GLP-1 Prescriptions Remain in the Crosshairs of Auditors

GLP-1 medications continue to come under scrutiny from PBM auditors for several reasons. High cost, off-label use, rising utilization, and billing irregularities make these easy audit targets. Pharmacies must remain diligent to ensure accuracy and appropriateness when dispensing these medications to avoid recoupments.

The latest in audit recoupments have come from…

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prescriptions for “microdosing”. Patients and prescribers have become aware of an internet sensation of injecting smaller doses for titration or maintenance therapy. The concept of using a certain number of clicks on the pen dial may be prescribed to obtain this microdose. Dosing at this level may be an attempt at reducing side effects or saving money.

GLP-1 pens are designed to deliver a specific, measured dose and the manufacturer instructions clearly indicate the pens should only be dialed to the appropriate dose and the number of clicks should not be counted. Pharmacies can refer to DailyMed for each medications’ package insert.

Manufacturers of these GLP-1 medications have not gone through the approval process from the FDA to ensure this practice is safe or effective. Consequently, PBMs may consider these prescriptions experimental or not medically appropriate. Pharmacies should consult with prescribers on the appropriate dosing and obtain new instructions, as needed.

PAAS Tips:

COVID-19 Vaccine Update: Shared Clinical Decision-Making

The CDC recently revised recommendations for COVID-19 vaccination by (i) removing the recommendation for pregnant women to receive the vaccine and (ii) that individuals ages 6 months to 17 years may receive the vaccine using a shared clinical decision-making (SCDM) approach. The SCDM recommendations are meant to be flexible and informed by the characteristics, values, and preferences of the individual patient (or guardian) and the clinical discretion of the health care provider.

There are now five vaccines that follow the SCDM approach rather than routine, catch-up, or risk-based approach where the default is to “vaccinate, unless contraindicated”.

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  1. Meningococcal B (MenB) vaccination for adolescents and young adults aged 16–23 years
  2. Hepatitis B (HepB) vaccination for adults aged 60 years and older with diabetes mellitus
  3. Human papillomavirus (HPV) vaccination for adults aged 27–45 years
  4. Pneumococcal conjugate vaccination (PCV20 or PCV21) for adults aged 65 years and older who have completed the recommended vaccine series with both PCV13 (at any age) and PPSV23 (which was administered at age ≥65 years)
  5. COVID-19 for individuals 6 months to 17 years

Multiple organizations have objected to these changes and some have even filed lawsuits against the U.S. Department of Health and Human Services.

PAAS Tips:

  • While PAAS has NOT seen PBMs request documentation related to SCDM, we recommend that pharmacies document in the event of future audits
  • CDC has SCDM Job Aids for four of the five SCDM vaccine recommendations; however, no such COVID-19 Job Aid exists as of early July 2025 due to recency of the revised recommendation
  • We suggest pharmacies download the most current CDC adult and adolescent immunization schedules

Why Are There So Many Audits? 

Many pharmacies that PAAS National® assists with audits have similar sentiments, “Why us?” or “We just had an audit with [insert PBM here]”. It can feel like it is a never-ending cycle, with shifting standards depending on which PBM is conducting the audit. At PAAS, we understand these concerns — and we’re here to help.

To support pharmacies in managing and minimizing audit risk, the PAAS portal includes a valuable resource under the “Proactive Tips”, called Audit Flags. This resource can help pharmacies identify characteristics of prescriptions that frequently trigger audits and provide insight into why they’re being flagged. While high-cost medications are commonly targeted, there are many other lesser-known reasons a claim might attract attention. For example, did you know…

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that PBMs may analyze the geographical distance between the patient, prescriber, and pharmacy? 

Additionally, the PAAS Self-Audit Article Series compliments this tool by offering actionable strategies to help reduce audit exposure. This series highlights different types of prescriptions that have historically led to PBM audits or recoupments and shares guidance to ensure your documentation and dispensing practices can withstand scrutiny. The series includes 12 different topics, each with links to relevant Newsline articles and additional resources for deeper learning.

Let PAAS help you stay ahead — with proactive tools and expert insights to protect your pharmacy. Access the additional resources available on the PAAS portal to better understand and manage audit risks. For additional support or questions, feel free to reach out to the PAAS team.

PAAS Tips:

Be prepared and confident BEFORE you receive an audit notice by reviewing the Self-Audit Article Series

DEA Alert: Electronic Prescription Fraud on the Rise

As technology continues to reshape modern medicine, medical providers have embraced electronic prescribing to improve patient care. Unfortunately, as the healthcare landscape evolves, so do the tactics of bad actors seeking to exploit it.  

Bad actors can use stolen login credentials from prescribers to gain access to electronic health record systems and initiate thousands of fraudulent e-prescriptions to pharmacies across the country within a very short period. For example, a 26-year-old Florida resident plead guilty in December 2024 and will serve two years and six months in federal prison for wire fraud and aggravated identity theft.

In response to this growing threat, the DEA is urging pharmacies to stay vigilant, as those that dispense fraudulent prescriptions may be held liable. For example, CVS agreed to pay $70,000 in 2023 to resolve allegations that the Controlled Substances Act (CSA) was violated at several of its locations.

According to an article published by Pharmacy Practice News, the DEA is on high alert. “Electronic prescription fraud is a real emerging trend that we’re seeing all across the country,” said Erin Hager, a DEA diversion investigator in the Phoenix-Tucson Tactical Division Squad. “What’s happening is … bad actors … who have been conducting prescription drug fraud are now utilizing the internet and electronic health record platforms to create electronic prescriptions that they can then send nationwide.”

What can pharmacies do to keep fraudulent prescriptions from being filled and dispensed? As mentioned in our February 2025 Newsline article, Electronic Prescription Fraud, we listed techniques to spot fraudulent e-prescriptions, like knowing the prescriber, the patient/caregiver, and reviewing the prescription for unusual items. The DEA has also released some helpful resources to help in preventing fraudulent prescriptions from being filled and dispensed, like the Pharmacists’ Guide to Prescription Fraud and the DEA Pharmacists’ Manual.

PAAS Tips:

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  • The DEA has an informative video about fraudulent e-prescriptions that can be found here
  • When in doubt, call the prescriber to confirm a prescription’s validity
  • If a prescription is identified as fraudulent, make documentation of this assessment on the prescription or in your pharmacy management software
  • For new patients, consider asking for their insurance card, rather than using the insurance look-up tool in your billing software. This allows pharmacies to confirm payor information and serves as another validation point.

AstraZeneca Letters re: Farxiga® Data Discrepancies

Numerous pharmacies have received letters from AstraZeneca, the manufacturer of Farxiga® 5 and 10 mg, regarding “discrepancies” identified in a reconciliation of purchase and dispensing data from 2024.

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Similar to the LifeScan letters highlighted in the April 2025 article, Diabetic Test Strip Authorized Distributors – LifeScan Audits Continue!, there are two different versions of the AstraZeneca letter. The gentle version requests that pharmacies review wholesaler invoices and pharmacy dispensing records to ensure that claims are dispensed/billed properly, while the stronger version requests cooperation by providing data to AstraZeneca to include total tablets purchased and dispensed in 2024. Both versions point out that 2023 data show no such discrepancies.

The unsupported assertions of an invoice shortage should prompt pharmacies to perform an internal review of their own purchase and dispensing data to see if the claim has any merit. If shortages are uncovered, then pharmacies should attempt to determine the root cause(s) and implement appropriate corrective actions to prevent a recurrence.

A few possible reasons that should be considered include:

  1. Excess supply on-hand from 2023
  2. Return to Stock Errors
  3. Claims with overbilled quantities
  4. Purchases from other pharmacies that may not be visible to the manufacturer
  5. Incorrect NDCs billed
  6. Counterfeit product in the supply chain
  7. Fraudulent billing of claims where no inventory was purchased
  8. Failure to reverse claims that were not picked up

While not stated directly, the tone and wording of the letters imply that AstraZeneca suspects that pharmacies purchased/dispensed the Authorized Generic NDC and billed claims under the Brand NDC. This type of error causes manufacturers to pay inappropriate rebates and is considered fraudulent, if done intentionally.

The Authorized Generic version of Farxiga® (dapagliflozin), labeled by Prasco Laboratories, entered the market January 3, 2024, and has the identical appearance (color, shape, size, imprint) as the branded product indicating that it is the exact same tablets in the bottles – with different labeling, NDCs, and most importantly, prices.

ProductLabelerNDCAWP per unitNADAC per unitTablet Description
Farxiga® 5 mgAstraZeneca00310-6205-30 00310-6205-90$23.99$19.15Color: Yellow Shape: Round Size: 7 mm Imprint: 5; 1427
Dapagliflozin Propanediol 5 mgPrasco Laboratories66993-0456-30$22.12$11.47
Farxiga® 10 mgAstraZeneca00310-6210-30 00310-3210-90$23.99$19.16Color: Yellow Shape: Diamond Size: 11 mm Imprint: 10; 1428
Dapagliflozin Propanediol 10 mgPrasco Laboratories66993-0457-30$22.12$11.54

As of this publication it is unclear how AstraZeneca will proceed. If you have a letter, be sure to send it into PAAS right away so that we may guide you through next steps.

PAAS Tips:

  • AstraZeneca has a list of Authorized Distributors of Record on its website. The contractual requirements are unclear as to whether pharmacies are obligated to purchase Farxiga only from an Authorized Distributor; however, one way to ensure you are not purchasing counterfeit product would be to order only from one of these authorized distributors.
  • Make sure that inventory purchased from another pharmacy or via a third-party marketplace is performed in accordance with DSCSA and that these transactions are thoroughly documented
  • Ensure that claims are billed with the exact NDC that is purchased/dispensed – this is a contractual requirement of every payor, for every claim
    • Pharmacist visual verification of Farxiga® tablets alone is insufficient to prevent this error type – make sure you check the NDC of the stock bottle against the claim to confirm accuracy
    • Consider staff education on this possible error type and implementing barcode scanners to prevent mistakes

OIG Semiannual Report to Congress Shows 11:1 Return On Investment

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently released its Semiannual Report to Congress summarizing program integrity efforts from October 2024 through March 2025 which showed a return of $11 for every $1 spent. The OIG is the lead federal agency combating healthcare fraud, waste, and abuse in federal programs such as Medicare, Medicaid and providers will likely see increased activity based on President Donald Trump’s goals to pay for the One Big Beautiful Bill Act.

OIG Highlights from October 1, 2024 – March 31, 2025:

  1. 78 reports issued
  2. 946 investigations closed
  3. 1,503 excluded individuals and entities
  4. 298 criminal informations and indictments (formal accusations)
  5. 1,209 referrals (to prosecutors)
  6. 349 criminal actions (convictions)
  7. 395 civil actions

OIG oversight impacting pharmacies includes:

  1. Medicare Part D improperly paid up to $465 million for drugs when payment was available under Medicare Part A over a 3-year period
  2. Medicare may have improperly paid up to $454 million for 39 million OTC COVID-19 tests in excess of the monthly limit of eight tests per enrollee
  3. Compounded prescriptions and HIV medications continue to be targets of FWA

NCPDP Package Size Updates: Gonal-f® RFF Redi-ject® and Teriparatide (Alvogen)

Similar to the recent package size changes for Forteo®, NCPDP reports that the FDA has requested product labeling changes on four additional products which will be revised in compendia this summer. The FDA is not requiring manufacturers to obtain new NDCs and there are no clinical changes to the products.

Products with coming package size changes include:

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ProductNDCOld Package SizeNew Package SizeCompendia Date
Teriparatide (Alvogen)47781-0652-892.48 mL2.24 mLJuly 1, 2025
Gonal-f® RFF Redi-ject®44087-1117-011.5 mL1.44 mLJuly 1, 2025
44087-1115-010.5 mL0.48 mLAugust 1, 2025
44087-1116-010.75 mL0.72 mLAugust 1, 2025

Alvogen’s teriparatide will have the strength corrected from 620 mg/2.48 mL to 560 mcg/2.24 mL to accurately reflect the intended delivery of 28 daily doses of 20 mcg. Products with revised labeling should be in the marketplace by mid-June 2025.

EMD Serono, Inc’s Gonal-f® RFF Redi-ject® (follitropoin alfa injection) will correct the currently rounded number volumes to more accurately reflect the volume delivered in a single patient use prefilled pen. Products with revised labeling should enter the marketplace in mid-June and mid-July 2025.

PAAS Tips:

  • Be careful when adjudicating claims and ensure that you bill for the quantity of the product in-hand
  • Pharmacies may need to contact PBM helpdesks if claims are paid incorrectly (overpay or underpay) or reject altogether

What’s New with Prescription Validation Requests in 2025?

In the PAAS National® January 2025 Newsline article, PBM Prescription Validation Requests – What Are They Looking At Now? we discussed the PBM trends we saw in 2024. Below is a list of drugs reviewed and analyst comments that have been compiled through the first six months of 2025 along with a comparison from 2024. While we are not surprised that Ozempic® continues to be the top drug on the prescription validation requests, the others are not surprising either.

January-June 2025July-December 2024January-June 2024
Ozempic®Ozempic®Ozempic®
Invega®Trelegy ElliptaNurtec®
Creon®Eliquis®Mounjaro®
Zepbound®EpinephrineCreon®
Nurtec®Creon®Ubrelvy®

The top 5 comments noted by an analyst after claim review for the first half of 2025 mirror those from 2024.

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  1. A clinical notation is needed and requires the following 4 elements:
    1. Date/time of the call/conversation
    2. Name and title of who you spoke with
    3. Specific details about the clarification
    4. Initials or name of the pharmacy employee making the clarification
  2. Black out acquisition cost and/or profit margin values on the backtag
  3. Document the reason for the cut quantity – auditor will want to know why the pharmacy dispensed less than what was prescribed
  4. Verify the quantity prescribed and make a clinical notation on the hard copy – Unit of Measure (UOM) is not specified or does not make sense for the medication ordered
  5. No backtag/sticker provided, typically requested by the PBM and helpful for PAAS to review the billing elements

PAAS Tips:

Manufacturer Coupons: Why It’s Important to Read the Fine Print

While PAAS National® sees a vast array of PBM audits daily, did you know that claims billed to a manufacturer coupon can also be audited by the coupon administrator? Each manufacturer coupon…

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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

Fraudulent Prior Authorization Submissions Costs Pharmacy Over $1 Million

A Florida-based pharmacy plead guilty to healthcare fraud and agreed to pay over $1 million to resolve False Claims Act violations stemming from falsified prior authorizations. The pharmacy dispensed Evzio® (injectable naloxone product for emergency treatment of opioid overdose—discontinued in October 2020) which frequently required prior authorizations due to its high cost. Instead of sending the prior authorization information and/or forms to the prescribers, the pharmacy would complete the forms and, in some cases, sign the required forms. It was made to appear that the physician (not the pharmacy) was submitting the information. Pharmacy staff also provided false information to the insurer that the patients had tried and failed to successfully use Narcan®.

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A pharmacy may believe they are “helping out” the prescriber by doing the prior authorization for them, but there is language in PBM provider manuals on this topic. For example, the Caremark provider manual section 5.06 states “For prior authorization, the Prescriber is required to supply additional documentation to Caremark or the Plan Sponsor to determine whether certain criteria are met for the drug to be covered under the Plan.” The restriction is intended to prevent kickbacks to prescribers from pharmacies for medication referrals, as well as falsification or manipulation of prior authorization information.

PAAS Tips:

  • Prior authorizations should be completed and submitted by prescribers, independent of the pharmacy, unless there is an explicit allowance from the PBM and the pharmacy has access to clinical information (where needed)