Incorrect Billing on Nayzilam® and Valtoco® Can Cost You

Nayzilam® and Valtoco® are indicated for the short-term treatment of seizure clusters that are distinct from a patient’s usual seizure pattern in patients with epilepsy. A seizure cluster is defined as periods of increased seizure activity-having two or more seizures in a 24-hour period.

Nayzilam®: Per the manufacturer product label, section 2.2 (Dosing Information), the initial dose of Nayzilam® is one spray into one nostril. If needed, and the directions support, an additional spray may be administered into the opposite nostril 10 minutes after the initial dose if the patient has not responded to the initial dose.

Valtoco®: The number of sprays per dose is dependent on the strength prescribed. According to the manufacturer product label, section 2.2 (Dosing Information), the initial dose for the 5 mg and 10 mg strengths is one spray into one nostril while the initial dose for the 15 mg and 20 mg strengths is two sprays – one spray into each nostril. If needed, and the directions support, a second dose may be administered at least 4 hours after the initial dose if the patient has not responded. 

Also, it is important to know the maximum number of episodes the patient can treat per month to correctly calculate the day’s supply. FDA-approved directions recommend no more than two doses of Nayzilam® should be used to treat a single episode and it should not be used to treat more than one episode every three days with a maximum of five episodes per month. Similarly, FDA-approved directions recommend that no more than two doses of Valtoco® should be used to treat a single episode, and it should not be used to treat more than one episode every five days with a maximum of five episodes per month. 

Both Nayzilam® and Valtoco® are rescue medications that are different from daily epilepsy medications used to manage epilepsy. Please see the chart below and PAAS Tips for recommended billing guidance and to protect your pharmacy from audit recoupments.

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Drug NameNCPDP Billing Unit per Box (i.e., number of doses/box)Number of Sprays per DoseNumber of Sprays per BoxSuggested Days’ Supply per Box where the Rx indicates a repeat dose per episodeMax Quantity for
30 Days’ Supply where the Rx indicates a repeat dose per episode
Nayzilam®
5 mg/spray		2 EA1 dose = 1 spray2 x 5 mg3 days10 EA (5 boxes)
      
Valtoco®
5 mg/spray		5 EA1 dose = 1 spray5 x 5 mg10 days*10 EA (2 boxes)
Valtoco®
10 mg/spray		1 dose = 1 spray5 x 10 mg
Valtoco®
15 mg/2 sprays		1 dose = 2 sprays10 x 7.5 mg
Valtoco®
20 mg/2 sprays		1 dose = 2 sprays10 x 10 mg

*A patient who is only prescribed one box with directions to use up to two doses per episode (every 5 days), will only have 1 dose left after 10 days, hence a 10 days’ supply since the patient will not have enough to complete another treatment.

PAAS Tips:

  • Medi-Span shows Valtoco® NDCs with the billing unit of 2 EA were inactivated as of 3/25/2025
  • Ensure both the quantity and unit of measure are clear on the prescription as “5 boxes” and “5 EA” will lead to different billing outcomes
  • Note the number of anticipated episodes the patient will be treating per month to ensure proper billing and use, paying particular attention to the refill intervals
  • If any clarifications need to be made on the directions, be sure to include a full clinical note, complete with the date, name and title of person spoken with, what was communicated, and your initials.  The patient label must also be updated prior to dispensing to reflect the clarified directions
  • Nayzilam® and Valtoco® are both DEA schedule 4 controlled substances, so be sure to include all controlled substance requirements on the hard copy – patient address, physician address and physician DEA # and any additional state requirements
  • Refer to our updated Nasal Inhaler Chart on the Member Portal

Understanding the DEA Exempted Product List

When working directly with prescription medications in the pharmacy, it is generally easy to tell which drugs are controlled substances and which aren’t. Controlled medications are typically packaged and shipped separately from non-controlled medications and the manufacturer bottles contain a required Symbol (i.e., C-II, C-III, C-IV or C-V).

However, …

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Title 21 of the Code of Federal Regulations, Part §1308.31 Application for exemption of a nonnarcotic prescription product, provides exemptions for certain drug products from the Controlled Substance Act (CSA). Exemptions are given when the products meet specific criteria, including the presence of active ingredients believed to reduce the potential for abuse. The DEA publishes a list of Exempted Prescription Products which details the NDCs that are not considered a controlled substance. A manufacturer must apply for the exemption to receive the designation. Therefore, you may see two different manufacturers of the same drug product not linked in your pharmacy software system because one is flagged as a controlled substance, another as a non-controlled. An example of a drug that is on the list is butalbital/APAP/caffeine capsules. The NDC manufactured by Dr. Reddy (NDC 75907-0009-01) is not on the exempted list (it’s a Schedule III), but the one made by Aurobindo (NDC 13107-0075-01) is on the list.  If the manufacturer has received an exemption, it will be listed in the above-mentioned table. This table is updated periodically by the DEA (last update was February 2025).

PAAS Tips:

  • Check drugs containing controlled substances against the DEA Table of Exempted Drug Products (and look for the required Symbol if the product is in stock) to determine which rules to follow
    • If the NDC is not on the list, consider this product a controlled substance
  • Check your software system to see if it flags products as a controlled substance down to the NDC level. There is a risk of refilling a controlled substance (that you thought was non-controlled) beyond the prescription expiration date or allowed refills
  • PAAS National® recommends proceeding cautiously when medications have controlled and non-controlled versions to avoid any controlled substance law violations
  • Review the June 2022 Newsline article, DEA Exempted Prescription Products and Pitfalls which discusses more background of the exemption list

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:

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Implementation DateElementValuesNCIt Code
September 15, 2025DoseUnitOfMeasureChewable gel (Gummy)
Enema
Kit		C186222
C42915
C47916
March 1, 2026StrengthUnitOfMeasureInternational UnitsC48579
QuantityUnitOfMeasureInternational Units
Microgram Inhaler
Milligram
Nebule
Pre-filled Pen Syringe
Syringe
Vial		C48579
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).

PAAS Tips:

  • NCPDP document SCRIPT Implementation Recommendations section 15 includes a good discussion of e-prescription quantities and quantity unit of measure
  • Check with your pharmacy management software vendors to confirm that these values will be incorporated into your dispensing system upon release

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 …

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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.

PAAS Tips:

  • Refer to the Medicare MLN Fact Sheet from October 2024 for more information
  • Educate staff to be on the lookout for BSQ 51 response messages when billing for Part B covered items to patients with MAPD plan
  • If patient states they are a QMB but the claim system does not provide BSQ 51 message, then follow up with the MAPD plan or the state Medicaid program
  • Pharmacies that receive an investigation notice or Cease & Desist, contact PAAS National® immediately for assistance

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!

PAAS Tips:

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  • Send the complete audit notice and any masked or unmasked list to PAAS when received
    • If you receive a prescription list (masked or unmasked), talk with your analyst before sending any prescriptions for review
  • The FWA/HIPAA Compliance Program through PAAS National® has many of the tools needed for the auditor to review during the onsite visit:
    • Access to required FWA/HIPAA training
    • OIG/GSA exclusion checks (done daily)
    • Detailed Policy & Procedure manual (includes policies for partial fills, copay collection, CMS-10882 and 10147, patient demographics, etc)
  • Auditors will typically leave an exit summary, which should be looked over carefully. Be sure to ask the auditor when you can expect to see the results.
  • Review the Onsite Credentialing Guidelines for an overview of the compliance questions you should be prepared for during the onsite audit
  • The Self-Audit Series has in-depth details of different types of prescriptions that have been targeted by PBM audits and recoupments

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 …

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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:

  1. The pharmacy must write a corrected NDC in the space provided on the chart in the recoupment notice which reflects the actual NDC dispensed
  2. The pharmacy reiterates that the original NDC billed was correct by sending a dated purchase order from the pharmacy’s supplier listing the NDC billed was shipped to the pharmacy prior to the fill date of the prescription

PAAS Tips:

  • All 11-digits are important, even the last two digits which are an indicator of package size. Ensure all 11-digits match on every claim billed to avoid shortage issues during an invoice audit.
  • Consider using barcode scanning technology as a method for verifying the 11-digit NDC billed matches the 11-digit NDC of the product dispensed. Systematic processes, such as barcode scanning technology, help eliminate human error and can block the claim from being finalized until the NDC is corrected.

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.

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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.

PAAS Tips:

  • Insulin, inhalers, topical medication, vaginal creams, and eye drops are frequently flagged for refill too soon or overbilled quantity
  • Many PBMs have built-in overrides for the smallest package sizes, so be sure to submit the claim with an accurate days’ supply first
  • Consider these resources on the Member Portal, under “Proactive Tips”
  • Notate the actual days’ supply on the patient label to help notify the patient and pharmacy staff on the true days’ supply in the case of plan limits
  • Check with your software vendor to see if additional days’ supply fields are available for internal tracking (i.e., billed days’ supply and actual days’ supply)
  • Avoid med sync or cycle fill programs for products whose correct days’ supply cannot be submitted for the smallest package size – See April 2025 Newsline article, Audit Considerations for Med Sync Programs for more information
  • Read more from October 2024 Newsline article, What to Do (and Not Do) When Your Days’ Supply is Rejected  
  • The Audit Violations and Discrepancy Descriptions for 1N and 2Z can be found in the OptumRx® Provider Manual on page 146 and page 148, respectively
  • Be proactive and utilize the PAAS RX Days’ Supply Calculator! Download the app for a free 7-day trial ($5.99/year thereafter) by visiting the Apple App Store or Android Google Play Store, or check out the website at PAASNational.com/app

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:

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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.

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 …

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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.

PAAS Tips:

  • Prescriptions should have the patient’s address, prescriber’s address and prescriber DEA number on the hard copy
  • Verify all controlled substance state required elements are present, including but not limited to alphanumeric quantity and marked quantity checkboxes (where required)
  • Dosage form should be specified as tablets or films
  • Directions should be in full dose units
    • If smaller or larger doses are needed, a separate prescription should be issued instead of splitting/cutting tablets or films
  • Route of administration should be “buccal” (films only), “sublingual” or “under the tongue” (films and tablets)
    • Claims can be recouped for directions of “by mouth”

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:

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  • When receiving a prescription for insulin vials, PAAS recommend verifying the following:
    • Is the patient Medicare eligible?Is the prescription for rapid-acting insulin?Is the patient receiving insulin syringes?
    • Is the patient using insulin in a pump?
  • Insulin used in a disposable (tubeless) pump does not meet Medicare Part B coverage criteria, therefore can be billed to Medicare Part D
    • Omnipod®, V-Go®, and CeQur Simplicity™ are examples of disposable insulin pumps
  • Insulin used in a durable (tubed) pump, for a patient that meets Medicare Part B coverage criteria, would be billed to Medicare Part B
  • Pharmacies that are not Medicare Part B suppliers are still required to follow these guidelines
  • Medicare Advantage Plans can be billed for insulin vials regardless of method of administration
  • Long-acting, pre-mixed or concentrated insulins are not approved to be used in insulin pumps
  • See the following Newsline articles: