In This Issue...


LDTs Not in FDA Plans for 2014

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its priority list of guidance documents that it plans to publish in 2014. Absent from the list, for the second year in a row, are the guidance documents pertaining to laboratory developed tests. The agency did state that it plans to release final guidance on In Vitro Companion Diagnostics and, if it has the resources, draft guidance on Direct to Consumer Genetic Testing: IVDs.

CBO Releases List of Potential Cuts -- Including Reductions in Lab Payments

The Congressional Budget Office (CBO) annually produces a listing of potential cuts legislators could adopt to decrease the deficit.  The 2014 listing mentions the establishment of a uniform Medicare cost sharing system as a means for cutting spending.  The adoption of this proposal would require clinical laboratories to collect a 20 percent co-payment from beneficiaries.  AACC opposes the creation of a Medicare copayment for laboratory services. 

CMS Reports More Hospitals Getting Payment Cuts than Bonuses under Value-Based System

The Chief Medical Officer of the Centers for Medicare and Medicaid Services (CMS), Patrick Conway, MD, recently posted the fiscal year 2014 results for the Hospital Value-Based Purchasing program, which provides higher payments to hospitals that meet certain performance factors and lower payments to those that don’t.  According to Dr. Conway, 630 hospitals will receive a bonus in the new fiscal year, while 778 will see a decrease in reimbursement.  Roughly half of all hospitals will break even.  Under the system, each hospital contributes 1.25 percent of its base-operating DRG payments to a common fund that is used to reward high achieving hospitals. 

AACC Initiated AHRQ Study on Troponin -- Open for Public Comment

The Agency for Healthcare Research and Quality (AHRQ) recently released a draft systematic review, Troponin Cardiac Marker Interpretation During Renal Function Impairment.  This study, which was initiated by AACC, examines the use of cardiac troponin levels in patients with chronic kidney disease in four key areas:

  • diagnosis of acute coronary syndrome (ACS);
  • management decisions for ACS;
  • prognosis after presenting with ACS; and
  • risk stratification in patients without symptoms of ACS.

The agency is accepting public comments on the document through December 4th.

AACC Webinar on Strategies for Dealing with Reimbursement Changes

With Medicare and other healthcare providers continuing to ratchet down reimbursement rates for clinical lab tests, lab administrators must remain keenly aware of how these activities will affect their bottom line. Attend this program and learn what payment changes are on the horizon, how they may affect your laboratory, and how to best position your lab to maximize reimbursement in this ‘race’ to cut laboratory fees. To learn more about this December 4th webinar, please visit the AACC website.