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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Development of Frozen Section Technology is Subject of Newspaper Story Highlighting the Value Pathology Brings to Medicine

Newspaper in Rochester, Minnesota, tells the story of how the 19th century use of frozen sections by pathologists at Mayo Clinic played key role in developing intra-operative diagnostics

It’s a good thing for pathologists each time a local newspaper runs a story that highlights the contribution of pathology to the practice of medicine. Since pathologists typically don’t see patients, media stories about the pathologist’s role in diagnosing disease are effective ways to educate consumers.

This was the case when Rochester, Minnesota-based PostBulletin.com recently ran a story about—who else—but the pathology laboratory at the Mayo Clinic. The story highlighted the early development of the frozen section technique (FST) at Mayo Clinic. This newspaper story created community exposure about the role of pathology and pathologists in delivering quality healthcare. (more…)

To Find Patients at Highest Risk, Hospitals Combine Consumer Data with Clinical Information—Including Clinical Laboratory Results

Health systems using big data in this manner include Carolinas Healthcare System and UPMC Health

Big data is all the rage in healthcare these days. However, one interesting development in this field is how hospitals are integrating consumer data with clinical data to identify patients at high risk. For example, if the post-surgical heart patient buys a package of cigarettes, some hospitals say they want to know.

This is a trend with interesting implications for clinical laboratories. For example, will hospitals using big data in this fashion want to include medical laboratory test results in the mix of information they collect and analyze on their patients? If so, are there ethical issues associated with using such lab test data in this manner? (more…)

Wall Street Journal Writes about Federal Investigation of Health Diagnostic Laboratory and Certain Specialty Medical Lab Test Companies

Did “processing fees” paid by certain clinical laboratory companies to physicians represent an inducement that violated federal anti-kickback laws?

Once again, allegations of fraudulent practices at a fast-growing clinical laboratory company have made national headlines. This time it was a front-page story in The Wall Street Journal (WSJ) that last week discussed the controversy surrounding Health Diagnostic Laboratory (HDL) of Richmond, Virginia.

According to the WSJ story, federal healthcare authorities are looking into a practice by HDL and other medical laboratory companies of paying physicians “to process” blood specimens collected in their offices. As described by the WSJ, this “processing fee” was as much as $20 and included a $3 portion for the venipuncture. (more…)

Understanding Today’s Trends in Healthcare and the Clinical Laboratory and Pathology Testing Marketplace

Recent White Papers detail solutions for implementing new payment strategies for medical laboratories and pathology groups

Clinical diagnostic laboratories, pathology groups and healthcare institutions are carrying significant and potentially unsustainable levels of unreimbursed services. Although bad debt and uncompensated care in the healthcare industry are not new, they have been increasing at the same time that downward pressure is being applied to reimbursement.

Medical laboratories and pathology groups are also facing enormous levels of change in their clinical, regulatory and financial environments. As the Affordable Care Act is implemented, laboratories see downward pressure on reimbursement at both the federal and payer level, coupled with increased emphasis on efficiency and quality.
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More Media Reports of Health Insurers’ Reluctance to Reimburse for Genetic Tests, Thus Angering Many Patients and Causing Medical Laboratories to Go Unpaid

Pathologists should take note that an increasing number of patients who want genetic tests are complaining when they learn their insurance plan will not pay for such tests

Concerned about the increased cost of genetic tests, health insurers are becoming reluctant to pay for many types of molecular diagnostics and gene tests. When refusing to pay for these tests, however, they face a buzz saw of angry patients—many of whom see a genetic test as their last resort for a diagnosis and selection of a therapy that might just work for them.

Reuters recently reported that health insurance companies are reluctant to pay providers for genetic-sequencing tests until more research becomes available. This is a sign for pathologists and clinical laboratory managers that enough patients have been affected by this situation to justify news coverage by a major news source. (more…)

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label

Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.

UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)

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