A press release on Rep. Waters' web site stated the bill would require health insurance plans to cover routine HIV tests under the same terms and conditions as other routine health screenings. "Standard health insurance plans now cover HIV tests only when there are clinical indications of infection or when there are known risk factors present, but they should cover HIV tests as routine procedures," said Congresswoman Waters in the press release. "Routine HIV screening is a key to stopping the spread of HIV/AIDS. It will encourage more people to get tested and raise awareness about the continuing risk of the disease. It will also allow thousands of Americans who are living with HIV/AIDS but do not know it to find out about their infection, begin life-extending treatment, and avoid spreading the virus to others."

The legislation has been referred to the Committee on Energy and Commerce, and to the Committees on Education and Labor, Ways and Means, and Oversight and Government Reform.


Federal: DOJ Settles with Quest Diagnostics over Misbranded Test Kits

The U.S. Department of Justice (DOJ) has announced that Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits the DOJ says NID manufactured, marketed and sold to laboratories in the U.S. until 2006. Part of the settlement is a payment of $302 million to resolve the allegations. According to a press release by the DOJ, this payment represents one of the largest recoveries ever in a case involving a medical device.

As part of the criminal resolution, NID pleaded guilty in a U.S. District Court in Brooklyn, New York to a felony misbranding charge in violation of the Food, Drug and Cosmetic Act relating to NID's Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay. The DOJ says this test was used by laboratories throughout the country to measure parathyroid hormone (PTH) levels in patients. As per the plea agreement, NID will pay a criminal fine of $40 million. Quest has also entered into a non-prosecution agreement with the United States.

For the civil settlement, the DOJ says that Quest and NID will pay the United States $262 million plus interest to resolve False Claims Act allegations relating to the Advantage Intact as well as four other NID assays that allegedly provided inaccurate and unreliable results. Quest has also agreed to pay various state Medicaid programs approximately $6.2 million for similar civil claims. The DOJ's press release says that Quest has also entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

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