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Results: 1-10 of 14

New guidance on the OIG’s ability to exclude owners, officers and managing employees; related FDA statements on pharmaceutical executives

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 1 2010

On October 20, 2010, the Office of Inspector General (OIG) of the Department of Health and Human Services issued significant new guidance for implementing its permissive exclusion authority under Section 1128(b)(15) of the Social Security Act

Pharmaceutical executives and in-house counsel beware: U.S. district court affirms exclusion of former purdue executives under "responsible corporate officer" doctrine

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 21 2010

On December 13, 2010, the United States District Court for the District of Columbia affirmed the decision of Kathleen Sebelius, Secretary of the Department of Health and Human Services (the "Secretary") excluding three former pharmaceutical executives for twelve years from participation in Medicare, Medicaid, and all other federal health care programs

Vermont modifies manufacturer gift ban and reporting law, effective July 1, 2011

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 14 2011

On May 26, 2011, Vermont Governor Peter Shumlin signed into law Senate Bill 104 (“S.104”), significantly modifying Vermont law banning the provision by manufacturers of gifts to health care providers and requiring disclosure of certain allowable expenditures and gifts to health care providers

Update on medical device manufacturer marketing activities: state and federal restrictions and reporting requirements

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 31 2011

As most medical device manufacturers are aware, states are increasingly imposing marketing restrictions on device manufacturers through laws that previously focused more specifically on pharmaceutical manufacturers

The Sunshine Physician Payment Final Rule overview and analysis

  • Reed Smith LLP
  • -
  • USA
  • -
  • March 5 2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the

Vermont offers limited amnesty to device and biologic manufacturers who failed to report payments to health care providers

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 6 2012

Today the Office of the Vermont Attorney General announced that the Vermont Attorney General is offering limited amnesty to medical device and biologic manufacturers who have failed to report pursuant to Vermont’s Prescribed Products Gift Ban and Disclosure Law

Overview and analysis of the proposed federal sunshine

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 30 2012

On December 19, 2011, the Centers for Medicare & Medicaid Services published a proposed rule related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act”

Massachusetts signals potential elimination of HCP payment reporting requirement through emergency regulatory amendments

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 1 2012

On September 19, 2012, the Massachusetts Public Health Council approved emergency amendments to the State’s Marketing Code of Conduct regulations, 105 CMR 970.000, which restrict certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners (“HCPs”) and require disclosure of payments and transfers of value to HCPs

As federal sunshine looms, massachusetts loosens manufacturer gift ban and disclosure law, and allows certain drug coupons and vouchers

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 16 2012

As drug and device manufacturers continue to await final regulations and subsequent implementation of the federal Physician Payment Sunshine Act, passed as part of the Affordable Care Act, Massachusetts has relaxed its similar state law banning the provision by manufacturers of gifts to health care practitioners (“HCPs”) and requiring disclosure of payments and transfers of value to HCPs

CMS announces data collection for the Physician Payments Sunshine Act will not be required before 2013

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 4 2012

This post was written by Elizabeth Carder-Thompson, Katie C