Building on a significant achievement last year that provided $2 million in new funding for laboratory test harmonization work at the Centers for Disease Control and Prevention (CDC), AACC’s continued advocacy on this issue was behind a House Appropriations Committee vote that could increase harmonization funding to $6 million for fiscal year 2020. Harmonization aims to achieve uniform test results across different laboratories and instruments and ensure the best treatment decisions possible for patients.

The $4 million increase is part of the 2020 Departments of Labor, Health and Human Services, Education, and related agencies spending bill that includes CDC’s budget. The next step is for the entire House of Representatives to vote on the bill. Then it’s up to the Senate to complete work on the measure before both chambers consider a final bill in advance of a September 31 deadline.

AACC for more than a decade had led advocacy for this issue on Capitol Hill, including congressional briefings, grassroots campaigns, meetings with legislators and their staff, and publishing a position statement. AACC will be seeking a new legislative partner since the association’s previous congressional advocate, Rep. Kevin Yoder (R-Kan.), did not win re-election.

So far, CDC has been using this special funding on projects that will enable harmonization of tests for free testosterone, thyroid stimulating hormone, and estrogen. The agency also is examining harmonization for parathyroid hormones, free thyroxine, and free testosterone.

Federal, State Officials Warn of Growing Genetic Testing Fraud

As awareness grows of direct-to-consumer genetic testing kits, local and national government agencies are warning about an uptick in fraud that capitalizes on consumers’ eagerness to take advantage of their genetic information.

Within the federal government, the Department of Health and Human Services Office of Inspector General (OIG) is alerting the public about a fraud scheme in which scammers offer Medicare beneficiaries cheek swabs for genetic testing in order to steal their personal information. Criminals can use the information for identity theft or fraudulent billing. In an announcement, OIG said fraudsters target people through health fairs, telephone calls, booths at public events, and even door-to-door visits. Some of the schemes involve sending a test kit to the victim even if the only goal is to steal personal information. In another approach to this crime, the kit is mailed to the victim before information is requested.

OIG’s warning includes the admonition that “a physician that you know and trust should approve any requests for genetic testing.”

States’ attorneys general also are warning the public about the growing fraud. In some states, scammers have targeted Medicaid beneficiaries by claiming to be working with a local Medicaid insurer. For example, in Louisville, scammers paid $20 to Medicaid recipients as an incentive for them to take a DNA test before requesting their Medicaid insurance information.

In Nebraska, authorities reported receiving multiple reports of groups going to senior living communities, assisted living facilities, and senior centers and offering cheek swabs for DNA testing purportedly to check for cancer.

Some of the fraud involves larger and more sophisticated networks that produce the test kits, send mail, and ostensibly provide customer service through staff call centers. When a viewer alerted television station WTHR in Indianapolis about receiving phone calls and a sample collection kit for DNA testing, a reporter called the customer service line to ask which kind of genetic testing would be performed. “It’s nothing scary. No craziness. It’s just going to tell her if she has the cancer gene,” a representative told the reporter.

Congress Steps into Lab Data Breach Issue

Data breaches of patient financial information from Quest Diagnostics, LabCorp, and Opko Health have caught the attention of local and national legislators, including Senators Bob Menendez and Cory Booker, both New Jersey Democrats. A total of 20 million patient records—12 million from Quest and 7 million from LabCorp—were compromised in a breech of the labs’ billing partner, American Medical Collection Agency (AMCA) over 8 months, beginning in August 1, 2018.

The senators are asking the three companies for detailed information on a timeline of the breach, who was affected, and how the companies plan to prevent future problems. In a letter to the companies, the senators wrote that “patients have a right to expect nothing more from laboratory testing than accurate results and a fair bill; a risk of identify theft should not be part of their testing experience.”

According to Quest and LabCorp, since AMCA was a billing vendor, only financial information, and not laboratory results, were affected by the breach. However, medical information other than that about testing could be vulnerable, according to a statement from Quest. “Certain medical information on AMCA’s affected system was provided by Quest to help patients understand what they were being charged for, and to allow patients to submit an insurance claim where appropriate,” the company said in the statement. AMCA is offering affected patients free credit monitoring and identity theft protection.

Hackers have hit both laboratory companies before. Most recently a ransomware attack targeted LabCorp in July 2018, but the hackers did not steal patient data.

Senators Question Genomic Testing Linked to China

As both China and the U.S. prepare for what could be a protracted battle over trade and technology, Senators Marco Rubio (R-Fla.) and Chuck Grassley (R-Iowa) are asking the Department of Health and Human Services Office of the Inspector General (OIG) to look into how the U.S. shares genomic data with China and whether the U.S. government pays for genomic testing provided by laboratories linked to Chinese companies.

The senators are particularly interested in whether the Centers for Medicare and Medicaid Services (CMS) has paid for genetic testing performed by domestic laboratories that partner with two Chinese firms, Shenzhen BGI Technology Company (BGI) and WuXi Nextcode Genomics (WuXi). The Federal Bureau of Investigation (FBI) has flagged these two companies as having links to the Chinese government, the senators noted in a letter to OIG.

The National Institutes of Health (NIH) has ramped up efforts in recent years to collect and study genomic data through numerous studies and data repositories, and the senators cite in their letter a February OIG report that recommended NIH bolster how it mitigates national security risks from Chinese companies.

Both companies have sought to expand U.S.-based operations. WuXi since 2016 has operated a CLIA-certified genetic sequencing laboratory. And BGI—an early participant in the Human Genome Project—has collaborations with Children’s Hospital of Philadelphia, University of Washington in Seattle, the Bill and Melinda Gates Foundation, and the Smithsonian Institution. All these factors make it “necessary for the OIG to determine whether CMS has the proper security protocols in place to protect Americans’ genetic information,” the senators wrote.

Part of the reason these Chinese firms have come under scrutiny may be their cloud computing ties to Huawei, a company that the Trump administration has effectively banned from U.S. networks.