340B Oversight Committees and 340B Program Integrity

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340B Oversight Committees and 340B Program Integrity

The word “committee” elicits a certain reaction in organizations. For some, it is not so positive. Some see managing committees as unavoidable chores and a frequent waste of time. Others see them as opportunities to promote personal agendas and gain approval for programs. Committees, however, can serve a valuable purpose and motivate teams to promote continuous quality improvement. This provides the basis for the integrity of the systems that they are intended to oversee.

No matter how you view committees, HRSA expects your 340B program to have the proper mechanisms in place to ensure program integrity. There is no script to follow in orchestrating this. One single committee structure will not work for all enti

The graphic below provides a high-level picture of what the 340B oversight committee is intended to deliver regardless of the covered entity type. We will delve further into the functions of the committee in the following paragraphs. We will also explore structures that may assist in implementing a committee – or even strengthening an existing one.340B oversight commitee

HRSA Expectations

HRSA expects that 340B entities have an oversight committee in place as part of their 340B program. The expectations include:

  1. Meets on a regular basis (monthly, quarterly, etc.) as defined in policy.
  2. Reviews 340B rules/regulations/guidelines to ensure consistent policies/procedures/oversight across covered entity.
  3. Identifies activities necessary to conduct comprehensive reviews of 340B compliance (i.e., performance improvement (PI) plan).
  4. Ensures that the organization meets compliance requirements of program eligibility, patient definition, 340B drug diversion, and duplicate discounts via ongoing multidisciplinary teamwork.
  5. Integrates departments such as information technology, legal, pharmacy, compliance, and finance.
  6. Oversees the review process of compliance activities, as well as taking corrective actions based on findings.
  7. Oversees the review process of compliance activities, as well as taking corrective actions based on findings.
  8. Assesses any audit findings for material breach.
  9. Identifies opportunities to optimize the 340B Program and determines how savings are used by the entity to support programs for the underserved.

These expectations should be included in your formal 340B Policy and Procedure. This list of functions is by no means all inclusive. Some details may be included in a committee charter depending on standard processes within the covered entity.

Who’s Involved?

The participants of an oversight committee will depend heavily on the organization’s own internal structures. However, for 340B oversight committees, we suggest that membership is best with the following personnel included:

  • Chief Executive Officer
  • Chief Financial Officer
  • Chief Pharmacy Officer or Director of Pharmacy
  • Chief Compliance Officer
  • Director of Internal Audit
  • Director of Finance
  • Director of Reimbursement
  • Director of Hospital Supply Chain
  • Pharmacy Buyer
  • 340B Program Manager or Coordinator
  • IT Representative

Why so many people? Although 340B may be seen as a “pharmacy” program, it is not. 340B program health benefits the entire organization. Program integrity, operations, and optimization is everyone’s responsibility. Program integrity will be stronger with a knowledgeable leadership team that is engaged and understands the potential impact of changes within each covered entity department.

Starting Your Own

340B Oversight Committee

Covered entities who have successful oversight committees often start by finding a C-suite champion to buy in. Many organizations have a process to “charter” a new committee. Here are some items for a charter to consider:

  1. Establish and authorize – what authority will the committee have?
  2. Purpose and Responsibilities – define the scope of purpose and responsibilities.
  3. Composition – who will be on the committee, and what is their purpose?
  4. Leadership – who runs the committee and approves actions?
  5. Meeting Frequency – how often and how long are the meetings?
  6. Reporting – who does the committee report to, and how frequently.

Agenda Items

Congratulations! Your C-suite champion agreed to be the committee’s sponsor and leader and you are now holding your first meeting. What does a typical agenda look like?

The first meeting should include a brief education about 340B for the members. Consider including a description of the charter items to ensure everyone understands their role and responsibilities. Consider using published educational tools and resources and build upon the education with each meeting.

Consider these agenda items for your meetings:

  • General Information
    • New legislation
    • Threats or actions pertinent to the program

Note that these discussions should lead to an evaluation of any necessary program changes which would impact daily operations and/or policies and procedures.

  • Compliance issues and external audit findings
  • Reports
    • 340B savings
    • Results of internal audits

Now define what actions should be taken based on the reported data. The PI plan should be developed by the oversight committee and be regularly updated.

  • Opportunities
    • Program optimization
    • Referral capture
    • Revenue/losses due to contract pharmacy operations
    • Use of 340B savings

As with any committee, performance will only be as good as its leadership. Keep your meetings dynamic and focused while being diligent in complementing the membership for participation.

Ideas from the Industry

Smaller covered entities may find it difficult to recruit and maintain members for a 340B oversight committee. Typically, leadership across smaller entities are wearing multiple hats and find it very difficult to add another responsibility to a busy calendar. HRSA does not require the oversight committee to be a separately functioning group. The functions of the oversight committee can be easily integrated into an already existing committee, such as the quality committee or a finance committee.

Health systems often struggle with maintaining separate committees with many key leaders functioning in a health system capacity. No one wants to sit through separate oversight committee meetings at each covered entity within the health system. But, in larger health systems, the individual covered entity program details can quickly become lost. Keep in mind that each covered entity is responsible for the 340B program within it.

Consider forming a health system oversight committee with a separate 340B operations committee. This may encourage more focused discussion relative to the daily operations of each covered entity. The health system 340B oversight committee may consist of the executive leadership and likely a senior pharmacy leader. The 340B operations committee may consist of those front-line staff members who are responsible for purchasing, internal monitoring, and others as larger projects are undertaken. The subcommittee work may report up to the health system committee with all decision making occurring within the 340B oversight committee.

HRSA and your Oversight Committee

When your facility is audited by HRSA, the auditor may ask to see the minutes of your oversight committee. If you do not have a committee, or lack notes, HRSA could cite your facility for lack of oversight. They would then expect a Corrective Action Plan (CAP) to be submitted to resolve the issue. You may also receive a recommendation for improvement which would not require a CAP. Be sure you maintain the minutes!

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