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FDA lacks the appropriate data to effectively conduct post market surveillance and safety tracking activities, according to two reports released earlier this month.
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Drug Costs, Risk Adjustment Drive Q2 Health Insurance Rate Increases

January 26, 2016 | Advisory | By Julie Cox, Stephen Weiner, Sasha Dudding

The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).
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Members of Ophthalmologist Group Charged with Illegal Boycott of Health Plan

January 24, 2016 | Alert | By Bruce Sokler, Robert Kidwell, Farrah Short

An ophthalmologist cooperative in Puerto Rico settled charges with the Federal Trade Commission (“FTC”) last week that it orchestrated an illegal boycott of a health plan.
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In keeping with the boom of telehealth legislation introduced last year at both the state and federal level, the Senate Finance Committee is considering several policy changes that, if ultimately enacted, could make telehealth the preferred method of care delivery for millions of Medicare beneficiaries living with chronic conditions.
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ML Strategies Publishes Washington Outlook for 2016

January 20, 2016 | Blog | By Bridgette Keller

Earlier today, my colleagues at ML Strategies published the Washington Outlook for 2016, offering their insights about what we might expect from Capitol Hill and the Administration in the coming year.
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On Tuesday, our colleague, Patricia Moran, discussed the importance of employers using “wrap” documents for certain health and welfare plans on Mintz Levin’s Employment Matters Blog.
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My colleagues Hope Foster, Larry Freedman, and Bridget Rohde, members of Mintz Levin’s Health Care Enforcement Defense group, recently published a report surveying health care enforcement trends and developments in 2015 and forecasting what these developments herald for 2016.
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In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion.
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Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

January 7, 2016 | Blog | By Lauren Moldawer, Daria Niewenhous

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites. Federal law already requires that those “engaged in the business” of selling guns must have a Federal Firearms License (FFL) and conduct background checks at the time of every purchase.
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The Managed Care Industry – 2015 Year in Review

January 6, 2016 | Blog | By Bridgette Keller

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016.
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Recognizing the importance of telemedicine, a committee of the Massachusetts Health Policy Commission recently voted on a grant program that will award up to $500,000 each for two telemedicine pilots that target the behavioral health needs of children, homebound seniors, and people with substance use disorders.
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As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016.
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Laboratories - 2015 Year in Review [VIDEO]

December 29, 2015 | Blog | By Joanne Hawana, Karen Lovitch, Samantha Kingsbury

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come.
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Last week, the Federal Trade Commission ("FTC" or "Commission") authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the proposed merger of Advocate Health Care Network (Advocate) and NorthShore University HealthSystem (NorthShore) in the Chicago area.
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Telemedicine – 2015 Year in Review

December 22, 2015 | Blog | By Ellen Janos, Carrie Roll

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring.
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A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its actions are not actively supervised by the state.
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Last week the Federal Trade Commission (FTC) authorized an action to block a proposed hospital merger pending an administrative trial. Last week the Federal Trade Commission (FTC) authorized an action to block a proposed hospital merger pending an administrative trial.
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Mintz Advisory Analyzes Health Care Qui Tam Litigation Trends

December 15, 2015 | Blog | By Samantha Kingsbury

Last week, my colleague Kevin McGinty published a fascinating advisory that provides a detailed analysis of data recently released by the Department of Justice (“DOJ”) in its annual report on False Claims Act (“FCA”) filings.
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FDA Legal and Regulatory – 2015 Year In Review

December 14, 2015 | Blog | By Joanne Hawana

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products.
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HIPAA and Health Care Data Privacy – 2015 Year in Review

December 11, 2015 | Blog | By Dianne Bourque, Ryan Cuthbertson

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. 
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