ANTI-KICKBACK

New Anti-Kickback Safe Harbor Allows Free Transportation Services

There are many benefits laboratories can't provide to beneficiaries or referral sources without running afoul of the Anti-Kickback Statute. New changes to safe harbor regulations, however, allow labs … [Read more...]

LEGISLATION

What Happens Next: Is a Trump Presidency Really the End for ACA?

Obamacare and the Affordable Care Act (ACA) are challenges you have been wrestling with for years. Now that Donald Trump has been elected president, was it all for naught? The short answer: No. While … [Read more...]

NEWS

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Ex-Hospital Exec Pays $1 Million for Role in Kickback Scheme. Case: Last fall, Tuomey Healthcare shelled out $72.4 million to settle claims of paying part-time specialists for referrals of hospital … [Read more...]

LEGISLATION

Senate Hearing Addresses Potential Stark Law Changes

Earlier this summer, the Senate Finance Committee heard testimony from stakeholders arguing for changes to the Stark Law that could make compliance easier and facilitate new business models that … [Read more...]

FDA

Liquid Biopsies Get FDA Attention

In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called "liquid … [Read more...]

STARK LAW

Senate Committee Hearing Contemplates Changes for Stark Law to Make Compliance Easier

By Kelly Hardy Briganti, Editorial Director, G2 Intelligence In mid-July, the Senate Finance Committee heard testimony from stakeholders arguing for changes to the Stark Law that could make … [Read more...]

Top 10 Compliance Issues and Tips for 2016

January is a time for reflection and resolutions. For compliance officers that means evaluating compliance risks. G2 Compliance Advisor surveyed experts in laboratory compliance for the top issues … [Read more...]

AMP Offers Proposal for Regulation of Laboratory Developed Tests

Last month in Compliance Perspectives, we highlighted the current status of the Food and Drug Administration's proposed regulation of laboratory-developed tests (LDTs). While the FDA's proposed … [Read more...]

Outcome of LDT Regulation Controversy Defies Forecasting

Few, if any, device regulatory issues are as controversial or as important as FDA's proposal to regulate Laboratory-Developed Tests (LDTs). If FDA LDT regulation does occur, it would represent the … [Read more...]

News at a Glance – Jul 2015

Medicare Celebrates 50th Birthday. This month, Medicare and Medicaid reached a milestone birthday. On July 30, 1965, President Lyndon B. Johnson signed legislation establishing those federal health … [Read more...]


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