AACC is supporting a recommendation from the Centers for Medicare and Medicaid Services (CMS) that would exempt molecular pathology tests and so-called advanced diagnostic laboratory tests (ADLTs) from the agency’s 14-day rule, also referred to as the Medicare date of service regulation.
Currently, the rule only allows a hospital to bill for laboratory testing within 14 days of a patient’s discharge when testing is performed using a sample collected at the hospital. This creates problems for hospitals when an independent laboratory performs testing within that 14-day window, as the independent lab cannot bill Medicare and so bills the hospital. Further complicating matters are cases in which the hospital and the independent lab are in different jurisdictions with different coverage policies and payment rates. The rule also has forced some hospitals to bar physicians from ordering certain esoteric tests due to prohibitive billing problems and costs.
AACC wrote to CMS in support of the overall recommendation that would exempt some tests from the rule, which the association noted had led to “administrative and financial problems for hospitals and commercial laboratories.” However, AACC is recommending several changes, including that CMS broaden its terminology around molecular pathology test codes excluded from the rule. The additional test codes AACC wants to see excluded include genomic sequencing procedures as well as other advanced tests that have codes under the rubric of multi-analyte assays with algorithmic analyses and proprietary lab codes that involve analysis of DNA or RNA.
AACC also recommends that the same criteria apply to ADLTs since any Food and Drug Administration-approved test or panel of multiple proteins can qualify as an ADLT without being based on DNA or RNA.