BlueCross BlueShield of Tennessee Medical Policy Manual

Intravenous Immune Globulin (IVIG) Therapy

NDC CODE(S)

59730-6502-XX - Bivigam 5 g protein

 

59730-6503-XX - Bivigam 10 g protein

 

44206-0416-XX - Carimune NF 3 g protein

 

44206-0417-XX - Carimune 6 g protein

 

44206-0418-XX - Carimune 12 g protein

 

61953-0005-XX - Flebogamma 10% DIF 5, 10, 20 g protein

 

61953-0004-XX - Flebogamma 5% DIF 2.5, 5, 10, 20 g protein

 

13533-0800-XX - Gamunex-C 1, 2.5, 5, 10, 20, 40  g protein

 

00944-2700-XX - Gammagard Liquid - 1, 2.5, 5, 10, 20, 30 g protein

 

00944-2656-XX - Gammagard S/D 5 g protein

 

00944-2658-XX - Gammagard S/D 10 g protein

 

76125-0900-XX - Gammaked 1, 2.5, 5, 10, 20 g protein

 

64208-8234-XX - Gammaplex 2.5, 5, 10, 20 g protein

 

68982-0850-XX - Octagam 10% 2, 5, 10, 20 g protein

 

67467-0843-XX - Octagam 5% 1, 5 g protein

 

44206-0436-XX - Privigen  5 g protein

 

44206-0437-XX - Privigen  10 g protein

 

44206-0438-XX - Privigen  20 g protein 

 

44206-0439-X X- Privigen  40 g protein

 

Immune globulins or immunoglobulins (Ig) are specialized glycoproteins which function in the body as antibodies in the immune system.  Produced by plasma cells, there are five human isotypes of immunoglobulins, IgA, IgD, IgE, IgG and IgM.  Of these, IgG, IgA and IgM are referred to as natural antibodies as they are produced without deliberate immunization or antigen exposure.  IgD and IgE are generally produced in response to the introduction of foreign antigens to which they bind and deactivate.  Together, all immunoglobulin isotypes are vital components of the body’s immune response.

IgG is the most common of the immunoglobulins.  It has multiple functions including placental antibody transfer, phagocytic cell surface binding and the activation of complement.  Commercial preparations of intravenous immune globulins (IVIGs) are sterile, highly purified IgG products manufactured from large pools of human plasma, typically from 1000 or more healthy blood donors.  They contain more than 95% unmodified IgG but only trace amounts of IgA and/or IgM.  IVIG products are used in the treatment of multiple conditions.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

 

INDICATION(S)*

DOSAGE

Auto-immune blistering diseases

2g/kg divided over 5 days in a 28 day cycle

CLL

400mg/kg every 3 weeks

PID

up to 800mg/kg every 21 days

CIDP

2g/kg divided over 2-4 days X 1, then 1g/kg every 21 days.

Dermatomyositis/Polymyositis

2g/kg divided over 5 days in a 28 day cycle

ITP

2g/kg divided over 5 days in a 28 day cycle

FAIT

1g/kg/week until delivery

Guillain-Barre

2g/kg divided over 5 days x 1 cycle

Hemolytic disease of the newborn

1g/kg x 1 dose, may be repeated once if needed

Kawasaki’s Disease (Pediatric Patients)

2g/kg x 1 single dose

Multifocal Motor Neuropathy

2g/kg divided over 5 days in a 28 day cycle

Myasthenia Gravis

1 g/kg x 1 dose (acute attacks)

Pediatric HIV

400mg/kg every 28 days

Bone Marrow or Stem Cell Transplant

500mg/kg/week x 90 days, then 500 mg/kg/month up to 360 days post-transplant

Complications of transplanted solid organ: (kidney, liver, lung, heart, pancreas) transplant

2g/kg divided over 5 days in a 28 day cycle

Stiff Person

2g/kg divided over 5 days in a 28 day cycle

Toxic shock syndrome

2g/kg divided over 5 days x 1 cycle

*Dosing for IVIG is highly variable depending on numerous patient specific factors, indication(s), and the specific product selected. For specific dosing regimens refer to current prescribing literature.

Dosing Optimization Recommendations:

Dosing should be calculated using adjusted body weight if one or more of the following criteria are met:

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of intravenous immune globulin (IVIG) therapy for the treatment of other conditions or diseases.

SOURCES

Attarian, S., Boucraut, J., Uzenot, D., Delmont, E., Verschueren, A., Franques, J., et al. (2010). Chronic ataxic neuropathies associated with antii-GD1b IgM antibodies: response to IVIG therapy. The Journal of Neurology, Neurosurgery and Psychiatry, 81: 61-64.

Bhatti, A., Gazali, Z. (2015, December). Recent advances and review on treatment of stiff person syndrome in adults and pediatric patients. Cureus, 7(12): e427. DOI 10.7759.

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2015). Immune globulin therapy (8.01.05). Retrieved June 3, 2016 from BlueWeb.

Lexicomp Online. (2016, March). AHFS DI. Immune Globulin. Retrieved June 3, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, May). Immune globulin. Retrieved June 3, 2016 from MICROMEDEX Healthcare Series.

National Organization for Rare Disorders (NORD). (2010). Stiff person syndrome. Retrieved June 3, 2016 from http://rarediseases.org/rare-diseases/stiff-person-syndrome/.

U. S. Food and Drug Administration.  (2012, June). Center for Biologics Evaluation and Research. Gammagard® liquid, immune globulin infusion (human), 10% Solution, for intravenous and subcutaneous administration. Retrieved February 12, 2015 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM070010.pdf.

U. S. Food and Drug Administration.  (2013, July). Center for Biologics Evaluation and Research.   Gammagard® S/D immune globulin intravenous (human). Retrieved February 12, 2015 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM197905.pdf.

U. S. Food and Drug Administration. (2007, July). Center for Biologics Evaluation and Research. Privigen®, immune globulin intravenous (human), 10% liquid. Retrieved November 13, 2012 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM303092.pdf.

U. S. Food and Drug Administration. (2009, February). Center for Biologics Evaluation and Research. Gamunex®-C, [Immune Globulin Injection (Human). Retrieved November 13, 2012 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM069968.pdf.

U. S. Food and Drug Administration. (2009, September). Center for Biologics Evaluation and Research. Gammaplex® immune globulin intravenous (human), 5% liquid. Retrieved November 13, 2012 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM182963.pdf.

U. S. Food and Drug Administration. (2012, January). Center for Biologics Evaluation and Research. Flebogamma® 5% DIF (immune globulin intravenous [human]), solution for intravenous administration. Retrieved November 13, 2012 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM172599.pdf.

U. S. Food and Drug Administration. (2012, January). Center for Biologics Evaluation and Research. Flebogamma® 10% DIF [immune globulin intravenous (human)] for intravenous administration, 10% liquid preparation. Retrieved November 13, 2012 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM296138.pdf.

U. S. Food and Drug Administration. (2013, August). Center for Biologics Evaluation and Research. Carimune® NF, nanofiltered: immune globulin intravenous (human). Retrieved February 17, 2015 from http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM152763.pdf.

U. S. Food and Drug Administration. (2013, June). Center for Biologics Evaluation and Research. Immune globulin intravenous (human), 10% liquid, Bivigam®. Retrieved March 5, 2015 from http://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm334609.pdf.

U. S. Food and Drug Administration. (2014, July). Center for Biologics Evaluation and Research. Octagam® 10% [immune globulin intravenous (human)] liquid solution for intravenous administration. Retrieved February 12, 2015 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM064946.pdf.MOST

ORIGINAL EFFECTIVE DATE:  12/4/1997

MOST RECENT REVIEW DATE:  3/14/2017

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment. 

Pharmaceutical Decision Support Tree

Intravenous Immune Globulin (IVIG) Therapy (Bivigam®, Carimune®, Carimune® NF, Flebogamma® 5% DIF, Flebogamma® 10% DIF, Gamunex®-C, Gammagard® Liquid, Gammagard® S/D, Gammaked®, Gammaplex®, Octagam® 5%, Octagam® 10% and Privigen®)

  1. Is this the initial request for IVIG therapy?

If yes, go to question #2

If no, go to questions #51

  1. Is there a baseline BUN (blood urea nitrogen) and serum creatinine value that has been obtained within 30 days?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of ataxic neuropathies associated with anti-GD1b IgM antibodies considered to be chronic disease?

If yes, go to question #4

If no, go to question #5

  1. Is the request for 460 billable units or less per 28 days (1 billable unit = 500 mg) for a period of 1 month for review with specific dosage regimen per current prescribing literature?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of autoimmune mucocutaneous blistering diseases with a diagnosis of ANY ONE of the following?

And the disease is ALL of the following:

If yes, go to question #6

If no, go to question #7

  1. Is the request for 460 billable units or less per 28 days (1 billable unit = 500 mg) for a period of 6 months with dosing at 2g/kg divided over 5 days in a 28 day cycle?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of bacterial infections associated with neonates, as treatment or prevention, if therapy is adjunctive (i.e., to increase efficacy of primary treatment)?

If yes, go to question #8

If no, go to question #9

  1. Is specific dosage determined by current prescribing literature with authorization valid for 1 course (1 month) only?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of chronic inflammatory/immune demyelinating polyneuropathy (CIDP) if ALL of the following?

If yes, go to question #10

If no, go to question #11

  1. Is the request for 460 billable units per 4 days or less for loading dose and 230 billable units per 21 days for maintenance with a dosage of 2g/kg divided over 2-4 days X 1, then 1g/kg every 21 days?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of chronic lymphocytic leukemia, for prevention of infections, if there is a finding of ANY ONE of the following?

If yes, go to question #12

If no, go to question #13

  1. Is the request for 92 billable units or less for a dosage of 400mg/kg every 3 weeks for an initial approval authorization of 1 course (1 month) for review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of dermatomyositis/polymyositis if ALL of the following?

If yes, go to question #14

If no, go to question #15

  1. Is the request for 460 billable units per 28 days or less for a dosage of 2g/kg divided over 5 days in a 28 day cycle for an initial approval valid for 3 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of fetal alloimmune thrombocytopenia (FAIT) for authorization until delivery date if ANY ONE of the following?

If yes, go to question #16

If no, go to question #17

  1. Is the request for 200 billable units or less per 7 days for a dosage of 1g/kg/week until delivery?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Guillain-Barré Syndrome (GBS) if ALL of the following?

If yes, go to question #18

If no, go to question #19

  1. Is the request for 460 billable units or less per 5 days x 1 cycle for a dosage of 2g/kg divided over 5 days x 1 cycle with and authorization is valid for 2 months only?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of immune thrombocytopenia / idiopathic thrombocytic purpura (ITP) for the acute disease state of ANY ONE of the following with authorization valid for one month only?

If yes, go to question #21

If no, go to question #20

  1. Does the individual have a diagnosis of immune thrombocytopenia / idiopathic thrombocytic purpura (ITP) for Chronic immune thrombocytopenia (CIT) if ALL of the following?

If yes, go to question #21

If no, go to question #22

  1. Is the request for 460 billable units or less per 28 days for dosage of 2g/kg divided over 5 days in a 28 day cycle?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Kawasaki disease for the prevention of coronary artery aneurysms if ALL of the following?

If yes, go to question #23

If no, go to question #24

  1. Is the request for 232 billable units x 1 dose for dosage of 2g/kg x 1 single dose?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Lambert-Eaton Myasthenic Syndrome if the individual has failed conventional therapy?

If yes, go to question #25

If no, go to question #26

  1. Is the request for 460 billable units or less per 28 days for specific dosage determined by current prescribing literature with authorization valid for 1 course (1 month) for review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of measles postexposure for ANY ONE of the following?

If yes, go to question #27

If no, go to question #28

  1. Is the request for specific dosage determined by current prescribing literature with authorization valid for 1 course (1 month) for review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of multifocal motor neuropathy if ALL of the following?

If yes, go to question #29

If no, go to question #30

  1. Is the request for 460 billable units or less per 28 days for dosage of 2g/kg divided over 5 days in a 28 day cycle for 1 month to assess viability of treatment?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of multiple sclerosis if ALL of the following?

If yes, go to question #31

If no, go to question #32

  1. Is the request for specific dosage determined by current prescribing literature with authorization valid for 1 course (1 month) for review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of myasthenia gravis if ALL of the following?

If yes, go to question #33

If no, go to question #34

  1. Is the request for 230 billable units X 1 dose for dosage of 1 g/kg x 1 dose (acute attacks)?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of parvovirus B19 if ALL the following?

If yes, go to question #35

If no, go to question #36

  1. Is the request for specific dosage determined by current prescribing literature with authorization valid for 1 course (1 month) for review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of pediatric HIV for prevention of bacterial infection if experiencing serious bacterial infections over a 1 year period (e.g., meningitis, bacteremia, pneumonia)?

If yes, go to question #37

If no, go to question #38

  1. Is the request for 47 billable units or less per 28 days for dosage of 400mg/kg every 28 days?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of primary immunodeficiencies (PID)/defective antibody synthesis (i.e., genetic defects), including but not limited to Common variable immunodeficiency (CVID) (i.e., hypogammaglobulinemia with recurrent infections); Congenital agammaglobulinemia (e.g., X-linked agammaglobulinemia); Hyperimmunoglobulin E (Hyper-IgE) syndrome; Severe combined immunodeficiencies (SCID); Wiskott-Aldrich syndrome (thrombocytopenia and eczema); X-linked hyperimmunoglobulin M (Hyper-IgM) syndrome if ANY ONE of the following?

If yes, go to question #39

If no, go to question #40

  1. Is the request for 184 billable units or less per 21 days for dosage up to 800mg/kg every 21 days?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of a solid organ or bone marrow transplant if ANY ONE of the following?

If yes, go to question #41

If no, go to question #42

  1. Is the request for 460 billable units or less per 28 days for dosage of 2g/kg divided over 5 days in a 28 day cycle?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of a stem cell or allogeneic bone marrow transplant if ALL of the following?

If yes, go to question #43

If no, go to question #44

  1. Is the request for 115 billable units per 7 days for dosage of 500mg/kg/week x 90 days, then 500 mg/kg/month up to 360 days post-transplant?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Stiff person syndrome with ALL of the following?

If yes, go to question #45

If no, go to question #46

  1. Is the request for 460 billable units or less per 28 days for dosage of 2g/kg divided over 5 days in a 28 day cycle?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of tetanus postexposure when tetanus immune globulin (TIG) is unavailable?

If yes, go to question #47

If no, go to question #48

  1. Is the request for 460 billable units or less per 28 days (1 billable unit = 500 mg) for a period of 1 month for review with specific dosage regimen per current prescribing literature?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of toxic shock syndrome with ALL of the following?

If yes, go to question #49

If no, go to question #50

  1. Is the request for 460 billable units or less per 5 days x 1 cycle for dosage of 2g/kg divided over 5 days x 1 cycle?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was the infusion completed with absence of unacceptable toxicity?

If yes, go to question #51

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria for the particular indication as required in questions 3 through 50?  

If yes, go to question #52

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was a BUN level and serum creatinine obtained within the last 6 months with the concentration and rate of infusion adjusted accordingly?

If yes, go to question #53

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for diagnosis of autoimmune mucocutaneous blistering diseases with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #54

  1. Is the request for a diagnosis of chronic immune thrombocytopenia/ITP with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #55

  1. Is the request for a diagnosis of Chronic Inflammatory/Immune Demyelinating Polyneuropathy with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #56

  1. Is the request for chronic lymphocytic leukemia with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #57

  1. Is the request for Dermatomyositis/Polymyositis with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #58

  1. Is the request for Multifocal Motor Neuropathy with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #59

  1. Is the request for Pediatric HIV for bacterial control or prevention with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #60

  1. Is the request for primary immunodeficiency (PID) with ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #61

  1. Is the request for solid organ (kidney, liver, lung, heart, pancreas) and bone marrow transplant complications if ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #62

  1. Is the request for Stem Cell or Allogeneic Bone Marrow Transplant if ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #63

  1. Is the request for Stiff Person Disease if ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #64

  1. Is the request for renewal for an additional indication on review?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.