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…
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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:
Review Audit Flags to identify possible audit triggers that may be occurring in your pharmacy
Be prepared and confident BEFORE you receive an audit notice by reviewing the Self-Audit Article Series
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/08/04104611/iStock-2162411925.jpg11521920Erin McDonald, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngErin McDonald, PharmD2025-08-06 10:43:292025-08-04 10:46:54Why Are There So Many Audits?
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:
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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.
https://paaswp.s3.amazonaws.com/wp-content/uploads/2023/02/03102850/iStock-1421859468.jpg12801920Heaven Bennett, CPhThttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngHeaven Bennett, CPhT2025-08-04 15:12:202025-07-25 15:14:46DEA Alert: Electronic Prescription Fraud on the Rise
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.
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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:
Excess supply on-hand from 2023
Return to Stock Errors
Claims with overbilled quantities
Purchases from other pharmacies that may not be visible to the manufacturer
Incorrect NDCs billed
Counterfeit product in the supply chain
Fraudulent billing of claims where no inventory was purchased
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.
Product
Labeler
NDC
AWPper unit
NADACper unit
Tablet Description
Farxiga® 5 mg
AstraZeneca
00310-6205-30 00310-6205-90
$23.99
$19.15
Color: Yellow Shape: Round Size: 7 mm Imprint: 5; 1427
Dapagliflozin Propanediol 5 mg
Prasco Laboratories
66993-0456-30
$22.12
$11.47
Farxiga® 10 mg
AstraZeneca
00310-6210-30 00310-3210-90
$23.99
$19.16
Color: Yellow Shape: Diamond Size: 11 mm Imprint: 10; 1428
Dapagliflozin Propanediol 10 mg
Prasco Laboratories
66993-0457-30
$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
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently released its Semiannual Report to Congresssummarizing 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:
78 reports issued
946 investigations closed
1,503 excluded individuals and entities
298 criminal informations and indictments (formal accusations)
1,209 referrals (to prosecutors)
349 criminal actions (convictions)
395 civil actions
OIG oversight impacting pharmacies includes:
Medicare Part D improperly paid up to $465 million for drugs when payment was available under Medicare Part A over a 3-year period
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
Compounded prescriptions and HIV medications continue to be targets of FWA
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/07/25150339/iStock-2223053610.jpg14401920Eric Hartkopf, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngEric Hartkopf, PharmD2025-07-31 15:01:232025-07-25 15:03:53OIG Semiannual Report to Congress Shows 11:1 Return On Investment
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:
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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
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 2025
July-December 2024
January-June 2024
Ozempic®
Ozempic®
Ozempic®
Invega®
Trelegy Ellipta
Nurtec®
Creon®
Eliquis®
Mounjaro®
Zepbound®
Epinephrine
Creon®
Nurtec®
Creon®
Ubrelvy®
The top 5 comments noted by an analyst after claim review for the first half of 2025 mirror those from 2024.
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
A clinical notation is needed and requires the following 4 elements:
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
Black out acquisition cost and/or profit margin values on the backtag
Document the reason for the cut quantity – auditor will want to know why the pharmacy dispensed less than what was prescribed
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
No backtag/sticker provided, typically requested by the PBM and helpful for PAAS to review the billing elements
PAAS Tips:
Use our Self-audit Mindset tool found under the “Proactive Tips” tab to review your prescriptions prior to sending them to PAAS
Be sure to include a backtag or screenshot of billing information for a PAAS analyst to review
Be sure to add all employees to the Member Portal and give them permission to access helpful tools, resources and eNewsline
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/07/25145323/iStock-1818264966.jpg9601920Jennifer Ottman, CPhThttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngJennifer Ottman, CPhT2025-07-27 14:51:282025-07-25 14:54:02What’s New with Prescription Validation Requests in 2025?
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…
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/07/25145050/iStock-2018248359.jpg11491920Erin McDonald, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngErin McDonald, PharmD2025-07-25 14:51:002025-07-25 14:51:01Manufacturer Coupons: Why It’s Important to Read the Fine Print
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®.
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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)
PAAS National® recommends attention to detail when it comes to typing directions for patient labels. Pharmacies are often very familiar with prescribers and what they likely intended to include on the prescription, but didn’t. This can range from a specifying a quantity to providing detailed patient instructions. Unfortunately,…
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
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
This new tool will provide staff with a billing flowchart to follow when the primary payor prefers brand and a second chart to follow when the secondary prefers brand. These flowcharts can serve as a quick reference guide that can be printed out and posted at the data entry station for easy reference. At the end of this new tool, there is a table with a more in-depth explanation of this multi-payor billing process.
While the majority of the pharmacy’s claims are likely to process through just one payor, it is not uncommon to have a patient with a secondary payor (e.g., Medicaid). While Medicaid as a secondary payor is not the only scenario where this tool will be helpful, it is likely the most common. Primary payors often have different formulary preferences for multi-source brand products than Medicaid due to various manufacturer rebates. PAAS analysts frequently receive questions about the proper way to bill these claims and which DAW code is appropriate to use. While an analyst is always happy to guide you through these scenarios, this tool can be at your fingertips and can also guide you through the process of how to correctly bill these claims.
Find this tool, and other amazing PAAS tools and aids, on the Member Portal. Here you can find Proactive Tips, Days’ Supply Charts, and even On-Demand Webinars! If you are not able to find something you’re looking for, just reach out to a PAAS representative for additional guidance.
https://paaswp.s3.amazonaws.com/wp-content/uploads/2024/11/04105411/iStock-1145179413.jpg19201920Sara Hathaway, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngSara Hathaway, PharmD2025-07-19 14:34:412025-07-25 14:37:15New PAAS Tool! Flowchart for Multi-Payor Claims with Conflicting Coverage
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…
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:
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.
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:
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.
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:
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:
OIG oversight impacting pharmacies includes:
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:
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:
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.
The top 5 comments noted by an analyst after claim review for the first half of 2025 mirror those from 2024.
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…
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:
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®.
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:
Preventing Misfill Recoupments Through Documentation
PAAS National® recommends attention to detail when it comes to typing directions for patient labels. Pharmacies are often very familiar with prescribers and what they likely intended to include on the prescription, but didn’t. This can range from a specifying a quantity to providing detailed patient instructions. Unfortunately,…
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:
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:
New PAAS Tool! Flowchart for Multi-Payor Claims with Conflicting Coverage
In last month’s Newsline article, “A” for Abandoned: The Short Life of DAW Code A and What it Means for Multi-Payor Claims, PAAS National® provided insight into the revised billing process for multi-payor claims where one payor prefers the brand and the other payor prefers generic. Due to the complexity of this billing process, a new PAAS tool has been developed, Conflicting Coverage: When One Payer Covers Brand and the Other Prefers Generic.
This new tool will provide staff with a billing flowchart to follow when the primary payor prefers brand and a second chart to follow when the secondary prefers brand. These flowcharts can serve as a quick reference guide that can be printed out and posted at the data entry station for easy reference. At the end of this new tool, there is a table with a more in-depth explanation of this multi-payor billing process.
While the majority of the pharmacy’s claims are likely to process through just one payor, it is not uncommon to have a patient with a secondary payor (e.g., Medicaid). While Medicaid as a secondary payor is not the only scenario where this tool will be helpful, it is likely the most common. Primary payors often have different formulary preferences for multi-source brand products than Medicaid due to various manufacturer rebates. PAAS analysts frequently receive questions about the proper way to bill these claims and which DAW code is appropriate to use. While an analyst is always happy to guide you through these scenarios, this tool can be at your fingertips and can also guide you through the process of how to correctly bill these claims.
Find this tool, and other amazing PAAS tools and aids, on the Member Portal. Here you can find Proactive Tips, Days’ Supply Charts, and even On-Demand Webinars! If you are not able to find something you’re looking for, just reach out to a PAAS representative for additional guidance.