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

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:

1. The pharmacy must write a corrected NDC in the space provided on the chart in the recoupment notice which reflects the actual NDC dispensed
2. 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.

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
• Watch our on-demand webinar, What Are The Audit Risks For Dispensing Prescriptions Off-Label?

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”