Category Archives: Health Care Law

The American Health Care Act – A Side-by-Side Comparison to Existing Law

As reported in our January 23, 2017 post entitled “Status of the Affordable Care Act Repeal Efforts,”1 on January 12 and 13, 2017, the Republican-controlled Congress took the first step toward repealing certain provisions of the Patient Protection and Affordable Care Act (“ACA”) (Public Law 111-148) by adopting a fiscal budget resolution containing a “reconciliation …

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Congressional Budget Office Releases Report on American Health Care Act

The Congressional Budget Office (CBO) released its cost estimate of the American Health Care Act (AHCA) as reported by the Committees on Ways and Means and Energy and Commerce. CBO estimates that AHCA would reduce federal deficits by $337 billion over ten years. The total consists of $323 billion in on-budget savings and $13 billion …

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Trump Administration Takes First Steps to Support Healthcare Exchanges, but Key Questions Remain

In an effort to stabilize the Exchanges and encourage issuer participation, the Centers for Medicare & Medicaid Services (CMS) recently extended the federal Exchange application and rate filing deadlines and published a proposed rule affecting the individual health insurance market and the Exchanges. While issuers will likely see these actions as encouraging signs of the …

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Fifth Circuit Judge Blocks Rule That Would Ban Arbitration in Nursing Home Disputes

A federal district court recently issued a preliminary injunction barring enforcement of a rule prohibiting the use of pre-dispute arbitration agreements with patients in long-term care facilities that participate in Medicare and Medicaid programs. The new rule, promulgated by the Centers for Medicare and Medicaid Services (CMS), would have taken effect on November 28, 2016. …

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How Does the 21st Century Cures Act Affect Employee Benefits?

There are two key benefits takeaways for employers in the bipartisan 21st Century Cures Act, which President Obama signed into law on December 13, 2016. The act, which passed both houses of Congress by large majorities, is designed to increase funding for medical research, ease the development and approval of experimental treatments, and reform federal …

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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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