no FDA-approved treatment is likely to prolong life. It warns about worsening symptoms, hastened death, insurance not being required to pay, and the patient's responsibility for expenses. It also explains that pursuing curative treatment can suspend hospice, with reinstatement after treatment ends if hospice criteria are met.
Sponsors & Cosponsors
Sponsor
Andera, Bobbi L.
Republican • House
Cosponsors
Auch, Julie
Republican • House
Aylward, Aaron
Republican • House
Baxter, Heather
Republican • House
Emery, Eric
Democratic • House
Heinemann, Leslie J.
Republican • House
Jordan, Dylan C.
Republican • House
Perry, Carl
Republican • Senate
Randolph, Tony
Republican • House
Reder, Christopher
Republican • House
Schaefbauer, Brandei
Republican • House
Roll Call Votes
Senate vote • 3/6/2025
Do Pass
Yes: 34 • No: 0
Senate vote • 3/5/2025
Do Pass
Yes: 7 • No: 0
House vote • 2/12/2025
Do Pass
Yes: 68 • No: 0
House vote • 2/11/2025
Do Pass
Yes: 13 • No: 0
Actions Timeline
Signed by the Governor
3/31/2025HouseDelivered to the Governor
3/12/2025HouseSigned by the President
3/11/2025SenateSigned by the Speaker
3/10/2025HouseSenate Do Pass, Passed, YEAS 34, NAYS 0
3/6/2025SenateCertified uncontested, placed on consent
3/5/2025SenateSenate Health and Human Services Do Pass, Passed, YEAS 7, NAYS 0
3/5/2025SenateScheduled for hearing
3/5/2025SenateFirst read in Senate and referred to Senate Health and Human Services
2/13/2025SenateHouse of Representatives Do Pass, Passed, YEAS 68, NAYS 0
2/12/2025HouseCertified uncontested, placed on consent
2/11/2025HouseHouse Health and Human Services Do Pass, Passed, YEAS 13, NAYS 0
2/11/2025HouseScheduled for hearing
2/11/2025HouseReferred to House Health and Human Services
2/3/2025HouseFirst Reading House
1/30/2025House
Bill Text
Introduced
1/29/2025
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