Dose-capping—limiting the amount of methadone a patient can take on a daily basis—was ruled “contrary to the current state of the medical literature and the principle of individualized treatment” in 2007 by the Substance Abuse and Mental Health Services Administration (SAMHSA) in the Federal Guidelines for Opioid Treatment. So it’s surprising that it still goes on.
Some patients metabolize medications faster, so need higher doses for therapeutic effectiveness. There are also interactions with other medications the patient may be on, requiring higher doses.
From the guidelines, promulgated by SAMHSA’s Center for Substance Abuse Treatment (CSAT): “Program-wide dosage caps or ceilings are contrary to the current state of the medical literature and the principle of individualized treatment. Programs should eliminate their use. In addition, opioid treatment programs (OTPs) should avoid establishing procedures or policies that hinder the ability of physicians or authorized healthcare professionals, as appropriate, to adjust patient dosages whenever the need is indicated.”
And: “The Federal Guidelines for Opioid Treatment Programs advises against dosage caps. Medical evidence does not support their use. For additional information, access TIP 43 (http://staging3.atforum.com/documents//MAT-TIP_43-MMT_Guidelines2005.pdf). Educating OTP physicians and staff appears to be the best approach for encouraging individualized treatment without dosage cap restrictions.”
Accreditation Standards—CARF and The Joint Commission
Although the federal guidelines are just that—guidelines—accreditation bodies take them seriously. The Joint Commission, for example, is in the process of revising its OTP accreditation standards to align with the 2015 revised Federal Guidelines for Opioid Treatment Programs. “The language contained in the revised guidelines is written clearly, prohibiting program-wide dosage caps or ceilings,” said Megan Marx, MPA, associate director for Behavioral Health at The Joint Commission. “This language will be reviewed and assimilated into The Joint Commission’s accreditation standards for opioid treatment programs.”
The Joint Commission surveys OTPs “with regard to appropriate, individualized dosing in OTPs, taking into account the potential effects of atypical metabolic patterns, the synergistic effect of other prescribed medications, and other possible concurrent health conditions,” added Ms. Marx. “The accreditation standards require that the OTP monitor patients to determine the effect of their medication(s), that the maintenance dose be individually determined based on this monitoring, and that physicians evaluate each patient’s response to take-home medication and adjust the dosage, if adjustment is needed, at regular intervals.”
Bettye Harrison, MSW, account manager for OTPs at CARF, said that dose-capping is usually encountered by CARF surveyors “through conversations with the medical director or nursing staff, or in the review of the records,” all done as part of the survey. The CARF survey also involves patient interviews, where dose-capping may come up. If the physician is the source of the dose-capping, the CARF surveyors would “provide consultation that this is not considered good practice,” said Ms. Harrison. If the handful of records pulled show that no patient is getting more than 80 or 90 milligrams a day, the surveyors may “randomly pull some more records, and then ask the question” about dose-capping, she said. Dose-capping per se does not put the OTP’s accreditation at risk unless there are patient reports, said Ms. Harrison. “It is one single element, and one single element does not put their accreditation at risk, as long as surveyors are not having patients report to them that the dose is not sustaining them.”
But that is exactly what is happening. While the prohibition on program-wide dose caps may have resulted in policy changes in OTPs, in practice, dose-caps still exist—sometimes sanctioned by the state—such as is the case in Tennessee.
Tennessee is a case study in state-encouraged, if not state-required, dose-capping. Ms. Harrison and Zac Talbott, CMA, who is the Director of the Tennessee statewide and Northwestern Georgia Chapter of the National Alliance for Medication Assisted Recovery (NAMA-R) as well as the Administrator of the Peer Recovery Network of the Medication Assisted Recovery Services (MARS) Project, led a roundtable discussion on dose-capping at the AATOD national conference in March. The topic was chosen because Mr. Talbott, who was on the workshop committee, reported to the committee on dose-capping stories he was getting from patients around the country—especially in the Southeast. Ms. Marx, also on the committee, recommended that Ms. Harrison speak for the accreditation community.
In Tennessee, under regulations implemented in 2012, any dose exceeding 120 mg requires prior authorization of the State Opioid Treatment Authority (SOTA). Even for patients who are getting 100 mg, the SOTA must be notified.
The former SOTA, a PharmD (not a physician), left in early May for a position in the private sector. There is currently an interim SOTA.
But in practice, it has been Ira Lacy, whose title is Opioid Treatment Program director in the Division of Substance Abuse Services in the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS), who is making decisions about doses.
The 190-mg Patient
One patient in Tennessee, a fast metabolizer, was required by the state to have a peak and trough testing, which involves daily dosing at the clinic for three to five days, at the exact same time. Blood tests are done to identify the high and low levels of the medication.
For this patient, peak and trough testing was a hardship, since he had one-week take-homes. He also had to pay for the testing himself—all OTP treatment in Tennessee is cash-only, since the state’s Medicaid program doesn’t cover it. The peak and trough testing was $50 each time—on top of the $400 a month for treatment. For each additional 10 mg, the state required another round of peak and trough testing. And with each round, the testing showed that the methadone levels were sub-therapeutic.
“He finally got up to 190 milligrams, which is unheard of in Tennessee,” said Mr. Talbott. “He got there because he stuck it out.” Most patients can’t afford the time or the money for peak and trough tests, added Mr. Talbott. But the 190 mg were still not enough to hold the patient, who requested another 10 mg.
Mr. Lacy then spoke with the patient on the phone, saying, according to Mr. Talbott, “I just don’t want you to be on this stuff the rest of your life,” and trying to persuade him to taper. “The patient, who is well educated, said, ‘I can’t think about tapering until I’m stable,’” Mr. Talbott recalled. So at that point, Mr. Lacy said the patient could have 10 more milligrams, but would have to come to the clinic every day for 30 days. The patient couldn’t do that—he had a job, and the trip to the clinic took two hours round trip.
“Tennessee says they don’t have a dose-cap, but look at this patient on 190 milligrams, at what they put him through, and what he had to pay,” said Mr. Talbott. “To this day he’s stuck at 190.”
We spoke with Mr. Lacy in a conference call, along with Howard Burley, MD, assistant commissioner for the Division of Clinical Leadership in the TDMHSAS, in mid-May. Mr. Lacy remembered the conversation with the patient. “I’m passionate about this program and what I’m doing, and about the patient,” he said. “What I wanted him to understand was, the higher you go up, the harder it would be for him to lead a normal life. What’s a normal life to him may be different from me. I don’t want him to be in a fog all day every day in his life.”
At this point in the call, Dr. Burley interjected that indeed, high doses are sometimes needed. “I can’t dispute the fact that there are people who are rapid metabolizers who may go up to 250 milligrams or greater dosing per day,” he said. “We don’t dispute that those people exist. The only problem is the longer you’re on it and the higher the dose, the harder the process is to taper.”
Dr. Burley, who wasn’t familiar with the case, said that in addition to the peak and trough testing, the state would look at the patient’s “overall level of functioning,”
Dr. Burley also said that it would have been helpful for the patient’s clinic “to provide information to support” the patient’s need for an increase. “The clinic needs to be a patient advocate,” he said. “All they need to say is that they’ve done peak and trough testing, and they need to go up to a higher dose.”
Gaps in Accreditation
It’s situations like Tennessee’s that complicate surveys for the accrediting bodies. The Joint Commission and CARF do go further than just looking for program-wide dose caps. “OTPs are surveyed to determine if they are developing individualized treatment plans that reflect the assessed needs, strengths, preferences, and goals of the individual served,” said the Joint Commission’s Ms. Marx.
But if a state has a dose cap—which is the effect of Tennessee’s policy—there is little CARF can do about it, said Ms. Harrison. “We couldn’t tell an organization to violate state regs.” If the medical director has to get approval from the SOTA to go above 120 milligrams, then CARF can’t hold the OTP accountable, she said.
In addition, CARF can “provide the doctor with education, but I can’t second-guess a doctor’s decision,” said Ms. Harrison. “I can tell the doctor that CSAT doesn’t think there should be dose-capping, but all any of us can do is try to educate the doctor and move him or her to a comfort level” that allows for prescribing higher doses. “In addition, we can’t hold the doctor accountable; we have to hold the organization we accredit accountable,” she said. “We make it known to the leadership of the organization that the doctor may be dose-capping, and then it becomes the organization’s responsibility for the follow-through.”
In reality, dose-capping is rarely reported by CARF surveyors, said Ms. Harrison. “I can’t remember the last time a surveyor reported that to us.” All the surveyors can do is to ask if there is dose-capping, and “to rely on people to say either yes or no,” she said. “If they say no, that’s all the surveyor can go by, unless it’s reported to us by a patient or another employee.” In interviewing patients, CARF surveyors don’t look for specific problems, but the question, “Are you satisfied with the service here?” can produce an answer such as “Everything’s fine, except I wish I weren’t limited to 100 milligrams,” said Ms. Harrison. “That would pique the surveyor’s interest—that would show there’s a dose cap.”
CARF surveyors are at an OTP for two days, and can interview any patient who comes in during that time. Patients can decline to be interviewed, and if they are interviewed, they are anonymous—they don’t have to give their names to the surveyors. In addition, 30 days before a survey, CARF-accredited organizations are required to post a notice of the forthcoming survey, so that patients can provide feedback anonymously, either via e-mail or call.
Patients can also say that they would like to talk to the surveyors off-site, while the survey is taking place. At that time, the surveyors will call the patient at home, or at whatever number the patient designates. This is better than the feedback to the 800 number, since it happens at the same time as the survey, and goes to the surveyors themselves.
But patients need to speak to programs first, said Ms. Harrison. “Please don’t wait until CARF comes to talk about grievances,” patients are told. “If you call the CARF office, I won’t take any response if you haven’t gone through the organization.”
In addition, CARF wouldn’t consider one complaint about dose-capping as a problem. “CARF looks at the process, not at your individual problem,” said Ms. Harrison. “Unless we receive multiple complaints that seem to be a pattern or a trend, we wouldn’t call that dose-capping.”
The ‘Magic Dose’
Methadone is unique among medications when it comes to getting the perfect dose, one that is neither too low nor too high, said Tennessee’s Dr. Burley. “You’re trying to block the withdrawal, stop the craving, and make sure the dose is high enough to block an effect from other opioids. You’re trying to find this magic dose that’s going to work for them, and take into consideration that you might get the dosing too high. But we recognize that people have different rates of metabolizing. We don’t want a patient to be undermedicated, because we know that increases their risk of relapse.”
For the Federal Guidelines for Opioid Treatment, go to http://staging3.atforum.com/wp-content/uploads/Federal-Guidelines-For-Opioid-Treatment-Programs-March-2015.pdf
For TIP 43, go to http://staging3.atforum.com/documents//MAT-TIP_43-MMT_Guidelines2005.pdf
For the Tennessee OTP regulations, go to http://www.tn.gov/mental/up_event_images/Rulemaking%20Hearing%20Rules%20Filed%20by%20SOS-FINAL%20FILING09202012.pdf