On-Demand Webinar: Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19

On April 7, 2022 PAAS National® hosted Compliance Issues, HIPAA Enforcement and Audit Risks with COVID-19 webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.

This webinar reviews:

  • Compliance Program Requirements (and why it matters to community pharmacies)
  • HIPAA Enforcement/Action
  • COVID-19 Vaccine Audit Risks (updated)
  • OTC COVID-19 Tests Audit Risks (and Medicare B guidance)
  • Onsite Audit Preparation

Yes, OTC COVID-19 Tests Can Be Audited!

Dispensing OTC COVID-19 tests is widespread through community pharmacies. Pharmacies must be aware that submitting claims to PBMs for these tests opens the window for auditing. Ensuring you have procedures in place to accurately purchase, bill and dispense these home tests is imperative. While the dollar amount of these claims does not seem audit worthy, PBMs will be checking for Fraud, Waste and Abuse and contract violations.

PAAS National® has created a COVID-19 Resources section for our members on the PAAS Member Portal. Here you can find the Patient Request and Attestation for OTC COVID-19 Test Billing and Frequently Asked Questions. These documents have been created for our members to help answer questions and ease the documentation burden so pharmacies can save time and be audit ready.

Recently, a PAAS member received an audit request and results for an invoice audit targeting OTC COVID-19 tests. The audit was for a very short time frame and the PBM had already contacted patients to verify what manufacturer and quantity of tests the patient had received. Only tests that have been authorized by the FDA should be billed and dispensed. You can find a list of approved tests here.

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.

Medi-Span® Generic Product Identifier

Health Information Technology vendors in the pharmacy industry utilize large drug compendia databases to manage electronic drug files so that electronic transactions are all “speaking the same language”. The two largest databases are Medi-Span® and First Databank.

These compendia have hundreds of datapoints for every drug product in the marketplace and some of these datapoints may be subject to frequent changes (e.g., pricing fields such as AWP, WAC, NADAC, etc.) while others are static (e.g., unit of measure).

Drug wholesalers (e.g., McKesson) and Pharmacy Software Management Systems (e.g., PioneerRx) rely on these drug compendia to build out their platforms and regularly update pricing files.

Medi-Span® uses a proprietary14-digit hierarchy system called Generic Product Identifier (GPI) to organize drug products at seven levels including drug group, class, subclass, base, name, dose form, and dose strength. Unfortunately, this hierarchy does not include information about FDA therapeutic equivalency which may lead pharmacies to come to the wrong conclusion about which products may, or may not, be substituted without prescriber approval.

Wholesaler online ordering systems and Pharmacy Software that rely on GPI hierarchy alone may yield both false positives (imply that products may be substituted) and false negatives (imply that products may not be substituted).

Examples that may cause problems include:

  1. BX rated generics
  2. Albuterol sulfate inhalers
  3. Insulin glargine products (Lantus®, Basaglar®, Semglee®)

The best resources to determine if products may be substituted without prescriber approval are the FDA Orange Book and Purple Book.

PAAS Tips:

  • Review FDA Orange Book or Purple Book for information about equivalency and interchangeability
  • Call PAAS National® at (608) 873-1342 if you are unclear if products may be substituted without prescriber approval
  • Find more details about Medi-Span® GPI here

Audit Issue: Patient or Prescriber Denials of Prescriptions

PAAS National® analysts have seen numerous PBM audit results where pharmacies had recoupments related to patient or prescriber denials of medications. Pharmacies are able to appeal by obtaining signed statements to overturn the denials.

In certain instances, such as investigations, PBMs are reaching out to both patients and prescribers to validate pharmacy claims. Presumably, PBM auditors/investigators are independently collecting evidence to ensure that “the stories match” to determine if pharmacies are acting in good faith. Unfortunately, they typically presume guilt until proven innocent.

Patients may be sent official letters from PBMs asking various questions detailing the interaction with your pharmacy. Here are some common questions that letters may include:

  1. Did you receive the following prescriptions?
  2. Did you authorize the pharmacy to refill the following prescriptions?
  3. Did you pay the copay?
  4. Did the pharmacy offer you a discount on your copay?
  5. How did you receive the following prescriptions (in-person, delivery, mail)?

Some patients may not remember the details of a prescription from years ago, or be scared to answer incorrectly, and decide to not respond. If a patient fails to respond to such a request, this non-response may be deemed a denial, and thus the pharmacy is presumed guilty.

Additionally, PBMs are reaching out to prescribers to determine if prescriptions were authorized to confirm legitimacy. Like patient denials, a non-response from a prescriber’s office paints the pharmacy as guilty (even if you have a date/time stamped electronic prescription – absurd!). Other issues that may come up include prescriber moving practices, retiring or if the pharmacy accidentally billed the claim under the wrong prescriber’s NPI.

If you receive audit results that include recoupments for patient or prescriber denials, consider the tips listed below to help you in your response.

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.

Insulin for a Pump – Medicare B or Medicare D?

PAAS National® analysts are frequently asked how insulin for a pump should be billed for Medicare eligible patients. Incorrect billing has caused very high dollar recoupments for some pharmacies. Be sure you know how to correctly bill your patients’ insulin.

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.

Caremark Complex Compounds

PAAS National® analysts have recently worked with multiple pharmacies that received Compound Contract Violation notices from Caremark stating that the pharmacy must cease and desist submitting claims for “complex compounds” and reverse claims provided on an attached list. Letters state that failure to comply could result in network termination. In one instance, the notice was labeled “Second notice” and referred to a previously issued “First notice” reportedly issued in 2020, however the pharmacy had no record of the prior notice.

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.

Cash Copay Collection

Numerous PBMs are conducting audits and asking for proof of copay collection. This is relatively easy to respond to (albeit annoying) when patients have paid by check or credit card as there is a “paper trail” of the financial transaction. PAAS National® analysts have seen some pharmacies struggle to provide evidence of cash transactions as they do not have sophisticated point-of-sale systems that record the method of payment or they lack consistent cash handling policies and procedures, or both.

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.

Small Differences Between Prescription Directions and Patient Label Can Lead to BIG Recoupments

PAAS National® recommends attention to detail when it comes to typing directions for patient labels. Many PBMs require the patient label directions match the prescription directions exactly, or a pharmacy may face recoupment for a “misfilled” prescription.

Errors on the patient label can range from simple typos to dosing errors. Even seemingly innocuous additions to the patient label (e.g., a diagnosis code or time of administration) can lead to potential audit discrepancies when added without prescriber approval (or documentation). If the prescription directions are clarified with the prescriber’s office, make sure to add a clinical note and update the patient label. See our November 2020 article Are Your Pancreatic Enzyme Prescriptions Audit Ready? for a common issue between the prescription directions and patient label.

Another problematic patient label issue PAAS frequently sees is regarding units. Consider Victoza®, which typically has directions in mg, but has often been mistyped as mL. See our January 2021 article Victoza – One Letter Can Cost You! for more detail.

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.

  • Label directions should be typed exactly as they appear on the prescription and mathematically calculable for days’ supply
    • PBMs look to recoup on a prescription/label mismatch when it could cause a clinical error or if it appears that a clinical annotation was added after the prescription was dispensed
    • Adding the route of administration is typically not an issue unless the route added is incorrect (see our September 2019 article Route of Administration is Important)
  • If clarifying directions with the prescriber, the updated directions need to be included on the patient label
  • Examples of instructions that should be clarified:
    • Sliding Scale Insulin without a max daily dose, pancreatic enzymes taken with meals and snacks, and instructions to be taken “As Needed” should have a maximum daily dose
    • “Use as Directed” – per package? Off-label? See PAAS Newsline article February 2022 Use Care with Unit of Use Packages and “Use as Directed” for more information
    • Topical products should ideally contain a mathematically calculable amount to be applied per application or maximum per day. See our Topical Creams and Ointments days’ supply chart for more details
  • Diagnoses should only be included if written by the prescriber
[/paasblur]

Billing the Correct Insulin for Use in a Pump

Insulin is a very popular audited drug category due to its complexity, frequency of use, and high cost. When used in conjunction with an insulin pump, it adds another layer of complexity.

One of the reasons insulin claims for Medicare Part D patients are commonly audited is because the PBMs can’t identify if the patient is self-administering (and Part D is responsible) or using in a pump (where Part B may be responsible) at adjudication. PBMs may isolate insulin claims if a member does not have any syringes being billed to Part D along with their insulin. The pharmacy should always verify with the patient or prescriber if insulin is being used in a pump.

Billing the wrong type of insulin for a pump can also result in large audit recoupments. See the tips below for which insulin types should, and should not, be used in an insulin pump.

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.

Hackers Don’t Sleep, Your PHI is At Risk! What Are Your Safeguards?

Pharmacies, big and small, may find themselves on the probing end of a hacker’s criminal scheme designed to access and steal protected health information (PHI). Recently, CVS Pharmacy, Inc., Ravkoo (affecting Amazon Web Services), and Florida-based BioPlus Specialty Pharmacy Services LLC have all been targets of malicious actors after PHI. It comes as no surprise that the U.S. Department of Health and Human Service’s Office for Civil Rights (OCR) 2022 first quarter Cybersecurity Newsletter reported an increase in cyberattacks from 2020 to 2021. According to the OCR’s report, cyberattacks and “IT incidents” accounted for 66% of breaches affecting 500 individuals or more, and according to the 2020 Data Breach Investigations Report by Verizon, over 80% of data breaches due to hacking were from weak authentication requirements.

Having safeguards in place to detect, and prevent, unauthorized users from accessing PHI and electronic PHI (ePHI) is a requirement for all covered entities as outlined in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and clarified by the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009. Although ePHI is usually the target of cyberattacks, it is important to be aware of the potential for internal breaches as well, some of which may be the result of inadequate policies and procedures, not necessarily malicious actors. Rite Aid pharmacy chain found out the hard way that tossing medication vials with patient information into their regular trash bins was not the correct way to dispose of PHI. Rite Aid’s $1 million settlement for having insufficient internal policies and procedures for handling PHI can serve as a reminder of the importance of evaluating your own HIPAA policies and procedures. In fact, periodically reviewing your security protocols and correcting your security shortcomings is a HIPAA Security Rule requirement.

PAAS National® has a customizable Fraud, Waste & Abuse (FWA) and HIPAA Compliance Program with tools and resources to help pharmacies meet HIPAA and HITECH compliance requirements. The PAAS FWA/HIPAA Compliance Program walks members through setting up a robust compliance program which includes:

  • appointing HIPAA Privacy and Security Officers,
  • performing a Risk Analysis to identify and document threats and vulnerabilities that may impact ePHI,
  • developing administrative, technical and physical safeguards to protect ePHI,
  • developing customized HIPAA Policies and Procedures (including proper PHI disposal, security reminders, access controls, prevention of malicious software, etc.),
  • online HIPAA training and much, much more!

Having a robust HIPAA Compliance Program and an educated workforce that is fully engaged in protecting PHI can greatly reduce the risk of unauthorized access to PHI and ePHI. Don’t be the weak link and have no plan in place – it’s the law!

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.