OVERPAYMENTS

Avoid False Claims Liability: CMS Clarifies How to Comply with 60-Day Deadline for Returning Medicare Overpayments

The Affordable Care Act requires labs, pathology groups and other providers to return overpayments to Medicare within 60 days of identifying the overpayment. Failing to comply with that deadline can … [Read more...]

LDTs

FDA’s LDT Oversight Framework Could Impact 60,000+ Tests

The U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) could affect more than 60,000 genetic tests, according to analysis by Tenn.-based IT firm … [Read more...]

COMPLIANCE PLANS

Make Sure Existing Compliance Policies Match Current Operations

While labs may draft a comprehensive compliance plan and policies and procedures, those policies, procedures and plan can be a liability if they aren’t being followed. There can often be “a lot … [Read more...]

Overpayments

CMS Final Rule Clarifies 60-Day Deadline for Returning Overpayments

Labs and other providers are required by a provision enacted in the Affordable Care Act to return overpayments to Medicare within 60 days of identifying the overpayment. Violations of the rule subject … [Read more...]

Patient Safety

Labs Urged to Examine Internal Processes to Ensure Accuracy of Patient Identification

The innovator who develops the best solution to accurately identify patients throughout the health care continuum may earn a $1 million reward. That’s the idea behind the College of Healthcare … [Read more...]

COMPLIANCE

Cybersecurity and Social Media Lead Compliance Concerns for Health Care Compliance and IT Professionals

In 2014, the Federal Bureau of Investigation warned that the health care industry wasn't prepared for cyber risks. Last year, National Intelligence Report reported on a May 2015 Ponemon Institute … [Read more...]

Managing Staff

Make Sure Disciplinary Action Doesn’t Equal Retaliation

Whistleblowers are a driving force behind many of the recent settlements with laboratories and other providers under the False Claims Act (FCA). Whistleblowers are often former employees of the … [Read more...]

COMPLIANCE

Marketing of Laboratory Tests to Consumers: Is a Practitioner Order Enough to Avoid FDA Enforcement?

Danielle Sloane, Esq., Bass, Berry & Sims Courtney Ginn, Esq., Bass, Berry & Sims Laboratory developed tests (LDTs) are tests designed, manufactured, and used within a single laboratory. … [Read more...]

COMPLIANCE

FDA LDT Regulation Could Affect 60,000+ Tests

The U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) could affect 60,000 genetic tests, according to analysis by Tenn.-based IT firm NextGxDx. … [Read more...]

OVERPAYMENTS

CMS Offers Long-Awaited Clarification of Deadline for Returning Overpayments

Labs and other providers are required by a provision enacted in the Affordable Care Act to return overpayments to Medicare within 60 days of identifying the overpayment. Violations of the rule subject … [Read more...]


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