Apr 22, 2016 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
A hospital in Virginia now offers a genetic service to new parents that could impact clinical pathology laboratories if it develops into a trend
Here’s a first in the rapidly-developing field of pharmacogenomics testing. A hospital in Virginia announced that it would offer a free pharmacogenomics test to newborns. This is a development that will catch the attention of clinical pathologists and medical laboratory professionals at other hospitals across the country.
Inova Women’s Services at the Inova Woman’s Hospital on the Inova Fairfax Medical Campus in Falls Church, VA, has begun offering free MediMap tests to newborns. MediMap is a pharmacogenomics (PGx) test that looks for variations in seven genes that could indicate a child might process certain drugs differently than the majority of the population.
The program is an example of a well-known and often-used marketing tactic: “Buy X and get Y free!” Given the choice between a new free diaper bag and a free, painless test that, as Inova’s website states, “personalizes prescriptions to more effectively treat and manage illnesses in the future,” what new mother would choose the diaper bag? (more…)
Apr 20, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
Latest news follows reports that Theranos was facing sanctions that include revoking its CLIA license and a two-year ban on its executives Holmes and Balwani and its former medical director, Dhawan
Federal prosecutors began a criminal investigation into whether Theranos misled investors about its medical laboratory technology and operations, The Wall Street Journal (WSJ) reported on Monday evening.
Investigators recently sent subpoenas to Walgreens Boots Alliance Inc. (NASDAQ: WBA) and the New York State Department of Health (NYSDOH) seeking documents and testimony about statements Theranos made, according to WSJ reporters Christopher Weaver, John Carreyrou, and Senior Editor Michael Siconolfi. As sources, the WSJ cited unnamed people familiar with the matter. (more…)
Apr 18, 2016 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Human genome pioneer J. Craig Venter’s newest project seeks to ‘change the way medicine is practiced’ by creating genomic-based medicine model
With little fanfare or public notice, a start-up company in San Diego is busy sequencing the largest number of whole human genome sequences in the world. The knowledge expected to result from this effort promises to revolutionize healthcare, as well as clinical laboratory testing.
Human Longevity Inc. (HLI) is a genomics and cell therapy company that has assembled the largest human genome sequencing operation in the world. It’s goal is to use whole genome sequencing and cell-based therapeutics to redefine aging and “meaningfully extend the human lifespan.”
“HLI’s mission is to identify the therapeutically targetable mechanisms responsible for age-related human biological decline, and to apply this intelligence to develop innovative solutions to interrupt or block these processes, meaningfully extending the human lifespan,” HLI states on its website. “We are trying to tackle some of the most vexing diseases like cancer, heart disease, and diabetes … we are working to change the way medicine is practiced through our genomic-focused, preventive model.” (more…)
Apr 15, 2016 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Pathology, Laboratory Testing
Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states
Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.
Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.
Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.
They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)
Apr 14, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal
Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.
In a letter to Theranos executives, CMS said it is prepared to:
• revoke the company’s CLIA certificate;
• impose a fine of $10,000 per day;
• suspend and cancel the lab’s approval to receive Medicare payments; and
• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.
Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)
