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|21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence|
Bethany Hills, Benjamin Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
January 5, 2017, previously published on December 19, 2016As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved...
|CMS Releases Final Medicare Outpatient Observation Notice|
Catherine Breaux Moore; Breazeale, Sachse & Wilson, L.L.P.;
January 5, 2017, previously published on December 2016The Centers for Medicare & Medicaid Services (“CMS”) posted the final approved version of the Medicare Outpatient Observation Notice (“MOON”) on the CMS Beneficiary Notices Initiative website on December 8, 2016. According to CMS, all hospitals and critical access...
|Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors|
Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
January 5, 2017, previously published on December 22, 2016Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions. One small, but by no means insignificant, change is the Cures Act’s explicit recognition that drug...
of the PIP Deductible to Bills Submitted by Hospitals and Other Non-emergency
Cole Scott Kissane P.A.;
January 5, 2017, previously published on December 12, 2016Let’s face it, accidents happen. But, when they do, we hope for a host of reasons that the injuries are not severe enough to warrant a visit to the hospital. For insurers, this concern goes beyond the concern for the claimant’s physical well-being. Rather, the insurer must also concern...
|Update - Ontario Passes the Patients First Act to Implement Health Sector Reform|
Meghan Lindo, Lydia Wakulowsky; Borden Ladner Gervais LLP;
January 4, 2017, previously published on December 14, 2016On December 7, 2016, Ontario passed the Patients First Act, significantly expanding the role of Local Health Integration Networks ("LHINs") and the Minister of Health and Long-Term Care (the "Minister") in the delivery of health care services.
Adopts Advanced Home Health Aide Law|
Rosemary McKenna, Emily E. Whalen; Jackson Lewis P.C.;
January 3, 2017, previously published on December 2, 2016New York State has adopted new law that establishes the advanced home health aide (AHHA) job designation. The AHHA program was first recommended in 2011. Governor Andrew Cuomo signed S. 8110/A.10707 into law on November 28, 2016.
|The Trump Administration: The Future of Health Care|
Kathy Hirata Chin, Pamela Landman, Stephanie Marcantonio, Brian T. McGovern, Paul W. Mourning; Cadwalader, Wickersham & Taft LLP;
January 3, 2017, previously published on December 6, 2016The election of Donald J. Trump as the 45th President of the United States, along with the Republican control of the majority of both the House of Representatives and the Senate, will likely set in motion a major overhaul of the nation’s health care system. As a candidate, President-elect...
|Small Victory in Fight Against Mesothelioma|
Waters Kraus LLP;
January 3, 2017, previously published on December 13, 2016It seems like a war sometimes for those battling pleural mesothelioma. One of the most stubborn and aggressive types of cancer, researchers report that only 1 in 10 patients survive more than five years after diagnosis. Patients and their loved ones often have no choice but to seek physical and...
|What Employers Need to Know About Florida's New Medical Marijuana Law|
Rachel D. Gebaide, Timothy C. Haughee; Lowndes, Drosdick, Doster, Kantor & Reed Professional Association;
January 3, 2017, previously published on December 14, 2016In addition to selecting a new President, Florida voters approved Amendment 2, which amends the Florida Constitution to legalize medical marijuana for use by individuals with specific debilitating medical conditions, as determined by a Florida licensed physician. With its passage, Amendment 2...
Legal Marijuana Be One of History's Most Disruptive Technologies?|
Timothy J. McCunn; Perley-Robertson, Hill & McDougall LLP/s.r.l.;
January 3, 2017, previously published on December 5, 2016The market potential for legalized marijuana is enormous. One market in particular that could be significantly impacted is alcohol beverages - a trillion dollar market. Another is the “wellness” market - selling of a natural product with significant health benefits, from pain management...