Article - Billing and Coding: Immune Globulin Intravenous (IVIg) (A57194)

CMS National Coverage PolicyTitle XVIII of the Social security Act; Section 1862(a)(1)(A) section allows coverage and payment for only those services that are considered to be reasonable and necessary.Title XVIII of the Social Security Act; Section 1833(e). This section prohibits Medicare payment for any claim, which lacks the necessary information to process the claim.CMS Manual, Pub.100-2, Chapter 15, section 50.4 and section 50.4.2. This section addresses coverage of drugs and biologicals.CMS Manual, Pub.100-3, Chapter 1, Section 250.3. This section describes coverage for IVIg for treatment of Autoimmune Mucocutaneous Blistering Diseases."Intravenous immune globulin (IVIg) 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.Effective October 1, 2002, IVIg is covered for the treatment of biopsy-proven: (1) Pemphigus Vulgaris, (2) Pemphigus Foliaceus, (3) Bullous Pemphigoid, (4) Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid), and (5) Epidermolysis Bullosa Acquisita for the following patient subpopulations: Patients who have failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy; Patients in whom conventional therapy is otherwise contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or Patients with rapidly progressive disease in whom a clinical response could not be affected quickly enough using conventional agents. In such situations IVIg therapy would be given along with conventional treatment(s) and the IVIg would be used only until the conventional therapy could take effect.In addition, IVIg for the treatment of autoimmune mucocutaneous blistering diseases must be used only for short-term therapy and not as a maintenance therapy. Contractors have the discretion to decide what constitutes short-term therapy."See associated article for ICD-10 diagnosis codes.CMS Manual, Pub. 100-2, Chapter 15, Section 50.6. This section describes coverage of IVIg for the treatment of Primary Autoimmune Deficiency Disease in the home."Beginning for dates of service on or after January 1, 2004, The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIg) for the treatment of primary immune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, D83.9 and G11.3) in the home. The Act defines intravenous immune globulin as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. The benefit does not include coverage for items or services related to the administration of the derivative. For coverage of IVIg under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment."See associated article for ICD-10 diagnosis codes.Article TextThe following billing and coding guidance is to be used with its associated LCD.Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate IVIg therapy and the continued need thereof. Required documentation of medical necessity could include: History and physical; Office/progress note(s); Test results with written interpretation; and An accurate weight in kilograms should be documented prior to the infusion since the dosage is based mg/kg/dosage.