LCD/NCD Portal

L28979

 

RHO (D) IMMUNE GLOBULIN INTRAVENOUS

 

 

10/01/2010

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Medicare will consider Rho (D) Immune Globulin Intravenous medically necessary for the following Food and Drug Administration (FDA) approved indications:

• For the suppression of Rh isoimmunization. These include:

o Rho (D) negative female children and adults in their childbearing years upon exposure to Rho (D) positive transfusions or massive fetal hemorrhage.

o Non-sensitized Rho (D) negative women within 72 hours after:

 Abortions (spontaneous or induced).

 Amniocentesis.

 Chorionic villus sampling.

 Ruptured tubal pregnancy.

 Abdominal trauma.

 Transplacental hemorrhage.

 In the normal course of pregnancy unless the blood type of the fetus or the father is known to be Rho (D) negative.

 Maternal bleeding due to threatened abortion should be treated by administration of Rho (D) as soon as possible.

o Non-sensitized Rho (D) negative women during pregnancy at 28 weeks gestation and within 72 hours following delivery which meet the following criteria:

 The mother must be Rho (D) negative.

 The mother is carrying a child whose father is either Rho (D) positive or Rho (D) unknown.

 The baby is either Rho (D) positive or Rho (D) unknown, and isoimmunized to the Rho (D) factor.

 Abdominal trauma.

 Mismatched blood transfusion (Transfusion accident).

• For the treatment of pregnancy and other obstetrical concerns, Rho (D) can be administered intramuscularly or intravenously as follows:

o 1500 IU should be administered at twenty-eight (28) weeks gestation. If administered earlier in pregnancy, it is recommended by the manufacturer that administration should be at twelve (12) week intervals.

o 600 IU should be administered as soon as possible after delivery of a confirmed Rho (D) positive baby and no later than 72 hours. If more than 72 hours have elapsed, Rho (D) should be administered as soon as possible up to twenty-eight (28) days after delivery.

o 600 IU should be administered immediately after abortion, amniocentesis (after 34 weeks gestation) or any other manipulation late in pregnancy (after 34 weeks gestation) associated with increased risk of Rh isoimmunization. Administration should take place within 72 hours after the event.

o 300 IU should be administered immediately after amniocentesis before 34 weeks gestation or after chorionic villus sampling. This dose should be repeated every 12 weeks while woman is pregnant. In case of threatened abortion, Rho (D) should be administered immediately.

• For the treatment of massive fetal hemorrhage or incompatible blood transfusion, Rho (D) should be administered within 72 hours after exposure utilizing the following formulas:

o If exposed to Rho (D) positive whole blood, administer 90 IU/mL blood IM or 45 IU/mL blood IV.

o If exposed to Rho (D) positive red blood cells, administer 60 IU/mL IM or 120 IU/mL IV.

o Administer 3000 IU every 8 hours via the IV route until total dosage calculated is administered.

o Administer 6000 IU every 12 hours via the intramuscular route until total dose calculated is administered.

• For the treatment of ITP for non-splenectomized Rho (D) positive individuals in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in:

o Children with acute or chronic ITP.

o Adults with chronic ITP.

o For the purpose of this policy, ITP is defined by the following criteria:

 Signs and symptoms of bleeding, a platelet count of less than 30,000/mm3, Rho (D).positive status and non-splenectomized status.

 Acute ITP: for duration of less than 6 months.

 Chronic ITP: for duration of greater than 6 months.

• For the Treatment of non-splenectomized Rho (D) positive children and adults with immune thrombocytopenic purpura (ITP) secondary to HIV who meet the following criteria:

o Platelet count below 30,000 with signs and symptoms of bleeding and undergoing antiretroviral therapy.

o Individuals with a platelet count below 30,000 who are receiving anti-retroviral therapy and are undergoing a surgical or extensive dental procedure. Treatment may be initiated prior to the procedure.

• This is a prophylactic procedure and it is not expected that treatment with Rho (D) will continue after the procedure.

Initial Dose

• For the treatment of ITP, Rho (D) must be given by intravenous administration.

o An initial dose of 250 IU/Kg body weight, given as a single injections, is recommended.

 The initial dosage can be administered in two divided doses given on separate days.

o If the patient has a Hgb level that is less than 10g/dL, a reduced dose of 125 to 200 IU/Kg should be given to minimize the risk of increasing the severity of anemia in the patient.

• Retisert (fluocinolone acetonide intravitreal implant) is a single-indication orphan drug, which is FDA-approved for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

o If subsequent therapy is required to elevate platelet counts to > 30,000 and the clinical condition calls for a higher platelet count, an intravenous dose of 125 to 300 IU/Kg body weight of Rho (D) is recommended.

Maintenance Therapy

• After the first two infusions, clinically indicated repeat doses would not be expected sooner than 3-4 weeks.

• Dosing 125-300 IU/Kg individualized based on platelet and Hgb levels.

• If patient does not respond to initial dose, administer a subsequent dose based on Hgb:

o Hgb between 8-10 g/dL, re-dose between 125-200 IU/Kg.

o Hgb > 10 g/dL, re-dose between 250-300 IU/Kg.

o Hgb > 8 g/dL, use with caution.

• All patients should be monitored to determine clinical response by assessing platelet counts, red blood cell counts, hemoglobin (Hgb) and other indices as necessary.

• The average interval is every three weeks but may be more frequent dependent upon the clinical condition of the patient.

• Initially, complete blood counts (CBC) should be performed at least weekly and prior to every dose of Rho (D) but then can be done less often.

• However the CBC should always be performed prior to the administration of Rho (D).

 

 

Coding Information

 

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 policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

23x Skilled Nursing - Outpatient

85x Critical Access Hospital

 

 

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 policy 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 policy should be assumed to apply equally to all Revenue Codes.

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

J2788 INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, MINIDOSE, 50 MICROGRAMS (250 I.U.)

J2790 INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, FULL DOSE, 300 MICROGRAMS (1500 I.U.)

J2791 INJECTION, RHO(D) IMMUNE GLOBULIN (HUMAN), (RHOPHYLAC), INTRAMUSCULAR OR INTRAVENOUS, 100 IU

J2792 INJECTION, RHO D IMMUNE GLOBULIN, INTRAVENOUS, HUMAN, SOLVENT DETERGENT, 100 IU

 

 

ICD-9 Codes that Support Medical Necessity

 

287.30 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED

287.31 IMMUNE THROMBOCYTOPENIC PURPURA

287.32 EVANS’ SYNDROME

287.33 CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA

287.39 OTHER PRIMARY THROMBOCYTOPENIA

656.10 RHESUS ISOIMMUNIZATION UNSPECIFIED AS TO EPISODE OF CARE IN PREGNANCY

656.11 RHESUS ISOIMMUNIZATION AFFECTING MANAGEMENT OF MOTHER DELIVERED

656.13 RHESUS ISOIMMUNIZATION AFFECTING MANAGEMENT OF MOTHER ANTEPARTUM CONDITION

773.0 HEMOLYTIC DISEASE OF FETUS OR NEWBORN DUE TO RH ISOIMMUNIZATION

999.70 RH INCOMPATIBILITY REACTION, UNSPECIFIED

999.71 RH INCOMPATIBILITY WITH HEMOLYTIC TRANSFUSION REACTION NOT SPECIFIED AS ACUTE OR DELAYED

999.72 RH INCOMPATIBILITY WITH ACUTE HEMOLYTIC TRANSFUSION REACTION

999.73 RH INCOMPATIBILITY WITH DELAYED HEMOLYTIC TRANSFUSION REACTION

999.74 OTHER RH INCOMPATIBILITY REACTION

999.75 NON-ABO INCOMPATIBILITY REACTION, UNSPECIFIED

999.76 NON-ABO INCOMPATIBILITY WITH HEMOLYTIC TRANSFUSION REACTION NOT SPECIFIED AS ACUTE OR DELAYED

999.77 NON-ABO INCOMPATIBILITY WITH ACUTE HEMOLYTIC TRANSFUSION REACTION

999.78 NON-ABO INCOMPATIBILITY WITH DELAYED HEMOLYTIC TRANSFUSION REACTION

999.79 OTHER NON-ABO INCOMPATIBILITY REACTION

 

 

Documentation Requirements

 

• Medical record documentation (e.g. history and physical, office/progress notes) maintained by the performing physician must clearly indicate the medical necessity to initiate Rho (D) Immune Globulin therapy.

o Medical record documentation should demonstrate continued need for the administration of Rho (D).

o Documentation must clearly indicate relevant signs and symptoms related to the condition for which this therapy is indicated.

o If product recommended dosages are exceeded, the provider must document medical necessity in the medical record.

• Documentation supporting the use of Rho D in patients with HIV/AIDS and severe thrombocytopenia must include Rh-positive status, all relevant platelet counts, clinical history of bleeding signs or symptoms, and notes of a surgical or extensive dental procedure if applicable.

o Also, status of current antiretroviral therapy must be outlined.

o If the physician providing the Rho (D) infusion incident to his/her evaluation and management is not the prescribing physician of antiretroviral therapy, the physician must verify in the medical record as to why Rho (D) therapy is being prescribed outside adjustment and management of antiretroviral therapy.

o This should occur rarely and Medicare will review the evaluation that initiates the Rho (D) therapy for medical necessity.

o The entire episode of care of Rho (D) infusion will be denied if the initiating evaluation does not meet medical necessity.

Treatment Logic

• Rho (D) Immune Globulin Intravenous (Rho [D] IGIV) is a gamma globulin (IgG) which contains antibodies to Rho (D).

o Rho (D) IGIV currently has two medical applications.

o The first application is to suppress Rh isoimmunization in nonsensitized Rho (D) antigen-negative individuals following Rho (D) antigen-positive red blood cell or whole blood exposure.

o Rho (D) antigen-positive red blood cell or whole blood exposure can occur by fetomaternal hemorrhage during delivery of a Rho (D) antigen-positive infant, during an abortion (spontaneous or induced), during amniocentesis, abdominal trauma or during a mismatched transfusion (transfusion accident).

• The second application of Rho (D) IGIV is to increase platelets in:

o non-splenectomized, Rho (D) positive children with acute or chronic immune thrombocytopenic purpura (ITP).

o Adults with chronic ITP, or ITP secondary to human immunodeficiency virus (HIV) infection.

 

 

Sources of Information and Basis for Decision

 

Blood, Vol 95 No. 8 pp.2523-2529. Abstract. Retrieved March 31, 2004. This reference used to determine laboratory values essential to Rho (D) administration.

 

FCSO LCD 29270, Rho (D) Immune Globulin Intravenous, 10/01/2010. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Food and Drug Administration Drug and Device Product Approvals. [On-line.]. Available: http://www.fda.gov/cder/da/ddpa.htm

 

Gaines, Reed (2000). Acute onset hemoglobinemia and/or hemoglobinuria and sequalae following Rho (D) immune globulin intravenous administration in immune thrombocytepenic purpura patients. This reference was used to review the result of laboratory values after the administration of Rho (D).

 

McCrae, K., Bussel, J., Pier, M.M., et al (2001). Platelets: An Update on Diagnosis and Management of Thrombocytopenic Disorders. Abstract. This reference was used to review the treatment of thrombocytopenic disorders.

 

Mosby’s Drug Consult (2003). Rho (D) Immune globulin. Retrieved January 20, 2004. This reference used to obtain recommended dosages for specific indications.

 

Nabhan, C., & Kwann, H. (2003). Current concepts in the diagnosis and management of thrombotic thrombocytopenic purpura. Hematology/Oncology Clinics of North America. Vol. 17, Number 1. Retrieved January 20, 2004. This reference used to review current concepts in managing thrombotic thrombocytopenic purpura.

 

Physician’s Desk Reference Book. (2000). (54th ed.).

 

WinRho SDF™ package insert, 2002. This reference used to obtain manufacturer recommended doses.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L28979 RHO (D) IMMUNE GLOBULIN INTRAVENOUS