Laboratory and Pathology Services

Updated: January 2026

Purpose

This policy explains the coverage criteria and billing requirements for laboratory and pathology services for enrolled ND Medicaid providers.

Applicability

Eligible Providers

To receive payment from ND Medicaid, the eligible servicing and billing providers must be enrolled with ND Medicaid on the date of service, and their National Provider Identifiers (NPIs) must be active in their Medicaid enrollment records. Servicing providers acting as a locum tenens provider must be enrolled with ND Medicaid, and services they provide must be billed with their NPI. Please refer to provider enrollment for additional details on enrollment eligibility and supporting documentation requirements.

Enrolled ND Medicaid providers who can provide laboratory or pathology services to ND Medicaid members, including:

  • Physicians and Other Licensed Providers (OLPs);
  • Clinics;
  • Hospitals; and
  • Independent Laboratories.

Eligible Members

Providers are responsible for verifying a member’s eligibility before providing services. Eligibility can be verified using the ND Medicaid MMIS Portal or through the Automated Voice Response System by dialing 1.877.328.7098.

Refer to the Member Eligibility Manual for additional information regarding eligibility including information regarding limited coverage categories. 

Covered Services and Limits

General Provider Policies

The General Provider Policies details basic coverage requirements for all services. Basic coverage requirements include:

  • The provider must be enrolled in ND Medicaid;
  • Services must be medically necessary;
  • The member must be eligible on the date of service; and
  • If applicable, the service has an approved service authorization. 

The Procedure Code Look-up Tool  can be used to identify if a procedure code is covered by ND Medicaid along with code specific details such as ORP requirements, Service Authorization requirements, and current rates. 

ND Medicaid covers medically necessary laboratory tests for diagnostic and treatment purposes. Services must: 

  • Be ordered and provided under the direction of a recipient’s treating physician or OLP who gives a consultation or treats a specific medical problem within their scope of practice as defined by state law; 
  • The service must yield results that are used by the treating physician or other licensed practitioner in the screening, diagnosis, or management of a recipient’s specific medical problem; and
  • Be allowed under the laboratory's CLIA certification if the service is classified under the CLIA program and the certification must be current.

Genetic Testing

When requesting a genetic test, the provider must document at least one specific disease that, if diagnosed, will result in an evidence-based change in the active treatment plan. The provider must document the exact changes in the treatment plan that would not otherwise occur without the genetic test results. A change in the treatment plan does not include covered routine screenings for potential diseases or knowledge of risk for acquiring an associated disease (for example, risk of cardiac or ophthalmologic problems or increased risk for development of malignancies). Genetic testing is not covered to determine the risk of occurrence in other family members (for example, genetic testing for family planning purposes).

Most Molecular Pathology, Genomic Sequencing, and Multianalyte Assays require an approved Service Authorization (SA) before being performed. Please see the Service Authorization policy and the SA section below for details. 

Newborn Metabolic Screening

ND Medicaid covers the newborn metabolic screening panel. The screening must include the tests specified in the NBS List of Conditions under ND Newborn Screening Laws. Services are covered under the hospital’s inpatient reimbursement if provided while the newborn is inpatient and must not be billed separately.

Specimen Collection and Handling

ND Medicaid will cover the following specimen collection and handling when performed for a covered lab service:   

  • Routine venipuncture (36415);
  • Collection of capillary blood specimen, finger, heel, ear stick (36416);
  • Collection of blood specimens from a completely implantable venous access device (36591); and
  • Collection of blood specimens using established central or peripheral catheter, venous, not otherwise specified (36592).

Medical Necessity

Medical or remedial services or supplies required for treatment of illness, injury, disease condition, or impairment; consistent with the recipient’s diagnosis or symptoms; appropriate according to generally accepted standards of medical practice; not provided only as a convenience to the recipient or provider; not investigational, experimental, or unproven; clinically appropriate in terms of scope, duration, intensity, and site; and provided at the most appropriate level of service that is safe and effective. 

National and Local Coverage Determinations (NCDs and LCDs)

ND Medicaid edits claims for medical necessity against the following NCDs and LCDs. 

The Centers for Medicare and Medicaid Services (CMS) uses local coverage determinations (LCDs) and national coverage determinations (NCDs) to determine whether Medicaid covers a service or item. 

CMS National Coverage Determinations (NCDs) 

  • 190.12 Urine Culture, Bacterial
  • 190.14 HIV
  • 190.15 Blood Counts
  • 190.16 Partial Thromboplastin Time (PTT)
  • 190.17 Prothrombin Time (PT)
  • 190.18 Serum Iron Studies
  • 190.19 Collagen Crosslinks 
  • 190.20 Blood Glucose Testing 
  • 190.21 Glycated Hemoglobin / Glycated Protein
  • 190.22 Thyroid Testing
  • 190.23 Lipid Testing
  • 190.24 Digoxin
  • 190.27 Human Chorionic Gonadotropin
  • 190.28 CA 125
  • 190.29 Tumor Antigen by Immunoassay CA15-/CA27.29
  • 190.30 Tumor Antigen by Immunoassay CA19-9
  • 190.31 Prostate-Specific Antigen
  • 190.32 Gamma Glutamyl Transferase
  • 190.33 Hepatitis Panel/Acute Hepatitis Panel
  • 190.34 Fecal Occult Blood Test

Local Coverage Determinations (LCDs) 

  • L34038 B-type Natriuretic Peptide (BNP) Testing 
  • L36692 Vitamin D Assay Testing
  • L36678 Lab: Bladder/Urothelial Tumor Markers 
  • L36668 Urine Drug Testing
  • L36702 Serum Magnesium
  • L34215 Lab: Flow Cytometry
  • L37066 Lab: Coenzyme Q10 (CoQ10)
  • L37616 Lab: Cystatin C Measurement
  • L37620 MDS FISH

Service Authorization Requirements

Service Authorization requirements for lab services can be found in the Procedure Code Look-up Tool. Acentra processes all Service Authorizations for genetic testing through the Atrezzo portal. 

Noncovered Services

General Noncovered Services

The Noncovered Services Policy contains a general list of services that are not covered by North Dakota Medicaid.

The following specific lab and pathology services are non-covered:

  • Routine handling charges (99000-90000);
  • Stat fees (S3600-S3601);
  • Paternity testing;
  • Postmortem examinations;
  • Labs related to infertility testing or treatment; and
  • Pharmacogenetic testing.

Documentation Requirements

General Requirements

Providers must keep legible medical and financial records that fully justify and disclose the extent of services provided and billed to ND Medicaid. Records must be retained for at least 7 years after the last date the claim was paid or denied. Providers must follow the documentation requirements in the Provider Requirements Policy. 

Reimbursement Methodology and Claim Instructions

Timely Filing

ND Medicaid must receive an original Medicaid primary claim within one hundred eighty (180) days from the date of service. The time limit may be waived or extended by ND Medicaid in certain circumstances. The Timely Filing Policy contains additional information.

Third-Party Liability

Medicaid members may have one or more additional source of coverage for health services. ND Medicaid is generally the payer of last resort. Providers must pursue the availability of third-party payment sources. The Third Party Liability Policy contains additional information.

Client Share (Recipient Liability)

Client share (recipient liability) is the monthly amount a member must pay toward the cost of medical services before the Medicaid program will pay for services received. The Client Share Policy contains additional information. 

Reimbursement

A claim for services must be submitted at the provider’s usual and customary charge. Payment for services is limited to the lesser of the provider’s usual and customary charge or the ND Medicaid calculated reimbursement. 

Reference and Outside Lab Services 

The laboratory that performed the test must submit the claim for the test. However, a laboratory participating in ND Medicaid that did not perform the test may submit the claim for the test only when the participating lab cannot complete the test as ordered by the referring physician and the outside lab receiving the applicable test is not enrolled in North Dakota Medicaid. The date of service is the date the specimen was drawn. 

Laboratory Panels 

The laboratory tests listed under each panel identify its defined components, and all listed tests must be performed to bill for that panel. Tests conducted in addition to those specifically indicated for a particular panel can be billed separately from the panel code. Lab panels should be reported as one line item, with a single service unit per panel.

If a panel is submitted and one of the lab procedures/tests is repeated, that single repeat component may be billed with the individual service code with modifier -91 appended. Do not report two or more panel codes comprising the same tests; report the panel with the highest number of tests to meet the code's definition and report the remaining tests individually.

Unbundling is the submission of multiple procedure codes for a group of specific procedures that are components of a single comprehensive code. ND Medicaid will reject the individual component codes related to the extensive procedure code for payment.

Test Components

  • Professional component—The professional component includes examining the patient when indicated, performing or supervising the procedure, and interpreting and writing a report of the examination. Professional components should be reported by appending modifier 26 to the usual procedure code number.
  • Technical component - Refers to the facility and equipment costs of performing a study, including supplies and a technologist or technician to conduct the exam. It is represented by appending the modifier -TC to the procedure code.
  • Total component - Represents the complete study, including both technical and professional components. It is represented by reporting the procedure code without the 26 or TC modifiers. 
    • Clinics billing for lab services performed on clinic-owned equipment should not separate services into professional and technical components. 

National Correct Coding Initiative (NCCI) Editing 

The Medicaid National Correct Coding Initiative (NCCI) program allows states to reduce improper payments in Medicaid and the Children's Health Insurance Program (CHIP).

The Medicaid NCCI methodologies must be applied to Medicaid fee-for-service (FFS) claims, which are submitted with and reimbursed based on Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) codes. This includes claims reimbursed on an FFS basis in state Medicaid Primary Care Case Management (PCCM) managed care programs. Application of NCCI methodologies to FFS claims processed by limited benefit plans or Managed Care Organizations (MCOs) is desirable but optional. The Medicaid NCCI program has certain edits unique to the Medicaid NCCI program (e.g., edits for codes that are noncovered or otherwise not separately payable by the Medicare program).

Lab services for members undergoing Medication for Opioid Use Disorder (MOUD) Treatment. 

Pregnancy testing, drug testing, and any other lab tests that are performed as part of clinic protocols for MOUD treatment are included in the weekly all-inclusive rate paid to the Opioid Treatment Program (OTP) or Office-Based Opioid Treatment Program (OBOT) and cannot be billed separately.  This applies to labs provided in-house or sent to an outside lab for processing.

Claim Form

Professional pathology services and clinic-based labs should be reported on the CMS-1500 claim form or the 837p HIPPA complaint form. Facility-based pathology and lab services must be billed using the CMS UB-04 claim form or the 837i HIPPA compliant form. Detailed claim instructions are available on the ND Medicaid Provider Guidelines, Policies & Manual webpage.

Claim Requirements

Ordering, Referring, and Prescribing (ORP) Requirements 

All lab services require the ordering, referring, or prescribing provider’s NPI to be listed on the CMS-1500 claim form or the 837p claim. Please see the ORP Policy for further details. 

Out of State Labs 

Labs that are sent out of state for processing from North Dakota do not require out-of-state service authorization. Providers should include a statement in Box 19 or its electronic equivalent that the labs were drawn in North Dakota. 

Labs performed as part of approved out-of-state services will be matched to the out-of-state approval. 

Definitions

CLIA – Clinical Laboratory Improvement Amendments Certificate 

Reference Lab – a laboratory that receives a specimen from another laboratory and performs one or more tests on such specimen.

References

Related Policies

Frequently Asked Questions

Question (Q): Can I appeal lab services that were denied for medical necessity? 
Answerrt (A): Yes, denials for medical necessity can be appealed. Do not submit the entire  
medical record without providing a statement and supporting literature as to why the LCD or NCD should be applied to the test for the member.

Contact

Medical Services
600 East Boulevard Ave 
Bismarck, ND 58505-0250
Phone: (701) 328-2310
Email: dhsmedicalservices@nd.gov

Policy Updates

July 2025

  • Medical Necessity
    • Added additional LCDs/NCDs that will be effective for dates of service on and after 07/01/025.  L36680, L37068, L37618, L37622, 190.20, 190.14, 190.19, 190.24, 190.28, 190.29, 190.30, 190.31, 190.32, 190.33, 190.34.

September 2025

  • Medical Necessity
    • Updated the LCD number for Lab: Controlled Substance Monitoring and Drugs of Abuse Testing.

January 2026

  • Entire Document 
    • Updated the format of the entire policy; the hyperlinks were changed to black text for ADA compliance.
  • Medical Necessity
    • Updated LCD numbers for Vitamin D Assay Testing, Serum Magnesium, Flow Cytometry, Cystatin C Measurement, Coenzyme Q10, and MDS FISH.   
  • Reimbursement
    • Added language regarding lab services for members in Medication-Assisted Opioid Use Disorder (MOUD) treatment.