Adapting to 340B Program Mega Guidance

Covered entities awaiting publication of HRSA’s mega-guidance should prepare to be compliant with the 340B program  on the effective date of new guidance.  Entities will need to assess its compliance with the final rules and implement processes that support a compliant program in the new environment.   The following strategy offers a simple view of how to act now for future program modifications, if needed.


Step 1: Assessing Your 340B Program

Entities should identify vulnerable areas of their 340B program and need to make necessary policy modifications and process improvements in order to be compliant. Entities need to be aware of issues, how to address them and assign staff to  handle them so that the program is compliant. The following are categories and questions to consider:

  • Patient eligibility: Are patient eligibility criteria sufficient and defensible? Who are the individuals who will need to implement the necessary changes?
  •  Auditing and monitoring: What are the processes and have they been effective? What are the results and have non-compliant findings been addressed?
  • Accumulator and splitter software: Is software configured properly to facilitate the program, identify qualifying dispensed drugs and capture and store records? What settings need to be addressed to ensure compliance?
  • Oversight and governance: Is a multidisciplinary committee in place to review significant components of the program such as documentation and software updates on a regularly scheduled basis?


Step 2: Anticipating – How will the program look structurally, operationally, and financially?

A majority of covered entities are not structured to accommodate certain new proposed restrictions, such as stringent MCO pharmacy eligibility requirements and exclusions from the HRSA guidance.

For instance, the revised definition of a patient as an individual billed as an outpatient to their insurance or third-party payer could impact system configuration, documentation and program savings. Quantifying the impact of these changes using analytics will aid organizations in preparing for the financial and operational impact of HRSA’s proposals. The additional restrictive language regarding referrals will certainly have an immediate impact on access to care, in some instances.

The proposed guidance will  require covered entities to address how the following changes will affect their 340B Drug Programs:

  • 340B drug discounts in the contract pharmacy setting may significantly reduce the volume of subsequent savings and qualified 340B dispensations.
  • The requirement to bill on behalf of participating providers may shorten the list of eligible providers.
  • Discharge prescriptions linked to inpatient stays would no longer qualify for 340B replenishment.


Step 3: Capitalizing on Opportunities

Lastly, it is advised that covered entities execute a full review of their practices, which will highlight opportunities for improved efficiency and enhancement. . Ensuring programs  operate efficiently and effectively will  simplify the steps necessary to align with future regulatory changes.

The 340B Program has been under increasingly intense review over the past few years. Entities should monitor the published findings from audits and use the information to identify and assess known high risk areas within their operations.  By continuous diligence, any Entity will be able to address potential problems, take corrective action and avoid findings of program non-compliance in the future.    Proactive actions of assessing, anticipating and capitalizing will ensure success in the revised 340B environment.

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