CPT 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

CPT code 0616U is a Proprietary Laboratory Analyses (PLA) code for the TruD MDS Alzheimer's & MCI test from TruDiagnostic™ Inc., which evaluates DNA methylation patterns at more than 30,000 sites in whole blood and uses an algorithmic analysis to report a positive or negative dementia-related risk result; the service is a specialized laboratory molecular diagnostic assay (PLA) typically performed by the manufacturer's or designated clinical laboratory and reported as an in‑lab blood-based diagnostic test.

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CPT 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

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Get alerted when payer policies referencing 0616U are released or updated.

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Clinical & Coding Specifications

Clinical Context

A typical patient is an adult aged 60–75 who presents to a primary care physician or neurologist with new concerns about cognitive decline, memory loss, or subtle changes in executive function reported by the patient or a family member. The clinician documents a focused cognitive history, performs a cognitive screening (for example, MoCA or MMSE), and completes a neurological exam. After initial assessment and when diagnostic uncertainty remains between normal aging, mild cognitive impairment (MCI), and early dementia, the clinician orders the TruD MDS Alzheimer’s & MCI blood-based test (0616U) to assess dementia-related risk using DNA methylation patterns from whole blood.

The clinical workflow typically includes:

Patient visit with cognitive screening and history.
Order placement for the proprietary laboratory analysis 0616U with appropriate requisition and informed consent for genetic/epigenetic testing.
Blood draw performed in an outpatient clinic, phlebotomy center, or diagnostic lab; sample shipped to the performing laboratory (TruDiagnostic™ Inc.).
Laboratory processes methylation assay, runs algorithmic analysis, and returns a binary risk result (positive/negative) to the ordering provider.
Ordering clinician reviews results in context of clinical exam, imaging, and other labs, and documents interpretation and next steps in the medical record. Typical sites of service are outpatient clinics, ambulatory care centers, and commercial laboratory collection sites. The service type is a proprietary laboratory analysis performed by a single manufacturer's laboratory under 0616U.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0616U`	TruD MDS Alzheimer’s & MCI (Proprietary Laboratory Analyses) — DNA methylation analysis of >30,000 sites in whole blood with algorithmic risk output.	This is the primary PLA test performed by TruDiagnostic™ Inc.; report for the specific proprietary assay.

36415 | Collection of venous blood by venipuncture. | Performed at the time of ordering 0616U to obtain the whole blood specimen for the methylation assay.

80307 | Drug testing: molecular pathology procedures, host genomic testing when applicable — (placeholder example). | May be used when companion molecular testing or additional molecular diagnostics are ordered alongside the PLA, depending on payer policies (use payer-specific guidance).

83516 | Drug/therapeutic drug assay (example biochemical assay). | May be billed for ancillary laboratory analyses that are part of the diagnostic workup but not for the PLA itself.

G0473 | Advanced Diagnostic Imaging (example) | Dementia evaluation may include imaging like MRI or PET; this code represents related advanced diagnostic services in the broader workflow.

Related Modifiers

5 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…
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…
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…
52	Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…	- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
22	Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…	- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
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…
207P00000X	Emergency Medicine Physician	An emergency physician focuses on the immediate decision making and action necessary to prevent death or any further disability both in the pre-hospit…
363L00000X	Nurse Practitioner	(1) A registered nurse provider with a graduate degree in nursing prepared for advanced practice involving independent and interdependent decision mak…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
163WR0006X	Registered Nurse First Assistant	A perioperative registered nurse who works in collaboration with the surgeon and other health care team members to achieve optimal outcomes. The RNFA…
363LC0200X	Critical Care Medicine Nurse Practitioner	Physician Assistants & Advanced Practice Nursing Providers · Nurse Practitioner
1835G0000X	Deactivated - Pharmacist

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.

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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

The clinical workflow typically includes:

Patient visit with cognitive screening and history.
Order placement for the proprietary laboratory analysis 0616U with appropriate requisition and informed consent for genetic/epigenetic testing.
Blood draw performed in an outpatient clinic, phlebotomy center, or diagnostic lab; sample shipped to the performing laboratory (TruDiagnostic™ Inc.).
Laboratory processes methylation assay, runs algorithmic analysis, and returns a binary risk result (positive/negative) to the ordering provider.
Ordering clinician reviews results in context of clinical exam, imaging, and other labs, and documents interpretation and next steps in the medical record. Typical sites of service are outpatient clinics, ambulatory care centers, and commercial laboratory collection sites. The service type is a proprietary laboratory analysis performed by a single manufacturer's laboratory under 0616U.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0616U`	TruD MDS Alzheimer’s & MCI (Proprietary Laboratory Analyses) — DNA methylation analysis of >30,000 sites in whole blood with algorithmic risk output.	This is the primary PLA test performed by TruDiagnostic™ Inc.; report for the specific proprietary assay.

36415 | Collection of venous blood by venipuncture. | Performed at the time of ordering 0616U to obtain the whole blood specimen for the methylation assay.

83516 | Drug/therapeutic drug assay (example biochemical assay). | May be billed for ancillary laboratory analyses that are part of the diagnostic workup but not for the PLA itself.

G0473 | Advanced Diagnostic Imaging (example) | Dementia evaluation may include imaging like MRI or PET; this code represents related advanced diagnostic services in the broader workflow.

Related Modifiers

5 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…
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…
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…
52	Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…	- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
22	Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…	- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
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…
207P00000X	Emergency Medicine Physician	An emergency physician focuses on the immediate decision making and action necessary to prevent death or any further disability both in the pre-hospit…
363L00000X	Nurse Practitioner	(1) A registered nurse provider with a graduate degree in nursing prepared for advanced practice involving independent and interdependent decision mak…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
163WR0006X	Registered Nurse First Assistant	A perioperative registered nurse who works in collaboration with the surgeon and other health care team members to achieve optimal outcomes. The RNFA…
363LC0200X	Critical Care Medicine Nurse Practitioner	Physician Assistants & Advanced Practice Nursing Providers · Nurse Practitioner
1835G0000X	Deactivated - Pharmacist

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 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

Sign up for cpt 0616U policy alerts

OpenPayer

CPT 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

Sign up for cpt 0616U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

References

CPT 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

Sign up for cpt 0616U policy alerts

CPT 0616U: TruD MDS Alzheimer's & MCI DNA Methylation Blood Test

Sign up for cpt 0616U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

What does CPT 0616U represent and what result does the test provide?

In what clinical context and workflow is 0616U commonly used?

Which related CPT/collection codes and modifiers are relevant when billing 0616U?

Which payers are noted for 0616U and does the page provide reimbursement rates?

What diagnosis codes are associated with clinical indications for ordering 0616U?

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

What does CPT 0616U represent and what result does the test provide?

In what clinical context and workflow is 0616U commonly used?

Which related CPT/collection codes and modifiers are relevant when billing 0616U?

Which payers are noted for 0616U and does the page provide reimbursement rates?

What diagnosis codes are associated with clinical indications for ordering 0616U?

References