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|U.S. District Court Issues Ruling on Preliminary Motion to Dismiss Interpreting 60-Day Overpayment Rule: Holds Identification Occurs when Providers Are "Put on Notice" of Potential Overpayment|
Lindsey Lonergan, Rebekah N. Plowman; Jones Day;
September 10, 2015, previously published on September 2015Compliance with the labyrinth of health care rules and regulations has always been a burdensome challenge for health care providers, and particularly for compliance officers who are frequently presented with potential overpayments that after months of investigation fail to reveal an actual...
|The TCPA & Healthcare: FCC Limits “House Calls” to Cellphones|
Richik Sarkar, Jane Marie Pine Wood; McDonald Hopkins LLC;
September 10, 2015, previously published on September 8, 2015The Federal Communications Commission (FCC) ruling this summer on the Telephone Consumer Protection Act (TCPA) had direct implications for many health care institutions - and recent case law continues to define the guidance with respect to health care related debt collection.
|HHS Proposes Revisions to the Common Rule for Protection of Human Research Subjects|
Edgar J. Asebey, Maureen Bennett, Michele R. Goodman, Glenn L. Krinsky, Heather O'Shea; Jones Day;
September 10, 2015, previously published on September 2, 2015On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") and numerous other federal departments and agencies released the long-awaited proposed revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule," now published in the...
|CON Laws, COPAs and the FTC: 7 Antitrust Points for the Healthcare Sector|
Steven Levitsky, Lesli C. sposito; DLA Piper (Canada) LLP;
September 10, 2015, previously published on August 6, 2015The Federal Trade Commission is on a roll in its attack on what it considers anti-competitive effects in the healthcare industry. And that roll has consistently involved challenging activity that once appeared to be protected by state laws.
|Federal Court Sides with Government in First Interpretation of ACA’s 60-day False Claims Act Rule: Takeaway for Health Systems|
Karen Nelson, Adam J. Rogers, Bradley Smyer; DLA Piper (Canada) LLP;
September 9, 2015, previously published on August 13, 2015In a significant development for healthcare providers, a federal court in New York has adopted the government’s interpretation of the 2010 Patient Protection and Affordable Care Act’s (ACA’s) so-called 60-day rule, which governs when an “identified” overpayment must be...
|Drastic Changes Proposed for Clinical Research Rules|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
September 8, 2015, previously published on September 8, 2015The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common Rule,” originally promulgated in 1991. A Notice of...
|Summary of 340B Drug Pricing Program Proposed Omnibus Guidance|
Joel M. Hamme, Jason B. Reddish, Barbara Straub Williams, William H. von Oehsen; Powers Pyles Sutter & Verville, PC;
September 7, 2015, previously published on September 4, 2015The following summarizes the provisions of the 340B drug pricing program (340B Program) omnibus guidance (Proposed Guidance) released by the Health Resources and Services Administration (HRSA) on August 28, 2015. The Proposed Guidance is attached to this summary. The Proposed Guidance touches on...
|FDA Updates List of Tropical Diseases Eligible for Award of Priority Review Voucher|
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
September 4, 2015, previously published on September 2015In a final order issued August 20, 2015, FDA updated the list of tropical disease products eligible to receive a priority review voucher ("PRV"), an incentive to encourage the development of new drugs for the prevention or treatment of certain diseases by providing priority review of a...
|Know Your Options Before Signing Up for Medicare|
Ryan W. Barry; Chambliss, Bahner & Stophel, P.C.;
September 4, 2015, previously published on September 2015As you get ready to turn 65, you may be inundated with information about Medicare. All this information is confusing, but it is important to do your research before choosing your plan. If you aren’t fully informed, you could end up making mistakes that will cost you down the road,...
|Obama Signs Law Requiring Hospitals to Warn of Costly Medicare Loophole|
Ryan W. Barry; Chambliss, Bahner & Stophel, P.C.;
September 4, 2015, previously published on September 2015President Obama has signed a new law intended to prevent Medicare beneficiaries from spending days in a hospital only to find that they hadn’t been admitted to the hospital at all - they were only under “observation.” This is important because Medicare covers nursing home stays...