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

On December 14, the Federal Communications Commission (FCC) voted to remove regulations that prohibit providers from blocking websites or charging for high quality service to access specific content. Many worry that allowing telecommunications companies to favor certain businesses will cause problems within the health care industry. Specifically, concerns have risen about the effect of the

New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.

The first rule exempts “autosomal recessive carrier screening gene mutation detection systems” that are offered DTC from FDA premarket review.  FDA first proposed this exemption in

On November 1, 2017, the Centers for Medicare & Medicaid Service (“CMS”) released the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) final rule (“Final Rule”), finalizing a Medicare payment reduction from Average Sales Price (“ASP”) + 6% to ASP – 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the

On April 14, 2017, CMS issued the FY 2018 Medicare Hospital IPPS Proposed Rule that includes numerous proposed changes.   However, there is a very small provision in this proposed rule that organizations may not be aware of …. especially those that are not hospitals and who normally would not look at the Hospital IPPS rule.