On November 3, 2023, Eli-Lilly was granted the highly anticipated weight loss indication on their tirzepatide injection, ZepboundTM. ZepboundTM is indicated as an adjunctive therapy for adults with a body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) plus at least one weight-related comorbidity, such as type 2 diabetes mellitus, dyslipidemia, or hypertension – the same indication as Wegovy® and Saxenda®. Although this is an exciting advancement in the realm of GLP-1 agonist prescribing, PAAS National® would like to take this opportunity to update our members on what PBM trends we have seen thus far, draw attention to the guidelines laid out by PBMs and regulations in which we can rely on, and give our thoughts on the current audit situation in the hopes of allowing you to make the most informed business decision.
As of this publication, recoupments on type 2 diabetes mellitus (T2DM) GLP-1 agonists due to off-label indication use, defined as anything other than being used as an adjunct therapy for adults with T2DM, is nominal. Elixir communicated via their Pharmacy Audit Whisperer from April 2023 that Ozempic® and MounjaroTM being used for an indication of obesity or weight loss would not be covered and they have pursued recoupment of such claims. Caremark has been sending notices to pharmacies dispensing GLP-1 agonist at a volume identified as an outlier in their region. We’ve also seen OptumRx/EXL Health flag Ozempic® for off-label use. Notably, PAAS is aware of nine state Medicaid programs that were negotiating prices for Wegovy® earlier this year.
Despite the de minimis recoupments seen thus far, PBMs and insurance companies have put out communications advising pharmacies they reserve the right to report suspected improper dispensing practices to federal or state agencies, which may result in an additional level of scrutiny placed on pharmacies. As it states in Section 10.6 – “Medically-Accepted Indication” of the Medicare Part D Manual, “Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medically-accepted indications using the tools and data available to them to make such determinations.” Therefore, according to this guideline, Medicare Part D may pay for a GLP-1 agonists prescribed for its appropriate indication but will not pay for a GLP-1 agonist with an indication that does not match the patient’s intended use. In addition to being mindful of the CMS billing guidelines, pharmacies must be mindful of individual PBM’s expectations for billing practices. Some PBM’s have explicit language in their Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”, both alluding to claims that are for medically accepted indications. Yet pharmacies have processed prescriptions for off-label use without issue. If Medicare Part D states they will not pay for off label use, then why are these claims to go through without issue? If commercial plans state they will only cover medication for certain indications, why not put diagnosis restrictions in place to stop claims from going through at the point of adjudication? We know that PBMs have highly intricate algorithms that can focus in on prescription specifications; why aren’t they targeting GLP-1 agonists being used off-label on audits? One could speculate due to the vast amount of administration fees and rebates they are currently reaping there isn’t a reason to impose their regulation at this time, but these claims may be in the PBM’s crosshairs in the coming years. After all, audits typically target claims from previous years and PBMs do not mind using a “pay and chase” approach because they can just withhold future payments.
Beyond audits originating from PBMs for off-label use, manufacturers can cause trouble as well. Eli Lilly and Novo Nordisk have sued medi-spas, clinics, and compounding pharmacies over counterfeit versions of their GLP-1 agonists.
Ultimately, we urge you to consider the following when deciding how to handle adjudicating GLP-1 agonist prescriptions for off-label use: “How much do you trust the PBM to act favorably to your pharmacy – now and in the future?” While the future of GLP-1 agonist audits is obscure, our guidance remains conservative – tread cautiously.
- When diagnosis codes are known, be sure the prescription is written for the appropriate GLP-1
- If you are dispensing MounjaroTM for weight loss, best practice would be to contact the prescriber for a new prescription for ZepboundTM
- Refresh yourself on PAAS’ suggested workflow when approaching GLP-1 agonist claims, outlined in the May 2023 Newsline article, Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk