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Archive for November, 2013

Energy and Commerce Health Subcommittee Hearing on FDA Oversight of Mobile Apps and Other Software

November 19, 2013 Leave a comment

On November 19, the House Energy and Commerce Health Subcommittee held a hearing on “Examining Federal Regulation of Mobile Medical Apps and Other Health Software.” Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health; Dr. J. Leonard Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society; and assorted representatives of the health IT industry participated as witnesses.

The hearing was primarily focused on the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013 (HR 3303), a bill that would codify certain aspects of FDA’s guidance on mobile medical applications while adding restrictions on FDA’s regulatory authority over certain types of software. FDA’s concern is that the current version of the bill would remove the agency’s existing authority over diagnostic software such as electronic blood glucose meters, computer-aided detection (CAD), and more.

As of this writing, the SOFTWARE Act only has 7 cosponsors and no Senate counterpart.

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Categories: EHR, FDA, radiation safety

RSNA 2013: Latest Developments in Meaningful Use, Ask the Experts

November 14, 2013 Leave a comment

For readers interested in learning more about the EHR Incentive Program and the American College of Radiology’s related advocacy efforts, I am participating in a refresher course at RSNA 2013 on December 5 at 8:30AM titled “Latest Developments in Meaningful Use: Ask the Experts” (RC626).  The session will be held in room E451A.

Curtis P. Langlotz MD, PhD will moderate, and Keith J. Dreyer DO, PhD and I are slated to present. There should be plenty of time and opportunity for extensive Q&A.

Categories: EHR, meaningful use, Medicare

Final Rules on EHR Exception and Safe Harbor from Self-Referral/Anti-Kickback Now Under OMB Review

November 8, 2013 Leave a comment

The Centers for Medicare and Medicaid Services (CMS) submitted its final rule “Physicians’ Referrals to Health Care Entities with Which They Have Financial Relationships; Amending the Exception for Certain Electronic Health Records Arrangements” to the Office of Management and Budget (OMB) for regulatory review on November 7. The HHS Office of Inspector General (OIG) its final rule “Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute” to OMB on November 6.  The final rules are expected to renew and revise the EHR exception and safe harbor from self-referral/anti-kickback requirements.

The OMB Office of Information and Regulatory Affairs will likely expedite its review process given that the 2006 EHR exception and safe harbor will sunset at the end of 2013. The final rules will likely be submitted for publication in the Federal Register (i.e., publicly accessible for the first time) in December 2013.

Categories: EHR, Medicare

Many Vendors Continue to Struggle with 2014 Edition EHR Certification Criteria

November 7, 2013 1 comment

On November 6, the Office of the National Coordinator for HIT (ONC) HIT Policy Committee held its first business meeting since the federal government shutdown. The most interesting discussion was an update from ONC staff on the certification status of products supporting the Medicare/Medicaid EHR Incentive Programs (“meaningful use” or MU).

As of October 21, only 33 vendors with 2011 Edition certified products used by eligible professionals (EPs) in previous years of MU are now offering 2014 Edition certified products. Of those, only 22 vendors now offer products certified for all criteria in the “Base EHR” definition. Note that this data is limited to vendors with 2011 Edition certified products that were the primary components of actual meaningfully used certified EHR technology (CEHRT).

Alarmingly, only about half of the vendors whose 2011 Edition certified products were the primary component of diagnostic radiologists’ certified EHR technology (CEHRT) in previous years of MU now offer 2014 Edition certified products. Of the vendors who do, only slightly more than half now offer products certified for all criteria in the Base EHR definition.

The point is that everyone participating in MU must use 2014 Edition certified products next year. Moreover, everyone must have the Base EHR definition covered, plus any additional criteria that correspond with CMS MU measures they need to meet, in order to have a product combination that meets the regulatory definition of “CEHRT” in 2014 and beyond.  Therefore, previous MU participants should be fully cognizant of their vendors’ certification plans; EPs should not just assume they will be taken care of by their existing vendor.

Categories: EHR, meaningful use, Medicare