Regulatory Profiles

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February 2014 Clinical Laboratory News: Volume 40, Number 2


In This Issue...

Labs May No Longer Donate Electronic Health Records
Labs will no longer be allowed to donate electronic health records (EHR) to physicians under new rules issued by the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General (OIG) for the Department of Health and Human Services. Since 2006, labs have been under a special exemption from laws meant to prevent physicians from receiving kickbacks—the Stark law and the anti-kickback statute. CMS had hoped that such exemptions would encourage more physicians to adopt EHRs, but now says it created problems and will be reversed for 2014.

According to OIG, some labs abused the exemption, donating EHRs not to improve coordination of care or quality of care, but to benefit financially.

OIG said it also heard from labs that the EHR donations were stifling competition in the lab market and increasing the price of lab services.

More information is available from the OIG website, http://oig.hhs.gov.

Newborn Screening Bill Passes Senate Committee
The Newborn Screening Saves Lives Act, supported by AACC, is now one step closer to passing the U.S. Senate after winning unanimous approval from the Senate Health, Education, Labor, and Pensions (HELP) Committee. Co-sponsored by senators Orrin Hatch (R-Utah) and Kay Hagan (D-N.C.), chair of the Subcommittee on Children and Families, the timeline for passing the bill became key after recent news reports uncovered serious lapses in the newborn screening system at hospitals and laboratories. An investigation by the Milwaukee Journal Sentinel found that some hospital labs were batching newborn screening samples, causing delays in sending them to public health labs for testing and delaying diagnosis.

Hagan included several new provisions in the Newborn Screening Saves Lives Reauthorization Act intended to improve the timeliness of the newborn screening system, including sample collection, delivery, receipt, and testing to ensure a rapid diagnosis and appropriate treatment. These provisions include: allowing Health Resources and Services Administration grants received by states to be used to improve the timeliness of newborn screening systems; requiring that demonstration grants include evaluation of newborn screening timeliness; directing the Advisory Committee on Heritable Disorders in Newborns and Children to provide recommendations, advice, and information on timely collection, delivery, receipt, and screening of specimens to ensure rapid diagnosis and follow up; and clarifying the Centers for Disease Control and Prevention’s role to include laboratory quality and surveillance activities, with a focus on timeliness.

Minnesota Must Destroy 1 Million Newborn Blood Samples
The State of Minnesota and the Minnesota Department of Health reached a settlement over allegedly illegal and improper use of blood samples obtained under the state’s newborn screening program.

More than 20 families filed a lawsuit against the Minnesota Department of Health, accusing it of secretly establishing a bio-bank in 1997 of blood samples and test results from the blood left over after newborn screening. More than 50,000 blood samples and tests results were used for research, including research for drug companies and equipment manufacturers, according to the allegations. The Minnesota Supreme Court ruled in November 2011 that written, informed consent is required for the storage, use, or dissemination of any remaining blood samples or test results after completion of newborn screening.

The lawsuit called for the Minnesota Department of Health to destroy more than 1,100,000 blood samples and 900,000 test results it retained. The settlement also lifts a temporary injunction obtained to preserve the evidence of blood samples and test results pending the litigation. Now that the case has been settled, the blood samples and test results are expected to be destroyed.

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