The Fight Against Fraud in HIV Prevention Medications
According to the Centers for Disease Control (CDC) there is a federal initiative to end the HIV epidemic by 2030. One such effort to meet this initiative is to provide these medications to at least 50% of the “population who could benefit from” these antiviral drugs. While trends show improvements in these efforts, there is uncertainty as to if the 50% goal will be met by 2025 due to prominent levels of potential fraud, waste, and abuse (FWA).
The first medication to hit the market for pre-exposure prophylaxis (PrEP) was Truvada from Gilead Sciences in 2012. Like many pharmaceutical companies and manufacturers, Gilead created a patient assistance program. However, in 2019, Gilead noticed discrepancies between patient assistance redemptions and overall sales reported by distributors. Concerns over these discrepancies led to the discovery of a scheme that included clinicians, pharmacists, prescribers, and lab technicians, and that scheme resulted in “tens of millions of dollars” in FWA.
Unfortunately, similar schemes were occurring at the same time and remain prevalent within pharmacy claims. Many of these elaborate schemes involved telemedicine services, unsuspecting patients, and patients that received kickbacks for claiming they received these medications. Efforts to avoid detection included utilizing shell companies, closing clinics and pharmacies, and opening new ones with new National Provider Identifier (NPI) and National Association of Boards of Pharmacy (NABP) numbers. Some of the schemes involving PrEP and treatment medications resulted in over $100 million in fraudulent claims. Many of those fraudulent claims that were identified came from a provider offering telemedicine services and mail order pharmacies.
Antivirals & FWA
When it comes to PrEP and other antiviral medications, the prescriber and the patient have certain responsibilities prior to administration. These responsibilities include various labs to be drawn prior to and sometimes during treatment, at regular intervals. With these types of requirements, one would think it would be difficult to submit claims with potential FWA. However, that is not the case, especially if patients and lab technicians may be colluding, as found in kickback schemes during previous fraud investigations.
Truvada is a medication that is used to “reduce the risk of sexually acquired HIV-1 infection” for adults and adolescents weighing at least 35kg (77lbs). When a patient is diagnosed with HIV-1 infection, the current standard of care is antiretroviral therapy, also known as ART. Some of those medications include Descovy and Biktarvy, which, along with Truvada, are some of the most common medications subjected to pharmacy schemes and potential FWA.
NABP credentialing requirements
If a Special Investigations Unit (SIU) and Pharmacy Benefit Manager (PBM) team has any concerns around PrEP and other antiviral medication claims, they can first check to see if the dispensing pharmacy has NABP accreditation. Obtaining this accreditation requires the following:
- Operating in the United States
- Have a current license in all jurisdictions in which business is conducted
- Having a prescription count with less than 20% of claims considered “veterinary”
- Operational in all activities for at least 30 days
- Dispense at least one prescription drug
- Have a pharmacist-in-charge (PIC)
- Compliant with State and Federal guidelines
- A website offering at least one digital practice (patient counseling, new/refill/transfer prescription requests, and/or patient portals)
While these credentialling requirements do not guarantee a pharmacy will not submit claims with potential FWA, it does reduce the chances so focus can be placed on other pharmacies and prescribers with suspicious PrEP claims.
NABP approved online pharmacies
Although a publicly accessible NABP license verification resource is unavailable at this time, the References section of this AI (Artificial Intelligence) Alert contains three URLs associated with the NABP “Find Safe Online Pharmacies” webpage. After the user clicks the URL for the ‘Find Safe Online Pharmacies’ webpage, they have an option to click the ‘Verify Before You Buy’ icon to the right of the ‘Purchase Medication from Legitimate Website’ section, which opens a different URL containing a PDF. At the bottom of the PDF is a QR code that will navigate users to an online Excel document containing 340+ NABP approved websites for online pharmacies. When the user navigates to the webpage containing the Excel document, they will be prompted to save the document. Informationally, the Excel document includes the Country of the pharmacy, NABP account name, Doing Business As (DBA) pharmacy name, and the URL for the approved website that can be copied and pasted into your preferred browser.
Notice of best practices regarding internet safety and security:
Codoxo’s experts safely clicked on, navigated to all three URLs, and downloaded the PDF and Excel file; however, our experts did not visit any of the 340+ NABP approved websites within the Excel file. For your safety, Codoxo recommends that readers of this AI Alert follow their corporate internet security policies before navigating to any website and downloading any documents, even those from a trusted online source, such as NABP or other websites in the References section.
How can Fraud Scope assist your SIU or PBM team with identifying suspicious PrEP claims?
Fraud Scope can assist SIU and PBM teams with identifying pharmacy claims associated with potential FWA using AI detectors, provider monitoring options, and query tools. Moreover, combining these options can strengthen your case and provide further insight into the practices of your pharmacy providers.
Fraud Scope’s pattern-based and deterministic detector models easily identify inconsistencies in PrEP and antiretroviral medications from filling and prescribing providers. Conveniently, all available pharmacy detectors that flagged claims during the most current reporting period in your Fraud Scope platform are on the Schemes, Pharmacy page within the Top Detection Categories widget. Moreover, every detector and the flagged claim results can be viewed at the Reason, Provider, or Patient level. Pattern-based detectors, such as Time Behavior or Suspicious Trends, identify significant changes or trends in pharmacy dispensing habits, which can be a strong signal for potential FWA. The Missing Medical Claim detector identifies instances of PrEP drugs being prescribed without required lab tests in the patient’s medical history. The High DAW 1 and 4 Claims detector identifies pharmacies with higher-than-average claim counts with a DAW code of 1 from filling or prescribing providers for Truvada, which is available in generic form.
Fraud Scope offers provider and code monitoring widgets on the Provider Dashboard within the Providers page. The three widgets are New Providers, Returning Providers, and New Utilization of Codes, all of which are powerful tools to find potentially emerging FWA threats. For example, when a provider is removed from a network, they may re-enter the network using a new NPI and NABP number or stop billing claims until they are no longer under suspicion. The New Providers or Returning Providers widget will identify those providers and flag them for review. The New Utilization of Codes widget works similarly by flagging providers who are billing new medications that they were not filling previously. If a pharmacy was submitting suspicious claims for Truvada and they received notification that the Truvada claims were flagged for audit, the pharmacy may begin submitting claims for Descovy to avoid detection and further scrutiny.
The Query Builder toolkit allows users to gather insights into pharmacy billing practices by defining the criteria important to their review at the claim or aggregate level. For example, a Query Claims Filling search to target mail order pharmacies with potentially suspicious PrEP claims is easily built by choosing the mail order specialty with filters on the therapeutic/pharmaceutical class of antiretroviral medications, specific DAW codes, and any other criteria that is material to the user’s review, such as a rejected claims indicator or metric quantity dispensed. Query Aggregates can identify pharmacies that should be reviewed based on their claim composition and patient percentage for PrEP drugs as well as the percentage of how different those filling pharmacies practice compared to their peers, all of which are calculated by Codoxo’s patented AI.
Most importantly, applying these review practices to medications other than PrEP and antiretrovirals can assist the users with finding pharmacy claims associated with potential FWA.
References
Department of Justice – Press Release – December 2021
Centers for Disease Control Newsroom – Fact Sheets for PrEP
Gilead Sciences – Truvada – Food and Drug Administration (FDA) Prescribing Information
https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf
NABP – Digital Pharmacy Accreditation information
https://nabp.pharmacy/programs/accreditations/digital-pharmacy/
NABP resource – Find Safe Online Pharmacies
https://safe.pharmacy/buy-safely/
NABP resource – Before you Buy, Verify PDF with QR code
https://safe.pharmacy/wp-content/uploads/2022/12/BuySafelyFlyerEnglish.pdf
NABP resource – NABP Accredited Merchants List – Excel download
https://safe.pharmacy/wp-content/uploads/2023/02/Accredited-Merchants-List.xlsx