In This Issue...


FDA Issues Draft Guidance Document on Blood Glucose Meters

On January 7, 2014, the Food and Drug Administration (FDA) issued two draft guidance documents for blood glucose monitors.  The first, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use,” is for health care providers, whereas the second, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use,” is for home-use.  This is the first time the agency has made a distinction between the two sites for 510(k) submissions.

According to the FDA, a number of concerns have emerged in recent years that led them to regulate the intended use differently, such as:

  • Concerns over infection control, particularly in regards to the spread of bloodborne pathogens;
  • Questions about the safety and effectiveness of the devices given their use with “acutely ill and medically fragile;” and
  • Uncertainty about the accuracy of some meters that could result in harmful medical decisions.

The agency documents also indicate a change in how the meters will be regulated in different settings.  Currently, all blood glucose meters are waived under CLIA’88.  For lay users, the home use device will remain within that category.  However, the professional use meters will be categorized as moderate complexity, which has different personnel and quality control requirements.  To view the documents, please go to the FDA website.  The agency will be accepting public comments through April 7th.

Congress Approves FY'14 Funding Bill

The House of Representatives and Senate have passed H.R.3547, the Consolidated Appropriations Act of 2014, which funds federal agencies through the end of the current fiscal year.  The $1.1 trillion dollar measure reflects the December 2013 budget agreement  reduced the broad cuts mandated by sequestration by adopting specific spending reductions.  Under the new deal, a number of agencies received spending increases over last year’s levels, such as:

  • The National Institutes of Health – $ 1 billion increase
  • Centers for Disease Control and Prevention -- $567 million increase
  • Food and Drug Administration -- $217 million increase

On the losing end was the Centers for Medicare and Medicaid Services, which received a $195 million reduction.  On the plus side, funding for the NIH National Children’s Study remained steady at $165 million.  For a more detailed summary of the agreement, please go the Senate Appropriations Committee website.

CMS Not Doing Enough to Stop Medicare Fraud Linked to EHRs

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently released a study entitled, “CMS and Its Contactors Have Adopted Few Program Integrity Practices To Address Vulnerabilities in EHRs,” which examined the failure of the agency implement up-to-date fraud techniques to address the shift from a paper to electronic records environment.   The OIG is recommending that CMS:

  • work with contractors to identify best practices and develop guidance and tools for detecting fraud associated with EHRs; and
  • direct its contractors to use providers' audit logs to distinguish EHRs from paper medical records when reviewing medical records.

The complete report is on the OIG website.

A Q&A With the FDA on the RUO/IUO Final Guidance

On February 26, 2014, AACC will be conducting a webinar with the Food and Drug Administration to explore the agency’s final guidance on the sale and use of research use and investigational use only products.  Although the guidance is directed towards industry, clinical labs are worried that manufacturers may limit or stop selling RUO/IUO reagents out of concern they will be used to generate clinical diagnostic results.  Join us for this 60-minute webinar and learn which concerns are valid, which are unwarranted, and what you would need to do to be in compliance.