Managing Pharmacy Operations and Controlled Substances

Managing Pharmacy Operations and Controlled Substances
Managing Pharmacy Operations and Controlled Substances

Pharmacy departments face unique risks and regulations that govern their processes while focusing on timelines of drug delivery and patient safety. Many organizations find it difficult to understand the complex billing structures associated with drugs, and the ever-rising drug costs have many pharmacy directors concerned about their revenue.

In addition, the ongoing opioid crisis has many pain points that affect pharmacy, quality and practitioner processes as organizations attempt to focus on new ways to ensure that prescribers are following recommendations of the Centers for Disease Control and Prevention, as well as Joint Commission guidelines, related to appropriate prescribing of pain medication and to pain management and assessment of all patients.

How We Can Help

Pharmacy Revenue and Billing Accuracy

Pharmacies continue to face challenges in capturing full and appropriate reimbursement. We help hospitals realize their pharmacies’ revenue potential by identifying and evaluating internal controls intended to capture all pharmacy charges, manage data integrity, and determine compliant billing for all drugs and the associated administration (such as accurate injection and infusion coding, appropriate use of modifiers, and conversions to billing units).

In January 2017, Medicare implemented new billing requirements for drug waste with the JW modifier. Due to the complexity of the requirements and a misunderstanding of the impact on reimbursement, many organizations have decided to not bill for drug waste. This could result in millions of dollars of missing revenue, especially when drug waste for expensive chemotherapy drugs is considered. By performing a quick assessment of drugs billed with the JW modifier, we can help develop efficient processes and provide recommendations to configure systems to accurately document and bill for drug waste in accordance with the regulations.

Drug Diversion

We have extensive knowledge of and experience with drug diversion prevention and monitoring processes that can be used to evaluate internal controls to prevent and detect drug diversion in inpatient and outpatient pharmacies, research facilities, and clinical and procedural areas. Specifically, we can help by assessing and providing recommendations to get to leading practice related to:

  • Organizational structure and buy-in from all appropriate leadership
  • Procurement, receiving, inventory management and transfers/restocking practices, including appropriate segregation-of-duties and system controls
  • Prescribing, dispensing and administration
  • Waste disposal systems and compliance in nursing and procedural areas
  • Monitoring, investigation and response procedures, and educational processes

Opioid Crisis Response and Pain Management and Assessment Protocols

Many hospitals are taking a hard look at their pain management processes to ensure effective treatment of patients while reducing opioid and other controlled substance addictions and improving access to addiction recovery services. Some of the ways Protiviti helps our clients include:

  • Performing an assessment to determine compliance with new Joint Commission pain-assessment and management standards (required as of January 2018) related to leadership, pain screening, treatment planning, performance monitoring and data analytics
  • Determining compliance with applicable state Board of Nursing requirements for prescribing of controlled substances by advanced-practice registered nurses (APRNs)
  • Data analysis of prescribing patterns and identification of outliers


As the 340B Drug Pricing Program continues to be reshaped by regulators and lawmakers, many covered entities are unsure of their role in the program going forward and how processes may need to change to keep up. Specifically, we can evaluate policies and procedures for compliance with regulatory requirements and offer guidance on leading practices for documenting how the covered entity’s savings are utilized and tracked. We can also review billing practices to determine whether JG and TB modifiers are used appropriately, evaluate current protocols for a HRSA-initiated audit, and perform an overall assessment of internal controls related to vendor relationships and contracting, Medicaid duplicate discounts, inventory management, and finance and accounting.


Richard Williams

Managing Director

Global Healthcare Leader


[email protected]
Julia Russell

Associate Director


[email protected]

Ready to work with us?

Richard Williams
Richard Williams
Managing Director