July 2010 Clinical Laboratory News: Regulatory Profiles

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July 2010: Volume 36, Number 7




AHRQ Makes Public Quality Reporting Easier

The Agency for Healthcare Research and Quality (AHRQ) has launched a free, Microsoft Windows-based software application aimed at significantly reducing the cost and time that a state, hospital, or other organization needs to spend compiling, analyzing, and posting data on quality of hospital care. Called MONAHRQ—My Own Network Powered by AHRQ—the software allows users to create a customized website with data that can be used both for internal quality improvement and reporting quality information to the public. Currently, many states require that quality data be reported publicly and other states are considering doing so.

The cost of creating a hospital’s own website with this data is estimated to be $300,000 or more, and the time required could be up to 1 year, according to states that tested MONAHRQ as it was being developed. MONAHRQ can cut that time to a few days.

A state or other organization, referred to as the host user, can download MONAHRQ from AHRQ's website and enter its own hospital administrative data, which includes such elements as patient characteristics, diagnoses, procedures, health insurance type, and charges. MONAHRQ processes that information and then creates a website that the host user can customize by selecting a specific color scheme, inserting logos, and using other features.

The download and more information are available on the new MONAHRQ website.

Bill Aims to Cut Financial Ties Between FDA, Industry

Representative Maurice Hinchey (D-N.Y.) introduced legislation, H.R. 4816, the Food and Drug Administration Improvement Act of 2010, that would eliminate the direct payment user fees to FDA and redirect them to the Department of Treasury. The objective of the bill is to eliminate direct ties between FDA and the industries it regulates.

The bill would also require drug and device manufacturers to pay additional fees for FDA to oversee and regulate advertisements and require all FDA advisory panels to be composed of qualified experts who do not have any financial ties to companies. In addition, the bill would permit the public to file lawsuits against medical device manufacturers in state courts if they or family members are harmed or killed by a medical device.

According to Hinchey, FDA has become too cozy with industry, while at the same time continues to operate without the sufficient independent authority needed to fulfill its mission of protecting the public. The bill has been referred to the House Energy and Commerce Committee.

Hinchey’s press release describing the legislation is available on his congressional website.

Plans  CBO Revises Potential Costs of Healthcare Reform

The Congressional Budget Office (CBO) has issued a new cost analysis of the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148) that reduces the proposed saving of reform legislation from its earlier reports. Previously CBO projected a surplus of $143 billion over 10 years (2010–2019) from the reform law. The new estimate slashes that figure to $28 billion.

In particular, the new report provides an update of the earlier tally of specified authorization amounts, as well as a list of programs or activities for which the reform legislation did not identify specific funding levels, but instead authorizes Congress to appropriate “such sums as may be necessary.”

The report underscores the fact that the law establishes a number of new programs and activities, as well as authorizing new funding for existing programs that by their nature are subject to future appropriation decisions by Congress. This could mean greater or smaller costs than what the legislation originally set out.

CBO estimates that it would cost the government in excess of $115 billion to fund those projects for which the law provides guidelines, yet more than 40 programs remain for which legislators provided no spending guidelines and so CBO has no estimate. These programs include the remodeled AHRQ preventive services task force and the National Health Care Workforce Commission.

The new CBO analysis is available from the CBO website.

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