Affordable Care Act, Healthcare, Pharmaceutical Industry

Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for...

Alston & Bird on 9/3/2024

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

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

ArentFox Schiff on 2/22/2024

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

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

Ballard Spahr LLP on 12/11/2023

The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

McDermottPlus Check-Up: June 16, 2023

McDermott+ on 6/16/2023

The House and Senate were both in session this week, with healthcare activity continuing at the committee level. The House Energy and Commerce Committee held hearings on the Pandemic and All Hazards Preparedness Act (PAHPA)...more

McDermottPlus Check-Up: May 19, 2023

McDermott+ on 5/19/2023

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Summary of Health Care Provisions in Energy & Commerce Reconciliation Bill

Brownstein Hyatt Farber Schreck on 9/21/2021

This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more

ML Strategies Health Care Preview - July 2019

Mintz - Health Care Viewpoints on 7/9/2019

Welcome back. This week, the Senate Finance Committee is set to meet privately to discuss the drug pricing legislation being developed by the committee. All signs point to a deal being close with a few outstanding provisions,...more

ML Strategies Health Care Preview - May 2019 #4

Mintz - Health Care Viewpoints on 5/22/2019

We are a few legislative days from the Memorial Day recess with the trajectory of issues like drug pricing and surprise medical billing still emerging. The House has passed several drug pricing bills in the past month, with...more

Health Care Weekly Preview from ML Strategies – February 2019

Mintz - Health Care Viewpoints on 2/5/2019

The long-awaiting safe harbor proposed rule was published last week as the Administration looks to get out in front of the drug pricing debate that is sure to shape the 116th Congress. Under the proposed rule,rebates offered...more

Is the Affordable Care Act a House of Cards? If Yes, What Does the Recent Texas Court Decision Mean for the US Health Insurance...

Epstein Becker & Green on 12/19/2018

In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Mintz - Health Care Viewpoints on 10/11/2018

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more

Health Care Policy Newsletter

Foley & Lardner LLP on 5/14/2018

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more

Health Care Weekly Preview from ML Strategies – January 2018 #3

Mintz - Health Care Viewpoints on 1/30/2018

This week, President Trump will go before Congress for his first State of the Union address. Will it be olive branches or brickbats? The next deadline for a government-funding bill is February 8th, a week from Thursday. Will...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

Polsinelli on 1/25/2017

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on 1/9/2017

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on 12/16/2016

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

Stinson - Benefits Notes Blog on 12/14/2016

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

Repealing and Replacing the ACA: Five Developments Likely to Occur in the Years Ahead

Proskauer Rose LLP on 12/7/2016

On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

Cadwalader, Wickersham & Taft LLP on 11/30/2016

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

A Trump Presidency: Potential Impact on Employee Benefits Law and Policy

Franczek P.C. on 11/10/2016

For many months, we have been speculating about how the results of the 2016 presidential election would impact employee benefits policy going forward. Now that Donald Trump has won the election and Republicans have secured a...more

The 2016 Election and Your Healthcare System: What’s at Stake?

Manatt, Phelps & Phillips, LLP on 10/26/2016

Regardless of the 2016 general election outcome, a new administration will have to respond to pressing policy issues that will shape continued transformation of the U.S. healthcare system. What are the issues and where do...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on 10/26/2015

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on 10/26/2015

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

Troutman Pepper on 10/26/2015

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

Saul Ewing Arnstein & Lehr LLP on 9/30/2015

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

Patient Protection and Affordable Care Act (PPACA) › Healthcare › Pharmaceutical Industry

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