Health Care Reform - On February 25, the White House convened a six-hour bipartisan, bicameral, televised health reform summit. In advance of the meeting, the President released a summary proposal to "bridge the gap" between the House- and Senate-passed health care reform bills. The President's plan is based on the Senate bill, but key changes would close the Medicare Part D "donut hole"; require states to update plans to reduce drug utilization; ban settlements between brand and generic companies; and increase the fee on brand pharmaceuticals by $10 billion over 10 years, with the fee starting in 2011. The summit was structured to cover four issues: controlling costs; overhauling insurance regulations; reducing the deficit; and expanding health coverage. President Obama tried to moderate a real discussion and to avoid having Democrats and Republicans simply trade talking points, but coming out of the summit, bipartisanship remains elusive. The path forward for health care reform remains uncertain, but Democrats are considering several legislative strategies.
President's Budget Request - The President's $3.8 trillion fiscal year (FY) 2011 budget proposal was released at the beginning of this month. The budget assumes passage of some form of health care reform legislation. Major Health and Human Services (HHS) provisions of the budget include: $1 billion in new spending for the National Institutes of Health (NIH); increased funding for health information technology, health research, preventative care, autism and HIV/AIDS programs; and increased funding for FDA food safety programs. Additional proposals of interest include the following:
- $561 million in discretionary resources, an increase of $250 million over FY 2010 levels, to strengthen Medicare and Medicaid program integrity activities, with a particular emphasis on fighting health care fraud in the field, increasing Medicaid audits, and strengthening program oversight while reducing costs (includes funds to increase claims oversight and reduce overutilization of Medicaid prescription drugs);
- $1.4 billion, an increase of $101 million, for the FDA Medical Product Safety Initiative-the $101 million increase includes an additional $40 million to the generic drugs program, at least $10 million for postmarket drug safety;
- $25 million for advancing regulatory science at FDA, which includes resources to enable FDA to provide regulatory pathways for new technologies, such as biosimilars; · $1.1 billion for comparative effectiveness research on different medical treatments;
- New user fees, including a generic drug user fee (budgeted to raise $38 million in 2011) and a reinspection user fee requiring manufacturers to pay the full costs of reinspections and associated follow-up work (budgeted to raise $27 million in 2011); and
- $5 million to improve access to drugs as authorized by section 340B of the Public Health Service Act, allowing federally funded grantees and other health safety net providers to purchase medications at significantly discounted prices.
Food Safety Reform - The Senate will likely bring S.510, the FDA Food Safety Modernization Act, to the floor before the Easter recess. Committee staff have recently begun the process of walking through the legislation and assembling final changes to the legislation to include as part of a manager's amendment.