Blood and Blood Derivatives (blood)

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Blood and Blood Derivatives (blood)

Transcript Of Blood and Blood Derivatives (blood)

Blood and Blood Derivatives

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Page updated: August 2020

This section describes the policy and billing instructions for blood and blood derivative products. For additional help, refer to the Blood and Blood Derivatives Billing Examples section of this manual.

Designated Blood Donation
Additional payment for the handling of blood designated by the donor for a specific patient is not a Medi-Cal benefit. Claims for this service will be denied.

Blood Factors Billing for Bleeding and Clotting Disorders:
Blood factor billing codes differ depending on the provider type. Pharmacists must bill using National Drug Codes (NDC). All other providers must bill according to physicianadministered drug policy, which may be found in the Physician-Administered Drugs – NDC section in this manual. For physician claim form completion instructions, refer to the Physician-Administered Drugs – NDC: CMS-1500 Billing Instructions, or PhysicianAdministered Drugs – NDC: UB-04 Billing Instructions section in the appropriate Part 2 manual.
Blood factor reimbursement is based on the lesser of:
• The manufacturer’s reported Average Sales Price (ASP), which is updated quarterly, plus 20 percent, or
• The provider’s billed Actual Acquisition Cost plus applicable professional dispensing fee.
– Claims submitted by federally recognized Hemophilia Treatment Centers must use the Actual Acquisition Cost for the drug as defined in Welfare and Institutions Code section 14105.46, plus a professional dispensing fee of $0.14 per unit.
– Claims submitted by all other providers must use the Actual Acquisition Cost for the drug equal to invoice price minus any discounts (excluding a prompt pay discount of less than or equal to 2%), rebates, or chargebacks, plus a professional dispensing fee of $0.04 per unit.
Coagulation factors for bleeding disorders, such as hemophilia, represent the first class of specialty drugs to utilize provider contracts. These products are identified in Welfare and Institutions Code (W&I Code) 14105.86(a)(2)(A). The Department of Health Care Services (DHCS) will contract with any specialty pharmacy that will sign a contract to meet a list of performance obligations. These include, but are not limited to, delivery time requirements, providing patient education and submitting quarterly and yearly reports to DHCS. A provider who does not sign an agreement to become a provider under these provisions will no longer be allowed to provide the specialized drug to Medi-Cal, California Children’s Services (CCS) or Genetically Handicapped Persons Program (GHPP) recipients.

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Contract Blood Factors

The following blood factors, covered by Medi-Cal, are listed by product name ‹‹next to›› their respective HCPCS code.

‹‹Table of Blood Factor HCPCS Codes››

HCPCS Code J7175 J7179 J7180 J7181 J7182
J7183
J7185 J7186
J7187 J7188 J7189 J7190
J7192

Description

Product Name Reimbursement

Injection, factor X, (human), 1 IU *
Injection, von Willebrand factor (recombinant), (Vonvendi®), 1 IU *
Injection factor XIII (anti-hemophilic factor, human), 1 IU
Injection, factor XIII a-subunit, (recombinant), per IU *
Injection, factor VIII, antihemophilic factor, (recombinant), (Novoeight), per IU * Injection, von Willebrand factor complex (human), wilate per IU VWF:RCO.

‹‹Not Applicable›› ‹‹Not Applicable›› Corifact® * ‹‹Not Applicable›› ‹‹Not Applicable››
‹‹Not Applicable››

Factor VIII (antihemophilic factor, recombinant), per IU Antihemophilic factor VIII/von Willebrand factor complex (human), per factor VIII IU
Von Willebrand Factor Complex, human Injection, factor VIII (antihemophilic factor, recombinant), (obizur), per IU * Factor VIIa (antihemophilic factor, recombinant), per mcg* Factor VIII (antihemophilic factor, human), per IU
Factor VIII (antihemophilic factor, recombinant), per IU

Xyntha™
Alphanate®
Humate P® *
‹‹Not Applicable››
NovoSeven® *, NovoSeven® RT * Hemofil-M *, Koate® DVI, Monarc-M™*, Monoclate-P® * Advate *, Helixate® FS *, Kogenate® FS *, Recombinate *, ReFacto

‹‹Not Applicable›› ‹‹Not Applicable››
‹‹Not Applicable››
‹‹Not Applicable››
‹‹Not Applicable››
Reimbursable in conjunction with ICD-10-CM code D68.0 ‹‹Not Applicable››
Reimbursable with ICD-10-CM codes D66, D68.0 and D68. 4 ‹‹Not Applicable››
‹‹Not Applicable››
‹‹Not Applicable››
‹‹Not Applicable››
‹‹Not Applicable››

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HCPCS Code J7193 J7194 J7195
J7197 J7198 J7200 J7201 J7202 J7203
J7204

Table of Blood Factor HCPCS Codes (continued)

Description

Product Name Reimbursement

Factor IX (antihemophilic factor, purified, nonrecombinant), per IU. Factor IX complex per IU.
Injection, factor IX (antihemophilic factor, recombinant) per IU, not otherwise specified (Benefix®), (Ixinity®) * Antithrombin III (human), per IU * Antiinhibitor, per IU * Injection, factor IX, (antihemophilic factor, recombinant), Rixubis, per IU * Injection, factor IX, Fc fusion protein (recombinant), per IU (Alprolix™) Injection, factor IX, albumin fusion protein, (recombinant), Idelvion®, 1 IU* Injection Factor IX, (antihemophilic factor, recombinant), glycopegylated, (Rebinyn), 1 IU * Injection, Factor VIII, antihemophilic factor (recombinant), (Esperoct), glycopegylated-exei, per IU)

Mononine® *, AlphaNine® SD Bebulin® VH *, Profilnine® SD * Not Applicable
Thrombate III * Feiba VH * Not Applicable
Not Applicable
Not Applicable
Not Applicable
Esperoct® *

Not Applicable Not Applicable Not Applicable
Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable
Not Applicable

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HCPCS Code J7205 J7207 J7208
J7209 J7210 J7211 ‹‹J7212

‹‹Table of Blood Factor HCPCS Codes (continued)››

Description

Product Name Reimbursement

Injection, factor VIII fc fusion (recombinant), per iu
Injection, factor VIII, (antihemophilic factor, recombinant), PEGylated, 1 IU*
Injection, Factor VIII, (antihemophilic factor, recombinant), PEGylated-aucl, (Jivi®), 1 IU
Injection, factor VIII, (antihemophilic factor, recombinant), Nuwiq®, 1 IU
Injection, factor VIII (antihemophilic factor, recombinant), Afstyla®, 1 IU*
Injection, factor VIII (antihemophilic factor, recombinant), Kovaltry®, 1 IU
Injection, factor VIIa (antihemophilic factor, recombinant)-jncw (Sevenfact®), 1 mcg

Not Applicable Not Applicable Not Applicable
Not Applicable Not Applicable Not Applicable Sevenfact®

Not Applicable Not Applicable Not Applicable
Not Applicable Not Applicable Not Applicable Not Applicable››

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Blood Factors Billing: Non-Pharmacists
The above listed HCPCS Level II codes are for blood factors billed by physicians, hospital outpatient departments, clinics and blood banks. Failure to use the above codes when billing for factors VIIa, VIII or IX may result in claim denial. ‹‹Other codes such as P9010 thru P9012, P9016, P9019 thru P9023, P9025, P9026, P9031 thru P9040, P9043, P9044, P9048, P9050 thru P9058 and Z7610 are not to be used when billing for blood factors.››
NDC Billing Requirement Billing Guidelines
Providers must bill according to the physician-administered drug policy, which may be found in the Physician-Administered Drugs – NDC section in this manual. For physician claim form completion instructions, refer to the Physician-Administered Drugs – NDC: CMS-1500 Billing Instructions, or Physician-Administered Drugs – NDC: UB-04 Billing Instructions sections in the appropriate Part 2 manual. Non-pharmacy providers must use the appropriate HCPCS injection codes and modifiers (when required) to bill for all immunizations and injections listed in the Injections: Code List section in the appropriate Part 2 manual. In addition, providers must include the number of units provided in the Remarks field (Box 80)/Additional Claim Information (Box 19) of the claim. Providers may be reimbursed for the outpatient use of Factor VIIa (HCPCS code J7189). Claims billed with code J7189 must contain an approved TAR unless a manufacturer rebate is provided. Examples of medical justification include but are not limited to:
• Treatment of bleeding episodes in hemophilia A or B with inhibitors and in acquired hemophilia
• Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia
• Treatment of bleeding episodes in congenital Factor VII deficiency • Prevention of bleeding in surgical interventions or invasive procedures in congenital
Factor VII deficiency
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Blood Factor Billing Pharmacists:
Pharmacies must bill blood factor products using the National Drug Code (NDC) via a pharmacy claim form. Attachments are not required. ‹‹Pharmacy providers who bill for CCS-only, GHPP-only eligible beneficiaries, and MediCal/CCS/GHPP eligible beneficiaries who bill with legacy authorizations must bill using the paper Pharmacy Claim Form (30-1). Claims must contain required authorization as required by the Children’s Medical Services Branch.›› Reimbursement under this method is based on the lesser of the manufacturer’s Average Selling Price (ASP) plus 20 percent or the provider’s usual and customary charges. Providers should submit claims with their usual and customary charges. The ASP price is updated by the manufacturer quarterly.
Continuing Care
Medi-Cal will provide reimbursement for blood factors marked “authorization required” only with an approved Treatment Authorization Request (TAR) or the beneficiary qualifies for continuing care. To be eligible for continuing care and exemption from the authorization requirement, the following conditions must be met:
• The beneficiary must be taking the drug when it is suspended or deleted from the List of Contracted Blood Factors; and
• The California MMIS Fiscal Intermediary must have received a claim for the drug, in the same dosage form and strength, within 100 days prior to the drug’s suspension or deletion. Providers may access the Provider Telecommunications Network (PTN) to determine if a beneficiary has been dispensed a continuing care drug that is eligible under continuing care. For complete information on the PTN, see the Provider Telecommunications Network (PTN) section in the Part 1 manual.
• To maintain beneficiary eligibility under continuing care, a claim must be submitted for the drug, in the same dosage form and strength, at least every 100 days from the date of service. The beneficiary may switch between brands of the drug in the same dosage form and strength and maintain their continuing care status.
Contracted Providers
To meet the unique specialized care needs of the Medi-Cal population who utilize specialty drugs, only contracted providers are eligible to provide contract blood factors. A list of the contracted specialty providers who are eligible to provide those blood factors included in the contract blood factor list is available on the “Pharmacy Benefits Division and Vision Care Program” page of the DHCS website (www.dhcs.ca.gov).
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Blood Products and Blood Derivatives Other Than Blood Factors
‹‹Use HCPCS codes P9010 thru P9012, P9016, P9019 thru P9023, P9025, P9026, P9031 thru P9040, P9043, P9044, P9048, P9050 thru P9058 and P9073 to bill for blood products and blood derivatives (for example, platelets, plasma, granulocytes or red blood cells), with the exception of Blood Factors: Bleeding and Clotting Disorders and other exceptions specified on a following page.››
Pathogen(s) Test for Platelets
For information on billing for HCPCS code P9100 (pathogen(s) test for platelets) refer to the Pathology: Microbiology section of the appropriate Part 2 manual.
Fresh Frozen Plasma
Use HCPCS codes P9017, P9023, P9059 or P9060 for reimbursement of fresh frozen plasma. Billing with any other code may result in claim denial. Medi-Cal coverage of fresh frozen plasma is restricted to:
• Replacement of isolated coagulation factor deficiencies • Reversal of warfarin effect • Massive blood transfusion (although prophylactic administration of fresh frozen plasma
does not appear to decrease transfusion requirements in patients who do not have documented coagulation defects) • Use in antithrombin III deficient conditions • Treatment of thrombotic thrombocytopenic purpura
Services Not Covered
Fresh frozen plasma should not be used as a volume expander or as a nutritional supplement due to risks accompanying its use. These risks include:
• Post-transfusion hepatitis • AIDS • Allergic reactions • Volume overload • Alloimmunization
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Pheresis
Pheresis, the separation of plasma from the formed elements of the blood by filtration and centrifugation, requires authorization when billed fee-for-service and performed either on an outpatient or an inpatient basis.
Plasmapheresis Primary Treatment:
Plasmapheresis may be authorized as the primary treatment in the following diseases: • Guillian-Barre Syndrome • Thrombotic thrombocytopenic purpura • Goodpasture’s syndrome • Rapidly progressive glomerulonephritis • Anti-glomerular basement membrane disease • Waldenstrom’s macroglobulinemia • Multiple myeloma • Protein-bound poisons
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Secondary Treatment
Plasmapheresis also may be authorized when there is documented evidence of far-advanced disease, unresponsive to drug therapy in patients with the following diseases, most of which are thought to be mediated through immune mechanisms:
• Systemic lupus erythematosus • Rheumatoid vasculitis • Myasthenia gravis • Progressive systemic sclerosis • Hemolytic anemia • Immune neutropenia • Immune thrombocytopenia • Polymyositis • Idiopathic thrombocytopenic purpura • Cryoglobulinemia • Vasculitis, associated with circulating immune complexes, as seen in hypersensitivity
disorders and Henoch-Schonlein purpura • Chronic inflammatory polyneuropathy • Relapsing polyneuropathy
Cytapheresis
Cytapheresis is covered for the following problems: • Acute or chronic leukemia (cell counts more than 100,000) • Thrombocytosis (platelet count more than 1,000,000) • Sickle cell disease in severe crisis, preoperatively or when complicated by pregnancy or priapism
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Therapeutic Apheresis Billing Procedures:
CPT® codes 36511 thru 36516 must be billed with modifier AG for any type of therapeutic apheresis. Claims for therapeutic apheresis billed with HCPCS codes P9010 thru P9012, P9016, P9019 thru P9023, P9031 thru P9040, P9043 thru P9044, P9048 and P9050 thru P9058 will be denied. The approved Treatment Authorization Request (TAR) determines the number of pheresis treatments allowed. The HCPCS codes listed above must be used to bill for blood products/blood derivatives (for example: platelets, plasma, granulocytes or red blood cells) collected from donors by apheresis.
Administering Plasmapheresis
All plasmapheresis procedures should be done in a hospital setting, whether on an inpatient or an outpatient basis, with readily available lifesaving equipment. The physician who bills for these procedures should be available to provide help to the plasmapheresis technician or registered nurse at all times during the procedure.
Extracorporeal Photopheresis
Extracorporeal photopheresis (ECP), also called photochemotherapy, involves ex vivo separation of leukocytes from erythrocytes and exposure of the leukocytes to 8-methoxypsoralen and ultraviolet light. 8-MOP is a naturally occurring furocoumarin that is biologically inert, unless exposed to ultraviolet A light, whereupon it becomes photo activated and covalently binds and cross-links DNA. The combination of 8-MOP and UVA radiation causes apoptosis of the treated T cells and may cause preferential apoptosis of activated or abnormal T cells, thus targeting the pathogenic cells of cutaneous T-cell lymphoma (CTCL), chronic graft versus host disease (GVHD), lung transplant rejection or cardiac allograft rejection.
Indications
ECP is indicated for the treatment of any of the following: • CTCL Stage IIIA or IV • Cardiac allograft rejection • Chronic GVHD • Lung transplant rejection (bronchiolitis obliterans)
ECP is not to be used for the prophylaxis of any of the indications above.
Part 2 – Blood and Blood Derivatives
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