Ozempic and Mounjaro Prescriptions – Between a Rock and a Hard Place

Some Payors have implemented Utilization Management tools such as Prior Authorization or Diagnosis Restriction to confirm why the patient is using the medication before paying (or denying) the claims – in these situations the pharmacy should be much less concerned.

• There is not a known list of “acceptable” diagnosis codes for PBMs or Plans
• If the PBM has not designated the particular NDC as diagnosis restricted, then any diagnosis codes (ICD-10) submitted by the pharmacy are likely not reviewed, and pharmacies should not assume the PBM used the code as part of adjudication logic to determine payment of claim

When claims for GLP-1 medications pay at point-of-sale without any utilization management, PBMs may still expect pharmacies to “police” these medications and be able to accurately tell patients that the drug is covered or not covered (PAAS Audit Assistance members can see Mounjaro Off-Label Use for Weight Loss Spells T-R-O-U-B-L-E from November 2022). Inevitably, this puts pharmacy staff between a rock and a hard place when patients are using medications off-label.

• For patients with type 2 diabetes (ICD-10 diagnosis code “E11”), pharmacies can bill insurance and follow corresponding claim adjudication logic without additional concerns.
• However, for any other diagnosis the pharmacy should consider stating: “I don’t know if your insurance covers for indication X”.

Understandably, pharmacies have a difficult time determining if an individual patient’s insurance company will approve coverage for a GLP-1 medication for conditions other than type 2 diabetes. Researching plan benefits is often an exercise in futility, and PBM help desks are unlikely to have the clinical expertise.

The risk of a future PBM audit looms and it would be easy for a crooked PBM to pay the claim now, audit the pharmacy later and argue that “you (the pharmacy) should have known that we (the PBM) only cover this drug for type 2 diabetes”. Is this fair? Absolutely not, but when was the last time PBM audits were fair?

Consider these audit discrepancies from MedImpact:

• The diagnosis code of the corresponding medical claim does not support the billing of this medication
• There is no corresponding medical claim to support the billing of this medication

While these claims were not related to Ozempic^® or Mounjaro^TM, they easily could have been. With vertical integration amongst PBMs and Health Insurers, it’s easy to see how data could flow amongst them to identify off-label drug utilization; and with an annual treatment cost of nearly $12K per year, payors are going to look to reduce its utilization.

Dispensing these medications, when you can even get them in stock, is very complicated based on the large sticker price, the risk of audit and the immediate backlash you may face from patients and local prescribers if you say “no” or even “let’s try to figure this out”.

PAAS wants to help you and your patients get access to prescribed therapies and we recognize that refusing to fill prescriptions is not good for business or customer satisfaction. While there is not a one-size-fits-all approach, here are some best practice suggestions to keep your pharmacy safe from audit and create the fewest waves with parties involved.

PAAS Tips:

1. All prescriptions for GLP-1s should be verified for indication of use
   1. Check patient profile for previous use of type 2 diabetes medications as a proxy
   2. Check the prescription to see if it came with a diagnosis code
   3. Contact the prescriber to confirm indication and document a clinical note
2. If patient has E11 type 2 diabetes mellitus, then you should have limited concerns
   1. Your pharmacy will need to determine which other diagnoses you are comfortable billing to insurance without questioning further
3. If claim requires prior authorization or is diagnosis code restriction (regardless of patient diagnosis), follow standard processing procedures
4. All other claims pose audit risk and the pharmacy should consider giving the patient options to proceed
   1. Explain to the patient that insurance may not cover without type 2 diabetes diagnosis
   2. If indication is for weight loss, pursue prescription for Saxenda^® or Wegovy^® first, as these two medications are FDA approved for weight loss
      1. Medicare Part D currently excludes coverage of weight loss agents as per CMS Prescription Drug Benefit Manual Chapter 6, section 20.1
      2. The “Treat and Reduce Obesity Act of 2021” (HR 1577) was introduced in 2021 to allow coverage of prescription drugs for treatment of obesity or weight loss, however this bill is not a law
   3. Explain that the pharmacy wants to help them get their medication, but due to the high cost (>$1,000 per month) it is important to confirm coverage, which can take time
      1. If the patient is willing to wait a few days to start therapy, pursue 4b above (if this hasn’t been explored) and encourage the patient to contact their insurance to confirm coverage for their condition. Note that the PBM help desk is unlikely to have clinical knowledge and patient (or pharmacy) would need to speak with clinical staff such as prior authorization department
5. If you bill insurance and claims are subsequently audited, PBMs may try to recoup payment of claims if patients do not have type 2 diabetes
   1. Should this occur, PAAS is here to support you throughout the audit process with strategies and resources to fight the recoupments