Health Law Advisor

Healthcare Fraud and Abuse is an ever growing problem.  The Federal government has taken several steps in its enforcement efforts to cut down on health care fraud.  It is estimated that health care fraud costs the United States about $80 billion per year.  And it continues to rise in an alarming manner, as total U.S. health care spending continues to rise, currently topping $2.7 trillion.

In the last year, spending on home health care has increased over 5 percent from previous years.  Since 2000, the senior population has increased by 15.1% versus 9.7% for the population as a whole.  According ...

About a month ago, I had the opportunity to participate at the Inaugural Advances in Clinical Technology conference in London.  The conference covered a broad array of topics relating to how technology can and is changing how clinical trials are conducted.  Here are the top three things that I took away from the conference.

1. The upsides of the e-patient far outweigh the downsides 

Earlier this year, the Wall Street Journal published an article highlighting one of the biggest downsides of the e-patient, their use of electronic communication tools to learn more about their condition ...

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Earlier this year, FDA released draft guidance the pharmaceutical and medical device industries had been awaiting for five years.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 ...

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 ...