Over the past couple of weeks, the newly formed Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup, administered by the Food and Drug Administration, Office of the National Coordinator for HIT (ONC), and Federal Communications Commission, held its first series of virtual meetings and established subgroups. The three subgroups will address taxonomy, risk assessment, and regulatory levers.
The plan is for a series of draft FDASIA Workgroup recommendations to be presented to the ONC HIT Policy Committee on August 7, with final recommendations presented on September 4. The three agencies intend to publish draft strategies/recommendations for public comment between September 2013 and January 2014. The goal is to release a final report by the end of January 2014.
On April 18, the U.S. Department of Health and Human Services (HHS) released the roster of the Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup administered by the Food and Drug Administration, Office of the National Coordinator for HIT (ONC), and Federal Communications Commission. The important objective of the FDASIA Workgroup is to develop recommendations on a risk-based regulatory framework for health IT, including mobile applications. Richard Eaton (staff person, Medical Imaging and Technology Alliance) was selected as a member. Dr. David Bates (Brigham and Women’s Hospital) was identified as the workgroup chair, despite ONC’s informal announcement during the March 27 HIT Standards Committee meeting that Dr. Paul Tang (Chair, HIT Policy Committee) would serve in that capacity.
On April 25, HHS announced ONC’s revocation of certification for EHRMagic-Ambulatory and EHRMagic-Inpatient products by EHRMagic Inc. of Santa Fe Springs, CA. This is the first official revocation of product certification status by ONC.
On April 16, Senate Republicans published a white paper criticizing HHS’ implementation of the Medicare/Medicaid EHR Incentive Program. Most of the issues discussed in the October 2012 Senate and House Republican criticisms are addressed in the white paper, such as EHR-enabled upcoding, oversight concerns, lack of perceived progress on interoperability, and more.
On April 26, the Government Accountability Office (GAO) released a call for nominations for a research community representative slot on the ONC HIT Policy Committee. Nominations are due by May 18.
On April 15, the American College of Radiology submitted comments to the HHS Office of the National Coordinator for HIT and Centers for Medicare and Medicaid Services regarding the March 7 Request for Information (RFI) on interoperability and health information exchange.
ACR’s comments focused on concerns regarding closed EHR donor-recipient exchange relationships facilitated, in part, by a combination of confusion with weak implementation of the interoperability prerequisite to the 2006 EHR exception/safe harbor to self-referral/anti-kickback requirements. The ACR provided recommendations that would push EHR donors to fully enable donation recipients to exchange with imaging providers outside of donors’ systems.
CMS and HHS OIG Publish Proposed Rules on Self-Referral EHR Exception and Anti-Kickback EHR Safe Harbor
On April 10, the HHS Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) published proposed rules regarding the EHR exception to self-referral prohibitions and the EHR safe harbor under the anti-kickback statute. The two proposed rules would extend the expiration date for these items and update donated EHR “interoperability” requirements.
The ACR government relations staff are currently reviewing both proposed rules. Any ACR members interested in providing feedback should contact Michael Peters, Director of Legislative and Regulatory Affairs, at email@example.com/202-223-1670.
On April 9, the Centers for Medicare and Medicaid Services (CMS) announced additional guidance related to the pre-payment and post-payment EHR Incentive Program audits. The recently released material includes a fact sheet addressing supporting documentation that meaningful use participants need for an audit, as well as a sample audit request letter from the CMS contractor, Figliozzi and Company.
Of note, the fact sheet includes an extensive list of potential documentation to demonstrate compliance with the yes/no meaningful use measures (note that certified EHR technology is currently required to automatically calculate the percentage-based measures). Verifying compliance with the yes/no measures was one of the big sticking points of the November 2012 HHS Office of Inspector General report on “oversight of meaningful use.”
On April 5, Dr. Farzad Mostashari (National Coordinator for HIT) announced a much needed update to the public data file that shows de-identified meaningful use attestation data by product, specialty, location, and other attributes. This data file is important because it is the only currently available way for all medical specialties to know how many of their physicians have successfully attested to MU and which products they have been using.
The updated data is apparently current as of January 31, 2013, which means the last minute February 2013 attestations for CY 2012 are not yet included.
The numbers for the American College of Radiology’s membership are as follows:
- Diagnostic radiology: 2657 total attestations from 2457 different diagnostic radiologists
- Interventional radiology: 152 total attestations from 130 different interventional radiologists
- Radiation oncology: 998 total attestations from 948 different radiation oncologists
- Nuclear medicine: 56 total attestations from 55 different nuclear medicine physicians
The American College of Radiology added two new educational resources to its Meaningful Use (MU) Resources page:
- ACR’s Pocket Guide to Meaningful Use in 2013: A two-page pamphlet explaining the basics of MU in CY 2013 with links to pertinent federal resources.
- ACR’s Overview of Stage 1 Meaningful Use Objectives in 2013: This document shows the basic user requirements of all Stage 1 MU objectives in CY 2013. The explanations for each objective include short explanatory notes from ACR, and links to the related federal resources.
More ACR MU educational resources will be coming in future months, including CY 2014 Stage 1 and Stage 2 pocket guides and objective overviews. We also plan to revise or retire older educational resources.
A special thank you to Adeel Siddiqui, MD (Clinical Fellow in Neuroradiology, Johns Hopkins Hospital and Research fellow in Radiology Informatics, Massachusetts General Hospital) for guiding the development of the objectives overview and reviewing the pocket guide.