Blue Cross Blue ShieldCommercial Clinical Policy

138 Form

Chat with GenHealth to automate any policy or prior auth task.


138

Indications

(1) No references added. Policy statements unchanged. 8/2022 Annual policy review. Policy revised to include coverage for serologic measurement of deamidated gliadin peptide (DGP) antibodies. Clarified coding information. Effective 8/1/2022. 1/2022 Clarified coding information. 2/2020 Policy updated with literature review through February 1, 2020. No references added. Policy statements unchanged. 2/2013 Annual policy review. New references added. 2/2013 Annual policy review. Changes made to policy statement. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements. 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition/ Organ Transplantation No changes to policy statements. 9/1/2011 Annual policy review. Policy revised to include a new policy statement stating that serologic measurement of deamidated gliadin peptide antibodies is investigational. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition/ Organ Transplantation No changes to policy statements. 11/01/2009 New policy. Effective 11/01/2009. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines 14 References 1. Catassi GN, Pulvirenti A, Monachesi C et al. Diagnostic Accuracy of IgA Anti-Transglutaminase and IgG Anti-Deamidated Gliadin for Diagnosis of Celiac Disease in Children under Two Years of Age: A Systematic Review and Meta-Analysis. Nutrients. 2021 Dec 21;14(1):7. 2. Saadah OI, Alamri AM, Al-Mughales JA. Deamidated gliadin peptide and tissue transglutaminase antibodies in children with coeliac disease: A correlation study. Arab J Gastroenterol. 2020 Sep;21(3):174-178. 3. Ortiz G, Messere G, Toca MDC et al. IgA anti-tissue transglutaminase antibodies and IgG antibodies against deamidated gliadin peptides as predictors of celiac disease. Arch Argent Pediatr. 2019 Feb 1;117(1):52-55. 4. Hill M, Watkins R, Leonard-Puppa E et al. Usefulness of deamidated gliadin peptide antibodies in diagnosing coeliac disease in children younger than 3 years old. J Paediatr Child Health. 2021 Dec 6. 5. Horton RK, Hagen CE, Snyder MR. Pediatric Celiac Disease: A Review of Diagnostic Testing and Guideline Recommendations. J Appl Lab Med. 2022 Jan 5;7(1):294-304. 6. American College of Gastroenterology Clinical Guideline: Diagnosis and Management of Celiac Disease May 2013. Am J Gastroenterol 2013; 108:656–676. 7. Sonia Niveloni, Emilia Sugai, Ana Cabanne et al. Antibodies against Synthetic Deamidated Gliadin Peptides as Predictors of Celiac Disease: Prospective Assessment in an Adult Population with a High Pretest Probability of Disease. Clinical Chemistry, Volume 53, Issue 12, 1 December 2007, Pages 2186–2192. https://academic.oup.com/clinchem/article/53/12/2186/5627321?login=false? 
(2) Green PH, Cellier C. Celiac disease. N Engl J Med 2007; 357(17):1731-43. 9. Walker-Smith JA GS, Schmitz J et al. Revised criteria for diagnosis of coeliac disease. Report of Working Group of European Society of Paediatric Gastroenterology and Nutrition. Arch Dis Child 1990; 65(8):909-11. 10. NIH consensus development conference on celiac disease. Consensus development conference statement. 2004. Available online at: http://consensus.nih.gov/2004/2004CeliacDisease118.html.htm. . Last accessed March 2010. 11. AGA Institute Medical Position Statement on the Diagnosis and Management of Celiac Disease. Gastroenterology 2006; 131(6):1977-80. 12. Hill ID, Dirks MH, Liptak GS et al. Guideline for the diagnosis and treatment of celiac disease in children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2005; 40(1):1-19. 13. Hill ID. What are the sensitivity and specificity of serologic tests for celiac disease? Do sensitivity? 
(3) and specificity vary in different populations? Gastroenterology 2005; 128(4 Suppl 1):S25-32.? 
(4) Zintzaras E, Germenis AE. Performance of antibodies against tissue transglutaminase for the diagnosis of celiac disease: meta-analysis. Clin Vaccine Immunol 2006; 13(2):187-92. 15. Naiyer AJ, Hernandez L, Ciaccio EJ et al. Comparison of commercially available serologic kits for the detection of celiac disease. J Clin Gastroenterol 2009; 43(3):225-32. 16. Sugai E, Moreno ML, Hwang HJ et al. Celiac disease serology in patients with different pretest probabilities: is biopsy avoidable? World J Gastroenterol 2010; 16(25):3144-52.? 
(5) Lagerqvist C, Dahlbom I, Hansson T et al. Antigliadin immunoglobulin A best in finding celiac disease in children younger than 18 months of age. J Pediatr Gastroenterol Nutr 2008; 47(4):428- 35. 18. Foucher B, Johanet C, Jego-Desplat S et al. Are Immunoglobulin A anti-gliadin antibodies of any help in the diagnosis of coeliac disease in children below 2 years-old? a French multicenter study. J? 

YesNoN/A
YesNoN/A

Sign up to see the rest of the questions

Unlock the remaining questions and the full coverage workflow.

Sign up for free
Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



1

Medical Policy Serological Diagnosis of Celiac Disease Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description • References • Authorization Information • Policy History
• Endnotes Policy Number: 138

BCBSA Reference Number: 2.04.30A (For Plan internal use only) NCD/LCD: N/A Related Policies Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon #185 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Diagnosis Serologic measurement of tissue transglutaminase (TTG) or antiendomysial antibodies (EMA) may be considered MEDICALLY NECESSARY in individuals with signs or symptoms suggestive of celiac disease.

Serologic measurement of antigliadin antibodies may be considered MEDICALLY NECESSARY in children less than 24 months of age with signs or symptoms suggestive of celiac disease.

Serologic measurement of deamidated gliadin peptide (DGP) antibodies is considered MEDICALLY NECESSARY in individuals with signs or symptoms suggestive of celiac disease.1

Serologic measurement of deamidated gliadin peptide antibodies is considered INVESTIGATIONAL in individuals without signs or symptoms suggestive of celiac disease.1

HLA-DQ2 and HLA-DQ8 testing may be considered MEDICALLY NECESSARY to rule out celiac disease in individuals with discordant serologic and histologic (biopsy) findings or if persistent symptoms warrant testing despite negative serology and histology. (see LCD L35000 for Medicare HMO/PPO Blue)

Monitoring
Monitoring adherence to a gluten-free diet with serum IgA anti-gliadin or IgA transglutaminase (TTG) levels is considered MEDICALLY NECESSARY.1

2

Screening Screening of asymptomatic at-risk patient groups for celiac disease using one or more serologic IgA or IgG measures is considered INVESTIGATIONAL.

Population screening for celiac disease using one or more serologic IgA or IgG measures is considered INVESTIGATIONAL.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.


Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 86364 Tissue transglutaminase

The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met:

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description D50.8 Other iron deficiency anemias D50.9 Iron deficiency anemia, unspecified D51.0 Vitamin B12 deficiency anemia due to intrinsic factor deficiency D51.1 Vitamin B12 deficiency anemia due to selective vitamin B12 malabsorption with proteinuria D51.3 Other dietary vitamin B12 deficiency anemia D51.8 Other vitamin B12 deficiency anemias

3

D51.9 Vitamin B12 deficiency anemia, unspecified D53.1 Other megaloblastic anemias, not elsewhere classified D73.0 Hyposplenism D80.2 Selective deficiency of immunoglobulin A [IgA] E06.3 Autoimmune thyroiditis E10.65 Type 1 diabetes mellitus with hyperglycemia E10.69 Type 1 diabetes mellitus with other specified complication E10.8 Type 1 diabetes mellitus with unspecified complications E10.9 Type 1 diabetes mellitus without complications E30.0 Delayed puberty E43 Unspecified severe protein-calorie malnutrition E44.0 Moderate protein-calorie malnutrition E44.1 Mild protein-calorie malnutrition E46 Unspecified protein-calorie malnutrition E55.9 Vitamin D deficiency, unspecified E86.0 Dehydration E88.09 Other disorders of plasma-protein metabolism, not elsewhere classified F93.8 Other childhood emotional disorders G11.10 Early-onset cerebellar ataxia, unspecified G11.19 Other early-onset cerebellar ataxia G11.2 Late-onset cerebellar ataxia G40.B01 Juvenile myoclonic epilepsy, not intractable, with status epilepticus G40.B09 Juvenile myoclonic epilepsy, not intractable, without status epilepticus G40.B11 Juvenile myoclonic epilepsy, intractable, with status epilepticus G40.B19 Juvenile myoclonic epilepsy, intractable, without status epilepticus G43.701 Chronic migraine without aura, not intractable, with status migrainosus G43.709 Chronic migraine without aura, not intractable, without status migrainosus G43.711 Chronic migraine without aura, intractable, with status migrainosus G43.719 Chronic migraine without aura, intractable, without status migrainosus G43.E01 Chronic migraine with aura, not intractable, with status migrainosus G43.E09 Chronic migraine with aura, not intractable, without status migrainosus G43.E11 Chronic migraine with aura, intractable, with status migrainosus G43.E19 Chronic migraine with aura, intractable, without status migrainosus G62.9 Polyneuropathy, unspecified G90.09 Other idiopathic peripheral autonomic neuropathy J84.03 Idiopathic pulmonary hemosiderosis K02.51 Dental caries on pit and fissure surface limited to enamel K02.61 Dental caries on smooth surface limited to enamel K12.0 Recurrent oral aphthae K12.30 Oral mucositis (ulcerative), unspecified K14.0 Glossitis K14.4 Atrophy of tongue papillae K20.0 Eosinophilic esophagitis K21.00 Gastro-esophageal reflux disease with esophagitis, without bleeding K21.01 Gastro-esophageal reflux disease with esophagitis, with bleeding K21.9 Gastro-esophageal reflux disease without esophagitis K50.00 Crohn's disease of small intestine without complications K50.011 Crohn's disease of small intestine with rectal bleeding K50.012 Crohn's disease of small intestine with intestinal obstruction K50.013 Crohn's disease of small intestine with fistula

4

K50.014 Crohn's disease of small intestine with abscess K50.018 Crohn's disease of small intestine with other complication K50.019 Crohn's disease of small intestine with unspecified complications K50.10 Crohn's disease of large intestine without complications K50.111 Crohn's disease of large intestine with rectal bleeding K50.112 Crohn's disease of large intestine with intestinal obstruction K50.113 Crohn's disease of large intestine with fistula K50.114 Crohn's disease of large intestine with abscess K50.118 Crohn's disease of large intestine with other complication K50.119 Crohn's disease of large intestine with unspecified complications K50.80 Crohn's disease of both small and large intestine without complications K50.811 Crohn's disease of both small and large intestine with rectal bleeding K50.812 Crohn's disease of both small and large intestine with intestinal obstruction K50.813 Crohn's disease of both small and large intestine with fistula K50.814 Crohn's disease of both small and large intestine with abscess K50.818 Crohn's disease of both small and large intestine with other complication K50.819 Crohn's disease of both small and large intestine with unspecified complications K50.90 Crohn's disease, unspecified, without complications K50.911 Crohn's disease, unspecified, with rectal bleeding K50.912 Crohn's disease, unspecified, with intestinal obstruction K50.913 Crohn's disease, unspecified, with fistula K50.914 Crohn's disease, unspecified, with abscess K50.918 Crohn's disease, unspecified, with other complication K50.919 Crohn's disease, unspecified, with unspecified complications K51.00 Ulcerative (chronic) pancolitis without complications K51.011 Ulcerative (chronic) pancolitis with rectal bleeding K51.012 Ulcerative (chronic) pancolitis with intestinal obstruction K51.013 Ulcerative (chronic) pancolitis with fistula K51.014 Ulcerative (chronic) pancolitis with abscess K51.018 Ulcerative (chronic) pancolitis with other complication K51.019 Ulcerative (chronic) pancolitis with unspecified complications K51.20 Ulcerative (chronic) proctitis without complications K51.211 Ulcerative (chronic) proctitis with rectal bleeding K51.212 Ulcerative (chronic) proctitis with intestinal obstruction K51.213 Ulcerative (chronic) proctitis with fistula K51.214 Ulcerative (chronic) proctitis with abscess K51.218 Ulcerative (chronic) proctitis with other complication K51.219 Ulcerative (chronic) proctitis with unspecified complications K51.30 Ulcerative (chronic) rectosigmoiditis without complications K51.311 Ulcerative (chronic) rectosigmoiditis with rectal bleeding K51.312 Ulcerative (chronic) rectosigmoiditis with intestinal obstruction K51.313 Ulcerative (chronic) rectosigmoiditis with fistula K51.314 Ulcerative (chronic) rectosigmoiditis with abscess K51.318 Ulcerative (chronic) rectosigmoiditis with other complication K51.319 Ulcerative (chronic) rectosigmoiditis with unspecified complications K52.831 Collagenous colitis K52.832 Lymphocytic colitis K52.838 Other microscopic colitis K52.839 Microscopic colitis, unspecified K52.89 Other specified noninfective gastroenteritis and colitis

5

K52.9 Noninfective gastroenteritis and colitis, unspecified K59.00 Constipation, unspecified K75.4 Autoimmune hepatitis K83.01 Primary sclerosing cholangitis K90.0 Celiac disease K90.3 Pancreatic steatorrhea K90.41 Non-celiac gluten sensitivity K90.49 Malabsorption due to intolerance, not elsewhere classified L13.0 Dermatitis herpetiformis M08.90 Juvenile arthritis, unspecified, unspecified site M25.50 Pain in unspecified joint M25.511 Pain in right shoulder M25.512 Pain in left shoulder M25.519 Pain in unspecified shoulder M25.521 Pain in right elbow M25.522 Pain in left elbow M25.529 Pain in unspecified elbow M25.531 Pain in right wrist M25.532 Pain in left wrist M25.539 Pain in unspecified wrist M25.541 Pain in joints of right hand M25.542 Pain in joints of left hand M25.549 Pain in joints of unspecified hand M25.551 Pain in right hip M25.552 Pain in left hip M25.559 Pain in unspecified hip M25.561 Pain in right knee M25.562 Pain in left knee M25.569 Pain in unspecified knee M25.571 Pain in right ankle and joints of right foot M25.572 Pain in left ankle and joints of left foot M25.579 Pain in unspecified ankle and joints of unspecified foot M25.59 Pain in other specified joint M62.5 Muscle wasting and atrophy, not elsewhere classified M81.6 Localized osteoporosis [Lequesne] M81.8 Other osteoporosis without current pathological fracture M83.2 Adult osteomalacia due to malabsorption M83.3 Adult osteomalacia due to malnutrition M83.8 Other adult osteomalacia M83.9 Adult osteomalacia, unspecified N46.9 Male infertility, unspecified N91.2 Amenorrhea, unspecified N97.9 Female infertility, unspecified P94.2 Congenital hypotonia Q90.9 Down syndrome, unspecified Q93.82 Williams syndrome Q96.8 Other variants of Turner's syndrome Q96.9 Turner's syndrome, unspecified R10.0 Acute abdomen R10.10 Upper abdominal pain, unspecified

6

R10.11 Right upper quadrant pain R10.12 Left upper quadrant pain R10.13 Epigastric pain R10.2 Pelvic and perineal pain R10.30 Lower abdominal pain, unspecified R10.31 Right lower quadrant pain R10.32 Left lower quadrant pain R10.33 Periumbilical pain R10.84 Generalized abdominal pain R10.9 Unspecified abdominal pain R11.0 Nausea R11.10 Vomiting, unspecified R11.11 Vomiting without nausea R11.2 Nausea with vomiting, unspecified R14.0 Abdominal distension (gaseous) R14.1 Gas pain R14.2 Eructation R14.3 Flatulence R19.4 Change in bowel habit R19.5 Other fecal abnormalities R19.7 Diarrhea, unspecified R19.8 Other specified symptoms and signs involving the digestive system and abdomen R21 Rash and other nonspecific skin eruption R23.8 Other skin changes R23.9 Unspecified skin changes R27.0 Ataxia, unspecified R27.8 Other lack of coordination R27.9 Unspecified lack of coordination R45.4 Irritability and anger (child) R51.9 Headache, unspecified R53.1 Weakness R53.8 Other malaise and fatigue R53.81 Other malaise R53.83 Other fatigue R60.0 Localized edema R60.1 Generalized edema R60.9 Edema, unspecified R62.51 Failure to thrive (child) R62.52 Short stature (child) R63.0 Anorexia R63.4 Abnormal weight loss R74.01 Elevation of levels of liver transaminase levels Z83.79 Family history of other diseases of the digestive system CPT Codes CPT codes: Code Description 86258 Gliadin antibody

The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met:

7

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description D50.8 Other iron deficiency anemias D50.9 Iron deficiency anemia, unspecified D51.0 Vitamin B12 deficiency anemia due to intrinsic factor deficiency D51.1 Vitamin B12 deficiency anemia due to selective vitamin B12 malabsorption with proteinuria D51.3 Other dietary vitamin B12 deficiency anemia D51.8 Other vitamin B12 deficiency anemias D51.9 Vitamin B12 deficiency anemia, unspecified D53.1 Other megaloblastic anemias, not elsewhere classified D73.0 Hyposplenism D80.2 Selective deficiency of immunoglobulin A [IgA] E06.3 Autoimmune thyroiditis E10.65 Type 1 diabetes mellitus with hyperglycemia E10.69 Type 1 diabetes mellitus with other specified complication E10.8 Type 1 diabetes mellitus with unspecified complications E10.9 Type 1 diabetes mellitus without complications E30.0 Delayed puberty E43 Unspecified severe protein-calorie malnutrition E44.0 Moderate protein-calorie malnutrition E44.1 Mild protein-calorie malnutrition E46 Unspecified protein-calorie malnutrition E55.9 Vitamin D deficiency, unspecified E86.0 Dehydration E88.09 Other disorders of plasma-protein metabolism, not elsewhere classified F93.8 Other childhood emotional disorders G11.10 Early-onset cerebellar ataxia, unspecified G11.19 Other early-onset cerebellar ataxia G11.2 Late-onset cerebellar ataxia G40.B01 Juvenile myoclonic epilepsy, not intractable, with status epilepticus G40.B09 Juvenile myoclonic epilepsy, not intractable, without status epilepticus G40.B11 Juvenile myoclonic epilepsy, intractable, with status epilepticus G40.B19 Juvenile myoclonic epilepsy, intractable, without status epilepticus G43.701 Chronic migraine without aura, not intractable, with status migrainosus G43.709 Chronic migraine without aura, not intractable, without status migrainosus G43.711 Chronic migraine without aura, intractable, with status migrainosus G43.719 Chronic migraine without aura, intractable, without status migrainosus G43.E01 Chronic migraine with aura, not intractable, with status migrainosus G43.E09 Chronic migraine with aura, not intractable, without status migrainosus G43.E11 Chronic migraine with aura, intractable, with status migrainosus G43.E19 Chronic migraine with aura, intractable, without status migrainosus G62.9 Polyneuropathy, unspecified G90.09 Other idiopathic peripheral autonomic neuropathy J84.03 Idiopathic pulmonary hemosiderosis K02.51 Dental caries on pit and fissure surface limited to enamel K02.61 Dental caries on smooth surface limited to enamel K12.0 Recurrent oral aphthae K12.30 Oral mucositis (ulcerative), unspecified

8

K14.0 Glossitis K14.4 Atrophy of tongue papillae K20.0 Eosinophilic esophagitis K21.00 Gastro-esophageal reflux disease with esophagitis, without bleeding K21.01 Gastro-esophageal reflux disease with esophagitis, with bleeding K21.9 Gastro-esophageal reflux disease without esophagitis K50.00 Crohn's disease of small intestine without complications K50.011 Crohn's disease of small intestine with rectal bleeding K50.012 Crohn's disease of small intestine with intestinal obstruction K50.013 Crohn's disease of small intestine with fistula K50.014 Crohn's disease of small intestine with abscess K50.018 Crohn's disease of small intestine with other complication K50.019 Crohn's disease of small intestine with unspecified complications K50.10 Crohn's disease of large intestine without complications K50.111 Crohn's disease of large intestine with rectal bleeding K50.112 Crohn's disease of large intestine with intestinal obstruction K50.113 Crohn's disease of large intestine with fistula K50.114 Crohn's disease of large intestine with abscess K50.118 Crohn's disease of large intestine with other complication K50.119 Crohn's disease of large intestine with unspecified complications K50.80 Crohn's disease of both small and large intestine without complications K50.811 Crohn's disease of both small and large intestine with rectal bleeding K50.812 Crohn's disease of both small and large intestine with intestinal obstruction K50.813 Crohn's disease of both small and large intestine with fistula K50.814 Crohn's disease of both small and large intestine with abscess K50.818 Crohn's disease of both small and large intestine with other complication K50.819 Crohn's disease of both small and large intestine with unspecified complications K50.90 Crohn's disease, unspecified, without complications K50.911 Crohn's disease, unspecified, with rectal bleeding K50.912 Crohn's disease, unspecified, with intestinal obstruction K50.913 Crohn's disease, unspecified, with fistula K50.914 Crohn's disease, unspecified, with abscess K50.918 Crohn's disease, unspecified, with other complication K50.919 Crohn's disease, unspecified, with unspecified complications K51.00 Ulcerative (chronic) pancolitis without complications K51.011 Ulcerative (chronic) pancolitis with rectal bleeding K51.012 Ulcerative (chronic) pancolitis with intestinal obstruction K51.013 Ulcerative (chronic) pancolitis with fistula K51.014 Ulcerative (chronic) pancolitis with abscess K51.018 Ulcerative (chronic) pancolitis with other complication K51.019 Ulcerative (chronic) pancolitis with unspecified complications K51.20 Ulcerative (chronic) proctitis without complications K51.211 Ulcerative (chronic) proctitis with rectal bleeding K51.212 Ulcerative (chronic) proctitis with intestinal obstruction K51.213 Ulcerative (chronic) proctitis with fistula K51.214 Ulcerative (chronic) proctitis with abscess K51.218 Ulcerative (chronic) proctitis with other complication K51.219 Ulcerative (chronic) proctitis with unspecified complications K51.30 Ulcerative (chronic) rectosigmoiditis without complications K51.311 Ulcerative (chronic) rectosigmoiditis with rectal bleeding

9

K51.312 Ulcerative (chronic) rectosigmoiditis with intestinal obstruction K51.313 Ulcerative (chronic) rectosigmoiditis with fistula K51.314 Ulcerative (chronic) rectosigmoiditis with abscess K51.318 Ulcerative (chronic) rectosigmoiditis with other complication K51.319 Ulcerative (chronic) rectosigmoiditis with unspecified complications K52.831 Collagenous colitis K52.832 Lymphocytic colitis K52.838 Other microscopic colitis K52.839 Microscopic colitis, unspecified K52.89 Other specified noninfective gastroenteritis and colitis K52.9 Noninfective gastroenteritis and colitis, unspecified K59.00 Constipation, unspecified K75.4 Autoimmune hepatitis K83.01 Primary sclerosing cholangitis K90.3 Pancreatic steatorrhea K90.41 Non-celiac gluten sensitivity K90.49 Malabsorption due to intolerance, not elsewhere classified L13.0 Dermatitis herpetiformis M08.90 Juvenile arthritis, unspecified, unspecified site M25.50 Pain in unspecified joint M25.511 Pain in right shoulder M25.512 Pain in left shoulder M25.519 Pain in unspecified shoulder M25.521 Pain in right elbow M25.522 Pain in left elbow M25.529 Pain in unspecified elbow M25.531 Pain in right wrist M25.532 Pain in left wrist M25.539 Pain in unspecified wrist M25.541 Pain in joints of right hand M25.542 Pain in joints of left hand M25.549 Pain in joints of unspecified hand M25.551 Pain in right hip M25.552 Pain in left hip M25.559 Pain in unspecified hip M25.561 Pain in right knee M25.562 Pain in left knee M25.569 Pain in unspecified knee M25.571 Pain in right ankle and joints of right foot M25.572 Pain in left ankle and joints of left foot M25.579 Pain in unspecified ankle and joints of unspecified foot M25.59 Pain in other specified joint M62.5 Muscle wasting and atrophy, not elsewhere classified M81.6 Localized osteoporosis [Lequesne] M81.8 Other osteoporosis without current pathological fracture M83.2 Adult osteomalacia due to malabsorption M83.3 Adult osteomalacia due to malnutrition M83.8 Other adult osteomalacia M83.9 Adult osteomalacia, unspecified N46.9 Male infertility, unspecified

10

N91.2 Amenorrhea, unspecified N97.9 Female infertility, unspecified P94.2 Congenital hypotonia Q90.9 Down syndrome, unspecified Q93.82 Williams syndrome Q96.8 Other variants of Turner's syndrome Q96.9 Turner's syndrome, unspecified R10.0 Acute abdomen R10.10 Upper abdominal pain, unspecified R10.11 Right upper quadrant pain R10.12 Left upper quadrant pain R10.13 Epigastric pain R10.2 Pelvic and perineal pain R10.30 Lower abdominal pain, unspecified R10.31 Right lower quadrant pain R10.32 Left lower quadrant pain R10.33 Periumbilical pain R10.84 Generalized abdominal pain R10.9 Unspecified abdominal pain R11.0 Nausea R11.10 Vomiting, unspecified R11.11 Vomiting without nausea R11.2 Nausea with vomiting, unspecified R14.0 Abdominal distension (gaseous) R14.1 Gas pain R14.2 Eructation R14.3 Flatulence R19.4 Change in bowel habit R19.5 Other fecal abnormalities R19.7 Diarrhea, unspecified R19.8 Other specified symptoms and signs involving the digestive system and abdomen R21 Rash and other nonspecific skin eruption R23.8 Other skin changes R23.9 Unspecified skin changes R27.0 Ataxia, unspecified R27.8 Other lack of coordination R27.9 Unspecified lack of coordination R45.4 Irritability and anger (child) R51.9 Headache, unspecified R53.1 Weakness R53.8 Other malaise and fatigue R53.81 Other malaise R53.83 Other fatigue R60.0 Localized edema R60.1 Generalized edema R60.9 Edema, unspecified R62.51 Failure to thrive (child) R62.52 Short stature (child) R63.0 Anorexia R63.4 Abnormal weight loss R74.01 Elevation of levels of liver transaminase levels

11

Z83.79 Family history of other diseases of the digestive system

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 86231 Endomysial antibody
Description Celiac disease, which may be referred to as celiac sprue or gluten-sensitive enteropathy, is defined as inflammation of the small intestine resulting from an immunologic intolerance to gluten (i.e., the proteins derived from wheat, barley, and rye). The diagnosis criteria reflects a positive biopsy at presentation, in conjunction with consistent history and serologic results, followed by a clinical response to a gluten-free diet, and relapse when dietary gluten is reintroduced.

Clinical symptoms are variable, nonspecific, and are often overlooked. In addition, the disease may develop at any time in life, from infancy to very old age. While a positive biopsy result is considered the gold standard for diagnosis, serologic evaluation of individuals with possible celiac disease can be used to triage the large numbers of individuals with nonspecific symptoms for biopsy.

Serologic diagnosis is focused on the detection of IgA antibodies, such as antigliadin, antiendomysial, and tissue transglutaminase. Antigliadin antibodies (AGA) can be detected using an enzyme-linked immunosorbent assay (ELISA) test. Another serologic study is to test for the presence of antiendomysial antibodies (EMA) also with an ELISA-based test, and a dot blot procedure that can be performed in the physician's office.

Deamidated gliadin peptide (DGP) antibody tests are the newest tests for celiac disease. Individuals have elevated levels of these antibodies if the celiac disease is untreated. The test measures levels of deamidated gliadin antibodies in the blood and if elevated it is indicative of celiac disease. The small intestine may be damaged, and malnutrition may occur in undiagnosed individuals. The test may be requested as deamidated gliadin peptide antibodies, DGP, DGP-AGA, or DGP IgA and IgG. The testing method is enzyme-linked immunosorbent assay, and the specimen is serum.

deamidated gliadin peptide (DGP) antibodies (anti-DGP), IgA or IgG may also be requested in individuals with suspected celiac disease who are negative for anti-TTG, especially children younger than 2 years old.

Examples of antibody testing for celiac disease are widely available from laboratories such as Quest, LabCorp, and Prometheus. All antibody tests for celiac disease are considered investigational regardless of the commercial name, the manufacturer or FDA approval status, except when used for the medically necessary indications that are consistent with the policy statement.

Summary Tissue Transglutaminase (TTG) and Antiendomysial Antibody (EMA)
Use of serology tests, if accurate, reduce the need for multiple biopsies. Evidence from systematic reviews and head-to-head comparative studies using biopsy as the gold standard conclude there is sufficient evidence that tissue transglutaminase and antiendomysial antibody tests are reasonably accurate for identifying celiac disease in individuals with signs or symptoms of the disease. One study found that in children under 18 months old, serologic measurement of antigliadin antibodies is more sensitive than either of the other 2 tests. For these reasons, these tests for the defined population may be considered medically necessary.

12

Deamidated Gliadin Peptide (DGP) Antibody
Evidence from a systemic review and meta-analysis evaluated by head-to-head comparison the diagnostic accuracy of TTG IgA and DGP IgG antibodies and concluded that TTG IgA specificity was significantly higher while the sensitivity of DGP IgG was higher. The authors concluded that both meta- analysis and the systematic review showed that some children with early celiac disease were missed without the DGP IgG test. While TTG IgA is the best celiac disease test in children <2 years of age, the study noted that the addition of DGP IgG may increase the diagnostic sensitivity. Catassi 2021

TTG-IgA antibody was compared with the deamidated gliadin peptide (DGP), of both IgG (DGP-IgG) and IgA (DGP-IgA) types, in individuals with celiac disease. The study included individuals with a median age of 15 years (range, 5-18 years). The authors found good correlation between TTG-IgA and DGP-IgG and TTG-IgA and DGP-IgA, and substantial agreement between TTG-IgA and DGP-IgG, but moderate agreement between TTG-IgA and DGP-IgA. The results indicated that DGP-IgG was comparable to TTG- IgA and may be useful as an alternative to TTG-IgA in the diagnosis and follow-up of individuals with celiac disease. Saadah OI 2020

This study compared the performance of IgA anti-tissue transglutaminase antibodies (IgA anti-TTG), IgA anti-endomysial antibodies (IgA EMA), and IgA/IgG antibodies against deamidated gliadin peptides (IgA/IgG anti-DGP) for the diagnosis of celiac disease. A total of 136 children were included with a median age of 78.4 months old. The authors concluded that IgA EMA, IgA anti-TTG, and IgG anti-DGP antibodies showed adequate specificity and sensitivity. The IgG anti-DGP/anti-TTG combination showed a 98-99 % sensitivity and a 100 % specificity. The anti-TTG and IgG anti-DGP option yields excellent results, with a low cost and independence from the observer. Ortiz G 2019.

This retrospective review (n=478) included children 3 years old and under, who had DGP and/or TTG serologies along with duodenal biopsies during their initial diagnostic evaluation. The authors reported that the positive predictive value (PPV) of the DGP-IgA test was 91.7% while DGP-IgG was 77.8%. When DGP serology was examined in conjunction with TTG-IgA, the PPV with DGP-IgA was 90.9% and with DGP-IgG was 87.5%. The study concluded that DGP-IgA provides high PPV and specificity for celiac in children younger than 3 years old while DGP-IgG showed lower PPV in this age group. When used alone or in conjunction with TTG-IgA, the DGP-IgA test results in a high PPV of 91.7 and 90.9%. This study recommended obtaining both the DGP-IgA and the TTG-IgA serology when screening infants and children younger than 3 years old for celiac disease. Leonard-Puppa 2021.

Pediatric Celiac Disease: A Review of Diagnostic Testing and Guideline
• For children under 2 years of age, the guidelines suggest that anti-DGP assays may be preferable to anti-TTG and that a biopsy was still recommended in these situations. • This newer guideline puts even more focus on TTG-IgA testing, recommending that this test be used for all children regardless of age and citing that anti-DGP may have lower specificity in younger children. Horton RK 2022.

This prospective study (n=141 adult individuals) showed that anti-DGP tests are accurate markers of celiac disease. The combinations of 2 tests, IgG a-DGP plus IgA a-TTG or the single blended conjugate detecting IgA + IgG a-DGP plus IgA a-TTG had 100% positive and negative predictive values. The authors concluded that a-DGP test, alone or in combination with the more commonly used a-TTG test, can potentially be used in many cases to avoid intestinal biopsy, thus having an impact on cost savings and better acceptance by individuals. Niveloni 2007

Based on the studies noted above, there is sufficient evidence that deamidated gliadin peptide (DGP) tests may be considered medically necessary in individuals with signs or symptoms suggestive of celiac disease.

There is insufficient evidence that measurement of DGP antibodies in asymptomatic individuals or population screening improves the net health outcome of asymptomatic individuals. On March 28, 2017,

13

the USPSTF concluded that current evidence is insufficient to assess the balance of benefits and harms of screening for celiac disease in asymptomatic individuals.

Monitoring adherence to a gluten-free diet with serum IgA anti-gliadin or IgA transglutaminase (TTG) levels Immunoglobulin A antibodies to deamidated gliadin peptides and tissue transglutaminase had the best and more consistent performances. The serial measurement of antibody levels seems to be more reliable in monitoring compliance than the positive/negative expression of results. Nachman F 2011

Gluten-free diet treatment produced rapid and significant qualitative and quantitative changes in celiac disease-related antibodies which may be useful for monitoring dietary compliance. Sugai E 2010

The World Gastroenterology Organization Global Guidelines 2016 suggested that periodic testing for IgA anti-tTG or IgA anti-DGP is the preferred method for monitoring compliance. UpToDate October 2022 recommended that serologic testing: IgA anti tissue transglutaminase (tTG) or IgA (or IgG) deamidated gliadin peptide (DGP) should be used to monitor the response to gluten-free diet Serologic testing is generally performed 6 and 12 months after the initial diagnosis of celiac disease and annually thereafter.

Policy History Date Action 10/2023 Coding information clarified. 3/2023 Policy revised to include that monitoring adherence to a gluten-free diet with serum IgA anti-gliadin or IgA transglutaminase (TTG) levels is considered medically necessary. Reference 28-38 added. Coding Clarified. Effective 3/1/2023. 1/2023 Added LCD information to HLA-DQ2 and HLA-DQ8 testing. 9/2022 Annual policy review. Policy updated with literature review through September

  1. No references added. Policy statements unchanged. 8/2022 Annual policy review. Policy revised to include coverage for serologic measurement of deamidated gliadin peptide (DGP) antibodies. Clarified coding information. Effective 8/1/2022. 1/2022 Clarified coding information. 2/2020 Policy updated with literature review through February 1, 2020. No references added. Policy statements unchanged. 2/2013 Annual policy review. New references added. 2/2013 Annual policy review. Changes made to policy statement. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
    10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition/ Organ Transplantation No changes to policy statements. 9/1/2011 Annual policy review. Policy revised to include a new policy statement stating that serologic measurement of deamidated gliadin peptide antibodies is investigational. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition/ Organ Transplantation No changes to policy statements. 11/01/2009 New policy. Effective 11/01/2009.
    Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

14

References

  1. Catassi GN, Pulvirenti A, Monachesi C et al. Diagnostic Accuracy of IgA Anti-Transglutaminase and IgG Anti-Deamidated Gliadin for Diagnosis of Celiac Disease in Children under Two Years of Age: A Systematic Review and Meta-Analysis. Nutrients. 2021 Dec 21;14(1):7.
  2. Saadah OI, Alamri AM, Al-Mughales JA. Deamidated gliadin peptide and tissue transglutaminase antibodies in children with coeliac disease: A correlation study. Arab J Gastroenterol. 2020 Sep;21(3):174-178.
  3. Ortiz G, Messere G, Toca MDC et al. IgA anti-tissue transglutaminase antibodies and IgG antibodies against deamidated gliadin peptides as predictors of celiac disease. Arch Argent Pediatr. 2019 Feb 1;117(1):52-55.
  4. Hill M, Watkins R, Leonard-Puppa E et al. Usefulness of deamidated gliadin peptide antibodies in diagnosing coeliac disease in children younger than 3 years old. J Paediatr Child Health. 2021 Dec
  6. Horton RK, Hagen CE, Snyder MR. Pediatric Celiac Disease: A Review of Diagnostic Testing and Guideline Recommendations. J Appl Lab Med. 2022 Jan 5;7(1):294-304.
  7. American College of Gastroenterology Clinical Guideline: Diagnosis and Management of Celiac Disease May 2013. Am J Gastroenterol 2013; 108:656–676.
  8. Sonia Niveloni, Emilia Sugai, Ana Cabanne et al. Antibodies against Synthetic Deamidated Gliadin Peptides as Predictors of Celiac Disease: Prospective Assessment in an Adult Population with a High Pretest Probability of Disease. Clinical Chemistry, Volume 53, Issue 12, 1 December 2007, Pages 2186–2192. https://academic.oup.com/clinchem/article/53/12/2186/5627321?login=false
  9. Green PH, Cellier C. Celiac disease. N Engl J Med 2007; 357(17):1731-43.
  10. Walker-Smith JA GS, Schmitz J et al. Revised criteria for diagnosis of coeliac disease. Report of Working Group of European Society of Paediatric Gastroenterology and Nutrition. Arch Dis Child 1990; 65(8):909-11.
  11. NIH consensus development conference on celiac disease. Consensus development conference statement. 2004. Available online at: http://consensus.nih.gov/2004/2004CeliacDisease118.html.htm. . Last accessed March 2010.
  12. AGA Institute Medical Position Statement on the Diagnosis and Management of Celiac Disease. Gastroenterology 2006; 131(6):1977-80.
  13. Hill ID, Dirks MH, Liptak GS et al. Guideline for the diagnosis and treatment of celiac disease in children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2005; 40(1):1-19.
  14. Hill ID. What are the sensitivity and specificity of serologic tests for celiac disease? Do sensitivity and specificity vary in different populations? Gastroenterology 2005; 128(4 Suppl 1):S25-32.
  15. Zintzaras E, Germenis AE. Performance of antibodies against tissue transglutaminase for the diagnosis of celiac disease: meta-analysis. Clin Vaccine Immunol 2006; 13(2):187-92.
  16. Naiyer AJ, Hernandez L, Ciaccio EJ et al. Comparison of commercially available serologic kits for the detection of celiac disease. J Clin Gastroenterol 2009; 43(3):225-32.
  17. Sugai E, Moreno ML, Hwang HJ et al. Celiac disease serology in patients with different pretest probabilities: is biopsy avoidable? World J Gastroenterol 2010; 16(25):3144-52.
  18. Lagerqvist C, Dahlbom I, Hansson T et al. Antigliadin immunoglobulin A best in finding celiac disease in children younger than 18 months of age. J Pediatr Gastroenterol Nutr 2008; 47(4):428-
  20. Foucher B, Johanet C, Jego-Desplat S et al. Are Immunoglobulin A anti-gliadin antibodies of any help in the diagnosis of coeliac disease in children below 2 years-old? a French multicenter study. J Pediatr Gastroenterol Nutr 2012; 54(1):110-2.
  21. Panetta F, Torre G, Colistro F et al. Clinical accuracy of anti-tissue transglutaminase as screening test for celiac disease under 2 years. Acta Paediatr 2011; 100(5):728-31.
  22. Hojsak I, Mozer-Glassberg Y, Segal Gilboa N et al. Celiac disease screening assays for children younger than 3 years of age: the performance of three serological tests. Dig Dis Sci 2012; 57(1):127-32.
  23. Hopper AD, Hadjivassiliou M, Hurlstone DP et al. What is the role of serologic testing in celiac disease? A prospective, biopsy-confirmed study with economic analysis. Clin Gastroenterol Hepatol 2008; 6(3):314-20.

15

  1. Katz KD, Rashtak S, Lahr BD et al. Screening for celiac disease in a North American population: sequential serology and gastrointestinal symptoms. Am J Gastroenterol 2011; 106(7):1333-9.
  2. Basso D, Guariso G, Bozzato D et al. New screening tests enrich anti-transglutaminase results and support a highly sensitive two-test based strategy for celiac disease diagnosis. Clin Chim Acta 2011; 412(17-18):1662-7.
  3. Mubarak A WV, Gmelig-Meyling FH, et al. Tissue transglutaminase levels above 100 U/ml and celiac disease: a prospective study. World J Gastroenterol 2012; 18(32):4399-403.
  4. Alessio MG TE, Brusca I, et al. Correlation between IgA tissue transglutaminase antibody ratio and histological finding in celiac disease. J Pediatr Gastroenterol Nutr 2012; 55(1):44-49.
  5. Catassi C, Kryszak D, Louis-Jacques O et al. Detection of celiac disease in primary care: a multicenter case-finding study in North America. Am J Gastroenterol 2007; 102(7):1454-60.
  6. Korponay-Szabo IR, Szabados K, Pusztai J et al. Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: diagnostic accuracy and feasibility study. BMJ 2007; 335(7632):1244-7.
  7. Sugai E, Nachman F, Váquez H, González A, Andrenacci P, Czech A, et al. Dynamics of celiac disease-specific serology after initiation of a gluten-free diet and use in the assessment of compliance with treatment. Dig Liver Dis 2010;42(5):352–8.
  8. Di Sabatino A, Volta U, Salvatore C, Biancheri P, Caio G, De Giorgio R, et al. Small amounts of gluten in subjects with suspected nonceliac gluten sensitivity: a randomized, double-blind, placebo- controlled, cross-over trial. Clin Gastroenterol Hepatol 2015;13(9):1604–1612.e3.
  9. Nachman F, Sugai E, Vázquez H, González A, Andrenacci P, Niveloni S, et al. Serological tests for celiac disease as indicators of long-term compliance with the gluten-free diet. Eur J Gastroenterol Hepatol 2011;23(6):473–80.
  10. Alberto Raiteri et al. Current guidelines for the management of celiac disease: A systematic review with comparative analysis. World J Gastroenterol. 2022 Jan 7; 28(1): 154–175.
  11. Mayo Clinic Laboratories Celiac Disease Routine Treatment Monitoring Algorithm
  12. http://www.mayocliniclabs.com/it- mmfiles/CeliacDiseaseRoutineTreatmentMonitoring_Algorithm.pdf
  13. Hopper AD, Hadjivassiliou M, Hurlstone DP, et al. What is the role of serologic testing in celiac disease? A prospective, biopsy-confirmed study with economic analysis. Clin Gastroenterol Hepatol 2008; 6:314.
  14. Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology 2006; 131:1981.
  15. Herman ML, Rubio-Tapia A, Lahr BD, et al. Patients with celiac disease are not followed up adequately. Clin Gastroenterol Hepatol 2012; 10:893.
  16. Rubio-Tapia A, Hill ID, Kelly CP, et al. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol 2013; 108:656.

  17. Husby S, Murray JA, Katzka DA. AGA Clinical Practice Update on Diagnosis and Monitoring of Celiac Disease-Changing Utility of Serology and Histologic Measures: Expert Review. Gastroenterology 2019; 156:885.

    Endnotes

    1 Based on expert opinion

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.