When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in? On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2,…

Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants. The March 26, 2019,…

On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division’s 2017 guidance publication “Evaluation of Corporate Compliance Programs.”  In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.”  He noted that DOJ also sought “to provide additional transparency in how [it] will analyze…

On May 7, 2019, the Department of Justice (“DOJ”) released new guidance for trial attorneys in the DOJ’s civil division regarding how entities under False Claims Act investigation can receive credit for cooperation.  The release of this new guidance follows public comments delivered in March by Michael Granston, director of DOJ’s civil fraud section, noting that DOJ was considering issuing additional guidance on cooperation credit related to False Claims Act matters. The policy explains that…

On Friday April 26, 2019, the US Department of Health and Human Services (“HHS”) issued a notification regarding HHS’ use of Civil Monetary Penalties (“CMP”) under the Health Insurance Portability and Accountability Act (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties.  The notice provides: “As a matter of enforcement discretion, and pending further rulemaking, HHS will apply a different cumulative annual CMP limit for each of…

Florida has been at the forefront of some very interesting healthcare M&A activity in the past year, including an influx of private equity and consistent growth in Hospital and Health Plan vertical integration.  Unless subject to antitrust filing requirements, these high profile transactions are typically carried out under veils of confidentiality and announced upon completion.  However, Florida M&A is not insulated from recent Florida House health reform initiatives.  If the Florida House gets its way,…

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to provide “greater flexibility to Medicare Advantage plans, [so] beneficiaries can receive more benefits, at lower costs and better quality.”[2]…