On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to lower the prices and out-of-pocket costs of prescription drugs by having manufacturers give discounts … [Read more...]
ANTI-KICKBACK
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
March 15, 2019
FDA
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
March 11, 2019
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together … [Read more...]
OIG OPINION
Is Your Billing Company Putting You At Compliance Risk?
March 11, 2019
By Sean McSweeney bio Does your orthopedic billing company charge a percentage of collections for their coding and billing? They might break out separate charges for statements or other … [Read more...]
HIPAA
Enforcement Trends: Record Breaking Year for HIPAA Fines
March 4, 2019
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in $28.7 million in fines, easily surpassing the old … [Read more...]
NEWS
Medical Marijuana: CBD Doesn’t Get You “High” But May Make You Fail a Drug Test
February 25, 2019
Testing for marijuana isn't as simple as it used to be thanks to the increased use of cannabidiol (CBD) products. Based on oils extracted from hemp plants, CBD contains little to no … [Read more...]
FOCUS ON
Medicare Reimbursement: New Guidance on Date of Service Rules for Part B Billing of Hospital Outpatient Lab Tests
February 19, 2019
In 2018, new date-of-service rules took effect for billing and coding of outpatient lab tests under Medicare Part B, rather than as part of the Hospital Outpatient Prospective Payment System (HOPPS) … [Read more...]
COURT CASES
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
February 19, 2019
Texas Pathology Lab Settles EHR Consulting Kickback Claims for $63.5 Million Case: In 2006, HHS implemented an AKS safe harbor and Stark exception letting non-physician providers pay up to 85% … [Read more...]
FOCUS ON
How the Opioid Crackdown Is Affecting Lab Enforcement & Test Utilization
February 18, 2019
103 in 1: Odds of dying in a motor vehicle crash 96 in 1: Odds of dying from an opioid overdose The alarming finding that a person is now more statistically likely to die of an opioid overdose … [Read more...]
CYBERSECURITY
HIPAA ePHI Violation Costs Colorado Hospital $111,400
February 15, 2019
Case: This case began when the Office of Civil Rights (OCR) received a complaint contending that an ex-employee of Pagosa Springs Medical Center (PSMC) still had remote access to the critical access … [Read more...]
NEWS
ASCP Agreement with G2 Broadens Member Access to Quality Pathology and Diagnostics Content
February 11, 2019
Collaboration Allows ASCP to Better Meet Member Needs ASCP has entered into an agreement with G2 Intelligence, a division of Plain Language Media LLP, a leading provider of multimedia specialty … [Read more...]
