On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [Read more...]
Technology
CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices
September 17, 2020
PANDEMIC
Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules
September 17, 2020
Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]
Stark Law
CMS Proposes to Peel Back Restrictions on Physician Owned Hospital Expansions
September 4, 2020
From the onset, the Administration has assigned a high priority to loosening Stark Law and Anti-Kickback Statute (AKS) restrictions. And now CMS has floated two new proposals allowing for greater … [Read more...]
Fee Schedules
2021 Medicare Physician Fee Schedule Slashes Lab Reimbursements 5% but Provides Some PAMA Relief
September 4, 2020
On Aug. 3, CMS released the proposed Medicare Physician Fee Schedule (PFS) rule for 2021. Bottom line on top: The agency is slashing lab reimbursement rates. Here are the four key takeaways for labs. … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
July 2, 2020
Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]
