Manufacturers go through rigorous testing to bring their products to market and part of the tedious approval process includes stability, sterility, and beyond-use date (BUD) testing. Pharmacies should be familiar with a product’s stability, sterility, and BUD information since these timeframes may come into play when determining the correct quantity and days’ supply to bill. Insulin pens and vials are the most commonly billed products where the BUD may influence the days’ supply. For example, a single vial of Lantus® or NovoLog® is good for 28 days once the top is punctured; therefore, a single vial of either of these insulins should always be billed for 28 days or less. Alternatively, a single vial of Levemir® is good for 42 days once it has been punctured; therefore, a single vial of Levemir® should always be billed for 42 days or less. For additional BUD information, refer to Section 16 of the manufacturer product labeling, or see PAAS’ various Days Supply Charts found in the Tools & Aids section of the PAAS Member Portal.
Pharmacies billing for nursing home patients may come across yet another “date of importance” – the maximum time a product may be stored according to the facility’s storage policy. PAAS National® analysts see pharmacies billing eye drops, inhalers, and insulin products as a 28-day or 30-day supply even though the directions on the prescription, the manufacturer product sterility information, and the BUD all support a longer days’ supply. Using the Levemir® example from above, if a pharmacy had a prescription for a Levemir® vial 100 units/mL, injecting 12 units subcutaneously nightly (dispense 10 mL), a single vial would have 83.3 doses or 83 days of medication. However, the BUD of a single vial is only 42 days; therefore, this should be billed as a 42-day supply. If a nursing home facility has a policy to discard all insulin vials after 28 days, then a pharmacy would be tempted to bill this as a 28-day supply but be aware of the repercussions this billing process could have! Nursing home practices and policies do not invalidate FDA/manufacturer sterility testing. Adjusting the days’ supply to 28 days to follow the facility’s policy often leads to “invalid day supply” penalty fees and full recoupments on early refills since PBMs will not take into consideration nursing home policies when determining days’ supply.
- Always attempt to bill the true/accurate days’ supply on a claim.
- Utilize PAAS tools to facilitate correct billing:
- If there is no state law to substantiate a facility’s storage policy which is more restrictive than manufacturer’s storage guidance (i.e., billing eye drops, inhalers, insulins, etc. for 28 or 30 days due to facility policy when they truly would last longer according to directions and manufacturer sterility information):
- Consider talking to the facility’s Director of Nursing about revising their policy so your pharmacy can avoid penalty fees and recoupment issues, or
- Insist that the pharmacy must bill for the true days’ supply according to directions and product labeling. If the facility’s storage policy requires early fills, then the facility will have to pay for those early fills. This is unlikely to be well-received by any facility and may help open lines of communication about changing the facility’s policy.