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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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
Model Workplace Romance & Fraternization Policy
It’s important to implement a policy that allows you to keep control over the potential issues romantic relationships can cause in the lab.
Courts Dismiss Two Whistleblower Lawsuits
In this month’s Labs in Court roundup, a medical device company and genetic testing company each win key victories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
CMS to Crack Down on Unnecessary COVID-19 Add-on Tests
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
CGx Testing and Kickbacks Remain Key Enforcement Targets
In our latest roundup, schemes involving cancer genetic testing and kickbacks remain the most common, but there were some surprises.
January 2023 Labs in Court: Two Usual Cases, Two Unusual Ones
Key cases over the last month include a CGx testing kickback scheme, false billing, and violations of a non-compete clause and HIPAA.
HHS Proposes New Privacy Rules for Substance Abuse Patient Records
Laboratories may have to revise their own medical records disclosure policies to ensure compliance.
How to Comply with New Specimen Collection Fee and Travel Allowance Rules
Here are the changes to Medicare specimen collection fee and travel allowances included in the 2023 PFS and what you’ll need to know to comply.
Avoiding Improper Use of HCPCS Codes for COVID-19 Test Specimen Collection Fees
One of the biggest danger areas that labs and their billing staffs face in COVID-19 test reimbursement is improper use of HCPCS code G2023.
Top 10 OSHA 300 Form Bad Ideas to Avoid
How to steer clear of assumptions commonly made by employers that can lead to citations under SEC. 1904.32 of the OSHA recordkeeping standard.
