Harvard Pilgrim HealthCare Medical Policy

Cholecystectomy Surgery

STRIDEsm (HMO) MEDICARE ADVANTAGE

Subject: Cholecystectomy Surgery

Background:

Cholecystectomy is the surgical removal of the gallbladder, generally in response to gallstones causing pain or infection. It can be performed laparoscopically or as an open procedure. Some indications for laparoscopic and open cholecystectomy include gallbladder polyps, symptomatic and acalculous cholelithiasis, porcelain gallbladder, and asymptomatic cholelithiasis in patients who are at increased risk for gallbladder carcinoma or gallstone complications.

Authorization:

Prior authorization is required for all cholecystectomy procedures provided to members enrolled in Harvard Pilgrim StrideSM (HMO).

Urgent/emergent cholecystectomy procedures (i.e., services provided immediately following an ER visit) may be reviewed retrospectively to evaluate medical necessity and clinical appropriateness of the urgent/emergent procedure.

Policy and Coverage Criteria:

Harvard Pilgrim StrideSM (HMO) considers laparoscopic and/or open cholecystectomy procedures as medically necessary for members when medical record documentation confirms ANY of the following conditions;

• Acute Acalculous Cholecystitis when medical record documentation confirms ALL the following:
  • Documented consideration given to percutaneous cholecystostomy tube insertion;
  • Temperature >100.4 F (38.0 C);
  • Elevated white blood cell (WBC) count (above normal range);
  • Absence of gallstones or sludge on ultrasound;
  • Gallbladder wall thickening and pericholecystic fluid on ultrasound OR Nonvisualization of gallbladder on HIDA scan; and
  • ANY of the following:= Biliary colic,
    • Biliary colic,
    • Pain in upper abdomen or back,
    • Intolerance of feeding,
    • Nausea or vomiting,
• Acute Cholecystitis when medical record documentation confirms ALL the following:
  • Temperature >100.4 F (38.0 C),
  • Nausea or vomiting,
  • Temperature >100.4 F (38.0 C),
  • Elevated WBC (above normal),
  • Biliary colic, or pain in upper abdomen or back,
  • Right upper quadrant (RUQ) tenderness to manual or sonographic probe palpation (positive sonographic Murphy's sign), and EITHER of the following:
    • Gallstones with gallbladder wall thickening or pericholecystic fluid on ultrasound OR Non-visualization of gallbladder on HIDA scan

HPHC Medical Policy
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VA01APR22P

Harvard Pilgrim StrideSM (HMO) policies are based on medical science and relevant information including current Medicare coverage (including National and Local Coverage Determinations), Harvard Pilgrim medical policies, and Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan materials. These policies are intended to provide benefit coverage information and guidelines specific to the Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan.

Providers are responsible for reviewing the CMS Medicare Coverage Center guidance; in the event that there is a conflict between this document and the CMS Medicare Coverage Center guidance, the CMS Medicare Coverage Center guidance will control.

Acute Biliary Colic

when medical record documentation confirms ALL of the following:

• Emergency Room visit for acute abdominal pain refractory to IV Toradol and/or narcotics
  • Ultrasound documenting presence of gallstones, and
  • Right upper quadrant (RUQ) tenderness to manual or sonographic probe palpation (positive sonographic Murphy’s sign),

Biliary Colic

when medical record documentation confirms BOTH the following:

• Recurrent pain in upper abdomen or back and
  • Gallstones on imaging

Biliary Dyskinesia/Suspected Chronic Acalculous Cholecystitis or Biliary Hyperkinesia

when medical record documentation confirms ALL the following:

• Recurrent postprandial pain in upper abdomen or back,
• Absence of gallstones or sludge (by ultrasound), and
• Either
  • Gallbladder ejection fraction <35% (by CCK-HIDA or CCK-ultrasound study) or <50% with reproduction of pain by CCK injection or
  • Gallbladder ejection fraction >70% (by CCK-HIDA or CCK-ultrasound study)

Gallbladder polyp

when medical record documentation confirms that polyp is not non-calcified gallstone and ANY the following:

• Polyp size >10 mm,
• Growth in polyp size on serial imaging,
• Sessile polyp (i.e., attached by a broad base, as opposed to being pedunculated or stalked),

Gallbladder Wall Abnormality

when medical record documentation confirms the presence of ANY of the following:

• Gallbladder mucosal wall thickening (on ultrasound) without metastases (on imaging)

Pancreatitis

when documentation confirms ANY the following:

• Common Bile Duct stones or sludge on imaging (Ultrasound, MRCP, or CT)
• Presence of stones or sludge in the gallbladder with documented pancreatitis.
• Recurrent, idiopathic pancreatitis

History of gallstone ileus

when confirmed by computed tomography (CT), plain film or ultrasound, or

Suspected Chronic Cholecystitis

when medical record documentation confirms BOTH the following:

• Recurrent pain in upper abdomen or back
• Gallstones on imaging

NOTE: Minilaparoscopic cholecystectomy (MLC) is an approach of laparoscopic cholecystectomy rather than a procedure in and of itself and is therefore neither coded nor reimbursed separately. Harvard Pilgrim Healthcare (HPHC) considers single incision, natural orifice, robotic-assisted, and other forms of “improved” laparoscopic cholecystectomy besides MLC experimental/investigational and therefore not covered.

Exclusions:

Harvard Pilgrim StrideSM (HMO) Medicare Advantage does not cover laparoscopic or open cholecystectomy when the criteria above are not met. HPHC considers single incision, natural orifice, robotic-assisted, and other forms of “improved” laparoscopic cholecystectomy besides MLC experimental/investigational and therefore not covered.

HPHC Medical Policy
Page 2 of 4 Cholecystectomy Surgery
VA01APR22P

Harvard Pilgrim StrideSM (HMO) policies are based on medical science and relevant information including current Medicare coverage (including National and Local Coverage Determinations), Harvard Pilgrim medical policies, and Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan materials. These policies are intended to provide benefit coverage information and guidelines specific to the Harvard Pilgrim StrideSM (HMO) Medicare Advantage Plan.

Providers are responsible for reviewing the CMS Medicare Coverage Center guidance; in the event that there is a conflict between this document and the CMS Medicare Coverage Center guidance, the CMS Medicare Coverage Center guidance will control.

Supporting Information:

Polypoid lesions of the gallbladder, while usually benign or small, non-calcified gallstones that have been misdiagnosed due to a similar appearance in imaging, can be an early sign of gallbladder cancer, with size being the most trusted indicator of malignancy. While the traditional standard has been 10mm, recent research has indicated that polyps up to 13mm tend to be benign in patients younger than 46 years old and can be safely monitored for progression. A sessile (mound like, rather than the more typical stalk-like) shape and rapid growth are also reliable indicators of malignancy.

Cholecystectomy is the standard treatment for biliary colic, with some evidence suggesting that delaying treatment is more likely to lead to complications and morbidity than immediate cholecystectomy. Similar evidence exists for mild acute biliary or idiopathic pancreatitis.

In recent years, several less invasive forms of laparoscopic cholecystectomy, including single-incision laparoscopic cholecystectomy (SILC), minilaparoscopic cholecystectomy (MLC), natural orifice transluminal endoscopic surgery (NOTES), and robotic cholecystectomy, have been developed. As complication rates for laparoscopic cholecystectomy are already low, these procedures are largely hoped to improve recovery, patient experience, and cosmetic impact. While the advantages of MLC are marginal at best, MLC has a morbidity rate that appears to be similar if not slightly better than conventional laparoscopic cholecystectomy, uses reusable equipment common to offices that carry out laparoscopies, and uses similar technique to the more established procedure, so it can be considered and treated as a particular approach to laparoscopic cholecystectomy. While NOTES appears promising, it has yet to be subject to high-powered studies in humans and has not been extant for a sufficient period to study long term effects. SILC and robotic cholecystectomy have struggled to demonstrate non-inferiority.