OptumRx continues to focus audits on prescriptions that must be dispensed in their original container per the manufacturer’s [FDA approved] labeling and package insert. If the prescription claim detail shows that a pharmacy dispensed a medication in a quantity different from the original package size (and not a multiple), the audit risk is significant and discrepancies can be difficult to appeal.
OptumRx’s latest targets are Isentress® and Dificid®.
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Section 16 How Supplied/Storage and Handling of the product labeling state the following:
Product
Dosage Form
Guidance
Isentress®
Tablets
Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.
Oral Suspension
Store in the original container. Do not open foil packet until ready for use.
Dificid®
Tablets
Store DIFICID tablets at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). See USP controlled room temperature. Store in the original bottle.
Granules for oral suspension
Store DIFICID granules for oral suspension at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). Store in the original package. Do not open pouch until time of use.Once reconstituted, store DIFICID oral suspension refrigerated at 2°C-8°C (36°F-46°F) for up to 12 days. Store capped in the original bottle.
PAAS National® continues to express frustration and disdain with OptumRx’s audit practices. OptumRx would rather develop audit algorithms to profit from this dispensing behavior than put in hard-stop rejections to stop claims at the Point-of-Sale (something they would do if they were really concerned with patient safety).
Unfortunately, the FDA has also been lackadaisical by allowing inconsistent and vague manufacturer labeling. Store in the original container does not necessarily mean Dispense in the original container – how is a pharmacist to know if the FDA has approved the product to be dispensed in a vial in these situations? It’s simply not clear. Consider Section 16 from Linzess®: “Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.” This direction is very clear to dispensing pharmacists. PAAS has made several requests [to the FDA] to standardize the manufacturer Storage and Labeling requirements for products that must be dispensed in the original container– from a patient safety, and pharmacist awareness, perspective. The FDA, unfortunately, defers to the manufacturer submission for labeling and package insert information language, but they have intervened on other labeling requirements when patient safety is involved (e.g., insulin pens).
PAAS continues to reach out to manufacturers as PBM audit issues arise, with mixed results. For example, Auvelity® has the same language “Store AUVELITY in original bottle”; however, the manufacturer indicated to PAAS that, “When a quantity less than the amount available in the manufacturer’s original bottle is prescribed, transferring the tablets to a pharmacy vial does not conflict with the AUVELITY labeling.” The manufacturers of Isentress® and Dificid® would only reiterate that the products must be “stored in the original container”.
Due to the difficulty of appealing these type of discrepancies, PAAS has added them to the Dispense in Original Container Chartto help protect our members and support conservative dispensing practices. Unfortunately, the burden falls on the pharmacy to ensure FDA dispensing requirements are met even if the PBM does not put a hard stop in place on these medications.
Pharmacies that utilize compliance packaging to serve LTC and assisted living facilities are not exempt from these FDA storage and handling requirements. These medications are exempt from Medicare Part D short-cycle dispensing requirements which apply to patients in skilled facilities.
Communicate with facilities and patients who utilize special packaging on the requirements for dispensing full bottles with certain medications.
If a prescription is written for a quantity different from the package size, contact the prescriber to inform them of the dispensing requirements and request authorization to change the quantity.
Approval should be documented with a clinical note containing the date, name and title of who you spoke with, a summary of your discussion, and your initials.
If a prescriber insists on a patient receiving less than a full bottle, document this along with the clinical reason given by the prescriber (e.g., patient received some doses in the hospital and the prescriber does not want to give the patient more due to waste – prescriber is aware of storage requirements and requests pharmacy to dispense as is). There is no guarantee this type of note will prevent a recoupment; however, it shows the pharmacy did their due diligence to attempt to dispense in the original container and that the authorization was denied by the prescriber (versus refusing to dispense altogether, which is an option).
Contact your pharmacy’s software vendor to see if NDCs can be flagged with alerts at data entry to ensure the quantity billed matches the package size.
Flag inventory shelves for medications with special packaging/dispensing requirements.
Consider performing scheduled self-audits to ensure appropriate dispensing.
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/05/22091722/iStock-1646132154.jpg7681920Jenevra Azzopardi, CPhThttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngJenevra Azzopardi, CPhT2025-06-12 09:13:272025-05-22 09:17:45Update: Isentress® and Dificid® Added to Dispense in Original Container Chart
Prime Therapeutics acquired Magellan Rx in 2022 and released the first “integrated” Provider Manual for network pharmacies in January 2024. An important change in the revised Provider Manual is the guidance for billing eye drop medications, which carries billing and audit implications.
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Old Guidance:“Calculate eye drops days’ supply using 15 drops per mL for solutions and 12 drops per mL for suspensions.”
New Guidance:“Calculate eye drops days’ supply based on the specific product.”
This guidance is challenging, as there is no master list of eye drop medications where the drop/mL information is specified by the manufacturer. New eye drops are coming to market that are free of water and preservatives; consequently, the drop size is approximately 66% – 80% less than traditional eye drops (see example list below). Absent this information, PAAS National® suggests that pharmacies use 20 drops per mL for solutions and 15 drops per mL for suspensions when products do not specify drops/mL.
Manufacturer Specific Drop per mL:
Miebo® 272 drops per 3 mL (~90 drop per mL)
Vevye® 200 drops per 2 mL (100 drop per mL)
Vyzulta® 81 drops per 2.5 mL (~32 drop per mL)
PAAS Tips:
Download the most current Eye Drop Days’ Supply Chartlocated on the Member Portal under “Days Supply Charts”
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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NCPDP Billing Unit per Box (i.e., number of doses/box)
Number of Sprays per Dose
Number of Sprays per Box
Suggested Days’ Supply per Boxwhere the Rx indicates a repeat dose per episode
Max Quantity for 30 Days’ Supply where the Rx indicates a repeat dose per episode
Nayzilam® 5 mg/spray
2 EA
1 dose = 1 spray
2 x 5 mg
3 days
10 EA (5 boxes)
Valtoco® 5 mg/spray
5 EA
1 dose = 1 spray
5 x 5 mg
10 days*
10 EA (2 boxes)
Valtoco® 10 mg/spray
1 dose = 1 spray
5 x 10 mg
Valtoco® 15 mg/2 sprays
1 dose = 2 sprays
10 x 7.5 mg
Valtoco® 20 mg/2 sprays
1 dose = 2 sprays
10 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
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/05/22085443/iStock-2179978486.jpg7681920Jennifer Ottman, CPhThttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngJennifer Ottman, CPhT2025-06-06 08:51:492025-05-22 09:09:59Incorrect Billing on Nayzilam® and Valtoco® Can Cost You
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
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/05/22085053/iStock-2190389211.jpg9601920Erin McDonald, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngErin McDonald, PharmD2025-06-04 08:48:282025-05-22 08:51:18Understanding the DEA Exempted Product List
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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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
https://paaswp.s3.amazonaws.com/wp-content/uploads/2025/05/22084233/iStock-2159167434.jpg12801920Eric Hartkopf, PharmDhttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngEric Hartkopf, PharmD2025-05-31 08:39:412025-05-22 08:42:46Electronic Prescriptions: Upcoming Changes to Quantity and Unit of Measure
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
https://paaswp.s3.amazonaws.com/wp-content/uploads/2024/09/27145522/iStock-1908249816.jpg10801920Dana Westberg, CPhThttps://paaswp.s3.amazonaws.com/wp-content/uploads/2021/03/24084106/Paas-National_Logo_RGB_transparency-224x300.pngDana Westberg, CPhT2025-05-29 08:36:122025-05-22 08:39:15Are You Familiar with Qualified Medicare Beneficiary (QMB) Billing Obligations?
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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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
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:
The pharmacy must write a corrected NDC in the space provided on the chart in the recoupment notice which reflects the actual NDC dispensed
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 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!
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
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:
Atypical prescriptions that are outside the FDA approved labeling should be given further scrutiny; consider dosing, frequency and route
Update: Isentress® and Dificid® Added to Dispense in Original Container Chart
OptumRx continues to focus audits on prescriptions that must be dispensed in their original container per the manufacturer’s [FDA approved] labeling and package insert. If the prescription claim detail shows that a pharmacy dispensed a medication in a quantity different from the original package size (and not a multiple), the audit risk is significant and discrepancies can be difficult to appeal.
OptumRx’s latest targets are Isentress® and Dificid®.
Section 16 How Supplied/Storage and Handling of the product labeling state the following:
PAAS National® continues to express frustration and disdain with OptumRx’s audit practices. OptumRx would rather develop audit algorithms to profit from this dispensing behavior than put in hard-stop rejections to stop claims at the Point-of-Sale (something they would do if they were really concerned with patient safety).
Unfortunately, the FDA has also been lackadaisical by allowing inconsistent and vague manufacturer labeling. Store in the original container does not necessarily mean Dispense in the original container – how is a pharmacist to know if the FDA has approved the product to be dispensed in a vial in these situations? It’s simply not clear. Consider Section 16 from Linzess®: “Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.” This direction is very clear to dispensing pharmacists. PAAS has made several requests [to the FDA] to standardize the manufacturer Storage and Labeling requirements for products that must be dispensed in the original container– from a patient safety, and pharmacist awareness, perspective. The FDA, unfortunately, defers to the manufacturer submission for labeling and package insert information language, but they have intervened on other labeling requirements when patient safety is involved (e.g., insulin pens).
PAAS continues to reach out to manufacturers as PBM audit issues arise, with mixed results. For example, Auvelity® has the same language “Store AUVELITY in original bottle”; however, the manufacturer indicated to PAAS that, “When a quantity less than the amount available in the manufacturer’s original bottle is prescribed, transferring the tablets to a pharmacy vial does not conflict with the AUVELITY labeling.” The manufacturers of Isentress® and Dificid® would only reiterate that the products must be “stored in the original container”.
Due to the difficulty of appealing these type of discrepancies, PAAS has added them to the Dispense in Original Container Chart to help protect our members and support conservative dispensing practices. Unfortunately, the burden falls on the pharmacy to ensure FDA dispensing requirements are met even if the PBM does not put a hard stop in place on these medications.
PAAS Tips:
Eye Drop Guidance Updates: Prime Therapeutics
Prime Therapeutics acquired Magellan Rx in 2022 and released the first “integrated” Provider Manual for network pharmacies in January 2024. An important change in the revised Provider Manual is the guidance for billing eye drop medications, which carries billing and audit implications.
Old Guidance: “Calculate eye drops days’ supply using 15 drops per mL for solutions and 12 drops per mL for suspensions.”
New Guidance: “Calculate eye drops days’ supply based on the specific product.”
This guidance is challenging, as there is no master list of eye drop medications where the drop/mL information is specified by the manufacturer. New eye drops are coming to market that are free of water and preservatives; consequently, the drop size is approximately 66% – 80% less than traditional eye drops (see example list below). Absent this information, PAAS National® suggests that pharmacies use 20 drops per mL for solutions and 15 drops per mL for suspensions when products do not specify drops/mL.
Manufacturer Specific Drop per mL:
PAAS Tips:
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.
30 Days’ Supply where the Rx indicates a repeat dose per episode
5 mg/spray
5 mg/spray
10 mg/spray
15 mg/2 sprays
20 mg/2 sprays
*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:
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, …
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:
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).
PAAS Tips:
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.
PAAS Tips:
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:
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:
PAAS Tips:
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.
PAAS Tips:
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: