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Testing Serum Vitamin D Levels

Policy Number: MP-732

Latest Review Date: January 2024

Category: Laboratory

POLICY:

Effective for dates of service on and after October 16, 2023:

Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density.  These conditions are:

  1. Biliary cirrhosis and other specified disorders of the biliary tract
  2. Blind loop syndrome
  3. Celiac Disease
  4. Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
  5. Dermatomyositis
  6. Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
  7. Hyperparathyroidism or hypoparathyroidism
  8. Hypervitaminosis of vitamin D
  9. Individuals receiving hyperalimentation
  10. Intestinal malabsorption
  11. Liver cirrhosis
  12. Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
  13. Lymphoma
  14. Malnutrition (e.g. Cystic Fibrosis)
  15. Myopathy related to endocrine diseases
  16. Obesity
  17. Osteogenesis imperfecta
  18. Osteomalacia
  19. Osteopetrosis
  20. Osteopenia
  21. Osteoporosis
  22. Pancreatic steatorrhea
  23. Primary or miliary tuberculosis
  24. Psoriasis
  25. Regional enteritis
  26. Renal, ureteral or urinary calculus
  27. Rickets
  28. Sarcoidosis
  29. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  30. Systemic lupus erythematosus
  • Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
  • 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
  • Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
  • Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.

Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:

  1. Disorders of calcium metabolism
  2. Familial hypophosphatemia
  3. Fanconi syndrome
  4. Hyperparathyroidism or hypoparathyroidism
  5. Individuals receiving hyperalimentation
  6. Neonatal hypocalcemia
  7. Osteogenesis imperfecta
  8. Osteomalacia
  9. Osteopetrosis
  10. Primary or miliary tuberculosis
  11. Renal, ureteral or urinary calculus
  12. Sarcoidosis
  13. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  14. Vitamin D resistant rickets
  15. Pseudovitamin D-deficiency rickets
  • 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.

25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.

Effective for dates of service March 1, 2021 through October 15, 2023:

Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density.  These conditions are:

  1. Biliary cirrhosis and other specified disorders of the biliary tract
  2. Blind loop syndrome
  3. Celiac Disease
  4. Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
  5. Dermatomyositis
  6. Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
  7. Hyperparathyroidism or hypoparathyroidism
  8. Hypervitaminosis of vitamin D
  9. Individuals receiving hyperalimentation
  10. Intestinal malabsorption
  11. Liver cirrhosis
  12. Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
  13. Lymphoma
  14. Malnutrition (e.g. Cystic Fibrosis)
  15. Myopathy related to endocrine diseases
  16. Obesity
  17. Osteogenesis imperfecta
  18. Osteomalacia
  19. Osteopetrosis
  20. Osteoporosis
  21. Pancreatic steatorrhea
  22. Primary or miliary tuberculosis
  23. Psoriasis
  24. Regional enteritis
  25. Renal, ureteral or urinary calculus
  26. Rickets
  27. Sarcoidosis
  28. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  29. Systemic lupus erythematosus
  • Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
  • 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
  • Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
  • Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.

Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:

  1. Disorders of calcium metabolism
  2. Familial hypophosphatemia
  3. Fanconi syndrome
  4. Hyperparathyroidism or hypoparathyroidism
  5. Individuals receiving hyperalimentation
  6. Neonatal hypocalcemia
  7. Osteogenesis imperfecta
  8. Osteomalacia
  9. Osteopetrosis
  10. Primary or miliary tuberculosis
  11. Renal, ureteral or urinary calculus
  12. Sarcoidosis
  13. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  14. Vitamin D resistant rickets
  15. Pseudovitamin D-deficiency rickets
  • 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.

25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.

Effective for dates of service January 1, 2020 through February 28, 2021:

Serum testing of 25-hydroxyvitamin D levels may be considered medically necessary in individuals with a clinically documented underlying disease, condition, or risk factor which is specifically associated with vitamin D deficiency, toxicity, or decreased bone density.  These conditions are:

  1. Biliary cirrhosis and other specified disorders of the biliary tract
  2. Blind loop syndrome
  3. Celiac Disease
  4. Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
  5. Dermatomyositis
  6. Hypercalcemia, hypocalcemia or other disorders of calcium metabolism
  7. Hyperparathyroidism or hypoparathyroidism
  8. Hypervitaminosis of vitamin D
  9. Individuals receiving hyperalimentation
  10. Intestinal malabsorption
  11. Liver cirrhosis
  12. Long term use of anticonvulsants, glucocorticoids and other medications known to lower vitamin D levels
  13. Lymphoma
  14. Malnutrition
  15. Myopathy related to endocrine diseases
  16. Obesity
  17. Osteogenesis imperfecta
  18. Osteomalacia
  19. Osteopetrosis
  20. Osteoporosis
  21. Pancreatic steatorrhea
  22. Primary or miliary tuberculosis
  23. Psoriasis
  24. Regional enteritis
  25. Renal, ureteral or urinary calculus
  26. Rickets
  27. Sarcoidosis
  28. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  29. Systemic lupus erythematosus
  • Testing for D2 and D3 fractions of 25-hydroxyvitamin D may be considered medically necessary as part of the total 25-hydroxyvitamin D analysis.
  • 25-hydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.
  • Repeat testing of serum 25-hydroxyvitamin D levels may be considered medically necessary in individuals who have documented vitamin D deficiency, at least twelve (12) weeks after initiation of vitamin D supplementation therapy.
  • Testing of serum 25-hydroxyvitamin D levels more frequently than twice in a rolling twelve (12) month period is considered not medically necessary for any diagnosis other than chronic kidney disease (CKD) or intestinal malabsorption.

Serum testing of 1, 25-dihydroxyvitamin D levels may be considered medically necessary in the evaluation or treatment of conditions that are associated with defects in vitamin D metabolism. These conditions are:

  1. Disorders of calcium metabolism
  2. Familial hypophosphatemia
  3. Fanconi syndrome
  4. Hyperparathyroidism or hypoparathyroidism
  5. Individuals receiving hyperalimentation
  6. Neonatal hypocalcemia
  7. Osteogenesis imperfecta
  8. Osteomalacia
  9. Osteopetrosis
  10. Primary or miliary tuberculosis
  11. Renal, ureteral or urinary calculus
  12. Sarcoidosis
  13. Stage III-V Chronic Kidney Disease and End Stage Renal Disease
  14. Vitamin D resistant rickets
  15. Pseudovitamin D-deficiency rickets
  • 1, 25-dihydroxyvitamin D serum testing is considered not medically necessary for all other medical conditions.

25-hydroxyvitamin D and/or 1, 25-dihydroxyvitamin D serum testing for routine screening of vitamin D deficiency is considered not medically necessary.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1, 25-dihydroxy vitamin D deficiency exists; mostly, in those with renal disease.

DESCRIPTION OF PROCEDURE OR SERVICE:

Vitamin D, also known as calciferol, is a fat-soluble vitamin that has a variety of physiologic effects, most prominently in calcium homeostasis and bone metabolism. In addition to the role it plays in bone metabolism, other physiologic effects include inhibition of smooth muscle proliferation, regulation of the renin-angiotensin system, a decrease in coagulation, and a decrease in inflammatory markers.

Vitamin D

Vitamin D, also known as calciferol, is a fat-soluble vitamin that has a variety of physiologic effects, most prominently in calcium homeostasis and bone metabolism. In addition to the role vitamin D plays in bone metabolism, other physiologic effects include inhibition of smooth muscle proliferation, regulation of the renin-angiotensin system, a decrease in coagulation, and a decrease in inflammatory markers.

Vitamin D Replacement

The Institute of Medicine (now the National Academy of Medicine [NAM]) has recommended reference values for the intake of vitamin D and serum levels, based on available literature and expert consensus. Recommended daily allowances are 600 IU/d for individuals between one and 70 years of age, and 800 IU/d for individuals older than 70 years.

Estimates of vitamin D requirements are complicated by the many other factors that affect serum levels. Sun exposure is the most prominent of factors that affect serum levels, and this is because individuals can meet their vitamin D needs entirely through adequate sun exposure. Other factors such as age, skin pigmentation, obesity, physical activity, and nutritional status also affect vitamin D levels and can result in variable dietary intake requirements to maintain adequate serum levels.

Excessive intake of vitamin D can be toxic. Toxic effects are usually due to hypercalcemia and may include confusion, weakness, polyuria, polydipsia, anorexia, and vomiting. In addition, high levels of vitamin D may promote calcium deposition and have the potential to exacerbate conditions such as calcium kidney stones and atherosclerotic vascular disease.

The Institute of Medicine defined 3 parameters of nutritional needs for vitamin D, on the assumption of minimal sun exposure. These parameters were the estimated average requirement, defined as the minimum intake required to maintain adequate levels; the recommended daily allowance, defined as the optimal dose for replacement therapy; and the upper-level intake, defined as the maximum daily dose to avoid toxicity. These recommendations are summarized in Table 1.

Table 1. Institute of Medicine Recommendations for Vitamin D Dietary Intake

Patient Group 

Estimated Average Requirement, IU/d

Recommended Daily Allowance, IU/d

Upper Limit Intake, IU/d

1 to 3 years of age

400

600

2500

4 to 8 years of age

400

600

3000

9 to 70 years of age

400

600

4000

>70 years of age

400

800

4000

Adapted from Institute of Medicine (2011).

KEY POINTS:

The most recent literature update was performed through October 16, 2023.

Summary of Evidence

For individuals who are asymptomatic without conditions or risk factors for which vitamin D treatment is recommended who receive testing of vitamin D levels, the evidence includes no randomized controlled trials (RCTs) of clinical utility (i.e., evidence that patient care including testing vitamin D levels versus care without testing vitamin D levels improves outcomes). Relevant outcomes are overall survival, test validity, symptoms, morbid events, and treatment-related morbidity. Indirect evidence of the potential utility of testing includes many RCTs and systematic reviews of vitamin D supplementation. There is a lack of standardized vitamin D testing strategies and cutoffs for vitamin D deficiency are not standardized or evidence-based. In addition, despite the large quantity of evidence, considerable uncertainty remains about the beneficial health effects of vitamin D supplementation. Many RCTs have included participants who were not vitamin D deficient at baseline and did not stratify results by baseline 25-hydroxyvitamin D level. Nonwhite race/ethnic groups are underrepresented in RCTs but have increased risk of vitamin D deficiency. For skeletal health, there may be a small effect of vitamin D supplementation on falls, but there does not appear to be an impact on reducing fractures for the general population. The effect on fracture reduction may be significant in elderly women, and with higher doses of vitamin D. However, high doses of vitamin D may be associated with safety concerns in patients at risk for falls. For patients with asthma, there may be a reduction in severe exacerbations with vitamin D supplementation, but there does not appear to be an effect on other asthma outcomes. For patients who are pregnant, vitamin D supplementation may improve maternal and fetal outcomes. For overall mortality, there is also no benefit to the general population. RCTs evaluating extra skeletal, cancer, cardiovascular, and multiple sclerosis outcomes have not reported a statistically significant benefit for vitamin D supplementation. Although vitamin D toxicity and adverse events appear to be rare, few data on risks have been reported. The evidence is insufficient to determine the effects of the technology on health outcomes.

Vitamin D testing may benefit those at risk for severe deficiency or those with laboratory or radiographic findings commonly associated with vitamin D deficiency in these patients, knowledge of the 25 (OH) D blood level provides an accurate assessment of vitamin D body stores, helps identify the need for vitamin D therapy, and may help to determine an effective dose. There are no evidence-based clinical practice guidelines that recommend screening of persons without a clinically documented underlying disease or condition which is specifically associated with the risk of decreased bone density or osteoporosis.

The relationship between vitamin D and multiple sclerosis is being explored. Currently, data are mixed regarding the efficacy of vitamin D supplementation on clinical and radiographic outcome measures. To date, studies have been limited by small sample sizes, short durations, and concurrent use of disease modifying therapies, which may have confounded results. Recent meta-anlayses have not clearly identified the benefit of vitamin D in the treatment of multiple sclerosis. Larger studies with longer durations are needed to prove the efficacy of vitamin D supplementation and provide clearer evidence regarding the role of supplement in multiple sclerosis. The impact of vitamin D supplementation on multiple sclerosis activity remains inadequately investigated. At this time, the available well-designed, peer reviewed, scientific evidence is insufficient to prove an increase in net health outcomes for the use of vitamin D supplementation in multiple sclerosis.

Practice Guideline and Position Statements

American College of Obstetrics and Gynecology

The American College of Obstetrics and Gynecology (2011, reaffirmed 2021) issued a committee opinion on the testing of vitamin D levels and vitamin D supplementation in pregnant women. The following recommendation was made concerning testing vitamin D levels:

“At this time there is insufficient evidence to support a recommendation for screening all pregnant women for vitamin D deficiency. For pregnant women thought to be at increased risk of vitamin D deficiency, maternal serum 25-hydroxyvitamin D levels can be considered and should be interpreted in the context of the individual clinical circumstance. When vitamin D deficiency is identified during pregnancy, most experts agree that 1,000-2,000 international units per day of vitamin D is safe.”

Bone Health and Osteoporosis Foundation

The Bone Health and Osteoporosis Foundation updated recommendations for the prevention and treatment of osteoporosis in 2021. They recommended monitoring serum 25-hydroxy vitamin D levels in postmenopausal women and men 50 years of age and older, and vitamin D supplementation as necessary to maintain levels between 30 and 50 ng/mL.

Endocrine Society

In 2011, The Endocrine Society published clinical practice guidelines on the evaluation, treatment, and prevention of vitamin D deficiency. The following recommendations were made regarding testing vitamin D levels:

  • 25-hydroxyvitamin D serum level testing is recommended: “to evaluate vitamin D status only in patients who are at risk of deficiency.” The guideline did not recommend screening of individuals not at risk of vitamin D deficiency.
  • 1, 25-dihydroxyvitamin D testing was not recommended to evaluate vitamin D status. However, the guideline did recommend monitoring calcitriol levels under certain conditions.

Indications for 25(OH)D measurement (candidates for screening) published by the Endocrine Society are as follows:

  • Rickets Osteomalacia Osteoporosis
  • Chronic kidney disease Hepatic failure Malabsorption syndromes
  • Cystic fibrosis
  • Inflammatory bowel disease Crohn’s disease
  • Bariatric surgery Radiation enteritis
  • Hyperparathyroidism Medications
  • Antiseizure medications Glucocorticoids
  • AIDS medications
  • Antifungals, e.g. ketoconazole Cholestyramine
  • African-American and Hispanic children and adults Pregnant and lactating women
  • Older adults with history of falls
  • Older adults with history of nontraumatic fractures Obese children and adults (BMI > 30 kg/m2)
  • Granuloma-forming disorders
  • Sarcoidosis Tuberculosis Histoplasmosis Coccidiomycosis Berylliosis
  • Some lymphomas

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force published an updated recommendation and associated evidence report and systematic review in 2021 on vitamin D screening. The Task Force concluded that the current evidence was insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic individuals (grade I [insufficient evidence]). 

KEY WORDS:

Vitamin D, calciferol, serum levels, 25-hydroxyvitamin D, hypervitaminosis D, 1, 25-dihydroxyvitamin D

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA) has cleared a number of immunoassays for in vitro diagnostic devices for the quantitative measurement of total 25-hydroxyvitamin D through the 510(k) process.

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Lab tests for vitamin D are available under the auspices of the CLIA. Laboratories that offer laboratory-developed tests must be licensed by CLIA for high-complexity testing. To date, the FDA has chosen not to require any regulatory review of this test.

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. 

CURRENT CODING:

CPT codes:

0038U

Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative (Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay)

82306

Vitamin D; 25 hydroxy, includes fraction(s), if performed

82652

Vitamin D; 1, 25 dihydroxy, includes fraction(s), if performed

REFERENCES:

  1. American Academy of Family Physicians. Screening for Vitamin D Deficiency in Adults: Recommendation Statement. 2015; http://www.aafp.org/patient-care/clinical-recommendations/all/vitamin-D-deficiency.html.
  2. American Academy of Family Physicians. Vitamin D Screening and Supplementation in Community-Dwelling Adults: Common Questions and Answers. 2018; https://www.aafp.org/afp/2018/0215/p254.html.
  3. American College of Obstetrics and Gynecology Committee on Obstetric Practice. ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. Obstet Gynecol. Jul 2011; 118(1):197-198.
  4. Andujar-Espinosa R, Salinero-Gonzalez L, Illan-Gomez F, et al. Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial. Thorax. Feb 2021; 76(2): 126-133. 
  5. Appel LJ, Michos ED, Mitchell CM, et al. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial. Ann Intern Med. Feb 2021; 174(2): 145-156.
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  55. Kahwati LC, LeBlanc E, Weber RP, et al. Screening for Vitamin D Deficiency in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Apr 13 2021; 325(14): 1443-1463. 
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POLICY HISTORY:

Medical Policy Group, November 2019 (9): New policy

Medical Policy Administration Committee, December 2019

Available for comment November 18, 2019 through January 2, 2020.

Medical Policy Panel, December 2020

Medical Policy Group, December 2020 (9): 2020 Updates to Key Points, Description, References. No change to policy statement.

Medical Policy Group, February 2021 (9): Added indication for coverage in Cystic Fibrosis to policy statement. Other portions of policy section updated to remove not medically necessary from statement, no change to other portions of policy section intent.

Medical Policy Administration Committee, February 2021

Available for comment February 16, 2021 through April 2, 2021

Medical Policy Group, December 2021 (9): 2021 Updates to Key Points, Description, References. No change to policy statement.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (9): Updates to References. No change to policy statement.

Medical Policy Group, November 2022 (9): Updates to Key Points, References, Practice Guidelines and Position Statements. No change to policy statement.

Medical Policy Panel, December 2022

Medical Policy Group, December 2022 (9): 2022 Updates to Key Points, Description, References. Replaces word "patient" with "individual" in policy statement; no change to policy intent.

Medical Policy Group, September 2023 (5): Policy Statement updated to include Osteopenia to list of medically necessary conditions for serum testing of 25-hydroxyvitamin D levels.

Medical Policy Administration Committee, August 2023

Available for comment September 1, 2023 through October 16, 2023.

Medical Policy Panel, December 2023

Medical Policy Group, January 2024 (5): Updates to Description, Key Points; Practice Guidelines and Position Statements, Benefit Application, and References. No change to Policy Statement.

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.