AN ACT EXPANDING THE RIGHT TO TRY ACT TO PROVIDE ACCESS TO INVESTIGATIONAL ADULT STEM CELL TREATMENTS FOR PATIENTS DIAGNOSED WITH A TERMINAL OR CHRONIC ILLNESS. SL 2019-70. Enacted July 1, 2019. Effective December 1, 2019.
Summary date: Jul 8 2019 - View summary
Summary date: Jun 13 2019 - View summary
Senate committee substitute to the 2nd edition makes the following changes.
Amends new GS 90-325.12, by requiring that investigational adult stem cell treatment, as authorized, be provided at an accredited medical school located in the state, an affiliated facility of an accredited medical school located in the state, or any other facility approved by the institutional review board overseeing the treatment (previously, allowed for treatment at a licensed hospital, a licensed ambulatory surgical center, or an accredited medical school located in the state). Amends new GS 90-325.13, by requiring an institutional review board overseeing investigational adult stem cell treatments be affiliated with an accredited medical school located in the state or an affiliated facility of a medical school located in the state (previously, required affiliation with an accredited medical school in the state or a licensed hospital with at least 150 beds).
Amends new GS 90-325.14, which prohibits the purchase and sale of adult stem cells for certain investigational treatments, by excepting from the prohibition health care providers, medical researchers, or biosciences professionals who are either (1) engaged in research, clinical trials, or investigational adult stem cell treatment being overseen or having been approved by an institutional review board meeting the specified requirements or (2) otherwise engaged in legal research, clinical trials, or investigational adult stem cell research. Makes conforming changes.
Summary date: May 1 2019 - View summary
House committee substitute to the 1st edition makes the following changes. Amends new GS 90-325.14, by correcting the punishment to a Class A1 misdemeanor for knowingly offer to buy or sell, sell, acquire, receive, or otherwise transfer any adult stem cells for valuation consideration for use in a treatment. Corrects an internal subsection reference.
Summary date: Apr 30 2019 - View summary
House committee substitute to the 1st edition is to be summarized.
Summary date: Apr 22 2019 - View summary
Places the existing statutes of Article 23A, Right to Try Act, of GS Chapter 90, into new Part 1, titled Experimental Treatments. Makes conforming changes to existing statutes to refer to Part 1 rather than the entire Article. Enacts the following statutes into new Part 2, Investigational Adult Stem Cell Treatments.
Enacts GS 90-325.10 and GS 90-325.11 to establish the Part's purpose and set forth applicable defined terms.
Enacts GS 90-325.12, authorizing an eligible patient, meeting five specified criteria, to access and use an investigational adult stem cell treatment if the treatment meets the following criteria: (1) is administered directly by a physician ferried by an institutional review board which meets the requirements of GS 90-325.13, as enacted; (2) is overseen by an institution review board that meets the requirements of GS 90-325.13; and (3) is provided at a licensed hospital, licensed ambulatory surgical center, or an accredited medical school located in the State. Defines investigational adult stem cell treatment (treatment) to mean such treatment that is under investigation in a clinical trial and being administered to human participants in the trial, and that has not yet been approved for general use by the US Food and Drug Administration. Requires compliance with all other state law and rules adopted by the Medical Board.
Requires an institutional review board that oversees treatments administered under Part 2 to be affiliated with an accredited medical school in the State or a licensed hospital with at least 150 beds. Allows these boards to certify physicians to provide treatments under the Part. Establishes record requirements for treatments administered and their effects. Requires each board overseeing treatment to submit an annual report to the Medical Board, excluding any patient-indentifying information, which must be made available to the public in both written and electronic form. Authorizes the Medical Board to adopt rules concerning the role and function of boards under the Part.
Enacts GS 90-325.14, making it a misdemeanor to knowingly offer to buy or sell, sell, acquire, receive, or otherwise transfer any adult stem cells for valuation consideration for use in a treatment. Permits fess for services rendered by a health care provider in the usual course of medical practice or for hospital or other clinical services, reimbursement of legal or medical expenses incurred for the benefit of the ultimate receiver of the treatment, and reimbursement of expenses for travel, housing and lost wages incurred by the adult stem cell donor.
Enacts GS 90-325.15 to prohibit licensing boards and entities responsible for Medicare certification from disciplining physicians who recommendation or administration of treatment to an eligible patient, so long as the recommendation and/or care is consistent with the applicable standard of care and the Part's requirements.
Enacts GS 90-325.16 to prohibit any government official, employee or agent from interfering with or attempt to interfere with an eligible patient's access to an authorized treatment. Specifies that counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider does not constitute a violation of the statute.
Enacts GS 90-325.17 to specify that Part 2 does not affect a health benefit plan's obligation to provide coverage for an insured's participation in a clinical trial under GS 58-3-255.
Applies to acts committed on or after December 1, 2019.