the splitting of buprenorphine/naloxone tablets and films. The package insert explicitly states that the tablets and films should be taken whole and not to cut, chew, or swallow. Films have been approved to be administered sublingually or buccally, where tablets are only approved to be taken sublingually.

The question remains of how to handle a prescription where the prescriber writes for Suboxone^® splitting films or tablets. The best practice would be to contact the prescriber and ask for a second prescription for the lower strength instead of splitting, where possible. Suboxone^® films are available in 4 different strengths: 2-0.5 mg, 4-1 mg, 8-2 mg, and 12-3 mg.  Suboxone^® sublingual tablets are available in 2 strengths: 2-0.5 mg and 8-2 mg. Interchanging between the Suboxone^® products should only be done under prescriber supervision as the products are not bioequivalent.

PAAS Tips:

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

Institutional size packages primarily exist to allow pharmacies to dispense a smaller package for acute care and institutional settings. The existence of these products can cause audit discrepancies when a prescription is written for a quantity of “1 inhaler” or “1 unspecified.” Many retail pharmacies have expressed to PAAS National^® that they cannot order the institutional size packages, so they assume billing one inhaler at the retail quantity is sufficient – auditors disagree. If multiple package sizes exist (including institutional size packages), an auditor will insist that they do not know what quantity the prescriber intended and require you to obtain a prescriber statement clarifying the quantity on appeal.

How can you preemptively avoid this situation? PAAS has updated our Oral Inhalers Chart to include a column for institutional size packages and their billing units. Train your technicians to look closely at the written quantity on the prescription. Does it make sense for the package size being dispensed? If the quantity is written for “1 inhaler,” is there an institutional size package or an additional package size to be considered? Clarify any incorrect, unspecified or ambiguous quantities with the prescriber and document a clinical note on the prescription prior to dispensing.

PAAS Tips:

• Written quantities on a prescription should contain the proper billing unit of measure (UOM) per NCPDP guidelines, especially if multiple package sizes exist
• Pay close attention to electronic prescription quantities which have the biggest potential for incorrect or “unspecified” UOM
• Other prescription origins (written, fax, and transfer) may need clarification for missing UOM
• Notating UOM on all telephone orders would be considered the best practice

• Clinical notes should contain the date, the name and title of who you spoke with, a summary of your discussion, and your initials
• Download the Oral Inhalers chart for the information on package sizes and other useful information like number of puffs per package, beyond use dates, and days’ supply calculations
• Review our December 2024 Newsline article, 2024 Self-Audit Series #10: Nasal and Oral Inhaler Prescriptions, for more tips on audit-proofing your oral inhalers

• Review the November 2024 article, Understanding Biologic Substitutions – New Tool Available! for a refresher on terms used to describe biologic products such as reference product, biosimilar, and interchangeable
• Remember to document prescriber approvals for substitution with a clinical note on the prescription or in your pharmacy software

PBMs will require proof of delivery that contains information clearly showing what was in the package delivered. Most PBMs require a link between the delivery confirmation (via a tracking number) and the prescription record to show which prescription was being delivered. There should also be a patient signature or tracking detail from the carrier showing the date and location where the medication was ultimately received.

Notably, not all PBM agreements allow the mailing of prescriptions, while others may restrict mailing to a percentage. Humana and OptumRx typically prohibit mailing under retail agreements, and OptumRx further restricts delivery to within 100 miles by W-2 pharmacy employees. Caremark only allows up to 20% of their claims to be mailed.

Another consideration for pharmacies is ensuring you are licensed in any state you are mailing to. Many states have laws that require pharmacies to obtain a non-resident license to ship, mail, deliver, or dispense prescription medications into their states. Auditors look for these [expensive] claims to take advantage of well-meaning pharmacies who may not know of these requirements. Pharmacies located on state borders making deliveries into another state may also run into this problem as well.

PAAS Tips:

• Have a system that links the tracking number to the prescription record to indicate the contents being shipped.
• Print confirmation of delivery and keep it in a readily retrievable manner for audit – some carriers only keep tracking information for as little as 120 days, depending on the service used.
• Before mailing/delivering prescriptions out of state, it is a good idea to check with that state’s Board of Pharmacy to see if there are any licensure requirements for doing so.
• Be aware of your contract obligations and which PBMs do not allow mailing prescriptions to patients.
• For all DMEPOS items and supplies billed to Medicare Part B, proof of refill request and an affirmative response is required to occur and be documented prior to shipment.
• PAAS’ Proof of Refill Request and Affirmative Response for DMEPOS Items can be downloaded from our portal.
• If you do not require signatures upon delivery, consider providing the patient with a copy of our Signature Log Trifold Mailer to sign, fold up, and mail back to the pharmacy.
• Some PBMs, like Navitus Health Solutions, require a signature regardless of tracking information.
  • Have a follow-up plan in place if you do not receive the signed Signature Log Trifold Mailer back from patients.
• See the March 2025 Newsline article, Will Your Signature Logs Pass an Audit? for information on what auditors look for when patients pick up their medications or have them delivered.

*Also available in 5 and 10 kit packages       **Also available in a pack of 10 pre-filled syringes

1. Abrysvo^®
   1. 60 years of age and older
   1. Pregnant women at 32 to 36 weeks gestational age
   1. 18 – 59 years of age who are at an increased risk
2. Arexvy^®
   1. 60 years of age and older
   1. 50 through 59 years of age who are at an increased risk
3. mResvia^®
   1. 60 years of age and older

The CDC recommends a single dose of any FDA licensed RSV vaccine be given to all adults ages 75 and older and adults who are between the ages of 60 and 74 who have an increased risk of severe RSV. The conditions that increase the risk of severe RSV can be found on the CDC website. The CDC also recommends pregnant women receive a dose of the maternal RSV vaccine (Abrysvo^®) during weeks 32 through 36 of their pregnancy sometime between September through January.  To prevent severe RSV in infants, it is recommended that the mother receive the maternal RSV vaccination or the infant receive the vaccination with RSV monoclonal antibody.

PAAS Tips:

• Be cautious when billing mRESVIA® as each pre-filled syringe is billed as 0.5 mL versus the Abrysvo® and Arexvy® vials which are billed as 1 EACH
• Medicare covers RSV vaccine under Part D
• Pharmacists play a key role in educating high-risk patients on RSV prevention
• Eligible patients can receive the RSV vaccine at any time, but the best time to vaccinate is late summer or early fall before RSV starts to spread
• Like all vaccines, pharmacies should maintain documentation in case of an audit:
  • Authorization to administer, which may include a patient-specific prescription or a collaborative practice agreement (CPA)/protocol
  • Signed prescription or placeholder prescription (when using a protocol or CPA)
  • Vaccine Administration Record (VAR)
  • Screening checklist
  • Vaccine Information Statement (VIS)