Self-Administered Drug Exclusion List (SAD List)
The full list
Excluded CPT/HCPCS codes
Our full list of 168 excluded entries from Noridian Healthcare Solutions, LLC's CMS self-administered drug exclusion list (article A53032), last refreshed October 6, 2026. Search, sort, or export the list, which may change and could contain errors.
- J3590 42 entries Unclassified biologics
- C9399 38 entries Unclassified drugs or biologicals
- J3490 33 entries Unclassified drugs
These three unclassified-drug codes account for 113 of the 168 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 | Adalimumab-aacf (Idacio®) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-aaty (Yuflyma) | 1/14/24 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-adaz (Hyrimoz) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-afzb (Abrilada™) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-aqvh (Yusimry) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-atto (Amjevita™) | 2/28/17 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-bwwd (Hadlima) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-fkjp (Hulio®) | 6/25/23 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Albiglutide for SQ injection (Tanzeum™) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Alirocumab (Praluent®) | 11/24/15 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | All insulin products | 6/27/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Asfotase-alfa (Strensiq™) | 2/28/17 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | bimekizumab-bkzx (Bimzelx®) | 8/29/26 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Brodalumab (Siliq) | 8/7/17 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Dulaglutide (Trulicity®) | 6/27/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Dupilumab (Dupixent) | 8/7/17 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Etanercept-SZZS (Erelzi™) | 12/6/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Evolucumab (Repatha™) | 11/24/15 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Exenatide (Byetta®) | 9/16/13 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Exenatide XR (Bydureon®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Interferon beta 1a (Rebif ®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Ixekizumab (Taltz™) | 2/28/17 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | lebrikizumab-lbkz (Ebglyss) | 6/1/25 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Methotrexate - Solution Auto-injector Non Chemotherapeutic (Otrexup™, Rasuvo®) | 6/27/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Metreleptin for injection (Myalept ™) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Nemolizumab-ilto (Nemluvio) | 6/6/26 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | ofatumumab (Kesimpta®) subcutaneous use* | 7/17/22 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Parathyroid Hormone (Natpara®) | 6/27/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Pasireotide (Signifor®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Peginterferon beta-1a (Plegridy™) | 6/27/16 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Risankizumab-rzaa (Skyrizi™) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Ropeginterferon alfa-2b-njft (Besremi®) | 4/24/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Secukinumab (Cosentyx) subcutaneous use | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | somapacitan-beco (Sogroya®) | 4/5/21 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Tirzepatide (Mounjaro™, Zepbound) | 11/19/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | tralokinumab-ldrm (Adbry™) | 11/1/22 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | ustekinumab-stba (SteQeyma)* | 6/1/25 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Vedolizumab (Entyvio®) subcutaneous use* | 1/14/24 | 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) | Orencia® subcutaneous use* | 4/5/21 | N/A | Apparent on its Face |
| J0139 | INJECTION, ADALIMUMAB, 1 MG | Adalimumab | 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) | Alprostadil®, Caverject®, Edex®, Prostin VR Pediatric® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J0364 | INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG | Apokyn® | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J0490 | INJECTION, BELIMUMAB, 10 MG | Belimumab (Benlysta)* | 11/15/25 | N/A | Apparent on its Face |
| 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-flyo (TAKHZYRO) | 12/2/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J0599 | INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS | HAEGARDA® | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J0630 | INJECTION, CALCITONIN SALMON, UP TO 400 UNITS | Calcimar®, Miacalcin, Osteocalcin, Salmonine, Fortical | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J0801 | INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS | H.P. Acthar® Gel subcutaneous use** | 10/1/23 | N/A | Apparent on its Face |
| J0802 | INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS | H.P. Acthar® Gel subcutaneous use** | 10/1/23 | N/A | Apparent on its Face |
| J1324 | INJECTION, ENFUVIRTIDE, 1 MG | Fuzeon® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| 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® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1595 | INJECTION, GLATIRAMER ACETATE, 20 MG | Copaxone® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1628 | INJECTION, GUSELKUMAB, 1 MG | guselkumab (Tremfya®)* | 5/15/21 | N/A | Acceptable Evidentiary Criteria Available |
| J1675 | INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS | Supprelin LA® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1744 | INJECTION, ICATIBANT, 1 MG | Icatibant (Firazyr®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1748 | INJECTION, INFLIXIMAB-DYYB (ZYMFENTRA), 10 MG | Injection, infliximab-dyyb (zymfentra) | 8/18/24 | N/A | Apparent on its Face |
| J1811 | INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | Fiasp® | 8/20/23 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1812 | INSULIN (FIASP), PER 5 UNITS | Fiasp® | 8/20/23 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1813 | INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | Lyumjev® | 8/20/23 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1814 | INSULIN (LYUMJEV), PER 5 UNITS | Lyumjev® 100 IU* | 8/20/23 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1814 | INSULIN (LYUMJEV), PER 5 UNITS | Lyumjev® 200 IU | 8/20/23 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1815 | INJECTION, INSULIN, PER 5 UNITS | All insulin products | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1817 | INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | All insulin products | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| 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® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J2170 | INJECTION, MECASERMIN, 1 MG | Increlex®, Iplex | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J2212 | INJECTION, METHYLNALTREXONE, 0.1 MG | Relistor® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J2267 | INJECTION, MIRIKIZUMAB-MRKZ, 1 MG | Mirikizumab-mrkz* | 7/1/24 | N/A | Apparent on its Face |
| J2354 | INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG | Octreotide Acetate (Sandostatin)* | 9/16/13 | N/A | Presumption of Long-Term Non-Acute Administration |
| J2440 | INJECTION, PAPAVERINE HCL, UP TO 60 MG | Papaverine HCL | 9/16/13 | N/A | Apparent on its Face |
| J2941 | INJECTION, SOMATROPIN, 1 MG | Humatrope, Genotropin, Omnitrope, (Saizen, Zorbtive, Zomacton, Norditropin, Nutropin) | 9/16/13 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| 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® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| 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) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3110 | INJECTION, TERIPARATIDE, 10 MCG | Forteo® | 9/16/13 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara® | 10/15/21 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-aacf (Idacio®) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-aaty (Yuflyma) | 1/14/24 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-adaz (Hyrimoz) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-adbm (Cyltezo) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-afzb (Abrilada™) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-aqvh (Yusimry) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-bwwd (Hadlima) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Adalimumab-fkjp (Hulio®) | 6/25/23 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Albiglutide for SQ injection (Tanzeum™) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | All insulin products | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | bimekizumab-bkzx (Bimzelx®) | 8/29/26 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Exenatide (Byetta®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Exenatide XR (Bydureon®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Interferon beta 1a, (Rebif®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | lebrikizumab-lbkz (Ebglyss) | 6/1/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Liraglutide GLP-1 (Victoza®, Saxenda®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Metreleptin for injection (Myalept ™) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | mipomersen sodium (Kynamro®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Nemolizumab-ilto (Nemluvio) | 6/6/26 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | ofatumumab (Kesimpta®) subcutaneous use* | 7/17/22 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Pasireotide (Signifor®) | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Peginterferon Alfa 2-b (Sylatron, Pegintron) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Pramlintide acetate (Symlin®, SymlinPen 60, SymlinPen 120) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Risankizumab-rzaa (Skyrizi™) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Ropeginterferon alfa-2b-njft (Besremi®) | 4/24/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Secukinumab (Cosentyx) subcutaneous use | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | somapacitan-beco (Sogroya®) | 4/5/21 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tesamorelin Acetate (Egrifta®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Tirzepatide (Mounjaro™, Zepbound) | 11/19/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | tralokinumab-ldrm (Adbry™) | 11/1/22 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | TriMix | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | ustekinumab-stba (SteQeyma)* | 6/1/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Vedolizumab (Entyvio®) subcutaneous use* | 1/14/24 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Abaloparatide (Tymlos) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Abatacept (Orencia®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-aacf (Idacio®) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-aaty (Yuflyma) | 1/14/24 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-adaz (Hyrimoz) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-afzb (Abrilada™) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-aqvh (Yusimry) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-atto (Amjevita™) | 2/28/17 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-bwwd (Hadlima) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-fkjp (Hulio®) | 6/25/23 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Alcanezumab-gnlm (Emgality) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Alirocumab (Praluent®) | 11/24/15 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | All insulin products | 6/27/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Anakinra (Kineret®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Asfotase-alfa (Strensiq™) | 2/28/17 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | bimekizumab-bkzx (Bimzelx®) | 8/29/26 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Brodalumab (Siliq) | 8/7/17 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Dulaglutide (Trulicity®) | 6/27/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Dupilumab (Dupixent) | 8/7/17 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Erenumab-aoooe (Aimovig) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Etanercept-SZZS (Erelzi™) | 12/6/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Evolucumab (Repatha™) | 11/24/15 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Golimumab (Simponi®) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Ixekizumab (Taltz™) | 2/28/17 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | lebrikizumab-lbkz (Ebglyss) | 6/1/25 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Methotrexate - Solution Auto-injector Non Chemotherapeutic (Otrexup™, Rasuvo®) | 6/27/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Nemolizumab-ilto (Nemluvio) | 6/6/26 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | ofatumumab (Kesimpta®) subcutaneous use* | 7/17/22 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Parathyroid Hormone (Natpara®) | 6/27/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon Alfa-2a (Pegasys™, Roferon®-A) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon beta-1a (Plegridy™) | 6/27/16 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Pegvisomant (Somavert®, variable) | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Risankizumab-rzaa (Skyrizi™) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Ropeginterferon alfa-2b-njft (Besremi®) | 4/24/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Sarilumab (Kevzara) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Secukinumab (Cosentyx) subcutaneous use | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Semaglutide (Ozempic, Wegovy) | 9/18/19 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | somapacitan-beco (Sogroya®) | 4/5/21 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Tirzepatide (Mounjaro™, Zepbound) | 11/19/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | tralokinumab-ldrm (Adbry™) | 11/1/22 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | ustekinumab-stba (SteQeyma)* | 6/1/25 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Vedolizumab (Entyvio®) subcutaneous use* | 1/14/24 | N/A | Apparent on its Face |
| J9213 | INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS | Roferon®-A | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J9216 | INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS | Actimmune® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J9218 | LEUPROLIDE ACETATE, PER 1 MG | Leuprolide Acetate, Leuprolide Acetate Inj | 9/16/13 | N/A | Presumption of Long-Term Non-Acute Administration, Acceptable Evidentiary Criteria Available |
| Q0515 | INJECTION, SERMORELIN ACETATE, 1 MICROGRAM | Geref® | 9/16/13 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| Q3027 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE | Avonex®, Avonex Pen® | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| Q3028 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE | Rebif® | 6/4/15 | N/A | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| Q5098 | INJECTION, USTEKINUMAB-SRLF (IMULDOSA), BIOSIMILAR, 1 MG | ustekinumab-srlf (imuldosa)* | 7/1/25 | N/A | Apparent on its Face |
| Q5099 | INJECTION, USTEKINUMAB-STBA (STEQEYMA), BIOSIMILAR, 1 MG | ustekinumab-stba (steqeyma)* | 7/1/25 | N/A | Apparent on its Face |
| Q5100 | INJECTION, USTEKINUMAB-KFCE (YESINTEK), BIOSIMILAR, 1 MG | ustekinumab-kfce (yesintek)* | 7/1/25 | N/A | Apparent on its Face |
| Q5137 | INJECTION, USTEKINUMAB-AUUB (WEZLANA), BIOSIMILAR, SUBCUTANEOUS, 1 MG | ustekinumab-auub (wezlana) | 7/1/24 | N/A | Apparent on its Face |
| Q5140 | INJECTION, ADALIMUMAB-FKJP, BIOSIMILAR, 1 MG | adalimumab-fkjp | 1/1/25 | N/A | Apparent on its Face |
| Q5141 | INJECTION, ADALIMUMAB-AATY, BIOSIMILAR, 1 MG | adalimumab-aaty | 1/1/25 | N/A | Apparent on its Face |
| Q5142 | INJECTION, ADALIMUMAB-RYVK BIOSIMILAR, 1 MG | adalimumab-ryvk | 1/1/25 | N/A | Apparent on its Face |
| Q5143 | INJECTION, ADALIMUMAB-ADBM, BIOSIMILAR, 1 MG | adalimumab-adbm | 1/1/25 | N/A | Apparent on its Face |
| Q5144 | INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 1 MG | adalimumab-aacf (idacio) | 1/1/25 | N/A | Apparent on its Face |
| Q5145 | INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 1 MG | adalimumab-afzb (abrilada) | 1/1/25 | N/A | Apparent on its Face |
| Q5164 | INJECTION, USTEKINUMAB-HMNY (STARJEMZA), BIOSIMILAR, 1 MG | ustekinumab-hmny (starjemza)* | 8/29/26 | N/A | Apparent on its Face |
| Q9996 | INJECTION, USTEKINUMAB-TTWE (PYZCHIVA), SUBCUTANEOUS, 1 MG | ustekinumab-ttwe (pyzchiva) | 1/1/25 | N/A | Acceptable Evidentiary Criteria Available |
| Q9998 | INJECTION, USTEKINUMAB-AEKN (SELARSDI), BIOSIMILAR, 1 MG | ustekinumab-aekn (selarsdi)* | 1/1/25 | N/A | Apparent on its Face |
| Q9999 | INJECTION, USTEKINUMAB-AAUZ (OTULFI), BIOSIMILAR, 1 MG | Ustekinumab-aauz (Otulfi)* | 6/1/25 | N/A | Apparent on its Face |
Exclusion ended
Non-excluded (ended) codes
20 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 |
|---|---|---|---|---|---|
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Daclizumab (Zinbryta™) | 2/28/17 | 2/18/21 | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Mirikizumab-mrkz (Omvoh™) subcutaneous use* | 1/14/24 | 6/30/24 | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Tezspire™ (tezepelumab-ekko) | 7/17/22 | 7/17/22 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | ustekinumab-auub* (Wezlana) | 3/17/24 | 6/30/24 | 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® | 9/16/13 | 7/14/17 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1559 | INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG | Hizentra® | 9/16/13 | 12/31/20 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J1575 | INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN | Immune globulin | 2/11/16 | 7/25/16 | |
| J1628 | INJECTION, GUSELKUMAB, 1 MG | Tremfya® | 5/3/20 | 5/3/20 | Acceptable Evidentiary Criteria Available |
| J2502 | INJECTION, PASIREOTIDE LONG ACTING, 1 MG | Pasireotide long acting | 2/11/16 | 10/1/16 | Apparent on its Face |
| J2760 | INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG | Regitine | 9/16/13 | 7/14/17 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara® subcutaneous | 5/3/20 | 5/3/20 | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Mirikizumab-mrkz (Omvoh™) subcutaneous use* | 1/14/24 | 6/30/24 | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tezspire™ (tezepelumab-ekko) | 7/17/22 | 7/17/22 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | ustekinumab-auub* (Wezlana) | 3/17/24 | 6/30/24 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Daclizumab (Zinbryta™) | 2/16/17 | 2/18/21 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Efalizumab, Raptiva | 9/16/13 | 7/14/17 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Mirikizumab-mrkz (Omvoh™) subcutaneous use* | 1/14/24 | 6/30/24 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | risankizumab-rzaa (Skyrizi™) | 12/2/19 | 12/2/19 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Tezspire™ (tezepelumab-ekko) | 7/17/22 | 7/17/22 | Apparent on its Face, Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | ustekinumab-auub* (Wezlana) | 3/17/24 | 6/30/24 | 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.
