Self-Administered Drug Exclusion List (SAD List)
The full list
Excluded CPT/HCPCS codes
Our full list of 137 excluded entries from Palmetto GBA's CMS self-administered drug exclusion list (article A53066), last refreshed October 6, 2026. Search, sort, or export the list, which may change and could contain errors.
- J3590 38 entries Unclassified biologics
- J3490 32 entries Unclassified drugs
- C9399 18 entries Unclassified drugs or biologicals
These three unclassified-drug codes account for 88 of the 137 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 | Abrilada™ (adalimumab-afzb) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adbry™ (tralokinumab-Idrm) | 11/1/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | All insulin products | 11/19/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Bimzelx® (bimekizumab-bkzx) | 8/29/26 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Cosentyx® (secukinumab), subcutaneous use | 10/1/15 | N/A | Acceptable Evidentiary Criteria Available |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Ebglyss™ (lebrikizumab-lbkz) | 6/1/25 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Entyvio® (vedolizumab), subcutaneous use* | 1/14/24 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Hadlima (adalimumab-bwwd) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Hulio® (adalimumab-fkjp) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Hyrimoz® (adalimumab-adaz) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Idacio® (adalimumab-aacf) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Kesimpta® (ofatumumab) subcutaneous use* | 7/1/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Mounjaro® (tirzepatide) Zepbound™ (tirzepatide) | 11/19/22 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Nemluvio (nemolizumab-ilto) | 6/1/26 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Skyrizi™ (risankizumab-rzaa) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Steqeyma® (ustekinumab-stba) subcutaneous use* | 6/1/25 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Yuflyma® (adalimumab-aaty) | 1/14/24 | N/A | Apparent on its Face |
| C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Yusimry (adalimumab-aqvh) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| 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®, subcutaneous use* | 10/3/13 | N/A | Presumption of Long-Term Non-Acute Administration |
| J0139 | 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®, Prostin VR® | 12/1/02 | N/A | Acceptable Evidentiary Criteria Available |
| J0490 | INJECTION, BELIMUMAB, 10 MG | Benlysta® subcutaneous use* | 7/20/19 | N/A | Acceptable Evidentiary Criteria Available |
| J0599 | INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA), 10 UNITS | Haegarda | 1/1/19 | N/A | Acceptable Evidentiary Criteria Available |
| J0801 | INJECTION, CORTICOTROPIN (ACTHAR GEL), UP TO 40 UNITS | Acthar® Gel, subcutaneous use** | 10/1/23 | N/A | Apparent on its Face |
| J0802 | INJECTION, CORTICOTROPIN (ANI), UP TO 40 UNITS | Purified Cortrophin Gel®, subcutaneous use** | 10/1/23 | N/A | Apparent on its Face |
| J1324 | INJECTION, ENFUVIRTIDE, 1 MG | Fuzeon® | 12/1/02 | N/A | Acceptable Evidentiary Criteria Available |
| 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® | 12/1/02 | N/A | Presumption of Long-Term Non-Acute Administration |
| J1595 | INJECTION, GLATIRAMER ACETATE, 20 MG | Copaxone®, Glatopa® | 9/15/03 | N/A | Acceptable Evidentiary Criteria Available |
| J1628 | INJECTION, GUSELKUMAB, 1 MG | Tremfya 1 mg, subcutaneous use* | 1/1/19 | N/A | Apparent on its Face |
| J1675 | INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS | Supprelin LA® | 1/1/06 | N/A | Acceptable Evidentiary Criteria Available |
| J1744 | INJECTION, ICATIBANT, 1 MG | Firazyr® | 6/18/12 | N/A | Acceptable Evidentiary Criteria Available |
| J1748 | INJECTION, INFLIXIMAB-DYYB (ZYMFENTRA), 10 MG | Zymfentra™ (infliximab-dyyb) | 8/18/24 | N/A | Apparent on its Face |
| J1811 | INSULIN (FIASP) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | All insulin products | 7/1/23 | N/A | Apparent on its Face |
| J1812 | INSULIN (FIASP), PER 5 UNITS | All insulin products | 7/1/23 | N/A | Apparent on its Face |
| J1813 | INSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | All insulin products | 7/1/23 | N/A | Apparent on its Face |
| J1814 | INSULIN (LYUMJEV), PER 5 UNITS | All insulin products | 7/1/23 | N/A | Apparent on its Face |
| J1815 | INJECTION, INSULIN, PER 5 UNITS | All insulin products | 1/1/04 | N/A | Acceptable Evidentiary Criteria Available |
| J1817 | INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS | All insulin products | 1/1/04 | N/A | Acceptable Evidentiary Criteria Available |
| 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® | 12/1/02 | N/A | Acceptable Evidentiary Criteria Available |
| J1941 | INJECTION, FUROSEMIDE (FUROSCIX), 20 MG | Furoscix® | 7/1/23 | N/A | Apparent on its Face |
| J2170 | INJECTION, MECASERMIN, 1 MG | Increlex® | 7/16/07 | N/A | Acceptable Evidentiary Criteria Available |
| J2212 | INJECTION, METHYLNALTREXONE, 0.1 MG | Relistor® | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J2267 | INJECTION, MIRIKIZUMAB-MRKZ, 1 MG | Omvoh™ (mirikizumab-mrkz), subcutaneous use* | 7/1/24 | N/A | Apparent on its Face |
| J2354 | INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG | Sandostatin® subcutaneous use* | 5/1/03 | N/A | Presumption of Long-Term Non-Acute Administration |
| J2440 | INJECTION, PAPAVERINE HCL, UP TO 60 MG | Papaverine (generic) | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J2941 | INJECTION, SOMATROPIN, 1 MG | Biotropin®, Genotropin® Nutropin®, Humatrope®, Genotropin®, Genotropin Miniquick®, Norditropin®, Nutropin®, Nutropin AQ®, Omnitrope®, Saizen®, Saizen Somatropin RDNA Origin®, Serostim RDNA Origin®, Zorbtive®, Serostim®, Accretropin™ | 12/1/02 | N/A | Presumption of Long-Term Non-Acute Administration |
| 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®, Imitrex Statdose Pen®, Zembrace™- SymTouch™, Alsuma™, Sumavel® DosePro® | 12/1/02 | N/A | 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) | Ajovy® | 10/1/19 | N/A | Apparent on its Face |
| J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara® | 10/15/21 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Abrilada™ (adalimumab-afzb) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Adbry™ (tralokinumab-Idrm) | 11/1/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Albiglutide, Tanzeum® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | All insulin products | 7/20/19 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Anakinra, Kineret® | 9/15/03 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Bimzelx® (bimekizumab-bkzx) | 8/29/26 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Cosentyx®, secukinumab, subcutaneous use | 10/1/15 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Cyltezo® (adalimumab-adbm) | 7/20/19 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Dulaglutide, Trulicity® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Ebglyss™ (lebrikizumab-lbkz) | 6/1/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Entyvio® (vedolizumab), subcutaneous use* | 1/14/24 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Exenatide, Byetta®, Bydureon® | 7/16/07 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Hadlima (adalimumab-bwwd) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Hulio® (adalimumab-fkjp) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Hyrimoz® (adalimumab-adaz) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Idacio® (adalimumab-aacf) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Kesimpta® (ofatumumab) subcutaneous use* | 7/1/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Mipomersen sodium, Kynamro® | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Mounjaro® (tirzepatide) Zepbound™ (tirzepatide) | 11/19/22 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Nemluvio (nemolizumab-ilto) | 6/1/26 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Pasireotide, Signifor® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Peginterferon Alfa 2-b, Peg-Intron®, Peg-Intron Redipen®, Sylatron® | 5/1/03 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Pramlintide acetate, Symlin®, SymlinPen 60®, SymlinPen 120® | 7/16/07 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | QuadMix (tri-mix+atropine) | 7/17/17 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Skyrizi™ (risankizumab-rzaa) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Steqeyma® (ustekinumab-stba) subcutaneous use* | 6/1/25 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Tesamorelin, Egrifta® | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | TriMix | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Victoza® (liraglutide) | 9/3/13 | N/A | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Yuflyma® (adalimumab-aaty) | 1/14/24 | N/A | Apparent on its Face |
| J3490 | UNCLASSIFIED DRUGS | Yusimry (adalimumab-aqvh) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Abrilada™ (adalimumab-afzb) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Adbry™ (tralokinumab-Idrm) | 11/1/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Aimovig™ (erenumab-aooe) | 7/20/19 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Alirocumab, Praluent® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | All insulin products | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | BESREMi® (ropeginterferon alfa-2b-njft) | 4/24/22 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Bimzelx® (bimekizumab-bkzx) | 8/29/26 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Cosentyx® (secukinumab), subcutaneous use | 10/1/15 | N/A | Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Dupixent® | 7/17/17 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Ebglyss™ (lebrikizumab-lbkz) | 6/1/25 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Emgality® (galcanezumab-gnlm) | 7/20/19 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Entyvio® (vedolizumab), subcutaneous use* | 1/14/24 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Erelzi™ | 7/17/17 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Evolcumab, Repatha® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Golimumab, Simponi® | 10/22/12 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Hadlima (adalimumab-bwwd) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Hulio® (adalimumab-fkjp) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Hyrimoz® (adalimumab-adaz) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Idacio® (adalimumab-aacf) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Ixekizumab, Taltz® | 11/14/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Kesimpta® (ofatumumab) subcutaneous use* | 7/1/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Kevzara® (sarilumab) | 7/20/19 | N/A | Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Metreleptin, Myalept® | 11/14/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Mounjaro® (tirzepatide) Zepbound™ (tirzepatide) | 11/19/22 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Nemluvio (nemolizumab-ilto) | 6/1/26 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Ozempic® (semaglutide) Wegovy® (semaglutide) | 7/20/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Parathyroid Hormone, Natpara® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon beta-1a, Plegridy® | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Pegvisomant, Somavert® | 7/16/07 | N/A | Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Pegylated Interferon Alfa-2a, Pegasys® , Pegasys ProClick™ | 10/3/13 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Saxenda® (liraglutide) Victoza® (liraglutide) | 11/14/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Siliq™ | 7/17/17 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Skyrizi™ (risankizumab-rzaa) subcutaneous use | 5/15/22 | N/A | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Sogroya (somapacitan-beco) | 4/5/21 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Steqeyma® (ustekinumab-stba) subcutaneous use* | 6/1/25 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Tymlos® (abaloparatide) | 7/20/19 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Yuflyma® (adalimumab-aaty) | 1/14/24 | N/A | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Yusimry (adalimumab-aqvh) | 6/25/23 | N/A | Presumption of Long-Term Non-Acute Administration |
| J9216 | INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS | Actimmune® | 5/1/03 | N/A | Acceptable Evidentiary Criteria Available |
| J9218 | LEUPROLIDE ACETATE, PER 1 MG | Eligard® | 12/1/02 | N/A | Presumption of Long-Term Non-Acute Administration |
| Q3027 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE | Avonex Pen® | 7/17/17 | N/A | Presumption of Long-Term Non-Acute Administration |
| Q3028 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE | Rebif®, Rebif®Rebidose | 5/16/16 | N/A | Presumption of Long-Term Non-Acute Administration |
| Q5098 | INJECTION, USTEKINUMAB-SRLF (IMULDOSA), BIOSIMILAR, 1 MG | Imuldosa subcutaneous use* | 7/1/25 | N/A | Apparent on its Face |
| Q5099 | INJECTION, USTEKINUMAB-STBA (STEQEYMA), BIOSIMILAR, 1 MG | Steqeyma® subcutaneous use* | 7/1/25 | N/A | Apparent on its Face |
| Q5100 | INJECTION, USTEKINUMAB-KFCE (YESINTEK), BIOSIMILAR, 1 MG | Yesintek™ subcutaneous use* | 7/1/25 | N/A | Apparent on its Face |
| Q5137 | INJECTION, USTEKINUMAB-AUUB (WEZLANA), BIOSIMILAR, SUBCUTANEOUS, 1 MG | Wezlana™ (ustekinumab-auub) | 7/1/24 | N/A | Acceptable Evidentiary Criteria Available |
| Q5140 | INJECTION, ADALIMUMAB-FKJP, BIOSIMILAR, 1 MG | Hulio® (adalimumab-fkjp) | 1/1/25 | N/A | Apparent on its Face |
| Q5141 | INJECTION, ADALIMUMAB-AATY, BIOSIMILAR, 1 MG | Yuflyma® (adalimumab-aaty) | 1/1/25 | N/A | Apparent on its Face |
| Q5142 | INJECTION, ADALIMUMAB-RYVK BIOSIMILAR, 1 MG | Simlandi® (adalimumab-ryvk) | 1/1/25 | N/A | Apparent on its Face |
| Q5143 | INJECTION, ADALIMUMAB-ADBM, BIOSIMILAR, 1 MG | Cyltezo® (adalimumab-adbm) | 1/1/25 | N/A | Apparent on its Face |
| Q5144 | INJECTION, ADALIMUMAB-AACF (IDACIO), BIOSIMILAR, 1 MG | Idacio® (adalimumab-aacf) | 1/1/25 | N/A | Apparent on its Face |
| Q5145 | INJECTION, ADALIMUMAB-AFZB (ABRILADA), BIOSIMILAR, 1 MG | Abrilada™ (adalimumab-afzb) | 1/1/25 | N/A | Apparent on its Face |
| Q5164 | INJECTION, USTEKINUMAB-HMNY (STARJEMZA), BIOSIMILAR, 1 MG | Starjemza™ (ustekinumab-hmny) subcutaneous use* | 7/1/26 | N/A | Apparent on its Face |
| Q9996 | INJECTION, USTEKINUMAB-TTWE (PYZCHIVA), SUBCUTANEOUS, 1 MG | Pyzchiva® (ustekinumab-ttwe) | 1/1/25 | N/A | Apparent on its Face |
| Q9998 | INJECTION, USTEKINUMAB-AEKN (SELARSDI), BIOSIMILAR, 1 MG | Selarsdi™ (ustekinumab-aekn) subcutaneous use* | 1/1/25 | N/A | Apparent on its Face |
| Q9999 | INJECTION, USTEKINUMAB-AAUZ (OTULFI), BIOSIMILAR, 1 MG | Otulfi (ustekinumab-aauz) subcutaneous use* | 4/1/25 | N/A | Apparent on its Face |
Exclusion ended
Non-excluded (ended) codes
23 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 |
|---|---|---|---|---|---|
| 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® | 10/29/10 | 7/17/17 | Acceptable Evidentiary Criteria Available |
| J0364 | INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG | Apokyn | 10/22/12 | 9/3/13 | |
| J0604 | CINACALCET, ORAL, 1 MG, (FOR ESRD ON DIALYSIS) | Sensipar® | 1/1/18 | 8/6/18 | Presumption of Long-Term Non-Acute Administration |
| J0630 | INJECTION, CALCITONIN SALMON, UP TO 400 UNITS | Calcimar®, Miacalcin® | 12/1/02 | 7/17/17 | Acceptable Evidentiary Criteria Available |
| J1559 | INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG | Hizentra® | 11/18/13 | 12/31/20 | Acceptable Evidentiary Criteria Available |
| J1559 | INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG | Immune globulin Hizentra | 9/3/13 | 9/3/13 | |
| J1575 | INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN | HyQvia | 11/14/16 | 8/6/18 | Presumption of Long-Term Non-Acute Administration |
| J2760 | INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG | Regitine® | 9/3/13 | 7/17/17 | Acceptable Evidentiary Criteria Available |
| J3110 | INJECTION, TERIPARATIDE, 10 MCG | Forteo® | 5/1/03 | 7/17/17 | Acceptable Evidentiary Criteria Available |
| J3262 | INJECTION, TOCILIZUMAB, 1 MG | Actemra® | 7/17/17 | 7/3/17 | Presumption of Long-Term Non-Acute Administration |
| J3490 | UNCLASSIFIED DRUGS | Haegarda® | 10/2/17 | 2/9/19 | Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Nitroglycerine Lingual spray, Nitrolingual®, Nitromist® | 5/16/16 | 7/17/17 | Apparent on its Face, Acceptable Evidentiary Criteria Available |
| J3490 | UNCLASSIFIED DRUGS | Wezlana™ (ustekinumab-auub) subcutaneous use* | 3/16/24 | 6/30/24 | Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Actemra® | 7/3/17 | 7/15/20 | Presumption of Long-Term Non-Acute Administration |
| J3590 | UNCLASSIFIED BIOLOGICS | Efalizumab, Raptiva® | 7/16/07 | 4/8/09 | |
| J3590 | UNCLASSIFIED BIOLOGICS | Omvoh™ (mirikizumab-mrkz), subcutaneous use* | 1/14/24 | 6/30/24 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Tezspire™ (tezepelumab-ekko). | 7/1/22 | 7/1/22 | Apparent on its Face |
| J3590 | UNCLASSIFIED BIOLOGICS | Wezlana™ (ustekinumab-auub) subcutaneous use* | 3/16/24 | 6/30/24 | Acceptable Evidentiary Criteria Available |
| J3590 | UNCLASSIFIED BIOLOGICS | Zinbryta® | 7/17/17 | 7/15/20 | Presumption of Long-Term Non-Acute Administration |
| J9213 | INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS | Roferon-A® | 6/18/12 | 3/23/16 | |
| Q0515 | INJECTION, SERMORELIN ACETATE, 1 MICROGRAM | Sermorelin | 7/16/07 | 3/23/17 | Acceptable Evidentiary Criteria Available |
| XX000 | Not Applicable | XX000 | 1/1/14 | 1/1/14 | |
| XX000 | Not Applicable | xx000 | 11/19/12 | 11/29/12 |
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.
