- “This program allows an individual, for lack of a better term, to take a risk when all other options have been terminated for their own health care, and assuming that risk is on the individual themselves,” Rep. Allen Chesser, R-Nash.
On Tuesday, the House Health Committee discussed HB 1029, or “Right to Try Individualized Treatments.” This is the companion bill to SB 871, which was discussed in the Senate Healthcare Committee and currently resides in the Senate Judiciary Committee.
HB 1029 is sponsored by Rep. Allen Chesser, R-Nash, Rep. Hugh Blackwell, R-Burke, Rep. Larry W. Potts, R-Davidson, and Rep. Timothy Reeder, R-Pitt.
“In our Senate counterpart, Senator Sawrey is carrying this bill on the Senate side as well had a positive outcome in their health committee. And I would like to have that in the near future here as well,” said Chesser.
This bill expands on legislation that has been in place in North Carolina since 2015. When the legislation was passed in 2015, individualized treatments weren’t even on the horizon. However, experimental medicine has advanced to the point where individualized treatments are relatively commonplace.
“It uses incredible technology that is targeted and that individually specific, given the nature of that it’s not possible or plausible for a sample size to be achieved that would qualify for FDA approval,” said Chesser. “What this does is, it allows for people who are diagnosed with terminal or severely debilitated illnesses to be eligible to pursue those treatments on their own accord, does not require insurance companies or any other payer system to provide those treatments. It does not require manufacturers to produce any medication and it does not require any doctor to make the recommendation for the treatment. It does not interfere with the treatment protocol at all. It just opens another door for possible treatment for people who all other doors have been closed to.”
This legislation includes no obligation for any health insurance provider to cover experimental treatments, and bill sponsors say there is no intent to create that within the bill.
“There are requirements that you have to have exhausted other treatment options,” clarified Chesser. You do have to be under the direct supervision of a physician, and the physician does have to recommend this as a treatment option. So, it’s not I get out of jail free card… It’s not a gateway that we’re trying to create.”
As long as a physician is acting in good faith, bill sponsors say there is no liability on the physician if a patient were to die as a result of an experimental treatment.
“Usually, people that are needing these treatments aren’t always extremely wealthy, and there should be some consideration, I would think, to how this was going to be available through Medicaid or Medicare or any other private insurance, and maybe a discussion could be had with those that are looking at those sort of abilities to help people pay for treatment,” stated Rep. Diane Wheatley, R-Cumberland.” Usually, you know, the larger universities do have programs that have funding, and they take it through an application process. But then, you know, those all need to be speedy, I would think, in choosing special treatment that you can’t get anywhere else.”
Rep. Mary Belk, D-Mecklenburg, clarified that an individual who takes experimental treatments not approved by the FDA understands and acknowledges that they are taking on full responsibility, regardless of whether or not they found out about the treatment through someone in the medical field.
“If you’re going to recommend a treatment, you’d have to have some knowledge of and refer them to the expert who knows about whatever the gene therapy is,” said Reeder, a physician and primary sponsor of the bill. “So I feel like that would be covered under a routine medical malpractice or medical care… There are other statutes that talk about if you’re willful or wanton negligence. I think even though you sign a waiver that says, You are absolved, I think if you were acting in bad faith or other bad actions, you would still be liable under other statutes.”
Rep. Maria Cervania, D-Wake, requested that the legislation clearly define two terms used in the bill: “incapacitated” and “private right of action.”
“This bill does nothing to affect the financing within the experimental space; how they choose to finance the research and development of the drugs and treatments is up to them,” said Chesser. “What we do is clarify, and it’s in the 2015 law as well, that from the patient, they cannot recoup a profit, like a roof of cost.”
One public commenter was allowed to speak.
“The purpose of this particular legislative vehicle is to create an additional pathway for those who need individualized treatments,” said Naomi Lopez, Senior Fellow at the Goldwater Institute. “It works with the Department of Health and Human Services Office of Human Protection because these are not treatments that are marketing purposes; they are for individuals to try to save their lives and not for commercialization.”
The Goldwater Institute has been advocating for similar legislation in other states with a requirement that the experimental treatments have to be created in a facility that’s already federally approved, that uses an institutional review board.
“North Carolina can continue to lead on the important goal of getting the right treatment to the right patient at the right time, further removing government red tape that stands in the way of a doctor’s treatment options, and does not require additional taxpayer investment,” said Lopez. “It can be achieved in a manner that ensures patient safety and informed consent. North Carolina’s lawmakers have the authority, with this legislative vehicle, to unleash the potential of today’s medical innovations for further benefit did further benefit patients.”