- Process For Determining Benefit Category
- Self-Administered Drug Process Flow
- Consideration of Objective Evidence
- Evidence
- General Information
- Basis for Non-Coverage
- Provider and Physician Appeals
- Reasonable and Necessary
- Sources
- Self-Administered Drug Exclusion List
- Revision History
The following SAD list is current as of 10/15/21. However, the Noridian Contractor Medical Directors (CMDs) review the list on an ongoing basis and may update and republish at their discretion.
The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished “incident-to” a physician’s service provided that the drugs are not “usually self-administered” by the patient. Section 112 of the Benefits, Improvements & Protection Act of 2000 (BIPA), amended §§1861(s)(2)(A) and 1861(s)(2)(B) of the Social Security Act (SSA) to redefine this exclusion. The prior statutory language referred to those drugs “which cannot be self-administered by the patient.” Implementation of the BIPA provision requires interpretation of the phrase “not usually self-administered” by the patient.
CMS has defined “not usually self-administered” by the patient, according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. This is defined in the CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2, Determining Self-Administration of Drug or Biological.
For purpose of this exclusion, “the term ‘usually’ means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage” and this A/B MAC will make no payment for the drug.
“The term ‘administered’ refers only to the physical process by which the drug enters the patient’s body. Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the ‘incident to’ benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient.”
“The term ‘by the patient’ means Medicare beneficiaries as a collective whole. The determination is based on whether the drug is self-administered by the patient the majority of the time. This determination is made on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis.”
Noridian is committed to assuring appropriate coverage for those drugs that meet Medicare statute requirements for drugs “not usually self-administered by the patient.”
In the absence of objective data specific to the Medicare beneficiary population who are capable of self-administration of an injectable drug, this A/B MAC will consider the following factors listed below, weighted on a per indication basis, to estimate whether an injectable drug in the outpatient setting is “usually or not usually self-administered:”
- Route: Intravenous (IV) route and Intramuscular (IM) route of administration will be presumed to meet “not usually self-administered” requirements and therefore meets Medicare benefit category. We may consider the depth and nature of the particular injection in applying this presumption. Subcutaneous (SQ) route of administration will not be presumed to meet the “not usually self-administered by the patient.”
- Acuity of condition being treated: In accordance with CMS instructions, if the condition being treated is for a short term acute basis (e.g. less than two weeks), the drug for this indication is considered “not usually self-administered.” If the condition being treated is for a longer term (more than two weeks), the drug for this indication is considered “usually self-administered by the patient.”
- Setting of condition being treated: To the extent an injectable drug for a particular indication is given e.g. only in an emergency department setting, pre-operative outpatient setting, or in the context of chemotherapy administration, the drug for that indication would be presumed to be for an acute situation and therefore “not usually self-administered.”
- Frequency of administration: In accordance with CMS instructions, if a drug is administered once per month, it is less likely to be self-administered by the patient. If a drug is administered once or more per week, it is likely that the drug is administered by the patient.
Process For Determining Benefit Category
To determine if a drug meets the definition of “usually self-administered” on a Medicare population basis, as required by CMS instructions, Noridian will use the following process:
Self-Administered Drug Process Flow
The process steps to determine whether a drug is self-administered are as follows:
- Determine if the drug is produced in parenteral form.
- Determine the route of administration. If the drug is only administered IV, the drug is a covered benefit.
- Determine if the route of administration is IM or SQ, and if the drug is administered in the outpatient setting, list the clinical indications and determine the percent of utilization by clinical indication.
- Review claims data and check a variety of sources/factors to arrive at the preliminary recommendation:
- Acute/chronic setting
- Clinical indication
- FDA/drug package inserts
- Provider specialty
- Estimate the percent self-administered (greater than or less than 50 percent) by indication.
- Assess all information to determine whether the drug is covered under the benefit category and notify providers.
If a drug meets the definition of “usually self-administered,” Noridian will determine that the drug does not meet a Medicare benefit category. In this instance when the drug is administered “incident-to” the physician service, the provider may bill the beneficiary for the drug without an Advance Beneficiary Notice.
Consideration of Objective Evidence
In accordance with CMS instructions, Noridian will consider objective evidence when available to determine utilization of a particular drug.
Evidence
Noridian welcomes any data and evidence that describes utilization of injectable drugs in the outpatient setting, specific to the Medicare beneficiary population as outlined above.
Noridian is only required to consider the following types of evidence:
- Peer reviewed medical literature,
- Standards of medical practice,
- Evidence-based practice guidelines,
- FDA approved label, and package inserts.
Noridian may also consider other evidence submitted by interested individuals or groups subject to their judgment.
Noridian will consider all of the information it receives in order to make a balanced and considered determination of benefit category meeting “not usually self-administered” injectable drugs. The information will be weighted according to the strength of the evidence.
General Information
These drugs have been deemed by this A/B MAC to be excluded from payment “incident-to” a physician’s service because they are usually self-administered by the patients who take them.
The publication of this list begins a 45-day notice period. After the 45-day notice, this A/B MAC will deny payment for drugs subject to this notice. This list will be reviewed on a rolling basis and will be periodically updated as needed. Therefore, the absence of any particular drug on the exclusion list should not be taken to mean that at some later date the drug might be deemed excluded through application of the criteria referenced above.
Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for drugs that are listed in the Coding Table Information below will be denied.
For certain injectable drugs, it will be “apparent on its face” that the nature of the condition(s) for which they are administered, or the usual course of treatment for those conditions (chronic vs acute), in and of itself dictate the mode of usual administration. For example, a course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered by CMS as acute, and it would be unlikely that a patient would self-administer the drug in those circumstances [CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2]
Basis for Non-Coverage
- Apparent on its Face
- Presumption: Long-Term Non-Acute Administration
- Acceptable Evidentiary Criteria Available
Providers are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation, is reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera®), variable.]
If a beneficiary’s claim for a particular drug is denied because the drug is subject to the “self-administered drug exclusion,” the beneficiary may appeal the denial. Because it is a “benefit category” denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Non-coverage (ABN) is not required. A “benefit category” denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability [under Section 1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for such an excluded drug.
Route of Administration Modifier
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 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. The 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. Subcutaneously 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 a JA or JB modifier will also be denied.
CPT/HCPCS Modifiers
Group 1 Paragraph: Claim denials may occur when the appropriate modifier is not applied to a J code/medication, which has more than one route of administration
Group 1 Codes:
JA Intravenous administration
JB Subcutaneous administration
Providers are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation is reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera®), variable.]
If a beneficiary’s claim for a particular drug is denied because the drug is subject to the “self-administered drug exclusion,” the beneficiary may appeal the denial. Because it is a “benefit category” denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Non-coverage (ABN) is not required. A ‘benefit category” denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability under section 1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for such an excluded drug.
Provider and Physician Appeals
The hospital and a physician accepting assignment may appeal a denial under the provisions found in the IOM, Publication 100-04, Medicare Claims Processing Manual, Publication 100-04, Chapter 29, Section 200 This link takes you to an external website.
Reasonable and Necessary
Noridian will make the determination of reasonable and necessary with respect to the medical appropriateness of the drug to treat the patient’s condition and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate, as opposed to the oral form. We will also continue to make the determination as to whether a physician’s office visit was reasonable and necessary. However, while a physician’s office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually self-administered.
Sources
- IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological
- Transmittal 123, CR 6950 dated April 30, 2010
Self-Administered Drug Exclusion List
Code | Descriptor Generic Name |
Descriptor Brand Name |
Exclusion Effective Date | Exclusion End Date | Reason for Exclusion |
---|---|---|---|---|---|
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Albiglutide for SQ injection (Tanzeum™) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Metreleptin for injection (Myalept ™) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Pasireotide (Signifor®) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Interferon beta 1a, Rebif ® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Exenatide XR, Bydureon® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Cosentyx (Secukinumab) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Praluent® (Alirocumab) | 11/24/15 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Repatha™ (Evolucumab) | 11/24/15 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Dulaglutide, Trulicity® | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Methotrexate – Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Parathyroid Hormone, Natpara® | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Peginterferon beta-1a, Plegridy™ | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Insulin glargine injection, Toujeo® | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Exenatide Byetta® | 06/27/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Etanercept-SZZS (Erelzi™) | 12/06/16 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Asfotase-alfa (Strensiq™) | 02/28/17 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Ixekizumab (Taltz™) | 02/28/17 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Adalimumab-atto (Amjevita™) | 02/28/17 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Dupilumab (Dupixent) | 08/07/17 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Brodalumab (Siliq) | 08/07/17 | N/A | Apparent on its Face |
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Sogrova® (somapacitan-beco) | 04/05/21 | 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) | Orecia® subcutaneous use* | 04/05/21 | N/A | Apparent on its face |
J0135 | INJECTION, ADALIMUMAB, 20 MG | Humira® | 11/01/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
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® | 01/15/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J0364 | INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG | Apokyn® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
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) | 12/02/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J0599 | INJECTION, C-1 ESTERASE INHIBITOR (HUMAN), (HAEGARDA®) | HAEGARDA® | 09/18/19 | 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 | 01/15/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J0800 | INJECTION, CORTICOTROPIN, UP TO 40 UNITS | H.P. ACTHAR® | 06/26/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1324 | INJECTION, ENFUVIRTIDE, 1 MG | Fuzeon® | 05/01/04 | 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® | 01/15/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1595 | INJECTION, GLATIRAMER ACETATE, 20 MG | Copaxone® | 05/01/04 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1628 | INJECTION, GUSELKUMAB, 1MG | Tremfya® (guselkumab) | 05/15/21 | N/A | Acceptable Evidentiary Criteria Available |
J1675 | INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS | Supprelin LA® | 07/15/06 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1744 | INJECTION, ICATIBANT, 1 MG | Icatibant (Firazyr®) | 07/31/12 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1815 | INJECTION, INSULIN, PER 5 UNITS | Humalog, Humalog Mix 50/50, Humulin N. Humulin R, Lantus, Levemir, Novolin 70/30, Novolin N. Novolin R. Novolog, Novolog Flexpen, Novolog Penfill | 11/01/03 | 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 | Humalog, Humulin R, Novolin R, Novolog, Novolog Flexpen, Novolog Penfill | 01/15/03 | 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® | 01/15/03 | N/A | Presumption of Long-Term Non-Acute Administration Acceptable Evidentiary Criteria Available |
J2170 | INJECTION, MECASERMIN, 1 MG | Increlex®, Iplex | 04/15/07 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J2212 | INJECTION, METHYLNALTREXONE, 0.1 MG | Relistor® | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J2354 | INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG | Octreotide Acetate, Sandostatin* | 10/15/05 | N/A | Presumption of Long-Term Non-Acute Administration |
J2440 | INJECTION, PAPAVERINE HCL, UP TO 60 MG | Papaverine HCL | 11/01/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J2940 | INJECTION, SOMATREM, 1 MG | Protropin® | 01/15/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J2941 | INJECTION, SOMATROPIN, 1 MG | Humatrope, Genotropin, Omnitrope, Saizen, Zorbtive, Zomacton, Norditropin, Nutropin | 01/15/03 | 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® | 01/15/03 | 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) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3110 | INJECTION, TERIPARATIDE, 10 MCG | Forteo® | 11/01/03 | N/A | Presumption of Long-Term Non-Acute Administration |
J3355 | INJECTION, UROFOLLITROPIN, 75 IU | Metrodin®, Bravelle®, Fertinex® | 04/15/07 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara® | 10/15/21 | N/S | Apparent on its face/Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Peginterferon Alfa 2-b, Sylatron, Pegintron | 06/26/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Kynamro® (mipomersen sodium) | 06/26/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Pramlintide acetate, Symlin®, SymlinPen 60, SymlinPen 120 | 04/01/06 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Exenatide Byetta®) | 04/01/06 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Tesamorelin Acetate, Egrifta® | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Trimix | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Liraglutide GLP-1, Victoza®, Saxenda® | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Albiglutide for SQ injection (Tanzeum™) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Metreleptin for injection (Myalept™) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Pasireotide (Signifor®) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Interferon beta 1a, (Rebif®) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Exenatide XR, Bydureon® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Cosentyx (Secukinumab) | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Insulin Glargine (Recombinant), Lantus Solostar | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | adalimumab-adbm (Cyltezo) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3490 | UNCLASSIFIED DRUGS | Sogrova® (somapacitan-beco) | 04/05/21 | N/A | Apparent on its face |
J3590 | UNCLASSIFIED DRUGS | Sogrova® (somapacitan-beco) | 04/05/21 | N/A | Apparent on its face |
J3590 | UNCLASSIFIED BIOLOGICS | Abaloparatide (Tymlos) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Sarilumab (Kevzara) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Semaglutide (Ozempic) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Erenumab-aoooe (Aimovig) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Alcanezumab-gnlm (Emgality) | 09/18/19 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Praluent® (Alirocumab) | 11/24/15 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Repatha™ (Evolucumab) | 11/24/15 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Dulaglutide, Trulicity® | 06/27/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Methotrexate – Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® | 06/27/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Parathyroid Hormone, Natpara® | 06/27/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon beta-1a, Plegridy™ | 06/27/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Insulin glargine injection, Toujeo® | 06/27/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Pegvisomant Somavert®, variable | 05/01/04 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon Alfa-2a, Pegasys™, Roferon®-A | 05/01/05 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Anakinra (Kineret®) | 10/15/05 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Golimumab, Simponi® | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Abatacept Orencia® | 09/30/13 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Etanercept-SZZS (Erelzi™) | 12/06/16 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Asfotase-alfa (Strensiq™) | 02/28/17 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Ixekizumab (Taltz™) | 02/28/17 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Adalimumab-atto (Amjevita™) | 02/28/17 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Dupilumab (Dupixent) | 08/07/17 | N/A | Apparent on its Face |
J3590 | UNCLASSIFIED BIOLOGICS | Brodalumab (Siliq) | 08/07/17 | N/A | Apparent on its Face |
J9212 | INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM | Infergen® | 11/01/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J9213 | INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS | Roferon-A® | 11/01/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J9216 | INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS | Actimmune® | 01/15/03 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J9218 | LEUPROLIDE ACETATE, PER 1 MG | Leuprolide Acetate, Leuprolide Acetate Inj | 01/15/03 | N/A | Presumption of Long-Term Non-Acute Administration Acceptable Evidentiary Criteria Available |
Q0515 | INJECTION, SERMORELIN ACETATE, 1 MICROGRAM | Geref® | 04/15/07 | 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® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
Q3028 | INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE | Rebif® | 06/04/15 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
Non-Excluded CPT/HCPCS Codes
Code | Descriptor Generic Name |
Descriptor Brand Name |
Exclusion Effective Date | Exclusion End Date | Reason for Exclusion |
---|---|---|---|---|---|
C9399 | UNCLASSIFIED DRUGS OR BIOLOGICALS | Daclizumab (Zinbryta™) | 02/28/17 | 02/18/21 | 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 (Abatacept) | 09/30/13 | 09/30/13 | |
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® | 01/15/03 | 07/14/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J1562 | INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG | Vivaglobin | 04/15/07 | 07/14/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J1575 | INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN | Immune globulin | 02/11/16 | 07/25/16 | |
J1559 | INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG | Hizentra® | 02/15/11 | N/A | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
J1628 | INJECTION, GUSELKUMAB, 1 MG | Tremfya® | 05/03/20 | 05/03/20 | Acceptable Evidentiary Criteria Available |
J2502 | INJECTION, PASIREOTIDE LONG ACTING, 1 MG | Pasireotide long acting | 02/11/16 | 10/01/16 | Apparent on its Face |
J2760 | INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG | Regitine | 09/30/13 | 07/14/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J3357 | USTEKINUMAB, FOR SUBCUTANEOUS INJECTION, 1 MG | Stelara® subcutaneous | 05/03/20 | 05/03/20 | Acceptable Evidentiary Criteria Available |
J3490 | UNCLASSIFIED DRUGS | Methylnaltrexone bromide | 09/30/13 | 07/14/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Peginterferon Alfa 2-b, Sylatron, Pegintron | 11/01/03 | 06/06/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | efalizumab (Raptiva ®), variable | 05/01/04 | 07/14/17 | Apparent on its Face|Presumption of Long-Term Non-Acute Administration |
J3590 | UNCLASSIFIED BIOLOGICS | Daclizumab (Zinbryta™) | 02/28/17 | 02/18/21 | Apparent on its face |
J3590 | UNCLASSIFIED BIOLOGICS | risankizumab-rzaa (Skyrizi™) | 12/02/19 | 12/02/19 | Apparent on its Face Presumption of Long-Term Non-Acute Administration |
Revision History
Revision History Number | Revision History Date | Revision History Explanation |
---|---|---|
24 | 10/15/21 | The “Route of Administrative Modifier” paragraph is revised.
The drug J3357 Ustekinumab, for subcutaneous injection, 1 mg is added with an effective date of 10/15/21. |
23 | 05/15/21 | The article is updated to add: J1628, Injection, Guselkumab, (Tremfya®)1mg, effective 5/15/2021.
The asterisk does not apply to J3357 and therfore has been removed. |
22 | 04/05/21 | The article is revised to correct version 21. The asterisk criteria added in the “Descriptor Brand Name” section for J2354. Effective date remains 4/5/2021. |
21 | 04/05/21 | The article is updated to add: J0129 (Orencia®, subcutaneous use*), C9399.J3490 and J3590 Sogroya® (somapacitan-beco), effective 4/5/2021.
Removed the following drug to the Non-Excluded CPT/HCPCS Codes – Table Format: C9399 and J3590, Zinbryta (daclizumab), effective 2/18/2021. This drug was taken of the market. J2354 has been updated to add asterisk criteria in the “Descriptor Brand Name” section. Added the following in Article Guidance: Route of Administration Modifier CPT/HCPCS Modifiers Group 1 Codes: |
20 | 01/01/21 | Based on Transmittal 10463 (CR11880) (Billing for Home Infusion therapy Services On or After January 1, 2021), which includes changes to the Medicare home infusion therapy services benefit, the article has been updated to move Hizentra® (J1559) to the Non-Excluded CPT/HCPCS Codes-Table with an Exclusion End Date of 12/31/2020. |
19 | 05/03/20 | The effective date of 5/3/2020 for Guselkumab (Tremfya®) (J1628) and Ustekunumab (Stelara®) (J3357) will be deferred to 45-days after the public health emergency ends. A notice article will be posted to Latest Updates for the new effective date. |
18 | 05/03/20 | The following drugs are added to the SAD list with an effective date of 05/03/20: J1628 – Injection, Guselkumba, 1mg, (Tremfya®) J3357 – Ustekinumab, for subcutaneous injection, 1 mg, (Stelara®) |
17 | 12/02/19 | Due to the receipt of additional information and evidence-based literature, at this time the status of risankizumab-rzaa (Skyrizi) placement on the SAD List will be held pending further review. |
16 | 12/02/19 | This revision changes fremanezumab-vfrm (Ajovy) from code J3590 to code J3031, effective 10/01/19. Code J3590 is effective from 09/18/19 to 09/30/19.
This revision also adds the following drugs to the SAD exclusion list with an effective date of 12/02/19: Also, Rebif® was added to the Descriptor Brand Name field for Q3028 and the spelling of Exenatide was corrected from Exanatide. |
15 | 09/18/19 | This revision updates the effective date of the drugs listed in Revision 14 from 09/09/19 to 09/18/19 to give providers the 45-day notice. |
14 | 09/09/19 | The following drugs are added to the SAD list with an effective date of 09/09/19: J0599 – HAEGARDA J3490 – Insulin Glargin (recombinant), Lantus Solostar, Adalimumab-adbm (Cyltezo) J3590 – Abaloparatide (Tymlos), Sarilumab (Kevzara), Semaglutide (Ozempic), Fremanezumab-vfrm (Ajovy), Erenumab-aoooe (Aimovig), Alcanezumab-gnlm (Emgality) |
13 | 08/07/17 | The article is revised to correct the drug code J2075 to J0275 from Revision 12. Effective date remains the same |
12 | 08/07/17 | The article is revised to remove the following drugs from the SAD list effective 07/14/17: J2075, J1562, J2760 and J3590 (Efalizumab (Raptiva).
J3490 – UNCLASSIFIED DRUGS, Methylnaltrexone bromide is removed effective 07/14/17. This is duplicate to J2212. The following drugs added with an effective date of 08/07/17. J3590, C9399 – Dupilumab (Dupixent) J3590, C9399 – Brodalumab (Siliq) |
11 | 02/28/17 | The article is revised to change the effective date of service from 02/06/17 to 02/28/17 for the following drugs: Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™) |
10 | 02/06/17 | The article is revised to add the HCPCS codes J3590 and C9399 for the following drugs effective 02/06/17. Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™) |
9 | 12/06/16 | J2502 removed from the SAD list with an exclusion end date of 10/01/16. |
8 | 12/06/16 | Added HCPCS Codes J3590, C9399 for Etanercept-SZZS (Erelzi™) effective 12/06/16. Added Saxenda® brand name to include in HCPCS code J3490 Liraglutide GLP-1, Victoza®. The effective date remains 09/30/13. |
7 | 07/25/16 | The article revised to remove HCPCS code J1575 from the excluded table with an effective date 07/25/16. |
6 | 06/27/16 | The article is revised to add the following drugs effective 06/27/16: Dulaglutide, Trulicity® (C9399, J3590), Methotrexate – Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® (C9399, J3590), Parathyroid Hormone, Natpara® (C9399, J3590), Peginterferon beta-1a, Plegridy™ (C9399, J3590), Insulin glargine injection, Toujeo® (C9399, J3590) and exanatide (Byetta®), variable (C9399).The sentence “Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for drugs that are listed in the Coding Table Information below will be denied” is added under the “General Information” in the Article Text section.This revised article, effective 06/27/16 combines JF A A53035 into the JF B article so that both JFA and JFB contract numbers will have the same final Article number. |
5 | 02/11/16 | The article is revised to add J2502 and J1575 effective 02/11/16. |
4 | 11/24/15 | The article is revised only to correct the effective date noted in R3 with effective date 11/18/14. The correct effective date to deny J3590 or C9399 – Praluent® (Alirocumab) and J3590 or C9399 – Repatha™ (Evolucumab) is 11/24/15. |
3 | 11/24/15 | The article is revised to add the following drugs to the SAD Exclusion List: J3590 or C9399 – Praluent® (Alirocumab) J3590 or C9399 – Repatha™ (Evolucumab) Effective 11/18/15. |
2 | 10/01/15 | This article is revised with an effective date of 06/04/15 for the HCPCS code J0364, and the following miscellaneous C9399 and J3490 for Albiglutide for SQ injection (Tanseum™), C9399 and J3490 for Metreleptin for injection, (Myalept™), C9399 and J3490 for Pasireotide (Signifor®), C9399 and J3490 for Interferon beta 1a, (Rebif®), C9399 and J3490 for Exenatide extended release (Bydureon ™) and C9399 and J3490 for Cosentyx (Secukinumab). For HCPCS codes Q3027 and Q3028, the correct effective date of service is also 06/04/15.
J3140 and J3150 were deleted from the Code Table due to the 2015 CPT/HCPCS Updates. |
1 | 10/01/15 | The article is revised to add the correct URL link to the Self Administered Drug Process. |
Last Updated Aug 30 , 2021