Drug Compliance and Operations

Managing Pharmacy Operations and Controlled Substances
Drug Compliance and Operations

Healthcare organizations face unique risks and complex regulations that govern their pharmacy and clinical drug operations. Many organizations find it difficult to understand the complex billing structures associated with drugs, and ever-rising drug costs have many executives and pharmacy directors concerned about their revenue.

In addition, the ongoing opioid crisis has many pain points that affect pharmacy, quality, compliance and operations. Organizations are focusing on new ways to ensure not only that clinicians are following prescribing requirements and best practices, but also that clinicians are properly assessing and treating patients with substance use disorders (SUDs).

Solutions provided

How We Can Help

Pharmacy revenue

Protiviti helps healthcare organizations realize their revenue potential by identifying whether all relevant drug-related charges have been captured and optimized, data integrity is appropriately being managed, and drugs and associated administration are billed in a compliant fashion (such as accurate injection and infusion coding, appropriate use of modifiers, and conversions to billing units).

Due to the complexity of the JW modifier, many healthcare organizations have decided not to bill for drug waste, resulting in millions of dollars of missed revenue. Using our proprietary tool, Protiviti can quickly and effectively identify potential revenue opportunities from missed drug waste and noncompliant drug waste billing practices. We also advise on process and system reconfigurations for ongoing operational excellence and increased revenue.

Drug diversions reviews

Protiviti has 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 pharmacies and acute and post-acute care facilities. Protiviti can help by assessing and providing recommendations to achieve leading practices related to proper ownership, inventory management, clinical practice and monitoring, investigation, and response procedures.

Opioid Crisis Response 

Most healthcare organizations are developing and implementing opioid stewardship programs to ensure effective treatment of patients while reducing SUD and improving access to medication-assisted treatment (MAT) and SUD recovery services. Protiviti can assist with data analysis of prescribing patterns, Drug Enforcement Administration (DEA) licensing, and assessing for compliance with applicable state licensing requirements for prescribing of controlled substances by doctors and advanced-practice registered nurses (APRNs). Protiviti also performs accreditation and regulatory assessments.

Supply Chain Management

Protiviti has experience with improving supply chain processes in the pharmacy, including data analytics and benchmarking against leading procurement practices. Protiviti can assess your compliance with Drug Supply Chain Security Act (DSCSA) requirements, assist with inventory management solutions, and evaluate proper security and segregation of duties.

340B Complaince

Health Resources & Services Administration (HRSA) audits continue to identify gaps in covered entity compliance that can result in corrective action plans and removal from the 340B program. Protiviti’s robust audit procedures prepare covered entities for an HRSA-initiated audit. We also can perform an overall assessment of internal controls related to provider relationships and patient eligibility, Medicaid duplicate discounts, inventory management, and finance and accounting. Most covered entities struggle with optimizing their 340B program through contract pharmacy arrangements and decreasing weighted average cost (WAC) spend. Protiviti can assess the accuracy of registration records, evaluate policies and procedures for compliance, and perform required independent third-party reviews of contract pharmacy arrangements. Protiviti can also review billing practices to determine whether duplicate discounts are occurring and whether JG and TB modifiers are used appropriately.


Ready to work with us?

Richard Williams
Richard Williams
Managing Director
+1 (214) 395-1662
Leyla Erkan
Leyla Erkan
+1 312-551-8402