Jun 28, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg
FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs.
Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use new technologies to address unmet clinical challenges. As a result, these medical laboratory tests are critically important to the growth of personalized medicine. (more…)
Mar 2, 2012 | Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Medical laboratory directors and pathologists are likely to find their lab’s safety standards increasingly under the spotlight
Clinical laboratories and pathology groups should be aware of new safety guidelines that address the risk of laboratory-acquired infections (LAI). A panel of experts convened by the Centers for Disease Control and Prevention (CDC) recently released safety guidelines for medical laboratory workers.
The guidelines are intended to improve safety specifically in diagnostic laboratories that handle specimens from humans and animals. Statistics indicate the clinical laboratory workers have infection rates for certain diseases that can be up to 20 times greater than that of the general population! It is believed current data understate the true rate of laboratory-acquired infections within the nation’s medical laboratories and pathology groups. (more…)
Feb 20, 2012 | Laboratory News, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
A part of this legislation, the grandfather clause on Technical Component (TC) anatomic pathology services was extended through June 1, 2012.
Last Friday, clinical laboratories got bad news about new cuts to the Medicare Part B medical laboratory test fee schedule. Congress voted on a temporary funding fix to keep Medicare physician fees at current levels for 10 more months and a reduction in lab test fees was one source of the money that Congress used to fund this bill.
Pathologists and clinical laboratory managers will be disappointed to learn that the Medicare Clinical Laboratory Fee Schedule (CLFS) was cut by 2% when Congress voted on Friday, February 17, to approve a deal to extend the payroll tax cut for nine months. President Obama could sign the bill into law today (Monday, February 20). The cuts to lab test fees are estimated to total $2.7 billion over 10 years.
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Oct 19, 2011 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology
Nation’s clinical laboratories may see significant reductions in federal funding for medical laboratory tests in the 2012 federal budget
Unprecedented cuts in funding for clinical laboratory services are expected from Congress in coming months. That’s because federal legislators need deep cuts from many sources to cope with the current budget crisis. It is also why some Beltway insiders predict that fees for medical laboratory testing will be substantially reduced.
Although many lab industry associations have alerted their members to certain of these proposals—such as the proposed plan to reinstitute the patient co-pay/co-insurance requirement for Medicare Part B Medical Laboratory Tests—few clinical laboratory managers and pathologists know that there are at least three separate proposals to reduce funding for medical laboratory tests. Each proposal has a chance to make it through the legislative pipeline and become part of the final 2012 federal budget.
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Jul 15, 2011 | Laboratory News, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
Document leak earlier this week pulls curtain back on potential cuts to Medicare/Medicaid spending
Spending cuts of between $334 billion and $353 billion over the next 10 years are on the table in the negotiations over the federal debt ceiling. The bad news for the clinical laboratory industry is that restoration of the Medicare patient co-pay for medical laboratory tests is not only on the list of proposed spending cuts, but represents a significant chunk of money—as much as $16 billion during the next decade!
Typical of beltway politics, it was only because of a leak that the list of proposed Medicare and Medicaid spending cuts became public knowledge. On Tuesday this week, Kaiser Health News was one of the first to report the leak of the documents. It also posted a copy of the briefing documents on its website.
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