News & Analysis as of

Life Sciences Patient Protection and Affordable Care Act (PPACA)

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

McDermott Will & Emery

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

McDermott Will & Emery on

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Another Interchangeable Biosimilar Drug

On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug.  That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021 #2

Latham & Watkins LLP on

Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more

Hogan Lovells

Election 2020 Snapshot: Impacts of the U.S. election for the life sciences and health care industry

Hogan Lovells on

On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Mintz - Health Care Viewpoints

Health Care Provisions in 2020 Spending Package

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges...more

Seyfarth Shaw LLP

Fifth Circuit Affirms Striking Down Individual Mandate of Affordable Care Act and Remands on Issue of Severability

Seyfarth Shaw LLP on

In a bold but conservative 2-1 decision Wednesday, The United States Court of Appeals for the Fifth Circuit affirmed the ruling of a federal district judge in Texas striking down the individual mandate of the Affordable Care...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

Morgan Lewis

US House Votes to Repeal Medical Device Excise Tax

Morgan Lewis on

While the US House of Representatives recently voted to repeal the medical device excise tax imposed by a 2010 amendment to the Affordable Care Act, there is no sign that the Senate will vote on this issue any time soon. ...more

Fenwick & West Life Sciences Group

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

Morgan Lewis

Preparing for an ACA Rollback: How to Get Paid for Treating the Uninsured - Hospital Industry Viewpoint

Morgan Lewis on

Given that Republicans will soon control both Congress and the White House, hospitals may be concerned that expenditures that have helped reduce the ranks of the uninsured will be ratcheted down. However, forward-thinking...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2016

The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World - In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more

Epstein Becker & Green

Five Recent Developments in Labor and Employment Law That Health Care Employers Need to Know

Epstein Becker & Green on

Recent actions by federal agencies and courts will have a direct impact on employers in the health care industry. While still wrestling with the changes wrought by the Affordable Care Act, health care employers will now need...more

Fenwick & West Life Sciences Group

Investments in Digital Health Infrastructure Dominate in August

At our Digital Health Summit earlier this year, Malay Gandhi, Managing Director at Rock Health, noted that once digital health venture investing accounts for 10% of all venture investment, we should start breaking out...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

King & Spalding

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

King & Spalding on

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening of...more

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