Laboratory Benefit Management Administrative Protocol

UnitedHealthcare Laboratory Benefit Management Program Page 1 Insurance coverage provided by UnitedHealthcare Insurance Company or its affiliates. Administrative services provided by United HealthCare Services, Inc., its affiliates or designees. Doc#: PCA16547_20150413

UnitedHealthcare Laboratory Benefit Management Program

Administrative Protocol

This administrative protocol is effective Oct. 1, 2014.

This Laboratory Benefit Management Program Administrative Protocol applies to laboratory services for

fully insured Commercial members who live in Florida.

Excluded Plans

Benefit plans that are not subject to the requirements in this administrative protocol include:

Neighborhood Health Partnership

UnitedHealthcare Oxford Commercial and Medicare

Benefit plans subject to the UnitedHealthcare of the River Valley Entities Supplement

Sierra Health and Life

UnitedHealthcare Medicare Advantage

The Empire Plan

Railroad

MD-Individual Practice Association, Inc. (MD-IPA) and Optimum Choice, Inc.

Other benefit plans such as UnitedHealthcare Community Plan, Children's Health Insurance

Program (CHIP), uninsured and other non-Commercial plans

In addition, the Laboratory Benefit Management Program does not apply for claims subject to:

Optum Transplant Resource Services

Optum Cancer Resource Services

UnitedHealthcare StudentResources

Administration of the Program

Beacon Laboratory Benefit Solutions, Inc. (BeaconLBS®) will administer the Laboratory Benefit

Management Program on our behalf. BeaconLBS is a subsidiary of Laboratory Corporation of America®

that provides laboratory services management.

Member Identification Cards Members who are part of the Laboratory Benefit Management Program will be identified with a

BeaconLBS logo on their member identification (ID) card.


Physician Decision Support

As part of the Laboratory Benefit Management Program, ordering and rendering providers will use

BeaconLBS Physician Decision Support for laboratory services. Physician Decision Support technology

can make it easier to choose the right tests and laboratories for members using evidence-based guidelines

and industry best practices. If you order laboratory services and your practice is located in Florida, you

must use BeaconLBS Physician Decision Support when ordering any of the Decision Support Tests for

members who are part of the program. These tests are listed in this administrative protocol.

To access Physician Decision Support:

Use the standalone Physician Decision Support application available to registered users at

BeaconLBS.com.

Use an electronic laboratory ordering system integrated with Physician Decision Support.

Call 800-377-8809 (Monday ‒ Friday, 8 a.m. – 5 p.m. EST).

For a current list of electronic ordering systems integrated with Physician Decision Support, please go to

UnitedHealthcareOnline.com > Tools & Resources > Policies, Protocols and Guides > Protocols >

UnitedHealthcare Laboratory Benefit Management Program.

Physician Registration

Please register by visiting BeaconLBS.com and selecting Login|Register. You must register with

BeaconLBS to use the standalone Physician Decision Support application to order Decision Support

Tests. If you have already registered with BeaconLBS or if you submit test orders through a laboratory

ordering application integrated with Physician Decision Support, no further action is necessary.

If you do not use Physician Decision Support to order Decision Support Tests within 90 days after the

Laboratory Benefit Management Program effective date, you may be subject to one or more of the

following administrative actions:

A decreased fee schedule

Termination of your agreement with us

UnitedHealthcare will provide 30 days’ notice to care providers before enforcing these administrative

actions.

If your practice performs and bills for laboratory tests that are not Clinical Laboratory Improvement

Amendments (CLIA)-waived, you must also register as a laboratory.

Laboratory Registration

Please register by visiting BeaconLBS.com and selecting Login|Register. By registering with

BeaconLBS, ordering providers can select your laboratory for services when ordering tests through

Physician Decision Support.

Laboratory registration includes the following:

Document laboratory quality criteria.

Identify and map information for the Decision Support Tests you perform.

Prepare to submit laboratory test identifiers on claims.

http://www.beaconlbs.com/



Laboratory Quality Criteria If you perform and bill for any laboratory services, you must demonstrate the following:

CLIA certification

Accreditation from the College of American Pathologists (CAP) or The Joint Commission for

certain complex pathology tests

Secondary review for certain complex pathology tests

Sub-specialist review for certain complex pathology tests

Capability to process test orders and results electronically

Test Mapping Test mapping allows BeaconLBS to map tests in Physician Decision Support to your laboratory’s

clinically equivalent tests. As part of registration, you will map tests by submitting a test compendium

that includes the following information for Decision Support Tests:

Narrative description of the test

List of all associated Current Procedural Terminology (CPT) or Healthcare Common Procedure

Coding System (HCPCS) codes that correspond with each test identifier

Units of measure, specimen type, test method, specimen container, volume info, etc.

Number of units for each CPT or HCPCS code associated with each test identifier

BeaconLBS test identifier that corresponds to the laboratory’s unique test identifier

BeaconLBS will provide the form and data transmission protocol to submit the test identifier elements.

If your laboratory updates its test compendium after submission to BeaconLBS ‒ including any additions,

deletions or modifications ‒ you should provide updated information to BeaconLBS 30 days prior to

publishing those updates to providers, or as reasonably requested by BeaconLBS.

Laboratories of Choice

BeaconLBS Laboratories of Choice offer consistent clinical practices and cost efficiency. These

laboratories and other network laboratories that register and meet quality criteria for tests can be selected

for laboratory services using Physician Decision Support.

Laboratory of Choice providers must meet these quality criteria:

CLIA certification

CAP or Joint Commission accreditation for certain complex pathology tests

Secondary review for certain complex pathology tests

Sub-specialist review for certain complex pathology tests

In addition, Laboratories of Choice must have the capabilities to allow physicians to order and receive test

results electronically.

Laboratory of Choice providers must sign a contract with BeaconLBS and have their UnitedHealthcare

agreement amended to add BeaconLBS criteria.

To learn more about Laboratory of Choice providers, please visit UnitedHealthcareOnline.com > Tools &

Resources > Policies, Protocols and Guides > Protocols > UnitedHealthcare Laboratory Benefit

Management Program.


Claim Submission Process

You may only bill for covered services performed by you or your staff. Billing for laboratory tests

performed by another provider or laboratory is not permitted, with the exception of hospital and reference

laboratories following Centers for Medicare & Medicaid Services (CMS) policies regarding referred

laboratory testing. Claim submissions must include a CLIA number or CLIA Certificate of Waiver

number.

Clinical laboratory claims must contain the following:

o Your laboratory’s unique test identifier

o The ordering provider’s name and national provider identifier (NPI) number

o Your laboratory’s CLIA number

Hospital laboratory claims must contain:

o The ordering provider’s name and NPI number

Claim Submission Formats

A laboratory test identifier is an internal laboratory code used to identify a specific test performed by a

laboratory. Please use the following guidelines to submit test identifiers and other submission elements on

claims for members who are part of the Laboratory Benefit Management Program.

Claim Format and Elements

CLIA Number Location Options

Ordering Provider Name and NPI

Number Location Options

Test Identifier Submission Options

CMS-1500

(formerly

HCFA 1500)

Must be represented

in field 23

Submit the ordering provider name and NPI number in fields 17 and 17b, respectively.

Each time a laboratory CPT code or HCPCS code is populated in Item Number 24D, your corresponding test identifier should be placed in the shaded section of 24A through 24G.

UB04 or

CMS 1450

Not applicable for

UB04 or CMS 1450

claims

Submit the ordering provider name and NPI number in field 76.

Each time a laboratory CPT code or HCPCS code is populated in Field Location 44, your corresponding test identifier should be placed in Field Location 43.

HIPAA 5010

837

Professional

Must be represented

in the 2300 loop,

REF02 element

Submit the ordering provider name and NPI number in the 2310A loop, NM1 segment.

Each time a laboratory CPT code or HCPCS code is populated in the SV101-2 element of:

Loop 2400 Service Line Number

SV1 Professional Service Segment

Place your corresponding test identifier in the:

NTE02 element, with the ADD qualifier placed in the NTE01 element of:

o Loop 2400 Service Line Number


Claim Format and Elements

CLIA Number Location Options

Ordering Provider Name and NPI

Number Location Options

Test Identifier Submission Options

o NTE Line Note Segment

If multiple test identifiers are provided, please separate with commas.

Example: Submission of one laboratory test identifier (e.g., 002303) per procedure line: NTE *ADD*002303~

HIPAA 5010

837

Institutional

Not applicable for

institutional claims

Submit the ordering provider name and NPI number in 2310A loop, NM1 segment.

Each time a laboratory CPT code or HCPCS code is populated in the SV202-2 element of:


o SV2 Institutional Service Line Segment

Place your corresponding test identifier in the SV202-7 element of:


o SV2 Institutional Service Line Segment

If multiple test identifiers are provided, please separate with commas.

Example: Submission of one laboratory test identifier (e.g., 002303) for CPT 81099 with a billed amount of $125.15 and a unit of service of 1: SV2*0300*HC:81099:::::002303*125.15*UN*1~

This information describes specific requirements intended to supplement, not replace, all requirements in the ANSI X12N implementation guides. The ANSI X12N implementation guides are available at x12.org or www.wpc-edi.com.

Quality Criteria

Providers who perform and bill for laboratory services must meet the following quality criteria.

Laboratory quality criteria will be confirmed through the laboratory registration process.

http://x12.org/

http://www.wpc-edi.com/


Providers who do not meet all criteria for the tests performed and billed will not be reimbursed. Per your

agreement with UnitedHealthcare, these services may not be billed to the member.

CLIA: You must meet CLIA requirements and place your laboratory’s CLIA number on the claim for

services performed and billed.

Accreditation: You must have CAP or Joint Commission accreditation if you perform and bill for the

following services:

Surgical pathology

Cytology (gynecological and non-gynecological)

Molecular tests (e.g., genetics, infectious disease)

Flow cytometry

Advanced complex chemistry

Hematology and immunology procedures that require interpretation (e.g., electrophoresis, gas

chromatography, mass spectrometry)

The accreditation requirement does not apply at this time to providers with a specialty of dermatology or

dermatopathology who perform in-office pathology services. UnitedHealthcare will provide a 30-day

notice when the accreditation requirement goes into effect for care providers with a specialty of

dermatology or dermatopathology.

Sub-Specialty Certification:* If your laboratory performs and bills for the following services, you must

have the following corresponding sub-specialty certification. Certification may include board eligibility or

board certification.

Laboratory Testing Discipline Sub-Specialty Certification

General anatomic pathology Anatomic pathology

Bone marrow (smear, flow cytometry, cytogenetics)

Hematopathology

Chromosomal analysis Cytogenetics

Molecular genetics Molecular genetic pathology or certified geneticist

Cytology (Pap or fine needle aspiration smear)

Cytopathology

Malignant dermatopathology (excludes services associated with Mohs surgery)

Dermatopathology

Genetic counseling Board-certified genetic counselors

Human leukocyte antigen (HLA) testing American Society for Histocompatibility and Immunogenetics (ASHI) director

Secondary Complex Pathology Reviews:* If your laboratory performs and bills for pathology services,

you must provide secondary complex pathology review per the following chart.

* We recommend that care providers meet both the Sub-Specialty Certification and Secondary Complex Pathology

Reviews requirements. However, if both requirements cannot be met for dermatopathology, cytopathology or

hematopathology services, we will accept either requirement.


Secondary Complex Pathology Review Requirements

Area Description Quality Measure

Breast Pathology All new malignancies, atypical hyperplasia and in situ cases

Secondary review required; both reviews can be performed by general anatomic pathologist

Cytopathology All new malignancies to include gynecologic cytology, all fine needle aspirates, and non-gynecologic cytology

Secondary review required unless the initial review was performed by a cytopathologist. Both reviews can be performed by a general anatomic pathologist.

Dermatopathology New severely dysplastic nevi, melanomas, atypical spitz nevi, malignant skin appendageal tumors, atypical lymphoid infiltrates and soft tissue tumors diagnostic of sarcoma (excludes

services associated with Mohs surgery)

Secondary review required unless the initial review was performed by a dermatopathologist. Initial review may be completed by a dermatologist or an anatomic pathologist; secondary review be performed by an dermatopathologist or anatomic pathologist.

Gastrointestinal Pathology

New endoscopic directed biopsies and/or anal biopsy diagnostic of carcinoma; colon biopsies that have high grade dysplasia in a setting of inflammatory bowel disease; upper endoscopy directed biopsies with high grade dysplasia of either the stomach or esophagus; and liver needle biopsies regarded as diagnostic of carcinoma


General Pathology New miscellaneous biopsies (not encompassed in other categories) that are malignant or suspect cases (e.g., dysplastic nevi)


Gynecology Pathology

All new biopsies diagnostic of carcinoma to include vaginal and cervical biopsies, LEEP and cone biopsies, endocervical curettings and endometrial biopsies


Head, Neck and Oral Pathology

New biopsies diagnostic of in situ or invasive carcinoma of the mucosa, salivary gland, sinonasal tract to include inverted papillomas


Hematopathology New tissue biopsies with lymphoma to include intranodal and extranodal

Secondary review required unless the initial review was performed by a hematopathologist. Both reviews can be performed by a general anatomic pathologist.

Respiratory Pathology

New needle biopsies and endoscopic biopsies diagnostic of carcinoma



Uropathology All new genital-urinary biopsies to include kidney needle core biopsies** with in situ or invasive carcinoma


** It is recommended that biopsies within certain specialized areas (e.g., non-tumor kidney biopsies, ophthalmological biopsies or brain biopsies) be reviewed by pathologists with advanced training.

Advance Notification and Prior Authorization Requirements

Excluded Plans*

The following benefit plans are not subject to the Laboratory Benefit Management Program advance

notification and prior authorization requirements:

Benefit plans for which the member (rather than the physician) is required to provide advance

notification ‒ such as UnitedHealthcare Options PPO (for states other than Colorado) and

UnitedHealthcare Indemnity

UnitedHealthOne ‒ Golden Rule Insurance Company only

All Savers products offered off-exchange

MD-Individual Practice Association, Inc. (MD-IPA)

Optimum Choice, Inc. (OCI), OCI Health Savings Account (HSA) or OneNet

UnitedHealthcare West

* The Laboratory Benefit Management Program advance notification and prior authorization

requirements will not apply to these benefit plans. However, these benefit plans may have separate

advance notification and prior authorization requirements. For more information, please refer to the

applicable Additional Manual in the Benefit plans table of the UnitedHealthcare Administrative Guide at

UnitedHealthcareOnline.com > Home > Tools & Resources > Policies, Protocols and Guides.

Advance Notification

Advance notification is required for Decision Support Tests rendered in the office (place of service 11) or

clinical laboratory (place of service 81). If advance notification is not confirmed for Decision Support

Tests, the test will not be eligible for payment.

This protocol is a notification requirement, not a precertification, prior authorization or medical necessity

determination. The participating physician (ordering provider) must notify UnitedHealthcare using

Physician Decision Support prior to ordering the service.

The rendering laboratory will receive advance notification confirmation in the Outcome Summary or at

BeaconLBS.com. The Outcome Summary is a printable onscreen message that includes test ordering

results when a Decision Support Test is ordered through:

Physician Decision Support (available to registered users at BeaconLBS.com);

An electronic laboratory ordering system integrated with Physician Decision Support; or

Phone: 800-377-8809 (Monday ‒ Friday, 8 a.m. – 5 p.m. EST)

Please note that you will not be able to request advance notification through

UnitedHealthcareOnline.com.




If the rendering laboratory confirms that advance notification is not on file, the rendering laboratory

should contact the ordering provider to complete the notification process. Advance notification must be

completed within 10 calendar days from the date of service. The date of specimen collection is the date of

service. You cannot request advance notification after the claim has been submitted or request batch

notifications.

Advance notification cannot be confirmed unless the entire advance notification process is completed.

Advance notification is valid for 60 days from the date of test order. If the date of service exceeds 60

days, a new notification must be obtained.

For additional details please go to UnitedHealthcareOnline.com > Tools & Resources > Policies,

Protocols and Guides > Protocols > UnitedHealthcare Laboratory Benefit Management Program. A list of

Decision Support Tests is included in this administrative protocol.

Physician Decision Support is a laboratory services ordering tool operated by Beacon LBS. Successful

completion of an order or notification in Physician Decision Support is not a guarantee of payment or

coverage. Beacon LBS does not authorize or deny coverage for services. Information provided on

Physician Decision Support and by BeaconLBS representatives about payer clinical policies is for

informational purposes only. UnitedHealthcare clinical policies are available to physicians at

UnitedHealthcareOnline.com.

Prior Authorization

For any tests requiring prior authorization, ordering providers must use Physician Decision Support to

request prior authorization before ordering the service. Physician Decision Support will send the

information to UnitedHealthcare, and we will review the clinical information, make a determination and

communicate the decision.

The rendering laboratory will receive advance notification confirmation in the Outcome Summary or at

BeaconLBS.com. If the rendering laboratory confirms that prior authorization has not been requested, the

rendering laboratory should contact the ordering provider to complete the prior authorization process.

No updates can be made to an existing prior authorization after the service has been delivered.

Prior authorization requests for members who are not part of the Laboratory Benefit Management

Program should follow the standard process.

Decision Support Tests

Decision Support Tests are subject to separate requirements outlined in the previous sections of this

administrative protocol. All Decision Support Tests require advance notification using Physician Decision

Support. The BRCA 1/BRCA 2 test requires prior authorization.

For some Decision Support Tests, advance notification includes validating the following requirements:

Ordering provider: Completion of an electronic question and answer (Q&A) through Physician

Decision Support

Rendering provider: CAP or Joint Commission accreditation, sub-specialty certification and/or

secondary pathology review

The following chart outlines the validation requirements by laboratory test.



Decision Support Test Electronic Q&A

CAP or Joint Commission accreditation

Sub-specialty certification

Secondary pathology

review

Allergen panel

Alpha-thalassemia Yes Yes Yes; certified geneticist or molecular pathologist

Anemia panel, comprehensive Yes

Antineutrophil cytoplasmic antibody (ANCA) profile

Yes

Antinuclear antibodies (ANA) Yes

ANA panel (includes specific connective tissue antibodies)

Yes

Beta-hemolytic Streptococcus culture, group A

BRCA 1/BRCA 2* Yes*

Yes

Cancer antigen (CA) 125

CD4/CD8 cells (percent and absolute) + ratio

Yes

Chlamydia trachomatis/Neisseria gonorrhoeae with or without Trichomonas vaginitis, nucleic acid test (NAT)

Yes

Chromosome, blood (constitutional), pediatric (non-prenatal/POC)

Yes Yes Yes; cytogenetic or

American Board of Medical Genetics (ABMG)-certified director

Chromosome SNP microarray panel

Yes Yes Yes; cytogenetic or ABMG-certified

director

Clostridium difficile toxins A and B, EIA

Yes

Cystic fibrosis extended panel Yes Yes Yes; certified geneticist, molecular

pathologist or ABMG-certified

director

Cystic fibrosis panel (non-extended)

Yes Yes Yes; certified geneticist, molecular

pathologist or





Secondary pathology

review

ABMG-certified director

Drug screen and/or confirmation testing

Yes

Factor V Leiden mutation analysis

Yes Yes Yes; ABMG-certified director

Fine needle aspiration cytology Yes Yes; cytopathologist

Yes

Free kappa+lambda light chains, quantitative

Yes

Genital culture, routine

Gynecological Pap test with or without additional tests for sexual transmitted diseases (STDs)

Yes Yes Yes; cytopathologist

Gynecological Pap test with or without additional tests for STDs and reflex to human papillomavirus (HPV)


Gynecological Pap test with HPV, and with or without additional tests for STDs


Helicobacter pylori, IHC Yes

Helper T-lymphocyte markers (includes CD3 and CD4 percent and absolute)

Yes

Hemoglobinopathy fractionation profile

Yes

Hepatitis B and C profile Yes

Hepatitis B virus (HBV) quantitative, NAT

Yes Yes

Hepatitis C virus (HCV) FibroSURE

Yes

HCV genotype Yes Yes

HCV quantitative, NAT Yes Yes

Hereditary hemochromatosis, DNA analysis

Yes Yes Yes; certified geneticist or molecular pathologist

Herpes simplex virus (HSV) antibodies

HSV culture and typing Yes

HLA B27 Yes

Human immunodeficiency virus (HIV-1) genotyping

Yes Yes





Secondary pathology

review

HIV-1 1/O/2 antibodies screening with confirmation

Yes

HIV-1, quantitative, RNA Yes Yes

HPV, high-risk DNA detection Yes Yes

Insulin-like growth factor 1 (IGF-1) Yes

Immunofixation (IFE) and protein electrophoresis

Yes

IFE Yes

Immunohistochemistry (IHC) Yes

Leukemia/lymphoma immunophenotyping profile (by flow cytometry)

Yes

Lipoprotein analysis by NMR

Lipoprotein subfractionation profile by ultracentrifugation

Lyme disease antibodies with reflex confirmation

Yes

Lyme disease, Western blot Yes

Microbiology special stain, histology

Yes

Miscellaneous cytology (e.g., fluids, smears, sputum)

Yes Yes; cytopathologist

Yes

Ova + parasite exam

Pathology ‒ breast Yes Yes

Pathology ‒ dermatopathology Yes Yes; dermato-pathologist

Yes

Pathology ‒ gastrointestinal Yes Yes

Pathology ‒ general Yes Yes

Pathology ‒ gynecology Yes Yes

Pathology ‒ hematopathology Yes Yes; hemato-pathologist

Yes

Pathology ‒ otolaryngology Yes Yes

Pathology – respiratory Yes Yes

Pathology ‒ uropathology (including urine cytology)

Yes Yes

Prostate biopsy Yes Yes

Protein electrophoresis Yes

Quadruple marker screen – prenatal (AFP, DIA, hCG, uE3)


Stool culture

Strep group B culture/DNA Yes Yes

Syphilis screen, qualitative, with confirmation

Yes

Systemic lupus erythematosus profile

Yes

Thyroid panel Yes





Secondary pathology

review

Thyroid-stimulating immunoglobulin (TSI)

Yes

Thyroxine (T4), free Yes

T-lymphocyte helper/suppressor profile (C4/C8)

Yes

Triiodothyronine (T3), free Yes

Triple marker screen – prenatal (AFP, hCG, uE3)


Urine cytology Yes

Urine cytology hematuria profile Yes

UroVysion Yes Yes

Vaginitis/vaginosis, NAT Yes

Vitamin D, 25-hydroxy

* Prior authorization required


For More Information

Resource Where to go What you can do there

UnitedHealthcare Online: UnitedHealthcareOnline.com Phone: Please refer to the phone number on the member ID card

Learn more about the Laboratory Benefit Management Program at UnitedHealthcareOnline.com > Tools & Resources > Policies, Protocols and Guides > Protocols > UnitedHealthcare Laboratory Benefit Management Program.

Verify claim payment status and submit a claim appeal for certain outpatient laboratory test services as described in the Advance Notification and Prior Authorization Requirements section of this administrative protocol.

BeaconLBS Online: BeaconLBS.com Phone: 800-377-8809 (Monday ‒ Friday, 8 a.m. – 5 p.m. EST)

View program information.

Register for the Laboratory Benefit Management Program.

Request participation in the Laboratory of Choice network, if interested. If you are already a Laboratory of Choice provider, contact BeaconLBS for questions about your contract, including reimbursement.

Access the standalone Physician Decision Support tool and technical support.

Documents

Laboratory Benefit Management Administrative Protocol