Regulatory changes have bombarded the addiction treatment space since Citizen Advocates CEO James Button took the reins at the company in 2020 – an especially precarious time for health care in general.

The biggest change he has seen since taking the helm? Balancing patient preferences and new regulations.

“We have to stay on our feet and ahead of what patient preferences are and what the community is struggling with to ensure that we’re relevant,” Button told Behavioral Health Business. “Patient preference is no longer limited to what was available. We went from a very static and structured environment to a very dynamic and undulating environment with constant evolution.”

Part of that evolution included new regulations that created challenges in meeting new patient preferences for mental health and addiction recovery providers like Malone, New York-based Citizen Advocates.

While there is a reinvigorated desire from many patients to “take charge of their own care,” even in addiction treatment, it can be challenging for providers to meet them where they’re at and come up with new ways to care for patients in this new landscape.

“It’s important for us to orient [ourselves] to this new patient landscape and patient empowerment and listen to people telling us how they would prefer to receive care. We’ve tried to solve for that for years – how do we get people more engaged in care?” Button said. “It turns out the answer was in front of us all along. We just needed to hand over the care to the people who are receiving it and have them tell us how they prefer to receive it.”

Changes to interstate prescribing rules, the explosion of telehealth and the modernization of methadone distribution have helped providers build more patient engagement. However, these changes have faced setbacks alongside a move by the Trump administration to walk back mental health parity enforcement, creating further challenges for the industry.

Providers preparing to operate within these complex frameworks should be prepared to keep a close eye on moves from the Centers for Medicare and Medicaid Services (CMS) and the Drug Enforcement Administration (DEA) and be ready to “dig deeper” on patient-centered approaches, regardless of how they feel about regulatory shifts, Button said.

“Regardless of how you feel about the changes to methadone – whether you think it’s really a modernization or a setback – patient-centered approaches seem to have the best efficacy and the best outcomes, so we’re obligated to try this,” Button said. “What we’ve been doing up until this point has been a noble effort, but we’re still falling short. We can’t celebrate. We’re still in the middle of an epidemic, and although we’ve started to see some positive results over the past couple of years, now is not the time to celebrate. Now’s the time to continue to dig deeper so that we can continue to see those gains and sustain those goals.”

The quotes below are excerpts from a conversation with Button. Responses have been edited for style, length and clarity. At BHB’s Addiction Treatment Forum on July 17 in Chicago, Button will discuss these topics in-depth on the panel “Regulatory Horizon: Navigating the Changing Landscape of SUD Treatment,” alongside co-speakers Dan Schwartz, vice president of public policy for the National Association for Behavioral Healthcare, and Pete Nielsen, CEO of the National Behavioral Health Association of Providers.

BHB: How have things changed the most in SUD treatment with the modernization of methadone distribution?

Button: There has been meaningful change from CMS with the modernization of methadone. The treatment model has moved from what I would call treatment with a certain set of conditions to a more collaborative approach.

It used to be that in order to receive methadone, you had to show up every day, you had to engage in counseling and you had to be pursuing some kind of sobriety. In doing that and creating that conditional approach, we were missing the mark with folks. I’m pleased to see CMS and to an extent the DEA recognizing the importance of engaging people in a less restrictive approach.

I also believe innovation continues to benefit from these relaxations in public policy. We’re seeing folks who are getting into this new way of delivering methadone with bundled payments and with take-home doses of up to 28 days. We’re able to help people get back on their feet and live a life less disrupted by treatment.

There are challenges, though, because there’s some discord between the CMS public policy approach and the DEA. The DEA is trying to ensure these controlled substances are handled appropriately. CMS is trying to increase access. In the middle of all of that, at the intersection, are our patients. One of the challenges we’re faced with as a provider industry population is how to make sense of the CMS approach and compare it with the DEA’s.

It’s hard right now to scale methadone maintenance and methadone treatment programs across multiple states, because each state has its own interpretation of these regulations and they have their own preferences. I think what’s especially true here with the modernization of methadone is that it’s difficult to scale to multi-state operations when each state has such a unique perspective on the delivery of methadone care.

What is needed to close the gap in methadone distribution and access?

I think we’re always going to have to contend with the nuances at the state level.

As providers, we’re hopeful to get on the same page to help us scale methadone availability. Our hope is that, although CMS and the DEA each have a unique perspective, they’re working together to increase access responsibly and create a uniform approach.

When you introduce the nuances in the states and you introduce the DEA perspective and then you layer on CMS perspective, there’s a point, there’s an inflection point where the hurdles that you have to jump through to scale methadone become cost-prohibitive and administratively prohibitive.

We hope that there will be a universal or a joint viewpoint at the federal level, at some point.

How are reimbursement models adapting, or failing to adapt, to flexible methadone delivery pathways?

State adoption varies on CMS rules, and as I mentioned, some states want in-person treatment or in-person delivery of addiction treatment services, while other states have rushed to really ease in-person requirements.

I’m grateful that CMS has put out guidance around bundle payments, but we still have different interpretations of what bundled payments can do for folks. You just have to be wary of which states you’re working in, because one state, whether it is right next to another, might have completely different approaches.

As we’ve looked at multiple states and looked into delivering services across multiple states, it’s not just enough to know the regulations. It’s important to know the regulator preferences in the state.

What might some of the biggest compliance risks over the next 12 to 18 months for providers be, and how should they prepare?

Even though CMS and the DEA are not quite aligned and despite the impermanence of telehealth, we’ve resumed our growth in this space. We’ve resumed opening methadone treatment facilities and methadone treatment programs.

I would say the biggest burden for us as providers is the change management associated with moving from a model that places strict conditions on people to a model that collaborates with people who are in treatment.

I would venture to say that all of us, for our entire careers, have mostly seen methadone administered one way. The rules hadn’t changed for years before they recently changed. One of the things that we’re doing while we are waiting for these federal regulations to become more permanent is that we’re retraining our teams.

It’s not just a shift in the care model. It’s a paradigm shift. We’re no longer placing conditions on treatment. We’re trying to get people into care. We’re trying to save lives. We’re no longer looking at ourselves as the experts. We’re looking at patient-first models. That requires a shift for all clinicians.

It requires a shift for folks who are used to billing a certain way. Importantly, it requires compliance to be on top of not only the shifting regulations but also the dissonance between regulations.

Shifting established care models and billing practices away from routine is difficult for many teams to understand. I’m worried that we don’t pay close enough attention to educating staff and billing teams and equipping your compliance teams to look at this, not only from a quality of care focus, but a regulatory and compliance focus. As long as the DEA and CMS are not necessarily aligned on their perspectives and approaches, there are compliance risks there as well.