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
Sign In

More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories

As tests explore genetic markers related to excessive weight gain, and breast and ovarian cancer, companies as well as employees are seeing returns on investment and participation

In a development that is auspicious for medical laboratories, more genetic tests are making their way into more corporate health benefit plans. Big brands—from Aetna to Visa—are partnering with personalized health companies and clinical lab companies doing genetic testing as they support tests to help employees head-off health risks.

Employers’ sponsorship of genetic testing is a trend that could become more common, noted Fortune. But human resources and benefits experts say the offerings are still uncommon. There are also unresolved issues, such as when genetic test results are inconclusive or questionable.

For medical laboratories, the companies’ genetic testing benefits could prompt more test orders from healthcare consumers. Based on the results of their genetic tests, people might decide to make lifestyle changes, work toward prevention of chronic conditions, and take further tests to assess progress. (more…)

New England Journal of Medicine Publishes Study Where Researchers Call Attention to Lack of Knowledge about Some Genes Included in Gene Panel Tests for Inherited Cancers

Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing

Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.

What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.

These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. (more…)

UnitedHealthcare Pushes Back Start Date for Making Claims-Payment Decisions Based on its Florida Pilot Management Program for Medical Laboratory Tests

Health plan sets no new date for BeaconLBS claims-payment decisions but promises 30-days’ notice before making decisions on claims payment

Physicians, pathologists, and clinical laboratories in Florida got a late Christmas present last week. UnitedHealthcare (UHC) (NYSE:UNH) postponed the date when its medical laboratory benefit-management pilot program in Florida, administered by BeaconLBS, would affect claims payments.

This was welcome news, because, beginning January 1, if physicians serving UHC patients had failed to use the BeaconLBS system to obtain pre-notification or pre-authorization for 82 medical laboratory tests, the physicians or labs performing the tests would not be paid by UHC—nor could clinical labs and pathology groups in the UHC provider network bill patients for these tests. (more…)

In Florida, UnitedHealthcare’s New Clinical Laboratory Benefit Management Program Triggers Objections from Physicians and Excludes Most Medical Laboratories

College of American Pathologists and associations for family physicians and ob-gyns in Florida have asked UnitedHealthcare to discontinue implementation of BeaconLBS system

Medical laboratory testing is at the center of a contest of wills in Florida. On one side is a health insurer that wants to require physicians to obtain pre-notification or preauthorization for a list of clinical laboratory tests. On the other side are the physicians who question the clinical basis for these requirements and the time and resources required to comply with the health insurer’s program.

This rancorous dispute is in reaction to the laboratory benefit management program created by UnitedHealthcare (NYSE: UNH) (UHC) administered by BeaconLBS, a business division of Laboratory Corporation of America (NYSE: LH) (LapCorp). (more…)

Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories

Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case

Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.

Moreover, this Supreme Court decision also opens the doors to other medical laboratories  to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)

;