MIR-2006-6A, June 2006

LCD and Article Revisions for June 2006  

Beta Glucocerebrosidase and Analogues -L2206

LCD Revisions:
The title of this LCD (and article) has been changed from “Ceredase and Cerezyme” to “Beta Glucocerebrosidase and Analogues.”

Under the “Indications and Limitations of Coverage and/or Medical Necessity” section, revised the first paragraph from:

Alglucerase and Imiglucerase are semisynthetic enzymes made from human placental tissue and recombinant DNA respectively. They are used as long-term therapy for patients who have Type I Gaucher disease because they have low levels of the enzyme glucocerebrosidase.

To show the following:  

Beta glucocerebrosidase (Ceredase®) is a semi-synthetic form of human glucocerebrosidase and is prepared from pooled human placenta tissue obtained from selected donors. It is missing in patients with Type I Gaucher disease (adult type). Deficiency of this enzyme can result in lipidosis characterized by accumulation of glucosylceramide, which is highly insoluble, in storage cells in the liver, spleen, bone marrow, lymph nodes, and rarely alveolar capillaries.

This information has been updated in the article under the “LCD Description” section.

Under the “Indications” section, letter A has been updated from:

1. Alglucerase (Ceredase) and Imiglucerase (Cerezyme) are used to treat Type I Gaucher Disease. The symptoms that mandate treatment include:

To show the following:

1. Beta glucocerebrosidase (Ceredase®) and Imiglucerase (Cerezyme®) are used to treat Type I Gaucher disease. The symptoms that mandate treatment include:

Letters B and C have been removed:

2. Alglucerase and Imiglucerase are administered intravenously over 1-2 hours.
3. The dose depends on the patient’s weight and severity of the disease. The patient may require high dosages and frequent administration initially.

Letters D and E are now B and C, and the lowercase letters under B and C have been changed to numbers.

Under the new letter C, number 3 (formerly c.) has been updated from:

3. The recent, rapid progression of the disease;

To show the following:

3. No obvious and recently rapid progression of the disease;

Under the “Limitations” section, letter A has been updated from:

1. Alglucerase and Imiglucerase are not covered in the following;

To show the following:

1. Beta glucocerebrosidase and analogues are not covered for:

Under the “Bill Type Codes” section, removed 14X. This code has been redefined and is no longer appropriate for this service.

This section has also been updated in the article.

Under the “CPT/HCPCS Codes” section, updated the code descriptors.

This section has also been updated in the article.

Under the “ICD-9-CM Codes That Support Medical Necessity” section for Secondary Diagnosis, removed the following code to coordinate with Empire Part B:

287.3 Primary thrombocytopenia

The following ICD-9-CM code has been added to coordinate with Empire Part B:

287.4Secondary thrombocytopenia

Under the “Utilization Guidelines” section, updated number 1 from:

1. The maximum dose expected for Alglucerase and Imiglucerase is in the range of 60 units per kilogram, every two weeks.

To show the following:

1. The maximum dose expected for Beta glucocerebrosidase and Imiglucerase is in the range of 60 units per kilogram, every two weeks.

Also under this section, added numbers 2, 3, and 4:

2. Beta glucocerebrosidase and Imiglucerase are administered intravenously over 1-2 hours.
3. The dose depends on the patient’s weight and severity of the disease. The patient may require high dosages and frequent administration initially.
4. Also, refer to the “Indications” section of this LCD, letters B and C, for additional information.

Under the “Sources of Information” section, added number 13:

13. National Institutes of Health Technology Assessment Conference statement dated February 27 - March 1, 1995: “Gaucher Disease: Current Issues in Diagnosis and Treatment.”

Breast Imaging - Mammography/Breast Echography (Sonography/Breast MRI/Ductography) - L481

LCD Revisions:
Under the “CMS National Coverage Policy” section, added numbers 11, 12, and 13:

11. Change Request (CR) 3835, dated October 28, 2005. Redefined Type of Bill 14X for Nonpatient Laboratory Specimens.
12. Change Request (CR) 4208, dated December 30, 2005. Redefined Type of Bill 14X for Non-Laboratory Specimens.
13. Change Request (CR) 5050, dated April 28, 2006. This CR concerns the correct reporting of diagnosis codes on screening mammography claims.

This section was also updated in the article.

Under the “ICD-9-CM Codes That Support Medical Necessity” section, removed the section titled “For screening mammography that converts to diagnostic mammography, prior to January 1, 2002”:

V76.12 Special screening for malignant neoplasm, other screening mammography Services prior to 01/01/02 are now beyond the time limit for filing claims.

Under the section titled “For a diagnostic mammography, and for a screening mammography that converts to diagnostic mammography, on or after January 1, 2002,” removed the statement “on or after January 1, 2002,” and the ICD-9-CM code V76.12. This section is for diagnostic codes only. The ICD-9-CM code V76.12 will only be indicated in the section for screening mammography.

Article Revisions:

Under the “Coding Guidelines” section, updated # 4 from:

4. Screening Mammogram
   For Part A billing of a screening mammogram use the following:

• Bill type 13X, 14X, 22X, 23X, and 85X

To show the following:

4. Screening Mammogram
   For Part A billing of a screening mammogram use the following:

• Bill type 12X, 13X, 22X, 23X, and 85X

Also under this section, removed the 14X type of bill from numbers 5 - 9.

Also under this section, updated number 34 from:

34. Effective July 1, 2006, type of bill 12X is to be used in place of type of bill 13X for the billing of screening mammography when provided to hospital inpatients under Part B.

To show the following:

34. Effective July 1, 2006, type of bill 12X (hospital inpatient ancillary) is to be used in place of type of bill 13X for the billing of screening mammography when provided to hospital inpatients under Part B.

Added numbers 35, 36, and 37:

35. A diagnostic mammography cannot be submitted on a claim for type of bill 12X (hospital inpatient ancillary).
36. Effective July 1, 2006, type of bill 12X is to be used in place of type of bill 13X for the billing of screening mammography when provided to hospital inpatients under Part B.
37. Effective October 1, 2006, the diagnosis codes V76.11 and V76.12 need not be reported as the primary diagnosis code if the claim contains services other than screening mammography services.