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Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold
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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.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
Quest Pays $88.7K to Settle Specimen Collection Fee Kickback Charges Against Its Subsidiary
Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million
New Jersey Lab Hit with $144.6K Settlement Tab for Improper Billing of Nerve Conduction Studies
You Make the Call: Does Lab Manager Have a Valid Claim for Age Discrimination?
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Brief Your CEO: It May Become Easier to Get CMS Stark Clearance for Business Deals with Referral Sources
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Compliance Perspectives: Avoid HIPAA Violations When Denying Patient Requests to Amend PHI
On Sept. 9, 2019, the HHS Office for Civil Rights (OCR), the agency that enforces HIPAA rules, announced that it had done something it has never done before: settle an enforcement action for not complying with HIPAA provisions ensuring individuals access to their...