The 340B Drug Pricing Program contains several complexities that covered entities are expected to govern and oversee.
The 340B Drug Pricing Program contains several complexities that covered entities (CEs) are expected to govern and oversee.1 Smaller entities may find it challenging to dedicate resources to 340B surveillance, as this oversight may exist as one of many hats worn by an individual.2 Larger entities, however, may find that the scope and size of their program warrants dedicated resources for 340B surveillance.
Previous articles1,2 in this 340B series have highlighted the importance of establishing a strong compliance framework and knowledge base for internal CE stakeholders. Although strong internal controls are the basis for a robust 340B program, situations may arise in which consultants are called upon to help provide additional expertise and assistance in a variety of capacities.
Engaging a Consultant
Like CEs, firms offering 340B consulting come in all shapes and sizes. From smaller boutique firms that specialize in 340B consulting to large-scale Fortune 500 companies offering consulting services in a wide variety of industries, it is key for the CE to critically evaluate the consulting services required and the type of consulting relationship desired.
Consultants may be identified through a variety of avenues. Existing vendors may offer 340B consulting as part of their suite of products. Perhaps the most trusted source when beginning the search for 340B consultant services is word of mouth. Approaching other known 340B CEs to learn about their experience with a given firm provides trusted insights into the quality of a firm’s services. Even an internet search can yield numerous results for companies offering a variety of 340B consulting services.
Regardless of the method used for identifying a 340B consultant, the CE should complete due diligence before contracting. Apexus offers a tool3 designed to assist CEs during this request-for-proposal (RFP) process, and it is key to establishing the grounds for a successful consulting engagement.
Types of Engagements
There are times when legal counsel is your best resource to fulfill consulting needs. Legal counsel can assist with interpretations of the law, weighing risks with taking actions, and other options when the avenue is otherwise unclear. They have expertise in contract development, review, and changes and can navigate complex relationships with other entities, such as split-billing vendors and manufacturers whose legal teams drive certain decisions and practices. Legal consultants can also assist with self-disclosures, government audits, and appeals of audit findings.3 Furthermore, the attorney-client privilege can be exercised to provide protections to the CE when necessary. It is generally recommended to perform independent external audits under attorney-client privilege, whether external counsel or in-house, to promote candid discussion and proper legal analysis without being compelled to disclose those matters when undergoing subsequent audit activity with other auditing parties.
Although =legal consultants may offer other general 340B-related services, such as policy and procedure development, nonlegal consultants are available to assist with most parts of a 340B program. From registration to termination, consultants can provide expertise and guidance to the CE year round and can be leaned upon to address program needs in a more timely manner than the CE. Some common considerations for consultant use are audit work, best practice development, financial review, growth opportunities, and training. Less common considerations for engagement are split-billing system selection and RFP guidance, software configuration and implementation, and staff training.
Tips for a Successful Working Relationship
Building a strong relationship with a consultant is the foundation to achieving and exceeding deliverables. When a consultant understands the education level, needs, and organization of a CE, efforts can be tailored to detailed statements of work and priorities of the engagement. A clear statement of work ensures clear expectations and benchmarks by which to measure success. The statement of work can also be used by other stakeholders to provide context to data or other information requested by the consultant. Additionally, in a consulting relationship focused on compliance, transparency drives improvement. Findings can be a good thing, as they provide opportunity for proactive improvement.
Finally, validate all assumptions regarding recommended actions and program analyses. This will provide a check on the consultant’s work and, more importantly, allow the CE and its program leadership to understand the rationale and supporting evidence to activities and decisions. Recall that responsibility for all program elements lies with the CE.
Whether an organization is considering consultants for the first time or keeps one on retainer, these concepts discussed herein are important to use throughout an engagement and revisit with each new statement of work. Their use can provide a significant return on investment.
Note: The contents of this article are intended to convey general information only and not to provide legal advice or opinions.
Ashley Mains Espinosa, PharmD, MS, CPHIMS, is director of system pharmacy business services at SCL Health in Denver, Colorado.Michael Starling, PharmD, MBA, BCPS, is the 340B operations manager at the University of Kansas Health System in Kansas City.