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Self Administered Drugs (SADs)

Self-Administered Drug Exclusion List

The following SAD list is current as of 02/28/2017.  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":

  1. 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."
  2. 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".
  3. 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".
  4. 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.

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
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
J0135 INJECTION, ADALIMUMAB, 20 MG Humira® 11/1/2003 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® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
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® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J0630 INJECTION, CALCITONIN SALMON, UP TO 400 UNITS Calcimar®, Miacalcin® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J0800 INJECTION, CORTICOTROPIN, UP TO 40 UNITS Acthar® - ACTH gel 6/26/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1324 INJECTION, ENFUVIRTIDE, 1 MG Fuzeon® 5/1/2004 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® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1559 INJECTION, IMMUNE GLOBULIN (HIZENTRA), 100 MG Hizentra® 2/15/2011 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1562 INJECTION, IMMUNE GLOBULIN (VIVAGLOBIN), 100 MG Vivaglobin® 4/15/2007 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1595 INJECTION, GLATIRAMER ACETATE, 20 MG Copaxone® 5/1/2004 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1675 INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS Supprelin LA® 7/15/2006 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1744 INJECTION, ICATIBANT, 1 MG Icatibant (Firazyr®), 1 mg 7/31/2012 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J1815 INJECTION, INSULIN, PER 5 UNITS Humalog®, Humulin®, Iletin®, Insulin Lispro®, Lantus®, Levemir®, NPH, Pork Insulin, Regular Insulin, Ultralente®, Velosulin®, Humulin R®, Iletin II Regular Pork®, Insulin Purified Pork, Relion®, Lente Iletin I®, Novolin R®, Humulin R U-50® 11/1/2003 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®, Vesolin BR®, Iletin II NPH Pork®, Lispro-PFC®, Novolin®, Novolog®, Novolog Flexpen®, Novolog Mix®, Relion Novolin® 1/15/2003 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® 1/15/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J2170 INJECTION, MECASERMIN, 1 MG Increlex® 4/15/2007 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J2212 INJECTION, METHYLNALTREXONE, 0.1 MG Relistor® 9/30/2013 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 Sandostatin® 10/15/2005 N/A Presumption of Long-Term Non-Acute Administration
J2440 INJECTION, PAPAVERINE HCL, UP TO 60 MG N/A 11/1/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J2760 INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG Regitine® 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J2940 INJECTION, SOMATREM, 1 MG Protropin® 1/15/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J2941 INJECTION, SOMATROPIN, 1 MG Humatrope®, Genotropin Nutropin®, Biotropin, Genotropin®, 1/15/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
Genotropin Miniquick®, Norditropin®, Nutropin®, Nutropin AQ®, Omnitrope®, Saizen®, Saizen Somatropin RDNA Origin®, Serostim®, Serostim RDNA Origin, Zorbtive®
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® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3110 INJECTION, TERIPARATIDE, 10 MCG Forteo® 11/1/2003 N/A Presumption of Long-Term Non-Acute Administration
J3355 INJECTION, UROFOLLITROPIN, 75 IU Metrodin®, Bravelle®, Fertinex® 4/15/2007 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Trimix 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Tesamorelin acetate 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Methylnaltrexone bromide 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS pramlintide acetate (Symlin®), variable 4/1/2006 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS exanatide (Byetta®), variable 4/1/2006 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Kynamro® (mipomersen sodium) 6/26/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Peginterferon alfa-2b ((Sylatron™) 6/26/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Liraglutide GLP-1, Victoza®, Saxenda® 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Orencia®-(abatacept 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Simponi®-anti-TNF (Golimumab) 9/30/2013 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS pegvisomant (Somavert®), variable 5/1/2004 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Peginterferon, alfa-2b (Peg-Intron®), variable 11/1/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS peginterferon, alfa-2a (Pegasys®), variable 5/1/2005 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS efalizumab (Raptiva®), variable 5/1/2004 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J3590 UNCLASSIFIED BIOLOGICS anakinra (Kineret®), variable 10/15/2005 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS albiglutide for SQ injection (Tanseum™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Metreleptin for injection (Myalept ™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Pasireotide (Signifor®) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Interferon beta 1a, Rebif ® 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Exenatide extended release (Bydureon ™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Cosentyx (Secukinumab) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Praluent® (Alirocumab) 11/24/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Repatha™ (Evolucumab) 11/24/2015 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Dulaglutide, Trulicity ® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Parathyroid Hormone, Natpara® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Peginterferon beta-1a, Plegridy™ 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Insulin glargine injection, Toujeo® 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS exanatide (Byetta®), variable 06/27/2016 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Etanercept-SZZS (Erelzi™) 12/06/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Asfotase-alfa (Strensiq™) 02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Daclizumab (Zinbryta™)  02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Ixekizumab (Taltz™)  02/28/2017 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Adalimumab-atto (Amjevita™)  02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Asfotase-alfa (Strensiq™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Daclizumab (Zinbryta™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Ixekizumab (Taltz™) 02/28/2017 N/A Apparent on its Face
C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS Adalimumab-atto (Amjevita™) 02/28/2017 N/A Apparent on its Face
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG Apokyn® 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Albiglutide for SQ injection (Tanseum™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Metreleptin for injection (Myalept™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Pasireotide (Signifor®) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Interferon beta 1a, (Rebif®) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Exenatide extended release (Bydureon™) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3490 UNCLASSIFIED DRUGS Cosentyx (Secukinumab) 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
J3590 UNCLASSIFIED BIOLOGICS Praluent® (Alirocumab) 11/24/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Repatha™ (Evolucumab) 11/24/2015 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Dulaglutide, Trulicity® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Methotrexate - Solution Auto-injector Non Chemotherapeutic, Otrexup™, Rasuvo® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Parathyroid Hormone, Natpara® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Peginterferon beta-1a, Plegridy™ 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Insulin glargine injection, Toujeo® 06/27/2016 N/A Apparent on its Face
J3590 UNCLASSIFIED BIOLOGICS Etanercept-SZZS (Erelzi™) 12/06/2016 N/A Apparent on its Face
J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Infergen® 11/1/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J9213 INJECTION, INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS Roferon-A® 11/1/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS Actimmune® 1/15/2003 N/A Presumption of Long-Term Non-Acute Administration
Acceptable Evidentiary Criteria Available
J9218 LEUPROLIDE ACETATE, PER 1 MG Lupron® 1/15/2003 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
Q0515 INJECTION, SERMORELIN ACETATE, 1 MICROGRAM N/A 4/15/2007 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
Q3027 INJECTION, INTERFERON BETA-1A, 1 MCG FOR INTRAMUSCULAR USE N/A 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration
Q3028 INJECTION, INTERFERON BETA-1A, 1 MCG FOR SUBCUTANEOUS USE N/A 6/4/2015 N/A Apparent on its Face
Presumption of Long-Term Non-Acute Administration

 

Revision History Number Revision History Date Revision History Explanation
11 02/28/2017 The article is revised to change the effective date of service from 2/6/2017 to 2/28/2017 for the following drugs:
Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™)
10 02/06/2017 The article is revised to add the HCPCS codes J3590 and C9399 for the following drugs effective 2/6/2017.
Asfotase-alfa (Strensiq™), Daclizumab (ZINBRYTA™), Ixekizumab (Taltz™), Adalimumab-atto (Amjevita™)
9 12/06/2016 J2502 removed from the SAD list with an exclusion end date of 10/1/2016.
8 12/06/2016 Added HCPCS Codes J3590, C9399 for Etanercept-SZZS (Erelzi™) effective 12/6 /2016.  Added Saxenda® brand name to include in HCPCS code J3490 Liraglutide GLP-1, Victoza®. The effective date remains 09/30/2013.
7 07/25/2016 The article revised to remove HCPCS code J1575 from the excluded table with an effective date 7/25/2016.
6 06/27/2016 The article is revised to add the following drugs effective 6/27/2016:
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 6/27/2016 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 02/11/2016 The article is revised to add J2502 and J1575 effective 2/11/2016.
4 11/24/2015 The article is revised only to correct the effective date noted in R3 with effective date 11/18/2014. The correct effective date to deny J3590 or C9399 - Praluent® (Alirocumab) and J3590 or C9399 - Repatha™ (Evolucumab) is 11/24/2015.
3 11/24/2015 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 11/18/2015.
2 10/01/2015 This article is revised with an effective date of 06/04/2015 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 June 4, 2015.

J3140 and J3150 wertr deleted from the Code Table due to the 2015 CPT/HCPCS Updates.
1 10/01/2015 The article is revised to add the correct URL link to the Self Administered Drug Process.

 

Last Updated Jan 10, 2017