LCD/NCD MedicationsL28979-LCD

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Local Coverage Determination (LCD) for Rho (D) Immune Globulin Intravenous (L28979)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28979

LCD Title Rho (D) Immune Globulin Intravenous

Contractor's Determination Number AJ2792

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2010

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). 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 §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:

Transmittal 1261 (Change Request 5635, dated 06/01/2007) Indications and Limitations of Coverage and/or Medical Necessity

Rho (D) Immune Globulin Intravenous (Rho [D] IGIV) is a gamma globulin (IgG) which contains antibodies to Rho (D). Rho (D) IGIV currently has two medical applications. 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. Rho (D) antigen-positive red blood cell exposure 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 non-splenectomized, Rho (D) positive children with acute or chronic immune thrombocytopenic purpura (ITP) and adults with chronic ITP, or ITP secondary to human immunodeficiency virus (HIV) infection.

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

1.) For the suppression of Rh isoimmunization. These include:

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

B.) 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, or 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.

C.) 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:

• 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.

• 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.

• 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.

• 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:

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

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

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

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

2.) 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:

• Children with acute or chronic ITP;

• Adults with chronic ITP;

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.

3. 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:

• Platelet count below 30,000 with signs and symptoms of bleeding and undergoing antiretroviral therapy or

• 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.

• 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.

• 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.

Subsequent Dosing

• 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

• 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 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.

013x Hospital Outpatient 023x Skilled Nursing - Outpatient 085x 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 - 287.39 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED - 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 - 999.79 RH INCOMPATIBILITY REACTION, UNSPECIFIED - OTHER NON-ABO INCOMPATIBILITY REACTION

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

N/A

General Information

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

clearly indicate relevant signs and symptoms related to the condition for which this therapy is indicated. 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. Also, status of current antiretroviral therapy must be

outlined. 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. This should occur rarely and Medicare will review the evaluation that initiates the Rho (D) therapy for medical necessity. The entire episode of care of Rho (D) infusion will be denied if the initiating evaluation does not meet medical necessity.

Appendices

Utilization Guidelines N/A

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.

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.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 10/01/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2010 Revised Effective Date:10/01/2010

LCR A2010-050

September 2010 Bulletin

Explanation of Revision: Annual 2011 ICD-9-CM Update. Deleted ICD-9-CM code 999.7. Added ICD-9-CM code range 999.70-999.79. The effective date of this revision is based on date of service

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-034FL

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28979) replaces LCD L1339 as the policy in notice. This document (L28979) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

09/06/2010 - This policy was updated by the ICD-9 2010-2011 Annual Update.

Reason for Change