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|Handling Ebola-Contaminated Waste: Guidance for Hospitals and Haulers|
Joseph J. McGovern; Obermayer Rebmann Maxwell & Hippel LLP;
November 20, 2014, previously published on October 9, 2014Ebola is a messy disease. Patient care, even in hospital isolation, produces large quantities of contaminated waste ... linens, towels, gowns, masks, gloves and sharps ... that many hospitals are not equipped to dispose on site. In non-hospital settings, symptomatic patients contaminate virtually...
|HIPAA in the Time of Ebola|
Conor McNally, Jenna K. Shedd, Lawrence J. Tabas; Obermayer Rebmann Maxwell & Hippel LLP;
November 20, 2014, previously published on November 12, 2014Ebola has recently been the source of much concern, and health care providers and hospitals are taking steps to prepare themselves for the possibility of treating patients with Ebola. In addition to all of the medical preparations underway, covered entities and business associates must also...
|AdvaMed Guidance on Sample Products, Loaned Products and Consignment Products: Avoiding Pitfalls in Medical Product Sales and Marketing|
Neal R. Roach; Taft Stettinius & Hollister LLP;
November 18, 2014, previously published on November 17, 2014The Advanced Medical Technology Association (“AdvaMed”) is a trade association that represents companies that develop, produce, manufacture and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health...
|Non-Compete and Step-in Clauses: High Court Carewatch Case Confirms their Validity|
Robyn Chatwood, Alex Haffner, Babette Märzheuser-Wood, Sam Szlezinger; Dentons Canada LLP;
November 18, 2014, previously published on November 10, 2014The case considered the validity of the non-compete and step-in clauses in a franchise agreement which a franchisor had sought to enforce against its former franchisee.
|Final Regulations Regarding Limited Scope Vision and Dental Benefits and Employee Assistance Programs as Excepted Benefits|
Dan Brown, Kenneth B. Schnoll; Dentons Canada LLP;
November 17, 2014, previously published on October 1, 2014On October 1, 2014, the US Department of Treasury issued final regulations (the "Regulations") regarding limited-scope vision and dental benefits and employee assistance programs as excepted benefits for purposes of the Affordable Care Act.
|CMS Extends Period of Exemption for Hospices Affected by Nursing Shortage|
Ari J. Markenson; Duane Morris LLP;
November 17, 2014, previously published on October 9, 2014On October 3, 2014, CMS issued S&C: 12-43-Hospice entitled “Impact of Nursing Shortage on Hospice Care”.
|FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA|
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
November 17, 2014, previously published on November 10, 2014The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE) exclusivity.
|OIG 2015 Work Plan - Skilled Nursing Facilities|
Ari J. Markenson; Duane Morris LLP;
November 17, 2014, previously published on November 13, 2014Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...
|HHS-OIG Issues Proposed Rule Relating to AKS, Beneficiary Inducement CMP, and Gainsharing CMP|
Ramy Fayed, Christopher G. Janney, Gadi Weinreich; Dentons Canada LLP;
November 17, 2014, previously published on October 2, 2014The US Department of Health and Human Services, Office of Inspector General ("HHS-OIG") has promulgated a proposed rule that would amend the agency's regulations governing:
|Hospitals Challenge AHCA Authority to Limit Reimbursement for Emergency Treatment of Undocumented Immigrants|
F. Ryan Waters; GrayRobinson, P.A.;
November 17, 2014, previously published on October 28, 2014On October 13, 2014, a coalition of hospitals filed a petition with the Florida Division of Administrative Hearings to challenge the Agency for Health Care Administration's ("AHCA") policies regarding emergency treatment of undocumented immigrants.