Over the summer, steps have been taken to increase the “cap”—the number of patients a physician can treat—with buprenorphine/naloxone. The American Association for the Treatment of Opioid Dependence (AATOD), opioid treatment programs (OTPs), and other national organizations watched the proceedings with concern, because there is no validation of whether most office-based physicians are providing comprehensive care for their patients.
Under the Drug Addiction Treatment Act of 2000 (DATA 2000), which made it possible for physicians to treat opioid addiction with an opioid outside of an OTP, a single physician could have 30 patients on buprenorphine. The law was amended to allow physicians to have up to 100 patients after one year (DATA 2006). The American Society of Addiction Medicine (ASAM) says that the cap is unfairly keeping patients out of medication-assisted treatment.
As H. Westley Clark, MD, who until his retirement October 3 was director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA), said at a June 18 congressional buprenorphine forum sponsored by Sen. Carl Levin (D-Michigan), “We are dealing with the issue of addiction, not simply a medication.” Dr. Clark added that the same concerns about diversion that led the original DATA 2000 law to cap patients at 30 are still present.
And even though buprenorphine has a safety profile that makes it unlikely for someone to overdose on that drug only—due to the “ceiling effect”—when combined with other drugs or alcohol, that safety profile might not be present; in particular, Dr. Clark cited benzodiazepines. The federal government never wanted to create “pill mills,” he said. But without pill counts, urine tests, and other aspects of treatment, especially in early treatment, it’s not clear that diversion would be prevented.
Lack of Comprehensive Treatment?
It’s not that expanding office-based buprenorphine is a threat to OTPs, so much as it is a threat to effective patient care. “It’s a threat to how comprehensive opioid addiction treatment should be provided to the patient, based on long-held research principles and clinical practice,” AATOD president Mark Parrino, MPA, told AT Forum. “On the one hand, you have OTPs providing comprehensive addiction treatment for patients.” OTPs are regulated by the State Opioid Treatment Authorities (SOTAs), as well as by SAMHSA and the Drug Enforcement Administration (DEA). “OTPs will continue to provide comprehensive services, but on the other side of the fence, with office-based buprenorphine, there’s very little oversight to guide therapeutic practices.” SAMHSA certifies office-based buprenorphine physicians, but leaves clinical practice up to the physician. This is far different for OTPs, who have many mandates from SAMHSA and the states. Everyone who dispenses and prescribes controlled substances is audited by the DEA, including OTPs and buprenorphine physicians.
Some OTPs don’t think there would be a problem with raising the cap from 100 to 150. But any more than that would be a problem. “My sense is this is a done deal,” said Jerry Rhodes, CEO of CRC Health Group. “I don’t know what the number will be, but the cap will be lifted.” While CRC is always in favor of increasing access to treatment, that isn’t what increasing the buprenorphine cap would do, he told AT Forum. “This isn’t increasing access to treatment, this is increasing access to medication,” he said.
Everyone should be concerned about patient care problems, but if the increase is to 150 patients, that would not be as worrisome, said Mr. Rhodes. “However, if you’re going to do a tripling or a quadrupling, then there’s a major concern, because you could see patients not getting good clinical intervention, and there would be diversion.”
ASAM’s View
We asked ASAM for a source to discuss the cap with, and they recommended Kelly Clark, MD, who spoke at a September 22-23 buprenorphine summit sponsored by SAMHSA. She was medical director for Behavioral Health Group until the second day of the summit.
ASAM is supporting a trial of increasing the cap to 250 patients per physician for a year, and then going to 500 patients per physician, she told AT Forum.
But the current 8-hour training for buprenorphine-certified physicians is insufficient to treat higher numbers of patients, she said. So ASAM is advocating for a training program lasting at least 40 hours, according to her. In addition, training would have to cover aspects of addiction medicine, including motivational enhancement and drug testing. ASAM does not favor regulations that would require that these aspects of addiction treatment be performed, but physicians would have to be trained in them. ASAM will be issuing new medication-assisted treatment guidelines next spring, which would apply to methadone, buprenorphine, and Vivitrol.
One of the arguments against raising the cap is that most physicians with waivers aren’t even using them. ASAM ‘s Dr. Clark conceded that this is a problem, but said that one reason is that physicians don’t want to deal with the DEA. So ASAM is also recommending that buprenorphine practices be audited by SAMHSA rather than by the DEA. “We also know that there are a few doctors who are going over the 100-patient limit, which is problematic,” she said.
Diversion
There’s no question that buprenorphine is diverted, and not just for people trying to stave off withdrawal, said ASAM’s Dr. Clark. “It’s diverted, and it’s diverted for people to use to get high,” she said. “We know the combination products are used intravenously.” This is a serious problem, because the naloxone was supposed to make it impossible for someone to inject the medication and have any euphoria. “But in reality, the naloxone is very short-lived in relation to the buprenorphine,” she said, adding that another problem is that buprenorphine has, in some cases, been a gateway drug leading to other drug abuse.
There have been cases in which patients were getting high doses of buprenorphine, and found to be diverting for profit what they didn’t need, according to ASAM’s Dr. Clark. In addition, some patients present histories in order to get buprenorphine, and then divert it. “The payers don’t want to be subsidizing diversion.” And it’s not only a matter of philosophy: payers are required by the DEA to monitor pharmacists who dispense controlled substances, she said.
The Number
Mid-summer there was a gathering in Boston with federal officials present that resulted in legislation being proposed by Sen. Ed Markey (D-Massachusetts), which would allow buprenorphine physicians to treat an unlimited number of patients. Senator Markey, whose bill would eliminate the cap completely, hosted the meeting.
SAMHSA says that legislation isn’t even necessary, that it has the ability to raise the cap without it. What the new number would be is unclear. In addition to the Markey bill’s “unlimited” number, other numbers being discussed are 250, 300, and 500 patients.
At the September 22-23 buprenorphine summit, it was clear that the logistics, and not the policy, of raising the cap was the agenda. At that summit, AATOD’s Mr. Parrino and other national association leaders were not allowed to speak. No OTPs were represented on the panel. There was a recurrent theme throughout the summit that more-effective care was offered to patients in DATA 2000 practices that had clinical and administrative support services. Illustratively, Anthony Folland, who serves as the SOTA from Vermont, discussed his state’s “hub and spoke” model, in which Vermont provides funds to have “embedded counselors” in DATA 2000 practices.
Mr. Parrino told AT Forum that without proper debate, everything that is known about addiction treatment may be set aside in the interests of showing some response to the opioid epidemic.
“I see this as the struggle for the heart and soul of what good treatment really is,” said Mr. Parrino. Yes, opioid addiction treatment needs to be made more accessible, in all parts of the country. But the policy debate about how to do that “has been overtaken by special interests, and that has replaced thoughtful policy deliberations,” he said. “Now people are in a panic, and the general feeling is that ‘we have to do something.’ When this turns bad, many of these decision-makers won’t be around to be held accountable.”
If an opioid-addicted patient wants medication, there are three choices, explained Mr. Parrino: medication in a DATA 2000 practice “where practitioners don’t have to do drug screens or provide counseling,” and patients visit once or twice a month; going to an OTP that has to follow guidelines and requires counseling and urine tests; the third choice is Vivitrol. An untreated patient is likely to choose a treatment intervention that is less-demanding with regard to medical care and compliance. This presents a potential threat to the stability of the entire treatment system.
In fact, SAMHSA has been under great pressure to respond to the opioid epidemic by raising the buprenorphine cap. ASAM, with support from the American Medical Association, agrees. The basic argument is that no physician treating any disease should have any limits on the number of patients they can treat.
It’s clear that SAMHSA is following the lead of Senators Levin and Markey by heading toward lifting the cap, and not talking about expanding access to OTPs. The “political energy” is behind lifting the cap. Whether that will be done by regulatory or legislative means is unclear, but both paths are now open to SAMHSA.
See related blog by Dr. Jana Burson – Office-based Opioid Addiction Treatment: Raising the One-hundred Patient Limit available at: http://janaburson.wordpress.com/2014/10/20/office-based-opioid-addiction-treatment-raising-the-one-hundred-patient-limit/
See related blog by Dr. Jana Burson – Expanding Access to Buprenorphine available at: http://janaburson.wordpress.com/2014/10/26/expanding-access-to-buprenorphine/