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Helicobacter Pylori Testing

Policy Number: MP-258

Latest Review Date: July 2018

Category: Medicine/Laboratory                                             

Policy Grade: Effective 02/06/2013: Active Policy but no longer scheduled for regular literature reviews and updates.

POLICY:

Effective for dates of service on and after September 10, 2018:

Urea Breath Testing using the carbon isotope (13C or 14C) or fecal antigen testing for Helicobacter Pylori (H. Pylori) may be considered medically necessary in patients who meet one of the following criteria below:

  1. Evaluation of new onset dyspepsia in persons younger than 60 years of age without alarm symptoms (anemia, weight loss, vomiting, lymphadenopathy); OR
  2. Evaluation of persons with persistent symptoms of dyspepsia despite 2 weeks of appropriate medication therapy for H. pylori; OR
  3. Evaluation of persons with a prior history of untreated H. Pylori infection and with recurrent symptoms.
  4. Before starting proton pump inhibitor therapy for dyspepsia; OR
  5. Before bariatric surgery for obesity; OR
  6. Re-evaluation to assess success of eradication of H. pylori infection (Note: testing to ensure eradication should occur no sooner than 4 weeks post treatment).

Serologic testing for H. Pylori may be considered medically necessary in patients who meet one of the following criteria below:

  1. Evaluation of new onset dyspepsia in patients younger than 60 years of age without alarm symptoms (anemia, weight loss, vomiting, lymphadenopathy); OR
  2. Before bariatric surgery for obesity

Urea Breath Testing using the carbon isotope (13C or 14C), fecal antigen testing, or serological testing for Helicobacter Pylori (H. Pylori) is considered not medically necessary and investigational for all other indications, including but not limited to, the following:

  1. Assessing the risk of developing dementia
  2. Dyspepsia associated with alarm markers (Endoscopy is recommended)
  3. Evaluating infantile colic
  4. Managing recurrent aphthous stomatitis
  5. New onset dyspepsia in persons aged 60 years or older (upper GI endoscopy is indicated because of concern for gastric neoplasia)
  6. Screening of asymptomatic person for H. pylori infection

Any combination of simultaneous urea breath testing, fecal antigen testing, and/or serological testing for H. pylori is considered not medically necessary.

Effective for dates of service prior to September 10, 2018:

The Urea Breath Test (UBT) using the carbon isotope (13C or 14C) or the fecal antigen test to detect Helicobacter Pylori (H. Pylori) infection may be considered medically necessary in patients who meet these criteria:

  1. Patients with a prior history of treated H. Pylori infection and with recurrent symptoms.
  2. As a follow-up to determine H. Pylori eradication in patients with peptic ulcer and either:
    1. Persistent symptoms after an initial course of anti-H. Pylori therapy; OR
    2. High risk factors for ulcer recurrence, such as documented peptic ulcers complicated by bleeding, perforation, or obstruction.
  3. In dyspeptic patients ≤ age 55 years with no alarm symptoms (e.g., weight loss, bleeding, dysphagia, anemia, abdominal mass, jaundice, family history of gastric cancer, personal history of peptic ulcer, anorexia, early satiety, etc.) in populations where there is a moderate to high prevalence of H. Pylori infection (≥ 10%).

Serologic testing for H. Pylori may be considered medically necessary as a part of the initial workup of a patient with newly diagnosed dyspepsia to guide appropriate empiric therapy or as part of the preoperative evaluation of patients undergoing bariatric surgery (Roux-en-y gastric bypass).

The UBT or fecal antigen test is considered not medically necessary in all other situations, including but not limited to the following conditions:

  1. Routine screening of asymptomatic persons for H. Pylori infection. As part of the initial work up in patients < 50 years of age with newly diagnosed dyspepsia to guide appropriate empiric therapy; serologic testing is sufficient.
  2. As a routine follow-up test to determine H. Pylori eradication in patients with peptic ulcer but without persistent symptoms or high risk factors for recurrence.
  3. As part of the initial work up of patients with dyspepsia and at increased risk for gastric malignancy, i.e., patients over age 50 and those with “alarm” symptoms of anorexia, early satiety, weight loss, anemia, or gastrointestinal bleeding.  These patients are candidates for immediate endoscopy.

The simultaneous use of the UBT and the fecal antigen test for H. Pylori infection is considered not medically necessary because concurrent testing with both methods is not necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

The recognition of the role of the bacterium Helicobacter Pylori (H. Pylori) in the pathogenesis of peptic ulcer disease has revolutionized the therapy of peptic ulcer. Specifically, 80% to 95% of patients with duodenal ulcers and 70% to 90% of patients with gastric ulcers have coexisting H. Pylori gastritis. Eradication of H. Pylori infection using a variety of combinations of antibiotics, bismuth compounds, and acid suppression therapy has emerged as a basic treatment strategy for these ulcers. However, it is important to realize that the majority of patients positive for H. Pylori do not develop ulcer symptoms.  In addition, the role of H. Pylori therapy in non-ulcer dyspepsia alone is uncertain. Dyspepsia refers to a group of symptoms which include epigastric pain or discomfort, indigestion, upset stomach, bloating or nausea. Some dyspepsia symptoms (e.g. postprandial gnawing or burning relieved by foods or antacids) are suggestive of ulcers. Other symptoms (e.g. belching, bloating, or fullness) may be related to non-ulcer dyspepsia.  Nevertheless, there is considerable overlap between ulcer and non-ulcer dyspepsia.  Invasive detection of H. Pylori involves upper GI endoscopy with a biopsy. Non-invasive methods include serologic identification of anti-H. Pylori antibodies, detection of H. Pylori antigens in the feces, or the urea breath test (UBT). While serologic tests indicate either past or present infection, fecal antigens and UBT indicates active disease.

Noninvasive Testing for H. pylori

Urea Breath Test (UBT)

Urea breath testing is based on the high urease activity of H. Pylori, which hydrolyzes urea to carbon dioxide and ammonia. In the urea breath test, the patient ingests urea labeled with a carbon isotope, either 13C or 14C, and then the concentration of the isotope is measured in the expired CO2. Analysis of the concentration of 13C requires the use of mass spectrometry, and the sample must be submitted to the manufacturer’s reference laboratory for analysis. In contrast, 14C is radioactive, and while its use exposes the patient to a small dose of radiation, its presence can be measured using scintillation counting.

The sensitivity and specificity of the UBT is reported to be 88% and 95-100%, respectively. False positive results are uncommon. Patients being tested for H. pylori should discontinue PPIs, bismuth, and/or antibiotics prior to being tested. These medications could cause false negative results.

Fecal Antigen Test

H. Pylori antigens can be detected in the stool by applying antibodies to a diluted stool sample complexed to a detection molecule.

The sensitivity and specificity of the fecal antigen test is reported to be 94% and 97%, respectively. This testing can be affected by PPIs, bismuth, and/or antibiotics as well and should be discontinued prior to testing.

Serological Test

Serological testing for H. pylori does not dependably differentiate between active and past infections, and additionally, it requires validation at the local level. The sensitivity and specificity of serological testing has been reported to be 85% and 79% respectively.

KEY POINTS:

Summary of Evidence

For individuals undergoing testing for H. pylori for the risk of developing dementia, dyspepsia with alarm markers, evaluating infantile colic, managing recurrent aphthous stomatitis, new onset dyspepsia older than 60 years, and the screening of asymptomatic patients for HP infection, the evidence consists of cohort studies and case control studies. Overall, the evidence is weak and only hypotheses are presented in several of the studies. High quality and long term data are needed to determine the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American College of Gastroenterology (ACG)

In 2017, the ACG and the Canadian Association of Gastroenterology published a joint guideline on the management of dyspepsia.

The summary and strength of recommendations are in Table 1.

Table 1:  Management of dyspepsia

We suggest dyspepsia patients aged 60 or over have an endoscopy to exclude upper gastrointestinal neoplasia.

Conditional recommendation, very low quality evidence.

We do not suggest endoscopy to investigate alarm features for dyspepsia patients under the age of 60 to exclude upper GI neoplasia.

Conditional recommendation, moderate quality evidence

We recommend dyspepsia patients under the age of 60 should have a non-invasive test for H. pylori , and therapy for H. pylori infection if positive.

Strong recommendation, high quality evidence

We recommend dyspepsia patients under the age of 60 should have empirical PPI therapy if they are H. pylori -negative or who remain symptomatic after H. pylori eradication therapy.

Strong recommendation, high quality evidence.

We suggest dyspepsia patients under the age of 60 not responding to PPI or H. pylori eradication therapy should be offered prokinetic therapy.

Conditional recommendation very low quality evidence.

We suggest dyspepsia patients under the age of 60 not responding to PPI or H. pylori eradication therapy should be offered TCA therapy.

Conditional recommendation low quality evidence.

We recommend FD patients that are H. pylori positive should be prescribed therapy to treat the infection.

Strong recommendation, high quality evidence.

We recommend FD patients who are H. pylori -negative or who remain symptomatic despite eradication of the infection should be treated with PPI therapy.

Strong recommendation, moderate quality evidence.

We recommend FD patients not responding to PPI or H. pylori eradication therapy (if appropriate) should be offered TCA therapy.

Conditional recommendation, moderate quality evidence.

We suggest FD patients not responding to PPI, H. pylori eradication therapy or tricyclic antidepressant therapy should be offered prokinetic therapy.

Conditional recommendation, very low quality evidence

We suggest FD patients not responding to drug therapy should be offered psychological therapies.

Conditional recommendation, very low quality evidence.

We do not recommend the routine use of complementary and alternative medicines for FD.

Conditional Recommendation, very low quality evidence.

We recommend against routine motility studies for patients with FD.

Conditional recommendation, very low quality evidence.

We suggest motility studies for selected patients with FD where gastroparesis is strongly suspected.

Conditional recommendation, very low quality evidence.

FD, functional dyspepsia; H. pylori , Helicobacter pylori ; PPI, proton pump

inhibitor; TCA, tricyclic antidepressant.

Also in 2017, the ACG updated their clinical guidelines regarding the treatment of Helicobacter pylori. 

The indications to test for, and to treat, H. pylori infection are in Table 2.

Table 2: Indications to test for and treat H. Pylori

Since all patients with a positive test of active infection with H. pylori should be offered treatment, the critical issue is which patients should be tested for the infection

strong recommendation, quality of evidence: not applicable

All patients with active peptic ulcer disease (PUD), a past history of PUD (unless previous cure of H. pylori infection has been documented), low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma, or a history of endoscopic resection of early gastric cancer (EGC) should be tested for H. pylori infection. Those who test positive should be offered treatment for the infection

strong recommendation, quality of evidence: high for active or history of PUD, low for MALT lymphoma, low for history of endoscopic resection of EGC

In patients with uninvestigated dyspepsia who are under the age of 60 years and without alarm features, non-endoscopic testing for H. pylori infection is a consideration. Those who test positive should be offered eradication therapy

Conditional recommendation, quality of evidence: high for efficacy, low for the age threshold

When upper endoscopy is undertaken in patients with dyspepsia, gastric biopsies should be taken to evaluate for H. pylori infection. Infected patients should be offered eradication therapy

Strong recommendation, high quality of evidence

Patients with typical symptoms of gastroesophageal reflux disease (GERD) who do not have a history of PUD need not be tested for H. pylori infection. However, for those who are tested and found to be infected, treatment should be offered, acknowledging that effects on GERD symptoms are unpredictable

strong recommendation, high quality of evidence

In patients taking long-term low-dose aspirin, testing for H. pylori infection could be considered to reduce the risk of ulcer bleeding. Those who test positive should be offered eradication therapy

conditional recommendation, moderate quality of evidence

Patients initiating chronic treatment with a non-steroidal anti-inflammatory drug (NSAID) should be tested for H. pylori infection

strong recommendation, moderate quality of evidence

Those who test positive should be offered eradication therapy. The benefits of testing and treating H. pylori in patients already taking NSAIDs remains unclear

conditional recommendation, low quality of evidence

Patients with unexplained iron deficiency (ID) anemia despite an appropriate evaluation should be tested for H. pylori infection. Those who test positive should be offered eradication therapy

conditional recommendation, high quality of evidence

Adults with idiopathic thrombocytopenic purpura (ITP) should be tested for H. pylori infection. Those who test positive should be offered eradication therapy

conditional recommendation, very low quality of evidence

There is insufficient evidence to support routine testing and treating of H. pylori in asymptomatic individuals with a family history of gastric cancer or patients with lymphocytic gastritis, hyperplastic gastric polyps and hyperemesis gravidarum

no recommendation, very low quality of evidence

KEY WORDS:

Helicobacter Pylori (H. Pylori), urea breath test (UBT), 13C isotope, 14C isotope, dyspepsia, peptic ulcer disease, fecal antigen test, serological testing

APPROVED BY GOVERNING BODIES:

The FDA has approved multiple tests for urea breath testing and fecal antigen testing.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CODING: 

CPT Codes:

78267              Urea breath test, C-14 (isotopic); acquisition for analysis
78268             

Urea breath test, C-14 (isotopic); analysis

83009             

Helicobacter Pylori, blood test analysis for urease activity, non-radioactive isotope (e.g., C-13)

83013             

Helicobacter Pylori; breath test analysis for urease activity, non-radioactive isotope (e.g., C-13)

83014             

Helicobacter Pylori; drug administration

86677             

Antibody; Helicobacter pylori

87338             

Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semi-quantitative, multiple step method; Helicobacter Pylori, stool

REFERENCES:

  1. Ables AZ, Simon I and Melton ER.  Update on helicobacter Pylori treatment.  American Family Physician, February 2007, Vol. 75, No. 3, pp. 351-358.
  2. Ali AM. Helicobacter pylori and infantile colic. Arch Pediatr Adolesc Med. 2012 Jul 1; 166(7):648-50.
  3. American Gastroenterological Association.  American Gastroenterological Association Medical Position Statement:  Evaluation of Dyspepsia, Gastroenterology, November 2005; 129: 1753-1755.
  4. Basset C, et al.  Review article: Diagnosis and treatment of Helicobacter: A 2002 updated review. Alimentary Pharmacology and Therapeutics, June 2003; 17 Suppl 2: 89-97.
  5. Baudron RC, Letenneur L, Langlais A, et al. Does helicobacter pylori infection increase incidence of dementia? The personnes agees QUID study. J Am Geriatr Soc. 2013 Jan; 61(1):74-8.
  6. Braden B, et al. Detection of Helicobacter Pylori infection: When to perform which test? Annals of Medicine, March 2001; 33(2): 91-97.
  7. Chaves LC, Borges IK, Souza MD, et al. Inflammatory disorders associated with helicobacter pylori in the roux-en-y bypass gastric pouch. Arq Bras Cir Dig. 2016; 29Suppl1(Suppl1):31-34.
  8. Chey WD. Accurate diagnosis of Helicobacter Pylori 14-C urea breath test. Gastroenterology Clinics, December 2000, Vol. 29, No. 4.
  9. Chey WD, et al.  Noninvasive Helicobacter Pylori testing for the “test and treat” strategy: A decision analysis to assess the effect of past infection on test choice. Archives of Internal Medicine, September 2001; 161(17): 2129-2132.
  10. Chey WD Wong BCY, et al. American College of Gastroenterology Guideline on the management of helicobacter Pylori infection. Am J Gastroenterol 2007; 102: 1808-1825.
  11. Chey WD, Leontiadis GI, Howden CW, et al. ACG clinical guideline: Treatment of helicobacter pylori infection. Am J Gastroenterol. 2017 Feb; 1112(2):212-239.
  12. Cutler AF.  Diagnostic tests for Helicobacter Pylori infection. Gastroenterologist, September 1997; 5(3): 202-212.
  13. Czinn SJ.  Helicobacter Pylori infection: Detection, investigation, and management. Journal of Pediatrics, March 2005, Vol. 146, No. 3 Suppl.
  14. Fani L, Wolters FJ, Ikram MK, et al. Helicobacter pylori and the risk of dementia: A population based study. Alzheimer’s Dement. 2018 Jun 20. Pii: S1552-5260 (18) 3030159-6.
  15. Fendrick AM, et al. Alternative management strategies for patients with suspected peptic ulcer disease. Annals of Internal Medicine, August 1995; 123(4): 260-268.
  16. Ferwana M, Abdulmajeed I, Alhajiahmed A, et al. Accuracy of urea breath test in helicobacter pylori infection: meta-analysis. World J Gastroenterol. 2015 Jan 28; 21(4):1305-14.
  17. Ford AC. Helicobacter Pylori “test and treat” or endoscopy for managing dyspepsia: An individual patient data. Gastroenterology, June 2005; 128(7): 1838-1844.
  18. Gatta L, et al. Non-invasive techniques for the diagnosis of Helicobacter Pylori infection. Clinical Microbiology and Infection, June 2003; 9(6): 489-496.
  19. Gisbert JP, et al.  Review article: C-urea breath test in the diagnosis of Helicobacter Pylori infection—A critical review. Alimentary Pharmacology and Therapeutics, November 2004; 29(10): 1001-1017.
  20. Gisbert JP. 13C-urea breath test in the management of Helicobacter Pylori infection. Digestive Liver Disease, December 2005; 37(12): 899-906.
  21. Gomes CC, Gomez RS, Zina LG, Amaral FR. Recurrent aphthous stomatitis and helicobacter pylori. Med Oral Patol Oral Cir buccal. 2016 Mar 1; 21(2):e187-91.
  22. Howden CW, et al. Guidelines for the management of Helicobacter Pylori infection, The American Journal of Gastroenterology. December 1998, Vol. 93, No. 12, pp. 2330-2338.
  23. Institute for Clinical Systems Improvement (ICSI). Dyspepsia and GERD, www.icsi.org/knowledge/detail.asp?catID=29&itemID=171. (Last updated 8/17/04)
  24. Iqbal S, Fatima S, Raheem A, et al. Agreement between serology and histology for detection of helicobacter pylori infection. J Coll Physicians Surg Park. 2013 Nov; 23(10):784-6.
  25. Kaplan LM. Gastrointestinal management of the bariatric surgery patient. Gastroenterology Clinics, March 2005, Vol. 34, No. 1.
  26. Klein PD, et al. Non-invasive detection of Helicobacter Pylori infection in clinical practice: The 13-C urea breath test. American Journal of Gastroenterology, April 1996, Vol. 91, No. 4, pp. 690-694.
  27. Ling D. Caron 13 urea breath test for helicobacter pylori infection in patients with uninvestigated ulcer like dyspepsia: an evidence based analysis. Ont Health Technol Assess Ser. 2013 Oct 1; 13(19): 1-30.
  28. Logan RP, et al. One week eradication regimen for Helicobacter Pylori. The Lancet, November 1991; 338(8777): 1249-1252.
  29. Loy CT, et al. Do commercials serological kits for Helicobacter Pylori infection differ in accuracy? A meta-analysis. American Journal of Gastroenterology, June 1996, Vol. 91, No. 6.
  30. Meurer LN and Dower DJ. Management of Helicobacter Pylori infection. American Family Physician 2002; 65(7).
  31. Mocanu V, Dang JT, Switzer N, et al. The effect of helicobacter pylori on postoperative outcomes in patients undergoing bariatric surgery: a systematic review and meta-analysis. Obes Surg. 2018 Feb; 28(2):567-573.
  32. Moayyedi PM, Lacy BE, Andrews CN, et al. ACG and CAG clinical guideline: Management of dyspepsia. Am J Gastroenterol. 2017; 112(7):987.
  33. Nakamura RM. Laboratory tests for the evaluation of Helicobacter Pylori infections. Journal of Clinical Laboratory Analysis, January 2001; 15(6): 301-307.
  34. National Institute for Clinical Excellence (NICE). Dyspepsia-management of dyspepsia in adults in primary care. London, UK 2004.
  35. National Institutes of Health (NIH) Consensus Statement. Helicobacter Pylori in peptic ulcer disease. January 1994, pp. 1-23.
  36. Ofman JJ, et al. Management strategies for Helicobacter Pylori-seropositive patients with dyspepsia: Clinical and economic consequences. Annals of Internal Medicine, February 1997; 126(4): 280-291.
  37. Pathak CM, et al. Urea breath test for Helicobacter Pylori detection: Present status. Tropical Gastroenterology, October 2004; 25(4): 156-161.
  38. Peng NJ, et al. Capsule 13C-urea breath test for the diagnosis of Helicobacter Pylori infection. World Journal of Gastroenterology, March 2005; 11(9): 1361-1364.
  39. Saad RJ, et al. Diagnosis and management of peptic ulcer disease. Clinics in Family Practice, September 2004, Vol. 6, No. 3.
  40. Saha R, Roy P, Das S, et al. Application of a stool antigen test to evaluate the burden of helicobacter pylori infection in dyspepsia patients. Indian J Pathol Microbiol. 2016 Jan-Mar; 59(1):66-8.
  41. Slomianski A, et al. [13C] Urea breath test to confirm eradication of Helicobacter Pylori. American Journal of Gastroenterology, February 1995, Vol. 90, No. 2.
  42. Soll AH. Consensus conference medical treatment of peptic ulcer disease. Practice Guidelines. Practice Parameters Committee of the American College of Gastroenterology, February 1996; 275(8): 622-629.
  43. Talley NJ, et al. Guidelines for the management of dyspepsia. American Journal of Gastroenterology 2005; 100: 2324-2337.
  44. The Helicobacter Foundation. Epidemiology. https://www.helico.com/epidemiology.html. Accessed July 247, 2018.
  45. Tsolaki F, Kountouras J, Topouzis F, et al. Helicobacter pylori infection, dementia and primary open angle glaucoma: Are they connected? BMC Ophthalmol. 2015 Mar 11; 15:24.
  46. Vaira D, et al. Review article: Diagnosis of Helicobacter Pylori infection. Alimentary Pharmacology and Therapeutics, March 2002; 16 Suppl 1: 16-23.
  47. Vakil N, et al. Non-invasive tests for the diagnosis of H. Pylori infection. Reviews in Gastroenterological Disorders, January 2004; 4(1): 1-6.
  48. Vakil N, et al. How to test for Helicobacter Pylori in 2005. Cleveland Clinic Journal of Medicine, May 2005; 72 Suppl 2: S8-13, Discussion S14-21.
  49. Vakil N, Moayyedi P, Fennerty MB, Talley NJ. Limited value of alarm features in the diagnosis of upper gastrointestinal malignancy: systematic review and meta-analysis. Gastroenterology. 2006 Aug; 131(2): 390-401.

POLICY HISTORY:

Medical Policy Group, October 2005 (3)

Medical Policy Administration Committee, November 2005

Available for comment December 1, 2005-January 14, 2006

Medical Policy Group, January 2006 (3)

Medical Policy Administration Committee, February 2006

Available for comment February 16-April 3, 2006

Key Points updated with ACG guidelines, no policy change, February 2008 (1)

Medical Policy Group, February 2010 (1) Updated Key Points

Medical Policy Administration Committee, February 2010

Medical Policy Group, February 2013: Effective 02/06/2013: Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, October 2013 (1): Removed ICD-9 Diagnosis/Procedure codes; no change to policy statement.

Medical Policy Group (4): Updates to Description, Policy, Key Points, Key Words, Approved by Governing Bodies, Current Coding and References. Updated policy section by adding bariatric surgery under UBT/fecal antigen testing, updated age for evaluation of new onset dyspepsia to younger than 60, added additional IV criteria. Added Key Word serological testing. Added CPT code 86677 to Current Coding.

Medical Policy Administration Committee, August 2018.

Available for comment July 27 through September 9, 2018.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.