On Oct. 2, CMS proposed revisions to rules for appealing adverse Medicare claim determinations (Proposed Rules). The goal is to speed the process that currently takes three to four years and loosen … [Read more...]
FOCUS ON
Medicare Reimbursement: 2019 CLFS Offers Some PAMA Relief But Not Nearly Enough
November 16, 2018
The battle between CMS and the lab industry over Medicare Part B pricing for lab tests is intensifying notwithstanding the ACLA's recent court loss and the supposed relief offered by the agency in its … [Read more...]
COMPLIANCE GUIDANCE
Kickbacks: OIG Okays Incentivizing MDs to Order More Early Screening Tests
November 16, 2018
Proactive rather than reactive has become a mantra of the modern health care model. Early and periodic testing of patients is a critical element in this strategy. The problem is that not a lot of … [Read more...]
ENFORCEMENT
Feds Continue Roundup of Physicians on Receiving End of Millennium Labs Test Cups Freebie
November 16, 2018
The Millennium Laboratories free point of care test (POCT) cups scandal has been described as the biggest kickback scandal involving lab services in history. And its legacy has now entered a new … [Read more...]
INNOVATION
Using Digital Technology and AI to Fight Cancer
November 16, 2018
It has the makings of a Hollywood movie. Three recent college grads start a medical testing software company that uses a digital pathology platform, meet with success, and then go on to utilize … [Read more...]
INNOVATION
LDTs: FDA Approves First NGS Residual Cancer Detection Test
November 16, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
REIMBURSEMENT
MACRA: QPP Year 1 By the Numbers
November 16, 2018
On Nov. 8, CMS posted Merit-based Incentive Payment System (MIPS) performance results for 2017, the first year of the Quality Payment Program (QPP) which it will use to determine 2019 Medicare … [Read more...]
COURT CASES
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
November 16, 2018
Abbott Pays $25 Million to Settle TriCor Kickback & Off-Label Marketing Claims Case: The case began when a sales rep accused Abbott Laboratories and AbbVie Inc. of paying kickbacks to induce or … [Read more...]
FALSE CLAIMS
Florida Doctor Jailed 5 Months for Lying to a Medicare Auditor
November 12, 2018
Lying to a Medicare auditor or otherwise obstructing a Medicare audit is a crime that can get you jailed. A 73-year-old endocrinologist specializing in diabetes management just learned that lesson the … [Read more...]
PATIENT SAFETY
Diagnostics & Demographics: Is Your Lab Prepared to Accommodate an Aging Population?
November 5, 2018
Talk of an aging population isn't idle chatter. According to the U.S. Census Bureau, 2030 will mark a significant turning point in the nation's history. By then, all baby boomers will be older than … [Read more...]
