The Double Threat: Ransomware Attack Followed by HIPAA Non-Compliance Settlement

Imagine getting a papercut then moments later, cleansing your hands with alcohol hand sanitizer—you can almost feel the instantaneous sting the alcohol causes in the fresh wound. Not only are you subjected to the initial affliction, but also the second round of pain from the alcohol in the wound. Now, imagine a deeper “cut” directed this time at your pharmacy. The initial barrage is a malicious ransomware attack to capture your pharmacy’s electronic protected health information (ePHI), and the secondary “sting” comes when the Office for Civil Rights (OCR) investigates the pharmacy’s policies and procedures. The pharmacy then forks over a hefty monetary settlement for HIPAA Rule non-compliance. Ouch!

A health system servicing patients in Pennsylvania, Ohio and West Virginia found themselves in this exact scenario. According to the published OCR Resolution Agreement and Corrective Action Plan, the OCR initiated a compliance review of Heritage Valley Health System (HVHS) after media reports that HVHS experienced a data security incident. The following HIPAA Security Rule non-compliance issues were identified:

  • Failure to “conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of all of its ePHI”
  • Failure to “establish and implement policies and procedures for responding to an emergency or other occurrence, such as a fire, vandalism, system failure, and natural disaster, that damages systems that contain ePHI”
  • Failure to “implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted access rights”

HVHS settled with OCR for a whopping $950,000, agreed to three years of OCR monitoring, and were required to take steps to resolve potential violations of the HIPAA Security Rule.

In addition to detailing the settlement with HVHS, OCR’s July 1, 2024 press release stated there has been a 264% increase in large breaches reported to OCR involving ransomware attack since 2018. This alarming statistic reflects the harsh reality that pharmacies, and their ePHI, are targets for criminals. Pharmacies are directly in the crosshairs of malicious actors and pharmacy owners [and employees] must take steps to safeguard their data. Not only is it the law, but it is your data, reputation, time and money on the line!

PAAS Tips:

  • Develop and implement policies and procedures to safeguard ePHI
    • For 15 years, PAAS FWA/HIPAA compliance program has been helping community pharmacies be compliant. Had HVHS implemented PAAS’ program, they would have not had the resulting non-compliance issues and resulting fines.
  • Ensure all staff handling ePHI receive training on a regular basis to understand their role in protecting ePHI and the implications of non-compliance, as well as intentional misuse (i.e., breach, fines, exclusion from Medicare/Medicaid, imprisonment, etc.)
  • At least once a year, the Security Officer should perform a thorough assessment of the potential threats, vulnerabilities and the associated risks to the confidentiality, integrity and availability of ePHI
  • PAAS’ FWA/HIPAA Compliance Program members can update their HIPAA Risk Analysis, complete HIPAA training and Cybersecurity training on the PAAS Portal

Are PBM Regulations Being Enforced by Your State? Let Your Voice Be Heard!

When PBMs violate state law, pharmacies need to scream from the mountain tops. Get the ball rolling by filing a complaint with your state regulators. As a local state representative said, “If there are no complaints, then we assume all of the regulations put forth are working great”. If you’re not sure where to start, the National Community Pharmacists Association’s (NCPA) has a webpage that provides instructions on how to file a complaint in your state.

Over the past several years, nearly every state has passed some type of PBM reform. While there have been great strides with comprehensive regulations, and court victories, this can be diminished if no complaints are reported [when laws are violated] and states are not held accountable for enforcing the laws being put in place.

You must be proactive and hold your state agency’s feet to the fire. You do that by filing complaints when the insurers/PBMs are NOT following the law. It surely does not shock any community pharmacy that PBMs willing violate these laws. The more detailed, factual-based complaints regulators receive, the more likely they are to investigate and ENFORCE the law.

Not only does failing to report violations undermine the effort that went into getting the law passed, but it also makes future PBM reform more difficult. With minimal complaints on record, legislators (and PBM lobbyists) may use that as rationale not to take up additional reform (i.e., the existing regulations are effective).   

Some of the common complaints with audits are:

  • Failure to adhere to audit timelines or limitations
  • Identifying audits as FWA or ‘investigational’ seemingly only to avoid state audit parameters
  • Auditors refusing to accept documentation
  • Inconsistent application of audit rules and guidelines
  • Recoupments for technical discrepancies

Pharmacies are often fearful of filing complaints due to the potential for PBM retaliation. Consequently, many states have included non-retaliation language in the reform. While it can understandably give pharmacy owners pause, if you’re not willing to stand up for your pharmacy, who will?

PAAS Tips:

  • Be familiar with your state PBM regulations
  • If you feel state laws have been violated – file a complaint
    • Unsure of whether an audit situation is complaint worthy? Talk with PAAS
    • Provide all necessary documentation to support (and explain) your dispute
    • Maintain thorough documentation of all pharmacy transactions and interactions relevant to the situation

PBM Audits on Ozempic®: 5 Common Discrepancies Revealed

Popularity for GLP-1 medications, like Ozempic®, continues to grow and, consequently, PAAS National® encounters these drugs on PBM audits frequently. This article outlines five common discrepancies observed in audit findings for Ozempic®.

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!

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.

Audit Risk: Prescriber Scope of Practice and Treating Self or Family

Everyone knows that PBMs do not perform “random” audits, nor do they select “random” claims in these audits. PBMs have sophisticated algorithms to look at thousands (if not millions) of prescription claims to find abnormalities and patterns that may be indicators of fraud, waste, or abuse. Two of the not-so-sophisticated formulas include comparing prescriber specialty to the drugs prescribed and matching last names of prescriber and patient.

In addition to having PBM audit risk …

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!

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.

Nondiscrimination in Health Programs and Activities – Cultural Competency Training is a Must!

Earlier this year the Office for Civil Rights (OCR) released the 2024 Final Rule under Section 1557 of the Affordable Care Act (ACA), reestablishing many of the 2020 Finale Rule protections that were removed by the prior administration. One of the noteworthy changes (or reinstated regulations) appears in 45 CFR 92.11, which requires covered entities who receive federal funding to let patients know that language assistance services and auxiliary aids and services are available if needed. The notice is to be provided in English plus at least the 15 most common languages spoken by individuals with limited English proficiency (LEP) in the United States. In addition, the notice should be provided via alternate formats for those individuals with disabilities that require auxiliary aids in order to provide equal access to services rendered by covered entities. Despite this seemingly large undertaking, OCR is giving covered entities until July 5th, 2025 to implement this requirement plus is providing sample “Notice of Availability of Language Assistance Services and Auxiliary Aids and Services” that have already been translated.

The notice is but a fraction of the overarching theme the 2024 Final Rule carries: inequality of services provided amongst federally-funded programs is not tolerated. Covered entities must urgently become mindful of their Section 1557 obligation of providing non-discriminatory services on the basis of race, color, national origin, sex, age, or disability as this has been enforced since its inception in 2020, primarily by OCR receiving and investigating discrimination grievances.

Although it may seem as though the likelihood of being in OCR’s crosshairs for a Section 1557 violation is low, by the time covered entities receive notice of an investigation for discriminatory actions, it is too late. Be proactive with Cultural Competency training to help avoid an investigation in the first place, and demonstrate that your pharmacy is making strides to provide equivalent access to care.

Pharmacies that complete cultural competency training, and have the training documented, should ensure their NCPDP profile reflects that training. Learn more about PAAS’ Cultural Competency Training here, or contact us today to add the training to your membership.

2024 National Health Care Fraud Takedown

On June 27th the U.S. Department of Justice (DOJ) issued a press release outlining a National Health Care Fraud Enforcement Action that resulted in 193 defendants charged, including doctors, nurses and pharmacists, and over $2.75 billion in false claims. This year marked the highest numbers since 2020 and included coordinated efforts by the DOJ, US attorneys’ offices, HHS Office of Inspector General, FBI, and the DEA.

Takedowns related to prescription drugs included:

  • Illegitimate distribution of Adderall® and other controlled substance stimulants via telemedicine
  • Distribution of diverted HIV medications through gray market wholesalers
  • Medically unnecessary prescriptions for compounds and foot baths
  • Submission of claims to federal payors for drugs that were not purchased or dispensed
  • Providing kickbacks to patients to fill medically unnecessary prescriptions
  • Bribing physicians with cash and entertainment to refer prescriptions

For 15 years, PAAS National®’s FWA/HIPAA compliance program has helped educate community pharmacies on federal regulations. Coupled with audit assistance and the Newsline, PAAS serves as a guiding light, steering pharmacies away from trouble and towards compliance. The FWA program not only meets CMS’ definition (and PBM requirements) of an effective compliance program, but also helps with written Policies and Procedure for credentialing.

PAAS Tips:

For more insight into these compliance issues, PAAS Audit Assistance members can consider reading the following articles (many more articles available on our eNewsline):

The Need for Clarification on Prescription Labels

Pharmacy staff frequently receive prescriptions from prescribers that lack (or are missing) complete quantities or instructions for use. Clarifying these details before dispensing can help prevent audit discrepancies. Pharmacies must document these clarifications made with the prescriber’s office utilizing a clinical note that contains all four essential elements:

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!

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.

Liraglutide Injection Marks Debut as First Authorized Generic GLP-1 Product

In late June, Teva Pharmaceuticals launched the first “generic” GLP-1 (Glucagon-Like-Peptide-1) receptor agonist in the United States, known as Liraglutide injection (6 mg/mL). This authorized generic of Victoza® is a once daily noninsulin injection approved to treat type 2 diabetes in adults and children aged 10 and older. It is also approved to reduce the risk of cardiovascular events like heart attacks and stroke in adults with type 2 diabetes and heart disease.

The FDA defines an authorized generic (AG) drug as the brand name drug that is marketed without the brand name on its label. So other than not having Victoza® on the label, Liraglutide is the exact same drug product as the brand Victoza®. An AG may be marketed by the brand name drug company or another company with the brand’s permission. While it is the same as the brand name product, companies typically choose to sell the AG at a slightly lower cost than the brand.

PAAS Tips:

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!

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.

2024 DMEPOS Series #6: Immunosuppressive Drugs for Transplant

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

Specifically, you need to demonstrate the following in case of an audit regarding immunosuppressive drugs for transplant:

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!

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.

DAW 8: Documentation When the Generic is Not Available

DAW code billing on multi-source brand medications is a frequent audit target for PBMs due to their potential higher cost, change in pharmacy reimbursement, and impact on patient copays. PAAS National® recommends …

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!

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.