HHS Releases Final Rule on “Meaningful Use” of Electronic Health Records

Update: On December 29, 2010, HHS published in the Federal Register a “Correcting Amendment” to its Final Rule on Meaningful Use, which can be viewed here.

HHS Secretary Kathleen Sebelius wasted no time in putting the brand new CMS Director to work on July 13, 2010, in announcing the release of two rules under the Health Information Technology for Clinical and Economic Health Act (HITECH), including the Final Rule on Meaningful Use and the Final Rule on Initial Set of EHR Standards and Certification Criteria. Donald M. Berwick, MD, MPP, FRCP, was sworn in as Director of the Centers for Medicare and Medicaid Services on Monday afternoon, July 12, 2010, and by the next morning was primed to discuss the important role of health information technology (HIT) in America. In addition to Dr. Berwick’s participation at the press briefing, other participants included David Blumenthal, MD, the Chief Coordinator for the HHS Office of National Coordinator of HIT (ONC), Regina Benjamin, MD, U.S. Surgeon General, and Regina Holiday, an individual who shared a personal experience involving access to health information and how such access impacts the care of patients. 

Quick Reference: The CMS Fact Sheet on both Final Rules is available here. 

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Learn about regulatory requirements to qualify for HITECH incentives

On Thursday, July 29, 2010, physicians, physician practice managers, and others interested in learning more about the regulations governing incentives under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) are invited to a free education session (by Kathie McDonald-McClure) and networking event hosted by MedX12.

Date: July 29, 2010.  Time: 6:00 pm (EST).

Place: Suburban Plaza 3, 4121 Dutchman’s Lane, Louisville, KY.

Call for a reservation due to limited seating:  502-339-7175 ext 225

For more information, click here: MedX12 EHR Brochure.

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ONC Releases Final Rule on EHR Temporary Certification Program

From the Office of National Coordinator of Health Information Technology (ONC HIT):

“On June 18, the Office of the National Coordinator for Health Information Technology issued its temporary certification program final rule, which establishes a way for organizations to become authorized by the National Coordinator to test and certify electronic health record technology.”

To read more information and to read the rule, click here.

DEA’s Interim Final Rule Allows Electronic Prescriptions for Controlled Substances

Update 9/24/2020:  In the 10 years since we wrote this article, the DEA received questions and requests for clarification on various issues concerning the implementation and technical requirements for e-prescribing controlled substances.  To provide further clarification, this year, the DEA reopened the EPCS Interim Final Rule for additional comments.  The DEA also noted that it anticipated issuing a final rule on the topic of EPCS. The additional comments period closed on June 22, 2020.

On March 31, 2010, the Drug Enforcement Agency (DEA) published its Interim Final Rule (IFR) addressing electronic prescriptions (e-prescribing) for controlled substances, 75 Federal Register 16236 (effective June 1, 2010). Prior to this, the DEA had been concerned that the lack of security controls for e-prescribing of controlled substances would lead to higher levels of illegal use. That concern, along with the rigid requirements of the Controlled Substances Act of 1970 (CSA), had been a barrier for DEA in moving forward with its e-prescribing rule, which was originally proposed in June 2008. The DEA’s IFR cites the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act of 2009 (ARRA), and HITECH’s encouragement of e-prescribing, as one impetus for propelling this issue forward. DEA also indicated that the lack of a mature standard that allows for electronic interoperability (i.e. formatting of prescription data) among e-prescribing applications (e.g., from physician to pharmacy) was another reason to forge ahead and fill the gap.

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ONC Issues Proposed Rule for Two EHR Certification Programs

On March 2, 2010, the Office of National Coordinator (ONC) issued its proposed rulemaking respecting the certification standards that an eligible health care provider’s electronic health record must satisfy in order to qualify for incentives under the Health Information Technology for Clinical and Economic Health Act (HITECH Act), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA). The ONC proposes establishing two certification programs:

1) A temporary certification program whereby the ONC would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments may begin demonstrating meaningful use of Certified EHR Technology; and

2) A permanent certification program that would replace the temporary certification program. The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the ONC related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the ONC to certify other types of health information technology besides Complete EHRs and EHR Modules.

The comment period for the proposed rule will be established once it is published in the Federal Register. In the meantime, you can read the proposed rule on the ONC’s webpage.