Category Archives: Health Care Law

Obama Administration Will Not Finalize Laboratory Developed Tests Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014. The document describes the Agency’s …

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Will Republicans Embrace Center for Medicare and Medicaid Innovation’s Authority?

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority. With Republicans set to take control of both the White House and Congress, the future of that authority is very …

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The Unknown Future Of The Affordable Care Act

Donald Trump’s victory to become the next president of the United States, and the Republican Party’s continued control of the United States Senate and House, will likely have a significant impact on the future of the Affordable Care Act (ACA). President-elect Trump (Trump) has vowed to immediately dismantle the ACA. To date, Trump has provided …

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Top Takeaways from FDA Draft Guidance on Software as Medical Device

FDA’s proposed adoption of an IMDRF document raises questions. On October 14, the US Food and Drug Administration (FDA) released a new draft guidance document, Software as a Medical Device (SaMD): Clinical Evaluation (Draft Guidance).[1] The Draft Guidance was developed by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF),[2] a voluntary …

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It’s Not Really ”Repeal and Replace”; It’s Transition – pt 1

For the last six years, Republicans have talked about repeal and replacement of the Affordable Care Act.  The election outcome now puts Republicans in a position of authority to take action on the Affordable Care Act.  As we look ahead to the 115th Congress, it is important to move away from political rhetoric and consider …

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Election 2016 Likely to Result in End of ACA as We Know It, But Employers and Plan Sponsors Should Stay Course for Now

Over the past five years or so, Republican Congressmen have repeatedly taken steps to repeal President Obama’s landmark legislative effort – the Patient Protection and Affordable Care Act (the “ACA”). However, those efforts either failed to advance in Congress or were vetoed by President Obama. Tuesday’s Presidential and Congressional election, in which Donald Trump was …

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President-Elect Trump’s Impact on Affordable Care Act

For years, the Republican-controlled Congress has vowed to repeal or significantly scale back President Obama’s landmark legislation – the Patient Protection and Affordable Care Act (the “ACA”). During his campaign, President-elect Donald Trump repeatedly promised that he would “immediately repeal and replace” the ACA upon taking office.  Assuming Trump follows through on his promise, the ACA’s days …

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New Presidency Will Compel Action in Key Areas of Health Care in 2017

As we enter the final stretch of the U.S. presidential election, health care remains one of the most contested issues with great potential for change, particularly to existing insurance and patient care systems. Compounding matters is the opening of enrollment season for exchange plans, which places the already hotly debated Affordable Care Act (ACA) at …

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DOJ-AmEx Case Could Have Ramifications for Health Care Providers

The U.S. Department of Justice’s loss to American Express sends a message to health care providers: Steering, tiering, exclusive dealing and other contractual arrangements that appear to suppress competition in one part of the market may be legitimate where the arrangements facilitate lower prices and better access to services in another part of the market, …

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OFAC Allows Joint Medical Research with Cuba

The Department of the Treasury, Office of Foreign Assets Control (OFAC), has modified the Cuban Assets Control Regulations (CACR) (31 C.F.R. Part 515) to allow joint medical research between persons subject to U.S. jurisdiction and Cuban nationals. In the context of the CACR, a “person subject to U.S. jurisdiction” includes any non-U.S. entity owned or …

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