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The Challenge of Non-Interference
January 29, 2016 | Blog
To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator.
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CBO’s Budget Forecast and the Silver Tsunami
January 28, 2016 | Blog
This week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade alone, and the number of seniors will steadily grow from 55 million today to more than 80 million by 2036.
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Massachusetts Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report
January 27, 2016 | Blog | By Daria Niewenhous
The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings.
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Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies
January 26, 2016 | Blog | By Joanne Hawana
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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Senate Working Group Considers Telehealth Policy Changes to Medicare
January 21, 2016 | Blog | By Carrie Roll
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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Employment Matters: “Wrap” Documents for Employee Health and Welfare Plans
January 15, 2016 | Blog
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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Health Care Enforcement Report: A Look Back at 2015 and a Forecast for 2016
January 11, 2016 | Blog | By Brian Dunphy
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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A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena
January 8, 2016 | Blog | By Joseph Lipchitz
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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Massachusetts Uses Telemedicine Technology to Expand Access to Behavioral Health Services
January 6, 2016 | Blog | By Ellen Janos
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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Upcoming Webinar and Report - Health Care Enforcement in 2016
December 30, 2015 | Blog
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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A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge
December 23, 2015 | Blog | By Dionne Lomax
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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Antitrust Suit Continues to Stymie New Texas Telemedicine Regulation
December 17, 2015 | Blog | By Dionne Lomax
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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FTC Alleges “Three-to-Two” Hospital Merger Will Reduce Competition
December 16, 2015 | Blog | By Dionne Lomax
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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