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
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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
OIG Roundup
In this OIG roundup, we cover the agency’s plans to modernize and improve the useability of its Compliance Program Guidance, which was first published in 1998.
Proposed FTC Ban on Noncompete Agreements Could Be Highly Disruptive to Lab Staffing
A proposed move to make noncompete agreements illegal could impact retention of some laboratory employees.
Weekly Enforcement Report: Drug Testing Fraud Dominates
Last week’s three key cases included two involving drug testing that was either medically unnecessary, or not provided at all.
Brief Your Billing & Coding Staff on New Medicare HCPCS & CLIA Code Changes
To avoid claims denials and improper billings, ensure billing and coding staff is aware of, and has adjusted to, all recent coding changes.
Compliance Alert: 8 New Medicare COVID-19 Test Payment Rules Take Effect on May 12
CMS recently issued long-awaited guidance on post-PHE changes to Medicare coverage of SARS-CoV-2 diagnostic tests.
Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.
Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements
An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.
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