By MARY SELL, Alabama Daily News
Pending state regulations on a prescription opioid used in non-residential addiction treatment are meant to curb possible “pill mills” and create better treatment for addicts, those working on the rules say.
But some doctors who accept cash for Buprenorphine prescriptions say they fear the regulations are meant to cut them out — and will leave some patients without needed care.
“We’re not trying to be the next pill mill craze,” said prescriber Dr. Richard C. Brown. “We are doing good, we are helping people. That’s what our concern is. With these changes, it is going to limit patient care.”
Buprenorphine, under the brand name Suboxone, is a low-grade opiate. It blocks cravings for opioids, without the same level high as methadone.
Brown is an obstetrician and gynecologist in Foley, but for half a day a week, he’s at the Freedom Center, a Suboxone clinic in Mobile.
“The opioid crisis has effected a lot of people, including women of child-bearing age,” Brown said.
As of November, there were 781 Buprenorphine prescribers in Alabama, according to the Substance Abuse and Mental Health Service Administration, part of the U.S. Department of Health and Human Services. Most are doctors, some are nurse practitioners and physicians assistants.
“We’re not interested in shutting anyone down, but we are interested in regulating the practice in order to create a relative consistent standard of care,” said Dr. Brent Boyett, the founder of Pathway Healthcare, an addiction recovery provider with six locations in Alabama, including Hamilton, Athens and Huntsville. Pathway focuses on medication-assisted treatment that includes counseling.
Boyett helped Sen. Larry Stutts, R-Tuscumbia, draft the bill that calls for increased regulations on Buprenorphine. He now leads the 17-member commission the legislation created that is drafting the rules.
“There is more to treating the disease of addiction than simply writing a Suboxone prescription,” Boyett said recently. Boyett no longer works at Pathway, but is a minority shareholder.
Buprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. These effects are weaker than full opioid agonists such as heroin and methadone.
Buprenorphine’s opioid effects increase with each dose until at moderate doses they level off, even with further dose increases. This “ceiling effect” lowers the risk of misuse, dependency, and side effects. Because of buprenorphine’s long-acting agent, many patients may not have to take it every day.
Buprenorphine has unique pharmacological properties that help:
- Lower the potential for misuse
- Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings
- Increase safety in cases of overdose
Source: Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services
The purpose of the bill and regulations, Stutts said, is to create best-practices for treating opioid addiction “and not just have methadone clinics on every corner but steer people to state-of-art practices that have been proven to be more effective.”
The bill outlines several areas to be addressed through new rules, including dosage and “minimum requirements for counseling, behavioral therapy and case management.” The legislation, approved by lawmakers on the last day of the 2019 legislative session, includes billing records requirements and says records of payments must be kept for three years.
Boyett said the working group’s recommendations will be sent to the Alabama Board of Medical Examiners around Jan. 1. An official draft of the proposed regulations was not available, but an apparent copy has been in circulation, including a proposal against cash payments. That concerns Dr. Gregory Funk and his son, Lincoln Funk, who operate the Freedom Center clinics in Mobile and Montgomery. They accept cash from patients whose addictions range from prescription opiates like Oxycontin to heroin.
“If there is indeed an opioid crisis, we do not need to restrict providers on what really helps patients,” Gregory Funk recently told Alabama Daily News.
He said there are two versions of successful treatment for opioid addiction. Some patients are eventually completely weaned off Suboxone, he said. Some maintain a small dosage indefinitely.
“Not everyone gets off of it, but if they’re gainfully employed, contribute to society, raising family, is not that success?” Gregory Funk said.
And not all those patients want to use their insurance, or have a paper trail on their addiction treatment.
“I would say 10 to15 percent of our patients don’t want anyone in the world to know they have this problem, so they pay cash,” Brown said.
He also estimates that 75 percent of patients became opioid addicts after being prescribed medication to treat an injury or condition.
“I would say 90 percent of them are good people who got sideways somehow,” Brown said.
Boyett said more insurance providers are now covering addiction treatment and one of the things the working group wants to do is “remove the cash culture of some of these clinics.”
“…There are problems in that in that cash is untraceable, it opens itself up to some unscrupulous behavior,” he said.
Re-selling of the drug on the street is a concern, he said.
“We wanted to create a situation where value exchange was at least traceable, not just cash for prescriptions,” said Boyett, who also serves on the Governor’s Task Force on Opioid Addiction and Abuse.
Arrests related to the misuse of Suboxone have been reported in Alabama media. Early this year, at least two people were arrested for mailing Suboxone strips, which resemble breath strips, to inmates at the Madison County jail.
Brown said he agrees that some additional regulations are warranted, but he’s also concerned that a counseling requirement will be expensive for low-income patients.
“I’m a huge believer in counseling, but some of them are on the low-end of the economic spectrum and can’t afford it,” he said.
The Funks said the state shouldn’t be telling any private business how it should to get paid.
“If I don’t want to take insurance, that’s my business,” Funk said.
Boyett said the rules won’t be a prohibition on the uninsured and credit cards are an acceptable form of payment. It’s cash that’s the problem.
“As long as the currency is traceable, I think you will see that the rules won’t prohibit it,” Boyett said.
Lincoln Funk, who manages the Freedom Center clinics, is blunt about what he says is the purpose of the new rules.
“I think they just want to take more business from us and put us out of business,” he said.
The Funks also point out that while this legislation passed in late May and they receive regular correspondence with the Board of Medical Examiners, they just recently found out about the pending rules. They say they don’t know of any of their colleagues with similar clinics who have been invited to participate in discussions.
The rules working group meets Tuesday in Montgomery.
Ultimately, adopting any new regulations or guidelines for Buprenorphine prescribers will be up to the Alabama Board of Medical Examiners. There will be a public comment period before that happens, board general counsel Wilson Hunter told ADN. He said some of the working group’s recommendations will become rules that prescribers must follow, others will be guidelines.
“It will be more rules than best practice guidelines,” he said.
The board organized the working group and sought recommendations for who should be on it, Hunter said.
“There are diverse opinions on this committee,” he said.
While many state agencies are addressing the opioid crisis, it is far from over. In the one-year period between Aug. 22, 2018 and Aug. 22, 2019, at least 540 Alabamians died of opioid drug overdoses, ADN reported last month.
“I feel like we may be getting to the peak of this opioid crisis, but we’re certainly not on the downhill side,” Brown said.