AATOD Policy Paper: Raising Buprenorphine Patient Cap Could Hurt Patient Care
- Changes in Confidentiality Regulations Would Hurt Opioid Treatment Program Patients, Damage Privacy
- ONDCP’s Michael Botticelli on the Importance of OTPs in Treating Opioid Use Disorders
- Medicaid Managed Care, New Insurance Rules Coming to New York Opioid Treatment Programs
- Research Report: Dosage Trends in Methadone Maintenance Treatment Programs: Significant Improvement, But Still Below Evidence-Based Standards
- Research Report: Patients Treated With Methadone vs. Buprenorphine: Differences in Demographic Characteristics and Treatment Outcomes
- Research Report: Life Concerns of Prescription Opioid and Heroin Users—What Are They, and How Do They Differ?
- Upcoming Events
Categories: 2014-Summer, Newsletter, TOC-News
The opioid overdose epidemic has led to a call by some to raise the 100-patient cap on buprenorphine, which can be dispensed and prescribed by office-based physicians. Even before Sen. Ed Markey of Massachusetts proposed a bill in July allowing physicians to treat an “unlimited” number of patients with buprenorphine, the American Association for the Treatment of Opioid Dependence (AATOD) took proactive steps to educate policymakers about the unintended consequences of such a move.
On July 2, AATOD president Mark Parrino, MPA, distributed a policy paper to regulators at the Substance Abuse and Mental Health Services Administration (SAMHSA), which, along with the Drug Enforcement Administration, oversees the waiver process that allows office-based physicians to treat patients with buprenorphine. He also distributed the policy paper to stakeholders in the field. It is a masterful analysis of using medication in the treatment of opioid dependence, outlining the history of opioid treatment programs (OTPs), methadone maintenance treatment (MMT), and the need patients have for comprehensive care.
Many prospective patients, given the choice between the rigor of treatment in an OTP, and being able to walk into a physician’s office and get buprenorphine immediately, followed by a prescription, would choose the physician’s office. But Mr. Parrino carefully did not use the policy paper to defend OTPs or OTP “turf.”
Asked whether unrestricted access to buprenorphine is a threat to OTPs, Mr. Parrino told AT Forum that “aside from being a threat, it’s a challenge to our principles of how we treat opioid addiction.” Noting that SAMHSA has issued research findings and practice guidelines supporting treatment the way it’s provided in OTPs, Mr. Parrino pointed out that if SAMHSA supports the approach of medication only, in the case of raising the buprenorphine cap, it is “endorsing the concept that medication is sufficient in and of itself.”
Contradicting the Evidence
If the National Institute on Drug Abuse (NIDA) and SAMHSA agree that physicians should be able to prescribe buprenorphine to more than 100 patients, and that those patients will not be getting access to other treatment interventions beyond the prescription, that would “contradict everything they have published in the past 40 or 50 years,” said Mr. Parrino.
The AATOD policy paper, however, makes it clear that not every patient needs access to all interventions throughout the course of their treatment. There are patients who are stabilized, whether it’s by MMT in an OTP or through office- based buprenorphine treatment. “Not all patients need access to a full range of services throughout their treatment,” he said.
Already, OTPs are able to treat a significant number of patients. In many cases OTPs can expand without having to go back to SAMHSA, he noted. That raises the question: why are policymakers focusing on office-based buprenorphine instead of OTPs as they struggle to find ways to handle the heroin epidemic? The reason is that the groups pressing for expansion of buprenorphine are the physicians— the American Medical Association and the American Society of Addiction Medicine (ASAM)—said Mr. Parrino.
There are already questions about how the 7,500 physicians currently certified to treat 100 patients with buprenorphine are doing. SAMHSA, for example, doesn’t know how many of these are at the patient limit, or how many are organized in group medical practices. Many of them are “rendering excellent care, are principled, and are treating patients effectively,” said Mr. Parrino. But as is well known to OTPs, there are some patients who want the medication but don’t want any services. Office-based buprenorphine caters to these patients.
Why Not Expand OTP Funding?
The AATOD policy paper references a very important document released by ASAM last year, which describes the difficulty of getting public and private payers to cover MAT in an OTP. Many states don’t even allow Medicaid to pay for treating patients in OTPs. “ASAM did a great job of describing the funding impediments,” said Mr. Parrino. “People want to expand access to treatment—what about putting increased public money into OTPs?”
There is no counterpart to the AATOD policy paper—nothing else has been written on such a complex topic. From what we have heard, SAMHSA and other administration officials who have seen it are impressed—at least, they are not discounting it. What the policy paper does is to ask them to think about the unintended consequences of abandoning what has been learned over the past 40 years. “This rush to—‘We need to lift the cap, and flood the market with buprenorphine’—is all based on the fact that there is a public health crisis,” said Mr. Parrino. “The reaction is that they have to do something.” Mr. Parrino hopes that they will not abandon comprehensive treatment in favor of only writing prescriptions.
For the policy paper, go to http://www.aatod.org/wp-content/uploads/2014/07/MAT-Policy-Paper-FINAL-070214-2.pdf.
Categories: Buprenorphine, Medication-Assisted Treatment (MAT), Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs)
Tags: AATOD, ASAM, Buprenorphine, Heroin, Opioid Treatment Programs, Prescription Opioids
The long process of reviewing 42 CFR Part 2, the regulation that governs confidentiality of alcohol and drug abuse treatment records, is underway. The law and regulation date from the 1970s, and prohibit any substance use disorder (SUD) treatment provider receiving federal funds from disclosing the identity of any patient without the written consent—on paper—of the patient. It was working fine until the electronic medical record made paper consents inconvenient, and the Substance Abuse and Mental Health Services Administration (SAMHSA), which has oversight over the regulation, has been under pressure to change it. On June 11, SAMHSA held a “listening session” at which all sides were given an opportunity to speak at the day-long meeting.
The battle lines were drawn between opioid treatment programs (OTPs) and their patient advocates, as well as addiction recovery organizations like Faces and Voices of Recovery, the Legal Action Center, the State Associations of Addiction Services (SAAS), and NAMA-R, who want the rule to stay the way it is. Many electronic health record (EHR) vendors, mental health providers, and others say that the rule needs to be changed for a variety of reasons.
But whatever the reason—convenience of EHR data exchange and integration of behavioral and medical health care were cited most often—patients need to know that changes mean they would no longer have control over their own information. Under the current rule, which was adopted in 1975, treatment programs may not release any identifying information about a patient unless the patient gives written consent for that release, and the consent must say to whom the information can be disclosed. Redisclosure is not allowed.
Areas of Concern
Comments from the American Association for the Treatment of Opioid Dependence (AATOD), focused on stigma. The comments, signed by AATOD president Mark Parrino, MPA, clearly state that the patients’ perspective is the most important—not the perspective of health care providers who think they know what’s best for these patients. The Legal Action Center made the same point in its comments: the patient views must come first. NAMA-R and Faces and Voices of Recovery represent the direct views of patients and people in recovery.
People with SUDs still face losing their jobs, their housing, the custody of their children, and their insurance, and face criminal arrest, prosecution, and incarceration, as well as discrimination in health care, the Legal Action Center said. AATOD agrees with this, and has had many reports that support it from OTPs and patient advocates.
About 41 percent of OTP patients are employed, according to AATOD, which represents more than 950 OTPs. Many of these patients talk to their counselors about whether they should tell their employers they are in methadone maintenance treatment. “This continues to be a sensitive topic since many patients are of the judgment that informing their employers of their involvement with methadone treatment will have negative consequences and potentially result in the loss of their job,” according to AATOD’s comments.
The criminal justice system, in particular, does not understand methadone maintenance, with few correctional facilities providing access to medications, noted AATOD. Patients who come before family court are frequently told that they can’t recover custody of their children unless they stop taking maintenance medication, and drug courts tell them they face jail time if they continue treatment. “This condition does not exist in the treatment of any other chronic disease in the U.S. where medications are used to treat the patient effectively and to preserve continued health,” noted AATOD.
In some cases, the only “crime” committed is being in treatment—which for pregnant women can mean losing custody of their babies. This is despite the fact that methadone and buprenorphine treatment are considered the best practices for pregnant patients who are opioid dependent.
Some things have changed since 42 CFR Part 2 was first created. There are now electronic health records, health information exchanges, health homes, and accountable care organizations (ACOs). But what hasn’t changed is discrimination against people with SUDs, especially when they are in medication assisted treatment (MAT). That’s why the Health Insurance Portability and Accountability Act (HIPAA), which governs privacy of other medical records, isn’t enough, advocates said.
Clinicians who work in OTPs understand that they “are simply custodians of the individual patient’s care,” Mr. Parrino said in the AATOD comments. It is the patient who takes on the risk of entering and remaining in treatment, and the patient who takes on the risk of discrimination if that treatment is disclosed to others.
If patients think their treatment will be disclosed, they will be far less likely to seek admission, people who know the addiction treatment field said. Moreover, stable patients will reconsider whether they want to continue in treatment.
Of particular concern are Prescription Monitoring Programs (PMPs), which are supported by AATOD as long as OTPs only access data from them. AATOD discourages OTPs from disclosing data about patients to PMPs, also called Prescription Drug Monitoring Programs (PDMPs). If PMPs, which are mainly managed by law enforcement agencies, have access to OTP patient information, patients would be deterred from seeking treatment.
As a signal of how serious the revising of 42 CFR Part 2 could be, one recommendation made at the June 11 listening session was to make all PMP data available to law enforcement organizations. In most cases the PMP is indeed under the aegis of law enforcement, not public health. “One such agency informed AATOD that they wanted access to confidential patient data for individuals participating in OTPs so they could cross match such data against outstanding warrants,” said Mr. Parrino.
The Other Side
Integration in Health Care
One of the main arguments for information sharing and weakening 42 CFR Part 2 comes from people, including physicians, who think that this is in the best interests of the patients, because integrated health care means the entire team can take care of a patient.
Many OTP patients don’t want to disclose their MAT status to medical professionals, and have told their OTP staff “about the change in attitude demonstrated by medical professionals” if they do disclose. “Until the medical professional is educated about methadone and addiction, methadone patients need the right to first develop a relationship with the physician or medical professional before they tell them they are a methadone patient in addiction treatment.”
EHRs—and especially, vendors—are advocating for dismantling 42 CFR Part 2 as it stands, to allow the free flow of all medical information, including SUDs, between medical providers and payers. But 42 CFR Part 2 can be updated to facilitate integration and communication in the EHR age, while still maintaining the core privacy protections of consent and prohibition against redisclosure. This is done by “data segmentation,” in which the SUD data is separate from the other medical information.
‘For the Good of the Patients’
The “for the good of the patients” argument was that of Eric Goplerud, PhD, who helped lead the “Patient Protection Coalition” that four years ago started working to weaken 42 CFR Part 2. He still feels that 42 CFR Part 2 should be abolished, either by legislation or regulatory guidance. In his comments that were filed, he agreed that people with SUDs suffer from stigma: “the general public is highly unwilling to work with, or socialize with alcoholics,” he writes, adding that “drug addicts” are the “most stigmatized.” Public opinion about mental illness, on the other hand, has “gotten more favorable.”
Dr. Goplerud is one of the leaders of the charge, starting four years ago, to do away with 42 CFR Part 2. He testified at the listening session as a private citizen, he told AT Forum.
It is unlikely that SAMHSA will ask Congress to change the law. What is more likely is that SAMHSA may propose subregulatory changes to 42 CFR Part 2. For OTP patients, the best possible outcome would be that there would be no changes made. Officials from SAMHSA who traditionally side with mental health providers are more likely to want to weaken the confidentiality provisions, as mental health providers and others who are entering the SUD treatment market don’t want to have to deal with the specialized consent issue. However, stalwart defenders of 42 CFR Part 2, like H. Westley Clark, MD, JD, who heads the Center for Substance Abuse Treatment (CSAT), are expected to continue to represent the voice of patients. If there are changes, they may be done through a rulemaking. Stay tuned.
When the comments are available online, they will be available at http://www.samhsa.gov/HealthPrivacy/
AATOD’s June 23 comments and response to the proposed confidentiality regulations are available online at:
Categories: 2014-Summer, Newsletter, Opioid Treatment Programs (OTPs)
Tags: Buprenorphine, Confidentiality, Methadone Treatment, Opioid Treatment Programs, Substance abuse treatment
Michael Botticelli, acting director of the Office of National Drug Control Policy (ONDCP) and a longtime friend of medication-assisted treatment (MAT), dating from his years heading the Massachusetts Bureau of Substance Abuse Services, gave AT Forum an exclusive interview this summer on how opioid treatment programs (OTPs) effectively treat their patients who have opioid use disorders. The current epidemic has put Mr. Botticelli in the spotlight as the top federal official on drug policy, and treatment advocates are depending on him to help improve access to treatment.
“It has always been the policy of this office to support access to the full spectrum of evidence-based treatment for substance use disorders,” he said. “We have been particularly diligent about making sure that people who have an opioid use disorder have access to MAT—one reason is that patients on MAT have better treatment retention.”
Comprehensive Services and Reduction in Overdoses
Mr. Botticelli singled out OTPs for their comprehensiveness. “We’re not talking about just drug administration—we want to make sure patients get the full continuum of other services,” he said.
MAT should be available wherever it’s needed, including primary care and criminal justice settings, said Mr. Botticelli, who himself is in long-term recovery from an alcohol use disorder. The benefit of the OTP, regardless of what medication (methadone or buprenorphine) is given, is that it is required to offer other behavioral therapies, he said. “The challenge is making sure patients who are getting MAT in non-OTP settings have access to full services. They need all of their health care attended to.”
Another reason that the ONDCP strongly supports MAT for opioid use disorders is to reduce overdoses (ODs). “Studies have shown that patients who are engaged in MAT have significantly lower rates of ODs,” he said, citing as an example Baltimore, which, after it expanded methadone maintenance treatment, saw a drop in OD rates. OTPs are a “proven OD prevention strategy,” he said. (A study published last year in the American Journal of Public Health showed that increasing access to methadone and buprenorphine resulted in a decrease in heroin overdoses: (http://www.ncbi.nlm.nih.gov/pubmed/23488511).
The ONDCP is working to change the stigma associated with addiction, in particular the language associated with opioid use disorders. “We don’t say ‘addict,’ we say ‘person with a substance use disorder,’” he said. “We have to stop talking about ‘clean’ and ‘dirty’ in urine testing. Our language needs to change so that we are not stigmatizing people.”
The Need to Expand Addiction Treatment
Even before Mr. Botticelli joined the ONDCP, the office’s national drug strategy was focusing on expanding addiction treatment. Now the ONDCP has convened a treatment workgroup from federal agencies looking at the need for treatment expansion in the context of the changing environment—the Affordable Care Act and the building prescription opioid and heroin crisis. “As a group, we’ve chosen increasing the access to MAT as the top priority,” he said.
ONDCP’s Treatment Coordination Group (TCG) is chaired by Mr. Botticelli (see participant list below).The TCG is working to:
- Coordinate and synchronize efforts of Federal partners who play a role in supporting the National Drug Control Strategy for substance use disorder treatment services;
- Increase understanding of the “state of the art” of treatment for substance use disorders;
- Ensure the adoption of quality, evidence-based services and systems of care across Federal agencies and contractors;
- Develop and promote opportunities among Federal partners to expand access to treatment services for substance use disorders;
- Ensure agency, programmatic, and interagency data (performance, research, etc.); inform discussions and decisions; and
- Share insight and experience to address issues pertaining to treatment for substance use disorders.
“There is no one silver bullet” when it comes to increasing access to MAT, he said. “We are open to a variety of ways” as long as care is high quality and minimizes diversion. “We get a tremendous amount of satisfaction in the number of patients who are able to access good, high-quality treatment through our OTPs. We want to make sure people have access to medications, and some way of decision-making for what medications are good for them—we believe a patient should be part of the decision making process.”
Goal to Increase Medicaid Coverage
Meanwhile, the ONDCP is trying to encourage states that don’t allow Medicaid to pay for OTP treatment to do so. “We participate in many state policy academies,” he said. “And we have always talked about access to MAT as part of any state strategy to appropriately respond to the opioid problem.” The ONDPC wants to make sure that states consider access to MAT as a response to the heroin and prescription opioid crisis, he said.
Categories: 2014-Summer, Medication-Assisted Treatment (MAT), Newsletter, Opioid Treatment Programs (OTPs)
Tags: Buprenorphine, Government, Methadone Treatment, ONDCP, Opioid Treatment Programs, Substance abuse treatment
There are big changes coming up for opioid treatment programs (OTPs) and other substance use disorder (SUD) programs in New York State. Starting next year, the longstanding fee-for-service Medicaid reimbursement system will be replaced by managed care; also starting next year, new insurance legislation to protect SUD patients is expected to be enacted.
Henry Bartlett, executive director of the Committee of Methadone Program Administrators (COMPA) of New York State, the trade association of OTPs, is in a position to know more than most observers about the plans for Medicaid managed care, private insurance, and OTPs.
Of one thing he is sure: OTPs will definitely be covered by Medicaid. Whether and how they will be covered by private insurance plans, either in the subsidized marketplace plans or other commercial plans, is unclear. But managed Medicaid, which is run by private companies but paid for by the state, will cover OTPs.
But the change from fee-for-service, in which OTPs are paid for what they provide, to managed care, in which an insurance company may restrict care in certain cases, raises questions. Although COMPA has advocated against onerous utilization review, in which the OTP has to continually justify a patient’s stay in treatment, there is “no guarantee” that this won’t happen, said Mr. Bartlett. COMPA has also advocated against any time limits in treatment.
Working closely with the New York State Office of Alcohol and Substance Abuse Services (OASAS), COMPA is trying to make sure the transition is as smooth as possible for OTPs and their patients. “We were asked by OASAS, how we should be measured in the world of managed care,” said Mr. Bartlett. “COMPA spent a lot of time hashing that out, and we developed a paper that we sent to OASAS that includes our statement of principles and how we think OTPs should be looked at.” In particular, COMPA stressed that care should be individualized. Furthermore, measurement of success should be based on reducing or eliminating the use of opioids, not other drugs. “We should focus on reducing secondary drug use only when that use becomes problematic to the patient or when it creates dysfunction,” he said. “In other words, OTPs should not be penalized if patients are using marijuana or other secondary drugs if that use is not problematic.”
The response from OASAS to COMPA has been positive. “They said they would use our paper when they work with DOH [the Department of Health] to develop contracts with managed care.” Mr. Bartlett is optimistic that the contracts will end up reflecting COMPA’s suggestions. “But until I see the written contracts, I won’t know for sure.”
New York will continue to be a state that is generous with Medicaid in terms of SUD treatment. “But things are going to change under managed care, because they will require additional authorizations,” he said. Asked whether this will affect patients, Mr. Bartlett said that “if OTPs have burdensome reporting requirements imposed on them, or burdensome reauthorization requirements, it will cost money. Money spent on administrative requirements is not available to be spent on direct patient care. Ironically that could end up negatively impacting both the quantity and quality of patient care,” he said.
The Private Sector
How OTPs will be treated by non-Medicaid health plans is another question. In the past, most have simply refused to consider paying for medication-assisted treatment (MAT) in OTPs. But under the Affordable Care Act and the Mental Health Parity and Addiction Equity Act, it’s not so clear that they can do so. There are many people with health insurance who could benefit from MAT but would have to pay for it out of pocket.
COMPA is working with the Albany-based New York Health Plan Association (HPA), which represents all insurance plans in the state. The president and CEO, Paul F. Macielak, is learning about OTPs, which are a very unusual kind of provider to the mainstream world of health insurance. COMPA has told them what OTPs are, the regulatory basis for their existence, and why it is so hard to obtain methadone outside of an OTP.
But this is not without challenges. A number of drug-free programs are also going to Mr. Macielak saying that health plans should be sending people with opioid addiction to them. In the end, insurance companies are going to be evaluating treatment options based on outcomes.
“They don’t want bad outcomes,” said Mr. Bartlett of insurance companies and health plans. Patients who are sent to drug-free treatment and relapse are the most expensive ones. These patients “show up in emergency rooms, in hospitals, and that’s what insurance companies care about,” he said. OTP patients, on the other hand, are treated effectively so that they have fewer long-term—and costly—medical problems.
It’s virtually impossible to find out what plans cover OTPs, as this is generally set up plan-by-plan.
That’s where two new bills recently agreed to by Gov. Andrew M. Cuomo and the legislature come in. Under these bills, announced on June 18, insurance companies will have to utilize an assessment tool that is approved by the Office of Alcoholism and Substance Abuse Services (OASAS). In another provision, insurance company staff who decide what level of care a patient should have must be experienced in SUD treatment.
In addition, if an insurance company does not approve a certain treatment, another bill will require that the insurance company pay the provider as long as there is an appeal in process. That means that a new patient in crisis will still have treatment paid for, at least until the appeal is upheld.
But this insurance legislation originally didn’t look good for OTPs. Initially, the bill said that insurance companies are required to pay for any level of care approved by an addiction professional. This was troublesome, because it meant that a professional whose philosophy was opposed to MAT could say the patient needed drug-free treatment.
“I went to the legislature and said, ‘Do you know what you’re on the verge of passing here? A CASAC who works for a drug-free program can bind an insurance company to a level of care even if the evidence does not show that the level of care is appropriate for a specific patient.’” (CASACs are Credentialed Alcoholism and Substance Abuse Counselors.) That shouldn’t be the measure used by insurance companies, who instead should be required to use an independent instrument, said Mr. Bartlett. Ultimately, that is what the bill—which still has not been signed—says.
And COMPA ended up getting help from, of all people, the health plans. The health plan administrators (HPAs), of course, didn’t want any legislation. “Some insurance companies were being unreasonable by requiring patients to fail first at one level of care before authorizing another level of care,” said Mr. Bartlett. “But the other side was being just as unreasonable by saying any “addiction professional” could make a level of care determination which would trump the insurance company.”
The “middle ground” is one that is being followed now—an independent tool that is evidence based. I’m guessing HPA views this as the lesser of two evils,” Bartlett said. “Being required to pay for all treatment recommended by any addiction professional would be far worse, by their reckoning, than being required to abide by an independent tool.”
Meanwhile, Allegra Schorr, president of COMPA and vice president of the West Midtown Medical Group in New York City, sent out an e-mail to the COMPA board saying that OTPs in New York should be proud of themselves for getting this changed.
Under the previous wording, “a CASAC-T with no understanding of addiction medicine could conclude that a chronic long-term opiate addict with multiple, failed attempts at drug-free treatment should once again be treated in a drug-free residential setting and the insurance company would have had to pay for that level of care,” Ms. Schorr wrote. “We believe such language would have been very disadvantageous for OTPs.” (CASAC-T is an advanced certification requiring additional education in areas such as psychopharmacology, alcohol, and drugs.)
COMPA deserves the credit for getting this language changed, said Ms. Schorr, noting that the language used by OASAS in announcing the plan states that insurers will be required “to use recognized, evidence-based and peer-reviewed clinical review criteria, approved by the State Office of Alcoholism and Substance Abuse (OASAS), when making decisions regarding the medical necessity of treatment.” This language is “virtually identical to what COMPA proposed,” she said. “This is no small victory, and it’s the kind of thing that we don’t much trumpet. We shouldn’t forget that without COMPA’s efforts in this and countless other areas, the landscape in which we operate would be far more hostile.”
There are about 120 OTPs and 40,000 OTP patients in New York.
COMPA’s recommendations that were sent to OASAS are available online at: http://atforum.com/documents/COMPASuggestionsManagedCareContracts.pdf
Categories: 2014-Summer, Medication-Assisted Treatment (MAT), Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs)
Tags: Medicaid, Opioid Treatment Programs
Research Report: Dosage Trends in Methadone Maintenance Treatment Programs: Significant Improvement, But Still Below Evidence-Based Standards
The sharp rise in heroin use and prescription opioid abuse in recent years underscores the need for effective treatment for opioid addiction. Yet previous studies have shown that most methadone maintenance treatment (MMT) programs—the primary treatment for opioid use disorders—haven’t provided doses that meet evidence-based standards, 80 mg/day and above. Evidence-based standards are interventions backed by scientific clinical evidence showing that they improve patient outcomes.
With this in mind, the authors of a new study sought the answers to two questions:
- How well are today’s MMTs meeting evidence-based standards of care for methadone doses?
- What characteristics of today’s programs are associated with how well they meet dosing standards?
The article was published online June 10, 2014 in the Journal of Substance Abuse Treatment.
Six waves of a survey conducted in previous years provided data on 718 MMT patients. The University of Michigan’s Institute for Social Research gathered information by telephone contact with directors and supervisors of clinical services during the following years: 1988 (n=172 patients), 1990 (n=140), 1995 (n=116), 2000 (n=150), and 2005 (n=146). Cornell University’s Survey Research Institute obtained additional data, for 140 patients, in 2011. Investigators calculated the percentage of stabilized patients in each program who received doses less than 40, 60, or 80 mg/day, and the percentage receiving doses of 80 mg/day or higher.
In 1988, almost 80 percent of patients received methadone doses too low to be effective, below 60 mg/day. By 2011 that proportion had dropped to 23 percent—a statistically significant improvement, but not good enough.
Looking at the evidence-based standard reveals a more telling story: only 59 percent of patients were receiving at least 80 mg/day. Given that 1,223 methadone programs treated 306,440 patients in 2011, this left more than 125,500 patients denied doses considered necessary to reduce opioid use and increase retention in treatment.
Several factors appear to be involved in underdosing.
For one, the authors see “a potential confusion” in methadone treatment, stemming from two needs: the need to ensure therapeutic dose levels, and the need to individualize dose levels (because of differences in how patients metabolize methadone). As the authors point out, however, “no studies have found that the relationships among methadone dose levels, retention in treatment, and treatment outcomes are mitigated by the need to individualize dose levels.” The fact that optimal doses may vary among individuals shouldn’t prevent programs from giving average doses of 80-100 mg/day. In fact, studies show that patients whose daily doses exceed 80 mg/day “engage in relatively little illicit drug use and have better treatment outcomes,” as long as they maintain average plasma concentrations of about 400 ng/mL.
(As for other factors involved in underdosing, AT Forum notes that for many years some clinicians have disregarded earlier research-based recommendations that MMT patients receive daily doses over 60 mg, claiming favorable clinical experience with lower doses. Some believe that abstinence is an achievable goal, with lower doses making future withdrawal easier. Others have linked lower doses with fewer adverse effects. Still others have cited concerns that larger methadone doses would result in more diversion to the street.)
From prior research, the study’s authors identified factors that reside in the programs themselves, influencing dosing practices (decreases or increases). These include patient characteristics, program characteristics, and “managerial attitudes and beliefs that may run counter to the use of evidence-based practices.” The table below lists them.
|Program Characteristic||Likely Dosing|
|Higher percentages of unemployed patients||Above 80 mg/day|
|Higher percentage of African American and Hispanic patients, compared to non-Hispanic whites||Below 40, 60, or 80 mg/day|
|Patients aged 40 and above||Above 60 or 80 mg/day|
|JCAHO accreditation (not mandated until 2001)||Higher doses|
|Midwest and South location, compared to Northeast||Below 40 mg/day|
|Personnel hold beliefs and values counter to best practices (favor abstinence approaches, oppose syringe exchange, offer limited or no support for HIV prevention measures, etc.)||Below 80 mg/day|
Programs that provide low doses may have another factor in common, the authors note: they may lack important human and financial resources. These resources could include stable work forces that are well trained, well paid, and well educated, and appropriate management systems, such as quality of care indicators and information systems. The authors suggest that examining factors that could be related to low dosing, such as educational backgrounds of personnel, should be a priority for future studies.
Finally, the authors applaud reports, studies, panels, and organizations that may have played a role in significantly improving methadone dose levels. But they return to the fact that too many patients receive doses too low to be effective, and they stress that “policy-makers and managers should emphasize the need for programs with low dose levels to carefully evaluate patient outcomes and take appropriate action.”
This well-designed study was supported by a grant from the National Institute on Drug Abuse.
D’Aunno T, Pollack HA, Frimpong JA, Wuchiett D. Evidence-based treatment for opioid disorders: A 23-year national study of methadone dose levels [Epub ahead of print June 10, 2014]. J Subs. Abuse Treat. doi: org/10.1016/j.jsat.2014.06.001.
Categories: 2014-Summer, Medication-Assisted Treatment (MAT), Methadone, Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs)
Tags: Dosing, Methadone Treatment, Opioid Treatment Programs, Research
Research Report: Patients Treated With Methadone vs. Buprenorphine: Differences in Demographic Characteristics and Treatment Outcomes
A study published online May 12, 2014 in Substance Abuse compared demographic characteristics and treatment outcomes of 252 patients enrolling in a methadone maintenance treatment (MMT) program with those of 252 buprenorphine patients starting treatment in an internal medicine practice affiliated with a medical school.
The authors planned the study as “a real-life comparison,” where opioid-dependent patients chose their type of treatment from two possibilities available at the same time, on the same medical campus, Johns Hopkins Bayview Medical Center in Baltimore.
MMT program. MMT patients received individual counseling, and selected patients could be required to attend weekly counseling groups as well. Staff collected urine samples for drug testing on a random schedule, one to four times each month, under observation. The average methadone dose was 80 mg/day.
Buprenorphine practice. Certified primary care physicians had discretion in dosing titration, patient monitoring plan, frequency of patient visits, and treatment discontinuation. Follow-up visits typically lasted 15 minutes and covered brief supportive interventions and primary care health issues. Once stabilized, patients visited the practice monthly—more often if illicit substance use continued. Attendance at self-help groups was encouraged. Staff did not collect urine samples under observation, but did check urine temperature to make sure the sample was fresh. The average buprenorphine dose was 16 mg/day.
Factors involved in choosing methadone vs. buprenorphine included patient preferences, provider decisions, and availability.
Data Collection and Analysis
Each month for one year, staff classified patients as “opioid-positive” or “opioid-negative,” based on provider assessment and urine drug testing. The “opioid-positive” category included any positive drug screen, patient report of opioid use, or lack of a urine collection, if the most recent test result was positive.
Criteria for Success
Investigators chose two patient criteria for successful treatment:
- Scoring at least six opioid-negative months
- Remaining in treatment after one year
Buprenorphine patients were more likely than methadone patients to:
- Be male
- Be employed
- Be HIV-infected (14.3% vs. 7.9%), despite reporting less exposure to injection-drug use
- Abuse prescription opioids
They were less likely to abuse benzodiazepines.
Looking at the predetermined criteria for successful treatment response—at least six opioid-negative months and remaining in treatment after one year—the results were as follows: methadone patients, 137 (54.4%); buprenorphine patients, 104 (41.3%). The difference was statistically significant.
Successful patients had several characteristics in common. They were more likely to
- be receiving MMT
- have been on opioid agonist treatment before starting either program
- Less likely to have faced recent criminal charges, or to have used heroin
Withdrawal from treatment. Methadone patients were significantly less likely to discontinue treatment during the first month (2.4% vs. 17.1%), but rates of discontinuation in later months were similar.
Reasons for discontinuation of therapy varied, as shown below.
|Reason||Methadone Patients (n)||Buprenorphine Patients (n)|
|Patient decision (dropout)||67||70|
|Transfer to another program||24||11a|
|Planned medication taper||0||8a|
|Lost health insuranceb||0||10a|
aThe difference is statistically significant.
bInsurance was required for buprenorphine patients.
The authors commented on the more difficult induction period with buprenorphine, referring to the opioid withdrawal symptoms that can occur during initial treatment with a partial opioid agonist. They said that the higher dropout rate in the first month accounted almost entirely for the difference in treatment retention, and added that the relative ease of access to buprenorphine may have “attracted less motivated patients.”
The authors found that the study “provides additional evidence that office-based buprenorphine and methadone maintenance programs serve different populations of opioid-dependent patients.”
Given the preselected criteria for success—at least six opioid-negative months, and remaining in treatment after one year—methadone therapy was found to be the only factor significantly associated with a successful treatment response. Both treatments were effective, but methadone patients had modestly better outcomes.
Fingerhood MI, King VL, Brooner RK, Rastegar DA. A comparison of characteristics and outcomes of opioid-dependent patients initiating office-based buprenorphine or methadone maintenance treatment [E pub ahead of print May 12, 2014]. Subst Abuse. 35:122-126. doi: 10.1080/08897077.2013.81928.
Categories: 2014-Summer, Buprenorphine, Medication-Assisted Treatment (MAT), Methadone, Newsletter, Opioid Abuse/Addiction, Opioid Treatment Programs (OTPs)
The daily worries and instabilities that plague opioid-dependent patients can make it difficult for providers to deliver effective long-term substance-abuse and medical treatment. Lack of information about patients’ life concerns leaves providers without direction about key issues that may cause patients to leave treatment.
In the first study to classify life concerns in drug users, investigators at Stanley Street Treatment Addiction and Recovery, Inc. (SSTAR), a detoxification facility in Fall River, Massachusetts, tallied the levels of concerns of 529 prescription-opioid or heroin users, 24.2% of whom used prescription opioids. Patients were interviewed as they entered opioid detoxification treatment between February and November 2013.
(Detoxification provides patients with a medically supervised protocol to mitigate drug withdrawal symptoms, begin counseling, and access additional treatment after discharge. Surprisingly, little research exists about the current life concerns of treatment-seeking opioid-dependent patients. This lack of information leaves treatment providers without direction about issues that could influence patients to continue treatment after detoxification and achieve long-term success.)
The study ratings were on a four-point scale, from “no concern” to “serious concern.” The study covered 43 health and welfare items in five categories: physical health, mental health, and concerns centered on economic, community safety, and relationship issues. The study was published online July 11, 2014, in the Journal of Substance Abuse Treatment.
The study sought to:
- Identify and categorize patients’ relevant life concerns
- Compare the life concerns of prescription opioid and heroin users
- Explore the association between life concerns and demographic factors
Previous studies have identified differences in clinical and demographic characteristics of prescription opioid and heroin users, as shown below:
|Type of Study||Patient Characteristics|
|Patients receiving methadone maintenance treatment (MMT)||Prescription opioid (PO) users were more likely than heroin users to report pain, and more likely to receive psychiatric treatment|
|Patients seeking office-based buprenorphine treatment||PO users were more likely to test negative for hepatitis C virus, and to have fewer years of opioid use; they were also less likely to have received treatment for substance abuse|
|Patients seeking short-term buprenorphine stabilization, then tapering discontinuation||PO users were more likely to be white and employed|
These underlying differences, the authors noted, may influence the life concerns of the two groups.
SSTAR detox provides only evaluation and inpatient detoxification services for patients who have a substance abuse problem with alcohol, opioids, or benzodiazepines. Average length of stay for opioid detoxification, which accounts for 80 percent of the detoxification facility’s admissions, is about six days. Affiliated SSTAR sites include Lifeline, which became a federally qualified health center (FQHC) in 1990, providing methadone, primary care, and behavioral health care to opioid-dependent patients.
- Male: 69.9%
- Non-Hispanic Caucasian: 87.5%
- Employed full- or part-time: 11.3%
- Average age: 32.2 years
- Average years of education: 11.7
- Injection drug use, past 4 weeks: 75.6%
- Recent cocaine use: 39.7%
- Recent benzodiazepine use: 46.7%
Heroin users were younger and less educated than prescription opioid users. The two groups did not differ significantly in the other characteristics listed above.
Of the 43 topics submitted, patients identified 10 areas of concern. They rated drug problems as the most serious, followed by money problems, relationship problems, mental health, and cigarette smoking. Completing the list were health insurance, alcohol problems, transmitted disease, serious physical illness, and community safety.
Life concerns and opioid type. Heroin users had significantly higher levels of concern about drug problems and transmissible diseases, and significantly less concern about alcohol-related problems. Their levels of concern for the seven other major areas did not differ significantly from those of prescription opioid users.
Life concerns and demographic factors. Age was positively and significantly correlated with concerns about alcohol problems and serious physical illness. Compared to women, men were significantly more concerned about health insurance, but significantly less concerned about mental health. Patients employed full- or part-time were significantly less concerned about money problems than those who were not.
The authors noted that opioid users often lead chaotic lives, “challenged by traumatic events, unemployment, housing and neighborhood problems, mental health disorders, stigma,” and a host of other problems. These issues may synergistically interact to undermine health, and make it difficult to set up long-term treatment.
They also commented that life concerns capture subjective worries that may influence or interact with patients’ drug-use behaviors, treatment decision-making, and the ability to engage in treatment. They suggested that by discussing patients’ health concerns with them, caregivers may be better able to plan effective relapse prevention and ongoing care.
In closing, the authors added: “Relapse prevention efforts that include linking this underserved population with appropriate resources to help them manage their life concerns may be beneficial as they plan for aftercare following discharge from detoxification.” The authors pointed specifically to motivational interventions that include discussion of the patients’ many life issues, and how the patients’ concerns may lead to ambivalence about seeking help with “what might seem to clinicians to be pressing health-related conditions.”
Stein MD, Anderson BJ, Thurmond P, Bailey GL. Comparing the life concerns of prescription opioid and heroin users [Epub July 11, 2014]. J Subst Abuse Treat. doi: 10.1016/j.jsat.2014.07.001
Categories: 2014-Summer, Heroin, Medication-Assisted Treatment (MAT), Methadone, Newsletter, Opioid Abuse/Addiction, Prescription Drugs
Tags: Heroin, Prescription Opioids, Research
September 15-18, 2014
2014 Harold Rodgers Prescription Drug Monitoring Program (PDMP) National Meeting
September 22-24, 2014
Substance Abuse Program Administrators Association (SAPAA) 2014 Annual Conference
September 24-27, 2014
NAADAC 2014 National Conference
September 27-October 1, 2014
Categories: 2014-Summer, Events, Newsletter
Results suggest that it may not be appropriate to consider powder and crack cocaine as diagnostically and clinically equivalent…
As part of ASAM’s “Advancing Access to Addiction Medications” project, the Treatment Research Institute was contracted to create “Medicaid Coverage of Medications for the Treatment of Opioid Use Disorder” state fact sheets. These two-page fact sheets summarize state Medicaid coverage of addiction treatment, both medication and counseling, and serve as an update to the June 2013 Patient Advocacy Task Force survey and research report on insurance coverage of addiction medications. In order to gather the most current nationwide coverage information, each state and the District of Columbia was surveyed to see if their Medicaid program covered methadone, Suboxone, buprenorphine/naloxone tablets (Zubsolv and generic), buprenorphine tablets, and injectable naltrexone (Vivitrol) under Fee-For-Service (FFS) or Managed Care (MC) plans.
The state fact sheets are currently available on the ASAM website, along with an interactive map of the United States. The purpose of this project is to improve access to addiction treatment by increasing knowledge and understanding of Medicaid coverage currently available and encouraging states to improve their program’s coverage of addiction treatment.
Source: American Society of Addiction Medicine – August 15, 2014