• Quantity: Unclear quantities and/or missing clear units of measure should be clarified with the prescriber’s office. Auditors look for mL, pens, boxes, or units, especially with highly targeted injectables. In addition, the quantity of “1” cannot be assumed when multiple package sizes are available.
  • See the December 2024 Newsline article, Why the Unit of Measure Matters in Audits: A Small Factor with Big Consequences
• NDC: The NDC reflected on an electronic prescription is considered “representative” according to NCPDP.  The Representative NDC Use in Electronic Prescribing Fact Sheet indicates “The representative NDCis not intended to infer specificity or preference to the embedded manufacturer/labeler”; therefore, determining which product to dispense cannot be solely based on the representative NDC, if present.
  • See the November 2024 Newsline article, Representative NDC on Electronic Prescriptions Do Not Infer Specificity for further details
• Instructions for Use
  • Ambiguous instructions should be clarified
  • Clarify when prescription appears to have two conflicting instructions
  • Check for “calculable” instructions; must be able to accurately calculate days’ supply based off instructions
  • Instructions, including clarifications, must be reflected accurately on the patient label prior to dispensing
• Days’ Supply
  • Auditors will generally not consider the days’ supply field on electronic prescriptions
  • Pharmacy must calculate days’ supply based on quantity and instructions for use
  • Use caution with a software’s default field for days’ supply as this information is frequently incorrect
  • Day’s supply must be billed accurately, bypassing days’ supply plan limits puts claims at risk of full recoupment
• DAW
  • Have documentation to support DAW codes billed other than “0”
  • Recommend confirming DAW 1 with prescriber when medication is new to patient
  • Check your state’s (and Medicaid’s) specific requirements for DAW 1 prescriptions
  • Brand name single source medications should not be billed with DAW 1 as this may increase audit risk
• Notes Field
  • Conflicting information in notes field should be clarified with the prescriber’s office
  • Be sure any additional instructions from the notes field are included on the patient label
• Failover Electronic Prescriptions
  • When electronic prescriptions fail to be transmitted, they may come through to the pharmacy’s fax machine
  • Confirm your state’s specific requirements for faxed prescriptions and call for verbal authorization, and document, when necessary
  • Explore techniques for spotting fraudulent electronic prescriptions in the July 2024 Newsline, How to Safeguard Your Pharmacy from Fraudulent Electronic Prescriptions

related to days’ supply issues. Do the directions on the hard copy give a calculable day supply? Are there grams per application? If not, the pharmacy should clarify with the prescriber prior to dispensing and put a clinical note on the hard copy. Directions like “one application twice weekly” or “use as directed, a pea-sized amount” would also not suffice for calculable directions, as they are not specific enough, and most PBMs will not assume “pea-sized” amount is 0.25 g. PAAS recommends communicating with the provider to clarify and adding a clinical note to the hard copy. Be sure that these clarifications (frequency and/or volume) are also reflected on an updated patient label prior to dispensing.

Once you determine the prescription contains calculable directions, the next step would be to bill the accurate day supply. Pharmacies can fall into the trap of assuming a days’ supply exceeding 90 days will surely be rejected based on historical experience; therefore, a 90 days’ supply is billed to the insurance. This places the pharmacy at risk for an invalid day supply discrepancy, as well as potential refilled too soon discrepancies on subsequent refills. Unbeknownst to many pharmacies, PBMs have begun to allow accurate [>90] days’ supplies to be billed for certain types of medications, including vaginal creams. Our recommendation is to always submit a claim with the true and accurate days’ supply first. If the plan rejects the days’ supply, PAAS recommends contacting the insurance help desk for an override. If the insurance does not have an override for the day supply, document this on the hard copy and bill for the maximum day supply allowed by insurance. To prevent accidental early refills, PAAS recommends adding a note on the pharmacy label in the directions, making both staff and patients aware of the actual day supply. The more visibility the note is, the less likely an early refill will be missed.  

PAAS Tips:

• Reminder that a clinical note should contain four elements
  • The date/time of the call
  • The name and title of the person you spoke with at the prescriber’s office
  • The clarification
  • Your initials
• Both products have a calibrated applicator for dosing, however each applicator is a different size
  • Estrace® is a 42.5 g tube with an applicator that can measure 1 to 4 grams in 1 g increments
  • Premarin® is a 30 g tube with an applicator that can measure 0.5 to 2 grams in 0.5 g increments
• Avoid putting vaginal creams on automatic refill or in a medication synchronization program if the pharmacy billed an inaccurate day supply due to a plan limit
• Review our new member benefit guidance Exceeding Days’ Supply Plan Limits for Unbreakable Packages

calling the geriatrician to explain that 0.25 mg is subtherapeutic for the frail 91-year-old patient isn’t always time well spent, it is worth confirming that the dose prescribed was truly the maintenance dose intended (and documenting the conversation on the hardcopy accordingly).

With the duplicity of GLP-1 medications being marketed separately for Type II Diabetes Mellitus or Weight-loss, there is a heightened sense of off-label use when Ozempic^® [instead of Wegovy^®] is prescribed for weight loss. Likewise, Ozempic 0.25 mg could be considered “off-label use”, although PBMs seem reluctant to do anything [at least for now] to disrupt the gravy train that is GLP-1 rebates.

So, beyond validating the ongoing Ozempic 0.25 mg dosing, how should pharmacies bill the claim? There are only 6 pen needles in the box, so an argument could be made that the days’ supply should be 42. However, this would be wasting two weeks’ worth of medication, and pen needles can be dispensed and sold separately (as is the case with insulin pens).

CVS/Caremark is the only PBM with written guidance available on their Audit Tips: Injectable GLP-1 Receptor Agonist Medications resource. Caremark states that a box of Ozempic^® 2 mg/3 mL giving 0.25 mg once weekly should be billed as a 56-day supply. With this billing guidance (which has not to our knowledge been spelled out before), it is likely to continue being an audit target. Caremark does state that if the plan limits the days’ supply to 34, to call the help desk to request a “Plan limitation exceeded” override and to document that information on the hard copy.

As for other PBMs, there has been no formal guidance as to the correct billing of the low-dose Ozempic^®. PAAS has seen Express Scripts also indicate (per audit results) that low-dose Ozempic^® at 0.25 mg once weekly ongoing as a 56-day supply. OptumRx, on the other hand, believes these directions constitute a 42 days’ supply (likely due to the limited pen needles available). PAAS considers the conservative approach to be always billing for a 56-day supply and dispensing/selling additional pen needles, as needed.

The recoupment risk for pharmacies billing a 42 days’ supply for low-dose Ozempic^® is the initial dispensing will be flagged for incorrect days’ supply and subsequent refills may be deemed as refill too soon (facing full recoupment). Any refills that are dispensed prior to the PBM’s utilization threshold [based on the actual days’ supply] is easily identified by the PBM and low hanging fruit for auditors (before they even asked for prescription documentation). If the PBM wanted a 56 days’ supply and the utilization threshold is 75%, pharmacies refilling prior to 42 days could face recoupment.

PAAS Tips:

• PAAS recommends billing Ozempic® 0.25 mg weekly as a 56-day supply to maintain consistency and avoid potential recoupment
  • Be careful of early refills if you must submit an altered day supply due to plan limitations
    • Utilization thresholds vary by plan and PBM – be judicious when allowing refills to process
  • See PAAS tool Exceeding Day’s Supply Plan Limitations for Unbreakable Packages to educate your team and develop a systematic process for handling these types of prescriptions
• Advise patient to NOT re-use pen needles
• Optum Rx Provider Manual states that the pharmacy should contact the help desk for an override if the days’ supply billed exceeds the plan limit, then document on the prescription hard copy
• Ozempic^® 0.25 mg weekly is not considered to be a therapeutic dose and could be considered off-label use
  • Medicare Part D and other federally funded plans will not pay for drugs for off-label use. Commercial plans can also deny payment, depending on the agreement/provider manual
• Ensure any diagnosis code present on the prescription is approved for use of Ozempic®
• If utilizing a coupon card, ensure it is being used in accordance with the terms and conditions listed

Prescriber statements should have all the elements of the original prescription, in statement form, and address the reason for the discrepancy:

• Prescriber full name, address and phone number (and DEA for a controlled substance)
• Patient name and date of birth (and address for a controlled substance)
• Written date of prescription
• Medication name, strength, and dosage form
• Quantity and refills prescribed
• Instructions for use
• DAW code if applicable
• Any additional information needed to clarify discrepancy flagged
• Prescriber’s handwritten signature (electronic and stamped signatures are not accepted)
• Date the statement was written/signed

PAAS Tips:

• Each PBM has their own requirements for prescriber statements. Consult with a PAAS analyst to ensure your prescriber statements meet all requirements.
  • Once obtained, PAAS is happy to review, and provide feedback, on your prescriber statement(s)
  • Prescriber statements that do not meet all PBM requirements may be denied on appeal.
• Prescriber statements MUST come from the prescriber’s office. Ensure legitimacy by having the prescriber send you the statement through fax with a cover sheet from their office, especially if it cannot be produced on their letterhead or office prescription pad.
  • Pharmacies should provide all the detailed information needed for the prescriber to be able to create the statement in their own words.
• A prescriber’s office stamp may be used to validate a statement not written on the prescriber’s letterhead, but then the statement should be sent back to the pharmacy by fax with a cover sheet from the prescriber to further prove legitimacy and proof of origin.
• Humana currently uses a prescriber statement template. This template will only be sufficient for Humana appeals and does NOT meet the requirements for other PBMs.
• Remember to add the prescription number to the prescriber statement for auditor reference.