What does this have to do with me?

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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.


About Author

Heidi Larson

Lead pharmacist auditor, provides onsite support for audits. She will also provide remote support for audits when other auditing staff are on-site for smaller hospitals and clinics. Heidi served as the Pharmacy Business Operations and Revenue Manager from 2012-2019, responsible for pharmacy drug procurement and contracts, vaccine programs, pharmacy budget and formularies, pharmacy revenue cycle, the medication prior authorization program, patient assistance programs, new business development, and had residency management rotation responsibilities. She also served as a voting member on several various hospital committees and worked closely with the electronic health record analysts as a certified EHR pharmacist. In addition, she restructured and maintained compliance of the health system’s 340B program which is comprised of a 484-bed academic DSH hospital. Heidi represented her entity as a HRSA 340B leading practice peer to peer site during 2012-16, was faculty at 340B University speaking on the GPO Prohibition and Hot Topics until 2016, has presented on numerous 340B webinars and was a contributor to the Apexus 340B On-Demand series.

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