News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel
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Attention Pathologists! New Prostate Cancer Test Has CPT Code, NCCN Guideline Recommendation, and Potential Market of One Million Prostate Biopsies Annually

Jan 22, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology

OPKO Health’s 4Kscore test predicts the rate of high-risk prostate cancer and may become a useful business case study for other labs developing proprietary diagnostic tests

Clinical laboratories and biotech companies with new medical laboratory tests are struggling to win coverage by Medicare and private payers. How big is this problem? There are currently tens of thousands of molecular diagnostic assays and genetic tests offered for clinical use.

Any lab company seeking to obtain an appropriate Current Procedural Terminology (CPT) code, favorable coverage guidelines, and adequate reimbursement from health insurers for its new lab test faces three big challenges, and they are related. First, payers are simply overwhelmed with requests to review new genetic tests. The flood of new test submissions exceeds the capability of payers to respond.

Most Payers May Not Have Right Scientific Expertise to Evaluate Genetic Tests

Second, most health insurance plans lack physicians and medical professionals who have the necessary experience in laboratory medicine, molecular diagnostics, and genetic medicine to evaluate these lab test submissions in a knowledgeable way. (more…)

Why Public Disclosure of Anatomic Pathology Errors in Canada, But No Similar Events Reported in the United States?

Sep 23, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

As healthcare systems make patient safety a greater priority, the public reporting of pathology errors in Canada has no comparable track record in the United States

Errors in anatomic pathology  testing in the Canadian provinces of Nova Scotia and Saskatchewan made media headlines this summer. In each case, it was just a limited number of cases where errors at pathology labs resulted in inaccurate diagnoses and, in at least one case, a needless mastectomy for a patient.

At a time when health systems in Canada, the United States, and other developed nations are giving great emphasis to patient safety, disclosure of life-changing diagnostic errors to patients is appropriate. Consumers are holding physicians—including surgical pathologists—to a higher standard of care. (more…)

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