Missing PBM Audit Notifications: How Are They Supposedly Sent?

At times, pharmacies fail to receive audit notifications, even though PBMs record them as “successfully” delivered. Thus, understanding how PBMs communicate with pharmacies can be beneficial. Here, we will examine the communication methods outlined in each major PBM provider manual:

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Caremark

Caremark’s Provider Manual states “notices will be delivered in person by mail, via fax the Provider’s fax number or by email via the email address provided by Provider in Provider’s enrollment documentation or as otherwise indicated by Provider to Caremark and agreed to by Caremark or via Pharmacy Portal.” It goes on to say that it is the responsibility of the provider to notify Caremark when contact information needs to be updated. There can also be times when Caremark will communicate via phone to pharmacies, most commonly seen with desk audits.

OptumRx

OptumRx’s Provider Manual states “Provider understands Administrator relies on the information about its Provider, as well as each Pharmacy location provided by NCPDP and directly to Administrator, therefore, Provider: (1) Agrees to update in a timely manner all information in the NCPDP database whenever … and (2) Immediately notifies ORx and NCPDP of updated contact information at pharmacyprograms@optum.com,including changes in telephone numbers, fax numbers, email address.” In addition, it states OptumRx may communicate via telephone, mail, fax, and/or email when it comes to conducting their audits.

Express Scripts

Express Script’s Provider Manual states “All changes to Provider demographic information for independent Network Providers must be submitted by logging onto https://www.esiprovider.com and completing the online Change of Demographics form. Provider shall also submit updated demographic information directly to NCPDP and/or any other third party website as applicable”. It also states Express Scripts will communicate via fax, email, or USPS when initiating an audit.

Prime Therapeutics

Prime Therapeutics uses the information pharmacies input to their NCPDP profile as their sole means of communication. In the Provider Manual, it states to go directly to the NCPDP’s website https://online.ncpdp.org to submit changes. Prime Therapeutic’s system will incorporate all new NCPDP updates on a weekly basis.

Humana

Humana’s Provider Manual states “[Humana] will notify all pharmacies via traditional mail (UPS or certified mail). If you prefer to be notified via email, we can send letters via secure message. To notify HPSX of your notification preference, please send an email to pharmacyaudit@humana.com.”

Elixir

Elixir also utilizes NCPDP to elicit pharmacy contact information. The Provider Manual states “Independent pharmacies are required to maintain NCPDP Part I and II with accurate and current information at all times as Elixir utilizes this information during its review.” Furthermore, the provider manual states “email is the preferred method for Pharmacy communications by Elixir. Pharmacies will be notified of any audit communications via fax unless the Pharmacy FWA Department has been notified of email preference”. The email to communicate an update in audit communication preference is PharmacyAudits@elixirsolutions.com

PAAS Tips:

  • Update your safe sender list and/or junk mail to ensure any audit notices sent via email are received
  • Educate pharmacy staff to watch faxes and email carefully for any PBM communications – tossing an audit can be costly
  • Consider using an electronic/paperless fax system that records/retains all incoming faxes
  • Ensure your pharmacy’s NCPDP profile is kept up to date as this is a primary means for many PBMs to gather pharmacies’ contact information – this should be updated whenever a change occurs
    • Designate an email address that is routinely monitored to avoid missing timely audit communications

2024 Self-Audit Series #4: Transferred Prescriptions

Making sure your transferred prescriptions are complete can be one of the easiest audit recoupments to prevent.

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Each state’s Board of Pharmacy outlines in their laws what is required to be included on a transferred prescription, and auditors love to identify missing information and marking the claim discrepant. Pharmacies should educate themselves on the individual requirements to avoid big recoupments during audit.

Transferred prescriptions can easily be targeted for audit based on the origin code billed on the claim. High dollar claims with an Origin Code of 5 have an increased likelihood for audit. Consider utilizing this information to self-audit your transferred prescriptions on a regular basis.

PAAS Tips:

  • Do not assume faxes you receive from other pharmacies are complete, missing requirements only affect your claims during an audit
  • Refresh your staff’s knowledge with your state’s current prescription transfer laws
  • Consider creating or utilizing transfer prescription blanks that include all required elements for your state
  • When using software transfer fields, consult with your PMS vendor to ensure all information is included and be sure to include this “screen shot” during audit
  • Run internal reports on a regular basis to review your transferred prescriptions
  • Be sure written dates are entered correctly to avoid filling past expiration
  • Always double check that quantities and refills are entered accurately to avoid billing over what is remaining on the prescription.
  • Origin code “5” should be billed for all transferred prescriptions.
  • Contact PAAS National®® analysts with questions or concerns on your transferred prescription, info@paasnational.com or (608) 873-1342.

OptumRx Continues to Cause Headaches!

PBMs monitor, and flag, migraine medications due to excessive cost, quantities submitted, days’ supply (and/or frequency of refills) and vague instructions. OptumRx often flags …

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“as needed” migraine medications with “Prescription lacks specific, calculable directions (use as directed or missing directions).” While this discrepancy may be appealable with a prescriber statement containing a maximum daily dose (MDD), the MDD may not support the quantity and days’ supply billed on the claim. To avoid this headache, and lessen your audit risk, follow the PAAS National®® tips below to ensure you have a compliant prescription prior to billing and dispensing.

PAAS Tips:

  • Confirm the dosage form prescribed is clearly indicated as many migraine medications come in multiple forms – oral, oral disintegrating, nasal spray, injectable
  • Vague instructions for use such as “Use as Directed” and “as needed” should always be clarified
  • Call the prescriber to verify the frequency of headaches per month on “as needed” migraine prescriptions and document a clinical note
    • A clinical note should contain the date, name and title of individual providing information, what was confirmed and the pharmacy staff initials
  • Review product labeling to identify the maximum daily/weekly/monthly dosing and have supporting documentation on the prescription if billing outside the maximum dose
  • More information about migraine prescriptions can be found in the archive Newsline articles

Pharmacy Owner’s Involvement in Fraud Scheme Leads to 4-Year Prison Sentence

The Department of Justice recently announced the sentencing for a New York pharmacy owner. A four-year prison term, three years extended supervision, and paying back restitution of more than $6 million dollars, is the outcome for this owner based on his involvement in a Medicare and Medicaid fraud scheme.

Investigators from the Federal Bureau of Investigation, the Office of Inspector General, and the U.S. Department of Health and Human Services discovered Medicare, Medicaid, and private insurance companies paid approximately $5.2 million dollars in fraudulent HIV claims to this pharmacy from 2021 to 2022.

The pharmacy owner was paying illegal kickbacks to low-income HIV patients if they would fill their expensive medications at his pharmacy. Part of this scheme was to repurchase (back from the patients), the unopened bottles of the expensive medications at a fraction of their actual value. These medications would then be “re-used” over and over, while never actually being dispensed to the patients.

The investigation also discovered the pharmacy owner was unlawfully selling pharmaceuticals to other pharmacies that had been obtained from illegal sources.

Ensure your pharmacy has a robust Fraud, Waste and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act and the Anti-Kickback laws. Contact PAAS National®® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web based and customized for your pharmacy.

Audit Risk: Billing DAW 1 Unnecessarily

In a time where every aspect of prescriptions is scrutinized, PAAS National® wants to ensure you don’t forget simple filling and billing practices; in this case, using DAW 1 appropriately. PBMs can flag pharmacies who use a high volume of DAWs (other than zero), increasing your pharmacy’s audit risk. A simple way to decrease the amount of non-DAW 0 claims that are being adjudicated is to …

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not use DAW 1 for single-source brand products, reference products without an interchangeable biosimilar, and medical supplies (e.g., test strips, lancets, and glucose meters).

This includes situations where the prescription comes to your pharmacy indicating “Dispense as Written” per prescriber. The best practice in those scenarios would be to contact the prescriber and inform them a DAW 1 is not appropriate since there is no product on the market deemed to be substitutable. Subsequently, make a full clinical note on the hardcopy with the date, name and title of the person you spoke with, a recap of the conversation, and your initials.

If there are questions regarding proper DAW use, refer to the DAW Codes Explained tool, which can be found under the “Proactive Tips” section on the PAAS Portal.

PAAS Tips:

  • The two most common Reference Product biologics with an interchangeable biosimilar on the market are Lantus® and Humira®

Diagnosis Restricted? Documentation Required!

PAAS National® is starting to see more audit recoupments on claims where a diagnosis code was required at adjudication but there was no documentation on the hardcopy to support the diagnosis code billed. PBMs may prompt pharmacies to enter a diagnosis code on claims when the medication billed is only covered for certain indications, helping to take the guesswork out of coverage limitations.

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Common diagnosis restricted drugs include GLP-1 (e.g. Trulicity®, Ozempic® and Mounjaro®), Nuedexta®, stimulants/ADHD medications, and Naltrexone. It is important to ensure the diagnosis code is present on the prescription or verified with the prescriber and a clinical note added to the prescription if you are prompted to enter a diagnosis code during claim adjudication. Do not process prescription claims for an assumed diagnosis code. Without any documentation to support the diagnosis code entered, the claim is likely to be flagged for recoupment if audited. Repeat prescriptions with a prior diagnosis code can likely be deferred to professional judgment but should have the diagnosis code (with a clinical note) transferred onto the new hardcopy to avoid audit trouble.

PAAS Tips:

  • Ensure diagnosis codes are properly documented on a prescription if entering them during claim adjudication
  • Entering a diagnosis code during adjudication, without PBM promoting, does not guarantee that a diagnosis is covered
    • In other words, PBMs ignore the diagnosis code field unless the PBM/Plan Sponsor requires it
  • Clinical notes should contain the date, name and title of who you spoke with at the prescriber’s office, a summary of the discussion, and your initials
  • Send all audit notices to PAAS for expert assistance. Pharmacies can securely upload files on the Member Portal under “Access Services

2024 DMEPOS Series #4: Surgical Dressings

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

In particular, you should be able to show the following if audited on surgical dressings:

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  • Standard Written Order (SWO)
    • A new order is required every 3 months for each qualified dressing dispensed, or sooner if the quantity required increases
  • Medical Records must support the surgical dressings are required for one of the following:
    • Treatment of a wound caused by, or treated by, a surgical procedure, or used after debridement of a wound
    • Initial wound evaluation must include:
      • Type, location, number, and size of qualifying wounds (L x W and depth)
      • Amount of drainage
      • Frequency of dressing change
    • Ongoing wound evaluation (weekly or monthly)
    • Specific dressing coverage criteria (in addition to meeting the criteria for qualifying wound)
    • Covered diagnoses can be found in the Local Coverage Determination (LCD) and Policy Article
  • Proof of Delivery
  • Proof of Refill Request and Affirmative Response
    • Required if delivered or mailed

PAAS Tips:

PAAS Audit Assistance members can search the Newsline archive for keyword “DMEPOS series” to read previous articles in this series. If you have any questions on accessing the Member Portal, or need help adding employees so they have access, please contact us at (608) 873-1342 or info@paasnational.com and our staff can assist you.

Do I Need to Consider Beyond Use Dating for Multi-dose Vial Medication?

The answer is YES! Multi-Dose Vials (MDV) for injection have Beyond Use Dates (BUD) that need to be followed. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer’s original expiration date. Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed.

The MDVs typically contain an antimicrobial preservative to help limit the growth of bacteria; however, over time, sterility can be impacted. All MDVs for injection will have a beyond use date – in some cases it is specifically identified in manufacturer labeling, in other cases it is not specified. If not specified, pharmacies will need to refer to The Joint Commission guidelines to assign BUD for multi-dose vials (explained below). Pharmacies should use the shorter date (beyond use OR days’ supply calculated per the instructions) when considering what days’ supply to submit (and corresponding refill intervals). Refer to the latest PAAS National® Insulin Medication chart for BUD information for various insulin vials. Remember that each insulin vial has its own BUD!

Example 1: Lantus® vial, 10 mL: Inject 20 units q HS = 1000 ÷ 20 = 50-day supply but should be discarded 28 days after opening (first needle puncture)

Example 2: Levemir®, 10 mL: Inject 20 units q HS = 1000 ÷ 20 = 50-day supply but should be discarded 42 days after opening (first needle puncture)

Here are a few common questions & answers that may assist your pharmacy in filling and billing MDVs accurately:

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Q: Do I have to bill the correct days’ supply if it pushes the patient into a 2-month copay?

A: Most likely yes; if you are contracted for an extended days’ supply plan you must bill an accurate days’ supply. If the patient isn’t happy about their copay, pharmacy staff, or the patient, could try to call customer service in an attempt to obtain a copay override (since they are not getting a full 2 months). The pharmacy must submit the days’ supply as supported by the instructions for use and beyond use dating unless given specific approval in advance from the PBM help desk. Don’t forget to document any help desk calls using the 4-element clinical note format on the prescription hardcopy.

Q: When should multi-dose vials be discarded?

A: Medication vials should always be discarded whenever stability or sterility is compromised or cannot be confirmed. In addition, The Joint Commission recommends the following for multi-dose vials of sterile pharmaceuticals:

  • If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial
  • If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer’s expiration date

PAAS Tips:

  • Always bill for the exact days’ supply as many plans have days’ supply overrides built in for certain medications
  • If no override is available, bill for the plan limit and document ILQ (Insurance Limits Quantity) – see Proactive Tips Can You Bill It as 30 Days on the PAAS Member Portalunder ‘Proactive Tips’
  • Document on hard copy – billed as 28-day supply due to The Joint Commission guidelines (when appropriate)
  • Counsel patient on the BUD – put BUD on patient label

Why You Should Care About PBM Provider Manuals (and Where to Find Them)

Whether your pharmacy contracts directly with a PBM or the agreements are negotiated through a Pharmacy Services Administrative Organization (PSAO), the terms and conditions within the agreements are just the beginning of a pharmacy’s obligations. Additional expectations for the pharmacy are laid out in the PBM’s Provider Manual. Understanding and following the stipulations contained therein can help decrease your risk of audit recoupments and keep the pharmacy in good standing. However, these manuals vary significantly by PBM, often exceed 150 pages, and can get updated multiple times throughout the year – making it impossible for pharmacies to keep up with all the requirements. Making matters worse, PBMs do not accept a plea of ignorance and violating the provider manual can lead to claim recoupment, accusations of fraud, waste, or abuse, and even contract termination!

Through our Newsline and audit assistance, PAAS National® helps pharmacies stay abreast of these changing requirements as they relate to audits. To access the Provider Manuals directly, follow the links below: 

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  • Caremark produces (and mails) a biennial version to all contracted pharmacies on even years and supplements on odd years. An electronic copy can also be found on the pharmacy provider website (log in required).
  • Express Scripts tends to update their manual periodically throughout the year and they post the newest version online in the Pharmacist Resource Center (log in required) along with an itemized list of updates. Reviewing the itemized updates is an efficient way to stay on top of the changes Express Scripts implements.
  • Humana publicly posts their provider manual online on the Pharmacy Manuals and Forms page of their website.
  • OptumRx updates their provider manual several times throughout the year and has a copy publicly available under the Manuals and Guides section of their Health Care Professionals website.

PAAS Tips:

  • Be proactive and read PAAS’ Newsline in its entirety each month
    • The paper Newsline only contains half the content that PAAS produces each month – be sure to log-in to the PAAS Portal to view additional articles and PAAS Tips
    • Add additional employees to the PAAS Portal to increase eNewsline readership and ensure that small details don’t get missed
  • Have questions about a specific topic and don’t know where to start? PAAS analysts can guide you through the PBM requirements and refer you to appropriate sections of the PBM’s provider manual, when applicable

OptumRx Auditing for Medical Supplies Billed Under Medicare Part D

In March 2024, PAAS National® analyst assisted nearly 100 pharmacies with desk audits from OptumRx requesting documentation related to claims for medical supplies (primarily alcohol swabs) that were processed by OptumRx under the Medicare Part D benefit. OptumRx asked pharmacies to provide copies of insulin prescriptions as well as the associated fill histories, signature logs and explanation of payment for these insulin prescriptions dispensed between July 2019 and June 2023.

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Most pharmacies report dispensing no insulin to the patients in question and explained that the alcohol swabs were being used in conjunction with diabetes testing supplies (test strips, lancets) that were also billed to OptumRx. Since OptumRx covered the cost for diabetes testing supplies, it would suggest that patients were enrolled in a Medicare Advantage (MAPD) plan and OptumRx incorrectly categorized the alcohol swab claims as “Part D” when they should have categorized as “Part B”. The OptumRx audits seem to stem directly from a nationwide CMS audit of Plan Sponsors initiated in December 2023. During this audit, CMS scrutinized Part D claims for medical supplies, such as alcohol swabs, in cases where patients lacked any claim history for insulin use.

The coverage of insulin and its related supplies may vary depending on the Medicare benefit type and the intended use of the item. Specifically, insulin vials and alcohol swabs could be eligible for coverage under either Medicare Part B or Part D.

Keep in mind that Medicare patients could have prescription and medical benefits that are separate or combined.

  • Separate: standalone medical benefit Fee-for-Service (FFS), also known as “Original Medicare” + stand-alone pharmacy benefit through a Part D Plan (PDP)
  • Combined: medical and pharmacy benefit under one roof (sometimes called Medicare Part C) through Medicare Advantage (MAPD) Plan

Here is a chart to help you identify the correct payer depending on the type of Medicare benefit and the item in question.

  Pharmacy Medical Combined
Medicare Part D (PDP) Original FFS Medicare

(Part B/DMEPOS)

Medicare Advantage

(MAPD)

Insulin supplies
Insulin pen Yes No Yes
Insulin vial for self-administration Yes No Yes
Insulin vial for DURABLE pump1 No Yes Yes
Insulin vial for DISPOSABLE pump2 Yes No Yes
Insulin syringes Yes No Yes
Alcohol Swabs for Part D insulin3 Yes No Yes
Alcohol Swabs for glucose testing No Yes Yes
Alcohol Swabs for any other use No No No
Testing Supplies
Test Strips No Yes Yes
Lancets No Yes Yes

A few nuances to keep in mind:

  1. Generally, insulin used in a DURABLE pump is covered under Medicare Part B, unless patient does not meet coverage criteria. See PAAS Newsline article, Billing Insulin for a Pump is Tricky, Especially for Medicare Patients for more details.
  2. Insulin used in a DISPOSABLE pump such as V-Go® or Omnipod®
  3. Alcohol swabs are only covered under Part D when used for the injection of insulin according to Section 10.5 from Chapter 6 of the Medicare Prescription Drug Benefit Manual. Additionally, PBMs are likely to audit for high AWP alcohol swabs or when used in excess (i.e., if patient is to use both “before and after” injection). See PAAS Newsline article, Why Would Anyone Audit Alcohol Swabs? For more details.

 PAAS Tips:

  • If you are unsure about a patient’s Medicare coverage (PDP vs MAPD), then ask to see a copy of their card and look for “MAPD” or “Medicare Advantage” wording, or call the patient help desk if needed
  • If a Medicare patient presents a prescription for insulin vials, clarify if self-administered or used in a pump