PBM Communications to Network Pharmacies Can Help Prevent an Audit!

PAAS National® knows community pharmacies are busier than ever, making it difficult to keep up with all the PBM communications. Just as PAAS provides monthly Newsline articles to keep our members up-to-date on current PBM trends and audit tactics, the PBMs also have resources to communicate with network pharmacies. Below are PAAS tips outlining which PBMs send out communications, how often they are sent and a link to their website or login page. These resources often give insight on audit targets and network compliance issues.

PAAS Tips:

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  •  Caremark
    • Sends out memos when applicable and relevant
    • These memos are not publicly available, pharmacy must log into the portal for access
    • https://rxservices.cvscaremark.com/
  • Elixir
    • Bi-annual “Pharmacy Audit Whisperer” bulletin to network pharmacies
    • The most current audit whisperer from April 20, 2023, has a Medicare Part D focus and advice on how to maintain pharmacy compliance by ensuring claims billed to Part D are prescribed for a medically accepted indication and not being used off label
    • https://www.elixirsolutions.com/providers
  • Express Scripts
    • Sends out communication letters when applicable and relevant
    • These letters are not publicly available, pharmacy must log into the portal for access
    • https://www.esiprovider.com/gen/express-scripts/index.cfm?cmd=1
  • Humana
    • Sends important news bulletins
    • These bulletins are not publicly available so pharmacy would need to log into the portal for access
    • https://account.humana.com/
  • MedImpact
    • Send messages about billing guidance and regulatory/program notices
    • These letters are not publicly available, pharmacy must log into the portal for access
    • https://pharmacy.medimpact.com/
  • Navitus
    • Spring and Winter Pharmacy Newsletter
    • Monthly network bulletins
    • These are not publicly available; pharmacy would need to log into the portal for access
    • https://pharmacies.navitus.com/
  • OptumRx
    • Monthly RxHighlights discussing recaps of new brand and generic drug approvals, revised drug indications or label updates, safety, recalls, withdrawals, shortages, new or revised treatment guidelines or recommendations
    • https://professionals.optumrx.com/publications/rx-highlights.html
  • Prime Therapeutics
    • Bi-Annual (June and December) pharmacy newsletters that provide information and updates about Prime services
    • The June 2023 letter discusses FWA updates for diabetic medications used for weight loss
    • https://www.primetherapeutics.com/resources/prime-perspective-newsletters/

PBM’s expect their network pharmacies to be familiar with the topics and information they provide and will hold you accountable for network compliance. PAAS will help keep you up to date on relevant communications, but should you receive any direct PBM communications (via email or fax), be sure to forward them to PAAS for review.

OMIG compliance reviews are happening now – this includes independent pharmacies!

PAAS National® has started to see New York State Office of the Medicaid Inspector General (OMIG) conducting reviews on pharmacies to evaluate if they have a compliance program that meets the new requirements of Social Services Law 363-d and 18 NYCRR Part 521.

As of March 28, 2023 there are NEW requirements. If your current program has not been updated to reflect these changes, you are not compliant.  

Avoid potential sanctions (including termination of your provider status) by joining the PAAS FWA/HIPAA Compliance Program.

PAAS has worked extensively to make sure our program meets NY Medicaid requirements! A typical pharmacy can have a fully customized compliance program up and running with only a few hours’ setup and general upkeep. PAAS also provides exceptional customer service, with pharmacists and technicians to help answer your questions about compliance related issues and guide you through a NY OMIG compliance review.

It’s NOT TOO LATE to get compliant! Ensure you have all your compliance bases met and attest with confidence.

Current members

If you receive a notification letter, please reach out to us to get customized guidance from an expert analyst, info@paasnational.com or (608) 873-1342 and we will guide you through a NY OMIG compliance review.

Social Media Mishap Leads to $30,000 Fine for Health Care Provider

When used correctly, social media can be a great tool for sharing the unique services your pharmacy has to offer patients and local community. However, be very cautious about what information is posted on social media because one slip up could land your pharmacy in the crosshairs of an Office for Civil Rights (OCR) investigation.

According to a U.S. Department of Health and Human Services press release on June 5, the OCR opened an investigation after a patient filed a complaint against a New Jersey health care provider specializing in adult and child psychiatric services, alleging the provider improperly disclosed protected health information (PHI). According to the press release, the patient claimed that the health center “posted a response to the patient’s negative online review that included specific information regarding the individual’s diagnosis and treatment of their mental health condition.” During the OCR’s investigation, improper disclosure of three additional patients’ information was found in responses to negative online reviews. To settle the complaint, the health care provider agreed to at least two years of monitoring by the OCR, to pay $30,000, and a corrective action plan (including written policies and procedures to meet the HIPAA Privacy Rule, providing additional staff training, issuing individual breach notifications, and issuing a breach notification to the Secretary of Health and Human Services).

PAAS Tips: 

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  • Ensure all social media posts are compliant with the HIPAA Privacy Rule
    • Restrict user access to pharmacy social media accounts to trusted personnel with a clear understanding of HIPAA privacy rules
    • Use extreme caution when responding to online reviews
  • PAAS Fraud, Waste and Abuse and HIPAA Compliance members can read section 11.11.5 of their Policy and Procedure Manual for more information regarding Physical Safeguards such as Facility Access Controls; specifically, social media
    • Do not permit any unauthorized video/audio in the pharmacy area
    • Train staff on methods to mitigate video and/or audio PHI breaches
    • Investigate, resolve, and document any potential HIPAA violations (all documents related to HIPAA must be maintained for a minimum of six years from the last effective date)
  • Refer to the June 2020 Newsline article, Smartphones put Pharmacies at Risk for Inappropriate PHI Disclosures for an additional discussion about protecting PHI

NEW PAAS Tool Available – The Insulin Flow Chart You NEED to Download Today!

Our PAAS National® Analyst team is at it again! A new tool has been developed to address and correct a common audit recoupment issue. Insulin remains at the heart of nearly all audits. Pharmacies often face recoupment for undocumented substitution (of non-interchangeable biologic drugs), dispensing more than the plan limit, billing an incorrect days’ supply (resulting in a subsequent early refill) and recoupment for non-calculable directions. In the May 2023 Newsline article, Insulin For a Pump: The Recoupment You Never Saw Coming, PAAS reminded pharmacies about a very different discrepancy seen on audit results—incorrectly billing insulin for a pump.

There is a complicated series of questions which must be answered when billing insulin, for patients who qualify for Medicare, to determine which of the patient’s Medicare benefits is the proper payor. Even pharmacies not enrolled to bill Medicare Part B [for insulin for a pump] need to go down this proverbial rabbit hole to determine the correct payor. Insulin claim(s) billed inappropriately to a patient’s Medicare Part D benefit could be fully recouped upon audit.

The new tool, Considerations for Billing Insulin Vials, provides a flow-chart of questions for pharmacy staff billing and verifying insulin. Designed as a quick reference guide for staff, it provides four pivotal questions used to determine if Medicare Part D or Part B is the appropriate payor. Visit the Proactive Tips section of the PAAS Member Portal to download a copy of this new tool today! 

 While on the website, check out PAAS’ Upcoming Events for locations you can find us. Stop by our booth to say “hi” and pick up our new 5×7 inch, Considerations for Billing Insulin Vials magnet and laminated Dispense in Original Container Chart!

Humana Provides Update on GLP-1 Prescriptions

PAAS National® has recently become aware of an update Humana published regarding new point-of-sale edits for specific medications. Included in this list are GLP-1 agonists.

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Effective June 2023, Humana commercial, Medicare and Medicaid plans will now require diagnosis codes at point of sale in hopes of eliminating the “clinical misuse” of certain medications. Pharmacies can find this information posted on the Humana website under the Pharmacy Resources tab.

Be aware that a diagnosis field is likely not reviewed by the PBM unless the plan requires it on claim submission. Entering in a diagnosis code and receiving a paid claim does not affirm plan benefit design nor guarantee coverage.

Audit Risks with Schedule II Laddered Prescriptions

Pharmacies receiving laddered Schedule II prescriptions must be aware of the DEA requirements and potential audit risks. Missing these requirements can lead to Federal law violations and PBM audit recoupment.

Laddered prescriptions are multiple prescriptions written on the same date for current and future fills. Since Schedule II prescriptions cannot be refilled, the DEA has allowed prescribers to issue multiple prescriptions totaling up to a 90-day supply if all requirements have been met.

Requirements included in 21 CFR §1306.12:

  • Prescription must be issued for a legitimate medical purpose
  • Other than the initial prescription, the prescriber must include written instructions of the earliest fill date
  • Prescriber must believe that issuing multiple prescriptions is not an increased risk of diversion or abuse
  • Prescriptions must comply with all applicable state laws and regulations

PAAS Tips:

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Billing Tips for Dexcom G6®

Dexcom G6® sensors, transmitters, and receivers continue to be audit targets. Pharmacies have faced recoupment on their Dexcom G6® claims for billing an incorrect days’ supply, refilling the item too soon, and for having vague directions. The proper quantity and days’ supply can be found in the table below, along with suggested instructions. Following these billing guidelines will help decrease the risk of recoupment on the Dexcom G6® continuous glucose monitor and supplies.

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Dexcom G6® Item NDC NCPDP Billing Quantity
(unit of measure)
Suggested Day Supply Suggested Instructions
Receiver 08627-0091-11 1 each 365 days Use receiver to check blood sugar; replace yearly
Transmitter 08627-0016-01 1 each 90 days Use transmitter to check blood sugar; replace every 90 days
Sensors
(3 sensors/box)
08627-0053-04 3 each 30 days Use sensors to check blood sugar; replace every 10 days

PAAS Tips:

  • Always double check the directions on each Dexcom G6® item to ensure they are specific enough for an auditor to determine the correct days’ supply
  • If there is an insurance plan limit which prevents the pharmacy from billing the true days’ supply for the transmitter or receiver (i.e., 30-day plan limit), PAAS analysts suggest adding the true days’ supply to the patient instructions to help patients and pharmacy staff recognize how long the item should last which can help prevent future claims from being billed too soon

Off-Label Use Beyond GLP-1

GLP-1 medications being used off-label for weight loss, and the corresponding audit risk, has been a hot topic for awhile now, but there are other medications that PAAS National® frequently sees recoupments for when being used off-label, especially when billed to a Medicare plan.

Other medications recently recouped by Medicare Part D Plan Sponsors and PBMs include:

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  • Diclofenac 3% indicated for actinic keratosis but being used for pain
  • Pennsaid® solution 2% indicated for the treatment of osteoarthritis of the knee but being used on other body parts
  • Prenatal vitamins prescribed for non-child bearing aged women
  • Alcohol swabs not being used for insulin administration
  • Compounds using bulk pharmaceutical powders, off-label, or unapproved uses
  • Ivermectin being used for COVID-19

PBMs seem to selectively enforce these provisions, but the reality is they are pursuing easy targets with high rewards. Audits typically identify claim outliers, and expensive medications with narrow therapeutic indications increase the likelihood of an audit. Prescriptions being used within FDA guidelines are much less likely to be identified as being used off-label.

Section 1860D-2(e)(4) of the Social Security Act defines medically accepted indications for the Medicare Part D program by referencing Section 1927(k)(6). It states that a medically accepted indication is “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations include or approved for inclusion in any compendia described in Section 1927(g)(1)(B)(i)”.

When recoupments from off-label uses happen, they can be difficult to appeal. Remember to send PAAS your audit notices as soon as you receive them to have the best chance at success.

PAAS Tips:

Billing Guidance: When to Use DAW 0 vs DAW 9

PAAS National® analysts frequently see PBM audit results where auditors have flagged claims with ‘incorrect DAW code submitted’ – while these are often educational discrepancies, it is important to understand the implications of incorrect DAW code submission and develop a consistent process for pharmacy staff to follow.

A common DAW code issue found during audits (and a common question received by PAAS analysts) is how to handle claims where the plan prefers the brand name due to formulary rebates.

NCPDP explains that DAW 9 should be used when the plan prefers brand and explicitly states that “DAW 0 is not appropriate and may result in a reject”. While this NCPDP guidance is intended to standardize claims adjudication process across the industry, it would seem that real-life adoption of this standard by PBMs varies considerably.

In many cases, the pharmacy will not know if the plan prefers brand or generic until the claim submission process has started – as a result, pharmacy staff will need to be able to recognize dynamic claim reject messages and respond appropriately. PAAS recommends that pharmacies develop a step-by-step process or algorithm to handle appropriate DAW code submission.

Here is a suggested workflow:

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  1. Attempt to bill “generic” product (AB rated generic/authorized generic or interchangeable biosimilar/unbranded biologic) and submit DAW 0, unless the prescriber or patient have indicated a preference for the brand (DAW 1, DAW 2 respectively) and make note of any claim reject messages.
  2. Respond to claim reject message regarding preferred product/DAW code; if no clear information is provided, then attempt to bill for the “brand/reference” product and submit DAW 9 and make note of any claim reject messages.
  3. Only after attempting steps #1 and #2 above should pharmacy attempt to bill the brand/reference product and submit DAW 0

Here are the full NCPDP definitions for DAW 0 and DAW 9 for related context.

Code Description
0 No Product Selection Indicated – This is the field default value that is appropriately used for prescriptions for single source brand, co-branded/co-licensed, or generic products. For a multi-source branded product with available generic(s), DAW 0 is not appropriate, and may result in a reject.
9 Substitution Allowed By Prescriber but Plan Requests Brand – Patient’s Plan Requested Brand Product To Be Dispensed – This value is used when the prescriber has indicated, in a manner specified by prevailing law, that generic substitution is permitted, but the plan’s formulary requests the brand product. This situation can occur when the prescriber writes the prescription using either the brand or generic name and the product is available from multiple sources.

PAAS Tips:

  • We recommend that pharmacies have documentation to support the submission of DAW codes 1-9, consider a brief clinical note with the date, staff initials and reason for DAW code submitted.
  • Review October 2022 Newsline article, Are You Utilizing DAW Codes Correctly? Updated Tool Available! and check out the resource, DAW Codes Explained to help train your team on appropriate DAW code submission.
  • Pharmacies may want to perform internal “self audits” on their DAW claims to check for accuracy and consistency. Run a report and look for any non-zero DAW codes (NCPDP field 408-D8) to ensure you have submitted the correct DAW code AND you have appropriate documentation to support.

Insurance Limits Quantity – Common Scenarios and Pitfalls

When processing prescriptions, insurance companies require pharmacies to bill an accurate days’ supply derived from mathematical calculations obtained from the directions. Pharmacies are not typically permitted to guess on the days’ supply, or simply process as 30 days for everything.

What happens when the calculated days’ supply is larger than the plan maximum?

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In most cases the pharmacy must bill smaller quantities to meet the plan maximum. For an easy example, a prescription comes in for #90 lisinopril 10 mg tablets and directions of 1 tablet daily. The pharmacy bills #90 for a 90-day supply. The plan rejects for a maximum of a 30-day supply. The pharmacy must then rebill the claim for #30 tablets as a 30-day supply and PAAS suggests that pharmacy staff document Insurance Limits Quantity (ILQ) as a reminder for your team of why the quantity was reduced.

Another common scenario with insulin, the pharmacy receives a prescription for 30 mL of Lantus® Solostar® with directions of 90 units at bedtime. The actual days’ supply comes out to just over 33 days. If the insurance maximum is 30 days, the pharmacy should rebill this claim for 15 mL for a 16- or 17-day supply and document the reason for the cut quantity.

What if the actual days’ supply is still greater than the plan maximum when dispensing the smallest package size?

PAAS National® frequently sees this problem with HFA inhalers such as Flovent HFA. The inhaler contains 120 puffs. If a prescription received has directions of 1 puff twice daily, the actual days’ supply is 60. If the plan limit is 30 days, the pharmacy should first call the help desk for a days’ supply override. If one is not able to be given, the pharmacy can then bill a 30-day supply, document the ILQ, but MUST NOT refill earlier than the actual 60-day supply or risk recoupment from a PBM during an audit.

This last scenario causes the most problems for pharmacies. Many systems are not set up to flag these prescriptions as early and rely on notes in the patient’s profile or in the label directions to remind pharmacy staff. Be aware of the recoupment possibilities and proactively take steps to ensure that the correct days’ supply is being billed.

PAAS Tips:

  • Insulin, inhalers, topical medications, and eye drops are frequently flagged for refill too soon or overbilled quantity
  • Always submit claims with an accurate days’ supply first; many PBMs now have built-in overrides in place for smallest package sizes
  • Include a notation on the patient label to help notify patient and pharmacy staff of the true days’ supply
  • Check with your software vendor to see if additional days’ supply fields are available for internal tracking
  • Avoid med sync or cycle fill programs for products whose correct days’ supply cannot be submitted for the smallest single package size
  • Self-audit prescriptions with multiple pack sizes available for days’ supply and refill accuracy; see our Self-Audit Series of articles in our archive on the PAAS Member Portal
  • Review our Can You Bill It As 30 Days? document under Proactive Tips on the PAAS Member Portal