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
Articles
When & How to Use Changed Clinical Laboratory Consult Codes
Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.
Liquid Biopsy Can Rule Out Need for Chemotherapy After Stage II Colon Cancer Surgery
New study shows that ctDNA liquid biopsy testing after stage II colon cancer may determine whether chemotherapy is required.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Breast Tissue Density Reporting Should Cover All Women
A recent study suggests that the US should standardize breast density reporting and require that all women receive notification.
How to Save Clinical Labs from Future Pandemic Challenges
A recent AMP report offers recommendations to policymakers to prevent problems in future public health emergencies.
MD Malpractice Premiums Rising at Rapid Rate: AMA Report
Malpractice premium costs are climbing at rates not seen since the turn of the century, according to a new AMA report.
Medicaid Fraud Enforcement Trends: Fewer Cases, Higher Penalties
MFCU enforcement activity has rebounded from recent declines but still hasn’t reached pre-pandemic levels, according to a recent OIG report.
NIPS Tests Are under Fire Again—This Time from the FDA
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
The Sun Is Setting on the Controversial SUNSET Rule
While HHS hasn’t yet officially withdrawn SUNSET, recent indications are that it’s only a matter of time.
OCR Cracks Down on Right of Access Foot Dragging
Thanks to recent federal enforcement initiatives, prompt response to patient PHI requests should be a growing priority for HIPAA compliance.
Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry
This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.
