News & Analysis as of

NIH

Healthcare Weekly Preview from ML Strategies – June 2017 #3

Welcome back everybody. In general, this week insurers will submit their applications for participating in the Marketplace for 2018. After this we will begin to find out where the insurance deserts are and how much rates will...more

NIH Begins Beta Test of Million Patient Cohort

by Foley & Lardner LLP on

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

Trump Administration Releases Fiscal Year 2018 Budget Proposal

by Baker Donelson on

On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

by Arnall Golden Gregory LLP on

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

Congress boosts NIH funding but CDC, drug czar’s office aren’t faring as well

Although its battles over health insurance have dominated the headlines, Congress also provided a glimmer of good news on funding for medical research. Lawmakers, at least for this fiscal year, shunned President Trump’s...more

Complicated Landscape Awaits New FDA Commissioner

by Holland & Knight LLP on

A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more

Capitol Hill Healthcare Update

by BakerHostetler on

Eight weeks after its introduction, legislation to “repeal and replace” the Affordable Care Act (ACA) won House approval today by a 217-213 vote. Vice President Mike Pence on Sunday said a vote in Congress to repeal the ACA...more

Window on Washington - Vol. 1, Issue 3

by Clark Hill PLC on

Budget/Appropriations - Spending Talks: House and Senate appropriators continue efforts to nail down an agreement on a stopgap spending measure to avert a government shutdown after the expiration of the current...more

Health-Related Programs Face Deep Cuts In President Trump’s “Budget Blueprint to Make America Great Again”

On March 16, 2017, President Trump Administration released his first budget outline for the 2018 fiscal year (FY 2018). In an effort to “shrink the role of government,” the $1.1 trillion budget proposal calls for a $54...more

President’s budget ax takes a big whack at medical, scientific funding

The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more

Trump Administration Budget Rocks Medical Research Advocates

by Faegre Baker Daniels on

The skinny on President Trump’s slimmed down Fiscal Year 2018 budget is anything but positive for advocates of medical research. In a White House budget officially released the morning of Thursday, March 16, the...more

Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees

by Reed Smith on

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget...more

More Time to Streamline: NIH Extends Deadline for Implementation of Single IRBs for Funded Studies

by BakerHostetler on

The research community has a full plate as it sifts through the final rule on the Common Rule issued last week. Many are now fully appreciating the December gift from the National Institutes of Health that granted an...more

Uncertainty rises about leadership in nation’s top health posts

Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Washington, D.C. Update – December 2016

by Baker Donelson on

With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more

21st Century Cures Passes Congress and is Signed into Law

by Baker Donelson on

After more than four years of halting progress, Congress approved and the President signed the 21st Century Cures Act. The legislation, which passed the Senate 94 to 5 and the House 392-26, authorizes $6.3 billion in...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

by Bass, Berry & Sims PLC on

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

21st Century Cures: Modernizing Public and Private Research

by McDermott Will & Emery on

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

by Morgan Lewis on

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

Universities Are Prime Targets for False Claims Act Liability

by McCarter & English, LLP on

Colleges and universities receive billions of dollars in federal funds, whether through research grants or student financial aid, or even by billing Medicare or Medicaid for services rendered at academic medical centers. As a...more

21st Century Cures Act – Provisions Relating to Regulation of Clinical Research

by Ropes & Gray LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

President Obama Signs the 21st Century Cures Act Into Law

by Latham & Watkins LLP on

The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens. On December 13, 2016, President Obama signed into...more

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