UnitedHealthcare Laboratory Benefit Management Program Administrative Protocol

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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.

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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.

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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.

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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

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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 Loop 2400 Service Line Number o SV2 Institutional

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

o Loop 2400 Service Line Number 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.

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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.

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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

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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.

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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.

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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

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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)

Yes Yes Yes;

cytopathologist

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

Yes Yes Yes;

cytopathologist

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

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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)

Yes Yes Yes; ABMG-

certified director Stool culture

Strep group B culture/DNA Yes Yes

Syphilis screen, qualitative, with confirmation

Yes

Systemic lupus erythematosus profile

Yes

Thyroid panel Yes

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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)

Yes Yes Yes; ABMG-

certified director

Urine cytology Yes

Urine cytology hematuria profile Yes

UroVysion Yes Yes

Vaginitis/vaginosis, NAT Yes

Vitamin D, 25-hydroxy

* Prior authorization required

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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.