MDMA's Washington Update

House Passes Medicare Package; Senate Yet to Act

The House of Representatives overwhelmingly passed a Medicare package that would prevent a scheduled 10.6% reduction in Medicare payments to physicians while providing a 1.1% payment increase. The package includes controversial cuts to the Medicare Advantage program as a means to fund continued physician payments. Also included in the legislation is language to delay implementation of the controversial competitive bidding program. The measure would delay the program for 18 months and allow regulators and lawmakers to evaluate the program.

The House vote was significant in that it passed with enough votes to overturn a veto. However, the bill still faces uncertainty in the Senate. It remains unclear whether the Senate will obtain enough votes to overturn the likely veto it will face by the President.

FDA Receives Diplomatic Approval to Open Offices in China
Department of Health and Human Services Secretary Michael Leavitt announced this that the Food and Drug Administration has received diplomatic approval from China to open three inspection offices in the region. Leavitt indicated that he hopes that inspection offices will open in Beijing, Shanghai and Guangzhou before the end of 2008 with a total staff of up to 12 people. The offices were agreed to in principle last year after several high-profile import safety issues involving pharmaceuticals and food.

Administration Resubmits FDA Budget Request; Asks for $275 Million.
The Bush Administration modified its budget request to Congress to ask for additional funding for the Food and Drug Administration. The budget request would be in addition to the already $2.4 billion initially proposed. The additional funds would pay for basing inspectors abroad, increasing the number of inspections and modernizing computer systems. The proposed budget represents an 18% increased over the current budget of the Agency.

In addition, the House also approved an additional $150 million for the FY2008 fiscal year which ends September 30. The supplemental now moves to the Senate.

MedPac Urges Short-Term Fix for Charge Compression
As part of MedPAC’s comment letter to CMS regarding the proposed inpatient prospective payment system (IPPS) rule, the advisory committee agreed with MDMA and other device stakeholders that CMS should implement a short-term fix to address the problems associated with charge compression. MedPAC specifically cited the use of a regression-based approach, as suggested in the 2007 RTI report commissioned by CMS, as the most appropriate approach to ensure adequate and timely payments for implantable devices.

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