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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If the provider is thinking about using an approved drug for an unapproved use, you may want to discuss the following:
- Are there other drugs or therapies that are approved to treat the disease or medical condition?
- What scientific studies are available to support the use of this drug to treat the disease or medical condition?
- Is it likely that this drug will work better to treat the disease or medical condition than using an approved treatment?
- What are the potential benefits and risks of treating the disease or medical condition with this drug?
- Will health insurance cover treatment of the disease or medical condition with this drug?
- Are there any clinical trials studying the use of this drug for the disease or medical condition that the patient could enroll in?
PAAS National® analysts have seen PBMs recoup medications being used off-label before. Medicare and Medicaid do not knowingly pay for off-label medication use. They employ a “pay and chase” model meaning that they assume the medication is being used for a medically accepted indication, so they pay the claim to ensure the patient is not inconvenienced – then they may audit the claim for appropriateness. Please see March 2022’s Newsline article, Off-Label Use Not Covered Under Medicare Part D, for more information.
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Electronic Prescriptions: Upcoming Changes to Quantity and Unit of Measure
The National Council for Prescription Drug Programs (NCPDP) is a not-for-profit organization that develops and promotes standards for the exchange of information within the pharmacy services space. This organization develops the e-prescribing SCRIPT standard as well as the pharmacy billed D.0 standard (among other things). NCPDP organizes numerous “work groups” with a variety of stakeholders representing industry, payers, and providers to solve problems related to the exchange of healthcare information between various stakeholders.
NCPDP recently announced upcoming changes to the e-prescribing SCRIPT standard that will impact the prescriptions that you will receive in the next 6-12 months. The following e-prescribing fields will see updates:
Enema
Kit
C42915
C47916
Microgram Inhaler
Milligram
Nebule
Pre-filled Pen Syringe
Syringe
Vial
C48152
C62275
C28253
C71204
C97717
C48540
C48551
Some of the QuantityUnitOfMeasure values are being reintroduced to reduce confusion and may help reduce audit liability. For example, e-prescriptions for Lantus® SoloStar® quantity of “15 EA” could be interpreted as 15 pens, 15 boxes, or even 15 mL. If prescribers begin to prescribe as “15 pre-filled pen syringes” this will be less confusing for dispensing pharmacies and likely reduce audit discrepancies (if eHR systems and prescribers use them).
PAAS National®® analysts often see PBM auditors challenging the interpretation of quantities on e-prescriptions, particularly when the unit of measure is “unspecified” or if the dosage form is a pre-filled pen syringe that comes with multiple syringes in one package (e.g., insulin pens or GLP-1 products).
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Are You Familiar with Qualified Medicare Beneficiary (QMB) Billing Obligations?
Qualified Medicare Beneficiary (QMB) is a program for patients that have Medicare Parts A and B coverage and qualify for additional coverage through Medicaid. This program assists low-income individuals with Medicare premiums and cost-sharing (copay coverage).
Providers, including pharmacies, are prohibited …
from charging QMB patients any Medicare cost-sharing/copay. If pharmacies submit a COB claim to Medicaid and a Medicaid copay remains, that is allowed to be collected. Pharmacies must be aware that many state Medicaid programs will reject a COB claim, or the reimbursement on the claim will be set at $0. Regardless of Medicaid’s rejection or reimbursement, the pharmacy is not allowed to charge the patient the Medicare cost-share/copay.
Pharmacies are most likely to encounter these situations when a dual eligible patient has a Medicare Advantage Plan (MAPD) and you are billing for Part B covered items like diabetic test strips, continuous glucose monitor supplies, or nebulizer drugs. Pharmacies may see a claim response of “Benefit Stage Qualifier (BSQ) 51” in NCPDP D.0 field 393-MV to alert you that items were covered under the Part B benefit and that balance billing is prohibited.
Pharmacies are very aware of PBM implications for waiving copays; however, this is an exception. By refusing to fill a QMB prescription or charging the patient a copay, you may be in breach of your Provider Agreement. This can result in PBM investigations and even Cease & Desist notifications.
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Preparing for Onsite Audit Success
Since the expiration of the COVID-19 Public Health Emergency in May 2023, PAAS National® has seen a significant increase in on-site audit notices from PBMs across the board. We have tools to help reduce stress and prepare your pharmacy for success ahead of the audit. Be sure to call PAAS promptly to open a case and send in your audit notice as soon as possible. We also recommend reviewing How to Be Prepared for an Onsite Audit under “Proactive Tips” on the Member Portal. Once your case is opened, an analyst will reach out to discuss the details. If you have specific questions about the audit, have them ready—our goal is to support you and help you succeed!
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Avoiding Recoupments: Why Accurate 11-Digit NDC Billing Matters
Matching all 11-digits of the NDC billed to the NDC dispensed is one critical step in ensuring the pharmacy has adequate records to support the appropriateness of every claim billed. This is one key element PAAS National® analysts discuss with members during consultations about invoice audits. The importance …
of the full 11-digit NDC billed also comes up when a pharmacy receives a notice from Humana indicating a claim (or multiple claims) are facing recoupment for billing an unlisted or invalid NDC.
These recoupment notices likely stem from claims identified by CMS through retroactive validation of Prescription Drug Event (PDE) records. The PDEs are compared to the FDA’s Comprehensive NDC SPL Data Elements (NSDE) File, an extensive database which includes NDCs, proprietary name, marketing category, application number, marketing start and end dates, billing unit of measure and more. Claims billed with an inactive or invalid NDC according to the data within the NSDE can be flagged by CMS in the PDE reviews.
When such claims are identified by CMS, they alert the plan sponsor (e.g., Humana) so the PDE can be corrected or reversed. This prompts Humana to reach out to the pharmacy to validate the claim data. Humana will send a notification to the pharmacy identifying such claim(s) by listing the member ID, date of service, prescription number and the original NDC submitted, then provide the pharmacy an opportunity to correct the NDC.
To validate the claim(s), the pharmacy has two options:
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OptumRx® Continues to Pocket More Money from Days’ Supply Issues
OptumRx® continues to maximize chargebacks on pharmacies due to days’ supply errors. It’s important to take the extra time to confirm billing elements are accurate prior to adjudicating – this could save you on the back end of an audit. The following is a common chain of events that happens when a pharmacy submits an incorrect days’ supply on a claim under audit.
OptumRx® will flag the initial fill of the prescription with an invalid days’ supply (1N) discrepancy and subsequently re-adjudicate the claim with the correct days’ supply. If the correct days’ supply increases the patient’s copay, the pharmacy will see the copay difference as recoupment. For example, an inhaler was billed with a 30-day supply and had a $20 copay, but it should have been billed as a 60-day supply (assuming no days’ supply limitation) and would have had a $40 copay. The recoupment difference would be $20. However, OptumRx® does not stop here. Since they found a discrepancy on the claim under audit, they will continue to look at all associated refills over the life of that prescription. The interval of time between each fill will be scrutinized to see if the pharmacy has refilled the prescription too soon according to the accurate [60] days’ supply. OptumRx® states in their provider manual on page 76 under Section H. Coverage Limitations,
“A Member may refill most Prescriptions when a minimum of seventy-five percent (75%) of the quantity is consumed based on the number of days supplied. This minimum quantity consumed amount is seventy percent (70%) for eye drops.”
In this example, let’s say the prescription was refilled every 30 days with a total of 6 refills. OptumRx® will flag every other fill as a refill too soon (2Z) and charge back the full amount of the claim. Now the recoupment has gone from one incorrect days’ supply to six incorrect days’ supply (1N) and three refill too soon discrepancies, assuming the pharmacy never caught the error. This causes the recoupment to alternate between the patient’s copay difference and the full claim, and this can add up very fast!
To see a more detailed example of this situation, please see October 2024 Newsline article, Avoid OptumRx® Double Chargeback Pitfalls – Review Your Days’ Supply.
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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:
If the provider is thinking about using an approved drug for an unapproved use, you may want to discuss the following:
PAAS National® analysts have seen PBMs recoup medications being used off-label before. Medicare and Medicaid do not knowingly pay for off-label medication use. They employ a “pay and chase” model meaning that they assume the medication is being used for a medically accepted indication, so they pay the claim to ensure the patient is not inconvenienced – then they may audit the claim for appropriateness. Please see March 2022’s Newsline article, Off-Label Use Not Covered Under Medicare Part D, for more information.
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 …
the splitting of buprenorphine/naloxone tablets and films. The package insert explicitly states that the tablets and films should be taken whole and not to cut, chew, or swallow. Films have been approved to be administered sublingually or buccally, where tablets are only approved to be taken sublingually.
The question remains of how to handle a prescription where the prescriber writes for Suboxone® splitting films or tablets. The best practice would be to contact the prescriber and ask for a second prescription for the lower strength instead of splitting, where possible. Suboxone® films are available in 4 different strengths: 2-0.5 mg, 4-1 mg, 8-2 mg, and 12-3 mg. Suboxone® sublingual tablets are available in 2 strengths: 2-0.5 mg and 8-2 mg. Interchanging between the Suboxone® products should only be done under prescriber supervision as the products are not bioequivalent.
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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.
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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.
Institutional size packages primarily exist to allow pharmacies to dispense a smaller package for acute care and institutional settings. The existence of these products can cause audit discrepancies when a prescription is written for a quantity of “1 inhaler” or “1 unspecified.” Many retail pharmacies have expressed to PAAS National® that they cannot order the institutional size packages, so they assume billing one inhaler at the retail quantity is sufficient – auditors disagree. If multiple package sizes exist (including institutional size packages), an auditor will insist that they do not know what quantity the prescriber intended and require you to obtain a prescriber statement clarifying the quantity on appeal.
How can you preemptively avoid this situation? PAAS has updated our Oral Inhalers Chart to include a column for institutional size packages and their billing units. Train your technicians to look closely at the written quantity on the prescription. Does it make sense for the package size being dispensed? If the quantity is written for “1 inhaler,” is there an institutional size package or an additional package size to be considered? Clarify any incorrect, unspecified or ambiguous quantities with the prescriber and document a clinical note on the prescription prior to dispensing.
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