ModifiedEmblemHealthPolicy AHS-G2051

Bone Turnover Markers Testing Lab Benefit Program (LBM)

Defines EmblemHealth's reimbursement stance for laboratory bone turnover marker (BTM) testing, including indications, limitations, and clinical context for use; applies to providers submitting claims to EmblemHealth products.

Policy Summary

PayerEmblemHealth

PolicyBone Turnover Markers Testing Lab Benefit Program (LBM)

Policy CodePolicy AHS-G2051

Change TypeCoverage criteria revisions and program scope expansion

Effective DateMar 1, 2023

Next Review Date

Key ActionFor patients treated with bisphosphonates, obtain baseline BTM before initiating therapy and repeat every 3 months during the first year, then every 2 years if no medication changes.

SourceLink

POLICY UPDATE CHANGES

Lab Benefit Program (LBM) expanded to include EmblemHealth HMO/PPO (Non-City) Commercial, Medicare and Medicaid plans effective 10/1/2024.

Removal of an earlier coverage criterion that allowed measurement of bone turnover markers for initial evaluation/management and fracture risk prediction.

Clarified and adjusted frequency criteria for measurement of bone turnover markers in individuals treated with bisphosphonates.

Updated policy language for clarity with no changes to coding or coverage criteria noted in one revision.

bisphosphonate monitoringBTM testing meets coverage criteria for assessing compliance and fracture risk in patients on bisphosphonates

teriparatide excludedBTM testing does not meet coverage criteria to monitor teriparatide in osteoporosis

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

BTMs not covered as diagnostic test for osteoporosis

PINP & CTXPreferred markers commonly cited

monitor adherence/responseCommon recommended application

use B-ALPCKD-specific recommendation

Coverage Determinations and Criteria

Coverage criteria

Covered when ALL of the following are met:

Measurement of bone turnover markers to monitor teriparatide treatment DOES NOT MEET COVERAGE CRITERIA

Measurement of bone turnover markers as a diagnostic test for osteoporosis DOES NOT MEET COVERAGE CRITERIA

Measurement of bone turnover markers for diagnosis and management of other conditions associated with high rates of bone turnover DOES NOT MEET COVERAGE CRITERIA

Note: Bone turnover markers include formation markers (e.g., serum bone-specific alkaline phosphatase [BSAP/BALP], osteocalcin, PINP) and resorption markers (e.g., urinary hydroxyproline, PYD, DPD, NTX, CTX), among others

Guideline-derived coverage considerations

Clinical guidance from professional societies and consensus groups — key points to consider when ordering and interpreting BTMs:

ONE of: BTMs cannot be used to diagnose osteoporosis

ONE of: BTMs may predict more rapid bone loss and are associated with increased fracture risk in some studies, but have limited incremental value over BMD and clinical risk factors

ONE of: Preferred markers for monitoring: PINP for formation and CTX for resorption; B-ALP may be used when renal insufficiency or other issues limit use of collagen markers

ONE of: Use of BTMs to assess adherence and early therapeutic response: consider targets such as suppression greater than the least significant change (LSC) or reduction to the lower half of the reference interval for young healthy premenopausal individuals

ONE of: Suggested measurement timing from guideline groups: for anti-resorptive agents (e.g., bisphosphonates) measure baseline, 3, 6, and 12 months; for anabolic agents measure baseline, 1–3, 6, and 12 months

Coverage criteria and notes (includes updates from revision history)

Current coverage stance and recent policy updates:

ALL of the following

ALL of the following
- Baseline before initiating treatment
- Every three months after initiation or change of therapy for the first year
- Every two years when no medication changes have occurred

Coverage narrowed: bone turnover marker testing for fracture risk prediction is recommended only for individuals who are receiving treatment (previous broader coverage for initial evaluation and fracture risk prediction was removed)

Procedure Codes, Markers, and Coding Notes

procedure codesmixed

No codes listed

Preferred and alternative BTMsmixed

Preferred markers identified: PINP (formation), CTX (resorption); bone-specific alkaline phosphatase (B-ALP) as alternative in renal insufficiency or insurance issues.

Example procedure codes referencedCPT

82523	Collagen cross links, any method
83500	Hydroxyproline; free
83505	Hydroxyproline; total
83937	Osteocalcin (bone protein)
84080	Phosphatase, alkaline; isoenzymes

inv-07: least significant change (LSC) examples

Serum NTX~14% decrease needed to be 90% confident a decrease is real (Eastell et al., 2000)

Urinary NTX~31% decrease needed to be 90% confident a decrease is real (Eastell et al., 2000)

Long-term CV for serum NTX~7.5% (Eastell et al., 2000)

Long-term CV for urinary NTX~15.6% (Eastell et al., 2000)

inv-08: Treatment adherence/response target

Primary treatment targetSuppression of PINP and/or CTX by more than the least significant change (LSC) or to the lower half of the reference interval for young healthy premenopausal individuals

What Providers Need To Do

Note

Coverage stance and monitoring intervals

For individuals treated with bisphosphonates, measurement of bone turnover markers to assess compliance or for fracture risk prediction meets coverage criteria when performed at baseline before initiating therapy and every three months after initiation or change for the first year; other uses (monitoring teriparatide, diagnostic testing for osteoporosis, management of other high-turnover conditions) do not meet coverage criteria.

Documentation Required

Guideline-based considerations for testing and treatment decisions

Consider targeting bone turnover marker values at or below the median for premenopausal individuals as a response goal for antiresorptive therapy; assess significant increases in formation markers as a pharmacologic response to anabolic therapy. Ending a bisphosphonate holiday may be based on individual circumstances such as an increase in bone turnover markers.

Documentation Required

Suggested monitoring intervals from IOF/AFOS/ISCD consensus

Key Terms and Marker Definitions

inv-13: BTMs (general definition and examples)

DefinitionBone turnover markers (BTMs) are biochemical markers reflecting bone formation (e.g., BSAP/B-ALP, osteocalcin, PINP) or bone resorption (e.g., urinary NTX, serum CTX, DPD, PYD)

Formation marker examplesBone-specific alkaline phosphatase (BSAP/B-ALP), osteocalcin (OC), PINP (procollagen type I N-terminal propeptide)

Resorption marker examplesUrinary hydroxyproline (HYP), urinary total pyridinoline (PYD), urinary free deoxypyridinoline (DPD), NTX, CTX, TRACP-5b, cathepsin K

inv-14: LSC (least significant change) definition

DefinitionLeast significant change (LSC) is a metric used to interpret whether change in a BTM exceeds analytical and biological variability and therefore represents a meaningful change

Purpose

Policy Summary

PayerEmblemHealth

PolicyBone Turnover Markers Testing Lab Benefit Program (LBM)

Policy CodePolicy AHS-G2051

Change TypeCoverage criteria revisions and program scope expansion

Effective DateMar 1, 2023

Next Review Date

Key ActionFor patients treated with bisphosphonates, obtain baseline BTM before initiating therapy and repeat every 3 months during the first year, then every 2 years if no medication changes.

SourceLink

On This Page

ONE of: Routine use of BTMs in all patients is not recommended; use selectively to aid treatment selection, monitor adherence, or provide early feedback on drug effect

Administrative: policy language updated for clarity; Lab Benefit Program expanded to additional product lines effective 10/1/2024

Governance note: if conflict exists with applicable government policies (NCD/LCD/state Medicaid), the government policy prevails

Use for adherence monitoringCTX and/or PINP can be measured at baseline, 3, 6, and 12 months after starting anti-resorptives to evaluate adherence and drug response

Use for anabolic therapy responseSignificant increases in formation markers (e.g., PINP) may indicate response to anabolic agents

CTX and/or PINP may be used to evaluate adherence and drug response with suggested measurement times: baseline, 3, 6, and 12 months after starting antiresorptive treatment; PINP for anabolic agents at baseline, 1–3, 6, and 12 months.

Billing Rule

Testing frequency for patients on bisphosphonates

For patients receiving bisphosphonates, bone turnover marker testing to assess compliance meets coverage criteria at these intervals: baseline before initiating treatment; every three months after initiation or change of therapy for the first year; every two years when no medication changes have occurred.

Helps distinguish true treatment-related change from assay or biologic variability

ContextLSC values depend on assay CVs and biological variability; standardization efforts aim to reduce variability and harmonize decision limits

inv-15: PINP definition and role

DefinitionPINP (procollagen type I N-terminal propeptide) is a bone formation marker used to monitor therapy, particularly recommended as a reference marker by IOF/IFCC

Clinical roleUseful for monitoring oral therapy and for assessing response to anabolic agents (measurements at baseline, 1–3, 6, and 12 months for anabolic agents)

PreferenceIdentified alongside CTX as preferred reference marker for fracture risk prediction and treatment monitoring

inv-16: CTX definition and role

DefinitionCTX (C-terminal crosslinking telopeptide) is a bone resorption marker commonly used to monitor anti-resorptive therapy response

Clinical roleCTX can be used to evaluate patient adherence and drug responses to anti-resorptive agents with suggested measurements at baseline, 3, 6, and 12 months

Guideline statusIdentified with PINP as a preferred reference marker by multiple international guidelines (IOF/IFCC, ESCEO consensus)

inv-17: Bone-specific alkaline phosphatase (B-ALP) definition

DefinitionBone-specific alkaline phosphatase (B-ALP, also BSAP) is an enzyme marker of osteoblast activity used as a formation marker

Clinical roleLess affected by renal failure and may be useful for assessing bone disease in CKD patients (KDIGO suggests B-ALP can be used in CKD G3a–G5D)

Alternative useConsidered an alternative formation marker when PINP/CTX are limited by renal impairment or assay availability

inv-18: Laboratory-developed tests (LDTs) explanation

DefinitionLaboratory-developed tests (LDTs) are assays developed and validated in-house by clinical laboratories and regulated under CLIA '88 as high-complexity tests; they are not FDA-cleared

RegulationLDTs are regulated by CMS under CLIA '88 and are not approved or cleared by the U.S. FDA, though FDA clearance is not currently required for clinical use

ImplicationMany laboratories use LDTs for specific BTM assays that must be validated and performed in-house

inv-19: Examples of FDA-cleared assays

Osteomark NTX Urine ELISAFDA 510(k)-cleared test measuring cross-linked N-telopeptides of type I collagen (NTx)

Serum Crosslaps One-step ELISAFDA 510(k)-cleared assay referenced for hydroxyproline/CTX measurements

Access Ostase (Beckman Coulter)FDA 510(k)-cleared assay measuring bone-specific alkaline phosphatase (B-ALP)

N-MID Osteocalcin One-step ELISA / Elecsys N-MID (Roche)FDA 510(k)-cleared assays for osteocalcin measurement (manufacturers include Nordic Biotech/Osteometer and Roche Diagnostics)