Author Archives: Jasmine Muniz-Cadorette, 340B ACE

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Don’t Miss Out On These Resources

The 340B Program is complicated. It’s intimidating, and let’s be honest, at times downright confusing, for newcomers and veterans alike. Those of us in the 340B world know that managing a successful 340B Program requires the juggling of what feels like a million things at once. Between keeping up with state Medicaid requirements, HRSA audit preparation, multiple third-party administrators, NDC crosswalks and formularies, OPAIS registrations, and beyond, it is easy to feel overwhelmed. 

That’s why we at Turnkey are committed to trying our very best to make your lives just a tiny bit easier. Today, we’re doing that by providing a list of some of the best resources in the industry (besides us of course). We encourage you to take advantage of all of these wonderful resources so that you can take your 340B Program to the next level. 

  1. HRSA (free):
    1. 340B Drug Pricing Program
    2. HRSA Program Integrity Page (aka audit results)
  2. Apexus:
    1. Free Resources:
      • 340B University on Demand”: 340B modules which are recommended for staff working closely with the 340B Program.
      • Apexus Universities (live and virtual sessions) focused on hot topics and 340B basics.
      • Apexus Answers: Email, Phone, or Chat with an Apexus staff member about any 340B questions you have.
      • HRSA FAQs, published by Apexus.
    2. Paid Resources:
  3. NACHC (for grantees):
    1. Free Resources:
      • NACHC 340B Website and Office Hours: Grantee related news and resources can be found on the NACHC website. Office hours occur on the 3rd Thursday of the month, covering hot topics with Q&A and expert speakers.
      • Noddlepod: A forum exclusively for covered entities. A great way to keep a pulse on the 340B Program and share with peers. Noddlepod can be accessed by emailing Colleen Meiman.
    2. Paid Resources:
      1. National Association of Community Health Centers (NACHC) released an updated edition (2018) of their 340B Manual for FQHCs
  4. 340B Health (for hospitals):
    1. Free Resources:
      • 340B Exchange: A forum for covered entities to discuss hot topics, get feedback from peers, and keep up to date with industry developments.
  5. 340B Report: Resource for breaking news about 340B. Previously free, will be subscription based starting in 2021.  
  6. 340B Coalition:
    • 340B Coalition Conference (paid): There is a 340B Coalition in the winter (San Diego) and summer (Washington D.C.). These conferences are great places to network with peers, meet various vendors in the 340B industry, stay up to date with industry developments, and attend exclusive entity specific breakout sessions.

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A Game of Capture the Referral

As the 340B Program faces increasing scrutiny and possible changes that could lead to reduced savings, covered entities are looking for ways to diversify and maximize their 340B Programs.  Maximization and diversification can come in the form of, for example, implementing software solutions, expanding the range of services offered, or, the topic of today’s blog, capturing referral prescriptions.  Referral prescriptions can provide significant savings opportunities for covered entities, but identifying and qualifying referral prescriptions compliantly can be a challenge. So, what does it take to capture the referral?

What is a referral prescription? 

A covered entity’s providers may refer patients out to specialists for care at a location that is not 340B eligible (i.e. a specialist’s private office). If the specialist writes prescriptions for the patient as a result of the referral by the covered entity’s provider, those prescriptions would be considered referral prescriptions.  For more information about unique referral scenarios, check out the Indirect Referrals blog post.

How can referral prescriptions qualify for 340B if they are written at ineligible locations?

According to HRSA’s patient definition, referral prescriptions may qualify as 340B eligible in certain circumstances. A patient is eligible if:

“1. the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care; and

 2. the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and

3. The individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally qualified health center look-alike status”[1]

There are several considerations when applying HRSA’s patient definition in the context of a referral prescription.  The sticking point is that, if a covered entity wishes to qualify referral prescriptions as 340B eligible, it must demonstrate that it has responsibility of care for the patient and referral prescription(s).  This can be achieved by implementing the best practice referral loop [JM1] (Figure 1). First, the covered entity must demonstrate that it has established care with the patient, typically by confirming that the patient has an associated visit at an eligible 340B location with an employed or contracted provider of the covered entity. If the patient is an established patient of the covered entity, documentation of an outgoing referral in the patient’s medical record on or prior to the written date of the referral prescription is necessary to support that the covered entity has responsibility of care for the referral prescription(s).  Finally, the covered entity must receive referral summary notes to be uploaded in the patient’s medical record in order to “close the loop”.  The covered entity’s provider should update the patient’s medical record with any new information, including medications prescribed during the referral visit.

What are the compliance risks associated with capturing referrals?

Capturing referral prescriptions can increase a covered entity’s compliance risks.  A covered entity interested in capturing referrals must first evaluate if the risk, potentially a HRSA diversion finding, is worth the benefits of increased program savings and patient care. Consider, are enough referrals being made by the covered entity’s prescribers?  Are the referral prescriptions being sent to pharmacies within the covered entity’s 340B network (i.e. contract or in-house), would a new contract pharmacy need to be added, or are the prescriptions scattered to multiple pharmacies? Keep in mind, increasing the number of contract pharmacies can introduce more program complexity (i.e new TPAs) and subsequently increase a covered entity’s chance of being selected for a HRSA audit. 

Once a covered entity determines that it is interested in capturing referral prescriptions, additional considerations need to be made.  To start, the covered entity must evaluate its referral process to determine if providers are documenting outgoing referrals consistently.  Some electronic health records (EHRs) may have standardized outgoing referral forms, while others may require manipulation by an IT department to create a template or field for free-form documentation.  Would additional provider training be required? Does the covered entity’s IT department need to be involved for EHR manipulation? Are providers reliably documenting outgoing referrals? Remember, a referral must be documented in the patient’s medical record on or prior to the written date of the referral prescription to be justifiable.

After standardizing the outgoing referral process, a covered entity must assess the risk associated with obtaining referral visit summaries promptly to corroborate the eligibility of the referral prescription. At a very minimum, the covered entity must have documented attempts for obtaining the referral documentation.  However, best practice would be to obtain the visit summaries and update the patient’s medical record prior to qualifying a referral prescription as 340B eligible. Does the covered entity share an EHR with the specialists?  Can the covered entity obtain referral consult notes and update the patient’s medical record in a timely manner?

How can a covered entity capture a referral prescription?

Meeting the recommended guidelines for documentation of referrals and subsequent prescriptions requires significant resources.  There are a few approaches that a covered entity may choose from when deciding what best suits the needs of the covered entity.  First, the covered entity must determine how it will identify referral prescriptions.  If there is a known list of specialists, these specialists could be added to an eligible provider list, on a limiting basis, for easy identification.  Some pharmacy Third Party Administrators (TPAs) can sort prescriptions from these specialists into a separate queue for manual review by the covered entity’s staff.   If the covered entity is not using a TPA, staff may use the list to cross reference against the prescription to determine if it could be a referral prescription.  These options require significant staff resources but allow the covered entity to keep most or all of the savings.   Another option is to outsource the entire process, from identification to retrieval of documentation and communication with pharmacy TPAs, to an external party.  A consideration when using an external vendor is that a covered entity will be forfeiting some of its savings.  However, by outsourcing the labor, the covered entity would be minimizing the operational changes that would need to be made internally to accommodate the demands of capturing referral prescriptions. 

As a covered entity, the decision to capture referral prescriptions is multifaceted and may require significant resources and operational changes.  However, the benefits of adding this to your 340B portfolio may have a significant impact to program savings and ultimately, patient care.  The undertaking may be worthwhile, because at the end of the day, 340B is the bloodline for those who are providing care where it is needed most.