Are You Missing Audit Communications?

PAAS National® analysts have recently seen many PBMs and audit contractors send communications, including audit letters, to network pharmacies via email instead of facsimile or postal mail. In most cases, these emails are sent to the address on file via your NCPDP Pharmacy Profile.

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One audit contactor, Conduent Payment Integrity Solutions, sends an email that includes an “acknowledgement” box within the email that pharmacies must click on to confirm receipt of the email. If the email is not acknowledged, then Conduent will send additional communications to confirm receipt.

PAAS Tips:

  • Ensure your NCPDP pharmacy profiles are up-to-date, particularly your email address and fax number
  • Choose your preferred email address carefully – it should be an email inbox that is attended to frequently (perhaps daily)
    • Consider if the email inbox should be accessible to management only or any staff member
    • If an audit email is “acknowledged” but not escalated to the appropriate person(s), it could put the pharmacy in a bind unnecessarily

Incorrect NDC or NPI Billed? Humana Requires Corrections

Humana has recently sent out another round of audits where either an incorrect NDC number or National Provider Identifier (NPI) was billed. The claim went through the switch at the time of fill, so why is Humana auditing these claims years later, and how do they know these data fields had incorrect information?

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These are likely Medicare claims that have been found to be invalid through retroactive validation of Prescription Drug Event (PDE) records by CMS. Humana must fix the incorrect information or face recoupment if it cannot be resolved.

An incorrect NDC is found when the NDC on the claim is billed before that NDC’s marketing start date, after the marketing end date, or not on the Food and Drug Administration’s (FDA) NDC Structured Product Labeling (SPL) Data Elements (NSDE) list. A pharmacy should not have access to a specific NDC before the marketing start date. The marketing end date will be the expiration date of the last lot manufactured of that NDC, so a pharmacy should not be filling that NDC any longer if following proper out-date procedures.

An incorrect NPI is found when a pharmacy inadvertently bills a claim under the wrong prescriber or when the PBM believes the prescriber billed does not have prescriptive authority. Many times, this happens when two practitioners in the area have the same first and last name. If the NPI billed does not have prescribing authority (e.g., occupational therapist, psychologist, or registered nurse), the claim could flag for further review. Some states may allow certain practitioners to have prescriptive authority that may not be allowed in other states (e.g., certified nurse midwives). In these cases, the pharmacy must prove the practitioner has prescribing authority in the state, usually through searching a state license database.

In both of these cases, Humana wants the pharmacy to investigate what happened to correct the claim. Humana knows that the claims may be too old to be corrected by the pharmacy, so they simply want the pharmacy to write in the correct information on the Claim Detail Sheet and send it back to Humana for them to correct (i.e., figure out which NDC was in stock on that date or which NPI should have been billed).

PAAS Tips:

  • Ensure correct NDC billing – this will also help in case of an invoice audit later
  • Confirm the correct prescriber is billed – this can be educational for some audits but others will recoup
  • For more information regarding this topic, and to find the Comprehensive NDC SPL Data Elements File (NSDE), visit https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm

At Your Own Risk: “Use as Directed”

How many times have you received a prescription for a bowel prep, starter pack, or pre-packaged taper where the directions simply state, “Use as Directed?” It is common for pharmacies to receive these medications, type “Use as Directed” for the patient label, bill the most common days’ supply, and move on. Unfortunately, this practice can lead to audit recoupment since there is no mathematical way to calculate the days’ supply for the claim without further clarification.

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When receiving a “Use as Directed” prescription, you must contact the prescriber to find out if the patient is to follow the package directions or if the prescriber had directed the patient to take it in a different manner, possibly off-label. Once clarified, you can make a clinical note on the prescription and update the patient’s label with the specific directions or “use as directed per package.” These simple actions will save a lot of headaches when the next audit is sent.

PAAS Tips:

  • PBMs expect pharmacies to obtain clear and mathematically calculable directions, including starter packs and other unit of use packages
  • Prescriptions with “use as directed” instructions ALWAYS need further clarification and are an audit risk
  • Consider adding full instructions to the patient label
    • If full instructions do not fit on the label, make a copy of the instructions on the package and attach it to the prescription in case of an audit to show what was given to the patient at time of dispensing
    • If the prescriber states the patient is to use “per package instructions,” make sure this is indicated on the label
  • A specific quantity should be present on the prescription and not be assumed to be the unit of use package quantity
  • Bill the appropriate days’ supply based on the directions
  • Proper Clinical Notes include the following information:
    • Date (and preferably time)
    • Name and title of individual providing information
    • Specific information provided
    • Pharmacy staff initials
  • See the December 2022 Newsline article, What Do Bowel Preps, EpiPen®, and Migraine Medications Have in Common? for information on commonly audited medications

HHS Reports Successes in Access to Meaningful Language Assistance Services

For the first time since 2016, Health and Human Services (HHS) released a report detailing the progress made in improving “meaningful access to language assistance services” for individuals who are considered to have limited English proficiency (LEP). The report was based off of Executive Order 13985 “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” and Executive Order 14012 “Restoring Faith in Our Legal Immigration Systems and Strengthening Integration and Inclusion Efforts for New Americans”. Collectively, these orders aimed to ease access to government services (that assist in overcoming barriers in federal programs) and formulate ways to encourage inclusion and integration of LEP individuals into the American democracy. Based on the 2022 HHS Equity Action Plan, successes over the past year were detailed. There was an increased ease of access to meaningful language tools in an individual’s preferred language via websites, listserv announcements, and public outreach material, something that was crucial during the Public Health Emergency.

However, HHS did receive a complaint alleging 19 states failed to provide individuals with meaningful access to their “COVID testing, inoculation, and treatment programs.” As a result, the Office for Civil Rights (OCR) addressed the complaint by teaming up with the Department of Homeland Security (DHS) and the Federal Emergency Management Agency (FEMA) to offer webinars about the importance of language access during emergency situations.

Also included in the report was a roadmap to further equal access to meaningful language assistance services. It details a need to eliminate the barriers in accessing language in core areas, including internet and telephone access, access to programs and activities, and federal funds used to provide the needed language services.

OCR also relaunched the Department’s Language Access Steering Committee on October 11, 2022. The committee will focus on implementing goals of the Equity Plan via language access quality assessments, summarizing the report findings to the Secretary on an annual basis. There is also the creation of a HHS Language Access Coordinator position, with the goal to set up a centralized language access center hub for HHS, update and revise HHS’s 2013 Language Access Plan, and take steps to address problems identified in OCR investigations of LEP grievances filed against HHS.

This report affirms how serious federal agencies are in supporting those individuals who are considered to have limited English proficiency. Likewise, PAAS National® aims to support our members in being culturally competent in how services are provided. Inquire about PAAS’ Cultural Competency training and the PAAS Care ModelTM to ensure your pharmacy is adherent to federal requirements.

PAAS Tips:

Remember to Maintain and Provide Complete Clinical Notes!

Physical storage for keeping paper records comes at a space premium for many pharmacies. With the significant increase of electronic prescriptions, many pharmacies are choosing not to keep printed copies, where allowed by state/federal law. Pharmacies must be very diligent with electronic documentation when electronically storing their prescriptions.

PAAS National® has always recommended four elements for clinical notations:

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  1. Date (and preferably time) of the call/conversation
  2. Name and title of who you spoke with
  3. Specific details about the clarification
  4. Initials or name of the pharmacy employee making the clarification

In the past, pharmacies would simply document this information on the prescription. If the prescription was audited, this information would be readily visible for the auditor’s review. If pharmacies are not printing electronic orders, these clinical notations are still imperative, but typically documented electronically. The same four elements are recommended for electronic notes, but preferably with date/time stamped user information.

During an audit, pharmacies must review prescriptions closely for any clinical notations, and ensure they are included with their documentation. Consult with your software vendor on the best ways to utilize the electronic notes field and how to easily access if needed.

Pharmacies that print images for audits must remember that faxed, written or telephone orders may have clinical notes written on the hard copy that did not get re-scanned in. Missing these clinical notations could lead to recoupments as the auditor can only see the information provided to them.

PAAS Tips:

  • Review clinical notations for completeness
  • Implement a policy for consistency on how all clinical notations will be documented
  • Ensure prescriptions printed for an audit contain electronic notes
  • See the June 2023 Newsline article, Carry Clinical Notes Forward for Audit Coverage

Dispense in Original Container – Know the Audit Risks

PAAS National® analysts want to remind pharmacies of the audit risks when medications are dispensed outside manufacturer storage/dispensing requirements. PBMs can easily identify claims billed for a quantity that does not match the package size for a particular NDC, making them an easy target for recoupment.

Manufacturers submit storage/dispensing requirements to the FDA, which in turn appears on the package and in the package insert. These requirements may be based on light or moisture sensitivity or simply that the product has not been tested outside the original container. Pharmacies can utilize the DailyMed website to find product labeling information; however, be aware that variations in labeling precautions exists. PAAS has spoken with the FDA about inconsistent verbiage for precautions, even amongst products from the same manufacturer. While standardization would provide clarity and be helpful for all dispensing pharmacists, the FDA defers this language choice to the manufacturers.

Another twist on quantity dispensed not divisible by package size is diabetic test strips – the NDC must match what you are dispensing. Claims billed for the 100-count box, but quantity billed is not divisible by 100 (e.g., 150) can result in a partial recoupment.

PAAS has created a chart for the most common medications targeted on audit for dispensing outside manufacturer requirements. Download the Dispense in Original Container Chart from the PAAS Member Portal and access many other Proactive Tips, Days’ Supply Charts, On-Demand Webinars and additional resources that further assist PAAS members and their staff.

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, laminated Dispense in Original Container Chart and Considerations for Billing Insulin Vials magnet!

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.

Don’t wait - get started today!

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!