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May 2014 VA Hep C Treatment Guidelines
UPDATE: Feb 26, 2016-
Funding and Prioritization Status Update

UPDATE: March 2016
VA Hep C Treatment Guidelines
VA to treat all vets in system
 

By Judith Graham
VA Extends New Hepatitis C Drugs to All Veterans in Its Health System

 
Orange Count Registry
Vietnam vets blame 'jet guns' for their hepatitis C
By Lily Leung Feb. 14, 2016 
 
CBS News Investigates
Congress outraged over hepatitis C treatment VA can't afford
Dr. Raymond Schinazi played a leading role developing a drug that cures hepatitis C while working seven-eighths of his time for the VA
 
ibtimes.com| By amynordrum
 


Hepatitis C drug costing VA, DoD millions
By Patricia Kime, Staff writer
We're looking at a company who is milking a cash cow for everything it's worth," Sanders said. 
 


VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Arizona Republic 12:27 a.m. EDT June 21, 2015
 


VA to outsource care for 180,000 vets with hepatitis C
, The Republic | azcentral.com 11:51 a.m. MST June 19, 2015
Dr. David Ross, the VA's director public-health pathogens programs, resigned from the working group. "I cannot in good conscience continue to work on a plan for rationing care to veterans," he wrote.
 


VA Region Stops Referring Patients To Outside Hospitals Thanks To Budget Shortfall
Michael Volpe Contributor ...According to a memo — the entire region has been forced to stop all “non-VA care” referrals due to a budget shortfall.
 

DisabledVeterans.org
OIG INVESTIGATES VA CHOICE PROGRAM PROBLEMS
Sen. Mark Kirk admitted the VA Choice Program is a failed joke in a letter to Secretary Bob McDonald despite attempts to fix it.
 

 
Denied Hep C VA dental care?
Please click here

 
Dried Hepatitis C Blood Exposure 11/23/2013 Weeks later inconspicuous blood transmits virus and more likely to cause accidental exposures to Hep C
 

Lack of Standards for
Mass Vaccinations
1970 Jetgun Nursing Instructions
 

2014 AASLD Study Hepatitis C not an STD

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Info: Plan Backfires-
VBA Fast Letter Boost Claims
 
Legal- Fed Regs state:
Judge decision may be relied upon
Cotant v. Principi, 17 Vet.App. 116, 134 (2003),
 
Service Connected Claims
# 1 Conclusion of Law 
# 2 Conclusion of Law 
 
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The fractionation process leading to immune globulin resulted in overall reduction in HCV RNA by a factor of 4.7 x 10(4). Although the presence of HCV RNA in the final product does not necessarily imply the presence of infectious virus, this work suggests that the safety of immune globulins with respect to HCV transmission is not due solely to the partitioning of HCV away from the immunoglobulin fraction.

Information about ISG

Immune serums (immune globulin) provide passive immunity to infectious disease. The protection will be of rapid onset, but of short duration (1-3 months). Immune sera are obtained from pooled human plasma of either general population donors or hyperimmunized donors. It may be administered either by intravenous (IV) or intramuscular (IM) injection.

Immune Globulin (Human) (IG) is a solution of immunoglobulin G (IgG) indicated for prophylaxis of hepatitis A, prevention or modification of measles (Rubeola), and for immunoglobulin deficiency. It is administered intramuscularly.

Additional specific immune globulins for intramuscular administration are obtained from donors whose plasma contains selected high titer antibodies. Products are available for use in the passive prophylaxis of varicella-zoster, tetanus, hepatitis B, rabies, and other infections. Another product, Rho(D) Immune Globulin (Human), is for the prevention of sensitization to the Rho(D) antigen and hemolytic disease of the newborn. Some of the intramuscular immunoglobulin products have been subjected to heat- or solvent/detergent-treatment.

Rh0(D) immune globulin is a plasma-derived product
comprised of anti-D immune globulin  Suppression of Rh isoimmunization related to transfusion or pregnancy: Intramuscular RhIg has been successfully used to prevent the development of Rho (D) antibodies for years. INTRAVENOUS (HUMAN) Rho(D) IMMUNE GLOBULIN A new preparation for the treatment of ITP and Rh isoimmunization  Katherine A. Anderegg, M.D., Fellow, The Institute For Transfusion Medicine Darrell J. Triulzi, M.D., Medical Director, The Institute For Transfusion Medicine

July 1995, when it was first demonstrated that the "new" screened commercial intramuscular immunoglobulin lacked anti-gpE1/E2 neutralizing antibodies, whereas the "old" unscreened commercial intramuscular immunoglobulin contained high titers of these antibodies.9,12

From August 1978 until March 1979, 14 batches of anti-D immune globulin contaminated with hepatitis C virus (HCV) genotype 1b (20,000-480,000 copies/dose) from a single erythrocyte donor had been administered for prophylaxis of rhesus isoimmunization throughout East Germany. All 2,867
Subcutaneous injections of a drug containing human immunoglobulins  1974 and early 1975, several cases of viral hepatitis were reported in Italy among subjects who had received subcutaneous injections of a drug containing human immunoglobulins that was prescribed for the treatment of allergies. The possibility that immunoglobulins can be responsible for the transmission of viral hepatitis raises a number of theoretical and practical problems concerning control and use of these blood products.
 

4.2.6 Intravenous anti-D immunoglobulin

Anti-D immunoglobulin is prepared from the plasma of donors with high concentrations of anti-rhesus D antibody. Intravenous anti-D immunoglobulin was first reported to be involved in the transmission of HCV in an outbreak of NANBH that occurred in East Germany between 1978 and 1979 (Dittmann et al 1991). A similar outbreak was also reported in Ireland where 12 women received anti-D immunoglobulin manufactured in 1977 that contained HCV-RNA sequences (Stevens et al 1984; Power et al 1994; Power et al 1995a). Both of these outbreaks were traced to index cases who donated HCV-antibody-positive blood.

Another intravenous preparation implicated in the transmission of HCV was an immunoglobulin product, Gammagard, used to treat primary immunodeficiency disorders such as hypogammaglobulinaemia. In the USA, 43 people with acute HCV infection were reported to the Centers for Disease Control and Prevention (CDC) between 1993 and mid 1994 where the only risk factor for HCV infection was receipt of the intravenous immunoglobulin, Gammagard (Anonymous 1994). Gammagard was subsequently removed worldwide in early 1994. Preliminary epidemiological investigations in the USA have indicated that no other intravenous immunoglobulin products or intramuscular immune globulin have been associated with HCV transmission (Anonymous 1994).

The recent introduction of anti-viral treatments used in the manufacture of immunoglobulin products has substantially reduced the risk of transmission of HCV to recipients of these products.

  1. Intramuscular immune globulin is available in broad-spectrum form, or disease-specific hyperimmune serum.
    1. Immune serum globulin intramuscular (IM) (IG, Gamma Globulin, ISG, Gamastan, Gammar) (HCPCS/CPT codes J1460-J1560) is indicated for the following conditions:
      1. Hepatitis A exposure (ICD-9: V01.7).
      2. Measles (Rubeola) : for a susceptible patient (has not been vaccinated and has not had measles and is at high risk for complication) who has been exposed less than three days prior to treatment (ICD-9 V04.2 ).
      3. Rubella: for a woman in early pregnancy, who is exposed to the virus and does not have immunity. (ICD-9 V22.2 and V01.4; or 647.50; or 647.53)
      4. Varicella: for passive immunization in immunosuppressed patients when varicella zoster immunoglobulin is not available (ICD-9: V05.4).
      5. Immunoglobulin deficiency: for prevention of serious infection when circulating IgG levels are low. Prophylactic therapy, especially against infections due to encapsulated bacteria, is often effective in Bruton-type, sex-linked congenital agammaglobulinemia, agammaglobulinemia associated with thymoma and acquired agammaglobulinemia (ICD-9: 042, 279.00-279.06, 279.2, 279.3). Therapy may not prevent chronic infections of external secretory tissues such as the respiratory or GI tracts.

       

    2. Specific hyperimmune serum globulin includes several different disease-specific drugs.
      1. Hepatitis B serum (CPT 90371) is indicated post-exposure for transient prevention of hepatitis B infection. (ICD-9 V15.85)
      2. Rabies serum (CPT 90375, 90376) is indicated post-exposure for transient prevention of rabies infection when the patient has not been completely immunized with the vaccination. (ICD-9 V01.5)
      3. Vaccinia serum (CPT 90393) is indicated for transient prevention of or modification of aberrant infections induced by vaccinia (smallpox) vaccine, the vaccinia virus, such as eczema vaccinatum, some cases of progressive vaccinia, and possibly ocular vaccinia. (ICD-9 V01.4)
      4. Varicella-zoster serum (CPT 90396) is indicated for transient prevention of varicella-zoster infection in exposed, susceptible individuals who have a greater risk of complications from varicella (ICD-9 V01.7). Documentation in the progress notes must indicate one of the following complicating conditions to verify medical necessity: - a personal history of leukemia or lymphoma - HIV infection - current immunosuppressive therapy - a newborn with exposure to chickenpox (the documentation must indicate why the newborn is at increased risk; e.g., if the mother was exposed within 5 days of delivery).
      5. Tetanus serum (J1670) is indicated for transient protection against tetanus post-exposure to tetanus (ICD-9 code V03.7). Documentation in the progress notes must identify the following: - The wound is other than a clean minor wound, and the date of the injury; - The active immunization with tetanus toxoid is unknown or uncertain; or - The patient has received either less than 2 prior doses of tetanus toxoid; or two prior doses of tetanus toxoid, but there has been a delay of 24 hours or more between the time of injury and the initiation of tetanus prophylaxis.


     

  2. *Intravenous immune globulin (IGIV, Gamimune N, Gammagard, Gammar-IV, Iveegam, Sandoglobulin, Venogloblin-I) (CPT codes J1563, *J1564) provides immediate antibody levels. IVIG has been used as a therapy of last resort for some of the conditions and is indicated only if standard approaches have failed, become intolerable, or are contraindicated. IVIG may be indicated for the following conditions:

     
    1. Immunodeficiency Syndrome: to include congenital agammaglobulinemia such as x-linked aglobulinemia, common variable hypoglobulinemia, x-linked immunodeficiency with hyper IGM, combined immunodeficiency, and AIDS (ICD-9: 042, 279.00-279.06, 279.2)

       
    2. Idiopathic thrombocytopenic purpura (ICD-9: 446.6, 287.3).

       
    3. Alloimmune thrombocytopenia, refractoriness to platelet transfusions (ICD-9 287.4). Routine use is not indicated. IVIG may have a role in patients with severe thrombocytopenia of documented immune basis for whom other modalities are unsuccessful or contraindicated. IVIG may be used in neonates with severe immune thrombocytopenia if other interventions are unsuccessful or contraindicated. Maternal antenatal infusion may be considered.

       
    4. Post-transfusion purpura (ICD-9 287.4). IVIG may be considered as first-line therapy in severely affected patients.

       
    5. B-Cell Chronic Lymphocytic Leukemia (ICD-9: 204.10)

       
    6. Autoimmune hemolytic anemia (ICD-9: 283.0). Routine use is not indicated. IVIG may have a role in patients with warm-type AIHA that does not respond to corticosteroids.

       
    7. Immune-mediated neutropenia (ICD-9 288.0). Routine use is not indicated. IVIG may have a role in severe illness that does not respond to other modalities or when the latter are contraindicated.

       
    8. Multiple Myeloma (ICD-9 203.00-203.80). Routine use is not indicated. It may have a role in patients with stable (plateau phase) disease and high risk of recurrent infections.

       
    9. Pediatric intractable epilepsy (ICD-9 345.11, 345.3, 345.61). Routine use is not indicated. IVIG may have a role in certain syndromes as a last resort, especially in patients who may be candidates for surgical resection.

       
    10. Guillian-Baré syndrome (ICD-9 357.0). IVIG is recommended as an equivalent alternative to plasma exchange in children and adults.

       
    11. Myasthenia gravis (MG) (ICD-9 358.0). Routine use is not indicated. IVIG may be considered in patients with severe MG to treat acute severe decompensation when other treatments have been unsuccessful or are contraindicated.

       
    12. Polyneuropathy, chronic inflammatory demyelinating (ICD-9 357.8). IVIG is recommended as an equivalent alternative to plasma exchange in children and adults.

       
    13. Dermatomyositis (ICD-9 710.3). Routine use is not indicated. IVIG may be used in patients with severe active illness for whom other interventions have been unsuccessful or intolerable.

       
    14. Polymyositis (ICD-9 710.4). Routine use is not indicated. IVIG may be used in patients with severe active illness for whom other interventions have been unsuccessful or intolerable.

       
    15. Systemic lupus erythematosus (SLE) (ICD-9 710.0). Routine use is not indicated. IVIG may be used in patients with severe active SLE for whom other interventions have been unsuccessful or intolerable.

       
    16. Kawasaki disease (ICD-9 446.1).

       
    17. Severe Vasculitic Syndromes, systemic (polyartaritis nodosa) (ICD-9 446.0). Evidence does not suppport routine use of IVIG. IVIG may be used in patients with severe active illness for whom other interventions have been unsuccessful. or intolerable.

     

  3. Intravenous immune globulin for the treatment of autoimmune mucocutaneous blistering diseases is a National Coverage Decision (NCD). It is binding on all Medicare carriers, intermediaries, peer review organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans. Under 42 CFR 422.256(b), an NCD that expands coverage is also binding on a Medicare+Choice Organization. In addition, an administrative law judge may not review an NCD. (See §1869(f)(1)(A)(i) of the Social Security Act.)

    Intravenous immune globulin (IVIg) (J1563) is a blood product prepared from the pooled plasma of donors. It has been used to treat a variety of autoimmune diseases, including mucocutaneous blistering diseases. It has fewer side effects than steroids or immunosuppressive agents.

 

To make immune serum globulin ( ISG) products, plasma is treated with a variety of substances to separate the desired proteins from others, in a process called fractionation. Fractionation  process used today is the Cohn-Oncley method. This process relies on precipitation of plasma proteins by a combination of cold alcohol (usually ethanol)-water mixtures and adjustments of pH, ionic strength, temperature, and protein concentration.

The fractionation process leading to immune globulin resulted in overall reduction in HCV RNA by a factor of 4.7 x 10(4). Although the presence of HCV RNA in the final product does not necessarily imply the presence of infectious virus, this work suggests that the safety of immune globulins with respect to HCV transmission is not due solely to the partitioning of HCV away from the immunoglobulin fraction.

Alternatively, some manufacturers separate plasma derivatives by column chromatography using ion exchange, gel filtration, or affinity methods, without alcohol. In all cases, fractions of plasma are separated sequentially, with the product from one step, such as the precipitate and/or supernatant, becoming the starting material for the next step in the fractionation process. If each step is not done properly, subsequent fractions can be adversely affected. Thus, the integrity of each final product is dependent on all of the preceding steps in the process.

After fractionation, derivatives undergo further processing to purify and concentrate proteins and to inactivate or remove (clearance) any bacterial or viral contaminants. While early steps in the manufacturing process are not performed aseptically, all final products must be  sterile. Types of viral clearance include those steps that are part of the fractionation process itself, e.g., pH4/pepsin or polyethylene glycol (PEG) fractionation, or those steps that are deliberately added, e.g., solvent/detergent treatment or viral filtration. In some instances more than one viral clearance step is used for a given product. Plasma derivatives are similar to other biological products in that they are protein-based and subject to denaturization at high temperatures. These products are usually filled by using aseptic processing techniques, and cannot be terminally sterilized, although in some instances they can be heat-treated in the final container to effect viral or bacterial inactivation.