LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
White House Proposes New AI “Bill of Rights”
US takes first steps to rein in abusive and privacy-invasive use of AI by corporations.
Theranos in Court: Holmes Sentenced to 11 Years Behind Bars
After delays in sentencing and attempts by her legal team to win a mistrial, Holmes was sentenced last week for her role in defrauding investors of millions.
Don’t Let “Digital Nomads” Expose Your Lab to Foreign Tax Liability
Where your remote employees actually work may have significant legal consequences for your lab.
Weekly Enforcement Report: Doctors in Hot Water for Billing-Related Issues
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
AACC Revises Reproductive POC Lab Test Guidelines
POC tests offer speed and simplicity, but are less reliable than tests performed in labs.
New Breast Density Reporting Final Rule Set to Be Released
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
FDA to Consider Health Disparities in Granting Breakthrough Device Designation
Medical device makers will have to show that their products will be accessible to disadvantaged populations.
Five Things Labs Need to Know About the 2023 Clinical Lab and Physician Fee Schedule
In case you don’t feel like reading all 3,300+ pages of the Final Rule, here’s a quick briefing on the main changes you should be aware of.
Weekly Enforcement Report: COVID-19-Related Cases Take Center Stage
Though light on lab-related cases, last week’s enforcement actions cracked down on COVID-19-related violations.
CMS Hikes 2023 Medicare OPPS Reimbursement Rate 3.8 Percent
However, the increase still isn’t enough to keep pace with inflation, providers contend.
