The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and monitoring acute and chronic...more
At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
After months of stay-at-home orders, quarantine protocols, social distancing, and back-to-school planning, the ever- present question on everyone’s mind is, When will we get back to business as usual? For many, the answer...more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
In Washington: The White House moved forward with officially withdrawing the U.S. from the World Health Organization (WHO). The withdrawal would not go into effect until July 6, 2021. Sen. Foreign Affairs Committee...more
On June 4, 2020, HHS released new guidance detailing what additional data laboratories must report to HHS along with COVID-19 test results. HHS explained that the new guidance standardizes reporting requirements in an effort...more
Due to expanded COVID-19 diagnostic testing availability, the Missouri Department of Health and Senior Services (MDHSS) is encouraging providers to test both symptomatic and asymptomatic individuals, if the clinician’s...more
Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more
In connection with its efforts to expand COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) announced last week that it will increase payment for high-throughput COVID-19 lab tests to $100. Before this...more
In response to the public health threat of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has formed a special emergency program to expedite development of COVID-19 therapies – the Coronavirus Treatment...more
The U.S. Food and Drug Administration (FDA) announced in a March 27, 2020 letter to industry that the Center for Biologics Evaluation and Research (CBER) has implemented new measures to prioritize biological product...more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...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
On March 18, 2020, the Connecticut Department of Public Health (DPH) issued an order requiring laboratories to report negative SARS-CoV-2 test results to DPH using the Electronic Laboratory Reporting System....more
In the early morning hours of Saturday, March 14, 2020, the House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act (the “Act”), by a bipartisan vote of 363-40. The Senate has postponed its...more
HDHP and HSA participants - The IRS has expanded prior guidance to allow health plans to pay first-dollar costs for testing and treatment of COVID-19 without jeopardizing the participant’s HSA eligibility. ...more
Employers and health plans that want to provide some relief for participants during the spread of the novel coronavirus (SARS-CoV-2, which causes the disease COVID-19) may waive deductibles for COVID-19 testing without...more
On March 11, 2020, the IRS issued Notice 2020-15, allowing health savings account (HSA)-compatible high deductible health plans (HDHPs) to provide coverage for testing and treatment of COVID-19-related services without an...more
Employers across the country are currently considering what actions to put in place in light of the potential spread of COVID-19 (the coronavirus). Many employers offer their employees high-deductible health plans that can...more
To encourage individuals to seek prompt medical attention for the coronavirus (COVID-19), a number of states have taken, or are considering, action to eliminate the costs associated with testing and treating the virus and to...more
The Internal Revenue Service (IRS) issued a notice that allows individuals to participate in a health savings account (HSA) while participating in a high deductible health plan (HDHP) that provides coverage for both the...more