After decades of complaining about the Stark Law, the lab industry may now have an actual opportunity to secure meaningful relief. On June 20, CMS issued a Request for Information (RFI) seeking input … [Read more...]
LITIGATION
Are Genetic Testing Labs Liable for Medical Malpractice?
July 13, 2018
Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth: malpractice liability. In the past … [Read more...]
FOCUS ON
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
July 13, 2018
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]
ENFORCEMENT
CMS Takes 3 New Measures to Bolster Medicaid Program Integrity
July 13, 2018
With Medicaid spending on the rapid ascent, CMS unveiled a trio of new initiatives to bolster program integrity and make states more accountable for compliance with federal rules. 1. MLR Audits CMS … [Read more...]
DATA
Case of the Month: Patients Can’t Sue Labs for Privacy Breaches, Federal Court Confirms
July 13, 2018
The HIPAA law sets out civil and criminal penalties that can be imposed on labs (and other providers) that commit privacy violations. But one thing the HIPAA law does not specify is whether an … [Read more...]
BILLING & CODING
Medicare Reimbursement: CMS Begins Implementing New HOPPS Date of Service Rules for ADLTs & Molecular Pathology Tests
July 13, 2018
CMS has begun implementing the new rules that exempt advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests from Medicare 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
July 13, 2018
Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by … [Read more...]
COMPLIANCE
Enforcement Trends: New Fraud Takedown Focuses on Opioid Drugs & Sophisticated Financial Schemes
July 13, 2018
The 2016 health care fraud takedown was the biggest in history; the 2017 version surpassed it; and the June 2018 reprise nearly doubled the 2017 effort, at least in terms of the false claims dollars … [Read more...]
DOJ
Criminal Charges May Spell the End for Theranos
July 13, 2018
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of $70 billion in annual sales. Today, the company … [Read more...]
DATA SECURITY
Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt
July 11, 2018
Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by the HHS Office for Civil Rights for a trio of incidents between 2012 … [Read more...]
