As the year winds down, it is important to verify that all staff have completed their required training. Once the clock strikes midnight on December 31st, all 2025 training requirements must be completed. If the pharmacy has staff who have not completed their training by this deadline, the pharmacy will be considered non-compliant with CMS and PBM requirements. Staff are not able to retroactively complete 2025 training in 2026. Auditors, especially those visiting on-site, routinely request proof of FWA and HIPAA training for all staff. Non-compliance can result in contract termination, so take action now to ensure your pharmacy avoids this risk.
FWA and HIPAA Training: All employees involved in the filling, billing, dispensing or delivery of Medicare and/or Medicaid prescriptions are required to complete FWA training within 30 days of hire (per PBM requirements) and at least once per year thereafter. The training itself should cover FWA and General Compliance topics and must include details outlining your pharmacy’s specific policies and procedures for how you prevent, detect, and correct FWA. Training and education for employees includes the CEO, senior administrators, and managers as per CMS Chapter 9.50.3. Since interns, float staff, cashiers and delivery drivers are involved in daily pharmacy operations such as billing, filling, counseling, dispensing, delivery of services and/or other professional services, they must also complete FWA training.
Safeguarding the pharmacy’s PHI is mandatory for all staff who may come into contact with this sensitive data (including cashiers and delivery drivers). Requiring HIPAA training before interns, job shadows, or floating pharmacy staff are allowed behind the pharmacy counter helps ensure they understand proper safeguards and the serious consequences (including civil monetary penalties and criminal consequences) of improperly disclosing PHI. Additionally, if an employee has access behind the pharmacy counter, they need to be HIPAA trained.
Pharmacy staff who are contracted to deliver medications for your pharmacy, work on a temporary basis or simply float through your store are also subject to FWA and HIPAA training requirements. Whether these employees are hired directly by your pharmacy (or paid through a 1099), or they are contracted through a third-party staffing company, the burden is on the pharmacy owners/operators to ensure all members of their staff have received appropriate training.
The PAAS National® FWA/HIPAA Compliance Program membership includes educational presentations and comprehension quizzes through the Member Portal. Current FWA/HIPAA Compliance Program members should log in and ensure their 2025 training is complete.
- All employees must complete the 2025 FWA Modules 1-4
- All employees must review and sign the Employee Compliance Training Handbook Acknowledgement as well as the Code of Conduct
- Account administrators should have received an email notification in mid-October if any of their employees have incomplete quizzes or missing signatures and will receive one to two more email reminders from PAAS before the end of the year if any quiz or signature remains incomplete
Cultural Competency Training: When completing your annual profile credentialing through the NCPDP website, pharmacies must indicate whether they train their staff on cultural competency. By answering “yes” the pharmacy attests to training their staff and to maintaining documented evidence of such training. An answer of “no” may lead to PBMs excluding your pharmacy from their list of providers offering culturally competent care (a requirement for Medicaid managed care plan directories). More information about this training can be found in the May 2024 Newline article and within the On-Demand Webinar, both titled Does My Pharmacy Really Need Cultural Competency Training? Both resources speak to the importance of this training as well as federal laws and regulations related to discrimination and cultural competency requirements for healthcare professionals.
Cybersecurity Training: The dynamic nature of cyberthreats necessitates continual adaptation and vigilance. Cybersecurity training helps equip staff with essential knowledge regarding best practices to hinder potential threats related to network connected medical device security, insider data loss, loss or theft of equipment and data, ransomware, and social engineering. Threats lurk around every digital corner and safeguarding sensitive information has never been more crucial. That is why PAAS added Cybersecurity training (starting in 2024) to the FWA/HIPAA Compliance Program Membership package at no additional cost!
USP 800 Compliance Training: USP 800 is not just for compounding pharmacies! Exposure to hazardous drugs (HDs) extend to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle HDs, to those who work at the pharmacy counter or in the receiving and delivery areas. The key is developing good practices to contain or reduce risk. Per OSHA, the safe handling of HDs in accordance with USP 800 is considered a “national professional standard” as a pharmacy process “to protect the safety and health of employees”. A USP 800 compliance program is a necessary step to protect the health and safety of employees, patients in the pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements.
Contact PAAS for more information on how we can help you reach your compliance requirements.
Time is Running Out! Is Your 2025 Training Complete?
As the year winds down, it is important to verify that all staff have completed their required training. Once the clock strikes midnight on December 31st, all 2025 training requirements must be completed. If the pharmacy has staff who have not completed their training by this deadline, the pharmacy will be considered non-compliant with CMS and PBM requirements. Staff are not able to retroactively complete 2025 training in 2026. Auditors, especially those visiting on-site, routinely request proof of FWA and HIPAA training for all staff. Non-compliance can result in contract termination, so take action now to ensure your pharmacy avoids this risk.
FWA and HIPAA Training: All employees involved in the filling, billing, dispensing or delivery of Medicare and/or Medicaid prescriptions are required to complete FWA training within 30 days of hire (per PBM requirements) and at least once per year thereafter. The training itself should cover FWA and General Compliance topics and must include details outlining your pharmacy’s specific policies and procedures for how you prevent, detect, and correct FWA. Training and education for employees includes the CEO, senior administrators, and managers as per CMS Chapter 9.50.3. Since interns, float staff, cashiers and delivery drivers are involved in daily pharmacy operations such as billing, filling, counseling, dispensing, delivery of services and/or other professional services, they must also complete FWA training.
Safeguarding the pharmacy’s PHI is mandatory for all staff who may come into contact with this sensitive data (including cashiers and delivery drivers). Requiring HIPAA training before interns, job shadows, or floating pharmacy staff are allowed behind the pharmacy counter helps ensure they understand proper safeguards and the serious consequences (including civil monetary penalties and criminal consequences) of improperly disclosing PHI. Additionally, if an employee has access behind the pharmacy counter, they need to be HIPAA trained.
Pharmacy staff who are contracted to deliver medications for your pharmacy, work on a temporary basis or simply float through your store are also subject to FWA and HIPAA training requirements. Whether these employees are hired directly by your pharmacy (or paid through a 1099), or they are contracted through a third-party staffing company, the burden is on the pharmacy owners/operators to ensure all members of their staff have received appropriate training.
The PAAS National® FWA/HIPAA Compliance Program membership includes educational presentations and comprehension quizzes through the Member Portal. Current FWA/HIPAA Compliance Program members should log in and ensure their 2025 training is complete.
Cultural Competency Training: When completing your annual profile credentialing through the NCPDP website, pharmacies must indicate whether they train their staff on cultural competency. By answering “yes” the pharmacy attests to training their staff and to maintaining documented evidence of such training. An answer of “no” may lead to PBMs excluding your pharmacy from their list of providers offering culturally competent care (a requirement for Medicaid managed care plan directories). More information about this training can be found in the May 2024 Newline article and within the On-Demand Webinar, both titled Does My Pharmacy Really Need Cultural Competency Training? Both resources speak to the importance of this training as well as federal laws and regulations related to discrimination and cultural competency requirements for healthcare professionals.
Cybersecurity Training: The dynamic nature of cyberthreats necessitates continual adaptation and vigilance. Cybersecurity training helps equip staff with essential knowledge regarding best practices to hinder potential threats related to network connected medical device security, insider data loss, loss or theft of equipment and data, ransomware, and social engineering. Threats lurk around every digital corner and safeguarding sensitive information has never been more crucial. That is why PAAS added Cybersecurity training (starting in 2024) to the FWA/HIPAA Compliance Program Membership package at no additional cost!
USP 800 Compliance Training: USP 800 is not just for compounding pharmacies! Exposure to hazardous drugs (HDs) extend to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle HDs, to those who work at the pharmacy counter or in the receiving and delivery areas. The key is developing good practices to contain or reduce risk. Per OSHA, the safe handling of HDs in accordance with USP 800 is considered a “national professional standard” as a pharmacy process “to protect the safety and health of employees”. A USP 800 compliance program is a necessary step to protect the health and safety of employees, patients in the pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements.
Contact PAAS for more information on how we can help you reach your compliance requirements.
What Is a Targeted Probe and Educate Audit?
CMS rolled out the Targeted Probe and Educate (TPE) program back in 2017. The goal of the TPE program is to help providers reduce the number of DMEPOS claim denials by using data analysis and providing one-on-one educational sessions to avoid common mistakes. DME Medicare Administrative Contractors (MACs) analyze data to identify providers who have the highest claim denial rates or who have billing practices that vary significantly from their peers. Please see the tips below to follow the steps of a TPE audit.
PAAS Tips:
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:
Billing Considerations That Will Save You Later
Filing and billing claims involves keeping track of what can feel like an endless number of details. The fast-paced environment of the pharmacy doesn’t always allow for keeping tedious details at the forefront of your mind. Below you’ll find a guide detailing common scenarios that should be considered while filling prescriptions to reduce your audit risk.
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:
The $40 Incentive Fee You Might Be Missing!
Since 2021, a program created by CMS has allowed eligible pharmacies to receive additional reimbursement for administering the COVID-19 vaccine to certain Medicare homebound patients.
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:
Billing Ozempic® 0.25 mg Weekly as a Maintenance Dose – What is the Big Deal?
PAAS National® analysts field many questions on Ozempic® relating to off-label use; however, we also receive questions about what days’ supply to submit on claims – particularly for initiation dosing. Section 2.2 of the manufacturer package insert (available on DailyMed) lists the recommended dosage schedule based on clinical trials and includes the following titration schedule:
Pharmacies often see prescribers write for Ozempic® 0.25 mg weekly as a maintenance dose. What days’ supply should the pharmacy transmit?
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:
Easy Pickings: Why Transferred Prescriptions are Audit Bait
Transferring prescriptions into your pharmacy is usually great for business; however, pharmacies must be aware of the additional audit risks with these prescriptions. PBM audit algorithms easily identify transfers due to the origin code of 5 being submitted during claim adjudication.
Each state has requirements put in place by their pharmacy board that outline what information must be obtained and documented when transferring a prescription. These requirements differ from state to state, so be sure to educate staff on the state specific elements. Missing even one small piece of information can result in a recoupment during an audit.
One common mistake pharmacies make…
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:
Compliance Check: Is Your Authority to Vaccinate Still Valid?
Vaccine season is upon us! Pharmacies who offer immunization services are likely seeing an influx in requests for seasonal influenza, COVID-19, and other routine vaccines. However, it is important to take a step back and evaluate exactly which vaccines you are formally allowed to authorize and administer, especially after the meeting of the Advisory Committee on Immunization Practices (ACIP) on September 18th and 19th, 2025.
Pharmacies typically gain authority to administer (and/or prescribe) vaccines by one of four avenues:
During the September ACIP meeting, the committee voted to relax the recommendations for the 2025-2026 COVID-19 vaccine as follows:
In the August 2025 Newsline article, COVID-19 Vaccine Update: Shared Clinical Decision-Making, PAAS National® shared information regarding the CDC’s shared clinical decision-making approach. The CDC’s guidance was used to update the Advisory Committee on Immunization Practices approved vaccine schedules for children and adults for the 2024-2025 season. As of the time of publication of this article, the CDC had yet to issue its final recommendations for the 2025-2026 season. These updates are important because many state laws, CPAs and even the PREP Act tie back to the CDC and ACIP-approved vaccine schedules.
It is important to note that pharmacies who vaccinate pursuant to the PREP Act…
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:
When Can a Wrong Origin Code Lead to Denial or Recoupment?
Per NCPDP’s Telecommunication Version D and Above: Questions, Answers and Editorial Updates, “the Prescription Origin Code (419-DJ) contains the value that represents the method in which the pharmacy originally received the prescription from the prescriber.” Any subsequent changes or modifications to the original prescription do not change the origin code even when clarifications of that prescription are done via telephone.
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:
USP 800: What Community Pharmacies Need to Know
Most community pharmacies don’t compound with hazardous drugs, but that doesn’t mean you’re off the hook when it comes to USP 800 compliance. This standard, USP General Chapter <800> Hazardous Drugs: Handling in Healthcare Settings, applies to anyone who receives, stores, or dispenses hazardous drugs (HDs). And yes, that includes community pharmacies.
What Makes a Drug Hazardous?
NIOSH defines a drug as hazardous if it’s linked to cancer, reproductive harm, organ damage, or genetic effects. There are over 250 medications that need to be handled safely to reduce potential harm to employees including medications commonly stocked in community pharmacies such as: azathioprine, carbamazepine, colchicine, finasteride, methotrexate, phenytoin, topiramate, warfarin, as well as hormone products including oral contraceptives.
Key Steps for Compliance
Why It Matters
A trace of powder left on a counting tray may seem harmless, but repeated exposure can cause long-term health risks. USP 800 isn’t just red tape, it’s about protecting your pharmacy team while they are handling hazardous drugs.
By taking small but consistent steps – hazardous drug list, risk assessments, PPE, training, and spill planning – community pharmacies can stay compliant and create a safer workplace for everyone.
PAAS Tips:
Real-World Examples of Fraud, Waste & Abuse and Audit Implications
It is no secret that margins are thin and pharmacies have been looking for additional revenue-generating opportunities. Some pharmacies have added immunization services, performed billable Medication Therapy Management, added Point of Care Testing, and/or found other non-PBM income sources to offset low (or negative) reimbursements from third-party payors. These services are patient-focused and can increase the community’s access to health care options, especially when primary care providers and health care clinics are less accessible. Providing these services to the community can help keep the pharmacy running.
Unfortunately, there are a few bad actors that have found unlawful revenue sources solely for their own financial prosperity. Audits are a method used (at least in part) to root out the activities of these bad actors by reviewing pharmacy claims, associated documents, and onsite resources to identify fraud, waste and abuse. Consider the following examples;
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: