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
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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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
Genomic Tests for Prostate Cancer Risk Stratification Are Now Covered
A newly finalized local coverage determination from MAC Palmetto GBA sets out coverage criteria for two applications of these tests.
Protect Your Lab against HIPAA Right of Access Liability Risks
Key points to educate your staff on when it comes to patient requests for test records and other protected health information.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
In this month’s key cases, Myriad Genetics shells out, Illumina wins a decisive victory, a whistleblower suit is tossed, and false billing of UDTs costs a lab at least $11.6 million.
A Model Script to Help Avoid HIPAA Right of Access Violations
This script helps prepare frontline staff to answer questions that patients seeking access to their PHI are likely to ask.
Who’s Allowed to Bill for Laboratory Reference Testing?
An overview of the rules and requirements to help you keep your reference laboratory billing arrangements compliant.
Lowering the Boom on COVID-19 Relief Scammers
The DOJ recently charged 21 defendants across the US for allegedly carrying out COVID-19 scams worth just under $150 million.
Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies
CMS has published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments deficiencies for the previous year.
How to Comply with Medicare Signature & Documentation Requirements
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A Model Signature Log for Laboratories
If the signatures of ordering physicians or non-physician practitioners aren’t legible or done correctly, Medicare may not pay for lab tests.
Ohio Lab Company Settles Inpatient Double Billing Claims for $142.7K
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