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Goodwin

The Ten-Year Anniversary of the Enactment of the BPCIA

Goodwin on

Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act. The BPCIA - whose legislation certain members...more

K&L Gates LLP

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

Mintz - Health Care Viewpoints

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

Mintz - Health Care Viewpoints on

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Searcy Denney Scarola Barnhart & Shipley

What Does the Cures Act Really Mean for Patients?

Searcy Denney Scarola Barnhart & Shipley on

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

Hogan Lovells on

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

Hogan Lovells

The Obama Administration Eases Sanctions Against Sudan

Hogan Lovells on

On January 13, 2017, the White House, the U.S. Department of Treasury ’s Office of Foreign Assets Control (OFAC) , and the U.S. Department of Commerce ’s Bureau of Industry and Security (BIS) announced a host of policy...more

Ballard Spahr LLP

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

Ballard Spahr LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

McDonnell Boehnen Hulbert & Berghoff LLP on

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

Polsinelli

Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Polsinelli on

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more

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