Esoteric tests expert witness

esoteric tests expert witness
Michael Arrigo, Managing Partner advises prospective investors in esoteric testing.  He also serves as an expert witness in Federal State and Civil Courts in laboratory testing business models, Clinical Laboratory Improvement Amendments (CLIA), medical billing, and medical coding. He is trained in medical coding for clinical pathology and recognizing specimen interference in clinical laboratories He also provides testimony regarding the Affordable Care Act, HIPAA, usual customary and reasonable charges in malpractice and personal injury, False Claims Act cases involving Medicare Advantage, and Electronic Health Records.  CONTACT

The esoteric tests expert witness work regarding coding and billing includes reviewing the test charge amounts versus national and regional charge averages, evaluating the National Correct Coding Initiative (NCCI) standards, modifiers, medical necessity criteria, clinical documentation, and MUEs, which are “Medically Unlikely Edits,” as well as the cost of care based on national and regional rates. Depending on the jurisdiction and type of litigation, Usual Customary and Reasonable (UCR) charges or net payments by insurance may be used as a Standard. The collateral source rules in some states preclude evidence of insurance in personal injury cases.

Esoteric testing COVID-19 Update
Esoteric testing COVID-19 Update. How new tests are growing the market and creating demand for business model validation and compliance programs

Determining usual customary and reasonable costs for esoteric tests or any new area of medicine requires careful analysis to present 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 to ensure that charges are not unbundled.

What is Esoteric Testing?

The analysis of ‘rare’ substances or molecules that are not performed in a routine clinical laboratory. Esoteric tests are the analysis of unique, “niche” assays not routinely performed in clinical laboratories as they often require specialized personnel. Some of these tests have been or are currently being analyzed using RIA (radioimmunoassay) technique which is both costly and time-consuming.   All laboratories will benefit from volume increases due to both population growth and the aging population, an increase in the number of tests per patient, and an increase in esoteric and genomic tests which are part of the trend to customize treatments.

Categories of Esoteric Test

Esoteric tests are generally considered to include Biochemical Genetics, Cytogenetics/FISH, Flow Cytometry, Microbiology, Molecular Genetic Pathology, RBC, Special Studies, Special Coagulation, and Virology.

Esoteric Testing Market Growth and COVID-19

Esoteric testing has applications in Infectious Disease, Endocrinology, Oncology, Toxicology, Immunology, and Neurology.  According to Research and Markets, the esoteric testing market is projected to grow by $15 billion in a five year period (USD 35.24 Billion By 2023 from USD 20.38 Billion in 2018, at a CAGR of 11.6%).  Growth in this market is primarily driven by :

  • the increasing burden of chronic diseases (due in part to the rising geriatric population),
  • rising prevalence of infectious diseases,
  • rising demand for early disease diagnosis using specialized tests,
  • growing awareness of personalized medicine,
  • increasing government funding for the research and development of innovative esoteric tests.

Clinical Context is Important for an Esoteric tests expert witness

The recent COVID-19 pandemic is driving an increase in esoteric testing.  Esoteric tests are being performed for the identification of SARS-CoV-2 RNA.  For example, the COVID-19 RT-PCR test is a real-time reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasal, nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of COVID-19 by their healthcare provider.

An emerging market is developing in processing blood samples to determine whether people who have recovered from COVID-19 develop antibodies that give them immunity.  Esoteric testing facilities are open in certain states by various providers. Recently, one test company announced that select service centers and phlebotomy sites are able to collect nasopharyngeal specimens in states including Alabama Arkansas Florida.

Links Between COVID, Microvascular Disease, and Importance of Esoteric Testing

According to physicians at Johns Hopkins, and Brigham and Women’s Hospital:

“Although most patients with COVID-19 present with a mild upper respiratory tract infection and then recover, some infected patients develop pneumonia, acute respiratory distress syndrome, multiorgan failure and death,” wrote co-authors Charles J. Lowenstein, MD, of Johns Hopkins University School of Medicine in Baltimore, and Scott D. Solomon, MD, of Brigham and Women’s Hospital in Boston. “Clues to the pathogenesis of severe COVID-19 may lie in the systemic inflammation and thrombosis observed in infected patients. We propose that severe COVID-19 is a microvascular disease in which coronavirus infection activates endothelial cells, triggering exocytosis, a rapid vascular response that drives microvascular inflammation and thrombosis.”

There are links emerging between COVID, microvascular diseases such as acute microvascular thrombosis found in postmortem examinations and esoteric testing.

The key to realizing economic growth in this sector will be:

  1. Solidifying business models that work with regarding insurance reimbursement and medical coding and medical billing Standards
  2. Regulatory compliance risk management

Esoteric Testing Experts Can Help with Regulatory Risk Management

Esoteric testing laboratories are generally covered by:

  • CLIA (Clinical Laboratory Improvement Amendments)
  • HIPAA (Health Information Portability and Accountability Act of 1996.
  • ARRA HITECH Act of 2009 with respect to Protected Health Information (PHI) Safeguards

Both Acts have specific requirements to ensure the accuracy of test results and maintenance of the privacy of those results when reported.    A typical CLIA certification would be ISO 13485:2016 certified manufacturer of quality immunoassays for the measurement of biomarkers in blood and blood-derived specimens.  HIPAA, the HIPAA Omnibus Rule of 2013, and the Protected Health Information Safeguards of the 2009 ARRA HITECH Act are important areas to consider.

Typical Esoteric Tests

Activin A
Activin B
Activin AB
AMH (Human, Rat/Mouse, Bovine, Equine, Canine, Feline, Porcine, Ovine, and more)
AMH, Dried Blood Spot
AMH (picogram level detection)
BMP-15/GDF-9 Heterodimer Complex
Bone Morphogenetic Protein-15 (BMP-15)
C-Peptide of Insulin
Follistatin Like 3
Glucagon-like Peptide-1 (GLP-1)
Glucagon-like Peptide-2 (GLP-2)
Growth Differentiation Factor-9 (GDF-9)
IGF-I, Free
IGF-I, Total
IGFBP-3, Intact
IGFBP-3, Total
IGFBP-4, Intact
IGFBP-4, Total
Inhibin A
Inhibin B
Inhibin, Total
Myelin Basic Protein (MBP)
PAPP-A (picogram level detection)
PAPP-A / Stanniocalcin 2 Complex
SARS-CoV-2 IgG / IgM
Stanniocalcin 2

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