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.
A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law. The result of an ambitious effort by lawmakers to overhaul how Florida regulates healthcare, the bills represent a striking departure from the current regulatory environment. Passed during the last week of the legislative session with a July 1, 2019, general effective date, providers will want to begin reviewing their policies in anticipation of the coming change.
In its updated guidance issued on Tuesday, the US Department of Justice Criminal Division places effectiveness at the epicenter of its factors to be utilized when evaluating a company’s compliance program in the context of a criminal investigation.
The US Department of Justice (DOJ) published updated guidance on April 30 on factors prosecutors should consider when analyzing the effectiveness of a corporate compliance program to prevent or detect fraud and other misconduct. The “Evaluation of Corporate Compliance Programs” updates guidance previously released on February 8, 2017, and provides companies with increased clarity on the government’s evaluation of corporate compliance programs.
This is the first formal guidance issued by the DOJ’s Fraud Section since the confirmation of the new US Attorney General.
Now in its ninth year, our annual Technology May-rathon focuses on all things tech – including issues, trends, and developments of interest to Health Law Scanreaders. So be sure to check out and register for some of the webinars and in-person programs below:
May 7 - Digital Health Privacy: Avoiding the Landmines featuring Reece Hirsch
May 14 - Development of Blockchain in Healthcare featuring Jonelle Saunders
May 16 - Fast Break: Digital Health Regulatory Update featuring Michele Buenafe and Jake Harper
May 20 - Making It Personal: Regulatory Challenges and Opportunities featuring Kathleen Sanzo, Michele Buenafe, and Jacqueline Berman
May 22 - Advancements in Telehealth Law featuring Jake Harper and Anthony Ferrara
May 22 - Opportunities in Food and Agricultural Tech featuring Robert Hibbert
May 23 - Latest Developments in IP, FDA, and AI featuring Michele Buenafe and Christopher Halliday
And don’t forget our Technology May-rathon page for our full list of events on AI, Global Commerce, Fintech, and much more.
The US Department of State has released its May 2019 Visa Bulletin with important information for US healthcare entities employing non-US nationals. The bulletin sets out per-country priority date cutoffs that regulate immigrant visa availability and the flow of status adjustments and consular immigrant visa application filings and approvals. In a recent LawFlash, Morgan Lewis partner James Vázquez-Azpiri discusses what’s in the bulletin, including dates and actions for filing applications for adjustments of status or immigrant visas, and when adjustment of status applications or immigrant visa applications may be approved and permanent residence granted.
The Office of Management and Budget’s (OMB’s) policy statement emphasizes the role of the Congressional Review Act in the rulemaking process and incorporates rulemaking actions that were not consistently subject to prepublication review under standing executive orders. Questions remain regarding the prospects for regulatory gridlock and burdensome delays.
A recent OMB memorandum instructs departments and agencies of the executive branch to submit “guidance documents, general statements of policy, and interpretive rules” to the OMB’s Office of Information and Regulatory Affairs (OIRA) for prepublication review. The April 11 memorandum, which also expands OIRA review to agency rules historically submitted through the centralized process designated in Executive Order 12866, is effective May 11, 2019. Regulatory watchers caution that the OMB’s action could increase the volume of rules that require OIRA review and potentially result in regulatory gridlock and rulemaking delays.
While Maryland became the first state in the nation to pass legislation creating a Prescription Drug Affordability Board, it may not be the last. Several other states are exploring similar legislation but legal challenges may follow.
In this video our resident healthcare privacy and cybersecurity authority, Reece Hirsch, discusses data breaches caused by cyberattacks and other incidents that are an increasingly common worry for in-house counsel. Morgan Lewis has recently partnered with Lawdition, a new service that makes presentations available online, exclusively and for free to in-house lawyers. Watch a full version of the video that includes five things you can start doing today to help prevent data breaches and better prepare your company to respond if they do occur.
We had a great time last Thursday celebrating the American Health Lawyers Association's AHLA Day 2019. Each April, AHLA hosts receptions in multiple cities to bring together the health lawyer community. This year, Morgan Lewis came out in force at the Washington, DC, reception held at McCormick and Schmick's. Michele Buenafe, Joyce Cowan, Ryan Kantor, Amanda Robinson, Jonelle Saunders, and Jake Harper had the opportunity to catch up with colleagues and friends new and old.
We're excited to introduce Tele-Tuesdays, a new feature on Health Law Scan where we'll bring you the latest updates in the world of telehealth legal issues. From new regulations and legislation to enforcement actions and changes in the telehealth landscape, we'll cover it all.
Federally, telehealth continues to be a central feature of the government’s efforts to expand access and control soaring healthcare costs. Just last week, CMS finalized its rules implementing the Bipartisan Budget Act of 2018, which will increase flexibility for Medicare Advantage (MA) plans offering telehealth services irrespective of whether a patient is in a rural or urban area. Right now, MA plans are working feverishly to redesign their telehealth benefits in anticipation of plan year 2020. Providers interested in offering telehealth services should assess their current MA contracts and consider engaging with plans to make sure their telehealth services are covered. According to Kaiser Family Foundation, MA plans now cover 34% of Medicare beneficiaries, so this will be a momentous occasion in the expansion of telehealth coverage. And should the results of this expansion be as favorable as anticipated, expect future legislation that will expand telehealth to all Medicare beneficiaries, whether enrolled in MA plans or in Original Medicare.