While the imposition of a therapeutic threshold on pharmacy claims could have a detrimental effect on a pharmacy’s business operations/model, there are a variety of legal defenses to oppose such thresholds.
Many pharmacy benefit managers (PBMs) use the beginning of a new year as an opportunity to update their provider manuals. It is critical for pharmacies to be aware of any updates to PBM provider manuals because noncompliance can result in clawbacks—or worse, termination. Further, such changes are usually helpful to gain insight on what a specific PBM may be focused on from both an audit and regulatory perspective in the upcoming year.
For 2026, OptumRx made a major update to its provider manual, specifically as to how it defines a “retail pharmacy.” Page 124 of OptumRx’s 2026 Provider Manual now states:
Network Pharmacy Providers in the retail network, without specific other arrangements previously approved by Administrator (e.g. Specialty Credentialing and Compound Credentialing) shall maintain a breadth of acute and maintenance medications as to service routine Retail Pharmacy customers. … 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. [Emphasis added.]
While the imposition of a therapeutic threshold on pharmacy claims could have a detrimental effect on a pharmacy’s business operations/model, there are a variety of legal defenses to oppose such thresholds. However, this new provision cannot be looked at on its own without taking into consideration the other applicable provisions in the same section.
Based on the specific language in this new provision, Optum appears to assure pharmacies that if credentialed as a specialty and/or compound pharmacy, the 25 percent cap on a single therapeutic category does not apply.
Therefore, while Optum’s new 25 percent threshold rule, on its face, may seem unsettling or disconcerting, it applies to fewer pharmacies than it appears to. The key takeaway is that pharmacies must take a close look at and analyze their PBM agreements to determine whether they have a “specific arrangement” (i.e., specialty or compound credentialing) that would render the 25 percent threshold policy inapplicable.
We will continue to follow closely how Optum enforces this policy. Optum’s threshold policy is not novel. Over the years, other PBMs have tried to impose similar caps on therapeutic category dispensing (i.e., CVS Caremark’s aberrant dispensing policy). However, pharmacies have been able to successfully oppose such caps based on various legal grounds.
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If you have any questions about this Alert, please contact Jonathan L. Swichar, Bradley A. Wasser, Nikki Baniewicz, any of the attorneys in our Pharmacy Litigation Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.