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.
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.
340B Exchange: A forum for covered entities to discuss hot topics, get feedback from peers, and keep up to date with industry developments.
340B Report: Resource for breaking news about 340B. Previously free, will be subscription based starting in 2021.
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.
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.