Off-label use refers to the practice of prescribing a medication for a purpose, dosage, patient group, or form of administration that has not been approved by the FDA.
Healthcare providers may consider off-label prescribing when they believe it is medically appropriate for a patient’s condition, even though the specific use is not included in the FDA-approved labeling. For example, a drug approved to treat one type of cancer might be used off-label to treat a different type of cancer.
There continues to be interest in ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.
For humans, ivermectin tablets are approved at specific doses to treat some parasitic worms, and there are topical formulations for head lice and skin conditions like rosacea (see DailyMed for Indication and Usage section).
Off-label use carries both potential benefits and risks. While it can provide access to “potentially” effective treatments not otherwise available, it also means that the medication has not undergone the same level of scrutiny by the FDA for the specific use, which may lead to unforeseen adverse effects. Therefore, healthcare providers must weigh the available scientific evidence and consider the patient’s specific circumstances before prescribing medications off-label.
Questions you may want to consider:
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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.
Off-Label: Why Drugs Like Ivermectin Spark Debate
Off-label use refers to the practice of prescribing a medication for a purpose, dosage, patient group, or form of administration that has not been approved by the FDA.
Healthcare providers may consider off-label prescribing when they believe it is medically appropriate for a patient’s condition, even though the specific use is not included in the FDA-approved labeling. For example, a drug approved to treat one type of cancer might be used off-label to treat a different type of cancer.
There continues to be interest in ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.
For humans, ivermectin tablets are approved at specific doses to treat some parasitic worms, and there are topical formulations for head lice and skin conditions like rosacea (see DailyMed for Indication and Usage section).
Off-label use carries both potential benefits and risks. While it can provide access to “potentially” effective treatments not otherwise available, it also means that the medication has not undergone the same level of scrutiny by the FDA for the specific use, which may lead to unforeseen adverse effects. Therefore, healthcare providers must weigh the available scientific evidence and consider the patient’s specific circumstances before prescribing medications off-label.
Questions you may want to consider:
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:
USP 800 Compliance Program Updates: NIOSH 2024 List
USP 800 outlines the standards for healthcare providers that handle hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH). Pharmacies that handle hazardous drugs (including carbamazepine, clonazepam, colchicine, and cyclosporine – these are just a few of the “C” drugs – there are over 400 unique drug/dosage forms in all that must be considered) should have a list of all hazardous drugs in their pharmacy, specific policies and procedures on how they will receive, store, and dispense these drugs, and provide staff training on specific policies and procedures. Pharmacies are also required to label the hazardous drugs to ensure staff are aware of occupational risks. Additionally, an “assessment of risk” must be performed and documented for each unique hazardous drug and dosage form to determine appropriate safety measures and minimize exposure.
NIOSH recently released the updated 2024 List of Hazardous Drugs in Healthcare Settings in December 2024. This list replaces the previously official 2016 list and must be incorporated into the USP 800 compliance programs for all healthcare entities as soon as possible.
The “2024 list” has various changes including:
PAAS National®’s USP 800 Compliance Program has been updated to incorporate these changes and pharmacies utilizing the PAAS program will need to login to the Member Portal and perform the following steps to maintain compliance:
PAAS Tips:
Keeping Your Suboxone Claims Safe from Recoupment
As of December 29, 2022, the DEA no longer requires prescribers to include a DATA 2000 Waiver ID (commonly called an “XDEA number”) on buprenorphine prescriptions used to treat patients with opioid use disorder via the Consolidated Appropriations Act of 2023. With additional prescribers now able to issue prescriptions, and opioid dependence still plaguing America, oral buprenorphine products remain commonly used and filled by local pharmacies.
A frequent problem that PAAS National® analysts see on audits is …
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:
Medicare Billing for Insulin Pump Therapy
Pharmacies billing insulin vials for eligible Medicare patients must pay extra attention to ensure proper coverage. Since the frequency of dispensing insulin vials has greatly decreased due to the introduction of insulin pens, it is very important pharmacies take a pause and investigate how the patient is utilizing the insulin vials.
Medicare covers insulin vials both for self-administration via injections and when used in an insulin pump. When used in a pump, pharmacies must determine if Medicare Part D or Part B is appropriate. Confirming the correct billing falls on the shoulders of the pharmacy as the Medicare D plans will not reject claims at the point of sale. Incorrect billing is often not identified until months or even years down the road with limited ability for pharmacies to rebill.
PAAS National® has created a tool for pharmacies to help determine which Part of Medicare to bill. Considerations for Billing Insulin Vials: Medicare Part B vs Part D can be found on our website under Proactive Tips. Sharing this guidance with your pharmacy staff can help avoid costly recoupments.
PAAS Tips:
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:
Oral Inhalers – What You Need to Know About Institutional Pack Sizes
Oral inhaler prescriptions are frequently targeted for audit by PBMs because of their cost, frequent billing errors (e.g., incorrect days’ supply), or prescribing errors (e.g., non-mathematically calculable directions or incorrect written quantity). Vague written quantities can cause recoupments when multiple package sizes exist, including institutional package sizes.
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:
Is Your Pharmacy Prepared for a Cyberattack?
In this episode of The Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP and Austin Murray sit down with Trenton Thiede, President of PAAS National®, to unpack the rising cybersecurity threats facing independent pharmacies and what owners must do to stay compliant and protected.
We dive into:
Tune in by clicking on one of the links below:
FDA Approves First Rapid-Acting Insulin Biosimilar: MerilogTM (insulin aspart-szjj)
On February 14, 2025, the FDA approved the first rapid-acting insulin biosimilar, MerilogTM (insulin aspart-szjj) manufactured by Sanofi Aventis. MerilogTM is expected to reach the U.S. market in July 2025 and will require prescriber approval before pharmacies can substitute for other insulin aspart products such as Fiasp® or NovoLog®.
MerilogTM is the third insulin biosimilar approved by FDA (along with RezvoglarTM and Semglee®).
PAAS Tips:
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:
Audit and Appeal Due Dates: Stay Ahead of the Clock with These Essential Tips
Pharmacy practice often revolves around meeting tight deadlines. Prioritizing can become challenging when you’re focused on providing prompt service to waiting patients or rushing to meet inventory ordering deadlines, all while managing your daily tasks. It’s tempting to push aside a PBM audit request, or its results, to tackle more immediate responsibilities. Unfortunately, neglecting audit or appeal due dates can lead to significant, and unnecessary, financial losses to the PBMs.
One of PAAS National®’s top priorities is helping pharmacies navigate the audit process successfully from start to finish. Remember to engage PAAS early by submitting your audit notice or audit results as soon as you receive them. Discussing your audit notice or results with your assigned analyst early can help you avoid unnecessary work when putting documentation together. This can also eliminate providing unnecessary information to auditors.
A great way to begin is by establishing a workflow process when audits are received. The following tips can assist you with a more efficient and effective audit outcome.
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:
Mailing Prescriptions? How to Ensure Audit Success
While some pharmacies make mailing prescriptions a regular practice, others may only do so on a case-by-case basis. PBMs require signature logs to prove that a patient received their medication in a timely manner, but how is proof obtained when the patient is not standing in front of you at the pharmacy counter?
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:
Audit Considerations for Med Sync Programs
Medication synchronization (med sync) programs are common across pharmacies and yield many benefits. Patients can request it to manage medication better and reduce the number of trips needed to the pharmacy. Patient adherence increases and pharmacies can keep tighter control over inventory while having more efficient workflow.
NCPA promotes the improved adherence and quality of care through med sync programs. They call it a “once a month appointment day” for patients enrolled, saying pharmacist-patient dialogue increases with more time to focus on additional patient care services.
NCPA collaborated with the Arkansas Pharmacists Association to conduct a study measuring the impact of med sync programs on medication adherence and persistence across 82 independently owned pharmacies. The workflow tool was provided to the pharmacies by PrescribeWellness operating on 13 pharmacy management systems. Over 8,000 patients enrolled for this year-long retrospective cohort study. The key findings state that med sync patients are over 2.5 times more likely to be adherent to medications and 21% less likely to discontinue drug therapy. For more details, see the Study Overview and Full Report.
It’s a win all around – until it poses a waste or abuse issue. PBM audit algorithms are made to seek out fraud, waste, and abuse. PBMs will flag pharmacies for audit if claims are billed particularly early every month; for example, every 23 days on a 30 day’s supply.
PAAS National® recommends …
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: