Health Law Advisor

The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") has extended the deadline, to December 28, 2014, for comments to the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997.  See our previous blog post for information on the OIG's initial solicitation for comments.

Please reach out to George Breen, Jonah Retzinger, or Marshall E. Jackson, Jr., for assistance with the preparation and submission of comments.

Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.

In November 2013, Congress enacted the Drug Supply Chain Security Act ("DSCSA") with the intent of establishing a "Uniform National Policy" for wholesale distributor and third party logistics provider ("3PL") licensure.  Congress hoped to achieve this goal by adding Section ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled The Impact of Value-Based Purchasing and Other Employee Initiatives on Population Health.  This session will discuss several approaches for population health managers to reduce costs and improve health care.

The webinar, scheduled for November 20, 2014, at 12:00 p.m. ET, will be led by Laurel Pickering, MPH, President & CEO of Northeast Business Group on Health, and David Lansky, PhD, President & CEO of Pacific Business Group on ...

By Clifford E. Barnes and Marshall E. Jackson, Jr.

Recent enforcements in home health fraud have highlighted the need for home health companies of every state to engage the State Medicaid payment agency in pro-active affirmative discussion to work together to identify issues related to fraud and abuse.  Such discussions will provide home health companies further insight regarding compliance with federal and state fraud and abuse laws. That being said, recent enforcement actions have shown that home health companies may be liable under fraud and abuse laws, despite efforts to ...

There can be no question that telehealth has gone mainstream.  The numbers speak volumes. Telehealth companies have been able to raise almost $500 million since 2007 according to a noted venture capital analyst.  A recent study indicated that U.S. employers could save up to $6 billion a year through telehealth.  Per the American Telemedicine Association, more than half of all U.S. hospitals now offer some form of telehealth service.  Some leading analysts estimate that global revenue for telehealth will reach $4.5 billion by 2018, and the number of patients using telehealth services ...

As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).  FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant.  In all three cases, FDA received communications from stakeholders requesting additional time to digest the ...

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 ...

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 ...