It has been many years—almost 60 in fact—since I took my last French class, so it is safe to say I do not remember much. One phrase, however, has stayed with me through the years: “Plus ça change, plus c’est la même chose.” The more things change, the more they stay the same.
It has been more than 4 years since the team at CRST invited me to serve as the guest editor for an issue dedicated to regulatory matters. In preparing for this project, I revisited the topics we covered then. As you will see in this issue, some of those topics have resurfaced—more complex today than they were just a few years ago. Others are entirely new, presenting fresh challenges for ophthalmology practices striving to maintain compliance.
In reflecting on my previous guest editorial, I recalled how one of my first clients in the 1980s became so frustrated with the regulatory hurdles he faced that he decided to retire early. At the time of that writing, as I looked back 40 years, I noted that he likely did not appreciate how much simpler things were compared to what was the current regulatory landscape. I find myself saying the same thing again as I write this: “Plus ça change, plus c’est la même chose.”
This edition of CRST includes an update on comanagement, a growing compliance concern following recent settlements under the False Claims Act. These cases alleged that certain comanagement practices violated the Anti-Kickback Statute. An overview of enforcement trends is also provided that highlights key areas of regulatory risk for physicians today. HIPAA privacy and security issues, which were addressed 4 years ago, remain pressing concerns, and this issue offers updates on developments in this area. For as long as I have worked with ophthalmology clients, the complexities of Medicare coverage and payment rules have been a source of struggle. This edition of CRST addresses those concerns, particularly in the context of new technologies. Finally, the challenges posed by differing regulatory standards for technology approval between the US FDA and its EU counterparts are explored.
In closing, I echo a sentiment I shared 4 years ago: “If the information in this issue even slightly alleviates the burden on your practice, we have succeeded.” I will risk quoting another well-known adage: Forewarned is forearmed. This month’s cover series aims to arm practices with the knowledge needed to navigate the ever-evolving world of regulatory compliance. Unfortunately, there will always be those who push the envelope—and sometimes cross the line. For attorneys, such individuals can be described with yet another saying: They are the gift that keeps on giving.
