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2008 physician fee schedule regulations include anti-markup and IDTF rule changes

  • McDermott Will & Emery
  • -
  • USA
  • -
  • November 16 2007

The final rule, effective January 1, 2008, narrows the Stark Law in-office ancillary services exception in a manner that will disrupt a number of medical group practices’ diagnostic imaging and pathology arrangements

HRSA releases two 340B advanced notices of proposed rulemaking

  • McDermott Will & Emery
  • -
  • USA
  • -
  • September 22 2010

On September 20, 2010, the Health Resources and Services Administration (HRSA) released two Advanced Notices of Proposed Rule Making (ANPRMs) related to provisions of the Accountable Care Act (ACA) affecting the 340B drug discount program

DEA issues proposed regulations for e-prescribing of controlled substances

  • McDermott Will & Emery
  • -
  • USA
  • -
  • July 14 2008

The new Proposed Regulations published by the Drug Enforcement Administration could potentially provide licensed prescribers and pharmacies a way to electronically write, receive, deliver and archive prescriptions

OIG issues favorable ambulatory surgery center advisory opinion

  • McDermott Will & Emery
  • -
  • USA
  • -
  • August 6 2008

The conclusion of the OIG in Advisory Opinion 08-08 seems to indicate an interest in promoting, rather than restricting, the development of physician-hospital ASCs, so long as appropriate measures to protect against fraud and abuse are included

In with the new, part III: 2014 privacy, advertising and digital media predictions

  • McDermott Will & Emery
  • -
  • USA
  • -
  • January 31 2014

Boston-based litigation partner Matt Turnell shares his predictions about class action litigation under the Telephone Consumer Protection Act (TCPA

Pennsylvania federal judge finds the individual mandate unconstitutional and strikes down closely related provisions

  • McDermott Will & Emery
  • -
  • USA
  • -
  • September 14 2011

On September 13, 2011, a federal district court judge in Pennsylvania ruled that the individual mandate under the Affordable Care Act (ACA) is unconstitutional and that certain provisions closely linked to the individual mandate must also be struck down

Proposed changes to HSR rules for pharmaceutical companies

  • McDermott Will & Emery
  • -
  • USA
  • -
  • August 14 2012

Today the Federal Trade Commission (FTC) announced proposed changes to the Hart-Scott-Rodino (HSR) premerger notification rules that will impact the types of transactions for which pharmaceutical companies will be required to file HSR notifications with the Department of Justice and FTC

If it is obvious to try, it still might not be obvious

  • McDermott Will & Emery
  • -
  • United Kingdom
  • -
  • September 10 2008

In Conor Medsystems Inc v Angiotech Pharmaceuticals Inc 2008 UKHL 49, the House of Lords has revisited the test of “obvious to try” most often raised in patent validity actions

District court power to enjoin improper use code is limited

  • McDermott Will & Emery
  • -
  • USA
  • -
  • August 30 2012

Addressing for the first time the role of a district court to remedy an improper use code submitted to the U.S. Food and Drug Administration (FDA), the U.S. Court of Appeals for the Federal Circuit held that a federal court’s powers are limited to enjoining an improper use code and that the party is “given the opportunity to propose the specific language of the use code.”

First-dollar coverage of designated preventive services

  • McDermott Will & Emery
  • -
  • USA
  • -
  • July 19 2010

Health care reform requires non-grandfathered group health plans and health insurance coverage to provide first-dollar coverage of certain preventive services furnished by in-network providers