Self-Administered Drug Exclusion List (SAD List)
The full list
Excluded CPT/HCPCS codes
Our full list of 103 excluded entries from CGS Administrators, LLC's CMS self-administered drug exclusion list (article A52527), last refreshed October 6, 2026. Search, sort, or export the list, which may change and could contain errors.
- J3490 27 entries Unclassified drugs
- J3590 19 entries Unclassified biologics
- C9399 2 entries Unclassified drugs or biologicals
These three unclassified-drug codes account for 48 of the 103 excluded entries; the remainder are specific J-codes for individual products.
| Code | Descriptor Generic Name | Descriptor Brand Name | Exclusion Effective Date | Exclusion End Date | Reason for Exclusion |
|---|---|---|---|---|---|
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Besremi (ropeginterferon alfa-2b-njft) | 4/24/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Kesimpta® (ofatumumab) Can be billed under J3490, J3590 as well | 11/19/22 | N/A | Apparent on its Face |
| J0129 | INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Abatacept* Orencia* Orencia Clickjet* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 3/27/21 | N/A | Acceptable Evidentiary Criteria Available |
| J0139 | INJECTION, ADALIMUMAB, 1 MG | Injection, adalimumab, 1 mg Humira® | 1/1/25 | N/A | Apparent on its Face |
| J0270 | INJECTION, ALPROSTADIL, 1.25 MCG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Caverjet®, Edex® | 3/15/03 | N/A | Apparent on its Face |
| J0364 | INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG | Apokyn | 5/31/17 | N/A | Apparent on its Face |
| J0490 | INJECTION, BELIMUMAB, 10 MG | Belimumab* Benlysta* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 3/27/21 | N/A | Acceptable Evidentiary Criteria Available |
| J0593 | INJECTION, LANADELUMAB-FLYO, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED) | LANADELUMAB-FYO (Takhzyro) | 10/1/19 | N/A | Apparent on its Face |
| J0599 | INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS | C1 Inhibitor (Human) Berinert Cinryze Haegarda Note: Prior to 01/01/2019 billed under J3490 | 9/25/17 | N/A | Apparent on its Face |
| J0630 | INJECTION, CALCITONIN SALMON, UP TO 400 UNITS | Calcimar Fortical-DSC Miacalcin Osteocalcin Salmonine | 3/15/03 | N/A | Apparent on its Face |
| J0801 | INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS | Acthar® Gel* (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 10/1/23 | N/A | Apparent on its Face |
| J0802 | INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS | Purified Cortrophin Gel ®*(use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 10/1/23 | N/A | Apparent on its Face |
| J1324 | INJECTION, ENFUVIRTIDE, 1 MG | Fuzeon | 5/16/07 | N/A | Apparent on its Face |
| J1438 | INJECTION, ETANERCEPT, 25 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Enbrel® Enbrel Mini Enbrel Sure Click Brenzys Also see J3590 Etanercept-szzs (Erelzi) | 3/15/03 | N/A | Apparent on its Face |
| J1595 | INJECTION, GLATIRAMER ACETATE, 20 MG | Copaxone Glatopa | 5/16/07 | N/A | Apparent on its Face |
| J1628 | INJECTION, GUSELKUMAB, 1 MG | Guselkumab Tremfya *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 5/15/21 | N/A | Acceptable Evidentiary Criteria Available |
| J1675 | INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS | Supprelin | 5/16/07 | N/A | Apparent on its Face |
| J1744 | INJECTION, ICATIBANT, 1 MG | Firazyr | 10/23/13 | N/A | Apparent on its Face |
| J1811 | INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | Insulin via insulin pump (fiasp) | 8/20/23 | N/A | Apparent on its Face |
| J1812 | INSULIN (FIASP), PER 5 UNITS | Inj. Insulin (fiasp) *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 8/13/23 | N/A | Apparent on its Face |
| J1813 | INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | Insulin via insulin pump (lyumjev) | 8/20/23 | N/A | Apparent on its Face |
| J1814 | INSULIN (LYUMJEV), PER 5 UNITS | Inj. insulin (lyumjev) U-100 and U-200 *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 8/13/23 | N/A | Apparent on its Face |
| J1815 | INJECTION, INSULIN, PER 5 UNITS | All Insulin products | 11/19/22 | N/A | Apparent on its Face |
| J1815 | INJECTION, INSULIN, PER 5 UNITS | Humalog®, Humulin® R, Humalin® 50/50, Lente® Iletin® II, Novolin® | 3/15/03 | N/A | Apparent on its Face |
| J1817 | INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | All Insulin Products | 11/19/22 | N/A | Apparent on its Face |
| J1817 | INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | Humalog, Humulin, Iletin etc. | 5/16/07 | N/A | Apparent on its Face |
| J1826 | INJECTION, INTERFERON BETA-1A, 30 MCG | Avonex Pen Rebif Rebif Rebidose | 5/31/17 | N/A | Apparent on its Face |
| J1830 | INJECTION, INTERFERON BETA-1B, 0.25 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Betaseron® Extavia | 3/15/03 | N/A | Apparent on its Face |
| J1941 | INJECTION, FUROSEMIDE (FUROSCIX), 20 MG | furosemide (Furoscix) | 8/20/23 | N/A | Apparent on its Face |
| J2170 | INJECTION, MECASERMIN, 1 MG | Increlex | 5/16/07 | N/A | Apparent on its Face |
| J2212 | INJECTION, METHYLNALTREXONE, 0.1 MG | Relistor | 10/23/13 | N/A | Apparent on its Face |
| J2267 | INJECTION, MIRIKIZUMAB-MRKZ, 1 MG | Omvoh mirikizumab-mrkz* (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 7/1/24 | N/A | Apparent on its Face |
| J2354 | INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG | Sandostatin* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 8/15/05 | N/A | Apparent on its Face |
| J2440 | INJECTION, PAPAVERINE HCL, UP TO 60 MG | Papaverine Hydrochloride | 10/23/13 | N/A | Apparent on its Face |
| J2941 | INJECTION, SOMATROPIN, 1 MG | Genotropin® Humatrope® Norditropin® Nutropin® Omnitrope Saizen Serostim Tev-Tropin DSC Zomacton Zorbtive | 3/15/03 | N/A | Apparent on its Face |
| J3030 | INJECTION, SUMATRIPTAN SUCCINATE, 6 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Imitrex® Alsuma DSC Imitrex STATdose Refill Imitrex STATdose System Onzetra Xsail Sumavel DosePro Zecuity DSC Zembrace SymTouch | 3/15/03 | N/A | Apparent on its Face |
| J3031 | INJECTION, FREMANEZUMAB-VFRM, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED) | Fremanezumab-vfrm AJOVY | 9/9/19 | N/A | Apparent on its Face |
| J3110 | INJECTION, TERIPARATIDE, 10 MCG | Forteo® | 10/15/06 | N/A | Apparent on its Face |
| J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | 11/1/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Albiglutide, SQ Tanzeum Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Alirocumib Praluent Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 10/17/16 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | All Insulin Products Also can be billed under J3590 and C9399 | 11/19/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Asfotase-alfa Strensiq Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Dulaglutide Trulicity Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/1/15 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Dupilumab Dupixent Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 9/28/18 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Ebglyss (lebrikizumab-lbkz) | 6/30/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Evolocumab Repatha Repatha Pushtronex System Repatha SureClick Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Exenatide Byetta Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 8/15/05 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Exenatide XR Bydureon Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Golimumab - Non-IV Form Simponi - Non-IV Form Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 10/17/16 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. ABRILADA (adalimumab-afzb) is biosimilar* to HUMIRA (adalimumab). HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab) HULIO® (adalimumab-fkjp) is biosimilar* to HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) is biosimilar* to HUMIRA (adalimumab) YUSIMRY (adalimumab-aqvh) is biosimilar* to HUMIRA (adalimumab) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Ixekizumab Taltz Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Liraglutide-GLP-1 agonist DM Victoza Saxenda Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/23/13 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Methotrexate - Solution Auto-injector Non Chemotherapeutic Otrexup Rasuvo Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/1/15 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Metreleptin Myalept Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Mipomersen Sodium Kynamro Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/23/13 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Pasireotide Diaspartate SIGNIFOR Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. (J2502 is only to be used when the LAR form is administered IM under the direct supervision of a physician) | 10/23/13 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Pramlintide Acetate SymlinPen 60 or 120 Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 8/15/05 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Secukinumab Cosentyx Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/1/15 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | SteQeyma* Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) Can be billed with J3490, J3590, or C9399 | 6/30/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tesamorelin Egrifta Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply | 5/31/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tirzepatide (Monjaro, Zetbound) Also billed under: J3590 and C9399 | 11/19/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tralokinumab-Idrm (Adbry™) This can also be billed with J3590 and C9399 | 11/1/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Trimix (alprostadil, papaverine and phentolamine) Quadramix (alprostadil, papaverine, phentolamine and atropine) Note: If billed under any other miscellaneous code (i.e., J3590, J7999, J9999, or C9399) same rules apply. . | 8/15/10 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Vedolizumab* Entyvio* (J3490, J3590, C9399) (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 1/13/24 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Yuflyma (J3490, J3590, C9399) | 1/13/24 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Abaloparatide Tymlos Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-adaz (Hyrimoz) Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-adbm Cyltezo Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/28/18 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-atto Amjevita Biosimilar to Adalimumab (Humira) Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-bwwd (Hadlima) biosimilar to Adalimumab Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Anakinra Kineret Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 5/16/07 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Brodalumab Siliq Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Erenumab-aoooe Aimovig Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Etanercept-SZZS Erelzi Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 10/17/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Galcanezumab-gnlm Emgality Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | nemolizumab-ilto (Nemluvio) Can alos be billed with code J3490 and C9399 | 6/14/26 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Parathyroid Hormone Natpara Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 4/15/15 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Peg-interferon Alfa 2B Pegintron Sylantra Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 5/16/07 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon Alpha-2A Pegasys Pegasys Proclick Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 5/16/07 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Pegvisomant Somavert Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 5/16/07 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Risankizumab-rzaa (Skyrizi™) This can also be billed with J3490 or C9399 as well as J3590. | 5/15/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Sarilumab Kevzara Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Semaglutide Ozempic Wegovy Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply | 9/9/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Somapacitan-beco Sogroya | 3/27/21 | N/A | Apparent on its Face |
| J9213 | INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS | Peginterferon Alpha 2A Roferon A Pegasys Proclick | 5/16/07 | N/A | Apparent on its Face |
| J9216 | INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS | Actimmune | 5/16/07 | N/A | Apparent on its Face |
| J9218 | LEUPROLIDE ACETATE, PER 1 MG | Lupron® Eligard® | 3/15/03 | N/A | Apparent on its Face |
| Q0515 | INJECTION, SERMORELIN ACETATE, 1 MICROGRAM | INJECTION, SERMORELIN ACETATE, 1 MICROGRAM Geref Diagnostic | 10/25/23 | N/A | Apparent on its Face |
| Q3027 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE | Injection, INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE Avonex | 6/4/21 | N/A | Acceptable Evidentiary Criteria Available |
| Q3028 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE | INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE Rebif | 6/4/21 | N/A | Acceptable Evidentiary Criteria Available |
| Q5098 | INJECTION, USTEKINUMAB-SRLF (IMULDOSA), BIOSIMILAR, 1 MG | Inj ustekinumab-srlf, 1 mg*Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 7/1/25 | N/A | Apparent on its Face |
| Q5099 | INJECTION, USTEKINUMAB-STBA (STEQEYMA), BIOSIMILAR, 1 MG | Inj ustekinumab-stba, 1 mg *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 7/1/25 | N/A | Apparent on its Face |
| Q5100 | INJECTION, USTEKINUMAB-KFCE (YESINTEK), BIOSIMILAR, 1 MG | Inj ustekinumab-kfce, 1 mg *Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 7/1/25 | N/A | Apparent on its Face |
| Q5140 | INJECTION, ADALIMUMAB-FKJP, BIOSIMILAR, 1 MG | Injection, adalimumab-fkjp, biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q5141 | INJECTION, ADALIMUMAB-AATY, BIOSIMILAR, 1 MG | Injection, adalimumab-aaty, biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q5142 | INJECTION, ADALIMUMAB-RYVK BIOSIMILAR, 1 MG | Injection, adalimumab-ryvk biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q5143 | INJECTION, ADALIMUMAB-ADBM, BIOSIMILAR, 1 MG | Injection, adalimumab-adbm, biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q5144 | INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 1 MG | Injection, adalimumab-aacf (idacio), biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q5145 | INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 1 MG | Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg | 1/1/25 | N/A | Apparent on its Face |
| Q9996 | INJECTION, USTEKINUMAB-TTWE (PYZCHIVA), SUBCUTANEOUS, 1 MG | Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg pyzchiva | 1/1/25 | N/A | Acceptable Evidentiary Criteria Available |
| Q9998 | INJECTION, USTEKINUMAB-AEKN (SELARSDI), BIOSIMILAR, 1 MG | Injection, ustekinumab-aekn (selarsdi), 1 mg ustekinumab-aekn (selarsdi)*Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 1/1/25 | N/A | Acceptable Evidentiary Criteria Available |
| Q9999 | INJECTION, USTEKINUMAB-AAUZ (OTULFI), BIOSIMILAR, 1 MG | Otulfi*Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 6/30/25 | N/A | Apparent on its Face |
Exclusion ended
Non-excluded (ended) codes
19 CPT/HCPCS codes whose exclusion carries an end date. As of that date the exclusion no longer applies, so the code is no longer treated as self-administered for Part B purposes.
| Code | Descriptor Generic Name | Descriptor Brand Name | Exclusion Effective Date | Exclusion End Date | Reason for Exclusion |
|---|---|---|---|---|---|
| J0129 | INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Abatacept (Orencia) | 10/17/16 | 4/17/17 | Apparent on its Face |
| J0129 | INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Abatacept; Orencia when self administered Note: J0129 Abatacept should only be used for Medicare when administered under the direct supervision of a physician, not for use when drug is self administered. If filing for self-administered form for Medicare denial, use J3490, J3590, or C9399 listed within this document. | 10/17/16 | 1/23/20 | Apparent on its Face |
| J0275 | ALPROSTADIL URETHRAL SUPPOSITORY (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) | Muse | 3/15/03 | 4/17/17 | Apparent on its Face |
| J1555 | INJECTION, IMMUNE GLOBULIN (CUVITRU), 100 MG | Immune Globulin Cuvitru | 3/27/21 | 3/27/21 | Apparent on its Face |
| J1558 | INJECTION, IMMUNE GLOBULIN (XEMBIFY), 100 MG | Immune Globulin-klhw Xemblify | 3/27/21 | 3/27/21 | Apparent on its Face |
| J1559 | INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG | Hizentra | 10/23/13 | 12/31/20 | Apparent on its Face |
| J1602 | INJECTION, GOLIMUMAB, 1 MG, FOR INTRAVENOUS USE | Simponi Note: If billing for any other form of this drug, use J3490. Removing J1602 from list as code is for IV form only and references Simponi Aria. | 10/17/16 | 10/17/16 | Apparent on its Face |
| J1628 | INJECTION, GUSELKUMAB, 1 MG | Tremfya | 5/1/20 | 5/1/20 | Acceptable Evidentiary Criteria Available |
| J2760 | INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG | Regitine | 10/23/13 | 7/24/19 | Apparent on its Face |
| J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara | 5/1/20 | 5/1/20 | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Abatacept, SQ Orencia Orencia Prefilled Syringe Orencia Clickjet Note: Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules applySpecial Instruction: (Note: J0129 Abatacept is only to be used when administered by IV infusion under direct supervision of a physician) Note: End dating and adding code J0129 with additional information | 5/31/17 | 3/27/21 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Insulin Glargine (pen injector) Toujeo SoloStar Lantus Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply. | 10/1/15 | 11/19/22 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Omvoh mirikizumab-mrkz (J3490, J3590, C9399) (use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 1/13/24 | 6/30/24 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Otrexup (Methotrexate - Solution Auto-injector Non Chemotherapeutic) See under J3490 Methotrexate Solution Auto-injector Non Chemotherapeutic | 10/1/15 | 4/18/17 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Quadmix (alprostadil, atropine, papaverine, phentolamine) Note: If billed under any other miscellaneous code (i.e., J3590, J9999, or C9399) same rules apply Note End dating as this is a duplicate entry see under J3490 with Timix and Quadramix | 5/31/17 | 2/10/21 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tezspire (Tezepelumab-Ekko) CUrrently billed with unlisted codes J34490, J3590 or C9399 for ASC and facility POS Effective 07/01/2022 use J2356 Note: If being administered IV use modifier “JA”; if administered subcutaneously use modifier “JB” (subcutaneous injection is considered self-administered) | 7/10/22 | 7/10/22 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Etanercept-szzs Erelzi Biosimilar to Etanercept (Enbrel) under J1438 Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply **End dating 09/09/2019 entry only as this is already listed under J3490 effective 10/17/2016 which still applies. | 9/9/19 | 9/9/19 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon Beta-1A Plegridy Note: If billed under any other miscellaneous code (i.e., J3490, J9999, or C9399) same rules apply Note: End dating as this is listed under J9213 | 10/17/16 | 3/27/21 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Raptiva removing no longer available | 5/16/07 | 4/18/17 | Apparent on its Face |
Overview
What is the SAD exclusion list?
The CMS self-administered drug exclusion list contains drugs that are usually self-administered by the patient and, therefore, are not typically covered by Medicare Part B when administered by a physician, whether in a physician's office or a hospital outpatient department. This is because Medicare Part B generally does not cover the cost of self-administered drugs that beneficiaries would typically take on their own.
Each Medicare Administrative Contractor (MAC) maintains its own exclusion list, and CMS refreshes the underlying data quarterly. BuyandBill.com republishes each MAC's self-administered drug exclusion list from the CMS Coverage API so providers can check a code before billing.
How it is decided
How CMS decides a drug is self-administered
A drug lands on the exclusion list when CMS determines it is usually administered by the patient. Four factors drive that determination.
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Usually self-administered
CMS excludes a drug when it is self-administered more than 50% of the time across all Medicare beneficiaries who use it, a population-level determination rather than a single claim.
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Route of administration
Products a patient can reasonably give themselves, such as subcutaneous injections or oral therapies, are far more likely to be excluded than infusions that require clinical administration.
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Apparent on its face
Some products are excluded because they are plainly intended for patient self-administration. This is the determination method recorded for the entries on this list.
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Acute vs. chronic use
CMS weighs whether a drug treats an acute condition, more often given in the office, or a chronic one the patient manages at home over an extended course of therapy.
FAQ
Frequently asked questions
What is the self-administered drug (SAD) exclusion list?
The SAD exclusion list is a CMS list of drugs that are usually self-administered by the patient and are therefore not typically covered by Medicare Part B when administered by a physician, whether in a physician's office or a hospital outpatient setting. Each Medicare Administrative Contractor (MAC) publishes its own exclusion list; BuyandBill.com republishes the list in conjunction with the CMS data file.
Why does Medicare Part B not cover these drugs?
Medicare Part B generally covers drugs that are administered by a physician or under direct supervision and that are not usually self-administered. When a drug is usually self-administered, the cost is expected to fall under Part D or the patient rather than Part B.
What does "Apparent on its Face" mean?
It is one of the methods CMS uses to determine that a drug is self-administered. The product is excluded because it is clearly intended for the patient to administer themselves.
How often is the SAD list updated?
CMS updates the self-administered drug exclusion data on a quarterly basis. BuyandBill.com refreshes the list monthly from the CMS Coverage API so it reflects the current version of each contractor’s article.
What is the difference between the excluded and the non-excluded (ended) list?
The excluded list contains codes currently treated as self-administered and not covered by Part B in the outpatient setting. The non-excluded list contains codes whose exclusion has an end date, meaning the exclusion no longer applies as of that date.
How does the SAD list affect buy and bill?
If an office-administered drug appears on the exclusion list, a Part B claim in the outpatient setting may be denied as self-administered. Checking the list before billing helps providers avoid denials and route the claim correctly.
