LCD/NCD Portal
Automated World Health
Local Coverage Determination (LCD) for Hemophilia Clotting Factors (L29187)
Contractor Information
Contractor Name First Coast Service Options, Inc.
Contractor Number 09102
Contractor Type MAC - Part B
LCD Information
Document Information
LCD ID Number L29187
LCD Title Hemophilia Clotting Factors
Contractor's Determination Number J7183
Primary Geographic Jurisdiction Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 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 CDT-2010 are trademarks of the American Dental Association.
Original Determination Effective Date
For services performed on or after 02/02/2009
Original Determination Ending Date
Revision Effective Date
For services performed on or after 01/01/2012
Revision Ending Date
CMS National Coverage Policy
Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.
Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 6, Section 20
CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50.5.5
CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 8, Section 70
CMS Manual System, Pub. 100-04, Medicare Claims Processing, Chapter 3, Section 20
CMS Transmittal 2207,Change Request 7303,dated April 29, 2011 CMS Transmittal 2223, Change Request 7430, dated May 20, 2011
CMS Transmittal 2227, Change Request 7303, dated May 24, 2011
CMS Transmittal 2235, Change Request 7445, dated June 3, 2011
CMS Transmittal 1984, Change Request 7008, dated June 11, 2010
Indications and Limitations of Coverage and/or Medical Necessity
Hemophilia is a hereditary blood disease characterized by greatly prolonged coagulation time. The blood fails to clot and abnormal bleeding occurs. It is a sex-linked hereditary trait transmitted by normal heterozygous females who carry the recessive gene. It occurs almost exclusively in males. For purposes of Medicare coverage, hemophilia encompasses Factor VIII deficiency (classic hemophilia, hemophilia A), Factor IX deficiency (hemophilia B, Christmas disease, plasma thromboplastin component), and von Willebrand’s disease. Approximately 80% of those with hemophilia have type A and both are associated with recurrent, spontaneous, and traumatic hemarthrosis.
The frequency and severity of hemorrhagic events induced by hemophilia are related to the amount of coagulation factor in the blood. Those with mild hemophilia (defined as having from 5% to 40% of normal
coagulation factor activity) experience complications only after having undergone surgery or experiencing a major physical trauma. Those with moderate hemophilia (from 1% to 5% of coagulation factor activity) experience
some spontaneous hemorrhage but normally exhibit bleeding provoked by trauma. Those with severe hemophilia (less than 1% of coagulation factor activity) exhibit spontaneous hemarthrosis and bleeding. Treatment for these patients is dependent on the severity of the disease and may include the administration of blood clotting factors such as Factor VIII, Factor IX, Factor VIIa and, Anti-inhibitors to control the bleeding.
Medicare provides coverage of self-administered blood clotting factors for hemophilia patients who are competent to use such factors to control bleeding without medical supervision. Medicare covers blood clotting factors for the following conditions:
• Factor VIII deficiency (classic hemophilia, hemophilia A).
• Factor IX deficiency (hemophilia B, Christmas disease, plasma thromboplastin component).
• von Willebrand’s disease.
Anti-inhibitor coagulant complex (AICC) is a drug used to treat hemophilia in patients with Factor VIII inhibitor antibodies. AICC has been shown to be safe and effective and is covered by Medicare when furnished to patients with hemophilia A and inhibitor antibodies to Factor VIII who have major bleeding episodes and who fail to respond to other less expensive therapies.
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.
99999 Not Applicable
CPT/HCPCS Codes
J7183 INJECTION, VON WILLEBRAND FACTOR COMPLEX (HUMAN), WILATE, 1 I.U. VWF:RCO J7187 INJECTION, VON WILLEBRAND FACTOR COMPLEX (HUMATE-P), PER IU VWF:RCO J7189 FACTOR VIIA (ANTIHEMOPHILIC FACTOR, RECOMBINANT), PER 1 MICROGRAM
J7190 FACTOR VIII (ANTIHEMOPHILIC FACTOR, HUMAN) PER I.U. J7191 FACTOR VIII (ANTIHEMOPHILIC FACTOR (PORCINE)), PER I.U.
J7192 FACTOR VIII (ANTIHEMOPHILIC FACTOR, RECOMBINANT) PER I.U., NOT OTHERWISE SPECIFIED
J7193 FACTOR IX (ANTIHEMOPHILIC FACTOR, PURIFIED, NON-RECOMBINANT) PER I.U. J7194 FACTOR IX, COMPLEX, PER I.U.
J7195 FACTOR IX (ANTIHEMOPHILIC FACTOR, RECOMBINANT) PER I.U.
J7198 ANTI-INHIBITOR, PER I.U.
XX000 Not Applicable
ICD-9 Codes that Support Medical Necessity
286.1 CONGENITAL FACTOR VIII DISORDER
286.2 CONGENITAL FACTOR IX DISORDER
286.3 CONGENITAL FACTOR XI DEFICIENCY
286.4 CONGENITAL DEFICIENCY OF OTHER CLOTTING FACTORS
286.5 VON WILLEBRAND'S DISEASE
286.52 - 286.59 ACQUIRED HEMOPHILIA - OTHER HEMORRHAGIC DISORDER DUE TO INTRINSIC CIRCULATING ANTICOAGULANTS, ANTIBODIES, OR INHIBITORS
286.7 ACQUIRED COAGULATION FACTOR DEFICIENCY
Diagnoses that Support Medical Necessity N/A
ICD-9 Codes that DO NOT Support Medical Necessity N/A
XX000 Not Applicable
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity N/A
General Information
Documentations Requirements
Medical record documentation maintained in the patient’s file must document the condition for which the blood clotting factor is being given. In addition, the name of the factor and the dosage required and/or given must be included in the records. This information is normally found in the office/progress notes, pharmacy forms, hospital
records, and/or treatment notes.
Appendices
Utilization Guidelines N/A
Sources of Information and Basis for Decision
Goldman: Cecil Textbook of Medicine (2004). Hereditary coagulation deficiencies (pp 1069-75) W. B. Saunders This source used to gain textbook knowledge of hemophilia and the physiological implications of the disease.
Roberts HR, Monroe DM, Escobar, MA: Current Concepts of Hemostasis. Anesthesiology 2004 100:722-30. This source used to provide information about the role of blood clotting factors in hemostasis.
Shapiro, A. Inhibitor treatment: State of the art. Disease-A-Month 2003 49 This source provides information on the efficacy of the administration of blood clotting factors to assist in preventing and reducing bleeding episodes.
Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was
developed in cooperation with advisory groups, which includes representatives from numerous societies.
Start Date of Comment Period
End Date of Comment Period
Start Date of Notice Period 01/01/2011
Revision History Number 6
Revision History Explanation Revision Number:6 Start Date of Comment Period:N/A
Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012
LCR B2012-022
December 2011 Connection
Explanation of Revision: Annual 2012 HCPCS Update. HCPCS code Q2041 was deleted and replaced with HCPCS code J7183. Changed Contractor Determination Number to AJ7183. The effective date of this revision is based on date of service.
Revision Number:5
Start Date of Comment Period:N/A Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011
LCR B2011-101
September 2011 Connection
Explanation of Revision: Annual 2012 ICD-9-CM Update. Deleted diagnosis code 286.5 and replaced it with diagnosis code range 286.52-286.59. The effective date of this revision is based on date of service.
Revision Number:4
Start Date of Comment Period:N/A Start Date of Notice Period:07/01/2011 Revised Effective Date: 07/01/2011
LCR B2011-067
June 2011 Connection
Explanation of Revision: LCD revised in accordance with CMS Transmittal 2207, Change Request 7303, dated 04/29/11, CMS Transmittal, 2227, Change Request 7303, dated 5/24/11, CMS Transmittal 2223, Change Request 7430, dated 05/20/11; and CMS Transmittal 2235, Change Request 7445, dated 06/03/11 under the ‘CPT/HCPCS Codes’ section to delete HCPCS code J7184 and replace with HCPCS code Q2041. Changed the “Contractor Determination Number” to J7187. The effective date of this revision is based on date of service.
Revision Number:3
Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2011 Revised Effective Date: 01/01/2011
LCR B2011-025
December 2010 Update
Explanation of Revision: Annual 2011 HCPCS Update. Deleted “For Ambulatory Surgical Centers (ASCs) only: HCPCS code C9267” and replaced with HCPCS code J7184. Changed “Contractor Determination Number” to J7184. The effective date of this revision is based on date of service.
Revision Number:2
Start Date of Comment Period:N/A Start Date of Notice Period:07/01/2010 Revised Effective Date: 07/01/2010
LCR B2010-052
June 2010 Update
Explanation of Revision: LCD revised in accordance with CMS Change Request 7008, dated 06/11/2010 under the ‘CPT/HCPCS Codes’ section to add HCPCS code C9267. The effective date of this revision is for claims processed on or after 07/06/2010 for dates of service on or after 07/01/2010.
Revision Number:1
Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010
LCR B2010-019
December 2009 Update
Explanation of Revision: Annual 2010 HCPCS Update. Descriptor revised for HCPCS code J7192. The effective date of this revision is based on date of service.
Revision Number:Original
Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009
LCR B2009-
December 2008 Bulletin
This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).
For Florida (00590) this LCD (L29187) replaces LCD L6651 as the policy in notice. This document (L29187) is effective on 02/02/2009.
11/15/2009 - The description for CPT/HCPCS code J7192 was changed in group 1 11/21/2010 - The following CPT/HCPCS codes were deleted:
C9267 was deleted from Group 2
08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update. 11/21/2011 - The following CPT/HCPCS codes were deleted:
Q2041 was deleted from Group 1
Reason for Change
Related Documents
This LCD has no Related Documents.
LCD Attachments
There are no attachments for this LCD.
All Versions
Updated on 12/19/2011 with effective dates 01/01/2012 - N/A Updated on 09/14/2011 with effective dates 10/01/2011 - 12/31/2011 Updated on 07/08/2011 with effective dates 07/01/2011 - 09/30/2011 Updated on 07/08/2011 with effective dates 07/01/2011 - N/A Updated on 12/16/2010 with effective dates 01/01/2011 - 06/30/2011 Updated on 12/16/2010 with effective dates 01/01/2011 - N/A Updated on 07/08/2010 with effective dates 07/01/2010 - 12/31/2010 Updated on 07/07/2010 with effective dates 07/01/2010 - N/A
Some older versions have been archived. Please visit the MCD Archive Site