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Results: 1-10 of 127

Hospitals get another Form 990 reprieve

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • June 20 2011

Hospitals won’t be required to complete part of Schedule H on their Form 990 for 2010, according to an IRS announcement issued on June 9

FDA and European Medicines Agency to do parallel evaluation of new drug marketing applications

  • Hodgson Russ LLP
  • -
  • European Union, USA
  • -
  • April 4 2011

FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA

St. Jude Medical pays $3.65 million to settle overcharge claims

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • June 1 2012

St. Jude Medical Inc. has settled, for $3.65 million, federal False Claim Act allegations arising from a qui tam case in which the relators alleged that the company inflated the cost of replacement pacemakers and defibrillators purchased by the Departments of Defense and Veterans Affairs, the U.S. Department of Justice announced recently

Health reimbursement arrangements and waivers: immediate action required

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • November 19 2010

Under the Patient Protection and Affordable Health Care Act (PPACA), a group health plan's ability to impose annual limits on essential health benefits is restricted for plan years beginning before January 1, 2014 and prohibited altogether for plan years beginning on or after January 1, 2014

Agencies issue amendments to the PPACA claims and appeals processes

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 29 2011

The Treasury, DOL, and the Department of Health and Human Services jointly issued amendments to the interim final rules governing the internal claims and appeals and the external review processes required under the Patient Protection and Affordable Care Act (PPACA

Supreme Court considers constitutionality of individual mandate

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • April 27 2012

At the end of March, the U.S. Supreme Court heard arguments on the constitutionality of a provision in the Patient Protection and Affordable Care Act (ACA) that requires most U.S. residents to maintain health care coverage for themselves and their dependents

FDA's final rule for combination products

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 29 2013

On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable

FDA and FTC issue warnings for illegal homeopathic weight-loss remedies

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 20 2011

At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG

Is PPACA constitutional?

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • August 30 2011

On August 12, 2011, in State of Florida v. United States Department of Health and Human Services, the Court of Appeals for the Eleventh Circuit held that the provision in the Patient Protection and Affordable Care Act (PPACA) that requires individuals to buy health insurance or pay a tax penalty (the so-called “individual mandate”) is unconstitutional

Medical plan preauthorization language violates SPD standards

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • August 29 2012

In Koehler v. AETNA Health Inc., the U.S. Court of Appeals for the Fifth Circuit held that Aetna’s benefits decision was not, as a matter of law, entitled to deference where the same document, Aetna’s certificate of coverage, served as both the plan document and summary plan description (SPD