Mounjaro^TM Off-Label Use for Weight Loss Spells T-R-O-U-B-L-E

We strongly advise pharmacies to confirm (and document) whether patients have a diagnosis of type 2 diabetes as that is the only FDA-approved indication as of October 2022 (although Lilly has received a fast track designation from the FDA in review for obesity).

• If you have a diabetes diagnosis, or antidiabetic medications on the patient’s profile, you have less to worry about and should not need to do any extra leg work.
• If the patient profile is void of any diabetes medications, a due diligence phone call to the prescriber’s office to confirm diagnosis is the safest approach.
  • Keep in mind pre-diabetes is not an approved diagnosis code for Mounjaro^TM.

The risk of audit recoupment varies by payor type as described below.

Medicaid and Medicare Part D

Medicaid and Medicare only pay for products when used for medically accepted indications. Claims for off-label use are not covered as per coverage limitations outlined in the Social Security Act. See the March 2022 article Off-Label Use Not Covered under Medicare Part D for additional discussion.

Commercial

Commercial payors have more flexibility to cover off-label uses, if they choose, as coverage criteria is not limited by federal law. However, many private insurers do not cover “lifestyle drugs” for sexual dysfunction, wrinkles or weight loss. Pharmacies should not assume that a claim paid at adjudication (without any type of utilization management tools such as prior authorization or diagnosis code restriction) will remain paid.

Payors assume prescriptions are for the medically accepted indication and respond with paid claims, often without special coverage hurdles to jump through. This results in a pay and chase audit method and PBMs could come back in an audit 1-2 years later stating that the pharmacy “should have known” the drug wasn’t truly covered. Would you be surprised if the PBMs were setting a trap for you?

Let’s look at what OptumRx^®, Express Scripts^®, Caremark^® and have to say about off-label use:

• OptumRx^® defines a “Clean Claim as follows:
  • Prescription claims with active ingredients [active ingredients not defined] which are not being used for a documentable medically accepted indication or for which the Prescriber is unable to provide adequate documentation for the basis of use may not be considered a Clean Claim. For example, a claim that utilizes atypical directions for drug products which conflict with typical drug information available in pharmacy systems for patient education without medical necessity and of limited clinical value.
• Express Scripts – Section 10 of the Provider Manual discusses Plan Sponsor Specific Requirements, and 10.5 address Prime Therapeutics. Under General Claims Submission Policies, Prime addresses “Appropriate Dispensing Practices” and puts the onus on Providers to determine if “claims are submitted for a valid use of a medication”. Auditors may request documentation to support appropriate dispensing of medications.
• Caremark – does not directly address off-label use within the Provider Manual but states the Provider must comply with the Terms and Conditions of any Pharmaceutical Manufacturer Coupon Program being used.

Pharmaceutical Manufacturer Coupons

Pharmacies (and patients) must also be aware of manufacturer savings card “Terms and Conditions” that also limit coverage.

• First, to obtain a savings card from the manufacturer website, patients must confirm their eligibility by checking a box stating, ‘I confirm that I have a Mounjaro prescription for Type 2 Diabetes.’
• Second, the printed savings card has Terms and Conditions that spell out that patients must have a prescription “consistent with FDA-approved product labeling”.
• Third, the savings card is only for patients with commercial insurance, and we have heard some pharmacies trying to use an in-house discount program as “primary” so they can then bill a “secondary” claim to the savings card. While the claims processor for the savings card cannot readily identify the primary payer, this workaround to gain coverage for the uninsured patient could result in an accusation that the pharmacy committed fraud – something PAAS has seen with other coupon card Sponsors.

As Mounjaro^TM has recently entered the market, we have not seen any PBM or manufacturer recoupments due to off-label use; however, if pharmacies overlook the fine print in PBM Provider Manuals and manufacturer Terms and Conditions, it could spell T-R-O-U-B-L-E.

PAAS Tips:

• Confirm and document diagnosis/indication for all Mounjaro^TM prescriptions
• Do not use a discount program to work around manufacturer savings card Terms and Conditions
• Consider reviewing previous Newsline articles for additional background information
  • Off-Label Use Not Covered under Medicare Part D (March 2022)
  • When Should I Obtain a Diagnosis Code for Ozempic? (July 2022)