GAO Report

Federal COVID-19 Testing Data Collection Effort Has Been Ineffective

The federal government has done a poor job of collecting and reporting COVID-19 testing data to the CDC since the pandemic began. That’s the conclusion of a U.S. Government and Accountability Office … [Read more...]

Compliance Corner

Compliance Corner: The HIPAA Right of Access Crackdown Continues

On Sept. 9, 2019, the Office for Civil Rights (OCR), the HHS agency in charge of federal HIPAA enforcement, did something it had never done before by entering into a monetary settlement with a … [Read more...]

Compliance Corner: Must Employee Notify Lab of DUI?

QUESTION If one of our employees gets a DUI, do they have to notify us? ANSWER It depends. EXPLANATION There are at least four factors affecting whether the employee would have to come … [Read more...]

Compliance Corner: Must Employee Notify Lab of DUI?

QUESTION If one of our employees gets a DUI, do they have to notify us? ANSWER It depends. EXPLANATION There are at least four factors affecting whether the employee would have to come … [Read more...]

COMPLIANCE CORNER

HIPAA Compliance: The Pitfalls of PHI De-Identification & How to Avoid Them

In 2016, the Australian government released medical billing records of 2.9 million people. They tried to protect patient privacy by removing names and other identifying data. But it didn't work. … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

COMPLIANCE CORNER

Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats

HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the agency's expectations of the … [Read more...]

PAMA

Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019

The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to resolution notwithstanding the ACLA's recent court loss. But even as the legal battle … [Read more...]

LEGISLATION

New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more

By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]

COMPLIANCE CORNER

Stark Relief: Change Seems Imminent but Less Dramatic than Industry Wants

CMS is giving serious indications of its willingness to entertain Stark Law relief. Back in June, CMS issued a Request for Information (RFI) seeking public comments and suggestions on changes to … [Read more...]


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