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Clinical Laboratories and Pathology Groups

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Experts at National Comprehensive Cancer Network conference voice opinions

It may surprise many pathologists and clinical laboratory managers to learn that a number of prominent healthcare leaders recently voiced significant reservations about the current status of molecular genetics testing. In their view, clinical pathology laboratory testing that incorporates genetic and molecular technologies needs further refinement, improved billing codes, and additional regulation before it can fulfill its potential to be a precise diagnostic tool.

That was the conclusion reached by a panel of distinguished physicians representing healthcare organizations, pharmaceutical giants, insurance companies, and the government at this year’s annual National Comprehensive Cancer Network (NCCN) conference.

Genetic Medical Laboratory Testing a Mixed Bag at Best According to Panel

Clifford Goodman, Ph.D., of the Lewin Group, moderated the NCCN panel. The prominent panelists included:

Goodman asked the panel to consider four issues associated with the genetic tests and molecular assays regularly performed by pathology groups and medical laboratories:

  • Efficacy of molecular tests,
  • Regulation of the industry,
  • How to bring molecular testing into practical diagnostic settings, and,
  • How to determine the “value” of individual molecular tests.
(Sourced from NCCN website.)

(Sourced from NCCN website.)

One panelist voiced his concerns about the performance of a certain molecular test that is frequently run after a patient is diagnosed with breast cancer. “Thirty percent of the HER2 tests have the wrong results,” said Newcomer. “We have to get better at analytic validity.”

Newcomer then noted that, despite a “lack of evidence,” lung cancer patients routinely experience “180 to 190” molecular tests. He also observed that current billing systems do not adequately allow for precise billing of genetic testing.

“We [health insurers] don’t know what we are paying for,” Newcomer added. “The absence of more specific coding does not allow assessment of costs or benefits that could help establish the value of individual tests.”

Newcomer specifically discussed how existing billing systems do not allow physicians to specify what type of molecular assay or genetic test they performed. The typical billing system only allows for the line item “genetic test.” Thus, any integration of diagnostic genetic testing in a practical sense must—by necessity—include a revamp of the current set of CPT codes, and possibly, ICD-10-PCS codes as well.

During this session at the NCCN conference, the panelists also discussed the lack of practical and standardized methods for transferring biological samples from hospital labs to molecular testing facilities.

“We need to bring order out of chaos,” said Andrew von Eschenbach, M.D., Samaritan Health Initiatives. Eschenbach called for increased regulation of diagnostic molecular testing.

Molecular Diagnostics for Cancer Testing is an Immature Industry

Oncologist Mark Kris, M.D., described molecular testing in a cancer setting as an “immature industry” during the NCCN panel discussion.

Kris noted that the efficacy of certain molecular tests for lung cancer, such as the EGFR test, have been validated in healthcare settings and are useful as diagnostic tools. In his view, there should be a method by which similar molecular diagnostic tools can be validated using the principles of evidence-based medicine. Then these pathology laboratory tests can be used by physicians in practical settings.

“It is our job as clinical researchers to provide the data that regulators and payers need to make decisions,” said Kris.

Astute readers of Dark Daily are not unfamiliar with the issues surrounding the efficacy and value of diagnostic molecular genetics testing. Dark Daily covered this emerging trend as far back as 2007. And, most recently in articles titled “New Rapid Molecular Pathology Test for Tuberculosis Wins Favor with World Health Organization,” “NIH Plans To Create New Genetics Testing Registry of Molecular Diagnostics Tests Offered by Clinical Pathology Laboratories ,” and “ Molecular Diagnostics Laboratory in a Suitcase Travels to Farms to Test Livestock.” Diagnosing disease and predicting the outcome of a patient’s illness is not a new aspect of molecular diagnostics.

Clinical laboratory managers and pathologists who currently perform molecular and genetic tests in their laboratories would probably challenge some of the opinions expressed by this panel. There are already a significant number of genetic tests and molecular assays that meet evidence-based medicine guidelines and have contributed to more diagnostic precision.

It is likely that the panelists at the NCCN conference were referring to the explosion in the number and variety of new molecular assays being offered in the clinical marketplace, a large number of which have only limited clinical study data to support their accuracy and clinical efficacy. This proliferation of new genetic and molecular tests is one reason why payers are taking steps to more strictly manage utilization of these clinical laboratory tests.

—Michael McBride

Related Information:

Molecular Testing Has a Long Way to Go, Says NCCN Panel

NCCN Panel Calls for Higher Standards, Better Ways of Translating Molecular Genetics into Clinical Practice (Medical News Today)

NCCN Annual Conference Site

Recap of the NCCN 16th Annual Conference

NCCN Panel Calls for Higher Standards, Better Ways of Translating Molecular Genetics into Clinical Practice (Business Wire)