Regulatory Profiles

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December 2013 Clinical Laboratory News: Volume 39, Number 12


In This Issue...

 

CMS Will Share Data With Quality Researchers

The Centers for Medicare and Medicaid Services (CMS) announced the launch of the CMS Virtual Research Data Center (VRDC), part of President Obama’s Big Data Research and Development Initiative, which aims to improve researchers’ ability to gain insights from large and complex collections of digital data. The VRDC offers a secure means for researchers to virtually access and analyze CMS’s vast store of healthcare data.  

Researchers will be able to access CMS data from their own workstations and perform analyses and manipulate data within the VRDC. Historically, CMS has filled researchers’ data requests by preparing and shipping encrypted data files. But given the rapidly growing demand for timelier Medicare and Medicaid data, the agency was looking for a less resource-intensive means to respond to these data requests.

“We’re acutely aware of the huge potential that CMS data holds for creating a more efficient, higher quality healthcare system, and researchers play a large part in this transformation,” said CMS Administrator Marilyn Tavenner. “By providing researchers with secure, timely, and affordable access to CMS data, the agency is making it easier to do the important research that will lay the foundation for better quality and lower costs in the healthcare system.”

The VRDC offers researchers several advantages over the traditional shipped encrypted data files, including significantly lower cost. Physical delivery of a large sample of Medicare data can cost more than $100,000 for just one year of data.  In contrast, using the VRDC, a single researcher conducting one project over the course of the year can access as much Medicare data as needed for approximately $40,000. Additionally, researchers will not need to maintain expensive computer systems of their own because they will access the data within CMS’s own virtual desktop. Keeping data within the VRDC virtual environment also helps protect against breaches of individually-identifiable information about Medicare beneficiaries.

More information on the VRDC is available online.  

HHS Moves to Develop New, Faster Anthrax Blood Test

The U.S. Department of Health and Human Services (HHS) will support development of a rapid blood test for anthrax infection that can be used by clinical labs following an anthrax attack. The test is the first for anthrax to be supported by the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response.

With a rapid, accurate blood test, healthcare providers would be able to identify people who are ill as early as possible, provide the appropriate medical treatment to save lives, and minimize unnecessary use of medications or hospitalization, according to HHS. If cleared by the Food and Drug Administration (FDA), the test could be used in labs in an affected area after bioterrorism surveillance detects an anthrax release that subsequently is confirmed by state and local labs.

“This project is the first that BARDA will sponsor to develop new diagnostics for biothreats for use during public health emergencies,” said BARDA Director Robin Robinson, PhD. “Quickly identifying people exposed to anthrax is crucial to providing appropriate care.”

HHS has contracted with MRIGlobal of Kansas City, Mo., for 15 months and approximately $1.6 million to develop the new test. The development work includes studies needed to apply for FDA approval of the test for use on a commercially available lab testing instrument, the ABI7500 Fast Dx, made by Life Technologies.

More information about BARDA’s research and development of medical countermeasures is available online.

New York to Require Hospitals to Offer Hepatitis C Testing

New York Governor Andrew Cuomo signed a new law aimed at protecting baby boomer New Yorkers from hepatitis C that will require hospitals and other health service providers to offer testing for the virus to all patients born between 1945 and 1965.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 75% of hepatitis C infection and about 73% of hepatitis C-associated mortality occurs in individuals born between 1945 and 1965. New York State Department of Health statistics show that as many as 150,000 New Yorkers are unaware of their hepatitis C status. The new law (A.1286-A/S.2750-A) will ensure that all individuals born between 1945 and 1965 are offered a hepatitis C screening test or diagnostic test whenever they are a patient at a hospital, clinic, or a physician’s office.

“Hepatitis C is a debilitating and potentially fatal disease that disproportionately affects the baby boomer generation in New York and nationwide,” Cuomo said in a statement after signing the bill. “This new law will help fight hepatitis C and keep New Yorkers safe by providing testing to those most likely to have this virus whenever they visit a medical facility.”

The new law will take effect on January 1, 2014. The bill is available from the state’s website.

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