NEW LAW

New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs

In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws … [Read more...]

HIPPA

HIPAA Compliance with Document Management

By Andreas Rivera bio Record-keeping can be one of the most stressful aspects of running a healthcare business since privacy compliance is scrutinized in healthcare more than any other industry. … [Read more...]

COMPLIANCE GUIDANCE

Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions

In late July, CMS proposed to update the advisory opinion process that labs and other providers use to get a determination about whether a proposed business arrangement would violate the Stark Law. … [Read more...]

Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready

After months of promises, posturing and public consultation, the Department of Health and Human Services is getting ready to unveil a proposed rule to liberate labs and other providers from the … [Read more...]

COMPLIANCE

New OIG Report Confirms that Labs Are Still on the Enforcement Radar

After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the basic punchline from the newly published OIG Semiannual Report to Congress … [Read more...]

ENFORCEMENT

From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood

Clinical labs are not usually the stuff of Hollywood. But the story of Theranos and its charismatic leader has attracted filmmakers the way regular law-abiding labs never do, spawning not one but a … [Read more...]

OSHA

Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules

January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are exempt from these requirements. Here's an overview of the OSHA … [Read more...]

COMPLIANCE

Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back

Although the False Claims Act (FCA) remains a federal enforcement cash cow, the growth rate has fallen off in recent years, at least in the healthcare sector. But that short-term trend could be in … [Read more...]

ENFORCEMENT

Provider Fined for Not Taking Compliance Measures Required by Its CIA

Case:┬áNearly 10 years ago, a new Affordable Care Act rule requiring labs and other providers to investigate their credit balances for potential Medicare overpayments took effect. In 2015, Pediatric … [Read more...]

ENFORCEMENT

New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution

Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]


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