Complying to 340B Program Mega Guidance
By: Bob Brown
Covered entities waiting for publication of HRSA's mega-guidance should get ready to be compliant with the 340B program on the effective date of new guidance. Entities will need to evaluate its compliance with the latest rules and incorporate 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 need to determine at risk parts 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 problems, how to address them and designate staff to take care of them so that the program is compliant. The following are categories and inquiries to consider:
Patient eligibility: Are patient eligibility requirements adequate 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 outcomes and have non-compliant findings been addressed ? Accumulator and splitter software: Is software configured correctly to facilitate the program, recognize qualifying dispensed drugs and capture and store records? What settings need to be focused on to ensure compliance? Oversight and governance: Is a multidisciplinary committee in place to review important components of the program such as documentation and software updates on a regularly planned basis?
Step 2: Anticipating-- How will the program appear structurally, operationally, and financially?
A a large number of covered entities are not structured to accommodate specific new proposed restrictions, such as stringent MCO pharmacy eligibility criteria 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 is going to require covered entities to address how the following changes will influence their 340B Drug Programs:
340B drug discounts in the contract pharmacy setting may significantly decrease the volume of subsequent savings and qualified 340B dispensations. The requirement to bill on behalf of participating service providers may shorten the list of qualified 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 carry out a full review of their methods, which will highlight opportunities for improved efficiency and enhancement. Assuring programs function efficiently and effectively will simplify the steps required to align with future regulatory changes.
The 340B Program has been under significantly more 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 attentiveness, any Entity will be able to attend to possible problems, take corrective action and avoid findings of program non-compliance in the future. Proactive steps of assessing, anticipating and capitalizing will ensure success in the altered 340B environment.
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