Self-Administered Drug (SAD) Exclusion List – R22,
Effective October 15, 2021

This coverage article has been revised and published for notice under contractor numbers: 02102 (AK), 03102 (AZ), 02202 (ID), 03202 (MT), 03302 (ND), 02302 (OR), 03402 (SD), 03502 (UT), 02402 (WA), and 03602 (WY).

Effective Date: October 15, 2021

Summary of Changes: The “Route of Administrative Modifier” paragraph is revised for clarity: The use of the JA and JB modifiers is required for drugs which have one HCPCS level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Absent evidence to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. Th Contractor will process claims with the JA modifier still applying the policy as stated in Medicare Benefit Policy Manual Chapter 15, section 50.2 that not only must the drug be medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. Subcutaneous administered drugs listed on the Usually Self-Administered  list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either JA or JB modifier will also be denied.

The Drug J3357 Ustekinumab, for subcutaneous injection, 1 mg is added to the SAD list with an effective excluded date of October 15, 2021.

Visit the Self-Administered Drugs (SADs) webpage to view the locally hosted Self-Administered Exclusion List.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Last Updated Aug 25 , 2021