Medicare Prescription Drug Coverage and Your Rights (CMS-10147)

When a pharmacy receives an NCPDP Reject Code 569 <Provide Notice: Medicare Prescription Drug Coverage and Your Rights> on a Medicare Part D claim, the pharmacy “must” provide the patient with the CMS-10147 form, also known as the Medicare Prescription Drug Coverage and Your Rights notice. The notice instructs enrollees about their right to contact their Part D plan to request a “coverage determination” or prior authorization.

In general, all pharmacies must arrange for this form to be distributed to the patient. While retail pharmacies must provide the notice at point-of-sale, mail order and specialty pharmacies have up to 72 hours to provide it to the patient. Importantly, CMS recognizes the uniqueness of LTC settings and that there is no practical means to deliver the notice directly to the patient; as a result, if the pharmacy can resolve the matter and ensure the LTC patient receives the needed medication or an appropriate substitute, they do not need to deliver the notice. If the matter cannot be resolved, then the pharmacy must deliver the notice within 72 hours to the patient, patient’s representative, prescriber or appropriate staff person at the LTC facility.

The 569 reject will NOT be returned in the following scenarios:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

  • Claim rejects only because it does not contain all necessary data elements for adjudication;
  • Drug in question is an OTC drug that is not covered by the member’s Part D plan;
  • Prescription is written by a sanctioned provider who has been excluded from participation in the Medicare program;
  • Drug is not listed on the participating CMS Manufacturer Labeler Code List;
  • Drug is not listed on the FDA Electronic List—NDC Structured Product Labeling Data Elements File (NSDE);
  • The Part D plan rejects the claim for the drug in question only because of NCPDP Reject Code 79 <Refill too soon/early refill> edit;
  • Drug in question is rejected by the Part D plan benefit but is covered by a co-administered insured benefit managed by a single processor. In this scenario, the pharmacy submits a single claim transaction for the drug and the drug is covered by the co-administered insured benefit after being rejected by Part D and processed in accordance with the benefits offered by the supplemental payer.

While documentation is not required when distributing the CMS-10147, your pharmacy should have a policy and procedure in place addressing how and when the form is being distributed to patients. PBM field auditors may ask you questions about your process and will possibly want to see a copy of your form to ensure you have the most up-to-date version. OptumRx auditors may even look to see if you have a copy of the CMS-10147 posted in the pharmacy. However, the OptumRx Provider Manual does not require the form to be posted, and Chapter 18 of the Prescription Drug Benefit Manual does not obligate the pharmacy to post the notice.

PAAS Tips:

  • Download the current version of the Medicare Prescription Drug Coverage and Your Rights (Form CMS-10147) at https://www.cms.gov/medicare/appeals-grievances/prescription-drug/plan-sponsor-notices-documents
    • The zip file includes instructions as well as MS Word and PDF versions of the notice in English, Spanish, Korean, Chinese, and Vietnamese
  • The CMS-10147 must be distributed even if you obtain an alternative therapy or prior authorization is approved (LTC exception)
  • Posting the CMS-10147 notice does not satisfy Medicare requirements
  • Check with your pharmacy software vendor to see if the program can automatically print a copy of the CMS-10147 when required
  • PAAS FWA/HIPAA Compliance Program members should review section 4.5 of their PAAS National® FWA/HIPAA Policy and Procedure manual

Proof of Patient Consent for a Refill Request: What You Need to Know

If you are a DMEPOS supplier billing Medicare Part B claims, then you should be familiar with the proof of refill request requirement. All DMEPOS items and supplies billed to Medicare Part B that are delivered or mailed require proof of refill request and an affirmative response to occur and be documented prior to shipment. PAAS National®’s Proof of Refill Request and Affirmative Response for DMEPOS Items form can be downloaded from the Member Portal.

For non-Part B claims, many PBM provider manuals include language requiring pharmacies to obtain (and retain) proof of member consent prior to delivery. However, enforcement of this requirement is often at the PBM’s discretion (i.e., variable). These policies, at least in part, originate from the 2020 CMS Call letter revisions concerning Part D Mail Order Auto-Ship Modifications. While PBM requests are uncommon, they may ask pharmacies to provide “proof of patient consent to refill” during audits‒ often catching pharmacies off guard. When PAAS National® sees this request, there is typically an underlying reason and it is a seemingly effortless way for the PBMs to recoup claims if the pharmacy does not have the proof. PBM audit algorithms are looking for Fraud, Waste and Abuse conducted by bad actors and will use data analysis as a reason to audit suspicious claims. See the PAAS Tips below for potential reasons why a PBM may ask for proof of refill request upon an audit, and how to ensure compliance of an automatic refill or medication synchronization program.

PAAS Tips:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

  • When does PAAS see these proof of refill requests on an audit?
    • Medicare Part B claims when an item is delivered or mailed
    • Pharmacies under an Investigative Review
    • Pharmacies located in a Health Care Fraud Prevention and Enforcement Action Team (HEAT) Zone -HEAT Zones are designated by CMS as having high rates of health care fraud
    • When there is a questionable patient/prescriber/pharmacy relationship that could occur via claims from telehealth
    • If there is a larger than average distance between patient/prescriber/pharmacy or if pharmacies are mailing to patients who live outside their normal delivery areas
    • Billing for high AWP items
    • Auto-refills (Many state Medicaid plans prohibit auto-refills)
    • Medication Synchronization – high-cost maintenance medications filled early every month
    • Beneficiaries complaining they received medications they did not order or need
    • Beneficiaries denying they requested medication due to the patient misunderstanding the request by the PBM
  • In particular, MedImpact has squeezed pharmacies for missing or invalid proof of member’s consent to fill or refill a prescription
    • MedImpact cites section 4.9 of the Provider Manual (requires a login)
  • Medicare Part B will deny and recoup a claim if the pharmacy does not have proof of refill request and affirmative response documented prior to the delivery or mailing of a DMEPOS item.
  • Avoid “automatic refills” and instead implement a “medication synchronization” program that includes a telephone check-in prior to medication billing and delivery to ensure the patient is still living at the same address, has not been hospitalized since last delivery (or had medication therapy changes), and confirms the needed medications prior to delivery

“A” for Abandoned: The Short Life of DAW Code A and What it Means for Multi-Payor Claims

Just 11 short months ago, PAAS National® released the NEW Dispense As Written (DAW) Code Revealed Newsline article about DAW code value “A” (408-D8). DAW A was designed to be utilized on multi-payor claims when one payor required a multi-source brand (or reference biologic with an approved interchangeable biosimilar in the marketplace) and the other payor preferred the generic or interchangeable biosimilar. Today…we bring you news of DAW A’s demise.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

The National Council for Prescription Drug Programs (NCPDP) has concluded DAW A was more trouble than it was worth. As stated in Version 69 of the NCPDP Telecommunication Version D and Above Questions, Answers and Editorial Updates (here in “NCPDP FAQ”), “the use of DAW A may create barriers, such as:

  • Pharmacy systems ability to support multiple DAW codes for a single prescription fill,
  • Payor systems determining payer coverage, reimbursement, and variation in reject codes when receiving the value of “A”
  • COB payer systems not recognizing the reject codes or payment amount from the primary payor responding to DAW A.”

NCPDP’s original approval set in motion plans which would make DAW A “effective” as of October 2025 when it becomes incorporated into the Annual External Code List (ECL). However, information about the appropriate use of DAW A was available in advance of its “effective” date. The NCPDP FAQ (Version 65) had DAW A information added in May of 2024, and DAW A explanations were found within the April 2024-April 2025 ECL Publications. With early access to the definition of DAW A and utilization guidance from NCPDP, some software vendors and/or payors may have proactively implemented DAW A as a billing option.

With the recent decision to eliminate this code, DAW A should be “obsolete” as of July 2025; except, the removal of DAW A is not truly “effective” until October 2026 based on the innate timeline of the NCPDP Data Element Request Form (DERF) process. This means there will be one year (October 2025 through October 2026) where DAW A is “available”, but its utilization will be discouraged through adjudication messaging. NCPDP’s guidance states “Payors should reject all claims where value A is submitted with Reject Code (511-FB) value 8K: DAW Code Value Not Supported”.

With this shift, NCPDP has released updated guidance regarding DAW code utilization (specifically, new instructions on the appropriate use of DAW 9 utilization) in their newest NCPDP FAQ. Below are several key points from the FAQ document:

  • DAW 9 is accepted when the prescriber allows substitution on the prescription, but the plan formulary requests the brand or reference product be dispensed.
  • Plans requesting the multi-source brand/reference product should support the use of DAW 9.
  • The use of DAW 9 for a multi-source brand/reference product not requested, or no longer required by the plan, should result in a point of service rejection to indicate the brand/reference product is not required by the plan to allow for substitution where applicable. This point-of-sale rejection allows pharmacies to update the claim before re-adjudicating.
  • Now until October of 2026, the reject code is “22: M/I Dispense as Written (DAW)/Product Selection Code”
  • Effective October 2026, the reject code will be “XXX: Plan Does Not Request Brand or Reference Product”
  • There are options for payors on multi-payor claims (where one payor prefers the multi-source brand/reference product, and the other payor prefers the generic) to decrease the risk of delaying patient access to care:
  • The secondary payor may relax their formulary requirement to match the requirement of the primary payor to allow the claim to successfully process
    • i.e., the secondary payor will accept the generic, despite the brand being their formulary preference, since the primary payor required generic
    • Example: The secondary usually prefers Symbicort® with DAW 9, however, the primary payor prefers budesonide/formoterol. The pharmacy will bill the generic to the primary for a successful claim then proceed to bill the generic to the secondary payor. Even though the formulary preference for the secondary is Symbicort®, they will allow the generic to successfully adjudicate by relaxing enforcement of their formulary preference.
  • The secondary payor may enforce their formulary requirement by accepting the missing/invalid DAW rejection from the primary payor as acceptable
    • i.e., the secondary payor enforces their formulary preference for a multi-source brand/reference product billed with DAW 9 with Other Coverage Code 3 (308-C8) and will accept the rejection message from the primary payor to allow the claim to process as brand/reference product to the secondary payor
    • Example: The pharmacy bills generic Symbicort® and receives a paid claim from the primary payor, but a rejection from the secondary payor indicating the brand is preferred. The pharmacy reverses the claim to the primary payor, swaps out the generic for brand Symbicort® and reprocess to the primary payor with DAW 9. The primary rejects the claim with “22: M/I Dispense as Written (DAW)/Product Selection Code” (until October 2026). The pharmacy will continue to adjudicate the claim to the secondary with Symbicort, DAW 9 and Other Coverage Code 3. The secondary payor will accept the reject code as appropriate and pay the claim.

PAAS Tips:

  • Do not use DAW A, even on multi-payor claims where one prefers the brand and the other prefers generic
  • Ensure billing staff closely watch adjudication messaging regarding DAW codes, especially when using DAW 9
  • Review the updated DAW Codes Explained tool for comprehensive insight into appropriate DAW code utilization

When Precision Fails: The Hidden Issues in Insulin Pen Dosing Calculations

Undoubtedly, a calculator can be found near every data entry and verification station throughout the prescription workflow line. This is, in part, due to PBM requirements that prescriptions have a mathematically calculable set of instructions. Consequently, pharmacies should strive to bill every claim with an appropriate quantity and days’ supply to prevent claim recoupment issues (e.g., overbilled quantity, refill too soon, exceeding plan limitations, etc.). However, there are instances where the pharmacy has the math correct, but the answer is clinically incorrect.

PAAS National® analysts are seeing correct mathematical calculations, but incorrect days’ supply with insulin pens because pharmacies are missing two very important considerations:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

  1. Not all pens can deliver insulin in 1-unit increments
  2. Not all pens use a 2-unit prime

Let’s look at an example using Toujeo® Max U-300 SoloStar® Pen. Imagine a patient was prescribed 1 box (6 mL) of Toujeo® Max with directions to inject 57 units nightly at bedtime. The pharmacy correctly determines each 6 mL box has 1,800 units. Since this pharmacy chooses to use priming units in their days’ supply calculation, they add in a 2-unit prime to their days’ supply equation. They determine 6 mL is a 30.5 days’ supply (rounding to a 30 or 31 days’ supply – either is allowable). The math is right; however, this days’ supply would be wrong!

How is it wrong? The first mistake is that Toujeo® Max U-300 SoloStar® can only deliver doses in 2-unit increments. Since the prescription was written for 57 units nightly, the pharmacy should have contacted the prescriber’s office to clarify the prescription to a dose which could be dialed by the Toujeo® Max pen. Second, Toujeo® Max uses a 4-unit prime, therefore, the assumption that it used a 2-unit prime was also wrong.

Going back to the example above, let’s figure out the correct days’ supply. In this alternate timeline, the pharmacy called the prescriber’s office and clarified the directions to inject 58 units nightly at bedtime. They documented the change within the prescription record with a full clinical note and updated the patient label with the new directions. Now, the days’ supply calculation is made using 1,800 units per box, 58 units per day plus the 4-unit prime making 6 mL a 29 days’ supply.

While the days’ supply in this scenario was only altered marginally, there can still be subsequent consequences for having the wrong days’ supply on a claim, no matter how significant the error. For example, an incorrect days’ supply could cause a patient’s copay to increase (or decrease) once corrected. Additionally, the pharmacy could receive penalty fees during an audit for an incorrect days’ supply or recoupment against the claim if there is a difference in the reimbursement or patient’s copay once the days’ supply is corrected. There could also be issues with an overbilled quantity, refill too soon, or with exceeding plan limitations which can all lead to significant recoupment.

Below is a reference table which shows insulin pens with unique dosing increments and a list of insulin pens which do not use the standard 2-unit prime.

Insulin Pens Which Do Not Use a 1-unit Dosing Increment Insulin Pens Which Do Not Use a 2-unit Prime
Humalog® Junior KwikPen®0.5-unitsToujeo® SoloStar®3-units
Toujeo® Max SoloStar®2-unitsToujeo® Max SoloStar®4-units
Tresiba® U-200 FlexTouch®2-unitsHumulin® R U-500 KwikPen®5-units
Humulin® R U-500 KwikPen®5-units

PAAS Tips:

  • Always submit an accurate days’ supply, when possible.
  • Pharmacies are NOT required to use priming units in their days’ supply calculations. If priming units are included, be sure this is reflected on the hardcopy record and visible to an auditor.
  • Information about which insulin pens do not follow the standard 1-unit dosing increment or 2-unit prime can also be found in the foot notes of the PAAS Insulin Medication Chart.
  • A complete clinical note should include:
    • Date and time
    • Name and title of individual providing information
    • Specific information clarified
    • Pharmacy staff initials
  • The patient label must be updated with the clarified directions prior to dispensing to avoid recoupment for mis-matched directions (i.e., the directions on the hardcopy don’t match the patient label).

LTC Essentials: A Guide to Residence Codes, Pharmacy Service Types, and Submission Clarification Codes

With more pharmacies exploring the world of long-term care and LTC Pharmacy at Home dispensing increasing daily, PAAS National® has also been seeing audits on these claims. One area PBMs have been targeting surrounds…

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

erroneous billing of Patient Residence Codes, Pharmacy Service Types, and Submission Clarification Codes (SCC). Recoupments primarily focus on SCC issues.

Please see the following tables to determine if you are billing the correct codes and service types to avoid potential audit recoupment:

Residence CodeNCPDP Definition
0Not specified, other patient residence not identified below
1Home
3Nursing Facility
4Assisted Living Facility
6Group Home
9Intermediate Care Facility/Mentally Retarded
11Hospice
Pharmacy Service TypeNCPDP Definition
1Community/Retail Pharmacy Services
2Compounding Pharmacy Services
3Home Infusion Therapy Provider Services
4Institutional Pharmacy Services
5Long Term Care Pharmacy Services
6Mail Order Pharmacy Services
7Managed Care Organization Pharmacy Services
8Specialty Care Pharmacy Services
99Other
Submission Clarification CodeNCPDP Definition
16LTC Emergency Box (kit) or automated dispensing machine – Indicates that the transaction is a replacement supply for doses previously dispensed to the patient.
21LTC dispensing: 14 days or less not applicable – Fourteen days or less dispensing is not applicable due to CMS exclusion and/or manufacturer packaging may not be broken or special dispensing methodology (i.e. vacation supply, leave of absence, E-Kit, spitter dose). Medication quantities are dispensed as billed
22LTC dispensing: 7 days – Pharmacy dispenses medication in 7 day supplies
23LTC dispensing: 4 days – Pharmacy dispenses medication in 4 day supplies
24LTC dispensing: 3 days – Pharmacy dispenses medication in 3 day supplies
25LTC dispensing: 2 days – Pharmacy dispenses medication in 2 day supplies
26LTC dispensing: 1 day – Pharmacy or remote (multiple shifts) dispenses medication in 1 day supplies
27LTC dispensing: 4-3 days – Pharmacy dispenses medication in 4 day, then 3 day supplies
28LTC dispensing: 2-2-3 days – Pharmacy dispenses medication in 2 day, then 2 day, then 3 day supplies
29LTC dispensing: daily and 3-day weekend – Pharmacy or remote dispensed daily during the week and combines multiple days dispensing for weekends
30LTC dispensing: Per shift dispensing – Remote dispensing per shift (multiple med passes)
31LTC dispensing: Per med pass dispensing – Remote dispensing per med pass
32LTC dispensing: PRN on demand – Remote dispensing on demand as needed
33LTC dispensing: 7 day or less cycle not otherwise represented
34LTC dispensing: 14 days dispensing – Pharmacy dispenses medication in 14 day supplies
35LTC dispensing: 8-14 day dispensing method not listed above – 8-14-Day dispensing cycle not otherwise represented
36LTC Dispensing: dispensed outside short cycle – Medicare Part D coverage was determined post dispensing

PAAS Tips:

  • Educate all staff on proper residence codes, pharmacy service types, and SCCs.
  • Consult your PSAO/GPO if you are unsure what the correct residence code should be when submitting a claim. Be judicious with LTC at home, independent living and various assisted living facility patients that can fall into grey areas.
  • See the NCPDP WG9 Medicare Part D Questions and Answers document for more information on Patient Residence Codes and Pharmacy Service Types.
  • See the NCPDP Telecommunication Version D and Above Questions, Answers and Editorial Updates document for more information on SCCs.
  • See the March 2021 Newsline article, Are You Documenting DUR and Submission Clarification Codes?, for information on billing other common SCCs.

Combo Shop Pharmacy Inventory Considerations

Independent pharmacies are diving into the long-term care world to improve care for their patients and maximize revenue. Pharmacies can run both retail and combo-shop LTC pharmacies under one roof; typically with the same computer system. However, even though the pharmacies have a single location, the processing of claims and sharing of drug inventory can be challenging.

With a new NCPDP number for the combo-shop LTC, pharmacies will have new wholesaler accounts for ordering medications. Combo-shop LTC locations often have access to lower-cost brands through their LTC agreements. While the two NCPDPs operate in the same location, in many aspects, they need to be treated as two separate “pharmacies”. This raises two key questions that PAAS National® has received from members:

  • Can claims be strategically billed under different NCPDP numbers to take advantage of better reimbursement?
  • Can inventory be transferred between the retail and LTC pharmacies?

PAAS recommends …

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

classifying a patient as either retail or LTC (i.e., not both based on reimbursement for individual prescriptions). When determining the classification, consider patient qualifications (e.g., for LTC Pharmacy at Home) and the patient reimbursement profile holistically. Billing prescriptions between the two NCPDP numbers and different Pharmacy Service Types simultaneously can raise red flags to the PBMs and draw scrutiny to claims. 

The separation of inventory can also be important in the event of an invoice audit. If a pharmacy receives an invoice audit for the retail NCPDP number but brand drugs are being ordered via the LTC agreement (and used throughout the pharmacy for both LTC and retail), this could result in class of trade issue and a shortage/recoupment of claims that don’t have enough inventory to cover the dispensing.

PAAS Tips:

  • PAAS recommends, at a minimum, keeping a separate brand inventory to prevent any future audit problems.
  • Review Newsline March 2025 article, The NEW Inventory Transfer Log and Why it Could Save You Big! for other pharmacy transfer inventory considerations.
  • The Alliance for LTC Pharmacy at Home has published LTC Pharmacy at Home guidelines to help pharmacies with meeting the requirements developed by CMS’s Long Term Care Facility Standards.
  • Avoid filling prescriptions for the same patient between the LTC and retail side—billing a specific drug on the retail side and the rest of the medications on the LTC side may raise red flags from the PBM.

Filling Prescriptions with Two NDCs – What You Need to Consider

We’ve all been in the sticky situation of having a few straggling pills left associated with one NDC that would be ideal to get off the shelf and free up some space. Maybe this NDC used to be the preferred product and now it has changed, or the manufacturer was bought out by another company. What is the proper way to bill and dispense two different NDCs on the same fill? It’s important to take both physical dispensing and claim processing into consideration to avoid the additional risk of this situation.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

It should be clear to the patient that they are receiving two NDCs when dispensing. Some pharmacies prefer to place both products in the same vial (separated with clean cotton) and include an auxiliary sticker that notifies the patient that ‘This is the same medication you have been getting. Color, size, or shape may appear different’. Note that dispensing two products in one vial could lead to misbranding the product dispensed, as there is likely only going to be only one NDC with the manufacturer and item description listed on the label. To avoid unintended allergic responses, do not use recycled cotton from manufacturer stock bottles (e.g., sulfasalazine, penicillin, etc.). Pharmacies may want to consider using two separate vials, each labeled with the correct NDC, manufacturer, and item description accurately reflecting its contents. While this method does not require cotton, it should still include an auxiliary sticker to inform the patient.

Processing the claim appropriately can be a complex endeavor. The data logged in the pharmacy dispensing software and submitted to the third-party payors has important downstream purposes. Incorrect data reflecting the claim can cause problems with FDA recalls and PBM audits.

Let’s consider an example where the pharmacy is dispensing #30 atorvastatin 20 mg tablets and only has #20 tablets of old manufacturer NDC ‘A’ and needs #10 tablets of new manufacturer NDC ‘B’ to complete the fill. Many pharmacies would process a single claim transaction with only one of the NDCs being filled. In this example, NDC ‘A’ would likely be billed as this NDC represents most of the fill. This can cause many problems including the following:

  • If there is ever an FDA recall on NDC ‘B’ that requires a claim utilization report for the pharmacy to find impacted patients, you may not be able to find this claim. Recalls may be rare, but patient safety can be at risk
  • The claim may be considered in violation of PBM contracts – identification and enforcement by PBMs may be difficult
  • The pharmacy may have an inventory shortage on a future PBM invoice audit

The best practice to avoid these issues would be to process two separate claim transactions. This way each NDC is appropriately accounted for in your pharmacy software and adjudicated to the PBM. This may require the utilization of the Submission Clarification Code (SCC) value of 62. In Section 3.1.12 Submission Clarification Code (SCC) of the NCPDP Telecommunication FAQ document defines this value as being,

“Shortened Days Supply of Same Drug, Strength and Dosage Form with Multiple NDCs Dispensed.

Used to request an override to plan limitations and/or copay benefits when there are multiple claim billing transactions for same drug and strength due to NDC change(s)”

This will tie the claims together to help align with the plan benefit parameters. When using this override on a plan that recognizes the code, the pharmacy should receive Approved Message Code (548-6F) value 023, “Prorated copayment applied based on days supply. Plan has prorated the copayment based on days supply,” according to the NCPDP Telecommunication FAQ document linked above.

PAAS Tips:

  • Pharmacies may need to contact PBM helpdesks if they do not recognize SCC-62 to resolve an early refill and/or duplicate copays
  • Pharmacies will need to assess their own risk tolerance and practicality of using SCC-62
    • While great in theory, the application may be cumbersome in workflow and not work well in your setting
    • Consider the frequency of manufacturer changes and costs for determining your own policies
  • Prescriptions for multiple package sizes require additional considerations

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®.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

Section 16 How Supplied/Storage and Handling of the product labeling state the following:

ProductDosage FormGuidance
Isentress®TabletsStore in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.
Oral SuspensionStore in the original container. Do not open foil packet until ready for use.
Dificid®TabletsStore 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 suspensionStore 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.

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.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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:

  1. Miebo® 272 drops per 3 mL (~90 drop per mL)
  2. Vevye® 200 drops per 2 mL (100 drop per mL)
  3. Vyzulta® 81 drops per 2.5 mL (~32 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.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

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