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Documents on health care
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|HHS Says New Healthcare Website Will Work|
McDonald Hopkins LLC;
October 19, 2014, previously published on October 10, 2014Federal health officials say they have reconfigured and rebuilt the enrollment website for the Affordable Care Act to avoid a repeat of last year's disastrous launch.
|Are You Prepared to Deal with Potential Exposure to Ebola in the Workplace?|
Bennet D. Alsher, Amy R. Turci; Ford & Harrison LLP;
October 17, 2014, previously published on October 14, 2014Executive Summary: With the diagnosis of the second Ebola case in the United States on October 12, 2014 - one in which a healthcare worker contracted the lethal disease while performing her job duties - U.S. employers are examining what necessary precautions should be taken to control and prevent...
|Telemedicine Advances Allow Remote Patient Care|
Sigrid C. Haines; Lerch Early Brewer Chartered;
October 17, 2014, previously published on September 25, 2014The field is changing for the use of remotely-provided medical services. While the possibility of remotely-provided medical services received attention in the press some years ago, it has been slow to become a reality. Various issues have contributed to its slow adoption, including the need for...
|No Data from Self-Insured Plans|
Mary L. Porter; Gordon Feinblatt LLC;
October 17, 2014, previously published on Fall 2014The U.S. Court of Appeals for the Second Circuit recently held in Liberty Mutual v. Donegan that the federal Employee Retirement Income Security Act (ERISA) prohibits states from requiring self-insured health plans and their third party administrators to provide participant eligibility and claims...
|Why Whistleblowing Laws Are So Significant to Health Care Entities|
Galit Kierkut; Sills Cummis & Gross P.C.;
October 17, 2014, previously published on September 30, 2014The New Jersey Supreme Court has recently rejected a whistleblower’s attempt to rely on, among other sources, the American Nursing Code of Ethics (the “Nursing Code”) to establish his claim under the Conscientious Employee Protection Act (“CEPA”). The Court’s...
|The Employer’s Reference Guide to Information About Ebola|
Maria Greco Danaher; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
October 17, 2014, previously published on October 13, 2014Concerns related to the Ebola outbreak are increasing among both employers and employees in the United States. The outbreak is currently most active in the West African nations of Guinea, Liberia, Nigeria, and Sierra Leone. However, there has been at least one confirmed death from the disease in...
|Commercially Confidential Information at Risk: The European Medicines Agency Issues Disclosure Policy|
Christian B. Fulda; Jones Day;
October 16, 2014, previously published on October 2014As if the fight for reasonable returns on investment into drug development, currently exemplified by the discussion on the pricing of innovative products, is not enough, the pharmaceutical industry is facing one of its biggest challenges in Europe: the protection of commercially confidential...
|FDA: Industry Must Address Cybersecurity Risks for Medical Devices.|
Theodore P. Augustinos, Sharon A. Blinkoff, Ellen Marie Giblin, Mark E. Schreiber, David S. Szabo; Edwards Wildman Palmer LLP;
October 16, 2014, previously published on October 2014On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The purpose of the guidance is to encourage manufacturers to consider possible cybersecurity risks while...
|OIG Seeks Comment on Recently Published Proposed Rule Expanding Anti-Kickback Safe Harbors|
Lynsey Morris Barron, Richard H. Deane, Gerald M. Griffith, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
October 16, 2014, previously published on October 2014The federal Anti-Kickback Statute ("AKS") criminalizes the solicitation or payment of remuneration in order to induce business that is reimbursable under the Medicare and/or Medicaid programs, such as kickbacks, bribes, and certain rebates. The U.S. Department of Health and Human Services...
|Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals|
Theresa C. Carnegie, Thomas S. Crane, Carrie A. Roll, Stephanie D. Willis; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 15, 2014, previously published on October 9, 2014Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments to the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe...