Health Care

On September 19, 2017, the Tennessee Department of Health ("TDOH") granted the request for a Certificate of Public Advantage (“COPA”) from Wellmont Health System and Mountain States Health Alliance. This approval paves the way for the two entities to form a single corporate entity called Ballad Health.

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) reminded health care providers of the importance of ensuring the availability and security of health information during and after natural disasters.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 18, 2017. This week’s preview focuses on the prognosis for the Graham-Cassidy bill to block grant ACA funding to states, including potential roadblocks imposed by Senators John McCain (AZ), Susan Collins (ME) and Lisa Murkowski (AK).

On Monday, September 11, our colleagues in the Antitrust Section published an alert describing a developing antitrust lawsuit against Franciscan Health System (“CHI Fanciscan”): State of Washington v. Franciscan Health System, et al. No. 3:17-cv-05690 (W.D. Wash. Aug. 31, 2017).

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 11, 2017. This week’s preview focuses on Congress' efforts to stabilize the ACA marketplaces, as well as the proposal from Senators Lindsey Graham (SC) and Bill Cassidy (LA) to use block grants to fund Medicaid expansion and private insurance subsidies.

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.”

Our colleagues at ML Strategies have provided their Fall Health Care Preview for Fall 2017.

Over the past month, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program and Medicare Therapy Caps. In this post we will go into detail on the structure, funding, and outlook of the “primary care cliff,” and specifically the three programs relating to community health centers.

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with "red tape." The letters are in response to the first stage of a House initiative dubbed the "Medicare Red Tape Relief Project," which was announced earlier this summer by the House Committee on Ways and Means' Subcommittee on Health.

Our colleagues on the Employment Matters blog have been following Massachusetts' efforts to make up a funding shortfall in the Commonwealth’s Medicaid program and its Children’s Health Insurance Program (CHIP).

A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for billing agents.

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug Rebates for EpiPen.

The U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model.

On the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place ("MCEP") against Premier Health Partners ("Premier") have been dismissed with prejudice. This case represents an important development in the body of case law addressing the antitrust risk introduced by joint ventures. 

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo.

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.

Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017.

A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit.