How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
OTC COVID-19/Influenza Test Approval Comes Too Late to Save Lucira Health
No company better embodies the vicissitudes of running a COVID-19-focused diagnostics business during the pandemic period than Lucira Health.
FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Lab Companies Turn to Product Integrations to Cut Costs, Risks, & Time
Product integration collaborations have become increasingly common, with five such deals being announced between February and mid-March.
Med-Tech Startups Survive SVB Collapse but Face New Concerns
While only time will tell how bad the ultimate damage turns out to be, it appears for now at least that the industry has dodged a bullet.
Illumina Faces Proxy Battle Over Grail Acquisition
Carl Icahn has decided to take his beef with Illumina’s board of directors over the acquisition directly to company shareholders.
Medicare Pay Rates Are Adequate without Major Hikes, MedPAC Says
Agency’s annual report to Congress concludes that providers are doing just fine and don’t need a big bump in pay at this time.
Medicare to Pay for 22 Additional PLA Codes, Starting April 1
To ensure proper Medicare Part B billing and coding, your billing staff must be aware of all 22 of the newly recognized PLA codes.
The ABN Modifiers and How to Properly Use Them
Proper usage of ABN-related modifiers is a significant issue that has a direct impact on your lab’s reimbursement and compliance.
Labs in Court: Three Lawsuits Tossed
In this month’s roundup, three cases—including two whistleblower lawsuits and one workplace discrimination case—get dismissed.
What Can Go Wrong with Outsourcing Lab Billing and Coding?
Lab leaders must be able to make a sound assessment of both the costs and benefits, and the liability risks involved.
