American Clinical Laboratory Association

Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the “Proposed Rule”) released by CMS earlier this month. If finalized, these proposals would likely expand the number of laboratories, including hospital laboratories, subject to PAMA’s reporting requirements and may ultimately impact the rates paid under the Medicare Clinical Laboratory Fee Schedule (“MCLFS”).

As discussed in a previous post, PAMA made sweeping changes to the rate-setting process under the MCLFS. PAMA and its implementing regulations require “applicable laboratories” to report the private payor rates they receive for laboratory tests during specific data collection periods, and those rates then determine the rates paid under the MCLFS. Continue Reading Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

The Senate approved the previously House-passed Taking Essential Steps for Testing Act  (also known as the “TEST Act”) this week, clearing the way for President Obama’s signature and enactment.  The legislation, which amends a provision of the Clinical Laboratory Improvement Amendments (CLIA), makes clear that the Centers for Medicare & Medicaid Services (CMS) has the authority to impose intermediate sanctions instead of revoking the CLIA certificate of a laboratory that has referred a proficiency testing sample to another laboratory.  The TEST Act was introduced by Rep. Michael Grimm (R-NY), and it quickly gained wide bipartisan support.  According to the American Clinical Laboratory Association, “[t]he bill grants [CMS] much-needed discretion so that clinical laboratories will not have their CLIA certificates revoked for the unintentional referral of proficiency testing samples to other laboratories.”   The legislation also received support from the College of American Pathologists.