Local Coverage Article: Self-Administered Drug Exclusion List (A51866)

Local Coverage Article: Self-Administered Drug Exclusion List (A51866) Contractor Information Contractor Name Novitas Solutions, Inc. Article Information General Information Article ID A51866 General Article Information Table Article Title Self-Administered Drug Exclusion List Article Type SAD Exclusion Article AMA CPT / ADA CDT Copyright Statement CPT only copyright 2002-2013 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and Original Effective Date 08/13/2012 Revision Effective Date 09/11/2014 Revision Ending Date Retirement Date

CDT-2010 are trademarks of the American Dental Association. Article Guidance Article Text: Medicare provides only 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 administered by the patients who take them. Each Medicare Administrative Contractor (MAC) as well as fiscal intermediary and carrier must make its own determinations for determining which drugs will be excluded from coverage. The detailed process for this determination is available in the Medicare Benefit Policy Manual Internet-Only Manual (IOM) Publication 100-02, Chapter 15, Section 50.2. DEFINITIONS In making these determinations, Novitas Solutions used the following definitions: Self administered administered by the patient to him or herself. This does NOT include administration by spouses, nursing aides, allied health professionals, or physicians. Therefore, oral medications are considered self administered drugs. However, payment for an oral drug is made as a rare exception when the drug is an oral anti-cancer drug or an oral antiemetic that is given with chemotherapy treatments (See IOM 100-02, Chapter 15, Section 50.5.3 and 50.5.4). Usually self administered 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 the contractor may not make any Medicare payment for it. In other words, this determination is made by evaluating beneficiaries as a collective whole rather than basing it on an individual drug or individual beneficiary. Acute condition any condition that the expected course of treatment is less than two weeks. Chronic condition any condition that requires treatment for more than two weeks. PROCESS OF DETERMINATION In making these determinations, Novitas Solutions uses the process prescribed by CMS. The process is summarized as follows. Statistical information is used to make the required decisions. However, when this data is not available the following factors are considered: route of administration, status of the condition, frequency of drug administration. Route of Administration

Drugs delivered intravenously are presumed to be NOT usually self administered Drugs injected intramuscularly are presumed to be NOT usually self administered, although depth and nature of the drug may be considered. Drugs administered subcutaneously are considered to be usually self administered. Status of the Condition Acute: any condition that the expected course of treatment is less than two weeks Chronic condition: any condition that requires treatment for more than two weeks. Frequency of Administration Infrequent injection: e.g., drug given monthly or less than once per month Frequent injections: e.g., drug given one or more times per week or more than once per month Novitas Solutions arrived at a single determination for each drug by reviewing each indication and route of administration for that indication. The relative contribution for each indication to the total use of that drug (i.e., weighted average) was obtained to determine the overall status of administration. For example, if a drug has three indications where the first indication makes up 40% of its use and is usually self administered, the second and third indications make up 60% of its use and the drug is not usually self administered for these indications, then the overall determination of that drug is that it is not usually self administered. Conversely, if the first indication makes up 60% of its use and the drug is usually self administered, and the second indication makes up 40% of its use and the drug is not usually self administered, the overall determination made is that the drug is usually self administered. After the route of administration is determined, the status of the condition and the frequency of administration are assessed. If the condition is acute or if the drug is given less frequently than one time per week, the drug is determined to be not usually self administered. For certain injectable drugs, it is apparent that due to the nature of the condition(s) for which they are self-administered or the usual course of treatment for those conditions, they are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self administered. For these drugs, the rationale for the determination is apparent on its face value. BENEFICIARY APPEALS 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 (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 an excluded drug. PROVIDER AND PHYSICIAN APPEALS

A physician accepting assignment may appeal a denial under the provisions found in Chapter 29 of the Medicare Claims Processing Manual. For complete information on Medicare Regulations regarding Drugs and Biologicals, please refer to the CMS IOM Publication 100-2, Chapter 15, Section 50. Coding Information DRUGS AND BIOLOGICALS FURNISHED INCIDENT TO A PHYSICIAN S SERVICE ARE SUBJECT TO THE MEDICARE SELF-ADMINISTRATION DRUG EXCLUSION. This list will be continuously updated as soon as new determinations are made available. This list contains only those drugs and biologicals that are determined to be usually self-administered by the patients and therefore not eligible for Medicare coverage. Other Comments Certolizumab pegol (Cimzia) and golimumab (Simponi) have been removed from the exclusion list due to the frequency for these injections. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims. Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the article services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes. CPT/HCPCS Codes

Covered ICD-9 Codes Non-Covered ICD-9 Codes Coding Table Information CPT/HCPCS Codes - Table Format Code J0135 J0270 J0275 J0630 Descriptor Generic Name INJECTION, ADALIMUMAB, 20 MG 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 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) INJECTION, CALCITONIN SALMON, UP TO 400 UNITS INJECTION, ENFUVIRTIDE, 1 J1324 MG INJECTION, ETANERCEPT, 25 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE J1438 DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED) INJECTION, GLATIRAMER J1595 ACETATE, 20 MG Descriptor Brand Name Humira Caverject, Edex, Provistin VR Muse Miacalcin, Fortical, Calcimar Fuzeon Enbrel Copaxone Exclusion Effective Date Exclusion End Date Comments

J1815 J1817 J1830 J2170 J2354 INJECTION, INSULIN, PER 5 UNITS INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS 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) INJECTION, MECASERMIN, 1 MG INJECTION, OCTREOTIDE, NON-DEPOT FORM FOR SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG Regular, NPH, Lente, Ultralente, etc. Lispro, Humalog, etc. Betaseron Iplex, Increlex Sandostatin J2940 INJECTION, SOMATREM, 1 MG Protropin J2941 J3030 J3110 J3355 INJECTION, SOMATROPIN, 1 MG 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) INJECTION, TERIPARATIDE, 10 MCG INJECTION, UROFOLLITROPIN, 75 IU Genotropin, Humatrope, Norditropin, Nutropin, Saizen, Serostim Imitrex Forteo Metrodin, Bravelle, Fertinex

J3490 UNCLASSIFIED DRUGS J3490 UNCLASSIFIED DRUGS J3490 UNCLASSIFIED DRUGS J3490 UNCLASSIFIED DRUGS J3490 UNCLASSIFIED DRUGS J3590 UNCLASSIFIED BIOLOGICS J3590 UNCLASSIFIED BIOLOGICS J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM Byetta (Exenatide Injection) PegIntron (injection, pegylated interferon alfa- 2b) Pegasys (injection, pegylated interferon alfa- 2a) Symlin (Pramlintide Acetate Injection) Kinert (Anakinra) Raptiva (Efalizumab) *discontinued drug Somavert (Pegvisomant for injection) Infergen INJECTION, INTERFERON, J9213 ALFA-2A, RECOMBINANT, 3 Roferon-A MILLION UNITS INJECTION, INTERFERON, J9216 GAMMA 1-B, 3 MILLION UNITS Actimmune LEUPROLIDE ACETATE, PER 1 J9218 Lupron MG INJECTION, SERMORELIN Q0515 Geref ACETATE, 1 MICROGRAM Non-Excluded CPT/HCPCS Ended Codes - Table Format Descriptor Generic Descriptor Brand Exclusion Exclusion Code Name Name Effective Date End Date J3590 UNCLASSIFIED Simponi (Injection, 08/13/2012 08/13/2012 BIOLOGICS golimumab) XX000 Not Applicable 08/13/2012 08/13/2012 Comments

XX000 Not Applicable Not Applicable 08/13/2012 08/13/2012 Revision History Information Please note: The Revision History information included in this Article prior to 06/20/2013 will now display with a Revision History Number of "R1" at the bottom of this table. All new Revision History information entries completed on or after 06/20/2013 will display as a row in the Revision History section of the Article and numbering will begin with "R2". Revision History Date 09/11/2014 R7 09/01/2014 R6 08/14/2014 R5 08/14/2014 R4 01/01/2014 R3 11/19/2012 R2 11/19/2012 R1 Revision History Number Revision History Explanation Article revised to update SAD Process URL 1 in the Associated Documents section of this Article. This revision updates the Novitas Solutions MAC numerical jurisdictional designation to the new MAC Lettered jurisdiction designation(s). No other changes were made to this Article. Article updated on August 15, 2014 to remove the following states which were incorrectly applied to this article: Pennsylvania, Maryland, Delaware, New Jersey and the District of Columbia. This article never became effective for these states. Note regarding original JL Source, A47773, Self Administered Drug Exclusion List also removed from article. Article published on 08/21/2014. Article revised for dates of service on and after 08/14/2014 to create uniform article with other Novitas MAC jurisdiction. (Novitas Jurisdiction L states added). Original Source added to Article Text. LCD revised for dates of service on and after 01/01/2014 to reflect the annual CPT/HCPCS code updates. References to J0718 including previous exclusion effective and end date of 08/13/2012 have been deleted. Article updated on August 8, 2013 to restore Other Comments which were deleted when the article format was updated. 11/19/2012 A51866 Per CMS Change Request (CR) 7812, this article has been updated with the original effective date of 11/19/2012 to add the Novitas Jurisdiction H Part B MAC Contract Numbers 04112, 04212, 04312, and 04412 for Colorado Part B, New Mexico Part B, Oklahoma Part B, Texas Part B, Indian Health Service (IHS)/Tribal/Urban Indian Providers Part B, and Veterans Affairs (VA) Part B. No other changes were made to this article. 10/29/2012 A51866 Article revised effective for dates of service on and after 08/13/2012 to remove certolizumab pegol (Cimzia) and golimumab (Simponi) from the exclusion list due to the frequency for these injections. Article also clarified regarding injection frequency parameters, and Provistin VR and Fortical brand names added.

10/29/2012 A51866 Per CMS Change Request (CR) 7812, this article has been updated with the original effective date of 10/29/2012 to add the Novitas Jurisdiction H Part A MAC Contract Numbers 04911, 04111, 04211, 04311, and 04411 for Colorado Part A, New Mexico Part A, Oklahoma Part A, Texas Part A, Indian Health Service (IHS)/Tribal/Urban Indian Providers Part A, and Veterans Affairs (VA) Part A. No other changes were made to this article. 10/22/2012 A51866 Article original effective date of 10/22/2012 for Mississippi Part B. 08/20/2012 A51866 Article original effective date of 08/20/2012 for Arkansas Part A, Louisiana Part A and Mississippi Part A. 06/28/2012 A51866 Article posted for notice and will become effective on 08/13/2012 for Arkansas and Louisiana Part B Associated Documents SAD Process URL 1 http://www.novitassolutions.com/webcenter/faces/oracle/webcenter/page/scopedmd/sad78b265_6797_4ed0_a02f_ 81627913bc78/Page49.jspx?wc.contextURL=%2Fspaces%2FMedicareJH&wc.originURL=%2F spaces%2fmedicarejh%2fpage%2fpagebyid&contentid=00006147&_afrloop=675043587716 000#%40%3F_afrLoop%3D675043587716000%26wc.contextURL%3D%252Fspaces%252FMe dicarejh%26wc.originurl%3d%252fspaces%252fmedicarejh%252fpage%252fpagebyid% 26contentId%3D00006147%26_adf.ctrl-state%3D1aohou1zbd_140 SAD Process URL 2 Related Local Coverage Document(s) Related National Coverage Document(s) Statutory Requirements URL(s) Rules and Regulations URL(s) CMS Manual Explanations URL(s) Public Version(s) Updated on 09/04/2014 with effective dates 09/11/2014 - Updated on 08/26/2014 with effective dates 09/01/2014 - Updated on 08/15/2014 with effective dates 08/14/2014 - Updated on 08/07/2014 with effective dates 08/14/2014 -

Updated on 02/22/2014 with effective dates 01/01/2014 - Updated on 08/08/2013 with effective dates 11/19/2012 - Updated on 11/05/2012 with effective dates 11/19/2012 - Some older versions have been archived. Please visit MCD Archive Site to retrieve them.