Medication	Dosage Form	Strength	Billing Unit	FDA Approved For	Dose
Baqsimi®	Nasal Powder	3 mg	EA	Age ≥ 4	3 mg
Glucagon Emergency Kit (glucagon for injection)	Vial for injection	1 mg/ml	EA	Adults and pediatric patients weighing 20 kg or more	1 mg
				Pediatric patients weighing less than 20 kg	0.5 mg
Gvoke HypoPen® (glucagon injection)	Auto-injector	0.5 mg/0.1 mL 1 mg/0.1 mL 1 mg/0.2 ml	mL	Age 2-11 and < 45 kg	0.5 mg
Gvoke® PFS (glucagon injection)	Pre-filled syringe	0.5 mg/0.1 mL 1 mg/0.2 mL		Age ≥ 12 or > 45 kg	1 mg
Gvoke Kit (glucagon injection)	Vial for injection	1 mg/0.2 ml	mL	Age 2-11 and < 45 kg	0.5 mg
				Age ≥ 12 or > 45 kg	1 mg
Zegalogue® (dasiglucagon injection)	Auto-injector   Pre-filled syringe	0.6 mg/0.6 mL	mL	Age ≥ 6	0.6 mg

PAAS Tips:

• Typically, billing one product for a 1-day supply is appropriate
• Ensure staff are aware of which products are billed as “EA” vs. “mL”
• Note the different age groups that each product is FDA approved for and the correct corresponding dose
• If multiple kits are being prescribed and dispensed, document the need (e.g., one for home and one for school or daycare)
• Note the frequency of refills and use caution with excessive refills – balance patient care and clinical intervention with waste
• Always clarify with the prescriber if the unit of measure is incorrect or listed as “unspecified” and document a clinical note accordingly
• A complete clinical note should include:
  • Date and time
  • Name and title of individual providing information
  • Specific information clarified
  • Pharmacy staff initials  

• 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

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

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.

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.