As 2019 came to an end, CMS announced that the rate of improper Medicare payments during the year continued to decline, hitting its lowest point since 2010. Here are some of the key numbers: … [Read more...]
PAMA: The New LAB Act Buys Labs One Year of Price Reporting Relief
January 13, 2020
The lab industry has been making slow but steady progress in its quest for PAMA relief. After winning a federal court appeal preserving its right to challenge CMS’s PAMA pricing systems, the industry … [Read more...]
Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility
January 2, 2020
In a reversal, CMS is now proposing to cover FDA-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to … [Read more...]
CLIA: CMS Revises State Operations Manual for Labs
January 2, 2020
In late September, the Centers for Medicare and Medicaid Services (CMS) released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, … [Read more...]
CMS
Hospital Labs: CMS Pushes Forward with Controversial Price Transparency Rules
January 2, 2020
Brushing aside the intense objections and negative feedback, CMS pressed forward with price transparency by including as part of the 2020 Outpatient Prospective Payment System final rules the … [Read more...]
NEWS
The Year in Labs Regulation: The 6 Biggest Stories of 2019
January 2, 2020
"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [Read more...]
REIMBURSEMENT
Medicare Reimbursement: CMS Eases Coverage Restrictions on NGS Testing of Early-Stage Cancer Patients
November 11, 2019
After years of resistance, CMS is now prepared to pay for germline (inherited) next-generation sequencing (NGS) testing of Medicare early-stage cancer patients under certain conditions. Here’s a look … [Read more...]
CMS
Newly Proposed CMS Hospital Transparency Rules & their Impact on Labs
September 30, 2019
It's an all too common occurrence. You or a loved one require an in-hospital procedure, but you have no idea of what the out-of-pocket costs will be. Afterwards, you get hit with an enormous bill that … [Read more...]
CMS
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
September 23, 2019
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]
CMS
Environmental Briefing: New EPA Laws Ban Flushing of Opioids & Other Hazardous Pharmaceuticals
September 9, 2019
On Aug. 21, a new federal rule took effect banning labs and other healthcare facilities from flushing hazardous waste pharmaceuticals into the sewer system. If you haven't already done so, you'll need … [Read more...]
