Be Aware of Federal Crackdown on Health Care Fraud

Across the country, health care fraud affects all areas of the healthcare system, but how does it affect your pharmacy? Bad actors in pharmacy give validation to PBM audit practices, adding to the audit burden. PBMs leverage these audits as a method to keep the “bad actors” out of the health care field and save Plan Sponsors, and taxpayers, money. 

Certain individuals validate PBM audit practices, thereby contributing to the overall audit burden. This is, at least in part, an effort to prevent unethical participants from entering the healthcare field and to help Plan Sponsors and taxpayers reduce costs.

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) have announced the formation of the DOJ-HHS False Claims Act (FCA) Working Group. This is a new joint initiative to strengthen enforcement efforts against health care fraud. The False Claims Act is one of the most effective tools for addressing fraud and this group formalizes a coordinated strategy to pursue high-priority violations.

The group is encouraging whistleblowers to report fraud, waste and/or abuse in priority areas. For pharmacies, the increased scrutiny will be on Medicare Advantage operations, pricing practices and network compliance. PAAS will be watching closely to see how auditors will scrutinize these areas going forward.

PAAS Tips:

Largest Health Care Fraud Takedown in History

We are living in unprecedented times as the Justice Department announced the outcome of their 2025 National Health Care Fraud Takedown, marking one of the largest enforcement actions of its kind. Criminal charges were filed against 324 individuals, from various health care professions, for their alleged participation in a range of fraud schemes. The total intended losses amount to approximately $14.6 billion – more than double the previous record of $6 billion.

This nationwide effort involved collaboration between federal and state law enforcement agencies across the country including 50 federal districts and 12 State Attorneys General’s Offices. As part of the operation, the government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets.

Leading up to the takedown, the CMS suspended or revoked billing privileges for 205 providers, which successfully helped prevent over $4 billion in false and fraudulent claims.

One area of focus in the investigation was the illegal distribution of prescription opioids. Authorities charged 74 individuals in 58 cases involving alleged diversion of more than 15 million pills, including opioids and other controlled substances. In one case, five individuals associated with a Texas pharmacy were charged with unlawfully distributing over 3 million opioid pills, which were allegedly sold through street-level trafficking operations.

Additionally, the DEA reported filing 93 administrative cases over the past six months aimed at revoking the prescribing or dispensing authority of controlled substances of certain pharmacies, medical practitioners, and companies. DEA Acting Administrator Robert Murphy stated:

“We’re targeting the entire ecosystem of fraud — from pill mills in Texas to kickback clinics exploiting Native communities. If you abuse your medical license to push poison or pad your pockets, we will hold you accountable.”

Telemedicine and genetic testing fraud schemes accounted for over $1.17 billion in alleged fraudulent claims billed to Medicare. According to the report, these schemes often intersect with other areas of concern, including durable medical equipment and COVID-19 testing – both of which remain priorities for ongoing enforcement efforts. In addition, approximately $1.84 billion was associated with alleged false and fraudulent claims billed to federally funded plans and private insurance for reasons deemed medically unnecessary, tied to kickbacks and bribes, or not provided at all.

PAAS Tips:

Fraudulent Prior Authorization Submissions Costs Pharmacy Over $1 Million

A Florida-based pharmacy plead guilty to healthcare fraud and agreed to pay over $1 million to resolve False Claims Act violations stemming from falsified prior authorizations. The pharmacy dispensed Evzio® (injectable naloxone product for emergency treatment of opioid overdose—discontinued in October 2020) which frequently required prior authorizations due to its high cost. Instead of sending the prior authorization information and/or forms to the prescribers, the pharmacy would complete the forms and, in some cases, sign the required forms. It was made to appear that the physician (not the pharmacy) was submitting the information. Pharmacy staff also provided false information to the insurer that the patients had tried and failed to successfully use Narcan®.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.

Why Adhering to Your Return to Stock Policy Is So Important

Pharmacies often struggle with patients not picking up prescriptions on a timely basis. The lag time could be caused by several reasons – cost concerns, transportation issues, mental health factors, or miscommunication are just a few of the possibilities. While pharmacies are sympathetic to patient situations, it is prudent to be aware of the consequences for not following a strict return to stock policy.

PBM return to stock policies range from 10 to 30 calendar days. Accordingly, PAAS National® advises pharmacies…

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.

Interested in a customized FWA/HIPAA Compliance Policy and Procedure program? Contact PAAS National® at info@paasnational.com or (608) 873-1342 to get started today! 

Is Your Pharmacy Prepared for a Cyberattack?

In this episode of The Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP and Austin Murray sit down with Trenton Thiede, President of PAAS National®, to unpack the rising cybersecurity threats facing independent pharmacies and what owners must do to stay compliant and protected.

We dive into:

  • HIPAA compliance updates
  • AI risks, multi-factor authentication, and risk assessments
  • The growing pressure of PBM audits and the need for strong advocacy

Tune in by clicking on one of the links below:

The Next Big Wave: Anticipating a Surge in HIPAA Compliance Audits

Desk audits, onsite audits, invoice audits…and HIPAA compliance audits?! Unfortunately every community pharmacy has some familiarity with third party payor audits, and PAAS National® audit analysts bring their expertise to guide members through the entire audit process, ensuring everything goes as smoothly as possible.

But what about HIPAA compliance audits? With a potential surge in these audits on the horizon, it is important for covered entities (i.e., pharmacies) to evaluate their HIPAA compliance policies and procedures to fortify their program.

You may ask, “Why are these audits being performed?”. The Health Information Technology for Economic and Clinical Health (HITECH) Act requires that the Department of Health and Human Services (HHS) conduct periodic HIPAA audits, submit an annual report to Congress on HIPAA compliance, and provide annual guidance on the most effective technical safeguards for meeting Security Rule requirements. The Office for Civil Rights (OCR), within HHS, is tasked with overseeing these responsibilities. To verify OCR was performing their respective duties, the Office of Inspector General (OIG) performed a review of OCR’s HIPAA compliance audit process.

According to the OIG November 2024 brief, “OCR fulfilled its requirement under the HITECH Act to perform periodic HIPAA audits. However:

  • OCR’s HIPAA audit implementation was too narrowly scoped to effectively assess ePHI protections and demonstrate a reduction of risks within the health care sector. Specifically:
    • OCR’s audits consisted of assessing only 8 of 180 HIPAA Rules requirements; and
    • Only 2 of those 8 requirements were related to Security Rule administrative safeguards and none were related to physical and technical security safeguards.
  • OCR oversight of its HIPAA audit program was not effective at improving cybersecurity protections at covered entities and business associates.”

OIG recommended OCR increase the volume and breadth of their audits to raise their assurance that covered entities (like pharmacies) and business associates have complied with the Security Rule. OIG stated these audits will also help OCR provide covered entities with more opportunities to strengthen their security over ePHI.

Additionally, on December 27, 2024, OCR issued a Notice of Proposed Rule Making (NPRM) to modify the HIPAA Security Rule to strengthen cybersecurity protections for ePHI. This is the first time since 2013 that OCR seeks to update the Security Rule. With the dramatic increase in cybersecurity threats, both malicious and unintentional, it seems that updates are more important now than ever. A fact sheet on the NPRM is available online.

Since HIPAA compliance audits may be in your future (along with Security Rule updates), now is a great time to evaluate your HIPAA compliance program to get a good handle on where your vulnerabilities are, what threats you have and the risk of those threats. If you’re not sure where to start, check out the PAAS FWA/HIPAA Compliance Program!

PAAS Tips:

  • Understand the components and importance of a HIPAA Security Risk Analysis
    • Perform an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the pharmacy’s ePHI
    • Identify and implement reasonable and appropriate physical, technical, and administrative safeguards as required by the HIPAA Security Rule
  • Know the terms
    • Vulnerability – a flaw or weakness in system security procedures, design, implementation or internal controls
    • Threat – the potential for a person or thing to exercise a specific vulnerability (natural, human, and environmental)
    • Risk – a function of the probability that a threat will attack a vulnerability and the resulting impact to the organization
  • PAAS’ FWA/HIPAA Compliance Program members have access to:
    • Update their HIPAA Risk Analysis
    • Complete annual Cybersecurity training on the Member Portal
    • Policies and procedures to comply with HIPAA Privacy, Security and Breach Notification rules which include customized administrative, physical and technical safeguards
    • Contingency Planning and Preparedness
    • Pharmacist experts to support you in FWA/HIPAA Compliance
  • Watch the PAAS National® webinar, Cybersecurity Considerations for Community Pharmacies located on the Member Porta

Best Practices for Out-of-Stock Medications

PAAS National® analysts continue to see pharmacies struggle with invoice audits, which are most frequently performed by Caremark® and OptumRx®.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.

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.

The HIPAA Hot Seat: What You Need to Know About the “2024 Privacy Rule” and Reproductive Health Care

The 2022 Dobbs v. Jackson Women’s Health Organization ruling, which overturned Roe V. Wade, prompted modifications to the Privacy Rule (45 CFR Parts 160 and 164). The Biden-Harris administration, partially through President Biden’s Executive Order (EO) 14076, aimed to better protect information related to reproductive health care, to bolster patient-provider confidentiality, and promote trust between patients and their health care providers. Subsequent to EO 14076, the HIPAA Privacy Rule was updated to limit the circumstances in which the use or disclosure of PHI related to reproductive health care is permitted. The final rule (“2024 Privacy Rule”) became effective June 25, 2024, with compliance enforcement effective December 23, 2024; except for the requirement to update the covered entity’s Notice of Privacy Practices which is delayed until February 16, 2026.

The 2024 Privacy Rule strengthens privacy protections by prohibiting the use or disclosure of PHI by a covered entity (e.g., pharmacy), or business associate, for either of the following activities:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.

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.

2025 PAAS 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.

PAAS has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance program members can login to the member portal to view the 2025 FWAC and HIPAA Updates. This year’s updates included a procedure for CMS-10882 (Medicare Prescription Payment Plan), PHI safeguard considerations for Remote/Hybrid work, enhancements to the required HIPAA Security Risk Analysis, Pharmacy-to-Pharmacy Inventory Transfer Log, and a policy and procedure related to the 2024 Privacy Rule (request to access or release PHI potentially related to reproductive health).

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.

The Clock is Ticking: Complete Your Annual Training!

It is that glorious time of year again! Time for staff to be occupied not only with the daily activities of billing and filling medications, but also occupied with cough/cold/flu season, vaccine administration, answering Medicare Part D open enrollment questions, and holiday closures. Now is the time to ensure staff complete their annual Fraud, Waste & Abuse and HIPAA Compliance, Cultural Competency, and USP 800 Compliance training since the December 31st deadline will be here before we know it!

FWA/HIPAA Compliance Training: Employees who are involved with filling, billing, dispensing or delivery of Medicare and/or Medicaid prescriptions are required to be trained within 30 days of hire (per PBM requirements) and at least annually thereafter. Per CMS Chapter 9.50.3, training and education for employees does include the CEO and senior administrators or managers. Relief pharmacists, students, interns, job shadows, and delivery drivers also need training. The training must cover FWA and General Compliance topics and must include details outlining your pharmacy’s specific policies and procedures of how you prevent, detect, and correct FWA.

Current PAAS National® FWA/HIPAA Compliance Program members can meet annual training requirements through the PAAS Member Portal. A few important things to note:

  • All employees must complete the 2024 FWA Modules 1-4 and review/sign the Employee Compliance Training Handbook and Code of Conduct to meet training requirements.
  • If a staff member misses the December 31st deadline, 2024 training cannot be retrospectively completed.
  • Account administrators that have employees with outstanding quizzes or signatures will receive two more email reminders from PAAS before the end of the year.

Cultural Competency Training: As of April 2021, NCPDP required pharmacies to indicate if they train their staff on cultural competency and maintain evidence of such training, when going through the pharmacy’s annual NCPDP profile credentialing. Since adding this question, PBMs have decreased the number of direct attestations required of community pharmacies. However, indicating ‘no’ in NCPDP is not without potential repercussions as PBMs may exclude you from provider listings of culturally competent care, as this was required for Medicaid managed care plan directories. Additionally, there are federal requirements that have been in place for many decades. Read more on Does My Pharmacy Really Need Cultural Competency Training?

USP 800 Compliance Training: USP 800 is not just for compounding pharmacies, this occupational exposure extends to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle hazardous drug (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 greatly reduce risk. Per OSHA, the safe handling of hazardous drugs in accordance with USP 800 is now 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 your employees, patients in your pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements. 

If you are unsure of all the necessary requirements, contact PAAS at (608) 873-1342 today for more information.