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The AHA today urged the Centers for Medicare & Medicaid Services to increase the number of hospital-based and physician office laboratories that qualify as applicable laboratories under its proposed rule for the new Clinical Laboratory Fee Schedule to ensure its rates are representative of overall market rates. “[T]he AHA is concerned that, under CMS’s proposed [Tax Identification Number]-level definition, virtually no hospital-based laboratories and only 4 percent of physician office laboratories would qualify as applicable laboratories,” AHA Executive Vice President Tom Nickels wrote. “...Therefore, the weighted median CLFS payment rates would be dominated and driven by payment data submitted primarily by the large independent laboratories – and not actually market based.” AHA also urged CMS to delay implementation of the new payment system until at least 2018 to allow the agency more time to issue guidance on data collection and reporting and engage in end-to-end testing. “Reporting data in the absence of a final rule and comprehensive guidance based on the policies described in the final rule exposes laboratories to compliance risks and enforcement penalties, including civil monetary penalties of up to $10,000 per day for each failure to report or each misrepresentation or omission,” Nickels wrote. AHA also commented on the definition of an advanced diagnostic laboratory test and coding for ADLTs and other clinical tests.