Jul 27, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market
Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.
One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.
Announced in a May 2016 statement, the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).
Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)
Jul 25, 2016 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
The idea that human beings could be created without biological parents sounds like the stuff of science fiction, but it’s not, and the technology could be available in the not so distant future
It’s not known how many pathologists and clinical chemists were in attendance at a secret meeting that took place in Boston in May, which was organized to investigate the feasibility of building a synthetic human genome.
Nearly 150 scientists, lawyers, entrepreneurs, and ethicists met in a closed-door session at Harvard Medical School to discuss creating a synthetic human genome. Although this meeting was secret, people took notice. The possibility of using a synthetic genome to create human beings—without biological parents—understandably caused concern among the life science communities, the New York Times reported, and the apparent secrecy fueled speculation that ignited controversy, which spread rapidly. (more…)
Jul 22, 2016 | Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement
Biodiagnostic Laboratory Services fraud case continues to bring more criminal convictions of physicians in a rare case of tough federal enforcement of anti-kickback laws
There’s good news for sales representatives who work for clinical laboratories and anatomic pathology groups and regularly run up against the sales practices of shyster labs that offer inducements to that class of doctors who are open to personal enrichment by accepting different forms of kickbacks in return for lab test referrals.
The good news comes from New Jersey, where one U.S. attorney has prosecuted dozens of doctors who accepted various illegal inducements and bribes from BioDiagnostic Laboratory Services Inc. (BLS) of Parsippany, the discredited lab company that was closed in 2012 after it was indicted by Paul J. Fishman, the U.S. attorney for Newark.
The most recent conviction was announced in April, 2016, when another New Jersey physician pleaded guilty in the continuing clinical laboratory fraud case involving BLS.
Gary Safier, MD, pleaded guilty to taking bribes in excess of $350,000 over a period of seven years. He was sentenced to two years in prison and, upon release, will have to perform an additional two years of supervised release. He was also instructed to forfeit the $353,000 he received for his role in the scam. (more…)
Jul 20, 2016 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Comparing results from more than 300,000 individuals, international experts recommend using non-fasting blood screening for most cholesterol and triglyceride tests
Every clinical laboratory offering cholesterol testing across the globe must deal with a common issue: because patients are told to fast overnight before giving a blood specimen, patient service centers (PSCs) and blood collection centers are overcrowded when they first open their doors in the morning. That’s because hungry patients want their sample collected so they then go eat something as soon as possible.
It has long been recognized that the overnight fasting requirement for collecting blood samples used in cholesterol testing is unpleasant for patients. It also adds cost to the healthcare system because labs must staff an adequate number of phlebotomists in their PSCs to handle the predictable early morning rush of hungry patients wanting to be done with this task. Meanwhile, in the afternoons, patient traffic in the same PSCs can dwindle to near nothing, leaving phlebotomists in those PSCs with little to do. (more…)
Jul 18, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement, Management & Operations
Analysis shows new rule requires data gathering effort that favors larger medical laboratories and thus threatens community labs that serve smaller towns and rural areas
When The Centers for Medicare and Medicaid Services (CMS) issued their Final Rule for lab test market price reporting under the Protecting Access to Medicare Act of 2014 (PAMA) last month, it put the clinical laboratory industry on a path that will have significant financial consequences for all labs, whether large or small. Some experts believe this will be the most disruptive event to the medical laboratory industry in the past 30 years.
By now, the story is well known among pathologists and clinical laboratory directors. That story comes from CMS, which issued the Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule—AKA the Clinical Laboratory Fee Schedule (CLFS)—that directly affects clinical labs. Under this Final Rule, published in the Federal Register, June 17, 2016, “laboratories and physician offices are required to report private payer rate and volume data if they have more than $12,500 in Medicare revenues from laboratory services on the CLFS and they receive more than 50% of their Medicare revenues from laboratory and physician services during a data collection period. Laboratories will collect private payer data from January 1, 2016 through June 30, 2016 and report it to CMS by March 31, 2017.
“The first data reporting period (that is, the period during which data from the collection period will be submitted to CMS) will be from January 1, 2017, through March 31, 2017. All subsequent data collection and reporting periods for CDLTs [Clinical Diagnostic Laboratory Tests], except for ADLTs [Advanced Diagnostic Laboratory Tests], will follow this same data collection and reporting schedule, every three years. Reporting of private payer rates for ADLTs will occur on the same schedule except it will be on an annual basis,” states the Final Rule. (more…)
Jul 15, 2016 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Most insurers still determine coverage on a case-by-case basis, but two major payers now have coverage policies that are helpful to clinical labs that perform WES
Whole exome sequencing (WES) is not new for clinical pathologists, but it is becoming more common in a clinical setting as more physicians learn about its uses.
This is due to two reasons. First, researchers are identifying new ways to use whole exome sequencing to improve patient care. Second, the cost of whole genome sequencing continues to fall at a steady rate, making it ever more affordable to use in clinical settings.
As recently as 2009, WES was prohibitively expensive and there was little possibility that insurers would cover the cost of the test, as it was considered experimental. Now, however, evidence is mounting that it is an effective diagnostic tool. Therefore, more payers are announcing coverage for WES for an expanding number of diagnostic purposes. (more…)
