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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
The DX Pipeline: A Roundup of the Month’s Key New Product Launches
Here's a summary of the key product launches announced from late August through the third week of September, 2019:
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
Kickbacks: Medical Practices and Doctors Settlements for Accepting Millennium Freebies
In 2016, Millennium Health settled one of the largest lab kickback schemes ever concocted for $256 million. In September 2017, federal enforcers turned their attention to the practices that accepted bribes from Millennium in the form of...
Tool: Model PHI Amendment Denial Letter
There are two things you must do to lawfully deny a patient’s request to amend his/her own PHI: i. Have a legal basis for the denial, i.e., at least one of four circumstances described in the main article must be present; and ii. You must put the denial in writing and ensure it meets the criteria for a denial notice in the HIPAA privacy regulations.