healthcare

Cyber-Secure Your Business!

It’s no secret that managers across North America and Europe have been marshalling forces for digital transformation in a high-stakes battle to ward off ambitious insurgents, maintain market share and address the changing demands of today’s customers. This is a once-in-a-generation challenge for any business leader, but it’s not the Read more…

By Nia, ago
healthcare

Structuring and Auditing Non-Physician Practitioner Arrangements Under the Anti-Kickback and Stark Laws

As health care organizations and physicians develop Non-Physician Practitioner arrangements, they must manage their compliance and enterprise risk by ensuring their arrangements are defensible under the Anti-Kickback and Stark Laws. Prior to moving forward with any NPP arrangements, the parties should carefully evaluate whether the proposed structure and financial terms Read more…

By Nia, ago
healthcare

FDA’s Two New Draft Guidance

Medical Device- FDA & 510(k) notifications Know When to Submit a 510(k) Notice for a Medical Device Change The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device Read more…

By Nia, ago
healthcare

OTC Drug Regulation by the FDA

The distribution of medicine in the U.S. is based on a two-class system: prescription and non-prescription medicines. A non-prescription, or over-the-counter (OTC) medicine, is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the label instructions and Read more…

By Nia, ago
healthcare

CMS 2018 Documentation Guidelines for DME

Compliance with CMS Documentation Guidelines for DME to Avoid Overpayments and Recoupments in Medicare. Durable medical equipment (DME) billing continues to be scrutinized by Medicare and other commercial carriers. The Centers for Medicare and Medicaid Services (CMS) have extensive and detailed documentation guidelines for DME in general, as well as Read more…

By Nia, ago
healthcare

Fair Market Value and Commercial Reasonableness in Physician Transactions: Complying With the Anti-Kickback and Stark Laws

Given the trend in the industry toward greater collaboration between hospitals and physicians, hospital executive teams are increasingly finding themselves in the position of needing greater involvement from physicians in the day-to-day operations of their hospitals and service lines. As a result, physicians are frequently being employed or engaged as Read more…

By Nia, ago
healthcare

The False Claims Act

What is a False Claim? Liability under the federal False Claims Act occurs where a defendant (1) knowingly presents (or causes to be presented) a false or fraudulent claim for payment; (2) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or Read more…

By Nia, ago
healthcare

EU Annex 15 Qualification and Validation

The current version of Annex 15 of the EU Guide to GMP was originally published in September 2001, and since then there have been significant changes in the GMP environment. The EMA is in the process of updating its guideline on Process Validation (a draft version is currently available), and Read more…

By Nia, ago
healthcare

How to Engage Your Board Members

Are your board members truly engaged in the work of your organization? If your organization is like most, the answer is “yes” and “no.” You’re doing well if engaged describes half of your board members. But what about the other half? Perhaps the biggest key to a non-profit’s success is the strength of Read more…

By Nia, ago