Tag Archives: MAT

FDA Push for MAT Means More Money for Big Pharma

Medication-Assisted Treatment (MAT), coupled with psychosocial counseling, is widely acknowledged to be the current “gold standard” of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

How effective is MAT for addiction? Here’s the science.

On Monday August 6th, the Food and Drug Administration announced a new policy in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

FDA Commissioner Scott Gottlieb, since his appointment, has been a strong proponent of MAT.

Now, the agency will also consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.

The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

According to STAT News, the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.

DOJ: Denying Services to Persons on MAT Violates ADA

On Thursday, May 10,2018, the US Department of Justice announced that it had reached a settlement agreement with Charlwell House, a skilled nursing facility in Norwood, Massachusetts, to resolve allegations that the facility violated Title III of the Americans with Disabilities Act (ADA) by refusing to accept a patient because they were being treated for Opioid Use Disorder (OUD).

Charlwell House is a 124-bed health and rehabilitation center that provides skilled nursing services and rehabilitation programs. According to a complaint filed with the United States Attorney’s Office, an individual seeking admission for treatment at Charlwell House was denied because they were being treated with Suboxone, a medication used to treat OUD. Individuals receiving treatment for OUD are generally considered disabled under the ADA, which among other things prohibits private healthcare providers from discriminating on the basis of disability.

According to DOJ: “Our office is committed to protecting the rights of people with disabilities, which includes those in treatment for an Opioid Use Disorder,” said United States Attorney Andrew E. Lelling. “The number one enforcement priority of my office is addressing Massachusetts’ opioid crisis. Overdoses killed more than 2,000 individuals in Massachusetts last year alone. As Massachusetts faces this overdose epidemic, now more than ever, individuals in recovery must not face discriminatory barriers to treatment. We appreciate the cooperation that Charlwell House has offered throughout our investigation.”

Under the terms of the agreement, Charlwell House will, among other things, adopt a non-discrimination policy, provide training on the ADA and OUD to admissions personnel, and pay a civil penalty of $5,000 to the United States.

Sally Friedman, the Legal Director of the Legal Action Center (LAC), applauded the U.S. Attorney’s office for taking action against this widespread form of discrimination, noting that it is likely the first ADA settlement against a skilled nursing facility for excluding patients because they are taking medication to treat their substance use disorder.

“The case law is abundantly clear that the ADA protects individuals with substance use disorder. This settlement by the Department of Justice should send a resounding message to skilled nursing facilities – and other entities – that denying care to people because they are taking life-saving medication to treat addiction is a discriminatory practice that will not be tolerated.”

This settlement announcement comes on the heels of a letter by the U.S. Attorney’s Office that it is investigating whether the Massachusetts correctional system is violating the ADA by forcing people off addiction medication when they become incarcerated, and an article in STATNews documenting the common practice of nursing facilities refusing to accept patients taking addiction medication.
Information about what to do when forced off medication assisted treatment (MAT) by the criminal justice and child welfare systems or employers is available in LAC’s MAT Advocacy toolkit,www.lac.org/MAT-advocacy.

What Does It Mean When We Call Addiction a Brain Disorder?

When the 2016 Florida Legislature allocated funds for the formation of the Palm Beach County Sober Homes Task Force, my first instinct was that the State of Florida was looking at the conundrum we here in South Florida were facing through the wrong shade of glasses. To target “sober homes” was simply feeding into the local movement to eradicate addicts in recovery from living amongst society, a long-standing issue which required the U.S. Department of Justice to intervene nationally under the Fair Housing Act and the Americans with Disabilities Act.

The “problem” that we were all experiencing was not “sober homes” [a term, by the way, which has taken on a pejorative meaning, and therefore now rightfully distinguished as either a “Recovery Residence” or a “flop house”], but rather the economy created within the health care sector for delivery of clinical services; the “churn and burn” of patients’ insurance benefits. Law enforcement and government regulators were unable at the time to grasp the vast underground network that was truly the foundational underpinning of everything that was going wrong. Flop houses were merely the effect; the cause was the demand from “health care entrepreneurs” for bodies to put through the machine to bill insurance and make money and the failure of the entire system to sufficiently develop a standard for treatment and post-treatment recovery that health insurance would be required to pay for as being “medically necessary.” This disconnect was further exacerbated by old school, traditional ways of recovery, such as AA and sober living providers, for whom “treatment” was not available decades ago, and who today understandably question the “medicalization” of addiction treatment and care.

As one of the original appointees to the Task Force, it was a pleasant surprise to find that the Palm Beach State Attorney’s Office inherently understood this as well. Their focus was on the entire health care industry serving those afflicted with Substance Use Disorder, and would NOT allow itself to be used as a puppet to develop more sophisticated exclusionary zoning tactics that for far too long had been used to ostracize addicts from cities and make access to care difficult at best. The empaneling of the Palm Beach Grand Jury to study the entire industry simply underscored and emphasized Dave Aronberg’s commitment to fact-finding.

The “Proviso Committee” of the Task Force were made of up health care practitioners, government officials, and industry representatives, who themselves, as a committee, would examine the modern paradigm of addiction care and associated recovery organizations to make recommendations to the Florida Legislature on how to effectively address where the wheels came off the wagon in Palm Beach County and to prevent similar issues developing statewide. Mr. Aronberg noted early on both that “we can’t arrest our way out of this problem” and that addiction treatment and recovery communities have been a long-standing, respectable, and honorable part of the fabric of Palm Beach County.Early on, the Task Force came to recognize the disparate opinions within the field itself. While some felt strongly the focus should be on recovery support services, others leaned towards a medical model of care (to include MAT). Advocates on both sides seemed (and appear to continue to be) at odds over what is the “right” way to address the current opioid epidemic, and well as how to define “best practices” for our future. Even those on the medical/clinic side seemed to debate whether addiction was rightfully classified as a “disease” or a “brain illness.”

As our science has evolved (rather quickly, it seems of late), Dr. Nora Volkow, the director of the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH), attempted to address the medical side of addiction care and the role that recovery support services has, in her article published in Scientific American entitled “What Does It Mean When We Call Addiction a Brain Disorder?” In the article, she writes:

Yet the medical model of addiction as a brain disorder or disease has its vocal critics. Some claim that viewing addiction this way minimizes its important social and environmental causes, as though saying addiction is a disorder of brain circuits means that social stresses like loneliness, poverty, violence, and other psychological and environmental factors do not play an important role. In fact, the dominant theoretical framework in addiction science today is the biopsychosocial framework, which recognizes the complex interactions between biology, behavior, and environment.

Critics of the brain disorder model also sometimes argue that it places too much emphasis on reward and self-control circuits in the brain, overlooking the crucial role played by learning. They suggest that addiction is not fundamentally different from other experiences that redirect our basic motivational systems and consequently “change the brain.”

Some critics also point out, correctly, that a significant percentage of people who do develop addictions eventually recover without medical treatment. It may take years or decades, may arise from simply “aging out” of a disorder that began during youth, or may result from any number of life changes that help a person replace drug use with other priorities. We still do not understand all the factors that make some people better able to recover than others or the neurobiological mechanisms that support recovery—these are important areas for research.

But when people recover from addiction on their own, it is often because effective treatment has not been readily available or affordable, or the individual has not sought it out; and far too many people do not recover without help, or never get the chance to recover. More than 174 people die every day from drug overdoses. To say that because some people recover from addiction unaided we should not think of it as a disease or disorder would be medically irresponsible. Wider access to medical treatment—especially medications for opioid use disorders—as well as encouraging people with substance use disorders to seek treatment are absolutely essential to prevent these still-escalating numbers of deaths, not to mention reduce the larger devastation of lives, careers, and families caused by addiction.

My takeaway from this is article is that my layperson opinion remains unchanged – medical treatment and recovery support services are the “yin” and “yang” of the same medallion. They cannot be separated but rather should be integrated into a continuous model towards sustainable recovery. Each path is different, as each person’s genetics as well as upbringing and life-experiences are unique. We are each a small universe onto ourselves. Therefore, it is my opinion that the billions of dollars being thrown into the “medical” side of the equation but failing entirely to fund the “recovery” side is to simply a band-aid. While I recognize and appreciate American hesitancy to adopt a welfare state for anyone, including the disabled, we must therefore double our efforts to fund and explore brain science so that effective modalities can be implemented which provide people seeking recovery with an accelerated jump start. Medication-Assisted Treatment is but one of those more recent efforts. But we can do more, and as a nation, should spend more, doing so.

Legal Action Center’s Response to President’s “Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand”

Yesterday in New Hampshire, President Trump outlined his administration’s three-pronged plan for addressing the opioid epidemic. While the strategy includes certain components critical to expanding access to evidence-based addiction care, it lacks specificity on health approaches and falls well short of the comprehensive public health response needed to address a crisis that is currently claiming the lives of over 175 Americans each day. Further, the plan’s emphasis on the failed punitive policies is out of step with what we know from decades of public health and public policy data.

One stated goal of the President’s “Initiative to Stop Opioid Abuse and Reduce Drug Supply” is to “expand access to evidence-based addiction treatment in every State, particularly MAT for opioid addiction”, a critical need which we strongly endorse. The Legal Action Center supports certain additional tactics outlined in the President’s plan to “increase availability of the life-saving overdose reversal drug Naloxone, to expand access to residential SUD treatment and to improve treatment options for people within the criminal justice system, and looks forward to hearing the details of their operationalization.

However, the President’s proposal does not sufficiently address the reality that bringing an end to the opioid epidemic is dependent on a significant federal investment to strengthen and expand the national system of care for all substance use disorders. Many communities, especially in rural areas, have a complete dearth of qualified addiction treatment providers. Strengthening the existing addiction care workforce and developing expertise in the rest of the healthcare system to help prevent and treat addiction also is critically needed. Addressing this gap in coverage will require both short and long term investments and policies that align with the goal of expanded access to effective community-based prevention, treatment and recovery supports. The 2010 Affordable Care Act, for the first time in history, included coverage of substance use disorders as an Essential Health Benefit, and the 2008 Mental Health Parity and Addiction Equity Act requires insurers to cover mental health and addiction services at a level that is equal to coverage of medical and surgical services. The federal government should be working with States to enforce the Parity Act, and to ensure that all insurers, including Medicaid, Medicare and commercial plans, are covering all evidence-based services – including all three FDA approved addiction medications – at par with other health conditions.

Good access to Medicaid is critical to achieving the goal of expanded access to substance use disorder care. This includes expanding – rather than restricting– Medicaid eligibility, which provides coverage for millions of Americans who struggle with substance use disorders. The Legal Action Center strongly supports and has long advocated for making residential substance use disorder care more accessible to people enrolled in Medicaid by repealing the IMD exclusion and CMS issuing waivers until Congress changes the law. At the same time, the initiative’s stated goal of expanding access to evidence based treatment cannot be achieved if the Administration continues to take regulatory actions to weaken the Medicaid program through severe funding cuts and enrollment restrictions such as work requirements and lockout provisions. The administration must stop taking actions to limit people’s ability to get Medicaid if it is serious about stemming the opioid crisis.

Similarly, the Legal Action Center strongly supports the need to link people struggling with addiction in the criminal justice system to the care they need, but this action must include people with all forms of substance use disorder, not just opioid use disorder as proposed by the President’s Initiative. We agree with, and have long advocated for, diverting as many people with addiction away from the criminal justice system and connecting them to treatment. We encourage the administration to support diversion as early in the process as possible and to consider use of other home and community-based settings. We also urge the Administration to ensure that there is good access to evidence-based harm reduction approaches, including syringe-exchanges and safe consumption facilities, as well as all three FDA-approved addiction medications and residential treatment.

The Legal Action Center strongly opposes several aspects of the President’s Initiative that focus on punitive approaches. Research has clearly and repeatedly shown that a heightened focus on enforcement does not work to either reduce drug supply or demand, and that the ‘War on Drugs’ disproportionately targeted low-income communities of color and fueled mass incarceration. There is wide agreement among the American public as well as on both sides of the aisle that we need to shift away from a punitive approach to drug policy to a much more effective and less costly approach of treating addiction and supporting effective re-entry policies. There is also robust evidence that the majority of those incarcerated have diagnosed substance use disorders, and that many of them have been incarcerated as a result of criminal activity arising directly from their addiction. This includes those who are convicted of low-level drug dealing to support their addiction. We strongly condemn the suggestion that the death penalty should be sought for drug trafficking, since all evidence shows that such a policy would not reduce drug use, would be very costly and would fall disproportionately on people of color and those without financial means.

While we appreciate the administration’s recognition of the need to develop a plan to address this critical public health emergency and some of its proposals, we urge the Administration to invest sufficient resources to successfully combat the opioid and other substance use epidemic; prioritize proven health responses including expanding health care coverage of substance use disorders and quality prevention, treatment services and medications, evidence-based harm reduction approaches, and recovery supports; and not return to failed punitive policies of the past that did great damage to our country without reducing drug misuse and addiction.

Negative Press Causing Referrals to Florida to Come Into Question

The Portland Press Herald reported on July 19, 2017 in the article “Operation Hope stops sending clients out of New England for opioid addiction treatment” about how the Scarborough (Maine) Police Department’s Operation Hope has stopped sending clients out of New England for treatment for opioid addiction, largely because of negative media about alleged unscrupulous programs, especially in Florida (a story published in May by STAT, a health journalism website that partners with The Boston Globe, detailed alleged insurance scams and referrals to Florida clinics where patients were receiving little or no treatment).

Launched in 2015, Operation Hope was conceived as a way for police to channel addicts who sought help into a treatment program as an alternative to criminal prosecution on drug-related charges.

In most cases, getting help from Operation Hope meant flying out of state – to Florida or one of eight other states – because Maine lacked treatment opportunities. In the program’s first six months, four out of five Operation Hope participants headed out of Maine, mostly to clinics in Florida, Arizona and Massachusetts.

“We always wanted to help people closer to home, but we really had no other choice. That was the only way to get people help,” said Steve Cotreau, program manager at Portland Community Recovery Center. The nonprofit social support center for people in recovery has helped with Operation Hope placements.

With the current black-and-white approach that many law enforcement agencies are taking with regard to “regulation” of treatment providers, many good providers are electing to close up shop due to lack of regulatory guidance. When the only guidance available is a knock at the door from a detective claiming you have violated the law, when the lawyers themselves may disagree whether the law was violated, but it is to be “left up to the judge and jury” to determine one’s fate, many good providers are simply walking away.

There is an absolute vacuum of publicly-funded beds in Florida, and nationally. Even when there is some modicum of availability, these facilities are generally not accessible to persons who do not qualify as being impoverished, and are often staffed by persons who lack the experience or education to be administering what is becoming an overwhelmingly medical modality.

The ignorance from the regulatory bodies about how the private sector must be allowed to work is impeding innovation as well as necessary investment in technologies for growth. A truly progressive society would stop complaining and fully support the treatment industry altogether.

The apparent restriction of prosecutorial discretion for purposes of achieving popular political gains is not only short-sighted, but also has a significant negative impact upon the substantial legitimate employment that the industry provides, along with choking off the ancillary revenue that local businesses experience from developing recovery communities.

We will simply go from one crisis, to another.