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Diagnostic test anti-markup provisions
  • McDermott Will & Emery
  • USA
  • November 14 2008

The anti-markup rule in the final 2008 Medicare Physician Fee Schedule will require a number of physician office-based diagnostic testing arrangements to be restructured or unwound by January 1, 2009


Sharp questions dominate Supreme Court oral arguments regarding the challenge to the availability of ACA premium tax credits
  • McDermott Will & Emery
  • USA
  • March 6 2015

On March 4, 2015, the Supreme Court of the United States heard oral arguments in King v. Burwell, the highest profile challenge to the Affordable


A closer look at the White House’s Precision Medicine Initiative
  • McDermott Will & Emery
  • USA
  • March 5 2015

On January 20, 2015, as part of his State of the Union Address, President Obama announced the upcoming launch of the White House's Precision Medicine


The new EU clinical trials regulation aims at harmonization and transparency
  • McDermott Will & Emery
  • European Union
  • October 20 2014

On June 16, 2014, Reg. (EU) No. 5362014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes


Illinois health facilities and services review board amends its procedural rules
  • McDermott Will & Emery
  • USA
  • May 30 2013

According to its statutory mandate to periodically review and revise its rules, the Illinois Health Facilities and Services Review Board has amended


Corporate Outsiders - on the Wrong Side of the Circuit Split on Rule 9(b)
  • McDermott Will & Emery
  • USA
  • October 4 2016

A district court in the Middle District of Florida issued a new decision that will continue to make it challenging for corporate outsiders to


New law extends federal oversight of compounding pharmacies, establishes national drug track-and-trace requirements
  • McDermott Will & Emery
  • USA
  • January 22 2014

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act addresses two


Proposed overpayment reporting requirements for MA and Part D programs may increase False Claims Act liability
  • McDermott Will & Emery
  • USA
  • January 24 2014

The Centers for Medicare & Medicaid Services continues to take an expansive view of the overpayment refund requirement, which in turn can give rise


Federal judge permits ACA premium tax credits in states with federally facilitated exchanges
  • McDermott Will & Emery
  • USA
  • January 23 2014

A federal district court judge has ruled in favor of the government on one of the most serious challenges to the Patient Protection and Affordable


CMS proposes significant changes to Medicare Part D program’s administration
  • McDermott Will & Emery
  • USA
  • January 23 2014

The Centers for Medicare & Medicaid Services proposes significant changes to several key Medicare Part D Program components, such as the “any willing