CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

CPT code 0619U is a Proprietary Laboratory Analyses (PLA) code for the TruD MDS COPD test from TruDiagnostic™ Inc., a whole-blood DNA methylation assay that analyzes methylation at more than 18,000 sites and uses an algorithm to report a positive or negative risk for pulmonary chronic obstructive pulmonary disease (COPD); this service is a molecular diagnostic laboratory test performed on a collected whole blood specimen, typically resulting from outpatient phlebotomy and processed in a clinical diagnostic laboratory.

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CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

Customize your policy alerts

Sign up for cpt 0619U policy alerts

Get alerted when payer policies referencing 0619U are released or updated.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Clinical & Coding Specifications

Clinical Context

A typical adult patient with a history of tobacco use, chronic respiratory symptoms, or an abnormal spirometry result presents to a primary care clinician or pulmonologist for risk stratification for chronic obstructive pulmonary disease (COPD). The clinician orders the proprietary TruD MDS COPD test (0619U) performed by TruDiagnostic™ Inc., which requires a whole blood sample collected in a standard phlebotomy setting. The blood specimen is sent to the manufacturer’s laboratory; results are returned as a binary risk output (positive or negative) based on methylation profiling at >18,000 CpG sites and a proprietary algorithm.

Clinical workflow:

The clinician documents indications such as unexplained chronic cough, dyspnea, history of smoking, or abnormal pulmonary function testing and places the order for the TruD MDS COPD test (0619U).
A phlebotomy technician collects a whole blood specimen at an outpatient clinic, hospital outpatient lab, or ambulatory phlebotomy site; specimen handling and shipping follow the laboratory’s required protocol.
The specimen is transported to the manufacturer’s reference laboratory for DNA extraction, methylation analysis, and algorithmic interpretation.
The laboratory issues a report with a positive or negative COPD risk result to the ordering clinician. The clinician integrates the test result with clinical evaluation, smoking history, spirometry, imaging, and other diagnostic data to inform risk assessment and management planning.

Typical site of service: outpatient clinic, ambulatory phlebotomy center, hospital outpatient laboratory, or reference lab processing location.

Service type: Proprietary Laboratory Analysis (PLA) — high-complexity molecular diagnostic testing performed by a single laboratory/manufacturer.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0619U`	TruD MDS COPD — DNA methylation analysis of >18,000 sites, whole blood; proprietary test providing positive/negative COPD risk	Primary PLA code for the proprietary methylation-based COPD risk assay performed by TruDiagnostic™ Inc.; billed when the manufacturer’s test is ordered and processed.
`36415`	Collection of venous blood by venipuncture	Performed at the ordering site to obtain the whole blood specimen required for `0619U`.
`99000`	Handling and/or conveyance of specimen to reference laboratory (if payer allows)	May be used per payer or facility policy to report special specimen handling/shipping when separate reimbursement is permitted.
`G0499`	This code is not applicable to PLA testing and is listed here only if required by specific payers for molecular test reporting	Use only if a payer explicitly requires an alternate lab reporting code in conjunction with a PLA test (payer-specific situations).
`CPT not provided`	Data not available in the input.	Additional local or payer-specific laboratory billing codes may apply for courier services, accessioning, or facility charges; use institutional billing guidance.

Related Modifiers

6 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
90	Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…	- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
24	Modifier 24 denotes an unrelated evaluation and management (E/M) service performed by the same physician or qualified healthcare professional during a postoperative global period. Per CPT guidance,…	- Use modifier 24 when you report an evaluation and management (E/M) service performed by the same physician or same-specialty group during a procedure’s postoperative global period that is unrelated…
25	CPT modifier 25 indicates that on the same day as another procedure or service, the same physician or other qualified health care professional provided a significant, separately identifiable…	- When to apply: Use modifier 25 only on an E/M code to indicate the same provider delivered a significant, separately identifiable E/M service on the same day as another procedure or service — i.e.,…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
2084P0800X	Psychiatry Physician	A Psychiatrist specializes in the prevention, diagnosis, and treatment of mental disorders, emotional disorders, psychotic disorders, mood disorders, …
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
363A00000X	Physician Assistant	A physician assistant is a person who has successfully completed an accredited education program for physician assistant, is licensed by the state and…
2085N0700X	Neuroradiology Physician	A radiologist who diagnoses and treats diseases utilizing imaging procedures as they relate to the brain, spine and spinal cord, head, neck and organs…
163WF0300X	Flight Registered Nurse	Nursing Service Providers · Registered Nurse
207K00000X	Allergy & Immunology Physician	An allergist-immunologist is trained in evaluation, physical and laboratory diagnosis, and management of disorders involving the immune system. Select…
364SI0800X	Informatics Clinical Nurse Specialist	Physician Assistants & Advanced Practice Nursing Providers · Clinical Nurse Specialist

Related ICD-10-CM Codes

29 rows

ICD-10-CM Code	Description
E11.9	Type 2 diabetes mellitus without complications
E66.9	Obesity, unspecified
E78.5	Hyperlipidemia, unspecified
F17.200	Nicotine dependence, unspecified, uncomplicated
F17.210	Nicotine dependence, cigarettes, uncomplicated
I10	Essential (primary) hypertension
J42	Unspecified chronic bronchitis
J43.0	Unilateral pulmonary emphysema [MacLeod's syndrome]
J43.1	Panlobular emphysema
J43.8	Other emphysema

Showing 1–10 of 29

Related Payer Policy Updates

Specialty: Genetic & Molecular Testing1 / 3

10 rows

Policy	Payer	Effective Date
RTM Testing of Homocysteine Metabolism-Related Conditions	Oscar Health	2026-10-01
Multimarker Serum Testing Related to Ovarian Cancer	Blue Cross Blue Shield - Rhode Island	2026-09-01
Genomic Profiling for Selecting Targeted Cancer Therapies	Blue Cross Blue Shield - Rhode Island	2026-09-01
Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders	Blue Cross Blue Shield - Rhode Island	2026-09-01
Biomarker and Genetic/Molecular Testing Coverage and Prior Authorization	Blue Cross Blue Shield - Rhode Island	2026-09-01
Non-Invasive Prenatal Testing (NIPT)	univerahealthcare	2026-08-17
Lumizyme (alglucosidase alfa) — Pompe Disease (acid alpha‑glucosidase deficiency)	Cigna	2026-08-15
Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Molecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Carrier Testing Panels for Genetic Diseases	Colorado Rocky Mountain Health Plans	2026-08-01

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

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.

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Clinical & Coding Specifications

Clinical Context

Clinical workflow:

The clinician documents indications such as unexplained chronic cough, dyspnea, history of smoking, or abnormal pulmonary function testing and places the order for the TruD MDS COPD test (0619U).
A phlebotomy technician collects a whole blood specimen at an outpatient clinic, hospital outpatient lab, or ambulatory phlebotomy site; specimen handling and shipping follow the laboratory’s required protocol.
The specimen is transported to the manufacturer’s reference laboratory for DNA extraction, methylation analysis, and algorithmic interpretation.
The laboratory issues a report with a positive or negative COPD risk result to the ordering clinician. The clinician integrates the test result with clinical evaluation, smoking history, spirometry, imaging, and other diagnostic data to inform risk assessment and management planning.

Typical site of service: outpatient clinic, ambulatory phlebotomy center, hospital outpatient laboratory, or reference lab processing location.

Service type: Proprietary Laboratory Analysis (PLA) — high-complexity molecular diagnostic testing performed by a single laboratory/manufacturer.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0619U`	TruD MDS COPD — DNA methylation analysis of >18,000 sites, whole blood; proprietary test providing positive/negative COPD risk	Primary PLA code for the proprietary methylation-based COPD risk assay performed by TruDiagnostic™ Inc.; billed when the manufacturer’s test is ordered and processed.
`36415`	Collection of venous blood by venipuncture	Performed at the ordering site to obtain the whole blood specimen required for `0619U`.
`99000`	Handling and/or conveyance of specimen to reference laboratory (if payer allows)	May be used per payer or facility policy to report special specimen handling/shipping when separate reimbursement is permitted.
`G0499`	This code is not applicable to PLA testing and is listed here only if required by specific payers for molecular test reporting	Use only if a payer explicitly requires an alternate lab reporting code in conjunction with a PLA test (payer-specific situations).
`CPT not provided`	Data not available in the input.	Additional local or payer-specific laboratory billing codes may apply for courier services, accessioning, or facility charges; use institutional billing guidance.

Related Modifiers

6 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
90	Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…	- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
24	Modifier 24 denotes an unrelated evaluation and management (E/M) service performed by the same physician or qualified healthcare professional during a postoperative global period. Per CPT guidance,…	- Use modifier 24 when you report an evaluation and management (E/M) service performed by the same physician or same-specialty group during a procedure’s postoperative global period that is unrelated…
25	CPT modifier 25 indicates that on the same day as another procedure or service, the same physician or other qualified health care professional provided a significant, separately identifiable…	- When to apply: Use modifier 25 only on an E/M code to indicate the same provider delivered a significant, separately identifiable E/M service on the same day as another procedure or service — i.e.,…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
2084P0800X	Psychiatry Physician	A Psychiatrist specializes in the prevention, diagnosis, and treatment of mental disorders, emotional disorders, psychotic disorders, mood disorders, …
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
363A00000X	Physician Assistant	A physician assistant is a person who has successfully completed an accredited education program for physician assistant, is licensed by the state and…
2085N0700X	Neuroradiology Physician	A radiologist who diagnoses and treats diseases utilizing imaging procedures as they relate to the brain, spine and spinal cord, head, neck and organs…
163WF0300X	Flight Registered Nurse	Nursing Service Providers · Registered Nurse
207K00000X	Allergy & Immunology Physician	An allergist-immunologist is trained in evaluation, physical and laboratory diagnosis, and management of disorders involving the immune system. Select…
364SI0800X	Informatics Clinical Nurse Specialist	Physician Assistants & Advanced Practice Nursing Providers · Clinical Nurse Specialist

Related ICD-10-CM Codes

29 rows

ICD-10-CM Code	Description
E11.9	Type 2 diabetes mellitus without complications
E66.9	Obesity, unspecified
E78.5	Hyperlipidemia, unspecified
F17.200	Nicotine dependence, unspecified, uncomplicated
F17.210	Nicotine dependence, cigarettes, uncomplicated
I10	Essential (primary) hypertension
J42	Unspecified chronic bronchitis
J43.0	Unilateral pulmonary emphysema [MacLeod's syndrome]
J43.1	Panlobular emphysema
J43.8	Other emphysema

Showing 1–10 of 29

Related Payer Policy Updates

Specialty: Genetic & Molecular Testing1 / 3

10 rows

Policy	Payer	Effective Date
RTM Testing of Homocysteine Metabolism-Related Conditions	Oscar Health	2026-10-01
Multimarker Serum Testing Related to Ovarian Cancer	Blue Cross Blue Shield - Rhode Island	2026-09-01
Genomic Profiling for Selecting Targeted Cancer Therapies	Blue Cross Blue Shield - Rhode Island	2026-09-01
Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders	Blue Cross Blue Shield - Rhode Island	2026-09-01
Biomarker and Genetic/Molecular Testing Coverage and Prior Authorization	Blue Cross Blue Shield - Rhode Island	2026-09-01
Non-Invasive Prenatal Testing (NIPT)	univerahealthcare	2026-08-17
Lumizyme (alglucosidase alfa) — Pompe Disease (acid alpha‑glucosidase deficiency)	Cigna	2026-08-15
Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Molecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Carrier Testing Panels for Genetic Diseases	Colorado Rocky Mountain Health Plans	2026-08-01

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

OpenPayer

CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

Sign up for cpt 0619U policy alerts

OpenPayer

CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

Sign up for cpt 0619U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related ICD-10-CM Codes

Related Payer Policy Updates

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related ICD-10-CM Codes

Related Payer Policy Updates

Related Codes

References

CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

Sign up for cpt 0619U policy alerts

CPT 0619U: TruD MDS COPD DNA Methylation Blood Test

Sign up for cpt 0619U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related ICD-10-CM Codes

Related Payer Policy Updates

Related Codes

What does CPT code 0619U represent?

Where and how is the specimen for 0619U collected and processed?

Which billing modifiers might apply when reporting 0619U?

What other CPT or billing codes should be considered alongside 0619U?

For which clinical indications and payers is 0619U typically used and covered?

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related ICD-10-CM Codes

Related Payer Policy Updates

Related Codes

What does CPT code 0619U represent?

Where and how is the specimen for 0619U collected and processed?

Which billing modifiers might apply when reporting 0619U?

What other CPT or billing codes should be considered alongside 0619U?

For which clinical indications and payers is 0619U typically used and covered?

References