On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to

For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.”  These updates were announced on January 9, 2019 and will become effective on January 1, 2020.

AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between

Please join Epstein Becker Green attorneys for a fall webinar series—via five 45-minute sessions—that will address how proactive compliance initiatives are critical to a platform’s operations, expansion efforts, and eventual monetization upon exit.

Immediate Post-Closing Operational Fixes
When:  October 2, 2018 at 12:00pm – 12:45pm
People:  John Eriksen, Josh Freemire, Gary Herschman, and Marc Mandelman

On June 20, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published an advance copy of a request for information seeking public input on reforms to the Physician Self-Referral Law (or “Stark Law”).

The request for information stems from on-going efforts by the Department of Health and Human Services (“HHS”) to accelerate the government’s

Our colleague  at Epstein Becker Green has a post on the Technology Employment Law blog that will be of interest to our readers: “The GDPR Soon Will Go Into Effect, and U.S. Companies Have to Prepare.”

Following is an excerpt:

The European Union’s (“EU’s”) General Data Protection Regulations (“GDPR”) go

The Centers for Medicare and Medicaid Services’ (“CMS”) recently announced its intent to expand what may be considered “supplemental benefits,” broadening the scope of items and services that could be offered to Medicare Advantage (“MA”) plan enrollees over and above the benefits covered under original Medicare. However, in articulating the standards for covering this broadened

On January 5, 2018, consistent with the 21st Century Cures Act’s focus on creating interoperability and correspondingly a Trusted Exchange, the Office of the National Coordinator for Health Information Technology (“ONC”) released its “Draft Trusted Exchange Framework” (“Draft Framework”).  The Draft Framework is intended to streamline the exchange of Electronic Health Information (“EHI”) so

One of the challenges to increasing Medicare coverage of telehealth services is amending the statutory language in the Social Security Act (42 U.S.C. § 1395m) to remove geographic and other limitations. The Congressional Budget and Impoundment Control Act of 1974 requires the Congressional Budget Office (“CBO”) to provide cost estimates of proposed legislation. These CBO

Steven R. Blackburn, Member of the Firm in the Employment, Labor & Workforce Management practice will co-present a Practising Law Institute in-person event and webcast on January 25, 2018 at 10:00 a.m. PST titled “Tech Sector Employment Law Hot Topics for the California Lawyer.

This event will address current California employment law