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|Supreme Court Examines Boundaries of Antitrust Immunity in North Carolina State Board of Dental Examiners v. FTC|
Dionne C. Lomax; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 20, 2014, previously published on October 15, 2014On October 14, 2014, the United States Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a U.S. Court of Appeals Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners (the “Board”) did not...
|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.
|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...
|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...
|Hospice Industry Will Face Stricter Scrutiny Under New Law Aimed at Post-Acute Care Data Standardization|
Lisa A. Estrada, Asha M. Natarajan; Foley & Lardner LLP;
October 15, 2014, previously published on October 8, 2014President Obama signed the “Improving Medicare Post-Acute Care Transformation Act of 2014” or the IMPACT Act of 2014 (the Act) on October 6, 2014. The new law is broadly focused on requiring all post-acute care providers to adopt standardized data protocols for patient assessment,...
|Does the Medicare Telehealth Parity Act of 2014 Stand a Chance?|
Nathaniel M. Lacktman; Foley & Lardner LLP;
October 15, 2014, previously published on October 9, 2014“Telehealth saves money and helps save lives. By expanding telehealth services, we can make sure the best care and the best treatments are available to all Americans, no matter where they live.”