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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Window on Washington - Vol. 2, Issue 1

by Clark Hill PLC on

Another short-term continuing resolution is all but guaranteed as the current continuing resolution will expire later this month and budget talks last week did not result in a deal or hint at one in the near future. As the...more

Tax Reform Changes to Healthcare

by Holland & Knight LLP on

Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk. In addition to extensive revisions to the tax...more

2017 Healthcare Year in Review

by Burr & Forman on

If the 2017 healthcare environment could be summed up in one word, it would be “uncertainty.” With the largely unexpected election of Donald Trump as President, the multiple, unsuccessful attempts by the Republican controlled...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Proposed Law Would Criminalize Failures to Report Data Breaches

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax,...more

Recent Congressional Actions Bring Drug Pricing Debate Back Into National Spotlight

by Holland & Knight LLP on

In late October, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011; H.R. 4138), which would allow the Department of Health and Human Services (HHS)...more

Window on Washington - Vol. 1, Issue 37

by Clark Hill PLC on

House Majority Leader McCarthy informed members on Thursday that they should be ready to vote this evening on a motion to go to conference with the Senate on tax legislation, despite the House not scheduled to be in session....more

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

Window on Washington - Vol. 1, Issue 34

by Clark Hill PLC on

Short-term Continuing Resolution Likely Needed to Fund Government Past December Deadline: Republicans are focused on tax reform through Thanksgiving, and when lawmakers return from the upcoming holiday recess, they will have...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- 2017 Virginia Attorney General and New Jersey Governor Election Results- In Virginia’s AG race, Democrat incumbent AG Mark Herring defeated Republican John Adams by a margin of 53.3% to 46.7%. Virginia’s...more

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more

Healthcare Cyber: House Inquiry Targets Medical Software

In its latest inquiry into cybersecurity risks in the healthcare sector, the House Energy and Commerce Committee last week requested a “formal briefing” from medical transcription vendor Nuance Communications, Inc. concerning...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

Health Alert (Australia) 16 October 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales (NSW) 6 October 2017 - City of Ryde Council v Principal Healthcare Finance Pty Ltd (No 2) [2017] NSWLEC 134 -...more

News from Second & State

Weekly Wrap - Beyond the budget, there was some significant legislative activity. First, on Monday the House Education Committee reported out two noteworthy bills; H.B. 1386 (Hill, R-York), which would update teacher...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Frank White Announces Bid for Florida Attorney General- Republican state Representative Frank White announced his candidacy in the open 2018 race for Florida AG. He is also the general counsel...more

Uncle Sam should be wary in partnering with Big Pharma on cancer treatments

Is Uncle Sam launching a way to speed and improve cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just...more

California Enacts Bill on Drug Pricing Transparency

by Ropes & Gray LLP on

On October 9, 2017, California Governor Jerry Brown (D) signed into law what may be the most comprehensive prescription drug pricing transparency bill in the country. The bill, SB-17, is intended to foster transparency in...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 28

by Clark Hill PLC on

White House to Request Emergency Supplemental Funding for Puerto Rico: The White House will submit an additional request to Congress in the next two to four weeks which is not expected to include any deficit restructuring...more

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

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