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
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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.
Roche Alzheimer’s Early Detection Tests Get FDA Green Light
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
Huge Decline in Medicare Laboratory Testing Due to COVID-19
According to a recent OIG report, fewer Medicare Part B beneficiaries received lab tests during the first 10 months of the pandemic.
The Promise of State-of-the-Art Sequencing Technologies for Cancer Screening
Circulating tumor DNA sequencing technologies are tackling the challenges of early cancer detection.
