Skip To: Main content|Subnavigation|
Minnesota Department of Human Services Provider Manual
Advanced Search|  

Laboratory and Pathology Services

Revised: 05-24-2017

  • Eligible Providers
  • Covered Services
  • Authorization Requirements
  • Billing
  • Definitions
  • Legal References
  • Eligible Providers

    All providers of laboratory services to Minnesota Health Care Programs (MHCP) recipients must meet the following requirements:

  • • Be an enrolled MHCP provider
  • • For independent laboratories, be certified as an independent laboratory provider by Medicare
  • • Have a current CLIA certificate to receive reimbursement for a laboratory service classified under the Clinical Laboratory Improvement Amendments (CLIA) program. If you did not indicate your CLIA certificate number on your MHCP enrollment application, or your organization has an updated or new certificate, you must fax the following to MHCP Provider Enrollment, at 651-431-7462:
  • • CLIA certificate number(s) and expiration date(s)
  • • Provider name
  • • NPI
  • Covered Services

    MHCP follows Medicare payment guidelines, and most Medicare coverage policy guidelines and indications. To be eligible for MHCP payment as a laboratory or pathology service, the service must:

  • • Be ordered and provided by or under the direction of a recipient’s treating physician (MD, OD, DPM, DDS) or practitioner (nurse practitioner, clinical nurse specialist, physician assistant or certified professional midwife) who gives a consultation or treats a recipient for a specific medical problem within his or her scope of practice as defined by state law
  • • Yield results that are used by the treating physician or practitioner in the screening, diagnosis or management of a recipient's specific medical problem
  • • Meet Medicare or DHS coverage criteria
  • • Be allowed under the laboratory's CLIA certification if the service is classified under the CLIA program
  • Authorization Requirements

    Refer to the MHCP Provider Manual Authorization section for criteria and requirements and to the Laboratory Authorization Code List for services requiring authorization.

    Billing

    Reference and Outside Lab Services

    Effective for dates of service on and after Jan. 1, 2015, in conjunction with Section 1902(a)(32) of the Social Security Act, MHCP will no longer reimburse providers for lab tests they did not complete unless they meet an exception as noted below.

    Do not include lab services you did not complete on your claim. When a specimen is sent to another provider, the ordering provider must also send all necessary information required for that provider to claim for the service.

    This policy applies only to lab services where the costs are paid fee-for-service. This policy applies to all services reported on claim format 837I and 837P. Lab services that are part of an all-inclusive inpatient hospital DRG or nursing facility rate are not affected.

    Exceptions
    Dates of service on and after Oct. 1, 2015: An outpatient hospital laboratory or provider-based clinic may continue to bill for laboratory services performed by a reference or outside lab only if the lab is providing services either as part of the hospital or when operating under an arrangement that is within the scope of the hospital's certification. In this situation, MHCP can either pay the laboratory directly or pay the hospital with which it is affiliated. (Refer to Medicare direct payment requirements at 42 CFR 447.10.)

    A staff-model clinic that is part of a health maintenance organization (HMO) licensed by the Minnesota Department of Health under Chapter 62D may bill for lab tests performed at other sites within the same HMO. Lab services performed by a reference or outside lab that is not part of the same HMO must be billed by the lab that performed the test. HMOs wishing to use this exception must provide DHS a list of the staff-model clinics or labs (including the NPIs) within the HMO that will be billing for services that other labs within the same HMO provide.

    Minnesota Family Planning Program (MFPP) Lab Tests and Services

    Refer to the MFPP Billing, Lab Services entry on the MFPP section of the Provider Manual for information regarding MFPP lab tests and services.

    Unlisted Codes

    According to the HCPCS codebook, if you provide a service that is not accurately described by HCPCS CPT procedure codes, you may report the service using an unlisted procedure code.

    Before considering using an unlisted or NOC, procedure code, you must determine if another more specific code could describe the procedure or service being performed or provided. If there is no more specific code available, you may use an unlisted code and must attach documentation to the claim to justify the use of the unlisted procedure code and to describe the procedure or service rendered. If the documentation includes multiple tests, you must note which test is being claimed with the unlisted code.

    Date of Service

    Do not bill a date span for services defined as multiple treatments or units of service.

    Units

    Bill laboratory tests that are not repeats in units; do not use the repeat modifier. Examples: Bill blood, urine and other cultures in "units of." Bill multiple organism ID’s in "units of."

    Test Components

    When billing for lab services and you own the equipment used, the services cannot be separated into a professional and technical component. Bill the appropriate code without a modifier.

    CLIA Tests

    To bill CLIA waiver tests, certain procedure codes must have the modifier QW. Do not use your CLIA number on the claim transaction. Do not use the QW modifier for services excluded from CLIA edits or for waived tests that don’t require modifier QW.

    Outpatient Hospital Laboratory Tests

    Effective for dates of service on or after Jan. 1, 2016, through Dec. 31, 2016, MHCP follows Medicare hospital outpatient clinical laboratory test packaging payment and billing policy for conditionally packaged lab services. Use L1 modifier only to identify unrelated laboratory tests ordered by a different provider for a different diagnosis. Refer to MLN Matters MM9486 under Revisions to Laboratory Test Packaging.

    Effective for dates of service on or after Jan. 1, 2017, modifier L1 has been discontinued. Do not report L1 on unrelated laboratory services for dates of service on or after Jan. 1, 2017. Refer to CMS Hospital Outpatient Fact Sheet under Packaged Services Policy Refinements for additional information.

    Automated Multi-Channel Laboratory Organ or Disease Oriented Panels

    The organ and disease oriented panel codes represent chemistry tests frequently performed in combinations on automated multi-channel equipment. When combinations of these tests are provided for a recipient on the same date, claims submitted to MHCP are subject to a payment cap specified by CMS for the Medicare program.

    All multi-channel laboratory tests performed on the same date for the same recipient must be submitted on one claim transaction. Billing the complete automated chemistry panel is advisable if all tests are done. Additional tests for the same date and same recipient submitted on a separate claim are considered part of the panel and will be denied as a duplicate test.

    If subsequent tests are provided for the same patient on the same date, submit a replacement claim and include the additional tests on one claim transaction.

    The Physician's Current Procedural Terminology (CPT) manual defines the organ and disease oriented panel codes. If other tests are performed in addition to those indicated for a particular panel, report the tests on individual lines on the claim, along with CPT panel codes.

    Do not separately report individual laboratory tests that are components of a multichannel test analysis.

    MHCP will process Medicare crossover claims as submitted per Medicare's billing instructions in the Medicare Claims Processing Manual (PDF).

    Specimen Collection and Handling

    Effective for dates of service July 1, 2012, and after, MHCP will no longer reimburse for collection of blood by access port in conjunction with another service. These services are incidental or included in a primary service.

    MHCP will cover collection and handling (if applicable) for each of the following types of specimen per recipient per day:

  • • Routine venipuncture for collection of specimens
  • • Collection of pap smears
  • • Catheterization for collection of a specimen, single homebound, nursing facilities
  • • Catheterization for collection of a specimen, multiple recipients
  • Minnesota Department of Health (MDH) Newborn Screening Program

    Effective for dates of service on or after Jan. 1, 2013, MHCP will cover the cost of the MDH newborn screening for metabolic disorder card when the screening cannot be completed at the inpatient hospital or birthing center setting with HCPCS code S3620. If MDH requests a repeat newborn screening card, bill with S3620 and modifier 76 or 77.

    MHCP includes the payment for the newborn screening card in the DRG or facility service when provided in the inpatient hospital or birthing center. Do not bill separately.

    MDH Infectious Disease Reporting

    MHCP will only cover handling and conveyance of specimen (CPT 99000) if both of the following conditions are met:

  • • A specimen (biological) is required to be submitted to MDH for infectious disease reporting
  • • The provider uses a third party courier and incurs a fee to deliver the biological to MDH
  • You may claim the courier expense using the 837P or 837I claim and must identify the rendering provider number as MDH (use UMPI# M306253800).

    In all other instances, CPT 99000 is incidental to the primary service and is not covered.

    Laboratory Services in a Physician's Office

    Payment for a laboratory service performed in a CLIA certified physician's laboratory will not exceed the amount paid for similar services performed in an independent laboratory.

    Pathology Services

    Bill pathology services reported with the 26 modifier using the 837P. A CLIA-certified provider NPI must also be included in one of the three provider fields: rendering, pay-to or service facility location.

    Pap Smear

    MHCP covers one professional and one technical component for Pap smear testing, per specimen per day.

    Genetic Testing

    MHCP covers genetic testing when medically necessary. Genetic testing is considered medically necessary when all of the following conditions are met and documented in the medical record:

  • • The recipient displays clinical features or is at direct risk of inheriting the genetic condition in question (pre-symptomatic)
  • • The result of the test will have a clinically significant impact on the treatment being delivered for a disease or syndrome
  • • The testing method is considered scientifically valid for the identification of a specific genetically linked inheritable disease
  • • Appropriate genetic counseling occurs before and after testing. Counseling documentation supports the intent to change therapy based on the results of the testing
  • Genetic testing is not covered when performed in the absence of symptoms or high risk factors for an inheritable disease or when knowledge of genetic status will not affect treatment decisions. Tests for conditions that are treated symptomatically are not appropriate since the treatment would not change due to the test results.

    Exome and genome testing requirements will be reviewed on a case-by-case basis. Claims must include an attachment that explains the medical necessity for the test and indicates how the results of the test will influence treatment. Claims will pend until each case is reviewed for the medical necessity of the test and what the results of the test will have on treatment.

    Pharmacogenetic testing is covered when all the following conditions are met:

  • • Testing is required by the drug label
  • • The test will change the treatment course
  • • A drug trial is considered impractical due to safety or other factors prior to genetic testing
  • Pharmacogenetic panel tests for therapy selection, such as panel tests for psychotropics, analgesics or ADHD stimulant medications, are not covered.

    MHCP does not cover cytogenetic testing for:

  • • Legal, paternity or informational purposes
  • • Family members who are not MHCP recipients
  • • Fetus testing
  • Genetic Mutation Testing

    The BRCA Genetic Mutation Testing for Breast & Ovarian Cancer Susceptibility: Authorization Criteria defines coverage criteria.

    Genetic Testing for Breast Cancer

    Genetic testing for breast cancer aims to help breast cancer patients and their physicians determine whether adjuvant chemotherapy would be beneficial. Genetic testing is considered medically indicated for recipients with all of the following breast cancer characteristics:

  • • Stage I or II breast cancer
  • • Breast tumor is estrogen-receptor positive
  • • Breast tumor is HER2-receptor negative
  • • Tumor size 0.6-1 cm with moderate or poor differentiation or unfavorable features, or tumor size >1 cm
  • • Negative lymph nodes (nodes with micrometastases > 2 mm in size)
  • • Test result will be used to guide decision making about adjuvant chemotherapy
  • MHCP allows payment for one of the following tests:

  • • Oncotype Dx – bill this test using HCPC S3854
  • • EndoPredict – bill this test using HCPD S3854 effective Jan. 1, 2017
  • Home Monitoring of Anticoagulant Therapy

    For dates of service Jan. 1, 2012, and after, home use of Prothrombin Time (PT) testing and International Normalization Ratio (INR) monitoring may be covered for recipients taking oral anticoagulation and with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism if all the following medical indications are present and if prescribed by the treating physician:

  • • The patient must have been anticoagulated for at least three months prior to use of the home INR device
  • • The patient must receive face-to-face education from the treating provider on anticoagulation management and must demonstrate the correct use of the device prior to its use in the home
  • • The patient must continue to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring
  • • Self-testing with the device should not occur more frequently than once a week
  • The treating physician must also order the home monitoring supplies for these conditions.

    Lead Toxicity Testing

    The lead toxicity screening test consists of a capillary or venous blood lead test, hemoglobin (Hgb), hematocrit (HCT), and other age-appropriate exams or tests (as noted in the schedule of age-related screening standards). Refer to the Child and Teen Checkups (C&TC) section for more information pertaining to lead toxicity testing.

    The following lead testing services are not covered:

  • • Paint chip, water and soil testing
  • • Assessments performed by a registered environmental health specialist or sanitarian
  • HIV Tropism (Trofile assay) Testing

    HIV Tropism testing is considered medically necessary for selecting recipients for treatment with HIV co-receptor antagonists.

    MHCP covers tropism testing for recipients who meet all of the following criteria:

  • • Failed antiretroviral treatments
  • • Evidence of viral replication
  • • Diagnosis of 042
  • Report HIV Tropism Testing using CPT 87999 with the description “HIV Tropism” in the line note. Limit of once per lifetime.

    Drug Testing

    MHCP allows coverage for urine drug testing (UDT) that is medically necessary. Document medical necessity, specific to each patient, in the patient’s medical record and include it in the plan of care. Documentation should specify how the test results will be used to guide decision making.

    Drug or drug classes for which screening is performed, should only reflect those likely to be present based on the patients’s medical history or current clinical presentation. An appropriately licensed health care professional must order the UDT. The ordering health care professional must sign and date the orders and must specify all drugs and drug classes to be tested as well as the clinical indication or medical necessity for the drug test.

    Standing orders or orders to “conduct additional testing as needed” are not sufficiently detailed to verify medical necessity.

    If the provider of the drug testing is different than the ordering or referring clinician, that provider must maintain hard copy documentation of the lab results along with copies of the order for the drug test. Copies of test results alone without documentation of the treating clinician’s request are not sufficient to support the drug testing services. The frequency of drug testing should be individualized to the treatment plan and should not exceed one every seven days at any time during the treatment.

    For outpatient pain management or substance abuse settings, presumptive UDT may be considered medically necessary for the following:

  • • Baseline screening at the time treatment is initiated: One time per program entry
  • • Stabilization phase: Weekly screening for a maximum of four weeks
  • • Maintenance phase: Screening once every one to three weeks
  • Presumptive UDT is limited to 15 tests within a 12 month period. UDT after the identification of the patient’s drugs or use or abuse profile must be limited to the specific drugs present on the initial profile.

    Confirmatory UDT may be considered medically necessary under the following conditions:

  • • A screen results in a negative finding that is inconsistent with the patient’s medical history, current clinical condition or the patient’s own statement
  • • Presumptive testing is positive
  • • Providers must document exceptions with the rationale for the confirmation testing order in the medical record
  • Routine confirmations of drug screens with negative results are not deemed medically necessary and are not covered.

    Report drug screening using CPT codes 80305-80307 or HCPC codes G0480-G0483. Effective Nov. 1, 2016, CPT codes 80300-80304 and 80320-80377 are no longer covered.

    Required drug screening for employment related issues or when court ordered are not medically necessary and are not covered. For services other than medication assisted therapy, drug testing costs are not included in the CCDTF rate.

    Definitions

    Laboratory: A facility that performs laboratory testing on specimens derived from humans for the purpose of providing information on diagnosis, prevention care, health assessment or treatment of diseases or impairments.

    Panel Codes: Groups of laboratory test (components) frequently performed together. Tests included in each panel are listed by name with the CPT code identified in parenthesis. To report a panel code, all listed tests must be performed.

    Pathology: A service requiring additional medical interpretive decision, consisting of a written report performed by a pathologist, at the request of a physician.

    Professional Component: A physician’s exam (when indicated), performance or supervision, interpretation or written report of a diagnostic test.

    Provider Performed Microscopy Procedures (PPMP): This allows physician office laboratories to perform a limited number of microscopy procedures. Certified PPM approved procedures are subject to change at any time.

    Technical Component: Includes the personnel and materials, including contrast media and drugs, film or xerography, space, equipment or other facilities.

    Waived Complexity: CMS has identified a number of simple laboratory procedures that can be performed in the physician offices after obtaining a Certificate of Waiver. Waived tests are subject to change at any time, so review all Medicare mailings for changes to waived test.

    Legal References

    Minnesota Statutes 144.123 Fees for Diagnostic Services, Exceptions
    Minnesota Statutes 144.125 Tests of Infants for Heritable and Congenital Disorders

    Minnesota Statutes 256b.0625, Subd. 54 Service Provided in Birth Centers

    Minnesota Statutes 256.969, Subd. 29
    Reimbursement for the fee increase for the early hearing detection and intervention program
    Minnesota Rules, 4605.7040 Disease and Reports; Clinical Material Submission

    Minnesota Rules 9505.0305
    Laboratory and X-ray Services
    Minnesota Rules 9505.0445
    Payment Rates
    State Medicaid Manual, Section 4385 B
    42 CFR 440.30
    Other Laboratory and X-ray Services
    42 CFR 441.17
    Laboratory Services
    42 CFR 441.56
    Required Activities
    42 CFR 493
    Laboratory Requirements

    CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Apply.

    Rate/Report this pageReport/Rate this page

    © 2017 Minnesota Department of Human Services
    Minnesota.gov is led by MN.IT Services
    Updated: 5/31/17 12:41 PM | Accessibility | Terms/Policy | Contact DHS | Top of Page | Updated: 5/31/17 12:41 PM