Article Title

Botulinum Toxin Types A and B – 4I-84AB-R13

Contractor’s Determination Number

4I-84AB

Contractor Name

TrailBlazer Health Enterprises

Contractor Number

  • 04001 (04101, 04201, 04301, 04401, 04901).
  • 04002 (04102, 04202, 04302, 04402).

Contractor Type

  • MAC – Part A.
  • MAC – Part B.

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

  • CO.
  • NM.
  • OK.
  • TX:
    • Indian Health Service.
    • End Stage Renal Disease (ESRD) facilities.
    • Skilled Nursing Facilities (SNFs).
    • Rural Health Clinics (RHCs).
  • Transitioned WPS legacy providers.

Oversight Region

  • Region IV.
  • Region VI.

Original Article Effective Date

03/01/2008

03/21/2008

06/13/2008

Article Revision Effective Date

10/01/2011

Article Ending Effective Date

N/A

Article Text

Abstract

Botulinum Toxin Type A has been used for more than two decades and is derived from a culture of the Hall strain of Clostridium botulinum. Botulinum Toxin Type B was approved by the Food and Drug Administration (FDA) in December 2000 and is derived from the Bean strain of Clostridium botulinum. Type B has the same action on neuromuscular conduction (blockade) as Type A.

Botulinum Toxin Type A and Botulinum Toxin Type B have many similarities and as experience has been gained, medical consensus has gradually developed that the two toxins have similar, but not identical, properties. As a result, approved indications for the two toxins differ. The separate accepted indications for the two toxins will be combined into a single list of covered indications in this LCD. However, it is the responsibility of providers to use each drug in accordance with approved indications unless there are valid and documented reasons indicating why the unapproved form is used.

Part A Program Instructions:

Reasons for Denial

  • Treatment of skin wrinkles (ICD-9-CM code 701.8) is cosmetic and is not covered by Medicare (per Medicare Benefit Policy Manual Chapter 16, Section 120).
  • Anal spasm, irritable colon, biliary dyskinesia or any treatment of spastic conditions not listed as covered in the LCD are considered to be cosmetic, investigational or not safe and effective.
  • Treatment of muscle tension or migraine headaches for diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” sections is considered not proven effective.
  • All other indications not listed in the “Indications and Limitations of Coverage” section of the related LCD.
  • Service(s) rendered is (are) not consistent with accepted standards of medical practice.
  • The medical record does not verify that the service described by the CPT/HCPCS code was provided.
  • The medical record does not verify that the route of administration was medically necessary.
  • The amount of drug wasted is not reasonable or documented.
  • The service does not follow the guidelines of the related LCD.
  • The service is considered:
    • Investigational.
    • For cosmetic purposes.
    • A program exclusion.
    • Otherwise not covered.
    • Never medically necessary.

Coding Guidelines

  • Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.
  • Diagnosis(es) must be present on any claim submitted and coded to the highest level of specificity for that date of service.
  • To report these services, use the appropriate HCPCS or CPT code(s).
  • All coverage criteria must be met before Medicare can reimburse this service.
  • When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.
    • Modifiers:
      • GA: Waiver of liability statement issued as required by payer policy, individual case. (Use for patients who do not meet the covered indications and limitations of this LCD and for whom an ABN is on file.) (ABN does not have to be submitted but must be made available upon request.)
      • GZ: Item or service expected to be denied as not reasonable and necessary. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN and the provider expects the item/service to be denied. All claim line items submitted with the GZ modifier will be denied automatically and will not be subject to complex medical review.)
      • GY: Item or service is statutorily excluded or does not meet the definition of any Medicare benefit.
  • See also Bill Type and Revenue Code sections below.

Coding Drug Wastage (JW Modifier)

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. If after taking the above measures a portion of the single-use vial must be discarded, HCPCS modifier JW may be used to indicate the drug amount discarded/not administered to any patient. The amount administered and the amount wasted must be billed on the same claim. The amount administered must be on a separate detail line from the amount wasted, indicated with the modifier JW (when applicable). The modifier JW would not be used for claim billings when the actual dose of the drug/biological administered is less than the billing unit established by HCPCS description (e.g., the description of the HCPCS code already includes the amount administered along with the amount wasted. Example: 75 mg of meperidine HCl (J2175, meperidine hydrochloride, per 100 mg) is administered. Bill HCPCS code J2175 quantity “1.” Payment will be provided for J2175, 100 mg, which includes the amount administered (75 mg) and the amount discarded (25 mg)). Please reference “Drug Wastage” at http://www.trailblazerhealth.com/Publications/Job%20Aid/Drug%20Wastage.pdf  for examples of determining the correct way of billing drug wastage to Medicare.

Billing Examples Using JW:

“Per unit” Example, Multiple Patients:

A physician schedules three Medicare patients to receive Botulinum Toxin Type A on the same day within the designated shelf life of the product. Currently, Botox is available only in a 100-unit size. Once Botox is reconstituted in the physician’s office, it has a shelf life of only four hours. Often, a patient receives less than a 100-unit dose. The physician administers 30 units to each patient. The remaining 10 units are billed to Medicare on the account of the last patient.

The claim for the last patient would indicate J0585 billed at quantity 30 (to indicate the amount administered to the patient) on one detail line. The next detail line would indicate J0585JW billed at quantity 10 (to indicate the 10 units wasted from the 100-unit vial). When a “per unit” type HCPCS code is billed, the entire vial may be accounted for on more than one line and/or claim such as this example.

“Per unit” Example, Single Patient:

A physician must administer 15 units of Botulinum Toxin Type A to a Medicare patient, and it is not practical to schedule another patient who requires Botulinum Toxin. For example, the physician has only one patient who requires Botulinum Toxin, or when the physician sees the patient for the first time and did not know the patient’s condition.

The claim for this patient would indicate J0585 billed at quantity 15 (to indicate the amount administered to the patient) on one detail line. The next detail line would indicate J0585JW billed at quantity 85 (to indicate the 85 units wasted from the 100-unit vial).

Note: In both of the above examples the entire 100 units that were an expense to the billing provider are accounted for with the combination of the drug code on one detail line and the JW wastage on the next detail line. The code description for J0585 is billed in this manner because the code description does not indicate an entire 100-unit vial but a break down by units of the vial.

Part B Program Instructions:

Reasons for Denial

  • Treatment of skin wrinkles (ICD-9-CM code 701.8) is cosmetic and is not covered by Medicare (per Medicare Benefit Policy Manual Chapter 16, Section 120).
  • Anal spasm, irritable colon, biliary dyskinesia or any treatment of spastic conditions not listed as covered in the LCD are considered to be cosmetic, investigational or not safe and effective.
  • Treatment of muscle tension or migraine headaches for diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” sections is considered not proven effective.
  • All other indications not listed in the “Indications and Limitations of Coverage” section of the related LCD.
  • Service(s) rendered is (are) not consistent with accepted standards of medical practice.
  • The medical record does not verify that the service described by the CPT/HCPCS code was provided.
  • The medical record does not verify that the route of administration was medically necessary.
  • The amount of drug wasted is not reasonable or documented.
  • The service does not follow the guidelines of the related LCD.
  • The service is considered:
    • Investigational.
    • For cosmetic purposes.
    • A program exclusion.
    • Otherwise not covered.
    • Never medically necessary.

Coding Guidelines

  • Refer to the Correct Coding Initiative (CCI) for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Provisions of this LCD do not take precedence over CCI edits.
  • Diagnosis(es) must be present on any claim submitted and coded to the highest level of specificity for that date of service.
  • To report these services, use the appropriate HCPCS or CPT code(s).
  • All coverage criteria must be met before Medicare can reimburse this service.
  • When billing for this service in a non-covered situation (e.g., does not meet indications of the related LCD), use the appropriate modifier (see below). To bill the patient for services that are not covered (investigational/experimental or not reasonable and necessary) will generally require an Advance Beneficiary Notice (ABN) be obtained before the service is rendered.
    • Modifiers:
      • GA: Waiver of liability statement issued as required by payer policy, individual case. (Use for patients who do not meet the covered indications and limitations of this LCD and for whom an ABN is on file.) (ABN does not have to be submitted but must be made available upon request.)
      • GZ: Item or service expected to be denied as not reasonable and necessary. (Use for patients who do not meet the covered indications and limitations of this LCD and who did not sign an ABN and the provider expects the item/service to be denied. All claim line items submitted with the GZ modifier will be denied automatically and will not be subject to complex medical review.)
      • GY: Item or service is statutorily excluded or does not meet the definition of any Medicare benefit.
  • Bill Type and Revenue Codes below DO NOT apply to Part B. 

Coding Drug Wastage (JW Modifier)

Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. If after taking the above measures a portion of the single-use vial must be discarded, HCPCS modifier JW may be used to indicate the drug amount discarded/not administered to any patient. The amount administered and the amount wasted must be billed on the same claim. The amount administered must be on a separate detail line from the amount wasted, indicated with the modifier JW (when applicable). The modifier JW would not be used for claim billings when the actual dose of the drug/biological administered is less than the billing unit established by HCPCS description (e.g., the description of the HCPCS code already includes the amount administered along with the amount wasted. Example: 75 mg of meperidine HCl (J2175, meperidine hydrochloride, per 100 mg) is administered. Bill HCPCS code J2175 quantity “1.” Payment will be provided for J2175, 100 mg, which includes the amount administered (75 mg) and the amount discarded (25 mg)). Please reference “Drug Wastage” at http://www.trailblazerhealth.com/Publications/Job%20Aid/Drug%20Wastage.pdf  for examples of determining the correct way of billing drug wastage to Medicare.

Billing Examples Using JW:

“Per unit” Example, Multiple Patients:

A physician schedules three Medicare patients to receive Botulinum Toxin Type A on the same day within the designated shelf life of the product. Currently, Botox is available only in a 100-unit size. Once Botox is reconstituted in the physician’s office, it has a shelf life of only four hours. Often, a patient receives less than a 100-unit dose. The physician administers 30 units to each patient. The remaining 10 units are billed to Medicare on the account of the last patient.

The claim for the last patient would indicate J0585 billed at quantity 30 (to indicate the amount administered to the patient) on one detail line. The next detail line would indicate J0585JW billed at quantity 10 (to indicate the 10 units wasted from the 100-unit vial). When a “per unit” type HCPCS code is billed, the entire vial may be accounted for on more than one line and/or claim such as this example.

“Per unit” Example, Single Patient:

A physician must administer 15 units of Botulinum Toxin Type A to a Medicare patient, and it is not practical to schedule another patient who requires Botulinum Toxin. For example, the physician has only one patient who requires Botulinum Toxin, or when the physician sees the patient for the first time and did not know the patient’s condition.

The claim for this patient would indicate J0585 billed at quantity 15 (to indicate the amount administered to the patient) on one detail line. The next detail line would indicate J0585JW billed at quantity 85 (to indicate the 85 units wasted from the 100-unit vial).

Note: In both of the above examples the entire 100 units that were an expense to the billing provider are accounted for with the combination of the drug code on one detail line and the JW wastage on the next detail line. The code description for J0585 is billed in this manner because the code description does not indicate an entire 100-unit vial but a break down by units of the vial.

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.

12X, 13X, 18X, 21X, 22X, 23X, 71X, 73X, 77X,  85X

Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.

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.

Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all the CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.

0250, 0636

CPT/HCPCS Codes

Note:

Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.

J0585*

Injection, onabotulinumtoxina, 1 unit

 

Note: Use J0585 to bill Botox®.

J0586*

Injection, abobotulinumtoxina, 5 units

 

Note: Use J0586 to bill Dysport™ for DOS on or after 01/01/2010; use J3490 to bill Dysport™ for DOS on or before 12/31/2009.

J0587*

Injection, rimabotulinumtoxinb, 100 units

 

Note: Use J0587 to bill Myobloc®.

Q2040

Injection, incobotulinumtoxinA, 1 unit (Xeomin®)

64612©

Destroy nerve, face muscle

64613©

Destroy nerve, neck muscle

64614©

Destroy nerve, extrem musc

64650©

Chemodenerv eccrine glands

64653©

Chemodenerv eccrine glands

67345©

Destroy nerve of eye muscle

Other Comments

Requests may be considered for redetermination (formerly appeal) for continued treatment during a treatment period or for resumption at a later date if satisfactory results have not been obtained and compelling clinical evidence of medical necessity for continued treatment is presented.

Compliance with the provisions in this LCD may be monitored and addressed through post-payment data analysis and subsequent medical review audits.