CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Vitamin D laboratory testing (25‑OH and 1,25‑OH) — Coverage Criteria

Coverage policy for measurement of 25‑hydroxyvitamin D and 1,25‑dihydroxyvitamin D laboratory assays (including a specific LC‑MS microvolume assay) for Medicare Advantage and Commercial members of Blue Cross Blue Shield Rhode Island; describes covered indications, coding, and administrative rules affecting laboratories and ordering providers.

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 change

Effective DateN/A

Next Review DateN/A

Key ActionFile vitamin D assay claims with a covered diagnosis; laboratories must not obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2assays named

Multiplecovered indications listed

3coding provided

~20reference sections

Coverage Criteria

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inv-01: Covered Indications — 25‑OH Vitamin D

Measurement of 25‑OH Vitamin D level is covered when ALL of the following apply: filed with a covered diagnosis and one of the indications below is present.

Required for coverage: Test is filed with a covered diagnosis as listed in the policy's coding/diagnosis attachment

Per policy: assays are covered when filed with a covered diagnosis

One of the following indications must be present: chronic kidney disease stage III or greater; chronic use of anticonvulsant medications or corticosteroids; cirrhosis and chronic liver disease; malabsorption states; hypercalcemia; hypocalcemia; hypercalciuria; parathyroid disorders; hypervitaminosis D; obstructive jaundice; osteomalacia; osteopenia; DEXA T-score <= -2.5 (osteoporosis); FRAX 10-year probability >= 3% for hip fracture or >= 20% for other major osteoporotic fracture; initiating bisphosphonate therapy (vitamin D level and serum calcium should be determined and managed as necessary before initiation); rickets; osteosclerosis/petrosis; vitamin D deficiency on replacement related to a listed condition to monitor treatment efficacy

Source: policy indications list

inv-02: Covered Indications — 1,25‑OH Vitamin D

Measurement of 1,25‑OH Vitamin D level is covered when ANY of the following are present.

Covered indications for 1,25‑OH testing: unexplained hypercalciuria (suspected granulomatous disease or lymphoma); unexplained hypercalcemia (suspected granulomatous disease or lymphoma); suspected genetic childhood rickets; nephrolithiasis or hypercalciuria; suspected tumor‑induced osteomalacia

Source: policy indications list

For Medicare Advantage members, and for Commercial products when evidence of clinical benefit is lacking, all indications not filed with a covered diagnosis are not covered. The policy states that measurement of 25‑OH Vitamin D, 1,25‑OH Vitamin D, and the SensievaTM microvolume LC/MS assay are covered only when submitted with an appropriate covered diagnosis; all other indications are not covered for Medicare Advantage and are not medically necessary for Commercial Products when there is no evidence the testing improves net health outcome.

Routine screening and any indications not listed in the policy’s covered diagnosis attachment are considered not medically necessary for Commercial Products and are not covered for Medicare Advantage when the test is not filed with a covered diagnosis. Benefits may vary by contract; providers and members should refer to the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member‑specific coverage determinations.

Covered Indications and Supporting Evidence

inv-21: Clinical indications listed in policy (see 25‑OH and 1,25‑OH covered indications)

Testing must be filed with a covered diagnosis to be considered covered.

Filing requirement: All vitamin D assays (25‑OH, 1,25‑OH, and specified microvolume LC/MS) must be submitted with a covered diagnosis to be considered medically necessary and covered for Medicare Advantage and Commercial Products

Per policy: assays are covered when filed with a covered diagnosis

See specific assay indications: Refer to the Covered Indications for 25‑OH and 1,25‑OH testing for the full lists of clinical indications that meet medical necessity

See inv-01 and inv-02

inv-22: References supporting clinical contexts for vitamin D testing

Clinical references cited in the policy support vitamin D testing in several contexts; these citations provide the evidence base and clinical rationale.

Contexts supported by references: Chronic kidney disease / mineral and bone disorder; suspected vitamin D deficiency; osteoporosis or low bone density and fracture prevention considerations; systemic lupus erythematosus and autoimmune disease contexts; post‑renal transplantation outcomes and other conditions associated with low vitamin D

References: KDIGO guideline, systematic reviews on screening and treatment, studies on vitamin D in SLE and transplantation (see reference list)

Usage note: While references support testing in these contexts, coverage is determined by the policy's listed covered indications and the requirement that testing be filed with a covered diagnosis

Policy links evidence citations to indicated clinical contexts but requires alignment with listed indications for coverage

Coding

Covered CPT Codes (25‑OH)CPTCovered

82306

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

Covered HCPCS (microvolume LC‑MS assay)HCPCSCovered

0038U

Vitamin D, 25 hydroxy D2 and by LC‑MS/MS, serum microsample; quantitative D3

Covered CPT Codes (1,25‑OH)CPTCovered

82652

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

inv-08: DEXA T‑score — <= -2.5 (osteoporosis)

ThresholdDEXA T-score <= -2.5 (osteoporosis)

ContextListed as a covered indication for measurement of 25‑OH Vitamin D when filed with a covered diagnosis

Actionable useUsed to identify osteoporosis or high fracture risk prompting 25‑OH testing prior to therapy decisions (eg, bisphosphonate initiation)

inv-09: FRAX 10‑year probability — >= 3% for hip fracture or >= 20% for other major osteoporotic fracture

ThresholdFRAX 10‑year probability >= 3% (hip) or >= 20% (other major osteoporotic fracture)

ContextListed as a covered indication for measurement of 25‑OH Vitamin D when filed with a covered diagnosis

Actionable useMeets coverage criteria for 25‑OH testing in patients with elevated 10‑year fracture risk

Provider Actions and Administrative Rules

Prior Authorization

Not applicable. Laboratories are not allowed to obtain clinical authorization or participate in the authorization on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to authorization/medical necessity. In no circumstance shall a laboratory, a physician/provider, a representative of a laboratory, or anyone with a relationship to a laboratory and/or a third party obtain authorization on behalf of the ordering physician, facilitate any portion of the authorization process, or assist with any subsequent appeal where the authorization process was not followed and/or a denial for clinical appropriateness was issued. If a laboratory or third party is found to be supporting any portion of the authorization process, BCBSRI will deem the action a violation of this policy and may take severe action up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.

Ordering physician must handle authorizations, appeals, and administrative processes related to authorization/medical necessity.
Laboratories and third parties may not obtain or facilitate authorizations on behalf of ordering physicians.
Services provided by a laboratory without required authorization will be denied and the participating laboratory will be financially liable; such services may not be billed to the member.

Billing Rule

Billing, Coverage Verification, and Member Billing Risk

Measurement of 25-OH Vitamin D, Measurement of 1,25-OH Vitamin D, and Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS (InSource Diagnostics) are covered only when filed with a covered diagnosis per the coding section; all other indications are not covered for Medicare Advantage and are not medically necessary for Commercial products. For member-specific benefits and eligibility, providers should verify benefits via the provider call center and review the member's certificate/subscriber agreement or employer agreement, which supersede this medical policy. If services are determined to be not medically necessary (or are medically necessary but are non-covered benefits), providers may not bill the member unless the member was informed and agreed in writing in advance to proceed at their own expense.

Assays (e.g., 25-OH Vitamin D, 1,25-OH Vitamin D, Sensieva™ Droplet 25OH Vitamin D2/D3 LC/MS) are covered only when filed with a covered diagnosis (see coding section).
Other indications for these assays are not covered for Medicare Advantage and are not medically necessary for Commercial products.
Verify member-specific benefits and eligibility via the provider call center; the member's certificate/subscriber agreement and employer agreement control coverage.
If a service is determined not medically necessary or is a non-covered benefit, do not bill the member unless prior written agreement exists.

Denial Risk

Laboratory Authorization and Denial Risk

If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member. Providers and laboratories should ensure authorizations (when applicable) are completed by the ordering physician and maintain documentation to support medical necessity to avoid denials and member billing issues.

Unauthorized laboratory services will be denied and financial responsibility rests with the participating laboratory.
Do not bill members for services determined to be not medically necessary or non-covered unless the member provided prior written agreement to accept financial responsibility.

Definitions

inv-19: 25‑hydroxyvitamin D (25‑OH) — Laboratory measure more reflective of total body vitamin D stores and preferred as the initial assay in evaluation of hypovitaminosis D.

Definition25‑hydroxyvitamin D (25‑OH) is a laboratory measure more reflective of total body vitamin D stores and is the preferred initial assay in evaluation of hypovitaminosis D.

Clinical rolePreferred initial test for most patients with suspected vitamin D deficiency

Relationship to 1,25‑OHUndergoes renal 1‑alpha hydroxylation to form the active metabolite 1,25‑dihydroxyvitamin D

inv-20: 1,25‑dihydroxyvitamin D (1,25‑OH) — The active metabolite produced by renal 1‑alpha hydroxylation; assay reserved for patients with suspected kidney disease, parathyroid dis...

Definition1,25‑dihydroxyvitamin D (1,25‑OH) is the active metabolite produced by renal 1‑alpha hydroxylation; its assay is reserved for patients with suspected kidney disease, parathyroid disorders, or other conditions affecting activation.

IndicationsCovered when any of: unexplained hypercalciuria or hypercalcemia (suspected granulomatous disease/lymphoma), suspected genetic childhood rickets, nephrolithiasis, or suspected tumor‑induced osteomalacia.

Testing strategyNot the preferred initial assay for routine deficiency screening; use when disorders of activation/metabolism are suspected

OpenPayer

Vitamin D laboratory testing (25‑OH and 1,25‑OH) — Coverage Criteria

Coverage Criteria

Covered Indications and Supporting Evidence

Coding

Provider Actions and Administrative Rules

Ordering Requirements

Frequency Limits

Definitions

Background

Not Covered / Exclusions