In This Issue...


OIG to Evaluate LDT Oversight

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its 2013 Work Plan, which identifies federal oversight of laboratory developed tests (LDTs) as one of its key studies in 2013. The HHS 'watchdog' agency plans to examine the ability of the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) to oversee the "clinical effectiveness" of LDTs. The OIG plans to make recommendations in fiscal year 2014 on whether FDA should expand its oversight of LDTs.

The agency also plans for conduct laboratory-related studies on:

  • the increase in laboratory tests billed to Medicare over the past decade is medically
    justified;
  • Medicare is overpaying for laboratory tests compared to other public payers; and
  • Providers are over ordering and billing for A1C tests.

A copy of the OIG's 2013 Work Plan is available on the agency Web site

Health Care Think Tank Recommends Lab Competitive Bidding

The Center for American Progress (CAP), a group of leading Washington economists and budget experts, recently recommended in the New England of Journal of Medicine a number of changes to the current health care payment system. According to the Center, nearly 40 percent of federal expenditures will be spent on health care by 2037. CAP suggests health care spending can be restrained through reforming the fee-for-service payment process, such as adopting bundled payments for defined services or implementing a single global payment system for all patient care. The health experts also urge policymakers to expand competitive bidding to medical devices and laboratory services and the Medicare Stark self-referral prohibitions to private payers. To read the entire list of recommendations reforming health care payments, please visit the New England Journal of Medicine Web site.

AHRQ Releases Study on Biomarkers for Assessing and Managing Iron Deficiency Anemia

The Agency for Healthcare Research and Quality (AHRQ) recently released the 10th AACC initiated evidence-based study completed by the agency since 2003 -- "Biomarkers for Assessing and Managing Iron Deficiency Anemia in Late-Stage Chronic Kidney Disease." The findings from the study indicate:

"that all currently available laboratory biomarkers of iron status (either newer or classical markers) do not have an ideal predictive ability when used singly to determine iron deficiency as defined by a response to iron challenge test. Furthermore, we can conclude that there is insufficient evidence to determine the test performance of the combinations of newer biomarkers, or combinations of newer and classical biomarkers, for diagnosing iron deficiency."

AHRQ did state, however, that " it may be that CHr and %HYPO have better predictive ability for a response to IV iron treatment than classical markers (TSAT <20 or ferritin <100 ng/mL) in HD CKD patients. In addition, results from two RCTs showed a reduction in the number of iron status tests and resulting IV iron treatments administered to patients whose iron management was guided by CHr, compared with those guided by TSAT or ferritin. These results suggest that CHr may reduce potential harms from IV iron treatment by lowering the frequency of iron testing."

To view the full Iron deficiency anemia report, please go to the AHRQ web site.

Other recently published AHRQ AACC-initiated studies include: