There are often questions and confusion on what is included and acceptable when choosing “Drug therapy requiring intensive monitoring for toxicity” in the Medical Decision-Making Risk category for Evaluation and Management coding. This article reviews the definition and guidelines as provided by CMS and their Medicare Administrative Contractors (MACs).

    1. Risk: High MDM – Drug therapy requiring intensive monitoring for toxicity: Drugs that have a narrow therapeutic window and a low therapeutic index may exhibit toxicity at concentrations close to the upper limit of the therapeutic range and may require intensive clinical monitoring.
        1. Therapeutic agent that has the potential to cause serious morbidity or death
        2. Monitoring is performed for assessment of adverse effects and not primarily for assessment of therapeutic efficacy
        3. May be patient-specific in some cases
        4. Long term or short term
        5. Not less than quarterly
        6. Laboratory test, physiologic test or imaging
        7. History and exam does not qualify
        8. Cytotoxic chemotherapy treatment
        9. The table below is a list of examples of drugs that are approved for monitoring for toxicity – when used for the specific treatment listed (this is not an all-inclusive list)


Drug Category  Drugs in the Category  Treatment Use
Cardiac  Digoxin, Digitoxin, Quinidine,  Procainamide, Amiodarone Congestive heart failure, angina,  arrhythmias
Anticoagulants  Coumadin and intravenous  Heparin drip (Heparin must be  provided in the hospital setting) Prevention of thrombosis and thromboembolisms
Antiepileptic  Phenobarbital, Phenytoin, Valproic Acid, Carbamazepine, Ethosuximide, sometimes Gabapentin, Lamotrigine Epilepsy, prevention of seizures,  sometimes to stabilize moods
Bronchodilators  Theophylline, Caffeine  Asthma, chronic obstructive  

pulmonary disorder (COPD),  

neonatal apnea

Immunosuppressant  Cyclosporine, Tacrolimus, Sirolimus, Mycophenolate Mofetil, Azathioprine Prevent rejection of transplanted  organs, autoimmune disorders
Anti-Cancer  All Cytotoxic agents  Multiple malignancies
Psychiatric  Lithium, Valproic Acid, some  antidepressants (Imipramine,  Amitriptyline, Nortriptyline,  Doxepin, Desipramine) Bipolar disorder (manic depression),  depression
Protease Inhibitors  Indinavir, Ritonavir, Lopinavir,  Saquinavir, Atazanavir,  


Antibiotics  Aminoglycosides (Gentamicin,  Tobramycin, Amikacin) Vancomycin, Chloramphenicol, Cubicin, Zyvox Infections with bacteria that are  resistant to less toxic antibiotics
Insulin/Anti Diabetic Intravenous Insulin drip  Hyperglycemia

Stimulating Agents  (ESA)

Procrit and Epogen (Epoetin  Alfa) and Aranesp (Darbepoetin Alfa) Anemia