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Number: 0384 Policy Last Review - Aetna Medicaid€¦ · (MRCP) medically necessary ... Based on...

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1 of 22 6/7/17, 12:08 PM Number: 0384 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. Aetna considers magnetic resonance cholangiopancreatography (MRCP) medically necessary when any of the following is met: 1. Based on the initial work‐up, the member only requires diagnosis of suspected pancreaticobiliary pathology without the need for therapeutic intervention; or 2. Member has a documented allergy to iodine‐based contrast materials, or has a general history of atopy; or 3. Member has altered biliary tract anatomy that precludes endoscopic retrograde cholangiopancreatography (ERCP) (e.g., post‐surgical biliary tract alterations, prior gastrectomy, choledochojejunostomy, etc.); or 4. Member has undergone unsuccessful ERCP and requires further evaluation; or 5. Member is an infant or young child, or is an adult who is debilitated or uncooperative in such a manner that ERCP is unsafe or cannot be performed; or 6. Member requires definition of pancreaticobiliary anatomy proximal to a biliary tract system obstruction that cannot be opened by ERCP; or Last Review 04/13/2017 Effective: 02/01/2000 Next Review: 04/12/2018 Review History Definitions Clinical Policy Bulletin Notes
Transcript

1 of 22 6/7/17, 12:08 PM

Number: 0384

Policy

*Please see amendment for Pennsylvania Medicaid at the end

of this CPB.

Aetna considers magnetic resonance cholangiopancreatography

(MRCP) medically necessary when any of the following is met:

1. Based on the initial work‐up, the member only requires

diagnosis of suspected pancreaticobiliary pathology without

the need for therapeutic intervention; or

2. Member has a documented allergy to iodine‐based contrast

materials, or has a general history of atopy; or

3. Member has altered biliary tract anatomy that precludes

endoscopic retrograde cholangiopancreatography (ERCP) (e.g.,

post‐surgical biliary tract alterations, prior gastrectomy,

choledochojejunostomy, etc.); or

4. Member has undergone unsuccessful ERCP and requires

further evaluation; or

5. Member is an infant or young child, or is an adult who is

debilitated or uncooperative in such a manner that ERCP is

unsafe or cannot be performed; or

6. Member requires definition of pancreaticobiliary anatomy

proximal to a biliary tract system obstruction that cannot be

opened by ERCP; or

Last Review 04/13/2017

Effective: 02/01/2000

Next Review: 04/12/2018

Review History

Definitions

Clinical Policy Bulletin Notes

2 of 22 6/7/17, 12:08 PM

7. Member requires evaluation for a suspected congenital

anomaly of the pancreaticobiliary tract (e.g., aberrant ducts,

choledochal cysts, pancreas divisum, etc.); or

8. Diagnosing biliary obstruction in orthoptic liver transplant

recipients.

Aetna considers MRCP experimental and investigational for all

other indications (e.g., diagnosing autoimmune pancreatitis, and

monitoring of persons with primary sclerosing cholangitis)

because its effectiveness for indications other than the ones listed

above has not been established.

Aetna considers MRCP without IV contrast experimental and

investigational in the staging of pancreatic cancer, except in cases

of renal failure or other contraindications to administration of

gadolinium intravenous contrast.

Background

Ultrasonography (US) and computed tomography (CT) scanning

have been the standard non‐invasive techniques for showing

biliary calculi and pancreatic diseases, although magnetic

resonance imaging (MRI) and more recently endoscopic

ultrasound have shown excellent results. Magnetic resonance

cholangiopancreatography (MRCP) is a new non‐invasive modality

that shows fluid in the biliary and pancreatic ducts in an axial or

three‐dimensional image format, somewhat comparable in

appearance and diagnostic accuracy to radiographic techniques

seen with direct contrast endoscopic retrograde

cholangiopancreatography (ERCP). The major advantages of

MRCP include: (i) does not require administration of exogenous

contrast materials; and (ii) the potential avoidance of a purely

diagnostic ERCP with its attendant complications of cholangitis

and post‐ERCP pancreatitis. The major disadvantages of MRCP

include: (i) the lack of therapeutic capability; (ii) MRCP images are

not satisfactorily comparable to those provided by ERCP; (iii)

inability to provide information with regard to resectability of

pancreatic cancer; and (iv) MRCP equipment is not available at

every institution.

Endoscopic retrograde cholangiopancreatography remains the

gold standard in the diagnostic work‐up of the pancreaticobiliary

3 of 22 6/7/17, 12:08 PM

system. The real benefits of ERCP, as well as transhepatic

cholangiography, include: (i) ability to offer therapeutic

intervention at the time of the diagnostic procedure; (ii)

manometry can be performed; (iii) the ampulla of Vater can be

directly visualized; and (iv) the radiographic images obtained with

ERCP have a higher spatial resolution.

In current clinical practice, the majority of patients evaluated for

biliary tract disease have a high pre‐test likelihood of having a

problem requiring therapy (sphincterotomy, stone removal,

stenting, etc.), and should be directed toward ERCP for this

reason.

Magnetic resonance cholangiopancreatography may have a role

in those situations where initial evaluation suggests a benign

cause of biliary pathology requiring further cholangiographic

confirmation but not necessarily intervention. It may also be

useful in cases of failed ERCP before transhepatic

cholangiography, especially in cases where minimal intrahepatic

dilatation is suggested by ultrasound or CT, making percutaneous

transhepatic cholangiography more difficult. With complex

problems of the biliary tree, MRCP may allow a definitive

diagnosis, which may help plan a directed intervention

(endoscopic or transhepatic) that would have an increased

likelihood of success, with decreased risk. The utility of MRCP to

assess bile duct injuries, primary sclerosing cholangitis, sphincter

of Oddi dysfunction, and acute pancreatitis is unknown.

Fernandez‐Esparrach and colleagues (2007) compared the

diagnostic value of endoscopic ultrasonography (EUS) and MRCP

in: (i) patients with a dilated biliary tree unexplained by US (group

1), and (ii) the diagnosis of choledocholithiasis in patients with

non‐dilated biliary tree (group 2). Patients were prospectively

evaluated with EUS and MRCP. The gold standard used was

surgery or EUS‐FNA and ERCP, intra‐operative cholangiography, or

follow‐up when EUS and/or MRCP disclosed or precluded

malignancy, respectively. Likelihood ratios (LR) and pre‐test and

post‐test probabilities for the diagnosis of malignancy and

choledocholithiasis were calculated. A total of 159 patients met

one of the inclusion criteria but 24 of them were excluded for

4 of 22 6/7/17, 12:08 PM

different reasons. Therefore, 135 patients constituted the study

population. The most frequent diagnosis was choledocholithiasis

(49 % in group 1 and 42 % in group 2, p = 0.380) and malignancy

was more frequent in group 1 (35 % versus 7 %, respectively, p <

0.001). When EUS and MRCP diagnosed malignancy, its

prevalence in this series (35 %) increased up to 98 % and 96 %,

respectively, whereas it decreased to 0 % and 2.6 % when EUS

and MRCP precluded this diagnosis. In patients in group 2, when

EUS and MRCP made a positive diagnosis of choledocholithiasis,

its prevalence (42 %) increased up to 78 % and 92 %, respectively,

whereas it decreased to 6 % and 9 % when any pathological

finding was ruled out. The authors concluded that EUS and MRCP

are extremely useful in diagnosing or excluding malignancy and

choledocholithiasis in patients with dilated and non‐dilated biliary

tree. Thus, they are critical in the approach to the management

of these patients.

McMahon (2008) evaluated the relative roles of MRCP and EUS in

the investigation of common bile duct (CD) calculi using

"evidence‐based practice" methods. A focused clinical question

was constructed. A structured search of primary and secondary

evidence was performed. Retrieved studies were appraised for

validity, strength and level of evidence (Oxford/CEBM scale: 1 to

5). Retrieved literature was divided into group A: MRCP slice

thickness greater than or equal to 5 mm, group B: MRCP slice

thickness = 3 mm or 3D‐MRCP sequences. Six studies were

eligible for inclusion (3 = level 1b, 3 = level 3b). Group A:

sensitivity and specificity of MRCP and EUS were (40 %, 96 %) and

(80 %, 95 %), respectively. Group B: sensitivity and specificity of

MRCP and EUS were (87 %, 95 %) and (90 %, 99 %), respectively.

The authors concluded that MRCP should be the first‐line

investigation for CD calculi and EUS should be performed when

MRCP is negative in patients with moderate or high pre‐test

probability.

Autoimmune pancreatitis (AIP) represents a special type of

chronic pancreatitis. It occurs most commonly in elderly males

with painless jaundice or mild abdominal pain. It is a relatively

newly recognized type of pancreatitis that is characterized by

diffuse or focal swelling of the pancreas due to lympho‐

5 of 22 6/7/17, 12:08 PM

plasmacytic infiltration and fibrosis of the pancreatic

parenchyma. It is also known as ducto‐centric AIP, lobulo‐

centric AIP, idiopathic duct‐destructive pancreatitis, and lympho‐

plasmacytic sclerosing pancreatitis. The differential diagnosis of

AIP versus pancreatic cancer is important because AIP has been

found to respond to steroid treatment.

Fukumori and colleagues (20050 stated that MRCP visualizes only

the main pancreatic duct (MPD) in the pancreas head region.

Furthermore, while MRCP imaging of the MPD may be helpful in

the diagnosis of AIP, a negative result does not preclude such

diagnosis.

Carbognin et al (2009) retrospectively determined MRI, MRCP,

and secretin‐MRCP findings in patients with AIP. A total of 28

patients with histopathologically proven AIP were reviewed. In

14 cases, secretin‐enhanced MRCP was performed. The

observers evaluated pancreatic parenchymal enlargement, signal

intensity abnormalities, enhancement, vascular involvement,

bile‐duct diameter and MPD narrowing (diffuse/focal

/segmental). After secretin administration, the presence of the

"duct‐penetrating" sign was evaluated. Magnetic

resonance imaging showed diffuse pancreatic enlargement in

8/28 (29 %) cases, focal pancreatic enlargement in 16/28 (57 %)

cases and no enlargement in 4/28 (14 %) cases. The alteration of

pancreatic signal intensity was diffuse in 8/28 (29 %) cases (8

diffuse AIP) and focal in 20/28 (71 %) cases (20 focal AIP).

Delayed pancreatic enhancement was present in all AIP, with

peripheral rim of enhancement in 8/28 (29 %) AIP (1/8 diffuse,

7/20 focal); vascular encasement was present in 7/28 (25 %) AIP

(1/8 diffuse, 6/20 focal); distal common bile duct narrowing was

present in 12/28(43 %) AIP (5/8 diffuse, 7/20 focal). Magnetic

resonance cholangiopancreatography showed MPD narrowing in

17/28 (61 %) AIP (4/8 diffuse, 15/20 focal), MPD dilation in 8/28

(29 %) AIP (3/8 diffuse, 5/20 focal) and normal MPD in 1/8 diffuse

AIP. Secretin‐MRCP showed the duct‐penetrating sign in 6/14 (43

%) AIP (1 diffuse AIP with MPD segmental narrowing, 5 focal AIP

with MPD focal narrowing), demonstrating integrity of the MPD.

The authors concluded that delayed enhancement and MPD

stenosis are suggestive for AIP on MR and MRCP imaging.

6 of 22 6/7/17, 12:08 PM

Kamisawa et al (2009) stated that it is important to differentiate

AIP from pancreatic cancer. Irregular narrowing of the MPD is a

characteristic finding in AIP; it is useful for differentiating AIP from

pancreatic cancer stenosis. These investigators evaluated the

usefulness of MRCP for the diagnosis of AIP and assessed if MRCP

could replace ERCP for diagnosing AIP. The MRCP and ERCP

findings of 20 AIP patients were compared. On MRCP, the

narrowed portion of the MPD was not visible, while the non‐

involved segments of the pancreatic duct were visible. The

degree of upstream dilatation of the proximal MPD was milder in

AIP than in pancreatic cancer patients. In the skipped type, only

skipped narrowed lesions were not visible. After steroid therapy

for AIP, the non‐visualized MPD became visible. The authors

concluded that MRCP can not replace ERCP for the diagnosis of

AIP, since narrowing of the MPD in AIP was not visible on MRCP.

Moreover, MRCP findings of segmental or skipped non‐visible

MPD accompanied by a less dilated upstream MPD

may suggest the presence of AIP.

In a review on AIP, Detlefsen and Drewes (2009) stated that

pathologically, AIP shows narrowing of the pancreatic ducts and

the intra‐pancreatic portion of the common bile duct.

Obstructive jaundice is a common symptom at presentation, and

pancreatic cancer represents an important clinical differential

diagnosis. In late stages of the disease, the normal pancreatic

parenchyma is often replaced by large amounts of fibrosis.

Histologically, there seem to be 2 subtypes of the disease: (i) one

showing infiltration with IgG4‐positive plasma cells but lacking

granulocytic epithelial lesions (GELs), and (ii) the other showing

GELs but lacking strong IgG4 positivity. On the basis of

conventional pancreatic imaging (e.g., contrast‐enhanced CT, EUS,

dynamic T2‐weighted MRI, and trans‐abdominal US), together

with serological measurement of IgG4 and evaluation of other

organ involvement, many AIP patients can be identified. The

remaining patients require further diagnostic work‐up. In these

patients, pancreatic core needle biopsy and a trial with steroids

(since AIP responds to steroid treatment) can help to differentiate

AIP from pancreatic cancer.

Greenberger (2009) noted that the diagnostic criteria of AIP

7 of 22 6/7/17, 12:08 PM

proposed by the Mayo Clinic (the "HISORT" criteria) are most

commonly used in the United States and include the presence of

one or more of the following:

Diagnostic histology (based on resection specimen or

pancreatic core needle biopsy)

Response to steroid therapy of pancreatic (only in those

patients in whom a trial with steroid is indicated)/extra‐

pancreatic manifestations

Typical imaging (CT and pancreatography) plus any of the

following:

Compatible histology (i.e., at least supportive of AIP); or

Elevated serum IgG4 levels; or

Other organ involvement.

Moreover, Greenberger (2009) stated that ERCP or MRCP may

reveal a narrowed MPD and dorsal pancreatic duct; diffuse,

irregular narrowing of the pancreatic duct (beaded appearance),

or a focal stricture of the pancreatic duct, proximal or distal

common bile duct; or irregular narrowing of the intra‐hepatic

ducts. A stricture in the common bile duct or the finding of a

lesion in the head of the pancreas often prompts consideration of

malignancy. Thus, it may not be possible to distinguish AIP from

pancreatic cancer based upon the results of these imaging tests

alone.

Primary sclerosing cholangitis (PSC) is an immune‐

mediated, chronic cholestatic liver disease characterized by

progressive inflammation and fibrosis of the bile ducts, resulting

in biliary cirrhosis and is associated with a high‐risk of

cholangiocarcinoma (CCA), which develops in 10 to 30 % of PSC

patients. Early detection of CCA in PSC is achieved by using

serum tumor markers (carbohydrate antigen 19‐9 [CA 19‐9] and

carcinoembryonic antigen [CEA]), endoscopic ultrasonography

[EUS], as well as fluorescent in situ hybridization

[FISH] techniques to enhance the accuracy of biliary cytology

(Abbas and Lindor, 2009). Weismüller and colleagues (2008)

stated that the diagnosis of PSC is primarily based on endoscopic

cholangiography although MRI is increasingly used; biochemistry

8 of 22 6/7/17, 12:08 PM

and immuno‐serology as well as histology play only a minor role.

Due to the high‐risk of developing CCA and also other tumours of

the GI tract, surveillance strategies are essential, however they

have yet to be established and evaluated. Karnam and associates

(2009) stated that ERCP remains preferred in patients with PSC.

Moreover, the role of MRCP in the diagnosis and management of

bile duct malignancy is not yet defined.

Weber and associates (2008) stated that MRCP is a less‐invasive

alternative to ERCP for the diagnosis of PSC. These investigators

evaluated the diagnostic accuracy of MRCP in PSC compared with

ERCP, and assessed the diagnostic accuracy of different T2w

sequences. A total of 95 patients (69 PSC, 26 controls) were

evaluated using both ERCP and MRCP. Exclusion criteria included

secondary sclerosing cholangitis and contraindications to MRCP.

The diagnosis of PSC was confirmed in 69 patients based on ERCP

as the reference gold standard. Magnetic resonance

cholangiopancreatography was performed using a 1.5 Tesla MR

unit, using breath hold, coronal and transverse half‐Fourier

acquisition single‐shot turbo spin‐echo (HASTE), coronal‐oblique,

fat‐suppressed half‐Fourier rapid acquisition with relaxation

enhancement (RARE), and coronal‐oblique, fat‐suppressed, multi‐

section, thin‐section HASTE (TS‐HASTE) sequences. The MRCP

morphological criteria of PSC were evaluated and compared with

ERCP. The sensitivity, specificity, and diagnostic accuracy were 86

%, 77 %, and 83 %, respectively, using the MRCP‐RARE sequence,

and increased further to 93 %, 77 %, and 88 %, respectively, by

the inclusion of follow‐up MRCP in 52 patients, performed at 6‐

and 12‐month intervals. HASTE and TS‐HASTE sequences showed

significantly lower diagnostic accuracy but provided additional

morphologic information. The authors concluded that MRCP can

diagnose PSC but has difficulties in early PSC and in cirrhosis, and

in the differentiation of cholangiocarcinoma, Caroli's disease, and

secondary sclerosing cholangitis. A positive MRCP would negate

some diagnostic ERCP studies; but a negative MRCP would not

obviate the need for ERCP.

In a meta‐analysis, Dave et al (2010) determined the diagnostic

accuracy of MRCP for detection of PSC in patients with

biochemical cholestasis. Two reviewers searched MEDLINE,

9 of 22 6/7/17, 12:08 PM

EMBASE, and other electronic databases to identify prospective

studies in which MRCP was evaluated and compared with ERCP,

clinical examination, and/or histologic analysis for diagnosis of

PSC in cholestasis and control cases. Main study inclusion criteria

were (i) use of ERCP or percutaneous transhepatic

cholangiography (PTC) as part of the reference standard for the

diagnosis of PSC, (ii) inclusion of patients with hepatobiliary

disease other than PSC (i.e., non‐healthy control subjects), (iii)

blinding of MRCP image readers to reference‐standard results, (iv)

prospective study with ERCP or MRCP performed after subject

recruitment into the study, and (v) inclusion of raw data (for true‐

positive, false‐positive, true‐negative, and false‐negative results)

that could be found or calculated from the original study data.

Major exclusion criteria were duplicate article (on a primary

study) that contained all or some of the original study data and

inclusion of fewer than 10 patients with PSC. Methodologic

quality was assessed by using the Quality Assessment of

Diagnostic Accuracy Studies tool. Bi‐variate random‐effects meta‐

analytic methods were used to estimate summary, sensitivity,

specificity, and receiver operating characteristic (ROC) curves. A

total of 6 manuscripts with 456 subjects (with 623 independent

readings) ‐‐ 185 with PSC ‐‐ met the study inclusion criteria. The

summary area under the ROC curve was 0.91. High heterogeneity

(inconsistency index, 78 %) was found but became moderate

(inconsistency index, 36 %) with the exclusion of 1 study in which

the diagnostic threshold was set for high sensitivity. There was no

evidence of publication bias (p = 0.27, bias coefficient analysis).

Sensitivity and specificity of MRCP for PSC detection were 0.86

and 0.94, respectively. Positive and negative likelihood ratios with

MRCP were 15.3 and 0.15, respectively. In patients with high pre‐

test probabilities, MRCP enabled confirmation of PSC; in patients

with low pre‐test probabilities, MRCP enabled exclusion of PSC.

Worst‐ case‐scenario (pre‐test probability, 50 %) post‐test

probabilities were 94 % and 13 % for positive and negative MRCP

results, respectively. The authors concluded that MRCP has high

sensitivity and very high specificity for diagnosis of PSC. In many

cases of suspected PSC, MRCP is sufficient for diagnosis, and, thus,

the risks associated with ERCP can be avoided.

10 of 22 6/7/17, 12:08 PM

In a prospective study, Nebiker and colleagues (2009) analyzed

the rate of clinically inapparent common bile duct (CBD) stones,

the predictive value of elevated liver enzymes for CBD stones, and

the influence of the radiological results on the peri‐operative

management. A total of 465 patients were cholecystectomized

within 18 months, mainly laparoscopically. Pre‐operative MRCP

was performed in 454 patients. With MRCP screening, clinically

silent CBD stones were found in 4 %. Elevated liver enzymes have

only a poor predictive value for the presence of CBD stones

(positive predictive value, 21 %; negative predictive value, 96 %).

Compared to the recent literature, the post‐operative morbidity in

this study was low (0 % bile duct injury, 0.4 % residual

gallstones). The authors concluded that although MRCP is

diagnostically useful in the peri‐operative management in some

cases, its routine use in the diagnosis related group (DRG)‐era may

not be justified due to the costs.

Jorgensen et al (2011) stated that biliary complications are the

second leading cause of morbidity and mortality in orthotopic

liver transplant (OLT) recipients. Endoscopic retrograde

cholangiography is considered the diagnostic criterion standard

for post‐orthotopic liver transplantation biliary obstruction, but

incurs significant risks. These researchers ascertained the

diagnostic accuracy of MRCP for biliary obstruction in OLT

patients. A systematic literature search identified studies

primarily examining the utility of MRCP in detecting post‐

orthotopic liver transplantation biliary obstruction. A meta‐

analysis was then performed according to the Quality of

Reporting Meta‐Analyses statement. A meta‐analysis of 9 studies

originally performed at major transplantation centers was carried

out. A total of 382 OLT patients with clinical suspicion of biliary

obstruction were included in this analysis. major outcome

measures were sensitivity and specificity of MRCP for diagnosis of

biliary obstruction. The composite sensitivity and specificity were

0.96 (95 % confidence interval [CI]: 0.92 to 0.98) and 0.94 (95 %

CI: 0.90 to 0.97), respectively. The positive and negative

likelihood ratios were 17 (95 % CI: 9.4 to 29.6) and 0.04 (95 % CI:

0.02 to 0.08), respectively. All but 1 included study had

significant design flaws that may have falsely increased the

reported diagnostic accuracy. The authors concluded that high

11 of 22 6/7/17, 12:08 PM

sensitivity and specificity demonstrated in this meta‐analysis

suggested that MRCP is a promising test for diagnosing biliary

obstruction in patients who have undergone liver

transplantation. However, given the significant design flaws in

most of the component studies, additional high‐quality data are

necessary before unequivocally recommending MRCP in this

setting.

Giljaca et al (2015) stated that EUS and MRCP are tests used in

the diagnosis of common bile duct stones in patients suspected of

having common bile duct stones prior to undergoing invasive

treatment. There has been no systematic review of the accuracy

of EUS and MRCP in the diagnosis of common bile duct stones

using appropriate reference standards. These researchers

determined and compared the accuracy of EUS and MRCP for the

diagnosis of common bile duct stones. They searched MEDLINE,

EMBASE, Science Citation Index Expanded, BIOSIS, and

Clinicaltrials.gov until September 2012. In addition, they searched

the references of included studies to identify further

studies and of systematic reviews identified from various

databases (Database of Abstracts of Reviews of Effects (DARE),

Health Technology Assessment (HTA), Medion, and ARIF

(Aggressive Research Intelligence Facility)). They did not restrict

studies based on language or publication status, or whether data

were collected prospectively or retrospectively. These

investigators included studies that provided the number of true

positives, false positives, false negatives, and true negatives for

EUS or MRCP. They only accepted studies that confirmed the

presence of common bile duct stones by extraction of the stones

(irrespective of whether this was done by surgical or endoscopic

methods) for a positive test, and absence of common bile duct

stones by surgical or endoscopic negative exploration of the

common bile duct or symptom free follow‐up for at least 6

months for a negative test, as the reference standard in people

suspected of having common bile duct stones. They included

participants with or without prior diagnosis of cholelithiasis; with

or without symptoms and complications of common bile duct

stones, with or without prior treatment for common bile duct

stones; and before or after cholecystectomy. At least 2 authors

independently screened abstracts and selected studies for

12 of 22 6/7/17, 12:08 PM

inclusion. Two authors independently collected the data from

each study. They used the bi‐variate model to obtain pooled

estimates of sensitivity and specificity. The authors included a

total of 18 studies involving 2,366 participants (976 participants

with common bile duct stones and 1,390 participants without

common bile duct stones); 11 studies evaluated EUS alone, and 5

studies evaluated MRCP alone; 2 studies evaluated both tests.

Most studies included patients who were suspected of having

common bile duct stones based on abnormal liver function tests;

abnormal trans‐abdominal ultrasound; symptoms such as

obstructive jaundice, cholangitis, or pancreatitis; or a

combination of the above. The proportion of participants who

had undergone cholecystectomy varied across studies. Not one

of the studies was of high methodological quality. For EUS, the

sensitivities ranged between 0.75 and 1.00 and the specificities

ranged between 0.85 and 1.00. The summary sensitivity (95 % CI)

and specificity (95 % CI) of the 13 studies that evaluated EUS

(1,537 participants; 686 cases and 851 participants without

common bile duct stones) were 0.95 (95 % CI: 0.91 to 0.97) and

1.97 (95 % CI: 0.94 to 0.99). For MRCP, the sensitivities ranged

between 0.77 and 1.00 and the specificities ranged between 0.73

and 0.99. The summary sensitivity and specificity of the 7 studies

that evaluated MRCP (996 participants; 361 cases and 635

participants without common bile duct stones) were 0.93 (95 %

CI: 0.87 to 0.96) and 0.96 (95 % CI: 0.90 to 0.98). There was no

evidence of a difference in sensitivity or specificity between EUS

and MRCP (p value = 0.5). From the included studies, at the

median pre‐test probability of common bile duct stones of 41 %

the post‐test probabilities (with 95 % CI) associated with positive

and negative EUS test results were 0.96 (95 % CI: 0.92 to 0.98)

and 0.03 (95 % CI: 0.02 to 0.06). At the same pre‐test probability,

the post‐test probabilities associated with positive and negative

MRCP test results were 0.94 (95 % CI: 0.87 to 0.97) and 0.05 (95

% CI: 0.03 to 0.09). The authors concluded that both EUS and

MRCP have high diagnostic accuracy for detection of common bile

duct stones. People with positive EUS or MRCP should undergo

endoscopic or surgical extraction of common bile duct stones and

those with negative EUS or MRCP do not need further invasive

tests. However, if the symptoms persist, further investigations

will be indicated. The 2 tests are similar in terms of diagnostic

13 of 22 6/7/17, 12:08 PM

accuracy and the choice of which test to use will be informed by

availability and contra‐indications to each test.

An UpToDate review on “Magnetic resonance

cholangiopancreatography” (Karnam et al, 2015) states that

“Common bile duct stones ‐‐ The choice of procedure varies with

the clinical setting and local availability. In patients with

cholangitis, for example, ERCP is preferred because it permits

therapeutic drainage of the obstruction. However, MRCP may be

performed if cholangitis is not severe and the risks of ERCP are

high. MRCP may also be useful after unsuccessful or incomplete

ERCP and in imaging the CBD in patients undergoing laparoscopic

cholecystectomy. Endoscopic ultrasound may also be an option in

individuals considered at increased risk for ERCP”.

National Comprehensive Cancer Network’s clinical practice

guideline on “Pancreatic adenocarcinoma” (Version 1.2017) states

that “MR cholangiopancreatography (MRCP) without IV contrast

should not be utilized in the staging of pancreatic cancer, except

in cases of renal failure or other contraindications to

administration of gadolinium intravenous contrast”.

CPT Codes / HCPCS Codes / ICD‐10 Codes

Information in the [brackets] below has been added for clarification

purposes. Codes requiring a 7th character are represented by "+":

Other CPT codes related to the CPB:

43260 Endoscopic retrograde cholangiopancreatography

(ERCP); diagnostic, including collection of specimen(s)

by brushing or washing, when performed (separate

procedure)

74181 ‐

74183

Magnetic resonance (e.g., proton) imaging, abdomen

HCPCS codes covered if selection criteria are met:

S8037 Magnetic resonance cholangiopancreatography

(MRCP)

ICD‐10 codes covered if selection criteria are met:

B25.2 Cytomegaloviral pancreatitis

14 of 22 6/7/17, 12:08 PM

C22.1 Intrahepatic bile duct carcinoma

C23 Malignant neoplasm of gallbladder

C24.0 ‐

C24.9

Malignant neoplasm of other and unspecified parts of

biliary tract

C25.0 ‐

C25.9

Malignant neoplasm of pancreas

C78.80 ‐

C78.89

Secondary malignant neoplasm of other and

unspecified digestive organ

D01.5 Carcinoma in situ of liver, gallbladder and bile ducts

D37.8 ‐

D37.9

Neoplasm of uncertain behavior of other and

unspecified digestive organs

K74.3 ‐

K74.5

Biliary cirrhosis

K80.00 ‐

K80.81

Cholelithiasis

K82.0 Obstruction of gallbladder

K83.0 ‐

K83.9

Other diseases of biliary tract

K85.00 ‐

K86.9

Pancreatitis and other diseases of the pancreas

K87 Disorders of gallbladder, biliary tract and pancreas in

diseases classified elsewhere

K90.3 Pancreatic steatorrhea

K91.1 Postgastric surgery syndromes

K91.5 Postcholecystectomy syndrome

K91.89 Other postprocedural complications and disorders of

digestive system

P59.1 ‐

P59.29

Neonatal jaundice due to hepatocellular damage

P59.8 Neonatal jaundice from other specified causes

Q44.0 ‐

Q44.7

Congenital malformations of gallbladder, bile ducts

and liver

Q45.0 ‐

Q45.3

Congenital malformations of pancreas and pancreatic

duct

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R17 Unspecified jaundice

R93.2 Abnormal findings on diagnostic imaging of liver and

biliary tract

R94.5 Abnormal results of liver function studies

S31.001+, Open wound of lower back and pelvis with penetration

S31.011+ into retroperitoneum

S31.021+,

S31.031+

S31.041+,

S31.051+

S36.122+ ‐

S36.129

Injury of gallblader

S36.13x+ Injury of bile duct

Z94.4 Liver transplanr status

The above policy is based on the following references:

1. Carr‐Locke DL, Conn MI, Faigel DO, et al. Technology status

evaluation: Magnetic resonance

cholangiopancreatography: November 1998. From the

ASGE. American Society for Gastrointestinal Endoscopy.

Gastrointest Endosc. 1999;49(6):858‐861.

2. Georgopoulos SK, Schwartz LH, Jarnagin WR, et al.

Comparison of magnetic resonance and endoscopic

retrograde cholangiopancreatography in malignant

pancreaticobiliary obstruction. Arch Surg.

1999;134(9):1002‐1007.

3. Varghese JC, Farrell MA, Courtney G, et al. A prospective

comparison of magnetic resonance

cholangiopancreatography with endoscopic retrograde

cholangiopancreatography in the evaluation of patients

with suspected biliary tract disease. Clin Radiol.

1999;54(8):513‐520.

4. Lomas DJ, Bearcroft PW, Gimson AE. MR

cholangiopancreatography: Prospective comparison of a

breath‐hold 2D projection technique with diagnostic ERCP.

Eur Radiol. 1999;9(7):1411‐1417.

16 of 22 6/7/17, 12:08 PM

5. Hochwalk SN, Dobryansky M BA, Rofsky NM, et al.

Magnetic resonance cholangiopancreatography accurately

predicts the presence or absence of choledocholithiasis. J

Gastrointest Surg. 1998;2(6):573‐579.

6. Ferrucci JT. MRI and MRCP in pancreaticobiliary malignancy.

Ann Oncol. 1999;10 Suppl 4:18‐19.

7. Barish MA, Yucel EK, Ferrucci JT. Magnetic resonance

cholangiopancreatography. N Engl J Med.

1999;341(4):258‐264.

8. Halme L, Doepel M, von Numers H, et al. Complications of

diagnostic and therapeutic ERCP. Ann Chir Gynaecol.

1999;88(2):127‐131.

9. Deviere J, Matos C, Cremer M. The impact of magnetic

resonance cholangiopancreatography on ERCP. Gastrointest

Endosc. 1999;50(1):136‐140; discussion 140‐143.

10. Larena JA, Astigarraga E, Saralegui I, et al. Magnetic

resonance cholangiopancreatography in the evaluation of

pancreatic duct pathology. Br J Radiol.

1998;71(850):1100‐1104.

11. Sica GT, Braver J, Cooney MJ, et al. Comparison of

endoscopic retrograde cholangiopancreatography with MR

cholangiopancreatography in patients with pancreatitis.

Radiology. 1999;210(3):605‐610.

12. Owens GR, Shutz SM. Value of magnetic‐resonance

cholangiopancreatography (MRCP) after unsuccessful

endoscopic‐retrograde cholangiopancreatography (ERCP).

Gastrointest Endosc. 1999;49(2):265‐266.

13. Shimizu S, Kutsumi H, Fujimoto S, et al. Diagnostic

endoscopic retrograde cholangiopancreatography.

Endoscopy. 1999;31(1):74‐79.

14. Coakley FV, Schwartz LH. Magnetic resonance

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1999;19(1):25‐41; discussion 41‐44.

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20. Lee M‐G, Lee H‐J, Kim MH, et al. Extrahepatic biliary

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21. Soto JA, Barish MA, Yucel EK, et al. Magnetic resonance

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cholangiopancreatography. Gastroenterology.

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23. Reinhold C, Bret PM, Guibaud L, et al. MR

cholangiopancreatography: Potential clinical applications.

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25. Eisen GM, Dominitz JA, Faigel DO, et al. An annotated

algorithmic approach to malignant biliary obstruction.

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26. Prasad SR, Sahani D, Saini S. Clinical applications of

magnetic resonance cholangiopancreatography. J Clin

Gastroenterol. 2001;33(5):362‐366.

27. Albert JG, Riemann JF. ERCP and MRCP ‐‐ when and

why. Best Pract Res Clin Gastroenterol. 2002;16(3):399‐419.

28. Kalra M, Sahani D, Ahmad A, et al. The role of magnetic

resonance cholangiopancreatography in patients with

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Rep. 2002;4(2):160‐166.

29. Aronson N, Flamm CR, Mark D, et al. Endoscopic retrograde

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Publication No. 02‐E008. Rockville, MD: Agency for

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/ercpsum.htm. Accessed October 30, 2002.

30. Balfe DM, Ralls PW, Bree RL, et al. Imaging strategies in the

evaluation of the jaundiced patient. American College of

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2000;215(Suppl):125‐133.

31. American College of Radiology (ACR). ACR Appropriateness

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32. Motohara T, Semelka RC, Bader TR. MR

cholangiopancreatography. Radiol Clin North

Am. 2003;41(1):89‐96.

33. Fayad LM, Kowalski T, Mitchell DG. MR

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Am. 2003;41(1):97‐114.

34. Kaltenthaler E, Vergel YB, Chilcott J, et al. A systematic

review and economic evaluation of magnetic resonance

cholangiopancreatography compared with diagnostic

endoscopic retrograde cholangiopancreatography. Health

Technol Assess. 2004;8(10):iii, 1‐89.

35. Dalal PU, Howlett DC, Sallomi DF, et al. Does intravenous

glucagon improve common bile duct visualisation during

magnetic resonance cholangiopancreatography? Results in

42 patients. Eur J Radiol. 2004;49(3):258‐261.

36. Metreweli C, So NM, Chu WC, Lam WW. Magnetic

resonance cholangiography in children. Br J Radiol.

2004;77(924):1059‐1064.

37. Andersson M, Kostic S, Johansson M, et al. MRI combined

with MR cholangiopancreatography versus helical CT in the

evaluation of patients with suspected periampullary

tumors: A prospective comparative study. Acta Radiol.

2005;46(1):16‐27.

38. Hallal AH, Amortegui JD, Jeroukhimov IM, et al. Magnetic

resonance cholangiopancreatography accurately detects

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common bile duct stones in resolving gallstone pancreatitis.

J Am Coll Surg. 2005;200(6):869‐875.

39. Shanmugam V, Beattie GC, Yule SR, et al. Is magnetic

resonance cholangiopancreatography the new gold

standard in biliary imaging? Br J Radiol.

2005;78(934):888‐893.

40. Romagnuolo J, Bardou M, Rahme E, et al. Magnetic

resonance cholandiopancreatography: A metaanalysis of

test performance in suspected biliary disease. Ann Intern

Med. 2003;139(7):547‐557.

41. Medical Services Advisory Committee (MSAC). Magnetic

resonance cholangiopancreatography. MSAC Reference 25.

Canberra, ACT: MSAC; 2005.

42. Verma D, Kapadia A, Eisen GM, Adler DG. EUS vs MRCP for

detection of choledocholithiasis. Gastrointest Endosc.

2006;64(2):248‐254.

43. Hoeffel C, Azizi L, Lewin M, et al. Normal and pathologic

features of the postoperative biliary tract at 3D MR

cholangiopancreatography and MR imaging. Radiographics.

2006;26(6):1603‐1620.

44. Halefoglu AM. Magnetic resonance

cholangiopancreatography: A useful tool in the evaluation

of pancreatic and biliary disorders. World J Gastroenterol.

2007;13(18):2529‐2534.

45. Tipnis NA, Werlin SL. The use of magnetic resonance

cholangiopancreatography in children. Curr Gastroenterol

Rep. 2007;9(3):225‐229.

46. Fernández‐Esparrach G, Ginès A, Sánchez M, et al.

Comparison of endoscopic ultrasonography and magnetic

resonance cholangiopancreatography in the diagnosis of

pancreatobiliary diseases: A prospective study. Am J

Gastroenterol. 2007;102(8):1632‐1639.

47. McMahon CJ. The relative roles of magnetic resonance

cholangiopancreatography (MRCP) and endoscopic

ultrasound in diagnosis of common bile duct calculi: A

critically appraised topic. Abdom Imaging. 2008;33(1):6‐9.

48. Jain M, Agarwal A. MRCP findings in recurrent pyogenic

cholangitis. Eur J Radiol. 2008;66(1):79‐83.

49. McMahon CJ. The relative roles of magnetic resonance

cholangiopancreatography (MRCP) and endoscopic

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ultrasound in diagnosis of common bile duct calculi: A

critically appraised topic. Abdom Imaging. 2008;33(1):6‐9.

50. McMahon CJ. The relative roles of magnetic resonance

cholangiopancreatography (MRCP) and endoscopic

ultrasound in diagnosis of malignant common bile duct

calculi: A critically appraised topic. Abdom Imaging.

2008;33(1):10‐13.

51. Hekimoglu K, Ustundag Y, Dusak A, et al. MRCP vs. ERCP in

the evaluation of biliary pathologies: Review of current

literature. J Dig Dis. 2008;9(3):162‐169.

52. Fukumori K, Shakado S, Miyahara T, et al. Atypical

manifestations of pancreatitis with autoimmune

phenomenon in an adolescent female. Intern Med.

2005;44(8):886‐891.

53. Weismüller TJ, Wedemeyer J, Kubicka S, et al. The

challenges in primary sclerosing cholangitis ‐‐

aetiopathogenesis, autoimmunity, management and

malignancy. J Hepatol. 2008;48 Suppl 1:S38‐S57.

54. Carbognin G, Girardi V, Biasiutti C, et al. Autoimmune

pancreatitis: Imaging findings on contrast‐enhanced MR,

MRCP and dynamic secretin‐enhanced MRCP. Radiol Med.

2009;114(8):1214‐1231.

55. Kamisawa T, Tu Y, Egawa N, et al. Can MRCP replace ERCP

for the diagnosis of autoimmune pancreatitis? Abdom

Imaging. 2009;34(3):381‐384.

56. Detlefsen S, Drewes AM. Autoimmune pancreatitis. Scand J

Gastroenterol. 2009;44(12):1391‐1407.

57. Greenberger NJ. Autoimmune pancreatitis. UpToDate

[online serial]. Waltham, MA: UpToDate; reviewed

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58. Abbas G, Lindor KD. Cholangiocarcinoma in primary

sclerosing cholangitis. J Gastrointest Cancer.

2009;40(1‐2):19‐25.

59. Karnam US, Kruskal JB, Reddy KR. Magnetic resonance

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Waltham, MA: UpToDate; reviewed September 2009.

60. Weber C, Kuhlencordt R, Grotelueschen R, et al. Magnetic

resonance cholangiopancreatography in the diagnosis of

primary sclerosing cholangitis. Endoscopy.

2008;40(9):739‐745.

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61. Nebiker CA, Baierlein SA, Beck S, et al. Is routine MR

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cholecystectomy? Langenbecks Arch Surg.

2009;394(6):1005‐1010.

62. Sugumar A, Chari ST. Diagnosis and treatment of

autoimmune pancreatitis. Curr Opin Gastroenterol.

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63. Dave M, Elmunzer BJ, Dwamena BA, Higgins PD. Primary

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performance of MR cholangiopancreatography. Radiology.

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64. Jorgensen JE, Waljee AK, Volk ML, et al. Is MRCP equivalent

to ERCP for diagnosing biliary obstruction in orthotopic liver

transplant recipients? A meta‐analysis. Gastrointest Endosc.

2011;73(5):955‐962.

65. Xu YB1, Min ZG, Jiang HX, et al. Diagnostic value of

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a

partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide

health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are

independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating

providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be

updated and therefore is subject to change.

Copyright © 2001‐2017 Aetna Inc.

AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number:

0384 Magnetic Resonance Cholangiopancreatography

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 06/09/2017


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