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Bone Turnover Markers Testing
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Defines Oscar Health's coverage stance and clinical guidance for measurement of biochemical bone turnover markers (BTMs) in members with or at risk for osteoporosis and related conditions; intended for providers submitting claims and requesting authorizations.
No material clinical or coverage changes in this revision.
Coverage Determinations and Clinical Criteria
Covered uses (meets criteria)
Covered when ALL of the following are met for individuals with osteoporosis treated with bisphosphonates:
Baseline and monitoring for bisphosphonate therapy
- Baseline: a) To establish baseline levels before initiating bisphosphonate treatment
- Initial monitoring: b) Every three months after initiation or change of therapy for the first year3 months
- Long-term monitoring: c) Every two years when no medication changes have occurred2 years
Not covered / does not meet criteria
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIA
Guideline-based clinical use cases
Guideline-supported scenarios where BTMs are useful (society statements):
References: AACE/ACE, IOF/AFOS/ISCD, IOF/IFCC, ESCEO
References: AACE/ACE, IOF/ESCEO, Wei et al.
References: KDIGO, IOF/IFCC, ESCEO
References: IOF/AFOS/ISCD consensus, IOF/IFCC
Society Guidance Summary
Guidance from multiple societies summarized:
source: ESCEO/IOF/IFCC
sources: RACGP, ROS, ISCD
sources: ESCEO consensus, RACGP, ROS
Measurement of bone turnover markers (BTMs) to monitor therapy or for fracture-risk prediction in individuals with osteoporosis who are starting or receiving bisphosphonate treatment MEETS CRITERIA when all of the following are documented: baseline measurement prior to initiating bisphosphonate therapy; monitoring every 3 months after initiation or a therapy change during the first year; and routine monitoring every 2 years when no medication changes have occurred. Measurement of BTMs to monitor teriparatide treatment DOES NOT MEET CRITERIA. The policy further states that using BTMs as a diagnostic test for osteoporosis or for diagnosis/management of other high–bone-turnover conditions DOES NOT MEET CRITERIA because available published literature does not confirm the tests are required and beneficial for diagnosis and treatment.
The North American Menopause Society (NAMS) and the ESCEO consensus both emphasize that routine use of bone turnover markers in the evaluation of all patients with osteoporosis is not recommended. NAMS notes BTMs cannot diagnose osteoporosis and have limited ability to predict fracture risk in clinical practice, and routine use to assess adherence or effectiveness is not recommended. ESCEO similarly cautions against routine monitoring to assess individual treatment effect, while acknowledging BTMs can help detect some causes of secondary osteoporosis and may be useful for assessing adherence when defined suppression exceeds the least significant change or reaches the lower half of young reference ranges.
Guidance from Paget’s disease and ESCEO sources warns that BTMs should not be used as the sole diagnostic test for conditions such as Paget’s disease because elevations occur in many disease states (for example hyperparathyroidism, hyperthyroidism, malignancy, advanced renal failure, or recent fracture) and therefore cannot be interpreted in isolation; very high values (>1.5× upper reference limit) should prompt evaluation for alternate causes rather than being taken as a specific diagnosis.
Per this policy, the use of bone turnover markers as a diagnostic test for osteoporosis is not medically necessary. The document specifies that BTM measurement for diagnosis of osteoporosis does not meet criteria owing to insufficient evidence that the tests are required or beneficial for diagnosing this condition.
Several professional societies (including NAMS and ESCEO) do not support routine or universal BTM testing for diagnosis or for evaluation of all patients with osteoporosis; therefore, such routine testing would generally be considered not medically necessary under this policy. Societies note BTMs are primarily useful in research and select specialist settings rather than for broad, routine screening.
Multiple organizations advise against routine use of BTMs for monitoring osteoporosis care in general practice. ESCEO and a systematic evidence review conclude there is insufficient evidence to recommend routine monitoring to predict response to therapies such as teriparatide. RACGP recognizes BTMs change early after treatment and can aid adherence monitoring in some studies but does not recommend routine use. As a result, routine or universal monitoring of BTMs in primary care is not supported by these guideline bodies.
Applicable Codes, Test Methods, and Analytic Notes
| No codes listed |
Authorization, Documentation, and Billing Guidance for Providers
Authorization and benefit verification
Services must meet authorization and medical necessity guidelines and coverage determinations are dependent on the member’s benefit coverage at the time of the request. Providers are responsible for submitting accurate documentation and appropriate coding; failure to follow coding/billing guidelines or current reimbursement policies may result in denial or recoupment.
- Verify member benefits and that the requested BTM testing meets medical necessity per this policy before ordering or submitting a claim.
- Confirm any Medicare/Medicaid specifications in the ‘Applicable State and Federal Regulations’ section when relevant.
Prior authorization may be appropriate for routine or non-guideline BTM use
Some international groups endorse routine reimbursement and short-term monitoring with BTMs (eg, IOF/AFOS/ISCD recommendations), but multiple societies note limitations and recommend selective use — prior authorization may be reasonable when BTMs are requested for routine screening or outside guideline-indicated monitoring.
- If using BTMs for routine monitoring or outside guideline-supported indications, anticipate payer prior authorization requirements.
- Document the clinical rationale referencing guideline-supported scenarios if requesting authorization for non-standard use.
Prior authorization may be required for listed CPT/HCPCS codes
Procedure codes for bone turnover marker tests are listed in the policy; check payer prior authorization rules for these specific CPT/HCPCS codes when prior authorization is required.
Step therapy
Step therapy requirements are not specified in this policy.
Use BTMs after initial risk/BMD assessment
Guidelines recommend using BTMs primarily after initial clinical risk and BMD assessment — for monitoring treatment response, adherence, and to inform decisions (for example, bisphosphonate holidays), rather than as a first-line diagnostic test.
- Obtain BMD and perform clinical risk assessment before using BTMs to guide management decisions.
- Use BTMs to monitor response/adherence where guideline-supported (eg, serum CTX for antiresorptives, PINP/P1NP for anabolic agents).
Documentation to support medical necessity
Providers must submit accurate clinical documentation demonstrating that BTM testing is being performed for covered indications (for example, baseline measurement prior to initiating bisphosphonate therapy or monitoring at guideline-specified intervals).
- Include clinical indication tying the test to covered uses (eg, baseline before bisphosphonate start; monitoring every 3 months during first year; biennial monitoring if stable).
Suggested documentation elements
Documentation should specify the exact bone turnover marker ordered (eg, serum CTX for antiresorptive monitoring, P1NP for anabolic therapy), the indication (baseline vs monitoring), and the timing relative to therapy (eg, baseline, 1–3 months, 3, 6, 12 months as recommended by some groups).
- State whether the test is for baseline assessment, monitoring treatment response/adherence, or assessment during a bisphosphonate holiday.
- Record timing of collection relative to treatment initiation or change (examples: baseline; 3 months; 6 months; 12 months).
Test method and coding documentation
Use FDA‑cleared assays when available or validated laboratory-developed tests (LDTs) per CLIA regulations; when submitting claims include the appropriate CPT/HCPCS procedure code(s) listed in the policy.
Denial risk for improper coding/documentation
Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed or if clinical documentation is inaccurate or insufficient to support medical necessity.
- Ensure coding follows industry-standard guidelines and include supporting documentation linking the test to a covered indication.
- Be aware that failure to follow payer-specific billing rules can result in claim denial or repayment requests.
KDIGO measurement guidance
KDIGO advises against routine measurement of collagen-derived BTMs (for example, P1NP, CTX) in patients with CKD stages G3a–G5D; ordering these tests outside KDIGO‑recommended indications may not be supported.
- For CKD G3a–G5D, KDIGO suggests using serum PTH or bone-specific alkaline phosphatase instead of routine collagen-derived BTMs.
- If treating patients with CKD, document rationale when ordering P1NP or CTX if deviating from KDIGO guidance.
Conflict with government policy
If this policy conflicts with an applicable government policy (such as a Medicare LCD/NCD or state Medicaid coverage rule), the government policy will govern determinations and may lead to denial of nonconcordant claims.
- When applicable, check Medicare and state Medicaid coverage databases and follow those rules over this policy.
- Document compliance with the controlling government policy when submitting claims or authorization requests.
Background and Evidence Summary
Bone turnover markers (BTMs) are biochemical markers of bone formation (for example BSAP/BALP, osteocalcin, PINP) or bone resorption (for example NTX, CTX, TRACP5b) that may help assess fracture risk and rates of bone loss. Their clinical utility is limited by biological and assay variability and by lack of complete standardization; however, IOF/IFCC and related groups identify serum PINP and β-CTX (CTX) as reference markers commonly used for monitoring and research purposes. BTMs may add modest prognostic information beyond BMD and clinical risk factors, and are most often applied to monitor early treatment response or adherence rather than as sole diagnostic tools.
BTM Definitions and Analytical Notes
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