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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As ICD-10 Implementation Approaches October 1 Deadline, Clinical Pathology Laboratories Wonder if Providers and Payers Will Make a Smooth Transition

Medical laboratories and anatomic pathology groups could face payment delays if physicians fail to code lab test claims properly using ICD-10 codes

Just weeks remain before the implementation to ICD-10 begins. This will be a delicate time for clinical laboratories and anatomic pathology groups, since labs must rely on physicians to provide accurate ICD codes that labs must submit on test claims in order to be reimbursed by payers.

The much-delayed shift from ICD-9 to ICD-10 diagnosis codes will take place on Thursday, Oct. 1. When clocks strike midnight, years of debate over whether the conversion will create a financial hardship on physicians—and in turn disrupt payments to clinical laboratories and anatomic pathology groups—will begin to be answered.

The Medicare program requires appropriate ICD codes on medical laboratory test claims for Medicare patients. That is one reason why clinical laboratories and anatomic pathology are financially vested in a smooth conversion process. All Medicare Part B claims for medical laboratory tests must be submitted with an appropriate International Classification of Diseases (ICD) code provided by the physician who ordered the lab tests. The Medicare program will not reimburse lab test claims without an appropriate ICD code. (more…)

Noted Pathologist George Lundberg, M.D., Sees Opportunity for Pathology Profession to be Leaders in Diagnostics during the Era of Genomics

Noted pathologist encourages pathology profession to step up and assert leadership in clinical diagnostics as it enters the era of genomics-based medicine

Pathologists, embrace molecular testing or become irrelevant. In essence, that’s the message from pathology maven George D. Lundberg, M.D..

Lundberg is well known to pathologists in America. A board-certified pathologist himself, Lundberg served 17 years as Editor in Chief of the Journal of the American Medical Association (JAMA). He continues to write and blog for a variety of healthcare publications and Web sites.

That means Lundberg has watched the evolution of medicine from a unique perspective for an extended period of time. The fact that he recently issued a clear and unambiguous call to action for the pathology profession means that pathologists  and clinical laboratory managers should take heed. (more…)

FDA Panel Recommends Approval for OraSure’s In-Home Consumer HIV Test, Despite Some Concerns about False Positive Results

Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories

Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market.

On May 15, the 17 voting members of FDA’s Blood Products Advisory Committee (BPAC), concluded that the benefits of the OraQuick in-home HIV test outweigh the potential risks for consumers, according to a story published at cbsnews.com. The FDA advisory panel’s decision came despite earlier reported concerns regarding decreased accuracy of the OTC test when performed by consumers as compared to results from the professional-use version.
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HHS Proposes One-Year Delay for ICD-10 Implementation: Is This Good News for Clinical Pathology Laboratories?

AMA opposition to ICD-10 deadline moves HHS to reconsider, while leaving some transition-ready providers rankled

When it comes to implementation of ICD-10 in the United States, the “do it later” crowd seems to have convinced the Department of Health and Human Services (HHS) of the need to once again move back the compliance date for ICD-10. On April 9, HHS announced a proposed rule to defer implementation by one year, with a new effective date of October 1, 2014.

Clinical laboratories and anatomic pathology groups have a big stake in a successful transition from ICD-9 to ICD-10. Among other reasons, Medicare Part B claims for medical laboratory  tests must be submitted with an appropriate ICD code [provided by the physician who ordered the lab tests] for the clinical lab or pathology group to be paid by the Medicare program.
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Mobile Stroke Unit (MSU) Brings the Laboratory to the Patient at the Point of Care

Clinical laboratories will increasingly provide emergency diagnostic services through mobile-unit near-patient testing

In an innovation designed to bring the laboratory to the patient, use of a mobile stroke unit (MSU) shortened the time to treatment decision for acute stroke patients. MSUs equipped with imaging systems and medical laboratory point-of-care testing proved capable of providing early diagnosis and intervention.

Pathologists and clinical laboratory managers will immediately recognize the implications of these findings. This study demonstrates how clinicians are taking steps to move clinical laboratory testing out of the traditional central/core laboratory and bring it closer to the patient specifically to reduce the time-to-answer for certain medical conditions, like acute stroke.

One conclusion from this clinical study is that use of a mobile stroke unit offers a potential solution to the medical problem of stroke patients arriving at the hospital too late for treatment, wrote researchers in a study published in the medical journal The Lancet.

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