Question: According to the Risk of Complications element of the CPT® medical decision making (MDM) table, “drug therapy requiring intensive monitoring for toxicity” is listed as a high risk of morbidity. Does that mean any toxic drug administration automatically rises to that level? Ohio Subscriber Answer: The definitions that accompany the CPT® Evaluation and Management (E/M) Services Guidelines specify that this element applies to “a drug … [which] is a therapeutic agent that has the potential to cause serious morbidity or death” and “that requires intensive monitoring.” Palmetto GBA, the Part B Medicare Administrative Contractor (MAC), elaborates on this, and notes that “drugs with a well-defined clinical response and a high therapeutic index” are not highly toxic and, therefore, do not require monitoring. Such drugs would not rise to a high-risk level of MDM. “Drugs that have a narrow therapeutic window and a low therapeutic index,” however, “may exhibit toxicity at concentrations close to the upper limit of the therapeutic range and may require intensive clinical monitoring,” Palmetto continues. This agrees with CPT®’s guideline that “the monitoring is performed for assessment of these adverse effects and not primarily for assessment of therapeutic efficacy.” Drug examples: A good starting point for determining which drugs rise to a high-risk level of MDM is the table Palmetto provides (https://www.palmettogba.com/palmetto/jmb.nsf/ DID/8EELEJ7715). It includes all cytotoxic agents (such as the ones on this list provided by BC Cancer: http://www.bccancer. bc.ca/pharmacy-site/Documents/PharmacologyTable.pdf) and erythropoiesis stimulating agents (ESAs) such as Procrit and Epogen (Epoetin Alfa) and Aranesp (Darbepoetin Alfa), used to treat chemotherapy-induced anemia. How to justify high level MDM for toxic drugs: From Palmetto’s perspective, “to consider therapy with one of these drugs as a high-risk management option, we would expect to see documentation in the medical record of drug levels obtained at appropriate intervals.” Again, this agrees with CPT®, which tells you “monitoring should be that which is generally accepted practice for the agent but may be patient-specific in some cases.”