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Medical Device News

MDMA's Washington Update

Senate Confirms Sebelius and Hamburg

The Senate confirmed Kathleen Sebelius as Secretary of Health and Human Services. Ms. Sebelius was confirmed by a final vote of 65-31, with eight Republicans voting for her confirmation. She now takes control of the Agency as Congress and the President begin their efforts for broad-based health care reform.

The Senate also confirmed Dr. Margaret Hamburg as the 21st Commissioner of the Food and Drug Administration. Dr. Hamburg replaces Acting Commissioner Josh Sharfstein, who will now take the role of Deputy Commissioner. Hamburg received widespread support in the Senate and was approved by voice vote.


Medicare Releases Proposed FY 2010 IPPS Rule

The Centers for Medicare and Medicaid Services (CMS) recently released the FY 2010 IPPS proposed rule. The proposed regulation reduces payments for hospital inpatient care by 0.5 percent.  According to CMS, the reduced payments are the result of hospital coding practices during a transitional period when Medicare began adjusting reimbursements based on illness severity.  In addition, the Agency is reviewing five applications for products applying for the IPPS new technology add-on payment.
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Vermont Legislation Passes Gift Disclosure Law

The Vermont State Legislature passed a law in May requiring the disclosure of all payments made by device and drug manufacturers to physicians in the state.  The new law, viewed as one of the most stringent in the country, will take effect July 1.  The law goes further than most other state laws in that it bans all free meals to physicians.  The new requirement, however, exempts payments made for products in clinical research.

The passage of the Vermont law reaffirms the necessity that Congress enacts transparency legislation that broadly preempts state disclosure requirements.
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