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HHS Proposes New Financial Conflicts Of Interest Rules (Shook Hardy & Bacon LLP)
  • Citing the growing complexities of collaborations between investigators and the private sector, the Department of Health and Human Services (HHS) has proposed new rules for Financial Conflicts of Interest (FCOI).
    • Texas Case Raises Concerns Regarding Enforceability of Non-Compete Covenants Against Physicians (Bradley Arant Boult Cummings LLP)
  • On July 9, 2010, the Court of Appeals of Texas issued a noteworthy opinion that may jeopardize the enforceability of certain "covenants not to compete" in the State of Texas, as applied specifically to physicians.
    • CDRH Seeks to Assure Device Makers, But Holds Ground (Faegre & Benson LLP)
  • In an August 31, 2010 webinar, representatives from FDA's Center for Devices and Radiologic Health (CDRH) fielded questions concerning the reports with preliminary recommendations issued earlier this month by the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.
    • Adverse Event Compensation in China: A Growing Patchwork of Provincial Rules (CMS Cameron McKenna LLP)
  • Success in campaigns of prevention and control of epidemics will in no way veil the significance of adverse events following immunization ("AEFIs").
    • City of Otsego Decision Could Impact Municipalities' Bids to Exit Hospital Taxing Districts (Faegre & Benson LLP)
  • Many states throughout the country authorize the formation and operation of hospital taxing districts with property tax levying authority.
    • FDA Releases Guidance on Implementation of Menu Labeling Requirements of Health Care Bill (Faegre & Benson LLP)
  • FDA on August 24 released two guidance documents relating to implementation of the menu labeling requirements contained in the Patient Protection and Affordable Care Act of 2010 (PPACA), commonly known as the health care bill. Under the PPACA, certain chain restaurants with more than 20 locations are required to post calorie counts for all standard menu items on the menu boards.
    • Health Care Reform – New Claims and Appeals Requirements (Franczek Radelet P.C.)
  • As mentioned in a previous alert, group health plans will be subject to new claims and appeals requirements under the Patient Protection and Affordable Care Act (PPACA), signed into law on March 23, 2010, as modified by the Health Care and Education Affordability Act of 2010 ("Reconciliation Bill" and combined, "Health Care Act").
    • The Patient Protection and Affordable Care Act—Improving the Health Care Workforce: (Larkin Hoffman Daly & Lindgren)
  • In addition to extending health care coverage to millions, the Patient Protection and Affordable Care Act (PPACA) is also focused on improving the national health care workforce.
    • Countdown to Release of the Self-Referral Disclosure Protocol (Foley & Lardner)
  • Health care providers have long struggled with the issue of how to deal with the discovery that they have been involved in violations of the Stark law.
    • Good Intentions Gone Wrong: CMS Proposes New Rule to Clarify Home Health Agency 36 Month Rule (Waller Lansden Dortch & Davis)
  • The 36 Month Rule again has taken center stage as the Centers for Medicare and Medicaid Services (CMS) recently proposed new regulations governing ownership changes in the home health industry.