Register Today for the ASH™/FDA Workshop on Clinical Endpoints in Multiple Myeloma
ASH and the U.S. Food and Drug Administration (FDA) are co-sponsoring a Workshop on Clinical Endpoints in Multiple Myeloma on October 26 in Washington, DC. The public forum will explore clinical endpoints for use in regulatory approval of agents to treat patients with multiple myeloma. Kenneth C. Anderson, MD, from the Dana-Farber Cancer Institute, and Richard Pazdur, MD, Director of the Office of Oncology Drug Products within the Center for Drug Evaluation and Research at the FDA, are the co-chairs of the meeting and will work closely with a workshop panel consisting of representatives from the FDA and experts in the field of multiple myeloma. For additional information and to register for the workshop, visit the ASH Web site.
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Take Action
Before breaking for their August recess, members of Congress in both the House and Senate took steps to urge their leaders to address the 2007 Medicare physician payment reductions before adjournment in October. If Congress does not take action, the Medicare Sustainable Growth Rate (SGR) formula will cut payment to physicians by over 5 percent, effective January 1, 2007. This flawed formula is expected to cut Medicare physician reimbursement even further in subsequent years. Senators Jon Kyl (R-AZ) and Debbie Stabenow (D-MI) led a bipartisan group of 80 Senators in writing to the Senate leadership to address this issue before adjournment. Representatives Nancy Johnson (R-CT) and Ben Cardin (D-MD) instigated a similar letter in the House, urging House action to address the 2007 Medicare physician payment reductions before adjournment in October. The letters call on Congress to provide “a modest increase for physicians as they received a zero increase this year." Calling physicians the "foundation of our nation's health care system," the letters advise that a "stable and predictable payment law...is critical to preserving a patient-centered care system."
ASH continues to work with the Congress to prevent the scheduled 2007 cuts, as well as address the underlying problem of using a flawed formula. ASH members can help by contacting their Representatives and Senators through the ASH™ Advocacy Center. Take action today.
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News Headlines from Washington
Medicare Proposes Cuts to Physician Reimbursement
Medicare has released the 2007 Physician Fee Schedule Proposed Rule. As expected, the rule calls for a cut to physician Medicare payments of 5.1 percent. The Hospital Prospective Payment System Proposed Rule projects a 3 percent payment increase. This rule proposes to tie full outpatient reimbursement to compliance with reporting on inpatient quality measures. To learn how to prevent these cuts and take action, visit the ASH Web site.
Federal Funding for NIH Stalled Until After November Elections
The U.S. Senate and House of Representatives have not yet passed their respective versions of the FY07 Labor-HHS spending bills, which fund the National Institutes of Health (NIH), including the National Heart, Lung, and Blood Institute, the National Cancer Institute, and the National Institute of Diabetes and Digestive Kidney Diseases.
The House bill provides $28.26 billion for NIH in 2007. The Senate bill provides $28.46 billion for NIH, an increase of $220 million (0.8 percent) over FY06. However, funding for NIH is nearly $4 billion less than appropriated in FY05, factoring in inflation, and research advocates believe the lack of adequate funding for health programs will make it difficult for NIH to support crucial medical research.
The Senate and the House are expected to delay consideration of FY07 Labor-HHS spending bills until after the November elections when the Congress is expected to return to Washington for a “lame duck” session. More information is available on the ASH Web site, and the Society continues its advocacy efforts to urge Congress to provide increased funding for the NIH.
FDA Plans to Revamp Process For Selecting Scientific Advisors
The FDA announced that it is taking steps to revise its advisory committee process by providing greater disclosure about individuals who receive financial conflict-of-interest waivers. Over the next few months, FDA plans to issue guidelines that would clarify the conditions under which a candidate for an advisory panel could receive or be denied a waiver for conflict of interest. Under the system FDA is contemplating, waivers could continue and advisory panel members could own stock in a company seeking an FDA approval or be paid as a member of the company’s speakers bureau. However, FDA would rate the extent of the individual’s involvement. The issue of conflicts of interest on government advisory panels has received increased attention in Congress this year as part of proposed reforms at FDA. A drug safety bill drafted by the Senate Health, Education, Labor, and Pensions Committee would require FDA to provide greater disclosure of the financial involvement of its advisory panel members. The House Agriculture Appropriations bill would prohibit FDA from issuing waivers to advisers with financial conflicts.
Medicare to Place Temporary Hold on Payments in September
Medicare will place a brief hold on payments for all Medicare claims from September 22, 2006, through September 30, 2006, as mandated by the Deficit Reduction Act of 2005. No interest will be accrued and no late penalties will be paid to an entity or individual by reason of this one-time hold on payments. All claims held during this time will be paid on October 2, 2006. Visit the Medicare Web Site for more information.
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