Centers for Medicare and Medicaid Services (CMS ) did not enforce clinical indications for specific product categories during the Public Health Emergency (PHE), including Continuous Glucose Monitors (CGMs). During this time, the provider only needed to indicate the CGM and related supplies were reasonable and necessary. Pharmacies had to identify that these claims were excluded from enforcement by submitting a Catastrophe/Disaster Related (CR) modifier and a COVID-19 narrative on those claims.
Now that the PHE has ended and CMS is enforcing clinical indications for CGMs and supplies, pharmacies are left wondering what will happen with continued or refilled claims for CGM related supply items initially provided during the PHE under the waiver/non-enforcement.
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.
Post-PHE Claim Submission Requirements for Continuous Glucose Monitors
Centers for Medicare and Medicaid Services (CMS ) did not enforce clinical indications for specific product categories during the Public Health Emergency (PHE), including Continuous Glucose Monitors (CGMs). During this time, the provider only needed to indicate the CGM and related supplies were reasonable and necessary. Pharmacies had to identify that these claims were excluded from enforcement by submitting a Catastrophe/Disaster Related (CR) modifier and a COVID-19 narrative on those claims.
Now that the PHE has ended and CMS is enforcing clinical indications for CGMs and supplies, pharmacies are left wondering what will happen with continued or refilled claims for CGM related supply items initially provided during the PHE under the waiver/non-enforcement.
PAAS Tips:Join today!
- 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
- 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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Appropriate Billing for CeQur SimplicityTM Patch and Insulin
CeQur SimplicityTM is a meal-time insulin patch which can be worn for up to three days and is designed to replace up to nine meal-time insulin doses for type 1 or type 2 diabetic patients. The patch delivers rapid-acting insulin in 2-unit doses through a flexible cannula by depressing two buttons, one on each side of the patch.
Use the following information when billing CeQur Simplicity TM patches and the rapid-acting insulin used within the patch to decrease your risk of recoupment upon audit.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Quantity Changes Cause Audit Appeal Trouble
PAAS National® is seeing more discrepancies for “unauthorized” refills on audits and PBMs continue to make these discrepancies difficult to appeal.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Insulin For a Pump: The Recoupment You Never Saw Coming
There are many billing pitfalls related to insulin claims, which is why auditors love to target them. The claim can face recoupment for a missing or incorrect strength, formulation, substitution, days’ supply calculation and so on, but one recoupment many pharmacies never see coming is insulin for a pump being inappropriately billed.
Even if your pharmacy is not enrolled as a Medicare Part B supplier, you are still responsible for knowing how the patient is using their insulin because it determines which Medicare benefit is responsible for payment. If the claim is inappropriately billed to Medicare Part D, it would face full recoupment upon audit. PBM algorithms can easily pick out these claims when insulin vials are routinely being billed without insulin syringes. Additionally, the type of pump can impact the amount of insulin covered due to pump capacity and how frequently the disposable pump must be changed. To prevent chargebacks during an audit, pharmacies must be aware of the intricacies related to insulin pumps and the insulin used within them.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
On-Demand Webinar: Audit Preparation for the End of the Public Health Emergency
On May 4, 2023, PAAS National® hosted a webinar: Audit Preparation for the End of the Public Health Emergency. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.
For easy viewing, we’ve split the webinar into three separate recordings.
Should you have any questions, or need assistance getting access, call 608-873-1342 or email info@paasnational.com.
Ozempic® Package Size Change
In March 2023, Novo Nordisk introduced a new pen size for the 0.25 mg and 0.5 mg dose of Ozempic®. The previous pen was a 1.5 mL and the new pen is 3 mL. All strengths of Ozempic® now come in 3 mL pens. Pharmacies have frequently asked how this change affects patients’ current prescriptions.
PAAS National® analysts recommend pharmacies…
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk
Pharmacies continue to see a large number of prescriptions for GLP-1 medications like Ozempic® and MounjaroTM and have concerns about the risk of PBM audits and recoupments. While PAAS National® sees audits for these medications every day, there are only a few audits where the PBM has pursued recoupment for off label use. However, with continued popularity of these medications, audit practices may change.
PAAS National®® previously discussed this topic in our February 2023 article, Ozempic® and MounjaroTM Prescriptions – Between a Rock and a Hard Place which included an in-depth discussion on the background of how PBM adjudication systems appear to handle these medications. Outlined below is a systematic approach that we suggest pharmacies consider when evaluating which scenarios pose the most audit risk and how to balance patient care, pushback from patients & prescribers, and audit risk.
Three different scenarios, ranked from lowest to highest risk:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Continuous Glucose Monitors and Potential Audit Risk with PHE Ending
As the COVID-19 Public Health Emergency (PHE) declaration comes to an end on May 11, 2023, preparing for some changes to current flexibilities, actions and waivers that have been in place since COVID-19 began is crucial. While clinical indications for Continuous Glucose Monitors (CGMs) have not been enforced by Medicare during the PHE, PAAS National® advises pharmacies to take special precaution for any patients who obtained a CGM during this time.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
PBMs on the Hot Seat in Key Legal and Administrative Battles
In a not-so-strange turn of events, pharmacy benefits managers (PBMs) are under scrutiny for alleged legal and administrative violations in states with robust PBM reform. Additionally, the United States Senate Committee on Finance gathered insight from experts at an official hearing on PBM reform. Although the legal disputes and senate hearing are seemingly unrelated, together they offer optimism that PBM conduct will continue to be questioned in state and federal spotlights.
Ohio Attorney General Sues Multiple PBMs for Anticompetitive Practices
The Ohio Attorney General has filed a lawsuit against Express Scripts, Prime Therapeutics, and Humana Pharmacy Solutions, among other subsidiary and parent entities. The filing alleges that the three largest PBMs (Caremark, Express Scripts, and OptumRx) which control more than 75% of market share use mutually owned group purchasing organizations (GPOs) to collude on drug rebate negotiations. This produces a monopolistic environment which may benefit PBMs and harm patients by inflating drug list prices. Ohio’s Valentine Act prohibits such practices and is punishable by fines and banishment from doing business in Ohio.
CVS Caremark Faces Administrative Action in Oklahoma for Steering Practices
The Oklahoma Insurance Department, an agency responsible for PBM oversight, has filed administrative action against CVS Caremark for allegedly violating the Oklahoma Patient Right to Pharmacy Choice Act. The notice of hearing outlines over 100 instances where Caremark misinformed patients regarding their right to use an in-network pharmacy of their choice for 90-day drug supplies. Caremark coerced patients to use pharmacies they owned by rejecting drug claims and then telling patients via phone that they must use CVS or their mail-order pharmacies. Furthermore, upon initial warning by authorities, Caremark sent letters to patients falsely stating that they could no longer obtain 90-day drug supplies due to action by the Oklahoma government.
U.S. Senate Hearing on PBMs and the Drug Supply Chain
The U.S. Senate Committee on Finance heard from a panel of economists, business experts, and law experts to gather insights into the need for federal PBM reform. Throughout the hearing, Senate members demonstrated thorough understanding of the harms of PBMs by asking questions about rebate aggregation, increasing drug list prices, vertical integration within the healthcare system, and direct and indirect remuneration fees. Senate members called for more transparency in PBM practices and continued efforts to regulate the PBM industry. Watch the recording here.
PAAS Tips
HIPAA Breach Notification Letter Sent to 82,466 Patients Due to Improperly Shared Data
According to the U.S. Department of Health and Human Services breach portal, the mail-order pharmacy Healthy Options dba Kroger Postal Prescription Services (PPS) reported a breach of information which affected 82,466 patients. Kroger’s March 10, 2023 press release described the incident as “an internal error” which caused patient names and email addresses affiliated with Kroger PPS to be “improperly shared with its affiliated grocery business”.
This breach comes two years after the Accellion incident which also affected Kroger. Accellion is a company which provides secure third-party data file transfer services to businesses, one of which was Kroger. Their services were used to send human resources data, pharmacy patient information, clinic patient information, and money services records through secure file transfers. Kroger’s internal review indicated the Kroger systems were not directly accessed, and that the information was obtained only through Accellion. Kroger cut their ties with Accellion and sent out HIPAA breach notification letters to the affected individuals.
As these two incidents illustrate, breaches can happen—sometimes they are malicious in nature and sometimes it is due to poor training or lack of appropriate safeguards. PAAS National® analysts suggest regularly evaluating your pharmacy’s HIPAA compliance program and implementation to identify deficiencies so improvements can be made in a timely manner. If you are not sure where to begin or what a “top of the line” HIPAA program looks like, just contact us (608) 873-1342 for a virtual overview of the PAAS National® Fraud, Waste and Abuse and HIPAA Compliance Program. We are here to guide you through compliance – get started today.