CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Vitamin D laboratory testing (25‑OH and 1,25‑OH) coverage criteria

Policy governs coverage and indications for measurement of 25‑hydroxyvitamin D and 1,25‑dihydroxyvitamin D laboratory assays for Medicare Advantage and Commercial products for Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyVitamin D laboratory testing (25‑OH and 1,25‑OH) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFile vitamin D tests with a covered diagnosis code to be considered medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25-OH & 1,25-OHtested analytes covered when medically appropriate

numerousreferences cited

Jul 2024provider updates through

Coverage Criteria for Vitamin D Testing

Indications for 25-OH testing

Measurement of 25‑OH Vitamin D level is medically necessary when ANY of the following clinical indications are present:

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25-OH indications: chronic kidney disease stage III or greater

Use 25-OH assay as the preferred initial test to establish deficiency and to monitor therapy.

25-OH indications: cirrhosis

25-OH indications: hypocalcemia

25-OH indications: hypercalcemia

25-OH indications: hypercalciuria

25-OH indications: parathyroid disorders

25-OH indications: hypervitaminosis D

25-OH indications: malabsorption states

25-OH indications: obstructive jaundice

25-OH indications: osteomalacia

25-OH indications: osteoporosis with either history of fragility fractures OR meeting FRAX/T-score thresholds (e.g., FRAX >3% hip or specified 10-year major osteoporotic fracture thresholds)

25-OH indications: initiating bisphosphonate therapy (vitamin D level and serum calcium should be determined and managed as necessary before initiation)

25-OH indications: rickets

25-OH indications: monitoring vitamin D replacement therapy when related to the listed conditions

Indications for 1,25-OH testing

Measurement of 1,25‑OH Vitamin D level is medically necessary when ANY of the following clinical indications are present:

1,25-OH indications: unexplained hypercalciuria (e.g., when granulomatous disease or lymphoma is suspected)

1,25-OH is reserved for disorders affecting activation or when elevated active metabolite is suspected.

1,25-OH indications: unexplained hypercalcemia (e.g., when granulomatous disease or lymphoma is suspected)

1,25-OH indications: suspected genetic childhood rickets

1,25-OH indications: nephrolithiasis or hypercalciuria

1,25-OH indications: suspected tumor-induced osteomalacia

Covered Indications and Supporting Conditions

Chronic kidney disease stage III or greater and analyte preference

Clinical scenarios linking chronic kidney disease and related conditions to the preferred analyte:

CKD and analyte choice: Chronic kidney disease stage III or greater

For initial evaluation and routine monitoring of vitamin D status in CKD and most other indications, measure 25-OH. Reserve 1,25-OH testing for select disorders affecting activation of vitamin D (see 1,25-OH indications).

When to prefer 25-OH: Use 25-OH for initial assessment of vitamin D status, for monitoring replacement therapy, and for conditions listed under 25-OH indications (e.g., osteoporosis, malabsorption, cirrhosis, rickets, prior to bisphosphonate initiation).

When to prefer 1,25-OH: Use 1,25-OH in disorders that affect conversion to the active metabolite or when active metabolite dysregulation is suspected (e.g., unexplained hypercalcemia/hypercalciuria with suspected granulomatous disease or lymphoma, genetic rickets, tumor-induced osteomalacia, renal handling disorders).

References supporting covered indications and rationale

Literature and guideline references cited in support of covered indications include evaluations of screening, osteoporosis/low bone density, primary hyperparathyroidism, transplant outcomes, obesity, systemic lupus erythematosus, and muscle function:

Screening and deficiency: Systematic reviews and USPSTF evidence syntheses on screening for vitamin D deficiency and population-level recommendations.

References: LeBlanc et al.; USPSTF evidence syntheses and recommendation statements.

Osteoporosis and fracture prevention: Guidelines and systematic reviews addressing vitamin D in the evaluation and management of osteoporosis and fracture prevention.

References include AHRQ comparative effectiveness reviews and clinical practice guideline literature.

Primary hyperparathyroidism: Evidence addressing vitamin D deficiency in the context of primary hyperparathyroidism and its implications for management.

References include Silverberg and related endocrinology literature.

Provider Actions, Prior Auth, and Billing Notes

Prior Authorization

Prior authorization is not applicable for the tests referenced in this policy unless otherwise noted in an individual service or genetic testing policy. Providers should still verify member benefits and obtain prior authorization when required by the member's benefit plan or for specific genetic testing services that list authorization requirements in their coding sections or related policies.

Prior authorization generally not required for vitamin D testing under this policy; check individual genetic testing/proprietary laboratory analyses policies for exceptions.
Some genetic testing services may require authorization or may be contract exclusions for self-funded groups — see the Coding section of the Genetic Services or Proprietary Laboratory Analyses policies.

Note

Benefits and Eligibility Verification

Verify benefits and eligibility for the specific member before providing services. Providers should check the member's certificate/benefit booklet and call Provider Services or the call center as needed to confirm coverage, prior authorization requirements, and any contract-level restrictions.

Benefits and eligibility are determined by the member's subscriber agreement / certificate. Call Provider Services for member-specific questions.
If a service is determined not to be medically necessary or is a non-covered benefit, the provider may not charge the member unless the member was informed and agreed in writing in advance per participation agreement provisions.

Documentation Required

Diagnosis Code Requirement

Tests must be filed with a covered diagnosis code to be considered medically necessary. Refer to the policy attachment/coding section for the required ICD-10 diagnosis codes that support billing for the listed CPT codes (e.g., 82306, 82652).

82306 (Vitamin D; 25 hydroxy) — must be filed with one of the covered diagnosis codes in the attachment.
82652 (Vitamin D; 1,25 dihydroxy) — must be filed with one of the covered diagnosis codes in the attachment.

Note

Contract Restrictions and Genetic Testing Note

Contract-level restrictions and exclusions may apply, especially for genetic testing services and for self-funded group plans. Refer to the appropriate Benefit Booklet and related policies (Genetic Services, Proprietary Laboratory Analyses, Biomarker Mandate) to determine whether the member's plan has customized coverage or exclusions.

Some self-funded groups may have contract exclusions for genetic testing services — consult the member's benefit booklet.
See Related Policies and the Coding section of the Genetic Services or Proprietary Laboratory Analyses policies for lists of covered, authorized, not medically necessary, or excluded genetic services.

Billing Rule

Administrative/provider action reminders: follow the member-specific coverage determinations, do not bill members for non-covered or not medically necessary services unless proper advance written agreement exists, and consult participation agreements for billing obligations.

Do not charge members for services determined to be not medically necessary or non-covered unless the member provided prior written agreement.
BCBSRI may revise this policy at any time; providers should confirm current requirements before rendering services.

Frequency Limits

Frequency limits — inv-20: Frequency limits — key/value

Routine testing intervalNo frequency limits specified in policy; benefits and coverage may vary by contract—refer to Benefit Booklet/Subscriber Agreement

Monitoring during replacement therapyUse 25‑hydroxyvitamin D to monitor vitamin D deficiency on replacement therapy as indicated; no specific interval prescribed

Clinical reassessmentRepeat testing frequency should be guided by clinical indication and treating clinician judgment; policy provides no set periods

Definitions

25-hydroxyvitamin D (25-OH) — inv-16

Assay designation25‑hydroxyvitamin D (25‑OH) is the preferred initial assay and reflects total body vitamin D stores

Clinical useIndicated for establishing vitamin D deficiency and for monitoring response to replacement therapy in patients with listed clinical indications

Testing contextRecommended as initial test for most patients with suspected hypovitaminosis D; routine population screening is controversial and benefits vary by contract

1,25-dihydroxyvitamin D (1,25-OH) — inv-17

Assay designation1,25‑dihydroxyvitamin D (1,25‑OH) is the active metabolite assay reserved for select clinical situations

Appropriate indicationsMeasured when a contributory illness affecting activation is suspected (eg, kidney disease, parathyroid disease, liver disease, or genetic disorders) and for conditions listed in the policy (eg, unexplained hypercalcemia or hypercalciuria, suspected granulomatous disease or lymphoma, genetic childhood rickets, tumor‑induced osteomalacia)

Role relative to 25‑OHNot used as the routine initial assay; used when disorders of conversion to active metabolite are suspected or to evaluate elevated active metabolite

Background

25‑hydroxyvitamin D (25‑OH) reflects total body vitamin D stores and is the preferred initial assay to establish vitamin D deficiency and to monitor replacement therapy in most clinical situations. By contrast, 1,25‑dihydroxyvitamin D (1,25‑OH) is the biologically active metabolite and is reserved for patients with disorders that affect conversion or activation (for example, advanced kidney disease, parathyroid disorders, liver disease, certain genetic rickets, granulomatous disease, or suspected tumor‑induced osteomalacia) where measurement of the active form is required to answer the clinical question.

References and Supporting Literature

This policy's covered indications and clinical rationale are supported by multiple guideline and literature sources, including KDIGO and systematic reviews and guideline statements addressing screening and management of vitamin D deficiency, osteoporosis and fracture prevention, primary hyperparathyroidism, renal transplant outcomes, obesity, systemic lupus erythematosus, and muscle function. Representative references cited in the policy include KDIGO (37), USPSTF evidence syntheses and recommendation statements (39, 40, 42), comparative effectiveness and osteoporosis reviews (43, 44), and multiple specialty studies and systematic reviews on vitamin D clinical outcomes (references 45–68).