TIER 2 MOLECULAR PATHOLOGY PROCEDURES · Diagnosis and Monitoring Non - Cancer Indications, and Several Pharmacogenomic applications. Guidelines Tier 2 Molecular pathology procedures

Tier 2 Molecular Pathology Procedures Page 1 of 18 UnitedHealthcare Medicare Advantage Policy Guideline Approved 01/08/2020

Proprietary Information of UnitedHealthcare. Copyright 2020 United HealthCare Services, Inc.

TIER 2 MOLECULAR PATHOLOGY PROCEDURES Guideline Number: MPG381.01 Approval Date: January 08, 2020 Table of Contents Page POLICY SUMMARY .................................................... 1 APPLICABLE CODES ................................................. 3 PURPOSE ................................................................ 9 REFERENCES ........................................................... 9 GUIDELINE HISTORY/REVISION INFORMATION .......... 17 TERMS AND CONDITIONS ........................................ 17

POLICY SUMMARY

Overview According to The American Medical Association (AMA) Current Procedural Terminology (CPT) manual, molecular pathology procedures are medical laboratory procedures involving the analyses of nucleic acid (i.e., DNA, RNA) to detect variants in genes that may be indicative of germline (e.g., constitutional disorders) or somatic (e.g., neoplasia)

conditions, or to test for histocompatibility antigens (e.g., HLA). Code selection is typically based on the specific gene(s) that is being analyzed. Codes that describe tests to assess for the presence of gene variants use common gene variant names. Typically, all of the listed variants would be tested. However, these lists are not exclusive. If other variants are also tested in the analysis, they would be included in the procedure and not reported separately. Full gene sequencing should not be reported using codes that assess for the presence of gene variants unless the CPT code specifically states full gene

sequence in the code descriptor. In other words, you may only assign the CPT code that is described as “full gene sequence” if the test assay performed was a full gene sequence. There are Tier 1 and Tier 2 molecular pathology procedure codes. Tier 1 codes generally describe testing for a specific gene or HLA locus. Tier 2 molecular pathology procedures represent procedures that are generally performed in lower volumes than Tier 1 molecular pathology procedures (e.g., the incidence of the disease being tested is rare). They are

arranged by level of technical resources and interpretive work by the physician or other qualified healthcare professional.

Use the appropriate molecular pathology procedure level code that includes the specific analyte listed after the code descriptor. If the analyte/gene tested is not listed under one of the Tier 2 codes or is not represented by a Tier 1 code in CPT, use of the Not Otherwise Classified (NOC) CPT code 81479 is required.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a single gene or any combination of genes when testing is performed as part of a Next - Generation Sequencing (NGS) or other multiplexing technology panel. Molecular pathology procedures have broad clinical and research applications. The following examples of applications may not be relevant to a Medicare member or may not meet a Medicare benefit category and/or reasonable and necessary threshold for coverage. Such examples include Genetic Testing and Genetic Counseling (when applicable) for:

Disease Risk Carrier Screening

Related Medicare Advantage Policy Guidelines

Biomarkers in Cardiovascular Risk Assessment

Clinical Diagnostic Laboratory Services

Molecular Pathology/Molecular Diagnostics/Genetic Testing

Related Medicare Advantage Reimbursement Policies

Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy, Professional

Laboratory Services Policy, Professional

Related Medicare Advantage Coverage Summaries

Genetic Testing

Laboratory Tests and Services

UnitedHealthcare® Medicare Advantage Policy Guideline

Terms and Conditions

See Purpose

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/b/biomarkers-cardiovascular-risk-assessment.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/c/clinical-diagnostic-laboratory-services.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/m/molecular-pathology-diagnostics-genetic-testing.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/m/molecular-pathology-diagnostics-genetic-testing.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-reimbursement/MEDADV-CLIA-ID-Requirement-Policy.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-reimbursement/MEDADV-CLIA-ID-Requirement-Policy.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-reimbursement/MEDADV-Laboratory-Services-Policy.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/genetic-testing.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/laboratory-tests-services.pdf



Hereditary Cancer Syndromes Gene Expression Profiling for certain cancers Prenatal Diagnostic testing Diagnosis and Monitoring Non - Cancer Indications, and

Several Pharmacogenomic applications. Guidelines Tier 2 Molecular pathology procedures may be eligible for coverage when ALL of the following criteria are met: Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or

results are clearly equivocal; AND Availability of a clinically valid test, based on published peer reviewed medical literature; AND

Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) analytical validity and clinical utility; AND

Results of the testing must directly impact treatment or management of the member; AND For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered

approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are

reasonable and necessary to establish a diagnosis; AND Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic

testing for a disease should be performed once in a lifetime.) Screening services such as pre - symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a Medicare benefit and are not covered. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly effects

the management of the patient. A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically

useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage.

Based on the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (100 - 08), this policy addresses the circumstances under which the item or service is reasonable and necessary under the Social Security

Act, §1862(a)(1)(A). For laboratory services, a service can be reasonable and necessary if the service is safe and effective; and appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the patient's condition; furnished in a setting appropriate to the patient's medical needs and condition; ordered and furnished by qualified personnel; one that meets, but does not exceed, the patient's medical need; and is at least as beneficial as an existing and available medically appropriate alternative.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or injury...". Furthermore, it has been longstanding CMS policy that "tests that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered unless explicitly authorized by statute". Screening services, such as pre - symptomatic genetic tests and services, are

those used to detect an undiagnosed disease or disease predisposition, and as such are not a Medicare

benefit and not covered by Medicare. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the risk assessment clearly and directly effects the management of the patient. However, Medicare does cover a broad range of legislatively mandated preventive services to prevent disease, detect disease early when it is most treatable and curable, and manage disease so that complications can be avoided. These services can be found on the CMS website at http://www.cms.gov/PrevntionGenInfo/.

Per 42 Code of Federal Regulations (CFR) section 410.32 (a) states the following requirements: All diagnostic x - rays tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary (see 411.15(k)(1)). Also, see Medicare Benefit Policy Manual (100 - 02), Chapter 15, Section 80.6 for related physician order instructions.

http://www.cms.gov/PrevntionGenInfo/



Laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth at 42 CFR part 493. Section 1862(a)(1)(A) of the Act provides that Medicare payment may not be made for services that are not reasonable and necessary. Clinical laboratory services must be ordered and

used promptly by the physician who is treating the beneficiary as described in 42 CFR 410.32(a), or by a qualified non - physician practitioner, as described in 42 CFR 410.32(a)(3). Many applications of the molecular pathology procedures are not covered services given lack of benefit category (preventive service) and/or failure to reach the reasonable and necessary threshold for coverage (based on quality of clinical evidence and strength of recommendation). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service was not

audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the member. Certain tests and procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit. Tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually relevant to a Medicare member.

Documentation Guidelines

Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition that warrants the test(s).

Examples of documentation requirements of the ordering physician/non - physician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results). Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.

Documentation requirements for lab developed tests/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.

Providers are required to code to specificity however, if an unlisted CPT code is used the documentation must clearly identify the unique procedure performed. When multiple procedure codes are submitted on a claim (unique and/or

unlisted) the documentation supporting each code should be easily identifiable. If on review UnitedHealthcare cannot link a billed code to the documentation, these services will be denied. APPLICABLE CODES The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non - covered health service.

Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

CPT Code Description

81400 Molecular pathology procedure, Level 1 (short description)









CPT® is a registered trademark of the American Medical Association



Coding Clarification: This list contains ICD - 10 diagnosis codes that are never covered when given as the primary reason for the test. If a code from this section is given as the reason for the test and you know or have reason to believe the service may not be covered, call UnitedHealthcare to issue an Integrated Denial Notice (IDN) to the member and you. The IDN informs the member of their liability for the non - covered service or item and appeal

rights. You must make sure the member has received the IDN prior to rendering or referring for non - covered services or items in order to collect payment.

ICD - 10 Diagnosis Code Description

Non - Covered

R99 Ill - defined and unknown cause of mortality

Z00.00 Encounter for general adult medical examination without abnormal findings

Z00.01 Encounter for general adult medical examination with abnormal findings

Z00.110 Health examination for newborn under 8 days old

Z00.111 Health examination for newborn 8 to 28 days old

Z00.121 Encounter for routine child health examination with abnormal findings

Z00.129 Encounter for routine child health examination without abnormal findings

Z00.5 Encounter for examination of potential donor of organ and tissue

Z00.70 Encounter for examination for period of delayed growth in childhood without abnormal findings

Z00.71 Encounter for examination for period of delayed growth in childhood with abnormal findings

Z00.8 Encounter for other general examination

Z02.0 Encounter for examination for admission to educational institution

Z02.1 Encounter for pre - employment examination

Z02.2 Encounter for examination for admission to residential institution

Z02.3 Encounter for examination for recruitment to armed forces

Z02.4 Encounter for examination for driving license

Z02.5 Encounter for examination for participation in sport

Z02.6 Encounter for examination for insurance purposes

Z02.71 Encounter for disability determination

Z02.79 Encounter for issue of other medical certificate

Z02.81 Encounter for paternity testing

Z02.82 Encounter for adoption services

Z02.83 Encounter for blood - alcohol and blood - drug test

Z02.89 Encounter for other administrative examinations

Z02.9 Encounter for administrative examinations, unspecified

Z04.6 Encounter for general psychiatric examination, requested by authority

Z04.8 Encounter for examination and observation for other specified reasons (Removed 09/30/2018)

Z04.81 Encounter for examination and observation of victim following forced sexual exploitation (Effective 10/01/2018)

Z04.82 Encounter for examination and observation of victim following forced labor exploitation (Effective 10/01/2018)

Z04.89 Encounter for examination and observation for other specified reasons (Effective 10/01/2018)

Z04.9 Encounter for examination and observation for unspecified reason

Z11.0 Encounter for screening for intestinal infectious diseases

Z11.1 Encounter for screening for respiratory tuberculosis

Z11.2 Encounter for screening for other bacterial diseases

Z11.3 Encounter for screening for infections with a predominantly sexual mode of transmission




Non - Covered

Z11.4 Encounter for screening for human immunodeficiency virus [HIV]

Z11.7 Encounter for testing for latent tuberculosis infection (Effective 10/01/2019)

Z11.51 Encounter for screening for human papillomavirus (HPV)

Z11.59 Encounter for screening for other viral diseases

Z11.6 Encounter for screening for other protozoal diseases and helminthiases

Z11.8 Encounter for screening for other infectious and parasitic diseases

Z11.9 Encounter for screening for infectious and parasitic diseases, unspecified

Z12.0 Encounter for screening for malignant neoplasm of stomach

Z12.10 Encounter for screening for malignant neoplasm of intestinal tract, unspecified

Z12.13 Encounter for screening for malignant neoplasm of small intestine

Z12.2 Encounter for screening for malignant neoplasm of respiratory organs

Z12.6 Encounter for screening for malignant neoplasm of bladder

Z12.71 Encounter for screening for malignant neoplasm of testis

Z12.72 Encounter for screening for malignant neoplasm of vagina

Z12.73 Encounter for screening for malignant neoplasm of ovary

Z12.79 Encounter for screening for malignant neoplasm of other genitourinary organs

Z12.81 Encounter for screening for malignant neoplasm of oral cavity

Z12.82 Encounter for screening for malignant neoplasm of nervous system

Z12.83 Encounter for screening for malignant neoplasm of skin

Z12.89 Encounter for screening for malignant neoplasm of other sites

Z12.9 Encounter for screening for malignant neoplasm, site unspecified

Z13.0 Encounter for screening for diseases of the blood and blood - forming organs and certain disorders involving the immune mechanism

Z13.21 Encounter for screening for nutritional disorder

Z13.220 Encounter for screening for lipoid disorders

Z13.228 Encounter for screening for other metabolic disorders

Z13.29 Encounter for screening for other suspected endocrine disorder

Z13.3 Encounter for screening examination for mental health and behavioral disorders (Removed 09/30/2018)

Z13.30 Encounter for screening examination for mental health and behavioral disorders, unspecified (Effective 10/01/2018)

Z13.31 Encounter for screening for depression (Effective 10/01/2018)

Z13.32 Encounter for screening for maternal depression (Effective 10/01/2018)

Z13.39 Encounter for screening examination for other mental health and behavioral disorders (Effective 10/01/2018)

Z13.4 Encounter for screening for certain developmental disorders in childhood (Removed 09/30/2018)

Z13.40 Encounter for screening for unspecified developmental delays (Effective 10/01/2018)

Z13.41 Encounter for autism screening (Effective 10/01/2018)

Z13.42 Encounter for screening for global developmental delays (milestones) (Effective 10/01/2018)

Z13.49 Encounter for screening for other developmental delays (Effective 10/01/2018)

Z13.5 Encounter for screening for eye and ear disorders

Z13.71 Encounter for non - procreative screening for genetic disease carrier status

Z13.79 Encounter for other screening for genetic and chromosomal anomalies

Z13.810 Encounter for screening for upper gastrointestinal disorder

Z13.811 Encounter for screening for lower gastrointestinal disorder




Non - Covered

Z13.818 Encounter for screening for other digestive system disorders

Z13.820 Encounter for screening for osteoporosis

Z13.828 Encounter for screening for other musculoskeletal disorder

Z13.83 Encounter for screening for respiratory disorder NEC

Z13.84 Encounter for screening for dental disorders

Z13.850 Encounter for screening for traumatic brain injury

Z13.858 Encounter for screening for other nervous system disorders

Z13.88 Encounter for screening for disorder due to exposure to contaminants

Z13.89 Encounter for screening for other disorder

Z13.9 Encounter for screening, unspecified

Z36.0 Encounter for antenatal screening for chromosomal anomalies

Z36.1 Encounter for antenatal screening for raised alphafetoprotein level

Z36.2 Encounter for other antenatal screening follow - up

Z36.3 Encounter for antenatal screening for malformations

Z36.4 Encounter for antenatal screening for fetal growth retardation

Z36.5 Encounter for antenatal screening for isoimmunization

Z36.81 Encounter for antenatal screening for hydrops fetalis

Z36.82 Encounter for antenatal screening for nuchal translucency

Z36.83 Encounter for fetal screening for congenital cardiac abnormalities

Z36.84 Encounter for antenatal screening for fetal lung maturity

Z36.85 Encounter for antenatal screening for Streptococcus B

Z36.86 Encounter for antenatal screening for cervical length

Z36.87 Encounter for antenatal screening for uncertain dates

Z36.88 Encounter for antenatal screening for fetal macrosomia

Z36.89 Encounter for other specified antenatal screening

Z36.8A Encounter for antenatal screening for other genetic defects

Z36.9 Encounter for antenatal screening, unspecified

Z40.00 Encounter for prophylactic removal of unspecified organ

Z40.01 Encounter for prophylactic removal of breast

Z40.02 Encounter for prophylactic removal of ovary(s)

Z40.09 Encounter for prophylactic removal of other organ

Z40.8 Encounter for other prophylactic surgery

Z40.9 Encounter for prophylactic surgery, unspecified

Z41.1 Encounter for cosmetic surgery

Z41.2 Encounter for routine and ritual male circumcision

Z41.3 Encounter for ear piercing

Z41.8 Encounter for other procedures for purposes other than remedying health state

Z41.9 Encounter for procedure for purposes other than remedying health state, unspecified

Z46.1 Encounter for fitting and adjustment of hearing aid

Z56.0 Unemployment, unspecified

Z56.2 Threat of job loss

Z56.3 Stressful work schedule

Z56.4 Discord with boss and workmates

Z56.5 Uncongenial work environment

Z56.6 Other physical and mental strain related to work

Z56.81 Sexual harassment on the job




Non - Covered

Z56.82 Military deployment status

Z56.89 Other problems related to employment

Z56.9 Unspecified problems related to employment

Z57.0 Occupational exposure to noise

Z57.1 Occupational exposure to radiation

Z57.2 Occupational exposure to dust

Z57.31 Occupational exposure to environmental tobacco smoke

Z57.39 Occupational exposure to other air contaminants

Z57.4 Occupational exposure to toxic agents in agriculture

Z57.5 Occupational exposure to toxic agents in other industries

Z57.6 Occupational exposure to extreme temperature

Z57.7 Occupational exposure to vibration

Z57.8 Occupational exposure to other risk factors

Z57.9 Occupational exposure to unspecified risk factor

Z59.0 Homelessness

Z59.1 Inadequate housing

Z59.2 Discord with neighbors, lodgers and landlord

Z59.3 Problems related to living in residential institution

Z59.4 Lack of adequate food and safe drinking water

Z59.5 Extreme poverty

Z59.6 Low income

Z59.7 Insufficient social insurance and welfare support

Z59.8 Other problems related to housing and economic circumstances

Z59.9 Problem related to housing and economic circumstances, unspecified

Z60.2 Problems related to living alone

Z62.21 Child in welfare custody

Z71.0 Person encountering health services to consult on behalf of another person

Z74.1 Need for assistance with personal care

Z74.2 Need for assistance at home and no other household member able to render care

Z74.3 Need for continuous supervision

Z74.8 Other problems related to care provider dependency

Z74.9 Problem related to care provider dependency, unspecified

Z75.5 Holiday relief care

Z76.0 Encounter for issue of repeat prescription

Z76.1 Encounter for health supervision and care of foundling

Z76.2 Encounter for health supervision and care of other healthy infant and child

Z76.3 Healthy person accompanying sick person

Z76.4 Other boarder to healthcare facility

Z76.81 Expectant parent(s) prebirth pediatrician visit

Z80.1 Family history of malignant neoplasm of trachea, bronchus and lung

Z80.2 Family history of malignant neoplasm of other respiratory and intrathoracic organs

Z80.49 Family history of malignant neoplasm of other genital organs

Z80.51 Family history of malignant neoplasm of kidney

Z80.52 Family history of malignant neoplasm of bladder

Z80.59 Family history of malignant neoplasm of other urinary tract organ

Z80.6 Family history of leukemia




Non - Covered

Z80.7 Family history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Z80.8 Family history of malignant neoplasm of other organs or systems

Z80.9 Family history of malignant neoplasm, unspecified

Z81.0 Family history of intellectual disabilities

Z81.1 Family history of alcohol abuse and dependence

Z81.2 Family history of tobacco abuse and dependence

Z81.3 Family history of other psychoactive substance abuse and dependence

Z81.4 Family history of other substance abuse and dependence

Z81.8 Family history of other mental and behavioral disorders

Z82.0 Family history of epilepsy and other diseases of the nervous system

Z82.1 Family history of blindness and visual loss

Z82.2 Family history of deafness and hearing loss

Z82.3 Family history of stroke

Z82.41 Family history of sudden cardiac death

Z82.49 Family history of ischemic heart disease and other diseases of the circulatory system

Z82.5 Family history of asthma and other chronic lower respiratory diseases

Z82.61 Family history of arthritis

Z82.62 Family history of osteoporosis

Z82.69 Family history of other diseases of the musculoskeletal system and connective tissue

Z82.71 Family history of polycystic kidney

Z82.79 Family history of other congenital malformations, deformations and chromosomal abnormalities

Z82.8 Family history of other disabilities and chronic diseases leading to disablement, not elsewhere classified

Z83.0 Family history of human immunodeficiency virus [HIV] disease

Z83.1 Family history of other infectious and parasitic diseases

Z83.2 Family history of diseases of the blood and blood - forming organs and certain disorders involving the immune mechanism

Z83.3 Family history of diabetes mellitus

Z83.41 Family history of multiple endocrine neoplasia [MEN] syndrome

Z83.49 Family history of other endocrine, nutritional and metabolic diseases

Z83.511 Family history of glaucoma

Z83.518 Family history of other specified eye disorder

Z83.52 Family history of ear disorders

Z83.6 Family history of other diseases of the respiratory system

Z83.71 Family history of colonic polyps

Z83.79 Family history of other diseases of the digestive system

Z84.0 Family history of diseases of the skin and subcutaneous tissue

Z84.1 Family history of disorders of kidney and ureter

Z84.2 Family history of other diseases of the genitourinary system

Z84.3 Family history of consanguinity

Z84.81 Family history of carrier of genetic disease

Z84.89 Family history of other specified conditions



PURPOSE The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare

Advantage claims processing activities and facilitate providers’ submission of accurate claims for the specified services. The document can be used as a guide to help determine applicable: Medicare coding or billing requirements, and/or Medical necessity coverage guidelines; including documentation requirements. UnitedHealthcare follows Medicare guidelines such as LCDs, NCDs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to

support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply. REFERENCES

CMS National Coverage Determinations (NCDs) Related NCDs:

NCD 90.2 Next Generation Sequencing (NGS)

NCD 190.3 Cytogenetic Studies NCD 190.7 Human Tumor Stem Cell Drug Sensitivity Assays

CMS Local Coverage Determinations (LCDs) and Articles

LCD Article Contractor Medicare Part A Medicare Part B

APC and MUTYH Gene Testing

L36910 (MolDX: APC

and MUTYH Gene Testing)

A56828 (Billing and

Coding: MolDX: APC and MUTYH Gene)

CGS KY, OH KY, OH

L36882 (MolDX: APC


A57352 (Billing and

Coding: MolDX: APC and MUTYH Gene Testing)

Noridian AS, CA, GU, HI, MP, NV

AS, CA, GU, HI, MP, NV

L36884 (MolDX: APC and MUTYH Gene Testing)

A57353 (Billing and Coding: MolDX: APC and MUTYH Gene Testing)

Noridian AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY

AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY

L36827 (MolDX: APC


Billing and Coding:

MolDX: APC and MUTYH Gene Testing (A56824)

Palmetto GBA AL, GA, NC, SC, TN, VA, WV

AL, GA, NC, SC, TN, VA, WV

L37224 (MolDX: APC


A56901 (Billing and

Coding: MolDX: APC and MUTYH Gene Testing)

WPS AK, AL, AR, AZ, CA,

CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN,

TX, UT, VA, VT, WA, WI, WV, WY

IA, IN, KS, MI, MO, NE

ApoE Genotype

L36021 (MolDX:

Molecular Diagnostic Tests (MDT))

A54244 (Billing and

Coding: MolDX: ApoE Genotype)

CGS KY, OH KY, OH

L36358 (MolDX:

Biomarkers in Cardiovascular Risk Assessment)

A55094 (Billing and




L36362 (MolDX:

Biomarkers in Cardiovascular Risk Assessment)

A55095 (Billing and




https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=372&ncdver=1&DocID=90.2&bc=gAAAABAAAAAA&

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=198&ncdver=1&DocID=190.3&kq=true&bc=gAAAAAgAAAAAAA%3d%3d&

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=253&ncdver=1&DocID=190.7&kq=true&bc=gAAAAAgAAAAAAA%3d%3d&

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36910&ver=13&Date=&DocID=L36910&bc=iAAAABAAAAAA&



https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56828&ver=7&CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=81401&bc=gAAAACAAAAAA&






























https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=54244&ver=13&Date=&DocID=A54244&bc=hAAAABAAAAAA&




















ApoE Genotype

A53652 (Billing and Coding: MolDX: ApoE

Genotype)



L36807 (MolDX:


A55141 (Billing and



CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,

ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


ATP7B Gene Tests

L36021 (MolDX:


A54254 (Billing and

Coding: MolDX: ATP7B Gene Tests)

CGS KY, OH KY, OH

A55097 (Billing and




A55098 (Billing and Coding: MolDX: ATP7B Gene Tests)



A53550 (Billing and




L36807 (MolDX:


A55143 (Billing and




ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN,



BCKDHB Gene Test

L36021 (MolDX: Molecular Diagnostic Tests (MDT))

A54255 (Billing and Coding: MolDX: BCKDHB Gene Test)

CGS KY, OH KY, OH

A55099 (Billing and

Coding: MolDX: BCKDHB Gene Test)



A55100 (Billing and

Coding: MolDX: BCKDHB Gene Test)

Noridian AK, AZ, ID, MT, ND,

OR, SD, UT, WA, WY

AK, AZ, ID, MT, ND,

OR, SD, UT, WA, WY

A53600 (Billing and Coding: MolDX: BCKDHB Gene Test)






https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36807&ver=39&articleId=57772&CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=81370&bc=gAAAACABAAAA&













































BCKDHB Gene Test

L36807 (MolDX: Molecular Diagnostic

Tests (MDT))

A55145 (Billing and Coding: MolDX: BCKDHB

Gene Test)

WPS AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA,

HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


CDH1 Genetic Testing

A54878 (Billing and Coding: MolDX: CDH1 Genetic Testing)

CGS KY, OH KY, OH

A55970 (Billing and

Coding: MolDX: CDH1 Genetic Testing)



A55971 (Billing and




A54835 (Billing and Coding: MolDX: CDH1 Genetic Testing)



L36807 (MolDX:


A55622 (Billing and



CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ,

NM, NV, OH, OK, OR,

PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


CHD7 Gene Analysis

L36021 (MolDX:


A54243 (Billing and

Coding: MolDX: CHD7 Gene Analysis Guidelines)

CGS KY, OH KY, OH

A55085 (Billing and Coding: MolDX: CHD7 Gene Analysis)



A55086 (MolDX: CHD7

Gene Analysis Coding and Billing Guidelines)



A53565 (Billing and

Coding: MolDX: CHD7 Gene Analysis)

Palmetto GBA AL, GA, NC, SC, TN,

VA, WV

AL, GA, NC, SC, TN,

VA, WV


A55157 (Billing and Coding: MolDX: CHD7 Gene Analysis)

WPS AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN,

KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


















































ENG and ACVRL1 Gene Tests


Tests (MDT))

A54262 (Billing and Coding: MolDX: ENG and

ACVRL1 Gene Tests)

CGS KY, OH KY, OH

A55181 (Billing and

Coding: MolDX: ENG and ACVRL1 Gene Tests)



A55182 (Billing and




A53536 (Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests)



L36807 (MolDX:


A55159 (Billing and




ME, MI, MO, MS, MT,

NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


Genetic Testing for BCR - ABL Negative Myeloproliferative Disease

L36117 (MolDX:

Genetic Testing for BCR - ABL Negative Myeloproliferative Disease)

A56999 (Billing and

Coding: MolDX: Genetic Testing for BCR - ABL Negative Myeloproliferative Disease)

CGS KY, OH KY, OH

L36180 (MolDX:


A57421 (Billing and


Noridian AS, CA, GU, HI, MP,

NV

AS, CA, GU, HI, MP,

NV

L36186 (MolDX:


A57422 (Billing and




L36044 (MolDX:

Genetic Testing for BCR - ABL Negative Myeloproliferative

Disease)

A56959 (Billing and

Coding: MolDX: Genetic Testing for BCR - ABL Negative

Myeloproliferative Disease)



L36815 (MolDX: Genetic Testing for BCR - ABL Negative Myeloproliferative Disease)

A57570 (Billing and Coding: MolDX: Genetic Testing for BCR - ABL Negative

Myeloproliferative Disease)

WPS AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,


















































































Genetic Testing for Lynch Syndrome

L34912 (Genetic Testing for Lynch

Syndrome)

A57450 (Billing and Coding: Genetic Testing

for Lynch Syndrome)

First Coast FL, PR, VI FL, PR, VI

L35349 (MolDX:

Genetic Testing for Lynch Syndrome)

A56882 (Billing and

Coding: MolDX: Genetic Testing for Lynch Syndrome)

CGS KY, OH KY, OH

L35024 (MolDX:


A54987 (Billing and




L36370 (MolDX:


A54995 (Billing and




L36374 (MolDX:


A54996 (Billing and

Coding: MolDX: Genetic

Testing for Lynch Syndrome)



L36793 (MolDX:


A55135 (Billing and






HEXA Gene Analysis

L36021 (MolDX:


A54268 (Billing and

Coding: MolDX: HEXA Gene Analysis)

CGS KY, OH KY, OH

A55255 (Billing and




A55256 (Billing and Coding: MolDX: HEXA Gene Analysis)



A53598 (Billing and




L36807 (MolDX:


A55168 (Billing and



CO, CT, DE, FL, GA,

HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN,









https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35349&ver=24&Date=&DocID=L35349&bc=iAAAABABAAAA&



























































L1CAM Gene Sequencing


Tests (MDT))

A54274 (Billing and Coding: MolDX: L1CAM

Gene Sequencing Guidelines)

CGS KY, OH KY, OH

A55277 (Billing and Coding: MolDX: L1CAM Gene Sequencing)



A55278 (Billing and

Coding: MolDX: L1CAM Gene Sequencing)



A53659 (Billing and Coding: MolDX: L1CAM Gene Sequencing)



L36807 (MolDX:


A55192 (Billing and

Coding: MolDX: L1CAM Gene Sequencing)


CO, CT, DE, FL, GA, HI, IA, ID, IL, IN,

KS, KY, LA, MA, MD,



MMACHC Test

L36021 (MolDX:


A54209 (Billing and

Coding: MolDX: MMACHC Test)

CGS KY, OH KY, OH

A55288 (Billing and




A55289 (Billing and Coding: MolDX: MMACHC Test)



A54035 (Billing and




L36807 (MolDX:


A55191 (Billing and



CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN,



NSD1 Gene Tests


A54291 (Billing and Coding: MolDX: NSD1 Gene Tests)

CGS KY, OH KY, OH

A55609 (Billing and

Coding: MolDX: NSD1 Gene Tests)



A55615 (Billing and






























































NSD1 Gene Tests

A53585 (Billing and Coding: MolDX: NSD1

Gene Tests)



L36807 (MolDX:


A55198 (Billing and






RPS19 Gene Tests

L36021 (MolDX:


A54299 (Billing and

Coding: MolDX: RPS19 Gene Tests)

CGS KY, OH KY, OH

A55610 (Billing and




A55614 (Billing and Coding: MolDX: RPS19 Gene Tests)



A53587 (Billing and




L36807 (MolDX:


A55205 (Billing and




ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN,



STAT3 Gene Testing


A54284 (Billing and Coding: MolDX: STAT3 Gene Testing)

CGS KY, OH KY, OH

A55480 (Billing and

Coding: MolDX: STAT3 Gene Testing)



A55481 (Billing and

Coding: MolDX: STAT3 Gene Testing)

Noridian AK, AZ, ID, MT, ND,

OR, SD, UT, WA, WY

AK, AZ, ID, MT, ND,

OR, SD, UT, WA, WY

A53562 (Billing and Coding: MolDX: STAT3 Gene Testing)



















































STAT3 Gene Testing


Tests (MDT))

A55209 (Billing and Coding: MolDX: STAT3

Gene Testing)




TP53 Gene Test


A54281 (Billing and Coding: MolDX: TP53 Gene Test)

CGS KY, OH KY, OH

A53591 (Billing and

Coding: MolDX: TP53 Gene Test)



L36807 (MolDX:


A55221 (Billing and

Coding: MolDX: TP53 Gene Test)


CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR,

PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


A55484 (Billing and Coding: MolDX: TP53 Gene Tests)



A55487 (Billing and

Coding: MolDX: TP53 Gene Tests)



General Molecular Diagnostic Tests

L34519 (Molecular

Pathology Procedures)

A57451 (Billing and

Coding: Molecular Pathology Procedures)

First Coast FL, PR, VI FL, PR, VI

L35396 (Biomarkers for Oncology)

A52986 (Billing and Coding: Biomarkers for Oncology)

Novitas Solutions, Inc.

AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX

AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX

L35000 (Molecular

Pathology Procedures)

A56199 (Billing and

Coding: Molecular Pathology Procedures)

NGS CT, IL, MA, ME, MN, NH, NY, RI, VT, WI

CT, IL, MA, ME, MN, NH, NY, RI, VT, WI

L36021 (MolDX:


A56973 (Billing and

Coding: MolDX: Molecular Diagnostic Tests (MDT))

CGS KY, OH KY, OH


A56853 (Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT))



L35160 (MolDX:


A57526 (Billing and




L36256 (MolDX:


A57527 (Billing and













































https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56199&ver=28&LCDId=36807&CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=81370&bc=gAAAACAAgAAA&


















https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=57526&ver=7&LCDId=36807&CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=81370&bc=gAAAACAAAAAA&












General Molecular Diagnostic Tests


Tests (MDT))

A57772 (Billing and Coding: MolDX: Molecular

Diagnostic Tests (MDT))




Testing of Multiple Genes

A57910 (Billing and Coding: MolDX: Testing of Multiple Genes

CGS KY, OH KY, OH

A57503 (Billing and

Coding: MolDX: Testing of Multiple Genes)



A57880 (Billing and

Coding: MolDX: Testing of Multiple Genes)


CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA,

RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY


CMS Benefit Policy Manual Chapter 15; § 80.1 - 80.1.3 Clinical Laboratory Services

CMS Claims Processing Manual

Chapter 12; § 60 Payment for Pathology Services

Chapter 16, § 10.2 General Explanation of Payment; § 20 Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules; § 40 Billing for Clinical Laboratory Tests

Others CMS Clinical Laboratory Fee Schedule, CMS Website

Palmetto GBA MolDx Website GUIDELINE HISTORY/REVISION INFORMATION Revisions to this summary document do not in any way modify the requirement that services be provided and documented in accordance with the Medicare guidelines in effect on the date of service in question.

Date Action/Description

01/08/2020 New Policy

TERMS AND CONDITIONS The Medicare Advantage Policy Guidelines are applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates. These Policy Guidelines are provided for informational purposes, and do not constitute medical advice. Treating physicians and healthcare providers are solely responsible for determining what care to provide to their patients.

Members should always consult their physician before making any decisions about medical care. Benefit coverage for health services is determined by the member specific benefit plan document* and applicable laws that may require coverage for a specific service. The member specific benefit plan document identifies which services
















https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf

https://www.cms.gov/Medicare/Medicare-fee-for-service-Payment/clinicallabfeesched/index.html

https://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx



are covered, which are excluded, and which are subject to limitations. In the event of a conflict, the member specific benefit plan document supersedes the Medicare Advantage Policy Guidelines. Medicare Advantage Policy Guidelines are developed as needed, are regularly reviewed and updated, and are subject

to change. They represent a portion of the resources used to support UnitedHealthcare coverage decision making. UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website. Medicare source materials used to develop these guidelines include, but are not limited to, CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Benefit Policy Manual, Medicare Claims Processing Manual, Medicare Program Integrity Manual, Medicare Managed Care Manual, etc. The information presented in the Medicare Advantage Policy Guidelines is believed to be accurate and current as of the date of publication, and is provided on an "AS IS" basis. Where there is a conflict between this document and Medicare source

materials, the Medicare source materials will apply. You are responsible for submission of accurate claims. Medicare Advantage Policy Guidelines are intended to ensure that coverage decisions are made accurately based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Medicare Advantage Policy Guidelines use Current Procedural Terminology (CPT®), Centers for Medicare and Medicaid Services (CMS), or other coding guidelines. References to CPT® or other sources

are for definitional purposes only and do not imply any right to reimbursement or guarantee claims payment.

Medicare Advantage Policy Guidelines are the property of UnitedHealthcare. Unauthorized copying, use and distribution of this information are strictly prohibited. *For more information on a specific member's benefit coverage, please call the customer service number on the back of the member ID card or refer to the Administrative Guide.

https://www.uhcprovider.com/en/admin-guides.html

Documents

TIER 2 MOLECULAR PATHOLOGY PROCEDURES · Diagnosis and Monitoring Non - Cancer Indications, and Several Pharmacogenomic applications. Guidelines Tier 2 Molecular pathology procedures