After 30 years of serving vulnerable populations, the 340B Drug Pricing Program has grown considerably in scale and complexity. While it is arguably one of the most successful public/private partnerships in healthcare history, 340B is facing policy obstacles and headwinds that can make administering a program more challenging for covered entities than ever. This includes manufacturers limiting discounts to a single contract pharmacy and excluding high-cost drugs from the program. 340B administration is also complicated by perennial regulatory updates from CMS that impact the program directly and indirectly.

For these reasons and more, it can often make sense for covered entities to seek the expertise and assistance of a 340B vendor to reduce the complexity and optimize the savings from 340B.  When you are working with partners, it’s important to ensure you are setting yourself up for success and the greatest return on your investment from the start. The implementation and onboarding process almost always involves support from stakeholders outside of the 340B team, so it’s important to be prepared. 

The critical role of the 340B steering committee

Running a successful 340B program requires a dedicated group of stakeholders across the organization. If you don’t have a 340B steering committee, organizing one should be your first task. Chaired by the 340B leader, the committee should include representatives from pharmacy operations, IT, contracting, legal, and billing or revenue integrity. The chair should always make sure that the committee is aware of any new vendor relationships before onboarding. To ensure buy-in, each member should understand the benefit the partnership will deliver. It’s the job of the committee chair to educate the members on the needs and opportunities within your 340B program where a partnership could optimize processes and outcomes.

Implementation should involve a standardized process

While a 340B partner implementation is not overly complex, it will involve sharing and managing data between organizations. That typically starts with creating a secure file transfer protocol (SFTP) channel and folder structure with approved points of contact given access credentials. Next, the data feed is developed, the data files are tested by the vendor for quality assurance, and the portal gets a final review before going live.

The 4 key to implementation success

While the 340B vendor implementation process is generally straightforward, standard, and repeatable, there are some important things to keep in mind to ensure success:

1. Involve the IT team early
   Make sure your IT team understands the purpose and scope of the project. Having representation from IT on the kickoff call creates early engagement and ensures a good understanding of why 340B is important to the mission of the covered entity.
   
   Expert Tip for Referral Capture During the contracting process, ask the vendor what data feeds they will need specifically related to referral capture and make sure sure their owners are on the kickoff call.
2. Thoroughly review data specifications
   Both the covered entity IT team and the 340B team should understand all components of the vendor data specs and the reasons for the data requests. Some data with missing components can still be processed instead of errored out, so identifying those opportunities and getting the data feeds right are essential for savings optimization.
   
   Expert Tip for Referral Capture Spot check encounters that are less common than office or telemedicine visits to ensure such encounters are valid for patient care ownership, and ask the vendor what QA steps they are taking on your data.
3. Do quality assurance testing early and often
   Do quality testing beyond just the data format and include the data pulled as well. Be sure to run QA after the test file, the historical file, and the daily file. Auditing random data samples is a best practice and should be done at regular intervals.
   
   Expert Tip for Referral Capture Have the vendor go through each data feed and how it is used to make a referral match. If you don’t have some needed data, ask about what else can be used to serve a similar purpose.
4. Set up checks for post-implementation alerts
   Work with the vendor to to discover what methods are available for alerting the covered entity of potential data feed issues. These should include alerts for missing files and significant changes in volume.
   
   Expert Tip for Referral Capture Have the vendor set up alerts for things like file receipt timeframes or for high error rates in the file, and have them monitor on your behalf.

Getting the most bang for your partnership buck

Optimizing your 340B partner relationships from the beginning requires doing considerable research but in the end it will pay satisfying dividends. Remember, the more time you spend on the front end of an implementation the smoother it will go on the back end. Failing to prepare is preparing to fail, and doing so could create compliance and savings risk to your program. When it comes to referral capture specifically, you need to understand how the vendor uses your data to qualify 340B claims and ensure they qualify those claims in a way that is consistent with your written policies & procedures. Finally, always insist that your vendor take a compliance-first approach to 340B claim processing, but remember that ultimately compliance is the responsibility of each covered entity.

To learn more download our tip sheet, Important Considerations for 340B Referral Capture.

Meet the Expert 

Minh Hoang, PharmD, 340B ACE
Director of 340B Hospital Operations, Cloudmed

Minh completed her Doctor of Pharmacy at Northeastern University and Master of Public Health at Columbia University. Her residency was with Maine’s largest federally qualified health center (FQHC), Penobscot Community Health Care where she was introduced to the 340B program. Minh was later Director of 340B and Drug Supply Management at MaineHealth, where she supported 340B programs at seven hospitals.