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Building a Health App? Part 2: Protecting Your Intellectual Property
September 25, 2017 | Blog | By Christina Sperry
The second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful launch.
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New Jersey Supreme Court Reminder - Don’t Forget about the Corporate Practice of Medicine
September 21, 2017 | Blog | By Ryan Cuthbertson
A New Jersey Supreme Court case earlier this summer has New Jersey lawyers re-examining their clients’ business structures under the State's corporate practice of medicine doctrine.
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Tennessee Department of Health Grants COPA Request for Health Care Alliance
September 20, 2017 | Blog | By Dionne Lomax
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.
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In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules
September 19, 2017 | Blog
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.
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Health Care Weekly Preview from ML Strategies – Week of September 18, 2017
September 19, 2017 | Blog
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).
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Building a Health App? What You Need to Know
September 18, 2017 | Blog | By Ellen Janos
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out.
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Washington State AG Files Suit to Break Up Health System That Expanded Through Incremental Acquisitions
September 14, 2017 | Blog | By Benjamin Zegarelli
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).
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Health Care Weekly Preview from ML Strategies – Week of September 11, 2017
September 12, 2017 | Blog
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.
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FDA Takes First Steps to Cut Regulations, Solicits Public Feedback
September 11, 2017| Blog|
Fall Health Care Preview
August 31, 2017 | Blog
Our colleagues at ML Strategies have provided their Fall Health Care Preview for Fall 2017.
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Community Health Center Fund: A Minibus Rider
August 30, 2017 | Blog
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.
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Hospitals and Others Respond to "Red Tape Relief Project" Requests
August 30, 2017 | Blog
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.
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Massachusetts Moves Forward with Efforts to Shore up MassHealth
August 24, 2017 | Blog | By Lauren Moldawer
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).
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Implied False Certification Theory Fails in FCA Case Against Billing Agent
August 23, 2017 | Blog | By Laurence Freedman
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.
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The Four Things That Surprised Us in the EpiPen False Claims Settlement
August 23, 2017 | Blog
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.
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CMS Proposes to Cancel Bundled Payment and Incentive Models
August 21, 2017 | Blog
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.
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District Court Finds Hospital's Joint Venture Not "Per Se" Unlawful
August 16, 2017 | Blog | By Dionne Lomax
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.
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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4
August 14, 2017 | Blog | By Benjamin Zegarelli
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.
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CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients
August 10, 2017 | Blog | By Ryan Cuthbertson, Karen Lovitch
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.
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