What’s New in the Draft Opioid Treatment Program Federal Guidelines: Midlevel Providers and the Importance of Recovery and Retention

guidelinesUnder the federal draft guidelines for opioid treatment programs (OTPs) issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) May 16, nurse practitioners (NPs) and physician assistants (PAs) are explicitly given a much bigger role in methadone induction and dosing, something that medication-assisted treatment (MAT) advocates hope will be embraced by state accreditation authorities and recognized by the Drug Enforcement Administration (DEA).

AT Forum interviewed Ron Jackson, LICSW, who retired in December 2012 as executive director of Evergreen Treatment Services in Washington State, and H. Westley Clark, MD, director of SAMHSA’s Center for Substance Abuse Treatment (CSAT), about the impact of the guidelines on OTPs across the country. The interviews took place before the comment period closed July 16.

“We know that the Affordable Care Act (ACA) is going to create demand on many OTPs to take on additional patients with health insurance, and it’s going to force OTPs to think about how they’re going to deliver services,” said Dr. Clark. None of this was foreseen in 2007 when the last guidelines came out, but now, areas across the country will be facing physician shortages, he said.

Many OTPs are already using midlevel providers for this purpose, said Mr. Jackson, who was the representative from the American Association for the Treatment of Opioid Dependence (AATOD) for the committee that developed the draft guidelines. There is nothing in the regulations governing OTPs that prohibits it, and some state accrediting bodies specifically allow it. (The regulations, issued by SAMHSA in 2001, do require that the medical director be a physician.)

3rd Revision

This is the third set of federal guidelines for OTPs. The first set of guidelines was released in 1999, two years before the final rule governing OTPs was issued. In 2007 the second set of guidelines was released. The final guidelines are expected in time for the AATOD conference in Philadelphia November 9-13.

The guidelines were created by consensus, starting in January of 2012 when a committee convened to work on the guidelines revision, said Mr. Jackson, who served on the second revision committee as well. The committee included SAMHSA representatives, State Opioid Treatment Authorities (SOTAs), patient advocates, and OTP medical directors. After that, the bulk of the work was done by conference call and e-mail exchanges of drafts, said Mr. Jackson.

Nicholas Reuter, MPH, was the CSAT representative most closely involved with the guidelines revision, said Mr. Jackson. (Mr. Reuter left CSAT in February and went to work for Reckitt Benckiser, manufacturer and marketer of Suboxone.)

Message to the DEA

The guidelines are just that—unenforceable guidelines—but SAMHSA expects them to be used to direct state accreditation policies. “Our hope is that the accreditation bodies will adopt these guidelines and make them enforceable by the accreditation bodies themselves,” said Dr. Clark, adding that states often pay close attention to what is happening at the federal level.

In addition, Mr. Jackson hopes that the DEA will take the message from the guidelines that indeed, midlevel providers are allowed to do inductions. “We need to always keep in mind that we have to negotiate things with our colleagues at the DEA,” said Dr. Clark. The DEA was involved as an “outside commenter or editor” in the draft guidelines, according to Mr. Jackson. “I’m trying to be optimistic about it,” he said of the DEA’s approval of midlevels.

“From AATOD’s perspective, it was my job to make sure midlevels got the responsibility they needed,” said Mr. Jackson of his role in developing the guidelines. “I was upset by the Dear Colleague letter that said physicians had to do the face-to-face.” In fact, “qualified health professionals” are authorized to do the face-to-face contact in the state of Washington and under the federal rules governing OTPs, he said. (That Dear Colleague letter was sent to OTPs in September, 2007. For a link, go to http://www.dpt.samhsa.gov/pdf/dearColleague/09-04-07%20DearColleagueLetter%20on%20Dosing.pdf.)

Mr. Reuter was the among the more resistant committee members when it came to giving midlevel people this authority, said Mr. Jackson. But in Washington State, NPs and PAs have Schedule II prescribing authority (methadone is Schedule II). Mr. Jackson’s argument to Mr. Reuter was always, “How can you constrain them from doing inside a facility what they do outside?” When the Dear Colleague letter came out, Mr. Jackson didn’t change what he was doing at Evergreen —having midlevel people perform the face-to-face contact. “I don’t know if other people did,” he told AT Forum. “My midlevels have been doing this for 20 years. You can imagine how many inductions they’ve done.”

Having midlevel people do the face-to-face contact is going to become the standard model, because there aren’t enough physicians, said Mr. Jackson. And if the midlevels are sufficiently qualified and trained, and supervised by the medical provider, patient care won’t be diminished. “I wouldn’t have been promoting this if I thought any patients would be harmed,” he said. “If you had to have physicians do all this work, that’s how patients would be harmed—you wouldn’t be able to find enough physicians, so you would have to limit the number of patients.”


A section in the guidelines on the use of telemedicine remains vague because of “a big discussion with the DEA” about the degree to which medication ordering has to be face-to-face, said Mr. Jackson. One of the biggest challenges for OTPs is siting. “It’s really hard to get new methadone clinics open,” he said, noting that the “classic Not in My Back Yard (NIMBY) syndrome” is endemic. In the northwest, where heroin addiction is raging, there is a pressing need for OTPs, especially in rural areas. But Mr. Jackson was unable to open a clinic even in Bremerton, one of the least populated areas of the state.

“Nick took on the responsibility to put telemedicine in there, as a placeholder,” said Mr. Jackson, noting that the DEA is particularly skittish of orders via telemedicine. “If the ACA is going to be successful, and I hope it is, it’s going to force us to do things somewhat differently. I think telemedicine is going to be a big part of that.”

Recovery, Retention

Another new section of the guidelines refers to Recovery Oriented Systems of Care (ROSC), which explicitly refers to the work of William L. White. The section emphasizes that people in methadone maintenance are in real recovery, said Mr. Jackson.

The guidelines also stress the importance of retention in treatment, as a part of recovery. This means that sometimes, especially in early treatment, patients shouldn’t necessarily be discharged for abusing benzodiazepines, for example. “People who come to OTPs have had years of drug use, chaotic lives, and come in with multiple health problems that have been undiagnosed and untreated,” said SAMHSA’s Dr. Clark. “Turning people’s lives around doesn’t happen overnight or in a vacuum.” With the ACA’s focus on health homes, retention in treatment is a key indicator of a good outcome, he said. (A health home is the one place where a patient gets all health needs attended to, either directly or via connections to specialists. OTPs can be health homes.)

Being in treatment is better than not being in treatment, said Mr. Jackson, and he was glad that there was a focus on the importance of retention. But he is also wary of keeping patients on methadone if they are also abusing benzodiazepines uncontrollably. “The great dilemma we have is that sometimes it gets dangerous to continue to dispense methadone,” Mr. Jackson said. “Sometimes patients are their own worst enemy.

As the ACA takes effect and OTPs see many more patients come through their doors, they should look at the guidelines as a way to provide comprehensive care, said Dr. Clark. “We’re stressing the importance of OTPs as medical providers, and not just dose-and-run.”

For the Federal Register notice, the draft guidelines, and the accompanying Dear Colleague letter, go to http://www.dpt.samhsa.gov/pdf/FederalGuidelinesforOpioidTreatment5-6-2013revisiondraft_508.pdf, and http://www.dpt.samhsa.gov/pdf/dearColleague/DearColleagueAccredGuidelines5-16-13.pdf.

 For AATOD’s response to the Draft Guidelines dated July 12, go to http://www.aatod.org/wp-content/uploads/2013/07/Reduced-Size-WashingtonSmith-SAMHSA_Ltr071213-21.pdf.