- within Food, Drugs, Healthcare and Life Sciences topic(s)
OptumRx's decision to implement a 25 percent therapeutic class cap for network pharmacies beginning in 2026 marks an important moment in the continuing evolution of pharmacy benefit manager (PBM) oversight. According to this policy, a pharmacy may not derive more than 25 percent of its prescription volume or reimbursement from any single therapeutic category unless the pharmacy has obtained approval through a specific arrangement with OptumRx.
Although the announcement has generated concern in some corners of the pharmacy community, it is more accurately understood as OptumRx adopting a familiar PBM tactic rather than introducing a novel enforcement mechanism. Other PBMs, including some of the largest PBMs in the country, which includes Caremark and Express Scripts, began down this path years ago. This was first done in other instances through product-level monitoring and later through broader utilization controls that extended beyond individual drugs. In this instance, OptumRx's therapeutic class cap reflects the same logic, applied in a more formal and transparent way.
This is not a sudden shift in direction. It is the next step in a long-running trend toward standardized, data-driven oversight of pharmacy networks by the largest PBMs in the country.
Prior Experience Shows Where This Leads
In approximately 2019 into 2020, other PBMs began introducing similar frameworks, which focused on pharmacies whose dispensing of certain drugs exceeded certain percentages of their overall business. Over time, such frameworks expanded. More drugs were added to the list, analytical methods became more sophisticated, and enforcement increasingly focused on overall utilization patterns rather than isolated transactions.
Eventually, this type of scrutiny moved beyond individual NDCs and into therapeutic category-level analysis. Pharmacies with significant concentration in particular classes found themselves facing audits, corrective action plans and network-related consequences, even in the absence of allegations of improper conduct.
OptumRx's new policy mirrors this evolution. By establishing a therapeutic class cap upfront, OptumRx is signaling how it intends to evaluate utilization risk going forward, rather than relying solely on after-the-fact determinations.
Why PBMs Favor Therapeutic Class Caps
From the PBM perspective, concentration within a single therapeutic category is viewed as a potential indicator of elevated risk. That risk may relate to cost containment, utilization management, or fraud, waste and abuse monitoring. Whether those assumptions always reflect clinical realities is open to debate, but the PBM objective is consistency.
Therapeutic class caps provide PBMs with a brightline benchmark that can be applied across large, national networks. They also allow PBMs to demonstrate to plan sponsors and regulators that utilization oversight is systematic rather than discretionary. In that sense, these caps function less as punitive measures and more as governance tools.
It is also significant that OptumRx's policy allows for approved exceptions. That feature acknowledges that legitimate pharmacy models do not always conform to uniform metrics and that patient populations can drive concentration in ways that are both appropriate and necessary.
Greater Clarity Can Reduce Uncertainty
For many pharmacies, the most frustrating aspect of PBM oversight has been unpredictability. Vague references to "outlier behavior" or "aberrant trends" often surfaced only after an audit was underway. Numeric thresholds, while imperfect, offer a degree of transparency that was previously lacking.
A defined 25 percent cap gives pharmacies the ability to evaluate their own data, identify potential exposure, and plan accordingly. It shifts the dynamic from reactive defense to proactive management. Pharmacies that understand where they stand today are far better positioned to address potential concerns before they escalate.
In this respect, OptumRx's approach may ultimately be more manageable than informal standards that vary by auditor or review cycle.
The Impact Will Not Be Uniform
The practical effect of therapeutic class caps will vary depending on a pharmacy's business model. Many community pharmacies with diverse patient populations will likely find that their utilization patterns fall comfortably below the threshold. For those pharmacies, the policy may require little more than periodic monitoring.
Other pharmacies, however, serve defined patient populations or operate in clinical niches where concentration is unavoidable. Specialty pharmacies, pharmacies aligned with certain prescriber practices, or pharmacies serving high-need populations may naturally exceed the cap through legitimate operations.
For those pharmacies, OptumRx's allowance for specific arrangements is critical. It places a premium on early engagement, clear documentation, and thoughtful explanation of how the pharmacy's model serves patient needs without presenting undue risk.
Lessons from Prior Experience Apply Here
Prior experience offers a practical lesson. Pharmacies that dismissed early utilization controls as temporary often struggled when those controls expanded. Others recognized the direction of travel and adapted accordingly.
Those pharmacies invested in understanding their data, monitoring trends, and developing compliance narratives that explained their dispensing patterns in business and clinical terms. As a result, they were better equipped to respond when scrutiny increased.
OptumRx's policy creates a similar moment of choice. Pharmacies can wait and react, or they can prepare and engage.
What Pharmacies Should Be Doing Now
With implementation set for 2026, pharmacies have time to prepare, but that window will close quickly. Reviewing historical dispensing data is an essential first step. Pharmacies should identify whether any therapeutic category approaches or exceeds the 25 percent threshold and understand the drivers behind that concentration.
Where concentration exists, pharmacies should be prepared to articulate why it occurs, how it aligns with patient needs, and why it does not indicate inappropriate utilization. Documentation and analysis will matter far more than assumptions or anecdotal explanations.
For pharmacies that anticipate exceeding the cap, early discussions regarding specific arrangements are essential. PBMs are far more receptive to proactive engagement than to explanations offered after enforcement actions begin.
PBMs as De Facto Market Regulators
Like other PBMs before it, OptumRx is exercising the role PBMs increasingly play as de facto regulators of pharmacy networks. Their policies shape not only reimbursement, but also business strategy and operational decisions.
Recognizing that reality does not require agreement with every policy choice. It does, however, require disciplined preparation. Pharmacies that understand PBM logic and plan accordingly are better positioned to navigate oversight without disruption.
Looking Ahead
OptumRx's adoption of therapeutic class caps reflects a broader shift toward formalized, data-driven oversight across PBM networks. While these policies add complexity, they also provide clearer benchmarks and expectations.
Pharmacies that understand the pattern, prepare early, and engage thoughtfully will be positioned not only to comply, but to operate more confidently in an increasingly structured PBM environment.
In a market shaped by PBMs, readiness is not optional. It is the price of participation and the pharmacies that pay that price early will be the ones best positioned for the future.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
