Pathology Lab Test Expert Witness qualifications and experience

Pathology Lab Test Billing Expert Witness  work in this specialty includes usual customary and reasonable cost of care, appropriate coding and billing based on industry best practices and guidelines, payor policies and medical specialties as well as specific patient populations.  It may also include reviewing the test charge amounts versus national and regional charge averages, evaluating MUEs which are “Medically Unlikely Edits” as well as the cost of care based on national and regional rates.  In states where the standard allows experts to provide opinions on net reimbursement rates, 50th, 75th, and 90th percentile data may be presented.  Determining usual customary and reasonable costs for esoteric tests or any new area of medicine requires careful research to find data that represents the market rates in a specified A Core Based Statistical Area (CBSA). A CBSA is a U.S. geographic area defined by the Office of Management and Budget (OMB) that consists of one or more counties (or equivalents) anchored by an urban center of at least 10,000 people plus adjacent counties that are socioeconomically tied to the urban center by commuting..  Identification of providers who perform the tests in a similar time frame and setting may also be relevant.  Also, national correct coding initiative algorithms may be used to evaluate the tests versus national coverage determination and local coverage determination policies.

Pathology Lab Test Expert Witness
Michael Arrigo expert witness in Federal State and Civil Courts on ACA, HIPAA, Healthcare costs in malpractice and personal injury, False Claims Act cases involving Medicare Advantage and Electronic Health Records. He evaluates pathology tests toxicology tests reference lab tests esoteric tests from the perspective of medical coding, medical billing, medical cost and provides testimony as an expert witness.

See also Laboratory CPT Code Subsections and organization for test menus and our expert witness services for esoteric tests.

  • Pathology for Nephrology patients
  • Pathology for dialysis patients
  • Genetic tests for cancer patients
  • Esoteric tests
  • Reference lab / reference laboratory tests such as ‘sending out’ a test from a hospital to a specialized lab
  • CPT codes, CPT code most appropriate for medical service
  • National Correct Coding (NCCI) standards and edits

Genetic tests for cancer patients

For example on the oncology specialty, new cancer tests are constantly being evaluated by Federal agencies and other organizations.  One specific area are molecular pathology tests that identify pathogenic mutations and cytogenetic translocations help clinicians define the molecular subtypes of common cancers. Because several of these acquired mutations/translocations may predict response to specific therapies, screening tests for “targetable” mutations are now commonly available in clinical laboratory improvement amendments (CLIA)-approved clinical labs.  The Centers for Medicare and Medicaid published a technology assessment for pathology testing.  According to CMS, “The following tests are under consideration for this assessment and apply to all Key Questions (KQs): microsatellite instability (MSI) for colorectal cancer (CRC), MLH1 promoter methylation for CRC, KRAS mutations for CRC, BRAF mutations for CRC, Oncotype DX Colon mRNA expression for CRC, Oncotype DX Breast mRNA expression for breast cancer, MammaPrint mRNA expression for breast cancer, ALK cytogenetics for lung cancer, EGFR mutations for lung cancer, KRAS mutations for lung cancer, and UroVysion cytogenetics for urinary bladder cancer.”

According to AHRQ in a document referenced by CMS in 2014,  they “conduct[ed] a systematic review and meta-analysis assessing the prognostic value and test performance (analytic validity, clinical validity, clinical utility, and harms) associated with 11 prognostic molecular pathology tests. Many of these tests are indicated for prediction of therapeutic responses, but [the] review focuses on their potential use as prognostic factors…”  The paper continues that one focus area was “microsatellite instability assessment by polymerase chain reaction (PCR) for colorectal cancer (CRC).”

Pathology Supported Genetic Testing and Correlating CPT Codes

A Pathology Test Billing Expert Witness should be able to decipher complex medical descriptions, focusing on specific codes correlated to certain pathology tests.

According to Kotze and van Rensburg,

“Chronic, multi-factorial conditions caused by a complex interaction between genetic and environmental risk factors frequently share common disease mechanisms, as evidenced by an overlap between genetic risk factors for cardiovascular disease (CVD) and Alzheimer’s disease (AD). Single nucleotide polymorphisms (SNPs) in several genes including ApoE, MTHFR, HFE and FTO are known to increase the risk of both conditions. The E4 allele of the ApoE polymorphism is the most extensively studied risk factor for AD and increases the risk of coronary heart disease by approximately 40 %. It furthermore displays differential therapeutic responses with use of cholesterol-lowering statins and acetylcholinesterase inhibitors, which may also be due to variation in the CYP2D6 gene in some patients. Disease expression may be triggered by gene-environment interaction causing conversion of minor metabolic abnormalities into major brain disease due to cumulative risk. A growing body of evidence supports the assessment and treatment of CVD risk factors in midlife as a preventable cause of cognitive decline, morbidity and mortality in old age. In this review, the concept of pathology supported genetic testing (PSGT) for CVD is described in this context.  (See Kotze, M. J., & van Rensburg, S. J. (2012). Pathology supported genetic testing and treatment of cardiovascular disease in middle age for prevention of Alzheimer’s disease. Metabolic brain disease27(3), 255–266. )”

Isolating one of the tests noted by Kotze and van Rensburg, “APOE” which is “(apolipoprotein E) (eg, hyperlipoproteinemia type III, cardiovascular disease, Alzheimer disease), common variants (eg, *2, *3, *4)” leads to a specific CPT code for the test:

81401  Molecular pathology procedure, Level 2 (eg, 2-10 SNPs, 1 methylated variant, or 1 somatic variant [typically using nonsequencing target variant analysis], or detection of a dynamic mutation disorder/triplet repeat) ABCC8 (ATP-binding cassette, sub-family C [CFTR/MRP], member 8) (eg, familial hyperinsulinism), common variants (eg, c.3898-9G>A [c.3992-9G>A], F1388del) ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib resistance), T315I variant ACADM (acyl-CoA dehydrogenase, C-4 to C-12 straight chain, MCAD) (eg, medium chain acyl dehydrogenase deficiency), commons’

However this test is one of many that can be performed using CPT 81401. As of the last update to this code in 2019, there were at least 56 tests correlated to one CPT code.

According to Decision Health, the general description of these types of tests, “Molecular pathology procedures are tests performed at the molecular level to diagnose, treat, and provide prognostic indicators for genetic disorders, cancer, infectious diseases, and in the case of transplant procedures, to identify tissue histocompatibility. Molecular pathology procedures vary in complexity. The levels take into account the amount of professional work and the laboratory costs required to perform the procedure. Level 2 tests involve identification of 2-10 single nucleotide variants (SNPs), 1 methylated variant, or 1 somatic variant (typically performed using non-sequencing target variant analysis), or detection of a dynamic mutation disorder/triplet repeat. The molecular pathologist reviews the patient’s medical history, clinical findings, and results of other diagnostic tests and procedures. The Level 2 test is then performed. A number of Level 2 tests are specifically identified under this code. Molecular pathology procedures that are not specifically identified here but require similar levels of professional expertise, similar amounts of work and laboratory costs, and are performed by similar techniques but do not have a more specific code should also be reported with 81401. Following performance of the test, the molecular pathologist interprets the results and provides a detailed written report of the findings.”

Selected Pathology Test Billing Testifying Expert Witness Experience

I. Retained by Defense in case of Plaintiff v. Leading Academic Medical Center and  Pathology Group

Provide expert rebuttal opinion regarding molecular diagnostic pathology laboratory coding and billing and best practices in 31 U.S.C. § 3729.  (a) False Claims Act; opinions based in part on NCCI (National Correct Coding Initiative), and industry best practices and guidelines regarding CPT coding for pathology, diagnostics, clinical dosages, and physician supervision and Medicare Part C reimbursement under risk adjustment   Evaluation of use of combination of codes including:

  1. CPT 87491 infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique
  2. CPT 87623 Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (e.g., 6, 11, 42, 43, 44),
  3. CPT 87624 Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68),
  4. CPT 87625 Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed;
  5. Modifiers including 91 (repeat clinical diagnostic laboratory test is used to report the same lab test when performed on the same patient, on the same day, to obtain subsequent test results) and 59 (when reporting lab procedures, modifier 59 is used when the same lab procedure is done, but different specimens are obtained, or the cultures are obtained from different sites).

II. Retained by Plaintiff in Kidney Medical Group v Medical Management Group

Evaluate business, medical documentation, coding and claims reimbursement practices of a Nephrology business which offers diagnostic and interventional procedures related to patients’ dialysis access needs.

  • Opinions based on all-inclusive fees for risk-adjusted patients with End Stage Renal Disease (“ESRD”)
  • Medicare Part C reimbursement under risk adjustment scenarios including “Medicare composite rate,”
  • Routine pathology tests associated with ESRD patients, non-routine ‘send out’ tests,
  • Compliance with 42 CFR Part 422 – Medicare Advantage Program, 42 CFR §422
  • ESRD Prospective Payment System (ESRD PPS) – Section 153(b) of Pub. L. 110- 275,
  • Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended section 1881(b) of the Social Security Act to require the implementation of an ESRD bundled payment system and updates from 2004
  • Updates through 2015.
  • Evaluate potential issues with double billing / fraud.

III. Retained by defendant in a dispute with a private payer regarding reference laboratory billing, bill types, modifiers and medical codes primarily for ERISA plan insureds who received toxicology test screening.

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Medical coding for clinical pathology;[i] recognizing specimen interference in clinical laboratories 9/21[ii]

[i] Course and test administered via American Society for Clinical Pathology; 9/19/2021; certificate

[ii] Course and test administered via American Society for Clinical Pathology; 9/19/2021; certificate

Pathology testing, toxicology testing, genetic testing, reference lab medical billing expertise and specialized knowledge includes