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LCD Reference Article Billing and Coding Article

Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG)

A59105

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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General Information

Source Article ID
N/A
Article ID
A59105
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Off-Label Use of Intravenous Immune Globulin (IVIG)
Article Type
Billing and Coding
Original Effective Date
11/01/2022
Revision Effective Date
10/01/2024
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. 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 Section 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:

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 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications

CMS Publication Pub 100-02, Medicare Benefit Policy Manual, Chapter 15:

    50 - Drugs and Biologicals
    50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 17:

    10 - Payment Rules for Drugs and Biologicals

 

Article Guidance

Article Text

This article contains coding or other guidelines that complement the local coverage determination (LCD) for Off-Label Use of Intravenous Immune Globulin (IVIG). The use of IVIG for labeled indications is not addressed in this article.

The LCD and this article address off-label uses for IVIG. We define off-label as not in Medicare approved compendia or in the FDA label. However, for the convenience of providers, we have added a list of labeled and compendia approved diagnoses in the Group 2 section for ICD-10-CM Codes that Support Medical Necessity below.

Coding Information:

Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.

The diagnosis code(s) must best describe the patient's condition for which the service was performed.

Specific coding guidelines for this policy:

When administering IVIG to patients over continuous days, providers should report each day’s dosage on a separate line of coding, using the appropriate date of service with the units reported in the NOS field of the claim form.

When separately identifiable evaluation and management services are provided and documented on the same day as intravenous administration, they may be billed using modifier 25.

For claims submitted to the Part B MAC:

All services/procedures performed on the same day for the same beneficiary by the physician/provider should be billed on the same claim. 

Utilization:

The dose and frequency of administration should be consistent with the FDA approved package insert. When dose and/or frequency are different from the FDA approved package insert, literature support for the specific schedule chosen should be available.

Claims submitted for procedures performed at unusually frequent intervals or high dosages may be reviewed for medical necessity. If coverage of IVIG is denied, the administration and pre-administration services associated with IVIG will also be denied.

Documentation Requirements:

Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate intravenous immune globulin therapy and the continued need thereof. Required documentation of medical necessity should include:

  • history and physical;
  • office/progress notes(s);
  • test results with written interpretation;
  • accurate weight in kilograms should be documented prior to the infusion, since the dosage is based on a mg/kg dosage;
  • documentation of prior treatment therapies (where appropriate or referenced by this policy);
  • evidence of blood level results demonstrating a significant deficiency in gammaglobulin levels prior to initial treatment (where appropriate or referenced by this policy);
  • history of recurrent and severe infections;
  • current effectiveness of IVIG therapy; and
  • goals and/or treatment plan

Diagnostic testing appropriate for the condition under treatment should be documented, and this may include nerve conduction study (NCS), electromyography (EMG), cerebral spinal fluid (CSF), serum immunoprotein, or biopsy (muscle-nerve). The reason for choosing IVIG as a treatment must be well supported on review of records. Previous treatment failures with alternative agents should be documented.

When used for neuromuscular disorders, when there is improvement and continued treatment is necessary, then quantitative assessment to monitor progress is required. Quantitative monitoring may use any accepted measure, such as medical research council (MRC) scale and activities of daily living (ADL) measurements. Changes in these measures must be clearly documented. Subjective or experiential improvement alone is insufficient to support continued use of IVIG.

When used for chronic neuromuscular or immunologic conditions, there should be an attempt made to wean the dosage when improvement has occurred and an attempt to discontinue IVIG infusion when improvement is sustained with dosage reduction. In addition, when improvement does not occur with IVIG, then continued infusion would not be considered reasonable or necessary.

When used for recurrent severe infection and documented severe deficiency or absence of IgG subclass deficiency, a serum IgG subclass trough level should be monitored at least every three months prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.

When used for clinically significant functional deficiency of humoral immunity as evidenced by documented failure to produce antibodies to specific antigens and a history of recurrent infections, the deficient antibody(ies) should be monitored at least every 3 months, prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.

When used for the treatment of autoimmune mucocutaneous blistering disease please refer to CMS Publication 100-03, Medicare National Coverage Decisions Manual, Chapter 1, Section 250.3.

When used for bone marrow/stem cell transplantation, a) the recipient was seropositive for cytomegalovirus (CMV) before transplantation or b) after allogeneic transplantation for hematologic neoplasm when the donor(s) and recipient were seronegative.

When used for solid organ transplantation, the donor was seropositive and the recipient was seronegative for cytomegalovirus (CMV) before transplantation.

Documentation must be available to Medicare upon request.

FDA and Compendia Review:

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD:2007

Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 04/22/2022.

FDA label information:

  1. Bivigam™ [Product Information]. Boca Raton, FL. Biotest Pharmaceuticals Corporation. September 23, 2013. Available at: Bivigam-FDA. Accessed on May 17, 2019.
  2. Flebogamma 5% DIF® [Product Information]. Los Angeles, CA. Grifols Biologicals, Inc. September 23, 2013. Available at: Flebogamma-FDA . Accessed on May 17, 2019.
  3. Gammagard Liquid® [Product Information]. Westlake Village, CA. Baxter Healthcare Corporation. September 23, 2013. Available at: Gammagard Liquid-FDA . Accessed on May 17, 2019.
  4. Gammaked™ [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 2013. Available at: http://www.gammaked.com/filebin/pdf/2013-09-gammaked.pdf. Accessed on May 17, 2019.
  5. Gammaplex® [Product Information]. Temecula, CA. FFF Enterprises, Inc. September 23, 2013. Available at: Gammaplex-FDA . Accessed on May 17, 2019.
  6. Gamunex-C® [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 23, 2013. Available at: Gamunex-C-FDA . Accessed on May 17, 2019.
  7. Octagam® [Product Information]. Centreville, VA. Octapharma USA, Inc. July 11, 2014. Available at: Octagam-FDA . Accessed on May 17, 2019.
  8. Privigen® [Product Information]. Kankakee, IL. CSL Behring, LLC. September 23, 2013. Available at: Privigen-FDA . Accessed on May 17, 2019
  9. Asceniv™ Available at: Asceniv-FDA . Accessed on December 12/09/2020.

Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 04/22/2022.

Micromedex DrugDex® Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 04/22/2022.

National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 04/22/2022.

U.S. Food and Drug Administration label accessed on line at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 07/11/2007.

Response To Comments

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Coding Information

Bill Type Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

(78 Codes)
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 Group 1 Codes
Code Description
D60.0 Chronic acquired pure red cell aplasia
D60.1 Transient acquired pure red cell aplasia
D60.8 Other acquired pure red cell aplasias
D60.9 Acquired pure red cell aplasia, unspecified
D89.810 Acute graft-versus-host disease
D89.811 Chronic graft-versus-host disease
D89.812 Acute on chronic graft-versus-host disease
D89.813 Graft-versus-host disease, unspecified
G25.82 Stiff-man syndrome
G72.49* Other inflammatory and immune myopathies, not elsewhere classified
H35.89* Other specified retinal disorders
I78.8* Other diseases of capillaries
L98.5* Mucinosis of the skin
M32.0 - M32.9 Drug-induced systemic lupus erythematosus - Systemic lupus erythematosus, unspecified
T86.01 Bone marrow transplant rejection
T86.02 Bone marrow transplant failure
T86.03 Bone marrow transplant infection
T86.09 Other complications of bone marrow transplant
T86.11 Kidney transplant rejection
T86.12 Kidney transplant failure
T86.13 Kidney transplant infection
T86.19 Other complication of kidney transplant
T86.21 Heart transplant rejection
T86.22 Heart transplant failure
T86.23 Heart transplant infection
T86.290 Cardiac allograft vasculopathy
T86.298 Other complications of heart transplant
T86.31 Heart-lung transplant rejection
T86.32 Heart-lung transplant failure
T86.33 Heart-lung transplant infection
T86.39 Other complications of heart-lung transplant
T86.41 Liver transplant rejection
T86.42 Liver transplant failure
T86.43 Liver transplant infection
T86.49 Other complications of liver transplant
T86.5 Complications of stem cell transplant
T86.810 Lung transplant rejection
T86.811 Lung transplant failure
T86.812 Lung transplant infection
T86.818 Other complications of lung transplant
T86.830 Bone graft rejection
T86.831 Bone graft failure
T86.832 Bone graft infection
T86.838 Other complications of bone graft
T86.850 Intestine transplant rejection
T86.851 Intestine transplant failure
T86.852 Intestine transplant infection
T86.858 Other complications of intestine transplant
T86.890 Other transplanted tissue rejection
T86.891 Other transplanted tissue failure
T86.892 Other transplanted tissue infection
T86.898 Other complications of other transplanted tissue
Z41.8 Encounter for other procedures for purposes other than remedying health state
Z48.21 Encounter for aftercare following heart transplant
Z48.22 Encounter for aftercare following kidney transplant
Z48.23 Encounter for aftercare following liver transplant
Z48.24 Encounter for aftercare following lung transplant
Z48.280 Encounter for aftercare following heart-lung transplant
Z48.290 Encounter for aftercare following bone marrow transplant
Z76.82 Awaiting organ transplant status
Z94.0 Kidney transplant status
Z94.1 Heart transplant status
Z94.2 Lung transplant status
Z94.3 Heart and lungs transplant status
Z94.4 Liver transplant status
Z94.81 Bone marrow transplant status
Z94.82 Intestine transplant status
Z94.83 Pancreas transplant status
Z94.84 Stem cells transplant status
Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*H35.89 is covered for auto immune retinopathy
*I78.8 - use only for idiopathic systemic capillary leak syndrome (Clarkson's disease)

*L98.5 should be used to report scleromyxedema

*G72.49 should be used to report IMNM (immune mediated necrotizing myositis)

Group 2

(222 Codes)
Group 2 Paragraph

Labeled and compendia approved diagnoses for IVIG

 Group 2 Codes
Code Description
A41.01 Sepsis due to Methicillin susceptible Staphylococcus aureus
A41.02 Sepsis due to Methicillin resistant Staphylococcus aureus
A41.1 Sepsis due to other specified staphylococcus
A41.2 Sepsis due to unspecified staphylococcus
A41.3 Sepsis due to Hemophilus influenzae
A41.4 Sepsis due to anaerobes
A41.50 Gram-negative sepsis, unspecified
A41.51 Sepsis due to Escherichia coli [E. coli]
A41.52 Sepsis due to Pseudomonas
A41.53 Sepsis due to Serratia
A41.59 Other Gram-negative sepsis
A41.81 Sepsis due to Enterococcus
A41.89 Other specified sepsis
A41.9 Sepsis, unspecified organism
A42.7 Actinomycotic sepsis
A48.3 Toxic shock syndrome
A54.86 Gonococcal sepsis
A92.31 West Nile virus infection with encephalitis
A92.39* West Nile virus infection with other complications
B20* Human immunodeficiency virus [HIV] disease
B25.0 Cytomegaloviral pneumonitis
B25.1 Cytomegaloviral hepatitis
B25.2 Cytomegaloviral pancreatitis
B25.8 Other cytomegaloviral diseases
B25.9 Cytomegaloviral disease, unspecified
B34.3 Parvovirus infection, unspecified
B37.7 Candidal sepsis
B97.4 Respiratory syncytial virus as the cause of diseases classified elsewhere
C88.21 Heavy chain disease, in remission
C88.30 Immunoproliferative small intestinal disease not having achieved remission
C88.31 Immunoproliferative small intestinal disease, in remission
C88.40 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma] not having achieved remission
C88.41 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma], in remission
C88.81 Other malignant immunoproliferative diseases, in remission
C88.90 Malignant immunoproliferative disease, unspecified not having achieved remission
C88.91 Malignant immunoproliferative disease, unspecified, in remission
C90.00 Multiple myeloma not having achieved remission
C90.01 Multiple myeloma in remission
C90.02 Multiple myeloma in relapse
C90.10 Plasma cell leukemia not having achieved remission
C90.11 Plasma cell leukemia in remission
C90.12 Plasma cell leukemia in relapse
C90.20 Extramedullary plasmacytoma not having achieved remission
C90.21 Extramedullary plasmacytoma in remission
C90.22 Extramedullary plasmacytoma in relapse
C90.30 Solitary plasmacytoma not having achieved remission
C90.31 Solitary plasmacytoma in remission
C90.32 Solitary plasmacytoma in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
D59.0 Drug-induced autoimmune hemolytic anemia
D59.11 Warm autoimmune hemolytic anemia
D59.12 Cold autoimmune hemolytic anemia
D59.13 Mixed type autoimmune hemolytic anemia
D59.19 Other autoimmune hemolytic anemia
D59.2 Drug-induced nonautoimmune hemolytic anemia
D59.4 Other nonautoimmune hemolytic anemias
D59.9 Acquired hemolytic anemia, unspecified
D68.01 Von Willebrand disease, type 1
D68.020 Von Willebrand disease, type 2A
D68.021 Von Willebrand disease, type 2B
D68.022 Von Willebrand disease, type 2M
D68.023 Von Willebrand disease, type 2N
D68.03 Von Willebrand disease, type 3
D68.04 Acquired von Willebrand disease
D68.09 Other von Willebrand disease
D69.3 Immune thrombocytopenic purpura
D69.41 Evans syndrome
D69.42 Congenital and hereditary thrombocytopenia purpura
D69.49 Other primary thrombocytopenia
D69.51 Posttransfusion purpura
D69.59 Other secondary thrombocytopenia
D70.9 Neutropenia, unspecified
D80.0 Hereditary hypogammaglobulinemia
D80.1 Nonfamilial hypogammaglobulinemia
D80.2 Selective deficiency of immunoglobulin A [IgA]
D80.3 Selective deficiency of immunoglobulin G [IgG] subclasses
D80.4 Selective deficiency of immunoglobulin M [IgM]
D80.5 Immunodeficiency with increased immunoglobulin M [IgM]
D80.6 Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
D80.7 Transient hypogammaglobulinemia of infancy
D81.0 Severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1 Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
D81.2 Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
D81.5 Purine nucleoside phosphorylase [PNP] deficiency
D81.6 Major histocompatibility complex class I deficiency
D81.7 Major histocompatibility complex class II deficiency
D81.82 Activated Phosphoinositide 3-kinase Delta Syndrome [APDS]
D81.89 Other combined immunodeficiencies
D81.9 Combined immunodeficiency, unspecified
D82.0 Wiskott-Aldrich syndrome
D82.1 Di George's syndrome
D82.4 Hyperimmunoglobulin E [IgE] syndrome
D83.0 Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
D83.1 Common variable immunodeficiency with predominant immunoregulatory T-cell disorders
D83.2 Common variable immunodeficiency with autoantibodies to B- or T-cells
D83.8 Other common variable immunodeficiencies
D83.9 Common variable immunodeficiency, unspecified
D89.834 Cytokine release syndrome, grade 4
G11.3 Cerebellar ataxia with defective DNA repair
G35* Multiple sclerosis
G57.81 Other specified mononeuropathies of right lower limb
G57.82 Other specified mononeuropathies of left lower limb
G57.83 Other specified mononeuropathies of bilateral lower limbs
G60.0 Hereditary motor and sensory neuropathy
G60.1 Refsum's disease
G60.2 Neuropathy in association with hereditary ataxia
G60.3 Idiopathic progressive neuropathy
G60.8 Other hereditary and idiopathic neuropathies
G61.0 Guillain-Barre syndrome
G61.1 Serum neuropathy
G61.81 Chronic inflammatory demyelinating polyneuritis
G61.82 Multifocal motor neuropathy
G61.89 Other inflammatory polyneuropathies
G62.0 Drug-induced polyneuropathy
G62.81 Critical illness polyneuropathy
G62.89 Other specified polyneuropathies
G64 Other disorders of peripheral nervous system
G70.00 Myasthenia gravis without (acute) exacerbation
G70.01* Myasthenia gravis with (acute) exacerbation
G70.81 Lambert-Eaton syndrome in disease classified elsewhere
G72.41 Inclusion body myositis [IBM]
G73.1 Lambert-Eaton syndrome in neoplastic disease
G73.3 Myasthenic syndromes in other diseases classified elsewhere
H20.011 Primary iridocyclitis, right eye
H20.012 Primary iridocyclitis, left eye
H20.013 Primary iridocyclitis, bilateral
H20.021 Recurrent acute iridocyclitis, right eye
H20.022 Recurrent acute iridocyclitis, left eye
H20.023 Recurrent acute iridocyclitis, bilateral
H20.031 Secondary infectious iridocyclitis, right eye
H20.032 Secondary infectious iridocyclitis, left eye
H20.033 Secondary infectious iridocyclitis, bilateral
H20.041 Secondary noninfectious iridocyclitis, right eye
H20.042 Secondary noninfectious iridocyclitis, left eye
H20.043 Secondary noninfectious iridocyclitis, bilateral
H20.051 Hypopyon, right eye
H20.052 Hypopyon, left eye
H20.053 Hypopyon, bilateral
H20.11 Chronic iridocyclitis, right eye
H20.12 Chronic iridocyclitis, left eye
H20.13 Chronic iridocyclitis, bilateral
H20.21 Lens-induced iridocyclitis, right eye
H20.22 Lens-induced iridocyclitis, left eye
H20.23 Lens-induced iridocyclitis, bilateral
H20.811 Fuchs' heterochromic cyclitis, right eye
H20.812 Fuchs' heterochromic cyclitis, left eye
H20.813 Fuchs' heterochromic cyclitis, bilateral
H20.821 Vogt-Koyanagi syndrome, right eye
H20.822 Vogt-Koyanagi syndrome, left eye
H20.823 Vogt-Koyanagi syndrome, bilateral
H46.8* Other optic neuritis
I30.8 Other forms of acute pericarditis
I40.8 Other acute myocarditis
I44.0 Atrioventricular block, first degree
I44.1 Atrioventricular block, second degree
I44.2 Atrioventricular block, complete
I44.39 Other atrioventricular block
I45.0 Right fascicular block
I45.19 Other right bundle-branch block
I45.2 Bifascicular block
I45.3 Trifascicular block
I45.4 Nonspecific intraventricular block
I45.5 Other specified heart block
I45.6 Pre-excitation syndrome
I45.81 Long QT syndrome
I45.89 Other specified conduction disorders
I47.0 Re-entry ventricular arrhythmia
I47.21 Torsades de pointes
I47.29 Other ventricular tachycardia
J20.5 Acute bronchitis due to respiratory syncytial virus
L10.0 Pemphigus vulgaris
L10.1 Pemphigus vegetans
L10.2 Pemphigus foliaceous
L10.3 Brazilian pemphigus [fogo selvagem]
L10.4 Pemphigus erythematosus
L10.5 Drug-induced pemphigus
L10.81 Paraneoplastic pemphigus
L10.89 Other pemphigus
L10.9 Pemphigus, unspecified
L12.0 Bullous pemphigoid
L12.1 Cicatricial pemphigoid
L12.8 Other pemphigoid
L12.9 Pemphigoid, unspecified
L13.8 Other specified bullous disorders
L51.1 Stevens-Johnson syndrome
L51.2 Toxic epidermal necrolysis [Lyell]
L95.0 Livedoid vasculitis
M06.4 Inflammatory polyarthropathy
M30.3 Mucocutaneous lymph node syndrome [Kawasaki]
M33.00 - M33.99 Juvenile dermatomyositis, organ involvement unspecified - Dermatopolymyositis, unspecified with other organ involvement
M35.81* Multisystem inflammatory syndrome
M36.0 Dermato(poly)myositis in neoplastic disease
M60.9 Myositis, unspecified
N02.8 Recurrent and persistent hematuria with other morphologic changes
N28.9 Disorder of kidney and ureter, unspecified
R65.20 Severe sepsis without septic shock
R65.21 Severe sepsis with septic shock
T80.82XA Complication of immune effector cellular therapy, initial encounter
T80.82XS Complication of immune effector cellular therapy, sequela
T80.89XA Other complications following infusion, transfusion and therapeutic injection, initial encounter
T80.89XD Other complications following infusion, transfusion and therapeutic injection, subsequent encounter
T80.89XS Other complications following infusion, transfusion and therapeutic injection, sequela
Group 2 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*West Nile fever with meningitis should be reported using ICD-10-CM codes A92.39 and G02

*B20 - use in patients less than 13 years of age, who are immunologically abnormal with CD4+ lymphocyte count of 200/mm 3 or greater.

*G35 is covered for multiple sclerosis (relapsing-remitting)

*G70.01 is covered for myasthenia gravis with (acute) exacerbation, myasthenia gravis in crisis

*H46.8 is covered for recurrent-relapsing inflammatory optic neuropathy

*M35.81 must be billed with ICD-10 code Z20.822 to report multisystem inflammatory syndrome in children post SARS-CoV-2 infection 
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Additional ICD-10 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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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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 article, 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 article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2024 R4

The changes requested involved reclassifying the ICD-10-CM diagnosis codes for primary immune deficiency diseases in the Local Coverage Article (LCA) A59105. This adjustment was made to align with Chapter 15 Section 50.6 of the CMS Medicare Benefit Policy Manual, ensuring that these codes are correctly listed as on-label (Group 2) rather than off-label (Group 1) to accurately reflect their approved status for IVIG treatment. Revision date effective 1/1/2024. 

On 8/1/2024: Due to the annual ICD-10-CM update, codes C88.2, C88.8 deleted from the ICD-10-CM from Group 2. New codes C88.21, C88.30, C88.31, C88.40, C88.41, C88.81, C88.90, C88.91 were added. Revision date effective 10/1/2024. 

 
07/01/2023 R3

A list of labeled and compendia approved diagnoses have been added to the Group 2 section for ICD-10-CM Codes that Support Medical Necessity, based on provider request. 
07/01/2023 R2

Based on Transmittal 12072 (CR 13208) - Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2023 Update, HCPCS code J1576 has been added.
11/01/2022 R1

ICD-10-CM Codes that Support Medical Necessity has been revised to add ICD-10 code D81.82 as covered.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 2
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