As outlined in statute, Medicare Part B coverage of outpatient drugs is limited to “drugs and biologicals which are not usually self-administered by the patient.” The Centers for Medicare & Medicaid Services (CMS) established criteria based on its broad interpretation of law for Medicare Administrative Contractors (MACs) to determine whether a drug is “usually” self-administered, and therefore, excluded from Part B coverage. For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Drugs that meet this criteria are added to the Self-Administered Drug Exclusion List, or “SAD List.”
Drugs on the SAD Exclusion List are excluded from Part B coverage, leaving beneficiaries who require the physician-administered formulation of a specific drug to pay out-of-pocket. CSRO has argued that not only does this policy hinder access to medically necessary therapy, but it discriminates against individuals with disabilities and raises other health equity concerns.
The Coalition of State Rheumatology Organizations (CSRO) leads efforts to modify the SAD Exclusion List criteria, urging CMS to consider policy options that would ensure beneficiaries can access the medications they need while avoiding discrimination and protecting program integrity. CSRO's communications to CMS can be found here.
Email CSRO to share your stories about the impact the SAD Exclusion List has on your patient, so CSRO can share your experiences with CMS.
