Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
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New Guidance Released for Cervical Cancer Detection
Recently released AACC document covers newly updated screening guidelines as well as information on surveillance and diagnosis.
Lab Business: It’s Back to Basics for LabCorp & Enzo Biochem
Enzo recently announced that it is selling its lab division to LabCorp for $146 million in cash.
NIH Sees Budget Increase by $2 Billion
On March 15, President Biden signed the Consolidated Appropriations Act, 2022 into law, an omnibus bill that sets the budgets for all federal agencies for the rest of FY2022. The bill includes a $2 billion increase for the National Institutes of Health (NIH),...
New Smartphone App Encourages People to Seek Therapy for Heart Disease
Smartphone apps can already help manage many aspects of our health, from tracking physical activity to suggesting healthy eating options to monitoring heart rate. Now, a new app has been developed that predicts an individual’s genetic risk for coronary artery...
Quest and Walmart Partner to Make Consumer Lab Tests Accessible Online
Even before the pandemic, labs and major retailers have been partnering to make lab tests more accessible for consumers. Under a recently announced collaboration, Quest Diagnostics, the nation’s largest lab will work with retail giant Walmart to enable customers to...
FDA Orders LuSys and Celltrion to Recall Unauthorized COVID-19 Rapid Tests
This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance. San Diego-based LuSys Laboratories is recalling...
After Steady Decline, Telehealth Use Surges during Omicron
When the pandemic and lockouts first began, telehealth utilization soared to unprecedented levels. But while telehealth use remains well above pre-pandemic levels, thanks in part to relaxed Medicare coverage rules, the initial wave steadily ebbed starting in May...
FDA Grants Approval to Breast Cancer Treatment and Companion Diagnostic
Certain cancer patients now have access to a new treatment option and companion diagnostic. On March 11, the U.S. Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for treating adults with deleterious or suspected...
US Government Launches Nationwide Test-to-Treat Initiative
Recently unveiled program aims to ensure easy access to COVID-19 treatments for all eligible Americans.
Physicians Get a Break on 2021 MIPS Payment Adjustments
Just as it seemed like physician practice patterns were getting back to normal, the late-year Omicron surge skewed the Merit-based Incentive Payment System (MIPS) quality data for 2021. With that in mind, the Centers for Medicare & Medicaid Services (CMS) has...
Potential New Test Could Diagnose Lyme Disease Sooner
For scientists and clinicians alike, one of the Holy Grails for successfully treating and curing Lyme disease is developing tests that identify the disease sooner, show when people are cured of infection, and can diagnose reinfection. Now, researchers at Tufts...
FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees
For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...
