In This Issue...


House Panel Approves PT Referral Bill

On September 11, 2012, the House Energy and Commerce Subcommittee on Health unanimously approved H.R.6118, the Taking Essential Steps for Testing Act. This legislation would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) to give the Centers for Medicare and Medicaid Services (CMS) greater flexibility when punishing laboratories that send a proficiency testing (PT) specimen to an outside laboratory for analysis. Currently, CMS revokes a laboratory's certificate for two years and bars the laboratory director from directing a clinical laboratory for two years-regardless of whether the specimen was sent in error or not. H.R.6118 would permit CMS to impose lesser penalties if warranted. AACC has endorsed this measure. For a copy of the bill, please go to the congressional Web site, THOMAS, by clicking here. To see AACC’s endorsement, please go to the Association’s position statements page.

IOM Urges Transformation of Health Care System

On September 6, 2012, the Institute of Medicine (IOM) issued a report entitled, "The Best Care at Lower Cost: The Path to Continuously Learning Health Care in America," which urges an overhaul of the American health care system. The research group suggests that 30 percent of health care spending—roughly $750 billion annually -- is "wasted on unnecessary services, excessive administrative costs, fraud, and other problems."

IOM suggests a number of changes to improve the system, including:

  • greater and better use of electronic health data;
  • streamlined federal regulations;
  • financial incentives to reward continuous learning; and
  • more community partnerships.

To read the complete report, please go to the IOM Web site.

CMS Issues Initial Molecular Recommendations

CMS recently released its preliminary payment recommendations for the 2013 new molecular pathology test codes. The agency is proposing to keep the molecular tests on the clinical laboratory fee schedule (CLFS), but leaves open the option of shifting some of the tests to the physician fee schedule (PFS). CMS has previously stated that it prefers to place all of the molecular tests on a single fee schedule rather than dividing them among the two.

In general, the agency decision reflects the recommendations of the non pathology clinical laboratory associations. AACC objected to placing all of the molecular tests on the PFS, since many of these tests are interpreted by PhDs.  AAB and ACLA voiced similar concerns. CAP, AMP and ASCP urged CMS to place all of the tests on the PFS. CMS is accepting comments on the proposal through the end-of-the-month. The agency will publish its final decision this fall. For a copy of the recommendations, please visit the CMS Web site. To see AACC’s comments, please go to the Association’s position statements page.

CMS Removes Troponin Measure from Hospital Quality Report Set

CMS has removed OP-16 Troponin results for Emergency Department acute myocardia infarction (AMI) patients or chest pain patients received within 60 minutes of arrival from its Hospital Outpatient Quality Reporting measure set. This hospital information was to be included in the overall list of measures used by the agency to evaluate hospital performance and calculate outpatient payment updates. CMS responded to an early July recall by the Food and Drug Administration (FDA) of certain Class I POC test kits, which generated false results. According to the FDA, a Class I recall occurs when “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The CMS decision took effect on August 13th. A copy of the CMS document is available on the AHA Web site.

AACC’s Next Government Affairs Webinar:

The Impact of Comparative Effectiveness Research on Laboratory Medicine
Wednesday, October 17, 2012
2:00 - 2:45pm Eastern Time U.S.

Over the past decade, the Agency for Healthcare Research and Quality (AHRQ) has been the leading federal agency in comparative effectiveness research. The scope of its research ranges from diagnostics and research methodologies to patient care and medical errors. Joining AHRQ in the CER arena is the Patient Centered Outcomes Research Institute, which will spend more than a billion dollars on this research over the next ten years. Come hear what CER means for clinical laboratories. Also discover how the information from CER studies is being utilized, what challenges researchers are encountering and what is being done to overcome them.