Optum Rx has quietly taken a significant and troubling step in its 2025 Provider Manual revision. The pharmacy benefit manager (PBM) has formally codified a 25-percent therapeutic-class dispensing threshold. This new rule is not supported by medical necessity, patient-care principles, or recognized regulatory standards. Instead, it creates a rigid and arbitrary barrier that poses significant legal, operational, and competitive risks for pharmacies. We have witnessed Optum Rx enforcing this new rule against independent pharmacies in audits and corrective action plan requests.
This unilateral update to the Provider Manual marks Optum Rx’s intent to intensify compliance requirements for its network pharmacies and raises major concerns for pharmacies seeking to join its network.
What Optum Rx’s New Rule Says – And Why It’s So Problematic
Optum Rx’s Provider Manual now states:
Network Pharmacy Providers without specific arrangements previously approved by Administrator shall not have over 25% of their total claim submissions and/or amount paid related to Optum Rx members attributed to a single therapeutic class.
This threshold is disconnected from real-world pharmacy operations and may directly undermine patient access to medically necessary care.
Why Optum Rx’s 25-Percent Limit Is Arbitrary, Unworkable, and Potentially Unlawful
- It Ignores Critical Pharmacy and Patient Variables
The rule does not account for:
- Location: Optum Rx relies on general data points that compare pharmacies to their peers. However, this can be unreliable based on geographic factors, such as the location of certain provider types being in proximity to a pharmacy.
- Patient Population: Pharmacies serving patients with HIV, oncology needs, behavioral health conditions, or chronic diseases routinely can exceed a 25-percent threshold, particularly when the threshold is calculated on a dollar basis.
- Seasonality: Vaccination surges, respiratory illness seasons, and infectious-disease events can shift dispensing patterns.
- Pharmacy Size: Independent pharmacies face disproportionately higher risk compared to PBM–owned or high-volume chain pharmacies.
- There Is No Clinical or Regulatory Basis
There is no federal, state, or clinical standard endorsing a fixed therapeutic cap on an independent pharmacy. This rule is not tied to fraud, waste, or abuse prevention and is inconsistent with Centers for Medicare & Medicaid Services and state regulatory requirements for patient access, nondiscrimination, and medical necessity.
- Potential Conflicts With State and Federal Laws
Optum’s cap may also conflict with multiple federal and state legal frameworks, including recently enacted PBM transparency and credentialing statutes, state network-adequacy and patient-access mandates, Any Willing Provider laws, and state unfair trade-practice prohibitions.
In addition, the policy raises serious concerns under federal antitrust principles and may violate Medicaid and managed care organization (MCO) requirements that protect beneficiary access to medically necessary pharmacy services.
Operational, Clinical, and Patient-Care Impacts
The operational consequences of Optum Rx’s cap are substantial. Pharmacies face an elevated risk of network termination because ordinary fluctuations in dispensing patterns, often driven by seasonality or changes in physician prescribing, may suddenly push them beyond the 25-percent threshold, prompting audits, credentialing denials, or other adverse actions.
This instability threatens continuity of care, as patients could lose access to their trusted pharmacy mid-treatment despite the pharmacy’s dispensing patterns being dictated by legitimate clinical need. Pharmacies may also delay or avoid dispensing medically necessary prescriptions to avoid triggering penalties, creating treatment gaps that jeopardize patient outcomes.
These effects ripple outward, undermining established relationships between prescribers and pharmacies, particularly in specialized therapeutic areas where clinical expertise is essential. The cap also creates broader public-health risks because community demand for vaccines, antivirals, respiratory therapies, and other seasonally sensitive medications routinely increases during certain periods, naturally raising dispensing proportions above 25 percent at exactly the moment when communities rely on pharmacies the most.
The codification of the Optum’s limit poses new risks to enrolled pharmacies and those wishing to apply to the Optum network. Many independent pharmacies offer specialized services and care to patients suffering from particular diseases. Optum’s 25-percent limit unfairly targets and threatens these businesses.
A Clear Continuation of PBM Anticompetitive Behavior
Optum Rx’s newly codified limit is part of a larger pattern of anticompetitive PBM conduct. Barclay Damon’s Pharmacy Team has extensively documented similar tactics by CVS Caremark in recent years.i
Optum Rx’s new limit mirrors these tactics and reinforces concerns that PBMs are using concentration thresholds not to prevent fraud or abuse but to suppress competition and steer high-value prescriptions toward PBM–owned pharmacies.
Examples Illustrating the Rule’s Real-World Harm
The risks posed by Optum Rx’s cap are not theoretical.
- A rural pharmacy experiencing an influx of respiratory prescriptions during wildfire season could exceed the 25-percent limit precisely when its community relies on it most.
- A pharmacy specializing in HIV care could routinely dispense more than 60 percent antiretrovirals, placing it at immediate risk of denial despite its expertise and patient need.
- A pharmacy providing large volumes of flu, RSV, and COVID-19 vaccinations during peak immunization season could surpass the threshold solely because it is serving public-health needs.
- A pharmacy serving a population with chronic psychiatric or neurological conditions could be penalized for dispensing medically appropriate antidepressants or ADHD medications.
Each scenario shows how Optum Rx’s rule punishes pharmacies for doing exactly what patients require.
What Pharmacies Should Do Now
Pharmacies should take immediate and strategic action to protect their operations, their patients, and their legal rights in response to Optum Rx’s 25-percent therapeutic-class cap.
- Step 1: Carefully review dispensing data to determine whether current patterns for Optum Rx beneficiaries approach the threshold. Ensure credentialing applications are prepared with heightened scrutiny, as even marginal exceedances could trigger a network enrollment denial.
- Step 2: Preserve all communications from Optum Rx, including emails, notices, audit letters, and credentialing correspondence, as these documents may be critical in supporting appeals or regulatory complaints.
- Step 3: Maintain relationships with providers to ensure thorough clinical documentation to demonstrate that dispensing patterns reflect legitimate medical necessity rather than any improper conduct.
- Step 4: Take action beyond internal compliance. Pharmacies should actively engage with government agencies, such as state insurance departments, Medicaid and MCO oversight bodies, and federal regulators, to alert them to the cap’s potential to undermine patient access, disrupt continuity of care, and violate transparency and network adequacy laws. By formally advocating for regulatory review or intervention, pharmacies can help ensure PBMs are held accountable for policies that may be anticompetitive, discriminatory, or harmful to public health.
How Barclay Damon Can Help
Barclay Damon’s national Pharmacy Team is actively advising pharmacies on how to navigate and challenge Optum Rx’s newly codified therapeutic-class limit. The team assists with credentialing and recredentialing strategies, dispensing-pattern analysis, PBM dispute resolution, audit defense, appeals, and regulatory advocacy. The team also provides strategic guidance to pharmacies that focus on high-need or specialized patient populations, helping them continue meeting patient needs while managing PBM risk.
If your pharmacy dispenses a substantial portion of prescriptions within a single therapeutic class or if you are preparing or appealing an Optum Rx credentialing application, now is the time to act. Barclay Damon is ready to assist you today.
If you have any questions regarding the content of this alert, please contact Brad Gallagher, co-leader of the firm's Health Care Controversies and Pharmacy Teams, at bgallagher@barclaydamon.com; Alix Hirsh, associate, at ahirsh@barclaydamon.com; or another member of the firm’s Health Care Controversies or Pharmacy Teams.
iSee “PBMs Take Pharmacy Aberrant Dispensing Outlier Issues to Next Level”; “Caremark Ushers in New Year by ‘Clarifying’ Its Aberrant Quantities and Volume Provision”; and “Pharmacies, Beware: PBMs Enforce Restrictive Product Blacklists Through New, Unprecedented Terminations.”