“We’re penalized because we’re so highly regulated and there is little or no oversight over office-based opioid treatment.” This is Margaret B. Rizzo, executive director of JSAS HealthCare, an opioid treatment program (OTP) based in Neptune, New Jersey. But it could be almost anyone in the OTP world. In New Jersey, however, OTPs have provided a lot of input into new regulations for what is known in the state as office-based addiction treatment (OBAT).
“We’re penalized because we’re so highly regulated and there is little or no oversight over office-based opioid treatment.” This is Margaret B. Rizzo, executive director of JSAS HealthCare, an opioid treatment program (OTP) based in Neptune, New Jersey. But it could be almost anyone in the OTP world. In New Jersey, however, OTPs have provided a lot of input into new regulations for what is known in the state as office-based addiction treatment (OBAT).
Ms. Rizzo is also the New Jersey board member of the American Association for the Treatment of Opioid Dependence, and treasurer of the New Jersey Association for the Treatment of Opioid Dependence. The OTP federal regulations Ms. Rizzo speaks of are well known: the rules of the Drug Enforcement Administration (DEA), constantly checking the prescription monitoring program (PMP), and the scrutiny over possible diversion of methadone. Instead of coping with these OTP restrictions, patients have the option of getting 28 days of buprenorphine, with no drug testing, from a buprenorphine prescriber.
But now, New Jersey is considering making its own regulations for buprenorphine prescribers—defined above as office-based addiction treatment (OBAT), but sometimes known as office-based opioid treatment (OBOT). This may level the playing field to some extent between OTPs, which see their treatment threatened by OBOTs; and buprenorphine prescribers only, who are not required to provide comprehensive care like OTPs.
To be clear, it is not just because of regulations that OTPs provide comprehensive care, noted Ms. Rizzo. It’s because quality care is what’s needed, especially for new patients.
“We have diversion plans in place, the DEA is checking on us, we are checking the PMP [prescription monitoring program],” Ms. Rizzo told AT Forum. Buprenorphine prescribers do check the PMP, but other than that, they just prescribe. “How do they know that the patient is taking the medication as prescribed?”
New Jersey is concerned as well; it set up an OBAT workshop, and OTPs gave a lot of input. The state’s Division of Medical Assistance and Health Services, within the Department of Human Services, last year issued a newsletter to prescribers and managed care organizations. The newsletter explained the elimination of the prior authorization requirements for both naltrexone and buprenorphine, as well as codes and fees for evaluating new patients and treating ongoing patients. For that newsletter, go to https://atforum.com/wp-content/uploads/OBAT-NJ.pdf
To be clear, OTPs dispense buprenorphine as well as methadone. Patients who are getting buprenorphine in the OTP can earn take-homes faster – an obvious advantage to patients who don’t want to come in to the clinic every day. “We have a lot of patients who come here expecting take-homes,” said Ms. Rizzo. “It’s difficult to explain to them that this is about quality of care.”
X-ing the X waiver
There is some regulation of buprenorphine; physicians who prescribe it for opioid use disorder (OUD) must have an X-number—a special waiver granted by the DEA, which allows them to prescribe a narcotic for the treatment of narcotic addiction, banned by a law that is more than 100 years old. This law, the Harrison Narcotics Act of 1914, is also the reason that methadone treatment for OUD—approved for almost 50 years—is so highly regulated. The X-number gives physicians who have gone through the 8-hour training required by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA to be waived from the Harrison Narcotics Act ban.
But there is a call for eliminating the X waiver, making it as easy to prescribe buprenorphine as it is other opioids, prescribed for pain. “How is eliminating the X waiver going to reduce diversion?” asked Ms. Rizzo rhetorically.
This question is often responded to by the claim that diverted buprenorphine is used for therapeutic purposes on the street, by people who otherwise would resort to heroin or illicit fentanyl, obviously far less safe than pharmaceutical buprenorphine.
Ms. Rizzo, like other OTP executives, knows that buprenorphine is available on the street—it’s what many new patients test positive for. But what concerns her is the quality of the treatment provided by buprenorphine prescribers.
New Licensing Regulations in New Jersey
“I believe in New Jersey they have the same outlook, because there are new New Jersey licensing regulations being promulgated now,” said Ms. Rizzo. “I assume we’re going to see something more restrictive about OBOT.”
The state conducted an audit about two years ago to compare outcomes from OTP treatment with methadone or buprenorphine to OBOT treatment with buprenorphine. But while OTPs have detailed information on outcomes, OBOTs do not. “It’s really comparing apples and oranges,” said Ms. Rizzo. For the audit, go to http://atforum.com/wp-content/uploads/NJ-State-Audit-2018.pdf
Buprenorphine Versus Methadone
Of the 38 OTPs in New Jersey, 19 are already dispensing buprenorphine, said Ms. Rizzo. Whether a patient gets buprenorphine or methadone—or naltrexone—is up to the patient and physician. New patients are screened, and meet with the doctor; the two then decide together which medication is appropriate, she said.
Unfortunately, federal regulations require that the induction dose of methadone be no higher than 40 milligrams a day, which is too low. “But we can’t increase the dose until certain program requirements are met,” said Ms. Rizzo. Induction with buprenorphine, however, can start at a high enough dose to hold most patients.
Ms. Rizzo’s OTP uses generic Suboxone tablets (not film); their choice for pregnant women is generic Subutex (no naloxone). Induction with buprenorphine is always performed in the office. “We don’t do home inductions,” she said, noting that it’s something that the state’s regulations don’t allow OTPs to do. Prescribing physicians can send the patient home with the induction dose. Because buprenorphine can’t be given until the patient is in some withdrawal, many patients find that buprenorphine induction is more convenient at home).
“We’re penalized because we’re so highly regulated and there is little or no oversight over office-based opioid treatment.” This is Margaret B. Rizzo, executive director of JSAS HealthCare, an opioid treatment program (OTP) based in Neptune, New Jersey. But it could be almost anyone in the OTP world. In New Jersey, however, OTPs have provided a lot of input into new regulations for what is known in the state as office-based addiction treatment (OBAT).
Ms. Rizzo is also the New Jersey board member of the American Association for the Treatment of Opioid Dependence, and treasurer of the New Jersey Association for the Treatment of Opioid Dependence. The OTP federal regulations Ms. Rizzo speaks of are well known: the rules of the Drug Enforcement Administration (DEA), constantly checking the prescription monitoring program (PMP), and the scrutiny over possible diversion of methadone. Instead of coping with these OTP restrictions, patients have the option of getting 28 days of buprenorphine, with no drug testing, from a buprenorphine prescriber.
But now, New Jersey is considering making its own regulations for buprenorphine prescribers—defined above as office-based addiction treatment (OBAT), but sometimes known as office-based opioid treatment (OBOT). This may level the playing field to some extent between OTPs, which see their treatment threatened by OBOTs; and buprenorphine prescribers only, who are not required to provide comprehensive care like OTPs.
To be clear, it is not just because of regulations that OTPs provide comprehensive care, noted Ms. Rizzo. It’s because quality care is what’s needed, especially for new patients.
“We have diversion plans in place, the DEA is checking on us, we are checking the PMP [prescription monitoring program],” Ms. Rizzo told AT Forum. Buprenorphine prescribers do check the PMP, but other than that, they just prescribe. “How do they know that the patient is taking the medication as prescribed?”
New Jersey is concerned as well; it set up an OBAT workshop, and OTPs gave a lot of input. The state’s Division of Medical Assistance and Health Services, within the Department of Human Services, last year issued a newsletter to prescribers and managed care organizations. The newsletter explained the elimination of the prior authorization requirements for both naltrexone and buprenorphine, as well as codes and fees for evaluating new patients and treating ongoing patients. For that newsletter, go to https://atforum.com/wp-content/uploads/OBAT-NJ.pdf
To be clear, OTPs dispense buprenorphine as well as methadone. Patients who are getting buprenorphine in the OTP can earn take-homes faster – an obvious advantage to patients who don’t want to come in to the clinic every day. “We have a lot of patients who come here expecting take-homes,” said Ms. Rizzo. “It’s difficult to explain to them that this is about quality of care.”
X-ing the X waiver
There is some regulation of buprenorphine; physicians who prescribe it for opioid use disorder (OUD) must have an X-number—a special waiver granted by the DEA, which allows them to prescribe a narcotic for the treatment of narcotic addiction, banned by a law that is more than 100 years old. This law, the Harrison Narcotics Act of 1914, is also the reason that methadone treatment for OUD—approved for almost 50 years—is so highly regulated. The X-number gives physicians who have gone through the 8-hour training required by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA to be waived from the Harrison Narcotics Act ban.
But there is a call for eliminating the X waiver, making it as easy to prescribe buprenorphine as it is other opioids, prescribed for pain. “How is eliminating the X waiver going to reduce diversion?” asked Ms. Rizzo rhetorically.
This question is often responded to by the claim that diverted buprenorphine is used for therapeutic purposes on the street, by people who otherwise would resort to heroin or illicit fentanyl, obviously far less safe than pharmaceutical buprenorphine.
Ms. Rizzo, like other OTP executives, knows that buprenorphine is available on the street—it’s what many new patients test positive for. But what concerns her is the quality of the treatment provided by buprenorphine prescribers.
New Licensing Regulations in New Jersey
“I believe in New Jersey they have the same outlook, because there are new New Jersey licensing regulations being promulgated now,” said Ms. Rizzo. “I assume we’re going to see something more restrictive about OBOT.”
The state conducted an audit about two years ago to compare outcomes from OTP treatment with methadone or buprenorphine to OBOT treatment with buprenorphine. But while OTPs have detailed information on outcomes, OBOTs do not. “It’s really comparing apples and oranges,” said Ms. Rizzo. For the audit, go to http://atforum.com/wp-content/uploads/NJ-State-Audit-2018.pdf
Buprenorphine Versus Methadone
Of the 38 OTPs in New Jersey, 19 are already dispensing buprenorphine, said Ms. Rizzo. Whether a patient gets buprenorphine or methadone—or naltrexone—is up to the patient and physician. New patients are screened, and meet with the doctor; the two then decide together which medication is appropriate, she said.
Unfortunately, federal regulations require that the induction dose of methadone be no higher than 40 milligrams a day, which is too low. “But we can’t increase the dose until certain program requirements are met,” said Ms. Rizzo. Induction with buprenorphine, however, can start at a high enough dose to hold most patients.
Ms. Rizzo’s OTP uses generic Suboxone tablets (not film); their choice for pregnant women is generic Subutex (no naloxone). Induction with buprenorphine is always performed in the office. “We don’t do home inductions,” she said, noting that it’s something that the state’s regulations don’t allow OTPs to do. Prescribing physicians can send the patient home with the induction dose. Because buprenorphine can’t be given until the patient is in some withdrawal, many patients find that buprenorphine induction is more convenient at home).