Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
How Data Automation Solutions Can Improve Collections & Patient Satisfaction
Here’s an approach to ensure your lab patients have the most positive financial experience possible.
Digital Systems Expected to Drive 5% Annual Growth in PCR Testing Products
The total market for PCR products will likely top $5 billion in 2023, according to a new report.
M&A Report: The Top 15 Diagnostic Deals of 2022
M&A activity in the clinical diagnostics space was significantly down in 2022 in terms of both deal volume and deal value.
PAMA Alert: Hopes for SALSA Relief Die at the Eleventh Hour
Congress fails to include SALSA in the omnibus federal government spending bill passed at the end of 2022, but delays PAMA price cuts once again.
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.