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Documents on Government, Pharmaceuticals, Health Care
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|FDA Releases Recommendation against Using Power Morcellators to Treat Uterine Fibroids|
Burg Simpson; Burg Simpson Eldredge Hersh Jardine P.C.;
February 23, 2015, previously published on December 2, 2014The Food and Drug Administration warned against using laparoscopic power morcellators in either myomectomy or hysterectomy for the treatment of uterine fibroids. The warning is based on an FDA analysis of medical literature, from which it concludes that approximately 1 in 350 women undergoing...
|IRS Notice Provides More Flexibility to Rev. Proc. 97-13|
Kimberly K. Gibbens; Husch Blackwell LLP;
December 8, 2014, previously published on November 25, 2014The Internal Revenue Services (IRS) issued Notice 2014-67 on Oct. 24, 2014, to “amplify” Revenue Procedure 97-13 by (i) creating a new five-year safe harbor for management contracts, and (ii) expanding the permitted types of productivity awards allowed.
|Tenn. Federal Court OKs Extrapolation to Establish Liability in False Claims Act Case|
Kevin P. McCart, Kelly Schulz; Husch Blackwell LLP;
December 8, 2014, previously published on November 5, 2014The U.S. District Court for the Eastern District of Tennessee answered what it acknowledged was a novel question: whether statistical sampling and extrapolation are appropriate to establish liability under the False Claims Act (FCA). The court found the government could extrapolate from a sample of...
|HHS Releases Reminder about HIPAA Rules in Wake of Ebola Outbreak|
Lisa M. Luetkemeyer; Husch Blackwell LLP;
December 8, 2014, previously published on November 11, 2014The U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) released a bulletin on Nov. 10 reminding entities covered under the Health Insurance Portability and Accountability Act (HIPAA) that the protections continue to be in effect during emergencies, including Ebola...
|Ontario Government Re-Introduces Broader Public Sector Accountability Legislation Affecting Health Sector Organizations|
Meghan Lindo; Borden Ladner Gervais LLP;
December 5, 2014, previously published on November 20, 2014On July 8, 2014, the Ontario government re-introduced Bill 8, formerly Bill 179, which proposes to amend several laws affecting health sector organizations. If enacted, Bill 8 will expand government oversight of broader public sector organizations including hospitals, community care access...
|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.
|Ebola on Campus: Questions to Ask for Required Emergency Response Planning|
Anne D. Cartwright; Husch Blackwell LLP;
November 12, 2014, previously published on October 23, 2014Colleges and universities are required to develop and publish emergency response and evacuation procedures. Is Ebola the sort of “emergency” legislators and regulators had in mind and, if so, how do you plan for it?
|IRS Releases Favorable Private Business Use Rules for Facilities Financed With Tax-Exempt Bonds|
Michael G. Bailey, David Y. Bannard, Chauncey W. Lever, Richard F. Riley, Mark T. Schieble; Foley & Lardner LLP;
November 12, 2014, previously published on October 28, 2014On October 24, 2014, the IRS released Notice 2014-67, which establishes more favorable safe harbors for types of service contracts and other arrangements using property financed with tax-exempt bonds. The Notice also provides helpful guidance of more limited scope regarding the treatment of...
|House Hearing on Ebola Preparedness|
McDonald Hopkins LLC;
October 22, 2014, previously published on October 17, 2014On Thursday, the Energy and Commerce subcommittee on Oversight and Investigations, chaired by GOP Rep. Tim Murphy(R-PA), held a hearing on Ebola. In particular the hearing examined the preparedness of the United States ports, point of entry, healthcare facilities and other institutions to identify,...
|Life Care Centers Seeks Sixth Circuit Review of Decision Allowing Statistical Sampling/Extrapolation in FCA Case|
Laurence J. Freedman, Samantha P. Kingsbury, Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 21, 2014, previously published on October 16, 2014Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over 150,000 claims) by Life Care Centers of America, Inc. (a nursing home...