Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
CMS recently announced a 20 percent increase to the fees that laboratories must pay when certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is the first such increase in the last 20 years and...more
First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more
Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more