Drugs and Biologics (Non-chemotherapy) L32013

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation		 Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402		 Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L32013

LCD Title
Drugs and Biologics (Non-chemotherapy)

Contractor's Determination Number
INJ-041

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region

Original Determination Effective Date
For services performed on or after 11/15/2011

Original Determination Ending Date


Revision Effective Date
For services performed on or after 01/01/2012

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act (SSA):
Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1862(a)(1)(D) Investigational or Experimental

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publication Pub 100-02, Medicare Benefit Policy Manual, Chapter 15- Section 50 - Drugs and Biologicals:

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 17:
10 - Payment Rules for Drugs and Biologicals

Indications and Limitations of Coverage and/or Medical Necessity
The LCD has been promulgated to establish the clinical conditions for which the included drugs are considered to be medically reasonable and necessary and thus, covered by Medicare. The agents discussed in no way constitute a complete list of drugs and biologicals covered by Medicare. This document does not include chemotherapy drugs (See our Chemotherapy LCD). The contractor expects the use of those drugs and biologicals not listed here to be medically necessary and used according to their FDA indications.

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 patients who take them.

In order to meet all the general requirements for coverage under the incident-to provision, an FDA approved drug or biological must:
-Be of a form that is not usually self-administered;
-Must be furnished by a physician; and
-Must be administered by the physician, or by auxiliary personnel employed by the physician and under the physician's direct supervision.

The charge, if any, for the drug or biological must be included in the physician's bill and the cost of the drug or biological must represent an expense to the physician.

Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. (See the Medicare Benefit Policy Manual, Chapter 16, "General Exclusions from Coverage," §20.) Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling. Therefore, the program may pay for the use of an FDA approved drug or biological, if:
-It was injected on or after the date of the FDA's approval;
-It is reasonable and necessary for the individual patient; and
-All other applicable coverage requirements are met.

An unlabeled use of a drug is a use that is not included as an indication on the drug's label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice. An LCD reconsideration request with supporting documentation should be submitted via policycomments@wpsic.com to request off label use of a drug.

Limitations:
The following guidelines identify three categories with specific examples of situations in which medications would not be reasonable and necessary according to accepted standards of medical practice:

Medications given for a purpose other than the treatment of a particular condition, illness, or injury are not covered.

Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration. For example, the accepted standard of medical practice for the treatment of certain diseases is to initiate therapy with parenteral penicillin and to complete therapy with oral penicillin.

Carriers exclude the entire charge for penicillin injections given after the initiation of therapy if oral penicillin is indicated unless there are special medical circumstances that justify additional injections.

Medications administered for treatment of a disease and which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered.

If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the entire charge (i.e., for both the drug and its administration) is not considered medically necessary.

This is not an all inclusive list and will not be updated to include every newly FDA approved drug.

J0129 Abatacept 10 mg (Orencia TM) (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WWHEN DRUG IS SELF ADMINISTERED)
Rheumatoid Arthritis 714.0
Felty's Syndrome 714.1
Other rheumatoid arthritis with visceral or systemic involvement 714.2
Juvenile Arthritis 714.30-714.33

J0180 Agalsidase Beta 1mg, (Fabrazyme TM)
Fabry's disease (Lipidoses) 272.7

J0256 Alpha 1 Proteinase Inhibitor-Human, NOT OTHERWISE SPECIFIED,10 mg
Alpha 1-antitrypsin deficiency 273.4

J0257 ALPHA 1 PROTEINASE INHIBITOR (HUMAN), (GLASSIA), 10 MG
Alpha 1-antitrypsin deficiency 273.4

J0364 Apomorphine hydrochloride 1mg (Apokyn TM)
Acute, intermittent treatment of hypomobility associated with advanced Parkinson's disease
332.0

J1300 Eculizumab, 10 mg (Soliris TM)
Treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis 283.2

For the treatment of patients with atypical hemolytic uremic syndrome (aHUS) (283.11) to inhibit complement-mediated thrombotic microangiopathy. Effective 09/23/2011-FDA approval date.

J1745 Infliximab 10 mg (Remicade TM)
Behcet' s Syndrome 136.1
Colitis 556.0-556.9
Crohn's disease 555.0-555.9
Chronic severe plaque psoriasis 696.1
Psoriatic arthropathy 696.0
Rheumatoid Arthritis 714.0
Felty's Syndrome 714.1
Other rheumatoid arthritis with visceral or systemic involvement 714.2
Juvenile Chronic polyarthritis 714.30-714.33
Ankylosing spondylitis 720.0
Sarcoidosis: 135, 425.8; and 517.8 will be considered for treating patients with persistent symptomatic sarcoidosis despite corticosteroid and immunosuppressive treatment. Claims with one of these diagnoses will be developed for medical records.
Unspecified iridocyclitis (364.3): Infliximab will be covered for uveitis that is refractory to other immunosuppressive agents. Failure of previously used agents must be documented in the medical record

J1931 Laronidase 0.1mg (Aldurazyme TM)
Indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. (277.5)

J2001 Lidocaine HCL 10 mg
Paroxysmal Ventricular Tachycardia 427.1
Ventricular fibrillation 427.41
Ventricular flutter 427.42
Cardiac Arrest 427.5
Other-Ventricular premature beats 427.69
Cardiac Dysrhythmia 427.9

J2323 Natalizumab 1 mg, (Tysabri TM)
Multiple Sclerosis 340
Crohn's disease (555.0-555.9) will be covered for moderate to severely active Crohn's disease (CD) with evidence of inflammation for patients who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF.

J2357 Omalizumab 5mg, (Xolair TM)
Extrinsic Asthma, unspecified 493.00.

J2503 Pegaptanib sodium .3mg, (Macugen TM)
Diabetic macular edema 362.07
Central vein occlusion 362.35
"wet" macular degeneration 362.52

J2562 Plerixafor, 1mg, (Mozobil TM)
Indicated to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma (200.00-200.08, 200.10-200.18, 200.20-200.28, 200.30-200.38, 200.40-200.48,200.50-200.58, 200.60-200.68, 200.70-200.78, 200.80-200.88, 202.00-202.08, 202.10-202.18, 202.20-202.28, 202.30-202.38, 202.40-202.48, 202.50-202.58, 202.60-202.68, 202.70-202.78, 202.80-202.88, 202.90-202.98, 203.00-203.01)

J2778 Ranibizumab .1mg, (Lucentis TM)
Proliferative diabetic retinopathy 362.02
"wet" macular degeneration 362.52
Macular edema following Retinal vein occlusion (RVO). Code macular edema 362.83 and 362.35, Central retinal vein occlusion (CRVO) or 362.36, Venous tributary (branch) occlusion (BRVO)
Retinal neovascularization-choroidal 362.16

J2796 Romiplostim 10 mcg (Nplate TM)
For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. (287.31)

J3396 Verteporfin, 0.1 mg (Visudyne TM)
See National Coverage Determinations Manual 100-03 Section 80.3.
Verteporfin is covered with a diagnosis of neovascular age-related macular degeneration (ICD-9-CM 362.52) with predominately classic subfoveal choroidal neovascular (CNV) lesions (where the area of classic CNV occupies ≥ 50 percent of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram. Additional FDA approved indications include pathologic myopia (360.21) and presumed ocular histoplasmosis (115.02, 115.12, 115.92)

J3590 Bevacizumab (Avastin TM) 1-3 mg- (Use for administration in the office setting)
C9257 Bevaciumab 0.25 mg (For hospital outpatient and ASC settings)
Infection by histoplasma capsulatum-retinitis 115.02
Infection by histoplasma duboisii-retinitis 115.12
Ocular histoplasmosis 115.92
Proliferative diabetic retinopathy 362.02
Diabetic macular edema 362.07
Central retinal vein occlusion 362.35
Venous tributary (branch) occlusion 362.36
Rubeosis iridis 364.42
"wet" macular degeneration 362.52
Glaucoma associated vascular disorders 365.63
Retinal neovascularization-choroidal 362.16


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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy 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 policy 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 policy should be assumed to apply equally to all Revenue Codes.



CPT/HCPCS Codes

C9257INJECTION, BEVACIZUMAB, 0.25 MG
J0129INJECTION, 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)
J0180INJECTION, AGALSIDASE BETA, 1 MG
J0256INJECTION, ALPHA 1 PROTEINASE INHIBITOR (HUMAN), NOT OTHERWISE SPECIFIED, 10 MG
J0257INJECTION, ALPHA 1 PROTEINASE INHIBITOR (HUMAN), (GLASSIA), 10 MG
J0364INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG
J1300INJECTION, ECULIZUMAB, 10 MG
J1745INJECTION INFLIXIMAB, 10 MG
J1931INJECTION, LARONIDASE, 0.1 MG
J2001INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG
J2323INJECTION, NATALIZUMAB, 1 MG
J2357INJECTION, OMALIZUMAB, 5 MG
J2503INJECTION, PEGAPTANIB SODIUM, 0.3 MG
J2562INJECTION, PLERIXAFOR, 1 MG
J2778INJECTION, RANIBIZUMAB, 0.1 MG
J2796INJECTION, ROMIPLOSTIM, 10 MICROGRAMS
J3396INJECTION, VERTEPORFIN, 0.1 MG

Use J3590 for Bevacizumab (Avastin TM)1-3 mg

J3590UNCLASSIFIED BIOLOGICS

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.

See Indications and Limitations Section


XX000Not Applicable

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements
The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

The medical record must include the following information:
A physician's order
The name of the drug or biological administered;
The route of administration;
The dosage (e.g., mgs, mcgs, cc's or IU's);
The duration of the administration- start and stop time must be documented for IV infusions.
When a portion of the drug or biological is discarded, the medical record must clearly document the amount administered and the amount wasted or discarded.

Appendices

Utilization Guidelines
Injections of drugs that are administered at an excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than listed in the package insert or generally accepted by peers and the reason for additional services is not justified by documentation.

Sources of Information and Basis for Decision
Package Label/inserts
Other Contractors LCDs
Injection list- WI, IL, MI, MN

Emmett T. Cunningham Jr., MD, PhD, Anthony P. Adamis, MD, Michael Altaweel, MD, et al. A Phase II Randomized Double-Masked Trial of Pegaptanib, an Anti-Vascular Endothelial Growth Factor Aptamer, for Diabetic Macular Edema,. Ophthalmology Volume 112, Number 10, 2005.

Emmett T. Cunningham Jr., MD PhD, Anthony P. Adamis, MD, Neil M. Bressler MD, et al. Changes in Retinal Neovascularization after Pegaptanib (Macugen) Therapy in Diabetic Individuals. Ophthalmology Volume 113, Number 1, 2006-

Marla B. Sultan, MD, MBA, Duo Zhou, MD, MS, Jane Loftus, MSc, BSc et al
A Phase 2/3, Multicenter, Randomized, Double-Masked, 2-Year Trial of Pegaptanib Sodium for the Treatment of Diabetic Macular Edema, Ophthalmology Volume 118, Number 6, 2011

Ehrlich R, Ciulla TA, Maturi R, et al. Intravitreal bevacizumab for choroidal neovascularization secondary to presumed ocular histoplasmosis syndrome, Retina, 2009 Nov-Dec;29 (10):1418-23

Tolentino MD, Michael, MD, et al. Systemic and Ocular safety of intravitreal of Anti-VEGF Therapies for Ocular Neovascular Disease,. Survey of Ophthalmology, Volume 56 Number 2, March-April 2011

John J. Wroblewski, MD; John A. Wells III, MD; Anthony P. Adamis, MD, et al. Pegaptanib Sodium for Macular Edema Secondary to Central Retinal Vein Occlusion. Archives Ophthalmology, Volume 127 (NO. 4), APR 2009.

Miki Sawa, Fumi Gomi, Motokazu Tsujikawa, et al. Long-term Results of Intravitreal Bevacizumab Injection
for Choroidal Neovascularization Secondary to Angioid Streaks. Am J Ophthalmology 2009; 148:584590

Gerard Mimoun, Julien Tilleul, Anita Leys, et al. Intravitreal Ranibizumab for Choroidal Neovascularization in Angioid Streaks. Am J Ophthalmology 2010;150:692700.

Advisory Committee Meeting Notes
Meeting Date:
Wisconsin: 05/20/2011
Illinois: 05/25/2011
Michigan: 05/18/2011
Minnesota: 05/19/2011
J5 06/17/2011

Open Meeting Date:
04/28/2011

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.

Start Date of Comment Period
06/17/2011
End Date of Comment Period
08/01/2011
Start Date of Notice Period
10/01/2011
Revision History Number
X
Revision History Explanation
11/01/2011- Article published: J2562-Typo corrected 202.40-202.48 added & removed 204.00-204.48.

12/01/2011- Article published- added 283.11 to J1300

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
J0129 descriptor was changed in Group 1
J0256 descriptor was changed in Group 1

12/13/2012- 01/01/2012 Code update, added new code J0257 -payable for 273.4. J0129 & J0256-code description changes, Typo corrected -J2562 removed duplicate listing of codes 202.00-202.18.

Reason for Change

Related Documents
This LCD has no Related Documents.

LCD Attachments

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Page Last Updated: Wednesday, 04-Jan-2012 14:52:20 CST