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...]

Update: New Study Credits Criminal Attacks as Source of Most Health Care Data Breaches

As we reported in our April issue, cybersecurity is gaining national attention thanks to notorious data hacks like Sony and Anthem, and now Premera. The President has drawn attention to the issue … [Read more...]


MEDICARE OVERPAYMENT PERIOD EXTENDED: A provision in the American Taxpayer Relief Act of 2012, the “fiscal cliff” legislation signed into law Jan. 2, extends the statute of limitations on Medicare … [Read more...]

G2 Compliance Persectives: Torrid Pace of False Claims Act Recoveries Likely to Continue in 2013

Editor’s note: This article is excerpted from Gibson and Dunn’s “2012 Year-End False Claims Act Update.” The full article is available at … [Read more...]

HHS OIG Releases Updated Guidelines On Evaluating State False Claims Laws

The Department of Health and Human Services Office of Inspector General (OIG) March 15 issued updated guidelines for evaluating state false claims act legislation to reflect amendments made to the … [Read more...]

Congress Would Limit Stark In-Office Ancillary Services Exception

Narrowing the included services covered under the in-office ancillary services (IOAS) exception in the Physician Self-Referral Act (Stark law) would save Medicare millions and better reflect the … [Read more...]

Lab Institute Addresses Key Regulatory, Reimbursement Topics for Clinical Laboratories

Attendees at G2 Intelligence’s 31st annual Lab Institute (Oct. 16-18, Arlington, Va.) gleaned insight on issues vital to their survival as they navigate the rough waters of government regulations and … [Read more...]

G2 Compliance Perspectives: New Year Presents Compliance Officers With Challenges and Opportunities

One of the most important aspects of providing evidence to support that a laboratory’s compliance program is effective is through a process of constant activity, including annual reviews and updates … [Read more...]