No. CS/CS/SB 1092
Filed under Healthcare.
Podiatric Medicine; Requiring certain podiatric physicians, instead of all podiatric physicians, to complete specified continuing education; authorizing podiatric physicians to perform procedures using cellular or tissue-based products not approved by the United States Food and Drug Administration under certain circumstances; specifying requirements for the cellular or tissue-based products that may be used by such podiatric physicians; requiring podiatric physicians to obtain a signed consent form from the patient or his or her representative before performing procedures using cellular or tissue-based products, etc.
Plain English Summary
AI-GENERATEDPodiatric physicians may now perform procedures using cellular or tissue-based products not yet FDA-approved, for connective tissue, ligament, and tendon repair, wound care, or pain management, as long as the products are properly sourced and disclosed.
These products must come from an FDA-registered facility accredited by a named national tissue or marrow bank organization, and must be tested for live, viable cells before the podiatric physician uses them on a patient.
Patients must sign a consent form describing the treatment, its unapproved status, expected results, risks, and alternatives, and any advertisement for the procedure must carry a statutory notice that the products are FDA-unapproved.
Using cells or tissue taken from a fetus or embryo after an abortion is a third-degree felony for a podiatric physician, on top of the two-hour controlled-substance course now required only of DEA-registered prescribers.
AILets a podiatric physician perform a procedure with cellular or tissue-based products not approved by the FDA, if the use is within their scope of practice and involves connective tissue, ligament, or tendon repair, wound care, or pain management.
AIRequires any cellular or tissue-based product a podiatric physician uses to come from a facility registered with the FDA and separately certified or accredited by a named national marrow, blood, or tissue-bank organization, with viability confirmed before use.
AIMakes it a third-degree felony for a podiatric physician to willfully perform or participate in treatment or research using human cells or tissue derived from a fetus or embryo after an abortion, on top of professional discipline.
AIRequires a podiatric physician to obtain a signed consent form, from the patient or their representative, that explains the treatment's nature, its unapproved status, expected results, risks, benefits, and alternatives, including nontreatment, before performing the procedure.
AIRequires a podiatric physician who performs these procedures to include a specific statutory notice in any advertisement, stating the products are not yet FDA-approved and encouraging patients to consult their primary care provider first.
AIExempts a podiatric physician from these requirements if they already hold FDA investigational new drug or device approval, or if they work under contract for an institution accredited by named cellular-therapy or transplant organizations.
AILimits the existing 2-hour continuing-education requirement on safe controlled-substance prescribing to podiatric physicians who are registered with the DEA and authorized to prescribe controlled substances, rather than all licensees.
AISubjects a podiatric physician to disciplinary action by the Board of Podiatric Medicine for any violation of the new cellular and tissue-based product rules, separate from the felony charge tied to post-abortion tissue.