In This Issue...


AMA Urges HHS to Reconsider New ICD-10 Codes

The American Medical Association (AMA) has written to Health and Human Services (HHS) Secretary Kathleen Sebelius urging her to ‘reconsider’ the Department’s decision to implement the ICD-10 codes.  According to the medical society, the new coding system, which takes effect October 1st, would significantly increase the regulatory burden and costs to physicians without any corresponding improvement in patient care.  A cost analysis of the impact on small physician practices indicates that the ICD-10 coding system will cost physicians  $56,000 to $226,000 to implement. Senator Tom Coburn (R-OK), and a number of his colleagues, have introduced legislation, S.972, the Cutting Costly Codes Act of 2013, that would bar HHS from implementing the new ICD-10 codes.  As of now, HHS is unlikely to further delay the ICD-10 state date.      

HHS OIG Releases 2014 Work Plan

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its annual listing of investigative studies that it plans to conduct in 2014.  The document lists fewer laboratory-related studies than in years past.  One ongoing study is examining the recent growth in laboratory test volume and Medicare claims to determine whether laboratories are billing for unnecessary tests.  Another report, considered to be of more importance to many laboratories, is noticeably absent from the work plan--the OIG’s study on federal oversight of laboratory developed tests, which was due out in 2014.  For a complete listing of the 2014 studies, please go to the agency’s website.

CDRH Identifies Strategic Priorities for 2014

The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued its 2014 priorities. This year, the agency plans to focus its attention on three main areas: streamlining the clinical trials process; reforming the premarket and post-market data collection process; and improving its customer service.  For more details, please visit the FDA website.

FDA Requires Electronic Submission of Adverse Events in 2015

On February 14th, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) published a final Q&A guidance for manufacturers detailing their responsibilities for documenting and submitting information regarding adverse events.  The document requires all manufacturers to file adverse event submissions electronically starting on August 14, 2015.  For more information on the changes, please visit the FDA website.

PCORI Announces $200 million in CER Funding

The Patient-Centered Outcomes Research Institute (PCORI) issued eight new funding announcements for comparative effectiveness research projects totaling more than $200 million.  The congressional mandated research group plans to spend more than $1 billion over the next two years on CER research.  According to PCORI Executive Director Joe Selby, MD, MPH, the group expects to fund “bigger, longer comparative studies that can address complex questions and provide more definitive answers” for improving health care decision-making.  Since it opened in 2012, PCORI has awarded more than $464 million for patient-centered research studies.  For more about PCORI activities, please visit the research groups website.

AACC/FDA Webinar on New Draft Blood Glucose Monitor Guidance

On March 19th, AACC is sponsoring a webinar on the new Food and Drug Administration (FDA) draft guidance on blood glucose monitors used in professional settings.  Although the intent is to improve patient care, the document, if implemented, could have far-reaching implications for device manufacturers, hospitals, long-term care facilities and other health care providers.  Join us for a 60-minute discussion with the FDA on this important topic.