Off-Label Use Beyond GLP-1

• Diclofenac 3% indicated for actinic keratosis but being used for pain
• Pennsaid^® solution 2% indicated for the treatment of osteoarthritis of the knee but being used on other body parts
• Prenatal vitamins prescribed for non-child bearing aged women
• Alcohol swabs not being used for insulin administration
• Compounds using bulk pharmaceutical powders, off-label, or unapproved uses
• Ivermectin being used for COVID-19

PBMs seem to selectively enforce these provisions, but the reality is they are pursuing easy targets with high rewards. Audits typically identify claim outliers, and expensive medications with narrow therapeutic indications increase the likelihood of an audit. Prescriptions being used within FDA guidelines are much less likely to be identified as being used off-label.

Section 1860D-2(e)(4) of the Social Security Act defines medically accepted indications for the Medicare Part D program by referencing Section 1927(k)(6). It states that a medically accepted indication is “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations include or approved for inclusion in any compendia described in Section 1927(g)(1)(B)(i)”.

When recoupments from off-label uses happen, they can be difficult to appeal. Remember to send PAAS your audit notices as soon as you receive them to have the best chance at success.

PAAS Tips:

• Medicare gives preference to a “pay & chase” model when it comes to claims – they want their members to receive needed medications and will pay the claim at point-of-sale assuming the medication is being used in an FDA approved manner
• Know the common indications for drugs being dispensed, especially if expensive, and investigate any indication that does not fit the norm
• Verify FDA-approved indications for medication through DailyMed
• Check to see if there are peer-reviewed studies indicating safe and effective use of a drug being used off-label in American Hospital Formulary Service® Clinical Drug Information^TM or Micromedex®
• Watch our on-demand webinar, What Are The Audit Risks For Dispensing Prescriptions Off-Label?
• Review our Newsline articles:
• Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk (May 2023)
• Off-Label Use Not Covered Under Medicare Part D (March 2022)