AAHKS Washington Report

Despite the House of Representatives being in a functional state of recess this past week, there were still several noteworthy federal actions. Three items in particular—the budget, the Patient Protection and Affordable Care Act, and FDA efforts on improving the 510(k) process were of particular importance to the health care world:

Shutdown Averted, What Next?
After reaching a temporary agreement on how to fund disaster aid, Senate Democrats and Republicans passed a bill to keep the government running through at least October 4th, averting a shutdown that would have occurred on September 30th. The House passed this bill shortly thereafter. Originally, the House had passed a bill that would have provided $3.6 billion for disaster aid and offset about $1 billion of that amount with cuts to programs designed to develop alternative-energy technology. Democrats opposed the offsets, saying emergency funding should not be paid for with cuts elsewhere, and the House version never cleared the Senate. With the Federal Emergency Management Agency (FEMA) announcing that they had enough monies to last the remainder of the fiscal year, no offsets were necessary. Upon their return to Washington on October 3rd, lawmakers will need to revisit the FY 2012 budget issue, and the House is expected to take up a bill that would keep the government operating through Nov. 18

SCOTUS and the Affordable Care Act
Last week, the Obama administration petitioned the Supreme Court to decide on the constitutionality of PPACA, making it very likely that the high court will hear at least one of the cases challenging the healthcare reform law before the 2012 presidential election. A panel of the 11th Circuit Court of Appeals, the appeals court covering Alabama, Florida and Georgia, ruled the individual mandate portion of the law unconstitutional. Rather than appeal to the full circuit, the U.S. Department of Justice decided to go straight to the Supreme Court. The 11th Circuit ruling came after the 6th Circuit upheld the law, and the 4th Circuit Court of Appeals ruled that the issue is not ripe for adjudication until after the mandate actually goes into effect in 2014.

A variety of opinions have surfaced as to why the administration bypassed the full 11th Circuit. One school of thought is that the uncertainty of the 2012 presidential election requires immediate action by the administration, given that there could be a Republican administration in office in 2013 and presumably would not defend the law with the vigor of the Obama justice department. Another is that given the conservative makeup of the 11th Circuit that success was unlikely at the full court level, and thus going straight to the Supreme Court was the most logical choice.

FDA Seeks to Streamline 510(k) Process
The FDA announced that it is seeking comment on a new process aimed at making it easier for device makers of new low-to-moderate risk medical devices to gain approval. As those in the orthopaedic device world are keenly aware, currently all device makers looking to market a new product must apply for 510(k) approval, which is for devices that are similar to ones already on the market, even if their device is unlike anything on the market. Only after being denied 510(k) approval can they apply for "de novo" approval. The new proposal would allow device makers to apply for both at the same time so companies need not wait for the 510(k) denial before applying for de novo approval.

Click here to view the proposal. The FDA is seeking comment on the process no later than December 2nd.