Health Law Advisor

Earlier this week, a popular source of regulatory news published an article claiming FDA “finalized a new rule this week that prohibits manufacturers from using so-called “split-predicates”. However, it appears that the article may instead be referencing the Final Guidance for Industry and Food and Drug Administration Staff entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that FDA published earlier this week.  Unfortunately, as often occurs on the Internet, the post was disseminated by several other popular ...

With the consolidation of the healthcare industry creating different levels of integration and affiliation among providers and their various service providers and contractors, the issue of joint-employer status has become a prominent issue of concern. As the NLRB moves towards a broader definition of joint employer status, the  NLRB’s General Counsel’s position in a series of cases involving McDonald’s and numerous franchisees across the country appears to foreshadow the NLRB’s new, more aggressive position on what factors establish the joint employer ...

By Constance Wilkinson, Alan Arville, and Jonathan Hoerner

On July 23, 2014, the Health Resources and Services Administration ("HRSA") issued an "interpretive rule" entitled "Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program" (the "Interpretive Rule").[1] The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program (the "Final Rule").[2]

By way of background, the 340B ...

By Adam C. Solander, Kara M. Maciel, Mark M. Trapp, and Stuart M. Gerson

Yesterday, the U.S. Court of Appeals for the District of Columbia and the U.S. Court of Appeals for the Fourth Circuit sent shockwaves through the country when they issued conflicting opinions on a key aspect of the ACA.  The cases are Halbig v. Burwell, D.C. Cir., No. 14-508 and King v. Burwell, 4^th Cir., No. 14-1158.  The question at issue in both cases was whether the IRS has the authority to administer subsidies in federally facilitated exchanges when the statute itself specifically authorizes subsides only in ...

By: Adam C. Solander, Kara M. Maciel, Mark M. Trapp, and Stuart M. Gerson

Yesterday, the U.S. Court of Appeals for the District of Columbia and the U.S. Court of Appeals for the Fourth Circuit sent shockwaves through the country when they issued conflicting opinions on a key aspect of the ACA.  The cases are Halbig v. Burwell, D.C. Cir., No. 14-508 and King v. Burwell, 4^th Cir., No. 14-1158.  The question at issue in both cases was whether the IRS has the authority to administer subsidies in federally facilitated exchanges when the statute itself specifically authorizes subsides only in ...

Our Epstein Becker Green colleagues have released a new Take 5 newsletter: “Five Labor and Employment Issues Faced by Health Care Employers,” by Michael F. McGahan, D. Martin Stanberry, and Daniel J. Green.  Below is an excerpt:

As the Affordable Care Act and the challenges of reimbursement and funding for health care services drive changes in the health care delivery system and employment in the industry, new issues in labor and employment law are arising.   This month’s Take 5 addresses five of these new and important issues…

1. NLRB’s Proposed Changes to Its Union Election ...

Our colleagues at Epstein Becker Green released a client alert: "Medicare's Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies," by Emily E. Bajcsi and Serra J. Schlanger.

Following is an excerpt:

On July 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Home Health Prospective Payment System ("HH PPS") for calendar year 2015 ("Proposed Rule"). The Proposed Rule would update the HH PPS payment ...

The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf).  The OIG's permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant's response to the ...

Our colleagues at Epstein Becker Green released a client alert: "DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations," by George B. Breen, Jonah D. Retzinger, Marshall E. Jackson Jr., and Stuart M. Gerson.

Following is an excerpt:

Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the attorney-client privilege attached to internal compliance ...

On Epstein Becker Green’s OSHA Law Update blog, Eric Conn reviews the agreement between the NLRB and OSHA, which allows employees to file out-of-date safety related whistleblower claims to be filed with the NLRB.

Following is an excerpt from the blog post:

On May 21, 2014, the National Labor Relations Board (NLRB) published a memorandum discussing a new agreement between NLRB and OSHA regarding a backdoor route for employees to file safety related whistleblower claims that are too stale to be filed with OSHA. The NLRB memo directs OSHA representatives to “notify all complainants ...