Featuring Mallory Mojarro of True Rx Health Strategists on the Rising Burden of PBM Regulatory Compliance
PBM licensure and compliance requirements have intensified in recent years, transforming what was once a regulatory checkbox into a core business strategy.
In this episode of Regulatory Joe, ClearFile President Joe Boyle and Mallory Mojarro, Manager of Licensing and Regulatory Compliance at True Rx Health Strategists, discuss the future of PBM compliance, including state licensure trends, reporting burdens, and how leading PBMs are rethinking their regulatory strategies.
With requirements increasing across every jurisdiction—and regulators expecting more data, faster—PBMs that view compliance as a siloed or reactive task are being left behind.
The First Step in PBM Compliance? Organized Licensure Tracking
Mallory’s advice to PBMs navigating their first licensure or renewal filing is clear: it’s time to get organized.
“The most important thing to start with is having a system in place to keep track of what’s due and when,” she shared. “There are so many requirements that it can be easy to lose track.”
Whether it’s a PBM renewal deadline, a follow-up request from a state Department of Insurance, or a quarterly reporting obligation, missing a task can have significant downstream effects. Mallory noted that’s why True Rx partnered with ClearFile to centralize deadlines, documentation and state-specific requirements.
Proactive PBMs Reframe Compliance as a Continuous Process
A core theme of the episode was how proactive PBMs reframe compliance as a continuous process—not a scramble.
From completing state PBM licensure filings before onboarding a new client to adjusting internal compliance workflows based on new legislation, Mallory emphasized the importance of agility and strategic alignment.
“Compliance isn’t just reading statutes and filling out forms,” she said. “It requires a level of business fluency so you can recommend process changes or adjust program offerings based on what’s allowed where.”
This agility allows PBMs to serve clients more effectively—and keeps them from getting stuck behind regulatory shifts.
The PBM Compliance Burden Is Growing—Here’s How to Stay Ahead
As Joe and Mallory noted, the past 24 months have brought an intense increase in new licensure requirements, annual reporting, cybersecurity rules, and state-level mandates. These new PBM regulatory requirements aren’t going away—and for many pharmacy benefit managers, staying compliant now demands centralized systems, licensure tracking tools and proactive resource planning.
Whether it’s navigating overlapping TPA and PBM licensure, or preparing for robust financial and rebate disclosures, PBMs that invest early in infrastructure, partnerships and internal communication are the ones positioned to stay operational and competitive long-term.
PBM Compliance Tips from Regulatory Joe
Here are some of the biggest tips Mallory and Joe gave for PBM teams to stay ahead:
- Treat PBM Compliance as Strategy, Not Overhead: Licensure and reporting aren’t just red tape—they’re tools to build trust, expand into new markets, and reduce business risk.
- Prioritize Cross-Departmental Coordination: Involve legal, finance, analytics, and leadership early and often. Compliance can’t live in isolation.
- Use a Centralized PBM Licensure & Compliance Tracking System: Ditch the sticky notes. Adopt a system like ClearFile that gives your team clear visibility into licensure, deadlines, and state-specific templates.
- Map PBM Licensure Costs Against Your Strategic Plan: Some states require tens of thousands of dollars in fees, bonds and reporting. Use your footprint and client geography to prioritize—but be ready to register preemptively when growth is on the horizon.
- Get Comfortable Asking Regulators Questions: Don’t assume you have to figure everything out alone. States often welcome proactive communication. Reach out early to clarify requirements and avoid unnecessary delays or rework.
Episode Transcript
Joe: Hey everybody. Welcome to Regulatory Joe. I’m Joe Boyle, president of ClearFile, and I’m very excited to introduce our latest topic and special guest speaker, Mallory Mojarro of True Rx. Our topic today is being a proactive PBM and defining a stronger compliance strategy.
Mallory, welcome to the show. Tell us a little bit about your background and how you entered the PBM space.
Mallory: Thanks, Joe. I’m glad to be here today. I am the manager of licensing and regulatory compliance at True Rx Health Strategists.
True Rx is a proactive PBM. We try to be a different type of PBM where we put our patients before profit, and we work with self-funded employer health plans. So that’s really where my focus has been.
Joe: Starting in 2024, we’re at the cusp of the last 24 months where states and divisions of insurance have increased new policies, mandates, and regulations surrounding PBM licensure.
You’re definitely learning alongside PBMs across the industry. What are some of the key things that you think a proactive PBM should be looking at right now—whether it’s their first licensure application, renewal, or report?
Mallory: The most important thing to start with is having a system in place to keep track of what’s due and when. There are so many requirements that it can be easy to lose track—reports, renewals, licensure, and follow-up emails.
Keeping track of those deadlines can be difficult. Any type of system to keep track of that is good. ClearFile is great for that. We’ve partnered with ClearFile to keep track of deadlines, and that’s been very helpful.
Making sure to stay up to date with pending legislation is very important. We’re seeing a lot of bills in the legislature that can potentially have a major impact on requirements—new licensure requirements in different states and new reports.
Just make sure you’ve done research into what each state requires. Before starting a licensure application, I like to start on that state’s website, understand what they require, and review their PBM statute and what types of documents they need.
I find that there’s better outcomes if you reach out to the statutory authority—the division of insurance or whomever it may be—and see them more as a partner than an adversary. They’re often more than happy to answer questions or clarify what they’re looking for so you can get it right the first time.
Joe: Absolutely. Communication is key—and overcommunication is best. Building those relationships, having regulators and reviewers understand who the PBM is, what the business does, and what its mission is, is critical.
Aside from all of the nuanced requirements, spending time on phone calls to ask questions is worth the time investment. Having a centralized repository or workflow system is key.
More often than not, aside from True Rx, PBMs are using everything from Excel spreadsheets, sticky notes, OneNote, or Word docs off the side of their desks to try to track these complex requirements.
While states communicate with one another, each state has its own unique set of primary and secondary requirements, varying deadlines, and time-bound submissions.
Resourcing and staffing is critical. So am I safe to assume you’re a dedicated resource to this work at True Rx? And who else are you working with internally?
Mallory: Compliance is organization-wide. You can’t make decisions in a silo when it comes to compliance.
I focus mainly on compliance. We also have our Director of Compliance, Vicki Bohannan, and our General Counsel, Mike Chestnut, who are very involved.
We utilize data and assistance from our analytics team, especially for reporting requirements—when a state asks us how many claims there have been, how many rebates we received and passed on, and what clients are in which state. They’re a great resource.
We work directly with our legal team, especially when interpreting statutes and regulations. When ERISA and non-ERISA questions come up, that’s a big topic.
We keep our executive team apprised of what’s going on. They’re involved in licensing decisions and in instituting required statutes and regulations organization-wide. There can be changes that affect the entire business—not just what type of report we file.
We rely on our finance team to provide financial information needed by each state. When states ask for information, they want a little piece of everything—not just one particular thing. They want the whole picture.
Joe: Right, and you nailed that. As your organization grows and evolves, PBMs are also adjusting strategy—whether they’re ERISA, self-funded, or fully insured groups.
With stronger PBM requirements, they may exit or enter new states, leverage TPA licensure requirements, or turn mandates into opportunities.
Historically, licensure has been seen as administrative, but it’s highly strategic. Compliance work is always required, should always be funded, and is more strategic than we tend to remember.
I’d love to hear more about what you’re learning. As a paralegal absorbing all this, you’re probably even making process recommendations and helping build your well-oiled machine.
What should other PBMs learn from a proactive PBM like True Rx?
Mallory: True Rx has clients in most states, so we’ve taken the proactive stance to become registered in each state. That allows us to be ready when we get clients—so we’re not rushing to get licensed after a sale or RFP.
That was a business decision our executive team made to keep us ready no matter where clients come from.
We prioritize based on how many lives we have in a state. We do look at cost—some of these registrations are tens of thousands of dollars. Then there are reporting fees and required bonds.
So we make decisions based on that, but we’ve still moved forward with registration in each state where we’re able to because it made sense for us.
The most important thing I’m watching is how state regulations and legislation impact business. There are dispensing fee mandates, requirements for point-of-sale rebates, and prohibitions on certain pharmacy fees.
These impact what programs we can offer clients. So we keep the executive team updated on new laws and what’s allowed by statute. Maybe we can offer a program in one state but not another.
When new laws go into effect almost immediately, it keeps things interesting. Compliance isn’t just reading statutes and filling out forms—it requires agility to adjust programs or reprioritize licensure.
I’ve learned compliance is about continuous improvement, not perfection. My paralegal background was all about meeting every requirement immediately, but compliance—especially licensing—is about becoming more compliant each day and adapting as new requirements emerge.
Joe: What you just said is key—this isn’t just box-checking. You’re educating internal teams, leadership, and stakeholders. Everyone needs to be accountable—not just compliance.
Over the past 24 months, states have strengthened guidance. That’s not going away.
I’d love your thoughts on how proactive PBMs should approach disproportionate requirements. For example, a startup PBM entering a state like New York is facing a $20,000 licensure fee. That’s a bigger lift for them than for a larger PBM. What are your thoughts?
Mallory: We’re a medium-sized, transparent PBM. A lot of new regulations don’t even apply to us because we don’t use spread pricing.
New York’s cybersecurity rule is necessary, but for a company our size, it’s a heavy lift. It requires pulling in our IT and security teams. In the past, we were focused more on HIPAA and privacy. Now states are stepping into cybersecurity.
Some states require a lot of claims and rebate data. If you have a large footprint, that’s a big lift.
But we’ve found there’s not really a way around these requirements. When we see a new law or reporting mandate, we evaluate: Does it apply to us? Is it for ERISA, non-ERISA, self-funded, fully insured?
But when nothing exempts you, you just have to do it—even if you don’t like the requirement.
We appreciate ClearFile communicating with regulators and opening conversations like, “Why are these items required?”
When we’re asked for claims data or contracts, I wonder: Is someone reading this? Is the state using it to lower drug prices or help patients? I’d like to think so.
But sometimes it feels arbitrary. And like you said, many offices are lean. Sometimes you submit a report and don’t even get a confirmation that it was received.
I feel for the states. Legislatures pass laws but may not provide staffing to support them. We saw this with Rule 128 in Arkansas, and the dispensing fee mandate in Kentucky.
Better communication across legislatures, departments of insurance, boards of pharmacy, and PBMs would help.
At True Rx, we want our patients to thrive, we want to help employers offer benefits, and we want to meet the law. Those goals can seem conflicting, but they’re really not. We just want to lower prescription costs and follow the rules.
Joe: That’s a great point. Strengthening communication across divisions and bureaus is critical. For any PBMs listening: reach out to your regulators.
You mentioned Rule 128 in Arkansas, the Kentucky mandate, and other examples. Some states require audited financials, fingerprints, or biographical affidavits.
The message is: Make licensure part of your day-to-day work. Don’t deprioritize it. Don’t seasonally staff it. Make it an integrated workflow.
And like you said, be proactive—even if you don’t hear back. The requirement is still the requirement.
You’ve given us a lot of great advice today.
Let’s shift for a moment. Licensure wasn’t historically a full-time role. What kind of person makes the right fit for this work?
Mallory: I’ve always said I like paperwork. But really, someone energized by new challenges.
When I see a new law was passed, I don’t dread it—I want to dig in and figure out how to meet the requirement.
It’s a challenge, not a personal affront. States aren’t coming after me or True Rx. They’re trying to improve the industry.
I came from the relocation real estate world. It seems very different, but it actually helped a lot.
In relocation, every state, company, and employee had unique requirements. I got used to working with different regulatory bodies, keeping track of changes, and understanding how those changes impact business and clients.
There’s a lot of paperwork and precision. I used to say: if you type the wrong lot number, you’ve sold a different house.
It’s the same in PBM work—if a statute requires a very specific rebate or claim detail, you have to get that number right. That level of detail was ingrained in me already, and it helped a lot in PBM licensure.
Joe: That’s so valuable—and fascinating. It reminds me how complex even a Secretary of State filing can be.
This work doesn’t have to be scary. It can be a rewarding, successful career path—for early-, mid-, or late-career professionals.
It’s something people should be excited to do.
So, the past 24 months have been busy in the PBM world. Where do you see the next 24 months going? By 2027 or 2028?
Mallory: I think we’ll continue to see more laws regulating PBMs, especially in certain states.
Eventually, it will calm down. There are only so many ways to regulate a PBM. You can only tell us so many times not to steer, spread price, or charge fees.
Once most states implement those laws, it’ll become more routine—just filing reports and staying in good standing.
While there will probably be another year or so of new regulations, I think it’ll smooth out. Most states will have similar requirements.
There’s only so much they can impose—unless something new comes up, which it might. That’s what keeps it interesting.
Joe: Thank you, Mallory. I’d agree that the next year or two will be another period of change.
Mallory, we can’t thank you enough for your time and insights. Where can people find you and True Rx?
Mallory: Thank you so much for having me. It’s been a pleasure. You can find True Rx at TrueRx.com, reach us at hello@TrueRx.com, or check out our LinkedIn page. I’m on LinkedIn as well—Mallory Mojarro.
I’m excited to see where the PBM industry takes me next, to see True Rx grow, and to ride the rollercoaster of what happens next with legislation.
Joe: Thank you, Mallory. I hope many PBMs benefit from your insights and reach out to you and True Rx.
That’s a wrap for today. Thank you, everybody, for tuning in. Give us a like, give us a share, and we’ll see you next time.
