Best Practices: Medication Delivery

With the Public Health Emergency (PHE) for COVID-19 ending May 11, 2023, a return to pre-pandemic requirements for proving patient receipt of medications is anticipated. Many pharmacies have gotten into the habit of leaving medications at the door or in the mailbox for patients over the last three years and noting “Impacted by COVID-19” in place of a signature. Unfortunately, some pharmacies have run into problems with this procedure during audits due to patients deny ordering and/or receiving these medications. In some instances, the patient passed before the medications were delivered.

Review the PAAS Tips below to see what pharmacies can do to avoid audit problems when delivering medications.

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.

Prepare Yourselves! Onsite Audits Are Coming in Strong

Health and Human Services (HHS) is planning for the public health emergency (PHE) to expire on May 11, 2023 and PBM auditors are in full swing of resuming their onsite visits. Onsite audits have always been the most aggressive and highest risk to community pharmacies. PAAS National® saw a 300% increase in onsite audits in just the 3rd Quarter of 2022 and they continue to be on the rise! PAAS analysts have years of experience helping our members navigate through preparation for an onsite audit. We are available to assist you throughout your audit process starting with, How to Prepare for an Onsite Audit.

Your PAAS analyst can provide pre-audit consultations, helpful tips and tools, reminders on state law requirements, and discuss current PBM trends. Our Onsite Credentialing Guidelines document has been created specifically to help pharmacies be ready for questions the auditor may ask during their visit. This tool is updated frequently to provide members the most up to date information along with providing PAAS National® FWA/HIPAA Compliance members reference to locate specific policies in their customized FWA/HIPAA Compliance Policy & Procedure Manual.

PAAS Tips:

Contact PAAS National® (608) 873-1342 today to get your customized FWA/HIPAA compliance program! Or schedule a service overview of the program to see why it was designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program.

A Documentation Checklist for Continuous Glucose Monitor Claims

For any item to be covered by Medicare B, there must be clinical documentation to support the covered diagnosis, prove it is reasonable and necessary for treatment and meet all other Medicare requirements. While the Local Coverage Determination (LCD) outlines billing and documentation requirements specific to each DMEPOS item, and the DME MACs created documentation checklists for each DMEPOS item, they tend to be verbose and difficult to read. Additionally, during the COVID-19 PHE, CMS expressed enforcement discretion on clinical indications for Continuous Glucose Monitors (CGM). Prescribers, and pharmacies, only needed to make sure the medical record reflected the equipment furnished to patients was reasonable and necessary. The LCD for CGMs was updated 3/2/2023 with an effective date of 4/16/2023, although the enforcement discretion seemingly coincides with the end of the PHE on 5/12/2023. The CGM checklist listed below can help suppliers in adhering to all of Medicare rules in simplified terms.

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.

Express Scripts Provider Manual – 2023 Updates

All PBMs update their Provider Manuals at regular intervals and Express Scripts (ESI) is no exception. Express Scripts released an updated version of their Provider Manual in January 2023 and provided a “summation of changes” document for network pharmacies that provides a brief description of the changes and where in the Provider Manual the change occurred. Here are important changes that may impact audits:

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.

Black Market HIV Medications Are Not Worth the Savings!

According to a statement released by the U.S Attorney’s Office in the Southern District of New York, five individuals were arrested the morning of March 2, 2023 as a result of defrauding government insurance plans, including Medicaid and manipulating low-income individuals out of their HIV medications from July 2020 through February 2023. This resulted in $15 million worth of illegitimate payments to the pharmacy from government insurance plans. Instead of purchasing the HIV medications through accredited distributors, the pharmacy opted to buy HIV medications from the black market, totaling over $6 million worth of purchases.

In the fraud scheme, an individual sold the black-market HIV medications to a pharmacy store owner with two pharmacy locations in Bronx, New York. He subsequently dispensed the black-market medication to patients with HIV in addition to submitting fraudulent insurance claims for profit. The other three indicted individuals were employed by the pharmacy and assisted the pharmacy owner in paying illegal kickbacks to incentivize patients to use their pharmacy for their HIV medications. To make matters worse, the pharmacy team encouraged patients to sell their HIV medications back to the pharmacy, foregoing the treatment meant to control their HIV infections. The five individuals are looking at time in prison varying from 27 to 47 years if sentenced to the maximum.

Although this is a case that shows blatant intent of actions, the basis still applies:

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.

PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program keeps members compliant beyond training and exclusion checking. If you aren’t a member of FWA/HIPAA and are interested in saving $129 on your membership, please contact PAAS at (608) 873-1342.

Be On the Lookout for Prescription Reversal Requests from Humana

Humana periodically performs retrospective claim reviews. If upon review Humana determines a claim was billed in error (i.e., after the Humana coverage was terminated), the pharmacy will get a prescription reversal letter. The reversal letter will include a claim detail report listing the claims and dates of service for member(s) who no longer had coverage with Humana at the time the claims were billed. Please see the PAAS Tips below for guidance on what steps to take if your pharmacy receives one of these prescription reversal requests.

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.

Nuedexta® National Audit: A Tale of Medically Accepted Indications

PAAS National® stresses the importance of medications being prescribed for a medically accepted indication (MAI), particularly for Medicare, Medicaid and Tricare, as this carries an audit risk that is difficult to overturn on appeal. Nuedexta®, a medication approved for the treatment of Pseudobulbar Affect, or PBA, underwent a national audit conducted by Centers for Medicare & Medicaid Services (CMS) and Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC). PBA disorder is a neurological condition that results in an individual experiencing “emotional lability”. However, the FDA chose to use a more specific definition of PBA when determining Nuedexta®’s MAI. According to Section 1 – “Indications and Usage” in the package insert, it states “PBA occurs secondary to a variety of otherwise unrelated neurologic conditions…” and is a “specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”

CMS’ desire to conduct a national audit was substantiated by the fact that in September 2019, Avanir Pharmaceuticals, Inc., the manufacturer of Nuedexta®, paid over $95 million to the Department of Justice (DOJ) to resolve allegations of kickbacks and false or misleading marketing efforts that lead to long-term care patients being prescribed Nuedexta® outside of the MAI. Therefore, the goal of the Nuedexta® National Audit was to assess for fraud, waste, and abuse associated with the medication in addition to the risk the medication poses if not used in a clinically supported manner.

From January 1, 2019 through December 31, 2020, select plan sponsors were asked to submit prescription drug event (PDE) documentation that would substantiate their coverage of Nuedexta®. According to the results, CMS agreed with most of the prior authorization parameters put in place by plan sponsors. In the instances that documentation was improper, CMS had plan sponsors address their process that resulted in Nuedexta® being covered inappropriately, such as relying on patients’ historical medical claims or information from prior coverage requests instead of clarifying Nuedexta®’s intended use with prescribers or denying prior authorization requests on the basis of non-MAI uses. In conclusion, CMS is requesting all plan sponsors to evaluate their coverage and payment of Nuedexta® based on their formulary and utilization management edits in place, to prevent Nuedexta® from being used outside of its MAI.

PAAS Tips:

  • Be mindful of a medication’s indication for patients on government sponsored health plans to ensure you are lowering your risk for audit
  • Use pharmacist drug utilization reviews to your advantage to ensure medication is being used properly. Do not disregard or bypass system flags without due diligence.

Discount/Cash Cards Are Disruptors in the Industry

NCPA Multiple Locations Conference Panel Discussion Part 1 of 2

On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023.

IQVIA published a white paper entitled Pharmacy Discount Card Utilization and Impact in August of 2022 with several interesting findings. Among them, discount card utilization has grown to 5.4% of all pharmacy adjudications in 2021, a 63% increase over 2017 – of which “Not So GoodRx” now represents 46%. Only 9% of discount card transactions are for branded products. For Medicare patients, nearly 1 in 5 (19%) used a discount card. Commercial patients were 12%, but that doubled to 24% for those with an observed deductible. Cash paying patients represented 56% of all patients, and 52% of transactions.

While the discount card growth has been remarkable, what makes them disruptors in the industry has been their impact on the traditional PBM model. Discount cards have been effective at undermining the perceived benefit that PBMs are supposed to provide (i.e., why is GoodRx able to offer a better price on my prescriptions than my insurance).  Additionally, patients’ out of pocket costs are typically not captured when they use discount cards unless a patient is going to submit claims on their own (in addition to gaps in adherence metrics and other quality measures). In response, Express Scripts announced a partnership with GoodRx to include a “lesser of” logic when processing prescription claims through their Price Assure program. Not to be outdone, OptumRx launched Price Edge which will review direct-to-consumer prescription drug prices and offer members the lowest available price. Comically, OptumRx said they currently offer the best price to their members about 90% of the time, meaning 10% of the time patients are getting a raw deal. Both of these programs are automatically including these drug purchases into member’s deductibles going forward.

Pharmacies know that discount cards are really just another form of spread pricing, benefiting the discount card provider and PBM. GoodRx reports that it earns 15% of the patient’s total retail prescription cost, and that doesn’t include a fee for the PBM processor. Interestingly, GoodRx had disclosed that Kroger had accounted for only 5% of participating pharmacies, but nearly 25% of prescription transaction revenue. How could it have been that high? As a chain, Kroger was more likely dutiful in their utilization and/or promotion of GoodRx for patients. Most independents despise GoodRx and will create work arounds to avoid utilizing the card (e.g., with aggressive cash pricing or price-matching). Pharmacies should always be careful not to jeopardize their usual and customary. With the integration from these new programs by the PBMs, bypassing discount cards will likely no longer be an option for insured patients. The impact on BER, GER and even DIR fees for 2023, and beyond, are not clear.

Speaking of jeopardizing your Usual & Customary pricing, Amazon’s RxPass should be a flop. If you haven’t heard or read about it, Amazon is offering their Prime members “eligible medications for one flat, low monthly fee of $5, and have them delivered free of charge”. Patients with Medicare, Medicaid, or located in one of the seven states they exclude are not eligible to participate. The broader question is how long it will take the DOJ and HHS-OIG to enforce the U&C issue that has already played out with Walgreens (and many others). PAAS previously illuminated the $60 million settlement with the Prescription Savings Club in a March 2019 Newsline: AVOID “Discount Clubs” for Cash Patients. That same DOJ announcement also discussed the infamous Insulin Pen Box Settlement for $200 million. Amazon clearly missed this settlement, as the PillPack subsidiary paid a $5.79 million settlement in May 2022 for the same insulin pen dispensing practices.

Stay tuned for our second core issue from the NCPA MLC panel discussion in the April 2023 Newsline where we’ll discuss biosimilar adoption, insurance coverage and audit risks.

Not-So-GoodRx Reprimanded $1.5 million for Sharing Consumers’ Information

The article GoodRx Shares Consumer Data appeared in the April 2020 Newsline, which pertained to GoodRx sharing their consumers’ data with various platforms, including Facebook and Google. Key information from the article include:

  • Both Facebook and Google denied utilizing information, specifically personal health information, obtained from GoodRx to target ads to mutual consumers.
  • Despite Facebook and Google’s claims, GoodRx did issue an apology for their role they played in sharing consumer information to the platforms and vowed to “do better”
  • Since GoodRx is “a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it”

One could speculate that GoodRx was hoping this would be the end of the ordeal. However, it was not.

For the first time, the Federal Trade Commission (FTC) has enforced the Health Breach Notification Rule, due to “GoodRx Holdings Inc…failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google, and other companies.” Pending federal court approval, the Proposed Order will include numerous provisions that GoodRx will need to follow, including:

  • Prohibited from sharing user health data with applicable third parties for advertising purposes
  • Require user consent for sharing health information outside of advertising purposes
  • Implement a privacy program which includes safeguards from unauthorized access to user data
  • Mandatory outreach to third parties requesting consumer health data be deleted and disclose information about the breach of their health information and FTC’s legal action to consumers
  • Limit the amount of time consumers’ health information will be retained
  • Make available to the public how long their information will be retained, what information is collected, and why the information collected is necessary
  • Pay a civil penalty of $1.5 million due to “sharing sensitive personal health information for years with advertising companies and platforms -contrary to its privacy promises…”.

As alluded to above, GoodRx is not a HIPAA covered entity and therefore not legally bound to the same notification rules as covered entities. As such, patients should be made aware of this if they choose to upload information into GoodRx’s app or website or request that a pharmacy submit claims information to GoodRx. Patients can refer to  GoodRx’s updated “Privacy Policy” for more information.

Proof of Copay Collection – Secondary Payers Hidden in Plain Sight

If your pharmacy has not had to deal with proof of copay collection on an audit, your time is coming. More frequently, PBM auditors are comparing the copay amount on a point-of-sale receipt against the copay the PBMs expect based on the plan design and claim adjudicated. Copays are used by insurers to make patients aware of the cost of their medications and incentivize them to try less expensive alternatives. Waiving or discounting copays (unless permitted by law) or placing copays on a house account (with no intent to collect) are all fraudulent actions and may put your contract at 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.