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
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.
OIG: Medicare Advantage Plans Are Stiffing Physicians on Reimbursement
New report shows a fair portion of prior authorization and physician reimbursement request denials actually met Medicare coverage rules.
Labs in Court Weekly Roundup
In last week’s announced enforcement actions involving the healthcare industry, two defendants were sentenced, one was convicted, and two others were charged in various fraud-related schemes.
Florida Lab Owner Jailed for Telemedicine Genetic Test Ripoff
Case is part of a larger coordinated enforcement action targeting COVID-19-related fraud spanning seven judicial districts.
New Tech Could Make At-Home Disease Diagnosis More Feasible
A research team has developed a new, simpler microfluidic chip that could make at-home diagnosis of diseases faster and more affordable
PAMA Hasn’t Reduced Part B Lab Test Costs
For the third straight year since the PAMA pricing system has been in place, overall year-over-year spending on lab tests increased in FY 2020.
FDA Aims to Address Growing Cybersecurity Threats to Medical Devices
The agency recently issued draft guidance to medical device manufacturers to help protect their products from cyberattacks.
First G2 Webinar Since LMG Takeover Sees Lively Q&A Session
April 27 webinar featuring an update on the brand and talk on recent lab industry developments sees strong engagement.
Upcoding Accusations Cost Pathology Practice $2.4 Million
Recent case highlights importance of having an actual written analysis in your records justifying use of a certain code.
White House Asks Congress to Get Moving on COVID-19 Relief Funding
The Biden administration released another statement on Wednesday reminding lawmakers of the consequences of not resolving the issue quickly.
