Indications and Limitations of Coverage and/or Medical Necessity
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered.
For purposes of Medicare coverage, hemophilia encompasses:
  • Factor VIII deficiency – (classic hemophilia, hemophilia A).
  • Factor IX deficiency – (hemophilia B, Christmas disease, plasma thromboplastin component).
  • Von Willebrand disease.
Anti-Inhibitor Coagulation 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 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.

NovoSeven (J7189) is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX. NovoSeven should be administered to patients only under the direct supervision of a physician experienced in the treatment of hemophilia.
Note: This LCD and the related Article do NOT describe drug and biological coverage under the Medicare Part D benefit.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
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.
11X, 12X, 13X, 18X, 21X, 22X, 23X, 71X, 72X, 73X, 74X, 75X, 77X, 83X, 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 CPT/HCPCS codes included in this LCD. Providers are reminded that not all 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 books. The American Medical Association (AMA) and CMS require the use of short CPT descriptors in policies published on the Web.
J7185
Injection, factor VIII (antihemophilic factor, recombinant) (xyntha), per I.U.
J7186
Antihemophilic VIII/VWF comp
J7187
Injection, Von Willebrand factor complex, human, ristocetin cofactor, per IU
J7189
Factor VIIA (antihemophilic factor, recombinant), per 1 microgram
J7190
Factor VIII (antihemophilic factor, human), per IU
J7191
Factor VIII (antihemophilic factor (porcine)), per IU
J7192
Factor VIII (antihemophilic factor, recombinant) per I.U., not otherwise specified
J7193
Factor IX (antihemophilic factor, purified, non-recombinant) per IU
J7194
Factor IX, complex, per IU
J7195
Factor IX (antihemophilic factor, recombinant) per IU
J7198
Anti-inhibitor, per IU
J7199
Hemophilia clotting factor, not otherwise classified
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS code J7185:
Covered for:
286.0
Congenital Factor VIII disorder
Medicare is establishing the following limited coverage for CPT/HCPCS codes J7186 and J7187:
Covered for:
286.0
Congenital Factor VIII disorder
286.4
Von Willebrand’s disease
Medicare is establishing the following limited coverage for CPT/HCPCS Factor VIIA code J7189:
Covered for:
286.0*
Congenital Factor VIII disorder
286.1*
Congenital Factor IX disorder
Note: 286.0* and 286.1* requires documentation that patient has ongoing bleeding in Factor VIII and IX deficiencies.
Medicare is establishing the following limited coverage for CPT/HCPCS Factor VIII codes J7190, J7191 and J7192:
Covered for:
286.0
Congenital Factor VIII disorder
286.4
Von Willebrand’s disease
Medicare is establishing the following limited coverage for CPT/HCPCS Factor IX codes J7193, J7194 and J7195:
Covered for:
286.1
Congenital Factor IX disorder
Medicare is establishing the following limited coverage for CPT/HCPCS code J7199:
Covered for:
286.2
Congenital Factor XI deficiency
286.3
Congenital deficiency of other clotting factors
286.5
Hemorrhagic disorder due to intrinsic circulating anticoagulants
286.7
Acquired coagulation factor deficiency
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
  • Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
  • Documentation supporting the medical necessity must be provided upon request when billing HCPCS J7189 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII (286.0) or Factor IX (286.3).
  • Documentation must be provided on the claim form indicating the name of the drug, total dosage and method of administration when billing miscellaneous code J7199. Facilities must use the unit field as a multiplier to arrive at the dosage amount. Refer to Medicare Claims Processing Manual, Pub 100-04, Chapter 3, Section 20.7.3, for specific guidelines.
Appendices
N/A
Utilization Guidelines
N/A
Sources of Information and Basis for Decision
J4 (CO, NM, OK, TX) MAC Integration
TrailBlazer adopted the Arkansas BlueCross BlueShield (Pinnacle) LCD, “Hemophilia Clotting Factors” for the Jurisdiction 4 (J4) MAC transition.
Full disclosure of sources of information is found with original contractor LCD.
Other Contractor Local Coverage Determinations
“Hemophilia Clotting Factors,” Arkansas BlueCross BlueShield (Pinnacle) LCD, (NM, OK) L16113.
Start Date of Notice Period