CurrentAetnaPolicy 0259

Transjugular Intrahepatic Portosystemic Shunt (TIPSS)

Medical necessity and coverage guidance for TIPSS procedures, stent types, and indications/contraindications for Aetna members; applies to use of TIPSS for variceal bleeding, Budd-Chiari syndrome, portal hypertensive gastropathy, refractory ascites, and hepatic hydrothorax, and lists experimental/investigational indications.

Policy Summary

PayerAetna

PolicyTransjugular Intrahepatic Portosystemic Shunt (TIPSS)

Policy CodePolicy 0259

Change TypeNo material change

Effective DateJun 18, 1998

Next Review DateMar 14, 2024

Key ActionObtain prior authorization and document that the member meets one of the listed selection criteria before TIPSS or use of PTFE-covered stents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PTFE-coveredPTFE stents preferred

15Experimental indications

37182,37183Primary CPT codes

C1874,C1875HCPCS for coated stents

>15MELD threshold

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Medical Necessity — Covered Indications

Covered when ANY of the following clinical situations are present and selection criteria in background are met:

Covered Indications: Bleeding gastric, esophageal or ectopic (including anorectal, intestinal, and stomal) varices; Moderate Budd-Chiari syndrome in individuals who have failed to respond to anticoagulation; Portal hypertensive gastropathy with recurrent bleeding despite use of beta-blockers; Severe refractory ascites in individuals intolerant of repeated large-volume paracentesis; Refractory hepatic hydrothorax.

See background section for selection criteria and guideline recommendations.

Covered Device

Covered when ALL of the following are met:

Covered Device: Use of polytetrafluoroethylene (PTFE)-coated (covered) stents for TIPSS is considered medically necessary/preferred due to improved shunt patency and associated outcome benefits compared with bare stents.

Policy explicitly lists PTFE-coated stents as medically necessary; meta-analyses of RCTs show improved patency and survival with covered stents.

Experimental and Investigational — Not Covered Indications

TIPSS is considered experimental and investigational and therefore not covered for ALL other indications including, but not limited to:

Not covered indications list: Cirrhosis-related chylothorax; Controlling bleeding from gastric antral vascular ectasia in cirrhosis; Correction of hypersplenism and thrombocytopenia; Hepatopulmonary syndrome; Hepatorenal syndrome; Initial therapy for acute variceal hemorrhage; Initial therapy to prevent first or recurrent variceal hemorrhage; Portal hypertension associated with polycystic liver disease or Caroli disease; Portal-mesenteric venous thrombosis; Pre-hepatic portal hypertension; Pre-operative reduction in portal hypertension before liver transplantation; Prevention of re-bleeding in cirrhotic individuals with cavernous transformation of the portal vein; Prophylaxis of variceal hemorrhage; Pulmonary hypertension; Sinusoidal obstruction syndrome (veno-occlusive disease).

Document lists these as experimental/investigational because effectiveness has not been established.

Evidence-based indication summaries

Evidence-supported indications and findings summarized from guidelines, RCTs, and meta-analyses in the document:

TIPSS for acute variceal bleeding (high-risk): Randomized data (early TIPSS within 72 hours using covered stents) in high-risk cirrhotic patients demonstrated large reductions in treatment failure, rebleeding, and 1-year mortality compared with standard pharmacotherapy plus endoscopic therapy; early placement within 72 hours was used in trials.early placement within 72 hours; high-risk defined in trials

García-Pagán et al (2010) randomized trial.

TIPSS for refractory ascites: TIPS decreases the need for repeated large-volume paracentesis in refractory cirrhotic ascites but has uncertain effect on survival and increases encephalopathy risk; recommended for patients intolerant of repeated large-volume paracentesis and selected candidates after evaluation.diuretic-resistant or refractory ascites not controlled by medical therapy

UpToDate review and guideline recommendations.

Initial Candidate Criteria

Aetna considers TIPSS medically necessary when ANY of the following are met:

TIPSS selection criteria: Surgery is contraindicated and the member requires bleeding control from varices.

Selection criteria from Appendix.

TIPSS selection criteria: The member has failed sclerotherapy and has acute bleeding from varices.

Selection criteria from Appendix.

TIPSS selection criteria: The member has failed sclerotherapy and has had 2 or more episodes of re-bleeding requiring a transfusion during a 2-week period.

Selection criteria from Appendix.

TIPSS selection criteria: The member has severe debilitating ascites or hepatic hydrothorax refractory to medical management (e.g., oral diuretics and sodium restriction; and repeated large-volume paracentesis).

Do not use ICD-10 diagnosis codes that represent conditions listed as experimental/investigational to justify TIPSS coverage. Examples of such codes include D69.3–D69.6 (thrombocytopenia), D73.1 (hypersplenism), I81 (portal vein thrombosis / portal-mesenteric venous thrombosis), K76.5 (hepatic veno-occlusive disease / sinusoidal obstruction syndrome), K76.7 (hepatorenal syndrome), K76.81 (hepatopulmonary syndrome), Q44.6 (Caroli disease), and Z76.82 (awaiting organ transplant / preoperative reduction in portal hypertension).

Use of TIPS is not recommended for several specific conditions where guidelines or reviews state effectiveness is unproven or unfavorable. Clinical guidance notes TIPS should not be used to treat sinusoidal obstruction syndrome (veno-occlusive disease) or hepatopulmonary syndrome, and it is not appropriate as routine therapy for pulmonary hypertension. For diuretic‑resistant ascites, guidelines recommend serial large‑volume paracentesis as the initial therapy; TIPS may increase risk of hepatic encephalopathy and should be reserved for patients intolerant of repeated paracenteses or carefully selected candidates. TIPS is also not recommended as routine correction for hypersplenism/thrombocytopenia, pre‑hepatic portal hypertension, or as primary prophylaxis for variceal hemorrhage.

Cavernous transformation of the portal vein can limit the ability to decompress the portal circulation. Although TIPS may be technically feasible in some cases, the procedure is unlikely to adequately decompress the liver in most patients with established cavernous transformation; careful case selection, thorough preprocedural assessment, and consideration of anticoagulation after bleeding control are required when TIPS is contemplated.

Use of TIPSS for indications listed under the policy’s Experimental and Investigational section is considered not medically necessary. These include, but are not limited to, cirrhosis‑related chylothorax, controlling bleeding from gastric antral vascular ectasia in cirrhosis, correction of hypersplenism and thrombocytopenia, hepatopulmonary syndrome, hepatorenal syndrome, initial therapy for acute variceal hemorrhage, portal‑mesenteric venous thrombosis, pre‑operative reduction in portal hypertension prior to liver transplantation, prophylaxis of variceal hemorrhage, and sinusoidal obstruction syndrome.

TIPS should not be used as the initial therapy for diuretic‑resistant ascites when serial large‑volume paracentesis is the recommended initial approach. Guidelines recommend paracentesis as first‑line management because it is generally well tolerated and TIPS placement frequently results in hepatic encephalopathy; TIPS may be considered only in selected patients who are intolerant of or unsuitable for repeated paracentesis.

Coding and Clinical Thresholds

Covered CPT Codes (if selection criteria met)CPTCovered

37182	Insertion of transvenous intrahepatic portosystemic shunt(s) (TIPS) (includes venous access, hepatic and portal vein catheterization, portography with hemodynamic evaluation, intrahepatic tract formation/dilatation, stent placement and all associated imaging guidance and documentation).
37183	Revision of transvenous intrahepatic portosystemic shunt(s) (TIPS) (includes venous access, hepatic and portal vein catheterization, portography with hemodynamic evaluation, intrahepatic tract recanulization/dilatation, stent placement and all associated imaging guidance and documentation).

Covered HCPCS Codes for PTFE stentsHCPCSCovered

C1874	Stent, coated/covered, with delivery system [PTFE coated].
C1875	Stent, coated/covered, without delivery system [PTFE coated].

ICD-10 Codes covered if selection criteria metICD-10

I82.0	Budd-Chiari syndrome
I85.00	Esophageal varices without bleeding
I85.01	Esophageal varices with bleeding
I85.10	Secondary esophageal varices without bleeding
I85.11	Secondary esophageal varices with bleeding
I86.4	Gastric varices
J90	Pleural effusion, not elsewhere classified [hepatic hydrothorax]
K31.89	Other diseases of stomach and duodenum [portal hypertensive gastropathy]
R18.0	Ascites
K74.0	Hepatic fibrosis

1–10 of 15

1/2

ICD-10 Codes Not Covered / Experimental IndicationsICD-10Not Covered

D69.3-D69.6	Thrombocytopenia (listed as not covered for indications in CPB)
D73.1	Hypersplenism (listed as not covered)
I27.20-I27.29	Other secondary pulmonary hypertension (not covered)
I81	Portal vein thrombosis [portal-mesenteric venous thrombosis] (not covered)
K76.5	Hepatic veno-occlusive disease [Sinusoidal obstruction syndrome] (not covered)
K76.7	Hepatorenal syndrome (not covered)
K76.81	Hepatopulmonary syndrome (not covered)
Q44.6	Cystic disease of liver [Caroli disease] (not covered)
Z76.82	Awaiting organ transplant status [preoperative reduction in portal hypertension before liver transplantation] (not covered)

No explicit codes in this excerptmixed

No codes listed

MELD score and TIPSS outcomes

MELD score threshold> 15 is significantly associated with poorer survival after TIPSS (affects 30-day, 90-day, and 1‑year survival)

Study sourcePan et al (2008) analysis of 352 patients showing MELD > 15 predicted worse survival after TIPSS

Clinical implicationConsider MELD > 15 as a major risk factor when weighing TIPSS risk/benefit

Serum bilirubin and survival after TIPSS

Total bilirubin threshold> 2.5 mg/dL independently predictive of poor survival after TIPSS

Study sourcePan et al (2008) multivariable analysis (n=352)

Clinical implicationElevated bilirubin >2.5 mg/dL should prompt careful risk assessment before TIPSS

INR and TIPSS prognosis

INR threshold> 1.4 independently associated with poorer survival after TIPSS

Study sourcePan et al (2008) identified INR >1.4 as predictive of worse outcomes

Clinical implicationINR >1.4 should be considered when assessing procedural risk and prognosis

Serum creatinine and TIPSS outcomes

Serum creatinine threshold> 1.2 mg/dL independently predictive of poor survival after TIPSS

Study sourcePan et al (2008) multivariable analysis showed creatinine >1.2 mg/dL predicts worse survival

Clinical implicationRenal dysfunction (creatinine >1.2 mg/dL) increases risk; factor into selection and counseling

Age and survival after TIPSS

Age threshold> 70 years associated with poorer 90-day and 1‑year survival after TIPSS

Study sourcePan et al (2008) found age >70 years predicted worse survival (p < 0.05)

Clinical implicationAge >70 should prompt careful risk/benefit discussion before TIPSS

Portal pressure gradient reduction example

Example portal pressure gradient changeReported MTIPSS series documented portal pressure gradient reduction from ~30 mmHg to ~9 mmHg

ContextObserved in modified TIPSS (MTIPSS) series evaluating symptomatic improvement in Budd‑Chiari syndrome

Clinical implicationSubstantial portal pressure reduction can be achieved with TIPSS in select BCS patients, supporting symptomatic/technical benefit assessments

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for TIPSS procedures and for use of PTFE-coated stents when performed for covered indications. Requests for TIPSS must include clinical documentation supporting medical necessity and selection criteria from the Appendix.

Affected HCPCS: C1874, C1875
Affected CPT: 37182, 37183

Prior Authorization

Prior Authorization — Early TIPSS in High‑Risk Variceal Bleeding

Early-TIPSS (placement within 72 hours) for high‑risk acute variceal bleeding (e.g., Child‑Pugh class C or class B with persistent bleeding at endoscopy) has evidence of reduced treatment failure and mortality; such requests require prior authorization and documentation that the member meets high‑risk criteria.

Timeframe: within 72 hours of admission
Evidence reference: García‑Pagán et al. (2010)

Documentation Required

Medical Necessity Requirement

Medical necessity must be demonstrated for approval. Requests should document that the member meets one or more of the Appendix selection criteria (e.g., failed sclerotherapy with rebleeding, contraindication to surgery, severe refractory ascites intolerant of repeated large‑volume paracentesis).

Appendix selection examples: failed sclerotherapy with acute bleeding; ≥2 re‑bleeding episodes requiring transfusion in 2 weeks; refractory ascites or hepatic hydrothorax despite medical management

Note

Administrative / Contractual Context

This Clinical Policy Bulletin is intended to assist in administering plan benefits; specific prior authorization processes or forms may be implemented separately by the plan. The bulletin does not itself confer coverage and is not a contract; treating providers retain responsibility for clinical decisions.

Clinical Policy Bulletins are administrative guidance only
Coverage subject to plan/contract terms

Documentation Required

Required Documentation for Medical Necessity

Include detailed supporting documentation with authorization requests: pertinent procedure codes, clinical indication, prior treatments tried, imaging reports, and other diagnostic work‑up demonstrating the indication and selection criteria are met.

Include procedure codes: CPT 37182, 37183; HCPCS C1874, C1875 as applicable
Include clinical history of bleeding varices, ascites, or hydrothorax and prior therapy attempts

Documentation Required

Imaging and Diagnostic Documentation

For indications such as Budd‑Chiari syndrome or portal vein thrombosis, submit relevant imaging and diagnostic studies (e.g., duplex sonography, CT/MR venography, angiography, liver biopsy) to support the diagnosis and need for TIPSS.

Imaging: duplex ultrasonography, CT or MR venography, angiography
Pathology/biopsy reports when performed

Documentation Required

Required Clinical Justification

Clinical justification must explicitly support one of the medical‑necessity criteria. Demonstrate failure or intolerance of standard therapies (e.g., sclerotherapy, endoscopic band ligation, beta‑blockers, diuretics and sodium restriction, serial large‑volume paracenteses) or document that surgery is contraindicated.

State which standard therapies were tried, dates, and outcomes
If surgery is contraindicated, document reason

Step Therapy

Step Therapy for Refractory Ascites

For diuretic‑resistant (refractory) ascites, serial large‑volume paracentesis is the recommended initial therapy; TIPS is indicated only for selected patients after appropriate trials and documentation of intolerance or failure of paracentesis.

Document number and response to large‑volume paracenteses
Explain why TIPS is preferred over continued paracentesis for this member

Note

Step Therapy Not Specified / Plan‑Specific Rules

Where the policy does not specify formal step‑therapy requirements, individual prior authorization criteria and plan-specific utilization management rules may apply. If no step‑therapy is specified, follow the medical‑necessity and documentation requirements above.

Check plan-specific utilization rules for any additional requirements

Definitions

TIPSS — definition and purpose

DefinitionTransjugular intrahepatic portosystemic shunt (TIPSS) is a percutaneous, catheter-based creation of a permanent intrahepatic shunt between the hepatic and portal veins to reduce portal hypertension without an incision.

PurposeDiverts blood flow around the diseased liver to ease portal hypertension and treat complications such as uncontrolled variceal bleeding and refractory ascites

SettingUsually performed in the angiography or interventional radiology laboratory under intravenous anesthesia

PTFE-covered stent (definition and benefits)

Device descriptionPTFE-covered stents are polytetrafluoroethylene-coated stent grafts used in TIPSS to improve shunt patency and reduce variceal re-bleeding compared with bare stents.

EvidenceMeta-analyses and single‑center studies report improved primary patency and reduced re-bleeding with PTFE-covered stents

Clinical implicationPTFE-covered stents are preferred to lower risk of shunt dysfunction and re‑bleeding

Covered stent (CS) vs Bare stent (BS)

Comparison summaryCovered stents (e.g., PTFE/Viatorr/Fluency) are stent-grafts that reduce shunt dysfunction and are associated with improved primary patency and survival compared with bare stents in pooled analyses.

EvidenceMeta-analyses of RCTs and observational studies show higher patency, lower re-bleeding, and improved survival with covered stents versus bare stents

Clinical implicationPrefer covered stents for TIPSS when clinically appropriate to improve outcomes

Early‑TIPSS (definition and evidence)

DefinitionEarly‑TIPSS refers to placement of a PTFE-covered TIPSS within 72 hours of admission for selected high‑risk patients with acute variceal bleeding.

EvidenceRandomized data (García‑Pagán et al., 2010) showed early‑TIPSS reduced treatment failure, rebleeding, and 1‑year mortality compared with standard pharmacotherapy plus endoscopic therapy in high‑risk patients.

SelectionHigh‑risk status in trials included Child‑Pugh class C or class B with persistent bleeding at endoscopy

Refractory ascites (definition and policy context)

DefinitionRefractory ascites: ascites that is refractory to medical management such as oral diuretics and sodium restriction and requiring repeated large‑volume paracentesis.

Policy contextAetna considers TIPSS medically necessary for severe debilitating ascites or hepatic hydrothorax refractory to medical management and repeated paracentesis (see Appendix selection criteria).

Clinical implicationTIPSS may reduce need for paracentesis in selected patients but increases encephalopathy risk; reserve for those intolerant of repeated paracentesis

Failed sclerotherapy (definition and policy context)

DefinitionFailed sclerotherapy: persistent or recurrent variceal bleeding after sclerotherapy, including two or more episodes of re‑bleeding requiring transfusion during a 2‑week period.

Policy contextAetna lists failed sclerotherapy with acute or recurrent bleeding as a medical necessity indication for TIPSS (see Appendix selection criteria).

Clinical implicationDocument prior sclerotherapy attempts and transfusion‑requiring re‑bleeding when requesting TIPSS for this indication

OpenPayer

Transjugular Intrahepatic Portosystemic Shunt (TIPSS)

Coverage Criteria for TIPSS

Coding and Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions