In This Issue...

Senate Panel Releases Public Recommendation for Addressing Health Fraud

In 2012, five leading members of the Senate Finance Committee, including Chairman Max Baucus (D-MT), and Ranking Member Orrin Hatch (R-UT), invited public input on ways to combat waste, fraud and  abuse in the Medicare and Medicaid programs.  The panel received 164 comments covering five broad topic areas: improper payments; audit burden; enforcement; data management; and beneficiary protection.  The Finance Committee will review the recommendations in the report to determine whether legislative action is warranted.  The 29 page document is available on the Senate Finance Committee Web site.

Rep. Poe Seeks to Keep ICD-9 Coding System

Representative Ted Poe (R-TX) recently introduced legislation, H.R.1701, which would prevent the Department of Health and Human Services from adopting the ICD-10 coding system.  The bill would also mandate that the General Accountability Office conduct a study to identify steps to reduce any disruptions to health care providers if such a system were adopted.  Physician groups, such as the American Medical Association, have argued that moving to the new coding system would be costly and burdensome for many small practices, forcing many out of business.  The new code set scheduled to replace the existing ICD-9 system on October 1, 2014.  A copy of the Poe legislation is available on the congressional Web site, THOMAS.

PCORI to Develop National Patient-Centered Clinical Research Network

The Patient-Centered Outcomes Research Institute (PCORI) recently announced that it will create a national data infrastructure to advance comparative effectiveness research.  PCORI will allocate $56 million to Clinical Data Research Networks (CDRNs) to conduct randomized CER studies using data from clinical practices in large, defined populations.  The research group will direct another $12 million towards creating Patient-Powered Research Networks (PPRNs) that will create communities of patients with the same clinical condition to share information (data) on their health-related experiences to address questions raised by network members and/or to participate in formal research studies.  A copy of the announcement is available on the PCORI Web site.

FDA Issues New Guidance on Assay Migration Studies

On April 25, 2013, the Food and Drug Administration (FDA) released guidance detailing the least burdensome regulatory approach that manufacturers can employ when seeking to gain approval of a Class III device or certain licensed in vitro diagnostic devices “when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved or licensed.”  “The approach in this guidance is also applicable for some 510(k) cleared devices for which transition to a new system presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used (e.g., nucleic acid amplification tests).”  FDA is accepting comments on the guidance.  A copy of the document is available on the agency Web site.

Oppose New Cuts in Lab Payments

AACC urges you to contact your House and Senate legislators to oppose additional cuts in clinical laboratory reimbursement.  President Obama’s fiscal year 2014 budget would extend the 1.75 percent cut in the CPI update (that was included in the health care reform law) through 2023.  It was due to expire in 2015.  If enacted, lab payments will be cut by an additional $9.5 billion over ten years.