With so much activity occurring in the 340B space in recent months, including HRSA Frequently Asked Questions (FAQs) related to 340B eligibility, hospital recertification, manufacturer developments around contact pharmacies, and the uncertainty of what lies ahead following the upcoming election, now is as good a time as any to rally your organization’s key 340B stakeholders.  A recognized “best practice” to facilitate interdisciplinary 340B-focused discussion and planning is through a 340B oversight committee.  This month’s blog will highlight important considerations to help ensure your covered entity (CE) has built a dynamic, well-informed team to help navigate the future of your 340B program.

The most important aspect of a 340B oversight committee is the roster of participants.  It is well understood that 340B programs are incredibly complex, with operations spanning across numerous departments and business units within a single CE, and often across large multi-CE health systems.  Ensuring that the 340B oversight committee is comprised of a diverse group of representatives, each member bringing unique expertise and perspectives, will help to broaden the scope of the committee’s work and make sure that all the important bases are covered.  Below is a list of stakeholders to consider recruiting for your 340B oversight committee:

Hospital/Clinic Administration (“C-Suite”)

Starting with your covered entity’s Authorizing Official (AO) – for most CEs this is the Chief Financial Officer (CFO) –  involvement from executive leaders is crucial to make sure the direction of the 340B program is aligned with organizational goals and objectives.  Also, this provides a regular platform to inform and educate executive leadership on compliance trends, financial performance and resource gaps that may be impacting 340B program success.

Pharmacy

Pharmacy staff often serve as the “workhorse” of a CE’s 340B program, and there are many moving pieces of the pharmacy’s operations that can impact program compliance and performance.  Consider a variety of pharmacy participants, including representation from pharmacy leadership, pharmacy procurement, and pharmacy operations.  Shared representation with the Pharmacy & Therapeutics (P&T) Committee may be of value to determine how hospital formulary decisions may impact 340B, and to facilitate policy/procedure review and approval.

Finance

In addition to the CFO, key players in evaluating and monitoring for 340B program eligibility exist within the finance department.  Involvement from experts in revenue cycle and accounting is critical, given their familiarity with the Medicare Cost Report (MCR) and Trial Balance, and they can address questions related to Medicaid billing processes to promote Duplicate Discount prevention efforts.

Compliance & Internal Audit

340B program compliance will be a pillar of the oversight committee’s function, so engaging compliance and internal audit is essential to validate the effectiveness of the CE’s compliance strategy.  These participants can help establish a compliance framework, and provide direction for self-auditing exercises and responses to HRSA audit requests.  They can also provide a conduit to your CE’s legal department, who can help review contracts and other agreements with outside parties.

Government Relations

Include colleagues from your organization that interact with your CE’s congressional delegates.  They can help craft your “340B story” to make sure the legislators who represent your CE in Washington understand the impact that 340B has on your patients and your community.  Additionally, these committee members can keep you apprised of legislative changes, both at the federal and state levels, that may impact your 340B program.

Information Technology (IT)

With so many aspects of 340B operations reliant on data and software technologies, make sure you include leadership from your IT division.  Compliance risks and audit findings that warrant significant IT resources to mitigate should be shared, so that IT leadership can help allocate their expert work force accordingly.  Also, internal IT experts may be able to assist in responding to HRSA Audit data requests, which often require a substantial effort in response.

While the above are core representatives to consider in the 340B oversight committee, other departments, based on your organization’s needs and resources, may be worth including.  A CE may benefit from having a Medical Staff Office (MSO) participant on their committee, if assistance is routinely needed to validate provider eligibility.   Another CE may decide to include a representative from nursing leadership, if insufficient documentation of medication administration has been a root cause of diversion risk.  The key is to find a roster of experts that represent the various intersections of each of your CE’s 340B program elements.

Logistical arrangements for the 340B oversight committee, particularly with regard to meetings, should also be determined.  Executive leadership may have a specific vision for authority and governance of the 340B oversight committee, and the committee should be organized accordingly.  If this committee is new to your organization, consider drafting a “charter” to help clarify the scope and purpose of the committee, and to define a structure for how and when the group is to meet.   Consider adopting a “best practice” of quarterly meetings for your 340B oversight committee so that all members of the team are kept informed of key program changes and 340B developments, and also keep minutes summarizing the outcomes of your discussions.

Once your oversight committee’s membership is established, the information reviewed, i.e., the agenda for each oversight committee meeting, should be carefully constructed.  Routine updates on compliance efforts, financial performance, and optimization strategies should be provided.  Additionally, these meetings can serve as a valuable opportunity to provide continuing education to your key stakeholders on program requirements and updates on “hot topics” across the national 340B landscape.   An example of a potential 340B oversight committee meeting agenda is provided in Figure 1.

If your CE has an established 340B oversight committee, take some time to review your membership, and consider whether a key piece of the puzzle might be missing in your conversations around 340B program management.  And if you have not yet put a committee together and need some additional guidance, please don’t hesitate to reach out to the team at Turnkey Pharmacy Solutions with questions.