We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Lexology logo






  Request new password

Search results

Order by most recent / most popular / relevance

Results: 11-20 of 104

New year, new medical device tax: key questions answered

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 30 2013

On January 1, 2013 an excise tax of 2.3 percent on total revenues from manufacturers of medical devices in the U.S. took effect, impacting not just

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

New proposed regulation relating to wellness programs

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 28 2012

In late November, the Departments of Health and Human Services, Labor, and Treasury issued a proposed regulation that makes important changes in the HIPAA

Establishment registration: FDA's new importer disclosure policy burdens foreign establishments

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 24 2012

A foreign establishment cannot register with the FDA for the fiscal year 2013 without disclosing the names, addresses, and phone numbers of “all known importers” of its device in the United States

Notice 2012-59 90 day waiting period limitation

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • September 28 2012

For plan years beginning on or after January 1, 2014, a group health plan or health insurance issuer may not use a waiting period that exceeds 90 days

Notice 2012-58 play-or-pay

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • September 28 2012

Under Section 4980H of the Code, an “applicable large employer” (i.e., an employer with 50 or more full-time employees, including full-time equivalent employees) will pay a penalty for any month if at least one of its full-time employees is certified as having enrolled for that month in a qualified health plan through an exchange for which premium or cost-sharing assistance is allowed or paid and either (1) the employer fails to offer to its full-time employees (and their dependents) the opportunity to enroll in minimum essential coverage or (2) the employer offers its full-time employees (and their dependents) the opportunity to enroll in minimum essential coverage but that coverage is not affordable or does not provide minimum value

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

Decree on advertising medical devices in France

  • Hodgson Russ LLP
  • -
  • France
  • -
  • August 27 2012

A new French law wants to strengthen the safety of drugs and medical products

European Commission's roadmap for the recast of three medical devices directives

  • Hodgson Russ LLP
  • -
  • European Union
  • -
  • August 15 2012

In the 1990s, the European Union (EU) regulation of medical devices across the European Economic Area (EEA) was harmonized under three medical device directives

Commission recommendation: unique device identification (UDI)

  • Hodgson Russ LLP
  • -
  • European Union
  • -
  • August 10 2012

A proposed rule issued by the FDA pertaining to the unique device identification system likely foreshadows its mandatory implementation, as it is aimed at establishing compatible traceability systems between member states of the European Union

Current Search

Suggested Facets

Author

Jurisdiction

Workarea

© Copyright 2006-2013 Globe Business Publishing Ltd | Cookies | Disclaimer | Privacy policy