Currentblue cross blue shield - tennesseePolicy N/A

Vitamin D Testing (coverage criteria for 25-hydroxyvitamin D and related tests)

Coverage and medical necessity criteria for serum vitamin D (25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) testing and related fraction testing, including repeat testing and limitations, for Blue Cross Blue Shield - Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyVitamin D Testing (coverage criteria for 25OHD and 1,25-dihydroxyvitamin D)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionOrder 25-hydroxyvitamin D testing only when documentation supports an underlying disease or condition associated with vitamin D deficiency; document deficiency and wait ≥12 weeks after starting supplementation before repeat testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25OHDprimary analyte

1,25-OHsecondary analyte

12min interval (weeks)

2max repeats/year

<20 ng/mLdeficiency threshold

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Coverage Criteria

inv-01: Initial 25OHD testing indications

Covered when ANY of the following underlying conditions are present (testing meets coverage criteria):

Underlying disease/condition list: Any one of the following clinical conditions: biliary cirrhosis and other specified biliary disorders; blind loop syndrome; celiac disease; coronary artery disease when considering chronic vitamin D/calcium therapy; dermatomyositis; eating disorders; disorders of calcium metabolism (hypercalcemia, hypocalcemia); hyperparathyroidism or hypoparathyroidism; hypervitaminosis D; individuals receiving hyperalimentation; inflammatory bowel disease (Crohn's disease, ulcerative colitis); intestinal malabsorption; liver cirrhosis; long-term use of anticonvulsants, glucocorticoids, or other medications known to lower vitamin D; malnutrition; myalgia/myositis; endocrine-related myopathy; neoplastic hematologic disorders; obesity; osteogenesis imperfecta; osteomalacia; osteopetrosis; osteoporosis; pancreatic steatorrhea; primary or miliary tuberculosis; psoriasis; regional enteritis; renal/ureteral/urinary calculus; rickets; sarcoidosis; Stage III–V chronic kidney disease and end-stage renal disease; systemic lupus erythematosus.

Full enumerated list is from Guideline 1 and Guideline 2 in the policy (chunks 5-6).

inv-02: D2/D3 fraction testing

Covered when performed as part of total 25-hydroxyvitamin D analysis:

D2/D3 fraction testing: Measurement of D2 and D3 fractions meets coverage criteria when performed as part of the total 25-hydroxyvitamin D analysis.

Chunk 3

inv-03: Repeat testing for monitoring supplementation

Covered when ALL of the following are met:

Repeat testing after deficiency: Documented vitamin D deficiency and repeat test performed at least 12 weeks after initiation of vitamin D supplementation therapy.>=12 weeks after therapy start

Repeat monitoring limited to 2 tests per year while titrating therapy; once therapeutic range reached, annual testing meets coverage criteria (chunk 4).

inv-04: 1,25-dihydroxyvitamin D testing

Covered when ALL of the following are met for evaluation/treatment of defects in vitamin D metabolism:

Indications for 1,25-dihydroxyvitamin D testing: Testing for 1,25-dihydroxyvitamin D meets coverage criteria when used in the evaluation or treatment of conditions associated with defects in vitamin D metabolism, including disorders of calcium metabolism; familial hypophosphatemia; Fanconi syndrome; hyperparathyroidism or hypoparathyroidism; individuals receiving hyperalimentation; neonatal hypocalcemia; osteogenesis imperfecta; osteomalacia; osteopetrosis; primary or miliary tuberculosis; renal/ureteral/urinary calculus; rickets; sarcoidosis; and Stage III–V chronic kidney disease and end-stage renal disease.

Guideline 2 lists full indications (chunk 6).

inv-05: Indicated testing per specialty guidance

Testing is indicated in individuals at increased risk of vitamin D deficiency or where results would affect management, per specialty guidance.

Indications cited by professional societies: Serum 25-hydroxyvitamin D testing is recommended by specialty societies for individuals at increased risk of deficiency or where results would affect management — examples include patients with osteoporosis or other bone diseases, obesity, history of falls, low bone mass or recurrent low-impact fractures, children/adolescents with conditions associated with reduced bone mass, and baseline and annual postoperative monitoring after Roux-en-Y gastric bypass, sleeve gastrectomy, or biliopancreatic diversion. Society statements referenced include the Endocrine Society, National Osteoporosis Society, ACOG, AAP, AACE/Obesity/Bariatric Surgery societies and others.

See cited society guidance in chunks 25, 28-35 for scenario-specific recommendations and thresholds (e.g., National Osteoporosis Society thresholds and bariatric society monitoring; chunk 28, 32).

Measurement of serum 1,25-dihydroxyvitamin D to screen for vitamin D deficiency and routine screening in asymptomatic individuals or during general encounters does not meet coverage criteria. The policy explicitly lists measurement of serum 1,25-dihydroxyvitamin D for screening as a non-covered indication and excludes routine, asymptomatic screening from coverage.

Routine population screening of asymptomatic, community-dwelling adults is not supported by the USPSTF. The USPSTF concludes that current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults, and it does not endorse routine screening or supplementation for primary fracture prevention in this population.

FDA device database searches identify multiple 'vitamin D' device entries; however, many laboratories offer laboratory-developed tests (LDTs) for vitamin D that are validated and performed in‑house. These LDTs are regulated by CMS as high‑complexity tests under CLIA '88. As LDTs, they generally have not been approved or cleared by the FDA, although FDA clearance or approval is not required for clinical use.

Routine screening for vitamin D deficiency with serum testing in asymptomatic individuals and/or during general encounters is considered not medically necessary and does not meet coverage criteria under this policy.

Measurement of 1,25-dihydroxyvitamin D is not recommended for routine screening of at-risk individuals because it is the metabolically active form with a very short circulating half-life and provides limited value for routine deficiency screening; testing is reserved for specific conditions where formation of the active form may be impaired.

Coding

Covered tests (described, no codes listed)neutralCovered

No codes listed

Not covered tests (described, no codes listed)neutralNot Covered

No codes listed

Deficiency threshold — common threshold for vitamin D deficiency

Common deficiency thresholdSerum 25-hydroxyvitamin D (25OHD) < 20 ng/mL

Alternate threshold cited by some organizationsSome organizations consider < 30 ng/mL as insufficient

IOM recommended range contextIOM recommends maintaining serum 25OHD between 20–40 ng/mL (50–100 nmol/L)

25OHD sufficiency thresholds (National Osteoporosis Society)

DeficientSerum 25OHD < 30 nmol/L

May be inadequateSerum 25OHD 30–50 nmol/L (may be inadequate in some people)

Provider Actions and Notes

Documentation Required

Government policy precedence — follow applicable Medicare/Medicaid coverage

If there is a conflict between this policy and any relevant, applicable government policy for a particular member (for example, Local Coverage Determinations (LCDs) or National Coverage Determinations (NCDs) for Medicare and/or state coverage for Medicaid), the government policy will govern the coverage determination. Consult the CMS Medicare Coverage Database and the applicable state Medicaid website for the most current guidance.

Government policies (LCDs, NCDs, state Medicaid) take precedence over this policy when conflicts exist.
Check the Medicare Coverage Database (http://www.cms.gov/medicare-coverage-database/overview-and-quicksearch.aspx) for current Medicare guidance.
Consult the member's state Medicaid website for up-to-date Medicaid coverage rules.

Note

LDTs and CLIA regulation

Some laboratories use laboratory-developed tests (LDTs) for vitamin D assays. LDTs must be validated by the performing laboratory and are regulated as CLIA high-complexity tests. FDA has not approved or cleared many LDTs for vitamin D; FDA clearance is not required for clinical use of LDTs but they remain subject to CLIA oversight.

Covered Indications

inv-33: Clinical conditions associated with vitamin D deficiency or decreased bone density and conditions affecting vitamin D metabolism — full list in Guideline 1 and Guideline 2

Clinical conditions associated with vitamin D deficiency or decreased bone density and conditions affecting vitamin D metabolism — full lists from Guideline 1 and Guideline 2:

Guideline 1 — Conditions supporting 25OHD testing: A. Biliary cirrhosis and other specified biliary tract disorders; B. Blind loop syndrome; C. Celiac disease; D. Coronary artery disease in individuals where risk/benefit of chronic vitamin D/calcium therapy is being considered; E. Dermatomyositis; F. Eating disorders; G. Hypercalcemia, hypocalcemia, or other disorders of calcium metabolism; H. Hyperparathyroidism or hypoparathyroidism; I. Hypervitaminosis D; J. Individuals receiving hyperalimentation; K. Inflammatory bowel disease (Crohn's disease and ulcerative colitis); L. Intestinal malabsorption; M. Liver cirrhosis; N. Long-term use of anticonvulsants, glucocorticoids, or other medications known to lower vitamin D; O. Malnutrition; P. Myalgia and other myositis; Q. Myopathy related to endocrine diseases; R. Neoplastic hematologic disorders; S. Obesity; T. Osteogenesis imperfecta; U. Osteomalacia; V. Osteopetrosis; W. Osteoporosis; X. Pancreatic steatorrhea; Y. Primary or miliary tuberculosis; Z. Psoriasis; AA. Regional enteritis; BB. Renal, ureteral or urinary calculus; CC. Rickets; DD. Sarcoidosis; EE. Stage III–V CKD and ESRD; FF. Systemic lupus erythematosus.

Full enumerated lists are from Guideline 1 and Guideline 2 in chunks 5 and 6.

Guideline 2 — Conditions supporting 1,25-dihydroxyvitamin D testing:

Frequency Limits

25-hydroxyvitamin D (monitoring) — allowed repeat tests while titrating therapy

Allowed repeat tests while titrating therapyUp to 2 25-hydroxyvitamin D tests per year while achieving the therapeutic goal

Timing requirementRepeat testing should occur at least 12 weeks after initiation of supplementation before first repeat

DocumentationRepeat testing meets coverage criteria when vitamin D deficiency is documented

25-hydroxyvitamin D (maintenance) — allowed tests per year during maintenance

Maintenance testing frequencyOnce therapeutic range has been reached, annual 25-hydroxyvitamin D testing meets coverage criteria

Coverage conditionMaintenance testing contingent on prior documentation of achieved therapeutic range

Ordering Requirements

Billing Rule

Order 25OHD testing only with documented underlying condition or documented deficiency for repeats

Order 25‑hydroxyvitamin D testing only when documentation indicates an underlying disease or condition specifically associated with vitamin D deficiency or decreased bone density; documentation of deficiency is required for repeat testing to monitor therapy.

Include the clinical indication from Guideline 1 on the order or in the medical record.
Document vitamin D deficiency prior to ordering repeat monitoring tests.

Billing Rule

Check and follow applicable government ordering/documentation requirements

Coverage determinations must consider applicable government (Medicare/Medicaid) policies which may impose specific ordering or documentation requirements; verify and follow those policies for affected members.

Consult the Medicare Coverage Database and applicable state Medicaid resources for current requirements.

Not Covered

Measurement of serum 1,25-dihydroxyvitamin D to screen for vitamin D deficiency and routine screening in asymptomatic individuals/general encounters are explicitly listed as not covered by this policy.

Routine screening of asymptomatic, community-dwelling adults without risk factors is not supported by the USPSTF (evidence insufficient). Such routine population screening is not endorsed and, accordingly, is not covered under this policy.

The source chunks reviewed do not enumerate additional specific tests or indications that are explicitly not covered beyond those described. The document notes that many vitamin D assays are provided as laboratory-developed tests (LDTs) and that FDA approval or clearance is not generally present for LDTs, but this observation does not by itself list other non-covered tests.

Background

Vitamin D (D2 and D3) is converted in the liver to 25-hydroxyvitamin D (25OHD), the predominant and more stable circulating form used to assess vitamin D status, and is converted in the kidney to the active 1,25-dihydroxyvitamin D. Because 25OHD has a substantially longer half-life and better reflects total vitamin D stores, it is the preferred analyte for routine assessment and monitoring of deficiency. The active form, 1,25-dihydroxyvitamin D, has a short circulating half-life and is reserved for evaluation of specific disorders of vitamin D metabolism rather than routine screening.

Definitions

25(OH)D / 25OHD — predominant and most stable circulating form used to assess vitamin D status.

Definition25-hydroxyvitamin D (25OHD) — the predominant and most stable circulating form used to assess vitamin D status

SynonymsAlso referred to as 25(OH)D or calcidiol

Clinical notePreferred serum test to evaluate vitamin D status due to longer half-life (~15 days)

1,25-dihydroxyvitamin D — metabolically active form with short circulating half-life; not recommended for routine deficiency screening.

Definition1,25-dihydroxyvitamin D — the metabolically active form of vitamin D with a short circulating half-life (~15 hours)

Screening recommendationNot recommended for routine screening of vitamin D deficiency due to short half-life and limited utility

Revision History

2023-07-01adoptionLatest

Policy adopted effective 2023-07-01 based on Avalon policy recommendation

Policy Summary

Payerblue cross blue shield - tennessee

PolicyVitamin D Testing (coverage criteria for 25OHD and 1,25-dihydroxyvitamin D)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

SourceLink

On This Page

SufficientSerum 25OHD > 50 nmol/L (sufficient for almost the whole population)

Clinical biochemical alert — previous 25-OH-vitamin D values out of interval or >160 nmol/L noted

Biochemical alert — previous valuesPrevious serum 25-OH-vitamin D values within prior 6 months that are out of interval or >160 nmol/L should be noted

Associated indicatorsConsider alterations in serum/urine calcium and phosphorus or elevated alkaline phosphatase when interpreting results

Clinical relevancePrior abnormal values may inform need for repeat testing or therapy adjustment

LDTs are regulated by CMS as high-complexity tests under CLIA '88.
FDA has not approved/cleared many vitamin D LDTs; laboratories must validate assays internally.

Documentation Required

Clinical indication documentation required

Documentation in the medical record must support an underlying disease or condition specifically associated with vitamin D deficiency or decreased bone density when ordering 25-hydroxyvitamin D testing. Include relevant clinical findings, diagnoses, and prior laboratory values where applicable.

Record the specific underlying condition from Guideline 1 (e.g., malabsorption, liver disease, hyperparathyroidism, long-term anticonvulsant or glucocorticoid use).
Document clinical rationale when ordering 1,25-dihydroxyvitamin D (used for defects in vitamin D metabolism) and do not use 1,25-dihydroxyvitamin D for routine deficiency screening.
Previous 25-OH-vitamin D values within the prior 6 months may be relevant to support medical necessity.

Documentation Required

Post-bariatric surgery monitoring and documentation

For patients who have undergone bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy, biliopancreatic diversion with/without duodenal switch, or adjustable gastric banding), baseline and annual postoperative evaluation for vitamin D deficiency is recommended. Ensure documentation of surgical history and postoperative supplementation/titration plans.

Baseline vitamin D assessment prior to or shortly after bariatric surgery and annual monitoring thereafter.
Document vitamin D supplementation regimen (e.g., initial dosing recommendations and titration to therapeutic 25-hydroxyvitamin D levels >30 ng/mL).
For severe malabsorption, document use of higher oral doses such as vitamin D2 50,000 IU 1–3 times weekly or vitamin D3 3,000–6,000 IU/day as indicated.

Denial Risk

Repeat testing frequency and denial triggers

Repeat testing for monitoring supplementation is allowed but must follow frequency limits: perform repeat 25-hydroxyvitamin D testing at least 12 weeks after starting supplementation, limit monitoring testing to no more than two instances per year until therapeutic goal is achieved, and then continue with annual testing once therapeutic levels are reached. Routine screening in asymptomatic individuals is a denial trigger.

Repeat testing: at least 12 weeks after initiation of supplementation.
Monitoring frequency: ≤2 tests per year until therapeutic goal achieved; annual thereafter.
Denial triggers: routine screening in asymptomatic individuals and use of 1,25-dihydroxyvitamin D to screen for deficiency.

Disorders of calcium metabolism; familial hypophosphatemia; Fanconi syndrome; hyperparathyroidism or hypoparathyroidism; individuals receiving hyperalimentation; neonatal hypocalcemia; osteogenesis imperfecta; osteomalacia; osteopetrosis; primary or miliary tuberculosis; renal, ureteral or urinary calculus; rickets; sarcoidosis; Stage III–V CKD and ESRD.

From Guideline 2 (chunk 6).

inv-34: Evaluation of vitamin D status in patients with hip fracture, preoperative assessment, and baseline/annual postoperative monitoring after bariatric procedures

Evaluation of vitamin D status is indicated in the following perioperative and post-fracture contexts:

Hip fracture and bariatric surgery contexts: Evaluate vitamin D status in patients with hip fracture (preoperative assessment) and consider 25OHD measurement at intake; baseline and annual postoperative monitoring for vitamin D deficiency is recommended after Roux-en-Y gastric bypass, sleeve gastrectomy, or biliopancreatic diversion.

Study and society guidance noted in chunks 19 and 32; preoperative 25OHD best reflects postoperative walking outcomes (chunk 19).

inv-35: Assessment in patients with bone disease, low bone mass, recurrent low-impact fractures, and children/adolescents with conditions associated with reduced bone mass

Assessment is indicated in patients with bone disease, low bone mass, recurrent low-impact fractures, and pediatric patients with conditions associated with reduced bone mass:

Bone disease and pediatric considerations: Measure serum 25-hydroxyvitamin D for patients with bone diseases that may respond to vitamin D treatment; prior to specific bone treatments where correcting deficiency is appropriate; for musculoskeletal symptoms potentially attributable to vitamin D deficiency; and in children/adolescents with reduced bone mass or recurrent low-impact fractures. AAP recommends screening only in children/adolescents with these conditions.

See National Osteoporosis Society and AAP guidance in chunks 28 and 29 for details and thresholds.

inv-36: Clinical contexts referenced in literature (pregnancy screening, older adults, bone health, IBD, and other contexts) — see cited references

Clinical contexts referenced in the literature where vitamin D testing may be considered (see cited references for full guidance):

Additional clinical contexts from cited references: Contexts discussed in cited society statements and evidence include pregnancy (ACOG), older adults and fall/hip fracture risk, bone health and osteoporosis management, inflammatory bowel disease, and other specialty-specific situations where testing may affect management. The policy references Endocrine Society, National Osteoporosis Society, ACOG, AAP, and bariatric/endocrine society guidance among others.

See evidence-based references listed in chunk 38 and society guidance in chunks 33-35 for context-specific recommendations.

Limit after goal reachedFrequency limited to 1 test per year for maintenance monitoring

Interval before first repeat monitoring 25OHD test — minimum interval before first repeat after starting supplementation

Minimum interval before first repeat>= 12 weeks after initiation of vitamin D supplementation therapy

RationaleAllows adequate time for supplementation to change serum 25OHD (policy requirement for repeat testing)

Applies toIndividuals with documented vitamin D deficiency undergoing supplementation

25-hydroxyvitamin D — Baseline and annual postoperative evaluation for bariatric surgery patients; prior serum value within 6 months noted

Baseline and annual postoperative evaluationBaseline and annual postoperative 25-hydroxyvitamin D evaluation recommended after RYGB, sleeve gastrectomy, or biliopancreatic diversion

Supplementation guidanceSupplementation should be titrated to therapeutic 25OHD levels (examples: target >30 ng/mL for some bariatric guidance)

Prior serum value relevancePrevious serum 25-OH-vitamin D values within the prior 6 months may be relevant to postoperative assessment

(no entry)

Note

No specific ordering provider restrictions listed in policy

No specific ordering provider restrictions (such as who may order the test) are specified in the cited sections of this document.

Follow any plan- or state-specific ordering provider rules if separately specified elsewhere.

Use caseReserved for evaluation/treatment of disorders affecting vitamin D metabolism

Active form of vitamin D with very short half-life; not recommended for routine screening of at-risk individuals.

CharacteristicActive form of vitamin D with very short half-life; not recommended for routine screening of at-risk individuals

Clinical rationaleShort circulating half-life limits usefulness for assessing vitamin D status

IndicationsUsed when formation of active 1,25 form may be impaired (specific conditions listed in policy)

Laboratory-developed test (LDT) — definition and CLIA high-complexity regulation note.

DefinitionLaboratory‑developed test (LDT) — a test developed and validated by a laboratory and performed in‑house

RegulationLDTs for vitamin D are regulated by CMS as high‑complexity tests under CLIA '88

FDA statusAs LDTs, these tests have not been approved or cleared by the FDA; FDA clearance is not required for clinical use but validation/quality expectations apply