Cholecystokinin Cholescintigraphy
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This policy governs the medical necessity and coverage of cholecystokinin administration as an adjunct to cholescintigraphy (HIDA/GBEF testing) for diagnostic evaluation of gallbladder and sphincter of Oddi disorders for Aetna members.
No material clinical or coverage changes in this revision.
Coverage Criteria for CCK Cholescintigraphy
Medically Necessary Indications
Covered when ANY of the following indications are met:
Each item is an independent covered indication.
Experimental / Investigational
Not covered / Experimental and Investigational:
Effectiveness for other indications has not been established.
Use of cholecystokinin (CCK) cholescintigraphy outside the indications explicitly listed as medically necessary in this policy is considered experimental and investigational and may be denied. Examples of off‑label or unsupported uses include employing CCK cholescintigraphy solely to provoke symptoms or for diagnostic purposes not named in the seven covered indications. Additionally, certain diagnosis codes (for example, K82.8 and Z98.89) are identified in the policy as not covered when the request is for CPB‑listed indications that are excluded (e.g., pain provocation to predict post‑operative relief).
Reproduction of biliary pain during CCK‑cholescintigraphy has been investigated as a potential predictor of symptom relief after cholecystectomy, but the evidence does not support its reliability. Edwards et al (2014) found no significant correlation between either low gallbladder ejection fraction or symptom provocation during CCK‑CS and postoperative outcomes; therefore, using pain provocation alone to predict post‑operative relief is considered experimental/investigational and is not a covered indication under this policy.
Coding — Procedure and Diagnosis Codes
| J2805 | Injection, sincalide, 5mcg. |
| J2806 | Injection, sincalide (maia) not therapeutically equivalent to j2805, 5 micrograms. |
| K80.00 - K80.81 | Cholelithiasis. |
| K81.0 - K81.9 | Cholecystitis. |
| K82.0 | Obstruction of gallbladder. |
| K82.A1 - K82.A2 | Disorders of gallbladder in diseases classified elsewhere. |
| K83.1 | Obstruction of bile duct [common]. |
| K83.4 | Spasm of sphincter of Oddi. |
| K82.8 | Other specified diseases of gallbladder |
| Z98.89 | Other specified postprocedural states |
Provider Actions and Billing Notes
No step therapy required
This policy does not specify any step therapy requirements for CCK cholescintigraphy.
Required clinical documentation must support a listed indication
Clinical documentation submitted for authorization should support one of the policy’s medically necessary indications (for example: suspected chronic calculous or acalculous cholecystitis, sphincter of Oddi dysfunction, need to expedite imaging to 60 minutes, or patient fasting >24 hours) and include relevant imaging or clinical findings.
- Document the specific medically necessary indication being claimed
- Include relevant imaging results or clinical findings that support the indication
Denial risk for experimental/unlisted indications (e.g., pain provocation)
Requests for CCK cholescintigraphy for indications not listed as medically necessary—such as provocation of pain to predict postoperative symptom relief following cholecystectomy for biliary dyskinesia or chronic acalculous gallbladder disease—are considered experimental/investigational and may be denied.
- Pain provocation to predict post‑operative relief is specifically cited as experimental/investigational
- ICD-10 codes associated with these non-covered uses (e.g., K82.8, Z98.89) are noted as not covered for CPB-listed indications
Background
Cholescintigraphy (HIDA) is a nuclear medicine hepatobiliary imaging study used to evaluate bile ducts, gallbladder disease, and bile leaks. When combined with administration of cholecystokinin (sincalide), the test can be used to stimulate gallbladder emptying to measure gallbladder ejection fraction (GBEF), help distinguish obstruction from sphincter of Oddi spasm, exclude acute acalculous cholecystitis, and shorten imaging when delayed studies would otherwise be required. Literature references cite GBEF thresholds (for example, 35%–40%) as consistent with gallbladder dysfunction, though clinical correlation is required and some measures (such as pain provocation) have limited predictive value for surgical outcomes.
Definitions
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