AT Forum Volume 31, #1 December/January, 2020
Categories: Medication-Assisted Treatment (MAT), Newsletter, TOC
OUD Death Rates Rise, Methadone is Underused, and Insurers Favor Buprenorphine; Would Coverage of Methadone in Broader Practices Beyond OTPs Be a Solution?
By Barbara Goodheart, ELS
The problem of methadone underuse isn’t new—but the authors of a recently published paper offer ways to fix the situation; ways that are both new and innovative. If broad regulatory changes aren’t going to happen, they say, the solution may be to empower private insurers to make methadone more accessible to patients by, for example, allowing it to be prescribed without the comprehensive care required under the current system.
And they offer specific steps to make this happen.
There’s no question that something needs to be done. Opioid overdose deaths increased by 157% during the past 10 years, the authors point out, while the number of treatment facilities stayed roughly the same.
Background
- More than half of U.S. treatment facilities still treat patients without using medication—an approach that just doesn’t work for the vast majority of people
- Facilities offering buprenorphine have doubled in number over the last 10 years
- Yet methadone availability lags; facilities offering methadone have increased by only 19%
The suggestions for changing the situation come from “Private coverage of methadone in outpatient treatment programs,” published in December in ps.psychiatryonline. The authors are highly qualified to tackle the topic; lead author Daniel Polsky, PhD, has an impressive background in health care management, and currently serves as Bloomberg Distinguished Professor of Health Economics at Johns Hopkins University School of Public Health; Samantha Arsenault, MA, is vice president of National Treatment Quality Initiatives for Shatterproof, a national nonprofit group dedicated to reversing the nation’s addiction crisis; and Francisca Azocar, PhD, is vice president of Research and Evaluation of Behavioral Health Sciences at OptumHealth Behavioral Solutions.
Methadone, Long-Time Treatment Leader, Is Now a Laggard
Of the three medications approved to treat opioid use disorder (OUD), the other two being buprenorphine and naltrexone, methadone has been in use the longest time, and is backed by excellent treatment-related data. Yet it remains underused.
The reasons are clear:
- First, it’s the restrictions. Methadone for addiction treatment, unlike methadone for pain, must be administered at opioid treatment programs (OTPs). And that involves, at least initially, daily visits, and sometimes lengthy travel. Programs may be overcrowded, with long lines at the OTP, and costs to enter the program may be high
- OTPs have faced heavy regulation for about 50 years, not only from government agencies, but from the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration as well
- Alternatives to methadone offer convenience and time-savings: naltrexone treatment usually means a monthly injection in a doctor’s office; buprenorphine therapy may mean obtaining a prescription from a nurse practitioner or a physician, then picking up the medication at the pharmacy
So, why hasn’t the methadone treatment system been changed? Why can’t methadone offer the conveniences its competitors do, so it can challenge them on an equal footing?
Stigma against methadone maintenance treatment continues—yet no treatment has proven more effective in helping OUD patients. A high level of stigma, according to the paper’s authors, “has made it difficult to generate the cooperation among many stakeholders necessary to produce the regulatory reforms that are needed to trigger transformation.”
Needed, the authors say, are those reforms—as are measures “that directly address the issue of stigma.”
The Reformers
Reforms require action, and that means players. Here are players the authors called upon to accomplish reforms—and why they chose them:
Health insurers and employers —because they can build incentives for making methadone more available and more widely used, while they address immediate barriers to methadone access; and because they can act faster “than legislative and regulatory reform”
Financial systems—for they can improve access by driving “overdue changes” to the methadone maintenance system
Roles for Commercial Insurance Companies
When private health insurers have paid for methadone treatment, historically it’s been through the prior-authorization route. So, the authors undertook some field research, scheduling interviews with key people at three large health insurance companies. Topics included how private insurance firms can help overcome barriers to OUD treatment. The two groups collaborated; the actions directly below reflect their joint efforts.
Actions for Private Insurance Companies
Below is a brief summary; consult the published article for details.
Expand methadone coverage
Expansion begins by making sure that commercial health plans cover methadone treatment. Issuing a directive isn’t good enough; additional key steps include educating clients who are employers; the goal is to “help them overcome reticence to covering methadone.”
Delete prior-authorization requirements
Verifying medical necessity can take time—and, for patients, taking time can mean relapse and even death. The health insurers the authors interviewed indicated that some among them had tried to reduce prior authorization requirements, but that their efforts could be improved.
Reduce patients’ out-of-pocket costs
Patients may face unexpectedly high costs, even if they’re insured for methadone treatment, and their OTP accepts their insurance. Typically, a copay exists for each visit, and 20 visits per month could mean a copay exceeding $700 per month—more than many patients can afford.
Possible remedies: methadone could be prescribed, like buprenorphine, and covered by insurance; or, the authors suggest, “a single bundled payment for a weekly or monthly course of methadone treatment” could be provided.
Manage provider networks
In many areas, people seeking methadone treatment face two unpleasant options. One is a long drive each day to the nearest OTP, or, lacking an OTP nearby, payers could “work with state and community partners to identify reasons behind the shortage of providers and to implement solutions.”
Private Insurance Carriers Face Limitations
In the closing section, the authors point out some limitations private carriers face in trying to address barriers to access. OTPs tend to be tucked away in relatively less-safe areas, distant from medical complexes—a situation they describe as requiring a reversal in attitudes toward methadone. Behavioral health, they say, often is “‘carved out’ of the medical benefit and managed separately.” They see the system as favoring acute episodes of care, and failing to encourage the coordination of care.
Conclusions
Having set up a viable plan for making methadone more accessible to patients, the authors stress the importance of having options available, “so that every individual’s needs can be met.” For many, they point out, “methadone would be the best option if barriers to treatment access could be addressed.” And they would like to see addiction treatment viewed “on par with other chronic illnesses.”
A valuable short-term approach for directly increasing patient access, the authors say, is to change the ways methadone treatment is paid for. But greater efforts will be needed over the long term, they point out, to “reverse social stigma, promote system integration, and support regulatory reform, in order to transform methadone treatment and addiction treatment.
Another key point is the importance of greater access to methadone, “through commercial insurance reform and by streamlining public and private payment.” This, the authors believe, “would create incentives for new providers and investors to participate in and expand access to methadone treatment.”
Reference
Polsky D, Arsenault S, Azocar F. Private coverage of methadone in outpatient treatment programs [Epub ahead of print]. Psychiatr Serv. 2019; Dec 11:doi: 10.1176/appi.ps.201900373
Categories: Medication-Assisted Treatment (MAT), Newsletter
Buprenorphine Effectively Treats OUD, But Most Patients Quit Treatment Too Early—Risking Relapse, Overdose, and Other Potentially Fatal Events
By Barbara Goodheart, ELS
Here’s something most people in the field know: buprenorphine treatment lowers the risk of overdose and death in people with opioid use disorder (OUD).
And here’s what many don’t know: most patients don’t remain in buprenorphine treatment long enough to benefit from it. Six months is the shortest time endorsed by the National Quality Forum, but most patients—50% to 80%—stop taking buprenorphine after just a few weeks or months. Even the recommended six months of treatment is not long enough, an important new study shows. Patients still face a high risk of serious, potentially fatal problems when they do quit.
So, why do patients leave buprenorphine treatment so quickly?
And what length of buprenorphine treatment offers the best outcomes?
Answers to these questions, and others, are found in a recent article published online ahead of print in the American Journal of Psychiatry: “Acute care, prescription opioid use, and overdose following discontinuation of long-term buprenorphine treatment for opioid use disorder.” The investigators are from Columbia University Medical Center and Columbia’s Mailman School of Public Health, both in New York; and Rutgers University, in New Jersey.
Reasons Patients Quit Buprenorphine Therapy
Buprenorphine, the most widely used medication for OUD, is administered to about 700,000 people every year—a minority of the estimated 2 million to 5 million people who have OUD. Experts generally don’t put time limits on therapy to treat OUD, but –
- Insurance policies may restrict patients’ access to buprenorphine, or limit treatment to six-month intervals
- Patients often try to taper off treatment after early improvement; reasons include stigma, attitudinal factors (motivation, self-esteem), family pressure, and doctors’ lack of training
The result: patients stop taking buprenorphine much too soon.
The Study
This is the first study to look at data from patients who took buprenorphine continuously for at least six months, then discontinued treatment, and whose data were assessed during the six months after they stopped treatment. Other studies have assessed risks during treatment.
This was a retrospective study that tapped into the MarketScan multistate Medicaid claims database, a source that covers 12 million people each year. Study data are presented by three-month cohorts (patient groups), depending on treatment duration, shown in the table below.
Results
The analysis included 8,996 individuals on buprenorphine for a minimum of six months. Primary adverse outcomes were emergency department visits (all cause), inpatient hospitalizations (all cause), medically treated drug overdose (opioid and nonopioid), and receipt of full-agonist opioid prescriptions. (Because full-agonist opioids are generally contraindicated in OUD patients being treated with buprenorphine, such opioid prescriptions generally indicate relapse or poorly coordinated care.)
Adverse events were common in all study groups. More than one-fourth of patients had opioid prescription claims, and almost half had claims for one or more emergency department visits.
Overdoses: a special concern. The authors commented that medically treated overdoses occurred in about 5% of patients, across the board. So, overdose seems to remain a common event following discontinuation, regardless of the length of buprenorphine treatment. Another telling statistic: about two to three times as many people in the study groups had overdoses after discontinuation as are reported in the general population of people with OUD.
Six months: a high-risk period. The authors noted “a high-risk period for adverse events”—the six-month window after discontinuation. This was especially true for patients who also had a mental illness. The high risk existed no matter how long the patient had stayed in buprenorphine treatment, but was somewhat lower among those retained on medication for longer periods.
Outcomes over time. Outcomes for patients in the study did eventually improve somewhat, but not until 15 months of maintenance treatment with buprenorphine. Even then, substantial risks remained. Patients in the cohort with the longest treatment period,15 to 18 months, had the best clinical outcomes (see table below), although “rates of the primary adverse outcomes remained high,” the investigators commented.
Summary of Adverse Events (Table)
The table below summarizes findings on adverse events in the study group. To clarify: all patients remained in treatment for at least six months, but no longer than 18 months, then stopped taking buprenorphine. Investigators gathered the data on adverse events during the six months after treatment ended.
Thus, patients in the group in the first column on the left continued treatment for 6 to 9 months before stopping; data were analyzed during the six months that followed. Patients in the column on the far right remained in treatment for 15 to 18 months, then discontinued, and their data were analyzed during the next six months.
Incidence of Adverse Events
During the Six Months
After Buprenorphine Was Discontinued
| Reference Group 6–9 Months N=4,126 | 9–12 Months N=2,440 | 12–15 Months N=1,499 | 15–18 Months N=931 |
|---|---|---|---|
| Highest rates of adverse events occurred in this group,a although overdose was equivalent across all groups | Types of adverse events in this group were similar to those in the reference group | Findings for those in treatment for 12-15 months showed only lower rates of ED visits and opioid prescription use | The risk of three key adverse events was lower in this group than in the other cohorts,b but remained high |
aRates of adverse events were statistically significantly lower in all groups than they were in the reference group.
bThe difference in rates of adverse events between groups reached the highest level of statistical significance in the 15-18 Month group.
Key Findings
- Buprenorphine discontinuation is associated with serious risks, even after long-term (15 to 18 months) care episodes
- Rates of overdose after buprenorphine is discontinued are “approximately two to three times higher than those observed in a general sample of patients with opioid use disorder”
Recommendations
Ways to improve long-term retention, the authors noted, include directing “greater efforts at the clinical and systems levels,” with priority given to redesigning systems of care. Redesigning means emphasizing chronic disease management models under collaborative care teams. The teams should have “emergency response capabilities for reaching patients who discontinue medication or disengage from care,” by “leveraging public and private insurance benefit design, utilization management, and clinical policies.”
To improve patient outcomes, the authors suggested considering “structural interventions, such as placement of care coordinators, development and routine monitoring or quality measures, and capitated or enhanced provider reimbursement for extended buprenorphine treatment.”
The bottom line. The authors noted that in their study, “eventual treatment discontinuation was associated with high rates of potentially fatal adverse events in the ensuing months.” They added that the results of their investigation are consistent with those from a growing number of studies emphasizing the protective effects of long-term therapy in OUD—in sharp contrast to short-term therapy or brief detoxification. In a communication with Addiction Treatment Forum, the study’s lead author, Arthur Robin Williams, MD, MBE, commented: “Discontinuation of buprenorphine is a life-threatening event for many patients, and should be treated as such.”
Reference
Williams AR, Samples H, Crystal S, Olfson M. Acute care, prescription opioid use, and overdose following discontinuation of long-term buprenorphine treatment for opioid use disorder. AJP in Advance. 2019; doi: 10.1176/appi.ajp.2019.19060612
Additional Reading
Dennis ML, Foss MA, Scott CK. An eight-year perspective on the relationship between the duration of abstinence and other aspects of recovery. Eval Rev. 2007; 31:585-6122. doi: 10.1177/0193841X07307771
Sordo L, Barrio G, Bravo MJ, et al. Mortality risk during and after opioid substitution treatment: systematic review and meta-analysis of cohort studies. BMJ. 2017; 357:j1550. doi: https://doi.org/10.1136/bmj.j1550
Categories: Medication-Assisted Treatment (MAT), Newsletter
Incarcerated People Are Entitled to Medications for Their OUD; So Why Aren’t They Getting Them?
By Barbara Goodheart, ELS
There’s no question that opioid use disorder (OUD) is extremely common in incarcerated people. And yet, this group rarely receives medication treatment for OUD (MOUD).
Moreover:
- Each year, about one-third of people who have a heroin addiction are incarcerated
- This pool—this target population, easy to access—presents an opportunity to help many people who need it
- Methadone, buprenorphine, and naltrexone are effective, FDA-approved treatments, and are widely used to treat OUD in the community
- And yet—fewer than one percent of U.S. jails and prisons provide MOUD regularly
- Clearly, the situation is inherently unfair—especially in the eyes of those who have a good grasp of opioid addiction and its treatment, along with a strong ethical sense
And that brings us to the source of the data cited above: an article recently published in Substance Abuse: “An ethical analysis of medication treatment for opioid use disorder (MOUD) for persons who are incarcerated.” The paper’s three authors are affiliated with Montefiore Medical Center in New York, an institution whose population has strong ethical leanings. The Center describes itself as a national leader in its efforts to deliver state-of-the-art medical care to a vulnerable population. The paper’s lead author is Emma R. Brezel, MBE (Master of Bioethics); the second author, Tia Powell, MD, is Director of the Montefiore Einstein Center for Bioethics.
So, Why Are Incarcerated People Being Denied MOUD?
The authors pull no punches. They say the relative lack of MOUD in jails and prisons “reveals how competing concerns are prioritized over providing evidence-based medical treatment.” They list as among those who may be responsible: stakeholders who influence accessibility: “policymakers including legislators, judges, and correctional medical directors; and policy enforcers such as institutional medical staff and correctional officers,” whose priorities are dictated by different goals, responsibilities, and expertise. The authors recommend closely examining the ethicality of severely limiting the availability of the medications.
Part I of the published article asks why MOUD is rarely offered; Part II looks at the ethicality of the answers to Part I.
Part I: Factors Limiting Availability of MOUD
Stigma. Stigma appears to be the source of many—possibly most—of the problems discussed here.
Stigma can block the acceptance of MOUD. It can paint people with OUD as bad, or as morally compromised, so they face discrimination. And it can lead to the denial of basic rights, such as employment and housing.
Conditions that feed stigma. Using stigmatizing language and seeing addiction as “a willful choice or moral failing” feed stigma. Methadone and buprenorphine can have euphoric effects in people who lack physical tolerance to opioids, and some critics see this as a reason to delegitimize these medications, calling their use “trading one addiction for another”—a phrase all too familiar—and distressing—to those in the field.
Additional factors limiting accessibility of MOUD. The authors also cite uncertainty about MOUD’s effectiveness in incarcerated people, concerns about the risks of diversion, insufficient staff to ensure safety, concerns about overdose risks, lack of medications, problems associated with transporting patients, and opposition to MOUD on the part of administrators. Some requests for MOUD are turned down because people with OUD are deemed unable to provide informed consent—and yet, physicians can obtain the right to treat such patients, even if the patients refuse treatment.
Part II: The Ethical Imperative to Provide MOUD in Jails and Prisons
Looking at one of the themes of the Montefiore Medical Center: “Our actions are the result of a deep belief in fairness to those we serve”—it’s easy to understand the authors’ impatience with the current situation.
Montefiore Einstein Center for BioethicsThe Montefiore Einstein Center for Bioethics addresses value-laden issues at the interface of medicine, law and public policy and focuses on issues most likely to improve patient care, human subjects’ research, and health policy. We draw together expertise that promotes reasoned analysis of ethical issues in health care, both at the level of the individual patient and clinician, and at the level of society as a whole. |
In making their case—which they call “the ethical imperative”—the authors draw upon the four pillars of bioethics. The four are listed below, along with the obligation associated with each pillar. Definitions have been drawn from the article and several other sources.
The Four Pillars of Bioethics
|
The authors underscore the urgent need to provide MOUD in jails and prisons.
- The obligations to act in patients’ best interest and to do no harm extend to those who are incarcerated
- People who are incarcerated “have the right to evidence-based medical care for OUD”
- Jails and prisons are government institutions; as such, they and their employees are obligated to provide evidence-based treatment
In addressing public health concerns, clearly a major consideration at Montefiore, the authors make several points. Government agencies have an ethical responsibility “to create and enforce policies that aim to protect and promote public health.” Because treatment reduces crime and the use of health care resources, reaching people who are incarcerated would be cost effective. And the public-health benefits are obvious.
MOUD reduces all-cause mortality and the incidence of fatal overdoses post-release; if barriers stand in their way, jails and prisons must address those barriers.
Conclusions
“Common justifications for restricted use of MOUD in jails and prisons violate widely accepted ethical principles. . . . Strong evidence supporting the health benefits of MOUD cannot be subordinated to stigma or inaccurate assessments of health risks, security, costs, and feasibility.”
In closing, the authors make such a strong case for reform: “One of the great tragedies of the current opioid overdose crisis is that the most effective tools to reduce overdose, including MOUD, have not been rapidly deployed in the United States. Improving access to MOUD in jails and prisons is ethically imperative.“
Reference
Brezel ER, Powell T, Fox AD. An ethical analysis of medication treatment for opioid use disorder (MOUD) for persons who are incarcerated. Subst Abus. 2019; Dec 4:1-5. doi: 10.1080/08897077.2019.1695706.
Categories: Medication-Assisted Treatment (MAT), Newsletter
Explaining Quality of Care in New Jersey, as State Looks at More Regulations for OBOTs
By Alison Knopf
“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 TK (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://staging3.atforum.com/wp-content/uploads/NJ-State-Audit-2018.pdf (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).
Categories: Medication-Assisted Treatment (MAT), Newsletter
Surprise Speaker at NYSAM Focuses on Advantages of Comprehensive Care
By Alison Knopf
The surprise speaker was Mark W. Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). And he was standing in for Rep. Paul Tonko (D-New York), who couldn’t make it to the New York Society of Addiction Medicine (NYSAM) meeting on February 7.
It was surprising for this reason: the two men are on opposite poles when it comes to deregulating buprenorphine. Representative Tonko is sponsoring a bill that would eliminate the special Drug Enforcement Administration (DEA) waiver for prescribing buprenorphine. This bill (Mainstreaming Addiction Treatment Act) is endorsed by NYSAM and its parent association, the American Society of Addiction Medicine (for more on that, see https://atforum.com/2019/08/add-asam-to-x-the-x-waiver-movement/ ). Mr. Parrino, representing AATOD, is completely opposed to the bill.
Mr. Parrino is no stranger to speaking in hostile territory, and is always diplomatic. In this situation, many of the physicians present seemed unfamiliar with OTPs, but liked the idea of being able to prescribe buprenorphine without any interference from the DEA or anyone else.
“I’m sure some of you will agree with me and some will disagree,” said Mr. Parrino, opening his speech with his usual charm.
Mr. Parrino has always taken issue with the claim that there is no harm coming from buprenorphine diversion—that diverted buprenorphine is being used to stave off withdrawal, it’s intended purpose, even by people who buy it in the street. “These people say, ‘why should you be concerned about buprenorphine diversion?’” he said. “But that depends on where you sit.” He noted that abuse of buprenorphine pain-relievers is higher than abuse of any other opioid pain relievers, based on the Substance Abuse and Mental Health Services Administration (SAMHSA) data from 2018 to 2019.
Not Enough OTPs, Especially Rural
One of the problems for OTPs is that there aren’t enough of them, especially in rural areas. “We have good data showing that 16% of patients travel to another state” for treatment, said Mr. Parrino, noting that there are now about 450,000 OTP patients in the United States.
The number of qualifying practitioners for buprenorphine prescribing is increasing, but this is mainly due to more nurse practitioners and physician assistants, said Mr. Parrino. These mid-level practitioners have to take a 24-hour course, rather than the 8-hour course that is required for MDs and DOs.
8-hour Training: Is It Enough?
The 8-hour training requirement would be removed by the Tonko bill. Mr. Parrino was involved in this as early as 1998, when the question was how to determine whether eight hours of training was sufficient. At the time, H. Westley Clark, MD, then director of SAMHSA’s Center for Substance Abuse Treatment, which has authority over OTPs, wanted to testify that training should be at least 16 hours. There was disagreement in higher levels of government, and he did not prevail, Mr. Parrino recalled.
Now the question, for Mr. Parrino and for regulators, is how to measure what the buprenorphine prescriber does—who tracks it? How do you measure what the physician does? Who tracks that? Who follows it?
When CSAT approved up to 275 patients for that group, the requirement was for the prescriber to report the retention rate, the result of drug tests if any were done, and more. But a small percentage of the physicians who prescribe for up to 275 patients have completed that review, said Mr. Parrino. “SAMSHA is not following this even though it is a federal requirement based on a published Federal Register Notice.
There have also been reports uncoupling the use of medication-assisted treatment (MAT) with counseling and other clinical support services, among them articles that dismiss the need for any counseling. But this can be confusing, because of the unclear definition of counseling. It’s not psychotherapy, in the context of MAT. It can be as simple as the prescribing doctor asking the patient how he or she is doing, and titrating the dose to make the patient comfortable.
Counseling Requirements
The World Health Organization will release new international standards stating that clinical support services are necessary for MAT to be effective, said Mr. Parrino. At a recent corrections meeting, Mr. Parrino heard the sheriff of Middlesex County in Massachusetts, who started the state’s first treatment program that included all three OUD medications in the jail also point to the need for clinical services. The sheriff said that without them, the effectiveness of the medication is diminished. The other people in the room—other law enforcement officials and judges—agreed with him. “So, my question is, how do you engage justice people in MAT if you don’t listen to them?” In other words, corrections doesn’t want medication-only.
There is always criticism of programs that “require” counseling, and that do not let patients stay on medication if they don’t participate. “If the patient is doing well and is stable, mandating counseling is questionable,” conceded Mr. Parrino. “Sometimes counseling is not good. As I have said repeatedly, if the clinician doesn’t have good training, or lacks in compassion, or is overwhelmingly negative in dealing with the patient, then it’s not good.”
Fortunately, NYSAM members are supportive of patients with addiction; many spent decades working with heroin users in New York City. How they all fare in the controversy over what is widely seen as a turf war between OTPs and OBOTs is hoped not to affect patient welfare.
Buprenorphine’s labeling states that prescribers must have the ability to refer patients to counseling. It does not say that it is required.
For Mr. Parrino’s slide presentation at NYSAM, go to https://nysam-asam.org/wp-content/uploads/1.-1pm-Mark-Parrino.pdf
Categories: Medication-Assisted Treatment (MAT), Newsletter
Lawmakers Urge DEA to Move on Mobile Vans, Telemedicine
By Alison Knopf
Congress is getting annoyed with the stalling by the Drug Enforcement Administration (DEA) on mobile vans and telemedicine for treatment for opioid use disorder (OUD).
A letter sent in January by Sen. Patty Murray (D-WA), Sen. Elizabeth Warren (D-MA), and Congresswoman Annie Kuster (D-NH), to Uttam Dhillon, acting administrator of the DEA, called out the DEA for failing to increase actions in the face of the continuing opioid epidemic.
“We write today to urge the Drug Enforcement Administration (DEA) to take all available actions to address the opioid crisis, including expediting two key regulations concerning addiction treatment: first, authorizing special registration for health care providers to provide medication-assisted treatment (MAT) via telemedicine, and second, issue DEA regulations related to improving access to MAT through the use of mobile clinics,” the legislators wrote. “Both regulations have remained on the DEA’s unified agenda for nearly two years, with no rule promulgated for either. We ask that the regulatory process move forward quickly, since both provisions will help those on the frontlines better respond to the pressing opioid crisis.”
Congress set the deadline for these steps two years ago.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, enacted on October 24, 2018, includes a provision requiring the DEA to issue a rule within a year of enactment that would make it easier for health care providers to use MAT to treat patients.
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, the DEA can authorize “special registrations” that allow providers to prescribe controlled substances online without an in-person medical evaluation. However, the DEA has never implemented this authority.
In 2015, the DEA said it would start the rulemaking process allowing for telemedicine inductions of buprenorphine, but this has not happened. The statutory deadline passed last October, and there is still no proposed rule from the DEA.
Likewise, the DEA has been dragging its feet in approving mobile methadone clinics.
“We also urge the DEA to issue their expected regulations that would expand access to MAT through the use of mobile methadone clinics,” the lawmakers write. For almost 30 years mobile clinics to treat OUD have been useful in rural areas and underserved inner city areas, they add. In fact, methadone assisted treatment, one of the most effective methods of MAT available, is inaccessible for many patients, as it is only prescribed in 1,500 locations around the country,” the lawmakers write to the DEA. “Mobile methadone clinics have the potential to make MAT more accessible to patients, and we urge the DEA to issue their expected regulations as promptly as possible.”
Categories: Newsletter
Introducing Steve Woolworth, New Evergreen CEO
By Alison Knopf
Steve Woolworth, PhD, the new CEO of Evergreen Treatment Services, has big shoes to fill. Molly Carney, the longtime CEO, is retiring, and Dr. Woolworth—at the helm of the Seattle, Washington-based opioid treatment program (OTP) for only six weeks when we interviewed him in February, was humble about his familiarity with the controversies of the day, such as the move to “x the x-waiver” regarding buprenorphine prescribers.
About the patient population coming through Evergreen’s doors, however, he is well prepared to serve them. And he cut right to the chase when we asked him about the role of counseling in treatment for opioid use disorder (OUD). “There is a lot of recognition that medication-assisted treatment is not a cure,” he told AT Forum. “It is overdose prevention.” He’s also familiar with the research: “MAT lowers overdose by more than 75%—even more with methadone than with buprenorphine,” he said. “We don’t have the same research base for Vivitrol,” he added, noting that induction with Vivitrol, which requires a week of total abstinence, is “challenging.”
Dr. Woolworth had yet to attend his first meeting of the state chapter of the American Association for the Treatment of Opioid Dependence (AATOD), but when he does attend, he will bring a full background of the care needed for this population with him. It’s not just medical care: it’s housing, mental health, education, criminal justice, corrections—keeping people out of jail and prison, or getting them help if they need it while they’re there and afterward—and more.
Committed to the Community
Dr. Woolworth started working in non-profits when he was 15 years old, and has been working in community-based services ever since. Most recently, he was vice president of Pioneer Human Services, one of the country’s oldest and largest reentry organizations. “In that role I helped design and oversee a low-barrier harm reduction program for people with OUD, which led to lower arrests,” he said, referring to buprenorphine treatment. At Pioneer, he was responsible for several innovations, including the first residential treatment program in Washington State to use all three medications—methadone, buprenorphine, and naltrexone—to treat OUD. Program completion rates are more than 80%.
Under Dr. Woolworth’s leadership, Pioneer also opened the Snohomish County Diversion Center, which helps people stay out of the criminal justice system, and, instead, get treatment – the low barrier harm reduction program referenced above.
Evergreen is one of the first OTPs in the country to utilize mobile vans for methadone (as well as other medication). “This is continuing, but we need to get better at it,” said Dr. Woolworth. “There is room for us to improve our impact and the number of people reached.”
Homelessness, Addiction, and Incarceration
Why Evergreen? “It was a leadership challenge to be CEO, an opportunity for me personally, but also part of the inspiration to me is that Evergreen is uniquely situated to address homelessness, addiction, and incarceration at the same time,” said Dr. Woolworth. There are many good organizations working on each of those three issues, but it’s important to work together in an integrated fashion, he said.
Dr. Woolworth is also president of the International Community Corrections Association, which is also looking at the problem. And that problem is simple: the same individuals are showing up in each system—jail rosters, prison rosters, emergency departments, emergency shelter systems, public health outreach, and addiction treatment. “We have all of these resources scattered across separate systems, each with different practitioners,” he said. “We know these folks are high utilizers moving in an out of different systems—we have services that can and should be focused solely on them.”
Over the next 10 years, “bending and flexing and integrating systems” in ways that address whole person health and the full social determinants of health will be essential, he added. ‘We know that people’s health care has less to do with health care than it does housing and safety and access to clean air and water. These are things that the health system has no control over.”
In fact, there is a lot of duplication of work going on, and the work that is taking place is often not patient-friendly. Not even close. “We have cadres of people all working with these patients, all of whom are struggling with trauma, telling them they need to show up at this or that appointment, at a certain time,” said Dr. Woolworth. “There are opportunities at the systemic level to rethink what institutions should really be addressing in this space.”
And he suggests rethinking the role of some of the legacy professions in this space. Much of the confusion about addiction exists because it’s been treated as a criminal justice problem. “For decades we have invested in this ineffective war on drugs and have not acknowledged that addiction is an actual disease that should be addressed as a public health crisis,” he said. “We have a lot of housing providers who will evict people for substance use. We still have private housing providers who make it very difficult for people to be on addiction treatment medication.”
Right now, a focus is on doing induction in jails—with methadone or buprenorphine—so that when people are released, they don’t overdose, he noted. “We’re starting to see correctional institutions recognize this,” he said. This is especially true of some state prison systems. But there are still 10 to 11 million people who cycle in and out of local jails a year, and many have to detox cold turkey. “We need all different strategies to make this work.”
Categories: Medication-Assisted Treatment (MAT), Newsletter
Cannabis and OTPs: What Next?
By Alison Knopf
Not only is cannabis—marijuana—legalized for recreational use in many states; it’s also legal for medical use in even more states, and some states are even suggesting it can be used to treat opioid use disorders (despite the lack of scientific evidence supporting this as an indication)What’s an opioid treatment program (OTP) to do?
We talked with one opiate treatment provider (we actually have five OTPs) (in Colorado, the first state to legalize recreational use) and with a representative of the American Society of Addiction Medicine (ASAM).
“I can really only share our experience in Colorado,” said Tina Beckley, MA, CACIII regional director in Colorado for Behavioral Health Group (BHG). Ms. Beckley was the go-to source recommended by the American Association for the Treatment of Opioid Dependence (AATOD), as her experience early on will be helpful.
State Testing Requirement
For example, initially, BHG didn’t test for tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana, Ms. Beckley, who is based in Dallas (my home office is in Dallas, but I am based and live in Colorado), told AT Forum. As a result, many patients were using marijuana regularly, she said. However, once THC testing was implemented (Colorado required it in OTPs, starting in 2006), many patients began losing their take-home doses, one phase at a time. “Some of them decided to give [marijuana] up, and others decided that they would continue losing [take-home] phases and come into the clinic more often,” she said. “There were others who left treatment altogether.”
Cannabis was first legalized (it was first legalized for medical use)in Colorado, which presented an “immediate challenge” to OTPs in the state, said Ms. Beckley. “Patients who had been using THC for years thought that if they were able to get a medical marijuana card, they would be able to earn take-home medication if all other requirements were met,” she said. But only very few patients were able to continue to receive take-homes while using medical marijuana, she explained: those with no history of illicit marijuana use, who also had a medical condition that was identified as being treatable with marijuana, and whose primary care providers agreed to the use of medical marijuana. Only “a couple” of patients met those criteria, she said.
But once recreational marijuana was legalized, the situation become more complicated, said Ms. Beckley. “Many patients felt because it was legal, they could continue to use it. It has been a real challenge for the programs to explain that OTPs follow federal rules, so if a urine drug screen is positive for THC, it is considered a positive urine,” she said. “Many patients also believe that it is the clinic’s rule, and that it can be changed,” she added, citing the feedback locations get every year on patient satisfaction surveys.
And she pointed to a definite problem for OTPs in legalization states. “Initially, there were quite a few patients who moved here because of the marijuana industry,” she said. “They were quite discouraged that they could not earn take-home medication if they used marijuana.” And patients who transferred from states where OTPs did not test for marijuana also become discouraged when they found out they would be tested for it, and lose their take-homes.
One anecdotal note from Ms. Beckley: some of the patients who did stop using marijuana so they could keep their take-homes reported feeling “clearer” than they had in a long time.
Mood-Changing and Mind-Altering
“Our treatment staff feel that THC is mood-changing and mind-altering, with addictive properties, and is not conducive to sobriety, so it is a clinical and therapeutic struggle,” she said.
However, programs would like to see state regulations revised, said Ms. Beckley. “One of our programs recommended that THC be removed from the drugs tested for, and to leave it at the discretion of the OTP to treat clinically,” she said. Another option would be to allow patients who use recreational marijuana and meet all other requirements for take-home medication, to be allowed one take home a week (in addition to Sunday). That second option would significantly decrease the number of patients who must dose on Saturday, she said.
“We feel that it is unfortunate that cannabis is still considered a Schedule I drug,” said Ms. Beckley, noting that a number of states allow for recreational marijuana, and that even more states allow for medical marijuana. “Many of our patients, again anecdotally, report that THC helps with the opioid withdrawal symptoms, but without the ability to facilitate medical marijuana research, the positive claims cannot be substantiated,” she said.
ASAM View
While ASAM is opposed to asking patients to leave treatment because they use marijuana, there is a concern that other substances, whether cannabis, alcohol, cocaine, or any other drug, could adversely affect the OTP patients, said Yngvild Olsen, MD, medical director of the Institutes for Behavior Resources Inc/REACH Health Services in Baltimore City, and an ASAM Board Member. Use of cannabis or other substances “needs to be identified and treated as a health condition,” she told AT Forum.
What if the OTP patient—or, for that matter, an OBOT patient on buprenorphine—has a prescription for cannabis? “ASAM policy says that in those states where medical cannabis is permitted under state law, the same kind of clinical and health-related approaches should be used as for other medications, such as benzodiazepines and opioids,” said Dr. Olsen. “Even if it’s recommended or prescribed, it still may have negative consequences” for patients on methadone or buprenorphine, she said.
And while the Substance Abuse and Mental Health Services Administration and the Joint Commission do not require OTPs to test for marijuana, except upon admission, some states, such as Maryland and Colorado, do, said Dr. Olsen. “There are a number of OTP medical directors and other clinicians who wonder about the value and benefit of testing for marijuana,” she said. “But it’s similar to why we do breathalyzers for alcohol and test for other substances—it’s not to discharge patients, but it’s a marker for people who are at risk for other health conditions.”
Meanwhile, states continue to look at the idea of marijuana as a treatment for opioid use disorders, possibly replacing methadone and buprenorphine, despite the lack of evidence. “It’s frustrating,” said Dr. Olsen.
Categories: Medication-Assisted Treatment (MAT), Newsletter