It was an unusual meeting — a top legislator and a group of experts and officials sat around a horseshoe table for almost four hours on June 18 discussing possible regulatory changes to the Drug Addiction Treatment Act of 2000 (DATA 2000). The meeting, which was livestreamed, gave a glimpse into how a key lawmaker gets educated about a topic, while at the same time setting the course for change.

Sen. Carl Levin (D-Michigan) convened the forum along with Sen. Orrin Hatch (R-Utah). Both congressmen had also spearheaded the two laws allowing buprenorphine to be prescribed: DATA 2000, which limits physicians to 30 buprenorphine patients, and the 2006 amendment, which allows physicians to treat up to 100 patients after the first year of treating 30. The group was preselected to be in favor of buprenorphine expansion, with the exception of federal officials, who outlined pros and cons and focused on diversion and other consequences caused by lack of adequate care, including drug tests and counseling, for patients.

Senator Levin opened the meeting by saying there were too few doctors certified to prescribe buprenorphine and stressed that the current opioid addiction problem makes it important to remove as many barriers to treatment as possible.

The forum was only about buprenorphine, and the witnesses had been told to prepare their opening remarks accordingly. The participants included Michael Botticelli, acting director of the White House Office of National Drug Control Policy (ONDCP); Nora Volkow, M.D., director of the National Institute on Drug Abuse; H. Westley Clark, M.D., director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration (SAMHSA); Elinore McCance-Katz, M.D., chief medical officer of SAMHSA; Colleen LaBelle, program director with the office-based opioid treatment with buprenorphine program at Boston University Medical Center; Andrew Kolodny, medical director of the Phoenix House Foundation and president of Physicians for Responsible Opioid Prescribing; John Kitzmiller, M.D., a certified buprenorphine prescriber from Senator Levin’s home state of Michigan; and R. Corey Waller, M.D., a buprenorphine prescriber and founder of the Center for Integrative Medicine at Spectrum Health in Grand Rapids, Michigan, who was also representing the American Society of Addiction Medicine (ASAM). There were also buprenorphine patients who spoke.

After the prepared remarks, Senator Levin and the participants engaged in a colloquy that revealed some of the forces behind buprenorphine expansion, and the concerns about what will happen if in fact the “floodgates are opened,” as Botticelli put it.

Waivered physicians

Under the Harrison Narcotics Act of 1914, physicians are not allowed to prescribe narcotics to treat addiction, which is why opioid treatment programs (OTPs) — methadone is an opioid agonist — are so tightly regulated, allowing only dispensing and only under strict federal and state regulations. The 1914 law is also why DATA 2000 was needed, to allow buprenorphine — also an agonist — to be used in the treatment of opioid addiction. Under DATA 2000, physicians must receive eight hours of training to be “waivered” from the Harrison Narcotics Act, which is enforced by the Drug Enforcement Administration (DEA), and then they can prescribe Schedule III, IV or V controlled substances to treat addiction. Buprenorphine is Schedule III and is only indicated for addiction in this country. Methadone is Schedule II but can be prescribed for pain by any physician with a DEA license.

One theme that emerged was that there are barriers to treating buprenorphine even among the physicians who have been waivered. McCance-Katz said that the main barrier is a “lack of implementation tools.” After meeting with the Health Resources and Services Administration (HRSA) and the ONDCP, SAMHSA concluded that physicians need to understand the induction process better, need training for office staff on how to work with patients with addiction, and need more detailed information on documentation and billing for buprenorphine treatment.

“Only a small number of physicians are electing to use medication-assisted treatment,” said Botticelli. There are more than 25,000 waivered physicians, of whom about 2,500 are allowed to treat up to 100. But most of the 20,000 aren’t treating anybody.

SAMHSA’s role

Prior to DATA 2000, the only treatment for opioid addiction was in methadone programs and the only office-based treatment was with naltrexone, said Clark. DATA 2000 made it possible for patients to get treatment “in the privacy of a physician’s office,” and SAMHSA certifies the physicians who prescribe it, as well as certifying OTPs. The Department of Health and Human Services (HHS) “is considering the need for changing the cap,” said Clark, noting that the lack of physician access in underserved areas is a problem.

What is needed, more than the lifting of the cap, is more physicians to prescribe buprenorphine, said Clark, noting that there are already 20,000 doctors who could treat up to 100, but who aren’t — they are sticking with the 30, and most of them aren’t even treating one patient.

Another theme was that of changing times, with some witnesses suggesting that the new treatment population for opioid addiction is people who got into trouble with prescription pain medication and who are better candidates for office-based treatment than for OTPs. “Before DATA 2000, people suffering from opioid addiction were disproportionately African American and Latino, from poor districts,” said Kolodny. “Nobody paid attention to them.” Now, however, he said many people get addicted to opioids by being overprescribed pain medication, and progress to injecting heroin.

Problems with expansion

Because the forum was geared toward the topic of expanding buprenorphine treatment, and the witnesses had been told to be prepared to discuss the barriers to such expansion, Senator Levin didn’t seek out comments about the problems with buprenorphine expansion, and in fact his questions and comments were all geared toward removing the barriers. But after Botticelli, Clark and Volkow explained some of the problems with unmitigated expansion, he pulled back slightly, concluding that should be undertaken but “with caution.”

In OTPs, one physician can be responsible for up to 300 patients. Senator Levin asked why the cap couldn’t be similar for buprenorphine.

At this point, Clark stepped in, reminding Senator Levin that in the process of passing DATA 2000, lawmakers were concerned about creating pill mills. “We are dealing with the issue of addiction, not simply a medication,” he said. “The risk of diversion, or of comorbidity with benzodiazepines, could go up,” he said. “While the system has tolerated the modest diversion that has occurred because of access issues, once that lack of access disappears and diversion goes up, then you have the backlash.”

LaBelle said that there are serious problems with getting rid of limits. Physicians with a lot of patients may become pill mills, and then get shut down, so there are hundreds of patients whose source of medication is cut off. “We have many places we can send patients so they don’t go into withdrawal,” said LaBelle.

“The concept of backlash by opening up the floodgates is not theoretical,” said Botticelli. “As buprenorphine expands, there’s been a backlash, even with the 100-patient limit,” he said, noting that even now states are imposing restrictions on buprenorphine.

Senator Levin, who seemed to equate OTPs with buprenorphine despite there being a strict regulatory system for OTPs, asked if there was a backlash against methadone too, and Botticelli said there isn’t because it’s already “so heavily regulated.” But the physicians prescribing buprenorphine have no such regulations, and may indeed only be handing out prescriptions. “What is the physician support?” asked Botticelli. “Are they doing urine testing, are they doing pill counts, are they ensuring patients are getting access to other behavioral therapies?”

Lack of access

Volkow said that 95 percent of buprenorphine diversion is due to lack of access to the medication — that people are buying it on the street to forestall withdrawal. Whether the same could be said for other opioids bought on the street is unclear. The implication is that if these users could have access to buprenorphine, the diversion wouldn’t happen. Only 5 percent is due to patients seeking euphoria.

Diversion of buprenorphine isn’t being used recreationally by people who are opioid-naïve, said Kolodny, who thinks buprenorphine should be more available.

But when Kolodny said that it’s difficult to overdose on buprenorphine, Volkow stepped in to correct him. The situation in Europe, where buprenorphine is used for pain, has proven that buprenorphine combined with benzodiazepines does result in overdoses, she said. Then, Senator Levin asked why buprenorphine can’t be used for pain, and Volkow described another way in which buprenorphine can cause overdose — it’s so slow-acting that when the pain doesn’t go away after the first pill, the patient may take another, and another. “The dose accumulates and it can result in overdose,” she said.

Other issues

The use of nurse practitioners (NPs) to increase buprenorphine prescribers was also discussed. Senator Levin asked if it made sense that nurse practitioners can prescribe opioids for pain but can’t prescribe buprenorphine for addiction. “No, it does not make sense,” said Kolodny. McCance-Katz noted that NPs can’t prescribe buprenorphine but can perform other addiction treatment functions.

The DEA works in conjunction with SAMHSA on certifying physicians, but Kolodny wants to eliminate the DEA visit to buprenorphine doctors, which he says discourages new physicians from signing up.

Waller said that his addiction patients are “treated terribly” in the general medical system, and he thinks that this shows the stigma and discrimination among physicians that is another barrier.

In fact, the physicians who treat 100 seem to be the ones who focus on addiction — which was not necessarily the way the system was set up. “So at 30 you’re not an addiction doctor but at 100 you are?” asked Senator Levin.

Patients prefer to go to the 100-cap physicians, because these are the doctors most enlightened about addiction. Asked how patients know whether a physician has 100 instead of 30 patients, Waller said that “it’s the word on the street.” Because buprenorphine combined with naloxone can’t be started until the patient is in withdrawal, induction is something that physicians familiar with addiction are more comfortable handling.

He noted that he stays in the high 90s in terms of patients but has primary care physicians that he hands stable patients over to so he can keep taking new patients.

Regulatory fix

Senator Levin asked whether there was authority to increase the patient limit, so that he and Senator Hatch did not have to go the legislative route. “We believe the secretary [of HHS] through regulatory exercise may be able to increase the limit,” said Clark, telling Senator Levin that “we are briefing her as we speak, and we will let you know.”

Waller said that ASAM would take on Senator Levin’s questions about what the hurdles are in insurance to buprenorphine.

Training

Senator Levin also asked whether it was possible for the SAMHSA website to indicate what physicians are prescribing buprenorphine, or who have openings available for patients. But McCance-Katz said physicians don’t want their names published — they don’t want to deal with the annoyance of phone calls.

“We would need staff and funds for that because the list would need to be maintained,” added Clark.

There was also a discussion about training not being more available, with Kolodny complaining that any doctor who wants to get trained should be able to get it for free. In fact, SAMHSA offers free training through its Physician Clinical Support System (PCSS), and two of the groups named in DATA 2000 don’t charge for training. The other groups, including ASAM, do charge, however, and Clark said that in at least one case, the revenue from these trainings is significant. Physicians must belong to the medical society that is providing the training.

Still, training is only $200. “That’s an impediment?” asked Senator Levin, incredulously. “A lot of doctors won’t do it,” said Kolodny. McCance-Katz noted that SAMHSA gets no money from the trainings, but that groups that provide them under DATA 2000 can charge if they want.

Clark said the problem is not the cost of the training, it’s the fact that doctors aren’t interested in treating addiction. “The issue is whether I want to be bothered with the patients,” he said. They don’t mind paying for the junkets they go to for Continuing Medical Education (CME), he said. Physicians have “no problem paying to take the family to an event for CMEs and spend the afternoon on the golf course,” he said. “But if I don’t want to be bothered with the patients, then two hundred dollars for eight hours of training is prohibitive.”

Kolodny criticized President Obama for not speaking about the issue of opioid deaths, and Senator Levin said the issue was a good one for Mrs. Obama to take on.

Stay tuned.

For the forum, which is now on YouTube, go to https://www.youtube.com/watch?v=dXpFFwC-nZQ.