Octreotide Acetate for Injectable Suspension (Sandostatin LAR Depot)

LCD Information Document Information Source LCD ID N/A LCD ID L33438 Original ICD-9 LCD ID Not Applicable LCD Title Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot) Proposed LCD in Comment Period N/A Source Proposed LCD DL33438 Opens in a new window 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 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. 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. CPT is a registered trademark of the American Medical Association. Current Dental Terminology © 2025 American Dental Association. All rights reserved. Copyright © 2026, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at ub04@aha.org or 312‐422‐3366. Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates. Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD 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 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 Opens in a new windowis 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

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.