Drugs and Biologics (Non-chemotherapy) (DL32013)

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
Draft stamp
LCD ID Number
DL32013

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 2010 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


Original Determination Ending Date


Revision Effective Date


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)
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)
Fabry's disease (Lipidoses) 272.7

J0256 Alpha 1 Proteinase Inhibitor-Human, 10 mg
Alpha 1-antitrypsin deficiency 273.4

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

J3590 Bevacizumab (Avastin) 1-3 mg
362.52 "wet" macular degeneration
362.07 Diabetic macular edema
362.35 Central retinal vein occlusion
362.36 Venous tributary (branch) occlusion
364.42 Rubeosis iridis
365.63 Glaucoma associated vascular disorders

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

J1745 Infliximab 10 mg (Remicade)
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)
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)
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 who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF.

J2503 Pegaptanib sodium .3mg, (Macugen)
"wet" macular degeneration 362.52

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

J2778 Ranibizumab .1mg, (Lucentis)
"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)

J2796 Romiplostim 10 mcg (Nplate)
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)

J2562 Plerixafor, 1mg, (Mozobil)
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, 202.00 - 202.18, 202.20 - 202.28, 202.30 - 202.38, 204.00 - 204.48, 202.50 - 202.58, 202.60 - 202.68, 202.70 - 202.78, 202.80 - 202.88, 202.90 - 202.98, 203.00 - 203.01)

J3396 Verteporfin, 0.1 mg (Visudyne)
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)


Coding Information

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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
J0129 INJECTION, ABATACEPT, 10 MG
J0180 INJECTION, AGALSIDASE BETA, 1 MG
J0256 INJECTION, ALPHA 1 - PROTEINASE INHIBITOR - HUMAN, 10 MG
J0364 INJECTION, APOMORPHINE HYDROCHLORIDE, 1 MG
J1300 INJECTION, ECULIZUMAB, 10 MG
J1745 INJECTION INFLIXIMAB, 10 MG
J1931 INJECTION, LARONIDASE, 0.1 MG
J2001 INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG
J2323 INJECTION, NATALIZUMAB, 1 MG
J2357 INJECTION, OMALIZUMAB, 5 MG
J2503 INJECTION, PEGAPTANIB SODIUM, 0.3 MG
J2562 INJECTION, PLERIXAFOR, 1 MG
J2778 INJECTION, RANIBIZUMAB, 0.1 MG
J2796 INJECTION, ROMIPLOSTIM, 10 MICROGRAMS
J3396 INJECTION, VERTEPORFIN, 0.1 MG
Use J3590 for Bevacizumab (Avastin)1-3 mg
J3590 UNCLASSIFIED 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

XX000 Not 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

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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
Services performed for 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
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
Revision History Number
Revision History Explanation
Reason for Change
Last Reviewed On Date
04/01/2011
Related Documents
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LCD Attachments

Page Last Updated: Thursday, 15-Dec-2011 12:15:05 CST