The Department of Justice announced a Nebraska pharmacist, and owner of two pharmacies, was sentenced to two months of imprisonment, three years of supervised release, and ordered to pay restitution in the amount of $573,000.
The pharmacist was found guilty of making a false, fictitious, and fraudulent statement related to health care services. The investigation began in 2020 based on a tip to Federal Agents, and included pharmacy staff interviews, patient interviews and an inventory audit. The inventory audit reconciled claims billed to both Medicare and Medicaid with invoice purchases made by the pharmacy.
Upon completion of the investigation, the inventory audit identified significant shortages. Investigators discovered the pharmacist was billing for brand name drugs but ordering and dispensing the generics. Additionally, the pharmacist in question was submitting claims that were never dispensed to the patient.
PAAS Tips:
- PAAS Audit Assistance members can view these articles
Contact PAAS National®® today and start your robust Fraud, Waste and Abuse and HIPAA Compliance Program, ensuring your pharmacy employees are informed and trained against fraudulent activities.
Best Practices for DAW Billing in Pharmacies
In what should be a fairly straightforward process, proper DAW billing practices can be convoluted. Despite NCPDP guidance to standardize adjudication practices, PBMs do not always adopted these standards, leaving the pharmacy in a gray area of what proper DAW billing should look like.
Due to the variability between each PBM’s (and even individual Plan Sponsor) expectations for DAW billing, pharmacies need to have a multi-pronged approach that includes understanding biologic terminology (PAAS Audit Assistance members can see this month’s article, Insulin Substitution Review: Understanding Purple Book Terminology), a list of core “DAW billing guidelines” to follow, and additional considerations to guide your pharmacy in the scenarios where billing may not be straightforward.
Every claim adjudication comes with its own unique set of circumstances, making it difficult to establish a process that can be applied universally. Furthermore, audit tactics continue to morph and industry dynamics, such as the 2024 elimination of retroactive DIR fees, make the pharmacy’s reimbursement more transparent at point-of-sale, potentially driving DAW considerations. As such, having a grasp on the suggested DAW best practices is necessary.
PAAS Tip 1:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Tip to Federal Agents Leads to Jail Time for Pharmacy Owner
The Department of Justice announced a Nebraska pharmacist, and owner of two pharmacies, was sentenced to two months of imprisonment, three years of supervised release, and ordered to pay restitution in the amount of $573,000.
The pharmacist was found guilty of making a false, fictitious, and fraudulent statement related to health care services. The investigation began in 2020 based on a tip to Federal Agents, and included pharmacy staff interviews, patient interviews and an inventory audit. The inventory audit reconciled claims billed to both Medicare and Medicaid with invoice purchases made by the pharmacy.
Upon completion of the investigation, the inventory audit identified significant shortages. Investigators discovered the pharmacist was billing for brand name drugs but ordering and dispensing the generics. Additionally, the pharmacist in question was submitting claims that were never dispensed to the patient.
PAAS Tips:
Contact PAAS National®® today and start your robust Fraud, Waste and Abuse and HIPAA Compliance Program, ensuring your pharmacy employees are informed and trained against fraudulent activities.
DMEPOS Updated Refill Request and Affirmative Response Requirements
Medicare Part B/DMEPOS billing and documentation rules are VERY different from most of your pharmacy claims. If you don’t have a strong grasp of these differences, or a process for handling the documentation, then you are sure to experience significant problems during an audit. PAAS Audit Assistance members can download PAAS’ Basic DMEPOS Documentation Guidance resource for a helpful checklist when processing these claims.
This Newsline article focuses on the refill record request and affirmative response requirement that was updated January 1, 2024. Suppliers can find all the revisions in CMS Final Rule 1780-F. DMEPOS items and supplies that are provided on a recurring basis must be based on prospective, not retrospective, use. Medicare requires documentation to ensure the item(s) remain reasonable and necessary, existing supplies are expected to end, and to confirm if there are any changes to the order. If your pharmacy currently has a process for documenting a proof of refill request, PAAS National® would recommend you review and update your form if necessary to meet Medicare’s requirements.
The refill record request, at a minimum, must include:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Don’t Cut Corners: Notations on Prescriptions
Not only are new medications frequently released to market, but also new strengths and formulations of existing medications. For example, consider Humulin® R U-100 insulin which was developed in the early 1980s. In the mid-1990s, Humulin® R U-500 vials became available in the market. That meant prescribers and pharmacists alike needed to be mindful of indicating which formulation of Humulin® R insulin the patient was to receive.
Not only are there new strengths of existing medications, but also new formulations. In 2016, Humulin® R U-500 insulin became available with a dedicated device used for the delivery of insulin – the KwikPen® – after previously only being available by vial. Yet again, this meant pharmacists needed to be explicit in what the patient was to receive, not only for the sake of the patient but also for accurate billing and dispensing.
For medications that come in one strength or dosage form, PBMs have proven to be more lenient with prescription hard copies that do not contain that information. However, medications that come in different strengths or dosage forms must include that information on the hard copy for it to be accepted by PBMs. Instead of trying to remember whether a medication comes in multiple forms, get all pharmacy staff into the practice of including strength and formulation for prescriptions, especially on telephone and transferred prescriptions. Below are the more common types of medications that could be recouped with missing information:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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FDA Issues Updates to iPLEDGE® REMS Program
Isotretinoin capsules are FDA approved for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Due to the risk of severe life-threatening birth defects and risk of embryo-fetal toxicity, isotretinoin is only available under the iPLEDGE® Risk Evaluation and Mitigation Strategy (REMS) program.
On November 30, 2023, the FDA posted an update to the iPLEDGE® program“…to minimize burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin”. Several changes include:
Patients who cannot become pregnant and pharmacies dispensing isotretinoin products will see no changes to the iPLEDGE® program requirements. Pharmacies will still need to:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Law Enforcement Access to Protected Health Information – What’s Your Policy?
Understanding and adhering to the HIPAA Privacy Rule is required for covered entities who handle protected health information (PHI), but because the Privacy Rule was designed to be flexible, implementation of policies and procedures to meet the Privacy Rules can vary from covered entity to covered entity. Look no further than the December 12, 2023 letter from the United States Senate Committee on Finance (herein, “The Committee”) for evidence of this variation and how it can seriously impact the privacy of sensitive patient data.
In the December letter drafted to Xavier Becerra, Secretary of the U.S. Department of Health & Human Services, The Committee outlined the results of their oversight inquiry into the seven largest pharmacy chains (CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, Inc., The Kroger Company, and Rite Aid Corporation), and Amazon Pharmacy. The inquiry focused on obtaining briefings from the major pharmacy chains about their policies and procedures for releasing PHI to law enforcement agencies. Below is a general overview of the findings:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
2024 Fraud, Waste & Abuse and HIPAA Compliance Program Updates
PAAS National® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice, Office of Inspector General, State Attorney Generals, and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult, and a significant nuisance, to independent pharmacies.
The PAAS National® FWA/HIPAA Compliance Program has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance members can login to the member portal to view the 2024 FWAC and HIPAA Updates.
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
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.
Major PBMs Announce “Cost Plus” Pharmacy Networks
In the fourth quarter of 2023, two of the “Big 3” PBMs announced that they will introduce new reimbursement methods for network pharmacies in the coming year(s) based on Cost Plus formulas in place of the typical AWP Minus terms.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Prescriber Statements for Successful Appeal
One of the most common requirements for appealing audit discrepancies is to provide a signed statement from the prescriber to confirm, clarify, or validate a prescription. Prescriber statements that do not meet all PBM requirements may be denied on appeal.
Pharmacies are often confused by what or why these statements are necessary and often find it very difficult to obtain a statement that meets all the requirements. PAAS National® analysts have years of experience with prescriber statements and are happy to walk you through this process for the best possible outcome on your appeal.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Have audit results and need assistance with appeal? Contact PAAS National®® today for one-on-one assistance with an experienced analyst.
Be Conscientious When Refusing to Dispense (or Bill Insurance)…
No pharmacy should be forced to dispense prescriptions below their acquisition cost. With the effective date of the CMS Final Rule regarding DIR fees in 2024, we suspect that pharmacies will see an increased number of prescriptions paid below cost and PAAS National® wants to support you and help you steer clear of PBM scrutiny, where possible.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips: