GAO Sees Gloomy Fiscal Outlook without Health Reform

As the U.S. Supreme Court decides the fate of the Patient Protection and Affordable Care Act, a new report from the Government Accountability Office says that healthcare costs could soar if the law is overturned, further adding to the long-term challenge posed by the federal deficits and debt.

In its latest update of the federal government’s long-term fiscal outlook, the GAO makes projections based on two models, one baseline model that generally reflects current law, and another alternative model that assumes cost-containment mechanisms are not sustained over the long term. Even with the Affordable Care Act implemented as intended, the “structural gap between revenues and spending driven by rising healthcare costs and demographics” would not be closed, according to the GAO.
But spending on healthcare would grow “much more rapidly” in the alternative scenario, causing spending on Medicare and Medicaid to grow to more than 8 percent of GDP by 2030 from 5 percent of GDP in 2010. The baseline model finds Medicare and Medicaid growing to 7 percent under the baseline simulation, it says.

http://www.burrillreport.com/article-gao_sees_gloomy_fiscal_outlook_without_health_reform.html

GAO Says Device Reviews Are Taking Longer…and FDA Says It Is Because Your Submission had Quality Issues

In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and premarket approval (“PMA”) applications.

The study found that while FDA met performance goals for 510(k)s and the average number of submissions per year remained generally steady during fiscal year (“FY”) 2003 through FY 2010, the review times for 510(k)s increased.  Likewise, review times for PMAs also increased despite FDA meeting most performance goals for PMA applications.  There has also been a decrease in the number of 510(k) clearance determinations and PMA approvals.  In sum, FDA is taking longer to complete the reviews of 510(k)s and PMAs when the purpose of the user fee program was to streamline the regulatory process.

And who is responsible for this unintended effect?  While assuming some responsibility, FDA points a heavy finger at industry stakeholders.  We will explain this further below, after first providing a brief overview of the device user fee program and discussing the noteworthy GAO study results.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/gao-says-device-reviews-are-taking-longerand-fda-says-it-is-because-your-submission-had-quality-issu.html

GAO: FDA "inconsistent" in meeting performance goals

March 30, 2012 by MassDevice staff

The FDA met most performance goals between 2003 and 2010, but was inconsistent in its review of pre-market approval applications, especially those marked "expedited," according to a Government Accountability Office report.

The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.

"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."