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
Essential
Subscribe today for access to
Articles and Reports
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
A Due Diligence Checklist for Vetting Medical Billing Company Compliance
Labs have a duty to inquire into what their billing company is up to and whether it complies with all applicable regulations.
OIG OKs Pharma Company’s Use of Financial Help for Patients
Recent Advisory Opinion sheds light on offering patients financial assistance so they can receive the provider’s products and services.
No Surprises Act Controversy Takes Surprising Twist
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.
LDT Reform: If Congress Won’t Do It, We Will, Says FDA
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
New PLA Codes Billable Under the Medicare CLFS to Be Aware Of
Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.
Amazon Closes One Medical Acquisition but FTC Intervention Looms
The deal closed Feb.22, but the FTC has expressed concerns about the acquisition and Amazon’s business practices in general.
What COVID-19 Labs Must Do to Prosper in a Post-Pandemic World
With COVID-19 testing demand all but dried up, labs will have to make—or at least contemplate making—significant changes to their business.
What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
