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
Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more
On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...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
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19. With scarce availability, there have been some attempts to limit tests to, or...more
On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more
In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more
The Food and Drug Administration (FDA) announced a policy shift on March 16, 2020, to allow state health departments to approve COVID-19 (coronavirus) diagnostic tests without FDA involvement during the current public health...more
The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims - In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver function. According to an U.S. Food and Drug Administration (FDA)...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
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more