Under a draft rule released this week, Colorado’s regulatory board for doctors would not automatically consider so-called medication abortion “reversal” to be unprofessional conduct, a blow to Democrats in the legislature who hoped the state would become the first in the nation to ban the practice.
The draft rule comes in response to Senate Bill 190, which the legislature passed this year. The measure declared abortion pill reversal treatment to be unprofessional conduct, meaning doctors and others who provide it could face sanctions against their licenses. But the bill ultimately left room for the state’s medical, nursing and pharmacy boards to overrule that decision by declaring reversal to be a “generally accepted standard of practice.”
Those boards have yet to adopt final rules — they are still taking public comment on them, and debate on the final rules will come later this summer. But the draft rule, released Thursday, proposes that the boards not automatically seek to punish medical workers who provide reversal care, even though it also stops short of explicitly saying that reversal is an accepted practice.
“The board will not treat medication abortion reversal as a per se act of unprofessional conduct,” the draft rule states. “Rather, the board will investigate all complaints related to medication abortion reversal in the same manner that it investigates other alleged deviations from generally accepted standards of medical practice.”
“Reversal” is controversial
Abortion pill reversal is the term anti-abortion advocates use to describe attempts to counteract the effects of the first of two drugs taken during a medication abortion.
It occurs after women have taken the drug mifepristone but before they have taken misoprostol. Doctors typically prescribe high doses of the hormone progesterone in the hopes of reversing the effects of the mifepristone and preserving the pregnancy.
Whether this works is the subject of a furious medical debate. Supporters say there is some evidence that progesterone can counteract mifepristone. Opponents, though, say that the evidence is thin and unreliable. The American College of Obstetricians and Gynecologists has declared that reversal treatments “are not based on science and do not meet clinical standards.”
In recent years, several Republican-led states have passed laws requiring doctors to tell abortion patients that reversal is an option — to the outcry of doctors who say the laws force them to tell patients about an unproven treatment.
Democrats in Colorado took a different approach, passing the nation’s first law declaring abortion pill reversal to be unprofessional conduct. The bill, which Gov. Jared Polis signed into law in April, was amended on the Senate floor, though, to give the medical, nursing and pharmacy boards the authority to override the declaration, but only if they “in consultation with each other, each have in effect rules finding that it is a generally accepted standard of practice to engage in medication abortion reversal.”
The reasoning in the rule
The draft rule rebuffs the legislature by essentially saying that none of this is how the disciplinary process works.
Most commonly the boards act in response to complaints, where they are reviewing an individual situation — often with a specific person who was harmed — to decide whether the care provided meets acceptable standards.
“Each instance of medical care will involve its own unique set of facts that the board must evaluate against the backdrop of evidence-based practice standards,” the draft rule states. “For that reason, the board does not regularly adopt rules establishing a single standard of care applicable to all situations.”
The board notes, though, that medical providers are expected to receive “fully informed consent” from patients prior to performing a treatment. This includes telling patients about the potential risks and benefits, the evidence for and against the procedure, and the likelihood of success. The rule also states that doctors and other providers will be expected to document what they told a patient and keep that information in the patient’s file.
“Licensees are expected to practice evidence-based medicine, and any licensee who provides unscientific treatments that fall below the generally accepted standard of care may be subject to discipline,” the draft rule states.
“Incredibly disappointed”
State Rep. Karen McCormick, a Longmont Democrat who was a prime sponsor of the bill in the House, lamented the proposed rule.
“I’m incredibly disappointed,” McCormick said. “It’s more than disappointing — I’m incredibly concerned.”
She said it’s within doctors’ right to prescribe drugs off label but that there is typically — and should be — evidence that a medicine can be safely and effectively used for a therapy before that happens.
“By not calling it out, they’re giving it their blessing, which I think is problematic,” McCormick said of the draft rule.
State Sen. Janice Marchman, a Loveland Democrat and another prime sponsor of the bill, said she, too, was disappointed in the draft rule but saw some silver linings, including the language around informed consent and substandard care.
But she’s worried about whether Coloradans really know how to file a complaint about medical care and state regulators’ ability to field and investigate those reports.
“I had a lot of questions about what does the complaint process look like?” she said.
Marchman said the part of the bill giving the medical boards a chance to decide was included to appease the governor’s office. “It felt like a big concession for the governor’s office,” she said.
In a signing statement for the bill, Polis noted, “I don’t agree with legislating the practice of medicine,” but wrote that he signed the bill because it gave authority to the medical boards.
A spokesperson for Polis on Friday noted that the nursing and pharmacy boards still must review the practice, as is required by the law. “We are confident that their review will be in line with medical standards as well as Colorado law. The governor believes that standards of care are best managed by practitioners and their respective professional conduct boards, a system that has served Colorado medicine well for decades.”
“Very pleased”
Supporters of reversal treatment were encouraged by the draft rule.
“I’m very pleased,” said Dr. Thomas Perille, a retired internal medicine and hospital medicine physician and president of Democrats for Life of Colorado. “They’re not endorsing it but they’re not saying it’s substandard care.”
Perille provided lengthy testimony to the medical boards in support of abortion bill reversal during a stakeholder meeting last month. He said he will ask the boards in future public meetings to expand the draft rule to be focused not just on providers of abortion pill reversal. Instead, Perille said the rule should also encompass abortion providers and other OB-GYNs.
“I think it also applies to people who are aware of a patient who has changed her mind about abortion and isn’t offered the option of abortion pill reversal by her provider,” he said. “Based on the evidence, it obliges them to discuss abortion pill reversal.”
What comes next
The three medical boards have scheduled a joint stakeholder meeting Aug. 4 to receive public comment about the draft rule.
After that, the boards will meet separately to discuss whether to adopt the draft rule. The Colorado Medical Board is scheduled to hold its rulemaking hearing Aug. 17. The Board of Nursing and the Board of Pharmacy will then follow suit on Sept. 20 and 21, respectively.
Senate Bill 190 gave the boards until Oct. 1 to make a final decision.There’s also a pending federal lawsuit challenging the constitutionality of Senate Bill 190. It was filed by an anti-abortion clinic. There’s no timeline for when the case may be resolved. The state, though, has said it won’t enforce the law prior to the medical boards’ rulemaking.