The current state of 340B can best be described as trying to catch water with chopsticks. Everyone is attempting to grasp what they can before it is taken away. Days are filled with dreaded emails from manufacturers alerting covered entities to the next gut punch to 340B entities translating to further cuts to vital programs and community outreach. While administration scrambles to divert time and resources towards jumping through manufacturer’s hoops. 

340B has always come with compliance burdens that each covered entity must dedicate staff to oversee. Adding to the rigors of maintaining 340B compliance in a hospital or health center setting, we are now embarking on a new era of 340B which is geared toward complying with manufacturer’s request to submit claims data to ESP. This process sounded smooth in the beginning; Just sign up, submit claims data and you get pricing back. Unfortunately, we have all learned that the process to regain pricing is much more convoluted. The first challenge is to obtain approvals from administration, IT, pharmacies, TPA’s and pulling the data. Some TPA’s have jumped in the trenches, while others have sat back with a hands-off approach. The next challenge after submitting data to ESP is to find a way to confirm pricing is restored. ESP advises that it can take up to 14 days for pricing to be loaded to your accounts, but many are seeing the timeline take much longer. 

One of the biggest hurdles for Covered Entities has been straight from an Agatha Christy Novel. A modern day “who dunnit” without the invigorating twist at the end. Do you reach out to ESP, or the Wholesaler, your TPA or Manufacturer? Whose fault is it that pricing is not restored as promised? Unfortunately, the burden has fallen on already worn-out healthcare staff who are still navigating through a post pandemic era to determine the answer.  

In the last 6 months, the data submitted has been under strict scrutiny and reviews to ensure compliance with the manufacturer’s ever-changing policies. The conforming claim conundrum that states only claims dispensed within 45 days will be considered as eligible to replenish against, has led to many organizations losing pricing access, even after working tirelessly to gain it in the first place. The latest trend is the very manufacturers that created this extra burden for so many organizations have decided to stop extending access to 340B for contract pharmacies all together. Blow after blow, many organizations are left to feel helpless as their drug savings disappear all while trying to expand services to their communities. 

If you find yourself wondering where to begin with ESP, it helps to reach out to veterans of the claim submission process. Countless hours will be saved by knowing the many nuances ahead of time. Discuss with your TPA’s the various reports and tools they have created to assist with claim retrieval and pricing reviews. Many of the manufacturers allow the option to submit an attestation on the ESP portal. This allows you to gain pricing prior to claims submission, which can be helpful if you are just getting started. Before you unblock a manufacturer with your TPA, make sure the pharmacy is officially eligible on the ESP eligibility file. Entities have seen pricing access not removed by the wholesaler,  when it should have been. This “fake pricing” can lead to costly and unexpected rebills in the future. Always confirm ESP eligibility and 340B pricing is loaded in your wholesaler account and TPA. Work with your TPA to only carve in claims dispensed within 45 days to have your claims be “conforming”. 

Every month, ESP will review your conforming claims submitted vs. purchases either per pharmacy or grouped together by chain. Each manufacturer has a different threshold they will accept and each month the timeline reviewed can change. Sometimes it is 90 days of claims vs. purchases or back to policy inception. If you are flagged as “at risk,” it can mean that your purchases during that time frame exceeded the conforming claims and putting you in jeopardy of having 340B pricing removed. To avoid this, it is important to find the root cause of non-conforming claims in your data. Do you have staff manually approving claims and they are over 45 days old? Did you not communicate with your TPA’s to only carve in recent claims? Many things could lead to non-conforming claims and it is important to identify the root cause to avoid future headaches. Another suggestion is to submit more frequently than every 2 weeks as ESP suggests. Changing to at least once a week will keep claims from crossing that dreaded 45-day threshold due to capture delays. If your pricing is restricted, it is vital to contact ESP and find out reinstatement criteria to determine if you can take steps to regain access. 

ESP has added new functionality to their portal that allows you to see purchase vs. conforming claim ratios. Spend some time reviewing those ratios and report any discrepancies you find to ESP support. As claim files are uploaded, double check that ESP recognizes all your pharmacy NPI numbers or work with support to clear up any discrepancies.

As we all navigate the ever-changing landscape that is 340B, we must be willing to work together to advocate, share best practices, and challenges to ensure we are doing all we can to protect and be good stewards of such a vital program. At Alinea, we pride ourselves on staying up to date with the latest best practices and can help your facility navigate the many complexities of ESP Claim submission. 

As a subject matter expert in 340B compliance, operations, and optimization, Sherilyn can be reached at Sherilyn.Hutchinson@alinea-group.com.  Follow the Alinea Group on Twitter and LinkedIn.