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 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:

• Post the Dispense in Original Container Chart for staff to utilize at data entry and filling stations.
• 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.

Drug Name	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 Box where 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
  • Please refer to the July 2024 Newsline article, Proper Billing of Nayzilam® and Valtoco® Nasal Sprays for guidance on billing the 2 EA NDC’s if you still have them in stock
• 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

Implementation Date	Element	Values	NCIt Code
September 15, 2025	DoseUnitOfMeasure	Chewable gel (Gummy) Enema Kit	C186222 C42915 C47916
March 1, 2026	StrengthUnitOfMeasure	International Units	C48579
	QuantityUnitOfMeasure	International 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

• 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

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”
  • Can You Bill It As 30 Days?
  • Exceeding Days’ Supply Plan Limits for Unbreakable Packages
• 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