Author Archives: Jen Cook

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Referral Capture: Finding Additional Savings in Your 340B Program

Referral capture in the 340B world is not a new concept. What it requires is a Holmes and Watson investigative spirit, time, and most importantly…an eye focused to Compliance.

In the 340B world, we live and die by the 340B patient definition.  HRSA has given very specific guidelines that qualify a 340B prescription. First, the drug must be a covered outpatient drug. Second, the covered entity must have a relationship with the patient that is clearly documented in the health record. Third, the individual must have received care from a health care professional employed or under a contract or other arrangement (referral). Fourth, that the covered entity remains responsible for their care with respect to the drug. HRSA has made it clear that an individual will not be considered a patient of a covered entity if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.

A referral capture is looking for a way to tie a visit with a non-qualified referred provider to a qualified provider visit.  This referred provider may not work in the parent or child sites/associated sites of the entity.  However, if we can ‘close the loop’ on the documentation between the referred provider and the covered entity, you may be able to claim those prescriptions as eligible. These types of relationships are especially advantageous in facilities that have primary care services and a referral documentation process.

In order to have a compliant program, which is key here, you must make sure you can support any referral claim with documentation. It may seem easy to capture a referral once and rely on the patient or referred provider to be associated with an eligible claim every time, but unfortunately it does not work this way.

A great way to dip your toes into the referral pool is to work with your third-party 340B vendor to see if they can provide you with a list of prescriptions that did not qualify based on your established eligibility criteria.  You can then review the medical record for any patients with whom your entity has an established relationship to determine if the following elements are present:

  • A referral out from the patient’s primary care provider. 
  • A note back from the specialist, including a date, the provider the patient saw, and the medication prescribed.
    • This provider should match the fill from the entity’s contract pharmacy.
  • The medication is on the patient medication list in the entity’s health record. 

There you have it; a closed loop!

Unfortunately, this review process can be quite labor intensive. Members of the entity’s 340B team can dedicate time each week or month to research potential claims and manually qualify them, but what do you do if you are a small facility, or don’t have 340B staff resources available to research the claims appropriately? SpendMend Pharmacy is here to help! One of our newest service lines is 340B retail referral capture. Reach out to your auditor or our Leadership team to discuss this potential opportunity for your site at contact@spendmend.com. SpendMend Pharmacy has developed this program based on our HRSA audit experience, so you can feel confident that it will be compliant. It is our specialty!


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OPAIS Database: Missing Points and HRSA Findings

Turnkey has had the opportunity to support over 45 HRSA audits for our amazing clients.  One thing we have noted from each audit is the close evaluation of the new 340B Office of Pharmacy Affairs Information System (OPAIS) database and entity’s information.  Apexus tells us the purpose of the OPAIS database “increases the integrity and effectiveness of 340B stakeholder information and focuses on three key priorities: security, user accessibility, and accuracy.
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The Face of 340B

Life-changing experiences can manifest in many forms.  For me, it was a crooked smile.

A heart in your throat, can’t breathe, “Please, no”, crooked smile of my sweetheart having a stroke at 38.  Four days in the ICU with no answers and a CT scan documenting damage in his brain the size of a peach pit.  Two MRIs, CT scan, two spinal taps, labs, tests, and finally arteriography found Fibromuscular dysplasia (FMD).  FMD is a disease that causes one or more arteries in the body to have abnormal cell development in the artery wall.  He had suffered a stroke caused by a dissection of his carotid artery.

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Chief Cook and Bottle Washer: Self-Auditing For 340B, When You Are the ‘Whole Enchilada’

Let’s be honest, pharmacy is not for the faint of heart. Add to regular pharmacy duties the immense joy of the 340B program and you can be over your head…quickly. 340B self-auditing can feel like a pipe dream. HRSA auditors may haunt your nightmares, with Zombies, that have an uncanny resemblance to your CFO and Compliance Manager, waving a Medicaid Cost Report…(ahem), I digress.
340B is a complex program that requires hands on, good old-fashioned work. Even with fancy, schmancy 340B software, the covered entity is ultimately responsible for compliance. Therefore, self-auditing should be one of your top priorities.

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It Doesn’t Get Better than this, 340B fans!

The 340B Coalition.  The super bowl of 340B events.  All the 340B all-stars in one place at one time.  The energy is palpable and the excitement is giddy.  I expected to see Maureen Testoni do her touchdown dance at any moment and I awaited with baited breath.
This coalition was no exception and the topics were spot on in regards to several of the issues we see with our clients.  HRSA audits and Medicaid were the half time show and they did not disappoint.  Commentary provided by 340B Health and Apexus kept us all apprised of what is happening in the 340B arena.  If you were not able to make the show I will recap the highlights.  So now you can be a 340B fan, and WOW at the watercooler on Monday morning.
The first play began with Captain Krista Pedley of Office of Pharmacy Affairs (OPA).  She spent a conscious effort moving up the line by discussing HRSA audits.  The surprise to fans came when she informed us that the audit process will be moved to the OPA.  The OPA office will now be fulfilling the audit role.  She made certain to reiterate that this will not change the audit process nor will it affect the covered entities in any way.  The audit process will continue the same as always.  She also reminded fans that manufacturers can limit drugs provided to the 340B program as well as limit distribution in specialty items.  However, with communication to manufacturers and including HRSA in any challenges the covered entity encounter, HRSA can help resolve the ‘roughing the passer’ call.
Recertification was the second play.  Covered entities must be registered in the 340B program in order to participate.  A ‘time out’ from HRSA was the reminder to ensure everything is compliant within your entity.  Material breach was also discussed and should be disclosed to HRSA based on entity policy and procedure.  Manufacturers also need to be informed of material breach and communication initiated.
Orphan drugs finished up the third play with a touchdown!  Captain Pedley reminded the ‘water boy’ (which includes everyone that can’t purchase Orphan drugs) that you are free to purchase Orphan drugs outside of the 340B plan and encouraged you to find these drugs at other discounted prices.  In the words of Bobby Boucher “Now that’s what I call high quality H2O.”
QB Chris Hatwig stepped on the field to introduce Apexus’ 340B Operations Certificate Program.  This is where I pulled out my hot pink No. 1 foam finger.  The Operations certificate is beneficial for any individual who would like to pursue specialized training in 340B knowledge.  This is not a free program, but offered at a discounted rate for individuals in a 340B covered entity.
Chris also introduced a new service provided by Apexus that will help covered entities find orphan drug contracting.  Apexus will also incentivize manufacturers by waiving their fees if they offer orphan drugs at a discount.
A major ‘foul’ was called by Apexus to some manufacturers who are sending “inquiries” to covered entities that imply they are working with HRSA.  These “inquiries” have been sent to HRSA and they are false.  Manufacturers will not be sending communication to covered entities on behalf of HRSA. First step if you receive one of these is communication.  Contact the manufacturer immediately and if needed, contact HRSA.
Lastly, Medicaid, the ‘goodyear blimp’ that hovers over the 340B playfield. They reminded covered entities that duplicate discounts, fee-for-service, and managed care are all resources involved with Medicaid.  It is up to the covered entities to make sure they are correctly billing Medicaid.  Medicaid will not take the ‘ignorant’ plea.  The covered entity needs to know what their state is billing and what constitutes a duplicate discount.
Touchdown!!  Apexus is working on a master database that will include Medicaid policies for reimbursement from all states for duplicate discount prevention. The fans go wild!!!
340B fans, I cannot believe it, I cannot believe it, this will go down as the best 340B coalition in history.  This wraps up the highlights from day 1- Live from Washington DC.  Goodnight.
– Jenn Cook