In This Issue...


House Democrats Urge OMB to Release LDT Guidance

A number of leading House Democrats recently wrote to the Office of Management and Budget (OMB) urging the agency to release the Food and Drug Administration’s (FDA’s) guidance on laboratory developed tests (LDTs).  The letter, signed by Reps. Louise Slaughter, Rosa DeLauro, and Debbie Wasserman Schultz, and six other leading Democrats, asserts that it is “essential that FDA move this guidance forward to ensure oversight of safe and effective diagnostics.”  The House members particularly expressed concerns about molecular diagnostics stating that “widespread development and use of a new generation of advanced molecular diagnostics by clinical laboratories without FDA oversight has exposed a significant gap in the regulatory system.”  The legislators further added that its “imperative” the FDA assure the “safety and effectiveness” of molecular tests “prior to their use.”  Rep. Slaughter sent a similar letter to the OMB in June.  The FDA has not yet given Congress the required 60 day notice prior to releasing the LDT guidance documents.

CMS Releases Long-Awaited IQCP Document

The Centers for Medicare and Medicaid Services (CMS) recently released its new Individualized Quality Control Plan (IQCP), which will give laboratories alternative options for complying with the CLIA’88 quality control requirements.  CMS is planning a two-year transition plan to implement IQCP, while phasing out the equivalent quality control (EQC) option.  Therefore, labs will have the option of meeting the CLIA QC requirements for the next two years by:

  1. following the current CLIA standards as written; 
  2. adopting IQCP; or 
  3. continuing to use EQC. 

As of January 1, 2016, EQC will no longer be permitted.  Whether a laboratory chooses this voluntary option is the prerogative of the laboratory director, who is also responsible for ensuring CLIA’88 compliance.  AACC will be conducting a webinar on this topic with Judy Yost MT (ASCP), CMS, Director of the CLIA program, on November 14th.  For more information about the program, please go to the AACC site.  If you use the product code 146, you will get 20 percent off the cost of the program.  A copy of the new guidance is available on the CMS website.   

OIG Recommends CMS Improve Its Oversight of RACs


The Department of Health and Human Services (HHS)  Office of the Inspector General  (OIG) recently released a report entitled, “Medicare Recovery Audit Contractors and CMS’s Actions to Address Improper Payments, Referrals of Potential Fraud, and Performance,” which examined the role of RACs in identifying wrongful Medicare payments and the agency’s efforts to recapture the money.   For fiscal years 2010 and 2011, the OIG states that RACs identified $1.3 billion in improper payments. Although CMS took corrective actions in more than half the cases, it failed to evaluate the effectiveness of these actions.   In addition, CMS neglected to take action against six health care providers identified as potential sources of fraud by the RACs.  The OIG is recommending that CMS address these deficiencies.  The report is available on the OIG website.