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 Ninth Circuit recently decided United States v. Schena, 142 F.4th 1217 (9th Cir. 2025), which considered the Eliminating Kickbacks in Recovery Act (“EKRA”). EKRA, enacted in 2018 to address “body brokering” and other...more
The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion highlighting two important—if easy to overlook—areas that health care companies and providers should remain...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more
Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more
Whether you operated a traditional diagnostic lab, a toxicology lab, or one that performs high-complexity genetic and genomic testing, there were plenty of regulatory nightmares to keep you up at night in 2022. It seems “the...more
In this episode, Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act. They discuss the type of entities required to report, potential penalties...more
On this episode of the HealthLaw HotSpot, host Ericka Adler, Roetzel shareholder and Health Law Practice Group Leader, is joined by fellow Roetzel attorney Christina Kuta to discuss laboratory testing investigations related...more
EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more
Laboratory tests play a critical part of the healthcare system. Ordering and billing for these tests, however, is not always cut-and-dry. Compliance with federal laws and rules (like the Clinical Laboratory Improvement...more
Reproductive Biology Associates, LLC (RBA) and its affiliate, MyEggBank, notified approximately 38,000 patients that a data breach involving a ransomware attack had exposed the patients’ full names, addresses, Social Security...more
IN THIS ISSUE Home medical tests and health monitors are trendy now. How useful are they? As the saying goes: Let the buyer beware - Shaking up hidebound medicine could be a plus. But will key safeguards also stay?...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
Spring is approaching, pandemic restrictions are (we hope responsibly) lifting, and the April 5, 2021 deadline for compliance with the new information blocking rules are looming. We continue our Frequently Asked Question...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
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
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act...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
On March 27th, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). On both the federal and state levels we have seen efforts to support social distancing in the...more
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed by the President on March 27, 2020, includes several provisions affecting group health plans, as discussed below. Health Plan Rules and...more
On Mar. 25, the Senate passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The House of Representatives passed the CARES Act on Mar. 27, and President Trump signed the bill later in the day,...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 Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more
The OIG added 12 new items to its Work Plan in the August 2018 update. Hot topics related to Centers for Medicare & Medicaid Services (CMS) oversight in this month's Work Plan include: state oversight of opioids; potential...more