Health Law Advisor

Epstein Becker Green today announced that Lynn Shapiro Snyder and Tanya Cramer have written a newly released topical Portfolio for Bloomberg BNA on provider risk sharing arrangements entitled, "Accountable Care Organizations and Other Provider Risk Sharing Arrangements, 2nd edition." The Portfolio discusses the federal and state regulatory schemes for accountable care organizations (ACOs), integrated delivery systems, and other provider organizations that assume some or all of the financial risk for providing covered health care benefits to patients.  For ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled Moving to an Integrated Population Health Management Model. This session will highlight several approaches to help manage populations to promote better clinical outcomes, more cost savings and enhanced patient satisfaction.

The webinar, scheduled for October 30, 2014 at 12:00 p.m. ET, will be led by Sarika Aggarwal, MD, Senior Vice President and Chief Medical Officer of Fallon Community Health Plan, and Julie O'Brien, RN, BSN, MS ...

Earlier this year, FDA released draft guidance the pharmaceutical and medical device industries had been awaiting for five years.  But instead of revolutionizing the Agency's thinking on drug and device promotion, FDA's social media guidance essentially continued the familiar credo on advertisements—accurate and not misleading, fair balance, substantiation—and ignored some of the central features of social media.  Last week, FDA reopened the comment period for the character-space limited communications and correcting third-party misinformation guidances.  Now ...

On Thursday, October 30, 2014, our colleague Stuart M. Gerson of Epstein Becker Green’s Litigation and Health Care and Life Sciences practices in the firm's Washington, DC and New York offices will discuss the Hobby Lobby decision and its impact on the workplace.  The briefing will be held at the Cornell ILR School of Labor and Employment.  Other panelists include Marci A. Hamilton, Esq., Paul R. Verkuil, Esq., Arthur S. Leonard, Esq., and Paul W. Mollica, Esq. 

Click here to learn more and to register

When:
Thursday, October 30, 2014
8:30am – Registration & Breakfast

The Food and Drug Administration ("FDA") recently announced that it will be hosting a public workshop on October 21 and 22, 2014, in Arlington, Virginia, entitled "Collaborative Approaches for Medical Device and Healthcare Cybersecurity."

Officials from FDA, the Department of Health and Human Services ("HHS"), and the Department of Homeland Security ("DHS") will bring together medical device manufacturers, insurers, cybersecurity researchers, trade organizations, government officials, and other stakeholders to discuss the numerous challenges faced in medical device ...

By Stuart Gerson

The September 30, 2014 decision of a United States District Judge for Eastern District of Oklahoma in the case of State v. Burwell  adds an interesting wrinkle to the debate over whether the provision in the Affordable Care Act that authorizes federal subsidies (tax credits) applies to individuals who are covered by  a qualified health plan that is enrolled through an Exchange established by the Federal government, not a State.  An IRS Rule (26 C.F.R.§ 1.36B-1(k)) allows this, while the ACA itself bases eligibility on participation in a plan that was "enrolled in ...

by Michael Kun

We’re very pleased to announce that a brand-new version of our free, first-of-its-kind app, the Wage & Hour Guide for Employers, is now available for Apple, Android, and BlackBerry devices. The new app takes advantage of a software-as-a-service programming platform developed by Panvista Mobile.

Our newest version of the app is not only available to users of a variety of devices, but it offers simpler, faster, and more useful ways for employers to locate wage and hour information at the touch of a fingertip.  As new issues are constantly emerging in this area, we’re ...

Epstein Becker Green colleagues Robert S. Groban, Jr. and Matthew S. Groban provide an update to the health care industry in the Immigration Alert: September 2014, including an update on the Sixth Circuit Expanding the Liability of Health Care Employers for Sponsorship Costs.

Based on the Kutty decision, health care employers can expect more aggressive enforcement activity in connection with their employment of foreign nationals (“FNs”) generally and foreign medical professionals sponsored for H-1B classification and J-1 waivers of the two-year foreign ...

On July 15, 2014, the U.S. Food and Drug Administration ("FDA") released draft guidance that provides extensive commentary on FDA's current thinking regarding the clinical trial informed consent process. Once finalized, this document, entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors" ("Draft Guidance"), will replace FDA's 1998 informed consent guidance, "A Guide to Informed Consent."

Although the Draft Guidance is largely consistent with current practices a number of FDA's recommendations signal the modification ...

Earlier this month, Customed, Inc. initiated the largest medical device recall ever recorded in FDA history.  The recall was of sterile convenience surgical packs and was due to packaging flaws.  These flaws could result in loss of sterility and lead to infection.  There have also been a number of voluntary recalls on the drug side related to sterility.  FDA has also issued warning letters to pharmaceutical companies for poor aseptic practices, among other Good Manufacturing Practices (cGMP) related issues.  These headlines should remind the medical device and pharmaceutical ...