Currentmedical mutual - ohioPolicy AHS - G2005

Vitamin D Testing (25-hydroxyvitamin D and 1,25-dihydroxyvitamin D)

Defines medical coverage criteria, indications, limitations, and coding for serum vitamin D testing (25-hydroxyvitamin D including D2/D3 fractions and 1,25-dihydroxyvitamin D), monitoring frequency after supplementation, and cases where testing is not covered.

Policy Summary

Payermedical mutual - ohio

PolicyVitamin D Testing (25-hydroxyvitamin D and 1,25-dihydroxyvitamin D)

Policy CodePolicy AHS - G2005

Change TypeRevised; Removed language

Effective DateNov 16, 2015

Next Review Date

Key ActionEnsure clinical documentation supports one of the listed indications (Note 1 for 25OHD testing, Note 2 for 1,25-dihydroxyvitamin D) when ordering tests to meet coverage criteria.

POLICY UPDATE CHANGES

Edited CC3 for clarity and consistency.

Removed Note 1 point S: 'S. Obesity'.

Removed 'medical necessity' language from Notes 1 and 2.

Updated background, guidelines, and evidence-based scientific references.

2Primary tests referenced (25OHD, 1,25-dihydroxyvitamin D)

>=12Minimum retest interval (weeks)

MultipleGuideline references

3Explicit textual revisions listed

40+References cited (approx)

Coverage Summary

This coverage policy (Policy Number: AHS - G2005) addresses serum vitamin D testing for 25-hydroxyvitamin D (25OHD) and 1,25-dihydroxyvitamin D, including fractionated D2/D3 analysis, and defines indications, limits, and coding for when testing meets coverage criteria or is not covered. The policy stance is mixed: it permits testing for specific clinical indications and monitoring while disallowing routine population screening and use of 1,25-dihydroxyvitamin D for deficiency screening.

Key operational thresholds: retesting for serum 25-hydroxyvitamin D is allowed only at or after a 12-week interval following initiation of supplementation; monitoring is limited to up to twice per year while achieving a therapeutic goal and annual testing thereafter. Deficiency and target thresholds referenced in the policy include <20 ng/mL as deficiency and commonly recommended ranges of 20–40 ng/mL (IOM) or 30–50 ng/mL per some experts. The policy lists CPT/HCPCS codes for 25OHD (82306), 1,25-dihydroxyvitamin D (82652), and a referenced LC-MS/MS D2/D3 assay (0038U).

Quick thresholds & monitoring facts

Retest interval after supplementation>= 12 weeks

Monitoring frequency until therapeutic goal achievedUp to twice per year

Monitoring frequency after therapeutic range achievedAnnual

Deficiency threshold (commonly used)< 20 ng/mL

Insufficiency (per some organizations)< 30 ng/mL

Toxicity threshold> 200 ng/mL ( >500 nmol/L)

Medical Necessity / Coverage Criteria

Medically Necessary / Meets Coverage Criteria

Covered when ANY of the following are met:

ANY of the following

Individuals with an underlying disease or condition which is specifically associated with vitamin D deficiency or decreased bone density (see Note 1).
Individuals suspected of hypervitaminosis of Vitamin D.
As part of the total 25-hydroxyvitamin D analysis, testing for D2 and D3 fractions of 25-hydroxyvitamin D.
CC3 (retest timing and monitoring limits): For individuals who have documented vitamin D deficiency, repeat testing for serum 25-hydroxyvitamin D at least 12 weeks after initiation of vitamin D supplementation therapy.

Coding

Covered / Referenced Procedure CodesCPTCovered

82306	Vitamin D; 25 hydroxy, includes fraction(s), if performed.
82652	Vitamin D; 1, 25 dihydroxy, includes fraction(s), if performed.
0038U	Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative Proprietary test: Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay. Lab/Manufacturer: InSource Diagnostics

Provider Actions & Billing Rules

Documentation Required

Document indication from Note 1/Note 2

Ensure clinical documentation clearly indicates which Note (Note 1 for 25-hydroxyvitamin D testing or Note 2 for 1,25-dihydroxyvitamin D testing) supports the order. Affected codes: 82306, 82652, 0038U.

Document the specific indication from Note 1 or Note 2 in the medical record.
Retain supporting clinical notes when submitting claims for codes 82306, 82652, or 0038U.

Billing Rule

Retesting timing requirement

Do not perform repeat 25-hydroxyvitamin D testing sooner than 12 weeks after initiation of vitamin D supplementation; retesting performed earlier may not meet coverage criteria. Affected code: 82306.

Minimum retest interval after starting supplementation: >= 12 weeks.

Background & Definitions

Vitamin D exists in two major forms: ergocalciferol (D2) and cholecalciferol (D3); D3 is produced in skin after UV exposure and both forms require hepatic and renal hydroxylation to become active. In circulation two activated forms are measured: 25-hydroxyvitamin D (25OHD), the predominant and most stable biomarker of vitamin D status, and 1,25-dihydroxyvitamin D, the metabolically active form with a much shorter half-life.

Laboratory measurement methods include immunoassays (e.g., ELISA, RIA), HPLC, and mass spectrometry (LC-MS/MS). LC-MS/MS is considered the analytical gold standard because it can discriminate and quantitatively report D2 and D3 fractions as well as total 25OHD; however, LC-MS/MS is used by a minority of labs and substantial inter-assay variability exists across methods.

Because of method-related variability, the Centers for Disease Control and Prevention established the Vitamin D Standardization-Certification Program (VDSCP) to standardize assays, provide reference measurements for both 25-hydroxyvitamin D2 and D3, and set performance expectations (e.g., total CV ≤10% and mean bias within -5% to +5%) to improve comparability across laboratories and over time.

Term	Definition
25(OH)D	25-Hydroxyvitamin D, the predominant and most stable circulating form used to evaluate vitamin D status.
25OHD	25-Hydroxyvitamin D.
LC/MS/MS	Liquid chromatography coupled with mass spectrometry, assay method capable of differentiating D2 and D3; considered the gold standard for measuring vitamin D metabolites.
VDSCP	Vitamin D Standardization-Certification Program (CDC) to standardize vitamin D assays and ensure assay accuracy and reliability.

Evidence items (compact)

IOM / Expert recommended 25OHD range20-40 ng/mL (IOM); other experts 30-50 ng/mL

Vitamin D deficiency definitionSerum 25OHD < 20 ng/mL

Revision History

2015-11-16effective_date

Policy effective date established (Initial Presentation Date: 11/16/2015).

2024-12-04reviewLatest

Policy reviewed and updated: background, guidelines, and evidence-based scientific references were updated; coverage criterion CC3 text edited for clarity and consistency; Note 1 point 'S. Osteogenesis imperfecta' (originally listed as point S previously labeled 'Obesity' in the changes summary) was removed from Note 1; 'medical necessity' language removed from Notes 1 and 2, per revision summary.

2024-12-04material_change

Policy Summary

Payermedical mutual - ohio

PolicyVitamin D Testing (25-hydroxyvitamin D and 1,25-dihydroxyvitamin D)

Policy CodePolicy AHS - G2005

Change TypeRevised; Removed language

Effective DateNov 16, 2015

Next Review Date

Key ActionEnsure clinical documentation supports one of the listed indications (Note 1 for 25OHD testing, Note 2 for 1,25-dihydroxyvitamin D) when ordering tests to meet coverage criteria.

On This Page

>= 12 weeks retest interval; monitoring limited to twice per year until therapeutic goal achieved, then annual testing

With restrictions: twice per year for monitoring supplementation until therapeutic goal achieved; annual testing once therapeutic range achieved.

For evaluation or treatment of conditions associated with defects in vitamin D metabolism (see Note 2): serum 1,25-dihydroxyvitamin D testing.

Does Not Meet Coverage Criteria / Not Covered

The following testing does NOT meet coverage criteria:

ALL of the following

Exclusion A: Measurement of serum 1,25-dihydroxyvitamin D to screen for vitamin D deficiency.
Exclusion B: Routine screening for vitamin D deficiency with serum testing in asymptomatic individuals and/or during general encounters.

Note 1: Indications for serum measurement of 25-hydroxyvitamin D

Covered indications include, but are not limited to:

Note 1 indications

A: Biliary cirrhosis and other specified disorders of the biliary tract
Blind loop syndrome
Celiac Disease
D: Coronary artery disease in individuals where risk of disease progression is being considered against benefits of chronic vitamin D and calcium therapy
E: Dermatomyositis
F: Eating disorders
G: Bariatric procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, biliopancreatic diversion with/without duodenal switch)
Hypercalcemia, hypocalcemia, or other disorders of calcium metabolism
I: Hyperparathyroidism or hypoparathyroidism
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 and other medications known to lower vitamin D levels
O: Malnutrition
P: Myalgia and other myositis not specified
Q: Myopathy related to endocrine diseases
R: Neoplastic hematologic disorders
S: Osteogenesis imperfecta
T: Osteomalacia
U: Osteopetrosis
V: Osteoporosis
W: Pancreatic steatorrhea
X: Primary or miliary tuberculosis
Y: Psoriasis
Z: Regional enteritis
AA: Renal, ureteral, or urinary calculus
BB: Rickets
CC: Sarcoidosis
DD: Stage III-V Chronic Kidney Disease and End Stage Renal Disease
EE: Systemic lupus erythematosus

Note 2: Indications for serum testing of 1,25-dihydroxyvitamin D

Indications include:

Note 2 indications

A: Disorders of calcium metabolism
B: Familial hypophosphatemia
C: Fanconi syndrome
D: Hyperparathyroidism or hypoparathyroidism
E: Individuals receiving hyperalimentation
F: Neonatal hypocalcemia
G: Osteogenesis imperfecta
H: Osteomalacia
I: Osteopetrosis
J: Primary or miliary tuberculosis
K: Renal, ureteral, or urinary calculus
L: Rickets
M: Sarcoidosis
N: Stage III-V Chronic Kidney Disease and End Stage Renal Disease

Use CPT code 82306 for 25-hydroxyvitamin D testing when applying this timing rule.

Billing Rule

Monitoring frequency limits

Limit monitoring retests to up to twice per year until the therapeutic goal is achieved, then annual testing thereafter to meet coverage criteria. Affected code: 82306.

Monitoring frequency until therapeutic goal achieved: up to 2 times per year.
Monitoring frequency after therapeutic range achieved: once per year.
Apply these limits when billing CPT code 82306.

Documentation Required

Policy change implications

Coverage criterion CC3 was edited for clarity and consistency; Note 1 point 'S. Obesity' was removed from the list of indications; and the phrase 'medical necessity' was removed from Notes 1 and 2. Providers should verify the updated criteria and documentation requirements in the main policy before submitting claims.

Edited CC3 for clarity and consistency (refer to Revision History).
Note 1 point 'S. Obesity' has been deleted from indications for 25-hydroxyvitamin D testing.
The wording 'medical necessity' was removed from Notes 1 and 2 — confirm authorization language when claiming tests.

Toxicity threshold (reported)>200 ng/mL (>500 nmol/L)

Major guidelines citedAACE/ACE 2020; Endocrine Society 2011 & 2024; USPSTF 2021; NHS; Royal Osteoporosis Society; ACOG; AAP

Assay standardization programCDC Vitamin D Standardization-Certification Program (VDSCP)

Material edits made: CC3 operational wording revised for clarity; removal of Note 1 point 'S. Obesity'; removal of 'medical necessity' phrasing from Notes 1 and 2 (as listed in the 12/04/2024 revision summary).

Revision changes to coverage criteria (referenced edits)

Changes made during 12/04/2024 review:

Revision edits

Edited CC3 for clarity and consistency
Removed Note1 S: Removed Note 1 point S: 'S. Obesity'
Removed medical necessity language: Removed 'medical necessity' language from Notes 1 and 2