Download SAD Drugs

Self-Administered Drug Exclusion List R2
This updated article, published originally 09/26/2013 with an effective date of 09/30/2013 has
been further revised for publication 10/08/2013, still to be effective 09/30/2013, and replaces the
prior article in its entirety.
The prior article in this series, from “ Medicare A News,” Issue 2109 June 2013, and “ Medicare
B News,” Issue 286 June 2013 is being revised to add the following new drugs effective
September 30, 2013:
Certolizumab Pegol (Cimzia), J0718, Methylnaltrexone (Relistor), J2212, Phentolamine
mesylate (Regitine), J2760, Unclassified Drug (Methylnaltrexone bromide), J3490, Unclassified
Drug (Tesamorelin acetate), J3490, Unclassified Drug (Trimix), J3490, Unclassified Drug
(Liraglutide GLP-1, Victoza®), J3490 and Unclassified Biologics (Simponi-anti-TNF
(Golimumab), J3590 and abatacept (Orencia subcutaneous), J3590.
This revised list (from an earlier draft) indicates abatacept administered by subcutaneous
injection should be coded as J3590. The code J0129, which is specific for only the intravenous
formulation of abatacept (Orencia), has been removed from and is not included in Noridian’s
self-administered drug (SAD) determinations.
The unclassified drug Acthar – ACTH gel (J3490) is changed to HCPCS code J0800. All other
information remains the same.
This article provides notification of the Noridian SAD determinations. The following SAD list is
current as of 09/30/2013. However, the Contractor Medical Directors (CMDs) review the list on
an ongoing basis and may update and republish at their discretion.
The SAD review process only applies to medications described by Internet Only Manual (IOM)
Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, Section 50.2 at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf .
Further, effective 9/30/2013, the Centers for Medicare and Medicaid Services has determined
that the two drugs abatacept (J0129 Orencia®), and golimumab (J3590 for Simponi® Aria™)
are each separate drugs as defined in the Medicare Benefit Policy Manual, Publication 100-02,
Chapter 15, Section 50.1 (ref. http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/bp102c15.pdf ) and are not usually self-administered.
They are therefore covered pharmaceuticals when other conditions of coverage are met and the
use is a medically necessary intravenous infusion incident to a physician’s service.
For dates of service on and after 12/01/2013, to indicate that it was medically necessary to use
this formulation for this specific administration of either of the drugs abatacept (J0129
Orencia®), or golimumab (J3590 for Simponi® Aria™), the provider is to place the appropriate
HCPCS code for the drug on one claim line and one of the appropriate IV administration codes
(96365, 96366, 96367, 96368, 96374 or 96375) on an adjacent line of the same claim. The
medical record must clearly document why this specific form of the drug and this mode of
administration was medically necessary for this patient for this specific administration. To
indicate that these conditions of coverage have been met, the provider must append the KX
modifier to both the drug code (J0129 for Orencia® or J3590 for Simponi® Aria™) and to the
associated IV administration code (96365, 96366, 96367, 96368, 96374 or 96375). If these
conditions of coverage are not met, then the provider is to place the appropriate GA, GZ or GY
code on both the drug and the IV administration code. Claims for J0129 Orencia® and claims for
J3590 for Simponi® Aria™ submitted without a KX, GA, GZ or GY modifier on both the drug
and IV administration codes will be returned unprocessable. Providers are reminded that
convenience for the beneficiary or for the provider does not meet medical necessity under
Medicare. Therefore concern for a patient’s financial liability or that a patient’s compliance with
the medication regimen will suffer if the drug is not provided incident to a physician’s service,
does not justify medical necessity.
Additionally, effective 9/30/2013, the Centers for Medicare and Medicaid Services has
determined that the drug certolizumab in its lyophilized powder form for reconstitution (J0718
Cimzia®, used for the lyophilized form) is an individual drug (distinct from J0718 Cimzia®,
used for the non-lyophilized form) as defined in the Medicare Benefit Policy Manual,
Publication 100-02, Chapter 15, Section 50.1 (ref. http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/bp102c15.pdf ) and is not usually self-administered.
It is therefore a covered pharmaceutical when other conditions of coverage are met and the use is
a medically necessary reconstitution of the lyophilized powder form with subcutaneous injection,
provided incident to a physician’s service.
For dates of service on and after 12/01/2013, to indicate that it was medically necessary to use
this formulation for this specific administration of the drug, the provider is to place the
appropriate HCPCS code for the drug (J0718 used for the lyophilized form) on one claim line
and the appropriate subcutaneous administration code (96372) on an adjacent line of the same
claim. The medical record must clearly document why the lyophilized form of the drug was
medically necessary for this patient for this specific administration. To indicate that these
conditions of coverage have been met, the provider must append the KX modifier to both the
drug code (J0718) used for the lyophilized form and to the associated subcutaneous
administration code (96372). If these conditions of coverage are not met, then the provider is to
place the appropriate GA, GZ or GY code on both the drug and the subcutaneous administration
code. Claims for J0718 for the non-lyophilized form, if submitted, must have appended the
appropriate GY modifier on both the drug code (J0718) and on the associated subcutaneous
administration code (96372), reflecting the non-covered status as a usually self-administered
drug. Claims for J0718 submitted without a KX, GA, GZ or GY modifier on both the drug and
subcutaneous administration codes will be returned unprocessable. Providers are reminded that
convenience for the beneficiary or for the provider does not meet medical necessity under
Medicare. Therefore concern for a patient’s financial liability or that a patient’s compliance with
the medication regimen will suffer if the drug is not provided incident to a physician’s service,
does not justify medical necessity.
Additionally, based on chronic, frequent injections, typically by the patient and with prolonged
use, Noridian has determined that the following drugs are usually self-administered and therefore
NOT COVERED by the Medicare program effective for dates of service on/after the date of
service listed. (The article “Self-Administered Drugs – Process to Determine Which Drugs Are
Usually Self-Administered by the Patient” was published on the Noridian website,
https://www.noridianmedicare.com.
Descriptor Generic
Code
Name
J0135
J0270
J0275
J0630
J0718
J0800
J1324
J1438
J1559
J1562
J1595
J1675
J1744
Injection ,
Adalimumab, 20 mg
Injection, alprostadil
per 1.25, mcg
Alprostadil urethral
suppository, variable
Injection, calcitonin
salmon, up to 400
units
Injection,
Certolizumab pegol,
1 mg
Corticotropin, up to
40 units
Injection, enfuvirtide,
1 mg
Injection, etanercept,
25 mg
Injection, immune
globulin, 100 mg
Injection, immune
globulin, 100 mg
Injection, glatiramer
acetate, 20 mg
Injection, histrelin
acetate, 10 mcg
Injection, Icatibant, 1
mg
Descriptor Brand Name
Humira®
Exclusion
Basis for
Exclusion
Effective
Exclusion1
End Date
Date
A, B
11/01/2003 N/A
Alprostadil®, Caverject®,
01/15/2003 N/A
Edex®, Prostin VR Pediatric®
Muse®
Calcimar®,
Miacalcin®
01/15/2003 N/A
A, B
A, B
A, B
01/15/2003 N/A
A, B
Cimzia (self- administered
form only)
09/30/2013 N/A
Acthar* - ACTH gel
06/26/2013 N/A
Fuzeon®
05/01/2004 N/A
Enbrel®
01/15/2003 N/A
Hizentra®
02/15/2011 N/A
Vivaglobin®
04/15/2007 N/A
Copaxone®
05/01/2004 N/A
Supprelin LA®
07/15/2006 N/A
Firazyr®
07/31/2012 N/A
Humalog®, Humulin®,
Iletin®, Insulin Lispro®,
Lantus®, Levemir®, NPH,
Injection, insulin per
J1815
Pork Insulin, Regular Insulin, 11/01/2003 N/A
5 units
Ultralente®, Velosulin®,
Humulin R®, Iletin II Regular
Pork®, Insulin Purified Pork,
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B3
J1817
J1830
J2170
J2212
J2354
J2440
J2760
J2940
J2941
J3030
J3110
J3140
Relion®, Lente Iletin I®,
Novolin R®, Humulin R U500®
Humalog®, Humulin®,
Insulin for
Vesolin BR®, Iletin II NPH
administration
Pork®, Lispro-PFC®,
through DME per 50
Novolin®, Novolog®,
units (i.e. insulin
Novolog Flexpen®, Novolog
pump)
Mix®, Relion Novolin®
Injection interferon
Betaseron®
beta-1b, 0.25 mg
Injection,
Iplex®, Increlex®
mecasermin, 1 mg
Methylnaltrexone,
Relistor*
0.1 mg
Injection, ocetreotide,
non-depot form for
Sandostatin®
sub-q or intravenous
injection, 25 mcg
Injection, papaverine
N/A
HCL, up to 60 mg
Injection,
Phentolamine
Regitine*
mesylate, up to to 5
mg
Injection, somatrem,
Protropin®
1 mg
Humatrope®,
Genotropin Nutropin®,
Biotropin,
Genotropin®,
Genotropin Miniquick®,
Injection somatropin,
Norditropin®, Nutropin®,
1 mg
Nutropin AQ®, Omnitrope®,
Saizen®, Saizen Somatropin
RDNA Origin®, Serostim®,
Serostim RDNA Origin,
Zorbtive®
Injection sumatriptan
Imitrex®
succinate, 6 mg
Injection,
Forteo®
teriparatide, 10 mcg
Injection, testosterone
suspension , up to 50
A, B3
01/15/2003 N/A
01/15/2003 N/A
04/15/2007 N/A
09/30/2013 N/A
B, C
A, B
A, B
B
10/15/2005 N/A
11/01/2003 N/A
A, B
A, B
09/30/2013 N/A
01/15/2003 N/A
B, C
B, C
01/15/2003 N/A
01/15/2003 N/A
11/01/2003 N/A
10/15/2005 N/A
A, B
B
A, B
mg
Injection, testosterone
J3150 propionate, up to 100
mg
Injection,
Metrodin®, Bravelle®,
J3355
urofollitropin, 75 IU Fertinex®
J34902 Unclassified Drugs Liraglutide GLP-1, Victoza®
J34902 Unclassified Drugs Trimix
J34902 Unclassified Drugs Tesamorelin acetate
J34902 Unclassified Drugs Methylnaltrexone bromide
J34902 Unclassified Drugs exanatide (Byetta®), variable
Kynamro* (mipomersen
J34902 Unclassified Drugs
sodium)
Peginterferon alfa-2b
J34902 Unclassified Drugs
(Sylatron™)
pramlintide acetate (Symlin®),
J34902 Unclassified Drugs
variable
Unclassified
Simponi*-anti-TNF
J35902
Biologics
(Golimumab)
Unclassified
J35902
anakinra (Kineret®), variable
Biologics
Unclassified
efalizumab (Raptiva®),
J35902
Biologics
variable
Unclassified
peginterferon, alfa-2a
J35902
Biologics
(Pegasys®), variable
Unclassified
Peginterferon, alfa-2b (PegJ35902
Biologics
Intron®), variable
Unclassified
pegvisomant (Somavert®),
J35902
Biologics
variable
Unclassified
J35902
Abatacept (Orencia®)
Biologics
Injection, interferon
J9212 alfacon-1,
Infergen®
recombinant, 1 mcg
Injection, interferon,
J9213 alfa-2a, recombinant, Roferon-A®
3 million units
Injection, interferon
J9216 gamma-1b, 3 million Actimmune®
units
Leuprolide acetate,
J9218
Lupron®
per 1 mg
A, B
10/15/2005 N/A
04/15/2007 N/A
09/30/2013 N/A
09/30/2013 N/A
09/30/2013 N/A
09/30/2013 N/A
04/01/2006 N/A
06/26/2013 N/A
06/26/2013 N/A
04/01/2006 N/A
09/30/2013 N/A
10/15/2005 N/A
05/01/2004 N/A
05/01/2005 N/A
11/01/2003 N/A
05/01/2004 N/A
9/30/2013 N/A
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
B, C
A, B
B, C
A, B
A, B
B, C
11/01/2003 N/A
B, C
11/01/2003 N/A
B, C
01/15/2003 N/A
01/15/2003 N/A
A, B
Injection, sermorelin
A, B
04/15/2007 N/A
acetate, 1 mcg
Injection, interferon
A, B
Q3025 beta-1a, 11 mcg for Avonex®, Rebif®
10/20/2010 N/A
IM use
1
Key for basis for the decision “Usually Self-Administered”.
A
Excluded as "apparent on its face"
Excluded based on predominant use(s) being chronic or recurrent, identifiable by the
B
patient and provided long-term and by self-administration
C
Excluded based on detailed review of Medicare claims data
2
These are non specific codes.
Providers are reminded that no form of insulin, regardless of route of
administration including intravenous, intramuscular, subcutaneous, or inhalation, is
3
reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera®),
variable.]
Q0515
If a beneficiary's claim for a particular drug is denied because the drug is subject to the “selfadministered 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 Medicare Claims Processing Manual, Publication 100-04, Chapter 29, Section
200 at http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/clm104c29.pdf .
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 selfadministered.
Sources: IOM Medicare Benefit Policy Manual, Publication100-02, 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
Revision History
10/08/2013 - The article is being revised to include the CMS determination that each of the
drugs: abatacept and golimumab, when used as a medically necessary intravenous infusion
incident to a physician’s service, and the drug certolizumab, when used as a medically
R2
necessary injection in its lyophilized form incident to a physician’s service, are not to be
considered usually self-administered. Coding instructions to document these situations are
included with an effective date of 12/01/2013.
09/30/2013 - The article is being revised to remove the code for the intravenous formulation
of abatacept (Orencia) described by J0129 effective 09/30/2013. The subcutaneous
R1
formulation, currently described by the code J3590, is substituted with the effective date of
09/30/2013.
Last Updated: October 25, 2013