Compliance is often a misunderstood word that most healthcare professionals associate with spending more time and money. Typically, compliance is defined as a certification or confirmation that the doer of an action or manufacturer of a product meets the requirements of accepted practices, legislation, prescribed regulations, specified standard or terms of a contract. 340B Program compliance can be defined by many of these explanations, but it does not have to equate to incurring additional expenditures. HRSA and OPAIS have created accepted guidelines and practices that define general requirements and expectations for 340B Program participants. The interpretations and implementation of these requirements are where covered entities can become submerged in the minutia that ultimately leads to extending more resources than what is needed.

Leveraging 340B compliance efforts across the entire program can decrease the extra resources needed to correct errors or problems long after they have occurred. Developing, building and maintaining a compliant 340B Program, no matter the size, is the foundation that is needed for a 340B Program to reach the operational and financial success desired by a covered entity. Ideas that may assist in the establishment and leverage within a program include:

• Development of sound policies and procedures
• Identifying a 340B compliance committee or team
• Establishing a 340B program champion
• Investing in employee education and training
• Partnering with the best suited third-party administrator
• Understanding the relationship between covered entity and contract retail pharmacy providers
• Evaluating the profitability of contract retail pharmacy agreements
• Exploring entity owned retail pharmacy opportunities
• Recognizing and acting when substandard performance is identified
• Contracting with an independent 340B consulting firm to assist

Planning for Long-Term Compliance from the Start

Unfortunately, many covered entities wait to evaluate program compliance until it is too late. Additional employee hours, dedicated covered entity leadership time, and expenses incurred engaging independent advisors are compounded when speedy resolution is the only solution.

And while some 340B Programs are more complex than others, in general, program success lies in establishing accurate and firm policies and procedures, then leveraging current assets to ensure these defining principles are being followed. Leveraging the needs for long-term compliance into the program from the start may reduce the amount of time and effort needed later when called upon by HRSA.

Keeping Up With Regulatory Changes

There’s no question that the changing 340B regulatory landscape adds to the complexity of maintaining a compliant program. However, investing in employee education and continual development can assist a covered entity in adapting a 340B Program quickly and efficiently to new standards established by the regulatory agencies. Overall, the profitably of a 340B Program can be determined by how well a covered entity establishes internal governance of the program, follows and monitors the compliance of the program and leverages its resources to adapt to meet the ever-changing landscape of the regulations.

The 340B Consulting Team at Blue & Co. has assisted many covered entities in improving and leveraging their 340B resources into more compliant and profitable programs. All of our 340B consultants are Apexus 340B Certified Experts. If you would like more information as to how better leverage your 340B Program, please contact us.