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AACC Calls for Improved Oversight of Waived Testing Laboratories

Federal Insider: November 2018

In a new position statement, AACC encourages renewed federal surveillance of certificate of waiver laboratories such as physician offices, pharmacies, and home health agencies, to ensure patient safety and quality of care. In the statement, AACC urges Congress to direct the Department of Health and Human Services to study waived testing sites and recommend ways to improve quality. The association also calls for enhanced training of waived testing personnel and voluntary proficiency testing for these facilities.

Over the last several decades, the number of waived tests—and the number of sites that perform waived testing—has grown dramatically. AACC notes that when CLIA was implemented, only eight tests were waived. Now there are more than 130. Similarly, since 1993, the number of facilities performing only waived testing has grown more than 170% and now represents 71% of all clinical laboratory testing sites.

These sites receive scant federal oversight. By definition, waived tests are determined by regulators to be so simple that the chance of error is low. As such, sites that perform only waived testing are not subject to personnel, quality control, or proficiency testing requirements. These labs only must promise to follow manufacturers’ test instructions and to permit inspections by regulators—only, there are no inspections.

Studies have shown that many of these testing sites perform clinical tests incorrectly. For example, the Centers for Medicare and Medicaid Services (CMS) in the past conducted surveys of a sample of certificate of waiver sites and found about one-third did not have or did not follow test instructions.

To improve quality, AACC recommends that the government not only study the issue, but also provide ongoing educational programs designed to improve the quality of testing in these laboratories. The association also is encouraging certificate of waiver laboratories to improve their training practices by, for example, hiring qualified clinical laboratory professionals as consultants to supervise and train personnel onsite.

CMS Touts Latest Deregulation Push

The Centers for Medicare and Medicaid Services (CMS) is following through on its promise to cut paperwork and regulation with a proposed rule that the agency says will save hospitals $1.12 billion per year. Many of the proposals simplify and streamline Medicare’s conditions of participation and conditions for coverage. These standards document requirements for providers to receive Medicare reimbursement.

The proposed rule also would make quality reporting easier for large, multi-hospital systems with streamlined quality scores and would update the personnel requirements for portable x-ray technologists, allowing more hospital staff to perform testing.

House Bill Would Cut Employer Health Insurance Requirements

The House expects to consider a bill after the midterm elections that would significantly roll back provisions of the Affordable Care Act (ACA), especially for small employers. Sponsored by Rep. Jackie Walorski (R-Ind.), the Save American Workers Act of 2018 would change the definition of full-time work under the ACA to 40 hours per week rather than 30. Under the ACA, employers with 50 or more employees are required to offer health insurance or else pay a tax penalty for full-time employees. Critics of the ACA have argued that the requirement encouraged businesses to cut employee hours in order to limit health insurance costs.

The bill would also chip away at the employer mandate itself by eliminating 2015-2018 penalties for employers who did not previously comply with the insurance requirement. The bill also would delay the so-called Cadillac tax on expensive health insurance plans until 2023 and repeal the tax on indoor tanning services. Together, all provisions in the bill would cost $51.6 billion over the next decade, according to the Congressional Budget Office.

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