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21st Century Cures Act Includes Prohibition on Information Blocking and Mandates for Additional HIPAA Guidance

On November 30, 2016, the U.S. House of Representatives voted strongly in favor of the 21st Century Cures Act (the Act), an expansive health bill that addresses the discovery and development of new medical therapies as well...more

Congress weighs approval for sweeping, $6.3 billion 21st Century Cures Act

It’s almost 1,000 pages, culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the...more

Refined 21st Century Cures Act Passes in House and Heads to Senate Next Week

Yesterday, we reported that the House of Representatives was set to vote on a revised draft of the 21stCentury Cures Act...more

Navigating the ACA in the Trump Era

On November 8, 2016, the future of the Patient Protection and Affordable Care Act (ACA) became more uncertain. Republicans in Congress have been working to repeal the ACA since it was passed in 2010, and now, with control of...more

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

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

U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy...more

“May You Live in Interesting Times” – Some Healthcare Predictions for the Trump Administration’s First Year

The ancient Chinese curse – “May you live in interesting times” – certainly springs to mind these days. What does the election of Donald Trump mean for the healthcare industry, the Affordable Care Act and current healthcare...more

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

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

Will Trump’s Election Impact the BPCIA?

The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although...more

Big Pharma, Big Soda spending big to battle ballot measures

Just some quick updates on some topics that the blog has followed in recent days: Big Soda, Big Pharma spending big to battle ballot measures...more

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...more

CETA Implementation in Canada - Implications of Bill C-30 on the Pharmaceutical Industry

Bill C-30 presents significant changes to Canada’s pharmaceutical landscape by introducing supplementary protection for pharmaceutical products and proposing substantial modifications to the Patented Medicines (Notice of...more

The Changing Landscape of the Fight Against Opioid and Heroin Addiction and the Availability of Naloxone

In recent months, the Obama administration and many health and pharmaceutical players at the state and local levels have focused their attention on the national opioid epidemic. Based on recent findings from the National...more

Washington Healthcare Update

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Massachusetts Outlook: The Remainder of 2016 and Beyond

After closing the book on the formal sessions in July, Massachusetts lawmakers have turned their attention to the November election. The Senate and House of Representatives convene in informal sessions for the remainder of...more

With Short-Term Government Funding Bill in Place, Congress Adjourns until after Elections

On September 29, 2016, President Obama signed into law HR 5325, which averts a government shutdown by continuing funding for the federal government through December 9, 2016. The legislation also includes $1.1 billion in...more

Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Arkansas' New Telemedicine Rules a Small Step Forward

The Arkansas Legislative Council’s Rules and Regulations Subcommittee approved, on August 16, 2016, proposed regulations which, if accepted by the Arkansas Legislative Council, will remove some restrictions on telemedicine...more

EpiPens: the latest epic fail to halt Big Pharma’s relentless jacking up of prices

Martin Shkreli, the smirking Pharma CEO, has been replaced for now as the national symbol for outrage over Big Pharma’s price gouging. Enter, stage right: Heather Bresch, a 47-year-old executive-who also happens to be the...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Illinois Revises Data Privacy Statute

Earlier this year, Illinois enacted a number of changes to the Illinois Personal Information Protection Act (“PIPA”). The amendments to PIPA, among other things, expand the definition of personal information subject to...more

Illinois Authorized Electronic Monitoring in Long-Term Care Facilities Act: Proposed Amendments

Effective January 1, 2016, Illinois now permits residents or families of residents in long-term care facilities to install cameras or other electronic monitoring devices (audio and visual) in resident rooms. Illinois'...more

States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry

As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of...more

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