New program aims to improve compound medication safety

Calabrese, RPh, MHPEven today, the mortar and pestle remains the iconic symbol still representing our great profession.  

And, while we have witnessed unprecedented advancements in the development of thousands of safe and effective, commercially-manufactured drug products, the practice of drug compounding still remains a valued healthcare service for select individuals who, for various reasons, cannot be treated successfully with a commercially-manufactured, FDA-approved medication.

Recently however, the practice of compounding has come under enormous scrutiny due to a variety of quality, safety and economic concerns which have drawn significant attention from FDA, lawmakers, PBMs and public and private insurers alike. 

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Most notably, our nation has witnessed the emergence of hundreds of "compounding" pharmacies over the past decade producing, marketing, pricing and dispensing of these unapproved medications in ways that now have clearly stretched the boundaries of traditional compounding practice. 

In 2012, the subject of compounding was raised to new heights when 64 individuals were killed and another 750 injured due to a fungal meningitis outbreak caused by tainted injectable corticosteroid products made by a MA-based compounding facility.

Around the same time, PBMs began to witness sharp rises in pricing and utilization of compounded products, unexpectedly elevating these previously low-attention medications into primary focus on our radar screens, as well as those of contracted plan sponsors.

In light of these concerns, OptumRx developed the SECURE™ (Safe & Effective Compound Use Reassurance Effort) program to assist clients in better monitoring and managing the production, pricing and dispensing of today’s compound medications.  Recognizing that the success of such efforts requires a multi-dimensional effort, SECURE combines benefit design strategies along with utilization management protocols, extensive analytics and the nation’s first and only network compound credentialing program (NCCP). 

NEXT: SECURE's goals

The ultimate goal of SECURE is to both preserve the value of compounded medications for those who require them, while simultaneously ensuring that optimal standards of quality in production and business practice are being fully upheld by the pharmacies that produce and dispense them, and the clinicians who prescribe them.

At the Academy of Managed Care Pharmacy Nexus Conference on October 27 at 12:30 ET, OptumRx will share an overview of the SECURE program with a specific focus on the NCCP component and the various learnings that it has obtained in the implementation of this program. 

With SECURE, OptumRx has combined a variety of benefit design tactics including but not limited to the establishment of per prescription drug pricing thresholds as well as exclusion of compound kits, non-FDA approved pain patches and sprays, and select bulk chemicals of higher clinical/financial concern.

Additionally, the program embodies key utilization management strategies such as prior authorization on all compound prescriptions containing select ingredients (i.e., ketamine) of high safety concern; screening for duplicative ingredients and dosing of select ingredients; and step therapy for other compounds where an ample array of FDA-approved, commercially-manufactured products are available for 1^st-line use. 

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The SECURE program entails requirements around compound claims submission and a comprehensive set of analytics and reporting to track the prescribing, billing and dispensing of compound medications at both the pharmacy and prescriber level.

The NCCP program sets forth a broad array of stringent, yet very fair credentialing criteria to ensure that pharmacies producing and dispensing these medications are held to the highest standards of quality and integrity in their compounding practices. 

To maximize the proficiency of these efforts, OptumRx has partnered with United Compounding Management (UCM), a well-recognized leader in this space, to assist in qualifying pharmacies, monitoring submissions and intervening where necessary. 

Credentialing criteria developed by OptumRx include meeting several industry-wide standards as set forth by national bodies such as the Pharmacy Compounding Accreditation Board (PCAB). 

Additionally, this criteria include the assurance of pharmacy-specific continuous quality management and improvement functions; compliance with state and federal laws; ethics review regarding sales, marketing and other business practices; and defined code of conduct and trainings for pharmacy staff.

Lastly, the program also encompasses pre-adjudication screening, on-site audit and credentialing review by OptumRx and UCM team members.

OptumRx has seen positive adoption since the SECURE program’s inception in 2014. Many clients have chosen to add all of the program’s components with others selecting the components that best fit their individual needs. 

The credentialing component is the only feature which is mandatory for any OptumRx client utilizing our pharmacy network.  In the first year of the program, those who have adopted SECURE have witnessed more than a 90% decrease in PMPM compound expenditures with unnecessary compound prescribing and dispensing reduced by more than 50%.

All in all, the SECURE program has been extremely well-received by clients, providers and the industry as a whole. 

We believe that this approach represents an ideal compilation of components to drive quality and cost-efficiency, while still preserving access for those patients and financial viability for those pharmacies that hold true to high-integrity compounding practices.

David Calabrese, RPh, MHP, is vice president and chief pharmacy officer of OptumRx. He also is an editorial advisor for Managed Healthcare Executive.