By Alison Knopf
Loretta Finnegan, MD, a champion of medication-assisted treatment with methadone, developed her scoring system for newborns more than 40 years ago. The Finnegan Neonatal Abstinence Scoring System (FNASS) assigns a numerical score to 21 clinical signs, and babies are treated accordingly. Developing the test was an important step in making sure that these babies were treated with morphine, if necessary, to manage the symptoms of withdrawal.
But the work of Dr. Finnegan goes far beyond the Finnegan score. When she first started an opioid treatment program (OTP) at Thomas Jefferson University in Philadelphia, 44 years ago, Dr. Finnegan opened a landmark program for pregnant women addicted to opioids. Since then, the program, called Maternal Addiction Treatment Education & Research (MATER), has included intensive outpatient treatment as well as residential treatment.
Diane Abatemarco, PhD, MSW, director of MATER and associate professor of OB/GYN and Pediatrics at the Sidney Kimmel Medical College at Jefferson, talked with AT Forum about the scope and importance of Dr. Finnegan’s work.
Poverty and childhood trauma are the precipitating factors for almost all women who enter the MATER program, said Dr. Abatemarco. They are also the factors that make it difficult for the women to stay in recovery, she added.
What the MATER program offers is not only the medication—methadone or buprenorphine—and therapy needed to maintain recovery, but the wraparound services, which go farther than those of a typical OTP. Women attend seven days a week and spend at least 10 hours and 30 minutes weekly in group and individual substance use treatment. Their prenatal care is managed at Jefferson. “The fact that Loretta created an OTP here was just remarkable at that time, and housing it in a medical university, offering access to all the other kinds of care that women would need, shows her wisdom and vision,” Dr. Abatemarco said.
NAS Babies Grow Up to Become Normal
We first met Dr. Finnegan in Chicago, many years ago, when she and Ira Chasnoff, MD, presented a program on babies whose mothers had been addicted to cocaine. That presentation was crucial to helping erase the awful epithet “crack baby,” implying that the babies would be permanently damaged. These babies were, in fact, normal. And the same applies to babies born with neonatal abstinence syndrome (NAS). “Loretta was a key person in saying that while four in 10 babies exposed to opioids may have NAS, they’re going to be normal, healthy children and adults,” said Dr. Abatemarco.
Dr. Finnegan also strongly believes in the importance of the mother to the child. Great trauma ensues when the two are separated, and this separation often has taken place in the name of protecting the child, when in fact, just the opposite results.
“The problem is the deep misogyny in the United States, where corporations don’t have to cover birth control for their employees,” Dr. Finnegan said. Mothers who are faced with child abuse and neglect charges over opioid use disorders—or babies born with transient NAS, which can also be due to therapeutic methadone or buprenorphine—are victims, as well. “With these moms, it’s just an extension of that; they don’t have the rights over their own children.”
Mom Is the Best Medicine
“As a social worker and a researcher, I know that if you take kids away from their biological parent, and they go into the foster care system, the risk of the non-attachment is a lifelong brain injury,” said Dr. Abatemarco. Even in the worst case scenario—a child scoring “severe” on the Finnegan score—the mom can have rooming in and breastfeed her child, and that score drops exponentially, even without medication, she said. Keeping the mother and baby together from the beginning is a key contribution Dr. Finnegan made to the field.
Dr. Finnegan, who herself had five children in her 20s, continues to stress the importance of the mother-child bond.
“I really do feel if we’re going to battle this epidemic and win, we’re going to need comprehensive therapeutic programming everywhere in the country,” said Dr. Abatemarco. “It cannot be, ‘Just give a woman a prescription for methadone or buprenorphine,’ because that won’t solve the problem.”
Treating Mom, Too
In a study Dr. Abatemarco conducted with MATER patients, funded by a federal grant, she found that each patient had an average of four adverse childhood experiences (ACEs). Based on research, having four ACEs already puts an individual at very high risk for a mental illness or a substance use disorder.
That’s why methadone or buprenorphine alone won’t help them enough. “These women need psychotherapy, housing, they need help with the court system and more,” said Dr. Abatemarco, noting that these services are provided by MATER. “We’re going to have to go back to the social safety net, the way it used to be, and rebuild some programs the way Presidents Kennedy and Johnson developed them,” she said. “Programs need the ability to provide wraparound services.”
In addition, Dr. Abatemarco supports teaching mothers about parenting, “so we can stop the intergenerational trauma.” She has been using “mindfulness” training in her research.
How the Program Works
The MATER residential program has 22 beds for mothers, who can each bring up to three children.
The women come as soon as they know they are pregnant, usually finding their way to the program, which of course also has intensive outpatient and regular outpatient services. Usually the women go to the emergency department. If at Jefferson, they are taken right up to the labor and delivery area, and MATER “navigators” meet them at the bedside.
The women stay in the hospital for from a few days to a week for stabilization on either methadone or buprenorphine during their pregnancy. As soon as they are discharged from the hospital, they come to the MATER program, every day. If, when admitted, the mother was already on methadone, she stays on methadone. If she was already on buprenorphine, she can continue, or switch to methadone. “They make the decision with the doctor,” said Dr. Abatemarco.
Typically, the program used methadone in the past. “That was getting the women to come here 7 days a week,” said Dr. Abatemarco. “And, because we had them coming anyway, we could gently wrap the services around them.” Now, MATER is doing the same thing with buprenorphine, requiring patients to come in every day (the combination product, with naloxone, is not recommended for during pregnancy). As for Vivitrol, Dr. Abatemarco says it should not be used during pregnancy.
After Dr. Finnegan’s retirement from MATER, the next director was Karol Kaltenbach, PhD, followed by Dr. Abatemarco, who convinced Jefferson to buy a residential treatment facility for the program. Recently an open house reception was held for the opening, and Dr. Finnegan was present.
In addition to attending the open house, Dr. Finnegan was present when First Lady Melania Trump visited the program in November, and when President Trump signed the new opioid law this fall. She also attends every AATOD meeting. At last spring’s meeting, she spoke loudly and clearly about the challenges to OTPs and patients. Her awards are many, and keep coming.
For a 2015 news article based on an interview with Dr. Finnegan, go to http://www2.philly.com/philly/health/20151210_Helping_babies_born_to_addicted_moms.html
By Alison Knopf
Although the general attitude toward methadone and buprenorphine is not favorable on the part of many workers in correctional facilities, the trend is changing. This is partly due to the clear evidence that inmates with opioid use disorders (OUDs), once released, have greatly higher risks of overdosing than the general population, and partly due to several recent cases in which people with opioid use disorders died during forced detoxification without medication.
This fall, the National Commission on Correctional Health Care (NCCHC), in partnership with the National Sheriffs’ Association, released guidelines on medication-assisted treatment (MAT) in jails. And Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD), made the plenary speech at the annual conference of the NCCHC this fall.
The guide, “Jail-Based Medication-Assisted Treatment: Promising Practices, Guidelines, and Resources for the Field,” is important because jails, as shorter-stay facilities, have been less likely than prisons to offer methadone. For the guide itself, go to https://www.ncchc.org/jail-based-MAT.
Contributors to the guide are Kevin Fiscella, MD, MPH, an addiction medicine expert who serves on the NCCHC board of directors, and is a professor in the department of family medicine at University of Rochester, New York; Andrew Klein, PhD, of the Advocates for Human Potential, Inc.; and Jennie M. Simpson, PhD, of the Office of Policy, Planning, and Innovation at the federal Substance Abuse and Mental Health Services Administration.
Dr. Fiscella talked with AT Forum about the importance of opioid treatment programs (OTPs) in helping correctional facilities move ahead with instituting MAT.
“There’s a huge opportunity for partnership between OTPs and correctional facilities,” said Dr. Fiscella. This is particularly true for current OTP patients. “When someone gets into jail, if the jail personnel are doing what they should be doing, they should be confirming the dose of methadone, and having at least a minimal relationship with the OTP for coordination of care,” he said. Building on this minimal collaboration to a create genuine partnerships could prove mutually beneficial to OTPs and jails.
Getting Methadone to the Inmate
One of the big logistical problems is getting the methadone into the jail—or taking the inmate to the OTP for it. The Drug Enforcement Administration (DEA) is, it is fair to say, obsessed with the security of the methadone, requiring a specialized pharmacy for it (when used for treatment for addiction, not when used for treatment for pain).
Having an OTP in the jail, much like KEEP at Rikers, or the system in Rhode Island, where the vendor operates in facilities, would be best, but most likely this would be impractical in jails across the country.
However, jails have worked with OTPs on records and dosing of existing patients. “If they could build on that partnership, so the OTP does the dosing, then jails could get around the issue of needing an OTP license,” said Dr. Fiscella, noting that this is unlikely to happen in most small county jails, given the cost and logistics. “Most are probably not going to become OTPs, at least not in my lifetime,” he said.
“Short of that, you’re talking about transporting the person, which requires sheriff deputies taking the patient in custody to the OTP,” said Dr. Fiscella. Preferably, though, it could mean the OTP giving the methadone to the deputy, who then takes it to the jail; or having the OTP transport the methadone to the jail.
Stopping Methadone at the Time of Arrest: “Barbaric”
Early in his career, Dr. Fiscella was medical director of an OTP. “I was struck by the fact that as soon as someone got arrested, their methadone was abruptly stopped,” he said. “It was barbaric. I saw patients who evaded their warrant because they were terrified of jailhouse detox, of withdrawal.”
With an OTP, every drop of methadone has to be accounted for. It’s never clear when someone will be released. There are tracking problems. Methadone stored in jails can be diverted—even by jail staff. Some states, such as Vermont, have overcome these challenges.
Pregnancy Is a Different Situation
If the inmate is pregnant, this relationship is particularly important. Even jails that don’t otherwise offer agonists will often offer them during pregnancy, because of the risk to the fetus in withdrawing from opioids on which the mother is dependent. Typically, workers in jails and prisons who care for inmates (custodial staff) are opposed to agonists, thinking of them as merely prolonging an addiction. But when it comes to the babies, they are more willing to work with OTPs. These partnerships involving pregnant inmates can potentially be expanded to all inmates with OUD.
“Even in the minds of some hardened custodial staff—more sympathy for the fetus than the woman,” said Dr. Fiscella.
“There are jails that will use opioids, including methadone, to treat the pregnant woman, and believing it is legal, because they’re not treating the mom, they’re treating the fetus,” added Dr. Fiscella. A better alternative to meeting the needs of pregnant inmates is provide treatment through partnerships that fully conform with DEA regulations.
How OTPs Can Help
The time has come for OTP leadership to reach out to the local sheriff, for their own current patients, and for any possible new patients who could be admitted via the correction health system, said Dr. Fiscella. “Ask, ‘What can we do to work together better?’ Having those face-to-face meetings is crucial.”
Remember, though, that the biggest problem is that the OTP and the Sheriff are part of two extremely different, siloed institutions. “And now we’re asking them to begin collaborating, when they’re both inherently suspicious of the other.” Overcoming this mistrust takes time and persistence.
What About Buprenorphine and Vivitrol?
As for buprenorphine, there’s already a lot of mistrust because the Suboxone strips have been so easy to smuggle into jails, said Dr. Fiscella. Never mind that the reason that they are being smuggled in is to treat the inmates with OUDs who are sick (i.e., withdrawing). Other forms of buprenorphine might help mitigate these concerns.
Some sheriffs think that a two-week detoxification with buprenorphine is a humane way to treat opioid-dependent new inmates. But maintenance treatment is better. One way to convince the sheriff to work with the OTP is to explain the high risk that people will die of an overdose when they leave the facility. Neither jails nor OTPs want to see anyone die from opioid overdose. This common interest can become the foundation for partnerships.
Finally, Vivitrol, a favorite among many correctional workers because it is not addictive, is going to be difficult to for OTPs to fight. Dr. Fiscella concedes this. In fact, OTPs do treat patients with Vivitrol, and can help supervise the humane detox that can take place in jail, transferring people to Vivitrol when they leave. The challenges with this are, 1) most patients would prefer methadone or buprenorphine, and in this country, patient choice counts; and 2) if the patient doesn’t get repeat Vivitrol shots after discharge, he or she is just as likely to overdose as the patient who is put on abstinence-only treatment after hard detox in jail.
By Barbara Goodheart, ELS
This is the story of a young woman with a 15-year history of severe opioid use disorder (OUD), intermittent hospitalization, and incarceration, who becomes pregnant. She has a history of trauma and mental health issues, and few social supports. Her story is the subject of a case report recently published in the Journal of Addiction Medicine.
It’s well known that methadone, in adequate doses, helps to keep pregnant women in treatment and reduces the risks of illicit drug use and overdose. Across the country, some—but not all—corrections facilities will continue pregnant women on opioid agonist treatment. Overall, most correction facilities fail to follow evidence-based treatment guidelines for OUD.
When people with OUD are incarcerated, “methadone is generally stopped immediately—without a taper,” Jessica Gray, MD, lead author on the report, told AT Forum. “Opioid agonists are life-saving treatments that shouldn’t be withheld or limited when people are incarcerated, but outside of Rhode Island and a few other facilities, like Rikers, that’s not the case,” she added. Even jails that do provide methadone treatment for pregnant women generally fail to continue methadone when women return to jail after giving birth, according to Dr. Gray, who works at Massachusetts General Hospital and completed a fellowship in addiction medicine at Boston Medical Center.
The Patient’s Early History
The patient began using illicit medications at age 13 to self-medicate anxiety and depression. She attended a methadone program sporadically. While hospitalized for a benzodiazepine and opioid overdose, she learned that she was pregnant.
The months that followed were marked by repeated emergency department visits, hospitalizations, and incarcerations. The patient failed to return for prenatal care, despite follow-up appointments and outreach calls.
- Emergency department visits: 6+
- Hospitalizations: 3
- Incarcerations: 3
- Prenatal visit: 1 (while incarcerated)
She had bouts of sedation, probably due to the effects of “methadone treatment combined with illicit benzodiazepines, gabapentin, and clonidine,” the authors of the study believe. She also had pneumonia, a urinary tract infection, a broken arm (from falling), abdominal trauma (after an assault), a potentially life-threatening kidney infection, and a weeklong hospital stay related to abnormalities seen on the baby’s heart monitor. And she was HCV-positive, with a high viral load, indicating an infection that she could pass on to her baby.
According to a study by Kelsey and associates, examining national jail policies in the U.S:
- 69% of women admitted to local jails meet recognized diagnostic criteria for substance use disorder (previously termed substance abuse or dependence)
- About 6% to 10% of women in jails are pregnant
- Almost half of all pregnant women with OUD in U.S. jails went through withdrawal without the help of opioid agonists or similar medication
This patient was one of the lucky pregnant women whose methadone treatment was continued per protocol while she was in jail.
The patient was in jail and at term when labor began. She was taken to the hospital to have her baby. Her shackles were removed, but she was barred from contacting someone to be with her during labor. A corrections officer was posted in the hall outside her hospital room. As distressing as this sounds, Dr. Gray told AT Forum that some institutions still keep women shackled or restrained during labor, with a guard posted inside the room.
Because the woman was incarcerated when she gave birth, the newborn was taken away, and the mother’s custody rights were immediately suspended.
The infant, a son, was healthy and born at term—despite the mother’s lack of prenatal care, and her intermittent use of illicit substances during pregnancy. This was likely thanks in part to her continued treatment with methadone throughout her pregnancy.
Standard care at the woman’s jail is to abruptly stop methadone treatment after a woman gives birth, but the patient’s team—the authors of the study—convinced jail authorities that this would increase the patient’s risks of overdose and relapse post-release. So her methadone treatment continued in jail during the months postpartum, and eventually she was released from incarceration
Jails and OTPs in Alliance
Clearly, a need exists for jails and OTPs to work together to help women like this patient. But how to facilitate it?
According to Kevin Fiscella, MD, MPH, a board member of the National Commission on Correctional Healthcare (NCCHC), some jails have OTP licenses in place, but most need to partner with a community OTP.
Partnering is easier than it sounds, because usually a relationship already exists, Dr. Fiscella told AT Forum. “People come into a jail already taking methadone or buprenorphine, prescribed by an OTP, and the jail personnel need to know the dose.”
Dosing information and the dosing history are especially important for pregnant prisoners. As the pregnancy progresses, women may need higher doses in order to prevent withdrawal. So OTPs want jails to have the dosing information. They, and the jails, want treatment to continue, to protect not only pregnant patients, but all patients from the risks of overdosing once they leave jail.
This collaborative relationship isn’t difficult to establish, but it’s not very common—creating an opportunity for jails to expand their relationships with community OTPs, thus improving care.
The Silo Effect
The situation Dr. Fiscella described works well, but achieving it isn’t always without problems.
Dr. Gray described the treatment system for patients with OUDs as “broken” in some ways, and operating “in silos” that limit interactions. “OTPs are heavily regulated, not part of the mainstream health system or community organizations,” she explained. “Our corrections system is another silo. The more we can get out of these silos and engage our community partners and collaborate as teams the better we can understand complex treatment issues.”
The relationship can be developed either in a crisis, or ahead of time—so people know they can rely on the other entity, the OTP or the hospital, in the future.
“Understanding the safety, logistical, or other concerns and needs of the systems you work with is critical. Working across organizations to address those issues can improve the experience and comfort of all parties, such as in this case providing education and support to nursing staff around methadone in the jail.” You need to support each other, she added, pointing to the current case as a good example of what collaboration can do.
We asked Dr. Gray what OTP personnel can do to help other women facing these challenges. Are counselors—or management—most effective in communicating with jails?
Both, Dr. Gray said, for she sees a role for individuals and groups at all OTP levels. Members of a multidisciplinary team can choose the person best suited to present the message to the house of correction, but everyone can impact change. The idea is to create formal and informal partnerships, and make those relationships work—even before a crisis exists.
One Patient Can Make a Difference
“Advocacy can start on an individual level”, said Dr. Gray, “and in this case was used to change the local landscape for women with opioid use disorder who deliver in jail.” The Case Report patient transitioned from being at an incredibly high risk for a bad outcome, to turning her life around.
Dr. Gray later met another pregnant woman in similar circumstances—a woman who wasn’t afraid of what she faced, because of the team’s groundwork with the woman in the Case Report. Dr. Gray was deeply moved to have made such an impact. “The hope is that the precedent you set in providing evidence-based treatment behind bars will positively impact the treatment of future incarcerated patients.”
A Remarkable Change
The new mother discussed earlier in the Case Report underwent a remarkable change after giving birth, Dr. Gray told AT Forum.
There’s no way to know if the change will be permanent, but Dr. Gray is optimistic. “The more that evidence-based treatments (such as opioid agonist medications) are provided, the more likely our patients will survive long enough to be successful.”
# # #
Gray J, Saia K, Walley AY. Case Report: 28-year-old woman with opioid use disorder delivers healthy baby while in custody: Addressing Forced Detox. J Addict Med. October 30, 2018. doi:10.1097/ADM.0000000000000468.
Kelsey CM, Medel N, Mullins C, et al. An examination of care practices of pregnant women incarcerated in jail facilities in the United States. Matern Child Health J. 2017;21:1260–1266. doi.org/10.1007/s10995-016-2224-5.
American Society of Addiction Medicine: The ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. KM Kampman. 2015. https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf.
By Alison Knopf
More than two years ago, just before Donald Trump was elected president, Demetra Ashley, associate deputy assistant administrator of the office of diversion control with the Drug Enforcement Administration (DEA), told the American Association for the Treatment of Opioid Dependence (AATOD) that new licensing regulations that would provide for more mobile vans to provide methadone and buprenorphine for opioid use disorders were in the works. She told the AATOD board the same thing a few months later, just before the inauguration. A year later, however, the discussion appeared stalled.
It still is.
“I was advised that new regulations can take years to be issued, because they not only have to go through internal DEA review but also interagency review, including both other federal agencies and White House offices, such as the Office of Management and Budget,” said Barbara L. Carreno, DEA spokeswoman, in an email to AT Forum in December. “These new regulations are one of our top priorities, on which we are working diligently,” she said. Her source (at diversion control) “did not know how close to coming out these regulations are,” she added.
Department of Justice Under Extreme Pressure
To be fair, the Department of Justice, DEA’s parent department, has been under extreme pressure lately, to put it mildly. Attorney General Jeff Sessions stepped down—in the face of being fired—on November 7, the day after the midterms. The entire department has been caught up in issues that are not related to methadone or the opioid crisis, but fortunately for patients with opioid use disorder, the Department of Health and Human Services has been giving the subject a lot of attention. The Substance Abuse and Mental Health Services Administration, which is headed by HHS, sent its mobile van recommendations to the DEA years ago. The issue is now in the DEA’s court, where it has been for some time.
The idea was to connect these mobile vans to existing brick-and-mortar opioid treatment programs. To that end, some states are spending federal grant money to purchase the vans, using them for outreach, with the hope that one day, the vans can actually transport medication. In some places of the country, this is already happening. But the federal regulations need to change if mobile vans are to be helpful on a widespread basis.
For more coverage on this issue, see
By Alison Knopf
In a far-reaching policy paper to be published next year, a draft copy of which was obtained by AT Forum, the American Association for the Treatment of Opioid Dependence (AATOD) takes stock of the increasing prevalence of opioid use disorder (OUD). “Medications Used to Treat Opioid Use Disorder: Learning from Past Lessons to Guide Policy,” by Mark Parrino, MPA, AATOD president, discusses the current state of methadone maintenance treatment,
The overdose epidemic started with prescription opioid misuse and transitioned to heroin use; now, illicit fentanyl is the main substance involved in overdoses.
The question is, what can opioid treatment programs (OTPs), the AATOD members, do to help?
The treatment system, including OTPs and DATA 2000 (office-based buprenorphine prescribers) is expanding. The criminal justice system is increasingly involved, and there is a greater interest in treatment of OUDs in prisons and jails.
The policy paper asks key questions, including:
- Should we view treating OUD as a public health intervention, with the principal component of care utilizing federally approved medications (methadone, buprenorphine, and Vivitrol/naltrexone)?
- Should we devote resources to treating this disorder with medications and additional clinical services?
- Should we better-coordinate organized service delivery to treat this illness through a continuum of service delivery components?
- Should there be a better connection between DATA 2000 practices and OTPs, to facilitate referrals from one practice to the next?
The Meaning of “Assisted”
The very phrase Medication Assisted Treatment (MAT) suggests that medication alone is not sufficient to treat the complex disorder, the policy paper notes. Indeed, the National Institute on Drug Abuse says this in “Principles of Drug Addiction Treatment,” as does the Substance Abuse and Mental Health Services Administration (SAMHSA), in its “Treatment Improvement Protocol #43: Medication Assisted Treatment for Opioid Addiction in Opioid Treatment Programs.” The AATOD policy paper notes this also.
The policy paper includes a brief description of the early history of the development of methadone maintenance, and a discussion of the value of providing comprehensive treatment services.
The policy paper also goes through a history of MAT. One point was made by Vincent Dole, MD, who postulated that “the high rate of relapse of addicts after detoxification from heroin use is due to persistent derangement of the endogenous ligand-narcotic receptor system, and that methadone, in an adequate daily dose, compensates for this defect.” While some patients can do well after treatment is terminated, the majority do not, he wrote. “The treatment, therefore, is corrective but not curative for severely addicted persons.”
OTPs with methadone were developed through a closed panel system following regulation by the Food and Drug Administration (FDA) in 1972. However, the first compendium of clinical guidelines was not published until 1993, through SAMHSA’s first “Treatment Improvement Protocol State Methadone Treatment Guidelines.”
Then there was the General Accounting Office Report of 1990: “Methadone Maintenance—Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed.” Although the FDA had regulatory oversight, along with the Drug Enforcement Administration (DEA), the GAO found that the FDA’s oversight was inadequate. After this, regulations became stricter.
The policy paper also cites the findings of John Ball, PhD, that a significant determinant of the effectiveness of methadone maintenance on reducing IV drug use and needle sharing is long-term retention, along with high rates of attendance, and an enduring relationship with staff.
The bottom line point here is that the program characteristics are more important in determining patient outcome than pre-treatment patient characteristics, writes Mr. Parrino.
And a key point is that these findings are equally applicable to DATA 2000 practices—or should be, although there is little research about what DATA 2000 practices are doing, compared to OTPs.
In 2001, SAMHSA took over regulation of OTPs, using accreditation to monitor quality assurance. The National Commission on Correctional Heath Care implemented similar accreditation procedures for treatment in correctional settings.
The paper goes on to discuss problems of diversion, noting that the biggest problems occurred when physicians started to prescribe methadone to treat pain. Take-home methadone from OTPs has much greater restrictions than pain medications do.
With the advent of DATA 2000 practices and buprenorphine, however, the value of oversight seemed to be “forgotten,” writes Mr. Parrino.
The decision not to have any federal oversight for DATA 2000 practices was driven by several variables, he writes. The first was the attempt to normalize addiction treatment so that clinical practitioners could treat this illness without the regulatory burden that had been implemented for OTPs.
AATOD agrees with making standards of care required as a method of guiding clinical care in DATA 2000 practices, based on the history of treating this disorder with medications, writes Mr. Parrino.
The policy paper also discusses the importance of care coordination, which includes models such as the Vermont Hub and Spoke system, with OTPs as the hubs and DATA 2000 practices as spokes. This model has been very successful.
“There are large states that could certainly benefit from the coordinated models, by breaking them into counties or municipalities,” writes Mr. Parrino. “The point is that coordination of care is critically necessary as first responders save an individual from overdose through the administration of Narcan [naloxone]”, getting the individual to an emergency department, where trained personnel can get the person evaluated and referred to treatment.
Finally, the paper focuses on the emerging importance of the criminal justice system, citing positive initiatives in Connecticut and Rhode Island, in particular, where OTPs are operating within prisons and jails. The results from both state experiences is a significant reduction in recidivism: individuals do not return to the correctional system, and there is a dramatic reduction in opioid mortality, writes Mr. Parrino. That’s what happens when inmates are released to community-based practice settings, and smoothly transition into the OTP to continue their treatment, he said. Without question, this kind of intervention should be repeated throughout the United States, so that inmates with OUD can have access to treatment during incarceration, and referred to outpatient treatment facilities upon release.
The policy paper will be released in January.
“New York Society of Addiction Medicine (NYSAM) Annual Conference
February 1-2, 2019
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National Association for Court Management (NACM) 2019 Annual Conference
February 21-25, 2019
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March 21-23, 2019
ASAM Annual Conference
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By Alison Knopf
The 660-page opioid bill that passed Congress and was signed October 24 by President Trump has important provisions for opioid treatment programs (OTPs). The most significant provision expands coverage to Medicare patients. Starting in 2020, Medicare will be required to pay a bundled rate for medication-assisted treatment (MAT) in an OTP. This means that when patients turn 65 and lose their Medicaid or commercial insurance, getting Medicare instead, they will be able to stay in treatment.
Other aspects of H.R. 6, also called “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,’’ or the ‘‘SUPPORT for Patients and Communities Act,” have ramifications for OTPs as well (see below).
Opening the Door to Medicare for OTP Patients
The OTP Consortium has expressed its support for this measure since last February, when Rep. George Holding (R-North Carolina) first put forward the measure under House Resolution 5080, the Comprehensive Opioid Management and Bundled Addiction Treatment (COMBAT) Act of 2018. “Congressman Holding’s legislation opens the door to patient access for a vulnerable Medicare population that currently lacks coverage for Opioid Use Disorder (OUD) treatment provided by OTPs. I commend Congressman Holding and his colleagues for crafting a bill that will certainly improve our nation’s response to the opioid crisis by filling this treatment gap and assisting this population on their Road to Recovery,” stated Peter Morris, Group President of Acadia Healthcare.
That measure became incorporated into H.R. 6.
A Major Victory
“The bill is a major victory for patients who are Medicare eligible and who are about to be eligible,” said Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). “CMS Medicare will construct the rate, and I expect it to be a weekly bundled rate, which will include all three federally approved medications, in addition to lab testing and clinical services,” he told AT Forum. “For the present time, I will be informing programs about how to prepare, and will develop a webinar in order to provide technical assistance.”
The bill “is an extraordinary opportunity for patients, and I do not see any part that is a threat to treatment,” said Mr. Parrino.
“We are extremely pleased that Congress has included Medicare coverage of OTPs in the just-passed opioid package,” said Jason Kletter, PhD, president of BayMark Health Services. “This coverage will, once implemented, provide immediate benefit to the roughly 20,000 Medicare beneficiaries currently receiving treatment in OTPs, as well as create treatment access for the 300,000 beneficiaries with a diagnosis of opioid use disorder,” Dr. Kletter told AT Forum. “In addition, Medicare coverage will likely result in greater coverage of OTP services by commercial health plans, exponentially increasing access to high quality, evidence-based MAT across the country.”
The Need is Clear, and Methadone Works
OTPs provide not only medications—methadone, buprenorphine, and naltrexone—but support services, which may include counseling, toxicology screening and lab services, case management, primary care, and mental health services.
The FDA-approved medication methadone, as part of a MAT program, has been recommended by the National institutes of Health as the most effective treatment option for OUD. OTPs provide medically supervised access to this medication as well as buprenorphine and naltrexone, along with support services.
Medicare beneficiaries show a clear need for OUD treatment: 300,000 beneficiaries have been diagnosed with OUD, Medicare hospitalizations due to complications of opioid misuse increased 10% a year, and 30% of Medicare Part D enrollees used prescription opioids in 2015.
Success—After 10 Years’ Work
It has taken Mark Parrino more than 10 years to get this legislation passed. It was impossible for the Centers for Medicare and Medicaid Services to make the change on its own: Congress needed to act in order to approve the bundled rate. The Senate side had proposed a demonstration project, which would have covered a fraction of Medicare patients at greater cost.
According to the Congressional Budget Office, the full Medicare benefit will cost $243 million, which, if it covers all 300,000 Medicare beneficiaries with an OUD, would cost $810 per person.
The Medicare provision is Section 2005 of H.R. 6.
Now, it’s up to OTPs to gear up to bill Medicare, once CMS sets the bundling rate and codes.
From the bill, below are the Medicare provisions for OTPs:
All opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration for use in the treatment of opioid use disorder would be covered, including dispensing and administration.
Counseling, including individual and group therapy, for substance use would be covered to the extent authorized by state law.
Toxicology testing would be covered.
Medicare will pay OTPs an amount which is equal to 100% of a bundled payment for OUD treatment services, starting January 1, 2020.
Other aspects of the bill with relevance to OTPs:
- Demonstration project to increase substance use provider capacity under the Medicaid program.
- Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder.
- Medicaid health homes for substance-use-disorder Medicaid enrollees.
- More flexibility with respect to medication-assisted treatment for opioid use disorders.
- Medication-assisted treatment for recovery from substance use disorder.
- Grants to enhance access to substance use disorder treatment.
- Access expansion under the Medicare program to addiction treatment in Federally Qualified Health Centers and rural health clinics.
- Review required of quality measures relating to opioids and opioid use disorder treatments furnished under the Medicare program and other federal health care programs.
- Report on addressing maternal and infant health in the opioid crisis.
- Comprehensive opioid recovery centers , which would provide inpatient and outpatient treatment with all FDA-approved medications, including methadone.
For the bill, go to https://docs.house.gov/billsthisweek/20180924/HR6.pdf
By Alison Knopf
42 CFR Part 2 protects the privacy of patient substance use disorder (SUD) treatment records. It’s been under siege for 10 years, but so far, it is still the law.
H.R. 6082 would have replaced the confidentiality regulation, 42 CFR Part 2, with the Health Insurance Portability and Accountability Act (HIPAA). It would also have removed the requirement that patients consent to the release of their SUD treatment information. H.R. 6082 passed the House of Representatives last spring, but did not make it into the Senate version of the final opioid package signed by President Trump October 24.
And Congress received a letter from the American Medical Association (AMA) just days before the final vote in the Senate, clearly stating that H.R. 6082 would deter patients from seeking treatment. Congress may have decided to let the matter drop as a result of that letter.
There was a sigh of relief when 42 CFR Part 2 did not make it into the opioid package. But the regulation remains under siege.
Recommended Actions for CFR Part 2 From Key Groups
|Make No Major Changes||Make Changes,
To Resemble HIPAA
Faces & Voices of Recovery
Legal Action Center
|The American Society of Addiction Medicine
The Insurance Industry
The National Association of Addiction Treatment Providers
Partnership to Amend 42 CFR Part 2
At least two organizations still seeking a way to demolish 42 CFR Part 2 are The Association for Behavioral Health and Wellness (ABHW) (a membership association of behavioral care insurance companies), and the Partnership to Amend 42 CFR Part 2. Tiffany Huth, press person for both organizations, circulated a letter from Elinore McCance-Katz, MD, PhD, assistant secretary of the Department of Health and Human Services, to Rep. Earl Blumenauer (D-Oregon). The letter suggested that the Substance Abuse and Mental Health Services Administration (SAMHSA), which promulgates 42 CFR Part 2, and which Dr. McCance-Katz heads, support replacing the regulation with HIPAA.
In fact, SAMHSA has worked to make 42 CFR Part 2 more appealing to some critics. Last January, responding to many complaints from the insurance industry, SAMHSA issued a final rule on the regulation that did weaken 42 CFR Part 2, However, the final rule did keep the provision requiring SUD treatment providers to obtain consent from patients before sharing their information, as the law requires.
But this wasn’t enough for critics who want to dispose of the patient consent aspect entirely. These critics, including ABHW, want to make 42 CFR Part 2 like HIPAA, which allows information-sharing—without any consent by the patient.
“We’re aware efforts to weaken 42 CFR Part 2 to a HIPAA standard continue,” said Deborah A. Reid, senior health policy attorney with the Legal Action Center. “SAMSHA has been public about it; it’s pretty transparent.” However, some continue to object, among them the Legal Action Center, the American Association for the Treatment of Opioid Dependence (AATOD), patients, and the recovery community. They note that if their treatment isn’t confidential, patients will not want to go. “Weaker privacy rights will serve as a disincentive” to seeking help, said Ms. Reid.
But the role of the AMA is significant. If the AMA wants to preserve 42 CFR Part 2, this is something for the patient community to hold on to. “The AMA is a powerful entity, and what they say is very important, particularly in the medical community,” said Ms. Reid.
“In my judgement, the AMA letter was extremely important in the support of preserving the protections,” Mark W. Parrino, MPA, AATOD president, told AT Forum. “Our position has not changed. I am still of the opinion that 42 CFR Part 2 is critically important to preserve the core protections.”
Protecting Patients: Confidentiality Is Essential
“This would be a disaster for current patients and the opioid epidemic,” said Joycelyn Woods, head of NAMA Recovery. “Confidentiality is very important to patients. Many will not seek treatment because they are afraid, or they will leave treatment early thinking that it is better than nothing. It feeds into the belief that ‘I get on methadone or buprenorphine and get some short term goal and leave.’ The result is usually relapse.”
Furthermore, medication-assisted treatment (MAT) patients, if their information is released, can be denied life insurance, Ms. Woods noted. “It’s not just about medical records. This impacts people’s families.”
If you want to know who you’re up against, listen to the insurance groups. The ABHW and the Partnership to Amend 42 CFR Part 2 “continue to work with patient groups, treatment facilities, providers, Congress, and others, to find a path forward for passage of H.R. 6082 by the end of the year,” Rebecca Klein, chair of the Partnership to Amend 42 CFR Part 2, and director of government affairs for ABHW, told AT Forum.
Ms. Klein added, “Modernizing Part 2 to ensure that HIPAA-covered entities have access to pertinent substance use disorder information will improve patient safety, treatment, and outcomes across the care delivery spectrum, enhancing the entire opioid package passed by the House and Senate and ultimately, helping to save lives.”
But patients know that being unable to have privacy will deter them from seeking treatment; it will not save lives.
NAMA Recovery, the Legal Action Center, Faces & Voices of Recovery, the AMA, and AATOD are the main supporters of keeping 42 CFR Part 2 as it is. The insurance industry, the American Society of Addiction Medicine, and the National Association of Addiction Treatment Providers are among the groups who want to make it like HIPAA.
AT Forum has covered the progression of the 42 CFR Part 2 controversy. For more information, see: