The year 2020 blurred into 2021, leaving healthcare systems hoping for a better year on the horizon. However, 2021 brought no such relief as challenges continued to present themselves as the year went on. Not only did we head into the year still battling COVID-19, but we also began to see the domino effect that started with Eli Lilly’s first 340B policy change. More manufacturers continued to follow suit and it became more important than ever to start rethinking the way 340B programs were structured.

January 2021 kicked off the year with lawsuits filed by Eli Lilly, Sanofi, and AstraZeneca, in hopes to reverse the advisory opinion released by HHS just one month earlier. From there, it has been a whirlwind of motions and litigations, that to this day, are still underway.

With all this buzz in the 340B world, Covered Entities have made it a priority to advocate for their health centers, their 340B programs, and their patients. They have focused their efforts on navigating contract pharmacy designations, optimization, and creating access. Pharmacy designations are not simple by any means.  Instead, it has taken coordination with multiple vendors and time to ensure that all the steps were completed, and the 340B pricing restored for all designations However, Entities have remained diligent and dedicated to doing what they can to regain access to life-saving medications.

Here at RPh Innovations, we want nothing more than to help affected health centers recoup what has been lost and re-establish the access they deserve and need. During a recent webinar series for HCAN, we discussed some tips and tricks on navigating pharmacy designations and provided a checklist to assist Entities in the process, so that no steps were overlooked. Here are some of the important steps to keep in mind:

  1. Complete an analysis to determine which pharmacy to designate per each manufacturer. Don’t forget to consider your self-pay or charity programs!
  2. Consider if your health center will be submitting Claims Data to 340B ESP and setup the necessary resources to do so.
  3. Complete all designation forms and/or submissions. Make sure to have the pharmacy DEA and HIN (if applicable).
  4. Discuss your options with other resources such as, your TPAs or consultants. This will help you determine if a “lookback” to recapture missed claims is possible.
  5. Double check pricing when designations have been completed and stay on top of any further communications from the manufacturers.

Over the last several months, we have seen Covered Entities regain an average of 20% in 340B savings from their designations and lookbacks. But some entities did not stop there. Instead, these health centers sparked conversations about how to create more access for their patients, how to generate potential savings, and what avenues to explore to sustain their programs. This became a great opportunity for Entities to learn about referral capture and specialty pharmacies, as they would apply to 340B. It also became an opportunity to share ideas and lean on each other in the 340B Community.

All the changes circulating had entities at the forefront of their programs, changing the way they viewed their approach in sustaining 340B savings within their organizations.

RPh Innovations is often asked, “where is 340B headed?” To answer that question, unfortunately, there is no definite answer. 340B is always revamping, reshaping, and molding into what we need it to be to honor the intent of the program and help our communities. As 340B entities, pharmacies, and third-party stakeholders, we should instead focus our attention to answering the question, “what can we change?”

 written by:  Anita Miller, RPh Innovations


At this time of year, many of us are looking back at 2019 and looking forward to 2020.  As far as the 340B Program goes, although there was a lot of sabre rattling there were very few changes heading into 2020.

2019 Year in Review

Legislative Activity

Specific to FQHC’s, although 340B was mentioned in numerous pieces of legislation throughout the year no major 340B legislation materialized.  Because drug pricing is such a high priority, the program remains a talking point however the legislative focus has shifted from 340B to the PBM’s

Price compression

One of the biggest threats to 340B was not government related at all but rather the Pharmacy Benefit Industry (PBM) who has seen 340B as a threat to their rebate revenue stream. In late 2018, CVS Caremark, one of the country’s largest PBMs, sent notices to 340B providers and contract pharmacies notifying them of significant reductions in reimbursement rates. In essence they were attempting to recharacterize 340B pharmacy as non-retail pharmacies, which would allow CVS to reimburse these pharmacies at a much lower rate.  After a considerable outcry from a large number of 340B stakeholders and court rulings related to the reduce Medicare payments to 340B Hospitals, CVS Caremark backtracked and announced that it was reversing its decision.

Also, in late 2018, a federal district judge struck down HHS’ proposed cuts of almost 30% to Medicare Part B reimbursements for 340B providers stating CMS overreached its legal authority. This decision, however, was appealed and cuts remain in place.

A final hearing was held on November 8th with a decision expected soon. If the government prevails, we may see Caremark (and other PBM’s) attempt to lower reimbursement for 340B providers.

340B Drug Pricing Website

April 1st, HRSA finally launched its 340B Drug Pricing website, which provides additional transparency and assists safety-net providers in determining the maximum price manufacturers can charge under the program.  This implementation was driven by a 2010 law authorizing civil penalties for manufacturers who “knowingly and intentionally” overcharge covered entities. This should be accessible through the Covered Entity’s 340B PVP account.

On the audit front, HRSA suspended uploads of audit outcomes to its website during 2019.  The audits continued but between June 21st and October 10th no audit outcomes were posted on HRSA’s website.  HRSA states that it was reevaluating its level of authority and oversight of the program.

Looking Ahead to 2020

Focus of Attention

Drug pricing remains a focus of the Trump Administration as we enter the new year and most presidential candidates. This will keep a focus on the entire industry including 340B.

Rebates and Duplicate Discounts

The definition of “Medicaid” as it relates to 340B remains murky. At this time, HRSA only regulates Medicaid Fee-for-Service claims through the Medicaid Exclusion File located on the OPAIS. That said, it remains the covered entities responsibility to coordinate rebates/discounts with the state (which many states have not shown interest in doing).

Apexus provides a Medicaid profiles per State tool to assist entities in accurately billing Medicaid Fee-For-Service.  The tool can be found at

Individual states have recently begun to get explore various forms of 340B legislation. Some of these initiatives are advantageous to covered entities while others have the potential to be very detrimental.  Examples of these bills include:

  • Prohibition of discriminatory 340B reimbursements while others are considering the adoption of
  • Enhanced Medicaid billing procedures
  • Mandatory 340B reporting regulations

Changes to HRSA policy and areas of focus can affect a covered entity’s policies and procedures, contracts, and many other areas of program oversight.  RPh Innovations strives to keep up to date with what is happening with 340B, legislative and/or state involvement, HRSA changes, and other governmental and non-governmental organizations, to ensure covered entities are too. We suggest covered entities keep up to date on what is happening with proposed 340B legislation and sharing information gained with peers.

About RPHI

RPh Innovations offers many services to both its clients and to organizations such as HCAN and other state primary care associations such as:

  • 340B Program support
  • Independent, external audits
  • Contract pharmacy processing services
  • Consulting
  • Summit and other educational presentations

Please feel free to contact Myself, Lyn Mikesell at or Anita Miller, RPHI’s Nebraska dedicated Account Manager at or call 630-963-0024.

This promising practice is shared by OneWorld Community Health Centers, in Omaha, NE


Please give an overview of your work completed:

HCAN offered a unique opportunity to work with a 340B consultant Judy Lapinski.  OneWorld’s Pharmacy Director and CEO met with Judy via phone and email several times in 2019.  HRSA offers best practice suggestions for entities to follow and one of them is having an external review of the program.  OneWorld decided this would be a great opportunity to work with Judy to perform this external review. During the initial meetings we identified areas we would like to focus on as an external 340B review  Those area’s included a review of:  policy and procedures, operational agreement for Contract Pharmacies, internal review procedures for both in-house and contract pharmacies and discussion around USP 800.

HRSA offers a check list that includes essential elements that should be discussed with in our policy and procedures.  Judy also provided us with 12 essential elements on monthly reviews.  We reviewed our audit procedures and audit templates with these elements to ensure we are looking at all compliance elements.

Name something unique about this work completed:

This was an excellent, unique opportunity to work with a knowledgeable consultant regarding 340B.  Valuable insight and feedback was given on the area’s we focused on.  Internal process changes were made based upon feedback given.  Our work is not completed as Judy will be making an on-site visit to our location in January.  This is also a unique and excellent opportunity to look at process and procedures at an in-depth level outside of an actual HRSA 340B audit.

Please list lessons learned/process improvements:

Working with Judy created an excellent opportunity to review operations of our 340B program.  This allowed us to collaborate on process improvement in numerous areas.  Policy and procedures:  when reviewing our policy and procedures and evaluating them against the HRSA check list we discovered there were several area’s that needed to be updated and redefined.  Material breach is an example of one of those areas.  We needed to provide a clear understanding of our limits on material breach and process regarding that if something were to happen.  Another area needing updated was to include statements with regards to patient freedom of choice.

Prescription capture rate was something we looked at as well.  We were able to create detailed reports from our EHR to determine our in-house pharmacy capture rate of prescriptions.  The results of our capture rate was lower than we anticipated.  There have been good conversations and collaboration around how to increase that number.  During these conversations challenges were also discussed regarding how to maximize capture rate, physical space, staffing, patient wait time, patient satisfaction and patient perception.  This will continue to be an area that we look at and follow in the upcoming year.

Please list clinical outcomes/results from project:

Clinical outcomes and results from this project are not complete.  We are looking forward to Judy’s on-site visit in January 2020.  At that time, we will be taking a closer look at maximizing prescription capture rates, maximizing workflow opportunities, patient wait time, staffing models, billing procedures, sliding fee schedules, reducing duplicate processing and review of the OPA database.  This has been a unique opportunity to collaborate with a 340B expert and come up with creative solutions and ideas for operational improvement and compliance.

USP 800 was an area that is still very vague and not a lot of guidance has been issued surrounding this topic.  USP800 enforcement body is still undetermined as this went into effect on December 1, 2019.  Ideas on how to create the policy and procedure and implementation was minimally discussed with Judy.  Due to vague national guidance this became an internal research project.  OneWorld pharmacy did create a policy and procedure, perform risk assessments on high risk medications listed on NIOSH list and implemented employee safety procedures.

Submitted by Coleen Schrage

Director of Pharmacy

OneWorld Community Health Centers, Inc.