Leading experts weigh in on current policy issues and challenges

Should State and Local Governments Use Pay for Success Financing to Support Medication-Assisted Treatment (MAT) for Opioid-Use Disorder?

The increasing rate of opioid use disorder and overdose deaths has become a national opioid crisis, which has further increased pressure for policy-makers to “just do something.” However, the opioid crisis is complicated, and it isn’t always clear how state and local governments can improve the situations people are facing.

Pay for Success (PFS) is an innovative financing model that allows state and local governments to ensure their scarce resources are used for programs that actually improve people’s lives. As one of the only evidence-based solutions available to help address the opioid crisis, implementing Medication-Assisted Treatment (MAT) through PFS financing may be an effective means for jurisdictions to “do something” that improves the situation. However, successful PFS projects also involve requirements that are not well-suited to every program.

This debate brings together policy researchers, medical practitioners, decision-makers, and PFS experts to discuss and debate whether state and/or local governments could (or should) use PFS to implement MAT as an approach to address the opioid crisis in their jurisdictions.

The Urban Institute is talking with...
Lisa Clemans-Cope Lisa Clemans-Cope
Don Teater MD, MPH Don Teater MD, MPH
Sally Satel MD Sally Satel MD
Kelly Walsh Kelly Walsh
Jake Edwards Jake Edwards
Mireille Jacobson Mireille Jacobson
Cheryl Burnett Cheryl Burnett
Dave McClure
Moderated by:
Dave McClure
Research Associate
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The PFS financing model provides a way to link taxpayer dollars to positive outcomes rather than program activities. Information on how the PFS model works can be found at pfs.urban.org, but in a nutshell, third-party investors provide funds to standup or scale a program and an end payor (usually government) repays those investors if the program successfully improves the lives of the people in it.  Interventions with a lot of research supporting their effectiveness are a better fit for this model, as all that evidence provides a foundation for defining success and gives investors more confidence the program will achieve its target outcomes and they’ll be repaid.

 

Now, MAT is described as an effective treatment for opioid addiction. Potential PFS investors may decide this evidence-base as strong enough to invest their own capital. So, to get the debate started: If the evidence-base is so strong, why isn’t MAT already more available and used more often?

More individuals currently die from drug overdoses than from car accidents in the US. And more than 60 percent of these overdoses are from opioids. While we, as a nation, were late to recognize the depths of the opioid crisis, the alarm bells have been ringing for several years now.  It was in 2011 after all that the CDC first labeled the crisis an “epidemic.”

With that as background, it is disconcerting, to say the least, that we continue to ignore the evidence base for the treatment of opioid use disorders (OUDs).  A vast literature, summarized by NIDASAMHSA and other experts, strongly supports the use of medication-assisted treatment for OUDs.

Pay-for-Success (PFS) is a financing approach that can be leveraged to encourage risk-taking around social programs when the net benefits are unclear.  In that sense, PFS is well-suited to cases where the evidence base is especially thin.  MAT is not such a case, particularly as it pertains to primary outcomes such as opioid use and treatment retention.

Despite this, access to and availability of MAT remain limited. Regulatory hurdles account for some of this but the bigger issue is stigma.  Simply put, there is a strong belief, even among many treatment providers, that one drug should not be substituted for another and that abstinence is the only option.  This flies in the face of the evidence and is largely inconsistent with the way we understand chronic “physical” ailments. In patients with diabetes, asthma or hypertension, for example, the importance of medication adherence is typically reinforced rather than discouraged in cases of recurrence.

As a researcher, I am the last one to tell you that all the questions have been answered.  We can and should rigorously evaluate the most effective ways to link individuals to evidence-based treatment, to promote medication adherence, to treat special populations such as newborns with neonatal abstinence syndrome, and, most importantly, to prevent OUDs to begin with.  But, to my mind, the biggest challenge lies in moving the needle around what we do and not what we know with respect to OUDs and MAT.

I agree wholeheartedly with the concerns expressed by Mireille and Don about the need to address stigma associated with opioid agonist treatment that affects clinicians, patients, families, communities, substance use treatment programs (eg most 12-step programs), and many recovery housing programs. Many have a negative view of these medications, buprenorphine and methadone treatment for opioid use disorder, even though they are safe and effective, reduce the risk of overdose, increase social functioning, and other positive benefits. Stigma likely has an important role in the underuse of effective treatment and the persistent capacity shortages that limit access to opioid agonist treatment.

To focus in on a specific example – how clinician stigma affects access to buprenorphine treatment, and what can be done -- research plus some common sense suggest some of the reasons why clinicians likely hesitate to offer buprenorphine treatment for opioid use disorder. Issues that could be addressed in communication and policy include the following: clinicians don’t know how to get a buprenorphine waiver, they think there is no need for buprenorphine treatment in their community, clinicians are concerned about diversion of buprenorphine, they don’t want to be inundated with buprenorphine requests, clinicians are concerned about precipitating withdrawal, they worry about the regulatory requirements and DEA site visits, they don’t have an experienced buprenorphine provider to help mentor, they think other patients might be unhappy to be treated in the same clinic as patients with opioid use disorder, and they don’t want to take up an exam room for a lengthy induction.

This list suggests some low-hanging fruit in terms of policy responses: pairing clinicians with an experienced provider, providing more CME courses on this topic, financial assistance for obtaining a buprenorphine waiver, requiring this waiver as part of medical education, providing better information and plans about how to meet regulatory requirements, offering detailed information about other local resources related to MAT and counseling, and having buprenorphine inductions performed at a location other than the clinic.

And a host of barriers to accessing opioid agonist treatment that have more to do with cost than stigma can and should be tackled -- lack of insurance, under-insurance, affordability of treatment, insurance and regulatory requirements that make it difficult for providers to prescribe opioid agonist treatment including the buprenorphine waiver process (and the lack of mandatory training to prescribe buprenorphine in medical schools), extensive documentation, refill limitations and reauthorization rules, coverage limitations that do not align with the evidence base (e.g. covered dose is too low, or covered course of treatment is too short), and low reimbursements for treating patients with opioid agonist therapy. In addition, our fragmented delivery system sets up the situation where costs can be shifted to different silos, contributing to the lack of effective screening and referral to effective treatment  for substance use disorders. 

Lisa - Your description of the barriers related to clinician stigma is really interesting.  I think that some general public conversations around OUD and stigma focus first on the person with addiction, both their willingness to acknowledge the need help and then actively seeking it. But clinician stigma seems like an additional contributor to limited MAT availability. When a person with addiction overcomes their own stigma-related barriers to seek assistance, they could still be negatively impacted by provider stigma. 

Some of the solutions you pose, like requiring this waiver as part of medical education, are pure policy responses and don't need the PFS financing mechanism to move them forward.  But others, like clinician training, could benefit from the financial resources that PFS unlocks.  If places are considering PFS to for this issue, they may include provider-level outcomes along with patient-level outcomes in the evaluation plan to capture changes to both the provider and patient communities.

I believe that MAT is not more available because of society’s long-held stigma toward those with the disease of addiction.  For millennia, addiction has been considered as weakness. Though science has confirmed that addiction is a disease of the brain, many people continue to think of it as a moral failing.  Even the terminology of “medication assisted treatment” implies that treatment of addiction usually should not include medications.  We don’t use this terminology for any other disease.  Most people with hypertension, diabetes, heart disease, gastrointestinal disease, and lung disease will need – and will use - medications.   We don’t call that “medication assisted treatment”.  We call it “treatment”. 

As long as the public and the medical profession continue to think of this as a problem with choices instead of brain biology, society will continue to shun these individuals, doctors will not want to treat them, and insurance companies will limit coverage. 

One of the crucial elements of the Pay for Success model is achieving a "successful" result. This sounds straight-forward, but significant improvements in one outcome still might not be considered a success if the intervention makes another outcome worse.

 

MAT is a bit of an umbrella term that describes distinct forms of medication-assisted treatment. With that in mind, what forms of MAT are going to be most successful, and under what definition of success (e.g., fewer fatal overdoses, faster results, smaller collateral consequences, lower costs, etc.)?

First and foremost, I am not a medical professional and I am not qualified to treat individuals afflicted by substance use disorders. I am, however, well-versed in world of Pay for Success and assessing where and when the tool is best deployed to achieve meaningful social outcomes.

So where do this pressing challenge—which, as Mireille mentioned, now kills more people than car accidents—and this innovative financing tool intersect? They come together around outcomes, and the ability to allocate scarce resources towards the most effective treatments.

Pay for Success is best deployed when: 1) within a social challenge, we can identify outcomes that are meaningful to beneficiaries, communities, and governments; and 2) a government partner—from local to state to Federal—is willing to assign a dollar value to those outcomes, which it will pay should the outcomes be achieved.

Aligned with Dave’s recent post—the selection of outcomes, or measures of success, is where the rubber hits the road.

Are governments comfortable assigning value to participant engagement, treatment retention or abstinence outcomes—an area where MAT has an extensive evidence base? Or will they look to metrics tied to more tangible savings and benefits, such as reduced criminal justice involvement or reduced emergency service utilization where MAT has a less proven impact? The right answer may rest somewhere in the middle, with a range of outcomes that fall within both of these buckets. Doing so would allow us to develop performance expectations across shorter-term outcomes and expand MAT evidence base across broader social service utilization domains—all while enabling individuals to pursue fulfilling and productive lives.

Jake, across the country, we see jurisdictions in different places along the spectrum of data collection, analysis and outcome measurement for addressing the opioid crisis, as for any program and service counties provide!  County leaders are finding it invaluable to have measurement tools, so they can focus their resources to meet the increased demand on our services.  They are targeting populations and neighborhoods, and using predictive analysis to better align resources and save lives.  Importantly, they are also making every effort to collect and share data across departments, agencies and partner jurisdictions.  

As you know all too well, this is very often one of the biggest hurdles to launch a PFS project – we can get to the point of agreeing the metrics, but are the processes in place to secure the data needed to measure?  We are grateful to some of our corporate partners supporting local communities and helping them build the capacity and systems to better collect, analyze and use data to support their efforts during this crisis, including the type and intent of the drugs causing an overdose, the age and gender of those who overdosed, their zip code, the geographic distribution of prescriptions – all important data in local efforts to channel limited resources to combat the opioid epidemic:  Esri/Orange County

https://ochca.maps.arcgis.com/apps/MapJournal/index.html?appid=66c8b67aa72842f49431616c94bce302

 

I absolutely agree that data is such an important part of developing and improving opioid-related policies and programs. In partnership with folks at the National Governors Association, we released a guide on that very topic earlier this year: Using Data and Evaluation in Policy Development, Implementation, and Monitoring - Building Successful Policies to Reduce Prescription Opioid Misuse. The processes for securing regular and timely access to the necessary data, and then sharing those data across departments, agencies, and partner jurisdictions are critical. They can also be a significant challenge, both in terms of technical and organizational aspects.

I think it is fantastic that you're working with some of your corporate partners to address those technical challenges (and I'd love to read more about those efforts), but I'd like to hear more about overcoming some of those organizational challenges.

Achieving project alignment and multi-agency stakeholder support are two of the great benefits of using the PFS model. For the model to work, it necessarily requires the relevant stakeholders to be on the same page about what they're pursuing, and thus what they're measuring. Perhaps PFS could provide a productive means for at least improving the fragmented service delivery around MAT, if you're able to get those stakeholders to the point of agreeing on the metrics. There are a few reasons this can be a challenge.

Different departments and agencies can have different priorities and perspectives on what needs to be accomplished. Sometimes, they can also be hesitant to share their data too freely, even with other agencies, out of a concern for how that information might lead to negative impacts for their organization. I'm sure this tendency plays a role in the fragmented service delivery Lisa mentioned as one of the barriers to more widespread availability and use of MAT, as well as the lack of wrap-around services for incarcerated individuals you mentioned earlier.

What are some of the conflicting perspectives, priorities, and concerns that could prevent departments, agencies, and partner jurisdictions from becoming more aligned and coordinated with respect to MAT?

To piggy-back on this topic—I would echo Cheryl and Dave’s emphasis on the importance of data.

With that said, it seems as though there is a spectrum of “data-readiness”. The two poles are comprised of: 1) communities that are just beginning the process of using data to inform policy, and 2) communities—such as Orange County—that are effectively using data as a means to understand the population and thoughtfully deploy resources.

Pay for Success can be a helpful instrument in both cases.

On the former, PFS—as Dave noted—can be a forcing mechanism to bring together stakeholders across city, county, and state governments to have critical discussions about the opioid epidemic and how data can be a tool to assess the problem, identify measures of success, and determine in real-time the impact of treatments, such as MAT. We have seen numerous times how the presence of a 3rd party intermediary can be a catalyst to break down barriers and navigate the red tape that often hinders these critical data integration efforts.  

On the latter, PFS can be a mechanism to manage for results. In a PFS project, all partners—from service providers to government stakeholders to intermediaries—work hand-in-glove. Such governance structures ensure identification and treatment referral mechanisms are in place, data flows are set up to understand program performance and track service utilization across multiple agencies, and operational challenges are addressed in real-time.

In both cases, setting up PFS projects—and the data-related conversations that are part of the process—can help communities assess the problem and drive resources to scale effective treatment solutions.

The reason for challenges in sharing data across government departments and agencies are multi-fold.  Sometimes it is antiquated systems that can’t “talk to each other.” Sometimes it is the tradition and comfort of silos and not wanting to share “my” information. Sometimes law and regulations prevent some sharing (though we need to be sure not to default to this as an excuse). This is where I have seen the benefit of Pay for Success.  Despite the challenge of breaking down some of these silos or the need for finding ways to share data more effectively, Pay for Success requires it in order to get to shared metrics. While the development of a specific Pay for Success project is often arduous and takes significant time and commitment, the capacity-building that extends beyond the specific PFS project can have a huge impact on jurisdictions and the building of a culture of data-sharing and outcome measurement.

 

 

There are three medications that are used for MAT. Methadone is the oldest and has been used for treatment of Opioid Use Disorder (OUD) for over 50 years. Buprenorphine (Suboxone is one of the well-known name brands) was the second drug approved for this use in the U.S. and has been used for over 15 years here but for a longer period in Europe. Naltrexone is the newest drug. It comes in both an oral formulation and an extended-release injection that is given once a month. 
Methadone and buprenorphine are both opioid medications and are considered replacement therapy. They replace the critical endorphins that are depleted in the brains of individuals with OUD. 
Naltrexone is an opioid blocker. It attaches to the opioid receptor and blocks anything from activating it. If an individual takes an opioid or injects heroin, they will not feel a thing. It is being marketed as a non-addicting treatment for OUD. Unfortunately, it is also the least effective. The oral form is not effective for treating OUD and the long-acting injection appears to help about 20% of people in the first six months, however, this study and this study showed that longer term outcomes are not any better than no treatment. 
Methadone and buprenorphine help about 50% of people reach long-term recovery which is not great but is pretty good compared to any other addiction treatment available. A recent study also showed that these two drugs reduce crime-related costs over $17,000 per person over the first six months of treatment. 
Interestingly, methadone and buprenorphine are generic medications that do not make much money for the companies that produce them. Naltrexone injection (Vivitrol) however, does not have a generic and is very expensive at about $1600 per injection. Because the medical community has not chosen to use much of this product, the company has been marketing to law enforcement and legislators to make laws and rules that will bypass the medical decision-making of addiction specialists and primary care doctors. 
If PFS programs are going to look at supporting MAT, they must make sure they are supporting programs that have evidence of long-term success and are supported by science.

 

I echo what has been said about the unsavory reputation of opioid replacement therapies in the minds of some politicians/policymakers. Even the short-lived HHS Sec. Dr. Price alluded to it.  

But let's face it, addiction is not like other diseases. I am happy to elaborate on that further, but for now, it is important to recognize that people who are addicted to opioids and seek treatment with buprenorphine or methadone need observed urine tests and generally additional counseling -- at least until they are stable.  This is a tall order for busy primary care doctors. Also, it is not uncommon for patients to sell their medication. The drop out rates are high (about 50 percent by 6 months). It should not be a surprise that these patients are not necessarily the most attractive for these reasons and it explains why so many MDs who have a waiver to prescribe bupe choose not to treat at all or only treat a small number of opioid patients at any given time.

All this said, opioid replacement medication (methadone being the best studied) are almost always a benefit. They may not lead to abstinence but they reliably reduce costs associated with addiction such as crime, infectious disease, homelessness, health in general, employment etc.  For that reason, they are worth promoting and, it would seem, a good candidate from PFS. 

 

 

 

Thank you to the Urban Institute and to the participants in this discussion for taking the time to continue to raise awareness and look for solutions to helping communities address the opioid epidemic. 

The impact of this crisis is tearing apart families and overwhelming the resources of local jurisdictions.  Counties and cities across the nation are struggling to keep up with the dramatic increase in demand on many of our impacted systems – justice, public safety, coroners, child welfare, health – agencies and departments overloaded and with little dedicated funding.

The stigma issue discussed is real.  We know how to treat chronic illness.  According to the Centers for Disease Control and Prevention, nearly the same number of people need treatment for diabetes (29 million) as those needing treatment for substance use disorder (21 million). Yet roughly three of four diabetes patients receive treatment, while only 12 percent of those with substance use disorder do. Beyond the stigma, local governments are seeing other challenges to providing treatment which research shows will help those facing this disease, including:

  • Lack of access to MATs under insurance plans: there are great variations in coverage of MATs in private and public insurance plans (including Medicaid and Medicare). Beyond the question of whether or not MATs are generally covered, access to coverage is complicated by prior authorization requirements, “fail-first”/detox requirements and applicability of coverage to different medications and dosages of those medications. Insurers (and states when it comes to Medicaid/Medicare) play a significant role in determining whether MAT is accessible and affordable in the community.
  • Too few providers administering MATs: despite evidence of the effectiveness of MAT, not enough providers can prescribe the medications needed in the treatment, in part because of federal limits regarding the number of patients an MAT provider can see and what type of providers (doctor v. nurse, for example) can prescribe MATs. There is also ongoing skepticism among potential providers towards MAT. Some are hesitant to become involved in MAT administration because they are skeptical of the underlying concept of MAT and whether it represents “true recovery” or they are worried that providing MAT will bring them into contact with “undesirable” populations. Federal and state requirements and incentives can help increase the number of providers that offer MATs.
  • Limited access to MAT in jails and prisons: although the number of correctional facilities that provide some access to MATs is increasing, there is still limited access to MAT within the correctional setting. Treatment in jails is especially important because individuals returning to communities are acutely vulnerable to overdose. Cost of treatment is the key factor since federal benefits are typically suspended or terminated when an individual is booked into jail – and there is also the prevalence of detox as the preferred method of treatment in jails and prisons.  

Facing these challenges, local leaders are partnering with other local jurisdictions and community-based organizations to meet the treatment demand with limited resources.  They are increasingly using data to help target resources, which could support the potential of a Pay for Success funding model– more on that later!

 

 

Well, even though this is a debate, it seems there's a lot of agreement on some fundamental aspects of MAT.

Please correct me where I am mistaken, but it appears Methadone- and Buprenorphine-Assisted Treatment are the most effective forms of MAT. While they do not guarantee success in individual cases (Don and Sally both mentioned a 50% retention after 6 months), they can still contribute to a variety of societal benefits associated with reduced addiction. Sally mentioned this includes reduced costs of crime, infectious disease, homelessness, health in general, employment etc.. However, these forms to MAT are challenging to deliver for a variety of reasons.

  • OUD (opioid-use disorder) patients can be challenging and undesirable for providers:
    • potential to divert their medications
    • prescribers don't want to precipitate withdraw
    • may frustrate other patients who don't want to be treated along side OUD patients
  • While the drugs themselves aren't expensive, other factors affect providers' consideration of costs for providing these treatments:
    • regulations (challenging waiver process; extensive documentation; DEA site visits)
    • time-intensive to deliver these treatments properly
    • low reimbursements for delivering these treatments
    • limitations on the number of patients a provider can serve
    • prescribers' (mis-)perceptions of the demand for such treatment options in their communities (either think there isn't a need for such treatment options in their community or think they'll be inundated with requests)
  • Several additional barriers directly affect the effective delivery of these treatments:
    • refill limitations
    • lack of insurance coverage for proper dosage (e.g., too low)
    • lack of insurance coverage for the proper course of treatment (e.g., too short)
    • "fail first" coverage requirements that force the problem to become worse before more effective treatment can be covered
    • fragmented delivery of services
    • lack or removal of eligible services at critical points (e.g., incarceration)
    • lack of training and experienced mentors to help guide prescribers on delivering these treatments

These are a lot of challenges, and it's interesting that very few of these barriers could be directly mitigated by simply making more funding available. Considering the federal efforts to make resources (such as the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act), it seems that a lack of funding is and will not be the primary reason MAT is not more widely available.

While it's certainly true that PFS is a mechanism for funding implementing new programs, the model's emphasis on the importance of achieving very specific outcomes (rather than simply producing outputs) is another important benefit of using PFS. In the case of MAT, that focus on outcomes may be even more useful than making funding available.

Concerning the second of Jake's two criteria for the conditions under which PFS is best deployed, the federal government clearly seems willing to assign dollars to improving opioid outcomes. However, rather than funding, it seems Jake's first criteria for determining if/where PFS may be deployed to make MAT more widely available is the critical factor: identifying outcomes that are simultaneously meaningful from the perspective of beneficiaries, communities, and government.

As several folks have mentioned, stigma about MAT and OUD is a primary driver for most of the barriers we've identified for making MAT more widely available. Importantly, stigma probably also represents a significant constraint on finding outcomes that are simultaneously considered meaningful from the perspective of beneficiaries, communities, and government.

So, to spin-off a notion present across several of the comments so far: What are the specific beneficial outcomes of MAT (such as those mentioned by Sally) that are considered so meaningful and important across the perspectives of beneficiaries, communities, and government that they could overcome the barriers and stigma surrounding more widespread use of MAT?

Before we move on to measuring outcomes, I would like to go back to one thing Dave just mentioned: 

"These are a lot of challenges, and it's interesting that very few of these barriers could be directly mitigated by simply making more funding available. Considering the federal efforts to make resources (such as the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act), it seems that a lack of funding is and will not be the primary reason MAT is not more widely available."

The money in CARA and the 21st Century Cures Act is a start but is probably nowhere close to what is needed to make a significant – and ongoing - increase in treatment to meet the needs of the 2 million people with OUD. I believe that our market-based system of healthcare and the financial incentives associated with that is what has created the opioid epidemic and I think financial incentives to providers can help expand treatment. I can see money from PFS programs working in two ways: 

1. Increase incentives for docs to prescribe buprenorphine in their office. This could be an increase payment for each office visit, an additional capitation payment for each person in treatment, or maybe a bonus paid for each patient who has been successful in treatment for the past 6 months. 

2. Incentivize creative programs that make addiction treatment easier for primary care doctors. Vermont hub and spoke model is an example. The initiation of treatment is done at a methadone clinic or other addiction clinic. When the individual is stable in treatment for a specified period of time, referral is made to the primary care doctor to continue ongoing prescribing of buprenorphine (which may be years of treatment). If there is a relapse, the patient is referred back to the original treatment program until they are stable again. 

If these two programs would work together, I think we could see a significant increase in buprenorphine prescribers with an increase in access to treatment for those with OUD. 

I agree with everything Don has said. We just completed an implementation eval of opioid-focused Medicaid Health Homes, which were integrated into Vermont's hub and spoke system, and we found that it is a very promising model for coordinating effective opioid agonist treatment with primary and specialty care, plus it supports screening and referral to address patient's social determinant of health (SDOH). Yet only 3 states have tried the model. Since the ACA is still around, states can still get the enhanced match for those health home services. And states could also apply for a SAMHSA STR  grant to help cover start-up costs that are not covered by the enhanced federal match (i.e., staff training, staff meetings, and infrastructure development to support coordination services and data requirements).  But maybe that support is not enough to get the ball rolling in most places. Maybe PFS could have a role in helping states to consider whether they should try out the model -- since there is some financial support over the longer term (i.e. regular federal Medicaid match).

Before diving into this question, language is a critical part of communicating on this topic and it’s important to discuss the implications of this discussion's use of “MAT” especially in light of Don’s spot-on summary of the treatment efficacy literature.  MAT typically stands for “Medication-assisted treatment” which is misleading in two ways. First, it indicates that the main-stay medications are not effective therapies on their own. This runs counter to evidence showing that psychosocial therapies such as CBT and contingency management does provide additional benefit to effective medications (e.g. see Cochrane review). That said, counseling is part of the treatment of any serious chronic disease and more study is needed to explore which subgroups might still obtain additional benefit of psychosocial interventions. (However, insurers who require provision of counseling before covering the cost of opioid agonist treatment is not supported by research.) Second, MAT lumps together effective methadone and buprenorphine treatments with naltrexone, which, as Don says, does not reflect the evidence. For example, in this ICER review while methadone has the highest retention in treatment over 3-12 months (63% range 54-71%) and buprenorphine has a fairly high retention (52% range 40-65%), and naltrexone did not perform better than placebo. Injectable extended-release form naltrexone has shown better somewhat better outcomes than the oral form, but is it clearly not similar in effectiveness to methadone and bupe. So this is why you see language shifting away from the vague and unhelpful term “MAT”, and to Opioid agonist therapy (OAT) or “opioid agonist medication” which refer to effective methadone and bupe treatment for opioid use disorder. 

So the specific outcomes of interventions related to opioid agonist medications could cover many domains (and can and should be compared to the outcomes of injectable extended-release form naltrexone). I’ve listed some outcomes below that would be expected to respond to opioid agonist treatment, but want to point out that in many cases the typical outcomes in SUD research do not align with patient concerns, so there is definitely room for outcomes development.

Typical sources of outcomes information include self-report, official administrative records, clinical screens such as urine drug screening results, and treatment program records, with measurements at baseline, during treatment and follow-up for the intervention and control groups and could include some of the following:

- Treatment entry and retention in treatment, in days.
- Administrative data and costs related to criminal justice involvement.
- Administrative data on health care use and spending, identifying use and spending that relates to ambulatory-sensitive care (e.g. avoidable ED use).
- Self-reported data on substance use frequency and criminal activity during the treatment and follow-up, with the outcome measures adjusted for days at risk in the community, e.g. days reported using heroin and other opioids, and days reported committing criminal activity.
- Self-reported functional health and well-being using validated measures.
- Self-reported measures of risk behaviors such as behaviors that could transmit HIV and other infectious diseases, e.g. frequency of needle use and sharing.
- Urine toxicology for illicit substance use, treatment compliance, and a check of self-reported information.
- Measures of withdrawal and desire to use/need to use.
- Measures and costs related to family and children, housing stability, employment, social support, etc.
- QALY (Quality Adjusted Life Years), mortality

... just to name a few!

I think this thread drives home the point that picking the right outcomes to measure is no easy task, PFS or no PFS.  Factors to consider include the priorities of local stakeholders, the outcome level (e.g. person-level, community-level), the logical link between the outcomes and the treatment activities. And of course, whether the data systems exist to actually track that outcome.  If outcomes of interest are routinely tracked, that's great, if not, then evaluators are on the hook to do some primary data collection.  That can be an expensive and time consuming endeavor. 

For PFS planning, it's important to remember that while some outcomes need to trigger repayment to the investor, you can also track outcomes that don't.  This may be a good option for outcomes that are not part of the existing evidence base for the program but are of interest to the local PFS planners.

 

 

 

 

Over the course of this debate, we have discussed:

  1. which specific forms of MAT the research shows are most effective (Opioid Agonist Therapy/Medication)
  2. The beneficial outcomes created by these programs, both for the individual and society
  3. The barriers currently limiting the more widespread availability and use of these programs
  4. The benefits of PFS and even becoming PFS-ready can have for overcoming some of these barriers

Throughout all the comments, there have also been brief mentions and hints of how PFS could be applied to support OAT. As the final question of this debate, I would like folks to share their overall impressions of where PFS seems particularly well-aligned with state or local efforts to implement OAT. Or, if it doesn't seem well-aligned, to explain why PFS wouldn't be a good approach for state and local jurisdictions to implement OAT.

I am not an expert in the PFS model but as a clinician I am optimistic that a PFS model would work. I know that in many areas of the country law enforcement professionals feel almost overwhelmed by the increase in crime as a result of the opioid epidemic. They are trying many novel approaches to address this issue. Law enforcement and the correctional community would be two groups that would benefit financially with a decrease in OUD-related behavior. It may be that there is not an evidence base that would directly support the conclusion that PFS would be cost-effective for law enforcement, I think there is enough indirect and anecdotal evidence to support some organizations to try this.

I’ll take the glass half-full approach (while being fully cognizant to the fact that PFS is likely not the silver bullet to challenges surrounding expanding access to OAT). Based on the dialogue I think PFS could support OAT implementations across a  few distinct functions.

First, aligned with Lisa’s point, there are often activities that need to be carried out to ensure that the services delivered are done so in line with best practices and the underlying evidence. PFS can provide the capital to support strong technical assistance, staff training, and third party performance monitoring and management that may otherwise be difficult to fund

Second, there are likely wrap-around supports that may strengthen OAT recovery outcomes, but are not Medicaid billable. One example, Individual Placement and Support (IPS), operates under the theory of change that employment supports promote broader health and wellness outcomes. While data suggests promise, such programs can benefit from larger evaluations and private scaling capital as part of PFS initiatives. 

The discussants here have identified some potential opportunities for PFS to play a role in supporting and expanding evidence-based treatment. Thinking about where else PFS could be leveraged, the discussion here focused deeply on stigma, particularly patient and provider stigma related to opioid agonist treatment (OAT). The evidence base of effective ways to tackle stigma is fairly thin. But boosting evidence-based practice (EBP) in this area will require strategic thinking and planning to achieve leadership and organizational change. PFS could have a role in testing various interventions to stimulate organizational culture change that supports uptake of EBP.

Another issue to consider with treatment interventions for opioid use disorder and PFS is that, while the evidence base related to the efficacy of methadone and buprenorphine is strong, critical knowledge gaps present real barriers for policymakers and practitioners who wonder how a particular treatment will work with their patients and their context and concerns. The evidence base needs to be developed for disadvantaged populations and subgroups. So PFS may need only point estimates of treatment effects to be viable, but larger samples powered to show statistically significant findings (over a fairly long follow-up period) would be needed to drive larger changes in practice, and supporting the larger samples for this population in the real world could be very expensive due to the expense of tracking and following-up.  

Everyone here makes great points about the suitability of PFS to support OAT.  Alignment between an intervention and the PFS model is just one consideration when someone is trying to figure out if PFS is right for their community.   Other things to consider include the ability to create local buy-in, provider capacity, the local political landscape and the willingness and ability to be evaluated. We've created a tool that tackles these elements.  The PFS Project Assessment Tool (PAT) helps people answer a fundamental question: What makes for a strong PFS project? It describes core elements of PFS projects, explains why those elements are important, provides a scoring system to help distinguish the strengths and weaknesses of a proposed project, and generates recommendations for improving those weak areas. The PAT is designed for individuals, governments, and organizations working through PFS projects or, even earlier on, simply considering engagement with PFS. Broadly termed "stakeholders”, PAT users include government officials and advisors, public agency leadership, program managers, service providers, and others who are interested in learning whether PFS might work for their community. Completing the PAT also helps build the business case for a proposed project if that project scores well in each area.