Author Archives: Heidi Larson

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Recent HRSA Audit Trends: Supporting Documentation for Eligible Providers

Historically, HRSA auditors have requested a list of eligible providers from covered entities during HRSA audits. Recently, however, HRSA auditors have been requesting that covered entities upload documents demonstrating that, for each audited utilization record, the prescriber was (at the time the medication was administered or prescription written) employed by, under contract with, or had some other type of arrangement/relationship with the hospital such that responsibility for the clinical care provided to the patient remained with the covered entity. HRSA FAQ 1442 further explains that non-covered entity providers solely with admitting privileges at a covered entity hospital are insufficient to demonstrate that any person treated by that provider is a patient of the covered entity, for 340B Program purposes.

We often hear; the provider is credentialed or has privileges, but what does that really mean? Credentialing is the process of obtaining, verifying, and assessing the qualification of a provider to provide care or services for a health care organization. Credentialing documents include evidence of licensure, education, training, and experience. A privilege is defined as an advantage, right, or benefit that is not available to everyone. For providers, the act of being privileged is the process whereby a specific scope and clinical service of patient care is authorized for a healthcare practitioner by a health care organization, based on evaluation of the individual’s credentials and performance.

Back to the question at hand, what have HRSA auditors been requesting to demonstrate provider eligibility? The answer may depend on the type of provider.

Employed or Contracted Providers – Hospital or Clinic Administered and Retail Prescriptions

  • If the provider is employed by the covered entity, an auditor would expect to see confirmation of employment of the provider by the covered entity. This could be the cover or signed page of a provider contract, a checklist of privileges granted to the provider, a screenshot of the internal Medical Staffing Office platform, or other such document.
  • For residents (often an area of challenge for entities and focus for auditors), requested documentation may include a signed contract between the covered entity and the resident, or with a college/educational institution that allows residents to practice at the covered entity and is accompanied by a list of past and current residents. 
  • For health care providers who may not be directly employed with the hospital to provide services, an auditor may expect to see a signed collaborative practice agreement to provide services to patients whereby the care of the patient remains with the hospital. For contracted services, such as for the emergency department, a HRSA auditor may request a signed document with the contracted entity to provide services and a list of providers that fall under the contracted services agreement.
  • For providers with “privileges,” HRSA will expect to see a signed agreement that shows the scope of privileges and preferably documentation or confirmation from the covered entity that the responsibility for care of the patient remains with the covered entity and the providers privileges are not merely admitting privileges.

For each of these supporting documents, auditors have requested that they indicate start dates and, when possible or appropriate, duration of the agreement or granted privileges. Eligible provider lists are also requested to indicate start and term dates for providers.

Healthcare Professionals – Hospital and Clinic Administered Drugs

While supporting documentation to demonstrate responsibility of care may seem more straight forward for providers employed by or contracted with the covered entity, it can leave a bit of gray area for orders written by outside providers. For hospital or clinic administered drugs that are administered as a result of an order from an outside provider, most often observed in the infusion setting, many entities qualify drugs as 340B eligible under their healthcare professional definition. In doing so, they assert their responsibility of care through patient assessment and care related to the administration delivered by members of the entity healthcare team, such as nurses. As HRSA auditors have become more familiar with this practice, they have begun requesting documentation in the medical record to substantiate care beyond the simple administration of the drug, such  as vital signs or clinic notes stating the patient was evaluated for appropriateness of receiving the drug and that it was well tolerated (or that the patient had a reaction and was treated accordingly). In these instances, HRSA auditors have further validated the inclusion of this definition in the entity’s policy and requested documentation that the healthcare professional providing patient care is employed by the entity and was working that day. This may include a contract, privileging documentation, and/or a timecard.

Referrals – Retail Prescriptions

In scenarios in which covered entities have captured retail prescriptions as a result of a referral arrangement, HRSA auditors have requested copies or screen shots of the referrals in the course of the audit and for them to be uploaded to the NIH portal subsequent to the audit. While obtaining documentation back from the referral provider remains a best practice to demonstrate continued responsibility of care, this has not been requested in recent audits, and documentation of the medication in the patient’s medication list with the covered entity has been sufficient.

Preparing for HRSA Audit Success

The key to supporting documents is that they demonstrate that care for the patient by the provider remains with the covered entity at the time the medication was administered, or the prescription was written. Covered entities should consider all aspects of patient definition to use 340B drugs. It is also important to include entity management of provider privileges in policies and procedures.

Unfortunately, these documents are not always found in one location, with one person, or even within the same department. Start checking for these documents during your monthly self-audits, understand each provider type and the documents needed, and lastly, know who would be your point person for each type of provider to obtain the necessary documents and establish a working relationship with them so that you’re both prepared when your number is up for a HRSA audit.

Article written in collaboration with Chelsea Magee, Turnkey Pharmacy Lead Auditor.


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What does this have to do with me?

Many of us are so focused on our next meeting, the crisis that needs to be addressed now, or how we are going to get through all of our emails; that it is easy to read something and not think beyond the here and now.  Recently the state of Minnesota implemented an update effective August 1st that allows pharmacists to dispense a refill of a medication despite no refills remaining on the prescription. Emergency refills of prescriptions for a 30-day supply are allowable under the following circumstances:

  • The patient has been compliant with taking the medication and has consistently had the drug filled or refilled as demonstrated by records maintained by the pharmacy;
  • The pharmacy from which the legend drug is dispensed has record of a prescription drug order for the drug in the name of the patient who is requesting it, but the prescription drug order does not provide for a refill, or the time during which the refills were valid has elapsed;
  • The pharmacist has tried but is unable to contact the practitioner who issued the prescription drug order, or another practitioner responsible for the patient’s care, to obtain authorization to refill the prescription; or the drug is essential to sustain the life of the patient or to continue therapy for a chronic condition;
  • Failure to dispense the drug to the patient would result in harm to the health of the patient; and
  • The drug is not a controlled substance listed in Minnesota Statues Health section 152.02, subdivisions 3 to 6, except for a controlled substance that has been specifically prescribed to treat a seizure disorder, in which case the pharmacist may dispense up to a 72-hour supply.

Similarly, the Governor of the state of Florida, on August 28th, declared a State of Emergency, in which a pharmacist can use their judgement to refill prescriptions early for a 30-day supply provided certain criteria are met in the areas or counties affected by Hurricane Dorian.

In both states, the pharmacist must notify the practitioner who prescribed the medication.  In Minnesota it is no later than 72 hours after the drug was sold or dispensed. Florida does not define a time but rather states that the provider should be notified within a reasonable amount of time.  A record of the drug being dispensed should be maintained just as it would be for any other refills. 

Most would read these updates from the Board of Pharmacy and not think beyond the impact of the practice change.  I am challenging you to do just that and ask does this impact how we oversee our 340B Program and if so, how?  And would also argue it should be a thought every time practice change is implemented either by your State Board of Pharmacy or internally by your covered entity.  In response to the question above, the answer is, yes.  It could make it challenging to comply with the statutory requirement for auditable records.

Because there may not be auditable records for the fill (i.e., refill authorization) in the patient record at the covered entity, Turnkey is recommending that language be added to policy. Consider the following language for example: “The state of (insert applicable state) allows a one-time 30-day supply of a medication when certain requirements are met without provider authorization or documentation. In these cases, auditable records would include any documentation by the filling pharmacy to indicate the medication was refilled and the provider was contacted.” In addition, it may be wise to reference the link in which the practice change is stated in policy.  I have attached the link for both the state of Minnesota and Florida respectively, that outlines the practice change and requirements.

Just as you need to keep updated with practice changes, states can change their requirements to prevent duplicate discounts.  The state of North Carolina updated their Clinical Policy No. 9 for outpatient pharmacy on July 15th, 2019.  This update requires the use of both the ‘08’ in the basis of cost determination field via the National Council for Prescription Drug Programs (NCPDP D.0 field 423-DN) and a ‘20’ in the submission clarification field (NCPDP D.0 field 420-DK) for point of service claims.   Prior to this update a covered entity could use one or the other.  In addition, per the updated policy, only the actual purchased drug price should be submitted in the usual and customary charge field.

The state of Kentucky posted on August 2, 2019 changes to its Medicaid policies and procedures for Managed Care Organization (MCO) and Fee-for-Service (FFS) providers who participate in the 340B Drug Pricing Program.  Beginning on January 1, 2020, providers should submit 340B Medicaid FFS and MCO claims with the NCPDP D.0 value “20” in the field 420-DK submission clarification code.  This indicates to the Kentucky Department of Medicaid Services that a 340B purchased drug was used and not to collect rebates on the claim.

The following links outline the changes to the NCPDP requirements as discussed above for the states of North Carolina and Kentucky, respectively.

Key takeaway:  Stay abreast of what is happening with state requirements including changes to pharmacy practice.  One never knows when a change may impact your 340B Program.

P.S.  Although the picture above depicts a beautiful snow scene – the winters in Minnesota are long, and it gets very cold here -50 degrees with the windchill.  Okay, that is not typical, but it has been known to happen and impacting travel and one’s ability to be outside.  You need to be a lover of snow and really cold weather to live here year-round or crazy.  I think I am the latter.