The final revised guidelines for opioid treatment programs (OTPs) were released March 31 by the Substance Abuse and Mental Health Services Administration (SAMHSA). Timed to be issued at the conference of the American Association for the Treatment of Opioid Dependence (AATOD), the guidelines contain a huge disappointment for OTPs: mid-level practitioners will not have the same medication-ordering authority as physicians.
The draft of the guidelines, released for public comment in May of 2013, said that mid-level practitioners (physician assistants and nurse practitioners) would have this authority. AATOD strongly supported this, and sent in comments saying so.
Most OTPs already knew about the bad news by the time they got to AATOD. Melinda Campopiano, MD, medical officer for SAMHSA’s Center for Substance Abuse Treatment (CSAT) and others went to the AATOD board meeting in December 2014 to explain why the provision in the draft allowing the medication-ordering authority of mid-level practitioners had to be eliminated.
Ron Jackson, MSW, AATOD board representative on the expert panel that put together the guidelines, told AT Forum that the regulations have always referred to “qualified health professionals,” a term that was “never really defined.”
Mr. Jackson’s main mission in terms of the guidelines was to make sure that mid-level practitioners could have medication-ordering authority, in the states that had already decided that mid-levels could have such authority. His point was logical: “How can you constrain mid-level practitioners from doing work inside the OTP that the state had decided they could do outside the OTP?” These guidelines were put together when Nicholas Reuter was still at CSAT, and Mr. Jackson had “conversation after conversation with Nick about this.”
Nowhere in the OTP federal regulation (42 CFR) does it say that the person who orders the medication has to be a physician, said Mr. Jackson.
However, SAMHSA didn’t vet the draft through agency counsel before they put it out for public comment. When they did, SAMHSA lawyers disagreed, noting that the implementing regulation says that “dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling.” This is the line that CSAT is relying on in saying that physicians are the only ones who should be able to order the medication initially and make dose-change orders.
Reached after the AATOD conference, Dr. Campopiano explained that originally, SAMHSA had hoped that extending medication authority to mid-levels would help some states and areas where physicians were in short supply. This is in fact exactly what OTPs have been saying.
How to Get An Exemption
When the lawyers said this couldn’t be done, SAMHSA started working on a way to help OTPs. Dr. Campopiano explained how it can be done. She cited CFR Part 8, 811, Section H, which discusses exemptions. “It spells out fairly clearly that you have to provide a justification for the exemption, and that the exemption has to be approved by the state,” she told AT Forum. Then, the request for the exemption goes to SAMHSA. “We do ask that the state make a decision before this request is presented to us,” said Dr. Campopiano.
In most states, the State Opioid Treatment Authority (SOTA) would be the starting point for getting the approval for the exemption. The single state authority (SSA) or the director of the health department might be the one to give the final approval, but the “SOTA is likely to be the most knowledgeable person” about OTPs.
The exemption would be per program, not per patient, said Dr. Campopiano. “It’s not like getting take-homes. What we’re contemplating is that we would approve an exemption for the period that the program is certified by SAMHSA.” That means, she noted, that SAMHSA would look at the exemption again at recertification.
Some states may have OTP regulations that specifically don’t allow mid-level involvement with medication decisions, which is why SAMHSA wants the state to approve the exemption first. “There is also some discretion at the level of the state to put stipulations in if they feel it’s necessary,” said Dr. Campopiano.
The first state that applies for the exemption will take the longest, said Dr. Campopiano. “I have a feeling the learning curve will be steep at first.” But once the first state has been through the process, it should be smoother.
Guidelines, Not Regulations
Dr. Campopiano stressed that the SAMHSA accreditation guidelines are just that─guidelines, not regulations. “The process for rewriting regulations is even more onerous,” she said. Dr. Campopiano was not at SAMHSA during the writing of the initial draft, but does know that the problems of physician-supply have not improved since then, and the demand for treatment is still growing.
There are many areas of health care in which mid-levels are being more widely utilized. OTPs don’t think they should be left out of the trend. And SAMHSA, of course, is a strong supporter of expanding access to health care.
“We do have more people who have insurance coverage and have every reason to be able to receive care under that insurance,” said Dr. Campopiano. “The demand for quality care is great, and it’s unlikely that physicians alone can meet it. So this is just evidence that our relatively small field is nevertheless part of the bigger picture.”
“We do know that the current capacity for medication-assisted treatment (MAT) is inadequate to the need,” said Dr. Campopiano. “All forms of MAT need to be made more available─I mean buprenorphine, methadone, and extended-release naltrexone [Vivitrol],” she said. All three medications could be given in an OTP; only buprenorphine and naltrexone could be given in an office-based setting.
“It is necessary to assess the patient and decide which pharmacotherapy is appropriate,” said Dr. Campopiano, adding that many patients present for methadone “because they’re not aware of other options.” These patients “deserve an opportunity to know what their options are in a way that is individualized to their own needs.”
However, the reality is that methadone as a medication costs a fraction of the price for buprenorphine or Vivitrol, and unless payers are going to pay OTPs for the cost of the medication, it’s unlikely that they will be able to provide it, she admitted. “Resources are always going to be part of the equation,” she told AT Forum. “So having a discussion with the patient about what options are available in terms of pharmacotherapy, and what would be involved in getting access to those pharmacotherapies, is important. If one medication is covered by insurance, that will go into the decision.”
At Evergreen Treatment Services in Seattle, Washington, and throughout Washington State, the “mid-level” practitioners have been given controlled-substance authority from the state, said Mr. Jackson. But he would like to see this more widespread, and he is encouraged by CSAT’s willingness to work with states and OTPs on the issue.
But in general, OTPs “were disappointed with the whole process” of developing the accreditation guidelines. “It took so long, and it was torturous,” said Mr. Jackson.
“Many people who review our documents are outstanding researchers and scientists, but not that familiar with opioid agonist therapy and the regulatory environment,” said Dr. Campopiano, explaining why the process of getting out the guidelines has taken so long. “The fact that we had to revise it didn’t help─people needed time to regain some confidence in the process.”
At this point, Dr. Campopiano is happy about moving ahead. “I look forward to working with the states and the programs to get things operational in a way that increases capacity,” she said.
For the revised guidelines, go to Federal Guidelines For Opioid Treatment Programs March 2015
or the final rule, issued in 2001, governing OTPs, go to http://www.dpt.samhsa.gov/pdf/regs.pdf