Top Ten Newsline Articles for 2024

In today’s fast-paced world, it’s crucial to stay informed with the latest insights to avoid putting your pharmacy at risk. For all pharmacy staff, continuous education is key. Mailed to pharmacies with the January Newsline, this article reviews the top ten PAAS National® Newsline articles from 2024 that were the most read tips and trends to help be proactive in preventing audits.

  1. Be Conscientious When Refusing to Dispense (or Bill Insurance)…
  2. Insulin Substitution Review: Understanding Purple Book Terminology
  3. PBM Audits on Ozempic®: 5 Common Discrepancies Revealed
  4. New Dispense As Written (DAW) Code Revealed
  5. OptumRx Continues to Cause Headaches!
  6. Best Practices for DAW Billing in Pharmacies
  7. Continuous Glucose Monitor (CGM) Billing and Supply Allowance
  8. Major PBMs Announce “Cost Plus” Pharmacy Networks
  9. OptumRx Targeting Medications Requiring Dispensing in Original Containers
  10. Commercial Claims Reimbursed Through Embedded GoodRx® Discount Cards

In addition, below are the top articles that are available only on the Member Portal.

  1. Days’ Supply Considerations for Eye Medications
  2. Required: Proof of Patient Copay Collection
  3. Painful Lessons: What You Should Know About Return to Stock Timeframes
  4. Transfer Tragedy: A Timeworn PBM Target
  5. Addressing “Weird” Days’ Supply
  6. Metformin HCL ER – Audit Considerations
  7. Pharmacy Owner’s Involvement in Fraud Scheme Leads to 4-Year Prison Sentence

When using the PAAS eNewsline on the Member Portal, you are able to search the Newsline Archive via keyword. Let the knowledge from these articles fuel your journey toward improved operations and a more engaged pharmacy staff.

Access these popular articles via the links above or you can print the Top 10 Articles of 2024 resource for a quick read.

Unique Eyedrop Calculation Challenges

Pharmacy social media platforms host passionate discussions on the correct way to bill days’ supply for eyedrops almost every week. Do you use 15 drops/mL, 20 drops/mL, or something else? As it turns out, the “right answer”  depends on the PBM you are billing and if the eyedrop is a solution or a suspension. Sound complicated? PAAS National® has a one-page chart and an app for that!

To make matters worse, there are some unique situations where using the PBM guidance is not relevant.

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For example, some manufacturers have specific guidance for drops/mL due to a viscosity and drop size difference (e.g., Miebo® [272 drops/3 mL], Vevye® [200 drops/2 mL], and Vyzulta® [81 drops/2.5 mL]), and you should calculate the days’ supply based on the manufacturers’ guidance.

Additionally, some eyedrops have a specific beyond use date in Section 16 Storage and Handling of the product labeling (e.g., AzaSite® [14 days], Rocklatan® [42 days], Rhopressa® [42 days], Vyzulta® [56 days], Xalatan® [42 days]) and cannot have a days’ supply greater than the beyond use date. Do not assume that all eyedrops have a beyond use date of 28 days. This is NOT true in most cases.

If a prescriber indicates that patient should discard the eyedrop after using it for ’X’ number of days, this must be explicitly spelled out in the directions to the patient. For example, eye drops that are to be used in the right eye for two weeks after surgery then discarded for a new bottle to be used for the left eye should clearly indicate this in the directions before billing a 14-day supply. If multiple package sizes of the product exist, use the smallest bottle closest to the treatment duration as possible. The PBM will not pay for a patient to discard the remainder of a 15 mL bottle when a 5 mL bottle would have sufficed.

PAAS Tips:

  • There is no industry accepted conversion for Gel or Ointment products
  • Follow the individual PBM published guidelines when billing days’ supply
  • OptumRx is the only PBM the explicitly states you may use treatment duration (e.g., “Use for ten days”) as the days’ supply
  • The quantity prescribed should contain a unit of measure that corresponds to the billing unit; however, if written for a quantity of “1 bottle”, it should be interpreted as the smallest package size
  • Login to the Member Portal under “Days’ Supply Charts” to find the most current version of PAAS’ Eye Drop Chart with major PBM drops per mL ratios
  • Download the PAAS National® Rx Days’ Supply Calculator from the App Store or Google Play
  • Review the November 2024 article, 2024 Self-Audit Series #9: Eye Drop Days’ Supply for additional guidance

Best Practices for Out-of-Stock Medications

PAAS National® analysts continue to see pharmacies struggle with invoice audits, which are most frequently performed by Caremark® and OptumRx®.

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Most PBMs perform invoice audits on an aggregated basis and total all claims billed to their particular PBM over an entire date range (e.g. 12 months). The totals of each NDC billed are then compared against the pharmacy’s purchases from authorized wholesalers over a similar period. If a pharmacy has an “inventory shortage”, it is commonly explained by a missing wholesaler purchase file, wrong NDC billed, purchases from an unauthorized wholesaler, or even product on the shelf prior to the date range.

Occasionally, pharmacies have shortages due to a claim being billed at the end of an audit date range for a medication that the pharmacy has not ordered/stocked before. If this out-of-stock claim falls inside the audit date range but the date of invoice falls outside (after) the date range, this can create a mathematical shortage. These situations are generally rare but can create issues for pharmacies undergoing an invoice audit.

Most PBMs have language that states the date of service must reflect the date the prescription is “prepared/readied for dispensing”, which they can argue isn’t possible without the drug on-hand. OptumRx, Horizon NJ Health, and NJ Medicaid take the language in their Provider Manuals (or Agreements) even further, indicating that pharmacies are required to have product in stock prior to even submitting a claim for the drug product. This requirement is highly impractical as pharmacies cannot afford to stock every medication that exists and do not know if a prescribed medication is even covered (or if patient even wants it) until after the claim is billed. Pharmacies should consider reversing claims for high cost, out-of-stock medications and rebilling them after the product has been ordered and is on-hand to reduce audit liability.

PAAS Tips:

If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.

Oral-Only ESRD Drugs Removed from Medicare Part D Coverage in 2025

Starting January 1, 2025, Medicare Part D no longer covers “oral-only” medications used for patients with end-stage renal disease (ESRD) undergoing dialysis treatment. This mainly impacts payment of phosphate binders such as PhosLo® (calcium acetate) and Renvela® (sevelamer carbonate), as well as Xphozah® (tenapor).

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When used for ESRD patients, these oral-only medications will now be covered by Medicare Part B under the ESRD Prospective Payment System (PPS) bundled payment to dialysis facilities and should NOT be billed by pharmacies to a Medicare patient’s Part D plan (pharmacies will also not be able to bill Medicare B). If pharmacies are looking to continuing dispensing these medications, advanced coordination with dialysis facilities will be required to ensure pharmacies receive reimbursement.

Part D claims may reject with the following NCPDP reject codes:

  • 75>Prior Authorization Required
  • 569>Provide Notice: Medicare Prescription Drug Coverage and Your Rights
  • A4>This product may be covered under the Medicare-B Bundled Payment to an ESRD Dialysis Facility

If Part D claims do not reject and pharmacy bills Part D incorrectly, then there will likely be future coordination of benefit (COB) “audits” where the Part D plan recoups the pharmacy payment, leaving the pharmacy to reconcile with the dialysis facility after the fact. PAAS National® already sees these types of retroactive, COB audits when claims were billed to Part D but “should have” been billed to Part A for patients residing in a nursing home on a covered stay.

Phosphate binders remain coverable under Part D for other medically accepted indications for patients not on dialysis for ESRD. Pharmacies may want to obtain (and document) diagnosis codes to support these claims.

Numerous organizations, including NCPA, the American Society of Consultant Pharmacists (ASCP), and the American Society of Nephrology (ASN) provided feedback to CMS that this change in payment policy will negatively affect patients as many dialysis facilities do not have an in-house pharmacy and may supply these medications without the expertise of a pharmacist.

PAAS Tips:

  • Educate billing staff about the likely rejects for phosphate binder medications for Part D patients
  • Coordinate with dialysis facilities to ensure continuity of patient care and payment for pharmacy services

2024-2025 Self-Audit Series #12: Electronic Prescriptions

This month’s article will wrap up the 2024-2025 Self-Audit Series. Our focus for this article is electronic prescriptions and their potential audit risks. Electronic prescriptions have solved some problems (e.g., indecipherable handwriting), but have also created new problems. By focusing on the following tips when reviewing your electronic prescriptions, you can help prevent significant recoupments.

Be sure any clarifications are clearly documented with these four elements: date, name and title of who you spoke with, what was clarified, initials of who made the call. This information must be accessible to the auditor upon audit.

PAAS Tips:

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  • 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.
  • 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.
  • 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

Caremark Bulk Purchase Notification

Did you make any “bulk purchases” of inventory in December 2024? If so, then you must act now to protect against a Caremark invoice audit that could happen in 2026!

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Remember that a future invoice audit from Caremark could cover purchases made between 02/01/2025 – 01/31/2026 which means that any purchases made during December 2024 will NOT be credited unless you provide notification to Caremark within 21 days after the purchase.

Section 8.05 of the Caremark Provider Manual outlines the requirement to provide notification of these bulk purchases for audit purposes – you must notify Caremark via mail or email as outlined below:

  1. Pharmacy NCPDP
  2. Contact email address
  3. Drug name
  4. NDC
  5. Total quantity purchased
  6. Name of wholesaler used

Email:   PharmacyAudit@CVSHealth.com

Mail:    

CVS Caremark
Attn: Bulk Purchase Notification, MC 020
9501 E. Shea Boulevard
Scottsdale, AZ 85260

Pharmacies do not need to include cost information when submitting. Some pharmacies have received a notification back stating that their purchase was “routine in nature” and would not be considered a bulk purchase, but PAAS would encourage pharmacies to continually inundated/notify Caremark and document these responses as they could become relevant (and useful) in an audit situation.

PAAS Tips:

  • PAAS National®® recommends keeping record of both your submission and any responses received from Caremark in the event of a future audit.
  • Watch the June 15, 2022 on-demand webinar Caremark’s Bulk Purchasing Requirements for more background information

PREP Act Extended Through 2029!

Good news! The Public Readiness and Emergency Act (PREP Act) did not expire at the end of this year, according to a declaration published on December 11, 2024, by the U.S. Health and Human Services (HHS). The declaration has extended the authority for pharmacists, pharmacy interns and pharmacy technicians to administer vaccines and test patients for COVID-19 through December 31, 2029.

Per HHS Secretary Xavier Becerra, “COVID-19 continues to present a credible risk of a future public health emergency…Continued coverage under the PREP Act, as provided in this Declaration, is intended to prepare for and mitigate the credible risk presented by COVID-19. This includes extending the time period for PREP Act coverage for licensed pharmacists, pharmacy interns, and qualified technicians, which allows for continued access by the recipient Population to Covered Countermeasures that are COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests”.

Included in the amended Declaration, Secretary Becerra recognizes the impact that pharmacies have had in mitigating the effects of the PHE, asserting “As stated in prior amendments to this Declaration, licensed pharmacists, pharmacy interns and qualified pharmacy technicians are well positioned to provide continued access to Covered Countermeasures, particularly in certain areas or for certain populations that have too few primary-care providers or that are otherwise medically underserved. As of 2022, nearly 90 percent of Americans lived within five miles of a community pharmacy. During the COVID-19 pandemic, the majority of Americans have received their COVID-19 vaccines and tests from a pharmacy. In addition, continued access by the Population to seasonal influenza vaccines mitigates risks that seasonal influenza infections, in conjunction with COVID-19 infections, could overwhelm healthcare providers.”

For more details on the extension of the PREP Act, you can read the published declaration on the Federal Register. Due to this extension, the November 2024 Third Amendment to the PREP Act Expiring Soon! is now outdated.

PAAS Tips:

Are You Willing to Risk Recoupment for Missing DUR and SCC Documentation?

Pharmacies often work in a fast-paced environment with an increasing workload as we see stores closing, more transfer-ins, and higher patient demand. This results in an increased urgency to perform data entry faster, which can lead to the use of override codes to get the claim adjudicated quickly. PAAS National® is here to remind pharmacies to proceed with caution when handling clinical drug utilization reviews (DURs) and submission clarification codes (SCCs). Lack of proper documentation supporting the use of DURs and SCCs can result in audit recoupments.

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DUR messages are designed as a warning to avert potential patient harm and require pharmacist intervention before proceeding. These are the more obvious DURs to spot and handle. Soft DURs can be easily overlooked but still require thorough review. For example, a DUR indicating the prescription was filled at another pharmacy should generate questions regarding current therapy or possible duplicate therapies the patient may be unaware of.

SCCs might be necessary to use when a patient is requesting a refill due to an upcoming vacation, lost or stolen medication, or a change in therapy. Some PBMs are known for auditing high dollar claims with override codes, like Express Scripts and Prime Therapeutics. Auditors are looking for documentation, including rationale on the prescription, when the override codes are used, but what does this mean? Below is an example of appropriate DUR and SCC documentation.

DUR Documentation: HD/M0/1B – Verified with Dr. Jones they are aware this is a high dose/Told to fill prescription as is/Pharmacist’s initials/date

SCC Documentation: SCC 03 – Susan is going on vacation to Italy from 01/06/2025 to 01/20/2025 & requires a vacation supply of medicine/date

Simply documenting the override codes utilized does not provide the auditor with the explanation of why it was appropriate to use. When under audit, be sure to make all clinical notes visible for the auditor. Rescan hard copies into your pharmacy software system when handwriting notes if necessary; this can help ensure the notes will not be missed when under audit.

PAAS Tips:

  • A full clinical note should have four elements:
    • Date
    • Name and title of person you spoke with
    • What was discussed
    • Initials of who made the call
  • Professional service code “M0” requires consultation with the prescriber and a supporting clinical note
    • Consider other professional service codes like “MR” (Medication Review) or “R0” (Pharmacist consulted other source) if “M0” is not applicable
    • Rationale for these codes is still required to be documented
  • Vacation overrides should include documentation of where the patient will be and the dates they will be gone documented, as shown in the example above
  • If referencing a clinical note from a previous prescription, the full note should be carried over to the new prescription
  • Use professional judgement for when a follow-up with the prescriber is necessary to ensure the validity of the DUR code submitted and update when appropriate
    • It’s good practice to reconfirm at least once per year, or when there is a change in therapy or prescriber

Vaginal Creams: Why 30 Days’ Supply Is Probably Not Appropriate

Topical medications like creams and ointments are always a target for PBMs to audit, but lurking in those topicals is a bullseye that PBMs are always aiming for – vaginal creams. Estrace® and Premarin® are easy targets due to the variety of discrepancies that could be found when auditing.

The most common error PAAS National® Analysts come across when reviewing vaginal cream prescriptions is …

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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

PBM Prescription Validation Requests – What Are They Looking At Now?

The July 2024 PAAS National® Newsline article, What’s New with Prescription Validation Requests in 2024? compared the top five drugs targeted in the first six months of 2024. The chart below shows the top drugs picked for claim reviews in the second half of 2024, and a recap of the first half of 2024.

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July-December 2024January-June 2024
Ozempic®Ozempic®
Trelegy ElliptaNurtec®
Eliquis®Mounjaro®
EpinephrineCreon®
Creon®Ubrelvy®

As you can see (and probably not a surprise), Ozempic® is the top drug reviewed through all of 2024. Additionally, you can see how the PBMs shift their focus on which drugs they select to perform claim reviews on.

The top 5 comments noted by an analyst after claim review for the second half of 2024 are the same 5 from 2023:

  1. Document the reason for the cut quantity – auditor will want to know why the pharmacy dispensed less that what was prescribed
  2. Black out acquisition cost and/or profit margin values on the backtag
  3. A clinical notation is needed and requires 4 elements: Date, who you spoke with and their title, what they confirmed, and the pharmacy employee initials
  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 attached, typically requested by the PBM and helpful for PAAS to review the billing elements

PAAS Tips: