We invite you to join us on Wednesday, October 30, for Part 1 of our two-part Fast Break: Regulatory Sprint webinar. In a recent Health Law Scan post, we highlighted two rules proposed by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services calls the “Regulatory Sprint to Coordinated Care Initiative.” In Part 1 of this Fast Break, Donna Clark, Albert Shay, and Jacob Harper will discuss the CMS’s proposed rule on Stark Law changes. Stay tuned for Part 2 when we discuss the OIG’s proposed rule on Anti-Kickback Statute and Civil Money Penalty changes.
We hope you were able to join us for last month's Fast Break on the Physician Fee Schedule proposed rule. If not, you missed a great session featuring Eric Knickrehm discussing the important changes the proposed rule would have on Medicare Part B.
Eric provided an overview of the most important aspects of the proposed rule, which was published on August 4, 2019. A number of these changes highlight CMS's increasing emphasis on preventive and low acuity care. For instance, CMS has continued to incentivize Transitional Care Management services and Chronic Care Management services to ensure that patients who were either recently hospitalized or are very likely to be hospitalized have effective care management to avoid further hospitalization.
Please join us for our August 22 webinar, Fast Break: Physician Fee Schedule Update. The 2020 Medicare Physician Fee Schedule proposed rule includes a number of significant proposals that would incorporate several coding changes, implement new statutory requirements related to the treatment of substance abuse disorders, and further reduce administrative burden on practitioners. Eric Knickrehm will lead us through a discussion of these issues and more.
The Fast Break series, hosted by Jake-Harper, features 45-minute healthcare-focused webinars that explore important developments, trends, and hot topics in the healthcare industry in an easy-to-digest format.
We hosted a very informative Fast Break session last week on complex FCA issues. If you weren't able to join, the session was led by Katie McDermott and Matt Hogan, who are both authorities in False Claims Act (FCA) litigation. Understanding the complex dynamics for dealing with both the US Department of Justice (DOJ) and qui tam relators, Katie and Matt led us through the minute details of relator litigation, declined qui tams, and partial interventions, just to name a few things.
Among the overarching issues we discussed, coming on the heels of the US Supreme Court’s Cochise decision, is the Court’s seemingly renewed interest in the FCA and the possibility of statutory amendments to the FCA to balance out many of the, as Katie termed it, “procedural inequities” that now exist when a healthcare organization is an FCA defendant. Katie and Matt also discussed recent DOJ pronouncements about their FCA enforcement procedures and priorities, highlighting that the FCA remains the most significant overarching risk area for healthcare stakeholders.
We had a really fun and insightful edition of our Fast Break webinar series in June. If you didn’t get a chance to join in, the session featured Jonelle Saunders and Jake Harper discussing recent compliance guidance issued by the US Department of Justice (DOJ). Jonelle explained the reasons why the DOJ issued the guidance, how the guidance works, and some practical tips for healthcare providers in assessing their own compliance programs. The guidance can have a major impact on settlement dynamics for defendants in False Claims Act (FCA) cases and other matters, so it is important to understand the DOJ’s thinking on compliance.
We finally got to appear on camera for this Fast Break, which was an interesting experience (although a little more nerve-wracking than usual). It gave us the chance to better interact with our attendees, who asked some great questions on the topic.
Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series. Michele described how the FDA is treating various types of software and hardware that may have healthcare functions as well as certain clinical decision support systems. Michele discussed some of the new and innovative ways that the FDA is trying to regulate—perhaps with a lighter hand—various AI and software systems that have historically had challenges with FDA oversight.
We had a successful Fast Break on HealthTech Startups last month. The program, led by Morgan Lewis corporate partners Andy Ray (@AMRayEsq) and Jeff Bodle (@jeffbodle), explored a lot of the things that might affect the relationship between capital investors, including corporate venture capital and startup entrepreneurs. We discussed a bit about the background of how a startup begins and explored the process through which a successful startup begins to obtain capital, especially when integrating vertically with potential buyers of their products (not just their business). This Fast Break also touched on some of the common healthcare regulatory issues we have to contend with on both the startup and the corporate side during diligence. If you’d like to take a listen, here is a recording of the program.
We had a really enjoyable Fast Break yesterday on a non-traditional health law topic: radioactive material regulation. As it turns out, nearly all hospitals and larger provider groups, particularly those doing imaging, oncology, or neurosurgery, routinely use or come into contact with regulated radioactive material. PET scans, for instance, which are operated by a significant number of hospitals, rely on radioactive isotopes as the basis of the imaging procedure. Morgan Lewis partner Lewis Csedrik and associate Roland Backhaus explained that providers are regulated by the Nuclear Regulatory Commission (NRC) and/or similar state-based agencies (called Agreement States). Each provider has to secure a specific license for use of radioactive materials, which entails designating a radiation safety officer and establishing a radiation safety plan.
In case you’ve missed it, we’ve been running the Morgan Lewis Fast Break webinar series for more than two years now. The series examines a variety of different health law topics, from the old standards—Stark Law and Corporate Integrity Agreements, etc.—to topics on cutting-edge technology and legal developments such as Blockchain or our recent session on GDPR compliance. What we love about this series is that we get to highlight topics that may not be top of mind for many healthcare companies, helping listeners identify problems before they arise in their own practices or organizations. And as we explore these areas, we get to learn a lot as well.