Health Law Advisor

Upon learning that FDA had lost another round in its battle to classify Diphoterine® Skin Wash (DSW) as a combination product with a drug primary mode of action and that Prevor, DSW's manufacturer, was still fighting this issue nearly six years after it submitted its initial premarket notification for DSW, I turned into a five-year-old and kept asking why?

• Why does FDA insists that a skin wash intended to "help prevent and minimize accidental chemical burn injuries" must be regulated as a drug but a drug-coated stent intended to improves arterial diameter is regulated as a device?
• Why ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar on September 30, 2014 on emerging trends in value-based purchasing in health care. The next session will feature a former key official from the U.S. Department of Health and Human Services (HHS), Gary Cohen, JD, who played a central role in the implementation of the Affordable Care Act over the past several years and is moderated by Lynn Shapiro Snyder, Senior Member, Epstein Becker Green.  The session, The Impact of the Affordable Care Act on ...

By Stuart Gerson

As we noted in our various blogs and communications on the subject (HEAL Advisory and HEAL Blog), the United States Court of Appeals for the District of Columbia Circuit's action today, to rehear in December the Halbig case (Halbig v. Burwell, D.C. Cir., No. 14-508 ), challenging  Obamacare subsidies in the federal health exchange, is not unexpected given the current makeup of the Court. This development now makes it more likely that the Supreme Court will not take action on the King cert petition (King v. Burwell, U.S. 4th Circuit , No. 14-1158) until after the DC ...

By Stuart Gerson

In this blog and subsequently in an article on the subject under the aegis  of the American Health Lawyers Association that can be found at http://www.lexology.com/library/detail.aspx?g=b68c51ae-2bdb-490e-ac3d-02c351a19310 EBG analyzed the DC Circuit's decision  in  In re Kellogg Brown & Root, 2014 U.S. App. LEXIS 12115 (D.C. Cir. 2014).  The DC Circuit's holding reinforces the protections established by the Supreme Court 30 years ago in Upjohn Co. v. United States, 449 U.S. 383 (1981), that afford privilege to confidential employee communications ...

By Stuart Gerson

In the wake of the Hobby Lobby ruling with respect to the Affordable Care Act's contraceptive coverage mandate, the Administration (which already has taken steps to fund contraception for employees affected by their employers' exemption) is attempting also to deal with the issue by a recently-published DHHS regulation setting forth the procedures that "religious" employers might follow to gain exemption from having to provide contraceptive coverage in their sponsored health plans. The proposed rule covers both religious not-for-profits and closely held ...

By Adam Solander, Ali Lakhani and Wenxi Li

The increasing prevalence of mobile technology in the healthcare sector continues to create compliance concerns for physician practices and other health care entities.  While the Office of Civil Rights (OCR) of the Department of Health and Human Services, has traditionally focused on technology breaches within larger health systems, smaller physician practices and health care entities must also ensure that their policies and practices related to mobile technology do not foster non-compliance and create institutional risk.

On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency’s Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 (“Breach Report”). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services to prepare an annual report regarding the number and nature of ...

By Patricia Wagner, Ali Lakhani and Jonathan Hoerner

On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency's Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 ("Breach Report"). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in August on emerging trends in value-based purchasing in health care. The session, Population Health Strategies for Employer-Based Coverage, will assess how employers and other health plan sponsors are developing new programs to promote enhanced clinical and financial outcomes for the groups and populations they manage. In particular, speakers will highlight how the Affordable Care Act (ACA) is influencing population health ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in August on emerging trends in value-based purchasing in health care. The session, Population Health Strategies for Employer-Based Coverage, will assess how employers and other health plan sponsors are developing new programs to promote enhanced clinical and financial outcomes for the groups and populations they manage. In particular, speakers will highlight how the Affordable Care Act (ACA) is influencing population health ...