Identifying leads related to REMS program medications
REMS and Medical Claims
The risk evaluation and mitigation strategies (REMS) program is not new to the medical field. However, debates regarding the requirements to fill these medications have been making news headlines recently. There have been proposed changes to the program which have caused some REMS administrators to leave the space and others to join. This means that the new administrators need to learn the requirements and put a system in place to ensure their processes are compliant. There is concern that these changes could impact the availability of life-saving drugs. Many argue that the FDA should change the current requirements, so these drugs are more readily available. Many of the medications subject to this program require routine lab work or office visits. There are other requirements as well varying with each medication, such as administration by the provider.
What are some medical scenarios for REMS program medications
Qsymia® (phentermine and topiramate extended-release capsules) is one of the medications subject to the REMS program. Qsymia® is a weight loss medication, a rapidly growing area of medicine, that requires routine labs to test for use during pregnancy as there is an increased risk for congenital malformations. Indications for this medication include adults with a BMI of 30kg/m2 or greater or 27kg/m2 with at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia. In mid 2022 the FDA approved the use of Qsymia® in pediatric patients aged 12 and older with BMI in the 95th percentile. The manufacturers recommended modifying dosage also requires the patient to see their provider routinely as the dose adjusts based on the patients’ weight or BMI.
Another medication that is subject to the REMS program is Spravato. Spravato is a nasal spray used in the treatment of depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions and is also used for treatment resistant depression (TRD). During the induction phase Spravato is administered twice a week for 4 weeks and is available in 56mg and 84mg doses. Spravato is then given once a week for 4 weeks followed by once every two weeks beginning week 9.
Spravato is to be administered in a physician’s office and the patient is to be monitored for at least two hours after receiving the medication. The medication may temporarily increase patient’s blood pressure requiring the patient to have their blood pressure monitored. Because of this, the provider will need to bill for an office visit and extended observation. Absence of the office visit along with codes for the extended visit warrants further review. It could indicate the patient is not receiving the medication, which could mean the pharmacy is not dispensing it. It may also indicate that the patient is self-administering the medication outside of a Healthcare setting.
The frequency of the office billing and pharmacy dispensing may help identify potential billing issues or errors. If the pharmacy is dispensing one kit per week, then it is expected to see only one administration per week. If the pharmacy dispenses more kits than office visits this could indicate that the pharmacy is dispensing more than necessary.
How to identify pharmacies of interest using Fraud Scope
Identifying these claims is important not only to aid in the identification of potentially fraudulent claims, but also for patient safety and the associated teratogenic risks. One method to target and identify such medications is using a query-based search. The best way to do this is to select Query, select Query Builder, and build a query to fit your expected results. In this situation we conducted a pharmacy aggregates filling query and added a single filter, drug label name. Then we used “these” as the operator and added several REMS medications including Qsymia, Spravatol, and Clozapine. We saved this query for future use. Now we can look at pharmacies whose number of unique prescriptions or claim composition is higher than its peers.