CurrentClover HealthPolicy 5260-A

Jurisdiction Specific Medicare Part B Octreotide Acetate for Injectable Suspension (Sandostatin LAR)

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Prior authorization and Medicare Part B coverage of octreotide acetate injectable suspension for specified FDA-labeled and compendial indications in Medicare Administrative Contractor Jurisdictions J and M, including AL, GA, TN, NC, SC, VA, and WV.

Policy Summary

PayerClover Health

PolicyMedicare Part B Octreotide Acetate Injectable Suspension (Sandostatin LAR)

Policy CodePolicy 5260-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument effective and tolerated short-acting subcutaneous octreotide acetate treatment before requesting the long-acting injectable suspension when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14Covered uses listed

12 monthsStandard authorization period

1 monthHypoglycemia authorization period

7 statesJurisdiction J and M states

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CurrentClover HealthPolicy 5260-A

Jurisdiction Specific Medicare Part B Octreotide Acetate for Injectable Suspension (Sandostatin LAR)

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Policy Summary

PayerClover Health

PolicyMedicare Part B Octreotide Acetate Injectable Suspension (Sandostatin LAR)

Policy CodePolicy 5260-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument effective and tolerated short-acting subcutaneous octreotide acetate treatment before requesting the long-acting injectable suspension when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14Covered uses listed

12 monthsStandard authorization period

1 monthHypoglycemia authorization period

7 statesJurisdiction J and M states

Policy Background

This policy addresses octreotide acetate for injectable suspension (Sandostatin LAR) under Medicare Part B for selected endocrine, neuroendocrine, oncologic, gastrointestinal, and diarrhea-related conditions. Covered uses include acromegaly, malignant carcinoid syndrome, VIPomas, chemotherapy-induced diarrhea, and other specified tumor- and gastrointestinal-related conditions.

Covered Indications and Exclusions

Acromegaly

Covered for 12 months when all of the following are met.

Acromegaly criteria

Treatment goal: The goal of treatment is to reduce growth hormone and IGF-1 levels to normal.
Prior local treatment status
- The member had an inadequate response to surgery and/or radiotherapy.
- Surgery and/or radiotherapy is not an option.
Short-acting octreotide response: The member has been shown to respond to and can tolerate short-acting subcutaneous octreotide acetate.

Malignant carcinoid syndrome

Covered for 12 months when the indication-specific requirement is met.

Malignant carcinoid syndrome criteria

Treatment is for symptomatic treatment of severe diarrhea and flushing associated with malignant carcinoid syndrome.
Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Vasoactive intestinal peptide tumors

Covered for 12 months when the indication-specific requirement is met.

Vasoactive intestinal peptide tumor criteria

Treatment is for symptomatic treatment of profuse watery diarrhea associated with VIP-secreting tumors.
Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Chemotherapy-induced diarrhea

Covered for 12 months when all of the following are met.

Chemotherapy-induced diarrhea criteria

Treatment is for chemotherapy-induced diarrhea.
Oral antidiarrheal failure: Oral antidiarrheal medications, such as loperamide, have become ineffective.
Short-acting octreotide response: Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Other listed covered uses

Covered uses are subject to approval criteria and the absence of exclusions.

Listed covered uses

The indication is one of the policy’s listed covered uses: neuroendocrine or adrenal tumors; meningioma; acromegaly; malignant carcinoid syndrome; vasoactive intestinal peptide tumors (VIPomas); chemotherapy-induced diarrhea; pheochromocytoma or paraganglioma; thymoma; Zollinger-Ellison syndrome; sulfa urea induced hypoglycemia; bowel obstruction due to peritoneal carcinomatosis; postgastrectomy dumping syndrome; hepatocellular carcinoma; or Merkel cell carcinoma.
All applicable approval criteria are met and the member has no exclusions to the prescribed therapy.
For an indication other than those listed, the submission includes supporting evidence from Medicare-approved compendia.

Standard covered indications

Covered for a listed indication when the short-acting octreotide prerequisite is met.

Standard covered indication criteria

Covered indication
- Vasoactive intestinal peptide tumor (VIPoma) with symptomatic profuse watery diarrhea.
- Pheochromocytoma or paraganglioma.
- Thymoma.
- Neuroendocrine tumor.
- Zollinger-Ellison syndrome.

Chemotherapy-induced diarrhea

Covered when all criteria are met.

Treatment is for chemotherapy-induced diarrhea.
Oral antidiarrheal failure: Oral antidiarrheal medications, such as loperamide, have become ineffective.
Short-acting octreotide response: Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Sulfa urea induced hypoglycemia

Covered when the short-acting octreotide prerequisite is met.

Treatment is for sulfa urea induced hypoglycemia.
Short-acting octreotide response: Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Meningioma

Covered when all criteria are met.

Short-acting octreotide response: Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.
Disease status: The member has surgically inaccessible recurrent or progressive disease.

Merkel cell carcinoma

Covered when all required conditions are met and at least one disease-status criterion is satisfied.

Treatment is single-agent treatment of somatostatin receptor-positive Merkel cell carcinoma.
Immunotherapy contraindication: The member has a contraindication to anti-PD-L1 or anti-PD-1 therapy.
At least one disease-status criterion
- The member has regional or metastatic disease.
- The member has disease progression while on anti-PD-L1 or anti-PD-1 therapy.

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

A service performed more frequently than generally accepted by peers is not medically necessary unless the provider documents and justifies the reason for the additional service.

Initial Therapy Requirements

Acromegaly

Authorization of 12 months may be granted when all criteria are met.

Acromegaly initial therapy criteria

The treatment goal is to reduce growth hormone and IGF-1 levels to normal.
Prior local treatment status
- The member had an inadequate response to surgery and/or radiotherapy.
- Surgery and/or radiotherapy is not an option.
The member responds to and tolerates short-acting subcutaneous octreotide acetate.

Continuation and Ongoing Authorization

Effective and tolerated short-acting therapy

For most listed indications, authorization may be continued or granted when initial short-acting therapy has been effective and tolerated.

Continuation requirement

The member is being treated for a covered indication.
Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Required Treatment Sequence

Step	Requirement	Documentation or failure criterion
1	Use short-acting subcutaneous octreotide acetate before the long-acting injectable suspension when required by the indication.	Document that treatment was effective and tolerated. For acromegaly, document inadequate response to surgery and/or radiotherapy, or that these treatments are not an option.

Step	Covered indication	Required prior treatment
1	VIPoma with symptomatic profuse watery diarrhea; chemotherapy-induced diarrhea; pheochromocytoma or paraganglioma; thymoma; neuroendocrine tumor; or Zollinger-Ellison syndrome.	Initial treatment with short-acting, subcutaneous octreotide acetate must have been effective and tolerated before the long-acting injectable suspension is authorized.

Step	Indication	Required prior treatment	Failure criterion
1	Chemotherapy-induced diarrhea	Try oral antidiarrheal therapy, such as loperamide, before octreotide treatment.	The oral antidiarrheal medication must have become ineffective.

Authorization and Documentation Requirements

Prior Authorization

Acromegaly: 12-Month Prior Authorization

Authorization for 12 months may be granted for acromegaly when the treatment goal is to normalize growth hormone and IGF-1 levels, surgery and/or radiotherapy produced an inadequate response or is not an option, and the member responds to and tolerates short-acting subcutaneous octreotide acetate.

Document the treatment goal, prior surgery and/or radiotherapy response or treatment ineligibility, and response and tolerance to short-acting subcutaneous octreotide acetate.

Prior Authorization

Malignant Carcinoid Syndrome: 12-Month Authorization

Authorization for 12 months may be granted for symptomatic treatment of severe diarrhea and flushing associated with malignant carcinoid syndrome when initial treatment with short-acting subcutaneous octreotide acetate has been effective and tolerated.

Document the diagnosis, severe diarrhea and flushing, and effective and tolerated initial short-acting subcutaneous octreotide treatment.

Policy Summary

PayerClover Health

PolicyMedicare Part B Octreotide Acetate Injectable Suspension (Sandostatin LAR)

Policy CodePolicy 5260-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument effective and tolerated short-acting subcutaneous octreotide acetate treatment before requesting the long-acting injectable suspension when required.

SourceLink

On This Page

Bowel obstruction due to peritoneal carcinomatosis.

Postgastrectomy dumping syndrome.

Hepatocellular carcinoma.

Another approvable indication listed in LCA A56531.

Short-acting octreotide response: Initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.

Authorization is generally for 12 months.

Malignant carcinoid syndrome

Authorization of 12 months may be granted when the prerequisite short-acting treatment has been effective and tolerated.

Malignant carcinoid syndrome initial therapy criteria

Treatment is for symptomatic treatment of severe diarrhea and flushing associated with malignant carcinoid syndrome.
Initial short-acting, subcutaneous octreotide acetate treatment has been effective and tolerated.

Vasoactive intestinal peptide tumors

Authorization of 12 months may be granted when the prerequisite short-acting treatment has been effective and tolerated.

VIPoma initial therapy criteria

Treatment is for symptomatic treatment of profuse watery diarrhea associated with VIP-secreting tumors.
Initial short-acting, subcutaneous octreotide acetate treatment has been effective and tolerated.

Chemotherapy-induced diarrhea

Authorization of 12 months may be granted when all criteria are met.

Chemotherapy-induced diarrhea initial therapy criteria

Treatment is for chemotherapy-induced diarrhea.
Oral antidiarrheal medications, such as loperamide, have become ineffective.
Initial short-acting, subcutaneous octreotide acetate treatment has been effective and tolerated.

Prior Authorization

VIPoma: 12-Month Authorization

Authorization for 12 months may be granted for symptomatic treatment of profuse watery diarrhea associated with VIP-secreting tumors when initial treatment with short-acting subcutaneous octreotide acetate has been effective and tolerated.

Document the VIPoma diagnosis, profuse watery diarrhea, and effective and tolerated initial short-acting subcutaneous octreotide treatment.

Prior Authorization

Chemotherapy-Induced Diarrhea: 12-Month Authorization

Authorization for 12 months may be granted for chemotherapy-induced diarrhea when oral antidiarrheal therapy has become ineffective and initial short-acting subcutaneous octreotide acetate has been effective and tolerated.

Document prior oral antidiarrheal therapy, such as loperamide, its ineffectiveness, and response and tolerance to short-acting subcutaneous octreotide.

Prior Authorization

Standard 12-Month Authorization After Effective Trial

A 12-month authorization may be granted when initial short-acting subcutaneous octreotide acetate has been effective and tolerated for an eligible indication.

Applies to symptomatic treatment of VIPoma and to treatment of pheochromocytoma/paraganglioma and thymomas.
Document effectiveness and tolerance before requesting the long-acting injectable formulation.

Prior Authorization

Sulfa Urea Induced Hypoglycemia: One-Month Authorization

Authorization for 1 month may be granted for sulfa urea induced hypoglycemia when initial treatment with short-acting subcutaneous octreotide acetate has been effective and tolerated.

Document the diagnosis and effective, tolerated initial short-acting subcutaneous octreotide treatment.

Step Therapy

Chemotherapy-Induced Diarrhea: Treatment Response Requirements

For chemotherapy-induced diarrhea, authorization requires ineffective oral antidiarrheal therapy and effective and tolerated initial short-acting subcutaneous octreotide acetate treatment.

Document that loperamide or another oral antidiarrheal medication became ineffective.
Document the clinical response and tolerance to short-acting subcutaneous octreotide.

Prior Authorization

Merkel Cell Carcinoma: 12-Month Single-Agent Authorization

Authorization for 12 months may be granted as single-agent treatment of somatostatin receptor-positive Merkel cell carcinoma when the member has a contraindication to anti-PD-L1 or anti-PD-1 therapy and has regional or metastatic disease or progression during anti-PD-L1 or anti-PD-1 therapy.

Document single-agent use, somatostatin receptor-positive disease, the immunotherapy contraindication, and qualifying disease status.

Step Therapy

Short-Acting Octreotide Prerequisite

Where required by the indication, document that initial treatment with short-acting subcutaneous octreotide acetate was effective and tolerated before requesting long-acting octreotide authorization.

This prerequisite applies to acromegaly, malignant carcinoid syndrome, VIPoma, chemotherapy-induced diarrhea, pheochromocytoma/paraganglioma, thymomas, sulfa urea induced hypoglycemia, and meningiomas.

Step Therapy

Oral Antidiarrheal Failure Required

For chemotherapy-induced diarrhea, loperamide or a comparable oral antidiarrheal medication must have become ineffective before octreotide acetate for injectable suspension is authorized.

Record the medication used, the inadequate response or loss of effectiveness, and the relevant treatment dates when available.

Step Therapy

Document an Effective, Tolerated Octreotide Trial

Before long-acting authorization for applicable indications, the member must have an effective and tolerated trial of short-acting subcutaneous octreotide acetate.

Document the indication-specific symptoms or disease, treatment response, and tolerance during the initial trial.

Step Therapy

Prior Oral Antidiarrheal Therapy Required

Prior oral antidiarrheal treatment is required before treatment of chemotherapy-induced diarrhea can be authorized.

Loperamide or another comparable oral antidiarrheal must have been tried and become ineffective.

Prior Authorization

Compendial Support for Other Indications

Requests for indications other than those listed in the covered-use criteria are assessed individually and should include supporting evidence from Medicare-approved compendia.

Covered-use criteria list Merkel cell carcinoma; other indications require individualized review with compendial support.

Documentation Required

Clinical Criteria Documentation

Clinical documentation should establish the diagnosis, treatment goal or relevant symptoms, prior therapy, response and tolerance, and all indication-specific qualifying details.

For acromegaly, document the goal of normalizing growth hormone and IGF-1, surgery and/or radiotherapy response or ineligibility, and short-acting octreotide response and tolerance.
For diarrhea syndromes, document symptom severity, prior antidiarrheal treatment when applicable, and short-acting octreotide response and tolerance.
For other indications, document the diagnosis and the applicable disease-status and treatment requirements.

Documentation Required

Justify Excessive Service Frequency

Document justification whenever services are performed more frequently than generally accepted by peers. Services at excessive frequency are not medically necessary when the reason for additional services is not supported by documentation.

Include the clinical rationale for the additional frequency in the medical record and authorization request.

Documentation Required

Merkel Cell Carcinoma Documentation

For Merkel cell carcinoma, document use as a single agent, somatostatin receptor-positive disease, contraindication to anti-PD-L1 or anti-PD-1 therapy, and qualifying disease status.

Qualifying disease status is regional or metastatic disease, or progression while receiving anti-PD-L1 or anti-PD-1 therapy.

Documentation Required

Meningioma Disease-Status Documentation

For meningioma, document that the disease is surgically inaccessible and recurrent or progressive, along with effective and tolerated initial short-acting subcutaneous octreotide treatment.

Authorization may be granted for 12 months only when the indication-specific disease status and treatment-response requirements are supported.

Denial Risk

Acromegaly Criteria Not Met

Acromegaly authorization may be denied when the treatment goal, inadequate response to surgery and/or radiotherapy or treatment ineligibility, or effective and tolerated short-acting octreotide trial is not established.

The request must support normalization of growth hormone and IGF-1 as the treatment goal.
Failure to document response and tolerance to short-acting subcutaneous octreotide is a denial risk.

Denial Risk

Required Prerequisite Trial Not Documented

Authorization may be denied when the required short-acting subcutaneous octreotide trial or, for chemotherapy-induced diarrhea, the required ineffective oral antidiarrheal trial is not documented.

Document an effective and tolerated short-acting octreotide trial for the applicable indication.
For chemotherapy-induced diarrhea, document failure of loperamide or a comparable oral antidiarrheal.

Denial Risk

Excessive Frequency Without Justification

Services performed more frequently than generally accepted by peers are not medically necessary when documentation does not justify the additional services.

Include a specific clinical justification for any frequency exceeding peer-accepted practice.

Denial Risk

Merkel Cell Carcinoma Criteria Not Met

Merkel cell carcinoma authorization may be denied when single-agent use, somatostatin receptor-positive disease, contraindication to anti-PD-L1 or anti-PD-1 therapy, or a qualifying disease-status criterion is absent or undocumented.

The member must have regional or metastatic disease or progression while on anti-PD-L1 or anti-PD-1 therapy.

Denial Risk

Meningioma Criteria Not Met

Meningioma authorization may be denied when surgically inaccessible recurrent or progressive disease and effective and tolerated initial short-acting subcutaneous octreotide treatment are not documented.

Both the qualifying disease status and the effective, tolerated initial therapy requirement must be supported.