has Terms and Conditions that need to be followed in order to be compliant in the program.

Each coupon or card has its own set of limitations/parameters for use. All coupons and copay cards are not allowed if a patient is enrolled in any Federal-paying prescription program (such as Medicaid, Medicare Part D, and Tricare) due to the Anti-kickback Statute (42 U.S.C. 1320a-7b). A question that is often asked is: “what if the drug isn’t covered by the federal plan?” The answer to this question would come down to the wording in the Terms and Conditions. Many cards will say it cannot be used for patients covered under Medicare or Medicaid. However, even though the drug isn’t covered, the patient is still enrolled in the federally funded program and the coupon or copay card should not be applied. 

What if the pharmacy uses a discount card (instead of the primary insurance) or bypasses the primary insurance plan altogether? The answer should be in the details. For example, Linzess^® has a copay savings card available (called the Linzess^® savings program). After finding terms and conditions for the card, the first sentence states, “This offer is valid only for patient with commercial prescription insurance coverage…”. It would likely be considered a violation of the program to directly bill a discount card instead of the patient’s primary insurance coverage (with the exception of discount cards embedded in plans) and could result in recoupment of the money paid to the pharmacy, and possibly termination from the coupon’s processor. Many coupons are processed by the same payers and PBMs, which could exclude you from multiple coupon cards/discount programs and possibly draw scrutiny to commercial claims and contracts unknowingly.

PAAS Tips:

• Always use the correct ‘Other Coverage’ code indicator
• Do NOT bypass any primary insurance requirements, such as prior authorization, plan limits, or step therapy
• Ensure the patient does not have a federally funded plan, such as Medicare, Medicaid or Tricare when applying coupons and discount cards
• Review past Newsline articles for more information on billing coupons
  • Billing Coupons for Medicare Part D Patients—When Is It Okay? (November 2024)
  • Federal Employees and Coupon Cards (February 2021)

when a pharmacy supplements or documents clinical notations that are not explicitly written on the prescription (and do not appear on the patients prescription label), it risks the claim being considered a “misfill”. OptumRx and Caremark are very particular about the directions on the patient label matching exactly what the prescription, and any relevant clinical notations, contains.

Some of the following are examples of those errors:

• Grams per application or area applied for topical medications
• Which eye(s) an eye drop is being administered into
• Number of snacks for pancreatic enzymes
• Max daily dose for insulin with sliding scale or titration

Victoza^® is another example of a problematic patient label issue, which typically has directions in MG, but is often typed on the patient label as ML.

PAAS Tips:

• Verify any ambiguous information on the prescription with the provider prior to dispensing
• Include clinical notation about the clarification including the 4 elements below:
• Date/Time of the call/conversation
• Name and title of who you spoke with
• Specific details about the clarification
• Initials or name of the pharmacy employee making the clarification

• For more insight on clinical notations, see July 2025 Newsline article, PBMs Are Criticizing Clinical Notes!
• Educate all staff to include relevant clinical notation information on patient labels that relate to the instructions for use
• Be sure the auditor is receiving all clinical notations when submitting prescriptions for an audit

NCPDP billing standards determine the billing quantity and unit of measure on claims so that all parties involved in the billing transaction are “speaking the same language”. This holds true for vaccines, such that each vaccine has a set quantity based on the NDC billed. Therefore, billing a quantity incongruent with the standard may trigger a third-party payor’s claim algorithm and result in an audit. Knowing the appropriate quantity and NCPDP billing unit for each vaccine the pharmacy bills, and how your pharmacy software system handles these quantities, is critical for billing vaccines correctly. 

Listed in the chart below are many of the vaccines commonly billed by pharmacies, including their appropriate quantity and NCPDP billing unit. One factor that should immediately stand out is that many of these vaccines are billed with the NCPDP unit of “ML”, but most are less than 1 ML. If the pharmacy’s billing software is unable to handle/display decimals in the quantity field, the pharmacy must closely monitor these claims to ensure the vaccines are set up appropriately so the correct quantity is transmitting to third-party payors. The easiest way to confirm that the quantity is entered appropriately on the claim is to double check the cost of the vaccine on the claim. If the cost is double what you expect, it is possible the vaccine is not setup appropriately in the system. Take steps to correct the vaccine data elements before billing the claim to reduce audit risk.

Type of Vaccine	Vaccine Name	Quantity & NCPDP Billing Unit	Considerations
Influenza	Fluzone®	0.5 ML	Watch for yearly changes
	Afluria®	0.5 ML
	Flucelvax®	0.5 ML
	FluLaval	0.5 ML
	Fluarix	0.5 ML
	Flublok® (egg-free)	0.5 ML
	Fluad® (65+)	0.5 ML
	Fluzone® High-Dose (65+)	0.5 ML
	FluMist® (nasal)	1 EA
COVID-19	Comirnaty®	0.3 ML	Watch for yearly changes
	SpikevaxTM	0.5 ML
	Novavax	0.5 ML
Shingles	Shingrix	1 EA
Pneumococcal	Pneumococcal Conjugate Vaccines Vaxneuvance® (PCV15)Prevnar 20® (PCV20)CapvaxiveTM (PCV21)	0.5 ML 0.5 ML 0.5 ML
	Pneumococcal Polysaccharide vaccine Pneumovax® 23 (PPSV23)	0.5 ML
Tdap (Tetanus, Diphtheria, Pertussis)	Adacel®	0.5 ML
	Boostrix	0.5 ML
Hepatitis B	Engerix-B 10 mcg/0.5 ML 20 mcg/1 ML	0.5 ML 1 ML	Aged 10 years and younger: 0.5 ML Aged 11 years and older: 1 ML
	Recombivax HB® 5 mcg/0.5 ML 10 mcg/1 ML 40 mcg/1 ML (dialysis formulation)	0.5 ML 1 ML 1 ML	Birth through 19 years: a series of 3 doses (5 mcg/0.5 ML each)Adolescents 11 through 15 years: either a series of 3 doses (5 mcg/0.5 ML each) or a series of 2 doses (10 mcg/1 ML each)Adults 20 years and older: a series of 3 doses (10 mcg/1 ML each)Pre-dialysis and dialysis patients: a series of 3 doses (40 mcg/1 ML each)
	Heplisav-BTM	0.5 ML
Hepatitis A	Havrix 720 EL U/0.5 ML 1440 EL U/ML	0.5 ML 1 ML	12 months through 18 years: 720 EL U/0.5 ML19 years and older: 1440 EL U/ML
	Vaqta® 25 unit/0.5 ML 50 unit/ML	0.5 ML 1 ML	12 months through 18 years: 25 unit/0.5 ML19 years and older: 50 unit/ML
Hepatitis A + B	Twinrix	1 ML
HPV (Human Papillomavirus)	Gardasil® 9	0.5 ML
MMR (Measles, Mumps, Rubella)	M-M-R® II	1 EA
	Priorix	1 EA
Meningococcal	Bexsero	0.5 ML
	Trumenba®	0.5 ML
	Menveo	0.5 ML	One-vial presentation (NDC 58160-827-03); pink cap
		1 EA	Two-vial presentation (NDC 58160-955-09); gray cap + orange cap

PAAS Tips:

• Billing a vaccine with an incorrect days’ supply is also known to trigger an audit. Vaccines are typically billed with a 1-day supply, unless instructed otherwise per adjudication messaging.
• Remove or block the NDC for seasonal vaccines that are no longer relevant (e.g., the influenza or COVID vaccine from the prior season)
• For more insight into billing vaccines, check out these other Newsline articles:
  • Boost Your Bottom Line with In-Home Preventative Vaccine Administration (November 2024)
  • Medicare and Vaccine Billing: What You Need to Know (October 2024)
  • Flu Shot Season – Are You Prepared? (September 2024)

Long-acting antipsychotic injectables are a frequent audit target due to their complexity and high cost. Additionally, the [potentially transient] patient population is more likely to create patient denial discrepancies (an auditor’s best friend). While PAAS has written articles about passive denials (the patient never acknowledges the auditor’s inquiry), this dispensing practice is more likely to lead to active denials. Do these patients know that your pharmacy provides the medication? In many cases, the answer might be no; so, having documentation and controls in place becomes paramount.

Moreover, given the patient population, how likely are they to miss appointments? Does the clinic communicate with the pharmacy if the patient cancels? PAAS has seen pharmacies continue to deliver medications for extended periods of time only to find out the patient hasn’t been keeping their appointments, and the clinic has been stockpiling the medication. Without additional measures in place, the pharmacy carries the financial burden.

Insurance companies will simply not pay for medications the patient never actually receives. Setting up policies and procedures with the clinics you deliver to should be mandatory to protect your claims. Remember, you are the only one with money at stake. While there are no specific requirements, questions to consider include:

1. How are patient copays collected (when applicable)?
2. Who will oversee receiving and signing for delivery?
3. How will the medication be stored at the clinic prior to administration?
4. What is the targeted timeframe from delivery to administration?
5. How will the clinic and pharmacy communicate to confirm patient receipt?
6. What will happen with medication a patient never receives (e.g., change in therapy, cancelled appointment)?
   • How quickly will the clinic notify you (consider return to stock timeframes)?
   • Does your state allow for medication reclamation under certain conditions?

PAAS Tips:

• Maintain good communication with the clinic you are working with
• Avoid automatic refills for these medications; only fill upon request or coordinate based on scheduled appointments
  • See the June 2025 Newsline article, Proof of Patient Consent for Refill Request: What You Need to Know
• Be mindful of REMS delivery requirements
  • See the March 2025 Newsline article, Understanding Spravato^® Strict Delivery Requirements
• Adhere to return to stock policies
  • See the June 2025 Newsline article, Why Adhering to Your Return to Stock Policy Is So Important
• Check your state laws on medication returned to pharmacy
• 340B clinics have a conflict of interest with 340B-eligible prescriptions; consider additional controls (e.g., mandatory evidence of administration) to reduce audit risk

is flagging migraine medications as 1N-Incorrect Days Supply: Submitted Days’ Supply on Claim is Incorrect. Prior Authorization Required for Correct Days’ Supply. The auditor has calculated the days’ supply strictly based on the prescription instructions, without accounting for the fact that the medication is prescribed to be taken as needed. Consider the following example:

Prescription is written for Ubrelvy^® 100 mg, #16 tablets. Instructions are to take 1 tablet at onset and repeat in 2 hours if needed. Pharmacy billed this claim as a 30-day supply based on a plan limit rejection (when the pharmacy billed #16 for an 8 days’ supply); however, the auditor also calculated the days’ supply to be 8, and stated this prescription, as written, would require prior authorization.

PBMs simply don’t allow pharmacists to use their professional judgement to determine the days’ supply. Prescribers should be contacted to obtain the specific number of headaches per week/month they anticipate the patient to treat, or the maximum number of tablets the patient may use per week/month. This information should be obtained prior to dispensing, documented on the prescription, and included on the patient label.

Injectable, maintenance migraine medications have their own set of audit risks. Pharmacies must bill the days’ supply according to the exact instructions. If the patient is to inject “monthly”, the claim should be billed as a 30-day supply. When the patient is injecting “every 4 weeks,” the claim should be billed as a 28-day supply. While you may not think two days can make a difference, understating the days’ supply can create an opportunity for the PBM to argue a refill was too early.

PAAS Tips:

• Obtain utilization (headache frequency or maximum dosing over time) information directly from prescribers – patient notes are often not accepted by PBMs
  • Update the patient label accordingly
• A complete clinical note should include:
  • Date and time
  • Name and title of individual providing information
  • Specific information clarified
  • Pharmacy staff initials
• As needed migraine medications should only be refilled upon patient request