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 (flushing and diarrhea), and vasoactive intestinal peptide (VIP) secreting adenomas (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 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 because it is self-administrable.

Octreotide is covered for chemotherapy induced diarrhea (CID) when oral antidiarrheal medications, such as loperamide, have become ineffective.

Reasons for Noncoverage

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.

Payment for the drug and associated services will be denied as not medically necessary, when they are used for conditions other than those listed above. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

The patient's medical record must document the medical necessity of services performed for each date of service submitted on a claim, and documentation must be available on request.

When diagnosis code 995.2 is submitted for chemotherapy induced diarrhea (CID), the medical record must document the covered chemotherapy agent(s) causing the CID and the previous antidiarrheal treatments that have become ineffective.

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

If diagnosis codes 157.4, 159.0, 211.7, 211.9 are submitted on the claim, the medical record must document that the patient’s diagnosis is VIPoma.

If diagnosis code 790.99 is submitted on the claim, the patient’s record must document abnormal findings leading to suspicion of VIPoma.

If diagnosis code 794.6 is submitted, the patient’s record must document an abnormal octreotide scan leading to suspicion of VIPoma.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Use of these codes does not guarantee reimbursement. The patient's medical record must document that the coverage criteria in this policy have been met.

Covered Diagnosis Codes

For chemotherapy induced diarrhea (CID) use:

The following diagnosis codes must be used to designate VIPoma or suspected VIPoma:

The diagnoses for VIPoma or suspected VIPoma must also be accompanied by: