May 2010: Volume 36, Number 5

Aiming to fill information gaps and serve as a research resource, the National Institutes of Health (NIH) announced that it is creating a public database that researchers, consumers, healthcare providers, and others can use to search for information submitted voluntarily by genetic test providers. The Genetic Testing Registry (GTR) will work to enhance access to information about the availability, validity, and usefulness of genetic tests. Currently, more than 1,600 genetic tests are available to patients and consumers, but there is no single public resource that provides detailed information about them.

NIH wants the new registry to encourage providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests. It should also provide an information resource for the public, including researchers, healthcare providers and patients, to locate laboratories that offer particular tests, as well as facilitate genomic data-sharing for research and new scientific discoveries. The GTR project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011. GTR genetic test data will be integrated with information in other NIH/NCBI genetic, scientific, and medical databases to facilitate the research process.

NIH wants to engage stakeholders during the development process by seeking input from genetic test developers, test kit manufacturers, healthcare providers, patients, and researchers for their insights on the best way to collect and display test information. Other federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, will be consulted as well.

More information about the Genetic Testing Registry and NCBI is available from the NIH website.

The Department of Health and Human Services (HHS) announced more than $267 million in awards to 28 additional non-profit organizations to establish Health Information Technology Regional Extension Centers (RECs). This money, funded by the American Recovery and Reinvestment Act of 2009, aims to help grow the emerging health information technology industry.

According to HHS, RECs will enable healthcare practitioners to reach out to a local resource for technical assistance, guidance, and information on best practices. RECs are designed to address unique community requirements and to support and accelerate provider efforts to become meaningful users of electronic health records. This round of awards brings the total number of RECs to 60. The full list of awardees is available from the HHS website.

The Center for Medicare and Medicaid Services (CMS) announced a revised version of the Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. The update expands on language in the document to explicitly include use of electronic health records (EHR) and health information exchanges (HIE).

Laboratory information is an integral part of an EHR, and CLIA will require that accurate and reliable lab results be released to the authorized person who ordered the tests, those responsible for using the test results, and the lab that initially requested the tests, according to a memo attached to the revision.

The revisions cover four main areas: electronic transmission of results to authorized individuals; adding EHRs to data retention policy; special considerations for HIEs; and instructions on managing corrected laboratory reports for an EHR.

The memo also explains that CMS anticipates that when standards and practices become more “mature” for the exchange of laboratory information, CMS will again revisit the CLIA Interpretive Guidelines as needed.

The memo and revised Interpretive Guidelines are available from the CLIA website.

A Government Accountability Office (GAO) report found that the Center for Medicare and Medicaid Services (CMS) has not taken full advantage of its Recovery Audit Contractors (RAC), a program intended to revisit claims for any error that might allow CMS to recoup money from providers. The GAO report found that CMS could have recovered an additional $231 million in overpayments identified by RACs during a 3-year demonstration project.

For the RAC national program, CMS developed a process to compile areas vulnerable to overpayment and recommend actions to prevent improper payments. According to GAO, however, the process lacks essential procedures and staff with the authority to ensure that these vulnerabilities are resolved promptly and adequately to prevent further improper payments. Although the RAC demonstration project was supposed to obtain information to help prevent improper payments, GAO found that CMS has yet to deal with 60% of the most significant RAC-identified vulnerabilities that led to improper payments.

GAO is recommending that CMS develop and implement a process that includes policies and procedures to ensure that the agency more promptly evaluates findings of RAC audits, decides on the appropriate response and a time frame for taking action, and acts to correct the vulnerabilities identified.

The report is available from the GAO website.