Local Coverage Determination (LCD)

Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot)

L33438

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Palmetto GBA	A and B MAC	10112 - MAC B	J - J	Alabama
Palmetto GBA	A and B MAC	10212 - MAC B	J - J	Georgia
Palmetto GBA	A and B MAC	10312 - MAC B	J - J	Tennessee
Palmetto GBA	A and B and HHH MAC	11202 - MAC B	J - M	South Carolina
Palmetto GBA	A and B and HHH MAC	11302 - MAC B	J - M	Virginia
Palmetto GBA	A and B and HHH MAC	11402 - MAC B	J - M	West Virginia
Palmetto GBA	A and B and HHH MAC	11502 - MAC B	J - M	North Carolina

LCD Information

Document Information

LCD ID
L33438

LCD Title
Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot)

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL33438

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 07/18/2024

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
04/13/2017

Notice Period End Date
05/28/2017

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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1861(s) and (t) defines the terms "drugs" and "biological" and outlines coverage for the drugs, biologicals, services and supplies.

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.2 Determining Self-Administration of Drug or Biological, §50.4 Reasonableness and Necessity, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.4.1 Antigens, §50.4.4.2 Immunizations, §50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals and §50.4.5.1 Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Octreotide acetate is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone, somatostatin. Octreotide acetate for injectable suspension is a long-acting dosage form containing octreotide. It maintains all of the clinical and pharmacological characteristics of the immediate-release dosage form, octreotide acetate, with the added feature of slow release of octreotide from the site of injection, reducing the need for frequent administration.

Octreotide exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone, glucagon, and insulin than somatostatin. By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (severe diarrhea and flushing) and vasoactive intestinal peptide (VIP) secreting adenomas (profuse watery diarrhea).

Octreotide substantially reduces, and in many cases, can normalize growth hormone and/or IGF-1 (somatomedin C) levels in patients with acromegaly.

Octreotide acetate for injectable suspension is Food and Drug Administration (FDA) approved for the reduction of growth hormone and IGF-1 in patients with acromegaly, for whom medical treatment is appropriate, and who have been shown to respond to and can tolerate short-acting subcutaneous octreotide acetate. The goal of treatment is to reduce growth hormone and IGF-1 levels to normal. It is also used in patients who have had an inadequate response to surgery or in those for whom surgical resection is not an option. It is also used in patients who have received radiation and have had an inadequate therapeutic response.

It is FDA approved for the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.
It is FDA approved for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been shown to be effective.
The approved route of administration of octreotide acetate for injectable suspension is intragluteally, and it must be administered under the direct supervision of a physician.
Octreotide acetate for injectable suspension is covered only when it is used according to FDA guidelines.
A trial of therapy using the short-acting, subcutaneous form of octreotide acetate is a prerequisite prior to administering the long-acting octreotide acetate suspension. However, the short-acting, subcutaneous form of octreotide is noncovered by this A/B MAC, because it is self-administrable.
Octreotide is covered for chemotherapy-induced diarrhea (CID) when oral antidiarrheal medications, such as loperamide, have become ineffective.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

ICD-10-CM Codes that DO NOT Support Medical Necessity

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.

The ordering physician must document in the medical record relevant clinical signs and symptoms, which describe 1 of the covered indications.

Utilization Guidelines

Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.

Sources of Information

The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies from other Medicare contractors and discussions with appropriate specialists.

Bibliography

Garland J, Buscombe JR, Bouvier C, et al. Sandostatin® LAR (long-acting octreotide acetate) for malignant carcinoid syndrome: A 3-year experience. Aliment Pharmacol Ther. 2003;17(3):437-44.

Harris AG, O'Dorisio TM, Woltering EA, et al. Consensus statement: Octreotide dose titration in secretory diarrhea. Dig Dis Sci. 1995;40(7):1464-73.

Katznelson L, Atkinson JLD, Cook DM, Ezzat SZ, Hamrahian AH, Miller KK. American association of clinical endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly. Endocrine Practice. 2011;17(4):1-44.

Novartis Pharmaceuticals Corporation. [1988]. SANDOSTATIN® LAR DEPOT (octreotide acetate): Highlights of Prescribing Information. East Hanover, NJ: Author.

Rubin J, Ajani J, Schirmer W, et al. Octreotide acetate long-acting formulation versus open-label subcutaneous octreotide acetate in malignant carcinoid syndrome. J Clin Oncol. 1999;17(2):600-6.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
07/18/2024	R15	Under *CMS National Coverage Policy* the following regulation was removed and placed in the related Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin^® LAR Depot) A56531 article: CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 3, §3.4.1.3 Diagnosis Code Requirements. Formatting was corrected throughout the LCD.	Provider Education/Guidance
06/24/2021	R14	Under *LCD Title* deleted registered symbol from LAR and added registered symbol to Sandostatin. Under *CMS National Coverage Policy* added regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2 Determining Self-Administration of Drug or Biological, §50.4 Reasonableness and Necessity, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.4.1 Antigens, §50.4.4.2 Immunizations, §50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals and §50.4.5.1 Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. Under *Coverage Indications, Limitations and/or Medical Necessity* added hyperlink for FDA indications. Under *Bibliography* moved the verbiage “The development and coverage guidelines in this policy were based on a review or pertinent medical literature, policies from other Medicare contractors and discussions with appropriate specialists” to *Sources of Information*, added citation for octreotide acetate FDA indications and changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance
10/24/2019	R13	This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §§50-50.4.7 was removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot) A56531 article. Under *Bibliography* changes were made to citations to reflect AMA citation guidelines. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance
05/09/2019	R12	All coding located in the *Coding Information* section has been moved into the related Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot) A56531 article and removed from the LCD. All verbiage regarding billing and coding under the *Associated Information* section has been removed and is included in the related Billing and Coding: Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot) A56531 article. At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance
10/01/2018	R11	Under *ICD-10 Codes that Support Medical Necessity Group 1: Codes* ICD-10 code C7A.098 was added inadvertently to Revision #9. The effective date of ICD-10 code C7A.098 was 08/15/18 as indicated in Revision #8. This revision is due to a typographical error (the acronym CPT was used rather than ICD-10). At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Typographical Error
10/01/2018	R10	Under *ICD-10 Codes that Support Medical Necessity Group 1: Codes* CPT code C7A.098 was added inadvertently to Revision #9. The effective date of CPT code C7A.098 was 08/15/18 as indicated in Revision #8. At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Typographical Error
10/01/2018	R9	Under ICD-10 Codes that Support Medical Necessity Group 1: Codes the following ICD-10 codes have been added: C7A.010, C7A.011, C7A.012, C7A.019, C7A.020, C7A.021, C7A.022, C7A.023, C7A.024, C7A.025, C7A.026 , C7A.029, C7A.090, C7A.091, C7A.092, C7A.093, C7A.094, C7A.095, C7A.096, C7A.098, C7A.1. This revision is due to a reconsideration request. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes the following ICD-10 codes have been added: T43.641A, T43.641D, T43.641S, T43.642A, T43.642D, T43.642S, T43.643A, T43.643D, T43.643S, T43.644A, T43.644D, T43.644S. This revision is due to the Annual ICD-10 Code Update. This revision becomes effective 10/01/18. At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Revisions Due To ICD-10-CM Code Changes Reconsideration Request
08/15/2018	R8	The registered trademark symbol was added to the title “Octreotide Acetate for Injectable Suspension (Sandostatin LAR® depot)”. Under *Coverage Indications, Limitations and/or Medical Necessity* punctuation and grammar were corrected and acronyms were defined. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C7A.098. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph added the verbiage “NOTE: For K52.1, per ICD-10 coding conventions, use an additional code for adverse effect, if applicable, to identify the drug (toxic substance).” Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added K52.1. Under ICD-10 Codes that Support Medical Necessity Group 5: Codes added I85.00, I85.01, I85.10 and I85.11. Added a new ICD-10 Codes that Support Medical Necessity Group 6: Paragraph with the verbiage “Sulfa urea induced hypoglycemia”. Added a new ICD-10 Codes that Support Medical Necessity Group 6: Codes and added E13.641 and E13.649. Added a new ICD-10 Codes that Support Medical Necessity Group 7: Paragraph with the verbiage “Thymoma advanced” and “NOTE: Approved for use as a 2nd line therapy when disease progression occurs despite treatment with 1st line therapies”. Added a new ICD-10 Codes that Support Medical Necessity Group 7: Codes and added C37. Under *Bibliography* changes were made to reflect AMA citation guidelines. At this time 21^stCentury Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance Public Education/Guidance Reconsideration Request
02/26/2018	R7	The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.	Change in Affiliated Contract Numbers
07/27/2017	R6	Under *CMS National Coverage Policy* deleted “medically” from the verbiage cited for Title XVIII of the Social Security Act, §1862(a)(1)(A), deleted online from the cited CMS Internet-Only Manuals, and deleted CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §§13.1-13.13.15. Under *Coverage Indications, Limitations and/or Medical Necessity* deleted “GI” from the second bullet. Under *Sources of Information and Basis for Decision* deleted M Chaplin and added “et al.” At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.	Provider Education/Guidance Other
05/29/2017	R5	No revisions were made as no comments were received from the provider community.	Provider Education/Guidance
10/13/2016	R4	Under *CMS National Coverage Policy* for Title XVIII of the Social Security Act, Section 1861 (s) and (t) deleted the verbiage “These sections outline coverage for drugs and biologicals and services and supplies” and revised the verbiage to read “defines the terms drugs and biologicals and outlines coverage for the drugs, biologicals, services and supplies”. For Title XVIII of the Social Security Act, Section 1862(a)(1)(A) deleted the verbiage “This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary, i.e., reasonable and necessary are those tests used in the diagnosis and management of illness or injury or to improve the function of a malformed body part” and revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”. For CMS Online-internet only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13 deleted section 13.14 as this section was removed from Chapter 13. Under *Sources of Information and Basis for Decision* added author’s names and initials.	Provider Education/Guidance
10/01/2016	R3	Under *ICD-10 Codes That Support Medical Necessity* added Group 5 for Severe Liver Disease with ICD-10 codes K76.7, K91.82, K91.83 and O90.4.	Provider Education/Guidance Revisions Due To ICD-10-CM Code Changes
10/16/2015	R2	Under Coverage Indications, Limitations and/or Medical Necessity in the second paragraph changed (flushing and diarrhea) to (severe diarrhea/flushing) and added “profuse” to watery diarrhea. Under second bullet, added “GI” to flushing associated with malignant carcinoid syndrome.	Provider Education/Guidance Other (Annual validation)
10/01/2015	R1	Under *CMS National Coverage Policy* added additional citations for Pub. 100-02, Ch. 15, §50, to include §§50.1-50.4.7. Under *Associated Information,* subheading Documentation Requirements changed ICD-9 codes to ICD-10 codes and inserted ICD-10 codes where ICD-9 codes were placed. Under *Sources of Information and Basis for Decision* added author's initial of first name to Katznelson L, for 1st bibliography in this section and also updated Guidelines for this citation.	Provider Education/Guidance

Associated Documents

Attachments
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Updated On	Effective Dates	Status
07/12/2024	07/18/2024 - N/A	Currently in Effect	You are here
06/18/2021	06/24/2021 - 07/17/2024	Superseded	View
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Keywords

Octreotide
Sandostatin

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Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot)

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